-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DE47BMki/a2KAexm7j2tbN2ximwlp520IkU4JXiSfVz9a8H1j+e9PgbqhssCvUFI N/MNKJIZF2Qgss5/H8b3zA== 0000950123-10-000500.txt : 20100329 0000950123-10-000500.hdr.sgml : 20100329 20100105211016 ACCESSION NUMBER: 0000950123-10-000500 CONFORMED SUBMISSION TYPE: 10-12B/A PUBLIC DOCUMENT COUNT: 30 FILED AS OF DATE: 20100106 DATE AS OF CHANGE: 20100211 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Unilife Corp CENTRAL INDEX KEY: 0001476170 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 271049354 STATE OF INCORPORATION: DE FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 10-12B/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-34540 FILM NUMBER: 10509657 BUSINESS ADDRESS: STREET 1: 633 LOWTHER ROAD CITY: LEWISBERRY STATE: PA ZIP: 17339 BUSINESS PHONE: (717)938-9323 MAIL ADDRESS: STREET 1: 633 LOWTHER ROAD CITY: LEWISBERRY STATE: PA ZIP: 17339 10-12B/A 1 c93531e10v12bza.htm FORM 10-12B/A Form 10-12B/A
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Amendment No. 1
to
FORM 10
GENERAL FORM FOR REGISTRATION OF SECURITIES
Pursuant to Section 12(b) or 12(g) of the Securities Exchange Act of 1934
UNILIFE CORPORATION
(Exact name of registrant as specified in its charter)
     
Delaware   27-1049354
     
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)
     
633 Lowther Road, Lewisberry, Pennsylvania   17339
     
(Address of principal executive offices)   (Zip Code)
Registrant’s telephone number, including area code (717) 938-9323
Securities to be registered pursuant to Section 12(b) of the Act:
     
Title of each class
to be so registered
  Name of each exchange on which
each class is to be registered
     
Common Stock, par value $0.01 per share   The NASDAQ Stock Market, LLC
     
Securities to be registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
             
Large accelerated filer o   Accelerated filer o   Non-accelerated filer þ
(Do not check if a smaller reporting company)
  Smaller reporting company o
 
 

 

 


 

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 Exhibit 2.1
 Exhibit 2.2
 Exhibit 10.3
 Exhibit 10.5
 Exhibit 10.20
 Exhibit 10.21
 Exhibit 10.22
 Exhibit 10.23
 Exhibit 10.24
 Exhibit 10.25
 Exhibit 10.26
 Exhibit 10.27
 Exhibit 10.28
 Exhibit 10.29
 Exhibit 21

 

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Presentation of Information
Unilife Corporation was incorporated in the State of Delaware on July 2, 2009. As of the date of the filing of this registration statement, Unilife Corporation is a wholly-owned subsidiary of Unilife Medical Solutions Limited, or UMSL, an Australian corporation. UMSL is in the process of redomiciling in the State of Delaware. After completion of the redomiciliation transaction described herein, but before this registration statement becomes effective, Unilife Corporation will become the parent company of UMSL and its subsidiaries.
Except as otherwise indicated or unless the context requires otherwise, the information included in this registration statement, including the consolidated financial statements of Unilife Corporation, assumes the completion of the redomiciliation transaction. Unless the context requires otherwise, references in this registration statement to “Unilife,” the “Company,” “we,” “us” and “our” refer to Unilife Corporation, a Delaware corporation, and its consolidated subsidiaries, including UMSL.
Trademarks, Trade Names and Service Marks
UNITRACT® is a registered trademark of the Company in the United States and Australia, with trademark registrations filed or in process in other jurisdictions. Unitract™ Safe Syringe is a registered trademark in Australia. We have commenced applications to register trademarks for our company name Unilife and our ready-to-fill syringe brand name, Unifill. UNITRACT®, UNILIFE™ and UNIFILL™ are all trademarks held by UMSL’s wholly-owned subsidiary, Unitract Syringe Pty, Ltd., an Australian corporation. Each trademark, trade name or service mark of any other company appearing in this registration statement is, to our knowledge, owned by such other company.
Cautionary Note Regarding Forward-Looking Information
This registration statement contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. The forward-looking statements are contained principally in the sections entitled “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements.
These forward-looking statements are based on management’s beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in “Item 1A. Risk Factors” and elsewhere in this registration statement and those described from time to time in our future reports which we will file with the Securities and Exchange Commission. You should read this registration statement and the documents that we have filed as exhibits to this registration statement completely.
Currencies
Unless indicated otherwise in this registration statement, all references to $ or dollars refer to US dollars. References to A$ mean the lawful currency of the Commonwealth of Australia. References to or Euros are to the lawful currency of the European Union.

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Item 1.   Business
Overview
We are a U.S. based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for our products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities, and patients who self-administer prescription medication. All of our syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and injury from other unsafe injection practices. Our main product is the Unifill ready-to-fill syringe, which is designed to be supplied to pharmaceutical manufacturers in a form that is ready for filling with their injectable drugs and vaccines. We have a strategic partnership with sanofi-aventis, a large global pharmaceutical company, pursuant to which it has paid us a 10 million exclusivity fee and has committed to pay us up to an additional 17 million to fund our industrialization program for the Unifill syringe. Upon the scheduled completion of the industrialization program in late 2010, we expect to commence the supply and sale of the Unifill syringe to sanofi-aventis. We are also in discussions with other pharmaceutical companies that are seeking to obtain access to the Unifill syringe. In addition, we have recently begun to manufacture our Unitract 1mL insulin syringes at our FDA-registered manufacturing facility in Lewisberry, Pennsylvania.
In the United States and a number of other sophisticated healthcare markets, hospitals and other healthcare facilities, as well as pharmaceutical manufacturers who supply injectable drugs and vaccines in a prefilled syringe format, are increasingly required to comply with legislation aimed at protecting healthcare workers from the risk of acquiring blood-borne diseases such as HIV and hepatitis C via needlestick injuries. Our core portfolio of safety syringe products, including the Unifill syringe and the Unitract 1mL syringes, are designed for supply to pharmaceutical manufacturers and healthcare facilities which are seeking to comply with these needlestick prevention laws. We expect our products will also be used by patients who self-administer prescription medication outside of the healthcare setting. The safety features incorporated into our products include an automatic needle retraction mechanism which allows operators to control the rate of needle withdrawal directly from the body into the barrel of the syringe, as well as an independent auto-disable mechanism to prevent product tampering or re-use. The integration of these safety features within the barrel is designed to make them intuitive to use and compact in size for convenient handling and disposal.
The Unifill syringe is targeted for use by pharmaceutical manufacturers who utilize pre-filled (ready-to-fill) syringes as a preferred drug delivery device for injectable drugs and vaccines. We are aware of more than 50 drug products used within healthcare facilities, or by patients who self-administer prescription medication, that are currently available in a prefilled syringe format. We have designed the Unifill syringe so that it is compatible with the drug validation and manufacturing systems currently used by target pharmaceutical customers to fill and package standard prefilled syringes. To our knowledge, our Unifill product is the only known prefilled syringe with automatic safety features which are integrated inside the glass barrel.
We have signed an exclusive licensing agreement and an industrialization agreement with sanofi-aventis, who we believe to be the single largest global purchaser of pre-filled syringes. Under the exclusive licensing agreement, sanofi-aventis paid us a 10 million upfront one-time fee, and we granted sanofi-aventis a license to certain of our intellectual property in order and solely to develop, in collaboration with us, the Unifill syringe. Pursuant to the exclusive licensing agreement, we are negotiating a list of therapeutic drugs classes with respect to which sanofi-aventis would have the exclusive right to the product for a specified term, during which sanofi-aventis would purchase the product exclusively from us. We have retained the right to negotiate other business arrangements with additional pharmaceutical companies seeking to market the product for use within therapeutic drug classes outside of those exclusive to sanofi-aventis, or after the expiration of the exclusive license with sanofi-aventis.
Under the industrialization agreement, sanofi-aventis has agreed to provide us with up to 17 million in payments based upon milestones to be achieved under the industrialization program for the Unifill syringe. We expect to complete this program in late 2010. We have received payments of 11.5 million under the industrialization agreement from October 2008 through December 2009. We describe our arrangements with sanofi-aventis in more detail under “Strategic Partnership with sanofi-aventis.” We are also aware of more than 20 other pharmaceutical companies that supply injectable drugs in a prefilled syringe format, and we have received interest in the Unifill syringe from a number of these companies.
Our Unitract 1mL syringes are designed primarily for use in healthcare facilities and by patients who self-administer prescription medication such as insulin. We have recently begun U.S. production of this syringe, which we expect to release commercially in early 2010. We have received regulatory clearance for the marketing and sale of the Unitract 1mL syringe in the United States, the European Union, Canada and Australia. We have also filed patents for other clinical and prefilled safety syringe products that may incorporate certain aspects of our core technology for future commercialization. Our in-house team has fully designed, developed, built and validated, to the requirements of the U.S. Food and Drug Administration (FDA) and ISO 13485, the automated assembly system that we use to support production of our Unilife 1mL syringe at our FDA-registered manufacturing facility in Lewisberry, Pennsylvania. We consider our ability to design and develop highly sophisticated, innovative medical devices, and the automated assembly systems we use to manufacture them, to be a core business competency.
We also manufacture non-proprietary medical devices under contract for B. Braun Medical, Inc., a multinational healthcare equipment company. This contract manufacturing business was historically operated by Integrated BioSciences, Inc. which we acquired in January 2007. We are currently concentrating substantially all of our commercial and operational efforts towards the commercialization of our proprietary medical devices, namely the Unifill syringe and the Unitract 1mL syringe, and do not expect the contract manufacturing business to represent a significant portion of our business going forward.

 

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Market Opportunity
The Syringe Market and the Increasing Use of Pre-Filled Syringes
According to the International Association of Safe Injection Technology, approximately 35 billion syringes are manufactured every year, half of which are used within sophisticated healthcare markets such as North America, Europe, Japan and Australia. The majority of therapeutic injections occur within healthcare facilities such as acute-care hospitals and long-term care centers. Other sectors of the global syringe market include patients who self-administer prescription medication such as insulin, government agencies which sponsor harm reduction programs, and non-government organizations which conduct vaccination programs.
Injectable drugs and vaccines have traditionally been supplied in a vial or ampoule, with the operator required to draw up a measured dose of medication into a conventional plastic syringe immediately prior to an injection. Prefilled syringes typically utilize a glass barrel and are filled by pharmaceutical manufacturers so that they are ready for use prior to shipment. While conventional syringes make up the vast majority of syringes used, prefilled syringes are becoming an increasingly popular method of drug delivery.
We are aware of more than 50 drugs and vaccines that are currently available in a prefilled syringe format from more than 20 pharmaceutical companies, and believe that a number of pipeline drugs are likely to be supplied in this format in the future. Greystone Associates, a medical and health care technology consulting firm, has estimated that approximately 2.23 billion prefilled syringes will be used globally in 2009, and that this number will increase significantly in the coming years. Drugs that are currently supplied in a prefilled syringe format include anti-coagulants to prevent and treat thrombosis, anti-inflammatories to treat rheumatoid arthritis, anti-infectives to treat hepatitis B and C, hematological drugs to stimulate production of red or white blood cells to treat anemia or fight infection, and vaccines which seek to prevent a range of diseases. We expect that prefilled syringes will also be increasingly used in the coming years as a drug delivery device for other therapeutic drug classes including obstetrics, oncology, osteoporosis and human growth hormone treatment.
Prefilled syringes have a number of advantages over conventional plastic syringes. First, prefilled syringes help pharmaceutical companies improve manufacturing efficiencies through the elimination of drug wastage commonly associated with the overfilling of multi-use vials. Second, healthcare workers often prefer prefilled syringes because they can facilitate a relatively fast, accurate and convenient administration of a drug. Furthermore, a pre-measured dose of an injectable drug in a prefilled syringe can help reduce the risk of dosing errors. Finally, the relative ease-of-use by patients of prefilled syringes also makes them suitable for the self-administration of many types of prescription medication.
Increased Focus on Prevention of Needlestick Injuries
The World Health Organization estimates that 1.3 million people die each year as a result of needlestick injuries, syringe re-use, and other unsafe injection practices. Needlestick injuries and syringe sharing can result in the transmission of a number of blood-borne diseases such as HIV/AIDS and hepatitis C. The U.S. Centers for Disease Control and Prevention estimates that 385,000 needlestick and other sharps-related injuries are sustained by U.S. hospital-based healthcare personnel each year. The U.S. Occupational Safety and Health Administration, or OSHA, estimates that when other secondary healthcare settings are also taken into account, there are as many as 800,000 needlestick injuries to U.S. healthcare workers each year. To help minimize the transmission of blood-borne pathogens caused by unsafe injection practices, many international healthcare and pharmaceutical markets are transitioning to the mandatory use of safety syringes.
In sophisticated healthcare markets, governments are focused on the mandatory use of safety devices within healthcare facilities to protect healthcare workers from the risk of acquiring blood-borne pathogens such as HIV-AIDS and hepatitis C via needlestick injuries. The United States was the first nation to mandate the use of safety syringes within healthcare facilities, with the adoption of the Federal Needlestick Prevention Act in 2000, or FNSPA, and the subsequent revision to the Bloodborne Pathogens Standard (BPS). According to the International Healthcare Worker Safety Center at the University of Virginia Health System, approximately one in five healthcare facilities that were inspected by OSHA between 2002 and 2007 have been issued with citations for non-compliance with the BPS.
The European Union is also considering the introduction of legislation requiring member countries to use needlestick prevention products within healthcare facilities, while other countries such as Canada and Australia have also taken steps to encourage the use of safety syringes. As a result of this existing and proposed legislation, safety syringes are now commonly used within the healthcare facilities in a number of countries.

 

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The United States represents the largest and most mature market for safety syringes, with a substantial majority of hypodermic syringes and needles used within acute-care facilities featuring some type of needlestick prevention device. Notwithstanding the increased use of safety syringes, we believe that current safety syringe technologies are in several respects inadequate to fully protect healthcare workers from infection risk caused by needlestick injuries or other potential transmission modes. First, most products currently available require operators to manually slide an external plastic guard or sheath over the needle after use, or retract the needle into the barrel at a rapid, uncontrolled rate. Second, healthcare workers may choose to remove or not activate the safety feature of some types of safety syringe products. Moreover, activation of the needle retraction mechanism in the open air for some retractable syringes, rather than inside the body of the patient, may create the potential risk of infection via needlestick injuries or aerosol (splatter).
OSHA differentiates safety features in two primary ways. First, it differentiates passive safety features which “remain in effect before, during and after use” from active devices which “require the worker to activate the safety mechanism.” Second, OSHA regulations state that products with an “integrated safety design that is an integral part of the device and cannot be removed” are usually preferred to those with an accessory safety device with safety features that are “external” and “dependent on employee compliance.” We believe the majority of safety syringe products used in U.S. healthcare facilities incorporate active safety features which are not fully integrated within the barrel of the syringe.
We are not aware of any prefilled syringe with passive safety features that are integrated within the glass barrel. To improve compliance with legislation such as the FNSPA, a number of pharmaceutical companies attach ancillary safety products onto standard prefilled syringes following dose filling and prior to packaging. We estimate that approximately half of the drugs currently available in prefilled syringe format are supplied by the pharmaceutical manufacturer with an ancillary safety device. The majority of these ancillary safety products slide an external plastic sheath or guard over the needle once the injection has been completed.
It is costly for pharmaceutical companies to purchase these ancillary safety products and the automated assembly systems required to attach them onto a standard prefilled syringe. The relatively large size of prefilled syringes supplied with an ancillary safety device can also significantly increase the shipment and packaging costs of pharmaceutical companies. Furthermore, some of these prefilled syringes supplied with an ancillary safety device require the removal of the safety device from the syringe prior to use, creating the risk of infection via needlestick injury or aerosol (splatter). Thus, we believe that there is a significant market opportunity for a prefilled syringe with passive and integrated safety features that is compatible with pharmaceutical companies’ drug filling systems.
We also believe there are significant market opportunities for the use of conventional and prefilled safety syringes outside of mainstream healthcare facilities. In addition to insulin, a range of other injectable drugs designed for the prevention and/or treatment of chronic or debilitating conditions such as arthritis, multiple sclerosis and osteoporosis and thrombosis are now available for self-administration. We believe the popularity of safety syringes among patients who self-administer prescription medication may increase due to their capacity to prevent needlestick injuries to family members and encourage safe, convenient disposal. When purchased with a prescription, a number of insurance providers in the U.S. now cover safety insulin syringes under the same tier level for reimbursement as standard insulin syringes.
We believe that another market which may in the future transition towards the mandatory use of non-reusable safety syringes is the harm reduction market, where governments provide free or subsidized syringes to injecting drug users, or IDUs. The reuse and sharing of syringes by IDUs has been identified as a prime accelerant in the transmission of blood-borne diseases and is responsible for one-third of new HIV infections outside sub-Saharan Africa. The governments of more than 60 countries worldwide now sponsor harm reduction programs which seek to minimize unsafe injection practices by IDUs. While these programs have proven largely effective in preventing or containing HIV epidemics, the continued sharing of standard syringes among IDUs has contributed to the continuation of national epidemics of the relatively more infectious hepatitis C. Furthermore, the unsafe disposal of syringes in public areas creates public concern regarding the risk of needlestick injury. Recognizing the scale of HIV and hepatitis C epidemics, and the substantial economic costs associated with their long-term treatment, many governments are considering the use of single use, safety syringes as a way to enforce safe injection practices among IDUs.
Our Solution
Our clinical and prefilled safety syringes incorporate automatic, also known as passive, safety features which are fully integrated within the barrel. They are designed to assist pharmaceutical manufacturers and healthcare facilities comply with needlestick prevention laws and to encourage single use and safe disposal practices outside of healthcare settings. We consider the following combination of core proprietary features available in our safety products to be unique within the marketplace:
    Integrated design. All safety features are fully integrated inside the syringe barrel to facilitate compact handling, intuitive use and convenient disposal.

 

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    Passive retraction. The activation of the needle retraction mechanism occurs automatically while the needle is inside the body to help prevent the risk of needlestick injury.
    Controlled retraction. Operators can control the speed of needle retraction directly from the body into the syringe barrel to help reduce the risk of infection through transmission routes such as needlestick injuries and aerosol (splatter).
    Auto-disable. Upon withdrawal of the needle into the barrel, the plunger is automatically locked to prevent re-exposure or reuse.
We have utilized this core proprietary technology to design and develop a range of prefilled and clinical safety syringes. Furthermore, we are not aware of any other company that is manufacturing safety syringes with automatic, integrated safety features in both a prefilled (glass) and clinical (plastic) format which share the same common technology platform.
Key target markets for our products include pharmaceutical companies, healthcare facilities and patients who self-administer prescription medication. We believe that the majority of our products would be supplied, either directly or through pharmaceutical customers, for use within sophisticated healthcare markets such as North America, Western Europe and some Asia-Pacific countries that require or are transitioning toward the mandatory use of safety syringes.
Business Strategy
Our goal is to progressively move to the forefront of the international transition of healthcare and pharmaceutical markets to the mandatory use of prefilled and clinical safety syringes. We believe that the competitive strength of our proprietary technology puts us in a strong position to become an established and preferred supplier of “best-in-class” safety syringe products to pharmaceutical companies, healthcare facilities and patients who self-administer prescription medication.
Key elements of our business strategy are the development, production and sale of our patent-protected safety syringes, the continued expansion of our global operational and commercial presence and the establishment of long-term supply relationships with multinational pharmaceutical and healthcare equipment companies. We are committed to designing, developing and supplying innovative medical devices that can enhance and save lives. We plan to:
    Continue to build a strong relationship with sanofi-aventis: We believe sanofi-aventis is currently the world’s largest consumer of prefilled syringes. We have had a business relationship with sanofi-aventis since 2003, and under our industrialization agreement with sanofi-aventis, they are funding our industrialization program for the Unifill syringe. Upon completion of the industrialization program, we expect to begin supplying the product to sanofi-aventis for use within defined therapeutic drug classes.
    Enter into business relationships with additional pharmaceutical companies: We have retained the right to negotiate licensing and other business arrangements relating to the Unifill syringe with other pharmaceutical companies for use within those therapeutic drug classes outside of those held by sanofi-aventis during its period of exclusivity. It is our intention to secure agreements with other additional pharmaceutical companies who are industry leaders within their respective therapeutic areas of expertise. By pursuing this strategy, we believe our products can be marketed within a significant number of large therapeutic drug classes where prefilled syringes are commonly used.
    Expand our proprietary product portfolio: We will seek to enhance our competitive position in the design, development and supply of innovative safety medical devices for use within international pharmaceutical and healthcare markets. In addition to the production and supply of the Unifill syringe and the Unitract 1mL syringes, we intend to commercialize a number of additional proprietary products which we believe can also meet the functionality and safety requirements of target customers. This may include the commercialization of our range of Unitract Clinical Syringes in a 3mL and 5mL size targeted for use within acute care hospitals and other healthcare facilities. We may also commercialize additional ready-to-fill syringe products currently in our development pipeline which, like the Unifill syringe, would be designed for supply to pharmaceutical manufacturers. While our focus will remain on the pursuit of organic growth opportunities, we may evaluate opportunities to acquire other complementary technologies or products on a case-by-case basis.
    Expand our operational capabilities within Central Pennsylvania: The United States represents the world’s largest and most mature market for the supply and use of our products and services. We will continue to consolidate the majority of our commercial and operational activities within Central Pennsylvania, a national logistics hub situated between several major pharmaceutical and medical device industry clusters. We intend to make a significant investment in the expansion of our operational capabilities within Pennsylvania to support the commercialization of our core products, such as the Unifill syringe.

 

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    Manufacture and supply our Unitract 1mL Syringes to target international markets: We commenced production of the Unitract range of 1mL safety syringes at our facility in Pennsylvania in August 2009. We expect to release this product commercially in early 2010. Product variants within this range have been certified for marketing and sale within key international territories including the United States, Canada, Europe and Australia. We intend to continue to expand our customer base of pharmaceutical companies and healthcare distributors for the marketing and sale of the Unitract 1mL syringes.
Our Products
Unifill syringe
Our Unifill ready-to-fill syringe is, to our knowledge, the only prefilled syringe with passive (automatic) and fully integrated safety features. Manufacturing features include a staked needle with a glass barrel that requires shaping at only one end to allow sourcing from a multitude of glass cartridge suppliers, and the development of components in the fluid path that use the same materials as standard prefilled syringes to facilitate drug compatibility. The product is designed to be a safe, compact and intuitive primary drug container suitable for use within healthcare facilities and by patients who self-administer prescription medication.
The Unifill syringe is designed to fit the manufacturing systems currently used by pharmaceutical customers to load and package a measured dose of an injectable drug into a standard prefilled syringe. We believe the use of the Unifill syringe by a pharmaceutical customer can eliminate its need to purchase and attach ancillary safety products onto standard prefilled syringes to comply with needlestick prevention legislation. In addition to reducing production costs associated with the purchase and attachment of these ancillary devices, we believe our product can also significantly reduce comparable shipping and storage costs. The compact size, intuitive use, functionality and automatic safety features of the Unifill syringe may also help pharmaceutical companies extend product lifecycles, increase levels of market differentiation in competitive therapeutic areas, and expand the marketability of some drugs for convenient self-administration by patients outside of the healthcare setting.
We commenced initial pilot production of the Unifill syringe at our Lewisberry, Pennsylvania facility in 2008. We intend to file a Type III Drug Master File for the product with relevant regulatory authorities such as the FDA, although it is the ultimate responsibility of the pharmaceutical customer to obtain final approval of the combination drug-delivery device. We expect that the commencement of product sales will coincide with the completion of the industrialization program with sanofi-aventis.
Unitract 1mL syringes
The Unitract 1mL range of safety syringes is primarily designed for the subcutaneous injection of drugs within healthcare facilities and by patients who self-administer prescription medication such as insulin. In addition to insulin and tuberculin variants, the Unitract 1mL range also includes the Unitract safe syringe which is custom-designed for use by governments that utilize harm reduction (needle exchange) programs to prevent the reuse, sharing and unsafe disposal practices of IDUs. Unlike the Unifill ready-to-fill syringe, the Unitract 1mL syringes require healthcare workers or patients to draw up the dose from a vial or ampoule immediately prior to the injection.
We have received regulatory certification for the marketing and sale of various Unitract 1mL syringe products in the United States, Australia and Canada and have received CE Mark approval in the European Union. We commenced initial production of Unitract 1mL syringes in China during 2008 to support regulatory approval and marketing activities. In August 2009, we commenced production of the Unitract 1mL syringes at our Pennsylvania facility utilizing an automated assembly system that we designed and built in-house. We expect to commence commercial sales of U.S.-manufactured stock after the completion of required stability (aging) testing towards the end of 2009.

 

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Pipeline Products
We also hold additional syringe-related intellectual property for products which we intend to commercialize in the future. These pipeline products include a range of plastic clinical syringes to be developed in a range of larger sizes such as 3mL and 5mL. We believe that commercialization of this pipeline range of larger clinical syringes would further improve our opportunities to market and sell our products within healthcare facilities such as acute-care hospitals. We have also designed and filed patents for a number of other safety syringe products that utilize our proprietary technology. We intend to continue to expand our competitive position within target pharmaceutical and healthcare markets through the commercialization of a number of these other pipeline products.
Strategic Partnership with sanofi-aventis
We started to collaborate with sanofi-aventis in 2003 for the development of the Unifill syringe as a next-generation drug delivery safety device. Sanofi-aventis is a large, global pharmaceutical company, whose products span multiple therapeutic areas, including cardiovascular diseases, thrombosis, oncology, metabolic diseases, internal medicine and vaccines. We believe that sanofi-aventis is currently the world’s largest purchaser of prefilled syringes.
We have signed an exclusive licensing agreement with sanofi-aventis. Under the exclusive licensing agreement, we have granted sanofi-aventis an exclusive license to certain of our intellectual property in order and solely to develop, in collaboration with us, the Unifill syringe for use in and sale to the prefilled syringe market within those therapeutic areas to be agreed upon between us, and a non-exclusive license outside those therapeutic areas that are exclusive to sanofi-aventis or after the expiration of the exclusive license with sanofi-aventis. Pursuant to the exclusive licensing agreement, sanofi-aventis has paid to us a 10 million upfront one-time fee. The exclusive license granted thereunder has an initial term expiring on June 30, 2014, unless we and sanofi-aventis fail to agree upon the list of therapeutic areas that are exclusive to sanofi-aventis, in which event the exclusive license will have a term until June 29, 2012 for all therapeutic areas. If, during the term of the exclusive license, sanofi-aventis has purchased the Unifill syringe for use with a particular drug product, sanofi-aventis will receive a ten-year extension of the term of the exclusive license, which extension will be reduced to five years if sanofi-aventis does not sell a minimum of 20 million units of the product in any of the first five years of such ten-year extension period.
Under the exclusive licensing agreement, we are not precluded from using certain of our intellectual property to develop, license and sell any products in any market other than the ready-to-fill syringe market, or from entering into licensing or other business arrangements with other pharmaceutical companies for the ready-to-fill syringe market outside those therapeutic areas that are exclusive to sanofi-aventis, or after the expiration of the exclusive license with sanofi-aventis. If we grant a license to a third party in respect of the ready-to-fill syringe market, then we are required to pay sanofi-aventis 70% of any access, license or other upfront fee received from such third party for access to purchase the products until our payments to sanofi-aventis have totaled 10 million, following which we are required to pay 30% of such fees we receive through the end of the initial exclusivity period. We are also required to pay sanofi-aventis an annual royalty payment of 5% of the revenue generated from any sale of the Unifill syringe to third parties, up to a maximum amount of 17 million in such royalty payments.
On June 30, 2009, we signed an industrialization agreement with sanofi-aventis. The industrialization agreement sets forth the terms for the collaboration between the parties to design, develop, scale up and industrialize the Unifill syringe, including the timetable and milestones for the industrialization program. Under the industrialization agreement, sanofi-aventis has agreed to provide up to 17 million in payments to us based on milestones we achieve in our industrialization program. The industrialization program began in July 2008 and is scheduled to be completed by the end of 2010. From October 2008 through December 2009, we have received payments of 11.5 million under the industrialization agreement. Key hurdles which remain until we complete the industrialization program include the development of a pilot automated assembly system, the completion of a new manufacturing facility and the establishment of a designated cleanroom for the installation of the automated assembly system. The industrialization agreement required sanofi-aventis to provide a list to us that specifies therapeutic drug classes for which it seeks to market the Unifill syringe on an exclusive basis. We and sanofi-aventis are discussing the exclusivity list sanofi-aventis provided us and if the list is agreed, sanofi-aventis will retain exclusive rights to the use of the product within these designated therapeutic drug classes until June 30, 2014, subject to the extension described above. If we are unable to reach an agreement on the list, then sanofi-aventis will retain full exclusivity across all therapeutic classes only until June 29, 2012. Unless terminated earlier, the industrialization agreement has a term until the completion of the industrialization program.
The industrialization agreement provides that, subject to the full completion of the industrialization program, the parties will negotiate a supply agreement for the manufacture and purchase of the final product on a commercial scale. The supply agreement will provide that sanofi-aventis and its affiliates will purchase the final product exclusively from us, and the industrialization agreement provides that we are not required to commit more than 30% of our expected installed production capacity to sanofi-aventis and its affiliates for the 12 months following the receipt of a purchase order. Any order of sanofi-aventis, together with its other orders, that will exceed the 30% capacity limit will require up to a maximum of 24 months lead time before we are required to commence delivery of that order.

 

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Pursuant to the industrialization agreement, if UMSL agrees to, or proposes to agree to, a change of control with a third party, UMSL must give a written notice to sanofi-aventis, who will be entitled, within five business days, to make an offer on at least equivalent terms. In the absence of an improved change of control proposal, UMSL must accept the matching offer of sanofi-aventis. If UMSL receives an improved change of control offer from the third party, then UMSL must give a further notice to sanofi-aventis for it to make a further matching offer. In addition, if during the term of the industrialization agreement, a change of control that does not involve sanofi-aventis, or its affiliates, obtaining control of UMSL (i) is not recommended by UMSL’s board of directors, (ii) will cause harm to sanofi-aventis, as defined in the agreement or (iii) under which Mr. Alan Shortall, our CEO and director, is not to continue in such capacities for at least two years after the change of control, then sanofi-aventis will have the right to terminate the industrialization agreement within ten business days after receiving a notice from UMSL, or after it otherwise becomes aware of the change of control. Pursuant to the industrialization agreement, a change of control means, in general terms, a change in the ownership of 50% or more of UMSL’s shares or the power to determine the majority composition of UMSL’s board of directors or any other event that UMSL’s board determines to be a change of control event.
Manufacturing
We have an FDA-registered, 50,000 square foot medical device production facility in Lewisberry, Pennsylvania. This facility has two class-eight clean rooms. The first clean room houses a fully automated assembly system used to manufacture our Unitract 1mL syringes. This automated assembly system, which has an optimum capacity of up to 40 million units per year, was fully designed, developed, built and qualified by our in-house team. The other clean room is used to assemble non-proprietary medical devices under contract with B. Braun. Other areas of our Lewisberry facility are used for offices, product design and prototyping, engineering activities and the construction of automated assembly systems. Prior to the commencement of commercial production of the Unitract 1mL syringe at our Lewisberry facility, we utilized a medical device company in China to manufacture sufficient volumes of these products to obtain regulatory approvals and undertake preliminary marketing activities. We intend to focus upon the domestic manufacture of our Unitract 1mL syringe at our Lewisberry facility in the forseeable future.
To support our manufacturing plan for the high-volume production of the Unifill syringe, we are outsourcing the development and manufacture of automated assembly systems for this product to Mikron Assembly Technology, an established industry specialist. On November 12, 2009, we signed a purchase agreement with Mikron for the development and supply of a pilot automated assembly system to support the commercial production of our Unilfill syringe. The development of the automated assembly system began in December 2009, with completion and installation into our new facility scheduled for the fourth quarter of 2010. We anticipate that this automated assembly system will have a target production capacity of approximately 60 million units per year. Additional assembly lines, which we expect to commission and operate beyond 2010, are targeted to have a significantly higher annual manufacturing capacity. To support our business expansion activities, we are in the process of developing a new manufacturing facility close to our Lewisberry facility within York County, Pennsylvania. We expect to transition at least some of our manufacturing activities into the new manufacturing facility during 2010. For more details regarding the development of the new manufacturing facility, please see “Item 3. Properties”.
We source our components and raw materials under written contracts with a variety of suppliers, all of which specialize in the medical device and pharmaceutical sectors. We have also entered into a number of relationships with other companies for the initial supply of components, raw materials and related services for the Unifill syringe. Due to an initial requirement for only limited production volumes of components which comprise the Unifill syringe, we currently receive a majority, or in some cases all, our components such as rubber seals and glass barrels from a single source supplier. To support the industrialization program for this product and further strengthen our supply chain in the long-term, we intend to establish, wherever feasible, a dual-source strategy for the production of key components, raw materials and related services. The companies we expect to appoint for the production and supply of items and related services pertaining to the Unifill syringe all have an established presence in the international drug delivery market, with the majority having facilities in both North America and Europe.
Sales and Marketing
We expect that our primary customers will be pharmaceutical companies which utilize prefilled syringes as a primary container device for the administration of therapeutic drugs and vaccines. We intend to enter into supply agreements for the Unifill syringe with sanofi-aventis and some other pharmaceutical customers. The majority of these target pharmaceutical customers are multinational companies with headquarters located in either the United States or Europe.
We expect the pharmaceutical customer to be primarily responsible for the sale, marketing and clinical use of the combination drug-delivery device to target government agencies, healthcare facilities or patients who self-administer prescription medication within indicated therapeutic drug classes. We expect to support pharmaceutical customers in the development of documentation or marketing material pertaining to the recommended clinical use of the device with the contained drug or vaccine. We may also enter into agreements for the supply of the Unitract 1mL syringes directly to pharmaceutical companies for use with injectable drug products which are supplied in a vial and marketed in a kit format.

 

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We also intend to distribute our Unitract 1mL syringes within the United States via distributors which specialize in target markets such as long-term and acute care healthcare facilities or the direct mail order of prescription medication and medical equipment to patients for self-administration. We will also examine opportunities to enter into relationships for our Unitract 1mL syringes with group purchasing organizations, or GPOs, which secure competitive pricing for commodity items such as syringes on behalf of members such as acute-care hospitals. Over the past decade, many GPOs have introduced programs that encourage the expedient evaluation and selection of innovative products developed by smaller companies. However, we do not expect to fully penetrate the acute-care hospital market until we have a complete range of clinical syringe sizes.
Outside of the United States, we have a distributor to sell our Unitract 1mL syringes in Canada and expect to appoint other distributors within other international healthcare markets such as Western Europe and the Asia-Pacific region. Furthermore, we intend to review opportunities to collaborate with governments seeking to examine the use of our Unitract 1mL syringes as a means of helping to prevent the re-use, sharing and unsafe disposal of non-sterile syringes by injecting drug users.
We have a small internal team to support the training of appointed distributors in the marketing and clinical use of our Unitract 1mL syringes. We intend to expand this team as we commence sales of our Unitract 1mL syringes, appoint additional distributors and commercialize our larger-sized clinical syringes.
Intellectual Property
We have established an intellectual property portfolio through which we seek to protect our products and technology. Our intellectual property portfolio includes 24 issued patents in 13 countries, with two issued patents each in Australia and the United States. We have filed a significant number of patent applications that are now pending in Australia, the United States, Europe, China, India and other countries covered under the Patent Cooperation Treaty. We also hold provisional patent applications in both the United States and Australia and several registered trademarks. Our patents expire at various dates between 2018 and 2028. Trade secrets law in the United States and other jurisdictions provides additional protection. We also enter into non-disclosure agreements with certain vendors and customers. All active United States based employees have signed confidentiality, non-compete and intellectual property assignment agreements.
We classify our patents and patent applications as they relate to particular product categories including 1mL insulin and safe syringes with an attached needle; clinical syringes which include larger sizes and interchangeable luer needles; and our Unifill syringe. Many of the features claimed in the insulin and safe syringes patents, such as the mechanism allowing automatic and controlled needle retraction within an integrated medical device, also apply to our other safety syringe products, including the Unifill syringe. Some key patents covering countries such as Australia, the United States and Europe, as well as some of our international patent applications, are described below:
INSULIN AND SAFE SYRINGE (UNITRACT)
                                 
Description   Issued Patent No.     Patent Application No.     Publication No.     Patent Expiry Date  
Australian Patent
    731159                     September 22, 2018  
US Patent
    6,083,199                     September 22, 2018  
International Patent Application
          PCT/AU01/000458     WO 01/80930     April 20, 2021  
Europe
            01925194.1       1 276 530 A     April 20, 2021  
USA
    7,500,967               20030158525     July 15, 2022  
International Patent Application
          PCT/AU2004/000354     WO 2004/082747          
Europe
            04721775.7       1 608 421A     March 19, 2024  
USA
            10/549,710       20060235354     March 19, 2024*  
CLINICAL SYRINGE
                                 
Description   Issued Patent No.     Patent Application No.     Publication No.     Patent Expiry Date  
International Patent Application
          PCT/AU2005/000107     WO 2005/072801          
Europe
            05700138.0       1 708 772     January 28, 2025  
USA
            10/587,705       20080255513     January 28, 2025*  
International Patent Application
          PCT/AU2006/000618     WO 2006/119570          
Europe
            06721494.0       1 879 635A     May 11, 2026  
USA
            11/914,092       20090221962     May 11, 2026*  

 

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READY TO FILL SYRINGE (UNIFILL)
                                 
Description   Issued Patent No.     Patent Application No.     Publication No.     Patent Expiry Date  
International Patent Application
          PCT/AU2006/000516     WO 2006/108243          
Europe
            06721397.5       1 868 669     April 18, 2026  
USA
            11/911,481       2009093759     April 18, 2026*  
International Patent Application
          PCT/AU2008/000971     WO 2009/003234 A1          
Europe
            08757038.8             July 2, 2028  
     
*   subject to possible patent term adjustment
An issued patent, unlike a pending patent application, has been reviewed by the relevant national patent office and has met the legal requirements for patentability required by the law of that country. An issued patent can therefore be enforced against infringers in the courts of the country where granted, although an issued patent does not guarantee that the company has freedom to operate and could still infringe upon the issued patent of another patent held by a third party.
In a number of key countries, we have registered trademarks including Unitract™ and have commenced applications to register trademarks for our company name, Unilife, as well as our ready-to-fill syringe brand name Unifill. Unitract™ is a registered trademark in the United States and is also filed under the Madrid Protocol Agreement for the international registration of marks in 25 countries, including France, Germany, Japan, China, Switzerland and the United Kingdom. Additionally, Unitract™ is a registered trademark in Australia, Mexico, New Zealand, Canada, India, Indonesia, South Africa, and Brazil. Unitract™ Safe Syringe is also a registered trademark in Australia.
Government Regulation
The development, manufacture, sale and distribution of medical devices are subject to comprehensive government regulation. Our medical devices and manufacturing operations are subject to regulation under the Federal Food, Drug and Cosmetic Act, or the FDC Act, as implemented and enforced by the FDA and various other federal and state agencies and are also subject to regulation by foreign governmental agencies. These laws and regulations govern the development, testing, manufacturing, labeling, advertising, marketing and distribution and market surveillance of medical devices.
FDA’s Premarket Clearance and Approval Requirements
Unless an exemption applies, each medical device we wish to distribute commercially in the United States will require either prior 510(k) clearance or premarket approval from the FDA. The FDA classifies medical devices intended for human use into three classes: Class I, Class II and Class III. Class I or Class II devices require the manufacturer to submit to the FDA a premarket notification requesting permission to commercially distribute the device. This process is generally known as 510(k) clearance. Class III devices require premarket approval. Our clinical range of syringes, including our Unitract 1mL syringe, are Class II devices. Our Unifill syringe does not require 510(k) clearance because it will be sold to drug manufacturers for use as drug packaging. None of our products require premarket approval.
There is a different regulatory process that will apply to our Unifill syringe because it will be used by drug manufacturers to provide drugs in a prefilled format. In the case of the Unifill syringe, it is the responsibility of the pharmaceutical customer who will use the Unifill syringe for its drug to obtain final product approvals, either by submitting a new drug application or abbreviated new drug application. In order to support the pharmaceutical customer’s application, we intend to create what is known as a drug master file. A drug master file is a submission to the FDA that may be used to provide information about facilities, processes or articles used in the manufacturing, packaging and storing of one or more human drugs. The drug master file will define the manufacturing and safety characteristics of the Unifill syringe while protecting proprietary information regarding its technical design.
510(k) Clearance Pathway
When obtaining a 510(k) clearance is required, we must submit a premarket notification demonstrating that our proposed device is substantially equivalent to another legally marketed product (i.e., that it has the same intended use and that it is as safe and effective as a legally marketed, or predicate, device and does not raise different questions of safety or effectiveness than does a predicate device). According to FDA regulations, the FDA is required to clear or deny a 510(k) premarket notification within 90 days of submission of the application, or 30 days in the case of an abbreviated 510(k) application that may be filed for product line extensions. As a practical matter, 510(k) clearance often takes between three and twelve months.
We received 510(k) clearance for our Unitract 1mL insulin syringe in October 2008 that covered the production of the device by a contractor outside the United States. Since we will be producing this product in the United States, we will be required to submit a new 510(k) application that covers production of the device at our Pennsylvania manufacturing facility.
Premarket Approval Pathway
A premarket approval application must be submitted to the FDA if the device cannot be cleared through the 510(k) process. A premarket approval application must be supported by extensive data, including, but not limited to, technical, preclinical, clinical trials, manufacturing and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device. This process does not apply to our current range of products.
Pervasive and Continuing Regulation
After a device is placed on the market, numerous regulatory requirements apply. These include:
    quality system regulations, or QSR, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;
    labeling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or “off label” uses;
    medical device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to a death or serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if the malfunction were to occur; and
    post-market surveillance regulations, which apply when necessary to protect the public health or to provide additional safety and effectiveness data for the device.
The FDA has broad post-market and regulatory enforcement powers. We are subject to unannounced inspections by the FDA to determine our compliance with the QSR and other regulations, and these inspections may include the manufacturing facilities of our manufacturing subcontractors.
Failure to comply with applicable regulatory requirements can result in enforcement action by the FDA, which may include any of the following sanctions:
    fines, injunctions, consent decrees and civil penalties;
    recall or seizure of our products;
    operating restrictions, partial suspensions or total shutdown of production;
    refusing our requests for 510(k) clearance or premarket approval of new products or new intended uses;
    withdrawing 510(k) clearance or premarket approvals that are already granted; and
    criminal prosecution.
Regulation in the European Union and Australia
The European Union has adopted numerous directives regulating the design, manufacture, clinical trials, labeling and adverse event reporting for medical devices. Devices that comply with the requirements of the relevant directive will be entitled to bear CE conformity marking, indicating that the device conforms with the essential requirements of the applicable directives and, accordingly, can be commercially distributed throughout the member states of the European Union. The method of assessing conformity varies depending on the type and class of the product, but normally involves a combination of self-assessment by the manufacturer and a third party assessment by a “Notified Body” which is an independent and neutral institution appointed by a country to conduct the conformity assessment. This third-party assessment may consist of an audit of the manufacturer’s quality system and specific testing of the manufacturer’s device. An assessment by a Notified Body in one member state of the European Union is required in order for a manufacturer to commercially distribute the product throughout these countries. ISO 9001 and ISO 13845 are voluntary harmonized standards. Compliance establishes the presumption of conformity with the essential requirements for CE Marking. In July 2009, we received our ISO 13485:2003 quality system certification. Our certification includes the design, development, production and distribution or sterile syringes and insulin syringes and the provision of contract manufacturing services to the medical device industry.
We have successfully completed a Notified Body audit to allow our Unitract syringes to bear the CE mark and are currently awaiting certification from the Notified Body.
In Australia, the Therapeutic Goods Administration, or TGA, is responsible for administering the Australian Therapeutics Goods Act. The Office of Devices, Blood and Tissues is the department within the TGA responsible for medical devices. The Australian Register of Therapeutic Goods, or ARTG, controls the legal supply of therapeutic goods in Australia. The ARTG is the register of information about therapeutic goods for human use that may be imported, supplied in, or exported from Australia. Any use of an unapproved medical device in humans, even in pilot trials, requires an exemption from the requirement for inclusion on the ARTG. Our Unitract syringe products are currently included on the ARTG.

 

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Other Regulations
We are also subject to various federal, state and local laws and regulations, both in the United States and other international territories where we conduct business, relating to such matters as safe working conditions, laboratory and manufacturing practices and the use, handling and disposal of hazardous or potentially hazardous substances used in connection with our research and development work. Although we believe we are in compliance with these laws and regulations in all material respects, we cannot provide assurance that we will not be required to incur significant costs to comply with environmental laws or regulations in the future.
We are subject to various federal, state and local laws in the United States targeting fraud and abuse in the healthcare industry, which generally prohibit us from soliciting, offering, receiving or paying any remuneration in order to induce the ordering or purchasing of items or services that are in any way paid for by Medicare, Medicaid or other government-sponsored healthcare programs. Healthcare costs have been and continue to be a subject of study, investigation and regulation by governmental agencies and legislative bodies around the world. The U.S. federal government continues to scrutinize potentially fraudulent practices affecting Medicare, Medicaid and other government healthcare programs. Payers have become more influential in the marketplace and increasingly are focused on drug and medical device pricing, appropriate drug and medical device utilization and the quality and costs of healthcare. Violations of fraud and abuse-related laws are punishable by criminal or civil sanctions, including substantial fines, imprisonment and exclusion from participation in healthcare programs such as Medicare and Medicaid and health programs outside the United States.
Competition
The healthcare equipment, pharmaceutical and medical device industry sectors in which we operate are highly competitive. We compete with many companies, both public and private, that range in size from small, highly focused businesses to large diversified multinational manufacturers of healthcare and pharmaceutical equipment, as more fully described below.
While we do not believe there are any other companies that offer a ready-to-fill syringe with safety features which are fully integrated within the glass barrel, there is a highly concentrated market for the production of standard ready-to-fill syringes for supply to pharmaceutical manufacturers. We are aware of five companies which specialize in the production and supply of glass ready-to-fill syringes. These companies are Becton, Dickinson and Company, or BD, Gerresheimer Bünde GmbH, MGlas AG, SCHOTT forma vitrum AG, and Nuova Ompi. All of these companies are larger and better capitalized than we are, and have an extensive base of pharmaceutical customers. We estimate the market concentration rate for these five companies to be around 95%. We believe BD’s market share to be in excess of 50%, as it has supply relationships with most pharmaceutical companies and contract manufacturing organizations. Of these five aforementioned companies, we believe that BD is the only one which also markets and supplies ancillary safety products for attachment onto standard prefilled syringes to assist pharmaceutical companies in their compliance with needlestick prevention laws. We are aware of another specialist supplier of ancillary safety products, Safety Syringes Inc, which has contracts with a number of pharmaceutical manufacturers.
We have sought to strengthen our competitive position in this marketplace in a number of ways. For example, the design of the Unifill syringe incorporates the use of a glass barrel which requires shaping at only one end. As a result, the glass barrel for the Unifill syringe can be sourced from the many global suppliers of glass cartridges and not just the five specialty manufacturers mentioned above.
The global market for clinical (non-pre-filled) plastic syringes is highly competitive, with at least 50 manufacturers located across North America, Europe and the Asia-Pacific. The market for clinical safety syringes is relatively less competitive, yet highly concentrated. We believe BD is the largest global supplier of clinical safety syringes. Other companies which compete in this market sector include Retractable Technologies, Inc, Covidien and Smiths Medical. All of these companies offer a full range of clinical safety syringes, operate a strong sales, distribution and customer support network, and have existing supply relationships with major healthcare buying groups.
Research and Development
During the fiscal years ended June 30, 2009 and 2008, we incurred approximately $1.0 million and $0.5 million, respectively, on research and development of our technologies. Research and development costs include activities related to the research, development, design, testing, and manufacturing of prototypes of our products. It also includes clinical activities and regulatory costs. Research and development costs also include costs associated with certain consultants engaged in research and development activities along with a portion of the overhead costs we incur to operate our manufacturing facility. We expect our research and development expenses to continue as we continue to develop other pipeline product variants of our technology such as the Unitract clinical range of larger syringe sizes.

 

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Employees
As of December 22, 2009, we had 97 employees, of whom approximately 77 are engaged in operations activities including research and development, quality assurance and manufacturing activities, five are engaged in marketing and clinical activities and 15 are engaged in finance, legal and other administrative functions. All but four of our employees and all of our executive officers are located at our facilities in Central Pennsylvania. All but two of our employees are full-time employees. None of our employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relations with our employees to be good.
Corporate History
Unilife Corporation was incorporated in Delaware on July 2, 2009, and is currently a wholly-owned subsidiary of UMSL. As we describe in more detail under “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Redomiciliation,” Unilife Corporation will become the parent company of UMSL upon completion of the redomiciliation and UMSL’s shareholders and optionholders will exchange their interests in UMSL for equivalent interests in Unilife Corporation. Our principal executive offices are located at 633 Lowther Road, Lewisberry, PA 17339. Our telephone number at this address is +1 717 938-9323.
UMSL was incorporated on June 28, 1985, in South Australia, Australia. The registered office of UMSL is located at Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000. Originally known as Musgrave Block Holdings Limited, UMSL acquired all of the issued shares of Unitract Pty Limited in November 2002, and changed its name to Unitract Limited (now Unilife Medical Solutions Limited), listed on the Australian Securities Exchange, or ASX under the ticker “UNI” and continued the business operations of Unitract Pty Limited and the development of Unitract Pty Limited’s retractable syringe project. In January 2007, in order to obtain a manufacturing presence in the United States, UMSL acquired all the stock of Integrated BioSciences, Inc., a Pennsylvania-based company, which changed its corporate name to Unilife Medical Solutions, Inc. in February 2009. At the time of its acquisition by UMSL, Integrated BioSciences, Inc. was in the business of contract manufacturing of syringes for third parties and developing automated assembly equipment.
Item 1A.   Risk Factors
Our business faces many risks. We believe the risks described below are the material risks facing the Company. However, the risks described below may not be the only risks we face. Additional unknown risks or risks that we currently consider immaterial may also impair our business operations. If any of the events or circumstances described below actually occurs, our business, financial condition or results of operations could suffer, and the trading price of our shares of common stock could decline significantly. Investors should consider the specific risk factors discussed below, together with the “Cautionary Note Regarding Forward-Looking Information” and the other information contained in this Form 10 and the other documents that we will file from time to time with the Securities and Exchange Commission.
Risks Relating to Our Business
Our success depends in large part on our ability to finalize the design of and complete the industrialization program for our primary product, the Unifill syringe. If we experience problems or delays in completing these activities, our business, including our ability to generate significant revenues, will be materially and adversely affected.
We commenced the industrialization program for the Unifill syringe in July 2008 and expect to finalize the design of and complete the industrialization program for the product, as well as the development of production systems to support its manufacture and commercial sale, by the end of calendar year 2010. Since the Unifill syringe is our primary product, any failure or significant delay in completing these activities could materially harm our business and our ability to generate any significant amount of revenues for the foreseeable future. We do not expect that our existing contract manufacturing business will generate significant revenues in the future. In addition, our contract with B. Braun expired on December 31, 2009 and while we and B. Braun continue to operate under the contract, there is no assurance that we will be able to renew this contract on favorable terms, if at all.

 

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Our business is substantially dependent on our relationship with our strategic partner, sanofi-aventis, which is funding the industrialization program for the Unifill syringe, and our revenues from other sources are not significant.
To date, we have derived a substantial majority of our revenues from our exclusive licensing and industrialization agreements with sanofi-aventis. For the year ended June 30, 2009, our revenues from these agreements were $16.1 million, which represented 81% of our revenues for the period. We expect that revenues from sanofi-aventis will continue to account for a substantial majority of our revenues at least through the end of calendar 2010, which is when we expect to complete our industrialization program for the Unifill syringe. In addition, we will need to negotiate successfully with sanofi-aventis to finalize a supply agreement for the Unifill syringe. Even if we finalize this agreement and commence commercial sales to sanofi-aventis, we expect that sanofi-aventis will be our most significant customer, at least until its exclusive period terminates, and that revenues from sanofi-aventis will continue to account for a substantial majority of our revenues and cash flows from operations. Any termination or material breach of the existing agreements between sanofi-aventis and us, any failure to successfully negotiate a supply agreement, or any failure to perform under any supply agreement that we do negotiate, would be likely to materially and adversely affect our business.
Our research and development and other operating expenses are significant and we do not expect to be profitable unless and until we complete our industrialization program, negotiate a supply agreement with sanofi-aventis or other pharmaceutical companies and begin commercial sale of the Unifill syringe.
We have incurred and will continue to incur significant research and development expenses for the completion of the industrialization program for the Unifill syringe, as well as for the development of other product variants of our technology such as the Unitract Clinical Range of larger syringe sizes. We will also incur general and administrative expenses related to increasing our manufacturing operations, expanding our sales and marketing capabilities, seeking regulatory approvals, and complying with the requirements related to being a public company in both the United States and Australia. We will not be profitable unless we are successful in developing and commercializing the Unifill syringe and other new products, obtaining regulatory approvals, and manufacturing, marketing and selling commercial products.
The Unifill syringe has been designed to be compatible with the drug manufacturing systems currently utilized by sanofi-aventis, which may hinder our ability to sell the product to other pharmaceutical customers whose manufacturing processes may not be compatible with our current product designs.
The Unifill syringe has been designed to be compatible with the drug filling and packaging systems of sanofi-aventis. While the standard glass barrels to be used for the Unilfill syringe are also currently utilized by most pharmaceutical companies, the specific processes used by other pharmaceutical companies to fill, manufacture or package prefilled syringes with an injectable drug product may vary from those of sanofi-aventis. Furthermore, pharmaceutical companies may in some cases require the use of materials which are biocompatible with a particular drug compound and to which we do not have access. Such events may require design, material or process changes to our product, or restrict our ability to enter into supply relationships with other pharmaceutical companies and accordingly, may have a material adverse effect on our results of operations and financial condition.
Our ability to successfully market and sell our safety syringes outside of the pharmaceutical market may be impaired until we are able to offer a full range of safety syringes in sizes commonly used in acute-care facilities.
In addition to the Unifill syringe, our product portfolio also includes the Unitract 1mL syringe, a plastic syringe which we refer to as a clinical syringe. Acute-care hospitals are the largest single healthcare market for clinical syringes. These facilities use a range of clinical syringes, including 1mL, 3mL and 5mL sizes, for the subcutaneous and intramuscular administration of therapeutic drugs and vaccines. We have completed development and secured regulatory approvals only for the marketing and sale of our Unitract 1mL syringe. While we intend to market the Unitract 1mL syringe to other healthcare sectors in addition to acute-care facilities, our ability to market and sell our safety syringes successfully may be impaired until we are able to offer clinical syringes in a full range of sizes.
Our success will depend on the full commercialization of our current products, and the development and commercialization of other pipeline products. There can be no assurance that we will be successful in these efforts.
A significant element of our strategy focuses on developing products that deliver greater benefits to pharmaceutical companies, healthcare workers and patients. The development of these products requires significant research and development, clinical evaluations and regulatory approvals. The results of our product development efforts may be affected by a number of factors, including our ability to innovate, develop and manufacture new products, complete clinical trials, obtain regulatory approvals and secure customer orders for these products. In addition, patents attained by others can preclude or delay our commercialization of a product. There can be no assurance that any products now in development, or that we may seek to develop in the future, will achieve technological feasibility, obtain regulatory approval or gain market acceptance.

 

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We need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our efforts in developing our new manufacturing facility and in our product development or commercialization programs.
We are in the process of developing a new manufacturing facility in central Pennsylvania. We estimate the total cost to be approximately $26 million. We intend to internally fund $9 million of the cost and seek external financing for up to $17 million. Although we currently believe that our current cash resources, together with our anticipated cash flows, will be sufficient to fund our operations (other than the development of the new manufacturing facility which we expect to finance in part with the proceeds of external financing) through at least the end of fiscal 2010, we may also need to obtain additional funding in the future for our product development programs and commercialization efforts. In particular, if the amount of funding that sanofi-aventis has agreed to provide to us under the industrialization agreement is insufficient to complete the industrialization program for the Unifill syringe, we may need to obtain additional funding unless sanofi-aventis were to agree to provide us with additional funding, which it has no obligation to provide. We cannot assure you that we will be able to raise capital when needed on terms favorable to us, or at all. If we raise additional funds from debt financing, we may be obligated to abide by restrictive covenants contained in the debt financing agreements, which may make it more difficult for us to operate our business. If we raise additional funds through the issuance of equity securities, our shares of common stock may suffer dilution. If we are unable to secure additional funding when needed, our ability to develop the new manufacturing facility and continue in our product development and commercialization programs would be delayed, reduced or eliminated.
We may encounter difficulties managing our growth, which could materially harm our business.
We expect to expand our operations and grow our research and development, product development, regulatory, manufacturing, sales, marketing and administrative operations. This expansion has placed, and is expected to continue to place, a significant strain on our management, operational and financial resources. To manage our growth and to develop and commercialize our products, we will be required to improve existing, and implement new, operational and financial systems, procedures and controls and expand, train and manage our growing employee base. In addition, we will need to manage relationships with various manufacturers, suppliers, customers and other organizations. Our ability to manage our operations and growth will require us to improve our operational, financial and management controls, as well as our internal reporting systems and controls. We may not be able to implement such improvements to our management information and internal control systems in an efficient and timely manner and may discover deficiencies in existing systems and controls. Our failure to accomplish any of these tasks could materially harm our business.
We depend on our executive officers and key personnel and the loss of them could adversely affect our business.
Our success depends upon the efforts and abilities of our executive officers and other key personnel, particularly Mr. Alan Shortall, our Chief Executive Officer, to provide strategic direction, manage our operations and maintain a cohesive and stable environment. Although we have employment agreements with Mr. Shortall and other key personnel, as well as incentive compensation plans that provide various economic incentives for them to remain with us, these agreements and incentives may not be sufficient to retain them. Our ability to operate successfully and manage our potential future growth also depends significantly upon our ability to attract, retain and motivate highly skilled and qualified research, technical, clinical, regulatory, sales, marketing, managerial and financial personnel. We face intense competition for such personnel, and we may not be able to attract, retain and motivate these individuals. The loss of our executive officers or other key personnel for any reason or our inability to hire, retain and motivate additional qualified personnel in the future could prevent us from sustaining or growing our business. In addition, we have a limited history of operations under our current officers and directors. Our officers have not worked together for an extensive length of time. If for any reason our management members cannot work efficiently as a team, our business will be adversely affected.
We will incur increased costs as a result of being a US reporting company and we have no experience as a US reporting company.
Upon the effectiveness of this registration statement, we will become subject to the periodic reporting requirements of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Although UMSL has been listed on the ASX for several years and has been required to file financial information and make certain other filings with the ASX, our status as a U.S. reporting company under the Exchange Act will cause us to incur additional legal, accounting and other expenses that we have not previously incurred, including costs related to compliance with the requirements of the Sarbanes-Oxley Act of 2002. We expect these rules and regulations to increase our legal and financial compliance costs and to make some activities more time-consuming and costly. We cannot predict or estimate the amount of additional costs we may incur or the timing of such costs.

 

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If our internal control over financial reporting is found not to be effective by management or by an independent registered public accounting firm or if we make disclosure of existing or potential significant deficiencies or material weaknesses in those controls, investors could lose confidence in our financial reports, the price of our shares of common stock may decline, and we may be subject to increased risks and liabilities.
After we become a U.S. reporting company, we will be subject to the Sarbanes-Oxley Act of 2002 and applicable rules and regulations thereunder. Section 404 of the Sarbanes-Oxley Act will require that we include a report of our management on our internal control over financial reporting and a report of our independent registered public accounting firm on the effectiveness of our internal control over financial reporting in our Annual Report on Form 10-K beginning with our annual report for the fiscal year ending June 30, 2011. Our management may conclude that our internal control over financial reporting is not effective. Moreover, even if our management concludes that our internal control over financial reporting is effective, our independent registered public accounting firm, after conducting its own independent review, may issue a report that is qualified if it is not satisfied with our internal controls or the level at which our internal controls are documented, designed, operated or reviewed, or if it interprets the relevant requirements differently from the way we interpret them.
If we fail to achieve and maintain an effective internal control environment, we could suffer material misstatements in our financial statements and fail to meet our reporting obligations, which would likely cause investors to lose confidence in our reported financial information. This could lead to a decline in the trading price of our shares of common stock. Additionally, ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse of corporate assets and subject us to potential delisting from Nasdaq, regulatory investigations and civil or criminal sanctions.
We have limited sales, marketing and distribution experience.
We have a small internal team to support the training of appointed distributors in the marketing and clinical use of our Unitract 1mL syringes. Although we intend to expand this team as we commence sales of our Unitract 1mL syringes, appoint additional distributors and commercialize our larger-sized clinical syringes, we will have to devote significant financial and management resources to this effort. In developing our sales, marketing and distribution functions, we could face a number of risks, including:
    we may not be able to attract and build a significant marketing or sales force;
    the cost of establishing, training and providing regulatory oversight for a marketing or sales force may be substantial; and
    there are significant legal and regulatory risks in medical device marketing and sales, and any failure to comply with all legal and regulatory requirements for sales, marketing and distribution could result in enforcement action by the FDA or other authorities that could jeopardize our ability to market our product(s) or could subject us to substantial liability.
We have outsourced the development of automated assembly systems for our Unifill syringe to Mikron Assembly Technology, a third-party contractor. Our ability to commercialize the Unifill syringe will be dependent on the ability of this contractor to provide these systems according to specifications and in a timely manner.
We have outsourced the development of automated assembly systems for our Unifill syringe to Mikron Assembly Technology, a third party equipment manufacturer. The development of a pilot system with a target production capacity of approximately 60 million units per year began in December 2009 with completion and installation scheduled for the fourth quarter of 2010. Additional assembly lines with higher annual manufacturing capacity are expected to commission and operate beyond 2010. The failure of this company to supply these automated assembly systems to us which meet contracted specifications in a timely manner will significantly impair our business activities and the completion of the industrialization program.
If we experience delays in developing our new manufacturing facility, our ability to produce our Unifill syringe in commercial quantities would be impaired, which would harm our business. In addition, all of our current commercial and production activity takes place in one facility which subjects us to risk if we were to experience a catastrophic event at this facility.
We have a 50,000 square foot FDA-registered, medical device production facility in Lewisberry, Pennsylvania, for the production of the Unilife 1mL syringes and for the future production of the Unifill syringes. However, we will need to expand our manufacturing capabilities in order to produce Unifill syringes and our other products in the quantities that may be necessary to meet anticipated market demand. We are in the process of developing additional manufacturing facilities in central Pennsylvania in conjunction with Keystone Redevelopment Group LLC, a Pennsylvania-based real estate company. We may not successfully complete the development of the new manufacturing facility in a timely manner, or at all. If we are unable to do so, we may not be able to produce our products in sufficient quantities to meet the requirements for the launch of the products or to meet future demand, if at all.

 

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In addition, because all of our operations are currently conducted out of our Lewisberry facility, a catastrophic event, such as fire, natural disaster, pandemic, war, terrorism, labor disruption or governmental actions taken in response to such an event, could severely disrupt our business activities and adversely affect our results of operations and financial condition.
Our manufacturing facilities and the manufacturing facilities of our suppliers must comply with applicable regulatory requirements. If we or they fail to achieve or maintain regulatory approval for these manufacturing facilities, our business and our results of operations would be harmed.
Commercialization of our products requires access to, or the development of, manufacturing facilities that meet applicable regulatory standards to manufacture a sufficient supply of our products. In addition, the FDA must approve facilities that manufacture our products for US commercial purposes, as well as the manufacturing processes and specifications for the product. Suppliers of components of, and products used to manufacture, our products must also comply with FDA and foreign regulatory requirements, which often require significant time, money and record-keeping and quality assurance efforts and subject us and our suppliers to potential regulatory inspections and stoppages. We and our suppliers may not satisfy these requirements. If we or our suppliers do not achieve or maintain required regulatory approval for our manufacturing operations, our commercialization efforts could be delayed, which would harm our business and our results of operations.
The costs of raw materials have a significant impact on the level of expenses that we incur. If the prices of raw materials and related factors such as energy prices increase, and we cannot pass those price increases on to our customers, our results of operations and financial condition would suffer.
We use a number of raw materials including polymer plastics. The prices of many of these raw materials, such as those sourced from petroleum-based raw materials, are cyclical and volatile. While we would generally attempt to pass along increased costs to our customers in the form of sales price increases, we might not be able to do so, for competitive or contract-related reasons or otherwise. If we could not set our prices to reflect the costs of our raw materials, our results of operations and our financial condition would suffer.
Disruptions in the supply of key raw materials and difficulties in the supplier qualification process could adversely impact our operations.
We employ a supply chain management strategy which seeks to source components and materials from a number of established third party companies. Where possible, we seek to establish dual contracts for the supply of particular components or services. However, there is a risk that our supply lines may be interrupted in the event of a supplier production problem, material recall or financial difficulties. If one of our suppliers is unable to supply materials required for production of our products or our strategies for managing these risks are unsuccessful, we may be unable to complete the production of sufficient quantities of product to fulfill customer orders, or complete the qualification of new replacement materials for some programs in time to meet future production requirements. Prolonged disruptions in the supply of any of our key raw materials, difficulty in completing qualification of new sources of supply, or in implementing the use of replacement materials or new sources of supply, could have a material adverse effect on our results of operations, our financial condition or cash flows.
Some companies we may utilize for the supply of components are also competitors, and they could elect to cease supply relationships with us in the future for competitive reasons.
Some companies we may utilize for the supply of components for the Unifill syringe also develop and market their own safety products which can be attached onto standard prefilled syringes. These companies may elect to cease supply relationships with us in the future for competitive reasons. This may disrupt our supply chain, cause difficulties in the qualification of new sources of supply and impair our ability to supply customer orders. Such events may have a material adverse effect on our results of operations, our financial condition or cash flows.

 

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The medical device industry is very competitive.
Competition in the medical device industry is intense. We face this competition from a wide range of companies. These include large medical device companies, most of which have greater financial and human resources, distribution channels and sales and marketing capabilities than we do. Our ability to compete effectively depends upon our ability to distinguish our company and our products from our competitors and their products. Factors affecting our competitive position include, for example, product design and performance, product safety, sales, marketing and distribution capabilities, success and timing of new product development and introductions and intellectual property protection.
We may be adversely impacted by next generation drug delivery technologies.
Much of our potential sales and potential profitability depends to a large extent on the sale of drug products delivered by subcutaneous or intramuscular injection. Other device companies, and pharmaceutical companies, are attempting to develop alternative therapies or drug administration systems such as needle-free or intradermal injection technology for the treatment or prevention of various diseases. The development of new or improved products, processes or technologies by other companies may render our products or proposed products obsolete or less competitive. If the products developed in the future by our customers or potential customers use another delivery system, our sales and potential profitability could suffer. Furthermore, we will be largely reliant upon the receipt of revenues from the sale of the Unifill syringe and the Unilife 1mL syringe and will not have the benefit of diversification.
We are subject to extensive regulation.
We are subject to extensive regulation by the FDA pursuant to the FDC Act, by comparable agencies in other countries, and by other regulatory agencies and governing bodies. Our products must receive clearance or approval from the FDA or counterpart non-U.S. regulatory agencies before they can be marketed or sold. The process for obtaining marketing approval or clearance may take a significant period of time and require the expenditure of substantial resources. The process may also require changes to our products or result in limitations on the indicated uses of the products. In addition, regulatory requirements outside the U.S. change frequently, requiring prompt action to maintain compliance, particularly when product modifications are required.
Following the introduction of a product, these agencies also periodically review our manufacturing processes and product performance. Our failure to comply with the applicable good manufacturing practices, adverse event reporting, clinical trial and other requirements of these agencies could delay or prevent the production, marketing or sale of our products and result in fines, delays or suspensions of regulatory clearances, closure of manufacturing sites, seizures or recalls of products and damage to our reputation.
We are subject to regulation by governments around the world, and if these regulations are not complied with, existing and future operations may be curtailed, and we could be subject to liability.
The design, development, manufacturing, marketing and labeling of our products are subject to regulation by governmental authorities in the United States, Europe and other countries, including the FDA. The regulatory process can result in required modification or withdrawal of existing products and a substantial delay in the introduction of new products. Also, it is possible that regulatory approval may not be obtained for a new product. Our business may be adversely affected by changes in the regulation of drug products and medical devices.
Our target pharmaceutical customers are also subject to government regulations for the manufacturing, approval, marketing and labeling of therapeutic drug products. An effect of the governmental regulation of our customers’ injectable drug products and manufacturing processes is that compliance with regulations makes it costly and time consuming to transition to the use of our devices for existing products, or to secure approval for pipeline products targeted for use with our devices. If regulation of our customers’ products incorporating our devices increases over time, it is likely that this would adversely affect our sales and profitability.

 

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Product defects could adversely affect the results of our operations.
The design, manufacture and marketing of medical devices involve certain inherent risks. Manufacturing or design defects, unanticipated use of our products, or inadequate disclosure of risks relating to the use of the product can lead to injury or other adverse events. These events could lead to recalls or safety alerts relating to our products (either voluntary or required by the FDA or similar governmental authorities in other countries), and could result, in certain cases, in the removal of a product from the market. Any recall could result in significant costs, as well as negative publicity and damage to our reputation that could reduce demand for our products. Personal injuries relating to the use of our products can also result in product liability claims being brought against us. In some circumstances, such adverse events could also cause delays in new product approvals.
We may be sued for product liability, which could adversely affect our business.
The design, manufacture and marketing of medical devices carries a significant risk of product liability claims. We may be held liable if any product we develop and commercialize causes injury or is found otherwise unsuitable during product testing, manufacturing, marketing, sale or consumer use. In addition, the safety studies we must perform and the regulatory approvals required to commercialize our medical safety products will not protect us from any such liability. We carry product liability insurance. However, if there were to be product liability claims against us, our insurance may be insufficient to cover the expense of defending against such claims, or may be insufficient to pay or settle such claims. Furthermore, we may be unable to obtain adequate product liability insurance coverage for commercial sales of any of our approved products. If such insurance is insufficient to protect us, our results of operations will suffer. If any product liability claim is made against us, our reputation and future sales will be damaged, even if we have adequate insurance coverage. We also intend to seek product liability insurance for any approved products that we may develop or acquire in the future. There is no guarantee that such coverage will be available when we seek it or at a reasonable cost to us.
We may not be able to effectively protect our intellectual property rights which could have an adverse effect on our business, financial condition or results of operations.
Our success depends in part on our ability to obtain and maintain protection in the United States and other countries of the intellectual property relating to or incorporated into our technology and products. Our intellectual property portfolio includes, in addition to trademarks and trade secrets, 24 issued patents in 13 countries, a significant number of patent applications pending in the United States, Australia and the countries covered under the Patent Cooperation Treaty. Our patents expire at various dates between 2018 and 2028. Our pending and future patent applications may not issue as patents or, if issued, may not issue in a form that will provide us with any competitive advantage. Even if issued, existing or future patents may be challenged, narrowed, invalidated or circumvented, which could limit our ability to stop competitors from marketing similar products or limit the length of terms of patent protection we may have for our products. Changes in patent laws or their interpretation in the United States and other countries could also diminish the value of our intellectual property or narrow the scope of our patent protection. In addition, the legal systems of certain countries do not favor the aggressive enforcement of patents, and the laws of foreign countries may not protect our rights to the same extent as the laws of the United States. As a result, our patent portfolio may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. In order to preserve and enforce our patent and other intellectual property rights, we may need to make claims or file lawsuits against third parties. This can entail significant costs to us and divert our management’s attention from developing and commercializing our products.
Intellectual property litigation could be costly and disruptive to us.
The retractable syringe product lines in which we compete are relatively new inventions with numerous companies having patents. In recent years, there have been several patent infringement suits involving other industry participants. To-date, we have not been subject to any such patent infringement suits and also hold freedom to operate reports which we believe indicate that our technology and associated products are substantially different from other known patents. There is no assurance, however, that third parties will not assert any patent, copyright, trademark and other intellectual property rights to technologies used in our business. Any claims, with or without merit, could be time-consuming, result in costly litigation, divert the efforts of our technical and management personnel or require us to pay substantial damages. If we are unsuccessful in defending ourselves against these types of claims, we may be required to do one or more of the following:
    stop, delay or abandon our ongoing or planned commercialization of the product that is the subject of the suit;
    attempt to obtain a license to sell or use the relevant technology or substitute technology, which license may not be available on reasonable terms or at all; or
 
    redesign those products that use the relevant technology.

 

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If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected.
In addition to patented technology, we rely on our unpatented proprietary technology, trade secrets, processes and know-how. We generally seek to protect this information by confidentiality agreements with our employees, consultants, scientific advisors and third parties. These agreements may be breached, and we may not have adequate remedies for any such breach. In addition, our trade secrets may otherwise become known or be independently developed by competitors. To the extent that our employees, consultants or contractors use intellectual property owned by others in their work for us, disputes may arise as to the rights in related or resulting know-how and inventions.
Impairment of our goodwill, which represents a significant portion of our total assets, would adversely affect our net income and we may never realize the full value of our goodwill.
A substantial portion of our assets is composed of goodwill, which we recorded as a result of our acquisition activities. Goodwill is subject to, at a minimum, an annual impairment assessment of its carrying value. Goodwill impairment is deemed to possibly exist if the net book value of a reporting unit exceeds its estimated fair value. Any material impairment of our goodwill would likely have a material adverse impact on our results of operations and financial condition.
Fluctuations in foreign currency exchange rates could adversely affect our financial condition and results of operations.
Currently, the majority of our revenues are derived from payments under our industrialization agreement with sanofi-aventis which provides that sanofi-aventis will pay us in euros, while we incur most of our operating expenses in U.S. dollars or Australian dollars. Changes in foreign currency exchange rates can affect the value of our assets and liabilities, and the amount of our revenues and expenses. We do not currently try to mitigate our exposure to currency exchange rate risks by using hedging transactions. We cannot predict future changes in foreign currency exchange rates, and as a result, we may suffer losses as a result of future fluctuations.
Risk Factors Related to Our Shares of Common Stock
An active trading market for our shares of common stock in the United States may not develop and the trading price of our shares of common stock may fluctuate significantly.
Prior to the effective date of this registration statement, UMSL’s ordinary shares have not been listed on any U.S. securities exchange and there has been only a limited trading market in its shares in the United States. Although we intend to apply to list our shares of common stock on Nasdaq, a liquid public market for our shares may not develop in the United States. If an active trading market does not develop in the United States, the market price and liquidity of our shares may be adversely affected.
Prior to the redomiciliation, the ordinary shares of UMSL were traded on the ASX. After the redomiciliation, Unilife Corporation will replace UMSL as the listed entity on the ASX and its shares of common stock will be traded on the ASX in the form of CDIs. It is possible that the development of an active trading market in the United States may be adversely impacted by the existence of a trading market for CDIs in Australia.
The price of UMSL’s ordinary shares on ASX has been volatile and it is likely that the price of our shares, on both Nasdaq and the ASX, may also be volatile, which means that it could decline substantially within a short period of time. The trading price of the shares may fluctuate, and investors may experience a decrease in the value of the shares that they hold, sometimes regardless of our operating performance or prospects. The trading price of our common stock could fluctuate significantly for many reasons, including the following:
    future announcements concerning our business and that of our competitors including in particular, the progress of our industrialization program for the Unifill syringe;
    regulatory developments, enforcement actions bearing on advertising, marketing or sales of our current or pipeline products;

 

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    quarterly variations in operating results;
    introduction of new products or changes in product pricing policies by us or our competitors;
    acquisition or loss of significant customers, distributors or suppliers;
    business acquisitions or divestitures;
    changes in third party reimbursement practices;
    fluctuations of investor interest in the medical device sector; and
    fluctuations in the economy, world political events or general market conditions.
If there are substantial sales of our shares of common stock, our share price could decline.
As of September 30, 2009, we had 37,010,802 shares of common stock issued and outstanding. We issued 6,291,535 additional shares of common stock to certain investors in October and November of 2009. All of our shares of common stock that will be outstanding at the time of the redomiciliation, other than approximately [____] shares held by our affiliates, will be freely tradable. Commencing 90 days after the effectiveness of this registration statement, shares held by our affiliates will be eligible for resale pursuant to Rule 144. If our stockholders sell a large number of shares of common stock or the public market, should one develop, perceives that our stockholders might sell a large number of shares, the prices at which our common stock trades could decline significantly.
In addition, as of September 30, 2009, 5,587,500 shares of our common stock were subject to outstanding stock options. In November 2009, we issued options to purchase 3,645,767 additional shares of common stock to certain investors, placement agents and advisors in connection with our recent financing. After the redomiciliation transaction, we plan to file a registration statement on Form S-8 to cover the issuance of approximately [____] shares of our common stock that are issuable upon the exercise of outstanding options or options that may be issued in the future under our employee benefit plans. We may also file a registration statement on Form S-1 or another appropriate form to cover the resale of shares of our common stock that are issuable upon the exercise of options not eligible for inclusion in a registration statement on Form S-8. Even if no such registration statement is filed, the shares of our common stock issuable upon the exercise of options may be sold in reliance upon Rule 144 or another exemption from registration. The exercise of those options may have a dilutive effect on current stockholders and if those parties exercising their options choose to sell their shares, it could have an adverse effect on the market price for our shares.
We do not intend to pay cash dividends in the foreseeable future.
For the foreseeable future, we do not intend to declare or pay any dividends on our common stock. We intend to retain our earnings, if any, to finance the development and expansion of our business and product lines. Any future decision to declare or pay dividends will be made by our board of directors and will depend upon a number of factors including our financial condition and results of operations. In addition, under our current bank financing agreements, we are not permitted to pay cash dividends without the prior written consent of the lender.
We may be subject to arbitrage risks.
Investors may seek to profit by exploiting the difference, if any, in the price of our shares of common stock on the Nasdaq and on the ASX. Such arbitrage activities could cause our stock price in the market with the higher value to decrease to the price set by the market with the lower value.

 

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Our certificate of incorporation, bylaws, the Delaware General Corporation Law and the terms of our industrialization agreement with sanofi-aventis may delay or deter a change of control transaction.
Certain provisions of our certificate of incorporation and bylaws may have the effect of deterring takeovers, such as those provisions authorizing our board of directors to issue, from time to time, any series of preferred stock and fix the designation, powers, preferences and rights of the shares of such series of preferred stock; prohibiting stockholders from acting by written consent in lieu of a meeting; requiring advance notice of stockholder intention to put forth director nominees or bring up other business at a stockholders’ meeting; prohibiting stockholders from calling a special meeting of stockholders; requiring a 66 - 2/3 % majority stockholder approval in order for stockholders to amend our bylaws or adopt new bylaws; and providing that, subject to the rights of preferred shares, the number of directors is to be fixed exclusively by our board of directors. Section 203 of the Delaware General Corporation Law, from which we did not elect to opt out, provides that if a holder acquires 15% or more of our stock without prior approval of our board of directors, that holder will be subject to certain restrictions on its ability to acquire us within three years. In addition, our industrialization agreement with sanofi-aventis provides to sanofi-aventis the right to match a change of control proposal and to terminate the industrialization agreement under certain circumstances of a change of control event. See “Business — Strategic Partnership with sanofi-aventis”. These provisions may delay or deter a change of control of us, and could limit the price that investors might be willing to pay in the future for shares of our common stock.
Item 2.   Financial Information
Selected Financial Data
The following table presents our selected statement of operations data for the three months ended September 30, 2009 and 2008 and for each of the years in the five year period ended June 30, 2009 and our selected balance sheet data as of September 30, 2009 and as of June 30 of each year in the five year period ended June 30, 2009. The statement of operations data for the three months ended September 30, 2009 and 2008 and the balance sheet data as of September 30, 2009 have been derived from our unaudited condensed consolidated financial statements included elsewhere in this registration statement. The statement of operations data for the years ended June 30, 2009, 2008 and 2007 and the balance sheet data as of June 30, 2009 and 2008 have been derived from our audited consolidated financial statements included elsewhere in this registration statement. All such data should be read in conjunction with the information under “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and our consolidated financial statements and the related notes thereto included elsewhere in this registration statement. The statement of operations data for the years ended June 30, 2006 and 2005 and the balance sheet data as of June 30, 2007, 2006 and 2005 have been derived from our unaudited consolidated financial statements not included in this registration statement.
                                                         
    Three months ended        
    September 30,     Year ended June 30,  
    2009     2008     2009     2008     2007 (b)     2006     2005  
Statement of Operations Data:
                                                       
Revenues
  $ 3,108     $ 2,305     $ 19,976 (a)   $ 3,500     $ 2,070     $ 112     $ 42  
Net loss
    (2,064 )     (1,616 )     (517 )     (8,537 )     (8,969 )     (8,220 )     (6,466 )
Basic loss per share
    (0.06 )     (0.05 )     (0.02 )     (0.26 )     (0.38 )     (0.35 )     (0.41 )
Diluted loss per share
    (0.06 )     (0.05 )     (0.02 )     (0.26 )     (0.38 )     (0.35 )     (0.41 )
 
                                                     
Balance Sheet Data (end of period):
                                                     
Total assets
  $ 30,713     24,058      $ 32,212     $ 18,499     $ 16,926     $ 9,953       13,872  
Long-term debt, including current portion
    2,991       3,657       3,133       7,209       4,261       106       157  
     
(a)   Includes $16.1 million in connection with our exclusive licensing agreement and our industrialization agreement with sanofi-aventis.
 
(b)   Includes the results of Integrated BioSciences, Inc. since we acquired it on January 1, 2007.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our consolidated and condensed financial statements and related notes appearing elsewhere in this registration statement. This discussion and analysis includes certain forward-looking statements that involve risks, uncertainties and assumptions. You should review the “Risk Factors” section of this registration statement for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by such forward-looking statements. See “Cautionary Note Regarding Forward-Looking Information” at the beginning of this registration statement. References to our fiscal year refer to the fiscal year ending June 30.

 

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Redomiciliation
On September 1, 2009, UMSL entered into a Merger Implementation Agreement with Unilife Corporation, pursuant to which shareholders and optionholders of UMSL will exchange their existing interests in UMSL for equivalent interests in Unilife Corporation, and Unilife Corporation will become the parent company of UMSL and its subsidiaries. The redomiciliation will be conducted by way of schemes of arrangement under Australian law. The issuance of our common stock and stock options under the schemes of arrangement will be exempt from registration under Section 3(a)(10) of the Securities Act of 1933, as amended. Under the schemes, each holder of UMSL ordinary shares or share options will receive one share of our common stock or an option to purchase one share of our common stock, for every six UMSL ordinary shares or share options, respectively, held by such holder, unless a holder of UMSL ordinary shares elects to receive, in lieu of our common stock, our Chess Depositary Interests, or CDIs (each representing one-sixth of a share of our common stock), in which case such holder will receive one CDI for every UMSL ordinary share. UMSL’s ordinary shares are currently listed on the ASX. Subject to approval by the ASX, Unilife Corporation will replace UMSL as the ASX-listed entity and our CDIs will be listed on ASX. Each CDI will, in general terms, be equivalent to one existing UMSL ordinary share and six CDIs will, in general terms, be equivalent to one share of our common stock. We are applying for the listing of our common stock on Nasdaq and have filed this registration statement in order to register our common stock under Section 12(b) of the Exchange Act. The redomiciliation will occur prior to the effectiveness of this registration statement.
The redomiciliation transaction is subject to various conditions, including without limitation, approval by the Australian Federal Court, approval by the shareholders and optionholders of UMSL, and a report by an independent expert concluding that the redomiciliation transaction is fair, reasonable and in the best interests of the shareholders and optionholders.
Overview
We are a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for our products include pharmaceutical manufacturers and suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. All of our syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and other unsafe injection practices.
Our main product is the Unifill ready-to-fill syringe, which is designed to be supplied to pharmaceutical manufacturers in a form that is ready for filling with their injectable drugs and vaccines. We have a strategic partnership with sanofi-aventis, a large global pharmaceutical company, pursuant to which it has paid us a 10 million exclusivity fee and has committed to pay us up to an additional 17 million to fund our industrialization program for the Unifill syringe. Upon the scheduled completion of the industrialization program in late 2010, we expect to commence the supply and sale of the Unifill syringe to sanofi-aventis. We are also in discussions with other pharmaceutical companies that are seeking to obtain access to the Unifill syringe.
In addition, we have recently begun to manufacture our Unitract 1mL insulin syringes at our FDA-registered manufacturing facility in Lewisberry, Pennsylvania. Our Unitract 1mL syringes are designed primarily for use in healthcare facilities and by patients who self-administer prescription medication such as insulin. We have recently begun U.S. production of this syringe, which we expect to release commercially in early 2010.
Recent Developments
Recent Equity Financing
On October 8, 2009, UMSL issued 3,460,344 ordinary shares in a private placement to a group of sophisticated and professional Australian investors and accredited investors in the United States, and subject to shareholder approval, agreed to issue to the investors an additional 2,831,191 ordinary shares and options to purchase 3,145,767 ordinary shares. UMSL obtained shareholder approval for the issuance of the additional ordinary shares and share options at a meeting held on November 13, 2009. All of the ordinary shares were issued at a price of A$5.10 per share for aggregate proceeds of A$32.1 million and all of the share options were issued for no additional consideration. Each of the share options is exercisable within three years after the date of grant. Half of the share options have an exercise price of A$7.50 per share, and the other half of the share options have an exercise price of A$12.00 per share. In conjunction with the private placement, UMSL’s Australian and New Zealand shareholders were offered, and some of them purchased, ordinary shares under a share purchase plan, at a price of A$5.10 per share, for a total consideration of A$21.5 million. In addition, after receiving shareholder approval on November 13, 2009, UMSL issued share options to purchase up to 500,000 ordinary shares to certain advisors and brokers as compensation for their services with respect to the private placement and the share purchase plan. These share options have the same terms as the share options issued to the investors. The proceeds from the private placement and the share purchase plan will be used to accelerate the expansion of our U.S. operational capabilities and production facilities, to purchase capital equipment and complete the industrialization program for the Unifill syringe.

 

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While the private placement was conducted by UMSL prior to the redomiciliation, all of the share numbers and share option exercise prices referred to above give effect to the share consolidation we will effect in connection with the redomiciliation (one share of our common stock equals six ordinary shares of UMSL). The ordinary shares and share options issued in the placement will be exchanged for shares of our common stock and options to purchase our common stock in connection with the redomiciliation.
Pennsylvania Economic Development Assistance
During October 2009, we accepted a $5.2 million offer of assistance from the Commonwealth of Pennsylvania. The offer includes $2.0 million for the development of our new global headquarters and manufacturing facility as well as up to $2.0 million in low-interest financing loans for land, building, acquisition and construction costs. The offer also includes a $0.5 million opportunity grant as well as $0.5 million in tax credits. Finally, the offer includes up to $0.2 million for the reimbursement of eligible job training costs. The offer is based on our proposed project being expected to create more than 200 new full-time jobs by December 31, 2012, to retain our 97 existing employees and to have a total cost of $86.0 million and is contingent upon us submitting complete applications and meeting all program guidelines. We cannot assure you that we will be able to receive all or any of the assistance for our current development project or otherwise.
Critical Accounting Policies and Estimates
We prepare our financial statements in accordance with accounting principles generally accepted in the United States of America. This requires management to make certain estimates, judgments and assumptions that could affect the amounts reported in the consolidated financial statements and accompanying notes. The following accounting policies require significant estimates, judgments and assumptions.
Goodwill
Goodwill is the excess of purchase price over the value of net assets acquired in business acquisitions. Goodwill is subject to, at a minimum, an annual impairment assessment of its carrying value. Additional impairment assessments would be performed if events and circumstances warranted such additional assessments during the year. Goodwill impairment is deemed to exist if the net book value of a reporting unit exceeds its estimated fair value. Estimated fair values of the reporting units are estimated using an earnings model and a discounted cash flow valuation model. The discounted cash flow model incorporates management’s estimates of future cash flows, allocations of certain assets and cash flows among reporting units, future growth rates and management’s judgment regarding the applicable discount rates used to discount those estimated cash flows. The estimated fair value of each reporting unit, if lower than the carrying value of the respective reporting unit (such carrying value determined after management allocation of certain shared assets), would then be allocated to the reporting unit’s net identifiable assets based on their respective estimated fair values. The remaining unallocated reporting unit fair value, if any, would then be compared to the carrying amount of that unit’s goodwill and, if lower, the Company would recognize an impairment charge to the extent of the deficiency. We did not record any goodwill impairments during fiscal 2009, 2008 or 2007.
The Company currently has two reporting units, each a component of its single syringe manufacturing operating segment. One reporting unit is comprised of our contract manufacturing business which was acquired in our January 2007 acquisition of Integrated BioSciences, Inc. and primarily assembles syringes for its limited customers. This reporting unit has no goodwill. The second reporting unit is comprised of our developing Unitract and Unifill syringe business, the base technology which we obtained as part of our November 2002 acquisition of Unitract Syringe Pty Limited and the manufacturing capability which we obtained in our acquisition of Integrated BioSciences, Inc.
In estimating the reporting unit’s fair value for purposes of the Company’s fiscal 2009 impairment assessments, management prepared a cash flow analysis for the following five years, limited to the expected cash flows from solely the Unitract business. Key assumptions used in the cash flow analysis included a) sales volume which was dependent on expected timing of the completion of the various phases of our production capabilities, b) selling prices we expect to achieve based on our market studies and indications from identified willing buyers of this product, c) gross margins of 26% to 40%, and d) a discount rate of 10%. While our Unitract syringe has only recently been commercialized after its regulatory approval in the United States and has yet to achieve significant sales, management believes that the assumptions used in the cash flow analysis are reasonable. Included in the cash flows analysis is expected expenditure needed to build up our Unitract production capability. While we expect the Unifill syringe business to be profitable, including a fairly short payback period on the costs to build production lines dedicated to the Unifill syringe, we did not include any of that expected business or development in our 2009 estimated cash flows analysis. Even without this Unifill business, the resulting estimated fair value of the Unitract portion of this reporting unit was in excess of the reporting unit’s entire carrying value by 68%.
In addition to the above, management compared the estimated fair value of the Unitract business portion of our second reporting unit to the Company’s market capitalization as of June 30, 2009. Market capitalization of $55.7 million was well in excess of the Unitract business’ fair value. Management also considered that market capitalization through early November 2009 continued to be in excess of the Unitract business’ fair value, thereby providing some further assurance that the reporting unit is not impaired.
Share-Based Compensation
Share-based compensation expense relating to options to purchase common stock is estimated at the grant date based on the fair value of the related stock option using the Black-Scholes option pricing model, with the exception of grants subject to market conditions which are valued based on a Barrier option pricing model. These models use various assumptions including the expected dividend yield, the risk-free interest rate, the expected volatility and the expected life. We have not historically paid dividends to our shareholders, and, as a result, we have assumed a dividend yield of 0%. The risk free interest rate is based upon the rates of Australian bonds with a term equal to that of the option. The expected volatility is based upon our historical share price. The expected life of the options to purchase common stock is based upon the outstanding contractual term of the stock option on the date of grant.
Revenue Recognition
We recognize revenue from licensing fees, industrialization efforts and products sold.

 

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In June 2008, we granted an exclusive licensing arrangement to allow our pharmaceutical partner to use certain of our intellectual property in order and solely to develop in collaboration with us, our Unifill syringe for use in and sale to the pre-filled syringe market. The up-front, non-refundable fee paid for this license is being amortized over the expected life of the related agreement. In late fiscal 2009, we entered into an industrialization agreement with our pharmaceutical partner, retroactive to July 2008, under which we received payments upon achievement of certain pre-defined milestones in our development of the Unifill syringe. Revenue is recognized upon achievement of the “at risk” milestone events, which represents the culmination of the earnings process related to such events. Milestones include specific phases of the project such as product design, prototype availability, user tests, manufacturing proof of principle and the various steps to complete the industrialization of the product. Specific payment amounts and completion dates were established for each milestone payment. Revenue recognized is commensurate with the milestones achieved. Billings are similarly triggered, and we have no future performance obligations related to previous milestone payments. Each milestone payment is non-refundable when made.
We recognize revenue from sales of products at the time of shipment and when title passes to the customer.
Results of Operations
The following table summarizes our results of operations for the three months ended September 30, 2009 and 2008 and for the fiscal years ended June 30, 2009, 2008 and 2007.
                                         
    Three months ended        
    September 30,     Year ended June 30,  
    2009     2008     2009     2008     2007  
                    (in thousands)  
Revenues
  $ 3,108     $ 2,305     $ 19,976     $ 3,500     $ 2,070  
Cost of sales
    865       1,131       3,537       2,456       1,561  
 
                             
Gross profit
    2,243       1,174       16,439       1,044       509  
 
                             
Operating expenses:
                                       
Research and development
    399       131       1,048       532       265  
Selling, general, and administrative
    3,742       2,422       14,941       8,211       6,497  
Depreciation and amortization
    255       144       804       636       169  
Impairment of property, plant and equipment
                            547  
Loss on the sale of property, plant and equipment
                            1,608  
 
                             
Total operating expenses
    4,396       2,697       16,793       9,379       9,086  
 
                             
Operating loss
    (2,153 )     (1,523 )     (354 )     (8,335 )     (8,577 )
Interest expense
    47       125       249       459       537  
Interest income
    (5 )     (120 )     (361 )     (203 )     (111 )
Other (income) expense, net
    (131 )     88       275       (54 )     (34 )
 
                             
Net loss
  $ (2,064 )   $ (1,616 )   $ (517 )   $ (8,537 )   $ (8,969 )
 
                             
Weighted-average number of shares outstanding
    36,762,142       34,348,301       34,426,353       32,938,477       23,413,811  
 
                             
Loss per share — basic and diluted
  $ (0.06 )   $ (0.05 )   $ (0.02 )   $ (0.26 )   $ (0.38 )
 
                             
Three Months Ended September 30, 2009 Compared to Three Months Ended September 30, 2008
Revenues. Revenues increased by $0.8 million or 34.8%. The increase was primarily attributable to $1.7 million in revenue recognized under our industrialization agreement with sanofi-aventis based on milestones achieved during the three months ended September 30, 2009. The increase in revenues was partially offset by a $0.9 million decrease in revenue earned from our contract manufacturing business.
Cost of sales. Cost of sales decreased by $0.3 million or 23.5%. The decrease was primarily attributable to a reduction in contract manufacturing sales and development activity, as no cost of sales were associated with the revenue recognized under the exclusive licensing and industrialization agreements.
Research and development expenses. Research and development expenses increased by $0.3 million, or 204.6% primarily as a result of additional expenditures to finalize the product specifications of our Unifill syringe.
Selling, general and administrative expenses. Selling, general and administrative expenses increased by $1.3 million or 54.5%. During the later part of fiscal 2009 and the three months ended September 30, 2009, we increased the workforce at our Lewisberry, Pennsylvania facility, and as a result incurred $0.7 million in additional payroll and other employee-related expenses and recruiting fees during the first quarter of fiscal 2010. Additionally, during the three months ended September 30, 2009, our share-based compensation expense, included in selling, general and administrative expenses, increased by $0.5 million. The increase resulted from the issuance of a significant number of stock options to employees, directors and consultants during the second, third and fourth quarters of fiscal 2009.
Depreciation and amortization expense. Depreciation and amortization expense increased by $0.1 million or 77.1%, which was primarily attributable to $1.8 million we spent to purchase additional property, plant and equipment during the three months ended September 30, 2009.
Interest expense. Interest expense decreased by $0.1 million, primarily as a result lower levels of outstanding debt.
Interest income. Interest income decreased by $0.1 million, primarily as a result of fluctuations in interest rates.
Other (income) expense. Other income during the three months ended September 30, 2009 was $0.1 million compared to other expense of $0.1 million during the three months ended September 30, 2008, primarily as a result of the appreciation of the US dollar against Australian dollar.
Income taxes. Due to the significant net operating losses recorded over the recent years, the Company fully offsets any related income tax benefits with increases to its valuation allowance, thereby resulting in no income tax provision or benefit recorded for either period.
Loss per share Due to the factors described above, net loss for the three months ended September 30, 2009 and 2008 was $2.1 million and $1.6 million, respectively. Basic and diluted loss per share was $0.06 and $0.05, respectively, on weighted average shares outstanding of 36,762,142 and 34,348,301, respectively. The increase in the weighted average shares outstanding was due to issuances of common stock in connection with option exercises during the three months ended September 30, 2009, as well as the issuance of 1.7 million shares of common stock to our chief executive officer in November 2008.
Fiscal Year 2009 Compared to Fiscal Year 2008
Revenues. Revenues increased by $16.5 million or 470.7%. The increase was primarily attributable to $13.6 million in revenue recognized under our industrialization agreement with sanofi-aventis based on milestones achieved during fiscal 2009. Additionally, we recognized $2.5 million in revenue under our exclusive licensing agreement with sanofi-aventis based on amortizing over the term of the related agreement the up front, non-refundable intellectual property licensing fee we received. Revenues from our contract manufacturing business decreased by $0.7 million in fiscal 2009.
Cost of sales. Cost of sales increased by $1.1 million or 44.0%. The increase was primarily attributable to an increase in the cost of plastics and commodities we use to assemble certain of our products within our contract business line and to higher payroll-related expenses resulting from hiring additional manufacturing personnel. There was no cost of sales associated with the exclusive licensing or industrialization agreements.

 

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Research and development expenses. Research and development expenses increased by $0.5 million, or 97.0% primarily as a result of additional expenditures to finalize the product specifications of our Unifill syringe.
Selling, general and administrative expenses. Selling, general and administrative expenses increased by $6.7 million or 82.0%. During 2009, we significantly increased our workforce at our Lewisberry, Pennsylvania headquarters and manufacturing facility, which included hiring over ten management-level personnel for our operational, regulatory affairs and finance departments. As a result of these hires, we incurred $2.5 million in additional payroll, employee-related expenses and recruiting fees. In addition, we incurred $1.0 million in legal, consulting and professional fees, primarily related to our anticipated Nasdaq listing. Finally, during fiscal 2009, our share-based compensation expense, included in selling general and administrative expense, increased by $2.2 million. Of this increase, $1.5 million is due to the issuance of 1.7 million shares of common stock to our Chief Executive Officer in December 2008 and $0.7 million is due to additional expense resulting from significant issuances of stock options to employees, directors and consultants during fiscal 2009.
Depreciation and amortization expense. Depreciation and amortization expense increased by $0.2 million or 26.4%, which was primarily attributable to $3.0 million we spent to purchase additional property, plant and equipment.
Interest expense. Interest expense decreased by $0.2 million, primarily as a result of higher levels of outstanding debt during the prior year.
Interest income. Interest income increased by $0.2 million during fiscal 2009 primarily as a result of fluctuations in interest rates.
Other expense (income). Other expense during fiscal 2009 was $0.3 million compared to other income of $0.1 million during fiscal 2008, primarily as a result of the depreciation of the U.S. dollar against Australian dollar.
Income taxes. Due to the significant net operating losses recorded in recent years, we fully offset any related income tax benefits with increases to our valuation allowance, thereby resulting in no income tax provision or benefit recorded for either year.
Loss per share Due to the factors described above, net losses for the years ended June 30, 2009 and 2008 were $0.5 million and $8.5 million, respectively, with both basic and diluted losses per share totaling $0.02 and $0.26, respectively, on weighted average shares outstanding of 34,426,353 and 32,938,477 respectively. The increase in weighted-average shares outstanding is primarily due to 1.7 million shares of common stock issued to our chief executive officer in November 2008.
Fiscal Year 2008 Compared to Fiscal Year 2007
Revenues. Revenues increased by $1.4 million or 69.1%. The increase was primarily attributable to a full year of contract manufacturing business as compared to only six months in fiscal 2007, resulting from the acquisition of Integrated BioSciences, Inc. in January 2007.
Cost of sales. Cost of sales increased by $0.9 million or 57.3%. The increase was primarily attributable to a full year of contract manufacturing business as compared to only six months in fiscal 2007, resulting from the acquisition of Integrated BioSciences, Inc. in January 2007.
Research and development expenses. Research and development expenses increased by $0.3 million, or 100.8% primarily as a result of additional expenditures related to the development of our Unifill syringe.
Selling, general and administrative expenses. Selling, general and administrative expenses increased by $1.7 million or 26.4%. The increase is attributable to a full year of contract manufacturing business as compared to only six months in fiscal 2007, resulting from the acquisition of Integrated BioSciences, Inc. in January 2007. The increase is also attributable to a $0.3 million increase in non-cash compensation expense, which is included in selling general and administrative expense.
Depreciation and amortization expense. Depreciation and amortization expense increased by $0.5 million or 276.3%, which was primarily attributable to the acquisition of Integrated BioSciences, Inc. in January 2007.

 

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Impairment of property, plant and equipment and associated loss on sale. During fiscal 2007, we ceased operations at an Australian facility and made the determination not to relocate the manufacturing equipment to the new U.S. facility. As a result, we recorded an impairment on property, plant and equipment of $0.5 million. We sold the equipment and recorded a loss of $1.6 million.
Interest expense. Interest expense decreased by $0.1 million, primarily as a result of lower interest expense related to the convertible notes issued during December 2006, as a majority of the notes were converted during fiscal 2007.
Interest income. Interest income increased by $0.1 million, primarily as a result of fluctuations in interest rates.
Other expense (income). Other income during fiscal 2008 and 2007 was $0.1 million.
Income taxes. Due to the significant net operating losses recorded over the recent years, we fully offset any related income tax benefits with increases to our valuation allowance, thereby resulting in no income tax provision or benefit recorded for either year.
Loss per share. Due to the factors described above, net losses for the years ended June 30, 2008 and 2007 were $8.5 million and $9.0 million, respectively, with both basic and diluted losses per share totaling $0.26 and $0.38, respectively, on weighted average shares outstanding of 32,938,477 and 23,413,811 respectively. The increase in weighted average shares outstanding is due to issuances of common stock related to the private placement and conversion of convertible debt into common stock during fiscal 2008.
Liquidity and Capital Resources
To date, we have funded our operations primarily from a combination of equity issuances by UMSL prior to the redomiciliation, borrowings under our bank term loans and payments from sanofi-aventis under our exclusive licensing and industrialization agreements. UMSL raised $2.2 million from its initial public offering in Australia in 2002, and since that offering, UMSL raised an aggregate of $31.9 million through private placements of ordinary shares. As of September 30, 2009, cash and cash equivalents were $4.0 million and our long-term debt was $3.0 million. As of June 30, 2009, cash and cash equivalents were $3.6 million and our long-term debt was $3.1 million. As described above under “Recent Equity Financing,” since July 1, 2009, we have also raised approximately A$32.1 million in equity financing. We also expect to receive $5.2 million in assistance from the Commonwealth of Pennsylvania and 5.5 million of additional milestone-based payments from sanofi-aventis under the industrialization agreement during fiscal 2010. We believe that our cash on hand, together with the amount described above will be sufficient to fund our operations and business expansion activities (other than the full development of a new manufacturing facility) through the next 12 months.
We are in the process of developing a new manufacturing facility in central Pennsylvania. We estimate the total cost of the development to be approximately $26.0 million. We intend to fund approximately $9.0 million of the cost from our own cash reserves and seek external financing for up to approximately $17.0 million for construction during the next 12 months.
We expect to fund the costs of the redomiciliation through cash from operations and cash on hand. These expenditures will be expensed as incurred. Additionally, we will incur increased costs as a result of becoming a U.S. reporting company, primarily in areas of human resources, tax, risk management, accounting and financial reporting, investor relations, legal and other services.
We expect that the costs we will incur in connection with the completion of our industrialization program will be offset by the revenue we earn under the industrialization agreement with sanofi-aventis.
The following table summarizes our cash flows during the three months ended September 30, 2009 and 2008 and for the fiscal years ended June 30, 2009, 2008 and 2007:
                                         
    Three months ended September 30,     Year ended June 30,  
  (in thousands)  
    2009     2008     2009     2008     2007  
Net cash provided by (used in):
                                       
Operating activities
  $ 2,119     $ 11,290     $ 6,795     $ (7,623 )   $ (5,010 )
Investing activities
    (1,735 )     (98 )     (2,912 )     (624 )     (2,355 )
Financing activities
    346       (3,056 )     (3,265 )     7,882       8,378  

 

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Three Months Ended September 30, 2009 compared to Three Months Ended September 30, 2008
Net Cash Provided by Operating Activities
Net cash provided by operating activities during the three months ended September 30, 2009 was $2.1 million compared to $11.3 million during the three months ended September 30, 2008. The decrease in cash flow was primarily due to the 2008 receipt of $12.7 million under the exclusive licensing agreement with sanofi-aventis.
Net Cash Used in Investing Activities
Net cash used in investing activities increased by $1.6 million during the three months ended September 30, 2009, primarily due to costs incurred in connection with the purchase of machinery related to the pilot lines for our Unifill syringe.
Net Cash Provided by (Used in) Financing Activities
Net cash provided by financing activities during the three months ended September 30, 2009 was $0.3 million compared to net cash used in financing activities of $3.1 million during the three months ended September 30, 2008. During the three months ended September 30, 2009, we received $0.5 million from the issuance of common stock upon the exercise of stock options and made $0.1 million in principal payments on our long-term debt. During the three months ended September 30, 2008, we elected to terminate a licensing agreement that we determined was no longer consistent with our business strategies, and, as a final settlement, we repaid $2.3 million of the $3.0 million that we had originally received in 2008 under the licensing agreement, while retaining $0.7 million to cover related legal fees.
Fiscal Year 2009 Compared to Fiscal Year 2008
Net Cash Provided by (Used in) Operating Activities
Net cash provided by operating activities during fiscal 2009 was $6.8 million compared to net cash used in operating activities $7.6 million during fiscal 2008. The increase in cash flow was primarily due to $10.4 million of higher net income after adding back depreciation and amortization and share-based compensation expense. The increase was also attributable to $9.8 million of deferred revenue recorded in connection with our exclusivity agreement with sanofi-aventis, which was partially offset by amounts due from sanofi aventis under our industrialization agreement. Theses agreements were entered into during fiscal 2009.
Net Cash Used in Investing Activities
Net cash used in investing activities increased by $2.3 million, primarily due to significant costs incurred in connection with the production of machinery used in the manufacturing of our Unitract 1 mL Syringe. Additionally, during fiscal 2009, we incurred significant leasehold improvement costs at our Lewisberry, Pennsylvania headquarters and manufacturing facility.
During fiscal 2010, we expect to incur capital expenditures of approximately $12.0 million to purchase machinery required to manufacture our Unifill syringe and approximately $1.5 million to purchase machinery for the production of our Unitract 1 mL syringe. We may incur additional, less significant capital expenditures for general equipment, furniture and fixtures.
Net Cash (Used in) Provided by Financing Activities
Net cash used in financing activities was $3.3 million during fiscal 2009 compared to net cash provided by financing activities of $7.9 million during fiscal 2008. During fiscal 2009, we elected to terminate a licensing agreement that we determined was no longer consistent with our business strategies, and, as a final settlement, we repaid $2.3 million of the $3.0 million that we had originally received in 2008 under the licensing agreement, while retaining $0.7 million to cover related legal fees. During fiscal 2008, we received $2.8 million from the issuance of common stock and $1.9 million from the issuance of convertible debt.
Fiscal Year 2008 Compared to Fiscal Year 2007
Net Cash Used in Operating Activities
Net cash used in operating activities was $7.6 million during fiscal 2008 as compared to $5.0 million during fiscal 2007. The increase in cash flow was primarily due to $0.9 million of lower income after adding back depreciation and amortization, share-based compensation expense, impairment and a loss on the sale of property, plant and equipment in connection with the closing of a factory in Australia.
Net Cash Used in Investing Activities
Net cash used in investing activities decreased by $1.7 million during fiscal 2008 due to a decrease in the purchase of property, plant and equipment. During fiscal 2007, we incurred significant up-front fees in connection with the production of our machinery used to manufacture our 1 mL syringe.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $7.9 million during fiscal 2008 compared with $8.4 million during fiscal 2007. During fiscal 2008, we received $2.8 million from the issuance of common stock and $1.9 million from the issuance of convertible debt. During fiscal 2007, we received $3.5 million and $4.4 million from the issuance of common stock and convertible debt, respectively.

 

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Contractual Obligations
The following table provides information regarding our contractual cash obligations as of June 30, 2009:
                                         
    Payments Due by Period  
    Total     Less Than
1 Year
    1-3 Years     3-5 Years     More Than
5 Years
 
    (In Thousands)  
Long-term debt
  $ 3,133     $ 405     $ 653     $ 541     $ 1,534  
Interest
    811       148       222       170       271  
Operating leases
    1,253       455       755       43        
 
                             
Total contractual cash obligations
  $ 5,197     $ 1,008     $ 1,630     $ 754     $ 1,805  
 
                             
Our term loans bear interest at a rate of prime plus 1.50%. The future contractual cash obligations for interest is based upon 4.75%, which is the prime rate as of June 30, 2009 (3.25%) plus 1.50%.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as such term is defined in the SEC rules.
Recently Issued Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (“SFAS”) No. 168, “The FASB Accounting Standards CodificationTM and the Hierarchy of Generally Accepted Accounting Principles - - a replacement of FASB Statement No. 162” (“SFAS 168”). SFAS 168 represents the last numbered standard issued by the FASB under the old (pre-codification) numbering system, and amends the GAAP hierarchy. On July 1, 2009, the FASB launched its new codification (i.e. the FASB Accounting Standards Codification). The codification supersedes existing GAAP for nongovernmental entities. This Codification is effective for financial statements issued for interim and annual periods ending after September 15, 2009. We have adopted this Codification during our quarter ended September 30, 2009.
In December 2007, the FASB issued a new accounting standard included in ASC 805, Business Combinations, formerly SFAS No. 141 (revised), “Business Combinations.” ASC 805 significantly changes the accounting and disclosure requirements for business combinations. ASC 805 is effective for business combinations occurring in fiscal years beginning after December 15, 2008. ASC 805 will be applied prospectively to business combinations with an acquisition date on or after the effective date. The impact that the adoption of ASC 805 will have on our consolidated financial statements will be dependent upon the extent of future business combinations.
In December 2007, the FASB issued a new accounting standard included in ASC 810, Consolidation, formerly SFAS No. 160, “Non controlling Interests in Consolidated Financial Statements — and amendment of Accounting Research Bulletin No. 51”. This new standard establishes accounting and reporting standards for the non controlling interest in a subsidiary and for the deconsolidation of a subsidiary. ASC 810 is effective for financial statements issued for fiscal years beginning after December 15, 2008. We currently have no noncontrolling interests and therefore, do not believe that the adoption of ASC 810 will have a material impact on our consolidated financial statements.
In April 2008, the FASB issued a new accounting standard included in ASC 350 Intangibles - Goodwill and Other, formerly FASB Staff Position (“FSP”) No. 142-3, “Determination of the Useful Life of Intangible Assets”. This new standard amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS Statement 142,”Goodwill and Other Intangible Assets”. This new standard also provides guidance for expanded disclosures related to the determination of intangible asset useful lives and is effective for fiscal years beginning after December 15, 2008. Early adoption is prohibited. We do not believe that the adoption of this new standard will have a material impact on our consolidated financial statements.
In June 2008, the FASB issued a new accounting standard included in ASC 260, Earnings Per Share, formerly FSP No. EITF 03-6-1, “Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities”. This new standard states that unvested share-based payment awards that contain nonforfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are participating securities and shall be included in the computation of earnings per share pursuant to the two-class method and is effective for fiscal years beginning after December 15, 2008. We do not believe that the adoption of this new standard will have a material impact on our consolidated financial statements.
In May 2009, the FASB issued a new accounting standard included in ASC 855, Subsequent Events, formerly SFAS No. 165, “Subsequent Events.” ASC 855 sets forth: 1) the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements; 2) the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements; and 3) the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. ASC 855 is effective for interim and annual periods ending after June 15, 2009.
In August 2009, the FASB issued Accounting Standards Update No. 2009-05, Fair Value Measurements and Disclosures (Topic 820)—Measuring Liabilities at Fair Value, which provides guidance on how to measure liabilities at fair value in circumstances in which a quoted price in an active market for the identical liability is not available. This update is effective for the first reporting period, including interim periods, beginning after issuance. We have no liabilities that are governed by this update but will apply its provisions in the future as applicable.

 

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Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risk from changes in interest rates and foreign currency exchange rates. Changes in these factors could cause fluctuations in our results of operations and cash flows.
Interest Rate Risk
Our exposure to interest rate risk is limited to our cash that is invested in money market funds with highly liquid short term investments and our variable interest rate term loans. We currently do not utilize derivative instruments to mitigate changes in interest rates.
Foreign Currency Exchange Rate Fluctuations
The majority of our revenues are derived from payments under our industrialization agreement received in euros while we incur most of our expenses in U.S. dollars and Australian dollars. For U.S. reporting purposes, we translate all assets and liabilities of our non-U.S. entities into U.S. dollars using the exchange rate as of the end of the related period and we translate all revenues and expenses of our non-U.S. entities using the average exchange rate during the applicable period. We currently do not utilize options or forward contracts to mitigate changes in foreign currency exchange rates.
Item 3.   Properties
We currently lease approximately 50,000 square feet of a building in Lewisberry, Pennsylvania under an operating lease expiring in August 2012 of which approximately 6,000 square feet are being used as our executive offices and the remaining 44,000 square feet are being used as our manufacturing facility and warehouse. The manufacturing facility is an FDA-registered medical device production facility. This facility has two class-eight clean rooms. The first clean room houses a fully automated assembly system used to manufacture our Unitract 1mL syringes. The other clean room is used to assemble non-proprietary medical devices under contract for outsourcing customers. Other areas of the manufacturing facility are used for offices, product design and prototyping, engineering activities and the construction of automated assembly systems.
We have also entered into a short-term lease for a small office building near our main facility. This office building is used for engineering and product development.
We also occupy an office of 1,100 square feet in Sydney, Australia under a lease expiring in May 2010. This office space is used for certain finance and administrative operations in Australia.
Development of New Global Headquarters and Manufacturing Facility
To support our business expansion activities, we are in the process of developing a new global headquarters and manufacturing facility in Pennsylvania in order to accommodate our projected demand for the Unifill syringe. We purchased a tract of land on which we intend to develop our own custom-built facility in conjunction with Keystone Redevelopment Group LLC, or Keystone, a Pennsylvania-based real estate company specialising in large scale redevelopment and complex economic development projects. The following paragraphs summarize the key aspects of the proposed development of the new facility.
Acquisition of Property
We, through Unilife Cross Farm, LLC, or Unilife CF, our newly formed subsidiary, acquired a 38 acre block of land in York County, Pennsylvania from Greenspring Partners, LP on November 16, 2009 for a purchase price of $2.0 million for the purposes of developing the new facility. The site is located approximately 9.5 miles from our current premises in Lewisberry, Pennsylvania.
Development Agreement
On December 14, 2009, Unilife CF entered into a development agreement with Keystone to develop the newly acquired property by constructing an approximately 165,000 square foot office, manufacturing, warehousing and distribution facility to our specifications. The new facility is initially intended to accommodate Unifill automated assembly lines with a combined annual capacity of 360 million units per year, as well as the Unitract 1mL automated assembly line and other contract manufacturing systems currently situated at our Lewisberry facility. The new facility will also include a 54,000 square foot office section that will function as our global headquarters and support administrative, marketing, new product development, quality laboratories and other operational functions.
The new facility has been designed to allow for an additional 100,000 square feet of contiguous production space to be constructed when required at a later date by us. Upon this additional expansion occurring, it will provide us with the space required to produce up to one billion syringes annually via the installation of additional Unifill assembly lines. Although this additional expansion of the new facility forms part of the current planning approvals that have been received by us, it is not part of the current development activity nor is it covered or included in the contracts referred to in the development, construction and design agreements described herein.
Unilife CF has appointed Keystone to provide services under the development agreement including, but not limited to:
  assisting in the selection, review and management of architects, engineers, designers, contractors and other experts and consultants engaged to assist in the development of the new facility;
  assisting Unilife CF in obtaining financing for the development of the new facility;
  monitoring all development and construction work undertaken in connection with the development of the new facility; and
  assisting in obtaining all necessary approvals, licenses, permits, certificates and authorisations from all governmental authorities that are required for the new facility.
Unilife CF has agreed to pay Keystone $0.8 million as the development fee for the provision of these services, which is payable in the following tranches:
  $50,000 was paid in connection with the execution of the development agreement;
  $0.2 million will be paid to Keystone in six equal monthly installments commencing January 1, 2010 and ending on June 1, 2010;
  $0.2 million will be paid to Keystone upon Unilife CF obtaining access to the new facility to install production equipment; and
  $0.3 million will be paid to Keystone on the issue of the certificate of occupancy evidencing permission to commence general occupancy of the new facility and compliance with all applicable building codes affecting the new facility.
Construction Agreement
On December 14, 2009, Unilife CF entered into a Construction Agreement with HSC Builders & Construction Managers (HSC) of Pennsylvania, to construct the new facility. HSC is a Pennsylvania-based company that specialises in building custom-designed facilities for biotech, academic, healthcare, pharmaceutical and technology companies.
HSC has been engaged by Unilife CF under the construction agreement as the construction manager and constructor of the new facility. Under the construction agreement, Unilife CF is required to pay for the cost of construction (as defined in the construction agreement) estimated to be approximately $21.4 million (Cost of Work), together with HSC’s fee, subject to a Guaranteed Maximum Price (GMP) as described below.
HSC’s fee for constructing the new facility will be an amount equal to 1.25% of the Cost of Work (which is approximately $0.3 million (HSC Fee) assuming the Cost of Work is $21.4 million). The GMP has been established at $21,700,000 (comprising HSC’s Fee and the Cost of Work). Except for certain items beyond the control of Unilife CF or HSC, or items changed at the option of Unilife CF, any construction costs which exceed the GMP will be the responsibility and liability of HSC.
In the event that the final actual construction costs are less than the GMP, such savings will be shared between Unilife CF and HSC on an 85% / 15% basis.
Unilife CF has also agreed under the construction agreement to pay HSC a performance bonus of 15% of the HSC Fee if it achieves Phase 1 (see below) of the construction by April 15, 2010 and another 15% bonus of the HSC Fee if it achieves Phase 2 (see below) of the construction by December 10, 2010.
The fees payable to HSC and the Cost of Work as set out above, have been accounted for in the US$26 million budget for the development of the new facility (as detailed below).
The projected timetable for the construction of the new facility to be undertaken by HSC is as follows:
     
Date   Activity
By the end of June 2010
  Completion of utility rooms for equipment installation
By the end of October 2010
  Completion of clean rooms for equipment installation (Phase 1)
By the end of October 2010
  Temporary occupancy permit for
manufacturing/warehouse
By the end of December 2010
  Unrestricted occupancy permit for
manufacturing/warehouse (Phase 2)
By the end of December 2010
  Unrestricted occupancy permit for office
Design Agreement
In connection with the development of the new facility, we retained L2 Architecture, or L2, to provide architectural design and structural, mechanical and electrical engineering services for the new facility. L2 is a Philadelphia-based architectural and engineering design firm that specializes in the pharmaceutical and medical device sector.
The design created by L2 incorporates the latest innovations in personnel and material flow dynamics with the intention of maximising the industrial productivity of the site while ensuring compliance with the highest standards of good manufacturing practice.
L2’s fee for the architectural services it will be providing to us in respect of the project will be $1.56 million. In the event that additional services are required beyond the contracted services agreed between us and L2, we will be required to pay L2 for such services on an hourly basis. The fees payable to L2 have been accounted for in the budget for the development of the new facility (as detailed below).
Proposed Financing of the Development
We have prepared a detailed budget for developing the new facility and based on this budget the total cost is estimated to be approximately $26.0 million. This includes the projected construction costs, the projected manufacturing facility fit out costs and the fees payable to Keystone, HSC and L2.
We have provided for $8.0 million — $10.0 million in projected capital expenditure to be used towards the development of the new facility. At this stage, we intend to fund up to approximately $9.0 million of the development costs for the new facility out of our existing cash reserves, which includes amounts received in connection with our October and November 2009 equity financings and will seek external financing for up to approximately $17.0 million from a commercial bank or other lending institution in the US and/or from the Commonwealth of Pennsylvania or other federal and state bodies.
Under the development agreement, Keystone is required to assist Unilife CF in obtaining external finance, on terms that are satisfactory to Unilife CF, for $18.0 million (or less if that amount is not required). In the event that Keystone is unable to assist Unilife CF in obtaining commitments for the required financing on or before December 31, 2009, Unilife CF may terminate the development agreement without any further obligation to Keystone unless negotiations with lenders (satisfactory to Unilife CF) are ongoing as at that date in which case the deadline will be extended during the period of such negotiations. Unilife CF’s right to terminate the development agreement will expire in the event that the full financing commitments are obtained as a result of such negotiations. The development agreement will otherwise terminate on the issue of the certificate of occupancy evidencing permission to commence general occupancy of the new facility and compliance with all applicable building codes affecting the new facility. In the event that Keystone is unable to meet its commitments, we believe that we can secure an alternative development partner.
We are currently in discussions with a number of banks, government agencies and other interested parties with respect to the required financing for the project.
Sale of Minority Interest in Unilife Cross Farm LLC
In connection with the development of the new facility, Unilife CF has agreed to issue to a subsidiary of Keystone, Cross Farm, LLC, a 1% interest in Unilife CF for $90,000 and Unilife Corporation has entered into an operating agreement with Cross Farm LLC with respect to the operation and management of Unilife CF as the development company for the new facility.
Unilife CF has retained a call option over the minority interest which it can exercise at any time during the first five years after completion of the sale of the minority interest for a purchase price prescribed under the agreement. However, if certain events occur such as the sale of the new facility, a change of control of the Unilife entities (excluding pursuant to the proposed redomiciliation transaction) or a breach by Unilife CF of the terms of the development agreement, the call option will be accelerated and the minority interest must be repurchased by Unilife CF at the prescribed price upon such events occurring.
Item 4.   Security Ownership of Certain Beneficial Owners and Management
The following table sets forth information regarding ownership of our common stock as of September 30, 2009 by (i) each person, or group of affiliated persons who is known by us to beneficially own 5% or more of our common stock, (ii) each of our directors, (iii) each of our named executive officers and (iv) all current directors and executive officers as a group. All of this information gives effect to the redomiciliation and the share consolidation effected in connection therewith.

 

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Beneficial ownership is determined according to the rules of the SEC and generally includes any shares over which a person exercises sole or shared voting or investment power. The beneficial ownership percentages set forth below are based on 37,010,802 shares of common stock outstanding on September 30, 2009. All shares of common stock owned by such person, including shares of common stock underlying stock options that are currently exercisable or exercisable within 60 days after September 30, 2009 (all of which we refer to as being currently exercisable) are deemed to be outstanding and beneficially owned by that person for the purpose of computing the ownership percentage of that person, but are not considered outstanding for the purpose of computing the percentage ownership of any other person. Except as otherwise indicated, to our knowledge, each person listed in the table below has sole voting and investment power with respect to the shares shown to be beneficially owned by such person, except to the extent that applicable law gives spouses shared authority.
                 
    Number of Shares     Percentage of Shares  
Name and Address of Beneficial Owner   Beneficially Owned     Beneficially Owned  
Directors and Named Executive Officers (1)
               
Jim Bosnjak
    494,000 (2)     1.3 %
Alan Shortall
    2,992,296 (3)     8.1 %
John Lund
    16,667       *  
William Galle
    33,333 (4)     *  
Jeff Carter
    472,345 (5)     1.3 %
Daniel Calvert
    83,333 (6)     *  
Eugene Shortall
    125,000 (7)     *  
Bernhard Opitz
    83,998 (8)     *  
Stephen Allan
    144,892 (9)     *  
All directors and executive officers as a group (10 persons)
    4,513,197       12.2 %
     
*   Indicates less than 1%
 
(1)   The address of each director and executive officer listed above is c/o Unilife Corporation, 633 Lowther Road, Lewisberry, Pennsylvania 17339.
 
(2)   Includes options to purchase 166,667 shares of common stock which are currently exercisable. Does not include options to purchase 166,667 shares of common stock which are not currently exercisable.
     
(3)   Includes (i) 1,666,667 shares of common stock subject to certain transfer restrictions set forth in Mr. Shortall’s employment agreement dated October 26, 2008 and (ii) options to purchase 500,000 shares of common stock which are currently exercisable. Does not include options to purchase 750,000 shares of common stock which are not currently exercisable.
     
(4)   Represents options to purchase 33,333 shares of common stock which are currently exercisable. Does not include options to purchase 58,333 shares of common stock which are not currently exercisable.
 
(5)   Includes options to purchase 416,667 shares of common stock which are currently exercisable.
 
(6)   Represents options to purchase 83,333 shares of common stock which are currently exercisable. Does not include options to purchase 166,667 shares of common stock which are not currently exercisable.
 
(7)   Represents options to purchase 125,000 shares of common stock which are currently exercisable.
 
(8)   Includes options to purchase 83,333 shares of common stock which are currently exercisable. Does not include options to purchase 166,667 shares of common stock which are not currently exercisable.
 
(9)   Includes options to purchase 142,500 shares of common stock which are currently exercisable. Does not include options to purchase 116,667 shares of common stock which are not currently exercisable.

 

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Item 5.   Directors and Executive Officers
The following table sets forth the name, age and position of each of our directors and executive officers.
             
Name   Age   Position
Jim Bosnjak
    60     Chairman and Director
Alan Shortall
    55     Director and Chief Executive Officer
John Lund
    44     Director
William Galle
    70     Director
Jeff Carter
    51     Director
Daniel Calvert
    55     Chief Financial Officer
Eugene Shortall
    58     Senior Vice President of RTFS
Bernhard Opitz
    52     Senior Vice President of Operations
Mark Iampietro
    56     Vice President of Quality and Regulatory Affairs
Stephen Allan
    35     Vice President of Marketing and Communications
Biographical Summaries
Jim Bosnjak. Mr. Bosnjak has served as a director of UMSL since February 2003 and of Unilife Corporation since November 2009 and as Chairman of the board of UMSL since April 2006 and of Unilife Corporation since November 2009. Mr. Bosnjak has been a co-owner and director of the Le Meridian Lav Hotel in Split, Croatia since 2002 and is chairman and co-founder of Ultimate Outdoor Ltd., an Australian outdoor advertising company. Mr. Bosnjak was a director of Westbus Pty Ltd. from 1975 to 2001 and the chairman of Westbus Pty Ltd. between 1990 and 2001. He has also held positions on Commonwealth and New South Wales advisory bodies, including the Greater Western Sydney Economic Development Board, and the GROW Employment Council. Mr. Bosnjak also served as the Chairman of the Tourism Council of Australia and Bus 2000, which coordinated bus services for the Sydney 2000 Olympic Games. Mr. Bosnjak holds an honorary doctorate from the University of Western Sydney for his services related employment growth and economic development.
Alan Shortall. Mr. Shortall has served as Chief Executive Officer and director of UMSL since September 2002 and of Unilife Corporation since July 2009. Mr. Shortall co-founded Unilife in July 2002 and has guided the growth of Unilife since then. In 2008, the trade magazine Medical Device and Diagnostic Industry named him as one of 100 Notable People in the medical device industry worldwide. Mr. Shortall is the brother of Eugene Shortall, our Senior Vice President of RTFS, our Unifill syringes.
John Lund. Mr. Lund has served as a director of UMSL and Unilife Corporation since November 2009. Mr. Lund also serves as managing partner of M&A Holdings, LLC, a private consulting company since July 2003, and as Vice President Finance and Controller of E-rewards, Inc., an internet market research company since February 2009. Mr. Lund also served as Vice President and Controller of Nexstar Broadcasting Group, Inc., a NASDAQ listed television broadcasting company, from March 2008 to November 2008, Vice President of Finance and Corporate Controller of LQ Management, LLC (LaQuinta) from November 2006 to March 2008, and Corporate Controller of ExcellerateHRO from January 2005 to October 2006. Prior to that, Mr. Lund held Controller and Chief Financial Officer positions for various companies, and was a Manager at KPMG.
William Galle. Mr. Galle has served as a director of UMSL since June 2008 and of Unilife Corporation since November 2009. Mr. Galle has also been the managing director of American Marketing Complex in New York City since October 2007 and president of Diversified Portfolio Strategies LLC in Washington D.C. since 1993, which provides alternative investment advisory services for institutions and substantial investors. Mr. Galle is a graduate of Columbia University, Rutgers University, and the New York Institute of Finance.
Jeff Carter. Mr. Carter has served as a director of UMSL since April 2006 and of Unilife Corporation since November 2009. From February 2005 until December 2008, Mr. Carter served as Chief Financial Officer of UMSL. He has also served as Company Secretary since March 2007. From March 2003 to November 2004, Mr. Carter was the chief financial officer and company secretary of the former Ambri Ltd (currently Diversa Ltd.), a public company in Australia. Mr. Carter is a chartered accountant and holds a master’s degree in applied finance from Macquarie University of Sydney.
Daniel Calvert. Mr. Calvert has served as Chief Financial Officer of UMSL since December 2008 and of Unilife Corporation since our incorporation in July 2009. From September 2006 to November 2008, Mr. Calvert served as executive vice president and chief accounting officer of Standard Management Corporation, a company quoted on the OTC Bulletin Board. From May 2004 to March 2006, he was the chief financial officer of MBT International, a division of a publicly held company. Mr. Calvert is a certified management accountant, holds a Master of Business Administration in finance from Michigan State University and a Master of Science degree in taxation from the University of Baltimore.
Eugene Shortall. Mr. Shortall has served as Senior Vice President of RTFS of UMSL since February 2009 and of Unilife Corporation since November 2009. From October 2007 to February 2009 he served as our RTFS Project Director. From June 2003 to October 2007, Mr. Shortall was a consultant for the Public Institute for Social Security in Kuwait and was previously employed as a consultant for Behbehani National Construction. Mr. Shortall is the brother of Alan Shortall, our Chief Executive Officer and director.

 

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Bernhard Opitz. Mr. Opitz has served as Senior Vice President of Operations of UMSL since December 2008 and of Unilife Corporation since November 2009. From August 2007 to June 2008, Mr. Opitz served as Vice President — Manufacturing at Nanosphere, Inc., a Nanotechnology-based molecular diagnostics company. From December 2002 to July 2006, he was the Vice President - Engineering/Operations at Wells’ Dairy, Inc., a large manufacturer of ice cream. From September 2000 to April 2002, he was Senior Vice President of Operations at Ikonisys Inc., a cell-based diagnostics company. From 1980 to 2000, Mr. Opitz also held various positions at Bayer AG including project engineer, manager of plant engineering, manager of engineering, production manager, vice president of operations, and senior vice president of engineering. Mr. Opitz holds a Master of Science degree in mechanical/process engineering from Technical University Graz in Austria.
Mark Iampietro. Mr. Iampietro has served as Vice President of Quality and Regulatory Affairs of UMSL since October 2008 and of Unilife Corporation since November 2009. From May 2002 to July 2008, Mr. Iampietro was Vice President of Quality, Regulatory and Clinical Operations at Spherics, Inc., a pharmaceutical manufacturer, where he managed various phases of quality, regulatory, and clinical programs. Mr. Iampietro holds American Society for Quality certifications as both a quality and reliability engineer and holds a Bachelor of Science degree in life sciences with a minor in engineering from Worcester Polytechnic Institute.
Stephen Allan. Mr. Allan has served as Vice President of Marketing and Communications of UMSL since October 2008 and of Unilife Corporation since November 2009. He served as our Director of Communications from November 2007 to October 2008 and our Manager of Communications from July 2002 to November 2007. Prior to joining Unilife, Mr. Allan owned and operated his own Australian public relations firm, which assisted in the management of media relations and government liaison for industry groups in the transport, tourism and economic development sectors. He managed media liaison activities relating to bus transportation during the Sydney 2000 Olympic Games. He also spent five years as a journalist for various Sydney-based newspaper groups. Mr. Allan holds a Bachelor of Communications from Charles Sturt University.
Item 6.   Executive Compensation
COMPENSATION DISCUSSION AND ANALYSIS
Introduction
This Compensation Discussion and Analysis describes our compensation philosophy for those individuals who were our most highly compensated executives based on their fiscal 2009 compensation. These executives are referred to herein as “named executives”. Where applicable, this Compensation Discussion and Analysis also describes the ways in which we anticipate that our compensation philosophy may change after we become a U.S.-based public company.
During 2008, in anticipation of the relocation of our headquarters and principal operations from Australia to the United States, the board of directors granted Alan Shortall, our Chief Executive Officer, broad discretion to hire a new U.S.-based executive management team and to set the initial terms of their employment. In furtherance of this mandate, during fiscal 2009 Mr. Shortall assembled a new management team whose members joined us at various times during calendar year 2008 and 2009. In addition, Mr. Shortall, together with Stephen Allan, who had been with us since 2002, relocated to the United States in early 2009.
Our named executives are:
  Alan Shortall, who is our Chief Executive Officer;
  Jeff Carter, who was our Chief Financial Officer until December 2008;
  Daniel Calvert, who became our Chief Financial Officer in December 2008;
  Eugene Shortall, who became our Senior Vice President, RTFS in February 2009;
  Bernhard Opitz, who became our Senior Vice President of Operations in December 2008; and
  Stephen Allan, who became our Vice President of Marketing and Communications in October 2008.
During the process of assembling the new executive management team, our Chief Executive Officer negotiated on an arm’s length basis with each of our new named executives with respect to the terms of his compensation package and, in the case of Mr. Allan, the terms of his compensation package upon relocating to the United States. In each case, Mr. Shortall considered the individual’s prior relevant experience and compensation levels, as well as his prospective roles and responsibilities with our Company. Due in part to the necessity of assembling an entirely new team in a short amount of time, Mr. Shortall did not conduct a formal survey of compensation paid by other companies, but rather conducted these negotiations using his best judgment of what would constitute an appropriate compensation package. After reaching agreement with the prospective named executives, Mr. Shortall presented the compensation packages to the board of directors which agreed to the terms. The terms of the compensation packages were ultimately memorialized in agreements which we describe below under — “Employment Offer Letters, Employment Agreements and Consultancy Agreements.”
Historically, we did not have a separate compensation committee of the board of directors. Determinations regarding the compensation of our Chief Executive Officer, other executive officers and non-employee directors were made by the entire board of directors. Under ASX listing rules, board compensation and stock incentive compensation for executives is put to a vote of shareholders. After we become a Nasdaq-listed company, we will continue to be subject to these rules so long as we remain listed on the ASX. In preparation for our Nasdaq listing, we recently established a compensation committee which will consider and approve executive compensation as required by Nasdaq rules.

 

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Objectives of the Compensation Program
The primary objective of our executive compensation program is to deliver a competitive package to attract, motivate and retain key executives and align their compensation with our overall business goals, core values and shareholder interests. To this end, our board of directors followed an executive compensation philosophy that included the following considerations:
  a “pay-for-performance” orientation that delivers pay based on company and individual performance;
  long-term incentives, including stock-based awards, to more closely align the interests of executives and shareholders; and
  individual wealth accumulation through long-term incentives, rather than through pensions.
We expect that our compensation committee will establish a similar executive compensation philosophy with respect to our named executives following redomiciliation. We expect that our primary compensation objectives will be to reinforce consistent attainment of Unilife’s key strategic goals and to retain the executive talent we have hired.
The Design of the Compensation Program
Compensation for our named executives has included the following elements:
  base salary;
  annual cash incentives and discretionary bonuses;
  long-term incentives in the form of stock options and stock awards; and
  other benefits and perquisites.
We expect that our executive compensation program will continue to include these elements going forward following our redomiciliation. In addition, we expect our future compensation program to include grants of restricted stock which we could not issue as an Australian company. When making compensation-related decisions, we believe it is important to be informed about the current practices of similarly situated public companies. For this purpose, the board of directors has retained a compensation consulting firm, Strategic Apex Group LLC, or Strategic Apex, to assist our compensation committee in developing an appropriate comparator group for benchmarking. We currently expect that this comparator group will consist of companies in the medical device industry as well as companies in the mid-Atlantic region of the United States. We also expect that Strategic Apex will assist the compensation committee in developing performance metrics and long-term incentives for the named executives to ensure that key strategic goals are met and that the interests of key decision makers and shareholders are aligned. The goals of our compensation program for our named executives are to provide total direct compensation that is appropriate for an organization of our size and stage of development and that will support continued recruitment of top talent and retention of the executive team we have built over the last 18 months, as well as to reward achievement of key strategic goals and to align executive compensation with shareholder interests. We expect to evaluate individual performance in determining increases to base salary and awarding annual incentive compensation and future equity grants. We will also consider employment agreement terms and internal pay equity within the executive team. When considering internal pay equity, we will consider the reported market rate for these positions and total direct compensation of other executives who have a similar level of responsibility at the Company.
Elements of Compensation

 

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Base Salary
Base salary is an important element of compensation because it provides the named executives with a base level of income. Our board of directors negotiated the base salary of our Chief Executive Officer in connection with the employment agreement that we entered into with him in October 2008. Our board of directors set our Chief Executive Officer’s base salary at a level that the board believed was commensurate with our Chief Executive Officer’s skills, knowledge and duties. As described above, the initial base salary of each named executive (other than our Chief Executive Officer) was negotiated by our Chief Executive Officer with such executive during the hiring process of Messrs. Calvert and Opitz and, in the case of Eugene Shortall and Mr. Allan, in connection with their relocation to the United States.
Our compensation committee will determine whether and when to adjust the base salaries of the named executives in the future. We expect that our compensation committee will consider each executive’s performance and level of responsibility and market data for similar positions.
Annual Cash Incentive Compensation
Our Chief Executive Officer’s annual cash incentive award is a discretionary award up to a maximum amount provided for in his employment agreement. The amount of this award is determined by our board of directors based on satisfaction of key performance indicators, or KPIs, determined by our board of directors. Going forward, our compensation committee will set the KPIs of our Chief Executive Officer, review his performance and determine the amount of any annual incentive compensation earned by him.
As more fully described in the footnotes to the grants of plan-based awards table, each of Messrs. Calvert and Opitz were entitled pursuant to the terms of his employment offer letter to receive a cash incentive award, for calendar year 2009, and for the portion of calendar year 2008 during which he was employed with us, at the target level specified in his employment offer letter, if his performance satisfies certain KPIs. Our Chief Executive Officer establishes the KPIs for each named executive which are tailored to the named executive’s individual area of responsibility and key strategic goals. Our Chief Executive Officer has broad discretion in interpreting the KPIs and determining the extent to which a particular KPI has been met. In the case of fiscal 2009, the KPIs were established and communicated at various points during the course of the year, as each named executive was hired on a different date. In the future, we expect that KPIs will be established and communicated during the first or second quarter of the applicable performance period.
In respect of fiscal 2009, the following is a summary description of the KPIs for each named executive:
  Alan Shortall - relocation of our corporate headquarters to Lewisberry, Pennsylvania; signing the industrialization agreement with sanofi-aventis; initiation of production of the Unitract 1mL syringe in our FDA registered facility in Lewisberry; and implementation of a new quality system.
  Jeff Carter—transition of finance and accounting functions to U.S.-based personnel and undertaking corporate secretarial and ASX reporting requirements
  Dan Calvert—management of our financial affairs and the development of business plan models and corporate strategy
  Eugene Shortall—management of the ready-to-fill syringe project and completion of key project milestones
  Bernhard Opitz—expansion of our operational, engineering and production personnel
  Stephen Allan—management of our marketing and communications activities
Our board of directors and Chief Executive Officer determined that each of the named executives satisfied their KPIs. Consequently, the named executives received incentive compensation payments at their target levels for fiscal 2009 as reflected in the summary compensation table and grants of plan-based awards table below.
In addition to the incentive compensation awards, we may also provide discretionary cash bonuses to our named executives to reward them for their contribution toward the achievement of significant milestones of the Company. For fiscal 2009, our board of directors decided to pay a discretionary bonus of A$150,000 to our Chief Executive Officer in recognition of his efforts in securing the exclusive licensing agreement with sanofi-aventis in June 2008 and the industrialization agreement with sanofi-aventis in June 2009. Securing these two agreements were important milestones in our long-term business plan.

 

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Commencing in calendar 2010, we expect to adopt an annual incentive plan with terms to be determined by our compensation committee. We expect that our Chief Executive Officer, in consultation with our compensation committee, will establish KPIs that represent key strategic objectives relating to the industrialization of the ready-to-fill syringe, the commercial production and sale of our 1 mL syringe, the further development of a world-class organization and additional products, and building shareholder value. In accordance with our compensation committee’s charter, our compensation committee will evaluate the performance of each named executive in light of his KPIs and will determine the amount of any annual incentive compensation earned by the named executive based on such evaluation.
Long-Term Incentive Compensation
Our long-term incentive compensation has historically been in the form of grants of stock options and stock awards under our Employee Share Option Plan, or ESOP. These grants were designed to provide our executives with multiple awards over a number of years to encourage alignment with shareholder interests and to retain highly valued employees. The ESOP was approved by the shareholders of UMSL in 2007. Our board of directors historically has reviewed the performance of our Chief Executive Officer and determined the equity awards to be granted to him subject to shareholder approval pursuant to Australian law and ASX listing rules. Our Chief Executive Officer historically has reviewed the performance of the other named executives and recommended the equity awards to be granted to them for approval by our board of directors.
We view stock options as an important element of performance-based compensation because a stock option provides no realizable value to a recipient until the vesting requirements have been met and will increase in value only as the trading price of our shares increases. Vesting periods are intended to require a long-term focus on overall Company performance for the executive to realize any value from the exercise of options.
In fiscal 2009, we granted stock options to our named executives as reflected in the grants of plan-based awards table. These stock option grants were made in fulfillment of the terms of each named executive’s respective offer letter or employment agreement. The amount of each stock option grant for the named executives other than our Chief Executive Officer was determined by our Chief Executive Officer in his best judgment during arms’ length negotiation of the employment offer and approved by our board of directors.
In fiscal 2009, we granted stock options and a stock award to our Chief Executive Officer in fulfillment of the terms of his employment agreement. The size and nature of these grants were negotiated at arms’ length by our board of directors and Chief Executive Officer. Our Chief Executive Officer received a stock award in addition to stock options to more fully align his interests with those of our shareholders insofar as under the stock award, our Chief Executive Officer will share in the downside risk and realize an economic loss if our share price declines. As more fully described under —“Guidelines for Share Ownership and Holding Periods for Equity Awards,” restrictions have been placed on our Chief Executive Officer’s right to dispose of the shares received under his stock award.

 

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We have adopted our 2009 Stock Incentive Plan, subject to approval by shareholders. The plan, if approved, will permit us to grant stock options, stock appreciation rights, stock awards, and other stock-based awards and cash awards to employees. Long-term incentive target compensation of each named executive following redomiciliation is expected to be set by our compensation committee based on the named executive’s level of responsibility, peer group data for similar positions and the named executive’s long-term incentive compensation before redomiciliation. We anticipate that the total long-term incentive target multiplier of base salary for each of our named executives will target the 50th percentile of the comparator group that we expect to identify with the assistance of our compensation consultant, aligning with our philosophy of driving wealth accumulation through long-term incentives, and consistent with a business emphasizing high growth and innovation.
Savings Plans
We do not provide for wealth accumulation for retirement through defined benefit pension plans; however, we make superannuation payments of 9% of salary in accordance with Australian law for Australian employees and executives, including those who transferred to the United States. Superannuation is a retirement or pension contribution that is made to a pension fund selected by the employee, and is not available to the employee until retirement. In addition, our U.S. subsidiary, Unilife Medical Solutions, Inc., has a 401(k) plan, without a company match.
We expect to adopt a 401(k) plan to permit executives and other employees to accumulate wealth on a tax-deferred basis. We do not anticipate providing for wealth accumulation for retirement through defined benefit pensions or supplemental executive retirement plans. In addition, while our U.S. subsidiary does not currently make matching or fixed contributions to the balances of employees, including the named executives, under the 401(k) plan, we do expect to adopt a company match in future years.
Other Benefits and Perquisites
The named executives are eligible to participate in employee benefit programs generally offered to our other employees. In addition, we provide certain other perquisites to the named executives that are not generally available to other employees. We also provide temporary housing and other relocation assistance when an executive officer is hired or relocated for business reasons. For more detailed information regarding benefits and perquisites provided to the named executives, see — “Compensation of Named Executive Officers.”

 

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Our compensation committee will review these benefits and perquisites after redomiciliation. We expect that we will continue to offer relocation benefits to newly hired or relocated employees which are competitive and appropriate for their level of responsibility.

 

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Severance
We must comply with Australian legal requirements regarding obtaining shareholder approval of certain severance payments. Severance provisions are set forth in the employment agreements with our named executives, as described under —“Potential Payments Upon Termination or Changes in Control”, with the exception of Mr. Carter who is not entitled to receive severance upon termination of his consultancy agreement with us.
Our compensation committee will consider and develop policies, guidelines or programs with respect to severance benefits after the redomiciliation. We expect to continue the severance obligations under existing employment agreements. We believe that severance benefits allow us to attract and retain talented executives and other employees to accept positions with us and to relocate to our United States headquarters. In establishing these arrangements, we will consider that we do not provide defined benefit pension or supplemental executive retirement plan benefits. The employment agreements currently in place with the named executives have a “double-trigger” feature, mandating cash severance payments on a change of control only if employment is terminated in connection with or following the change of control.
The equity awards under our incentive compensation plans are “single trigger” awards and vest upon a change in control (as defined in the relevant plan). We adopted the single trigger treatment for our long-term compensation plan to be consistent with current market practice.

 

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Policies, Guidelines and Practices Related to Executive Compensation
The Compensation Committee
Our compensation committee will make executive compensation determinations for the named executives, and we anticipate that our executive officers will provide recommendations and support to our compensation committee. In addition, the board of directors has retained Strategic Apex to provide expert executive compensation advice and guidance to the compensation committee. The compensation committee will operate in accordance with a written charter and will be composed of three independent directors who will report their findings and recommendations to our board of directors. In developing a compensation strategy, the compensation committee will pursue the following goals:
  develop an executive compensation policy to support overall business strategies and objectives, attract and retain key executives, link compensation with business objectives and organizational performance, and provide competitive compensation;
  approve compensation for the Chief Executive Officer, including relevant performance goals and objectives, review and approve compensation for other executive officers, and oversee their evaluations;
  make recommendations to our board of directors with respect to the adoption of equity-based compensation plans and incentive compensation plans;
  review the outside directors’ compensation program for competitiveness and plan design, and recommend changes to our board of directors as appropriate;
  oversee the management succession process for our Chief Executive Officer and selected senior executives;
  oversee general compensation plans and initiatives; and
  consult with management on major policies affecting employee relations.

 

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Guidelines for Share Ownership and Holding Periods for Equity Awards
Our Chief Executive Officer is also currently our largest shareholder. Even though we have not had formal stock ownership requirements for our executives, our Chief Executive Officer’s ownership position assists in ensuring that management decisions are aligned with shareholder interests. For the stock award that our Chief Executive Officer received in fiscal 2009, he has agreed that he will not dispose of any of the shares received under that award until at least 12 months after the award was granted, and that he may dispose of no more than 50 percent of those shares until at least 24 months after the award was granted.
We expect our compensation committee to adopt stock ownership guidelines to require our named executives and directors to accumulate and hold a minimum number of shares of our common stock in order to ensure that their interests are aligned with shareholder interests. Decisions about the number of shares and time to accumulate will be made after consideration of best practices in the United States and the advice of our compensation consultant.
Potential Impact on Compensation from Executive Misconduct
Under our incentive plans, our board of directors has the authority to revoke stock option grants of employees who commit misconduct. These provisions are designed to deter and prevent detrimental behavior and permit us to prevent such employees from exercising stock options, which would lapse if that employee has engaged in certain misconduct.
We anticipate that our Compensation Committee will evaluate various “claw-back” options and consider the advisability of adopting such policies as will protect our investors from financial misconduct.

 

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Tax Matters
Section 162(m) of the Internal Revenue Code of 1986, as amended, or the Code, places a limit of $1,000,000 on the amount of compensation that certain publicly held corporations may deduct for U.S. federal tax purposes in any one year with respect to certain named executives. This limitation did not apply to us for fiscal 2009 because, as of June 30, 2009, none of our shares were required to be registered under the Exchange Act.
It is expected that Section 162(m) of the Code will apply to us following the re-domiciliation and that our compensation committee will adopt a general practice of considering the adverse effect of Section 162(m) of the Code on the deductibility of compensation when designing annual and long-term compensation programs and approving payouts under these programs. While the tax treatment of compensation is important, the primary factor influencing program design is the support of business objectives. Consequently, it is expected that our compensation committee will reserve the right to design and administer the programs in a manner that does not satisfy the requirements of Section 162(m) of the Code and to approve the payment of nondeductible compensation if the compensation committee believes doing so may achieve a result determined to be in Unilife’s best interest. Due to transition rules that apply to UMSL under Section 162(m) of the Code, we believe that all of the compensation that will result when our named executives exercise their currently outstanding stock options should be fully deductible.
Compensation Committee Interlocks and Insider Participation
Our compensation committee is composed of three independent directors, namely Jim Bosnjak, John Lund and William Galle. None of the members of the compensation committee has ever been an executive officer or employee of Unilife, UMSL or any of its subsidiaries, or has any relationship with Unilife, UMSL or its executives, other than their directorship and equity interests in UMSL as disclosed in “Item 4. Security Ownership of Certain Beneficial Owners and Management” of this registration statement. During its fiscal 2009, no executive officer of UMSL or Unilife Corporation served on the compensation committee or board of directors of any other entity that had any executive officer who also served on the compensation committee or board of directors of UMSL or Unilife Corporation.
Compensation of Named Executive Officers
The following table provides information regarding total compensation awarded to, earned by, or paid to our named executives.
                                                                         
Summary Compensation Table  
                                        Non-Equity     Nonqualified Deferred              
                            Stock     Option     Incentive Plan     Compensation     All Other        
            Salary     Bonus     Awards ($)     Awards     Compensation     Earnings     Compensation     Total  
Name and Position   Year     ($)     ($)     (1)     ($) (2)     ($) (3)     ($) (4)     ($)     ($)  
 
                                                               
Alan Shortall (5)
                                                                       
Chief Executive Officer
    2009       321,991       144,540     1,810,800       384,035       166,908           142,035 (6)     2,970,309  
Jeff Carter (7)
                                                                       
Former Chief Financial Officer
    2009       185,134       79,497           47,850       24,090     10,491       198,463 (8)     545,525  
Daniel Calvert (9)
                                                                       
Chief Financial Officer
    2009       86,154                   90,186       37,333             7,722 (10)     221,395  
Eugene Shortall (11)
                                                                       
Senior Vice President of RTFS
    2009       185,760                   48,571       41,941             8,225 (12)     284,497  
Bernhard Opitz (13)
                                                                       
Senior Vice President of Operations
    2009       121,154                   90,186       36,750             22,374 (14)     270,464  
Stephen Allan (15)
                                                                       
Vice President of Marketing and Communications
    2009       117,595       48,180           68,864           10,226       72,337 (16)     317,202  
     
(1)   All restricted stock grants are issued with fair values determined in Australian dollars. Amounts were converted using the exchange rate at June 30, 2009 of A$1.00 = US$0.8048. The amount referenced is equal to the weighted-average grant date fair value recognized during the year ended June 30, 2009.

 

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(2)   All option awards are issued with an exercise price in Australian dollars. Amounts were converted using the exchange rate at June 30, 2009 of A$1.00 = US$0.8048. The amount referenced is calculated using the Black-Scholes and Barrier pricing models. See Note 3 of our consolidated financial statements contained elsewhere in this registration statement.
 
(3)   Represents amounts paid as incentive compensation under the terms of the named executive’s employment offer letter or employment agreement.
 
(4)   Statutory payments for superannuation (i.e., pension fund) equal to 9% of annual salary. This applies only to Australian employees.
 
(5)   Prior to his relocation from Australia to the United States in February and until April 2009, Mr. Shortall had been receiving his cash compensation in Australian dollars, which, for purposes of this summary compensation table, were converted into U.S. dollars using the average exchange rate during the applicable period.
 
(6)   Includes a payment of $100,000 for relocation expenses as well as $32,582 related to the purchase of an automobile. Also includes A$9,453 related to parking and telephone costs.
 
(7)   Mr. Carter has been receiving his cash compensation in Australian dollars, which, for the purposes of this summary compensation table, were converted into U.S. dollars using the average exchange rate during the applicable period.
 
(8)   Includes $176,015 related to severance payments, as well as $12,213 related to the purchase of an automobile and $10,235 related to parking and other costs.
 
(9)   Mr. Calvert has served as our Chief Financial Officer since December 2008. The amounts disclosed in the table above reflect amounts earned from December 2008 to June 2009.
 
(10)   Represents amounts in connection with the rental of an apartment.
 
(11)   Mr. Shortall has been receiving his cash compensation primarily in Australian dollars, which, for purposes of this summary compensation table, were converted into U.S. dollars using the average exchange rate during the applicable period.
 
(12)   Represents amounts related to the rental of an office and residence.
 
(13)   Mr. Opitz has served as our Senior Vice President of Operations since December 2008. The amounts disclosed in the table above reflect amounts earned from December 2008 to June 2009.
 
(14)   Includes $19,657 in connection with the rental of an apartment and $2,717 in costs related to relocation.
 
(15)   Prior to his relocation from Australia to the United States in December 2008, Mr. Allan had been receiving his cash compensation in Australian dollars, which, for purposes of this summary compensation table, were converted into U.S. dollars using the average exchange rate during the applicable period.
 
(16)   Includes $60,000 related to relocation, as well as $12,337 related to the purchase of an automobile and rental of an apartment.

 

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Employment Offer Letters, Employment Agreements and Consultancy Agreements
We have used employment offer letters, employment agreements and consultancy agreements to set the initial compensation terms for our named executives. As described above, the employment offer letters with our named executives other than our Chief Executive Officer were negotiated by our Chief Executive Officer at arms’ length when he assembled the company’s senior management team. Below is a summary of the employment offer letters and employment agreements in effect with our named executives during fiscal 2009. Additional information regarding potential payments upon termination of employment pursuant to the terms of the employment offer letters and employment agreements is set forth under —“Potential Payments Upon Termination and Changes of Control.”
Alan Shortall, Chief Executive Officer
As our Chief Executive Officer, Mr. Shortall reports to our board of directors. He is responsible for the executive management team and has responsibility for the effective leadership and business development of the Company. The key elements of Mr. Shortall’s employment agreement are as follows:
    Annual salary of $420,000, subject to annual review.
    Incentive compensation awards per fiscal year of up to $200,000, subject to satisfaction of KPIs, to be determined by our board of directors.
    A grant of 1,666,667 shares of stock and 1,250,000 options.
    The employment agreement has a term of three years commencing on July 1, 2008.
    The employment agreement may be terminated by, among other ways, one party giving the other three months’ prior written notice (or by us paying Mr. Shortall three months of his total annual salary in lieu of the written notice).
    After the termination of Mr Shortall’s employment with us, he may not be involved in any business which is a competitor of the Company’s, or entice away any employee, customer or supplier of the Company for up to 24 months worldwide (or for such shorter period and geographical area as a court may decide).
Mr. Shortall’s base salary was paid in Australian dollars for the majority of fiscal 2009. In April 2009, after he relocated to the United States, he began receiving payment of his base salary in United States dollars. At the time of this change, the values of the United States and Australian dollars were relatively equivalent but the exchange rate began to diverge later in the year, accounting for the differential between the agreement rate and the amount reported in the summary compensation table.
Our board of directors determined that Mr. Shortall met his KPIs to receive full payment of his incentive compensation award. In addition, in recognition of the crucial role that Mr. Shortall played in obtaining the sanofi-aventis exclusive licensing agreement on June 30, 2008, which represented a significant milestone for the company, and the industrialization agreement with sanofi-aventis on June 30, 2009, which was the second critical step in the sanofi-aventis relationship, our board of directors awarded Mr. Shortall a discretionary bonus payment of A$150,000  for fiscal 2009.
Jeff Carter, Former Chief Financial Officer
Mr. Carter served as our Chief Financial Officer from February 2005 until December 2008. As our Chief Financial Officer, Mr. Carter was responsible for all financial aspects of the Company, including financial reporting, statutory reporting, taxation and secretarial functions. In December 2008, Mr. Calvert replaced Mr. Carter as our Chief Financial Officer.
The key elements of compensation for Mr. Carter while he served as our Chief Financial Officer during fiscal 2009 were as follows:
    Annual salary of A$200,000, subject to annual review.
    Incentive compensation awards in respect of each financial year of up to A$25,000, as determined at the discretion of our Chief Executive Officer, subject to satisfaction of KPIs.

 

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Our Chief Executive Officer determined that Mr. Carter met his KPIs to receive full payment of his incentive compensation award for fiscal 2009 notwithstanding the fact that he served as our Chief Financial Officer for only half of the fiscal year. Our Chief Executive Officer and board of directors also determined to award Mr. Carter an additional discretionary bonus of A$82,500 in recognition of his achievements in transitioning the Company’s financial reporting systems from Australia to the United States.
When the Company made Mr. Carter redundant as its Chief Financial Officer in connection with the relocation of the Company’s operations to the United States, we paid him a severance amount equal to nine months of his annual salary pursuant to the terms of his employment agreement.
Effective February 1, 2009, we entered into a consultancy agreement with Joblak Pty Ltd. under which Mr. Carter will provide to us, among other services, corporate secretarial services. Mr. Carter, through Joblak Pty Ltd., will receive compensation of $20,000 per month for the consulting services. The consultancy agreement may be terminated by either party by giving two months’ advance notice.
Daniel Calvert, Chief Financial Officer
As Chief Financial Officer, Mr. Calvert is responsible for all financial aspects of the Company, including financial reporting, statutory reporting and taxation. The key elements of compensation for Mr. Calvert under the terms of his employment offer letter in effect for fiscal 2009 are as follows:
    Annual salary of $160,000, subject to annual review.
    Incentive compensation awards in respect of calendar year 2009 (and a pro rata amount for services performed for December 2008) of up to 40 percent of base salary, subject to satisfaction of KPIs.
    A grant of 250,000 stock options.
    Reimbursement of relocation and temporary living expenses.
The employment offer letter with Mr. Calvert became effective on December 1, 2008, and did not have a specified term. The employment offer letter was superseded by an employment agreement effective November 10, 2009, which provides for the same cash compensation package and which is for an initial term expiring on December 31, 2012, subject to automatic renewal for successive one-year periods unless a non-renewal notice is given.
Our Chief Executive Officer determined that Mr. Calvert met his KPIs to receive full payment of his incentive compensation award for December 2008 and the six-month period ending June 30, 2009.

 

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Eugene Shortall, Senior Vice President of RTFS
As Senior Vice President of RTFS, Eugene Shortall is responsible for overall management of the project related to the design, development and production of our ready-to-fill syringe. During fiscal 2009, Eugene Shortall provided these services to us under the terms of a consultancy agreement between us and Medical Middle East Ltd. This consultancy agreement has been superseded by an employment agreement between us and Eugene Shortall that became effective November 10, 2009, and is for an initial term expiring on December 31, 2012, subject to automatic renewal for successive one-year periods unless a non-renewal notice is given.
The key elements of compensation for Eugene Shortall under the terms of the consultancy agreement in effect for fiscal 2009 are as follows:
    Monthly consulting fee of A$20,000 (A$240,000 per year).
In addition to the monthly consulting fee, our Chief Executive Officer determined that Eugene Shortall satisfied his KPIs set for fiscal 2009 and provided Medical Middle East Ltd. with an additional payment of A$120,000 to be paid to Eugene Shortall as an incentive compensation award for managing the ready-to-fill syringe project in such a manner that the Company earned and received the milestone payments from sanofi-aventis.
Bernhard Opitz, Senior Vice President of Operations
As Senior Vice President of Operations, Mr. Opitz is responsible for overseeing all aspects of operational activities, including manufacturing, supply chain and engineering. The key elements of compensation for Mr. Opitz under the terms of his employment offer letter in effect for fiscal 2009 are as follows:
    Annual salary of $210,000, subject to annual review.
    Incentive compensation awards in respect of calendar year 2009 (and a pro rata amount for services performed for December 2008) of up to $63,000, subject to satisfaction of KPIs.
    A grant of 250,000 stock options.
    Reimbursement of relocation and temporary living expenses.

 

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The employment offer letter with Mr. Opitz became effective on December 2, 2008, and did not have a specified term. The employment offer letter was superseded by an employment agreement effective November 10, 2009, which provides for the same cash compensation package and which is for an initial term expiring on December 31, 2012, subject to automatic renewal for successive one-year periods unless a non-renewal notice is given.
Our Chief Executive Officer determined that Mr. Opitz met his KPIs to receive full payment of his incentive compensation award for December 2008 and the six-month period ending June 30, 2009.
Stephen Allan, Vice President of Marketing and Communications
As Vice President of Marketing and Communications, Mr. Allan is responsible for the global marketing of our products and other communications functions. During fiscal 2009, we did not have a written employment agreement in place with Mr. Allan but the terms of his employment upon relocating to the United States were negotiated at arms’ length with our Chief Executive Officer. The key elements of compensation for Mr. Allan as in effect during fiscal 2009 are as follows:
    Annual salary of $150,000, subject to annual review.
    Incentive compensation awards in respect of each calendar year of up to 20 percent of base salary, subject to satisfaction of KPIs.
    A one-time housing allowance of $60,000 for his relocation from Australia to the United States in January 2009.
Mr. Allan’s base salary was paid in Australian dollars for the first half of fiscal 2009. In January 2009, after he relocated to the United States, he began receiving payment of his base salary in United States dollars. At the time of this change, the values of the United States and Australian dollars were relatively equivalent but the exchange rate began to diverge later in the year, accounting for the differential between the agreement rate and the amount reported in the summary compensation table.
Our Chief Executive Officer determined that Mr. Allan met his KPIs to receive full payment of his incentive compensation awards for the six-month period ending December 31, 2008 and the six-month period ending June 30, 2009, the first of which was paid during fiscal 2009.
We entered into an employment agreement with Mr. Allan effective on November 10, 2009 to memorialize the terms of his employment with us after his relocation to the United States. The employment agreement is for an initial term expiring on December 31, 2012, subject to automatic renewal for successive one-year periods unless a non-renewal notice is given.
The following table provides information regarding all option and stock awards made to our named executives during the year ended June 30, 2009:
                                                 
Grants of Plan-Based Awards  
For the year ended June 30, 2009 *  
            Estimated                              
            Future Payouts             All Option                
            Under Non-Equity     All Other Stock     Awards:             Grant Date  
            Incentive Plan     Awards:     Number of     Exercise or     Fair Value of  
            Awards     Number of     Securities     Base Price or     Stock and  
            Target     Shares of Stock     Underlying     Option Awards     Option Awards  
Name and Position   Grant Date     ($)     or Units     Options     ($) (1)     ($)  
 
                                               
Alan Shortall
    11/28/08             1,666,667                   1,810,800  
Chief Executive Officer
    11/28/08                   1,250,000       1.62       1,408,400  
Jeff Carter
                                   
Former Chief Financial Officer
                                   
Daniel Calvert
    12/2/08       37,333 (2)           250,000       1.62       277,656  
Chief Financial Officer
                                   
Eugene Shortall
          41,941                          
Senior Vice President of RTFS
                                   
Bernhard Opitz
    12/2/08       36,750 (3)           250,000       1.62       277,656  
Senior Vice President of Operations
                                   
Stephen Allan
    9/1/08       (4)           166,667       1.44       225,344  
Vice President of Marketing and Communications
                                   
     
*   Includes only those columns relating to grants awarded to the named executives in fiscal 2009. All other columns have been omitted.
 
(1)   All stock option awards are issued with an exercise price in Australian dollars. Amounts were converted using the exchange rate at June 30, 2009 of A$1.00 = US$0.8048.
 
(2)   Mr. Calvert has served as our Chief Financial Officer since December 2008. Pursuant to Mr. Calvert’s employment agreement, he was eligible to receive, subject to satisfaction of specified KPIs, an incentive compensation payment, payable on June 30, 2009, of up to 3.33% of his base salary for his services performed in December 2008 and incentive compensation of up to 40% of his base salary for services performed during calendar year 2009, payable in two installments on June 30, 2009 and December 31, 2009. The amounts reported in this grants of plan-based awards table are the target amounts that Mr. Calvert was eligible to receive during fiscal 2009.
 
(3)   Mr. Opitz has served as our Senior Vice President of Operations since December 2008. Pursuant to Mr. Opitz’s employment offer letter, he was eligible to receive, subject to satisfaction of specified KPIs, an incentive compensation payment, payable on June 30, 2009, of up to $5,250 for his services performed in December 2008 and incentive compensation of up to $63,000 for services performed during calendar year 2009, payable in two installments on June 30, 2009 and December 31, 2009. The amounts reported in this grants of plan-based awards table are the target amounts that Mr. Opitz was eligible to receive during fiscal 2009.
 
(4)   Mr. Allan became our Vice President of Marketing and Communications in October 2008 and relocated to the United States in early 2009. Mr. Allan was eligible to receive, subject to satisfaction of specified KPIs, an incentive compensation payment of up to 20 percent of his base salary for calendar year 2009. [We pay incentive compensation in June and December of each calendar year. The amount reported in this grants of plan-based awards table is the target amount that Mr. Allan was eligible to receive during fiscal 2009.

 

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During the year ended June 30, 2009, no options were exercised and no stock awards vested.
The following table provides information regarding all outstanding equity awards for our named executives as of June 30, 2009:
                                 
Outstanding Equity Awards  
As of June 30, 2009*  
    Option Awards  
    Number of     Number of              
    Securities     Securities              
    Underlying     Underlying              
    Unexercised     Unexercised              
    Options (#     Options (#     Option Exercise     Option  
Name and Position   Exercisable)     Unexercisable)     Price ($) (1)     Expiration Date  
Alan Shortall
                               
Chief Executive Officer
          1,250,000       1.62       09/30/13  
Jeff Carter
                               
Former Chief Financial Officer
    333,333       83,333       1.20       12/31/10  
Daniel Calvert
                               
Chief Financial Officer
    83,333       166,667       1.62       06/30/12  
Eugene Shortall
                               
Senior Vice President of RTFS
    100,000       25,000       1.68       12/31/10  
Bernhard Opitz
                               
Senior Vice President of Operations
    83,333       166,667       1.62       06/30/12  
Stephen Allan
                               
Vice President of Marketing and Communications
    9,167             9.18       12/31/09  
 
    83,333             1.20       12/31/09  
 
          166,667       1.44       06/30/12  
     
 
*   Includes only those columns which are applicable.
 
(1)   All option awards were issued with an exercise price in Australian dollars. Amounts were converted using the exchange rate at June 30, 2009 of A$1.00 = US$0.8048.
 
(2)   The market value of all stock awards is based upon the closing price of our common stock of A$0.31 on June 30, 2009 converted at the exchange rate on June 30, 2009 of A$1.00 = US$0.8048.
In connection with the redomiciliation transaction, we have adopted our 2009 Stock Incentive Plan, which is subject to the approval by the shareholders of UMSL at a meeting scheduled for January 8, 2010. On November 20, 2009, our compensation committee approved a new incentive package for Mr. Alan Shortall, our Chief Executive Officer, which package includes the issuance of 1,166,000 shares of restricted stock and 834,000 options to purchase common stock under our 2009 Stock Incentive Plan. The new incentive package is subject to the approval by the shareholders of UMSL at the meeting scheduled for January 8, 2010 and the share scheme of arrangement for the redomiciliation transaction becoming effective.
The shares of our restricted stock, if granted to Mr. Shortall, will be subject to vesting based on the achievement of the following performance milestones: 233,200 restricted shares will vest upon the signing of supply agreements with sanofi-aventis for 100 million or more Unifill syringes. 233,200 restricted shares will vest upon the signing of the first new agreement for the Unifill syringe with a pharmaceutical company other than sanofi-aventis or its affiliates. 233,200 restricted shares will vest upon the signing of an agreement with any pharmaceutical company, including sanofi-aventis, for a new product (other than the Unifill syringe). 233,200 restricted shares will vest upon the installation of the first Unifill syringe production line into a clean room in our new facility, including the successful operation qualification of the line. 233,200 restricted shares will vest upon the first shipment of production quality sterile Unifill syringes to sanofi-aventis from a commercial production line.
The options to purchase our common stock, if granted to Mr. Shortall, will have an exercise price equal to six times the closing price on ASX of our CDI’s (each CDI representing one-sixth of one share of our common stock) on the date of grant and will be exercisable for five years from the date of grant. The options will vest as follows: 250,000 options will vest upon our share price reaching $9.45 or more for a minimum of 20 out of any 30 consecutive trading days, 250,000 options will vest upon our share price reaching $12.15 or more for a minimum of 20 out of any 30 consecutive trading days and 334,000 options will vest upon our share price reaching $17.82 or more for a minimum of 20 out of any 30 consecutive trading days.
Potential Payments Upon Termination or Changes in Control
We have entered into employment and consulting agreements with our named executives. Below is a summary of the material termination and change in control provisions.

 

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Alan Shortall, Chief Executive Officer
      The employment agreement with Mr. Shortall has a term of three years commencing on July 1, 2008. The employment agreement may be terminated by, among other circumstances, one party giving the other three months’ prior written notice (or by paying Mr. Shortall three months of his total annual salary in lieu of the written notice). If Mr. Shortall’s employment is terminated without cause prior to the first anniversary of his relocation to the United States on February 6, 2009, he will receive severance equal to 15 months of his annual salary; if Mr. Shortall is terminated without cause after February 6, 2010, he will receive severance equal to nine months of his annual salary. Certain non-competition obligations, as specified in the employment agreement, apply to Mr. Shortall during his employment and within certain periods thereafter (ranging from six to 24 months depending on the specific non-competition obligations). We also have an obligation to pay for the relocation of Mr. Shortall and his dependents back to Australia, including moving his personal and household effects, at the end of his employment with Unilife in the United States. Assuming Mr. Shortall was so terminated as of June 30, 2009, he would have been entitled to receive severance in the amount of A$525,000, 15 months of his annual salary.

 

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Jeff Carter, Former Chief Financial Officer
      During January 2009, we made Mr. Carter redundant as our Chief Financial Officer and paid him severance in the amount of A$180,000, which was equal to nine months of his annual salary. Mr. Carter has remained on our board of directors and as our Company Secretary and as a consultant. We have entered into a consulting agreement with Mr. Carter, under which Mr. Carter receives a minimum compensation of A$20,000 per month for his consulting services.
Daniel Calvert, Chief Financial Officer
We entered into an employment offer letter with Mr. Calvert in November 2008 that was superseded by an employment agreement entered into in November 2009. Mr. Calvert’s employment offer letter, which was in effect on June 30, 2009, entitled him to receive severance consisting of six months of his annual salary if we terminated his employment other than for cause or inability to perform his duties.
Under Mr. Calvert’s current employment agreement, if we terminate Mr. Calvert’s employment without cause or elect not to renew the employment agreement, he will receive severance consisting of six months of his annual salary and payment for the cost of his COBRA health care contribution coverage for six months. Certain non-competition obligations, as specified in the employment agreement, apply to Mr. Calvert during his employment and for two years thereafter. Assuming Mr. Calvert’s current employment agreement was in effect as of June 30, 2009, and his employment was terminated without cause on that date, he would have been entitled to receive severance totaling $83,762, consisting of $80,000 (six months of his annual salary) and $3,762 (cost of his COBRA health care contribution coverage for six months).
In the event that Mr. Calvert’s employment is terminated coincident with or following a change in control of Unilife, then, in lieu of the severance described immediately above, Mr. Calvert is entitled to (i) 18 months of his annual salary, (ii) payment for the cost of his COBRA health care contribution coverage for 18 months, (iii) payment of an amount equal to the bonus, if any, earned by and paid to him for the prior completed fiscal year, and (iv) all of his outstanding options vesting immediately upon such termination. Assuming Mr. Calvert’s employment was so terminated as of June 30, 2009, and his current employment agreement was in effect as of that date, he would have been entitled to receive severance totaling $288,620, consisting of (i) $240,000 (18 months of his annual salary), (ii) $11,287 (cost of his COBRA health care contribution coverage for 18 months), and (iii) $37,333 (the bonus paid to him for the prior completed fiscal year). In addition, 166,667 unvested options would have vested.

 

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Eugene Shortall, Senior Vice President of RTFS
      We entered into an employment agreement with Mr. Shortall in November 2009. Under the terms of the employment agreement, if we terminate Mr. Shortall’s employment without cause or elect not to renew the employment agreement, he will receive severance consisting of six months of his annual salary and payment for the cost of his COBRA health care contribution coverage for six months. Certain non-competition obligations, as specified in the employment agreement, apply to Mr. Shortall during his employment and for two years thereafter. Assuming Mr. Shortall’s employment agreement was in effect as of June 30, 2009, and his employment was terminated without cause on that date, he would have been entitled to receive severance totaling $123,083, consisting of $120,000 (six months of his annual salary) and $3,083 (cost of his COBRA health care contribution coverage for six months).
      In the event that Mr. Shortall’s employment is terminated coincident with or following a change in control of Unilife, then, in lieu of the severance described immediately above, Mr. Shortall is entitled to (i) 18 months of his annual salary, (ii) payment for the cost of his COBRA health care contribution coverage for 18 months, (iii) payment of an amount equal to the bonus, if any, earned by and paid to him for the prior completed fiscal year, and (iv) all of his outstanding options vesting immediately upon such termination. Assuming Mr. Shortall’s employment was so terminated as of June 30, 2009, and his employment agreement was in effect as of that date, he would have been entitled to receive severance totaling $411,189, consisting of (i) $360,000 (18 months of his annual salary), (ii) $9,248 (cost of his COBRA health care contribution coverage for 18 months), and (iii) $41,941 (the bonus paid to him for the prior completed fiscal year). In addition, 25,000 unvested options would have vested. We also have an obligation to pay for the relocation of Mr. Shortall and his dependants to France or Kuwait, including moving his personal and household effects, at the end of his employment with Unilife in the United States.

 

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Bernhard Opitz, Senior Vice President of Operations
We entered into an employment offer letter with Mr. Opitz in November 2008 that was superseded by an employment agreement entered into in November 2009. Mr. Opitz’s employment offer letter, which was in effect on June 30, 2009, entitled him to receive severance consisting of nine months of his annual salary if we terminated his employment other than for cause or disability.
Under Mr. Opitz’s current employment agreement, if we terminate Mr. Opitz’s employment without cause or elect not to renew the employment agreement, he will receive severance consisting of nine months of his annual salary and payment for the cost of his COBRA health care contribution coverage for nine months. Certain non-competition obligations, as specified in the employment agreement, apply to Mr. Opitz during his employment and for two years thereafter. Assuming Mr. Opitz’s current employment agreement was in effect as of June 30, 2009, and his employment was terminated without cause on that date, he would have been entitled to receive severance totaling $163,167, consisting of $157,500 (nine months of his annual salary) and $5,667 (cost of his COBRA health care contribution coverage for nine months).
In the event that Mr. Opitz’s employment is terminated coincident with or following a change in control of Unilife, then, in lieu of the severance described immediately above, Mr. Opitz is entitled to (i) 18 months of his annual salary, (ii) payment for the cost of his COBRA health care contribution coverage for 18 months, (iii) payment of an amount equal to the bonus, if any, earned by and paid to him for the prior completed fiscal year, and (iv) all of his outstanding options vesting immediately upon such termination. Assuming Mr. Opitz’s employment was so terminated as of June 30, 2009, and his current employment agreement was in effect as of that date, he would have been entitled to receive severance totaling $363,083, consisting of (i) $315,000 (18 months of his annual salary), (ii) $11,333 (cost of his COBRA health care contribution coverage for 18 months), and (iii) $36,750 (the bonus paid to him for the prior completed fiscal year). In addition, 166,667 unvested options would have vested.
Stephen Allan, Vice President of Marketing and Communications

 

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      We entered into an employment agreement with Mr. Allan in November 2009. Under the terms of the employment agreement, if we terminate Mr. Allan’s employment without cause or elect not to renew the employment agreement, he will receive severance consisting of six months of his annual salary and payment for the cost of his COBRA health care contribution coverage for six months. Certain non-competition obligations, as specified in the employment agreement, apply to Mr. Allan during his employment and for two years thereafter. Assuming Mr. Allan’s employment agreement was in effect as of June 30, 2009, and his employment was terminated without cause on that date, he would have been entitled to receive severance totaling $80,896, consisting of $75,000 (six months of his annual salary) and $5,896 (cost of his COBRA health care contribution coverage for six months).
      In the event that Mr. Allan’s employment is terminated coincident with or following a change in control of Unilife, then, in lieu of the severance described immediately above, Mr. Allan is entitled to (i) 18 months of his annual salary, (ii) payment for the cost of his COBRA health care contribution coverage for 18 months, (iii) payment of an amount equal to the bonus, if any, earned by and paid to him for the prior completed fiscal year, and (iv) all of his outstanding options vesting immediately upon such termination. Assuming Mr. Allan’s employment was so terminated as of June 30, 2009, and his employment agreement was in effect as of that date, he would have been entitled to receive severance totaling $290,868, consisting of (i) $225,000 (18 months of his annual salary), (ii) $17,688 (cost of his COBRA health care contribution coverage for 18 months), and (iii) $48,180 (the bonus paid to him for the prior completed fiscal year). In addition 116,667 unvested options would have vested. We also have an obligation to pay for the relocation of Mr. Allan and his dependants back to Australia, including moving his personal and household effects, at the end of his employment with Unilife in the United States.
DIRECTOR COMPENSATION
The following table provides information regarding the total compensation that UMSL paid or awarded to its non-employee directors during the year ended June 30, 2009. Directors of UMSL who are also employees do not receive compensation for their services as directors.
                                                 
Director Compensation  
    Fees Earned                   Nonqualified              
    or Paid in     Stock     Option     Deferred     All Other        
    Cash     Awards     Awards     Compensation     Compensation     Total  
Name   ($)     ($)     ($) (1)     Earnings($)(2)     ($)     ($)  
 
                                               
Jim Bosnjak
    89,764 (3)           66,365       8,079             164,208  
 
                                               
William Galle
    52,500             43,986                   96,486  
 
                                               
Jeff Carter
    13,626 (4)                   1,458             15,084  
     
(1)   All option awards were issued with an exercise price in Australian dollars. Amounts were converted using the exchange rate at June 30, 2009 of A$1.00 = US$0.8048. The amount referenced is calculated using the Black-Scholes pricing model. See footnote 3 of our consolidated financial statements contained elsewhere in this registration statements.
 
(2)   Statutory contributions of 9% of fees to a superannuation fund (i.e., pension) for Australian directors only.
 
(3)   Mr. Bosnjak’s fees represent A$120,000 paid in Australian dollars. Amounts were converted using the average exchange rate during the applicable period.
 
(4)   Mr. Carter’s fees represent A$18,930 paid in Australian dollars. Amounts were converted using the average exchange rate during the applicable period. This amount represents fees earned solely for serving as a director. For Mr. Carter’s other compensation, see — “Compensation of Named Executive Officers.”
During fiscal 2009, we paid each of our three non-employee directors different amounts of cash compensation. The levels of cash compensation were based on what our board believed was appropriate for a company of our size, with recognition given to the amount of time a particular director was required to spend on Company matters and the director’s length of board service. We paid Mr. Bosjnak an annual cash fee of A$120,000 for all of his services as a director, including his service as chairman of the board. We did not compensate him separately for attendance at meetings or for service on board committees. Mr. Bosjnak received the highest level of cash compensation in recognition of his long standing board service and the significant amount of time he spent on the Company’s affairs.
Mr. Galle was also paid an annual fee with no separate meeting or committee fees. His level of compensation was determined by negotiation between our Chief Executive Officer and Mr. Galle at the time he joined the board.
Mr. Carter was also paid an annual cash fee with no separate meeting fees.
The amount under “Option Awards” represents share-based compensation expense in respect of (i) 166,667 options granted to Mr. Bosjnak in each of fiscal 2008 and 2009 at exercise prices of A$1.50 and A$1.98, respectively and (ii) 91,667 options granted to Mr. Galle in fiscal 2009 at an exercise price of A$2.10.
We have proposed the issuance of options to purchase ordinary shares to three members of the board of directors, Jeff Carter, John Lund and William Galle. Under such proposal, each of these board members would be entitled to receive 600,000 options exercisable at A$1.20 per share for a period of five years from the date of grant. The options would vest as follows: 100,000 options would vest on the date of grant, 150,000 options would vest on the 12 month anniversary from the date of grant, 150,000 options would vest on the 24 month anniversary from the date of grant and 200,000 options would vest on the 36 month anniversary from the date of grant. The issuance of these options is subject to shareholder approval at a meeting to be held on January 8, 2010. If shareholder approval is obtained and the options are granted, they will be exchanged for options to purchase our common stock in the ratio of one stock option for every six UMSL share options.

 

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Item 7.   Certain Relationships and Related Transactions, and Director Independence
Certain Relationships and Related Party Transactions
During the last three fiscal years, we have been a party to the following transaction in which the amount involved exceeded $120,000 and in which any director, executive officer, holder of more than 5% of our capital stock, or their immediate family members, had a material interest.
On January 22, 2009, we entered into a consulting agreement with Jeff Carter, a member of our board of directors and former Chief Financial Officer. Under the terms of the agreement, Mr. Carter will perform finance, accounting and secretarial consulting services in Australia. The agreement had an initial term of seven months that expired on September 30, 2009 and was extended for a six month term expiring on March 31, 2010. Under the agreement, we will pay Mr. Carter a fee for the consulting services of A$20,000 per month.
We review all relationships and transactions in which we and our directors and executive officers or their immediate family members are participants to determine whether such persons have a direct or indirect material interest. Our Chief Executive Officer and Chief Financial Officer are primarily responsible for the development and implementation of processes and controls to obtain information from the directors and executive officers with respect to related party transactions. Our audit committee reviews and approves or ratifies any related party transaction pursuant to the authority given under the charter of the audit committee.
Director Independence
Our board of directors currently consists of five members: Jim Bosnjak, Alan Shortall, John Lund, William Galle and Jeff Carter. Our board of directors has an audit committee, a compensation committee and a nominating and corporate governance committee, each consisting of Jim Bosnjak, John Lund and William Galle. Our board of directors has determined that each of Jim Bosnjak, John Lund, and William Galle is ‘independent” within the meaning of Rule 10A-3 under the Exchange Act and the Nasdaq listing standards.
Item 8.   Legal Proceedings
In the ordinary course of our business, we may be subject to various claims, pending and potential legal actions for damages, investigations relating to governmental laws and regulations and other matters arising out of the normal conduct of our business. We are not aware of any material pending legal proceedings to which we or any of our subsidiaries is a party or of which any of our properties is the subject.
Item 9.   Market Price of and Dividends on the Registrant’s Common Equity and Related Stockholder Matters
Market Information
UMSL’s ordinary shares have been traded on the ASX under the trading symbol “UNI” since November 1, 2002. Upon the completion of the redomiciliation transaction, subject to approval by the ASX, we will replace UMSL as the listed entity on the ASX and our shares of common stock will be traded on the ASX in the form of CDIs, each representing one-sixth of a share of our common stock.
The following table sets forth, for the periods indicated, the high and low closing prices of UMSL’s ordinary shares as reported on the ASX, in Australian dollars and as converted into United States dollars. These share prices do not reflect the one for six share consolidation in connection with the redomiciliation and represents actual high and low closing prices of UMSL ordinary shares.
                                 
    High     Low     High     Low  
Period   (AU$)     (AU$)     (US$)     (US$)  
Fiscal Year 2010:
                               
Second Quarter
    1.18       0.88       1.05       0.78  
First Quarter
    1.38       0.31       1.20       0.27  
Fiscal Year 2009:
                               
First Quarter
    0.41       0.25       0.34       0.21  
Second Quarter
    0.29       0.18       0.20       0.12  
Third Quarter
    0.28       0.23       0.19       0.16  
Fourth Quarter
    0.31       0.25       0.25       0.20  
Fiscal Year 2008:
                               
First Quarter
    0.31       0.20       0.28       0.18  
Second Quarter
    0.40       0.25       0.35       0.22  
Third Quarter
    0.36       0.21       0.33       0.19  
Fourth Quarter
    0.46       0.23       0.44       0.22  
All currency conversions are based on the prevailing Australian dollar to the U.S. dollar rate on the last day of each respective quarter.

 

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As of September 30, 2009, we had 37,010,802 shares of common stock issued and outstanding, and there were 6,955 holders of record of our common stock. We issued 6,291,535 additional shares of common stock to certain investors in connection with a recent financing in October and November of 2009. After the redomiciliation transaction which will be conducted in reliance upon the exemption from registration provided under Section 3(a)(10) of the Securities Act, approximately [____] shares of our common stock will be freely tradable and commencing 90 days after the effectiveness of this registration statement, approximately [____] shares of our common stock will be eligible for resale pursuant to Rule 144. Mr. Alan Shortall, our CEO and director, has agreed, with certain limited exceptions, not to transfer or otherwise dispose of 833,333 shares of our common stock held by him until October 26, 2010.
As of September 30, 2009, 5,587,500 shares of our common stock were subject to outstanding stock options. We issued options to purchase 3,645,767 additional shares of common stock to certain investors, placement agents and advisors in November 2009. After the redomiciliation transaction, we plan to file a registration statement on Form S-8 to cover the issuance of approximately [____] shares of our common stock that are issuable upon exercise of outstanding options or options that may be issued in the future under our employee benefit plans.
We have submitted a listing application to the Nasdaq Capital Market for listing of our common stock. There can be no assurance that the listing application will be approved or that a U.S. trading market for our common stock will develop.
Dividends
We currently intend to retain any earnings to finance research and development and the operation and expansion of our business and do not anticipate paying any cash dividends for the foreseeable future. The declaration and payment of any dividends in the future by us will be subject to the sole discretion of our board of directors and will depend upon many factors, including our financial condition, earnings, capital requirements of our operating subsidiaries, covenants associated with certain of our debt obligations, legal requirements, regulatory constraints and other factors deemed relevant by our board of directors. Moreover, if we determine to pay any dividend in the future, there can be no assurance that we will continue to pay such dividends. In addition, under our bank financing agreements, we are not permitted to pay cash dividends without the prior written consent of the lender.
Equity Compensation Plan Information
The following table provides information as of June 30, 2009 with respect to our equity compensation plans. See Note 3 to our consolidated financial statements included elsewhere is this registration statement for further information.
                         
                    Number of Securities  
                    Remaining Available for  
    Number of Securities             Future Issuance Under  
    to be Issued Upon     Weighted-Average     Equity Compensation  
    Exercise of     Exercise Price of     Plans (Excluding  
    Outstanding Options,     Outstanding Options,     Securities Reflected in  
Plan Category   Warrants and Rights     Warrants and Rights     Column (a))  
    (a)     (b)     (c)  
Equity compensation plans approved by security holders
                       
Employee Share Option Plan
    4,072,500     $ 1.54         (1)
2009 Stock Incentive Plan(2)
                6,000,000 (3)
Agreement with individual consultant
    83,333       3.00        
Equity compensation plans not approved by security holders
                       
 
                 
Individual agreements with various consultants, advisors and other third parties
    2,166,667       1.61        
 
                 
Total
    6,322,500     $ 1.58               
 
                 
     
(1)   Under this plan, no options can be offered if the total number of shares issuable upon exercise of such options, when aggregated with (i) the number of shares issued during the previous five years under the plan or any other similar plan available for employees and directors and (ii) the number of shares issuable upon exercise of options that are outstanding under the plan or any other similar plan available for employees and directors or that are being offered thereunder, but disregarding certain types of offers and grants, shall not exceed 5% of the total number of shares outstanding at the time of such offer. No further options will be granted under this plan after the reconciliation.
 
(2)   In connection with the redomiciliation transaction, shareholders of UMSL are being asked to approve this plan at an extraordinary general meeting of shareholders.
 
(3)   The number of shares available for issuance under the 2009 Stock Incentive Plan adjusts annually commencing on January 1, 2011 as provided therein.

 

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Item 10.   Recent Sales of Unregistered Securities
Issuances by UMSL:
During the past three years, UMSL has issued and sold the following securities that were not registered under the Securities Act: All of the share numbers and share option exercise prices referred to below give effect to the share consolidation we will effect in connection with the redomiciliation (one share of our common stock equals six ordinary shares of UMSL).
On January 1, 2007, in connection with its acquisition of Integrated BioSciences, Inc., a privately-held company, UMSL issued 1,833,333 ordinary shares to the selling shareholders of the acquired company. The issuance of these shares was exempt from registration pursuant to Section 4(2) of the Securities Act.
In May and June 2007, UMSL issued an aggregate of 2,303,562 ordinary shares in connection with two private placements to investors in Australia for aggregate proceeds of $2.5 million (A$3.0 million). The issuance of these shares was exempt from registration pursuant to Regulation S under the Securities Act.
During the year ended June 30, 2007, UMSL issued 3,990 ordinary shares upon the exercise of stock options for aggregate proceeds of $0.1 million (A$0.1 million). The issuance of these shares was exempt from registration pursuant to Rule 701 and/or Regulation S under the Securities Act.
On July 20, 2007, UMSL issued 2,333,333 ordinary shares in connection with a rights issue to its Australian shareholders for aggregate proceeds of $2.8 million (A$3.2 million). The issuance of these shares was exempt from registration pursuant to Regulation S under the Securities Act.
On June 27, 2008, UMSL issued 22,033 ordinary shares to certain Australian employees for no proceeds. The issuance of these shares was exempt from registration pursuant to Rule 701 and/or Regulation S under the Securities Act.
During the year ended June 30, 2008, UMSL issued 293,375 ordinary shares upon the exercise of stock options for aggregate proceeds of $0.4 million (A$0.4 million). The issuance of these shares was exempt from registration pursuant to Rule 701 and/or Regulation S under the Securities Act.
From time to time during 2007, 2008 and 2009, UMSL issued an aggregate of 5,666,667 ordinary shares to certain non-US noteholders in connection with the conversion of outstanding convertible notes. The issuance of these shares was exempt from registration pursuant to Section 3(a)(9) of the Securities Act.

 

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On December 29, 2008, UMSL issued 1,666,667 ordinary shares to its Chief Executive Officer, subject to certain transfer restrictions. The issuance of these common shares was exempt from registration pursuant to Regulation S under the Securities Act.
On February 1, 2009, UMSL issued 45,885 ordinary shares to certain employees for no proceeds. The issuance of these shares was exempt from registration pursuant to Rule 701 and/or Regulation S under the Securities Act.
During the year ended June 30, 2009, UMSL issued 97,532 ordinary shares upon the exercise of stock options for aggregate proceeds of $0.1 million (A$0.1 million). The issuance of these shares was exempt from registration pursuant to Rule 701 and/or Regulation S under the Securities Act.
In October and November 2009, UMSL issued 6,291,535 ordinary shares and options to purchase 3,645,767 ordinary shares to certain investors, brokers, and advisors in connection with a private placement for aggregate proceeds of $29.4 million (A$32.1 million). The issuances of these shares and options were exempt from registration pursuant to Regulation S and/or Regulation D under the Securities Act.
In conjunction with the private placement referenced in the immediately preceding paragraph, on November 17, 2009, UMSL issued 4,218,338 ordinary shares to certain shareholders Australian and New Zealand for aggregate proceeds of $20.1 million (A$21.5 million) pursuant to a share purchase plan. The issuance of these shares was exempt from registration pursuant to Regulation S under the Securities Act.
On November 17, 2009, UMSL issued 35,088 ordinary shares to certain US employees in connection with the exercise of stock options for aggregate proceeds of $0.2 million. The issuance of these shares was exempt from registration pursuant to Rule 701 under the Securities Act.
On November 17, 2009, UMSL issued 3,333,333 ordinary shares to four founders of UMSL pursuant to an agreement between UMSL and the founders, which required UMSL to issue certain number of shares to the founders depending on the results of operations of the UMSL. The issuance of these shares was exempt from registration pursuant to Regulation S under the Securities Act.
Issuances by Unilife Corporation:
Since our incorporation in July 2009, we have issued and sold the following securities that were not registered under the Securities Act:
In connection with our incorporation and initial organization, we issued 100 shares of common stock to UMSL for a total consideration of $1.00, which was exempt from registration pursuant to Regulation S under the Securities Act.

 

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Item 11.   Description of Registrant’s Securities to be Registered
The following description of our capital stock is a summary only and is qualified in its entirety by reference to our Certificate of Incorporation and Bylaws, which are included as Exhibits 3.1 and 3.2 of this registration statement.
Common Stock
We are authorized to issue up to 250,000,000 shares of common stock, US$0.01 par value per share.
Holders of our common stock are entitled to receive dividends when and as declared by our board of directors out of funds legally available.
Holders of our common stock are entitled to one vote for each share on all matters voted on by stockholders, including the election of directors.
Holders of our common stock do not have any conversion, redemption or preemptive rights. In the event of our dissolution, liquidation or winding up, holders of our common stock are entitled to share ratably in any assets remaining after the satisfaction in full of the prior rights of creditors and the aggregate liquidation preference of any preferred stock then outstanding. The rights, preferences and privileges of the holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock that we may designate and issue in the future.
All outstanding shares of our common stock are fully paid and non-assessable.
Preferred Stock
We are authorized to issue up to 50,000,000 shares of preferred stock, US$0.01 par value per share. We may issue any class of preferred stock in any series. Our board of directors has the authority to establish and designate series, and to fix the number of shares included in each such series and the variations in the relative rights, preferences and limitations as between series, provided that, if the stated dividends and amounts payable on liquidation are not paid in full, the shares of all series of the same class shall share ratably in the payment of dividends including accumulations, if any, in accordance with the sums which would be payable on such shares if all dividends were declared and paid in full, and in any distribution of assets other than by way of dividends in accordance with the sums which would be payable on such distribution if all sums payable were discharged in full. Shares of each series when issued shall be designated to distinguish the shares of each series from shares of all other series.

 

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Anti-Takeover Effects of Certain Provisions of Delaware Law and Our Certificate of Incorporation and Bylaws
Certain provisions of our Certificate of Incorporation and Bylaws may be considered as having an anti-takeover effect, such as those provisions:
    authorizing our board of directors to issue from time to time any series of preferred stock and fix the designation, powers, preferences and rights of the shares of such series of preferred stock;
    prohibiting stockholders from acting by written consent in lieu of a meeting, effective upon the implementation date (the “Implementation Date”) of the Implementation Agreement between us and UMSL;
    requiring advance notice of stockholder intention to put forth director nominees or bring up other business at a stockholders’ meeting;
    prohibiting stockholders from calling a special meeting of stockholders;
    requiring a 662/3% majority stockholder approval in order for stockholders to amend our bylaws or adopt new bylaws; and
    providing that, subject to the rights of the holders of any series of preferred stock, the number of directors shall be fixed from time to time exclusively by our board of directors pursuant to a resolution adopted by a majority of the total number of authorized directors (whether or not there exist any vacancies in previously authorized directorships). Newly created directorships resulting from any increase in our authorized number of directors will be filled only by a majority of our board of directors then in office, even less than a quorum, or, to the extent if there are no directors, by the stockholders.
We are also subject to Section 203 of the DGCL, which in general prohibits a Delaware corporation from engaging in any business combination with any interested stockholder for a period of three years following the date that the stockholder became an interested stockholder, unless:
    prior to that date, our board of directors approved either the business combination or the transaction that resulted in the stockholder becoming an interested stockholder;
    upon consummation of the transaction that resulted in the stockholder becoming an interested stockholder, the interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced, excluding for purposes of determining the number of shares outstanding (but not the outstanding voting stock owned by the interested stockholder) those shares owned by (i) persons who are directors and also officers and (ii) employee stock plans in which employee participants do not have the right to determine confidentially whether shares held subject to the plan will be tendered in a tender or exchange offer; or
    on or subsequent to that date, the business combination is approved by our board of directors and authorized at an annual or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 662/3% of the outstanding voting stock that is not owned by the interested stockholder.
In general, Section 203 defines an interested stockholder as an entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with or controlling or controlled by any of these entities or persons.
The above-summarized provisions of the Delaware General Corporation Law (the “DGCL”) and our Certificate of Incorporation and Bylaws could make it more difficult to acquire us by means of a tender offer, a proxy contest or otherwise, or to remove incumbent officers and directors. These provisions are expected to discourage certain types of coercive takeover practices and takeover bids that our board of directors may consider inadequate and to encourage persons seeking to acquire control of us to first negotiate with our board of directors. We believe that the benefits of increased protection of our ability to negotiate with the proponent of an unfriendly or unsolicited proposal to acquire or restructure us outweigh the disadvantages of discouraging takeover or acquisition proposals because, among other things, negotiation of these proposals could result in an improvement of their terms.
Listing
We plan to apply to list our common stock on the Nasdaq Capital Market under the symbol of “UNIS”. Subject to the approval by the ASX, our shares of common stock will be traded on the ASX in the form of CDIs under the symbol “UNS.”
Transfer Agent and Registrar
After the Implementation Date, the transfer agent and registrar for our common stock will be Computershare Investor Services Pty Limited.

 

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Item 12.   Indemnification of Directors and Officers
Our Certificate of Incorporation provides that, to the fullest extent permitted by the DGCL, our directors shall not be personally liable to us or our stockholders for monetary damages for breach of fiduciary duty as a director. Our Bylaws provide that, to the fullest extent permitted by Delaware law, we will indemnify, and advance expenses to, a director or officer in an action brought by reason of the fact that the director or officer is or was our director or officer, or is or was serving at our request as a director or officer of any other entity, against all expenses, liability and loss reasonably incurred or suffered by such person in connection therewith. We may maintain insurance to protect a director or officer against any expense, liability or loss, whether or not we would have the power to indemnify such person against such expense, liability or loss under Delaware law.
The limitation of liability and indemnification provisions in our Certificate of Incorporation and Bylaws may discourage stockholders from bringing a lawsuit against directors for breach of their fiduciary duty. These provisions may also have the effect of reducing the likelihood of derivative litigation against our directors and officers, even though such an action, if successful, might otherwise benefit us and our stockholders. However, these provisions do not limit or eliminate our rights, or those of any stockholder, to seek non-monetary relief such as injunction or rescission in the event of a breach of a director’s duty of care. The provisions will not alter the liability of directors under the federal securities laws. In addition, your investment may be adversely affected to the extent that, in a class action or direct suit, we pay the costs of settlement and damage awards against directors and officers pursuant to these indemnification provisions. There is currently no pending litigation or proceeding against any of our directors, officers or employees for which indemnification is sought.
Item 13.   Financial Statements and Supplementary Data
Our consolidated financial statements appear on pages F-1 through F-31 of this registration statement.
Item 14.   Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
The Company has not had a change in its independent registered public accounting firm during its last two fiscal years or through the date of this filing. However, as a result of the redomiciliation into the United States, the Company intends to change its public accounting firm to a U. S. firm. This change will likely occur subsequent to the effectiveness of this Form 10 and will be appropriately reported under Form 8-K. The Company notes that it has not had any disagreements with its current public accounting firm during the last two fiscal years or through the date of this filing on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement, if not resolved to the satisfaction of the public accounting firm, would have caused it to make reference to the subject matter of the disagreement in connection with its report on the Company’s financial statements.
Item 15.   Financial Statements and Exhibits
(a) Financial Statements
Our consolidated financial statements appear on pages F-1 through F-31 of this registration statement.
(b) Exhibits
                 
Exhibit Number   Description        
  2.1    
Amended and Restated Merger Implementation Agreement dated as of September 1, 2009 between Unilife Medical Solutions Limited and Unilife Corporation +
       
 
  2.2    
Share Purchase Agreement among Unilife Medical Solutions Limited, Edward Paukovits, Jr., Keith Bocchicchio, and Daniel Adlon dated as of October 25, 2006 and amended as of September 26, 2007+
       
 
  3.1    
Certificate of Incorporation of Unilife Corporation**
       
 
3.2  
Bylaws of Unilife Corporation**
       
 
  4.1    
Form of Common Stock Certificate**
       
 
  10.1    
Exclusive Agreement dated as of June 30, 2008 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie**
       
 
  10.2 *  
First Amendment dated as of June 29, 2009 to Exclusive Agreement dated as of June 30, 2008 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie**

 

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Exhibit Number   Description        
  10.3 *  
Industrialization Agreement dated as of June 30, 2009 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie
       
 
  10.4    
Business Lease, dated as of August 17, 2005, between Integrated BioSciences, Inc. and AMC Delancey Heartland Partners, L.P.**
       
 
  10.5    
Agreement dated as of September 15, 2003 between Integrated BioSciences, Inc. and B. Braun Medical, Inc. and amendments thereto
       
 
  10.6    
Promissory Note, dated as of December 30, 2005 between Integrated BioSciences, Inc. and Commerce Bank**
       
 
  10.7    
Promissory Note, dated as of August 25, 2006 between Integrated BioSciences, Inc. and Commerce Bank**
       
 
  10.8    
Employment Agreement, dated as of October 26, 2008 between Unilife Medical Solutions Limited and Alan Shortall**
       
 
  10.9    
Employment Agreement, dated as of February 15, 2005 between Unilife Medical Solutions Limited and Jeff Carter**
       
 
  10.10    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Daniel Calvert**
       
 
  10.11    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Bernhard Opitz**
       
 
  10.12    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Mark Iampietro**
       
 
  10.13    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Stephen Allan**
       
 
  10.14    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Eugene Shortall**
       
 
  10.15    
Consulting Agreement, dated as of January 22, 2009 between Unilife Medical Solutions Limited and Joblak Pty Ltd**
       
 
  10.16    
Deed of Mutual Release, dated January 12, 2009 between Unilife Medical Solutions Limited and Jeff Carter**
       
 
  10.17    
Unilife Corporation Employee Stock Option Plan**
       
 
  10.18    
Unilife Corporation 2009 Stock Incentive Plan**
       
 
  10.19    
Unilife Medical Solutions Limited Exempt Employee Share Plan**
       
 
  10.20 *  
Agreement dated November 12, 2009 between Unilife Medical Solutions, Inc. and Mikron Assembly Technology
       
 
  10.21    
Purchase and Mutual Indemnification Agreement dated November 16, 2009 between Unilife Cross Farm LLC and Greenspring Partners, LP
       
 
  10.22    
Offer of assistance dated October 16, 2009 from the Commonwealth of Pennsylvania to Unilife Medical Solutions and acceptance of the offer
       
 
  10.23    
Agreement Between Unilife Cross Farm LLC and L2 Architecture dated as of December 29, 2009, as amended
       
 
  10.24    
Agreement between Unilife Cross Farm LLC and HSC Builders & Construction Managers dated as of December 14, 2009, as amended
       
 
  10.25    
Development Agreement, dated December 14, 2009 between Unilife Cross Farm LLC and Keystone Redevelopment Group LLC
       
 
  10.26    
Amended and Restated Operating Agreement dated December 14, 2009 of Unilife Cross Farm LLC
       
 
  10.27    
Form of Share Purchase Agreement between Unilife Medical Solutions Limited and each of the US investors in the October and November 2009 private placement
       
 
  10.28    
Form of Subscription Agreement between Unilife Medical Solutions Limited and each of the Australian investors in the October and November 2009 private placement
       
 
  10.29    
2009 Share Purchase Plan Terms and Conditions
       
 
  21    
List of subsidiaries of Unilife Corporation
     
+   The annexures, schedules and exhibits to this exhibit have been omitted. A copy of any omitted annexure, schedule or exhibit will be furnished to the Securities and Exchange Commission supplementally upon request.
 
*   Confidential treatment has been requested for certain provisions of this Exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
 
**   Previously filed.

 

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SIGNATURES
Pursuant to the requirements of Section 12 of the Securities Exchange Act of 1934, the registrant has duly caused this Amendment No. 1 to the registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.
         
  Unilife Corporation
 
 
Date: January 5, 2010  By:   /s/ Alan Shortall    
    Name:   Alan Shortall   
    Title:   Chief Executive Officer   

 

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INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
         
    Page  
Unaudited Condensed Consolidated Interim Financial Statements
       
 
       
    F-2  
 
       
    F-3  
 
       
    F-4  
 
       
    F-5  
 
       
    F-6  
 
       
Audited Consolidated Financial Statements
       
 
       
    F-13  
 
       
    F-14  
 
       
    F-15  
 
       
    F-16  
 
       
    F-17  
 
       
    F-18  

 

F-1


Table of Contents

UNILIFE CORPORATION AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
                 
    September 30, 2009     June 30, 2009  
Assets
               
Current Assets:
               
Cash and cash equivalents
  $ 4,046     $ 3,627  
Accounts receivable
    2,515       7,333  
Inventories
    1,613       1,097  
Prepaid expenses and other current assets
    322       223  
 
           
Total current assets
    8,496       12,280  
Property, plant and equipment, net
    10,867       9,137  
Goodwill
    10,990       10,235  
Intangible assets, net
    46       43  
Other assets
    314       517  
 
           
Total assets
  $ 30,713     $ 32,212  
 
           
 
               
Liabilities and Stockholders’ Equity
               
 
               
Current Liabilities:
               
Accounts payable
  $ 567     $ 1,103  
Accrued expenses
    5,803       6,097  
Current portion of long-term debt
    405       405  
Deferred revenue
    2,866       2,642  
 
           
Total current liabilities
    9,641       10,247  
Long-term debt, less current portion
    2,586       2,728  
Deferred revenue
    7,880       7,926  
 
           
Total liabilities
    20,107       20,901  
 
           
 
               
Commitments and contingencies
               
 
               
Stockholders’ Equity:
               
Preferred stock, $0.01 par value, 50,000,000 shares authorized as of September 30, 2009; none issued or outstanding as of September 30, 2009 and June 30, 2009
           
Common stock, $0.01 par value, 250,000,000 shares authorized as of September 30, 2009; 37,010,802 and 36,625,802 shares issued and outstanding as of September 30, 2009 and June 30, 2009, respectively
    370       366  
Additional paid-in-capital
    59,041       57,987  
Accumulated deficit
    (51,966 )     (49,902 )
Accumulated other comprehensive income
    3,161       2,860  
 
           
Total stockholders’ equity
    10,606       11,311  
 
           
Total liabilities and stockholders’ equity
  $ 30,713     $ 32,212  
 
           
See notes to the condensed consolidated financial statements.

 

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UNILIFE CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
                 
    Three months ended September 30,  
    2009     2008  
Revenues
  $ 3,108     $ 2,305  
Cost of sales
    865       1,131  
 
           
Gross profit
    2,243       1,174  
 
           
Operating expenses:
               
Research and development
    399       131  
Selling, general and administrative
    3,742       2,422  
Depreciation and amortization
    255       144  
 
           
 
               
Total operating expenses
    4,396       2,697  
 
           
Operating loss
    (2,153 )     (1,523 )
Interest expense
    47       125  
Interest income
    (5 )     (120 )
Other (income) expense, net
    (131 )     88  
 
           
Net loss
  $ (2,064 )   $ (1,616 )
 
           
Loss per share:
               
Basic loss per share
  $ (0.06 )   $ (0.05 )
 
           
Diluted loss per share
  $ (0.06 )   $ (0.05 )
 
           
See notes to the condensed consolidated financial statements.

 

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UNILIFE CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Stockholders’ Equity and Comprehensive Income
(in thousands, except share data)
(unaudited)
                                                 
                                    Accumulated        
                    Additional-             Other        
    Common Stock     Paid-In     Accumulated     Comprehensive        
    Shares     Amount     Capital     Deficit     Income (Loss)     Total  
Balance as of July 1, 2009
    36,625,802     $ 366     $ 57,987     $ (49,902 )   $ 2,860     $ 11,311  
Comprehensive loss:
                                               
Net loss
                      (2,064 )           (2,064 )
Foreign currency translation
                            301       301  
 
                                             
Comprehensive loss
                                            (1,763 )
Share-based compensation expense
                570                   570  
Issuance of common stock upon exercise of stock options
    385,000       4       484                   488  
 
                                   
Balance as of September 30, 2009
    37,010,802     $ 370     $ 59,041     $ (51,966 )   $ 3,161     $ 10,606  
 
                                   
See notes to the condensed consolidated financial statements.

 

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UNILIFE CORPORATION AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
                 
    Three months ended September 30,  
    2009     2008  
Cash flows from operating activities:
               
Net loss
  $ (2,064 )   $ (1,616 )
Adjustments to reconcile net loss to net cash provided by operating activities:
               
Depreciation and amortization
    291       171  
Share-based compensation expense
    570       93  
Changes in assets and liabilities:
               
Accounts receivable
    5,161       230  
Inventories
    (516 )     308  
Prepaid expenses and other current assets
    (85 )     (35 )
Other assets
    201       24  
Accounts payable
    (553 )     55  
Accrued expenses
    (203 )     (608 )
Deferred revenue
    (683 )     12,668  
 
           
Net cash provided by operating activities
    2,119       11,290  
Cash flows from investing activities
               
Purchases of property, plant and equipment
    (1,735 )     (98 )
Net cash used in investing activities
    (1,735 )     (98 )
Cash flows from financing activities
               
Proceeds from the exercise of options to purchase common stock
    488       38  
Principal payments on long-term debt
    (142 )     (3,094 )
 
           
Net cash provided by (used in) financing activities
    346       (3,056 )
Foreign currency exchange on cash
    (311 )     (48 )
 
           
Net increase in cash and cash equivalents
    419       8,088  
Cash and cash equivalents at beginning of period
    3,627       2,887  
 
           
 
               
Cash and cash equivalents at end of period
  $ 4,046     $ 10,975  
 
           
Supplemental disclosure of non-cash activities
               
Conversion of convertible notes into common stock
  $     $ 75  
 
           
See notes to the condensed consolidated financial statements.

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
1. Description of Business and Unaudited Financial Statements
Unilife Corporation and subsidiaries (the “Company”) is a medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. The primary target customers for the Company’s products include pharmaceutical manufacturers and suppliers of medical equipment to healthcare facilities or patients who self-administer prescription medication. The Company also manufactures non-proprietary Class I and Class II medical devices, such as specialty syringes under contract for outsourcing customers.
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying unaudited condensed consolidated financial statements contain all normal and recurring adjustments that, in the opinion of management, are necessary for a fair presentation for the periods presented as required by Regulation S-X, Rule 10-01. Interim results may not be indicative of results for a full year. The condensed consolidated financial statements should be read in conjunction with the Company’s consolidated financial statements and the notes thereto contained in this registration statement for the year ended June 30, 2009.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The condensed consolidated financial statements include the accounts of Unilife Medical Solutions Limited (“UMSL”) and its wholly-owned subsidiaries. Subsequent to June 30, 2009, a newly formed subsidiary, Unilife Corporation, will become UMSL’s parent holding company in a transaction described below. The condensed consolidated financial statements have been prepared in accordance with GAAP and in U.S. currency. All intercompany accounts and transactions have been eliminated in consolidation.
On September 1, 2009, UMSL announced that it entered into a Merger Implementation Agreement with Unilife Corporation, pursuant to which shareholders and optionholders of UMSL will exchange their existing interests in UMSL for equivalent interests in Unilife Corporation and Unilife Corporation will become the parent, or ultimate parent of UMSL and its subsidiaries. Each holder of UMSL ordinary shares or share options will receive one share of common stock or one stock option, of Unilife Corporation for every six UMSL ordinary shares or share options, respectively, held by such holder, unless a holder of UMSL ordinary shares elects to receive, in lieu of common stock, Chess Depository Interests, or CDI’s (each representing one-sixth of a share of the Company’s common stock) of the Company, in which case such holder will receive one CDI of Unilife Corporation for each ordinary share of UMSL. All share and per share data have been retroactively restated to reflect the one for six share consolidation. The redomiciliation transaction is subject to various conditions, including without limitation, approval by the Australian Federal Court, approval by the shareholders and optionholders of UMSL, and a report by an independent expert concluding that the redomiciliation transaction is fair, reasonable and in the best interests of the shareholders and optionholders.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Inventories
Inventories consist primarily of plastic syringe components and include direct materials, direct labor and manufacturing overhead. Inventory is stated at the lower of cost or market, with cost determined using the first in, first out method. The Company routinely reviews its inventory for obsolete, slow moving or otherwise impaired inventory and records estimated impairments in the periods in which they occur. Inventories consist of the following:
                 
    September 30, 2009     June 30, 2009  
Raw materials
  $ 581     $ 567  
Work in process
    1,032       530  
 
           
Total inventories
  $ 1,613     $ 1,097  
 
           

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
Goodwill and Intangible Assets
Goodwill is the excess of purchase price over the value of net assets acquired in business acquisitions. Goodwill is subject to, at a minimum, an annual impairment assessment of its carrying value. Additional impairment assessments would be performed if events and circumstances warranted such additional assessments during the year. Goodwill impairment is deemed to exist if the net book value of a reporting unit exceeds its estimated fair value. Estimated fair values of the reporting units are estimated using an earnings model and a discounted cash flow valuation model. The discounted cash flow model incorporates the Company’s estimates of future cash flows, future growth rates and management’s judgment regarding the applicable discount rates used to discount those estimated cash flows. The estimated fair value of each reporting unit, if lower than the carrying value of the respective reporting unit (such carrying value determined after management allocation of certain shared assets), would then be allocated to the reporting unit’s net identifiable assets based on their respective estimated fair values. The remaining unallocated reporting unit fair value, if any, would then be compared to the carrying amount of that unit’s goodwill and, if lower, the Company would recognize an impairment charge to the extent of the deficiency. There were no impairments recorded on goodwill during the three months ended September 30, 2009 or 2008.
Definite-lived intangible assets include patents which are amortized on a straight-line basis over their estimated useful lives of 15 years. The Company reviews intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the estimated future cash flows (undiscounted) expected to result from the use and eventual disposition of an asset is less than the carrying amount of the asset, an impairment loss is recognized. Measurement of an impairment loss is based on the fair value of the asset. There were no impairments recorded on intangible assets during the three months ended September 30, 2009 or 2008.
The Company expenses costs related to internally developed patents as incurred.
Share-Based Compensation
The Company grants both stock options and shares as compensation to its employees, directors and consultants. Certain employee and director awards vest over stated service periods and others also require achievement of specific performance or market conditions. The Company expenses the grant date fair value of awards to employees and directors over their respective service periods or over the period from grant date to the date the required performance or market conditionals are expected to be met, if shorter. To the extent that employee and director awards vest only upon the achievement of a specific performance or market condition, expense is recognized over the period from the date management determines that the conditions are achievable through the date they are expected to be met. Awards granted to consultants are sometimes granted for past services, in which case their fair value is expensed on their grant date, and sometimes granted with future service, performance or market conditions. Timing of expense recognition for consultant awards is similar to that of employee and director awards; however, aggregate expense is re-measured each quarter end based on the fair value of the award at that date. The Company determines the fair value of stock options using the Black-Scholes option pricing model, with the exception of market-based performance grants, which are valued based on a Barrier pricing model. Option pricing methods require the input of highly subjective assumptions, including the expected stock price volatility. See Note 3 for additional information regarding share-based compensation.
Revenue Recognition
The Company recognizes revenue from licensing fees, industrialization efforts and products sold.
In early fiscal 2008, the Company granted an exclusive licensing arrangement to allow its pharmaceutical partner to use certain of the Company’s intellectual property in order and solely to develop in collaboration with the Company, the Company’s Unifill syringe for use in and sale to the pre-filled syringe market. The up-front, non-refundable fee paid for this license is being amortized over the expected life of the related agreement. In late fiscal 2009, the Company entered into an industrialization agreement with its pharmaceutical partner, retroactive to July 2008, under which the Company received payments upon achievement of certain pre-defined milestones in its development of the Unifill syringe. Revenue is recognized upon achievement of the “at risk” milestone events, which represents the culmination of the earnings process related to such events. Milestones include specific phases of the project such as product design, prototype availability, user tests, manufacturing proof of principle and the various steps to complete the industrialization of the product. Specific payment amounts and completion dates were established for each milestone payment. Revenue recognized is commensurate with the milestones achieved. Billings are similarly triggered and the Company has no future performance obligations related to previous milestone payments. Each milestone payment is non-refundable when made.

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
The Company recognizes revenue from sales of products at the time of shipment and when title passes to the customer. These amounts were $680 and $1,691 during the three months ended September 30, 2009 and 2008, respectively.
Recently Issued Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (“FASB”) issued Statement of Financial Accounting Standards (‘SFAS”) No. 168, “The FASB Accounting Standards Codification ™ and the Hierarchy of Generally Accepted Accounting Principles — a replacement of FASB Statement No. 162 (”SFAS 168”). SFAS 168 represents the last numbered standard issued by the FASB under the old (pre-codification) numbering system, and amends the GAAP hierarchy. On July 1, 2009, the FASB launched its new codification (i.e. the FASB Accounting Standards Codification). The codification supersedes existing GAAP for nongovernmental entities.
In May 2009, the FASB issued a new accounting standard included in ASC 855, Subsequent Events, formerly SFAS No. 165, “Subsequent Events.” ASC 855 sets forth: (1) the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements; (2) the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements; and (3) the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. ASC 855 was effective for interim and annual periods ending after June 15, 2009. The Company has evaluated subsequent events through the date the accompanying financial statements were issued, which was January 5, 2010.
In August 2009, the FASB issued Accounting Standards Update No. 2009-05, Fair Value Measurements and Disclosures (Topic 820)—Measuring Liabilities at Fair Value, which provides guidance on how to measure liabilities at fair value in circumstance in which a quoted price in an active market for the identical liability is not available. This update is effective for the first reporting period, including interim periods, beginning after issuance. The Company has no liabilities that are governed by this update but will apply its provisions in the future as applicable.
3. Share-Based Compensation
The Company recognized share-based compensation expense related to stock options and grants of common stock to employees, directors and consultants of $570 and $93 during the three months ended September 30, 2009 and 2008, respectively. The total tax benefit recognized related to these awards was $171 and $28 during the three months ended September 30, 2009 and 2008, respectively, which was fully offset by changes in the Company’s valuation allowance.
Stock Options
The Company has granted stock options to certain employees and directors under the Employee Share Option Plan, (the “Plan”). The Plan is designed to assist in the motivation and retention of employees and to recognize the importance of employees to the long-term performance and success of the Company. The Company has also granted stock options to certain consultants outside of the Plan. The majority of the options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to three years. Additionally, certain stock options vest upon the closing price of the Company’s common stock reaching certain minimum levels, as defined in the agreements. Finally, certain other stock options vest upon the meeting of certain Company milestones such as the signing of specific agreements and the completion of the Company’s anticipated listing on a U.S. stock exchange. As of September 30, 2009, the Company expects that all such market and performance conditions will be met. Share-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term. The Plan does not provide for a fixed number of available shares.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
The following is a summary of the Plan and non-Plan stock option activity during the three months ended September 30, 2009:
                                 
                    Weighted-        
                    Average        
            Weighted-     Remaining        
    Number of     Average     Contractual     Aggregate  
    Options     Exercise Price     Life (in years)     Intrinsic Value  
Outstanding as of July 1, 2009
    6,322,500     $ 1.58                  
Granted
    83,333       1.83                  
Exercised
    (385,000 )     1.31                  
Cancelled
    (433,333 )     2.14                  
 
                           
Outstanding as of September 30, 2009
    5,587,500     $ 1.56       2.6     $ 30,916  
 
                       
Exercisable as of September 30, 2009
    3,729,167     $ 1.69       2.2     $ 20,763  
 
                       
The aggregate intrinsic value is defined as the difference between the market value of the Company’s common stock as of the end of the period and the exercise price of the in-the-money stock options. The total intrinsic value of stock options exercised during the three months ended September 30, 2009 and 2008 was $1,030 and $0, respectively. Of the 1,858,333 non vested options, 83,333 are held by consultants.
The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model, with the exception of grants subject to market conditions which are valued based on a Barrier option pricing model. The Company has not historically paid dividends to its shareholders, and, as a result assumed a dividend yield of 0%. The risk free interest rate is based upon the rates of Australian bonds with a term equal to the expected term of the option. The expected volatility is based upon the historical share price of the Company’s common stock. The expected term of the stock options to purchase common stock is based upon the outstanding contractual term of the stock option on the date of grant. The Company used the following weighted-average assumptions in calculating the fair value of options granted during the three months ended September 30, 2009 and 2008.
                 
    Three Months ended September 30,  
    2009     2008  
Expected dividend yield
    0 %     0 %
Risk-free interest rate
    4.78 %     4.76 %
Expected volatility
    80 %     80 %
Expected life (in years)
    3.0       3.8  
4. Goodwill and Other Intangible Assets
The changes in the carrying amount of goodwill during the three months ended September 30, 2009 are as follows:
         
Balance as of July 1, 2009
  $ 10,235  
Foreign currency translation
    755  
 
     
Balance as of September 30, 2009
  $ 10,990  
 
     
In connection with the acquisition of Unitract Syringe Pty Limited in October 2002, the Company agreed to issue 1,666,667 shares of common stock to certain former shareholders of Unitract Syringe Pty Limited if the Company reported net income of at least A$6,500 during any fiscal year prior to October 31, 2014, as amended. The agreement also provided for the issuance of an additional 1,666,667 shares of common stock upon the Company reporting net income of at least A$12,000 during any fiscal year prior to October 31, 2014. During the year ended June 30, 2009, the Company met both the net income requirements, and as a result, has accrued for the issuance of 3,333,333 shares based upon the closing price of the Company’s common stock as of June 30, 2009. These shares were issued in November 2009.
As of September 30, 2009, intangible assets consist of patents acquired in a business acquisition of $80. Related accumulated amortization as of September 30, 2009 and June 30, 2009 was $39 and $37, respectively, and future amortization expense is scheduled to be $5 annually.

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
5. Long-Term Debt
Long-term debt consists of the following:
                 
    September 30, 2009     June 30, 2009  
Bank term loans
  $ 2,590     $ 2,709  
Pennsylvania State assisted loans
    401       424  
 
           
 
    2,991       3,133  
Less: current portion of long-term debt
    405       405  
 
           
Total long-term debt
  $ 2,586     $ 2,728  
 
           
Bank term loans consist of four term loans payable. The loans bear interest at a rate of prime (3.25% as of September 30, 2009) plus 1.50%. (4.75% as of September 30, 2009) per annum and mature on dates ranging from December 2010 through August 2021. The borrowings under the bank term loans are collateralized by the Company’s accounts receivable, inventory and certain pieces of machinery and equipment and are subject to certain financial covenants which require the Company’s tangible assets to equal at least 10% of the balance sheet equity determined in accordance with GAAP. Under the term loan agreements, the Company is not permitted to pay cash dividends without the prior written consent of the lender. The Company was in compliance with these covenants as of September 30, 2009.
The Company has qualified for two Pennsylvania state assisted loans for the purchase of specific machinery and equipment. These loans bear interest at rates ranging from 2.75% to 3.25% per annum and mature on dates ranging from July 2011 through July 2013. The borrowings under the state assisted loans are collateralized by certain production equipment.
During the year ended June 30, 2008, the Company issued A$2,000 (approximately $1,920) of convertible notes which were convertible into shares of the Company’s common stock at a conversion price of A$1.5 (approximately $1.44) per share. Interest was payable semi-annually at a rate of 12% per annum. A$80 of these convertible notes were exchanged for 53,333 shares of the Company’s common stock during the three months ended September 30, 2008.
6. Loss Per Share
The Company’s net loss per share is as follows:
                 
    Three Months ended September 30,  
    2009     2008  
Numerator
               
Net loss
  $ (2,064 )   $ (1,616 )
Denominator
               
Weighted average number of shares used to compute basic loss per share
    36,762,142       34,348,301  
Effect of dilutive options to purchase common stock
           
 
           
Weighted average number of shares used to compute diluted loss per share
    36,762,142       34,348,301  
 
           
Basic loss per share
  $ (0.06 )   $ (0.05 )
 
           
Diluted loss per share
  $ (0.06 )   $ (0.05 )
 
           

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
During the three months ended September 30, 2009 and 2008 options to purchase 5,587,500 and 3,339,167 shares of common stock were excluded from the computation of diluted loss per share, respectively, as their effect would have been anti-dilutive.
7. Contingencies
The Company is involved in, or has pending, various legal proceedings, claims, suits and complaints arising out of the normal course of business. Based on the facts currently available to the Company, management believes that these claims, suits and complaints are adequately provided for, covered by insurance, without merit or not probable that an unfavorable outcome will result.
8. Business Alliance
On June 30, 2008 the Company signed an exclusive licensing agreement with a pharmaceutical company, sanofi-aventis, which was amended in June, 2009. Under the amended agreement, the Company has granted sanofi-aventis an exclusive license to certain of the Company’s intellectual property in order and solely to develop, in collaboration with the Company, the Unifill syringe for use in and sale to the pre-filled syringe market within those therapeutic areas to be agreed upon between the Company and sanofi-aventis and a non-exclusive license outside those therapeutic areas that are exclusive to sanofi-aventis or after the expiration of the exclusive license with sanofi-aventis. Pursuant to the exclusive licensing agreement, sanofi-aventis has paid the Company a 10,000 Euro ($13,024) up front non-refundable one-time fee. The exclusive license granted thereunder has an initial term expiring on June 30, 2014, unless the Company and sanofi-aventis fail to agree upon the list of therapeutic areas that are exclusive to sanofi-aventis, in which event the exclusive license will have a term until June 29, 2012 for all therapeutic areas. If during the term of the exclusive license, sanofi-aventis has purchased the Unifill syringe for use with a particular drug product, sanofi-aventis will receive a ten-year extension of the term of the exclusive license, which extension will be reduced to five years if sanofi-aventis does not sell a minimum of 20,000 units of the product in any of the first five years of such ten-year extension period. During the year ended June 30, 2009, the Company recognized $2,456 of this up front payment as revenue and deferred $10,568 which will be recognized on a straight-line basis over the remaining term of the agreement. During the three months ended September 30, 2009 the Company recognized $683 of this up front payment as revenue.
Under the exclusive licensing agreement, the Company is not precluded from using certain of its intellectual property to develop, license and sell any products in any market other than the ready-to-fill syringe market, or from entering into licensing or other business arrangements with other pharmaceutical companies for the ready-to-fill syringe market outside those therapeutic areas that are exclusive to sanofi-aventis, or after the expiration of the exclusive license with sanofi-aventis. If the Company grants a license to a third party in respect of the ready-to-fill syringe market, then the Company is required to pay sanofi-aventis 70% of any access, license or other upfront fee received from such third party for access to purchase the products until our payments to sanofi-aventis have totaled €10 million, following which the Company is required to pay 30% of such fees it receives through the end of the initial exclusivity period. The Company is also required to pay sanofi-aventis an annual royalty payment of 5% of the revenue generated from any sale of the Unifill syringe to third parties, up to a maximum amount of €17 million in such royalty payments.
Under a related industrialization agreement, signed on June 30, 2009, sanofi-aventis has agreed to pay the Company up to 17,000 Euro ($23,400) in milestone-based payments to fund the completion of the Company’s industrialization program for the Unifill syringe. The industrialization program began in July 2008 and is scheduled to be completed by the end of 2010. The industrialization agreement requires sanofi-aventis to provide a list to the Company that specifies therapeutic drug classes for which it seeks to market the Unifill syringe on an exclusive basis. The Company and sanofi-aventis will then discuss the exclusivity list during a several month negotiation period, and if the list is agreed, sanofi-aventis will retain exclusive rights to the use of the product within these designated therapeutic drug classes until June 30, 2014, subject to the extension described above. If the Company and sanofi-aventis are unable to reach an agreement on the list, sanofi-aventis will retain full exclusivity across all therapeutic classes until July 1, 2012. Unless terminated earlier, the industrialization agreement has a term until the completion of the industrialization program. During the year ended June 30, 2009, the Company recognized $13,601 in revenue related to the milestones achieved under the industrialization agreement of which $7,024 was collected after year end. During the three months ended September 30, 2009, the Company recognized $1,745 in revenue related to the milestones achieved.

 

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Unilife Corporation and Subsidiaries
Notes to Condensed Consolidated Financial Statements
(in thousands, except share and per share data)
The industrialization agreement provides that, subject to the full completion of the industrialization program, the parties will negotiate a supply agreement for the manufacture and purchase of the final product on a commercial scale. The supply agreement will provide that sanofi-aventis and its affiliates will purchase the final product exclusively from us, and the industrialization agreement provides that we are not required to commit more than 30% of our expected installed production capacity to sanofi-aventis and its affiliates for the 12 months following the receipt of a purchase order. Any order of sanofi-aventis, together with its other orders, that will exceed the 30% capacity limit will require up to a maximum of 24 months lead time before we are required to commence delivery of that order.
9. Subsequent Events
On October 8, 2009, UMSL issued 3,460,344 ordinary shares in a private placement to a group of sophisticated and professional Australian investors and accredited investors in the United States, and subject to shareholder approval, agreed to issue to the investors an additional 2,831,191 ordinary shares and options to purchase 3,145,767 ordinary shares. UMSL obtained shareholder approval for the issuance of the additional ordinary shares and share options at a meeting held on November 13, 2009. All of the ordinary shares were issued at a price of A$5.10 per share for aggregate proceeds of A$32.086  and all of the share options were issued for no additional consideration. Each of the share options is exercisable within three years after the date of grant. Half of the share options have an exercise price of A$7.50 per share, and the other half of the share options have an exercise price of A$12.00 per share. In conjunction with the private placement, UMSL’s Australian and New Zealand shareholders were offered, and some of them purchased ordinary shares under a share purchase plan, at a price of A$5.10 per share, for a total consideration of A$21,500. In addition, after receiving shareholder approval on November 13, 2009, UMSL issued share options to purchase up to 500,000 ordinary shares to certain advisors and brokers as compensation for their services with respect to the private placement and the share purchase plan. These share options have the same terms as the share options issued to the investors. The proceeds from the private placement and the share purchase plan will be used to accelerate the expansion of the Company’s U.S. operational capabilities and production facilities, to purchase capital equipment and complete the industrialization program for the Unifill syringe.
While the private placement was conducted by UMSL prior to the redomiciliation, all of the share numbers and share option exercise prices referred to above give effect to the share consolidation we will effect in connection with the redomiciliation (one share of our common stock equals six ordinary shares of UMSL). The ordinary shares and share options issued in the placement will be exchanged for shares of the Company’s common stock and options to purchase the Company’s common stock in connection with the redomiciliation.
During October 2009, the Company accepted a $5,200 offer of assistance from the Commonwealth of Pennsylvania. The offer includes $2,000 for the development of the Company’s new global headquarters and manufacturing facility as well as up to $2,000 in low interest financing loans for land, building, acquisition and construction costs. The offer also includes a $500  opportunity grant, as well as $500 in tax credits. Finally, the offer includes up to $200  for the reimbursement of eligible job training costs. The offer is based on the Company’s proposed project being expected to create more than 200 new full-time jobs by December 31, 2012, to retain the Company’s 97 existing employees and to have a total cost of $86,000 and is contingent upon the Company submitting complete applications and meeting all program guidelines. The Company cannot assure that it will be able to receive all or any of the assistance for the Company’s current development project or otherwise.
On November 12, 2009, the Company signed a purchase agreement with Mikron Assembly Technology for the development and supply of a pilot automated assembly system to support the commercial production of its Unifill syringe. The development of the system is scheduled to begin during December 2009, with scheduled completion and installation into the Company’s new facility during the fourth quarter of 2010. The Company anticipates that this automated assembly system will have a target production capacity of approximately 60 million units per year.
On November 16, 2009, through Unilife Cross Farm, LLC (“Unilife CF”), the Company’s newly formed subsidiary, the Company acquired a 38 acre block of land in York County, Pennsylvania from Greenspring Partners, LP for a purchase price of $1,991.
On November 17, 2009, the Company issued 3,333,333 shares to former shareholders of Unitract Syringe Pty Limited. The value of these shares was accrued as of June 30, 2009 and September 30, 2009.
On December 14, 2009, Unilife CF entered into a development agreement with Keystone Redevelopment Group, LLC (“Keystone’) to develop the Company’s new 165,000 square foot office, manufacturing, warehousing and distribution facility to its specifications. In accordance with the agreement, Keystone will assist the Company with the selection of, as well as the review and management of, architects, engineers, designers, contractors and other experts and consultants engaged to assist in the development of the new facility. Additionally, Keystone will assist the Company in obtaining financing for the facility. Under the terms of the agreement, the Company will pay Keystone a total of $754.
On December 14, 2009, Unilife CF entered into a Construction Agreement with HSC Builders & Construction Managers of Pennsylvania (“HSC”) to construct the new facility for a total of 1.25% of the cost of work, which is estimated to be $268. Additionally, on December 29, 2009, Unilife CF entered into an agreement with L2 Architecture (”L2”) to provide architectural design and structural, mechanical, and electrical engineering services for the new facility for a total cost of $1,560.
The Company has prepared a detailed budget for developing the new facility and based on this budget the total cost is estimated to be approximately $26,000. This includes the projected construction costs, the projected manufacturing facility fit out costs and the fees payable to Keystone, HSC and L2.
The Company has provided for $8,000 - $10,000 in projected capital expenditure to be used towards the development of the new facility. At this stage, the Company intends to fund up to approximately $9,000 of the development costs for the new facility out of its existing cash reserves, which includes amounts received in connection with the Company’s October and November 2009 equity financings and will seek external financing for up to approximately $17,000 from a commercial bank or other lending institution in the U.S. and/or from the Commonwealth of Pennsylvania or other federal and state bodies.

 

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Report of Independent Registered Public Accounting Firm
Board of Directors and Stockholders
Unilife Corporation
Lewisberry, Pennsylvania
We have audited the accompanying consolidated balance sheets of Unilife Corporation and subsidiaries as of June 30, 2009 and 2008 and the related consolidated statements of operations, stockholders’ equity and comprehensive income, and cash flows for each of the three years in the period ended June 30, 2009. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Unilife Corporation and subsidiaries at June 30, 2009 and 2008, and the results of its operations and its cash flows for each of the three years in the period ended June 30, 2009, in conformity with accounting principles generally accepted in the United States of America.
/s/ BDO Kendalls Audit & Assurance (WA) Pty Ltd
Perth, Western Australia
November 11, 2009

 

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UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share data)
                 
    June 30,  
    2009     2008  
Assets
               
 
Current Assets:
               
Cash and cash equivalents
  $ 3,627     $ 2,887  
Accounts receivable
    7,333       745  
Inventories
    1,097       1,065  
Prepaid expenses and other current assets
    223       107  
 
           
Total current assets
    12,280       4,804  
Property, plant and equipment, net
    9,137       7,799  
Goodwill
    10,235       5,555  
Intangible assets, net
    43       60  
Other assets
    517       281  
 
           
Total assets
  $ 32,212     $ 18,499  
 
           
 
               
Liabilities and Stockholders’ Equity
               
 
               
Current Liabilities:
               
Accounts payable
  $ 1,103     $ 552  
Accrued expenses
    6,097       1,231  
Current portion of long-term debt
    405       4,169  
Deferred revenue
    2,642        
 
           
Total current liabilities
    10,247       5,952  
Long-term debt, less current portion
    2,728       3,040  
Deferred revenue
    7,926        
 
           
Total liabilities
    20,901       8,992  
 
           
 
               
Commitments and contingencies
               
 
               
Stockholders’ Equity:
               
Preferred stock, $0.01 par value, 50,000,000 shares authorized as of June 30, 2009; none issued or outstanding as of June 30, 2009 and 2008
           
Common stock, $0.01 par value, 250,000,000 shares authorized as of June 30, 2009; 36,625,802 and 34,295,718 shares issued or outstanding as of June 30, 2009 and 2008, respectively
    366       343  
Additional paid-in-capital
    57,987       53,835  
Accumulated deficit
    (49,902 )     (49,385 )
Accumulated other comprehensive income
    2,860       4,714  
 
           
Total stockholders’ equity
    11,311       9,507  
 
           
Total liabilities and stockholders’ equity
  $ 32,212     $ 18,499  
 
           
See notes to the consolidated financial statements.

 

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Table of Contents

UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except per share data)
                         
    Year ended June 30,  
    2009     2008     2007  
Revenues
  $ 19,976     $ 3,500     $ 2,070  
Cost of sales
    3,537       2,456       1,561  
 
                 
Gross profit
    16,439       1,044       509  
 
                 
Operating expenses:
                       
Research and development
    1,048       532       265  
Selling, general and administrative
    14,941       8,211       6,497  
Depreciation and amortization
    804       636       169  
Impairment of property, plant and equipment
                547  
Loss on sale of property, plant and equipment
                1,608  
 
                 
Total operating expenses
    16,793       9,379       9,086  
 
                 
Operating loss
    (354 )     (8,335 )     (8,577 )
Interest expense
    249       459       537  
Interest income
    (361 )     (203 )     (111 )
Other expense (income), net
    275       (54 )     (34 )
 
                 
Net loss
  $ (517 )   $ (8,537 )   $ (8,969 )
 
                 
Loss per share:
                       
Basic loss per share
  $ (0.02 )   $ (0.26 )   $ (0.38 )
 
                 
Diluted loss per share
  $ (0.02 )   $ (0.26 )   $ (0.38 )
 
                 
See notes to the consolidated financial statements.

 

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Table of Contents

UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Statements of Stockholders’ Equity and Comprehensive Income
(in thousands, except share data)
                                                 
                                    Accumulated        
                    Additional-             Other        
    Common Stock     Paid-In     Accumulated     Comprehensive        
    Shares     Amount     Capital     Deficit     Income (Loss)     Total  
Balance as of July 1, 2006
    21,378,854     $ 214     $ 38,424     $ (31,879 )   $ 2,083     $ 8,842  
Comprehensive loss:
                                               
Net loss
                      (8,969 )           (8,969 )
Foreign currency translation
                            1,225       1,225  
 
                                             
Comprehensive loss
                                            (7,744 )
Share-based compensation expense
                509                   509  
Issuance of common stock upon exercise of stock options
    3,990             7                   7  
Issuance of common stock upon conversion of convertible notes
    3,870,833       39       3,718                   3,757  
Issuance of common stock for cash, net of transaction costs
    3,284,133       33       3,515                   3,548  
Issuance of common stock in connection with the acquisition of Integrated BioSciences, Inc.
    1,833,333       18       1,936                   1,954  
 
                                   
Balance as of June 30, 2007
    30,371,143       304       48,109       (40,848 )     3,308       10,873  
Comprehensive loss:
                                               
Net loss
                      (8,537 )           (8,537 )
Foreign currency translation
                            1,406       1,406  
 
                                             
Comprehensive loss
                                            (7,131 )
Share-based compensation expense
                846                   846  
Issuance of common stock upon exercise of stock options
    293,375       3       431                   434  
Issuance of common stock upon conversion of convertible notes
    1,275,834       13       1,648                   1,661  
Issuance of common stock for cash, net of transaction costs
    2,333,333       23       2,801                   2,824  
Issuance of common stock in connection with Employee Share Plan
    22,033                                
 
                                   
Balance as of June 30, 2008
    34,295,718       343       53,835       (49,385 )     4,714       9,507  
Comprehensive loss:
                                               
Net loss
                      (517 )           (517 )
Foreign currency translation
                            (1,854 )     (1,854 )
 
                                             
Comprehensive loss
                                            (2,371 )
Share-based compensation expense
                3,059                   3,059  
Issuance of common stock upon exercise of stock options
    97,532       1       37                   38  
Issuance of common stock upon conversion of convertible notes
    520,000       5       616                   621  
Issuance of common stock in connection with Employee Share Plan
    45,885                                
Issuance of stock options in connection with the acquisition of Integrated BioSciences, Inc.
                457                   457  
Grants of common stock
    1,666,667       17       (17 )                  
 
                                   
Balance as of June 30, 2009
    36,625,802     $ 366     $ 57,987     $ (49,902 )   $ 2,860     $ 11,311  
 
                                   
See notes to the consolidated financial statements.

 

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Table of Contents

UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Statements of Cash Flows
(in thousands)
                         
    Year ended June 30,  
    2009     2008     2007  
Cash flows from operating activities:
                       
Net loss
  $ (517 )   $ (8,537 )   $ (8,969 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
                       
Depreciation and amortization
    915       727       218  
Share-based compensation expense
    3,059       846       509  
Impairment of property, plant and equipment
                547  
Loss on the sale of property, plant and equipment
    5             1,608  
Changes in assets and liabilities, net of effect of acquired business
                       
Accounts receivable
    (6,172 )     (6 )     503  
Inventories
    (40 )     (649 )     795  
Prepaid expenses and other current assets
    (126 )     (28 )     80  
Other assets
    (232 )     33       (51 )
Accounts payable
    586       (400 )     (295 )
Accrued expenses
    (506 )     391       45  
Deferred revenue
    9,823              
 
                 
Net cash provided by (used in) operating activities
    6,795       (7,623 )     (5,010 )
Cash flows from investing activities
                       
Purchases of property, plant and equipment
    (2,926 )     (904 )     (3,314 )
Proceeds from the sale of property, plant and equipment
    14       280       159  
Cash acquired in acquisition of subsidiary
                800  
 
                 
Net cash used in investing activities
    (2,912 )     (624 )     (2,355 )
Cash flows from financing activities
                       
Proceeds from the issuance of long-term debt
    88       3,017       500  
Principal payments on long-term debt
    (3,391 )     (313 )     (97 )
Proceeds from the issuance of convertible debt
          1,920       4,420  
Proceeds from the issuance of common stock
          2,824       3,548  
Proceeds from the exercise of options to purchase common stock
    38       434       7  
 
                 
Net cash (used in) provided by financing activities
    (3,265 )     7,882       8,378  
Foreign currency exchange on cash
    122       (334 )     (368 )
 
                 
Net increase (decrease) in cash and cash equivalents
    740       (699 )     645  
Cash and cash equivalents at beginning of year
    2,887       3,586       2,941  
 
                 
Cash and cash equivalents at end of year
  $ 3,627     $ 2,887     $ 3,586  
 
                 
Supplemental disclosure of cash flow information
                       
Cash paid for interest
  $ 183     $ 249     $ 251  
 
                 
Supplemental disclosure of non-cash activities
                       
Conversion of convertible notes into common stock
  $ 621     $ 1,661     $ 3,757  
 
                 
Provision for issuance of common shares to former shareholders
  $ 5,070     $     $  
 
                 
See notes to the consolidated financial statements.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
1. Description of Business
Unilife Corporation and subsidiaries (the “Company”) is a medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. The primary target customers for the Company’s products include pharmaceutical manufacturers and suppliers of medical equipment to healthcare facilities or patients who self-administer prescription medication. The Company also manufactures non-proprietary Class I and Class II medical devices, such as specialty syringes under contract for outsourcing customers.
2. Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of Unilife Medical Solutions Limited (“UMSL”) and its wholly-owned subsidiaries. Subsequent to June 30, 2009, a newly formed subsidiary, Unilife Corporation, will become UMSL’s parent holding company in a transaction described in Note 15. The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and in U.S. currency. All intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates.
Cash and Cash Equivalents
Cash and cash equivalents consist primarily of cash on hand, deposits at banks and other short-term highly liquid investments with original maturities of three months or less. Cash and cash equivalents are stated at cost which approximates fair value.
Accounts Receivable
Accounts receivable are stated at amounts due from customers, which also represents the net realizable amount. The Company has historically not recorded an allowance for doubtful accounts, but rather evaluates the collectability of its accounts receivable on a periodic basis. In instances in which management is aware of circumstances that may impair a particular customer’s ability to meet its obligation, the related obligation would be written off. Accounts receivable as of June 30, 2009 consists principally of amounts due from a pharmaceutical company related to the achievement of certain milestones under the related industrialization agreement described in Note 13.
Inventories
Inventories consist primarily of plastic syringe components and include direct materials, direct labor and manufacturing overhead. Inventory is stated at the lower of cost or market, with cost determined using the first in, first out method. The Company routinely reviews its inventory for obsolete, slow moving or otherwise impaired inventory and records estimated impairments in the periods in which they occur. Inventories consist of the following:
                 
    June 30,  
    2009     2008  
Raw materials
  $ 567     $ 457  
Work in process
    530       608  
 
           
Total inventories
  $ 1,097     $ 1,065  
 
           

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Property, Plant and Equipment
Property, plant and equipment, including significant improvements, are recorded at cost, net of accumulated depreciation and amortization. Repairs and maintenance are expensed as incurred.
Depreciation and amortization expense is recorded on a straight-line basis over the estimated useful life of the asset as listed below:
     
Asset Category   Useful Lives
Machinery and equipment
  3 to 15 years
Furniture and fixtures
  7 years
Leasehold improvements
  Shorter of improvement life or remaining term of lease
The Company reviews the carrying value of the long-lived assets periodically to determine if facts and circumstances exist that would suggest that assets might be impaired or that the useful lives should be modified. Among the factors the Company considers in making the evaluation are changes in market position and profitability. If facts and circumstances are present which may indicate impairment is probable, the Company will prepare a projection of the undiscounted cash flows of the specific business entity and determine if the long-lived assets are recoverable based on these undiscounted cash flows. If impairment is indicated, an adjustment will be made to reduce the carrying amount of these assets to their fair value.
Goodwill and Intangible Assets
Goodwill is the excess of purchase price over the value of net assets acquired in business acquisitions. Goodwill is subject to, at a minimum, an annual impairment assessment of its carrying value. Additional impairment assessments would be performed if events and circumstances warranted such additional assessments during the year. Goodwill impairment is deemed to exist if the net book value of a reporting unit exceeds its estimated fair value. Estimated fair values of the reporting units are estimated using an earnings model and a discounted cash flow valuation model. The discounted cash flow model incorporates the Company’s estimates of future cash flows, allocations of certain assets and cash flows among reporting units, future growth rates and management’s judgment regarding the applicable discount rates used to discount those estimated cash flows. The estimated fair value of each reporting unit, if lower than the carrying value of the respective reporting unit (such carrying value determined after management allocation of certain shared assets), would then be allocated to the reporting unit’s net identifiable assets based on their respective estimated fair values. The remaining unallocated reporting unit fair value, if any, would then be compared to the carrying amount of that unit’s goodwill and, if lower, the Company would recognize an impairment charge to the extent of the deficiency. There were no impairments recorded on goodwill during the years ended June 30, 2009, 2008 and 2007.
Definite-lived intangible assets include patents which are amortized on a straight-line basis over their estimated useful lives of 15 years. The Company reviews intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If the sum of the estimated future cash flows (undiscounted) expected to result from the use and eventual disposition of an asset is less than the carrying amount of the asset, an impairment loss is recognized. Measurement of an impairment loss is based on the fair value of the asset. There were no impairments recorded on intangible assets during the years ended June 30, 2009, 2008 or 2007.
The Company expenses costs related to internally developed patents as incurred.
Deferred Financing Costs
Deferred financing costs consist of costs incurred in connection with debt financings. These costs are amortized over the term of the related debt using the effective interest rate method.
Income Taxes
The Company uses the liability method of accounting for income taxes. Deferred income taxes reflect tax credit carryforwards and the net effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are established, when necessary, to reduce deferred tax assets to the amount expected to be realized.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The Company requires that the realization of an uncertain income tax position must be “more likely than not” (i.e., greater than 50% likelihood of receiving a benefit) before it can be recognized in the financial statements. The benefit to be recorded in the financial statements is the amount most likely to be realized assuming a review by tax authorities having all relevant information and applying current conventions. The Company includes interest and penalties related to uncertain tax positions within the provision (benefit) for income taxes within the Company’s consolidated statements of operations.
In June 2006, the Financial Accounting Standards Board (“FASB”) issued revised guidance regarding accounting for uncertainty in income taxes, which clarifies the accounting for uncertainties in income taxes recognized in an enterprise’s financial statements. The new guidance requires that the Company determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authority. If a tax position meets the more likely than not recognition criteria, the tax position be measured at the largest amount of benefit greater than 50% likely of being realized upon ultimate settlement. This accounting standard was effective for fiscal years beginning after December 15, 2006. Management has evaluated the positions taken in connection with the tax provisions and tax compliance for the years included in these financial statements. The Company does not believe that any positions it has taken will not prevail on a more likely than not basis. As such no disclosure of such positions was deemed necessary. Our open tax years include all returns filed for 2002 and later in Australia and for 2005 and later in the United States. Should the Company be required to provide for interest or penalties in regards to its tax positions, such changes will be included in selling, general and administrative expenses in the statement of operations.
Fair Value of Financial Instruments
The carrying value of financial instruments such as accounts receivable, accounts payable and accrued expenses are reasonable estimates of their fair value because of the short maturity of these items. The Company believes that the current carrying amount of its long-term debt approximates fair value because the interest rates on these instruments are subject to change with, or approximate, market interest rates.
Share-Based Compensation
The Company grants both stock options and shares as compensation to its employees, directors and consultants. Certain employee and director awards vest over stated service periods and others also require achievement of specific performance or market conditions. The Company expenses the grant date fair value of awards to employees and directors over their respective service periods or over the period from grant date to the date the required performance or market conditions are expected to be met, if shorter. To the extent that employee and director awards vest only upon the achievement of a specific performance condition, expense is recognized over the period from the date management determines that the conditions are achievable through the date they are expected to be met. Awards granted to consultants are sometimes granted for past services, in which case their fair value is expensed on their grant date, and sometimes granted with future service, performance or market conditions. Timing of expense recognition for consultant awards is similar to that of employee and director awards; however, aggregate expense is re-measured each quarter end based on the fair value of the award at that date. The Company determines the fair value of stock options using the Black-Scholes option pricing model, with the exception of market-based performance grants, which are valued based on a Barrier pricing model. Option pricing methods require the input of highly subjective assumptions, including the expected stock price volatility. See Note 3 for additional information regarding share-based compensation.
Foreign Currency Translation
The Australian dollar (“A$”) is the functional currency for the Company’s Australian operations. Foreign currency assets and liabilities are translated into U.S. dollars at the rate of exchange existing at the year-end date. Revenues and expenses are translated at the average annual exchange rates. Adjustments resulting from these translations are recorded in accumulated other comprehensive income (loss) within the Company’s consolidated balance sheets and will be included in income upon sale or liquidation of the foreign investment. Gains and losses from foreign currency transactions, denominated in a currency other than the functional currency, are recorded in other (income) expense within the Company’s consolidated statements of operations and aggregated $345, $(19) and $1 during the years ended June 30, 2009, 2008 and 2007, respectively.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Comprehensive Income (Loss)
Comprehensive income (loss) includes net income (loss) and other comprehensive income (loss). The Company’s other comprehensive income (loss) consists only of foreign currency translation adjustments.
Revenue Recognition
The Company recognizes revenue from licensing fees, industrialization efforts and products sold.
In early fiscal 2008, the Company granted an exclusive licensing arrangement to allow its pharmaceutical partner to use certain of the Company’s intellectual property in order and solely to develop in collaboration with the Company, the Company’s Unifill syringe for use in and sale to the pre-filled syringe market. The up-front, non-refundable fee paid for this license is being amortized over the expected life of the related agreement. In late fiscal 2009, the Company entered into an industrialization agreement with its pharmaceutical partner, retroactive to July 2008, under which the Company received payments upon achievement of certain pre-defined milestones in its development of the Unifill syringe. Revenue is recognized upon achievement of the “at risk” milestone events, which represents the culmination of the earnings process related to such events. Milestones include specific phases of the project such as product design, prototype availability, user tests, manufacturing proof of principle and the various steps to complete the industrialization of the product. Specific payment amounts and completion dates were established for each milestone payment. Revenue recognized is commensurate with the milestones achieved. Billings are similarly triggered and the Company has no future performance obligations related to previous milestone payments. Each milestone payment is non-refundable when made.
The Company recognizes revenue from sales of products at the time of shipment and when title passes to the customer. These amounts were $3,874, $3,420 and $1,946 during the years ended June 30, 2009, 2008, and 2007, respectively.
Advertising Costs
Advertising costs are expensed in the period incurred. The Company incurred total advertising costs of $51, $43 and $38 during the years ended June 30, 2009, 2008 and 2007, respectively.
Research and Development Costs
Research and development costs, which primarily consist of salaries, benefits and contracted services are expensed as incurred.
Earnings (Loss) Per Share
Basic earning (loss) per share is computed as net income (loss) divided by the weighted-average number of shares outstanding during the period. Diluted earnings per share reflect the potential dilution that could occur from common shares issued through common stock equivalents. The dilutive effect of potential common shares, consisting of outstanding options to purchase common stock, is calculated using the treasury stock method.
Government Grants
Government grants are recognized when there is reasonable assurance that the grant will be received and all attached conditions will be complied with. When a grant relates to an expense item, it is recognized as income over the period necessary to match the grant on a systematic basis to the costs that it is intended to compensate. When a grant relates to an asset, it is recognized as deferred income and recognized in the income statement on a systematic basis over the expected useful life of the related asset.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Recently Issued Accounting Pronouncements
In June 2009, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 168, “The FASB Accounting Standards CodificationTM and the Hierarchy of Generally Accepted Accounting Principles - - a replacement of FASB Statement No. 162” (“SFAS 168”) SFAS 168 represents the last numbered standard issued by the FASB under the old (pre-codification) numbering system, and amends the GAAP hierarchy. On July 1, 2009, the FASB launched its new codification (i.e. the FASB Accounting Standards Codification). The codification supersedes existing GAAP for nongovernmental entities.
In December 2007, the FASB issued a new accounting standard included in ASC 805, Business Combinations, formerly SFAS No. 141 (revised), “Business Combinations”. ASC 805 significantly changes the accounting and disclosure requirements for business combinations. ASC 805 is effective for business combinations occurring in fiscal years beginning after December 15, 2008. ASC 805 will be applied prospectively to business combinations with an acquisition date on or after the effective date. The impact that the adoption of ASC 805 will have on the Company’s consolidated financial statements will be dependent upon the extent of future business combinations.
In December 2007, the FASB issued a new accounting standard included in ASC 810, Consolidation, formerly SFAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements — and amendment of Accounting Research Bulletin No. 51”. This new standard establishes accounting and reporting standards for the noncontrolling interest in a subsidiary and for the deconsolidation of a subsidiary. ASC 810 is effective for financial statements issued for fiscal years beginning after December 15, 2008. The Company currently has no noncontrolling interests and therefore, does not believe that the adoption of ASC 810 will have a material impact on its consolidated financial statements.
In April 2008, the FASB issued a new accounting standard included in ASC 350, Intangibles-Goodwill and Other, formerly FASB Staff Position (“FSP”) No. 142-3, “Determination of the Useful Life of Intangible Assets”. This new standard amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS 142,”Goodwill and Other Intangible Assets”. This new standard also provides guidance for expanded disclosures related to the determination of intangible asset useful lives and is effective for fiscal years beginning after December 15, 2008. Early adoption is prohibited. The Company does not believe that the adoption of this new standard will have a material impact on its consolidated financial statements.
In June 2008, the FASB issued a new accounting standard included in ASC 260, Earnings Per Share, formerly FSP No. EITF 03-6-1, “Determining Whether Instruments Granted in Share-Based Payment Transactions Are Participating Securities”. This new standard states that unvested share-based payment awards that contain nonforfeitable rights to dividends or dividend equivalents (whether paid or unpaid) are participating securities and shall be included in the computation of earnings per share pursuant to the two-class method and is effective for fiscal years beginning after December 15, 2008. The Company does not believe that the adoption of this new standard will have a material impact on its consolidated financial statements.
In May 2009, the FASB issued a new accounting standard included in ASC 855, Subsequent Events, formerly SFAS No. 165, “Subsequent Events”. ASC 855 sets forth: 1) the period after the balance sheet date during which management of a reporting entity should evaluate events or transactions that may occur for potential recognition or disclosure in the financial statements; 2) the circumstances under which an entity should recognize events or transactions occurring after the balance sheet date in its financial statements; and 3) the disclosures that an entity should make about events or transactions that occurred after the balance sheet date. ASC 855 is effective for interim and annual periods ending after June 15, 2009. The Company has adopted ASC 855 for its year ended June 30, 2009. The Company originally evaluated subsequent events through the date the accompanying financial statements were originally issued, which was November 12, 2009. The Company re-evaluated subsequent events through January 5, 2010 (unaudited) for purposes of the reissuance of these statements on that date.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
3. Equity and Share-Based Compensation
During the year ended June 30, 2007, the Company issued 980,571 and 2,303,562 shares of its common stock in a private placement with various investors at a price of $0.90 and $1.26 per share, respectively. The aggregate offering price of the private placement was approximately $3,785, and the net proceeds to the Company, after payment of approximately $237 in expenses, was approximately $3,548.
During the year ended June 30, 2008, the Company issued 2,333,333 shares of its common stock in a private placement with various investors at a price of $1.32. The aggregate offering price of the private placement was approximately $3,080, and the net proceeds to the Company, after payment of approximately $256 in expenses, was approximately $2,824.
The Company recognized share-based compensation expense related to stock options and grants of common stock to employees, directors and consultants of $3,059, $846 and $509 during the years ended June 30, 2009, 2008 and 2007, respectively. The increased expense during the year ended June 30, 2009 is primarily related to more awards issued during that fiscal year compared to prior fiscal years. The total tax benefit recognized related to these awards was $918, $254 and $153 during the years ended June 30, 2009, 2008 and 2007, respectively, which was fully offset by changes in the Company’s valuation allowance. The Company calculated its available APIC pool of net excess benefits using the transition method as defined in ASC 718.
As of June 30, 2009, the total compensation cost related to all nonvested awards not yet recognized is $895. This amount is expected to be recognized over the remaining weighted-average period of 0.58 years.
Stock Options
The Company has granted stock options to certain employees and directors under the Employee Share Option Plan, (the “Plan”). The Plan is designed to assist in the motivation and retention of employees and to recognize the importance of employees to the long-term performance and success of the Company. The Company has also granted stock options to certain consultants outside of the Plan. The majority of the options to purchase common stock vest on the anniversary of the date of grant, which ranges from one to three years. Additionally, certain stock options vest upon the closing price of the Company’s common stock reaching certain minimum levels, as defined in the agreements. Finally, certain other stock options vest upon the meeting of certain Company milestones such as the signing of specific agreements and the completion of the Company’s anticipated listing on a U.S. stock exchange. As of June 30, 2009, the Company expects that all such market and performance conditions will be met. Share-based compensation expense related to these awards is recognized on a straight-line basis over the related vesting term. The Plan does not provide for a fixed number of available shares.
The following is a summary of the Plan and non-Plan stock option activity during the year ended June 30, 2009:
                                 
                    Weighted-        
                    Average        
            Weighted-     Remaining        
    Number of     Average Exercise     Contractual Life     Aggregate Intrinsic  
    Options     Price     (in years)     Value  
Outstanding as of July 1, 2008
    9,438,996     $ 2.00             $    
Granted
    3,850,000       1.63                  
Exercised
    (97,531 )     0.33                  
Cancellations
    (6,868,965 )     2.20                  
 
                           
Outstanding as of June 30, 2009
    6,322,500     $ 1.58       2.5     $ 551  
 
                       
Exercisable as of June 30, 2009
    3,339,167     $ 1.56       1.9     $ 519  
 
                       
The aggregate intrinsic value is defined as the difference between the market value of the Company’s common stock as of the end of the period and the exercise price of the in-the-money stock options. The total intrinsic value of stock options exercised during the years ended June 30, 2009, 2008 and 2007 was $93, $120, and $0, respectively. Of the 2,983,333 non vested options, 316,667 are held by consultants, the majority of which vested in August 2009.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The following is a summary of stock options outstanding and exercisable as of June 30, 2009:
                                                 
    Outstanding Options     Exercisable Options  
                    Weighted-                     Weighted-  
            Weighted-     Average                     Average  
            Average     Remaining             Weighted-     Remaining  
Range of Exercise   Outstanding as of     Exercise     Contractual     Exercisable as of     Average     Contractual Life  
Prices   June 30, 2009     Price     Life (in years)     June 30, 2009     Exercise Price     (in years)  
$0.00 – $1.50
    2,041,667     $ 1.23       1.5       1,791,667     $ 1.20       1.3  
$1.56 – $1.80
    3,733,333       1.61       3.3       1,083,333       1.62       3.2  
$1.86 – $9.30
    547,500       2.72       1.3       464,167       2.82       1.3  
 
                                           
 
    6,322,500     $ 1.58       2.5       3,339,167     $ 1.56       1.9  
 
                                   
The weighted-average fair value of stock options granted during the years ended June 30, 2009, 2008 and 2007 was $0.62, $0.87, and $0.42 respectively.
The fair value of each stock option is estimated at the grant date using the Black-Scholes option pricing model, with the exception of grants subject to market conditions which are valued based on a Barrier option pricing model. The Company has not historically paid dividends to its shareholders, and, as a result assumed a dividend yield of 0%. The risk free interest rate is based upon the rates of Australian bonds with a term equal to the expected term of the option. The expected volatility is based upon the historical share price of the Company’s common stock. The expected term of the stock options to purchase common stock is based upon the outstanding contractual term of the stock option on the date of grant. The Company used the following weighted-average assumptions in calculating the fair value of options granted during the years ended June 30, 2009, 2008 and 2007.
                         
    2009     2008     2007  
Expected dividend yield
    0 %     0 %     0 %
Risk-free interest rate
    4.76 %     5.61 %     6.05 %
Expected volatility
    80 %     55 %     67 %
Expected life (in years)
    4.4       3.5       2.8  
Grants of Common Stock to Employees
During the years ended June 30, 2009 and 2008, the Company granted 45,885 and 22,033 shares of common stock, respectively, to certain employees. During the years ended June 30, 2009 and 2008, the Company recorded a charge to operations of $44 and $48, respectively, related to these awards.
During the year ended June 30, 2009, the Company granted 1,666,667 shares of common stock to its Chief Executive Officer. The shares are subject to certain transfer restrictions in which 833,333 cannot be sold until the first anniversary of the date of grant and 833,334 cannot be sold until the second anniversary of the date of grant. During the year ended June 30, 2009, the Company recorded a charge to operations of $1,541 related to these awards. The charge represents the entire fair value of the awards.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
4. Property, Plant and Equipment
Property, plant and equipment consist of the following:
                 
    June 30,  
    2009     2008  
Machinery and equipment
  $ 5,906     $ 4,890  
Furniture and fixtures
    787       540  
Construction in progress
    3,041       3,222  
Leasehold improvements
    1,067       737  
 
           
 
    10,801       9,389  
 
           
Less: accumulated depreciation and amortization
    (1,664 )     (1,590 )
 
           
Property, plant and equipment, net
  $ 9,137     $ 7,799  
 
           
Construction in progress consists primarily of amounts incurred in connection with the construction of machinery that will be used to manufacture the Company’s Unitract 1 mL Syringe.
During the year ended June 30, 2007, the Company ceased operations at its Australian facility. The Company determined that it was not economically favorable to relocate certain manufacturing equipment to the new U.S. facility. In connection with this closing, the Company recorded an impairment on property, plant and equipment and a loss on the sale of property, plant and equipment of $547 and $1,608, respectively.
5. Goodwill and Other Intangible Assets
The changes in the carrying amount of goodwill during the years ended June 30, 2008 and 2009 are as follows:
         
Balance as of July 1, 2007
  $ 4,946  
Foreign currency translation
    609  
 
     
Balance as of June 30, 2008
    5,555  
Issuance of stock options in connection with the acquisition of Integrated BioSciences, Inc
    457  
Issuance of common stock to former Unitract Syringe Pty Limited shareholders
    5,070  
Foreign currency translation
    (847 )
 
     
Balance as of June 30, 2009
  $ 10,235  
 
     
In connection with the acquisition of Unitract Syringe Pty Limited in October 2002, the Company agreed to issue 1,666,667 shares of common stock to certain former shareholders of Unitract Syringe Pty Limited if the Company reported net income of at least A$6,500 during any fiscal year prior to October 31, 2014, as amended. The agreement also provided for the issuance of an additional 1,666,667 shares of common stock upon the Company reporting net income of at least A$12,000 during any fiscal year prior to October 31, 2014. During the year ended June 30, 2009, the Company met both the net income requirements, and as a result, has accrued for the issuance of 3,333,333 shares based upon the closing price of the Company’s common stock as of June 30, 2009.
During the year ended June 30, 2008, as approved by the stockholders, the Company granted options to purchase 1,166,667 shares of common stock to certain selling shareholders in connection with the acquisition of Integrated BioSciences, Inc. The vesting terms of the options were based upon the signing of the exclusive licensing agreement with sanofi-avenits. During the year ended June 30, 2009, options to purchase 500,000 shares of common stock vested and as a result, the Company has recorded $457 as an increase to goodwill based on the Black-Scholes pricing model assumptions as of June 30, 2008. During the year ended June 30, 2009, the remaining options to purchase 666,667 shares of common stock were cancelled, as the related financial milestones were not achieved.
As of June 30, 2009, intangible assets consist of patents acquired in a business acquisition of $80. Related accumulated amortization as of June 30, 2009 and 2008 was $37 and $20, respectively, and future amortization expense is scheduled to be $5 annually.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
6. Accrued Expenses
Accrued expenses consist of the following:
                 
    June 30,  
    2009     2008  
Accrued payroll and other employee related expenses
  $ 671     $ 494  
Accrued interest
          108  
Accrued other
    356       629  
Provision for the issuance of common stock to former Unitract Syringe Pty Limited shareholders
    5,070        
 
           
Total accrued expenses
  $ 6,097     $ 1,231  
 
           
7. Commitments
The Company leases certain facilities, office equipment and automobiles under non-cancellable operating leases. The future minimum lease payments related to the Company’s non-cancellable operating lease commitments as of June 30, 2009 were as follows:
         
For the year ending June 30,        
2010
  $ 455  
2011
    415  
2012
    340  
2013
    43  
 
     
 
  $ 1,253  
 
     
Rental expenses under operating leases during the years ended June 30, 2009, 2008, and 2007 was $686, $583 and $649, respectively.
8. Long-Term Debt
Long-term debt consists of the following:
                 
    June 30,  
    2009     2008  
Bank term loans
  $ 2,709     $ 2,946  
Pennsylvania State assisted loans
    424       514  
Convertible notes
          749  
MedPro Safety Products note payable
          3,000  
 
           
 
    3,133       7,209  
Less: current portion of long-term debt
    405       4,169  
 
           
Total long-term debt
  $ 2,728     $ 3,040  
 
           
Bank term loans include four term loans payable. The loans bear interest at a rate of prime (3.25% as of June 30, 2009) plus 1.50% (4.75% as of June 30, 2009) per annum and mature on dates ranging from December 2010 through August 2021. The borrowings under the bank term loans are collateralized by the Company’s accounts receivable, inventory and certain pieces of machinery and equipment and are subject to certain financial covenants which require the Company’s tangible assets to equal at least 10% of the balance sheet equity determined in accordance with GAAP. Under the term loan agreements, the Company is not permitted to pay cash dividends without the prior written consent of the lender. The Company was in compliance with these covenants as of June 30, 2009.
The Company has qualified for the two Pennsylvania state assisted loans for the purchase of specific machinery and equipment. These loans bear interest at rates ranging from 2.75% to 3.25% per annum and mature on dates ranging from July 2011 through July 2013. The borrowings under the state assisted loans are collateralized by certain production equipment.
During the year ended June 30, 2008, the Company issued A$2,000 (approximately $1,920) of convertible notes which were convertible into shares of the Company’s common stock at a conversion price of A$1.5 (approximately $1.44) per share. Interest was payable semi-annually at a rate of 12% per annum. A$780 and $A1,220 of these convertible notes were exchanged for 520,000 and 813,334 shares of the Company’s common stock during the years ended June 30, 2009 and 2008, respectively.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
During the year ended June 30, 2007, the Company issued A$5,200 (approximately $4,420) of convertible notes which were convertible into shares of the Company’s common stock at a conversion price of A$1.2 approximately $1.02 per share. Interest was payable semi-annually at a rate of 10% per annum. A$555 and A$4,645 of these convertible notes were exchanged for 462,500 and 3,870,833 shares of the Company’s common stock during the years ended June 30, 2008 and 2007, respectively.
During the year ended June 30, 2008, the Company signed an Option Agreement with MedPro Safety Products, Inc. (‘MedPro”) pursuant to which MedPro paid the Company $3,000 for an option to negotiate and enter into a License Agreement for the exclusive distribution of the Unitract 1mL safety syringe within the United States. During the year ended June 30, 2009, the agreement with MedPro was terminated and the Company repaid MedPro $2,300, plus interest at 7.0%. The Company retained the remaining $700 as reimbursement for legal fees.
As of June 30, 2009, aggregate maturities of long-term obligations are as follows:
         
For the year ending June 30,        
2010
  $ 405  
2011
    381  
2012
    272  
2013
    271  
2014
    270  
Thereafter
    1,534  
 
     
 
  $ 3,133  
 
     
9. Loss Per Share
The Company’s net loss per share is as follows:
                         
    Year ended June 30,  
    2009     2008     2007  
Numerator
                       
Net loss
  $ (517 )   $ (8,537 )   $ (8,969 )
Denominator
                       
Weighted average number of shares used to compute basic loss per share
    34,426,353       32,938,477       23,413,811  
Effect of dilutive options to purchase common stock
                 
 
                 
Weighted average number of shares used to compute diluted loss per share
    34,426,353       32,938,477       23,413,811  
 
                 
Basic loss per share
  $ (0.02 )   $ (0.26 )   $ (0.38 )
 
                 
Diluted loss per share
  $ (0.02 )   $ (0.26 )   $ (0.38 )
 
                 
During the years ended June 30, 2009, 2008 and 2007, options to purchase 6,322,500, 9,438,996 and 8,425,204 shares of common stock were excluded from the computation of diluted loss per share, respectively as their effect would have been anti-dilutive.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
10. Income Taxes
Income tax expense (benefit) is as follows:
                                                                         
    Year ended June 30,  
    2009     2008     2007  
                                                                 
    Current     Deferred     Total     Current     Deferred     Total     Current     Deferred     Total  
Federal
  $     $ (1,070 )   $ (1,070 )   $     $ (755 )   $ (755 )   $     $ (544 )   $ (544 )
State
          (339 )     (339 )           (123 )     (123 )           (82 )     (82 )
Australian
          (663 )     (663 )           (9,883 )     (9,883 )           (7,962 )     (7,962 )
Changes in valuation allowance
          2,072       2,072             10,761       10,761             8,588       8,588  
 
                                                     
Total income tax benefit
  $     $     $     $     $     $     $     $     $  
 
                                                     
Deferred Income Tax Assets and Liabilities
In 2005, the Company qualified and was awarded Job Creation Tax Credits from the Commonwealth of Pennsylvania, acting through the Department of Community and Economic Development. The maximum credits the Company qualifies for was $21 in Pennsylvania Corporate Net Income Tax, which expires in 2012. The credits are contingent on the Company maintaining its operating facility in York County, Pennsylvania, continued operations for five years after the award, creating 65 full-time jobs within three years which pay at least 150% of the Federal minimum wage rate and investing at least $2,425 in the business.
In assessing the realizability of deferred income tax assets, management considers whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The ultimate realization of deferred income tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. In assessing the realizability of the Company’s deferred tax assets, which are principally net operating loss carry forwards, management considers the reversal of deferred tax liabilities which are scheduled to reverse during the carry forward period and tax planning strategies.
As of June 30, 2009, the Company had net operating loss carry forwards for federal, state and Australian income tax purposes of approximately $3,146, $3,118 and $17,562, respectively which are available to offset future taxable income, if any. The federal, state and Australian net operating loss carry forwards begin to expire on various dates from 2023 through 2029.
Deferred taxes are comprised of the following at June 30, 2009 and 2008.
                 
    June 30,  
    2009     2008  
 
Net operating loss carryforwards
  $ 4,208     $ 10,270  
Share-based compensation expense
    1,112       183  
Deferred revenue
    3,170        
Depreciation differences
    239       55  
Valuation allowance
    (8,729 )     (10,508 )
 
           
Net deferred taxes
  $     $  
 
           

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
The reconciliation of income tax computed at the U.S. federal statutory rate to the effective income tax rate as follows:
                         
    Year ended June 30,  
    2009     2008     2007  
Tax at U.S. statutory rate
    (35 %)     (35 %)     (34 %)
State taxes, net of federal benefit
    (11 %)     (6 %)     (5 %)
Non-deductible and non-taxable items
    2 %     1 %     %
Change in valuation allowance
    44 %     40 %     39 %
 
                 
 
    0 %     0 %     0 %
 
                 
11. Employee Benefit Plans
The Company has a retirement savings 401(k) plan covering all U.S. employees. Participating employees may contribute up to 100% of their pre-tax earnings, subject to the statutory limits. During the years ended June 30, 2009, 2008 and 2007, the Company did not match any employee contributions.
12. Contingencies
The Company is involved in, or has pending, various legal proceedings, claims, suits and complaints arising out of the normal course of business. Based on the facts currently available to the Company, management believes that these claims, suits and complaints are adequately provided for, covered by insurance, without merit or not probable that an unfavorable outcome will result.
13. Business Alliance
On June 30, 2008 the Company signed an exclusive licensing agreement with a pharmaceutical company, sanofi-aventis, which was amended in June, 2009. Under the amended agreement, the Company has granted sanoifi-aventis an exclusive license to certain of the Company’s intellectual property in order and solely to develop, in collaboration with the Company, the Unifill syringe for use in and sale to the pre-filled syringe market within those therapeutic areas to be agreed upon between the Company and sanofi-aventis and a non-exclusive license outside those therapeutic areas that are exclusive to sanofi-aventis or after the expiration of the exclusive license with sanofi-aventis. Pursuant to the exclusive licensing agreement, sanofi-aventis has paid the Company a 10,000 Euro ($13,024) up front non-refundable one-time fee. The exclusive license granted thereunder has an initial term expiring on June 30, 2014, unless the Company and sanofi-aventis fail to agree upon the list of therapeutic areas that are exclusive to sanofi-aventis, in which event the exclusive license will have a term until June 29, 2012 for all therapeutic areas. If during the term of the exclusive license, sanofi-aventis has purchased the Unifill syringe for use with a particular drug product, sanofi-aventis will receive a ten-year extension of the term of the exclusive license, which extension will be reduced to five years if sanofi-aventis does not sell a minimum of 20,000 units of the product in any of the first five years of such ten-year extension period. During the year ended June 30, 2009, the Company recognized $2,456 of this up front payment as revenue and deferred $10,568 which will be recognized on a straight-line basis over the remaining term of the agreement.
Under the exclusive licensing agreement, the Company is not precluded from using certain of its intellectual property to develop, license and sell any products in any market other than the ready-to-fill syringe market, or from entering into licensing or other business arrangements with other pharmaceutical companies for the ready-to-fill syringe market outside those therapeutic areas that are exclusive to sanofi-aventis, or after the expiration of the exclusive license with sanofi-aventis. If the Company grants a license to a third party in respect of the ready-to-fill syringe market, then the Company is required to pay sanofi-aventis 70% of any access, license or other upfront fee received from such third party for access to purchase the products until our payments to sanofi-aventis have totaled 10 million, following which the Company is required to pay 30% of such fees it receives through the end of the initial exclusivity period. The Company is also required to pay sanofi-aventis an annual royalty payment of 5% of the revenue generated from any sale of the Unifill syringe to third parties, up to a maximum amount of 17 million in such royalty payments.

 

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Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
Under a related industrialization agreement, signed on June 30, 2009, sanofi-aventis has agreed to pay the Company up to 17,000 Euro ($23,400) in milestone-based payments to fund the completion of the Company’s industrialization program for the Unifill syringe. The industrialization program began in July 2008 and is scheduled to be completed by the end of 2010. The industrialization agreement requires sanofi-aventis to provide a list to the Company that specifies therapeutic drug classes for which it seeks to market the Unifill syringe on an exclusive basis. The Company and sanofi-avenits will then discuss the exclusivity list during a several month negotiation period, and if the list is agreed, sanofi-aventis will retain exclusive rights to the use of the product within these designated therapeutic drug classes until June 30, 2014, subject to the extension described above. If the Company and sanofi-aventis are unable to reach an agreement on the list, sanofi-aventis will retain full exclusivity across all therapeutic classes until July 1, 2012. Unless terminated earlier, the industrialization agreement has a term until the completion of the industrialization program. During the year ended June 30, 2009, the Company recognized $13,601 in revenue related to the milestones achieved under the industrialization agreement of which $7,024 was collected after year end.
The industrialization agreement provides that, subject to the full completion of the industrialization program, the parties will negotiate a supply agreement for the manufacture and purchase of the final product on a commercial scale. The supply agreement will provide that sanofi-aventis and its affiliates will purchase the final product exclusively from us, and the industrialization agreement provides that we are not required to commit more than 30% of our expected installed production capacity to sanofi-aventis and its affiliates for the 12 months following the receipt of a purchase order. Any order of sanofi-aventis, together with its other orders, that will exceed the 30% capacity limit will require up to a maximum of 24 months lead time before we are required to commence delivery of that order.
14. Quarterly Results (unaudited)
                                 
    Quarter ended     Quarter ended     Quarter ended     Quarter ended  
    September 30, 2008     December 31, 2008     March 31, 2009     June 30, 2009  
Year ended June 30, 2009
                               
Revenues
  $ 2,305     $ 5,822     $ 4,146     $ 7,703  
Gross profit
    1,174       4,780       3,466       7,019  
Net income (loss)
    (1,616 )     (861 )     (271 )     2,231
Basic earnings (loss) per share
  $ (0.05 )   $ (0.03 )   $ (0.01 )   $ 0.07  
Diluted earnings (loss) per share
  $ (0.05 )   $ (0.03 )   $ (0.01 )   $ 0.07  
 
                               
                                 
    Quarter ended     Quarter ended     Quarter ended     Quarter ended  
    September 30, 2007     December 31, 2007     March 31, 2008     June 30, 2008  
Year ended June 30, 2008
                               
Revenues
  $ 1,019     $ 553     $ 1,181     $ 747  
Gross profit
    418       (204 )     396       434  
Net loss
    (1,767 )     (2,690 )     (1,648 )     (2,432 )
Basic loss per share
  $ (0.05 )   $ (0.08 )   $ (0.05 )   $ (0.08 )
Diluted loss per share
  $ (0.05 )   $ (0.08 )   $ (0.05 )   $ (0.08 )
15. Subsequent Events
On September 1, 2009, UMSL announced that it entered into a Merger Implementation Agreement with the Unilife Corporation, pursuant to which shareholders and optionholders of UMSL will exchange their existing interests in UMSL for equivalent interests in Unilife Corporation and Unilife Corporation will become the parent, or ultimate parent of UMSL and its subsidiaries. Each holder of UMSL ordinary shares or share options will receive one share of common stock or one stock option, of Unilife Corporation for every six UMSL ordinary shares or share options, respectively, held by such holder, unless a holder of UMSL ordinary shares elects to receive, in lieu of common stock, Chess Depository Interests, or CDI’s (each representing one-sixth of a share of the Company’s common stock) of the Company, in which case such holder will receive one CDI of Unilife Corporation for each ordinary share of UMSL. All share and per share data has been retroactively restated to reflect the one for six share consolidation. The redomiciliation transaction is subject to various conditions, including without limitation, approval by the Australian Federal Court, approval by the shareholders and optionholders of UMSL, and a report by an independent expert concluding that the redomiciliation transaction is fair, reasonable and in the best interests of the shareholders and optionholders.

 

F-30


Table of Contents

Unilife Corporation and Subsidiaries
Notes to Consolidated Financial Statements
(in thousands, except share and per share data)
On October 8, 2009, UMSL issued 3,460,344 shares of common stock to a group of Australian and US investors in a private placement. As part of the private placement, UMSL will, subject to shareholder approval, issue an additional 2,831,191 shares of common stock and options to purchase 3,145,767 shares of common stock to the investors in the private placement. The shares of common stock were or will be issued at a price of A$5.10 per share for aggregate proceeds of A$32,086, of which A$14,439 is subject to shareholder approval and the options will be issued for no additional consideration. Each of the options will be exercisable within three years after the date of grant. Half of the options will have an exercise price of A$7.50 per share, and the other half of the options will have an exercise price of A$12.00 per share. In conjunction with the private placement, UMSL also provided its eligible Australian and New Zealand shareholders with an opportunity to purchase shares of common stock in a share purchase plan, at a price of A$5.10 per share, for a total consideration of up to A$10,000. In addition, UMSL will, subject to shareholder approval, issue options to purchase up to 500,000 shares of common stock to certain advisors and brokers as compensation for their services with respect to the private placement and the share purchase plan. These options will be exercisable within three years after the date of grant at a price of A$5.10 per share. UMSL plans to seek the requisite shareholder approval at a shareholders meeting to be held in November 2009. The Company intends to use the proceeds raised from the private placement and the share purchase plan to accelerate the expansion of its operational capabilities, production facilities and equipment requirements in the United States, and complete the industrialization of the Unifill syringe. As part of its subsequent events re-evaluation through January 5, 2010, the Company notes that shareholder approval was obtained in November 2009 and the Australian and New Zealand shareholders actually acquired A$21,500 (unaudited) under the share purchase plan.
While the private placement was conducted by UMSL prior to the redomiciliation, all of the share numbers and share option exercise prices referred to above give effect to the share consolidation the Company will effect in connection with the redomiciliation (one share of the Company’s common stock equals six ordinary shares of UMSL). The ordinary shares and share options issued in the placement will be exchanged for shares of the Company’s common stock and options to purchase its common stock in connection with the redomiciliation.
During October 2009, the Company accepted a $5,200 offer of assistance from the Commonwealth of Pennsylvania. The offer includes $2,000 for the development of the Company’s new global headquarters and manufacturing facility as well as up to $2,000 in low interest financing loans for land, building, acquisition and construction costs. The offer also includes a $500 opportunity grant, as well as $500 in tax credits. Finally, the offer includes up to $200 for the reimbursement of eligible job training costs. The offer is based on the Company’s proposed project being expected to create more than 200 new full-time jobs by December 31, 2012, to retain the Company’s 97 existing employees and to have a total cost of $86,000 and is contingent upon the Company submitting complete applications and meeting all program guidelines. The Company cannot assure that it will be able to receive any or all of the assistance for the Company’s current development project or otherwise.

 

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Table of Contents

EXHIBIT INDEX
         
Exhibit Number   Description
  2.1    
Amended and Restated Merger Implementation Agreement dated as of September 1, 2009 between Unilife Medical Solutions Limited and Unilife Corporation +
       
 
  2.2    
Share Purchase Agreement among Unilife Medical Solutions Limited, Edward Paukovits, Jr., Keith Bocchicchio, and Daniel Adlon dated as of October 25, 2006 and amended as of September 26, 2007+
       
 
  3.1    
Certificate of Incorporation of Unilife Corporation**
       
 
  3.2    
Bylaws of Unilife Corporation**
       
 
  4.1    
Form of Common Stock Certificate**
       
 
  10.1    
Exclusive Agreement dated as of June 30, 2008 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie**
       
 
  10.2 *  
First Amendment dated as of June 29, 2009 to Exclusive Agreement dated as of June 30, 2008 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie**
       
 
  10.3 *  
Industrialization Agreement dated as of June 30, 2009 between Unilife Medical Solutions Limited and Sanofi Winthrop Industrie
       
 
  10.4    
Business Lease, dated as of August 17, 2005, between Integrated BioSciences, Inc. and AMC Delancey Heartland Partners, L.P.**
       
 
  10.5    
Agreement dated as of September 15, 2003 between Integrated BioSciences, Inc. and B. Braun Medical, Inc. and amendments thereto
       
 
  10.6    
Promissory Note, dated as of December 30, 2005 between Integrated BioSciences, Inc. and Commerce Bank**
       
 
  10.7    
Promissory Note, dated as of August 25, 2006 between Integrated BioSciences, Inc. and Commerce Bank**
       
 
  10.8    
Employment Agreement, dated as of October 26, 2008 between Unilife Medical Solutions Limited and Alan Shortall**
       
 
  10.9    
Employment Agreement, dated as of February 15, 2005 between Unilife Medical Solutions Limited and Jeff Carter**
       
 
  10.10    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Daniel Calvert**
       
 
  10.11    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Bernhard Opitz**
       
 
  10.12    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Mark Iampietro**
       
 
  10.13    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Stephen Allan**
       
 
  10.14    
Employment Agreement, dated as of November 10, 2009 between Unilife Medical Solutions, Inc. and Eugene Shortall**
       
 
  10.15    
Consulting Agreement, dated as of January 22, 2009 between Unilife Medical Solutions Limited and Joblak Pty Ltd**
       
 
  10.16    
Deed of Mutual Release, dated January 12, 2009 between Unilife Medical Solutions Limited and Jeff Carter**
       
 
  10.17    
Unilife Corporation Employee Stock Option Plan**
       
 
  10.18    
Unilife Corporation 2009 Stock Incentive Plan**
       
 
  10.19    
Unilife Medical Solutions Limited Exempt Employee Share Plan**
       
 
  10.20 *  
Agreement dated November 12, 2009 between Unilife Medical Solutions, Inc. and Mikron Assembly Technology
       
 
  10.21    
Purchase and Mutual Indemnification Agreement dated November 16, 2009 between Unilife Cross Farm LLC and Greenspring Partners, LP
       
 
  10.22    
Offer of assistance dated October 16, 2009 from the Commonwealth of Pennsylvania to Unilife Medical Solutions and acceptance of the offer
       
 
  10.23    
Agreement Between Unilife Cross Farm LLC and L2 Architecture dated as of December 29, 2009, as amended
       
 
  10.24    
Agreement between Unilife Cross Farm LLC and HSC Builders & Construction Managers dated as of December 14, 2009, as amended
       
 
  10.25    
Development Agreement, dated December 14, 2009 between Unilife Cross Farm LLC and Keystone Redevelopment Group LLC
       
 
  10.26    
Amended and Restated Operating Agreement dated December 14, 2009 of Unilife Cross Farm LLC
       
 
  10.27    
Form of Share Purchase Agreement between Unilife Medical Solutions Limited and each of the US investors in the October and November 2009 private placement
       
 
  10.28    
Form of Subscription Agreement between Unilife Medical Solutions Limited and each of the Australian investors in the October and November 2009 private placement
       
 
  10.29    
2009 Share Purchase Plan Terms and Conditions
       
 
  21    
List of subsidiaries of Unilife Corporation
     
+   The annexures, schedules and exhibits to this exhibit have been omitted. A copy of any omitted annexure, schedule or exhibit will be furnished to the Securities and Exchange Commission supplementally upon request.
 
*   Confidential treatment has been requested for certain provisions of this Exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
 
**   Previously filed.

 

 

EX-2.1 2 c93531exv2w1.htm EXHIBIT 2.1 Exhibit 2.1
Exhibit 2.1
(DLA PHILLIPS FOX LOGO)
Amended and Restated
Merger Implementation Agreement
Unilife Medical Solutions Limited
Unilife Corporation

 

 


 

(DLA PHILLIPS FOX LOGO)
Table of contents
         
Date 1 September 2009
    1  
Parties
    1  
Background
    1  
Operative provisions
    2  
1 Implementation of the Proposed Transaction
    2  
2 Conditions
    2  
Conditions precedent to implementation of the Option Scheme
    3  
Reasonable endeavours
    3  
Waiver of conditions
    3  
Failure of condition
    3  
Notice of changes
    4  
3 Share Scheme
    4  
Share Scheme
    4  
Share Scheme Consideration
    4  
Election
    4  
Fractional entitlements
    4  
Ineligible Overseas Shareholders
    4  
General provisions
    5  
4 Option Scheme
    5  
Preliminary steps
    5  
Option Scheme
    5  
Option Scheme Consideration
    5  
Terms of Unilife Corporation Options
    5  
Fractional entitlements
    5  
General provisions
    5  
5 Co-operation
    6  
6 Implementation of Schemes
    6  
Preliminary steps
    6  
The Company’s obligations
    6  
Unilife Corporation obligations
    7  
7 Replacement of Non-ESOP Options
    8  
Cancellation of Non-ESOP Options and offer of Unilife Corporation Non-ESOP Options
    8  
Terms of Unilife Corporation Non-ESOP Options
    8  
8 Conversion of Company to a proprietary company
    8  
9 Termination
    8  
Termination by notice
    8  
Automatic termination
    8  
Mutual termination
    8  
Effect of termination
    9  
10 Public announcements and disclosure
    9  
Public announcements
    9  
Required disclosure
    9  
11 Buy back of shares in Unilife Corporation
    9  
12 Costs and stamp duty
    9  
13 Miscellaneous
    9  
Notices
    9  
No waiver
    10  
Remedies cumulative
    10  
Entire agreement
    10  
Amendment
    10  
Assignment
    10  
Consents or approvals
    10  
No merger
    10  
Further assurances
    10  
Severability of provisions
    10  
Counterparts
    10  
GST
    11  

 

 


 

(DLA PHILLIPS FOX LOGO)
         
14 Governing law and jurisdiction
    11  
15 Definitions and interpretations
    11  
Definitions
    11  
Interpretation
    13  
Construction
    14  
Payments
    14  
Execution and date
    15  

 

 


 

(DLA PHILLIPS FOX LOGO)
Date 1 September 2009
Parties
Unilife Medical Solutions Limited ABN 14 008 071 403 of Level 11, 1 Chifley Square, Sydney, NSW, Australia 2000 (Company)
Unilife Corporation a company incorporated in Delaware, United States of America, of 633 Lowther Road, Lewisberry, Pennsylvania 17339, United States of America (Unilife Corporation)
Background
A   The Parties have agreed that the Company will seek to implement a transaction in order to redomicile the Unilife group in the United States of America pursuant to which:
  (a)   Unilife Corporation will acquire all of the issued Shares of the Company in exchange for the issue of Unilife Corporation Shares or CDIs to shareholders of the Company by means of a scheme of arrangement under Part 5.1 of the Corporations Act (Share Scheme); and
  (b)   the existing Options issued under the Company’s Employee Share Option Plan will be cancelled in exchange for the issue of Unilife Corporation Options in Unilife Corporation to existing holders of Options in the Company by means of a scheme of arrangement under Part 5.1 of the Corporations Act (Option Scheme).
B   As a result of the Proposed Transaction, the Company will become a wholly-owned subsidiary of Unilife Corporation.
 
C   The Board unanimously considers that the proposed Schemes are in the best interests of Shareholders and Optionholders.
 
D   The Parties will implement the Schemes in good faith on the terms and conditions of this Agreement.
 
E   In conjunction with the Schemes, the Parties will seek to replace the existing options issued to certain consultants and advisers and other third parties outside the ESOP (Non-ESOP Options) with new options in Unilife Corporation.
 
F   Following the implementation of the Schemes, Unilife Corporation will:
  (a)   buy back the Unilife Corporation Shares issued to the Company on incorporation of Unilife Corporation for a nominal consideration of US$1.00; and
  (b)   convert the Company from a public company to a proprietary company limited by shares.

 

 


 

(DLA PHILLIPS FOX LOGO)
Operative provisions
1   Implementation of the Proposed Transaction
1.1   The Company will propose and the Parties will seek to implement the Proposed Transaction in accordance with this Agreement.
1.2   Unilife Corporation will comply with its obligations under the Proposed Transaction and provide reasonable assistance to the Company in proposing and implementing the Proposed Transaction in accordance with this Agreement.
2   Conditions
Conditions precedent to implementation of the Share Scheme
2.1   The transfer of the Scheme Shares and Unilife Corporation’s obligations under clause 3.2 are subject to each of the following conditions being satisfied or waived in accordance with this clause 2:
  2.1.1   (No prohibitive orders): Prior to 8.00am on the Second Court Hearing Date, no judicial authority or entity and no Government Agency taking and not withdrawing any action, or imposing any legal restraint or prohibition, to prevent the implementation of the Proposed Transaction (or any transaction contemplated by the Proposed Transaction).
  2.1.2   (Regulatory Consents): All approvals, consents or waivers which the Parties agree are required to implement the transactions envisaged by this Agreement (other than the approval by the Court of the Schemes under section 411(4)(b) of the Corporations Act) having been obtained or deemed to have been obtained by 5:00pm on the Business Day immediately prior to the Second Court Hearing Date including ASIC and ASX providing all consents, approvals and waivers and doing all other acts which are necessary or reasonably desirable to implement the Proposed Transaction on terms that are unconditional or subject only to conditions which are acceptable to the Company (Regulatory Consents).
 
  2.1.3   (ASX listing): ASX approving:
  (a)   Unilife Corporation for admission to the official list of ASX; and
 
  (b)   the CDIs for official quotation by ASX, in each case conditional only on the Share Scheme becoming Effective and Unilife Corporation providing the information required by the ASX approval or by the Listing Rules and satisfying any conditions in the ASX approval with regard to deferred settlement trading of the CDIs.
  2.1.4   (Shareholder approval): Shareholders approving the Share Scheme at the Share Scheme Meeting (or any adjournment or postponement of it at which the Share Scheme is voted on) by the requisite majorities under the Corporations Act.
  2.1.5   (Court approval of Share Scheme): The Court approving the Share Scheme in accordance with section 411(4)(b) of the Corporations Act either unconditionally or on conditions that are customary or usual.
  2.1.6   (Depositary): Before 5.00pm on the Business Day prior to the Second Court Hearing Date, Unilife Corporation has appointed a Depositary and the Depositary has agreed to the allotment to it of Unilife Corporation Shares under the Share Scheme.
  2.1.7   (Nominee): Before 5.00pm on the Business Day prior to the Second Court Hearing Date, Unilife Corporation has appointed a Nominee and the Nominee has agreed to sell the CDIs as contemplated by clause 3.7.
  2.1.8   (Ability to issue CDIs): Before 5.00pm on the Business Day prior to the Second Court Hearing Date, Unilife Corporation has done everything necessary under the ASTC Settlement Rules to enable it to issue CDIs other than the allotment to a Depositary of Unilife Corporation Shares under the Share Scheme.
  2.1.9   (Independent Expert): The Independent Expert giving a report to the Company that in its opinion the Proposed Transaction is fair and reasonable and in the best interests of Shareholders and Optionholders and the Independent Expert does not change its conclusion or withdraw its report prior to 5.00pm on the day prior to the Second Court Hearing Date.

 

2


 

(DLA PHILLIPS FOX LOGO)
Conditions precedent to implementation of the Option Scheme
2.2   The cancellation of the Options and Unilife Corporation’s obligations under clause 4.3 are subject to the satisfaction or waiver of each of the conditions set out in clause 2.1 and each of the following conditions being satisfied or waived in accordance with this clause 2:
  2.2.1   (Optionholder approval): Optionholders approving the Option Scheme at the Option Scheme Meeting (or any adjournment or postponement of it at which the Option Scheme is voted on) by the requisite majorities under the Corporations Act.
  2.2.2   (Court approval of Option Scheme): The Court approving the Option Scheme in accordance with section 411(4)(b) of the Corporations Act either unconditionally or on conditions that are customary or usual.
Reasonable endeavours
2.3   Each of the Parties must use its reasonable endeavours to procure that:
  2.3.1   each of the conditions in clauses 2.1 and 2.2 are satisfied as expeditiously as possible and in any event on or before the Sunset Date, including providing all reasonable assistance to the other Party as is necessary to satisfy such conditions; and
  2.3.2   there is no occurrence within the control of the Company or Unilife Corporation (as the context requires) which would prevent the conditions in clause 2.1 or 2.2 from being satisfied.
2.4   Without limiting clause 2.3.1, the Company and Unilife Corporation (as the case requires) must for the purpose of fulfilling their obligations under clause 2.3:
  2.4.1   promptly apply for all relevant Regulatory Consents and provide the other with a copy of all those applications;
  2.4.2   take all steps for which it is responsible as part of the approval process;
 
  2.4.3   respond to requests for information at the earliest practicable time;
  2.4.4   provide the other with all information reasonably requested in connection with the applications for Regulatory Consents; and
  2.4.5   so far as it is able, allow the other and its representatives the opportunity to be present at any meetings with any Government Agency.
2.5   Each of the Company and Unilife Corporation must promptly notify the other after it becomes aware that any condition in clause 2.1 or 2.2 has been satisfied or has become incapable of being satisfied.
Waiver of conditions
2.6   The conditions in clause 2.1.1, 2.1.2, 2.1.3, 2.1.6, 2.1.7 and 2.1.8 are for the joint benefit of the Company and Unilife Corporation and may only be waived jointly by them.
2.7   The condition in clause 2.1.9 is for the sole benefit of the Company and may only be waived by the Company.
 
2.8   The conditions in clauses 2.1.4, 2.1.5, 2.2.1 and 2.2.2 cannot be waived.
2.9   Any waiver of the conditions in clause 2.1 (that are capable of waiver) must take place prior to 8.00am on the Second Court Hearing Date to be effective.
Failure of condition
2.10   If:
  2.10.1   a condition in clause 2.1 or 2.2 is not satisfied or waived (where it is capable of being waived) by the date specified for its satisfaction; or
  2.10.2   a condition in clause 2.1 or 2.2 becomes incapable of being satisfied by the date specified for its satisfaction and is not waived (where it is capable of being waived), then unless the condition is waived (where it is capable of being waived), the Parties must consult in good faith to:
  2.10.3   determine whether the Proposed Transaction or an element of the Proposed Transaction (as relevant) may proceed by way of alternative means or methods;
  2.10.4   change the date of the application made to the Court for an order under section 411(4)(b) of the Corporations Act approving the Schemes or adjourning that application (as applicable) to another date agreed by the Company and Unilife Corporation (being a date no later than five Business Days before the Sunset Date); or
 
  2.10.5   extend the relevant date or Sunset Date.

 

3


 

(DLA PHILLIPS FOX LOGO)
2.11   If the Parties are unable to reach agreement under clause 2.10 within five Business Days of the date on which they both become aware that the condition has become incapable of being satisfied (or, if earlier, by 8.00am on the Second Court Hearing Date), then unless the condition is waived (where it is capable of being waived), the Party entitled to the benefit of that condition may terminate this Agreement at any time prior to 8.00am on the Second Court Hearing Date with immediate effect by written notice to the other Party.
2.12   Subject to the rights of the Parties under clauses 9.4, 9.5, 10, 12 and 13 of this Agreement, following any termination under clause 2.11, no Party will have any liability to the other Party in respect of this Agreement.
Notice of changes
2.13   The Company and Unilife Corporation must promptly notify each other of any change or event causing, or which, so far as can reasonably be foreseen, would cause:
  2.13.1   any of the conditions in clauses 2.1 or 2.2 being satisfied or becoming incapable of satisfaction; or
  2.13.2   a material breach of this Agreement.
3   Share Scheme
Share Scheme
3.1   The Company will propose a scheme of arrangement under which all the Scheme Shares are transferred to Unilife Corporation and Scheme Shareholders will be entitled to receive the Share Scheme Consideration.
Share Scheme Consideration
3.2   In consideration of the Scheme Shareholders transferring their Shares to Unilife Corporation on the Implementation Date, Unilife Corporation covenants in the Company’s favour (in its own right and separately as trustee or nominee for each Scheme Shareholder) that Unilife Corporation will, on the Implementation Date, and immediately before the transfer of the Shares to Unilife Corporation, issue to such Scheme Shareholder (or, in accordance with clause 3.7 to a Nominee on its behalf where such Scheme Shareholder is an Ineligible Overseas Shareholder):
  3.2.1   one Unilife Corporation Share for every six Shares held by the Scheme Shareholder on the Scheme Record Date, where such Scheme Shareholder has made an election to receive Unilife Corporation Shares in accordance with clause 3.3; or
  3.2.2   six CDIs for every Unilife Corporation Share to which the Scheme Shareholder would be entitled under clause 3.2.1, where the Scheme Shareholder has made an election to receive CDIs or has not made an election in accordance with clause 3.3.
Election
3.3   The Information Memorandum must be accompanied by written notice to the Company’s share registry, under which each Scheme Shareholder may make an election to receive Unilife Corporation Shares or CDIs under the Share Scheme, by completing, signing and returning the written notice by 5.00pm on the Scheme Record Date (or such other date as agreed by the Parties in writing) to the Company’s share registry.
3.4   An election under clause 3.3 may only be made in respect of all and not only some of the Shares held by a Scheme Shareholder.
3.5   If a Scheme Shareholder does not make an election in accordance with clause 3.3, a Scheme Shareholder will receive CDIs under the Share Scheme.
Fractional entitlements
3.6   Fractional entitlements to Share Scheme Consideration will be rounded down to the nearest:
  3.6.1   whole number of Unilife Corporation Shares, if the Scheme Shareholder has elected to receive Unilife Corporation Shares under the Share Scheme; or
  3.6.2   multiple of six CDIs, if the Scheme Shareholder has elected to receive CDIs or has not made an election under clause 3.3, after aggregating all holdings of such Scheme Shareholder.
Ineligible Overseas Shareholders
3.7   Where a Scheme Shareholder is an Ineligible Overseas Shareholder, the number of CDIs to which the Scheme Shareholder would otherwise be entitled under the ShareScheme will be issued to a Nominee of Unilife Corporation who will sell those CDIs as soon as reasonably practicable (at the risk of that Ineligible Overseas Shareholder) and pay the net proceeds received in Australian dollars (calculated on an averaged basis so that all Ineligible Overseas Shareholders receive the same price per CDI subject to rounding to the nearest cent), after deducting any applicable brokerage and other taxes and charges, to that Ineligible Overseas Shareholder in full satisfaction of that Ineligible Overseas Shareholder’s rights to Share Scheme Consideration.

 

4


 

(DLA PHILLIPS FOX LOGO)
General provisions
3.8   The obligations of Unilife Corporation to issue Unilife Corporation Shares under this Agreement will be satisfied by Unilife Corporation on the Implementation Date procuring the entry in the register maintained by Unilife Corporation of holders of Unilife Corporation Shares of each person who is to receive Unilife Corporation Shares.
3.9   After the satisfaction of the obligations of Unilife Corporation in clause 3.8, and within five Business Days after the Implementation Date, Unilife Corporation will:
  3.9.1   issue holding statements, certificates or transmittal letters (as the case may be) for such Unilife Corporation Shares in the name of such persons; and
  3.9.2   procure the despatch of such holding statements, certificates or transmittal letters to the address as shown in the register for such persons.
3.10   The obligations of Unilife Corporation to issue CDIs under clause 3.2 will be satisfied by Unilife Corporation on the Implementation Date procuring the entry in the register maintained by Unilife Corporation of holders of Unilife Corporation Shares of the Depositary as depositary to hold the Unilife Corporation Shares underlying those CDIs and procuring the Despositary to issue CDIs to Scheme Shareholders in accordance with the Share Scheme.
3.11   After the satisfaction of the obligations of Unilife Corporation in clause 3.10, and within five Business Days after the Implementation Date, Unilife Corporation will:
  3.11.1   issue holding statements or transmittal letters (as the case may be) for such Unilife Corporation Shares in the name of the Depositary and procure the despatch of such holding statements or transmittal letters to the Depositary;
  3.11.2   record in the CDI Register each person who is to receive CDIs under clause 3.2; and
  3.11.3   despatch to each person who is to receive CDIs under clause 3.2 a holding statement in the name of that person representing the number of CDIs to be issued to that person.
4   Option Scheme
Preliminary steps
4.1   On or before 8.00am on the Second Court Hearing Date, Unilife Corporation will adopt the Unilife Corporation Employee Stock Option Plan.
Option Scheme
4.2   The Company will propose a scheme of arrangement under which all of the Options are cancelled and Scheme Optionholders will be entitled to receive the Option Scheme Consideration.
Option Scheme Consideration
4.3   In consideration of the Scheme Optionholders agreeing to cancel their Options on the Implementation Date, Unilife Corporation covenants in the Company’s favour (in its own right and separately as trustee or nominee for each Scheme Optionholder) that Unilife Corporation will, on the Implementation Date, and immediately before the cancellation of the Options, issue to such Scheme Optionholder one Unilife Corporation Option for every six Options held by them on the Scheme Record Date.
Terms of Unilife Corporation Options
4.4   Each Unilife Corporation Option issued in accordance with clause 4.3 will:
  4.4.1   have an exercise price per Unilife Corporation Option equal to six times the exercise price per option of the relevant Options it replaces;
  4.4.2   have an exercise period equal to the unexpired exercise period of the relevant Options it replaces;
  4.4.3   be vested to the same extent and have the same terms as to vesting as the relevant Options it replaces; and
  4.4.4   otherwise be issued on the terms of the Unilife Corporation Employee Stock Option Plan.
Fractional entitlements
4.5   Fractional entitlements to Option Scheme Consideration will be rounded down to the nearest whole number of Unilife Corporation Options after aggregating all holdings of such Scheme Optionholder.
General provisions
4.6   The obligation of Unilife Corporation to issue Unilife Corporation Options under this Agreement will be satisfied by Unilife Corporation on the Implementation Date procuring the entry in the register maintained by Unilife Corporation of optionholders of each person who is to receive Unilife Corporation Options.

 

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4.7   After the satisfaction of the obligations of Unilife Corporation in clause 4.6, and within five Business Days after the Implementation Date, Unilife Corporation will:
  4.7.1   issue certificates for such Unilife Corporation Options in the name of such persons; and
  4.7.2   procure the despatch of such certificates to the address as shown in the option register for such persons.
5   Co-operation
5.1   Unilife Corporation and the Company must each use all reasonable endeavours to produce the Information Memorandum, seek the required Regulatory Consents and implement the Schemes as soon as reasonably practicable.
5.2   The Company and Unilife Corporation will for this purpose discuss the content of drafts of the Information Memorandum and the Company will consider all requests or suggestions by Unilife Corporation as to the content of the Information Memorandum.
 
6   Implementation of Schemes
Preliminary steps
6.1   On or before 8.00am on the Second Court Hearing Date:
  6.1.1   the Company will make an offer to each holder of Non-ESOP Options to cancel the Non-ESOP Options held by that person in accordance with clause 7; and
  6.1.2   the Company will apply for a ruling from the Australian Taxation Office that Australian resident Scheme Shareholders and Scheme Optionholders will receive capital gains tax rollover relief in relation to the transfer of their Shares to Unilife Corporation under the Share Scheme and the cancellation and replacement of their Options under the Option Scheme and for the Non-ESOP Optionholders in relation to the cancellation and replacement of their Non-ESOP Options in accordance with clause 7.
The Company’s obligations
6.2   The Company must take all necessary steps to propose, implement and complete the Schemes as soon as reasonably practicable. This includes taking each of the following steps:
  6.2.1   (Prepare Information Memorandum): Prepare the Information Memorandum in accordance with all applicable laws including the Corporations Act, applicable ASIC Policy Statements and the Listing Rules. The Information Memorandum must include, amongst other things:
  (a)   details of the Schemes;
 
  (b)   the Deeds Poll;
 
  (c)   an explanatory statement complying with the requirements of the Corporations Act in respect of the Schemes as a whole;
 
  (d)   a report from the Independent Expert;
 
  (e)   notices of the Scheme Meetings;
 
  (f)   proxy forms for the Scheme Meetings; and
 
  (g)   a statement that each director of the Company recommends that Shareholders and Optionholders vote in favour of the Schemes.
  6.2.2   (Consultation): Consult with Unilife Corporation and give Unilife Corporation and its representatives a reasonable opportunity to provide input about the Information Memorandum’s content and presentation.
  6.2.3   (Independent Expert): Appoint an independent expert to provide a report with respect to the Schemes to be included in the Information Memorandum in accordance with all applicable laws.
  6.2.4   (Registration): Request ASIC to register the explanatory statement included in the Information Memorandum in relation to the Schemes in accordance with section 412(6) of the Corporations Act.
  6.2.5   (Engage suitable counsel): Engage suitable counsel to represent the Company in all Court proceedings related to the Schemes.
  6.2.6   (Section 411(17)(b) statement): Apply to ASIC for a statement under section 411(17)(b) of the Corporations Act that ASIC has no objection to the Schemes.
  6.2.7   (Court direction): Apply to the Court for orders under section 411(1) of the Corporations Act directing the Company to convene the Scheme Meetings.
  6.2.8   (Scheme Meetings): Convene and hold the Scheme Meetings in order to seek approval of the Schemes in accordance with the Court’s orders.

 

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  6.2.9   (New information): Provide to Shareholders and Optionholders any further or new information that arises after the Despatch Date and prior to the Scheme Meetings that is necessary to ensure that the information contained in the Information Memorandum is not false, misleading or deceptive in any material respect.
  6.2.10   (Court approval): Apply to the Court for orders approving the Schemes if they are approved by the requisite majorities of Shareholders and Optionholders respectively at the Scheme Meetings.
  6.2.11   (Certificate): Provide the Court on the Second Court Hearing Date with a certificate confirming whether all of the conditions in clauses 2.1 and 2.2 have been satisfied or waived in accordance with the terms of this Agreement.
  6.2.12   (Lodge copy of Court order): Lodge an office copy of the Court order approving the Schemes (if made) with ASIC no later than 5.00pm on the day after the orders are made.
  6.2.13   (Registration): If the Share Scheme becomes Effective, enter in the Register all transfers of Scheme Shares to Unilife Corporation under the Share Scheme on the Implementation Date.
  6.2.14   (Register information): Provide Unilife Corporation and its share registry with all information necessary, or reasonably requested, in order to assist Unilife Corporation to provide the Scheme Consideration.
Unilife Corporation obligations
6.3   Unilife Corporation must take all necessary steps to implement and complete the Schemes as soon as is reasonably practicable. This includes taking each of the following steps:
  6.3.1   (Deeds Poll): Execute the Deeds Poll immediately following the Court making the orders under section 411(1) of the Corporations Act to convene the Scheme Meetings;
  6.3.2   (Unilife Corporation information): Prepare and provide to the Company all information regarding Unilife Corporation required by all applicable laws, including the Corporations Act, applicable ASIC Policy Statements and the Listing Rules for inclusion in the Information Memorandum.
  6.3.3   (Accuracy of Unilife Corporation information): Before the Despatch Date verify to the Company the accuracy of the Unilife Corporation information provided to the Company for inclusion in the Information Memorandum and consent to the inclusion of that information in the form and context in which it appears, in each case subject to Unilife Corporation being reasonably satisfied as to those matters.
  6.3.4   (Certificate): Provide to the Court on the Second Court Hearing Date a certificate confirming whether all the conditions in clauses 2.1 and 2.2 have been satisfied or waived in accordance with the terms of this Agreement.
  6.3.5   (Unilife Corporation new information): Provide to the Company any further or new information about Unilife Corporation which arises after the Despatch Date and prior to the Scheme Meetings which is necessary or reasonably required by the Company to ensure that the information concerning Unilife Corporation that is disclosed in the Information Memorandum is not false, misleading or deceptive in any material respect.
 
  6.3.6   (Scheme Consideration): If the:
  (a)   Share Scheme becomes Effective, issue the Share Scheme Consideration in accordance with clause 3.2; and
 
  (b)   Option Scheme becomes Effective, issue the Option Scheme Consideration in accordance with clause 4.3;
      in each case on the Implementation Date.
 
  6.3.7   (Independent Expert): Promptly provide all assistance and information reasonably requested by the Independent Expert to enable it to prepare its report for inclusion in the Information Memorandum.
  6.3.8   (Reasonable assistance): Provide any assistance or information reasonably requested by the Company in relation to the Schemes, including for the purposes of obtaining the Regulatory Consents.
  6.3.9   (Unilife Corporation Employee Stock Option Plan): The Board of Directors and shareholders of Unilife Corporation must adopt the Unilife Corporation Employee Stock Option Plan prior to the Lodgement Date.

 

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Quotation of Company Shares
6.4   If the Share Scheme is approved by the Court, the Company must take all reasonable steps to ensure that the Shares remain quoted on ASX until the transfer of all the Scheme Shares to Unilife Corporation is completed.
7   Replacement of Non-ESOP Options
Cancellation of Non-ESOP Options and offer of Unilife Corporation Non-ESOP Options
7.1   On or before 8.00am on the Second Court Hearing Date, the Company will make an offer to each Non-ESOP Optionholder to cancel the Non-ESOP Options held by that person. In consideration for and subject to that cancellation, Unilife Corporation will grant one Unilife Corporation Non-ESOP Option to each Non-ESOP Optionholder for every six Non-ESOP Options held by them as at the Implementation Date (rounded down to the nearest whole number of Unilife Corporation Non-ESOP Options) on the terms set out in clause 7.3 below.
 
7.2   The offers set out in clause 7.1 will be conditional upon:
  7.2.1   the Share Scheme becoming Effective; and
  7.2.2   ASX granting a waiver on or before the Implementation Date of the requirement under Listing Rule 6.23 to obtain Shareholder approval for the cancellation of the Non-ESOP Options.
Terms of Unilife Corporation Non-ESOP Options
7.3   Each Unilife Corporation Non-ESOP Option issued in accordance with clause 7.1 will:
  7.3.1   have an exercise price per option equal to six times the exercise price per option of the relevant Non-ESOP Options it replaces;
  7.3.2   have an exercise period equal to the unexpired exercise period of the relevant Non-ESOP Options it replaces;
  7.3.3   be vested to the same extent and have the same terms as to vesting as the relevant Non-ESOP Options it replaces; and
  7.3.4   otherwise be issued on the terms of the Unilife Corporation Option Deeds.
8   Conversion of Company to a proprietary company
8.1   Within 10 Business Days following implementation of the Share Scheme, Unilife Corporation will pass a special resolution to convert the Company from a public company to a proprietary company limited by shares and lodge all necessary documentation with ASIC to give effect to the conversion of the Company from a public company to a proprietary company.
9   Termination
Termination by notice
9.1   Without prejudice to any other rights of termination under this Agreement, either Party may terminate this Agreement by giving the other Party written notice at any time before 8.00am on the Second Court Hearing Date if:
  9.1.1   the other Party is in material breach of any term of this Agreement and:
  (a)   the Party wishing to terminate has given the other Party a written notice:
  (i)   setting out details of the breach; and
 
  (ii)   stating its intention to terminate, and
  (b)   the breach continues to exist five Business Days (or any shorter period ending at 5.00pm on the day before the Second Court Hearing Date) from the date the notice is given; or
  9.1.2   the Board withdraws its recommendation of the Schemes.
Automatic termination
9.2   All of the obligations in this Agreement with respect to a Scheme will terminate automatically without the need for action by any Party in the event that:
  9.2.1   the Independent Expert opines that such Scheme is not fair and reasonable and in the best interests of the Shareholders or Optionholders (as relevant); or
  9.2.2   the Company’s Shareholders or Optionholders (as relevant) fail to approve such Scheme by the necessary majorities at the relevant Scheme Meeting; or
  9.2.3   the Court refuses to grant an order convening any required Scheme Meeting or approving such Scheme and either the Parties agree not to conduct an appeal or the Parties agree to conduct an appeal but the appeal is unsuccessful; or
  9.2.4   such Scheme is not approved by the Court under section 411(4)(b) of the Corporations Act on or before the Sunset Date.
Mutual termination
9.3   This Agreement may be terminated at any time by mutual consent of the Parties, provided that such consent to terminate is in writing and is signed by each of the Parties.

 

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Effect of termination
9.4   If either the Company or Unilife Corporation terminates this Agreement under clauses 2.11 or 9.1 or this Agreement terminates automatically under clause 9.2, this Agreement and the Parties’ obligations under it cease without any liability or obligation on behalf of the Parties other than those obligations under this clause and clauses 10, 12 and 13.
9.5   Termination of this Agreement under clause 9 does not affect any accrued rights of a Party in respect of a breach of this Agreement prior to termination.
10   Public announcements and disclosure
Public announcements
10.1   Neither Party may make a public announcement about this Agreement, the Information Memorandum or the Schemes unless:
  10.1.1   the other Party has approved the form of the announcement; or
  10.1.2   the law or the Listing Rules requires an announcement to be made, subject to clause 10.2.
Required disclosure
10.2   If the law or the Listing Rules require a Party to make an announcement or disclosure about either the subject of this Agreement or the Information Memorandum, that Party must give the other Party as much notice as is reasonably practical and to the extent reasonably practical consult with the other Party about the form and content of the announcement or disclosure.
Privacy Act
10.3   Each Party acknowledges that the other has obligations under the Privacy Act 1988 (Cth) in relation to personal information (defined as any information identifying or potentially identifying an individual) in its possession and forming part of the Party’s confidential information. Each Party undertakes to comply with these obligations to the same extent and degree as the Party from whom each has obtained the information is bound to observe them.
11 Buy back of shares in Unilife Corporation
11.1   Within 10 Business Days following the implementation of the Share Scheme, Unilife Corporation will buy back the Unilife Corporation Shares issued to the Company on incorporation for a nominal consideration of US$1.00 in accordance with the requirements of Delaware law.
12 Costs and stamp duty
12.1   Subject to clause 12.2, each Party must bear its own costs and expenses (including professional fees and stamp duty) incurred by it in connection with the negotiation, preparation and execution of this Agreement and the implementation or attempted implementation of the Schemes.
12.2   Unilife Corporation must pay all stamp duty and any related fines or penalties in respect of this Agreement, the Deeds Poll and the acquisition of the Scheme Shares in accordance with the Share Scheme.
13   Miscellaneous
Notices
13.1   Any notice, demand, consent or other communication (a Notice) given or made under this Agreement:
  13.1.1   must be in writing and signed by a person duly authorised by the sender;
  13.1.2   must be delivered to the intended recipient by prepaid post or by hand or fax to the address or fax number below or the address (being an address in Australia) or fax number last notified by the intended recipient to the sender:
         
 
  Company:    
 
  Address:   Level 11, 1 Chifley Square,
 
      Sydney NSW 2000 Australia
 
  Fax:   (02) 8346 6511
 
  Attention:   Mr Jeff Carter
 
       
 
  Unilife Corporation:    
 
  Address:   633 Lowther Road
 
      Lewisberry, Pennsylvania 17339
 
      United States of America
 
  Fax:   + 1 717 938 9364
 
  Attention:   Mr Alan Shortall

 

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  13.1.3   will be taken to be duly given or made:
  (a)   in the case of delivery in person, when delivered;
 
  (b)   in the case of delivery by post:
  (i)   within Australia to an Australian address, two Business Days after the date of posting; and
 
  (ii)   in any other case, 10 Business Days after the date of posting;
  (c)   in the case of fax, on receipt by the sender of a transmission control report from the despatching machine showing the relevant number of pages and the correct destination fax machine number or name of recipient and indicating that the transmission has been made without error, but if the result is that a Notice would be taken to be given or made on a day that is not a Business Day in the place to which the Notice is sent or is later than 4.00pm (local time) it will be taken to have been duly given or made at the commencement of business on the next Business Day in that place.
No waiver
13.2   No failure to exercise nor any delay in exercising any right, power or remedy by a Party operates as a waiver. A single or partial exercise of any right, power or remedy does not preclude any other or further exercise of that or any other right, power or remedy. A waiver is not valid or binding on the Party granting that waiver unless made in writing.
Remedies cumulative
13.3   The rights, powers and remedies provided to each Party in this Agreement are in addition to, and do not exclude or limit, any right, power or remedy provided by law or equity or by any agreement.
Entire agreement
13.4   This Agreement contains the entire agreement between the Parties as at the date of this Agreement with respect to its subject matter and supersedes all prior agreements and understandings between the Parties in connection with it.
Amendment
13.5   No amendment or variation of this Agreement is valid or binding on a Party unless made in writing executed by the Company and Unilife Corporation which may so make an amendment or variation notwithstanding that one or more other persons may be entitled to the benefit of all or any of the provisions of this Agreement.
Assignment
13.6   The rights and obligations of each Party under this Agreement are personal. They cannot be assigned, encumbered or otherwise dealt with and no Party may attempt, or purport, to do so without the prior consent of the other Party.
Consents or approvals
13.7   A Party may:
  13.7.1   give conditionally or unconditionally; or
 
  13.7.2   withhold, its approval or consent in its absolute discretion unless this Agreement expressly provides otherwise.
No merger
13.8   The rights and obligations of the Parties will not merge on the completion of any transaction contemplated by this Agreement. They will survive the execution and delivery of any assignment or other document entered into for the purpose of implementing a transaction.
Further assurances
13.9   Each Party agrees to do all things and execute all deeds, instruments, transfers or other documents as may be necessary or desirable to give full effect to the provisions of this Agreement and the transactions contemplated by it.
Severability of provisions
13.10   Any provision of this Agreement that is prohibited or unenforceable in any jurisdiction is ineffective as to that jurisdiction to the extent of the prohibition or unenforceability. That does not invalidate the remaining provisions of this Agreement nor affect the validity or enforceability of that provision in any other jurisdiction.
Counterparts
13.11   This Agreement may be executed in any number of counterparts. All counterparts together will be taken to constitute one instrument, it being understood that both Parties need not sign the same counterpart.

 

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GST
13.12   Unless expressly included, the consideration for any supply under or in connection with this Agreement does not include GST.
13.13   To the extent that any supply made by a Party to another Party (Recipient) under or in connection with this Agreement is a taxable supply and a tax invoice has been provided to the Recipient, the Recipient must pay, in addition to the consideration to be provided under this Agreement for that supply (unless it expressly includes GST), an amount equal to the amount of that consideration (or its GST exclusive market value) multiplied by the rate at which GST is imposed in respect of the supply.
13.14   The amount of GST payable in accordance with clause 13.13 will be paid at the same time and in the same manner as the consideration otherwise payable for the supply is provided.
14   Governing law and jurisdiction
14.1   This document is governed by the law of New South Wales. The Parties submit to the non-exclusive jurisdiction of its courts and courts of appeal from them. The Parties will not object to the exercise of jurisdiction by those courts on any basis. Definitions and interpretation.
 
15   Definitions and interpretations
Definitions
15.1   In this Agreement the following definitions apply:
 
    APRA means the Australian Prudential Regulation Authority.
 
    ASIC means the Australian Securities and Investments Commission.
 
    ASTC means ASX Settlement and Transfer Corporation Pty Limited (ABN 49 008 504 532).
 
    ASX means ASX Limited (ACN 008 624 691) or the securities market which it operates, as the context requires.
 
    Board means the Board of Directors of the Company from time to time.
 
    Business Day means a day that is not a Saturday, Sunday or a public holiday or bank holiday in Sydney, Australia.
 
    CDI means the CHESS Depositary Interest to be issued in connection with the Share Scheme representing an interest in one sixth of a Unilife Corporation Share.
 
    CDI Register has the meaning given to that term in the ASTC Settlement Rules.
 
    CHESS Depositary Interest has the meaning given to that term in the ASTC Settlement Rules.
 
    Corporations Act means the Corporations Act 2001 (Cth).
 
    Court means the Federal Court of Australia or any other court of competent jurisdiction under the Corporations Act agreed in writing by the Company and Unilife Corporation.
 
    Deeds Poll means the Share Scheme Deed Poll and the Option Scheme Deed Poll.
 
    Depositary has the meaning given to it in the ASTC Settlement Rules.
 
    Directors means the directors of the Company.
 
    Despatch Date means the day that the Information Memorandum is despatched to Shareholders and Optionholders.
 
    Effective means, when used in relation to a Scheme, the coming into effect, under section 411(10) of the Corporations Act, of the Court order made under section 411(4)(b) of the Corporations Act in relation to that Scheme.
 
    Effective Date means the date on which a Scheme becomes Effective.
 
    ESOP means the Unilife Medical Solutions Limited Employee Share Option Plan.
 
    First Court Hearing Date means the date the Court hears the application to order the convening of the Scheme Meetings under section 411(1) of the Corporations Act.
 
    Government Agency means:
  (a)   a government, whether foreign, federal, state, territorial or local;
  (b)   a department, office or minister of a government (whether foreign, federal, state, territorial or local) acting in that capacity; or
  (c)   a court, administrative agency, arbitration tribunal, commission, delegate, instrumentality, agency, board, or other government, semi-government, judicial, administrative, monetary or fiscal authority, whether statutory or not and whether foreign, federal, state, territorial or local, and includes ASX, ASIC, the Takeovers Panel and APRA.

 

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GST means goods and services tax.
Implementation Date means the third Business Day following the Scheme Record Date.
Independent Expert means the independent expert in respect of the Schemes appointed by the Company in accordance with clause 6 to consider whether the Schemes are fair and reasonable to and in the best interests of Shareholders and Optionholders.
Ineligible Overseas Shareholder means a Scheme Shareholder who is registered in the Register with an address outside Australia and its external territories, New Zealand, United Kingdom, Ireland, France, Malta, Hong Kong, Croatia and the United States or any other country agreed to by the Company and Unilife Corporation.
Information Memorandum means the document containing the information described in clause 6.2.1 to be approved by the Court and to be despatched to Shareholders and Optionholders to assist them in deciding on how to vote on the Schemes.
Listing Rules means the official listing rules of ASX as amended from time to time.
Lodgement Date means the date of lodgement of the Information Memorandum with ASIC.
Nominee means the nominee selected by Unilife Corporation prior to the Implementation Date for the purposes of clause 2.1.7.
Non-ESOP Options means the options issued to certain consultants and advisers to the Company and other third parties all of which were issued outside of the ESOP.
Option Scheme means the proposed scheme of arrangement, substantially in the form set out in Annexure 2, under Part 5.1 of the Corporations Act between the Company and Scheme Optionholders as described in clause 4, subject to any alterations or conditions made or required by the Court and approved in writing by the Parties.
Option Scheme Consideration means the consideration for the cancellation of the Options as set out in clause 4.3.
Option Scheme Deed Poll means the deed poll to be executed by Unilife Corporation substantially in the form of Annexure 4, under which Unilife Corporation covenants in favour of Scheme Optionholders to perform its obligations under this Agreement and the obligations contemplated of it under the Option Scheme, with such amendments as are approved by the Court or as the Company and Unilife Corporation may otherwise agree.
Option Scheme Meeting means the meeting of Optionholders ordered by the Court to be convened under section 411(1) of the Corporations Act to consider the Option Scheme.
Optionholder means a person registered in the Company’s option register as a holder of Options.
Options means options issued under the ESOP entitling holders to subscribe for Shares.
Parties mean the Company and Unilife Corporation.
Proposed Transaction means the redomiciliation transaction which is to be effected on the Implementation Date, under which:
  (a)   Unilife Corporation will acquire all of the Shares under the Share Scheme;
 
  (b)   the Company will cancel all of the Options under the Option Scheme;
 
  (c)   the Company will cancel all of the Non-ESOP Options; and
  (d)   the existing security holders of the Company will receive Unilife Corporation Shares (or CDIs), Unilife Corporation Options and Unilife Corporation Non-ESOP Options (as relevant).
Register means the Company’s register of shareholders.
Regulatory Consents has the meaning given to that term in clause 2.1.2.
Related Bodies Corporate has the meaning given to that term in the Corporations Act.
Scheme Meetings means the Share Scheme Meeting and the Option Scheme Meeting.
Scheme Optionholder means an Optionholder as at the Scheme Record Date.
Scheme Record Date means 7.00 pm on the fifth Business Day after the Effective Date or any other date agreed with ASX to be the record date for the Schemes to determine entitlements to receive consideration pursuant to the Schemes.
Scheme Shareholder means a Shareholder as at the Scheme Record Date.
Scheme Shares means all Shares held by Scheme Shareholders as at the Scheme Record Date.
Schemes means the Share Scheme and the Option Scheme.
Second Court Hearing Date means the first day on which an application to the Court for orders under section 411(4)(b) of the Corporations Act approving the Schemes is heard.
Share means one fully paid ordinary share in the Company.
Share Scheme means the proposed scheme of arrangement, substantially in the form set out in Annexure 1, under Part 5.1 of the Corporations Act between the Company and Scheme Shareholders as described in clause 3 subject to any alterations or conditions made or required to be made by the Court and approved in writing by the Parties.
Share Scheme Consideration means the consideration for the transfer of the Scheme Shares to Unilife Corporation as set out in clause 3.2.

 

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Share Scheme Deed Poll means the deed poll to be executed by Unilife Corporation substantially in the form of Annexure 3, under which Unilife Corporation covenants in favour of Scheme Shareholders to perform its obligations under this Agreement and the obligations contemplated of it under the Share Scheme, with such amendments as are approved by the Court or as the Company and Unilife Corporation may otherwise agree.
Share Scheme Meeting means the Shareholders’ meeting ordered by the Court to be convened under section 411(1) of the Corporations Act to consider the Share Scheme.
Shareholder means each person who is registered in the Register as a holder of Shares.
Subsidiary has the meaning given to that term in section 46 of the Corporations Act.
Sunset Date means 5.00pm on 30 June 2010 or such other date and time agreed in writing between Unilife Corporation and the Company.
Unilife Corporation Employee Stock Option Plan means the Unilife Corporation Employee Stock Option Plan in the form agreed between the Parties to be adopted by Unilife Corporation in accordance with clause 4.1.
Unilife Corporation Non-ESOP Options means options granted by Unilife Corporation outside the Unilife Corporation Employee Stock Option Plan.
Unilife Corporation Option Deeds means the deeds under which the Unilife Corporation Non-ESOP Options will be granted by Unilife Corporation to each holder of Non-ESOP Options.
Unilife Corporation Options means options to subscribe for Unilife Corporation Shares under the Unilife Corporation Employee Stock Option Plan.
Unilife Corporation Shares means shares of fully paid common stock in the capital of Unilife Corporation.
Interpretation
15.2   In the interpretation of this Agreement, the following provisions apply unless the context otherwise requires:
  15.2.1   The singular includes the plural and conversely.
  15.2.2   If a word or phrase is defined, its other grammatical forms have a corresponding meaning.
  15.2.3   A reference to a person, corporation, trust, partnership, unincorporated body or other entity includes any of them.
  15.2.4   A reference to a clause, schedule or annexure is a reference to a clause of, or schedule or annexure to, this Agreement.
 
  15.2.5   A reference to A$ or cents is to the lawful currency of Australia.
  15.2.6   The clause headings contained in this Agreement are inserted for convenience only and shall not affect in any way the meaning or interpretation of this Agreement.
  15.2.7   A reference to an agreement or document (including a reference to this Agreement) is to the agreement or document as amended, varied, supplemented, novated or replaced, except to the extent prohibited by this Agreement or that other agreement or document.
  15.2.8   A reference to a person includes a reference to the person’s executors, administrators, successors, substitutes (including persons taking by novation) and assigns.

 

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  15.2.9   A reference to legislation or to a provision of legislation includes a modification or re-enactment of it, a legislative provision substituted for it and a regulation or statutory instrument issued under it.
  15.2.10   Words and phrases not specifically defined in this Agreement have the same meanings (if any) given to them in the Corporations Act.
 
  15.2.11   A reference to time is a reference to time in Sydney, Australia.
  15.2.12   A reference to the word ‘include’ or ‘including’ is to be construed without limitation.
  15.2.13   If the day on which any act, matter or thing is to be done is a day other than a Business Day, such act, matter or thing must be done on the immediately succeeding Business Day.
  15.2.14   The meaning of general words is not limited by specific examples introduced by including, or for example, or similar expressions.
  15.2.15   A reference to a Party using its best endeavours or reasonable endeavours does not include a reference to that Party paying money or providing other valuable consideration to or for the benefit of any person (and an obligation on a Party to use its best or reasonable endeavours does not oblige that Party to pay money or provide other valuable consideration to or for the benefit of any person).
Construction
15.3   This Agreement must not be construed adversely to a Party solely because that Party or its solicitors were responsible for preparing it.
Payments
15.4   Unless otherwise expressly provided in this Agreement, where an amount is required to be paid to a Party (Receiving Party) by another Party under this Agreement, that amount must be paid:
  15.4.1   in immediately available and irrevocable funds by electronic transfer to a bank account or accounts notified by the Receiving Party in writing on or before the due date for payment or in other such immediately payable funds as the Parties agree; and
  15.4.2   without deduction, withholding or set-off.

 

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Execution and date    
 
 
Executed as an agreement.    
 
           
Executed by Unilife Medical Solutions Limited acting by the
following persons:
   
 
           
/s/ Alan Shortall
      /s/ Jeff Carter    
 
Signature of director
     
 
Signature of director/company secretary
   
 
           
Alan Shortall
      Jeff Carter    
 
Name of director (print)
     
 
Name of director/company secretary (print)
   
 
           
Executed by Unilife Corporation acting by the following
persons:
   
 
           
/s/ Alan Shortall
           
 
Signature of duly authorised officer
     
 
Signature of duly authorised officer
   
 
           
Alan Shortall
           
 
Name of duly authorised officer (print)
     
 
Name of duly authorised officer (print)
   

 

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List of Omitted Schedules/Exhibits to Agreement*
     
Annexure 1
  Share Scheme of Arrangement
Annexure 2
  Option Scheme of Arrangement
Annexure 3
  Share Scheme Deed Poll
Annexure 4
  Option Scheme Deed Poll
     
*   The registrant agrees to furnish supplementally a copy of any omitted schedule/exhibit to the Securities and Exchange Commission upon request.

 

16

EX-2.2 3 c93531exv2w2.htm EXHIBIT 2.2 Exhibit 2.2
Exhibit 2.2
(PHILLIPS FOX LETTERHEAD)
     
Share Purchase Agreement
   
Unilife Medical Solutions Limited
   
The persons listed in Part 1 of Schedule 1
   

 

 


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
Table of contents
         
Parties
    1  
 
       
Background
    1  
 
       
Operative provisions
    1  
 
       
1 Sale Shares
    1  
Sale and purchase
    1  
All of the Sale Shares
    1  
Waiver of pre-emption rights
    1  
 
       
2 Conditions to Completion
    2  
Conditions
    2  
Purchaser may waive certain Conditions
    2  
Termination for failure of Conditions
    3  
 
       
3 Pre-Completion
    3  
Business to be conducted in ordinary course
    3  
Employees
    4  
Access by Purchaser and its representatives
    4  
 
       
4 Completion
    5  
Time and place of Completion
    5  
Obligations of Purchaser on Completion
    5  
Obligations of Vendors on Completion
    6  
Non compliance
    7  
Post Completion Assistance
    6  
 
       
5 Post Completion payments
    8  
Additional payments
    6  
EBITDA Statements
    8  
Dispute
    8  
Post-completion Share Issues
    9  
Call Options for Vendors
    13  
 
       
6 Warranties and indemnity
    15  
Warranties
    15  
Reliance
    15  
Disclosures
    9  
Indemnity
    15  
Prompt disclosure of breach
    15  
Assignment of Warranties
    10  
Warranty/indemnity payments
    15  
 
       
7 Non compete
    17  
General obligations
    17  
Restraints fair and reasonable
    18  
Severability
    18  
 
       
8 Confidentiality and announcements
    18  
Provisions to remain confidential
    18  
Permitted disclosures
    18  

 

 


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
         
Announcements
    18  
Return of information in the event of termination
    19  
 
       
9 Notices
    19  
Requirements
    19  
Receipt
    19  
 
       
10 General Provisions
    20  
Non merger
    20  
Effect of termination
    20  
Indemnities
    21  
Invalid or unenforceable provisions
    21  
Waiver and exercise of rights
    21  
Amendment
    21  
Counterparts
    21  
Further assurances
    21  
Assignment
    22  
Entire agreement
    22  
Rights cumulative
    22  
Consents and Approvals
    22  
Jurisdiction
    22  
Service of process
    22  
Governing Law
    22  
 
       
11 Definitions and interpretations
    23  
Interpretation
    28  
 
Execution and date
    31  
 
       
Schedule 1
     
Part 1 — Vendor Details
     
Part 2 — Minority Shareholder Details
     
 
       
Schedule 2
     
Accounts
     
 
       
Schedule 3
     
Assets
     
 
       
Schedule 4
     
Material Contracts
     
 
       
Schedule 5
     
Properties
     
 
       
Schedule 6
     
Plant and Equipment
     
 
       
Schedule 7
     
Intentionally Blank
     
 
       
Schedule 8
     
Intellectual Property Rights
     
 
       
Schedule 9
     
Employees
     

 

 


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
         
 
       
Schedule 10
     
Warranties
     
 
       
Schedule 11
     
Disclosures
     
 
       
Schedule 12
     
Purchaser’s existing D&O arrangements
     
 
       
Schedule 13
     
EBITDA calculation methodology
     
 
       
Schedule 14
     
Allocation of Options
       

 

 


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
Parties
Unilife Medical Solutions Limited ACN 008 071 403 of Level 5, 35 Clarence Street, Sydney NSW 2000, Australia (Purchaser)
Each of the persons whose name and address is set out in Part 1 of Schedule 1 (together the Vendors and each a Vendor)
Background
  The Company has an issued share capital made up of 10,333 shares, which are fully paid up and legally and beneficially owned by the Vendors and the Minority Shareholders as set out in Schedule 1.
 
  The Vendors agree to sell, and procure the sale by the Minority Shareholders, and the Purchaser agrees to purchase the Sale Shares under the following terms and conditions.
Operative provisions
1   Sale Shares
Sale and purchase
1.1   The Vendors agree to sell, and procure the sale by the Minority Shareholders, and the Purchaser agrees to purchase, the Sale Shares, free from all Third Party Interests, for the Purchase Price and in accordance with this Agreement.
All of the Sale Shares
1.2   The Purchaser will not be obliged to complete the purchase of any of the Sale Shares unless the purchase of all of the Sale Shares is completed simultaneously.
Waiver of pre-emption rights
1.3   The Vendors waive and prior to Completion must obtain the waiver from all other relevant persons, of all restrictions on transfer (including pre-emption rights) that might exist for the Sale Shares, whether under the Constitution of the Company or otherwise.

 

1


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
2   Conditions to Completion
Conditions
2.1   Completion is conditional upon:
  2.1.1   the approval of shareholders of the Purchaser in general meeting being obtained under ASX Listing Rule 7.1 for the issue of up to 33,000,000 shares in the Purchaser to the Vendors and the Minority Shareholders on the terms set out in this Agreement;
  2.1.2   each Warranty being true, accurate and not misleading as at Completion and at all times between the date of this Agreement and Completion;
  2.1.3   the Vendors performing all of their obligations contained in this Agreement;
  2.1.4   no disclosure being made, or arising from the Purchaser’s due diligence, and no other event occurring which materially adversely affects the value of the Sale Shares;
  2.1.5   the Vendors providing to the Purchaser a legal opinion from a US law firm approved by the Purchaser confirming that the Vendors have authority to enter into this Agreement, that all signatories of the Vendor have been duly authorised, and that the Company is in good standing;
  2.1.6   the Vendors and the Purchaser agreeing on the amount of the 2006 EBITDA;
  2.1.7   the Vendors providing to the Purchaser evidence satisfactory to the Purchaser (acting reasonably) that any obligation or loan of the Company will not be subject to acceleration as a result of the sale of the Sale Shares to the Purchaser or the replacement of the guarantees pursuant to clause 4.6;
  2.1.8   no disclosure being made, or arising from the Vendors’ due diligence which materially adversely affects the value of the ordinary shares in the Purchaser;
  2.1.9   the Purchaser providing to the Vendors a legal opinion from Phillips Fox confirming that the Purchaser has authority to enter into this Agreement, that all signatories of the Purchaser have been duly authorised, and that the Company is duly incorporated;
  2.1.10   each Purchaser warranty set out in clause 6.8 being true, accurate and not misleading as at Completion and at all times between the date of this Agreement and Completion; and
  2.1.11   the Purchaser performing all of its obligations contained in this Agreement.
Waiver of certain Conditions
2.2   The Conditions set out in clauses 2.1.2, 2.1.3, 2.1.4, 2.1.5 ,2.1.6 and 2.1.7 are imposed for the benefit of the Purchaser and the Purchaser may in its absolute discretion waive all or any of those Conditions by notice to the Vendors on or before Completion.
2.3   The Conditions set out in clauses 2.1.8, 2.1.9, 2.1.10 and 2.1.11 are imposed for the benefit of the Vendors and the Vendors may in their absolute discretion waive all or any of those Conditions by notice to the Purchaser on or before Completion.

 

2


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
Termination for failure of Conditions
2.4   If any of the Conditions are not satisfied or waived upon or prior to 31 December 2006, then:
  2.4.1   where the Condition is that contained in clause 2.1.1 or 2.1.6, either the Purchasers or the Vendors may terminate this Agreement by notice to the other party;
  2.4.2   where the Condition is that contained in clause 2.1.2, 2.1.3, 2.1.4, 2.1.5, 2.1.6 or 2.1.7 the Purchaser may terminate this Agreement by notice to the Vendors; and
  2.4.3   where the Condition is that contained in clause 2.1.8, 2.1.9, 2.1.10 or 2.1.11 the Vendors may terminate this Agreement by notice to the Purchaser.
3   Pre-Completion
Business to be conducted in ordinary course
3.1   Until Completion the Vendors will and will cause the Company to:
  3.1.1   conduct the Business in the ordinary course and in the same manner as it was conducted prior to the date of this Agreement;
  3.1.2   manage the working capital requirements and any Liabilities of the Company in the ordinary course of business;
  3.1.3   not, without prior written consent of the Purchaser:
  (a)   institute material changes in management policy;
  (b)   enter into any contract or commitment which would impose a significant financial obligation or which will have a material adverse effect on the Company;
  (c)   acquire, dispose of, or create a Third Party Interest over any of the Assets other than acquisitions or disposals in the ordinary course of business;
  (d)   distribute or return any capital or pay any dividend to its members;
  (e)   issue any shares, options or securities which are convertible into shares in the Company;
  (f)   alter the Company’s constitution or constituent documents;

 

3


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  (g)   employ any person where that employment would materially increase the operating costs of the Company;
  (h)   except in the ordinary course of business, terminate, change the terms of employment, or pay or provide any bonus, to any employee;
  (i)   except as otherwise provided in this Agreement amend a material term of or terminate any material Contracts; or
  (j)   do or fail to do anything as a result of which any of the Warranties are breached in any material respect or are untrue, inaccurate or misleading in any material respect.
Employees
3.2   The Vendors must:
  3.2.1   use their reasonable endeavours to ensure that the employees of the Company as at the date of this Agreement remain and continue as employees of the Company up to and after Completion; and
  3.2.2   take all reasonable steps to ensure that the Company is not subject to or threatened by any material interruption or impairment caused by any dispute with its employees up to Completion.
Access by Purchaser and its representatives
3.3   Until Completion the Vendors must:
  3.3.1   ensure the Company permits the Purchaser and/or its authorised representatives upon reasonable notice to Paukovits to have unrestricted access during normal business hours to the Properties and the Assets, including the Books and Records, provided, however, that the Purchaser shall not have access to documentation if such access would jeopardise the attorney-client privilege;
  3.3.2   answer any written enquiries or requisitions issued by the Purchaser;
  3.3.3   allow the Purchaser and/or its authorised representatives to consult the auditor, officers and employees of the Company.
Purchaser to provide information
3.4   Prior to Completion the Purchaser will regularly update Paukovits regarding the operations of the Purchaser.

 

4


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
4   Completion
Time and place of Completion
4.1   Completion must take place at the Purchaser’s Sydney offices on the Completion Date, or at such other place as the parties may agree in writing.
Obligations of Purchaser on Completion
4.2   On Completion the Purchaser must:
  4.2.1   Appoint Paukovits as a director of the Purchaser upon receipt of his consent to act as a director and provide the same indemnity and insurance benefits for Paukovits as provided to the existing directors of the Company;
  4.2.2   Immediately prior to the transfer of the Sale Shares pursuant to clause 4.3, provide a loan of US$1,055,000 to the Company on arms length commercial terms for working capital purposes, including for the Company to honour its existing obligations to make payments to its existing shareholders and senior employees.
  4.2.3   Issue to the Vendors and the Minority Shareholders in the proportions set out in Schedule 1 the number of ordinary shares in the Purchaser calculated as follows (having an issue price of US$0.1818 per share):
  (a)   11,000,000 shares in the event that the 2006 EBITDA agreed between the parties pursuant to clause 2.1.6 is greater than or equal to US$500,000; or
  (b)   in the event that the 2006 EBITDA agreed between the parties pursuant to clause 2.1.6 is less than $500,000 the Purchaser will issue that number of shares less than 11,000,000 as reduced pro rata by the percentage by which the 2006 EBITDA is less than US$500,000. For example, if the 2006 EBITDA is US$400,000 then the Purchaser will issue 8,800,000 shares (being 80% of 11,000,000). Any shortfall below 11,000,000 shares may be potentially subject to top-up under clauses 5.10.3 and 5.11.3.
In the event that a Bid Event occurs prior to Completion, then the Purchaser will issue to the Vendors and the Minority Shareholders in the proportions set out in            11,000,000 shares in the Purchaser (having an issue price of US$0.1818 per share) and the provisions of sub-clauses (a) or (b) will no longer apply.

 

5


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
Obligations of Vendors on Completion
4.3   At Completion the Vendors must:
  4.3.1   deliver to the Purchaser:
  (a)   transfers of the Sale Shares duly executed by the registered holders in favour of the Purchaser, together with the share certificates for the Sale Shares;
  (b)   all waivers or consents which the Purchaser may require to enable the Purchaser to be registered as holder of the Sale Shares;
  (c)   all of the following for the Company:
  (i)   all available copies of the constitution of the Company or other constituent documents;
  (ii)   the common seal and duplicate seals;
  (iii)   the Books and Records;
  (iv)   the certificates of incorporation or registration (as applicable);
  (v)   certificates of registration of the Business Names;
  (vi)   all certificates of title for the Freehold Properties and other Assets;
  (vii)   executed and stamped originals of the Contracts;
  (viii)   certificates of registration and other documents of title for the Intellectual Property Rights; and
  (ix)   all other Assets in the possession or control of the Vendors;
  (d)   the executed resignations of each of the directors of the Company and the secretary or secretaries of the Company (other than Paukovits, who will continue as President of the Company after Completion), effective from the close of the meeting referred to in clause 4.3.2; and
  (e)   the original executed documents required to satisfy the Conditions;
  4.3.2   cause to be held a meeting of the directors of the Company passing resolutions for:
  (a)   the approval of the registration of the transfers of the Sale Shares;
  (b)   the cancellation of the existing share certificates for the Sale Shares;
  (c)   the issue of new certificates for the Sale Shares in favour of the Purchaser;

 

6


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  (d)   the appointment of such individuals as nominated by the Purchaser as directors and secretary of the Company and who have consented in writing to act as directors and secretary respectively;
  (e)   the acceptance of the resignations of directors and secretaries received under clause 4.3.1(d); and
  (f)   the appointment of new signatories to the Company’s bank accounts and the revocation of existing authorities to operate those bank accounts, as notified by the Purchaser;
  4.3.3   deliver to the Purchaser certified copies of any powers of attorney under which any document referred to in this clause 4.3 is executed or evidence satisfactory to the Purchaser of the authority of any person signing on another’s behalf; and
  4.3.4   do all other things which are required by this Agreement to be done by the Vendors at Completion, or which are reasonably required by the Purchaser to give to the Purchaser the full possession and benefit of the Sale Shares.
Non compliance
4.4   If the Vendors have not complied with any of the provisions of clause 4.3 on the Completion Date, the Purchaser may at its option:
  4.4.1   defer Completion for up to 28 days after the Completion Date (in which case the provisions of this clause 4.4 will apply to the deferred Completion);
  4.4.2   proceed to Completion so far as is practical without affecting or waiving its rights under this Agreement; or
  4.4.3   terminate this Agreement by notice to the Vendors.
Release of Vendor guarantees
4.5   As soon as practicable after Completion, the Purchaser will procure the release of the personal guarantees provided by the Vendors in relation to the USDA Loans upon receipt of evidence satisfactory to the Purchaser (acting reasonably) that the Company’s obligation to repay any loan amounts under the USDA Loans will not be subject to acceleration as a result of the sale of the Sale Shares to the Purchaser or the replacement of the guarantees pursuant to this clause 4.5.
4.6   The Purchaser will indemnify the Vendors in respect of any liability under the personal guarantees described in clause 4.5 with effect from Completion.

 

7


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
5   Post Completion payments
EBITDA Statements
5.1   Within 20 Business Days after each of 30 September 2007 and 30 September 2008, the Purchaser must prepare a statement of the 2007 EBITDA and 2008 EBITDA respectively (each an EBITDA Statement) calculated in accordance with the EBITDA Accounting Principles and provide a copy to the Vendors.
Dispute
5.2   If the Vendors dispute the correctness of any EBITDA Statement, they may:
  5.2.1   within 5 Business Days of receiving the EBITDA Statement request a copy of and access to the Purchaser’s working papers and books and records in relation to the relevant EBITDA Statement, which the Purchaser must provide to the Vendors within a further 2 Business Days; and
  5.2.2   within 20 Business Days of receiving the EBITDA Statement issue a Dispute Notice to the Purchaser setting out in reasonable detail the basis of the dispute.
5.3   The parties must negotiate in good faith to resolve any dispute within 10 Business Days after the issue of a Dispute Notice.
5.4   If the dispute is not resolved under clause 5.3, the parties must appoint an Expert.
5.5   The Expert must be an independent firm of US-based chartered accountants selected by agreement between the parties or, failing agreement within 14 Business Days of any party issuing a Dispute Notice, as nominated by the President for the time being of the Institute of Chartered Accountants of Australia. The matters in dispute then must be promptly referred by the parties to the Expert for determination.
5.6   The Expert must be directed by the parties to settle any matter in dispute within 10 Business Days of its appointment by:
  5.6.1   applying the EBITDA Accounting Principles;
  5.6.2   having regard to any written submissions made to the Expert by the parties or their representatives within 5 Business Days of the appointment of the Expert;
  5.6.3   making such enquiries or inspections as the Expert considers in its absolute discretion to be necessary; and
  5.6.4   determining the form and content of the EBITDA Statements and providing notice of its determination to all parties.
5.7   The determination of the Expert as to the matters in dispute and the form and content of the EBITDA Statements will (in the absence of manifest error) be final and binding on the parties.

 

8


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
5.8   In making its determination the Expert will act as an expert and not as an arbitrator.
5.9   The costs of the Expert shall be borne by the parties in accordance with the Expert’s determination.
Post-completion Share Issues
5.10   Within 5 Business Days of finalisation of the 2007 EBITDA pursuant to clauses 5.1 to 5.9, the Purchaser will issue to the Vendors and the Minority Shareholders in the proportions set out in            the number of ordinary shares in the Purchaser calculated as follows (having an issue price of US $0.1818 per share):
  5.10.1   11,000,000 shares in the event that
  (a)   The 2007 EBITDA is greater than or equal to US$1,250,000; and
  (b)   The full 11,000,000 shares were issued by the Purchaser pursuant to clause 4.2.3; or
  5.10.2   In the event that the 2007 EBITDA is less than US$1,250,000, the Purchaser will issue that number of shares less than 11,000,000 as reduced pro rata by the percentage by which the 2007 EBITDA is less than US$1,250,000. For example, if the 2007 EBITDA is US$750,000 then the Purchaser will issue 6,600,000 shares (being 60% of 11,000,000); or
  5.10.3   In the event that the 2007 EBITDA is greater than US$1,250,000 and less than 11,000,000 shares were issued by the Purchaser pursuant to clause 4.2.3, then the Purchaser will issue that number of shares more than 11,000,000 as increased pro rata by the percentage by which the 2007 EBITDA is greater than US$1,250,000, provided always that the aggregate number of shares issued under this clause 5.10 and clause 4.2.3 must not exceed 22,000,000. For example, if the 2007 EDITDA is US$1,500,000 and a total of 9,600,000 shares were issued by the Purchaser under clause 4.2.3, then the Purchaser will issue 12,400,000 shares pursuant to this clause 5.10.
5.11   Within 5 Business Days of finalisation of the 2008 EBITDA pursuant to clauses 5.1 to 5.9 the Purchaser will issue to Stock Ownership Plan (being a Minority Shareholder) the number of ordinary shares in the Purchaser calculated as follows (having an issue price of US $0.1818 per share):
  5.11.1   1,769,900 shares in the event that:
  (a)   The 2008 EBITDA is greater than or equal to US$1,250,000; and
  (b)   The full 22,000,000 shares were issued in aggregate pursuant to clauses 5.10 and 4.2.3; or

 

9


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  5.11.2   In the event that the 2008 EBITDA is less than US$1,250,000, the Purchaser will issue that number of shares less than 1,769,900 as reduced pro rata by the percentage by which the 2008 EBITDA is less than US$1,250,000. For example, if the 2008 EDITDA is US$1,125,000 then the Purchaser will issue 1,592,910 shares (being 90% of 1,769,900); or
  5.11.3   In the event that the 2008 EBITDA is greater than US$1,250,000 and less than 22,000,000 shares were issued in aggregate pursuant to clauses 5.10 and 4.2.3, then the Purchaser will issue that number of shares more than 1,769,900 as increased pro rata by the percentage by which the 2008 EBITDA is greater than US$1,250,000, provided always that the aggregate number of shares issued to Stock Ownership Plan under this clause 5.11 and clauses 5.10 and 4.2.3 must not exceed 5,309,700.
Options
5.11A.1   The Purchaser agrees that by no later than 30 September 2007 it will issue the following unlisted options over unissued ordinary shares in the Purchaser to the Vendors as follows:
  5.11A.1.1   3,000,000 unlisted options;
 
  5.11A.1.2   2,000,000 unlisted options;
 
  5.11A.1.3   2,000,000 unlisted options,
(Options).
5.11A.2   The terms of the Options issued pursuant to clause 5.11A.1 will be as follows:
  5.11A.2.1   the exercise price of each Option will be A$0.25;
  5.11A.2.2   each Option will entitle the holder to be issued one fully paid ordinary share in the Purchaser if the relevant performance hurdles are met and they are exercised within the relevant exercise period;
  5.11A.2.3   subject to clause 5.11A.2.5, the following Options will vest, in number and to the respective parties per Schedule 14, on satisfaction of the following performance hurdles and will be exercisable in the period set out in this clause:
  (a)   if a binding prefilled industrialisation/development agreement is entered into between Sanofi Aventis and Unilife on or before 31 March 2009 the 3,000,000 Options will vest on the date of execution of that agreement and may then be exercised at any time from that date up to 5.00pm (Sydney time) on 30 September 2011. The industrialisation/development agreement will be a formal legally binding agreement for the next phase, of the development of the prefilled syringe, after the existing has been fulfilled.

 

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Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  (b)   if the 2008 EBITDA is greater than US$1,250,000 as determined in accordance with clauses 5.1 to 5.9 or if the Company receives revenue in excess of US$15 million from an individual contract, or signs a contract which would generate a guaranteed revenue in excess of US$15 million per annum in the first 12 months from the date of signing, during the period from 1 October 2007 to 30 September 2008 (excluding revenue derived from any contract between the Company and the Purchaser or the Company 2,000,000 Options will vest on the date on the earlier of attaining the 2008 EBITDA or the Company receiving revenue in excess of US$15 million (as defined in this paragraph) and may then be exercised at any time from that date up to 5.00pm (Sydney time) on 30 September 2011:
  (c)   if the market capitalisation of the Purchaser exceeds US$160 million at any time between 1 October 2007 and 30 March 2009 2,000,000 Options will vest on that date and may then be exercised at any time from that date up to 5.00pm (Sydney time) on the 30 September 2011.
  5.11A.2.4   any Options not exercised by the end of any period in which they must be exercised as set out in clause 5.11A.2.3 and clause 5.11A.2.5 will immediately lapse at the expiration of such period;
  5.11A.2.5   notwithstanding clause 5.11A.2.3, if a Bid Event occurs an optionholder may elect to require any unexercised Options referred to in clause 5.11A.1 that have not lapsed to vest and such Options will become immediately exercisable at any time from the date of the Bid Event up to 5.00pm (Sydney time) on 30 September 2011. Any Options that are not vested pursuant to this clause will continue to be subject to vesting under clause 5.11A.2.3;
  5.11A.2.6   the Options may only be exercised in minimum parcels of 50,000 Options;
  5.11A.2.7   the Options are not transferable unless agreed to by the Purchaser;
  5.11A.2.8   there are no participating rights or entitlements inherent in the Options and optionholders will not be entitled to participate in new issues of capital offered to the existing shareholders of the Purchaser during the currency of the Options. However, the Purchaser will send a notice to each optionholder at least 9 Business Days before the relevant record date. This will give optionholders the opportunity to exercise their vested Options prior to the date for determining entitlements to participate in any such issue;
  5.11A.2.9   the Options do not confer on the holder any right to participate in dividends until shares are allotted pursuant to the exercise of the Options;

 

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Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  5.11A.2.10   in the event of a reorganisation of the issued capital of the Purchaser on or prior to the expiry of the Options, the Options will be reorganised in accordance with the ASX Listing Rules (if applicable) and the rights of an optionholder will be changed to the extent necessary to comply with the applicable ASX Listing Rules in force at the time of the reorganisation. In any case, the Options will be reorganised in a manner which will not result in any benefits being conferred on the optionholder which are not conferred on shareholders of the Purchaser;
  5.11A.2.11   the number of shares to be issued pursuant to the exercise of Options will be adjusted, inaccordance with the ASX Listing Rules, for bonus issues made prior to exercise of the Options (if any) so that upon exercise of the Options the number of shares received by the optionholder will include the number of bonus shares that would have been issued to them if the Options had been exercised prior to the record date for the bonus issues. The exercise price of the Options will not change as a result of any such bonus issues;
  5.11A.2.12   if the Company makes (whether before or during the exercise period) a pro rata issue of shares (except a bonus issue) to existing holders of shares (other than an issue in lieu of or in satisfaction of dividends or by way of dividend reinvestment) and no share has been issued in respect of an Option before the record date for determining entitlements to the issue, the exercise price of the Option will be reduced in accordance with the ASX Listing Rules.
  5.11A.2.13   in applying any provisions of these terms to adjust a number of shares the subject of an Option or the exercise price for shares, account shall be taken of each prior event requiring adjustment under these terms so that the effect of successive applications of the provisions of these terms is cumulative.
  5.11A.2.14   in order to exercise a vested Option the optionholder must provide a notice of exercise (in a form approved by the Purchaser), any option certificate issued to the optionholder in respect of the Option being exercised and payment of the exercise price in cleared funds to the Purchaser prior to the Option lapsing. A notice of exercise provided to the Purchaser in accordance with this clause is only effective (and becomes effective) when the Purchaser has received the exercise price in cleared funds;
  5.11A.2.15   the Company will make application to the Australian Securities Exchange for Official Quotation of the shares allotted and issued upon the exercise of an Option within 10 Business Days after allotment and issue of those shares; and

 

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  5.11A.2.16   all shares issued upon exercise of any Options will rank pari passu in all respects with the Purchaser’s then existing ordinary shares.
5.11B   The Purchaser agrees to pay to the Vendors 10% of the gross profit (being revenue less the costs of goods sold) made by IBS in respect of the HME program during the period 1 October 2007 to 30 September 2009 in respect of units supplied by IBS during that period. This payment will be apportioned and paid to each party as outlined in Schedule 14. The aggregate amount payable under this clause must be paid within five Business Days of the later of shipment of the units to, or receipt of the funds from, HME. The gross profit for the purposes of this clause shall be determined by the Purchaser’s auditor and such determination will (in the absence of manifest error) be final and binding on the parties. Any payments under this clause are for the acquisition of all of the shares of IBS and reflects the status as shareholders, without regard to services rendered.
Bid Event
5.12   Notwithstanding clauses 5.10 and 5.11 above, in the event that a Bid Event occurs at any time after the date of this Agreement and prior to the due date for an issue of shares by the Purchaser pursuant to:
  (a)   clause 5.10, then the Purchaser will within 5 Business Days of the Bid Event occurring (or at Completion in the event that the Bid Event occurs prior to Completion) issue to the Vendors and the Minority Shareholders, in the proportions set out in Schedule 1, a total of 11,000,000 shares in the Purchaser (having an issue price of US $0.1818 per share) in respect of the issue date described in clause 5.10 which has not yet occurred, and the provisions of clause 5.10 will no longer apply; and
  (b)   clause 5.11, then the Purchaser will within 5 Business Days of the Bid Event occurring issue to Stock Ownership Plan (being a Minority Shareholder) 1,769,900 shares in the Purchaser (having an issue price of A$0.25 per share) in respect of the issue date described in clause 5.11 which has not yet occurred, and the provisions of clause 5.11 will no longer apply.
Call option for the Vendors
5.13   In the event that the Purchaser suffers an Insolvency Event prior to the Vendors becoming entitled to receive shares in the Purchaser under clauses 5.10 or 5.12, the Vendors may by joint notice in writing to the Purchaser within 30 days of the Insolvency Event occurring require the Purchaser to transfer all of the issued shares in the Company to the Vendors, in the proportions set out in column 6 of Schedule 1.

 

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5.14   Upon receipt of a valid notice from the Vendors under clause 5.13, the Purchaser must, transfer all of the issued shares in the Company to the Vendors, in the proportions set out in column 6 of Schedule 1 upon receipt from the Vendors, within 14 days of the notice described in clause 5.13, of:
  5.14.1   an amount in cleared funds equal to US$950,000 less any amounts in excess of US$950,000 distributed by the Company to the Purchaser following Completion and prior to issue of the notice under clause 5.13. The minimum amount for the purpose of this clause will be US$1; and
  5.14.2   Duly executed transfers for a consideration of A$1 in favour of the Purchaser’s nominee(s) of all shares in the Purchaser previously issued to the Vendors as at that date pursuant to this Agreement and still owned by the Vendors as at that date.
Conduct of Business post-Completion
5.15   Following Completion and up until the earlier of 30 September 2008 and the date that shares are issued by the Purchaser pursuant to clause 5.12, the Purchaser will not, without Paukovits’ prior consent, implement a material change in the manner in which the Business is operated as at the date of this Agreement where such change is likely to have a material adverse effect on the 2008 EBITDA. However, the parties agree that immediately following 30 September 2007 the engineering and automation department of the Company will become a direct cost centre of the Purchaser and under the Purchaser’s direct control.
5.16   During the period after Completion and prior to the Vendors becoming entitled to receive shares in the Purchaser under clauses 5.10 or 5.12, the Purchaser will not, without Paukovits’ prior consent, require the Company to dispose of any assets or create any liabilities which would result in a material decrease in the net asset position of the Company.
5.17   The parties will negotiate in good faith to amend the EBITDA target in clause 5.10 to reflect the underlying EBITDA calculation methodology set out in Schedule 13 in the event that:
  5.17.1   The Purchaser terminates after Completion any contracts in existence as at the date of this Agreement for the Company to provide manufacturing services to the Purchaser; or
  5.17.2   B Braun provides written notice to the Company terminating its existing contract with the Company on the grounds that the sale of the Sale Shares to the Purchaser represents a breach of that contract.
Employment agreements for key Vendors
5.18   Prior to Completion, the Purchaser will negotiate in good faith with each of Paukovits, Keith Bocchicchio and Daniel Adlon and will finalise employment agreements with those Vendors on terms commensurate with those of similar executives of the Purchaser and subject to the Purchaser’s corporate governance obligations.

 

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6   Warranties and indemnity
Warranties
6.1   The Vendors jointly and severally represent, warrant and covenant to and with the Purchaser that each statement contained in Schedule 10 (each a Warranty) is now and will be true, accurate and not misleading until Completion, (except that where any statement is expressed to be made only at a particular date it is given only at that date).
6.2   Each Warranty is separate and independent and unless expressly provided is not limited by reference to any other Warranty or provision of this Agreement.
6.3   Where any statement in the Warranties is qualified by the expression ‘so far as the Vendors are aware’ or ‘to the best of the Vendors’ knowledge and belief’ or any similar expression referring to the Vendors’ awareness or knowledge, that statement will be deemed to mean only the actual knowledge of any of the Vendors.
Reliance
6.4   The Vendors acknowledge that the Purchaser has been induced to enter into this Agreement by the Warranties and has fully relied on the truth and accuracy of the Warranties.
Indemnity
6.5   The Vendors jointly and severally indemnify the Purchaser (for itself and as trustee for the Company) against all proceedings, actions, claims, demands, losses (including any decrease in the value of the Assets or the value of the Sale Shares, whether or not realised), Liabilities, damages, costs and expenses (Indemnified Matters) which may be made, brought against, suffered or incurred by the Purchaser and the Company, and which arise directly or indirectly out of or in connection with any Warranty being untrue, inaccurate or misleading, or any breach of this Agreement by the Vendors whether or not the Indemnified Matters are within the parties’ reasonable contemplation as at the date of this Agreement.
Prompt disclosure of breach
6.6   The Vendors must immediately disclose to the Purchaser anything which becomes known to them which:
  6.6.1   is a breach of, or is inconsistent with, any Warranty; or
  6.6.2   has or is likely to have, a material adverse effect on the financial position of the Company.
Warranty/indemnity payments
6.7   If any sum payable by the Vendors to the Purchaser under this clause is subject to Tax (whether by way of deduction or withholding or direct assessment of the recipient), that sum must be increased by the amount necessary to ensure that after deduction, withholding or payment of Tax, the Purchaser will receive an amount equal to the sum otherwise required to be paid.

 

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Purchaser Warranties
6.8   The Purchaser represents, warrants and covenants to and with the Vendors that each of the following statements is now and will be true, accurate and not misleading until Completion, (except that where any statement is expressed to be made only at a particular date it is given only at that date):
  6.8.1   the Purchaser has full power and authority to enter into and perform this Agreement;
  6.8.2   the entry into and performance of this Agreement does not breach any obligation of the Company or its Constitution;
  6.8.3   the Purchaser has complied with its disclosure obligations under the ASX Listing Rules;
  6.8.4   all shares issued by the Purchaser under this Agreement will be issued free from Third Party Interests and will rank pari passu with all existing issued shares in the Purchaser;
  6.8.5   the Purchaser has in place at the date of this Agreement the indemnity and insurance arrangements for directors as set out in Schedule 12;
  6.8.6   upon quotation on ASX immediately following Completion, the shares in the Purchaser issued to the Vendors pursuant to this Agreement will be tradeable on ASX by the Vendors, subject to the requirements of law and the Purchaser’s policy on directors and senior executives dealing in securities.
  6.8.7   To the best of the Purchaser’s knowledge and belief, all representations and warranties about the Purchaser set out in this Agreement or in any certificate delivered by the Purchaser in connection with this Agreement are true and accurate and do not state or omit any material fact that make such representations and warranties misleading.
Limitations
6.9   The liability of the Vendors under the Warranties is limited as follows:
  6.9.1   The maximum aggregate amount for which the Vendors are liable in respect of all claims under the Warranties is the value of all shares which have been issued up to the date of the claim pursuant to clauses 4.2.3, 5.10 and 5.11 and using the US$0.1818 purchase price per share in the Purchaser to calculate such value;

 

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  6.9.2   Each Vendor’s maximum liability for any Warranty claim is limited to the proportion of the claim as set out against that Vendor’s name in column 5 of Schedule 1;
  6.9.3   The Vendors are not liable for any Warranty claim to the extent that the subject matter of the relevant claim is fairly disclosed in Schedule 11; and
  6.9.4   Notwithstanding anything in this Agreement to the contrary, the Vendors shall not have any liability for a claim under the Warranties (excluding the Warranties in clause 5.3 of Schedule 10) unless such claim is notified to the Vendors in writing on or prior to the later of the second anniversary of Completion and the date 3 months after shares in the Purchaser are issued to Stock Ownership Plan (being a Minority Shareholder) pursuant to clause 5.11.
7   Non compete
General obligations
7.1   Subject to clauses 10.2 and 10.4, each of the Vendors must not, and must ensure that the Vendor Associates do not, directly or indirectly, whether solely or jointly with any other person, and whether as principal, agent, director, executive officer, employee, shareholder, partner, joint venturer, adviser, consultant or otherwise:
  7.1.1   for a period of two years after Completion, within any country in which the Company has carried on business, carry on or be engaged or involved in any trade, business or undertaking which is in competition with the Company;
  7.1.2   for a period of two years after Completion canvass, solicit, or entice away from the Company the custom of any person who as at Completion or at any time during the period of 12 months prior to Completion was a client, customer, identified prospective customer, representative or agent or correspondent of the Company or was in the habit of dealing with the Company;
  7.1.3   for a period of two years after Completion, employ, solicit or entice away from the Company any person who as at Completion or at any time during the period of 6 months prior to Completion was an officer, manager, consultant or employee of the Company whether or not that person would commit a breach of contract by reason of leaving the Company;
  7.1.4   use or disclose, any Confidential Information (not being information which is or becomes available to the public other than by reason of a breach of this clause);
  7.1.5   use or register a name or trade mark which includes all or part of any Business Name, Trade Mark or the name of the Company or any confusingly similar word or words in such a way as to be capable of or likely to be confused with any Business Name, Trade Mark or name of the Company; or

 

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  7.1.6   attempt, counsel, procure or otherwise assist any person to do any of the acts referred to in this clause.
Restraints fair and reasonable
7.2   The Vendors acknowledge that:
  7.2.1   the covenants given in clause 7.1 are material to the Purchaser’s decision to enter into this Agreement; and
  7.2.2   the restraints contained in clause 7.1 are:
  (a)   fair and reasonable regarding the subject matter, area and duration; and
  (b)   reasonably required by the Purchaser to protect the business, financial and proprietary interests of the Company.
Severability
7.3   Each of the obligations set out in clause 7.1 is severable and independent so that if clause 7.1 or any part or provision of it is unenforceable then that clause or that part will be deemed eliminated or modified to the minimum extent necessary to make this Agreement or that clause or part enforceable.
8   Confidentiality and announcements
Provisions to remain confidential
8.1   Subject to clauses 8.2 and 8.3 each party must not, without the prior written consent of the other parties, disclose the content or effect of this Agreement.
Permitted disclosures
8.2   A party may make disclosures:
  8.2.1   to those of its employees, officers, professional or financial advisers and bankers as the party reasonably thinks necessary to give effect to this Agreement but only on a strictly confidential basis; and
  8.2.2   if required by law or the requirements of any stock exchange, after the form and terms of that disclosure have been notified to the other party and the other party has had a reasonable opportunity to comment on the form and terms.
Announcements
8.3   Any party may make announcements or statements at any time in the form and on the terms previously agreed by the parties in writing, which agreement must not be unreasonably withheld.

 

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Return of information in the event of termination
8.4   If this Agreement is terminated prior to Completion the Purchaser must return to the Vendors:
  8.4.1   all Confidential Information in written or deliverable form; and
  8.4.2   any other information obtained by the Purchaser, its officers, employees and advisers from the Vendors, the Company and their respective officers, employees and advisers under clause 3.3.
9   Notices
Requirements
9.1   All notices must be:
  9.1.1   in legible writing and in English;
  9.1.2   addressed to the recipient at the address or facsimile number set out below or to such other address or facsimile number as that party may notify to the other parties:
         
 
  to the Vendors:    
 
  Address:   720 Pine Tree Road, Hummelstown, PA 17036, USA
 
  Attention:   Edward J. Paukovits, Jr.,
 
  Facsimile No.   +1 717 938 9364
 
       
 
  to the Purchaser:    
 
  Address:   Level 5, 35 Clarence Street
 
  Attention:   Chief Executive Officer
 
  Facsimile No.   +61 (2) 8346 6511
  9.1.3   signed by the party or where the sender is a company by an officer of that company or under the common seal of that company; and
  9.1.4   sent to the recipient by hand, prepaid post (airmail if to or from a place outside Australia) or facsimile.
Receipt
9.2   Without limiting any other means by which a party may be able to prove that a notice has been received by another party, a notice will be deemed to be duly received:
  9.2.1   if sent by hand when left at the address of the recipient;
  9.2.2   if sent by internationally recognised express courier, 3 days after the date of posting; or

 

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  (PHILLIPS FOX LOGO)
  9.2.3   if sent by facsimile, upon receipt by the sender of an acknowledgment or transmission report generated by the machine from which the facsimile was sent indicating that the whole facsimile was sent to the recipient’s facsimile number;
but if a notice is served by hand, or is received by the recipient’s facsimile on a day which is not a Business Day, or after 5.00 pm on a Business Day, recipient’s local time the notice is deemed to be duly received by the recipient at 9.00 am on the first Business Day after that day.
10   General Provisions
Costs
10.1   Each party must pay its own costs in respect of this Agreement and the documents contemplated by this Agreement except that the Purchaser must pay all stamp duty payable on this Agreement, the transfer of the Sale Shares and any other documents contemplated by this Agreement.
Termination
10.2   Subject to clause 10.4, the Vendors may terminate this Agreement in the event that:
  10.2.1   the call option is validly exercised in accordance with clause 5.14; or
  10.2.2   the Purchaser fails to remedy within 60 days of receipt of a valid claim from the Vendors that the Purchaser has materially breached its obligations under clauses 5.10, 5.11 or 5.12.
Non merger
10.3   The warranties, other representations and covenants by the parties in this Agreement are continuing and will not merge or be extinguished on Completion.
Effect of termination
10.4   If this Agreement is terminated under clause 2.4, 4.4 or 10.2:
  10.4.1   the parties are released from the obligation to continue to perform this Agreement (including the obligations set out in clause 7) except those obligations contained in clause 8 and any other obligations which by their nature survive termination; and
  10.4.2   each party retains the rights it has against any other party for any past breach of the Agreement.

 

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Indemnities
10.5   The indemnities contained in this Agreement are:
  10.5.1   continuing, separate and independent obligations of the parties from their other obligations, and survive the termination of this Agreement; and
  10.5.2   absolute and unconditional and unaffected by anything which otherwise might have the effect of prejudicing, releasing, discharging or affecting the liability of the party giving the indemnity.
Invalid or unenforceable provisions
10.6   If a provision of this Agreement is invalid or unenforceable in a jurisdiction:
  10.6.1   it is to be read down or severed in that jurisdiction to the extent of the invalidity or unenforceability; and
  10.6.2   it does not affect the validity or enforceability of:
  (a)   that provision in another jurisdiction; or
  (b)   the remaining provisions.
Waiver and exercise of rights
10.7   A waiver by a party of a provision or of a right under this Agreement is binding on the party granting the waiver only if it is given in writing and is signed by the party or an officer of the party granting the waiver.
10.8   A waiver is effective only in the specific instance and for the specific purpose for which it is given.
10.9   A single or partial exercise of a right by a party does not preclude another or further exercise if that right or the exercise of another right.
10.10   Failure by a party to exercise or delay in exercising a right does not prevent its exercise or operate as a waiver.
Amendment
10.11   This Agreement may be amended only by a document signed by all parties.
Counterparts
10.12   This Agreement may be signed in counterparts and all counterparts taken together constitute one document.
Further assurances
10.13   Each party must, at its own expense, whenever requested by another party, promptly do or arrange for others to do everything reasonably necessary to give full effect to this Agreement and the transactions contemplated by this Agreement.

 

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Assignment
10.14   A party must not transfer, assign, create an interest in or deal in any other way with any of its rights under this Agreement without the prior written consent of the other parties.
Entire agreement
10.15   This Agreement is the entire agreement of the parties about the subject matter of this Agreement and supersedes any representations, negotiations, arrangements, understandings or agreements and all other communications.
Rights cumulative
10.16   The rights, remedies and powers of the parties under this Agreement are cumulative and not exclusive of any rights, remedies or powers provided to the parties by law.
Consents and Approvals
10.17   A party may give its approval or consent conditionally or unconditionally or withhold its approval or consent in its absolute discretion unless this Agreement expressly provides otherwise.
Jurisdiction
10.18   Each party irrevocably and unconditionally:
  10.18.1   submits to the non-exclusive jurisdiction of the courts of New South Wales, Australia; and
  10.18.2   waives any claim or objection based on absence of jurisdiction or inconvenient forum.
Service of process
10.19   Each party agrees that a document required to be served in proceedings about this Agreement may be served:
  10.19.1   if originating process or a subpoena to be served on a company or registered body by being sent by post to or left at its registered office, and in all other cases at its address for service of notices under clause 9; or
  10.19.2   in any other way permitted by law.
Governing Law
10.20   This Agreement is governed by the laws of New South Wales, Australia.

 

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11   Definitions and interpretations
Definitions
11.1   In this Agreement unless the context requires another meaning:
2006 EDITDA means the earnings before interest, taxes, depreciation and amortisation of the Company for the 9 month period ending on 30 September 2006.
2007 EDITDA means the earnings before interest, taxes, depreciation and amortisation of the Company for the 12 month period ending on 30 September 2007.
2008 EDITDA means the earnings before interest, taxes, depreciation and amortisation of the Company for the 12 month period ending on 30 September 2008.
A$ means the lawful currency of Australia.
Accounting Standards means Generally Accepted Accounting Principles in the United States of America.
Accounts means the audited annual accounts of the Company as at the Accounts Date, a copy of which are annexed at Schedule 2.
Accounts Date means 30 June 2006.
Assets means the assets owned or used by the Company in conducting the Business including the assets listed in Schedule 3.
Authorisation means:
  (a)   any authorisation, approval, licence, permit, consent, qualification, accreditation, filing, registration, certificate, resolution, direction, declaration, or exemption; and
  (b)   for anything which a Government Agency may prohibit or restrict within a specified period after it is notified, the expiry of that period without intervention or action by that Government Agency.
Balance Sheet means the balance sheet of the Company as at 30 September 2006 as prepared by the Vendors.
Bid Event means the board of directors of the Purchaser resolves to approve an offer from a third party to acquire substantially all of the issued shares in the Purchaser.

 

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Books and Records means originals and copies in machine readable or printed form of all registers, books, reports, correspondence, files, records, accounts, documents and other material in the possession or control of the Company or the Vendors about or used in connection with the Company including all:
  (a)   operational and financial records;
  (b)   employment records;
  (c)   documents of title for the Assets;
  (d)   all registers and constituent documents of the Company and all minute books of meetings of directors and members.
Business means the business carried on by the Company of contract manufacturing of medical devices in the USA as at the date of this Agreement.
Business Day means a day that is not a Saturday, Sunday or a public holiday or bank holiday in Sydney, Australia, or Lewisberry, USA.
Business Names means all business names and trade names (other than Trade Marks) registered in the name of the Company or under which the Company carries on business.
Code means the US Internal Revenue Code of 1986.
Company means Integrated BioSciences Inc. of 637 Lowther Road, Lewisberry, Pennsylvania 17339, USA.
Completion means completion of the sale and purchase of the Sale Shares under this Agreement.
Completion Date means the third Business Day after which the Conditions have been satisfied or waived, or any other date as the parties agree in writing.
Conditions means the conditions described in clause 2.
Confidential Information means all:
  (a)   know-how, trade secrets, ideas, concepts, technical and operational information, owned or used by the Company;
  (b)   information concerning the affairs or property of the Company or any business, property or transaction in which the Company may be or may have been concerned or interested;
  (c)   details of any customers or suppliers of the Company;
  (d)   information about the terms or effect of this Agreement; and
  (e)   information which by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to:
  (i)   the Company; or

 

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  (ii)   any third party with whose consent or approval the Company uses that information.
Contracts means all contracts or agreements to which the Company is a party or by which the Company may be bound, including all such contracts or agreements referred to in Schedule 4.
Control means any situation where a person or persons (each a Controlling Person) has, or is entitled to acquire, the right or power to secure whether directly or indirectly, that the affairs of another person (Controlled Person) are conducted in accordance with the wishes of the Controlling Person.
Dispute Notice means a written notice under clause 5.2 of any dispute about an EBITDA Statement.
Dollars, $ and US$ means the lawful currency of the United States of America.
EBITDA Accounting Principles means the Accounting Standards incorporating appropriate allowances to reflect forecast production charges from the Company to the Purchaser.
EBITDA Statement has the meaning set out in clause 5.1.
Environmental Laws means any law about the environment, planning, building or local government including any law about:
  (a)   land use or occupation of land or buildings;
  (b)   occupational health and safety;
  (c)   heritage preservation, protection or conservation of natural or cultural resources;
  (d)   pollution or contamination of air, water or soil;
  (e)   waste disposal, treatment or storage;
  (f)   chemical, toxic, hazardous, poisonous or dangerous substances;
  (g)   pesticides;
  (h)   noise or odour; or
  (i)   a Pollutant.
Expert means an independent firm of chartered accountants selected or nominated under clause 5.4.

 

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Freehold Properties means the properties detailed in Schedule 5 and all improvements on those properties.
Government Agency means:
  (a)   a government, whether foreign, federal, state, territorial or local;
  (b)   a department, office or minister of a government acting in that capacity; or
  (c)   a commission, delegate, instrumentality, agency, board or other governmental, semi-governmental, judicial, administrative, monetary or fiscal authority, whether statutory or not.
Gross Profit for the purposes of clause 5.11B means Revenue (less discounts and rebates) less Cost of Goods Sold (includes direct labour, direct materials and indirect manufacturing overheads).
Insolvency Event means the Purchaser having a liquidator, receiver or administrator appointed over substantially all of its business.
Intellectual Property Rights means all rights of the Company in and to:
  (a)   the Business Names;
  (b)   the Trade Marks; and
  (c)   all designs, patents, copyright, processes, methods, inventions, product formulations, plant variety rights, eligible layout rights owned or used by the Company.
Leasehold Properties means the properties detailed in Schedule 5 and all improvements on those properties.
Liabilities means all liabilities, whether actual or contingent, present or future, quantified or unquantified.
Minority Shareholders means the persons listed in Part 2 of Schedule 1.
Options has the meaning ascribed to that term in clause 5.11A.1.
Paukovits means Ed Paukovits of 720 Pine Tree Road, Hummelstown, PA 17036, USA .
Plant and Equipment means all fixed and loose plant, equipment, machinery, furniture, fixtures and fittings, computer hardware, vehicles, and all other tangible assets used in the Business by the Company.

 

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Pollutant means any solid, liquid, gas, odour, radiation, heat, sound, vibration, chemical, chemical waste or other substance:
  (a)   declared by a Government Agency to be hazardous, a contaminant, a risk to health or safety of any person, animal or plant, or to otherwise cause, or to be likely to cause, the environment to be degraded; or
  (b)   including asbestos, polychlorinated biphenyls and radioactive substances.
Properties means the Leasehold Properties and the Freehold Properties.
Property Leases means the leases and licences for the Leasehold Properties.
Purchase Price means the purchase price payable by the Purchaser for the Sale Shares by means of the issue of ordinary shares and Options in the Purchaser pursuant to clauses 4.2.3, 5.10, 5.11 and 5.11A.1 plus any amounts payable under clause 5.11B.
Related Body Corporate means that where a body corporate is:
  (a)   a holding company of another body corporate; or
  (b)   a subsidiary of another body corporate; or
  (c)   a subsidiary of a holding company of another body corporate;
the first-mentioned body and the other body are Related Bodies Corporate.
Relative, in relation to any person, means any of the following, namely:
(a) the parent, grandparent, brother, sister, uncle, aunt, nephew, niece, lineal descendant or adopted child of that person or of his or her spouse; and
(b) the spouse of that person or of any other person specified in paragraph (a).
Sale Shares means the shares in the Company to be acquired by the Purchaser, details of which are set out in Schedule 1, together with all rights attaching to those shares as at Completion.
Security Interest means an interest in an asset which provides security for, or protects against default by, a person for the payment or satisfaction of a debt, obligation or liability including a mortgage, charge, bill of sale, pledge, deposit, lien, encumbrance, hypothecation, or arrangement for the retention of title.
Stock means all raw materials, supplies, packaging and containers, work-in-progress, finished products, parts and components and other inventory of the Business including items of stock in transit or on consignment to customers.

 

27


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
Tax means a tax, levy, charge, impost, deduction, withholding or duty of any nature (including stamp and transaction duty and sales tax, value added or similar tax) at any time:
  (a)   imposed or levied by any Government Agency; or
  (b)   required to be remitted to, or collected, withheld or assessed by, any Government Agency; and
  (c)   any related interest, expense, fine, penalty or other charge on those amounts.
Third Party Interest means any Security Interest, lease, license, option, voting arrangement, easement, covenant, notation, restriction, interest under any agreement, interest under any trust, or other right, equity, entitlement or other interest of any nature held by a third party.
Trade Marks means the trade marks, service marks, brand names, or rights about the get up or trade dress of any product, packaging or outlet, logos, slogans and similar rights owned, used or licensed for use by the Company in connection with the goods and/or services made available by the Company whether or not registered.
USDA Loans means the USDA/Commerce Debts taken out by the Company in December 2005 and September 2006 in the amounts of US$1,200,000 and US$2,100,000 respectively.
Vendor Associate means:
  (a)   any Related Body Corporate of any of the Vendors;
  (b)   any director, secretary or chief executive officer of the Company or of any of the Vendors;
  (c)   any Relative of any of the Vendors or any person described in sub-clause (b); or
  (d)   any corporation or other entity over which any of the Vendors or any one or more of the persons described in sub-clauses (a), (b) or (c) have Control.
Warranties means the representations, warranties and covenants made by the Vendors under clause 6 and Warranty means any one of them.
Interpretation
11.2   In this Agreement, unless the context otherwise requires:
  11.2.1   a reference:
  (a)   to the singular includes the plural and vice versa;

 

28


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  (b)   to a gender includes all genders;
  (c)   to a document (including this Agreement) is a reference to that document (including any Schedules and Schedules) as amended, consolidated, supplemented, novated or replaced;
  (d)   to an agreement includes any deed, agreement or legally enforceable arrangement or understanding whether written or not;
  (e)   to parties means the parties to this Agreement and to a party means a party to this Agreement;
  (f)   to a notice means all notices, approvals, demands, requests, nominations or other communications given by one party to another under or in connection with this Agreement;
  (g)   to a person (including a party) includes:
  (i)   an individual, company, other body corporate, association, partnership, firm, joint venture, trust or Government Agency;
  (ii)   the person’s successors, permitted assigns, substitutes, executors and administrators,
  (h)   to a law:
  (i)   includes a reference to any constitutional provision, subordinate legislation, treaty, decree, convention, statute, regulation, rule, ordinance, proclamation, by-law, judgment, rule of common law or equity or rule of any applicable stock exchange;
  (ii)   is a reference to that law as amended, consolidated, supplemented or replaced; and
  (iii)   is a reference to any regulation, rule, ordinance, proclamation, by-law or judgment made under that law,
  (i)   to proceedings includes litigation, arbitration, and investigation;
  (j)   to a judgement includes an order, injunction, decree, determination or award of any court or tribunal;
  (k)   to time is a reference to Sydney time;
  11.2.2   headings are for convenience only and are ignored in interpreting this Agreement;

 

29


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
  11.2.3   a warranty, representation, covenant or obligation given or entered into by more than one person binds them jointly and severally;
  11.2.4   if a period of time is specified and dates from, after or before, a given day or the day of an act or event, it is to be calculated exclusive of that day;
  11.2.5   if a payment or other act must (but for this clause) be made or done on a day which is not a Business Day, then it must be made or done on the next Business Day;
  11.2.6   the words including or includes mean including but not limited to or including without limitation;
  11.2.7   where a word or phrase is defined, its other grammatical forms have a corresponding meaning; and
  11.2.8   this Agreement must not be construed adversely to a party solely because that party was responsible for preparing it.

 

30


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
             
Execution and date
           
 
           
Executed as an agreement.
           
 
           
Date:
           
 
           
Executed by Unilife Medical
           
Solutions Limited by :
           
 
           
/s/ Alan Shortall
 
      /s/ Jeff Carter
 
   
Signature of director
      Signature of director/company secretary    
 
           
Alan Shortall
      Jeff Carter    
 
           
Name of director (print)
      Name of director/company secretary (print)    
 
           
Signed by Edward J. Paukovits, Jr. in the presence of:
           
 
           
/s/ Cheryl S. Domsch
      /s/ Edward J. Paukovits, Jr.    
 
           
Signature of witness
      Signature of Edward J. Paukovits, Jr.    
 
           
Cheryl S. Domsch
 
           
Name of witness (print)
           
 
           
Signed by Keith A. Bocchicchio in the presence of:
           
 
           
/s/ Cheryl S. Domsch
      /s/ Keith A. Boccicchio    
 
           
Signature of witness
      Signature of Keith A. Bocchicchio    
 
           
Cheryl S. Domsch
 
           
Name of witness (print)
           

 

31


 

     
Share Purchase Agreement
  (PHILLIPS FOX LOGO)
             
Signed by Daniel T. Adlon in the presence of:
           
 
           
/s/ Cheryl S. Domsch
      /s/ Daniel T. Adlon    
 
           
Signature of witness
      Signature of Daniel T. Adlon    
 
           
/s/ Cheryl S. Domsch
 
           
Name of witness (print)
           

 

32


 

List of Omitted Schedules/Exhibits to Agreement*
     
Schedule 1
  Part 1 — Vendor Details
 
  Part 2 — Minority Shareholder Details
Schedule 2
  Accounts
Schedule 3
  Assets
Schedule 4
  Material Contracts
Schedule 5
  Properties
Schedule 6
  Plant and Equipment
Schedule 7
  Intentionally Blank
Schedule 8
  Intellectual Property Rights
Schedule 9
  Employees
Schedule 10
  Warranties
Schedule 11
  Disclosures
Schedule 12
  Purchaser’s Existing D&O Arrangements
Schedule 13
  EBITDA Calculation Methodology
Schedule 14
  Allocation of Options
     
*   The registrant agrees to furnish supplementally a copy of any omitted schedule/exhibit to the Securities and Exchange Commission upon request.

 

33

EX-10.3 4 c93531exv10w3.htm EXHIBIT 10.3 Exhibit 10.3
Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
This Agreement is made on June 30, 2009 (“Execution Date”)
BETWEEN THE UNDERSIGNED:
UNILIFE MEDICAL SOLUTIONS LIMITED ABN 14 008 071 403, a corporation existing and organized under the laws of Australia, having its registered office at Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia, represented by Mr Alan Shortall, Director, (hereafter referred to as “UNILIFE”)
hereinafter collectively referred to as “UNILIFE”,
ON THE ONE PART,
AND:
SANOFI WINTHROP INDUSTRIE, a company existing and organized under the laws of France, having its registered office at 82, avenue Raspail, 94255 Gentilly, France, represented by Mr Philippe Luscan, Chairman and Chief Executive Officer, and Mr Gérard Touratier, Chief Financial Officer, (hereafter referred to as “SWIND”), acting on its behalf and on behalf of its Affiliates, and in particular AVENTIS PHARMA S.A.
hereinafter referred to as “SWIND”,
ON THE OTHER PART,
WITNESSETH:
WHEREAS, AVENTIS PHARMA SA, and UNILIFE have signed on respectively November 20th 2006 for AVENTIS PHARMA SA, and December 11, 2006, for UNILIFE a Memorandum of Understanding (“MOU”) in order to allow AVENTIS PHARMA SA to evaluate certain ready to fill prototype syringes based on/using UNILIFE’s safety syringe technology with a view to using the Ready to Fill Syringe Range utilizing this technology for its pharmaceutical specialties.
WHEREAS, The Parties have completed an early technical evaluation on UNILIFE Ready to Fill Syringes technology based on the prototypes provided by UNILIFE to SWIND; to define the following steps of their collaboration and allow SWIND an exclusive access to the UNILIFE Ready to Fill Syringe safety syringe technology, they have in addition signed an agreement on June 30, 2008 as amended (hereafter the “Exclusive Agreement”) and attached to the Agreement as Exhibit 1.

 

 


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
WHEREAS, Under such Exclusive Agreement, the first step of the collaboration between the Parties is to negotiate and settle the final provisions of an industrialisation agreement for the Product design, development and industrial scaling up of the Product, as such term is defined hereafter, by UNILIFE.
WHEREAS, UNILIFE is willing to industrialize the Product for SWIND and its Affiliates.
NOW THEREFORE, in consideration of the premises and the mutual covenants and agreements herein contained, the Parties have agreed as follows:
ARTICLE 1 — DEFINITIONS
The following terms as used in this Industrialisation Agreement shall have the meanings set forth in this Article 1:
1.1  
“Affiliates” shall mean any company which, directly or indirectly, controls or is controlled or is under common control with a Party hereto, by means of ownership of more than fifty percent (50%) of the voting stock or similar interest in said company.
 
1.2  
“Agreement” shall mean this Industrialisation Agreement, including its exhibits.
 
1.3  
“Associate’’ has the meaning given to it in sections 11-17 of the Australian Corporations Act 2001 (Cth).
 
1.4  
“Base Technology” of a Party shall mean any Intellectual Property Rights existing and owned by that Party and/or its Affiliates or agents on or before the Effective Date relating to the RTFS technology or the Product and, for UNILIFE, includes the Patents.
 
1.5  
“Business Day” shall mean any day which is not a Saturday, a Sunday or a public holiday, in France, in the United States and/or in Australia, as applicable to the performance of an obligation under this Agreement by a Party in a particular country.
 
1.6  
“Change of Control Event’’ shall mean:
  1.6.1  
a takeover bid being made to the holders of UNILIFE shares which becomes unconditional and will result in a single person or entity together with their Associates owning 50% or more of the shares of UNILIFE;
 
  1.6.2  
through the acquisition of shares in UNILIFE a single person or entity together with their Associates is able to determine the majority composition of the Board of UNILIFE (“Board”); or

 

- 2 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
  1.6.3  
any other event which the Board determines, in its absolute discretion, to be a change of control,
but, for the avoidance of doubt, a ‘Change of Control Event’ does not include, unless otherwise determined by the Board, either an internal restructure of the UNILIFE group or a transaction whereby the UNILIFE group is redomiciled by imposing a new parent company of the UNILIFE group (including where such transaction is effected by a scheme of arrangement under the Australian Corporations Act 2001 (Cth)). This exception to a “Change of Control Event” includes a scheme of arrangement pursuant to which:
  (a)  
a subsidiary of UNILIFE will become the new parent company of UNILIFE; or
 
  (b)  
the shareholders of UNILIFE on the record date of the scheme of arrangement will be entitled to be issued shares equal to at least 50% of the issued ordinary share capital of the new parent company of UNILIFE on the implementation date of the scheme of arrangement.
1.7 “Change of Control Proposal” shall mean:
  1.7.1  
any expression of interest, proposal or offer for a takeover bid, scheme of arrangement, merger or amalgamation which would result in a single person or entity together with their Associates owning 50% or more of the shares of UNILIFE;
 
  1.7.2  
any expression of interest, proposal or offer to acquire all or a substantial part of the assets or business of UNILIFE; or
 
  1.7.3  
any expression of interest or proposal for UNILIFE to issue 25% or more of its shares or other securities to a single person or entity or their Associates,
in each case which is recommended by the Board of UNILIFE but, for the avoidance of doubt, a ‘Change of Control Proposal’ does not, unless the Board determines otherwise, include any expression of interest, proposal or offer in relation to or to effect either an internal restructure of the UNILIFE group or a transaction whereby the UNILIFE group would redomicile by imposing a new parent company of the UNILIFE group (including where such transaction would be effected by a scheme of arrangement under the Australian Corporations Act 2001 (Cth)). This exception to a “Change of Control Proposal” includes any expression of interest, proposal or offer in relation to or to effect a scheme of arrangement pursuant to which:
  (a)  
a subsidiary of UNILIFE would become the new parent company of UNILIFE; or
  (b)  
the shareholders of UNILIFE on the record date of the scheme of arrangement would be entitled to be issued shares equal to at least 50% of the issued ordinary share capital of the new parent company of UNILIFE on the implementation date of the scheme of arrangement.

 

- 3 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
1.8  
“COGs” shall mean costs of goods and includes all material, packaging, inbound freight, storage, inspection and handling costs prior to production, all employees related expenses involved in the processing, qualification, testing and release of the Final Product, sterilization, equipment depreciation, occupancy costs, utilities, supervisory labor, maintenance, supplies and related support costs required to produce the Final Product.
 
1.9  
“Co-Invention” shall mean an Invention (other than Base Technology or Future Technology) which is conceived, reduced to practice or created by the Parties together during the term of this Agreement and which concerns the RTFS technology or the Product, even if any of the conception, reduction to practice or creation of such Invention was started before the Effective Date or continues after the term of this Agreement.
 
1.10  
“Competing Product” means any syringe product with an integrated retraction mechanism.
 
1.11  
“Confidential Information” means information (wherever and in whatever form it was obtained) proprietary or confidential to a Party including:
  1.11.1  
in relation to any of a Party’s (whenever it was obtained) or its Affiliates’ business, operations or strategies;
 
  1.11.2  
the terms of this Agreement;
 
  1.11.3  
information designated as confidential by a Party;
  1.11.4  
information acquired by the other Party solely by virtue of provisions of this Agreement;
 
  1.11.5  
the Products, Intellectual Property Rights or other property of a Party or its Affiliates; and
 
  1.11.6  
actual or prospective customers, clients or competitors of a Party or its Affiliates.

 

- 4 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
1.12  
“Development Program” shall mean the detailed description of the Industrialisation and corresponding requirements, including the Milestones as set out in Exhibit 2 to this Agreement.
 
1.13  
“Effective Date” shall mean retroactively July 1st, 2008.
 
1.14  
“Exclusive Agreement’’ has the meaning given to that term in the recitals.
 
1.15  
“Final Product” shall mean the Product produced once the Industrialisation program is completed.
 
1.16  
“Future Technology” of a Party shall mean all Inventions (i) based upon any Base Technology or other background or pre-existing technology or Intellectual Property Rights of that Party or (ii) relating to the RTFS technology or the Product which are conceived, reduced to practice or created by that Party and/or its Affiliates or agents from and after the Effective Date independently of the other Party. Future Technology may also comprise Inventions as referred to hereabove whose conception, reduction to practice or the creation of which has already started before the Effective Date and/or goes on after the term of this Agreement
 
1.17  
“Good Distribution Practices” or “GDP” means those practices and standards which are part of GMP and that require that medicinal products are consistently stored, transported and handled under suitable condition as required by the product specification and that are set forth in the European Union Guidelines on GDP of Medicinal Products for Human Use (94/C 63/03), and any subsequent or future revisions of such guidelines.
 
1.18  
“Good Manufacturing Practices” or “GMP” means those practices laid down in international guidelines and regulations such as the GMP rules of the World Health Organisation, the United States Code of Federal Regulations (Title 21, Parts 210-211, as well as Parts 808, 812 and 820), and the European Union Guide to Good Manufacturing Practice including Annexes in the Production of Pharmaceutical Products, and any subsequent or future revisions of such guidelines and regulations.
 
1.19  
“Harm” means any significant negative and unreasonable impact on SWIND’s obligations or benefits under this Agreement and/or its business (including where a competitor of SWIND (i) becomes a subcontractor in respect of UNILIFE’s obligations under this Agreement or (ii) together with its Associates, becomes an owner of 50% or more of the shares of UNILIFE) that SWIND can establish to UNILIFE’s reasonable satisfaction will arise as a direct result of the occurrence of the subcontracting or the Change of Control Event, as the case may be.

 

- 5 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
1.20  
“Industrialisation” shall mean the design development and industrialisation program to be performed by UNILIFE subject to and in accordance with the terms and conditions of this Agreement in order that UNILIFE finalizes the RTFS design to ensure that it meets all necessary requirements for medical devices, drug compatibility, filling processes and other requirements as may be deemed necessary and provides to SWIND production quality products for verification, validation and qualification purposes.
 
1.21  
“Intellectual Property Rights” shall mean patents and patent applications, know-how (including, in particular, unpatented technical and other information such as, but without prejudice to the generality of the foregoing, ideas, concepts, inventions, discoveries, data, formulae, specifications, procedures, protocols, processes, results of experimentation or tests), utility models, trademarks, design rights, copyrights and any other proprietary rights, whether or not registered.
 
1.22  
“Invention” shall mean any invention (whether patentable or not) which may be used with the RTFS technology or with, for or in relation to the Product or which arises from or in connection with the performance of any Party’s obligations under this Agreement.
 
1.23  
“Material Obligation” means any obligation of a party under this Agreement which, considering the general nature of this Agreement as a whole, is of such importance to a Party that it would not have entered into this Agreement unless substantial performance of that obligation was assured and such was apparent to the other Party at the time of entering into this Agreement. However, Material Obligation does not include obligations in relation to:
  (a)  
accounting matters; or
 
  (b)  
any minor, procedural or administrative matter the breach of which does not significantly reduce a Party’s benefits or significantly increase its obligations under this Agreement.
1.24  
“Milestone” shall mean each one of the milestones identified in the Development Program as set forth in Exhibit 2.
 
1.25  
“Party” shall mean UNILIFE or SWIND, as the case may be, and “Parties” shall mean UNILIFE and SWIND collectively.
 
1.26  
“Patents” shall mean all international and national patent applications relating to the RTFS technology and, including the following international PCT (and corresponding non-PCT) applications and any national patent or patent application derived therefrom or corresponding thereto being numbers WO2006/119570, WO2006/108243, WO2004/082747, WO2005/072801, and any Patent Rights arising out of or relating to such patents applications and relating to the RTFS.

 

- 6 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
1.27  
“Patent Rights” shall mean patent applications or patents, author certificates, inventor certificates, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them of UNILIFE and includes any divisions, renewals, continuations, continuations-in part, extensions, reissues, substitutions, confirmations, registrations, revalidation or additions of or to them, as well as any supplementary protection certificate in respect of them, relating to the RTFS.
 
1.28  
“Product” shall mean the RTFS existing on the Effective Date for use in/for the RTFS Market and any variation in sizes or functionality as has been developed by UNILIFE and/or SWIND for use in the RTFS Market prior to the present Agreement.
 
1.29  
“Product Know-How” shall mean unpatented technical and other information including, but without prejudice to the generality of the foregoing, ideas, concepts, inventions, discoveries, data, formulae, specifications procedures for experiments and tests and other protocols, processes, results of experimentation and testing and assay protocols, relating directly or indirectly to the Products and known to UNILIFE, of which UNILIFE is the proprietor.
 
1.30  
“RTFS” shall mean UNILIFE’s Ready to Fill Syringe safety syringe with integrated auto and controlled retraction intended to be supplied to pharmaceutical companies as a drug delivery device.
 
1.31  
“RTFS Market” shall mean the market for sterile syringe products for use for ready to fill or primary packaged drug delivery solutions.
 
1.32  
“UNILIFE Intellectual Property” shall mean the Patents, Patent Rights and Product Know-How already existing on the Effective Date.
In this Agreement:
unless the context otherwise requires, all references to a particular article or paragraph shall be a reference to that article or paragraph in or to this Agreement as the same may be amended from time to time pursuant to this Agreement;
headings are inserted for convenience only and shall be ignored in construing this Agreement;
unless the contrary intention appears, words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa;
unless the contrary intention appears, words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust, association, organisation or other entity, in each case whether or not having separate legal personality;

 

- 7 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
reference to the words “include” or “including” are to be construed without limitation to the generality of the preceding words; and
reference to any statute or regulation includes any modification or re-enactment of that statute or regulation.
ARTICLE 2 — SCOPE OF THIS AGREEMENT
2.1  
SWIND hereby entrusts UNILIFE with, which in turn accepts, the performance of the Industrialisation according to the terms and conditions set forth in this Agreement including the Development Program, which is attached hereto as Exhibit 2.
 
2.2  
The timetable and the Milestones for the Industrialisation of the Product are set forth in the Development Program. UNILIFE undertakes and warrants to carry out the Industrialisation in accordance with the timetable and to use its best efforts to achieve the Milestones at the dates set forth in Exhibit 2, unless a failure to do so is as a direct result of SWIND. In such cases, both Parties shall discuss in good faith the consequences of said delay and the way to resolve it. UNILIFE shall carry out its obligations under this Agreement with all due care and skill and in accordance with all relevant legislation and regulatory standards, including GMP and GDP, and quality standards such as ISO 13485.
 
2.3  
The parties agree that the attached Exhibit 2 is a tentative Development Program which the parties undertake to finalize within sixty (60) Business Days of the Execution Date. If the parties fail to finalize the Development Program within the sixty (60) Business Days, the attached Exhibit 2 will be the final Development Program.
ARTICLE 3 — COLLABORATION BETWEEN THE PARTIES
3.1  
UNILIFE and SWIND shall each designate an individual to be responsible for the performance of this Agreement (“Responsible Person”) and the individuals shall cooperate and consult with each other on a reasonable basis and frequency in relation to the Industrialisation under this Agreement. UNILIFE and SWIND shall appoint their respective Responsible Person plus two other representatives each to a steering committee, which representatives shall jointly be referred to as the “Steering Committee”. The Steering Committee shall meet regularly throughout the course of the Agreement and, in any event, no less frequently than every six months. At such meetings which, unless otherwise agreed, are to take place in an agreed form mutually convenient to all the members of the Steering Committee (whether it be meetings in person, over the telephone or otherwise), questions relating to the subject matter of this Agreement shall be discussed to review the general implementation of this Agreement and to solve any pending issues in relation thereto.

 

- 8 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
3.2  
The Responsible Persons of UNILIFE and SWIND will have exchanges of information on the Industrialisation on a reasonable basis, no less than [***]. In addition, UNILIFE will submit to SWIND updates on the progress of the Industrialisation from time to time as agreed between the Responsible Persons, but no less than [***], and will submit Milestone final reports as provided in Exhibit 2 hereto within [***].
3.3  
For the performance of the Industrialisation, UNILIFE will use its own premises.
 
3.4  
UNILIFE shall itself exclusively determine the members of the team performing the Industrialisation and undertakes to ensure that such members are appropriately qualified and have the appropriate knowledge required for the proper performance of the Industrialisation. UNILIFE will be fully liable for the supervision and monitoring of its agents and employees. UNILIFE’s team performing the Industrialisation shall remain under UNILIFE’s sole control and management. SWIND will ensure that SWIND’s Responsible Person and all its key technical personnel are reasonably available during the course of the Industrialisation.
 
3.5  
Each Party shall promptly notify the other in writing of any pending processes, methods, specifications or manufacturing changes (hereafter the “Modification”) of which it becomes aware or it is proposing during the Industrialisation. UNILIFE shall promptly provide SWIND with an estimate of the cost changes — affecting in particular development costs and/or supply prices — and the timing impacts arising from such Modification. UNILIFE and SWIND shall evaluate together in good faith the benefit of such Modification and agree together on the need to implement it or not. SWIND however retains the final right to decide within sixty (60) Business Days whether to pay said costs to incorporate the Modification, or to refuse said Modification. However, (i) neither Party shall be obliged to accept or implement any Modification where the cost of such Modification to that Party is greater than the benefit of such Modification to that Party, and (ii) neither Party shall withhold or delay acceptance of any Modification where the cost of such Modification is nil or borne by the other Party. SWIND shall not be responsible for the costs to incorporate a Modification resulting from any failure of UNILIFE, in particular failure to achieve the desired features and functions and/or, subject to this Article 3.5, to abide by the timetable as set forth in Exhibit 2. For the avoidance of doubt, UNILIFE shall bear the portion of costs of any Modification it would have decided to implement irrespective of the Industrialisation of the Products, in order to maintain other products manufactured on its site. The parties acknowledge that the Development Program and Milestones may be adjusted as a result of the time impacts of any accepted Modification on such Milestones and the Development Program.

 

- 9 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
3.6  
UNILIFE acknowledges that SWIND shall independently support the Product Industrialisation in parallel in accordance with medical device procedures (FDA, MDD), i.e. SWIND shall own its own design history file. To this purpose, UNILIFE shall provide SWIND with a copy of their design development relevant documentation that constitutes UNILIFE’s design history file. UNILIFE agrees that SWIND shall perform the Final Product design verification according to SWIND documentation (Product design specification and design verification plan).
3.7  
UNILIFE agrees to take into account additional technical requirements coming from SWIND arising in the areas of human factor engineering, customer feedback, regulatory, marketing or risk management during the development program up to the earlier of European and US regulatory approval. The Development Program and the Milestones will be adjusted to accommodate any delays caused by such process and the time impacts of any such additional technical requirements.
 
3.8  
UNILIFE acknowledges that SWIND shall, at SWIND’s sole expense, submit the Final Product for registration with health authorities worldwide and shall ensure that the Industrialisation abides by the standards in this regard, such as ISO 13485, GMP and all applicable laws and regulations. Furthermore, UNILIFE shall give SWIND access to all Industrialisation data and agree to give SWIND all reasonable assistance that may be necessary for this purpose.
 
3.9  
During the term of this Agreement UNILIFE will supply product (technical material) to SWIND from time to time as requested by SWIND for SWIND activities such as market research, user evaluations, design evaluation testing, industrial trials etc at [***]. The estimated total quantity for such activities sum up to a maximum of [***].
ARTICLE 4 — INVOICING — PAYMENTS
4.1  
The amounts set forth in Exhibit 2 for each Milestone will be invoiced by UNILIFE to SWIND upon [***]. For the avoidance of doubt, said amounts under the Agreement are exclusive of any applicable taxes. SWIND agrees to pay up to a maximum of seventeen (17) million Euros, exclusive of taxes, under this Agreement and the Development Program, but in no event will the total amount invoiced by UNILIFE to SWIND under the Agreement exceed seventeen (17) million Euros exclusive of taxes. Any additional cost in relation with the completion of the Industrialisation that would exceed said amount will therefore be exclusively borne by UNILIFE.

 

- 10 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
4.2  
UNILIFE will invoice and address the invoices in the name of SANOFI WINTHROP INDUSTRIE, Services Comptables, 20, avenue Raymond Aron, 92165 Antony Cedex, France. Any and all UNILIFE invoices shall be paid by SWIND by bank transfer in Euros within thirty (30) days from the invoice date.
 
4.3  
Except with UNILIFE’s prior consent, all sums payable hereunder which are not paid in accordance with Article 4.2 shall bear interest at the rate per annum equal to EURIBOR for six months deposits five (5) basis points from and including the day payment was due through and including the day payment is made.
 
4.4  
Withholding Tax. If SWIND is compelled by any law to make any tax deduction or withholding from any payment due to UNILIFE under this Agreement then SWIND must:
  4.4.1  
make that deduction or withholding;
 
  4.4.2  
pay the full amount of the tax deduction or withholding in compliance with the law;
 
  4.4.3  
promptly, and in any event within 30 days of the end of the month in which that tax deduction or withholding is made, provide UNILIFE with a copy of the receipt for each payment from the relevant governmental agency; and
 
  4.4.4  
Make the payment to UNILIFE net of withholding tax. However if UNILIFE is able to provide documentation showing that it could not use the tax credit granted by the tax treaty between Australia and France corresponding to withholding tax and that consequently this tax credit is lost or is not able to be effectively used by Unilife (ie actually offset against an actual tax liability of Unilife), then SWIND will make an additional payment within a month of receiving such documentation by such amount that, after deduction of the withholding tax referred to above, Unilife receives all of the amount set out under the relevant section of this Agreement applied on both the original payment and the additional payment. Provided that, if UNILIFE can provide such documentation prior to the relevant payment, SWIND will increase its payment as necessary to ensure that UNILIFE receives the full amount which UNILIFE would have received if no tax deduction or withholding had been made.

 

- 11 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
4.5  
The Parties agree that, notwithstanding clause 8.4 or any other provision of this Agreement, the Exclusive Agreement or any determination as to the nature of this Agreement or the Exclusive Agreement by any authority, the payments made under the Exclusive Agreement and against UNILIFE’s invoices dated 30 September 2008, 31 December 2008 and 31 March 2009 (“Prior Payments”) were and the payments to be made under this Agreement are wholly for services rendered or to secure the exclusivity of the supply of the Product, as the case may be. The Parties agree that no part of such payments were or are to be in any way related to the licensing of the UNILIFE Intellectual Property, other than to identify the Product the subject of the Industrialisation and to allow the use of the relevant technology in the Industrialisation in order and to enable the Parties to fulfil their obligations under this Agreement.
4.6  
UNILIFE agrees to reimburse SWIND for any penalty tax imposed on SWIND prior to the execution of this Agreement by the French tax authority for failing to pay withholding tax on the Prior Payments.
ARTICLE 5 — SUPPLY
5.1  
Subject to the full completion of the Industrialisation of the Product, the Parties will negotiate a supply agreement for the manufacture and purchase of the Final Product on a commercial scale (“Supply Agreement”).
 
5.2  
The Supply Agreement will, in addition to all usual matters for such agreements, cover the following matters:
  5.2.1  
reflect the relevant terms of the Exclusive Agreement;
 
  5.2.2  
provide for SWIND and its Affiliates to exclusively purchase, subject only to UNILIFE being able to meet demand, all ready-to-fill glass syringe products with an integrated retraction mechanism for the RTFS Market from UNILIFE for the entire period UNILIFE is required to provide the Final Product exclusively to SWIND or its Affiliates;
 
  5.2.3  
provide for the pricing of units of the Final Product in accordance with Article 5.4;
 
  5.3.4  
provide for the placing of orders for the Final Product by SWIND and its Affiliates (including the process for placing orders, making payments and any times by which any specified orders must be placed); and
 
  5.2.5  
subject to the prior written agreement of UNILIFE and under conditions to be discussed and agreed upon in good faith between the Parties, provide that SWIND may be able to appoint additional or alternative suppliers of the Final Product.

 

- 12 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
5.3  
Although the price of the Final Product, which will apply to all commercial orders placed by SWIND from the first commercial order placed, still needs to be negotiated and finalized and set out in the Supply Agreement, the Parties agree nevertheless that such price of the Final Product (excluding any Product supplied by UNILIFE to SWIND as contemplated under Article 3.9) will exceed [***] US$ per piece. Furthermore, the Parties agree that the following calculation method shall be applied to the definition of the price: the calculation of the price shall be based on a cost plus basis with a [***] margin, where the costs shall be defined as the COGs and where the margin will not be lower than [***] US$ per piece. By way of illustration and not definition or limitation, for a COG of 0.10 US$, the price would be [***] US$, for a COG of 0.20 US$, the price would be [***] US$ (thus including the minimum [***] US$ margin), for a COG of 0.30 US$, the price would be [***] US$ (thus including a [***] US$ margin), and for a COG of 0.50 US$, the price would be [***] US$ (thus reaching the cap defined hereabove).
 
5.4  
Furthermore, the Parties agree that the suppliers for the pre-assembly components may be chosen, without limitation, from those listed in Exhibit 3.
 
5.5  
Upon completion of the Industrialisation, UNILIFE shall on receipt of an order from SWIND for Final Products for:
  (i)  
delivery over a 12 month period commencing, at the latest, 12 months after the date the order is received (“Delivery Date”); and
 
  (ii)  
in total, with all other orders placed by SWIND for delivery during the 12 month period following the Delivery Date (“Relevant Period”), up to 30 % of UNILIFE’s expected installed capacity for manufacture of the Final Product for the Relevant Period (“Relevant Capacity”)
ensure that it is able to deliver such order(s) in accordance with the agreed terms during the Relevant Period, commencing no later than the Delivery Date.
5.6  
Any order(s) placed by SWIND for the Relevant Period which in total, together with all other SWIND’s orders to be delivered during the Relevant Period, exceed 30 % of the Relevant Capacity will require a maximum of 24 months before the commencement of delivery.
 
5.7  
For the avoidance of doubt, subject only to agreeing the terms of the supply, any order placed by SWIND pursuant to and in accordance with Article 5.6 that is within (in total with all other SWIND orders to be delivered during the Relevant Period) 30% of UNILIFE’s actual installed capacity for the Relevant Period must be supplied by UNILIFE.

 

- 13 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 6 — TERM AND TERMINATION
6.1  
This Agreement shall become effective as of the Effective Date and, unless otherwise terminated as provided herein, shall remain in full force and effect until completion of Industrialisation as described in Article 2 and more particularly set out in Exhibit 2, following which it shall expire automatically.
 
6.2  
Each Party shall have the right at any time during the period of this Agreement by giving written notice to the other party to terminate this Agreement forthwith in any of the following events:
  6.2.1  
if the other Party enters into either administration, receivership or liquidation whether compulsory or voluntary otherwise than for the purposes of amalgamation or reconstruction or entering into a composition with its creditors or has a receiver appointed over all or the material part of its assets, provided and to the extent that such termination is permitted pursuant to the applicable legislation in the country of domicile of the relevant Party;
 
  6.2.2  
if a Party commits a breach of any Material Obligation which breach has not been cured within thirty (30) business days following receipt of notice in writing from the other Party detailing such breach (provided the breach is not the subject of a dispute being dealt with pursuant to Article 15.2.2) or if a Party is persistently in default of its other obligations having been repeatedly notified by the other Party of its breaches under this Agreement and such, when taken together, amount to a Material Obligation.
6.3  
Should the Industrialisation be terminated during any Milestone then, in addition to any other rights UNILIFE may have under this Agreement or at law, SWIND shall make a pro rata payment to UNILIFE of the total sums due under Article 4.1 in respect of each uncompleted Milestone(s) where UNILIFE has commenced work or committed itself such that it has incurred its own irrecoverable liability. The pro rata payment shall be fairly determined taking into consideration the amount of work or resources committed including an assessment of the number of man hours worked or set aside for the Industrialisation and any stranded costs of UNILIFE.
 
6.4  
If for technical or scientific reasons associated to the Industrialisation described in Exhibit 2 UNILIFE concludes that it cannot technically or scientifically or in any other way perform the Industrialisation and is desirous to terminate this Agreement, the Parties shall meet and discuss the difficulties and scientific and technical hurdles in an attempt to resolve such problems and negotiate in good faith the terms and conditions of the modifications to be made to the Industrialisation when possible or, as the case may be, terminate the Industrialisation and this Agreement. In such a case of termination, SWIND shall pay UNILIFE in full for all the completed Milestones of the Industrialisation performed up to the date of termination and a pro rata payment in respect of any uncompleted Milestone in accordance with Article 6.3.

 

- 14 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
6.5  
In the event that this Agreement is terminated by SWIND pursuant to Article 6.2.1, 6.2.2 or 7.2 or by either Party pursuant to Article 6.4 then, save for each Parties’ ongoing obligations pursuant to those Articles identified as surviving termination or expiry of this Agreement, neither Party shall incur any future liability towards the other party other than the payment by SWIND to UNILIFE in respect of Industrialisation performed up to and including the day of such termination including for all completed Milestones and in accordance with Article 6.3. UNILIFE will, on receipt of full payment of all sums due to UNILIFE under this Agreement, transfer all work noted as deliverable to SWIND for all completed Milestones covered by such payments. Such payment shall not occur in case of any gross negligence or wilful misconduct of UNILIFE in performance of its obligations.
 
6.6  
In the event UNILIFE can and does mitigate its loss under the termination of this Agreement, any savings made by UNILIFE shall be passed to SWIND in the form of a refund save that no refund shall exceed the total sums received by UNILIFE from SWIND under this Article.
 
6.7  
Termination of this Agreement for whatever reason shall not affect the accrued rights of either UNILIFE or SWIND arising under or out of this Agreement and all provisions which are expressed to survive this Agreement and the provisions of Articles 8, 9, 11 and 15 (Confidentiality, Intellectual Property, Liability — Indemnities, Applicable law and Jurisdiction) shall survive termination or expiry and remain in full force and effect. Article 5 shall survive expiry (but not termination) of this Agreement until execution of a Supply Agreement, if any.
 
6.8  
Subject to Articles 6.7 and 6.9 of this Agreement, termination of this Agreement for whatever reason (except for termination by SWIND pursuant to Article 6.2.1 and the expiry of this Agreement) will automatically terminate the Exclusive Agreement.
 
6.9  
If this Agreement is terminated by either party pursuant to Article 6.4 or by SWIND pursuant to Article 6.2.2 the Parties will, at SWIND’s request, negotiate in good faith how and on what terms any of SWIND’s rights under the Exclusive Agreement may continue after the termination of this Agreement.
ARTICLE 7 — CHANGE OF CONTROL
7.1  
If UNILIFE agrees or proposes to agree the terms of a Change of Control Proposal with a third party:
  7.1.1  
it must give SWIND written notice, within two Business Days of the terms of the Change of Control Proposal being agreed or proposed to be agreed, of the terms of the Change of Control Proposal (but, for the avoidance of doubt, not the identity of the third party);
 
  7.1.2  
within five Business Days of receiving notice of the Change of Control Proposal in accordance with Article 7.1.1, SWIND shall be entitled to make an offer or a counter proposal to UNILIFE on at least equivalent terms to the Change of Control Proposal (“Matching Offer”);

 

- 15 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
  7.1.3  
if a Matching Offer is made under Article 7.1.2, in the absence of a further Change of Control Proposal being made on improved terms, UNILIFE must accept the Matching Offer and not pursue the Change of Control Proposal with the third party; and
 
  7.1.4  
if the third party submits a revised Change of Control Proposal on improved terms (“Increased Offer”) to UNILIFE prior to UNILIFE’s acceptance of the Matching Offer, UNILIFE must serve a further written notice on SWIND in accordance with Article 7.1.1 detailing the terms of the Increased Offer and SWIND will have a further opportunity in accordance with Article 7.1.2 to make a further Matching Offer to reflect the Increased Offer and the terms of Article 7.1.3 shall apply with respect to the new Matching Offer.
7.2  
If a Change of Control Event occurs at any time during the term of this Agreement which does not involve SWIND or any Associate of SWIND obtaining control of UNILIFE under the Change of Control Event and:
  7.2.1  
which is not recommended by the Board of UNILIFE; or;
 
  7.2.2  
which will cause Harm to SWIND; or
 
  7.2.3  
under which the current CEO and director of UNILIFE (Mr Alan Shortall) is not to continue in his current role as the CEO and as a director of UNILIFE for at least two years after the Change of Control Event,
 
     
then:
 
  7.2.4  
UNILIFE must notify SWIND in writing within 5 Business Days of the occurrence of the Change of Control Event; and
 
  7.2.5  
SWIND shall have the right, exercisable within ten Business Days of receipt of a notice from UNILIFE under Article 7.2.1 or SWIND otherwise becoming aware of the Change of Control Event, to terminate this Agreement with immediate effect by notice in writing to UNILIFE.

 

- 16 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 8 — INTELLECTUAL PROPERTY
8.1  
Each Party shall be and remain the exclusive owner of its (i) Base Technology and (ii) Future Technology and each Party shall have the exclusive right to maintain and prosecute these rights. Each Party shall be solely responsible for the conduct and costs of filing, prosecution and maintenance of patents and patent applications for its own Intellectual Property Rights including, without limitation, for its Base Technology and Future Technology.
 
8.2  
Subject to Articles 8.3 and 8.5, SWIND shall be the sole owner of any Co-Invention. UNILIFE is to assign to SWIND all its rights to any Co-Invention. SWIND shall be solely responsible for the conduct of filing, prosecution and maintenance of any Intellectual Property Rights arising from such Co-Invention, as is reasonably appropriate. UNILIFE is to support SWIND with respect to the filing, prosecution and maintenance of the Intellectual Property Rights arising from such Co-Inventions in good faith. The costs for filing, prosecution and maintenance of any Intellectual Property Rights arising from such Co-Inventions shall be solely borne by SWIND. If SWIND intends to give up any Intellectual Property Rights arising from such Co-Invention, SWIND must first offer such Intellectual Property Rights in writing to UNILIFE. If UNILIFE does not answer within 3 months in writing to SWIND that it intends to take over the Intellectual Property Rights offered by SWIND at its own expenses, SWIND is entitled to give up such rights immediately, as it deems appropriate. If UNILIFE does answer in writing within 3 months that it wishes to take over the relevant Intellectual Property Rights (or any part of them), SWIND will do all things necessary to transfer such rights to UNILIFE as quickly as possible and, thereafter, UNILIFE will be solely responsible for such rights.
 
8.2  
Use of Co-Inventions by SWIND. SWIND must not use any Co-Invention in relation to or for any glass Competing Product.
 
8.4  
Licence from UNILIFE. UNILIFE hereby grants to SWIND and its Affiliates, during the term of this Agreement and solely for the purpose of and in order for SWIND to perform its obligations under this Agreement, a royalty free, non-exclusive, worldwide licence for the term of this Agreement to use and/or practice all UNILIFE-owned Intellectual Property Rights, Base Technology, Future Technology and Inventions (including all information, documents and tangible and intangible materials which result from the performance of the services under this Agreement by UNILIFE) concerning the RTFS technology or the Product.
 
8.5  
Licence from SWIND. Subject to Article 10, SWIND hereby grants to UNILIFE and its Affiliates a perpetual royalty-free, non-exclusive, worldwide licence to use and/or practice all Co-Inventions. In addition SWIND hereby grants to UNILIFE and its Affiliates, during the term of this Agreement for the purpose of the Industrialisation hereunder and otherwise to perform its obligations hereunder, a royalty free, non-exclusive, worldwide licence and to use and/or practice all SWIND-owned Intellectual Property Rights, Base Technology, Future Technology and Inventions and all information, documents and tangible and intangible materials provided by SWIND.

 

- 17 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 9 -LIABILITY - INDEMNITIES
9.1  
UNILIFE warrants that to the best of its knowledge, the UNILIFE Intellectual Property is valid, and that the marketing, sale or disposal of any Product and/or Final Product falling within the scope of the UNILIFE Intellectual Property does not to the best of UNILIFE’s knowledge infringe any third party Intellectual Property Rights. UNILIFE shall promptly inform SWIND of any infringement, or improper or unlawful use of, or any change to the validity of the UNILIFE Intellectual Property.
 
9.2  
SWIND warrants that to the best of its knowledge SWIND’s Base Technology and those Inventions which are conceived, reduced to practice or created under this Agreement by SWIND and/or its Affiliates or agents from and after the Effective Date are valid and such will not infringe any third party’s Intellectual Property Rights. SWIND shall promptly inform UNILIFE of any infringement, or improper or unlawful use of, or any change to the validity of SWIND’s Base Technology and such Inventions.
 
9.3  
Each Party (“Indemnifying Party”) shall indemnify and hold harmless the other Party (“Indemnified Party”) and its officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any contractual, tortious or other claims or proceedings by third parties against Indemnified Party arising out of the Indemnifying Party’s breach of this Agreement, including breach of representations and warranties, violation of applicable law, negligence or wilful misconduct.
 
9.4  
Neither Party shall be liable to the other in contract tort, negligence, breach of statutory duty or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by the other of an indirect or consequential nature, including any economic loss or other loss of turnover, profits, business or goodwill.
 
9.5  
Each Party’s aggregate liability to the other party under this Agreement for any loss or damage suffered by the other party as a result of breach of or in connection with this Agreement, or in respect of any other liability in respect of the performance or non-performance of the obligations covered by this Agreement, shall be limited to fifty million (50,000,000) Euros.
 
9.6  
The terms of this Article 9 shall survive expiration or termination of this Agreement for whatever reason.

 

- 18 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 10 — EXCLUSIVITY
10.1  
Should the Industrialisation process be delayed for any reason and outlast the duration of the Exclusive Licence or the Default Licence (as these terms are defined in the Exclusive Agreement), whichever is applicable, the Parties agree that, provided that this Agreement has not been terminated and the Supply Agreement has been executed, the exclusivity under the Exclusive Agreement will be extended at least for the period needed to cover the full completion of the Industrialisation.
 
10.2  
In addition to the provisions relating to exclusivity in the Exclusive Agreement, during the term of the Exclusive Agreement (and any extension pursuant to Article 10.1) SWIND:
  10.2.1  
will not, alone or through any Affiliate or third party arrangement, develop, industrialise, commercialise, acquire, use or sell any glass Competing Product;
 
  10.2.2  
will not, alone or through any Affiliate or third party arrangement, develop, industrialise, commercialise, acquire, use or sell any plastic Competing Product which utilises or infringes any of the UNILIFE Intellectual Property or UNILIFE’s Future Technology; and
 
  10.2.3  
may, subject to Articles 10.2.1, 10.2.2 and 10.3 develop, industrialise, commercialise, acquire or use other technologies/products for the RTFS Market (“New Product”).
10.3  
In respect of any proposed New Product, SWIND must:
  10.3.1  
first establish whether the New Product is subject to any third party Intellectual Property Rights or to other proprietary rights which prohibit or restrict the manufacturing of the New Product (“Restrictive Proprietary Rights”);
 
  10.3.2  
if SWIND finds any Restrictive Proprietary Rights it must in good faith approach the relevant third party(ies) which owns or control such Restrictive Proprietary Rights and try to licence or obtain such other approval or consent for such Restrictive Proprietary Rights for use by SWIND and UNILIFE on behalf of SWIND;
 
  10.3.3  
if SWIND is able to licence the Restrictive Proprietary Rights in accordance with Article 10.3.2 then UNILIFE will be entitled to manufacture the New Product on competitive terms to be agreed by the parties in good faith; or
 
  10.3.4  
if SWIND is unable to licence the Restrictive Proprietary Rights in accordance with Article 10.3.2 then, on providing all necessary evidence to reasonably satisfy UNILIFE that SWIND tried in good faith but failed to obtain such licence, SWIND may proceed for the New Product with the third party(ies) that owns or controls the Restrictive Proprietary Rights.

 

- 19 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 11 — CONFIDENTIALITY
11.1  
Each Party acknowledges and agrees that while performing this Agreement it will be exposed to or be given Confidential Information of the other Party.
 
11.2  
Each Party undertakes to maintain the secrecy of the Confidential Information of the other Party and to avoid any disclosure and/or use for a purpose other than performing this Agreement and shall take no less care in respect of such Confidential Information than it takes or should take regarding its own Confidential Information.
 
11.3  
Each Party undertakes to make the Confidential Information of the other Party available only to its employees who have a direct need to have access to such information in order to perform this Agreement and to take all reasonable steps necessary to ensure that such employees do not disclose and/or use such Confidential Information of the other Party in a manner which is not authorized under this Agreement.
 
11.4  
The foregoing undertaking of confidentiality and non-use shall remain in full force and effect for a period of ten (10) years as of the Effective Date of this Agreement, even if this Agreement is declared null and void for any reason, unless the Confidential Information:
  11.4.1  
was known to the public or was generally available to the public at the time of disclosure of such Confidential Information;
 
  11.4.2  
becomes known to the public or is generally available to the public after the disclosure of such Confidential Information, through no fault of the receiving Party or of its employees;
 
  11.4.3  
is obtained lawfully from a third party without any restriction, provided that such Confidential Information has not been acquired directly or indirectly by the third party from the disclosing Party under an enforceable secrecy obligation;
 
  11.4.4  
can be established by a Party to have been in its possession before the time of disclosure and was not acquired, directly or indirectly, from the other Party; or
 
  11.4.5  
can be established by a Party to have been developed by it independently of Confidential Information received from the other Party.

 

- 20 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
11.5  
Should a Party require the assistance of third parties (subject to the other Party’s prior written approval) for the performance of the Agreement, these third parties will be subject to the same conditions of confidentiality as the considered Party and will use the Confidential Information only for the purpose of performing the Agreement.
 
   
In case of a breach of these obligations by said third parties, the Party which required their assistance shall remain responsible for them towards the other Party.
 
11.6  
The restrictions on use and non-disclosure of Confidential Information shall not apply where the recipient Party is compelled to disclose the Confidential Information by reason of law or order of a tribunal having competent jurisdiction over the Party. The disclosure is strictly limited to what is legally required.
 
11.7  
Upon expiry or prior termination of this Agreement, unless the Parties should decide otherwise, each Party shall return to the other Party any and all written or recorded Confidential Information of the other.
 
11.8  
Except as strictly required by law, no press release or other public statements in connection with work performed under this Agreement intended for use in the public media, having or containing any reference to SWIND or UNILIFE, shall be made by either Party without the prior written approval of the other Party, which shall not be unreasonably withheld or delayed.
ARTICLE 12 — ASSIGNMENT — SUBCONTRACT
UNILIFE may subcontract, in whole or in part, the Industrialisation provided that it (i) first discusses such with SWIND and, in making its decision, takes into account all reasonable concerns of SWIND and (ii) may not, without the prior written consent of SWIND, subcontract any part of the Industrialisation so as to cause Harm to SWIND. UNILIFE may not otherwise assign, extend or transfer any of its rights and obligations under this Agreement, without the express and prior written consent of SWIND. Except to an Affiliate, SWIND may not assign, extend or transfer any of its rights and obligations under this Agreement without the prior written consent of UNILIFE. Any assignment, extension or transfer without the required consent and approval shall be null and void. In case of subcontract, UNILIFE remains fully responsible for the proper performance of this Agreement. SWIND may assign this Agreement to an Affiliate upon reasonable written notice to UNILIFE.

 

- 21 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
ARTICLE 13 — QUALITY — AUDIT
13.1  
UNILIFE undertakes to run the Industrialisation in compliance in particular with ISO 13485, the Medical Devices Directive requirements (Council Directive 93/42/EEC of 14 June 1993, as amended 2007/47/EC) and FDA regulation (GMP, 21CFR Part 820, GDP). Furthermore, both Parties will agree on a regulatory plan which lists notably all relevant applicable standards, guidelines etc.
 
13.2  
SWIND or any third party appointed by SWIND (provided that said third party has executed a confidentiality agreement with UNILIFE with regard to any audit) will be allowed on no more than two (2) occasions in any one calendar year, during the term of this Agreement during normal office hours on giving reasonable notice to UNILIFE, to carry out a technical, design development or quality assurance audit in the premises where the Industrialisation is performed by UNILIFE.
 
13.3  
UNILIFE undertakes to cooperate with and help SWIND, or any third party appointed by SWIND, for such audit.
 
13.4  
Where any audit conducted reveals a breach of the Agreement by UNILIFE, UNILIFE will undertake all efforts to resolve any issues notified during such audit.
 
13.5  
UNILIFE shall immediately inform SWIND of any audit or notification by a regulatory authority that could have an impact in any manner on the Product and/or on this Agreement.
ARTICLE 14 — GENERAL PROVISIONS
14.1  
Entire agreement: The Exclusive Agreement, this Agreement and its attached Exhibits contain the entire agreement and understanding between the Parties with respect to the subject matter, merge all prior discussions and negotiations between them and shall not be altered, amended or construed by any previous or contemporaneous oral or written agreement.
 
   
Any amendment of or supplement to this Agreement (including changes to the Exhibits) shall only be by written instrument signed by both Parties. No modification, extension or variation of this Agreement (or any document entered into pursuant to or in connection with this Agreement) shall be valid unless it is in writing and signed by or on behalf of each of the parties to this Agreement. For the avoidance of doubt, no modification or variation of this Agreement shall be valid if made by e-mail.
 
   
Unless expressly so agreed, no modification or variation of this Agreement shall constitute or be construed as a general waiver of any provisions of this Agreement, nor shall it affect any rights, obligations or liabilities under this Agreement which have already accrued up to the date of such modification or waiver and the rights and obligations of the parties under this Agreement shall remain in full force and effect, except and only to the extent that they are so modified or varied.

 

- 22 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
14.2  
Waivers: A waiver of a breach or default under this Agreement shall not be a waiver of any other or subsequent breach or default. The failure or delay by either Party in enforcing compliance with any term or condition of this Agreement shall not constitute waiver of such term or condition, unless such term or condition is expressly waived in writing.
 
14.3  
Force Majeure: Except for the failure to pay any money due under this Agreement, neither Party shall be held in breach of this Agreement by any reason of acts or omissions caused by any Force Majeure event. A Force Majeure event shall mean an event which is the result of any cause beyond the reasonable control of the concerned Party.
 
   
The affected Party shall use due diligence to remove any such causes and to resume performance under this Agreement as soon as it is reasonably feasible. Either Party shall notify in writing the other Party of any Force Majeure event which prevents such Party from performing its obligations under this Agreement. In the event a Force Majeure situation continues for more than 30 (thirty) days after notice is served, and is adversely effecting the performance of this Agreement, each Party will have the right, on 15 (fifteen) days advance written notice not to expire before the 30 (thirty) day period to terminate this Agreement.
 
14.4  
Hardship: Should any unforeseen event while not preventing either party from performing any of its obligations hereunder, cause either party inequitable hardship for the performance of such obligations, and/or substantially affect the economic balance of the Agreement — including unforeseen events leading to a substantial increase of the COGs per unit of the Final Product — and the party can demonstrate this by competent proof, then both parties shall negotiate in good faith an equitable way to adapt this Agreement to the new circumstances.
 
14.5  
Each of UNILIFE and SWIND warrants and undertakes that it is able to enter into this Agreement and is not restricted by any provisions of any agreements of any nature which prevent it from carrying out this Agreement fully according to its terms.
 
14.6  
Separate Entities: Nothing in this Agreement shall constitute or be deemed to constitute a partnership between the Parties hereto or constitute or be deemed to constitute either Party as an agent of the other for any purpose whatsoever, and neither Party shall have the authority or power to bind the other Party, or to contract in the name of and create a liability against the other Party in any way or for any purpose, unless explicitly instructed in writing to do so.
 
14.7  
Notices: All notices, reports and other writings which are required to be given or submitted pursuant to this Agreement shall be in writing and delivered personally or sent by international courier service, or by confirmed facsimile transmission, to the addresses set forth below or to such other address as a Party may from time to time notify to the other Party. Any and all notices sent to the other Party in accordance with this Article shall become effective as of receipt thereof by the other Party.

 

- 23 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
SWIND:
To the attention of the Chief Executive Officer
Sanofi Winthrop Industrie
20, avenue Raymond Aron
92165 Antony Cedex
France
Telephone:+ 33 1 55 71 71 71
Facsimile: + 33 1 47 02 50 14
UNILIFE:
Alan Shortall
Unilife Medical Solutions Limited
633, Lowther Road
Lewisberry PA 17339
USA
Telephone: +1 717 938 9323
Facsimile: +1 717 938 9364
ARTICLE 15 — GOVERNING LAW — DISPUTES
15.1  
Governing Law: The Parties hereto agree that this Agreement, including without limitation, all transactions affected hereunder, its validity and enforceability and all relationships between the Parties in this connection shall be construed under and be governed in all respects by the laws of France.
 
15.2  
Dispute:
  15.2.1  
In the event of a dispute relating to any obligation of a Party that is not a Material Obligation, the dispute shall be resolved in accordance with the dispute resolution procedure set out in Exhibit 4.
 
  15.2.2  
In the event of a dispute relating to a Material Obligation of either Party or otherwise relating to any question regarding the existence, validity or termination of this Agreement (save for a disputes referred for resolution in accordance with Exhibit 4 pursuant to Article 15.2.1) (“Material Dispute”), the Material Dispute shall be referred to the Steering Committee. If the Steering Committee does not resolve the Material Dispute within a period of fourteen (14) days, the Material Dispute shall be referred to the CEO of SWIND and the CEO of UNILIFE.

 

- 24 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
     
If the CEOs fail to resolve the Material Dispute within 30 days of receipt of the written notice requesting the referral, the Parties hereby agree that such Material Dispute shall exclusively submitted to and be settled by the courts of Paris, France and courts of appeal there from and the Parties hereby submit to such exclusive jurisdiction.
15.3  
In the event this Agreement, and any related document, should be translated from English to another language, the English version shall prevail in all respects in the case of any discrepancy.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be duly executed on the dates indicated herein below.
Made in two (2) original copies
                     
Antony, on June 29, 2009       Sydney, on        
 
             
 
   
 
                   
SANOFI WINTHROP INDUSTRIE       UNILIFE    
 
                   
By:
  /s/ Philippe Luscan
 
      By:   /s/ Alan Shortall
 
   
 
  Name: Philippe LUSCAN           Name: Alan SHORTALL    
 
  Title: Chairman and CEO           Title:    
 
                   
By:
  /s/ Gerald Touratier                
 
                   
 
  Name: Gerard TOURATIER                
 
  Title: CFO                

 

- 25 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
 REQUESTED PURSUANT TO RULE 24b-2
 
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
Exhibit 2
Development Program
Exhibit 2.a    Unilife Project Plan/ Development Programme

 

- 26 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
 REQUESTED PURSUANT TO RULE 24b-2
 
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
0
  [***]                   [***]   [***]   [***]
1
  [***]                   [***]   [***]   [***]
2
  [***]                   [***]   [***]   [***]
3
  [***]     4             [***]   [***]   [***]
4
  [***]     5       3     [***]   [***]   [***]
5
  [***]     6       4     [***]   [***]   [***]
6
  [***]     7,9       5     [***]   [***]   [***]
7
  [***]     728       6     [***]   [***]   [***]
8
  [***]                   [***]   [***]   [***]
9
  [***]     10       6     [***]   [***]   [***]
10
  [***]     11       9     [***]   [***]   [***]
11
  [***]     12       10     [***]   [***]   [***]
12
  [***]     13       11     [***]   [***]   [***]
13
  [***]             12     [***]   [***]   [***]
14
  [***]                   [***]   [***]   [***]
15
  [***]     16             [***]   [***]   [***]
16
  [***]     17       15     [***]   [***]   [***]
17
  [***]     18       16     [***]   [***]   [***]
18
  [***]             17     [***]   [***]   [***]
19
  [***]                   [***]   [***]   [***]
20
  [***]                   [***]   [***]   [***]
21
  [***]                   [***]   [***]   [***]
22
  [***]                   [***]   [***]   [***]
23
  [***]                   [***]   [***]   [***]
24
  [***]     25             [***]   [***]   [***]
25
  [***]     189,141,147,155       24     [***]   [***]   [***]
26
  [***]                   [***]   [***]   [***]
27
  [***]     28,217             [***]   [***]   [***]
28
  [***]             27     [***]   [***]   [***]
29
  [***]                   [***]   [***]   [***]
30
  [***]                   [***]   [***]   [***]
31
  [***]                   [***]   [***]   [***]
32
  [***]                   [***]   [***]   [***]
33
  [***]     34             [***]   [***]   [***]
34
  [***]     35       33     [***]   [***]   [***]
35
  [***]     36,37       34     [***]   [***]   [***]
36
  [***]     39       35     [***]   [***]   [***]
37
  [***]     38       35     [***]   [***]   [***]
38
  [***]     39       37     [***]   [***]   [***]
39
  [***]     40       38,36     [***]   [***]   [***]

 

- 27 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
40
  [***]     41       39     [***]   [***]   [***]
41
  [***]             40     [***]   [***]   [***]
42
  [***]                   [***]   [***]   [***]
43
  [***]     44       51,47     [***]   [***]   [***]
44
  [***]     45       43     [***]   [***]   [***]
45
  [***]     46       44     [***]   [***]   [***]
46
  [***]             45     [***]   [***]   [***]
47
  [***]     43             [***]   [***]   [***]
48
  [***]                   [***]   [***]   [***]
49
  [***]     50             [***]   [***]   [***]
50
  [***]             49     [***]   [***]   [***]
51
  [***]     43             [***]   [***]   [***]
52
  [***]     53             [***]   [***]   [***]
53
  [***]     55       52     [***]   [***]   [***]
54
  [***]                   [***]   [***]   [***]
55
  [***]     56       53     [***]   [***]   [***]
56
  [***]             55     [***]   [***]   [***]
57
  [***]                   [***]   [***]   [***]
58
  [***]                   [***]   [***]   [***]
59
  [***]     60             [***]   [***]   [***]
60
  [***]     61       59     [***]   [***]   [***]
61
  [***]     62       60     [***]   [***]   [***]
62
  [***]     63       61     [***]   [***]   [***]
63
  [***]     64       62     [***]   [***]   [***]
64
  [***]     66,65       63     [***]   [***]   [***]
65
  [***]     730       64     [***]   [***]   [***]
66
  [***]     85       64     [***]   [***]   [***]
67
  [***]     68             [***]   [***]   [***]
68
  [***]     69       67     [***]   [***]   [***]
69
  [***]     70       68     [***]   [***]   [***]
70
  [***]     71       69     [***]   [***]   [***]
71
  [***]     72       70     [***]   [***]   [***]
72
  [***]     73       71     [***]   [***]   [***]
73
  [***]     75,74       72     [***]   [***]   [***]
74
  [***]     738       73     [***]   [***]   [***]
75
  [***]     84       73     [***]   [***]   [***]
76
  [***]     77             [***]   [***]   [***]
77
  [***]     78       76     [***]   [***]   [***]

 

- 28 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
78
  [***]     79       77     [***]   [***]   [***]
79
  [***]     80       78     [***]   [***]   [***]
80
  [***]     81       79     [***]   [***]   [***]
81
  [***]     82       80     [***]   [***]   [***]
82
  [***]     83       81     [***]   [***]   [***]
83
  [***]     739       82     [***]   [***]   [***]
84
  [***]             75     [***]   [***]   [***]
85
  [***]     86       66     [***]   [***]   [***]
86
  [***]     87       85     [***]   [***]   [***]
87
  [***]     88       86     [***]   [***]   [***]
88
  [***]     89       87     [***]   [***]   [***]
89
  [***]     90       88     [***]   [***]   [***]
90
  [***]     91       89     [***]   [***]   [***]
91
  [***]     92       90     [***]   [***]   [***]
92
  [***]     93       91     [***]   [***]   [***]
93
  [***]     95,764       92     [***]   [***]   [***]
94
  [***]                   [***]   [***]   [***]
95
  [***]     96       93     [***]   [***]   [***]
96
  [***]     97       95     [***]   [***]   [***]
97
  [***]     98       96     [***]   [***]   [***]
98
  [***]     99       97     [***]   [***]   [***]
99
  [***]     100       98     [***]   [***]   [***]
100
  [***]     101       99     [***]   [***]   [***]
101
  [***]     102       100     [***]   [***]   [***]
102
  [***]     103,105       101     [***]   [***]   [***]
103
  [***]     768       102     [***]   [***]   [***]
104
  [***]                   [***]   [***]   [***]
105
  [***]     106       102     [***]   [***]   [***]
106
  [***]     107       105     [***]   [***]   [***]
107
  [***]     108       106     [***]   [***]   [***]
108
  [***]     109       107     [***]   [***]   [***]
109
  [***]     110       108     [***]   [***]   [***]
110
  [***]     111       109     [***]   [***]   [***]
111
  [***]     112       110     [***]   [***]   [***]
112
  [***]     113       111     [***]   [***]   [***]
113
  [***]             112     [***]   [***]   [***]
114
  [***]                   [***]   [***]   [***]
115
  [***]     116             [***]   [***]   [***]

 

- 29 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
116
  [***]     117       115,650     [***]   [***]   [***]
117
  [***]     118       116     [***]   [***]   [***]
118
  [***]     119       117     [***]   [***]   [***]
119
  [***]     120       118     [***]   [***]   [***]
120
  [***]     774       119     [***]   [***]   [***]
121
  [***]                   [***]   [***]   [***]
122
  [***]     123       308     [***]   [***]   [***]
123
  [***]     124       122     [***]   [***]   [***]
124
  [***]     125       123     [***]   [***]   [***]
125
  [***]     126       124     [***]   [***]   [***]
126
  [***]     127       125     [***]   [***]   [***]
127
  [***]     761       126     [***]   [***]   [***]
128
  [***]                   [***]   [***]   [***]
129
  [***]     130       251,252     [***]   [***]   [***]
130
  [***]     131       129     [***]   [***]   [***]
131
  [***]     132       130     [***]   [***]   [***]
132
  [***]     133       131     [***]   [***]   [***]
133
  [***]     741       132     [***]   [***]   [***]
134
  [***]                   [***]   [***]   [***]
135
  [***]     136             [***]   [***]   [***]
136
  [***]     137       135     [***]   [***]   [***]
137
  [***]     138       136     [***]   [***]   [***]
138
  [***]     139       137     [***]   [***]   [***]
139
  [***]     140       138     [***]   [***]   [***]
140
  [***]             139     [***]   [***]   [***]
141
  [***]             25     [***]   [***]   [***]
142
  [***]     143             [***]   [***]   [***]
143
  [***]     144       142     [***]   [***]   [***]
144
  [***]     145       143     [***]   [***]   [***]
145
  [***]     146       144     [***]   [***]   [***]
146
  [***]     715       145     [***]   [***]   [***]
147
  [***]     163       25     [***]   [***]   [***]
148
  [***]     149             [***]   [***]   [***]
149
  [***]     150,157       148     [***]   [***]   [***]
150
  [***]     151       149     [***]   [***]   [***]
151
  [***]     152       150     [***]   [***]   [***]
152
  [***]     716,153       151     [***]   [***]   [***]
153
  [***]     154       152     [***]   [***]   [***]

 

- 30 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
154
  [***]     720       153     [***]   [***]   [***]
155
  [***]             25     [***]   [***]   [***]
156
  [***]     157             [***]   [***]   [***]
157
  [***]     158       156,149     [***]   [***]   [***]
158
  [***]     159       157     [***]   [***]   [***]
159
  [***]     160       158     [***]   [***]   [***]
160
  [***]     717,161       159     [***]   [***]   [***]
161
  [***]     162       160     [***]   [***]   [***]
162
  [***]     721       161     [***]   [***]   [***]
163
  [***]             147     [***]   [***]   [***]
164
  [***]                   [***]   [***]   [***]
165
  [***]     174,181,262,349             [***]   [***]   [***]
166
  [***]     167             [***]   [***]   [***]
167
  [***]     168       166     [***]   [***]   [***]
168
  [***]     169,723       167     [***]   [***]   [***]
169
  [***]     170,171       168     [***]   [***]   [***]
170
  [***]             169     [***]   [***]   [***]
171
  [***]     172       169     [***]   [***]   [***]
172
  [***]     173       171     [***]   [***]   [***]
173
  [***]     175,729       172     [***]   [***]   [***]
174
  [***]     182       165     [***]   [***]   [***]
175
  [***]     176       173     [***]   [***]   [***]
176
  [***]     177       175     [***]   [***]   [***]
177
  [***]     178       176     [***]   [***]   [***]
178
  [***]     179       177     [***]   [***]   [***]
179
  [***]     180       178     [***]   [***]   [***]
180
  [***]     735       179     [***]   [***]   [***]
181
  [***]             165     [***]   [***]   [***]
182
  [***]     183       174     [***]   [***]   [***]
183
  [***]     184       182     [***]   [***]   [***]
184
  [***]     185       183     [***]   [***]   [***]
185
  [***]     186       184     [***]   [***]   [***]
186
  [***]     743       185     [***]   [***]   [***]
187
  [***]                   [***]   [***]   [***]
188
  [***]                   [***]   [***]   [***]
189
  [***]     190       25     [***]   [***]   [***]
190
  [***]     191       189     [***]   [***]   [***]
191
  [***]     192,235,197       190     [***]   [***]   [***]

 

- 31 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
192
  [***]     193       191     [***]   [***]   [***]
193
  [***]     194,239       192     [***]   [***]   [***]
194
  [***]             193     [***]   [***]   [***]
195
  [***]     718             [***]   [***]   [***]
196
  [***]                   [***]   [***]   [***]
197
  [***]     198       191     [***]   [***]   [***]
198
  [***]     199       197     [***]   [***]   [***]
199
  [***]     200,239       198     [***]   [***]   [***]
200
  [***]     201       199     [***]   [***]   [***]
201
  [***]     202       200     [***]   [***]   [***]
202
  [***]             201     [***]   [***]   [***]
203
  [***]     204             [***]   [***]   [***]
204
  [***]     205       203     [***]   [***]   [***]
205
  [***]     206,207,239       204     [***]   [***]   [***]
206
  [***]             205     [***]   [***]   [***]
207
  [***]     208       205     [***]   [***]   [***]
208
  [***]     209       207     [***]   [***]   [***]
209
  [***]     210       208     [***]   [***]   [***]
210
  [***]     252,253,211       209     [***]   [***]   [***]
211
  [***]     212       210     [***]   [***]   [***]
212
  [***]     213,214       211     [***]   [***]   [***]
213
  [***]     722       212     [***]   [***]   [***]
214
  [***]     215,216       212     [***]   [***]   [***]
215
  [***]     727       214     [***]   [***]   [***]
216
  [***]             214     [***]   [***]   [***]
217
  [***]             27     [***]   [***]   [***]
218
  [***]     219             [***]   [***]   [***]
219
  [***]     220       218     [***]   [***]   [***]
220
  [***]     221       219     [***]   [***]   [***]
221
  [***]     222       220     [***]   [***]   [***]
222
  [***]             221     [***]   [***]   [***]
223
  [***]     724             [***]   [***]   [***]
224
  [***]     465             [***]   [***]   [***]
225
  [***]     226             [***]   [***]   [***]
226
  [***]             225     [***]   [***]   [***]
227
  [***]     228,731             [***]   [***]   [***]
228
  [***]     229       227     [***]   [***]   [***]
229
  [***]     230       228     [***]   [***]   [***]

 

- 32 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
230
  [***]     231       229     [***]   [***]   [***]
231
  [***]     232       230     [***]   [***]   [***]
232
  [***]     233       231     [***]   [***]   [***]
233
  [***]     747       232     [***]   [***]   [***]
234
  [***]                   [***]   [***]   [***]
235
  [***]     239       191     [***]   [***]   [***]
236
  [***]     237             [***]   [***]   [***]
237
  [***]     238       236     [***]   [***]   [***]
238
  [***]             237     [***]   [***]   [***]
239
  [***]     251,253,252       235,193,199,205     [***]   [***]   [***]
240
  [***]     246,242,241,243             [***]   [***]   [***]
241
  [***]             240     [***]   [***]   [***]
242
  [***]     243,245,246       240     [***]   [***]   [***]
243
  [***]     244       242,240     [***]   [***]   [***]
244
  [***]             243     [***]   [***]   [***]
245
  [***]             242     [***]   [***]   [***]
246
  [***]     247       240,242     [***]   [***]   [***]
247
  [***]             246     [***]   [***]   [***]
248
  [***]     725             [***]   [***]   [***]
249
  [***]                   [***]   [***]   [***]
250
  [***]     272             [***]   [***]   [***]
251
  [***]     259,129       239     [***]   [***]   [***]
252
  [***]     260,129       210,239     [***]   [***]   [***]
253
  [***]     254       239,210     [***]   [***]   [***]
254
  [***]     255,256       253     [***]   [***]   [***]
255
  [***]     258       254     [***]   [***]   [***]
256
  [***]     257       254     [***]   [***]   [***]
257
  [***]             256     [***]   [***]   [***]
258
  [***]             255     [***]   [***]   [***]
259
  [***]     734       251     [***]   [***]   [***]
260
  [***]             252     [***]   [***]   [***]
261
  [***]     283             [***]   [***]   [***]
262
  [***]     263       165     [***]   [***]   [***]
263
  [***]     264       262     [***]   [***]   [***]
264
  [***]     265       263     [***]   [***]   [***]
265
  [***]     266       264     [***]   [***]   [***]
266
  [***]     267       265     [***]   [***]   [***]
267
  [***]             266     [***]   [***]   [***]

 

- 33 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
268
  [***]                   [***]   [***]   [***]
269
  [***]                   [***]   [***]   [***]
270
  [***]                   [***]   [***]   [***]
271
  [***]                   [***]   [***]   [***]
272
  [***]     287,278,288       250     [***]   [***]   [***]
273
  [***]     274             [***]   [***]   [***]
274
  [***]     275       273     [***]   [***]   [***]
275
  [***]     736       274     [***]   [***]   [***]
276
  [***]     641             [***]   [***]   [***]
277
  [***]     293,298,294             [***]   [***]   [***]
278
  [***]     279       272     [***]   [***]   [***]
279
  [***]     280       278     [***]   [***]   [***]
280
  [***]             279     [***]   [***]   [***]
281
  [***]                   [***]   [***]   [***]
282
  [***]                   [***]   [***]   [***]
283
  [***]     284       261     [***]   [***]   [***]
284
  [***]     285       283     [***]   [***]   [***]
285
  [***]     286       284     [***]   [***]   [***]
286
  [***]     306,311       285     [***]   [***]   [***]
287
  [***]             272     [***]   [***]   [***]
288
  [***]     289       272     [***]   [***]   [***]
289
  [***]     290       288     [***]   [***]   [***]
290
  [***]     291       289     [***]   [***]   [***]
291
  [***]     292       290     [***]   [***]   [***]
292
  [***]             291     [***]   [***]   [***]
293
  [***]     305,310       277     [***]   [***]   [***]
294
  [***]     295       277     [***]   [***]   [***]
295
  [***]     296       294     [***]   [***]   [***]
296
  [***]     297       295     [***]   [***]   [***]
297
  [***]     742       296     [***]   [***]   [***]
298
  [***]             277     [***]   [***]   [***]
299
  [***]     300             [***]   [***]   [***]
300
  [***]     305,310,301       299     [***]   [***]   [***]
301
  [***]     302       300     [***]   [***]   [***]
302
  [***]     740       301     [***]   [***]   [***]
303
  [***]                   [***]   [***]   [***]
304
  [***]     627             [***]   [***]   [***]
305
  [***]     306,307,477,473,489,493,308,654       300,293     [***]   [***]   [***]

 

- 34 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
306
  [***]             305,286     [***]   [***]   [***]
307
  [***]     353,315,323,316       305     [***]   [***]   [***]
308
  [***]     122       305     [***]   [***]   [***]
309
  [***]     328,693,515,627             [***]   [***]   [***]
310
  [***]     311,312,484,493,340,343,346,313,654       300,293     [***]   [***]   [***]
311
  [***]             310,286     [***]   [***]   [***]
312
  [***]     353,323,316       310     [***]   [***]   [***]
313
  [***]     315,394,400       310     [***]   [***]   [***]
314
  [***]                   [***]   [***]   [***]
315
  [***]             307,313     [***]   [***]   [***]
316
  [***]     317       307,312     [***]   [***]   [***]
317
  [***]     318,335,330       316     [***]   [***]   [***]
318
  [***]             317     [***]   [***]   [***]
319
  [***]                   [***]   [***]   [***]
320
  [***]     321             [***]   [***]   [***]
321
  [***]     322       320     [***]   [***]   [***]
322
  [***]     323       321     [***]   [***]   [***]
323
  [***]     324       312,307,322     [***]   [***]   [***]
324
  [***]     325,327       323     [***]   [***]   [***]
325
  [***]     335,330,326       324     [***]   [***]   [***]
326
  [***]     752       325     [***]   [***]   [***]
327
  [***]     328       324     [***]   [***]   [***]
328
  [***]             309,327     [***]   [***]   [***]
329
  [***]                   [***]   [***]   [***]
330
  [***]     331       317,325     [***]   [***]   [***]
331
  [***]     332,333,382,388,445,450       330     [***]   [***]   [***]
332
  [***]             331     [***]   [***]   [***]
333
  [***]             331     [***]   [***]   [***]
334
  [***]                   [***]   [***]   [***]
335
  [***]     336       317,325     [***]   [***]   [***]
336
  [***]     337,338,364,370,376,406,414,430,435,440,455,460,473,465,360,359,417       335     [***]   [***]   [***]
337
  [***]             336     [***]   [***]   [***]
338
  [***]             336     [***]   [***]   [***]
339
  [***]                   [***]   [***]   [***]
340
  [***]     341       310     [***]   [***]   [***]
341
  [***]             340     [***]   [***]   [***]
342
  [***]                   [***]   [***]   [***]
343
  [***]     344       310     [***]   [***]   [***]

 

- 35 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
344
  [***]             343     [***]   [***]   [***]
345
  [***]                   [***]   [***]   [***]
346
  [***]     347       310     [***]   [***]   [***]
347
  [***]             346     [***]   [***]   [***]
348
  [***]                   [***]   [***]   [***]
349
  [***]             165     [***]   [***]   [***]
350
  [***]     351             [***]   [***]   [***]
351
  [***]     352       350     [***]   [***]   [***]
352
  [***]     353       351     [***]   [***]   [***]
353
  [***]     354       312,307,352     [***]   [***]   [***]
354
  [***]     355       353     [***]   [***]   [***]
355
  [***]     356       354     [***]   [***]   [***]
356
  [***]             355     [***]   [***]   [***]
357
  [***]                   [***]   [***]   [***]
358
  [***]                   [***]   [***]   [***]
359
  [***]     425,695       336     [***]   [***]   [***]
360
  [***]             336     [***]   [***]   [***]
361
  [***]     362             [***]   [***]   [***]
362
  [***]             361     [***]   [***]   [***]
363
  [***]     635,628             [***]   [***]   [***]
364
  [***]     365,371,377,366,372,378       336     [***]   [***]   [***]
365
  [***]     755       364     [***]   [***]   [***]
366
  [***]     367,373,379       364     [***]   [***]   [***]
367
  [***]     368,374,380,638       366     [***]   [***]   [***]
368
  [***]     638       367     [***]   [***]   [***]
369
  [***]                   [***]   [***]   [***]
370
  [***]             336     [***]   [***]   [***]
371
  [***]     756       364     [***]   [***]   [***]
372
  [***]             364     [***]   [***]   [***]
373
  [***]             366     [***]   [***]   [***]
374
  [***]     638       367     [***]   [***]   [***]
375
  [***]                   [***]   [***]   [***]
376
  [***]             336     [***]   [***]   [***]
377
  [***]     757       364     [***]   [***]   [***]
378
  [***]             364     [***]   [***]   [***]
379
  [***]             366     [***]   [***]   [***]
380
  [***]             367     [***]   [***]   [***]
381
  [***]     667             [***]   [***]   [***]

 

- 36 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
382
  [***]     395,384       331     [***]   [***]   [***]
383
  [***]     753             [***]   [***]   [***]
384
  [***]     385       382     [***]   [***]   [***]
385
  [***]     386       384     [***]   [***]   [***]
386
  [***]             385     [***]   [***]   [***]
387
  [***]     667             [***]   [***]   [***]
388
  [***]     390       331     [***]   [***]   [***]
389
  [***]     754             [***]   [***]   [***]
390
  [***]     391       388     [***]   [***]   [***]
391
  [***]     392       390     [***]   [***]   [***]
392
  [***]             391     [***]   [***]   [***]
393
  [***]     667             [***]   [***]   [***]
394
  [***]     396       313     [***]   [***]   [***]
395
  [***]     758       382     [***]   [***]   [***]
396
  [***]     397       394     [***]   [***]   [***]
397
  [***]     398       396     [***]   [***]   [***]
398
  [***]             397     [***]   [***]   [***]
399
  [***]                   [***]   [***]   [***]
400
  [***]     402,401       313     [***]   [***]   [***]
401
  [***]     759       400     [***]   [***]   [***]
402
  [***]     403       400     [***]   [***]   [***]
403
  [***]     404       402     [***]   [***]   [***]
404
  [***]     638       403     [***]   [***]   [***]
405
  [***]                   [***]   [***]   [***]
406
  [***]     407       336     [***]   [***]   [***]
407
  [***]     408,760       406     [***]   [***]   [***]
408
  [***]     409       407     [***]   [***]   [***]
409
  [***]     410       408     [***]   [***]   [***]
410
  [***]     638       409     [***]   [***]   [***]
411
  [***]                   [***]   [***]   [***]
412
  [***]     413,420,422       624     [***]   [***]   [***]
413
  [***]     422       412     [***]   [***]   [***]
414
  [***]     415       336     [***]   [***]   [***]
415
  [***]             414     [***]   [***]   [***]
416
  [***]                   [***]   [***]   [***]
417
  [***]     418       336     [***]   [***]   [***]
418
  [***]     419       417     [***]   [***]   [***]
419
  [***]     420       418     [***]   [***]   [***]

 

- 37 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
420
  [***]     422,421       412,419     [***]   [***]   [***]
421
  [***]     422       420     [***]   [***]   [***]
422
  [***]           412,413,420,421,636FF     [***]   [***]   [***]
423
  [***]             637FF     [***]   [***]   [***]
424
  [***]             638FF     [***]   [***]   [***]
425
  [***]             359     [***]   [***]   [***]
426
  [***]     689             [***]   [***]   [***]
427
  [***]                   [***]   [***]   [***]
428
  [***]                   [***]   [***]   [***]
429
  [***]                   [***]   [***]   [***]
430
  [***]     431,436,441       336     [***]   [***]   [***]
431
  [***]     432,437,442       430     [***]   [***]   [***]
432
  [***]     433,438,443       431     [***]   [***]   [***]
433
  [***]             432     [***]   [***]   [***]
434
  [***]                   [***]   [***]   [***]
435
  [***]             336     [***]   [***]   [***]
436
  [***]             430     [***]   [***]   [***]
437
  [***]             431     [***]   [***]   [***]
438
  [***]             432     [***]   [***]   [***]
439
  [***]                   [***]   [***]   [***]
440
  [***]             336     [***]   [***]   [***]
441
  [***]             430     [***]   [***]   [***]
442
  [***]             431     [***]   [***]   [***]
443
  [***]             432     [***]   [***]   [***]
444
  [***]                   [***]   [***]   [***]
445
  [***]     446       331     [***]   [***]   [***]
446
  [***]     447       445     [***]   [***]   [***]
447
  [***]     448       446     [***]   [***]   [***]
448
  [***]             447     [***]   [***]   [***]
449
  [***]                   [***]   [***]   [***]
450
  [***]     451       331     [***]   [***]   [***]
451
  [***]     452       450     [***]   [***]   [***]
452
  [***]     453       451     [***]   [***]   [***]
453
  [***]             452     [***]   [***]   [***]
454
  [***]                   [***]   [***]   [***]
455
  [***]     456       336     [***]   [***]   [***]
456
  [***]     457       455     [***]   [***]   [***]
457
  [***]     458       456     [***]   [***]   [***]

 

- 38 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
458
  [***]             457     [***]   [***]   [***]
459
  [***]                   [***]   [***]   [***]
460
  [***]     461       336     [***]   [***]   [***]
461
  [***]     462       460     [***]   [***]   [***]
462
  [***]     463       461     [***]   [***]   [***]
463
  [***]             462     [***]   [***]   [***]
464
  [***]                   [***]   [***]   [***]
465
  [***]     466       224,336     [***]   [***]   [***]
466
  [***]     467       465     [***]   [***]   [***]
467
  [***]     468       466     [***]   [***]   [***]
468
  [***]     469       467     [***]   [***]   [***]
469
  [***]             468     [***]   [***]   [***]
470
  [***]                   [***]   [***]   [***]
471
  [***]     472,479,481             [***]   [***]   [***]
472
  [***]     481       471     [***]   [***]   [***]
473
  [***]     474       305,336     [***]   [***]   [***]
474
  [***]             473     [***]   [***]   [***]
475
  [***]                   [***]   [***]   [***]
476
  [***]     477             [***]   [***]   [***]
477
  [***]     478       476,305     [***]   [***]   [***]
478
  [***]     479       477     [***]   [***]   [***]
479
  [***]     481,480       471,478     [***]   [***]   [***]
480
  [***]     481       479     [***]   [***]   [***]
481
  [***]             471,472,479,480     [***]   [***]   [***]
482
  [***]                   [***]   [***]   [***]
483
  [***]                   [***]   [***]   [***]
484
  [***]     485       310     [***]   [***]   [***]
485
  [***]     486       484     [***]   [***]   [***]
486
  [***]     487,763       485     [***]   [***]   [***]
487
  [***]             486     [***]   [***]   [***]
488
  [***]                   [***]   [***]   [***]
489
  [***]     490       305     [***]   [***]   [***]
490
  [***]     491,751       489     [***]   [***]   [***]
491
  [***]             490     [***]   [***]   [***]
492
  [***]                   [***]   [***]   [***]
493
  [***]     495,494       305,310     [***]   [***]   [***]
494
  [***]     748       493     [***]   [***]   [***]
495
  [***]             493     [***]   [***]   [***]

 

- 39 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
496
  [***]                   [***]   [***]   [***]
497
  [***]                   [***]   [***]   [***]
498
  [***]     499             [***]   [***]   [***]
499
  [***]     500       498     [***]   [***]   [***]
500
  [***]     501       499     [***]   [***]   [***]
501
  [***]     502       500     [***]   [***]   [***]
502
  [***]     503,512,746       501,510     [***]   [***]   [***]
503
  [***]     504,513       502     [***]   [***]   [***]
504
  [***]     505       503,512     [***]   [***]   [***]
505
  [***]     514       504,513     [***]   [***]   [***]
506
  [***]                   [***]   [***]   [***]
507
  [***]     508             [***]   [***]   [***]
508
  [***]     509       507     [***]   [***]   [***]
509
  [***]     510       508     [***]   [***]   [***]
510
  [***]     502,511       509     [***]   [***]   [***]
511
  [***]     745       510     [***]   [***]   [***]
512
  [***]     504,513       502     [***]   [***]   [***]
513
  [***]     505,514       503,512     [***]   [***]   [***]
514
  [***]             505,513     [***]   [***]   [***]
515
  [***]             309     [***]   [***]   [***]
516
  [***]     517             [***]   [***]   [***]
517
  [***]             516     [***]   [***]   [***]
518
  [***]                   [***]   [***]   [***]
519
  [***]                   [***]   [***]   [***]
520
  [***]                   [***]   [***]   [***]
521
  [***]                   [***]   [***]   [***]
522
  [***]                   [***]   [***]   [***]
523
  [***]                   [***]   [***]   [***]
524
  [***]                   [***]   [***]   [***]
525
  [***]                   [***]   [***]   [***]
526
  [***]                   [***]   [***]   [***]
527
  [***]     528             [***]   [***]   [***]
528
  [***]     529       527     [***]   [***]   [***]
529
  [***]     530       528     [***]   [***]   [***]
530
  [***]     531       529     [***]   [***]   [***]
531
  [***]     532,537       530     [***]   [***]   [***]
532
  [***]     533,534       531     [***]   [***]   [***]
533
  [***]             532     [***]   [***]   [***]

 

- 40 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
534
  [***]     535       532     [***]   [***]   [***]
535
  [***]             534     [***]   [***]   [***]
536
  [***]                   [***]   [***]   [***]
537
  [***]     538       531     [***]   [***]   [***]
538
  [***]     539       537     [***]   [***]   [***]
539
  [***]     540,543,544,545,546,547,548       538     [***]   [***]   [***]
540
  [***]     541       539     [***]   [***]   [***]
541
  [***]     561,562       540     [***]   [***]   [***]
542
  [***]                   [***]   [***]   [***]
543
  [***]             539     [***]   [***]   [***]
544
  [***]             539     [***]   [***]   [***]
545
  [***]             539     [***]   [***]   [***]
546
  [***]             539     [***]   [***]   [***]
547
  [***]             539     [***]   [***]   [***]
548
  [***]     598,553       539     [***]   [***]   [***]
549
  [***]             548     [***]   [***]   [***]
550
  [***]             548     [***]   [***]   [***]
551
  [***]             552     [***]   [***]   [***]
552
  [***]     564,575             [***]   [***]   [***]
553
  [***]     554       548     [***]   [***]   [***]
554
  [***]     555       553     [***]   [***]   [***]
555
  [***]     556,557,558,559,602       554     [***]   [***]   [***]
556
  [***]             555     [***]   [***]   [***]
557
  [***]             555     [***]   [***]   [***]
558
  [***]             555     [***]   [***]   [***]
559
  [***]             555     [***]   [***]   [***]
560
  [***]                   [***]   [***]   [***]
561
  [***]             541     [***]   [***]   [***]
562
  [***]     563       541     [***]   [***]   [***]
563
  [***]     564       562     [***]   [***]   [***]
564
  [***]             552,563     [***]   [***]   [***]
565
  [***]                   [***]   [***]   [***]
566
  [***]     567             [***]   [***]   [***]
567
  [***]     569       566     [***]   [***]   [***]
568
  [***]             567     [***]   [***]   [***]
569
  [***]     571       567     [***]   [***]   [***]
570
  [***]           569FS-20w     [***]   [***]   [***]
571
  [***]     573       569     [***]   [***]   [***]

 

- 41 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
572
  [***]             571     [***]   [***]   [***]
573
  [***]     605,632,575       571     [***]   [***]   [***]
574
  [***]             573     [***]   [***]   [***]
575
  [***]     576       552,573     [***]   [***]   [***]
576
  [***]     769       575     [***]   [***]   [***]
577
  [***]                   [***]   [***]   [***]
578
  [***]     579             [***]   [***]   [***]
579
  [***]     580,581       578     [***]   [***]   [***]
580
  [***]     582       579     [***]   [***]   [***]
581
  [***]             579     [***]   [***]   [***]
582
  [***]     583       580     [***]   [***]   [***]
583
  [***]     584       582     [***]   [***]   [***]
584
  [***]     585       583     [***]   [***]   [***]
585
  [***]     587       584     [***]   [***]   [***]
586
  [***]             585     [***]   [***]   [***]
587
  [***]     589       585     [***]   [***]   [***]
588
  [***]           587FS-26w     [***]   [***]   [***]
589
  [***]     591       587     [***]   [***]   [***]
590
  [***]             589     [***]   [***]   [***]
591
  [***]     593       604,589     [***]   [***]   [***]
592
  [***]             591     [***]   [***]   [***]
593
  [***]             591     [***]   [***]   [***]
594
  [***]             636FF     [***]   [***]   [***]
595
  [***]             637FF     [***]   [***]   [***]
596
  [***]             638FF     [***]   [***]   [***]
597
  [***]                   [***]   [***]   [***]
598
  [***]     600       548     [***]   [***]   [***]
599
  [***]             598     [***]   [***]   [***]
600
  [***]           598     [***]   [***]   [***]
601
  [***]           600FS-8 w     [***]   [***]   [***]
602
  [***]     604       555     [***]   [***]   [***]
603
  [***]             602     [***]   [***]   [***]
604
  [***]     632,605,591       602     [***]   [***]   [***]
605
  [***]     606       573,604,636     [***]   [***]   [***]
606
  [***]     607,608       605,638     [***]   [***]   [***]
607
  [***]     773       606     [***]   [***]   [***]
608
  [***]     766       606     [***]   [***]   [***]
609
  [***]                   [***]   [***]   [***]

 

- 42 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
610
  [***]                   [***]   [***]   [***]
611
  [***]                   [***]   [***]   [***]
612
  [***]                   [***]   [***]   [***]
613
  [***]                   [***]   [***]   [***]
614
  [***]     615             [***]   [***]   [***]
615
  [***]     617       614     [***]   [***]   [***]
616
  [***]             615     [***]   [***]   [***]
617
  [***]     619       615     [***]   [***]   [***]
618
  [***]           617FS-5 w     [***]   [***]   [***]
619
  [***]     622       617     [***]   [***]   [***]
620
  [***]             619     [***]   [***]   [***]
621
  [***]     667             [***]   [***]   [***]
622
  [***]     624       619     [***]   [***]   [***]
623
  [***]             622     [***]   [***]   [***]
624
  [***]     626,644,697,412       622     [***]   [***]   [***]
625
  [***]             624     [***]   [***]   [***]
626
  [***]     629,649       624     [***]   [***]   [***]
627
  [***]             304,309     [***]   [***]   [***]
628
  [***]     649       363     [***]   [***]   [***]
629
  [***]     631       626     [***]   [***]   [***]
630
  [***]             629     [***]   [***]   [***]
631
  [***]     632       629     [***]   [***]   [***]
632
  [***]     636       631,604,573     [***]   [***]   [***]
633
  [***]             632     [***]   [***]   [***]
634
  [***]                   [***]   [***]   [***]
635
  [***]     636       641,363     [***]   [***]   [***]
636
  [***]   637,605,422FF,594FF       632,635     [***]   [***]   [***]
637
  [***]   638,423FF,595FF       636     [***]   [***]   [***]
638
  [***]   656,606,650,424FF,596FF,639       637,368,374,367,404,410     [***]   [***]   [***]
639
  [***]     772       638     [***]   [***]   [***]
640
  [***]                   [***]   [***]   [***]
641
  [***]     635       276     [***]   [***]   [***]
642
  [***]                   [***]   [***]   [***]
643
  [***]                   [***]   [***]   [***]
644
  [***]     645       624     [***]   [***]   [***]
645
  [***]     646       644     [***]   [***]   [***]
646
  [***]     762       645     [***]   [***]   [***]
647
  [***]                   [***]   [***]   [***]

 

- 43 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
648
  [***]     660             [***]   [***]   [***]
649
  [***]     650       626,628     [***]   [***]   [***]
650
  [***]     116,652,661       638,649     [***]   [***]   [***]
651
  [***]                   [***]   [***]   [***]
652
  [***]     656       650     [***]   [***]   [***]
653
  [***]                   [***]   [***]   [***]
654
  [***]   655FS-6w       305,310     [***]   [***]   [***]
655
  [***]     656     654FS-6w     [***]   [***]   [***]
656
  [***]     657       638,652,655     [***]   [***]   [***]
657
  [***]     658       656     [***]   [***]   [***]
658
  [***]     659       657     [***]   [***]   [***]
659
  [***]     709,664       658     [***]   [***]   [***]
660
  [***]             648     [***]   [***]   [***]
661
  [***]     662,663       650     [***]   [***]   [***]
662
  [***]             661     [***]   [***]   [***]
663
  [***]     664       661     [***]   [***]   [***]
664
  [***]     666       663, 659     [***]   [***]   [***]
665
  [***]     704             [***]   [***]   [***]
666
  [***]     682,680       664     [***]   [***]   [***]
667
  [***]     704       621,381,387,393     [***]   [***]   [***]
668
  [***]     672             [***]   [***]   [***]
669
  [***]     670             [***]   [***]   [***]
670
  [***]     671       669     [***]   [***]   [***]
671
  [***]             670     [***]   [***]   [***]
672
  [***]             668     [***]   [***]   [***]
673
  [***]     675             [***]   [***]   [***]
674
  [***]                   [***]   [***]   [***]
675
  [***]     677       673     [***]   [***]   [***]
676
  [***]                   [***]   [***]   [***]
677
  [***]     678       675     [***]   [***]   [***]
678
  [***]     681,685       677     [***]   [***]   [***]
679
  [***]                   [***]   [***]   [***]
680
  [***]             666     [***]   [***]   [***]
681
  [***]             678     [***]   [***]   [***]
682
  [***]     683       666     [***]   [***]   [***]
683
  [***]     775       682     [***]   [***]   [***]
684
  [***]                   [***]   [***]   [***]
685
  [***]             678     [***]   [***]   [***]

 

- 44 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
686
  [***]     687             [***]   [***]   [***]
687
  [***]             686     [***]   [***]   [***]
688
  [***]                   [***]   [***]   [***]
689
  [***]     690       426     [***]   [***]   [***]
690
  [***]     691       689     [***]   [***]   [***]
691
  [***]     692       690     [***]   [***]   [***]
692
  [***]             691     [***]   [***]   [***]
693
  [***]             309     [***]   [***]   [***]
694
  [***]                   [***]   [***]   [***]
695
  [***]     697       359     [***]   [***]   [***]
696
  [***]     749             [***]   [***]   [***]
697
  [***]     698       695,624     [***]   [***]   [***]
698
  [***]     767,699       697     [***]   [***]   [***]
699
  [***]     700,702       698     [***]   [***]   [***]
700
  [***]     701       699     [***]   [***]   [***]
701
  [***]     702       700     [***]   [***]   [***]
702
  [***]     703       699,701     [***]   [***]   [***]
703
  [***]     771       702     [***]   [***]   [***]
704
  [***]             667,665     [***]   [***]   [***]
705
  [***]                   [***]   [***]   [***]
706
  [***]                   [***]   [***]   [***]
707
  [***]                   [***]   [***]   [***]
708
  [***]                   [***]   [***]   [***]
709
  [***]     710       659     [***]   [***]   [***]
710
  [***]     711       709     [***]   [***]   [***]
711
  [***]     712       710     [***]   [***]   [***]
712
  [***]             711     [***]   [***]   [***]
713
  [***]                   [***]   [***]   [***]
714
  [***]                   [***]   [***]   [***]
715
  [***]             146     [***]   [***]   [***]
716
  [***]             152     [***]   [***]   [***]
717
  [***]             160     [***]   [***]   [***]
718
  [***]             195     [***]   [***]   [***]
719
  [***]                   [***]   [***]   [***]
720
  [***]             154     [***]   [***]   [***]
721
  [***]             162     [***]   [***]   [***]
722
  [***]             213     [***]   [***]   [***]
723
  [***]             168     [***]   [***]   [***]

 

- 45 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
724
  [***]             223     [***]   [***]   [***]
725
  [***]             248     [***]   [***]   [***]
726
  [***]                   [***]   [***]   [***]
727
  [***]             215     [***]   [***]   [***]
728
  [***]             7     [***]   [***]   [***]
729
  [***]             173     [***]   [***]   [***]
730
  [***]             65     [***]   [***]   [***]
731
  [***]             227     [***]   [***]   [***]
732
  [***]                   [***]   [***]   [***]
733
  [***]                   [***]   [***]   [***]
734
  [***]             259     [***]   [***]   [***]
735
  [***]             180     [***]   [***]   [***]
736
  [***]             275     [***]   [***]   [***]
737
  [***]                   [***]   [***]   [***]
738
  [***]             74     [***]   [***]   [***]
739
  [***]             83     [***]   [***]   [***]
740
  [***]             302     [***]   [***]   [***]
741
  [***]             133     [***]   [***]   [***]
742
  [***]             297     [***]   [***]   [***]
743
  [***]             186     [***]   [***]   [***]
744
  [***]                   [***]   [***]   [***]
745
  [***]             511     [***]   [***]   [***]
746
  [***]             502     [***]   [***]   [***]
747
  [***]             233     [***]   [***]   [***]
748
  [***]             494     [***]   [***]   [***]
749
  [***]             696     [***]   [***]   [***]
750
  [***]                   [***]   [***]   [***]
751
  [***]             490     [***]   [***]   [***]
752
  [***]             326     [***]   [***]   [***]
753
  [***]             383     [***]   [***]   [***]
754
  [***]             389     [***]   [***]   [***]
755
  [***]             365     [***]   [***]   [***]
756
  [***]             371     [***]   [***]   [***]
757
  [***]             377     [***]   [***]   [***]
758
  [***]             395     [***]   [***]   [***]
759
  [***]             401     [***]   [***]   [***]
760
  [***]             407     [***]   [***]   [***]
761
  [***]             127     [***]   [***]   [***]

 

- 46 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
                                 
ID   Task Name   Successor     Predecessor     Duration   Start   Finish
762
  [***]             646     [***]   [***]   [***]
763
  [***]             486     [***]   [***]   [***]
764
  [***]             93     [***]   [***]   [***]
765
  [***]                   [***]   [***]   [***]
766
  [***]             608     [***]   [***]   [***]
767
  [***]             698     [***]   [***]   [***]
768
  [***]             103     [***]   [***]   [***]
769
  [***]             576     [***]   [***]   [***]
770
  [***]                   [***]   [***]   [***]
771
  [***]             703     [***]   [***]   [***]
772
  [***]             639     [***]   [***]   [***]
773
  [***]             607     [***]   [***]   [***]
774
  [***]             120     [***]   [***]   [***]
775
  [***]             683     [***]   [***]   [***]

 

- 47 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
Exhibit 2.b
Unilife Milestones
Milestone Deliverables
The list of milestones are currently being reviewed and finalised and those listed be low are considered to be a preliminary list.
The following is a list of deliverable identified by documents which have been taken from the current Unilife project plan.
It has been agreed that these deliverables will be presented at quarterly intervals.
Sanofi-aventis will review the documents and where applicable submit comments for consideration by Unilife.
Unilife undertakes to address the comments received from sanofi-aventis and where necessary take the appropriate corrective action.
Where corrective action is required, Unilife will resubmit the document as a deliverable in the subsequent quarter.
2009 Q2 — Milestone
     [***]
2009 Q3 — Milestone
     [***]
2009 Q4 — Milestone
     [***]
2010 Q1 — Milestone
     [***]
2010 Q2 — Milestone
     [***]
2010 Q3 — Milestone
     [***]
2010 Q4 — Milestone
     [***]

 

- 48 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
Exhibit 3
List of potential suppliers — Components
The following is a list of potential supplier some of whom are currently supplying product to Unilife and/or sanofi-aventis
It is understood that all suppliers will be subject to full qualification as required under the relevant Unilife SOP and may also be subject to qualification by sanofi-aventis quality systems.
             
Material   Company   Telephone   Address
Glass
  [***]   [***]   [***]
Glass
  [***]   [***]   [***]
Glass
  [***]   [***]   [***]
Glass
  [***]   [***]   [***]
Glass
  [***]   [***]   [***]
Springs
  [***]   [***]   [***]
Plastics
  [***]   [***]   [***]
Plastics
  [***]   [***]   [***]
Rubber
  [***]   [***]   [***]
Rubber
  [***]   [***]   [***]
Rubber
  [***]   [***]   [***]
Needles
  [***]   [***]   [***]
Needles
  [***]   [***]   [***]

 

- 49 -


 

Exhibit 10.3
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
Exhibit 4
Dispute Resolution Procedure
In the event of a dispute between the Parties that is required to be resolved by the Agreement pursuant to the procedures of this Exhibit 4 the patties shall observe the following procedure:
1.  
The Parties shall make all reasonable efforts to resolve the dispute by amicable negotiations.
 
2.  
For factual matters related to the quality of Products, the Parties shall mutually select an independent laboratory to evaluate the materials. Such evaluation shall be binding on the Parties only with respect to the factual determinations made in such evaluation.
 
3.  
For factual matters related to GMP issues, the Parties shall mutually select an independent quality consultant to evaluate the issue. Such evaluation shall be binding on the Parties only with respect to the factual determinations made in such evaluation.
 
4.  
For factual matters related to an accounting matter, the Parties shall mutually select an independent certified accounting firm of international prominence in France to audit the relevant books and records of the Parties related to such matters. Such audit shall be binding on the Parties only with respect to the factual determinations made in such audit.
 
5.  
The provisions of this Exhibit shall govern to finally resolve all disputes, controversies and claims between the Parties hereunder; provided, however, that the factual determinations made pursuant to Sections 2, 3 and 4 of this Exhibit shall be final and binding upon the Parties.
 
6.  
No laboratory or quality consultant or accounting firm selected or acting pursuant to this Exhibit shall be deemed to be an arbitrator.
 
7.  
Costs and expenses of any such laboratory or quality consultant or accounting firm shall be borne by the non-prevailing Party.

 

- 50 -

EX-10.5 5 c93531exv10w5.htm EXHIBIT 10.5 Exhibit 10.5
Exhibit 10.5
SUPPLY AGREEMENT
 
THIS SUPPLY AGREEMENT (the “Agreement”) dated as of September 15 2003, by and between B. BRAUN MEDICAL INC., a Pennsylvania corporation having offices at 824 Twelfth Avenue, Bethlehem, Pennsylvania 18018 (“B. Braun”) and Integrated Biosciences, Inc., having offices at 3721 TecPort Drive Suite 150, Harrisburg, PA 17111 (“Company”).
The parties hereto, intending to be legally bound hereby, agree as follows:
1. Definitions. When used in this Agreement, capitalized terms, including their plural form, shall have the following meanings:
1.1 “Product” means, individually and collectively, the products listed in Exhibit Ahereto, as further described in the contract documents.
1.2 “Specifications” means the Product specifications, attached as Appendix B, C, D and E hereto.
2. Scope of Work. Company shall provide to B. Braun products meeting specifications set forth in exhibits and in accordance with individual purchase orders placed by Braun for delivery of product(s).
3. Contract Documents. The documents listed below are incorporated herein by reference:
a) Exhibit A — Commercial requirements product matrix-Syringes

b) Exhibit B — Product specifications

c) Exhibit C — Process/QA specifications

d) Exhibit D — Manufacturing specifications

e) Exhibit E — Siliconize Prices

f) Exhibit F — Memorandum of Understanding
4. Supply of Product. During the term of this Agreement and any extension or renewal thereof, and subject to the terms and conditions of this Agreement, Company shall manufacture and supply to B. Braun, and B. Braun shall purchase from Company, the Product that B. Braun may order pursuant to the terms of this Agreement. The ordering of Products shall be by means of individual purchase orders issued by B. Braun’s authorized procurement personnel. Binding purchase orders shall be issued with at least thirty (30) days notice prior to the required delivery dates thereunder, and shall specify the name, product code, quantities of each of the Products to be purchased, required delivery dates, and shipping instructions.
5. Price and Payment. The price of the Products shall be as set forth in Exhibit A hereto, and shall remain firm for the term of this Agreement. Company shall bear all federal, state and local taxes based upon or measured by its net income or its business. Company shall invoice B. Braun with any shipment of Products and B. Braun shall make payment to Company, at the address specified on the invoice, no later than the later of forty-five (45)days from the receipt of the invoice
6. Delivery. All shipments of Products shall be made on the Delivery Date, F.O.B. B. Braun’s delivery point on the purchase order. Cost of Freight shall be be prepaid by Company and added to invoice. If defective product is received and disposition determined by B. Braun and Company is to use as is due to schedule contraints, B. Braun will 100% inspect product for useable product. The time needed to perform 100% inspection will be charged Company at a rate of $25.00 /hr. B. Braun will not be required to pay for any defective product
7. Product Specifications; Etc. Any changes in the Specifications for any of the Products shall be mutually approved in writing in advance by the parties prior to the incorporation of any such change in any production units. Company agrees to promptly incorporate and validate with assistance of B. Braun all agreed-upon changes, consistent with good manufacturing practices. If Product does not meet Specifications, then B. Braun shall have a right, in addition to its other remedies at law or equity, to terminate this Agreement without any liability to Company. B. Braun may, from time to time, send representatives to Company’s manufacturing facility or its suppliers’ facilities to observe, audit and inspect the production facilities, and Company will allow B. Braun’s representatives reasonable access to all manufacturing records for the Product so as to ensure that Company is in compliance with the applicable government regulations and the Specifications.

 


 

8. Warranties. Company represents, warrants and covenants to B. Braun that the Products delivered under this Agreement shall be free from defects in material workmanship shall comply in all respects with the applicable Specifications for such product and shall be manufactured in accordance with all applicable laws, regulations, and directives. B. Braun shall notify Company in writing if it determines that any Product fails to meet the warranties set forth herein and at B. Braun’s option, Company will, at Company’s expense, immediately repair or replace the defective Product, or reimburse B. Braun the purchase price of such defective Product Company shall bear all freight cost and risk of loss or damage to returned and replacement Products while in transit. THE WARRANTIES PROVIDED IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE.
9. Compliance with Laws. Company represents, warrants and covenants to B. Braun that it shall, at all times, comply with all applicable laws, rules and regulations and standards applicable to manufacturing of the Products. Any provision required to be included in a contract of this type by any applicable and valid federal, state or local law, ordinance, rule or regulation shall be deemed to be incorporated herein, and Company agrees to comply with all applicable laws and regulations in connection with its obligations hereunder.
10. Insurance. Company represents and warrants to B. Braun that it is currently insured and covenants that at all times during the term of this Agreement it will maintain from a qualified insurance including without limitation, a comprehensive general liability insurance policy, product liability insurance, personal injury insurance and contractual liability coverage which is sufficient to adequately protect against the risks associated with its ongoing business, including the risks which might possibly arise in connection with the transactions contemplated by this Agreement, in an amount of at least $1,000,000 per single claim (with a deductible amount of no greater than $10,000). Company, at the time of signing, shall furnish B. Braun with a Certificate of Insurance evidencing that such insurance is in full force and effect, and providing that B. Braun will be provided written notice at least sixty (60) days in advance of any material change, cancellation or termination of insurance. Such insurance shall be on an occurrence-made basis, shall name B. Braun, as an additional insured All such policies shall contain an endorsement that they shall be primary in all instances regardless what, if any, like coverages are carried by B. Braun.
11. Indemnification. Company hereby indemnifies and agrees to defend and hold B. Braun, its offices, directors, agent and employees (individually and collectively, “B. Braun Parties”) harmless from and against any and all damages, liabilities, penalties, losses or expenses including, without limitation, legal fees, arising out of or resulting from any claims, actions, demands or proceedings asserted by a third party (“Claim”) which results from or arises out of (i) Company’s breach of any warranty, representation or agreement of Company in this Agreement (iii) and the death of, or bodily injury to, any person on account of the acts or omissions of Company Parties.
12. Term; Termination; Event of Default & Remedies.
12.1 This Agreement shall commence on the date set forth above and shall continue until Sept 2 2004, unless sooner terminated in accordance with the provisions hereof. Thereafter, this Agreement may be extended under terms mutually agreed upon by both parties and formalized in writing.
12.2 In addition, this Agreement may be terminated as follows:
(a) By either party, effective upon delivery of a termination notice, if the other party (i) files in any court pursuant to any statute of the United States or of any individual state, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or at the appointment of a receiver or trustee of the party of its assets, (ii) is served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after filing thereof, (iii) is a party to any dissolution or liquidation, (iv) makes an assignment for the benefit of creditors, or (v) discontinues its operations for any reason whatsoever.

 

2


 

(b) By B. Braun, immediately upon written notice to Company, if Company assigns or transfers this Agreement or any of its obligations hereunder to any party, including without limitation, any successor in interest through merger, sate of stock, assets, business line, or otherwise.
(c) By either party, in the event that the other party fails to perform or otherwise breaches any of its obligations hereunder, by giving notice of its intent to terminate and stating the grounds therefore. The party receiving such notice shall have thirty (30) days from the receipt thereof to cure the failure or breach at which time this Agreement shall terminate if said failure or breach has not been cured to the reasonable satisfaction of the other party. In no event, however, shall such notice of intention to terminate, or actual termination by the nonbreaching party, be deemed as a waiver of any other rights or remedies which such party may have as a consequence of such failure or breach, and such party shall have all other rights and remedies available at law or in equity.
10.3 Termination of this Agreement shall not relieve either party from its duty to discharge all obligations accruing prior to such termination, including parties’ obligations pursuant to any purchase order outstanding on the date of such termination and for payment for any Product delivered prior to the termination hereof. Notwithstanding Subsection 10.2(c), upon any breach, default or failure to perform by one party hereunder, the other party may continue to operate under this Agreement while pursuing any remedy it may have at law or equity, so long as such non-breaching party continues to meet all of its obligations under this Agreement, but only to the extend that the breach, default or failure to perform does not adversely and materially affect any such obligation of the non-breaching party.
10.4 Upon termination of this Agreement for any reason whatsoever, (i) B. Braun shall return to Company all confidential information and documents relating to or containing confidential information, together with all copies made thereof and extracts made therefrom, and (ii) Company shall return to B. Braun all confidential information and documents relating to or containing confidential information, together with all copies made thereof and extracts made therefrom; provided that the parties shall be entitled to retain one copy of the Confidential Information in their legal department files for the purpose of insuring compliance with any applicable governmental rules and regulations.
13. Limitation of Liability. Except for the obligations of indemnification hereunder, or as otherwise expressly provided herein neither party shall be liable to the other party for any indirect, special, punitive, incidental or consequential damages from any cause whatsoever, regardless if any remedy herein fails, including without limitation, damages for loss of profits or opportunity costs.
14. Force Majeure. If either party becomes unable to perform any of its obligations hereunder, in whole or in part, by reason of an act of God, acts of civil or military authorities or fires, floods, wars and riots or civil disturbances (a “Force Majeure”), such failure of performance shall be excused during the continuance of and to the extent of such Force Majeure event. Each party will promptly notify the other of any occurrence of an event of Force Majeure and of the termination thereof. B. Braun may terminate this Agreement if the Force Majeure event will exceed thirty (30) days.
15. Miscellaneous Terms and Conditions.
15.1 Each party agrees to hold in confidence and refrain from using, distributing, disseminating or disclosing to others any information of the other party that is designated by the discloser as “confidential” other than pursuant to this Agreement. The restrictions set forth in the preceding sentence shall not apply to confidential information that a receiving party proves: (a) was, at the time of disclosure hereunder, in the public domain or becomes at a later date reasonably available to the public through no fault of the recipient; (b) was in the possession of recipient prior to disclosure hereunder, as evidence by recipient’s written or tangible evidence: (c) was disclosed to recipient by a third party that has an independent right to disclose the information; (d) was independently developed by recipient as evidenced by competent proof; or (e) was required to be disclosed by judicial order, statute or governmental regulation, provided that the disclosing party is given reasonable prior written notice of any such required disclosure. This Section shall survive termination of this Agreement and any extension thereof, for a period of three (3) years.

 

3


 

15.2 The parties hereto shall be deemed to have the status of independent contractors, and shall have the relationship of buyer and seller. Nothing in this Agreement shall be deemed to place the parties in the relationship of partners, licensor-licensee, principal-agent or joint venturers. Neither party shall have any right or authority to create or assume any obligation or to bind the other party in any manner whatsoever.
15.3 Neither party shall assign this Agreement or their rights hereunder without the prior written consent of the other party, provided that this Section shall not apply to an assignment by B. Braun to an affiliated Company or any successor to its business. This Agreement shall inure to the benefit of, and be binding upon, the permitted assigns and successors of the parties hereto.
15.4 Any notice or request required or permitted to be given under or in connection with this Agreement shall be in writing and shall be deemed given only if delivered personally, sent by registered or certified mail, return receipt requested, or by overnight delivery service to the applicable address set forth above or such other address as a party may have specified in a notice duly given to the other party as provided herein,
15.5 This Agreement, including the Appendixes and exhibits attached hereto, and B. Braun’s purchase orders (and any future addenda, or amendments referencing this Agreement) contains the entire agreement and understanding between the parties with respect to the subject matter hereof and supersedes all prior proposals and agreements between the parties, whether oral or written, and there are no other promises or representations relating to the subject matter hereof that is not incorporated herein. No addition to or waiver or modification of any provision of this Agreement shall be binding unless in writing and signed by a duly authorized representative of each party. Without limiting the generality of the foregoing, no modification or amendment shall be effected by or result from the receipt, acceptance, signing or acknowledgment of any order acknowledgments, invoices, shipping documents or other business forms containing terms or conditions in addition to or different from the terms and conditions set forth in this Agreement or B. Braun’s purchase orders. Such documentation is permitted only as a convenience to the parties, and all such documentation shall be governed and superceded by the terms and conditions of this Agreement and B. Braun’s purchase orders. Any failure by either party to enforce any of their respective rights herein shall not be deemed a waiver of such rights, and it may, from time to time, and at its option, enforce any of its rights hereunder, notwithstanding any course of dealing or performance. Notwithstanding the termination of this Agreement, the rights and obligations of the parties set forth in the provisions of Sections 6, 8, 9, 10,11 and 13 of this Agreement shall survive the termination of this Agreement in accordance with their terms.
15.6 For the purpose of implementing Section 1861 (v)(I)(I) of the Social Security Act, as amended, and any written regulations thereto, Company agrees to comply with the following statutory requirements governing the maintenance of documentation to verify the cost of services rendered under this Agreement:
(a) Until the expiration of four (4) years after the furnishing of services pursuant to the Agreement, Company shall make available, upon written request, to B. Braun, the Secretary of HHS, or the Comptroller General of the U.S., or any of their duly authorized representatives, the contract, and books, documents, and records of Company that are necessary to certify the nature and extent of such costs, and
(b) If Company carries out any of the duties of the Agreement through a subcontract, with a value or cost of $10,000 or more over a 12-month period, with a related organization, such subcontract shall contain a clause to the effect that until the expiration of four (4) years after the furnishing of such services pursuant to such subcontract, the related organization shall make available, upon written request, to B. Braun, the Secretary, or the Comptroller General or any of their duly authorized representatives, the subcontract, and books, documents, and records of such organization that are necessary to verify the nature and extent of such costs.

 

4


 

15.7 Seller shall not maintain or provide racially segregated facilities for employees at any establishment under its control. Seller agrees to adhere to the requirements set forth in Executive Orders 11246 and 11375. Seller Agrees to comply with all state and federal Equal Employment Opportunity, Immigration, and Affirmation Action requirements including 42 U.S.C. 2000 (e) et seq., The Civil Rights Act of 1964, The Civil Rights Act of 1991, 503 and 504 of the Rehabilitation Act of 1973, 204 of the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, The Americans with Disability Act and the Immigration Reform Act of 1985 and any amendments and applicable regulations pertaining thereto.
15.8 Each party represents and warrants that (i) it has the right to enter into this Agreement and to perform all of its obligations hereunder, and (ii) this Agreement, when executed and delivered, will be a legal valid, and binding obligation of such party, enforceable against such party in accordance with its terms. Any ambiguities in this Agreement will not be interpreted against the drafting party.
15.9 The provisions of this Agreement shall be severable from each other and from the rest of this Agreement, and in the event that any portion of this Agreement shall be held invalid, void, unenforceable, or ineffective by a court of competent jurisdiction, the remaining portions thereof shall remain in full force and effect. If any of the terms of provisions of this Agreement are in conflict with any applicable statute or rule of law, then such terms or provisions shall be deemed inoperative to the extent that they may conflict therewith, and shall be deemed to be modified to conform with such statute or rule of law. The Headings in this Agreement are included for ease of reference only and shall have no legal effect.
15.10 This Agreement shall be governed and interpreted in accordance with the laws, but not the laws of conflict of laws, of the Commonwealth of Pennsylvania. Any controversy or claim arising out of or relating to this Agreement, or the breach thereof (“Claim”), shall be settled by arbitration pursuant to the Federal Arbitration Act, 9 U.S.C. § 1, et seq., in accordance with the Commercial Arbitration Rules of the American Arbitration Association. The decision of the arbitrator(s) shall be final and binding upon the parties and judgment upon the award may be entered in any court having jurisdiction thereof. Each party shall pay its own attorneys’ fees and expenses, except that the cost of arbitration shall be split between the parties involved, and mat if a prevailing party in court is required to initiate proceedings to enforce the award or confirm judgment, the prevailing party shall be entitled to recover its costs and attorneys’ fees associated with such action.
15.11 This Agreement may be executed by facsimile signatures and in one or more counterparts, each of which shall be deemed to be an original and one and the same Agreement.
IN WITNESS WHEREOF, the parries hereto have executed and delivered this Agreement as of the date set forth above.
                       
B. BRAUN MEDICAL INC.                  
 
                     
By:
  /s/ Michael Stammherr 9/29/03     By:   /s/ Edward J. Paukovits, Jr.    
 
 
 
Name: Michael Stammherr
 
 
       
 
Name: Edward J. Paukovits, Jr.
     
 
  Title:   Vice Present, Strategic Purchasing           Title:   Chairman      
 
                     
By:
  /s/ Mark Buckley 9/29/03     By:          
 
 
 
Name: Mark Buckley
 
 
       
 
Name:
     
 
  Title:   Commodity Manager, Strategic Purchasing           Title:      

 

5


 

         
    Exhibit A – Commercial Matrix   IBSASSY061604
                                                     
                Standard             Lead     Min Order     Incremental  
Part Number   Size     Description   Unit Cost     Range     Time     Qty     Order Qty  
S2000520
    1.25     Printed Barrel P1-0-L   $ 0.1111       0               1000       1000  
S2112071
    1.25     Printed Syringe - Henry Schein   $ 0.1965       0               1000       1000  
S2112072
    1.25     Printed Syringe - Henry Schein   $ 0.1965       0               1000       1000  
S2112073
    1.25     LL Controlled Stroke   $ 0.2279       0               1000       1000  
S2114209
    1.25     LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2114241S
    1.25     Generic Latex Free Syringe   $ 0.1156       15000               1000       1000  
S2114242S
    1.25     Generic Latex Free Syringe   $ 0.1156       12000               1000       1000  
S2114247S
    1.25     Logo Less Latex   $ 0.1965       0               1000       1000  
S2115002
    1.25     OEM Latex Free   $ 0.1965       0               1000       1000  
S2115005
    1.25     Latex Free Syringe - Arrow Intl   $ 0.1965       0               1000       1000  
S2115016
    1.25     Latex Free Syringe   $ 0.1965       15,000               1000       1000  
S2112053
    1.50     LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2040000
    3.00     1/2cc LL Controlled Stroke   $ 0.2279       0               1000       1000  
S2040001
    3.00     1/2cc LL Controlled Stroke   $ 0.2279       0               1000       1000  
S2040002
    3.00     1cc LL Controlled Stroke w/ Blue Plunger   $ 0.2279       0               1000       1000  
S2040505
    3.00     1-1/2cc LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2040755
    3.00     3/4cc Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2040800
    3.00     3/4cc Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2110000
    3.00     1/2cc LL Controlled Stroke   $ 0.2279       0               1000       1000  
S2110002
    3.00     1/2cc LL Controlled Stroke W/ Natural Plunger   $ 0.2279       0               1000       1000  
S2111005
    3.00     1cc Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2112070
    3.00     LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2112074
    3.00     Controlled Stroke - Arrow   $ 0.2279       0               1000       1000  
S2116009
    3.00     LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2116010
    3.00     LL Controlled Stroke W/ Nat Plunger   $ 0.2279       0               1000       1000  
S2116011
    3.00     LL Controlled Stroke   $ 0.2279       25000               1000       1000  
S2116012
    3.00     LL Controlled Stroke w/ White Plunger   $ 0.2279       0               1000       1000  
S2117045
    3.00     LL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2131002
    3.00     3/4mL Controlled Stroke Latex Free   $ 0.2279       0               1000       1000  
S2132000
    3.00     LL Latex Free w/ Cap   $ 0.2541       0               1000       1000  
S2132021
    3.00     LL Latex Free   $ 0.1469       30000               1000       1000  
S2132030
    3.00     LL Latex Free   $ 0.2279       0               1000       1000  
S2132205
    3.00     LL Latex Free   $ 0.1469       0               1000       1000  
S2171060
    5.00     LS Syringe   $ 0.2441       70000               1000       1000  
S2171062
    5.00     LL Adapter Syringe   $ 0.2703       0               1000       1000  
S2171100
    5.00     Bulk Pkg P5-O-A Syringe w/ Cap   $ 0.2279       0               1000       1000  
S2172035
    5.00     P5-0-L-A W/ Cap No Print   $ 0.2910       0               1000       1000  
S2000305
    10.00     Printed High Value Barrel   $ 0.1273       0               1000       1000  
s2001322
    10.00     Printed Barrel only Double Scale   $ 0.1111       0               1000       1000  
S2112032
    10.00     10cc High Value Syr Contr.   $ 0.2441       0               1000       1000  
S2112034
    10.00     10cc High Value Syr Red Nitro   $ 0.2441       0               1000       1000  
S2112042
    10.00     10cc High Value Syr Blue   $ 0.2441       0               1000       1000  
S2112043
    10.00     10cc High Value Syr Grn   $ 0.2441       0               1000       1000  
S2112044
    10.00     10cc High Value Syr Yel   $ 0.2441       0               1000       1000  
S2112045
    10.00     10cc High Value Syr Red   $ 0.2441       0               1000       1000  
S2112046
    10.00     10cc High Value Syr Wht   $ 0.2441       0               1000       1000  
S2170000
    10.00     LL Controlled Stroke W/ Latex Plunger   $ 0.2441       0               1000       1000  
S2170001
    10.00     LL Controlled Stroke W/ Latex Plunger   $ 0.2441       0               1000       1000  
S2170002
    10.00     LL Controlled Stroke W/ Latex Plunger   $ 0.2441       0               1000       1000  
S2170003
    10.00     LL Controlled Stroke W/ Latex Plunger   $ 0.2441       0               1000       1000  
S2190000
    10.00     LL Controlled Stroke   $ 0.4431       0               1000       1000  
S2191005
    10.00     Bulk Pkg P10-O-A w/ Cap   $ 0.1731       0               1000       1000  
S2191010
    10.00     Bulk Pkg P10-O-A No Cap   $ 0.1469       60000               1000       1000  
S2191020
    10.00     LL Syringe   $ 0.2279       0               1000       1000  
S2191030
    10.00     P10-0, No Cap, B   $ 0.2279       0               1000       1000  
S2192000
    10.00     LL Syringe w/ Cap   $ 0.2541       0               1000       1000  
S2192025
    10.00     Syringe, No Logo   $ 0.2279       0               1000       1000  
S2192027
    10.00     LL Syringe No Cap   $ 0.2279       0               1000       1000  
S2192030
    10.00     LL Double Scale   $ 0.2279       35000               1000       1000  
S2192040
    10.00     LL Rad Resistant Syringe   $ 0.3800       0               1000       1000  
S2000405
    20.00     Printed High Value Barrel   $ 0.1273       0               1000       1000  
S2112047
    20.00     20cc High Value Syr Blue   $ 0.2441       0               1000       1000  
S2112048
    20.00     20cc High Value Syr Grn   $ 0.2441       0               1000       1000  
S2112049
    20.00     20cc High Value Syr Yel   $ 0.2441       0               1000       1000  
S2112050
    20.00     20cc High Value Syr Red   $ 0.2441       0               1000       1000  
S2112051
    20.00     20cc High Value Syr Wht   $ 0.2441       0               1000       1000  
S2221000
    20.00     LS Latex Free w/ Cap   $ 0.3800       0               1000       1000  
S2221025
    20.00     LS Latex Free   $ 0.3800       15000               1000       1000  
S2221050
    20.00     LS Latex Free w/ Cap   $ 0.3800       0               1000       1000  
S2222110
    20.00     P-20-0-L, No Cap   $ 0.3800       0               1000       1000  
S2223012
    20.00     LL Adapter w/ Thumb Ring   $ 0.4831       0               1000       1000  
S2223013
    20.00     LL Adapter w/ Thumb Ring and Cap   $ 0.5383       0               1000       1000  
S2001382
    25.00     Printed Barrel 25ML (infl syringe)   $ 0.1273       0               1000       1000  
S2231000
    30.00     P30-0 (3 YR EXP)   $ 0.3894       0               1000       1000  
S2231200
    30.00     Bulk Pkg P30-O-L-B Latex Free   $ 0.4445       0               1000       1000  
S2232000
    30.00     LL Adapter Syring w/ Cap   $ 0.4445       0               1000       1000  
S2232010
    30.00     Printed Barrel w/ LL Adapter Welded   $ 0.1110       0               1000       1000  
S2232030
    30.00     LL Adapter Syring   $ 0.3894       0               1000       1000  
S2232040
    30.00     P30-O-L Syringe - Latex   $ 0.3894       0               1000       1000  
S2233301
    30.00     LL Adapter Syring   $ 0.3894       0               1000       1000  
S2233303
    30.00     LL Adapter Syring   $ 0.3894       0               1000       1000  
S2240000
    50.00     Controlled Stroke Syringe   $ 0.2953       0               1000       1000  
S2240500
    50.00     Printed Barrel w/ LL Adapter Welded   $ 0.1111       0               1000       1000  
S2240510
    50.00     LL Syringe Assy - Latex Free   $ 0.6008       0               1000       1000  
S2242010
    60.00     LL Adapter Syring   $ 0.4445       0               1000       1000  
     
**   Barrel Printing Prices Included in Assembled Syringe Prices

 

 


 

         
    Exhibit B – Drawings   IBSASSY061604
                                                                               
                                                Molded                        
                Drawing       Printed   Printed       Molded   Molded       Plunger   Molded       Siliconized   Siliconized        
                Number   Printed   Barrel   Barrel   Molded   Barrel   Barrel   Molded   Tip   Plunger tip   Siliconized   Plunger Tip   Plunger tip        
    Barrel       Drawing   Revision   Barrel Part   Drawing   Revision   Barrel Part   Drawing   Revision   Plunger tip   Drawing   Revision   Plunger tip   Drawing   Revision   Molded Plunger   Molded Plunger
Part Number   Size   Description   Number   Level   Number   Number   Level   Number   Number   Level   part number   Number   Level   part number   Number   Level   Part Number   Drawing Number
S2000520
  1.25cc   Printed Barrel Only P1-0-L   NA   NA   S2000520   C-200   none   M4260100   D-317   1   NA   NA   NA   NA   NA   NA   NA   NA
S2112071
  1.25cc   Printed Syringe - Henry Shein   H-346   3   S2002540   C-316   none   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2112072
  1.25cc   Printed Syringe - Henry Shein   H-499   0   S2002541   C-317   1   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2114241S
  1.25cc   Generic Latex Free Syringe   H-375   2   NA   NA   NA   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2114242S
  1.25cc   Generic Latex Free Syringe   H-375   2   NA   NA   NA   M6880102S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890102S   D-348
S2114247S
  1.25cc   Logo Less Latex   H-452   0   S2001066S   C-334   none   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2115002
  1.25cc   OEM Latex Free   H-396   0   S2000513   C-233   none   M6880100S   D-347   1   A200215 opt. A200206   R-117   4   S2002054 opt. S2002053   A-671   6   M6890100S   D-348
S2115005
  1.25cc   Latex Free Syringe - Arrow Intl   H-398   2   S2000507   C-296   none   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2115016
  1.25cc   Latex Free Syringe   H-405   1   S2000520   C-200   none   M6880100S   D-347   1   A2000215   R-117   4   S2002054   A-671   6   M6890100S   D-348
S2000305
  10cc   Printed High Value Barrel   NA   NA   S2000305   B-1381   none   M6271700   D-327   0   NA   NA   NA   NA   NA   NA   NA   NA
S2001322
  10cc   Printed Barrel only Double Scale   H-289   4   S2001323   C-188   none   M0330100   D-201   6   NA   NA   NA   NA   NA   NA   NA   NA
S2112032
  10cc   High Value Syr Contr.   H-477   0   S2000308   B-1385   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260605   D-328
S2112034
  10cc   High Value Syr Red Nitro   H-479   0   S2000311   B-1383       M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260613   D-328
S2112042
  10cc   High Value Syr Blue   H-480   0   S2000305   B-1381   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260603   D-328
S2112043
  10cc   High Value Syr Grn   H-481   0   S2000305   B-1381   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260605   D-328
S2112044
  10cc   High Value Syr Yel   H-482   0   S2000305   B-1381   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260606   D-328
S2112045
  10cc   High Value Syr Red   H-483   0   S2000305   B-1381   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260613   D-328
S2112046
  10cc   High Value Syr Wht   H-361   3   S2000305   B-1381   none   M6271700   D-327   0   A2101012   R-129   8   S2002312   A-671   6   M6260601   D-328
S2170000
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   1   S2000006   C-332   none   M7290100   D-352   0   A2101012   R-129   8   S2002312   A-671   6   M6940104   D-351
S2170001
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   1   S2000007   C-333   none   M7290100   D-352   0   A2101012   R-129   8   S2002312   A-671   6   M6940104   D-351
S2170002
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   1   S2000008   C-328   none   M7290100   D-352   0   A2101012   R-129   8   S2002312   A-671   6   M6940101   D-351
S2170003
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   1   S2000009   C-330   none   M7290100   D-352   0   A2101012   R-129   8   S2002312   A-671   6   M6940108   D-351
S2190000
  10cc   LL Controlled Stroke   H-381   1   S2000000   C-326   none   M7290100   D-352   0   A2101012   R-129   8   S2002312   A-671   6   M6930103   D-350
S2191005
  10cc   Bulk Pkg P10-O-A w/ Cap   H-204   6   NA   NA   NA   M0330100   D-201   6   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2191010
  10cc   Bulk Pkg P10-O-A No Cap   H-204   6   NA   NA   NA   M0330100   D-201   6   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2191020
  10cc   LL Syringe   H-132   13   S2001320   C-153   2   M0330100   D-201   6   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2191030
  10cc   P10-0, No Cap, B   H-289   4   S2001323   C-188   none   M0330100   D-201   6   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2192000
  10cc   LL Syringe w/ Cap   H-132   13   S2001321   C-153   2   M6850100   D-344   0   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2192025
  10cc   LL Syringe Assy, No Logo   H-182   9   S2001325   C-188   none   M6850100   D-344   0   A2101000   R-129   8   S2002310   A-671   6   M1790101   D-256
S2192027
  10cc   LL Syringe No Cap   H-132   13   S2001321   C-153   2   M6850100   D-201   6   A2101000   R-129   8   S2002312   A-671   6   M1790101   D-256
S2192030
  10cc   LL Double Scale   H-261   7   S2001322   C-197   1   M6850100   D-344   0   A2101012   R-129   8   S2002312   A-671   6   M1790101   D-256
S2192040
  10cc   LL Rad Resistant Syringe   H-278   5   S2001335   C-238   none   M6850100   D-344   0   A2101000   R-129   8   S2002310   A-671   6   M1790101   D-256
S2000405
  20cc   Printed High Value Barrel   NA   NA   S2000405   B-1387   none   M6251700   D-338   1   NA   NA   NA   NA   NA   NA   NA   NA
S2112047
  20cc   High Value Syr Blue   H-490   0   S2000405   B-1387   none   M6251700   D-338   1   A2101021   R-108   6   S2002411   A-671   6   M6240603   D-339
S2112048
  20cc   High Value Syr Grn   H-491   0   S2000405   B-1387   none   M6251700   D-338   1   A2101021   R-108   6   S2002411   A-671   6   M6240605   D-339
S2112049
  20cc   High Value Syr Yel   H-492   0   S2000405   B-1387   none   M6251700   D-338   1   A2101021   R-108   6   S2002411   A-671   6   M6240606   D-339
S2112050
  20cc   High Value Syr Red   H-493   0   S2000405   B-1387   none   M6251700   D-338   1   A2101021   R-108   6   S2002411   A-671   6   M6240613   D-339
S2112051
  20cc   High Value Syr Wht   H-354   8   S2000405   B-1387   none   M6251700   D-338   1   A2101021   R-108   6   S2002411   A-671   6   M6240601   D-339
S2221000
  20cc   LS Latex Free w/ Cap   H-130   10   S2001410   C-131   none   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M1750101   D-209
S2221025
  20cc   LS Latex Free   H-130   10   S2001410   C-131   none   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M1750101   D-209
S2221050
  20cc   LS Latex Free w/ Cap   H-313   2   NA   NA   NA   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M1750101   D-209
S2222110
  20cc   P20-0-L No Cap   H-183   4   S2001420   C-189   none   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M1750101   D-209
S2223012
  20cc   LL Adapter w/ Thumb Ring   H-264   3   S2001410   C-131   none   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M2950100   D-296
S2223013
  20cc   LL Adapter w/ Thumb Ring and Cap   H-281   2   S2001410   C-131   none   M0350100   D-210   3   A2101021   R-108   6   S2002411   A-671   6   M2950100   D-296
S2001382
  25cc   Printed Barrel 25ML (infl syringe)   NA   NA   S2001382   B-1378   2   M6411700   D-331   1   NA   NA   NA   NA   NA   NA   NA   NA
S2231000
  30cc   P30-0 (3 YR EXP)   H-129   5   S2001510   C-130   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760101   D-213
S2231200
  30cc   Bulk Pkg P30-O-L-B Latex Free   H-225   3   S2001515   C-192   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760101   D-213
S2232000
  30cc   LL Adapter Syring w/ Cap   H-129   5   S2001510   C-130   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760101   D-213
S2232010
  30cc   Printed Barrel w/ LL Adapter Welded   H-129   5   S2001510   C-130   none   M0360100   D-212   3   NA   NA   NA   NA   NA   NA   NA   NA
S2232030
  30cc   LL Adapter Syring   H-268   3   S2001510   C-130   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760101   D-213
S2232040
  30cc   P30-O-L Syringe - Latex   H-471   0   S2001510   C-130   none   M0360100   D-212   3   A2003005   R-100   4   S2002510   A-671   6   M1760101   D-213
S2233301
  30cc   LL Adapter Syring   H-301   2   S2001560   C-277   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760103   D-213
S2233303
  30cc   LL Adapter Syring   H-302   2   S2001561   C-278   none   M0360100   D-212   3   A2003010   R-247   1   S2002525   A-671   6   M1760101   D-213
S2040000
  3cc   1/2cc LL Controlled Stroke   H-386   0   S2000004   C-325   0   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1890100   D-284
S2040001
  3cc   1/2cc LL Controlled Stroke   H-386   0   S2000005   C-331   0   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1890100   D-284
S2040002
  3cc   1/2cc LL Controlled Stroke   H-386   0   S2000011   C-336   0   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1890100   D-284
S2040505
  3cc   1-1/2cc LL Controlled Stroke Latex Free   H-234   3   S2000500   C-269   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1890100   D-284
S2040755
  3cc   3/4cc Controlled Stroke Latex Free   H-235   3   S2000750   C-265   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1900100   D-285
S2040800
  3cc   3/4cc Controlled Stroke Latex Free   H-443   1   S2000800   C-338   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1900100   D-285
S2110000
  3cc   1/2cc LL Controlled Stroke   H-384   0   S2000002   C-327   0   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1910103   D-286
S2110002
  3cc   1cc Controlled Stroke W/ Natural Plunger   H-384   0   S2000012   C-337   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1910100   D-286
S2111005
  3cc   1cc Controlled Stroke Latex Free   H-236   3   S2001055   C-266   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1910100   D-286
S2112053
  3cc   LL Controlled Stroke Latex Free   H-370   2   S2001133   C-322   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2112070
  3cc   LL Controlled Stroke Latex Free   H-220   10   S2001138   C-203   2   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2112073
  3cc   LL Controlled Stroke   H-449   1   S2001137   C-311   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1850100   D-289
S2112074
  3cc   LL Controlled Stroke   H-451   1   S2001136   C-312   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2114209
  3cc   LL Controlled Stroke Latex Free   H246   3   S2001100   C-267   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1850100   D-289
S2116009
  3cc   LL Controlled Stroke Latex Free   H-377   1   S2001106   C-324   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2116010
  3cc   LL Controlled Stroke W/ Nat Plunger   H-214   6   S2001107   C-268   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2116011
  3cc   LL Controlled Stroke   H-352   4   S2001108   C-318   1   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870100   D-280
S2116012
  3cc   LL Controlled Stroke W/ White Plunger   H-214   6   S2001107   C-268   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1870101   D-280
S2117045
  3cc   LL Controlled Stroke Latex Free   H-237   4   S2001120   C-219   none   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1920100   D-287
S2131002
  3cc   3cc Black Plunger w/ Tip   H-317   3   NA   NA   n   n   n   n   A2000311   R107   5   NA   NA   NA   M1720102   D-202
S2132000
  3cc   LL Latex Free w/ Cap   H-123   13   S2001130   C-113   3   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1720101   D-202
S2132021
  3cc   LL Latex Free   H390   1   NA   NA   NA   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1720101   D-202
S2132030
  3cc   LL Latex Free   H-123   13   S2001130   C-113   3   M4260100   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1720101   D-202
S2132205
  3cc   LL Latex Free   H-271   2   NA   NA   n   M4260102   D-317   2   A2000311   R107   5   S2002111   A-671   6   M1720102   D-202
S2171060
  5cc   LS Syringe   H-226   5   S2001215   B-1364   2   M0392000   D-283   5   A2100510   R-233   1   S2002215   A-671   6   M1730101   D-207
S2171062
  5cc   LL Adapter Syringe   H-287   4   S2001215   B-1364   2   M0392000   D-283   5   A2100510   R-233   1   S2002215   A-671   6   M1730101   D-207
S2171100
  5cc   Bulk Pkg P5-O-A Syringe w/ Cap   H-212   5   NA   NA   NA   M0310100   D-208   5   A2100510   R-233   1   S2002215   A-671   6   M1730101   D-207
S2171110
  5cc   Bulk Pkg P5-O-A Syringe No Cap   H-212   5   NA   NA   NA   M0310100   D-208   5   A2100510   R-233   1   S2002215   A-671   6   M1730101   D-207
S2172035
  5cc   P5-0-L-A W/ Cap No Print   H-212   5   NA   NA   NA   M0310100   D-208   5   A2100510   R-233   1   S2002215   A-671   6   M1730101   D-207
S2240000
  60cc   Controlled Stroke Syringe   H-382   0   S2000001   B-1419   none   M0370100   D-215   7   A2101065   R-248   2   S2002615   A-671   6   M6920103   D-349
S2240500
  60cc   Printed Barrel w/ LL Adapter Welded   H-455   0   S2001605   C-270   none   M0370100   D-215   7   NA   NA   NA   NA   NA   NA   NA   NA
S2240510
  60cc   LL Syringe Assy - Latex Free   H-455   0   S2001605   C-270   none   M0370100   D-215   7   A2101065   R-248   2   S2002615   A-671   6   M1830101   D-288
S2242010
  60cc   LL Adapter Syring   H-454   0   S2001610   C-154   none   M0370100   D-215   7   A2101065   R-248   2   S2002615   A-671   6   M1770101   D-216

 

 


 

                                                                                         
            Molded       Molded   Molded           Molded Leur       Molded LL   Molded LL           Molded Ring   Qty                   Total    
            Plunger   Molded   Plunger Plug   Plunger Plug   Molded Leur   Molded Leur   Lock Adapter   Molded LL   Syring Cap   Syring Cap   Molded Ring   Molded Ring   Grip   Syringes   Ploybag   Qty   Qty   Ployliner   Syringes per    
    Barrel       Revision   Plunger Plug   Drawing   Revision   Lock Adapter   Lock Adapter   Revision   Syring Cap   Drawing   Revision   Grip Part   Grip Drawing   Revision   per   Part   Polybags   Polyliner   Part   Shipping   Shipping
Part Number   Size   Description   Level   Part Number   Number   Level   Part Number   Drawing Number   Level   Part Number   Number   Level   Number   Number   Level   Polybag   Number   per Tote   per Tote   Number   Container   Container
S2000520
  1.25cc   Printed Barrel Only P1-0-L   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   3   A4601216   2500   TOTE
S2112071
  1.25cc   Printed Syringe - Henry Shein   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2112072
  1.25cc   Printed Syringe - Henry Shein   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2114241S
  1.25cc   Generic Latex Free Syringe   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2114242S
  1.25cc   Generic Latex Free Syringe   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2114247S
  1.25cc   Logo Less Latex   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2115002
  1.25cc   OEM Latex Free   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2115005
  1.25cc   Latex Free Syringe - Arrow Intl   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2115016
  1.25cc   Latex Free Syringe   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   250   A4601300   10   1   A4601215   2500   TOTE
S2000305
  10cc   Printed High Value Barrel   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   2   A4601215   750   TOTE
S2001322
  10cc   Printed Barrel only Double Scale   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112032
  10cc   High Value Syr Contr.   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112034
  10cc   High Value Syr Red Nitro   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112042
  10cc   High Value Syr Blue   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112043
  10cc   High Value Syr Grn   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112044
  10cc   High Value Syr Yel   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112045
  10cc   High Value Syr Red   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2112046
  10cc   High Value Syr Wht   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2170000
  10cc   LL Controlled Stroke W/ Latex Plunger   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2170001
  10cc   LL Controlled Stroke W/ Latex Plunger   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2170002
  10cc   LL Controlled Stroke W/ Latex Plunger   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2170003
  10cc   LL Controlled Stroke W/ Latex Plunger   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2190000
  10cc   LL Controlled Stroke   0   NA   NA   NA   NA   NA   NA   NA   G-136   10   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2191005
  10cc   Bulk Pkg P10-O-A w/ Cap   4   NA   NA   NA   NA   NA   NA   M0480201   G-136   10   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2191010
  10cc   Bulk Pkg P10-O-A No Cap   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2191020
  10cc   LL Syringe   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2191030
  10cc   P10-0, No Cap, B   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2192000
  10cc   LL Syringe w/ Cap   4   NA   NA   NA   NA   NA   NA   B0843225   J-2238   1   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2192025
  10cc   LL Syringe Assy, No Logo   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2192027
  10cc   LL Syringe No Cap   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2192030
  10cc   LL Double Scale   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2192040
  10cc   LL Rad Resistant Syringe   4   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   750   TOTE
S2000405
  20cc   Printed High Value Barrel   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   2   A4601215   300   TOTE
S2112047
  20cc   High Value Syr Blue   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2112048
  20cc   High Value Syr Grn   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2112049
  20cc   High Value Syr Yel   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2112050
  20cc   High Value Syr Red   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2112051
  20cc   High Value Syr Wht   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2221000
  20cc   LS Latex Free w/ Cap   2   M1800101   D-211   1   NA   NA   NA   M0510201   G-119   9   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2221025
  20cc   LS Latex Free   2   M1800101   D-211   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2221050
  20cc   LS Latex Free w/ Cap   2   M1800101   D-211   1   NA   NA   NA   M0510201   G-119   9   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2222110
  20cc   P20-0-L No Cap   2   M1800101   D-211   1   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   300   TOTE
S2223012
  20cc   LL Adapter w/ Thumb Ring   0   NA   NA   NA   M0120100   G-101   17   NA   NA   NA   M1840100   D-295   1   N/A   N/A   N/A   2   A4601215   300   TOTE
S2223013
  20cc   LL Adapter w/ Thumb Ring and Cap   0   NA   NA   NA   M0120100   G-101   17   M0520201   G-100   7   M1840100   D-295   1   N/A   N/A   N/A   2   A4601215   300   TOTE
S2001382
  25cc   Printed Barrel 25ML (infl syringe)   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2231000
  30cc   P30-0 (3 YR EXP)   3   M1810101   D-211   1   NA   NA   NA   M0510201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2231200
  30cc   Bulk Pkg P30-O-L-B Latex Free   3   NA   NA   NA   M0120100   G-101   17   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2232000
  30cc   LL Adapter Syring w/ Cap   3   M1810101   D-214   1   M0120100   G-101   17   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2232010
  30cc   Printed Barrel w/ LL Adapter Welded   NA   NA   NA   NA   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2232030
  30cc   LL Adapter Syring   3   NA   NA   NA   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2232040
  30cc   P30-O-L Syringe - Latex   3   NA   NA   NA   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2233301
  30cc   LL Adapter Syring   3   M1810101   D-214   1   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2233303
  30cc   LL Adapter Syring   3   M1810101   D-214   1   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   250   TOTE
S2040000
  3cc   1/2cc LL Controlled Stroke   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2040001
  3cc   1/2cc LL Controlled Stroke   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2040002
  3cc   1/2cc LL Controlled Stroke   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2040505
  3cc   1-1/2cc LL Controlled Stroke Latex Free   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2040755
  3cc   3/4cc Controlled Stroke Latex Free   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2040800
  3cc   3/4cc Controlled Stroke Latex Free   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2110000
  3cc   1/2cc LL Controlled Stroke   2   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2110002
  3cc   1cc Controlled Stroke W/ Natural Plunger   2   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2111005
  3cc   1cc Controlled Stroke Latex Free   2   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2112053
  3cc   LL Controlled Stroke Latex Free   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2112070
  3cc   LL Controlled Stroke Latex Free   0   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601200   2000   TOTE
S2112073
  3cc   LL Controlled Stroke   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2112074
  3cc   LL Controlled Stroke   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2114209
  3cc   LL Controlled Stroke Latex Free   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2116009
  3cc   LL Controlled Stroke Latex Free   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2116010
  3cc   LL Controlled Stroke W/ Nat Plunger   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2116011
  3cc   LL Controlled Stroke   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2116012
  3cc   LL Controlled Stroke W/ White Plunger   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2117045
  3cc   LL Controlled Stroke Latex Free   3   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2131002
  3cc   3cc Black Plunger w/ Tip   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2132000
  3cc   LL Latex Free w/ Cap   5   NA   NA   NA   NA   NA   NA   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2132021
  3cc   LL Latex Free   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2132030
  3cc   LL Latex Free   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2132205
  3cc   LL Latex Free   5   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   2000   TOTE
S2171060
  5cc   LS Syringe   3   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2171062
  5cc   LL Adapter Syringe   3   NA   NA   NA   M0122000   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2171100
  5cc   Bulk Pkg P5-O-A Syringe w/ Cap   3   NA   NA   NA   NA   NA   NA   M0510201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2171110
  5cc   Bulk Pkg P5-O-A Syringe No Cap   3   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2172035
  5cc   P5-0-L-A W/ Cap No Print   3   NA   NA   NA   M0120100   G-101   17   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   1500   TOTE
S2240000
  60cc   Controlled Stroke Syringe   1   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   150   TOTE
S2240500
  60cc   Printed Barrel w/ LL Adapter Welded   NA   NA   NA   NA   M0120100   G-101   17   NA   NA   NA   NA   NA   NA   N/A   N/A   N/A   2   A4601215   150   TOTE
S2240510
  60cc   LL Syringe Assy - Latex Free   1   S1002901 S1002908   J-250
none
  0
none
  M0120100   G-101   17   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   150   TOTE
S2242010
  60cc   LL Adapter Syring   0   M1820101   D-217   3   M0120100   G-101   17   M0520201   G-100   7   NA   NA   NA   N/A   N/A   N/A   2   A4601215   150   TOTE

 

 


 

         
    Exhibit C – ProcQASpecs   IBSASSY061604
                                                                                   
                                                    Barrel                        
                            Plunger Tip       Barrel       Barrel       Printing       Syringe       Syringe        
                    Plunger Tip       Siliconizing       Printing       Printing   Barrel   Setup       Assembly       Assembly   Syringe   Setup
                Punger Tip   Siliconizing   Punger Tip   QAP   Barrel   PCP       QAP   Printing   Parameters   Syringe   PCP       QAP   Assembly   Parameters
    Barrel       Drawing   Siliconizing   PCP Revision   Siliconizing   Revision   Printing   Revision   Barrel Printing   Revision   Setup   Revision   Assembly   Revision   Syringe   Revision   Setup   Revision
Part Number   Size   Description   Number   PCP   Level   QAP   Level   PCP   Level   QAP   Level   Parameters   Level   PCP   Level   Assembly QAP   Level   Parameters   Level
S2000305
  10cc   Printed High Value Barrel   H-365   NA   NA   NA   NA   2145   5   101QAP006   D   SU 0116   3   NA   NA   NA   NA   NA   NA
S2000405
  20cc   Printed High Value Barrel   H-365   NA   NA   NA   NA   2145   5   101QAP006   D   SU 0116   3   NA   NA   NA   NA   NA   NA
S2000520
  1.25cc   Printed Barrel Only P1-0-L   H-405   NA   NA   NA   NA   2145   5   101QAP006   D   SU 0116   3   NA   NA   NA   NA   NA   NA
S2112071
  1.25cc   Printed Syring - Henry Shein   H-346   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2112072
  1.25cc   Printed Syring - Henry Shein   H-499   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2114241S
  1.25cc   Generic Latex Free Syringe   H-375   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   3510   3   101QAP001   D   SU 0126   1
S2114242S
  1.25cc   Generic Latex Free Syringe   H-375   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   3510   3   101QAP001   D   SU 0126   1
S2114247S
  1.25cc   Logo Less Latex   H-452   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2115002
  1.25cc   OEM Latex Free   H-424   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2115005
  1.25cc   Latex Free Syringe   H-398   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2115016
  1.25cc   Latex Free Syringe   H-405   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   3510   3   101QAP001   D   SU 0126   1
S2001322
  10cc   LL Double Scale   H-261   101PCP002   E   NA   NA   2145   5   101QAP006   D   SU 0158   2   NA   NA   NA   NA   NA   NA
S2112032
  10cc   High Value Syr Contr   H-477   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112034
  10cc   High Value Syr Red Nitro   H-479   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112042
  10cc   High Value Syr Blue   H-480   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112043
  10cc   High Value Syr Grn   H-481   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112044
  10cc   High Value Syr Yel   H-482   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112045
  10cc   High Value Syr Red   H-483   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2112046
  10cc   High Value Syr Wht   H-361   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0089   2   802   10   101QAP010   D   SU 0257   0
S2170000
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP009   D   SU 0157   1
S2170001
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP009   D   SU 0157   1
S2170002
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP009   D   SU 0157   1
S2170003
  10cc   LL Controlled Stroke W/ Latex Plunger   H-387   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP009   D   SU 0157   1
S2190000
  10cc   LL Controlled Stroke   H-381   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP009   D   SU 0157   0
S2191005
  10cc   Bulk Pkg P10-O-A w/ Cap   H-204   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101QAP003   D   SU 0249   0
S2191010
  10cc   Bulk Pkg P10-O-A No Cap   H-204   101PCP002   E   101QAP008   A   NA   NA   101QAP006   D   NA   NA   802   10   101QAP003   D   SU 0249   0
S2191020
  10cc   LL Syringe   H-132   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2191030
  10cc   P10-0, No Cap, B   H-289   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2192000
  10cc   LL Syringe w/ Cap   H-132   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2192025
  10cc   Syringe, No Logo   H-182   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2192027
  10cc   LL Syringe No Cap   H-132   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2192030
  10cc   LL Double Scale   H-261   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0254   0
S2192040
  10cc   LL Rad Resistant Syringe   H-278   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0158   2   802   10   101QAP003   D   SU 0249   0
S2112047
  20cc   High Value Syr Blue   H-354   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0090   3   3461   3   101QAP010   D   SU 0258   0
S2112048
  20cc   High Value Syr Grn   H-354   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0090   3   802   10   101QAP010   D   SU 0258   0
S2112049
  20cc   High Value Syr Yel   H-354   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0090   3   802   10   101QAP010   D   SU 0258   0
S2112050
  20cc   High Value Syr Red   H-354   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0090   3   802   10   101QAP010   D   SU 0258   0
S2112051
  20cc   High Value Syr Wht   H-354   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0090   3   802   10   101QAP010   D   SU 0258   0
S2221000
  20cc   LS Latex Free w/ Cap   H-130   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0072   2   3291   3   101QAP003   D   SU 0365   0
S2221025
  20cc   LS Latex Free   H-130   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0072   2   3291   3   101QAP003   D   SU 0251   0
S2221050
  20cc   LS Latex Free   H-313   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   3291   3   101QAP003   D   SU 0251   0
S2222110
  20cc   P20-0-L, No Cap   H-183   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0072   2   3291   3   101QAP003   D   SU 0251   0
S2223012
  20cc   LL Adapter w/ Thumb Ring   H-264   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0072   2   1172   3   101QAP003   D   SU 0264   0
S2223013
  20cc   LL Adapter w/ Thumb Ring and Cap   H-281   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0072   2   1172   3   101QAP003   D   SU 0264   0
S2001382
  25cc   Printed Barrel 25ML (infl syringe)   H-365   NA   NA   NA   NA   3472   5   101QAP005   D   SU 0091   2   NA   NA   NA   NA   NA   NA
S2231000
  30cc   P30-0 (3 YR EXP)   H-129   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   2   802   10   101QAP003   D   SU 0244   0
S2231200
  30cc   Bulk Pkg P30-O-L-B Latex Free   H-225   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   2   802   10   101QAP003   D   SU 0245   0
S2232000
  30cc   LL Adapter Syring w/ Cap   H-129   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   3   802   10   101QAP003   D   SU 0244   0
S2232010
  30cc   LL Adapter Syring w/ Cap   H-129   NA   NA   NA   NA   2145   5   101QAP006   D   SU 0073   3   NA   NA   NA   NA   NA   NA
S2232030
  30cc   LL Adapter Syring   H-268   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   3   802   10   101QAP003   D   SU 0245   0
S2232040
  30cc   P30-O-L Syringe - Latex   H-471   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   3   802   10   101QAP003   D   SU 0245   0
S2233301
  30cc   LL Adapter Syring   H-301   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   3   802   10   101QAP003   D   SU 0244   0
S2233303
  30cc   LL Adapter Syring   H-302   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0073   3   802   10   101QAP003   D   SU 0244   0
S2040000
  3cc   1/2cc LL Controlled Stroke   H-386   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2040001
  3cc   1/2cc LL Controlled Stroke   H-386   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2040002
  3cc   1/2cc LL Controlled Stroke   H-386   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2040505
  3cc   1-1/2cc LL Controlled Stroke Latex Free   H-234   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2040755
  3cc   3/4cc Controlled Stroke Latex Free   H-235   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   SU 0086   1
S2040800
  3cc   3/4cc Controlled Stroke Latex Free   H-443   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2111000
  3cc   1/2cc LL Controlled Stroke   H-384   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2111002
  3cc   1cc Controlled Stroke W/ Natural Plunger   H-384   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2111005
  3cc   1cc Controlled Stroke Latex Free   H-236   101PCP002   E   101QAP008   A   2145   5   101QAP005   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2112053
  3cc   LL Controlled Stroke Latex Free   H-370   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2112070
  3cc   LL Controlled Stroke Latex Free   H-220   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2112073
  3cc   LL Controlled Stroke   H-449   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2112074
  3cc   LL Controlled Stroke   H-451   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0086   1
S2114209
  3cc   LL Controlled Stroke Latex Free   H246   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2116009
  3cc   LL Controlled Stroke Latex Free   H-377   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0116   3   802   10   101QAP009   D   SU 0224   0
S2116010
  3cc   LL Controlled Stroke W/ Nat Plunger   H-214   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2116011
  3cc   LL Controlled Stroke   H-352   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0224   0
S2116012
  3cc   LL Controlled Stroke W/ White Plunger   H-214   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0086   0
S2117045
  3cc   LL Controlled Stroke Latex Free   H-237   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101QAP009   D   SU 0086   1
S2131002
  3cc   3/4mL Controlled Stroke Latex Free   H-443   101PCP002   E   101QAP008   A   2145   5   2.006   D   SU 0067   3   802   10   101QAP009   D   DB 5212   1
S2132000
  3cc   LL Latex Free w/ Cap   H-123   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101PCP002   D   DB 5212   1
S2132021
  3cc   LL Latex Free   H390   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101PCP002   D   NA   NA
S2132030
  3cc   LL Latex Free   H-123   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0067   3   802   10   101PCP002   D   DB 5212   1
S2132205
  3cc   LL Latex Free   H-271   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101PCP002   D   DB 5212   1
S2171060
  5cc   LS Syringe   H-226   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0088   2   802   10   101PCP002   D   SU 0369   0
S2171062
  5cc   LL Adapter Syringe   H-287   101PCP002   E   101QAP008   A   3472   5   101QAP005   D   SU 0088   2   802   10   101PCP002   D   DB 5213   1
S2171100
  5cc   Bulk Pkg P5-O-A Syringe w/ Cap   H-212   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101PCP002   D   DB 5213   1
S2171110
  5cc   Bulk Pkg P5-O-A Syringe No Cap   H-212   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101PCP002   D   DB 5213   1
S2172035
  5cc   P5-0-L-A w/ Cap No Print   H-212   101PCP002   E   101QAP008   A   NA   NA   NA   NA   NA   NA   802   10   101PCP002   D   DB 5213   1
S2240000
  60cc   Controlled Stroke Syringe   H-382   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0074   2   802   10   101QAP009   D   SU 0247   0
S2240500
  60cc   LL Syringe Assy - Latex Free   H-455   NA   NA   NA   NA   NA   NA   101QAP006   D   SU 0074   2   NA   NA   NA   NA   NA   NA
S2240510
  60cc   LL Syringe Assy - Latex Free   H-455   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0074   2   802   10   101QAP009   D   SU 0247   0
S2242010
  60cc   LL Adapter Syring   H-454   101PCP002   E   101QAP008   A   2145   5   101QAP006   D   SU 0074   2   802   10   101QAP004   D   SU 0246   0

 

 


 

         
    Exhibit D – MFG Specs   IBSASSY061604
                 
Work                
Center                
Number   Description   PCP   QAP   SU, DB
SA050
  Apex Printing   2145   101QAP006   SU 0067, SU 0072, SU 0073,
SU 0074, SU 0158
SA101
  1.25CC Automatic Syringe Machine   3510   101QAP001, 101QAP009   SU 0126
SA102
  3cc/5cc Semi-Automatic Assembly   802   101QAP002, 101QAP009   SU 0224, DB 5212, SU 0086,
SU 0369, DB 5213
SA104
  10cc/20cc Semi-Automatic Assembly   802/3291/1772/3461   101QAP003, 101QAP009   SU 0257, SU 0258, SU 0264,
SU 0365, SU 0251, SU 0264
SA106
  30cc/50cc Semi-Automatic Assembly   802   101QAP004, 101QAP009   SU 0244, SU 0245, SU 0246
CC040
  Imtram Barrel Printer   3472   101QAP005   SU 0088, SU 0089, SU 0090, SU0091
SA010
  Siliconization   101PCP002   101QAP008   None

 

 


 

Exhibit E – Siliconize prices
                                     
        Standard             Lead   Min Order   Incremental  
Part Number   Description   Unit Cost     Range     Time   Qty   Order Qty  
S1002932
  WASHED RUBBER VALVE .187 X .031   $ 55.00       0         1 batch   1 batch
S2002050
  SILICONIZED RUBBER B1-N, GREEN   $ 55.00       0         1 batch   1 batch
S2002054
  SILICONIZED PLUNGER TIP   $ 55.00       0         1 batch   1 batch
S2002111
  SILICONIZED RUBBERS   $ 55.00       0         1 batch   1 batch
S2002215
  SILICONIZED PLUNGER TIP - TRUMPET   $ 55.00       0         1 batch   1 batch
S2002555
  SILICONIZED STOPCOCK HANDLE   $ 55.00       0         1 batch   1 batch
S2002558
  SILICONIZED STOPCOCK HANDLE   $ 55.00       0         1 batch   1 batch
S2002559
  SILICONIZED STOPCOCK HANDLE   $ 55.00       0         1 batch   1 batch
S2002602
  O-RING SILICONIZED   $ 55.00       0         1 batch   1 batch
S2002605
  VALVE O-RING SILICONIZED   $ 55.00       0         1 batch   1 batch
S2002640
  SILICONIZED RUBBER ADD DEVICE   $ 55.00       0         1 batch   1 batch
S2002679
  SILICONIZE DISKS   $ 55.00       0         1 batch   1 batch
S2002693
  SILICONIZE VALVES   $ 55.00       0         1 batch   1 batch
S2002694
  SILICONIZE VALVES   $ 55.00       0         1 batch   1 batch
S2002310
  SILICONIZED RUBBER B-10, GREEN   $ 55.00       0         1 batch   1 batch
S2002312
  SILICONIZED SYRINGE PLUNGER TIP   $ 55.00       0         1 batch   1 batch
S2002411
  SILICONIZED PLUNGER TIP   $ 55.00       0         1 batch   1 batch
S2002525
  SILICONIZED PLUNGER TIP   $ 55.00       0         1 batch   1 batch
S2002615
  SILICONIZED RUBBERS   $ 55.00       0         1 batch   1 batch
S200568002
  GASKET, SLIT INTO LG MDX   $ 55.00       0         1 batch   1 batch
S2202604
  GREY O-RING SILICONIZED   $ 55.00       0         1 batch   1 batch
S2202665
  SILICONIZED PLUNGER TIP - TRUMPET   $ 55.00       0         1 batch   1 batch

 

 


 

Exhibit F – Tools & Equip
                         
Equipment           Tooling Number     Tooling  
Number   Equipment Description   Resource   (if available)     Description  
01
  3/5CC Syringe assembly table   SA102                
03
  10/20CC Syringe assembly table   SA104                
495
      SA101                

 

 


 

FIRST AMENDMENT TO SUPPLY AGREEMENT
THIS FIRST AMENDMENT TO SUPPLY AGREEMENT (this “Amendment”) is made and entered into as of this 20th day of January 2005, by and between B. Braun MEDICAL INC. (“B. Braun”) and INTEGRATED BIOSCIENCES, INC. (“Company”).
BACKGROUND
A. B. Braun and Company entered into a Supply Agreement dated as of September 15, 2003 (the “Supply Agreement”), pursuant to which Company agreed to manufacture and sell to B. Braun Products ordered from time to time; and
B. B. Braun and Company desire to extend the term of the Supply Agreement and otherwise amend the Supply Agreement, as set forth herein.
NOW THEREFORE, intending to be legally bound hereby, the parties agree as follows:
AGREEMENT
1  
Background Provisions: Defined Terms. The Background paragraphs set forth above are hereby incorporated in this Amendment as if fully set forth herein. Any capitalized terms not defined in this Amendment shall have the same meanings ascribed to such terms in the Supply Agreement.
2  
Amendments to Supply Agreement. The Supply Agreement is hereby amended as follows:
  a.  
The third sentence of Section 7 is hereby amended by deleting the reference to “Company” and replacing such deleted reference with “B. Braun”, effective as of September 15, 2003.
  b.  
Section 11 is hereby amended by deleting the reference to “Company Parties” and replacing such deleted reference with “Company, its officers, directors, employees, agents and/or subcontractors”, effective as of September 15, 2003.
  c.  
Section 12.1 is hereby amended by deleted the reference to “2004” and replacing such deleted reference with “December 31, 2006”, effective as of September 1, 2004. B. Braun shall the option to extend this agreement for two (2) additional years by providing supplier written notice of such extension at least 60 days prior to December 31,2006.

 

1


 

  d.  
The following new Section 16 is hereby added to the Supply Agreement immediately following Section 15.11:
 
     
“16. B. Braun Property. All the printers and other equipment described on Schedule 16 attached to the First Amendment to Supply Agreement dated as of January 20, 2005 (collectively, the “B. Braun Property”) shall be clearly marked and remain the personal property of B. Braun and shall be kept free of liens and encumbrances. Company shall (i) be responsible for the maintenance of the B. Braun Property; (ii) hold the B. Braun Property at Company’s own risk; and (iii) not modify the B. Braun Property without the permission of B. Braun. In addition, Company shall only use the B. Braun Property for the following purposes (i) for the manufacture, labeling and/or packaging of the Products for B. Braun; and (ii) for the manufacture, labeling and/or packaging of non-B. Braun products (the “Non-B. Braun Products”) only to the extent (aa) such Non-B. Braun Products are not syringes or components of syringes; (bb) Company’s supply of such Non-B. Braun Products do not and will not conflict with or affect Company’s fulfillment of B. Braun’s orders for Products; and (cc) such Non-B. Braun Products are not competitive with the Products or any other product manufactured or sold by B. Braun. Company shall redeliver the B. Braun Property to B. Braun in the same condition as originally received by Company plus improvements paid for by B. Braun upon the earlier of (i) termination of this Agreement; (ii) Company’s breach of or default under this Agreement and/or the Bill of Sale from Company dated 18 January 2005 (transferring certain printers from Company to B. Braun); or (iii) if B. Braun, in its sole discretion, provides Company with an option to match an offer from a third party to supply B. Braun with at least a majority of the Products on more favorable terms to B. Braun than the terms on which such Products are supplied hereunder and Company fails to match such third party offer. B. Braun makes no representations or warranties regarding the suitability of the B. Braun Property for the manufacture of any Non-B. Braun Products and Company hereby agrees to indemnify and hold B. Braun harmless from and against any and all damages, liabilities, losses or expenses, including legal expenses, arising from Company’s use of the B. Braun Property for the manufacture, labeling, packaging and/or sale of any Non-B. Braun Products.”
  e.  
Exhibit A is hereby amended and restated in its entirety by the Exhibit A attached to this Amendment, effective as of October 18, 2004.
  f.  
Exhibit F is hereby deleted in its entirety effective as of September 15, 2003.
  g.  
The Appendix D attached to this Amendment is hereby incorporated in to the Supply Agreement.

 

2


 

  h.  
The following new Sections 17, 18, 19, 20 and 21 are hereby added to the Supply Agreement immediately following Section 16 of the Supply Agreement:
17. Company shall manufacture, package, label, test, prepare and deliver the Products in accordance with Good Manufacturing Practices, applicable laws, the Specifications and such other specifications as are from time to time mutually agreed upon in writing by the parties hereto. Company shall not (i) make any process/product changes that would alter the chemical, biological or physical properties of the Product or any regulatory filings related to the Product or (ii) make any change in the Specifications, without B. Braun’s prior written consent. If at any time during the term of this Agreement, B. Braun desires to modify the Specifications, B. Braun shall have the right upon ninety (90) days prior written notice to Company, to modify or change the Specifications, subject to Company’s approval, which approval shall not be unreasonably withheld or delayed; provided that B. Braun shall have the right to terminate this Agreement if Company does not approve any requested change.
18. The parties shall promptly and fully advise each other of any instructions, recommendations or specifications required by the FDA or any other government regulatory agency concerning the Products. Company will notify B. Braun and B. Braun shall notify Company of any actions that Company or B. Braun, as the case may be, intends to take in response to government regulatory agency requirements concerning the Products. Disclosures by any party to the other parties may be modified to protect such disclosing party’s proprietary information and technology.
19. Quality Control and Assurance
19.1 Company will provide to B. Braun a Certificate of Compliance and/or a Certificate of Analysis for each delivery of Product. The Certificate of Compliance and/or Certificate of Analysis shall state compliance with Good Manufacturing Practices and the Specifications, provide documentation of test results and methods supporting such compliance and shall be in a form acceptable to B. Braun.
19.2 Company shall maintain the Device History File and/or Batch Production Control Records for the Products. Company shall retain samples from each lot in numbers that may be required for post-distribution testing in a manner consistent with its standard operating procedure and for a period of one (1) year past the supplier ship date to B Braun.

 

3


 

19.3 Company shall perform such quality control and quality assurance testing as is required by the Specifications, this Agreement and Applicable Laws. At B. Braun’s request, Company will provide all supporting documentation (including the complete batch record) to B. Braun for Company’s manufacturing processes showing compliance to Good Manufacturing Practices and such other information needed by B. Braun’s quality assurance personnel. It is understood between the parties hereto that all critical processes affecting the purported identity, strength, quality or purity of the Product being manufactured, assembled and/or packaged shall be qualified and maintained in a validated state, and the scope and extent of the necessary validation documentation shall be determined by B. Braun. B. Braun shall be notified in advance of any validation studies, and the completed studies shall be made available to B. Braun upon request.
20. It is understood that B. Braun may, from time to time, send representatives to Company’s manufacturing facility or its suppliers’ facilities to observe, audit and inspect the production facilities, and Company will allow B. Braun’s representatives access to all applicable manufacturing records for the Products so as to ensure that Company is in compliance with Applicable Laws and the Specifications. Said observation, audit, and/or inspection of Company shall be during normal working hours, of reasonable duration, and at the sole expense of B. Braun. As soon as reasonably practicable, Company will correct, to the reasonable satisfaction of B. Braun, any non-compliance with the above practices, regulations or Specifications that are discovered and brought to its attention as a result of such inspections. Company will provide B. Braun with a copy of all FDA or other regulatory agency correspondence relating to the Product, including without limitation any FDA Form 483 or warning letters relating to the manufacturing facility. Such information will be provided to B. Braun within five (5) days of Company’s receipt of the same.
21. In the event that a recall order is issued or requested on a Product or a B. Braun product incorporating a Product by an entity having authority and jurisdiction in the matter or in the event that B. Braun makes the decision to recall a Product or a B. Braun product incorporating a Product and it is determined by B. Braun that such recall arises from (i) a failure of a Product to meet the warranties in Section 8 of the contract or (ii) a breach of this Agreement by Company, then Company shall credit B. Braun’s account for the Products recovered and returned to it as a result of any action (or destroyed at Company’s request) and Company shall bear all costs of any recall, report of correction or removal activities and shall be responsible for B. Braun’s damages in connection therewith
3  
Incorporation: Ratification. Other than as specifically set forth in this Amendment, the terms and conditions of the Supply Agreement shall remain in full force and effect without modification, and are hereby ratified and affirmed. Without limiting the foregoing, the parties agree and confirm that the Supply Agreement has not terminated and/or expired since its original execution as of September 15, 2003. This Amendment is made a part of the Supply Agreement and the Supply Agreement is hereby incorporated herein. All references to the Supply Agreement shall mean the Supply Agreement as modified by this Amendment.

 

4


 

4  
Entire Agreement. The Supply Agreement, as amended by this Amendment, contains the entire agreement and understanding between the parties with respect to the subject matter hereof and supersedes all prior proposals and agreements between the parties, whether oral or written, and there are no other promises or representations relating to the subject matter hereof that is not incorporated herein
IN WITNESS WHEREOF, the parties have executed and delivered this Amendment as of the day and year first above written.
                 
B. BRAUN MEDICAL INC.       INTEGRATED BIOSCIENCES, INC.
 
               
By:
  /s/ Michael Stammherr       By:   /s/ Edward J. Paukovits, Jr.
 
               
 
  Name: Michael Stammherr           Name: Edward J. Paukovits, Jr.
 
  Title:   Vice President, Strategic Purchasing           Title:   President
 
               
Date:
  2/21/05       Date:   1/20/05
 
               
By:
  /s/ Mark Buckley            
 
 
 
Name: Mark Buckley
           
 
  Title:   Commodity Manager            
 
               
Date:
  2/21/05            
 
 
 
           

 

5


 

SCHEDULE 16
             
Equipment            
Description   Model #   Serial #   Associated Items
 
Apex Rotary Syringe Barrel Printer
  C-50   76102   mandrel tooling and print plates
Imtram Rotary Pad Syringe Barrel Printer
  GS200   97B02   barrel fixtures and print pads

 

6


 

Second AMENDMENT
TO SUPPLY AGREEMENT
This Second Amendment to Supply Agreement (“Amendment”) is made and entered into as of this 2nd day of March, 2009, by and between B. Braun MEDICAL INC. (“Company”) and INTEGRATED BIOSCIENCES, INC. (“Supplier”).
BACKGROUND
  A.  
B. Braun MEDICAL, INC. and INTEGRATED BIOSCIENCES, INC. entered into a Supply Agreement dated September 15, 2003 (the “Supply Agreement”), pursuant to which INTEGRATED BIOSCIENCES, INC. agrees to provide assembled syringes for Company.
 
     
B. Braun MEDICAL, INC. and INTEGRATED BIOSCIENCES, INC. amended the above Agreement on February 21, 2005.
  B.  
B. Braun MEDICAL INC. and INTEGRATED BIOSCIENCES, INC. desire to modify the amended Supply Agreement, as set forth herein.
 
     
NOW THEREFORE, intending to be legally bound hereby, the parties agree as follows:
AMENDMENTS
  1.  
Extend term of Agreement for one additional Year. The amended expiration date will be December 31, 2009.
  2.  
2009 unit price will be per attached.
  3.  
All other terms of original Agreement and the 1st Amendment will remain in effect.
IN WITNESS WHEREOF, the parties have executed and delivered this Amendment as of the day and year first above written.
         
    B. BRAUN MEDICAL, INC.
 
       
 
  By:   /s/ Marty Gahman
 
       
 
      Name: Marty Gahman
 
      Title:   Corporate Commodity Manager
 
       
    INTEGRATED BIOSCIENCES, INC.
 
       
 
  By:   /s/ Tina M. Hager
 
       
 
      Name: Tina M. Hager
 
      Title:   Vice-President of Finance and Administration

 

 


 

Integrated BioSciences, Inc.
Price list for B. Braun January 1 , 2009-December 31, 2009
                         
Work                   ’08 -09  
Center   Size     Part Number   Description   Pricing  
 
    25.00     S2001382   25ML PRINTED BARREL   $ 2.0360  
 
          S2002604   SIL, 0-RING GASKET   $ 0.0245  
 
          S2002679   SIL, LATEX FREE DISK   $ 0.0189  
 
          S2002693   SIL, HMOSTAS DUCKBILL VALVE SM BLUE   $ 0.0268  
 
          S2002694   SIL, HMOSTAS DUCKBILL VALVE LGE BLU   $ 0.0380  
 
          S200568002   SIL INTRODUCER GASKT, LG BODY, SLIT   $ 0.0721  
SA101
    1.25     S2112071   1.25CC SYR ASSY, 10% HENRY SCHEIN   $ 0.4102  
SA101
    1.25     S2112072   1.25CC SYR ASSY, LATEX FREE   $ 0.2682  
SA101
    1.25     S2114210   1.25CC SYR ASSY, NO PRINT, FEMALE   $ 0.1706  
SA101
    1.25     S2114241S   1.25CC SYR ASSY, NO PRINT, NATURAL   $ 0.2340  
SA101
    1.25     S2114247S   1.25CC SYR ASSY, NO LOGO LATEX FREE   $ 0.2798  
SA101
    1.25     S2114312   1.25CC SYR ASSY, NO PRINT, MALE, ATRX   $ 0.2180  
SA101
    1.25     S2115002   1.25CC SYR ASSY, FOREMOST DENTAL   $ 0.2725  
SA101
    1.25     S2115005   1.25CC SYR ASSY, ARROW INTL   $ 0.2725  
SA101
    1.25     S2115016   1 1/4CC SYR ASSY, NO LOGO   $ 0.2682  
SA102
    0.75     S2040755   CNTRLD STK SYR, 3/4CC, LATEX FREE   $ 0.4743  
SA102
    0.75     S2040800   0.75CC CONT STK SYR, LATEX FREE   $ 0.4743  
SA102
    1.00     S2111005   1CC CONT STK SYR, LATEX FREE   $ 0.3891  
SA102
    1.50     S2112053   1.5CC CONT STK SYR, CATHEX, LATXFRE   $ 0.4611  
SA102
    1.50     S2112070   1.5CC CONT STK ASSY, BECTN-DICKNSON   $ 0.4653  
SA102
    1.25     S2112073   1.25CC CONT STK SYR ASSY LATEX FREE   $ 0.4672  
SA102
    1.50     S2112074   1.5CC CONT STK SYR ASSY, LATEX FREE   $ 0.4653  
SA102
    1.25     S2114209   1.25CC CONT STK SYR, LATEX FREE   $ 0.4672  
SA102
    1.50     S2116009   1.5ML CONT STK SYR ASSY, LATEX FREE   $ 0.4723  
SA102
    1.50     S2116010   1.5CC CONT STK ASSY, NAT PLUNGER   $ 0.4653  
SA102
    1.50     S2116011   1.5CC CONT STK SYR ASSY, ACKRAD   $ 0.4653  
SA102
    1.50     S2116012   1.5CC CONT STK ASSY, WHITE PLNGRER   $ 0.4974  
SA102
    2.00     S2117045   2CC CONTROLLED STROKE, LATEX FREE   $ 0.4726  
SA102
    3.00     S2131002   3CC SYR ASSY,BLK PLNGR W/GREY TIP   $ 0.1677  
SA102
    3.00     S2132021   3CC SYRINGE, NO PRINT — LATEX FREE   $ 0.3283  
SA102
    3.00     S2132205   3CC LUER LOCK SYR ASSY, PULPDENT   $ 0.2495  
SA102
    5.00     S2171060   5CC ASSY, CLEAR (P5-0)   $ 0.4314  
SA104
    10.00     S2112030   10CC HV SYR ASSY, BLUE W/BLACK TIP   $ 0.8250  
SA104
    10.00     S2112033   10CC HV SYR ASSY, YELO W/BLACK TIP   $ 0.8301  
SA104
    10.00     S2112034   10CC HV SYR ASSY, RED W/BLACK TIP   $ 0.8225  
SA104
    10.00     S2112042   10CC HV SYR ASSY, BLUE W/BLACK TIP   $ 0.8110  
SA104
    10.00     S2112043   10CC HV SYR ASSY, GREEN W/BLACK TIP   $ 0.8155  
SA104
    10.00     S2112044   10CC HV SYR ASSY, YELO W/BLACK TIP   $ 0.8301  
SA104
    10.00     S2112045   10CC HV SYR ASSY, RED W/BLACK TIP   $ 0.8225  
SA104
    10.00     S2112046   10CC HV SYR ASSY, WHITE W/BLACK TIP   $ 0.8273  
SA104
    10.00     S2112055   10CC SYR ASSY, FLOSEAL POWDER   $ 0.4684  
SA104
    10.00     S2112056   10CC SYR ASSY, FLOSEAL MIXING   $ 0.4684  
SA104
    10.00     S2112080   10CC HV SYR ASSY, BLUE, NO LOGO LF   $ 0.8243  
SA104
    10.00     S2112081   10CC HV SYRINGE, GREEN W/GREY TIP   $ 0.8288  
SA104
    10.00     S2112082   10CC HV SYR ASSY, YELO, NO LOGO LF   $ 0.8294  

 

 


 

                         
Work                   ‘08 -09  
Center   Size     Part Number   Description   Pricing  
SA104
    10.00     S2112083   10CC HV SYR ASSY, RED W/GREY TIP   $ 0.8217  
SA104
    10.00     S2112084   10CC HV SYR ASSY, WHITE, NO LOGO LF   $ 0.8265  
SA104
    10.00     S2112085   10CC HV SYR, RED NITRO, NO LOGO LF   $ 0.8217  
SA104
    10.00     S2112087   10CC HV SYR, YELO, LOCAL, NO LOGO   $ 0.8294  
SA104
    10.00     S2112088   10CC HV SYR ASSY, BLUE, HEPARIN   $ 0.8243  
SA104
    10.00     S2191010   P10-0 SYR ASSY, NO PRINT, NO CAP A   $ 0.3752  
SA104
    10.00     S2192030   10CC SYR ASSY, DOUBLE SCALE, NO CAP   $ 0.4408  
SA104
    20.00     S2112047   20CC HV SYR, BLUE, GRADS, LATEXFREE   $ 0.9712  
SA104
    20.00     S2112048   20CC HV SYR-GREEN, GRADS, LATEXFREE   $ 1.0500  
SA104
    20.00     S2112049   20CC HV SYR, YELO, GRADS, LATEXFREE   $ 1.0641  
SA104
    20.00     S2112050   20CC HV SYR, RED, GRADS, LATEXFREE   $ 0.9726  
SA104
    20.00     S2112051   20CC HV SYR, WHT, GRADS, LATEXFREE   $ 0.9754  
 
SA102
    3.00     S2132030   3CC SYR ASSY, NO CAP, P3-0-L   $ 0.3864  
SA102
    5.00     S2171100   SYR ASSY, P5-0 ‘A’   $ 0.3198  
SA104
    10.00     S2112054   10CC HIGH VALUE SYRINGE, WHITE   $ 0.7834  
SA104
    20.00     S2221025   SYR ASSM, P20-0 NO CAP   $ 0.0000  
SA104
    20.00     S2223012   ASSM 20CC LL SYR - RING CONTROL   $ 0.0000  

 

 

EX-10.20 6 c93531exv10w20.htm EXHIBIT 10.20 Exhibit 10.20
Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
         
(UNILIFE LOGO)
  633 Lowther Road
Lewisberry, PA 17339
717-938-9323 | 717-938-9364 Fax
  Purchase Order 005718-00
Vendor 000913
     
To :
  Ship to :
MIKRON ASSEMBLY TECHNOLOGY
  UNILIFE MEDICAL SOLUTIONS, INC.
562 Sable Boulevard
  633 Lowther Road
AURORA CO 80011
  Lewisberry PA 17339
 
  United States
Phone (303)364-5222    Fax (303)364-5224
                             
PO Date   Ship Via     FOB     Planner     Confirming to     Terms
11/12/2009   Best Way     YOUR PLANT     AFG     CHUCK MRAZ     SEE BELOW
                                             
Item   Facility / Part / Rev / Description / Details     Vendor Quantity     Promised Delivery     Vendor Unit Cost     Extended Cost  
1  
IBS Part No. — PAYMENT 1
Rev NS
25% with order
  U/M EA                                
   
 
  Order Quantity     1.00000       11/16/2009       [***]       [***]  
 
   
Purchasing Category : CAPITOL PURCHASES
                               
 
   
The invoice trigger for this line item is the Unilife purchase order. The payment terms for this line are net 30 days upon receipt of invoice.
               
 
2  
IBS Part No. — PAYMENT 2
Rev NS
25% at Preliminary Design Review
  U/M EA                                
   
 
  Order Quantity     1.00000       01/04/2010       [***]       [***]  
 
   
Purchasing Category : CAPITOL PURCHASES
                               
 
   
The invoice trigger for this line item is meeting minutes posted from the Preliminary Design Review Meeting. The payment terms for this line are net 30 days upon receipt of invoice.
               
 
3  
IBS Part No. — PAYMENT 3
Rev NS
20% at Final Design Review
  U/M EA                                
   
 
  Order Quantity:     1.00000       02/01/2010       [***]       [***]  
 
    Purchasing Category : CAPITOL PURCHASES                                
 
    The Invoice trigger for this line item is meeting minutes posted from the Final Design Review Meeting. The payment terms for this line are net 30 days upon receipt of Invoice.                
             
VENDOR COPY
  Page # 1        
 
     
 
Authorized Signature
   

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
         
(UNILIFE LOGO)
  633 Lowther Road
Lewisberry, PA 17339
717-938-9323 | 717-938-9364 Fax
  Purchase Order 005718-00
Vendor 000913
     
To :
  Ship to :
MIKRON ASSEMBLY TECHNOLOGY
  UNILIFE MEDICAL SOLUTIONS, INC.
562 Sable Boulevard
  633 Lowther Road
AURORA CO 80011
  Lewisberry PA 17339
 
  United States
Phone (303)364-5222    Fax (303)364-5224
                             
PO Date   Ship Via     FOB     Planner     Confirming to     Terms
11/12/2009   Best Way     OUR PLANT     AFG     CHUCK MRAZ     SEE BELOW
                                             
Item   Facility / Part / Rev / Description / Details     Vendor Quantity     Promised Delivery     Vendor Unit Cost     Extended Cost  
4  
IBS Part No. — PAYMENT 4
Rev NS
15% at FAT
  U/M EA                                
   
 
  Order Quantity     1.00000       08/02/2010       [***]       [***]  
 
   
Purchasing Category : CAPITOL PURCHASES
                               
 
   
The invoice trigger for this line item is the successful completion of the FAT at Mikron’s Denver location and the delivery of the FAT Report. This report will also trigger Unilife’s approval to ship. The payment terms for this line are net 30 days upon receipt of invoice.
               
 
5  
IBS Part No. — PAYMENT 5
Rev NS
15% of SAT
  U/M EA                                
   
 
  Order Quantity     1.00000       10/01/2010       [***]       [***]  
 
    Purchasing Category : CAPITOL PURCHASES                                
 
   
The invoice trigger for this line item is successful completion of the SAT at Unilife’s manufacturing facility and the delivery of the SAT Report. The payment terms for this line are net 30 days upon receipt of invoice.
           
   
 
                                   
    The terms and conditions that have been mutually agreed to on 11 NOV 2009 between Mikron and Unlllfe apply to this order and are attached for reference. This order, with its mutually agreed upon terms and conditions, supersedes any prior or conflicting agreements, as well as any terms and conditions specified in Sellers invoicing.     Total Items Price
Sales Tax
Fixed Cost
      [***]
[***]
[***]
 
 
    This order is based on Mikron Proposal D0409032, which was tendered in response to Unilife request for proposal to URS E001-01. Mikron Proposal D0409032 is an integral part of this order.   Total PO Price     [***]  
 
    This purchase order is for a system to automatically assemble Unilife’s RTFS Barrel Subassembly. The system is a pilot production line lo show the scalability of the product process for a future, high production line. Details of what the system entails, the requirements of the system and its necessary performance are defined in Mikron Proposal D0409032. The primary components being purchased are:                
 
    Pilot Line Cost [***]*                
    Optional Component Costs:                
    Validation Documentation Assistance (Level 2) [***]                
    Utilization of a redeployed G05 assembly cells (2) [***]                
 
    Total [***]                
             
VENDOR COPY
  Page # 2        
 
     
 
Authorized Signature
   

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
         
(UNILIFE LOGO)
  633 Lowther Road
Lewisberry, PA 17339
717-938-9323 | 717-938-9364 Fax
  Purchase Order 005718-00
Vendor 000913
Purchase Order Status: OPEN
     
To :
  Ship to :
MIKRON ASSEMBLY TECHNOLOGY
  UNILIFE MEDICAL SOLUTIONS, INC.
562 Sable Boulevard
  633 Lowther Road
AURORA CO 80011
  Lewisberry PA 17339
 
  United States
Phone (303)364-5222    Fax (303)364-5224
                             
PO Date   Ship Via     FOB     Planner     Confirming to     Terms
11/12/2009   Best Way     OUR PLANT     AFG     CHUCK MRAZ     SEE BELOW
                                           
Item     Facility / Part / Rev / Description / Details   Vendor Quantity     Promised Delivery     Vendor Unit Cost     Extended Cost  
       
*Note: This price includes [***].
                             
 
        Invoices will be sent to Gary Reynolds and Tim Spang by e-mail.                
 
        The project start date is 16 NOV 2009.                
             
VENDOR COPY
  Page # 3        
 
     
 
Authorized Signature
   

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
TERMS AND CONDITIONS
1.0   OFFER AND ACCEPTANCE. This Order is an offer to purchase and is limited to the terms and conditions contained herein. Acceptance of this Purchase Order is expressly and exclusively made conditional on Seller’s assent to these terms and conditions. Any different or additional terms and conditions that may appear in Seller’s acknowledgement or acceptance shall have no effect. Unilife expressly objects to and rejects all inconsistent or additional terms and conditions and limitations contained on any of Seller’s forms or other writings. Seller may accept this order only by executing and returning to Unilife the acknowledgment copy hereof.
 
    If Seller shall, instead of accepting this Order, ship any goods in response to this order, Unilife may at its sole election, either reject the tendered goods or treat such action as constituting acceptance and assent to the terms and conditions hereof. This order is based on Unilife RFQ and Seller’s fixed price, response which is incorporated herein by reference. If changes (Price or Delivery) are required to this order due to Unilife’s modifying the equipment requirement(s) Seller must provide a change request to Unilife’s Project Manager. Until Seller receives a modified User Requirements Specifications document and Change Order, equipment changes are not authorized by Unilife.
 
2.0   SHIPMENT. The shipment will be made to Unilife, DDP Lewisberry, Pennsylvania. The Seller is responsible for selecting the carrier and insuring that this earlier is a cost efficient proper shipment method. Unilife will pay the cost of Freight and Insurance upon receipt of a copy of the shippers invoice to the Seller. Unless requested by Unilife in writing priority shipment methods will not be utilized. Unless otherwise agreed to in writing by Unilife, prices on the face hereof include all charges for packing, and crating, and Seller is obligated to suitably pack, mark and ship all goods to prevent damage and to conform to requirements of common carriers. Unless Seller can repair the damage at Unilife’s facilities within a reasonable period of time and to Unilife’s reasonable satisfaction, Unilife shall have the right to return all freight damaged merchandise, freight collect, to Seller and receive full credit if the unit cannot be repaired in a reasonable time, unless said damage has been caused by the negligence of Unilife.
 
3.0   DELIVERY. Time is of the essence: Unilife selected Seller in part based on the delivery data in its response to the Unilife URS number E001-01 and the Seller response Proposal D0409032 which are an integral part of this Order. Deliveries that are not made on the date or dates specified will be subject to Section 14. (Liquidated Damages). Unilife will perform a Design Qualification (DQ) at Seller’s site validating that the equipment performs to their Proposal output specifications. Successful completion of this test authorizes Seller to ship product but does not acknowledge that Unilife will receive a system from Seller that meets the order requirements. The Seller will electronically (E-Mail or Fax) send a notice of shipment within five (5) working days of the date the equipment is shipped to Unilife. This notification may be an invoice but needs to include the appropriate shipment tracking information.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
4.0   INSPECTION AND QUALITY CONTROL. Notwithstanding payment, passage of title, prior inspection or test, all items are subject to final inspection and acceptance or rejection at Unilife’s plant. Seller shall use an inspection system approved by Unilife in writing that is reviewed during the Design review at the Seller. Additionally, Unilife will at the design review provide the Seller with a high level overview of the DQ that will need to be completed. All inspection records relating to items covered by this order shall be available to Unilife during the performance of this order and shall be retained by Seller for three (3) years after final payment by Unilife. All items covered by this order may be inspected and tested by Unilife, its customers, designated affiliates, and the local, state and Federal government at all reasonable times and places during the period of Seller’s performance under this order. Seller shall provide, without additional charge, all reasonable facilities and assistance for such inspections and tests. The conditions of warranty, paragraph 6, are in addition to the conditions of this paragraph.
 
    Design Qualification (DQ) testing will occur at Seller’s site as noted above. Successful DQ testing means that the product has passed short turn run-off requirements and Unilife authorizes Seller to ship the product. Production Qualification (PQ) testing will occur at the destination point after the equipment has been received and set-up by Seller. This set up process will occur within 10 business day of the date the equipment is received by Unilife. PQ testing will take a minimum of thirty (30) and a maximum of forty-five (45) days. Unilife will authorize final payment upon successful SAT as defined in Seller’s proposal.
 
5.0   INTELLECTUAL PROPERTY. Intellectual Property means any know-how, trade secrets, inventions (patented or unpatented), improvements, patent applications, designs, data, copyrights, trademarks, technology and information or advice, oral or in writing, and includes any material or products made to Unilife’s RFQ requirements hereunder. In the event Intellectual Property is created or developed pursuant to this Order, Seller agrees that all Intellectual Property arising out of Unilife’s Confidential Information or otherwise in connection with this Order, shall be the sole and exclusive property of Unilife. To the extent necessary, Seller shall assign all of its rights, title and interest in all Intellectual Property, including copyrights, created pursuant to this Order. Seller specifically authorizes Unilife to take all necessary action to evidence the transfer of such ownership rights from Seller to Unilife.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
6.0   WARRANTIES AND LIABILITIES. Whether or not Seller is a merchant of goods, Seller warrants that all equipment provided by it: (i) shall be of good quality and workmanship and free from defects, latent or patent; (ii) shall strictly conform to all specifications, drawings and descriptions furnished, specified or adopted by Unilife; (iii) if, of Seller’s design, shall be free from design defects; (iv) shall be suitable and sufficient for their intended purposes; and (v) shall be free of any claim of any third party. NONE OF THE REMEDIES AVAILABLE TO Unilife FOR THE BREACH OF ANY OF THE FOREGOING WARRANTIES MAY BE LIMITED EXCEPT TO THE EXTENT AND IN THE MANNER AGREED UPON BY Unilife IN SEPARATE AGREEMENT SPECIFICALLY DESIGNATING SUCH LIMITATION AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF Unilife. NO LIMITATION ON LIABILITY OR ON DAMAGES FOR BREACH OF WARRANTY, BREACH OF CONTRACT, TORT OR OTHER LIABILITY SHALL APPLY, EXCEPT TO THE EXTENT AND IN THE MANNER AGREED UPON BY Unilife IN A SEPARATE AGREEMENT SPECIFICALLY DESIGNATING SUCH LIMITATION AND SIGNED BY AN AUTHORIZED REPRESENTATIVE OF Unilife. Except as specifically provided herein, Unilife limits liability of the Seller to $3,000,000.
 
    Unilife’s inspection and/or acceptance of and/or payment of goods shall not constitute a waiver by it of any warranties. Unilife’s approval of any sample or acceptance of any goods shall not relieve Seller from responsibility to deliver equipment conforming to specifications, drawings and descriptions.
 
    The warranty shall not apply to claims resulting from a failure of Unilife to operate the delivered goods in accordance with the written operation instructions provided by Seller, defective modifications or repairs undertaken by Unilife (unless same had been authorized by Seller), failure to use original Seller’s replacement parts (or parts approved by Seller) during the warranty period, or to the extent that Unilife does not give Seller an opportunity to remedy the defect itself. In addition, Unilife shall use its reasonable commercial efforts to prevent the damage from becoming more extensive once it is aware of the defect.
 
    The warranty and liability do not extend to damage which has demonstrably been caused by reasonable and natural wear and tear, Unilife’s defective maintenance, Unilife’s failure to comply with Seller’s written operating or safety instructions, building or assembly work which was not performed by Seller, its vendors or its subcontractors.
  6.1   Purchase Money Security Interest
  6.1.1   Grant of Security Interest
  6.1.1.1   Subject to the foregoing, Unilife hereby grants to Seller a security interest in and to the Equipment, and any and all additions, accessions and substitutions thereto or therefore (hereinafter called the “Collateral”) to secure Unilife’s payment for the Equipment (the “Obligations”). Unilife agrees to execute such documentation as may be reasonably required by Seller to further evidence and perfect such security interest, including without limitation financing statements. Unilife agrees that Seller can make whatever filings it reasonably deems necessary to perfect such security interest without Unilife’s signature, where allowed by applicable law. Upon payment in full, Unilife is hereby authorized, on Seller’s behalf, to execute and file such termination statements as it shall reasonably deem necessary to release such security interests.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
  6.1.1.2   Except for the security interest granted herein, Seller shall deliver to Unilife Collateral free from any adverse lien, security interest or encumbrances, and, until payment in full of the purchase price, that Unilife will defend the Collateral against all claims and demands of all persons at anytime claiming the same or any interest therein. The Collateral will be kept at Unilife’s address stated in this Agreement. Upon payment for the Equipment, Seller shall deliver a bill of sale to same as shall be acceptable to Unilife.
 
  6.1.1.3   Until such time as there shall occur a payment default, Unilife may have possession of the Collateral and use it in any lawful manner, and upon such default Seller shall have the immediate right to declare all Obligations secured hereby immediately due and payable and shall have the remedies of a secured party under Article 9 of the Pennsylvania Uniform Commercial Code. Seller may require Unilife to assemble the Collateral and deliver or make it available to Seller at a place to be designated by Seller which is reasonably convenient to both parties. Expenses of retaking, holding, preparing for sale, selling or the like shall include Seller’s reasonable attorney’s fees and legal expenses, and shall be the responsibility of Unilife.
  6.1.2   Intellectual Property
  6.1.2.1   The Equipment provided herein contains and requires intellectual property (including the intellectual property of third parties) in order to operate, such as software, formulas, processes and know how (i.e., “Intellectual Property”). By selling Unilife the Equipment, Seller is not transferring legal or equitable title to any part of the Intellectual Property. However, Seller hereby grants to Unilife a non-exclusive, perpetual worldwide, royalty-free license to use the Intellectual Property so long as and only in connection with the use of the Equipment by Unilife and its successors and assigns, and only if Unilife is not in default in its Obligations to Seller (the “Mikron License”). The Mikron License is strictly limited to use with the Equipment and may not be utilized independently of the Equipment.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
7.0   INDEMNIFICATION. Unilife shall indemnify, defend, and hold Seller harmless from and against all losses, costs, and expenses, including court costs and reasonable attorneys’ fees, for any claims, suits, judgments, demands, actions, or liabilities arising out of Unilife’s breach of any provision of the proposal or these Terms and Conditions of Sale by Unilife. Notwithstanding the foregoing, Unilife shall not be liable for damages in excess of the purchase price.
 
8.0   PATENT WARRANTY. Seller warrants that (i) neither the equipment furnished hereunder nor the sale or use thereof will infringe any United States or Foreign Letters Patent, trademark, copyright, or other proprietary or similar rights; (ii) Seller will, at its own expense, defend any suit that may arise with respect to any aforementioned infringement or allegation thereof; and (iii) Seller will indemnify and hold Unilife and/or its customers harmless from such loss and expense incurred on account of any alleged or actual infringement which indemnification shall not be subject to any of the monetary limitations set forth herein. Unilife shall promptly notify Seller of any such infringement claim made against it. The warranty provided here shall not apply to equipment to the extent such equipment comply with specifications furnished by Unilife.
 
    In the event that the use of said equipment is enjoined, Unilife at its election may require Seller, at Seller’s sole cost and expense, to: (i) procure for Unilife, within thirty (30) days, the right to continue using said equipment or part; (ii) modify same so it becomes non-infringing; (iii) replace it with non-infringing equipment or part; or (iv) take back the equipment and refund Unilife’s purchase price.
 
9.0   INDEMNITY AND INSURANCE. Seller shall indemnify and hold Unilife and its officers and directors harmless, and at Seller’s expense, defend Unilife from all liability, loss and expense, or claims therefore, arising out of death or injury to any person or damage to any property, or any other damage or loss, by whomsoever suffered, resulting in whole or in part from any alleged or actual defect, whether latent or patent, in equipment sold to Unilife hereunder including without limitation actual or alleged improper construction or design or failure to comply with specifications, or from the actual or alleged violation by such goods (or their manufacture, possession, use or sale) of any Federal, state or local rule, regulation or governmental order, or from the failure of such equipment to comply with any express or implied warranty of Seller or with any of the provisions which govern Seller’s performance under this purchase agreement provided that this indemnity shall be null and void to the extent such liability, loss or expense, or claim(s) therefore, results solely from the negligence of Unilife. Except as specifically provided herein, Unilife limits liability of the Seller to Three Million Dollars ($3,000,000.00). Seller will obtain and maintain in force, at no expense to Unilife, product liability and completed operations insurance with a Vendor’s Endorsement, if appropriate, naming Unilife as an additional insured on the policy. Seller shall maintain products liability insurance coverage for a period from the date of this Order through the warranty period set forth in the Proposal (“Insurance Period”) in a minimum amount of one million ($1,000,000 USD) per occurrence and three million dollars ($3,000,000 USD) aggregate, with contractual liability endorsement, exclusive of defense costs. Seller shall supply Unilife a certificate of insurance evidencing such insurance upon request as part of the execution of this agreement and at such other times as Unilife shall request. Unilife shall at all times be named as an additional insured. Unilife is to be notified by the carrier at least sixty (60) days in advance if this insurance is amended, cancelled/terminated before the end of the aforesaid Insurance Period.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
    Seller represents and warrants that all installation and other service work by Seller shall be performed in a workmanlike manner using qualified and trained personnel. Seller shall at all times be responsible for its personnel while on Unilife’s premises, and shall ensure that such personnel follow Unilife’s guidelines and instructions. Seller shall defend, hold harmless and indemnify Unilife and its officers and directors from and against any claims of wrongful death, bodily injury or property damage in connection with or arising out of the negligence or willful misconduct of its personnel while on Unilife’s premises, as well as for all claims by third parties for death, physical injury or property damage caused by the negligence or willful misconduct of Seller generally, and such indemnification shall not be subject to any monetary limitations set forth herein.
10.0   PRICE, AND TAXES. Seller shall furnish the goods and services called for by this order in accordance with the prices and delivery dates stated on the face of this order. The equipment being ordered will be used in Production and is tax exempt. Unilife will, at Seller’s request, provide the appropriate Sale Tax Exemption form.
 
11.0   TOOLS. Unless otherwise specified, all necessary material or tools including dies, gauges, jigs or fixtures required to execute this order are to be supplied by Seller. If Unilife agrees to pay for or furnish any material or tools, dies, gauges, jigs or fixtures in connection with this order, said items shall be and remain Unilife’s property, and shall be used exclusively for Unilife unless Unilife directs otherwise in writing. Seller will account for said items and keep them fully covered by insurance at all times without expense to Unilife. It is understood and agreed that said items may be removed by Unilife at any time and shall not otherwise be disposed of by Seller without written permission from Unilife. Seller will maintain said tools and similar equipment in good working condition and will return them to Unilife on request or termination of the work for which they were furnished.
 
12.0   CHANGES. Unilife reserves the right at any time prior to shipment to make changes to: (i) the methods of shipment or packing, or (ii) the place of delivery. If any such change causes an increase or decrease in the cost of or the time required for performance of this purchase order, an equitable adjustment shall be made in the contract price or delivery schedule, or both. Any claim by Seller for adjustment under this clause shall be deemed waived unless asserted in writing within ten (10) business days from receipt by Seller of the change.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
13.0   CANCELLATION AND REMEDIES. Unilife may cancel this order in whole or in part if: (i) Seller fails to make deliveries as provided herein; (ii) Seller breaches any other material term or condition herein; (iii) any material representation by Seller proves to have been false when made; or (iv) Seller is insolvent, a petition is filed for reorganization of Seller or for its adjudication as a bankrupt, Seller makes an assignment for benefit of creditors, and receiver or trustee is appointed for any of Seller’s assets or any other type of insolvency proceeding or formal or informal proceeding for the dissolution, liquidation, or winding up of affairs of Seller, is commenced. In the event of any breaches as described in (i-iv) above, Unilife shall have the right, in addition to its other rights: (i) to refuse to accept delivery of goods, at Unilife’s option, either recover all payments made therefor and expenses incident thereto or, at Seller’s expense, to receive replacement therefor, except that the rights set forth in this provision (i) shall not be available upon cancellation by Unilife because of the occurrence, alone, of any of the events set forth in (iv) above; (ii) to recover any advance payments to Seller for undelivered equipment; and (iv) to purchase elsewhere and charge Seller with any loss incurred as a result thereof. Upon cancellation as aforesaid, Unilife shall not have any liability to Seller, and Unilife and Seller will mutually agree upon payment of Seller’s actual costs for undelivered goods, in which event, such goods, whether in process or finished, and raw materials therefor, shall become Unilife’s property and shall be delivered to Unilife as herein provided. In no event shall Unilife be obligated to pay to Seller an amount greater than the price herein for said delivered and undelivered equipment in total.
 
14.0   LIQUIDATED DAMAGES: Unilife has eliminated all other bidders from consideration and placed this order in good faith based on the proposal provided by the Seller and discussion that all key elements (Price, Delivery and Equipment output) were achievable.
  14.1   Pricing. This order is a (fixed Price- not to exceed) and increase to the Purchase order price will only occur if all items in section 1.0 are completed.
  14.1.1   Delivery. The purchase price for Equipment that is not shipped due to or caused solely by seller or its contractors within ([***] business days) of the delivery date will be reduced by [***] of the total order and the percentage will increase by [***] for each additional [***]([***]) business days until either the equipment is shipped, provided that the total reduction may not exceed [***]([***]).

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
  14.1.2   Equipment output. Unilife will not release for shipment equipment that does not pass the Design Qualification (DQ) testing at the Sellers site. If Seller determines that they cannot meet the specifications Unilife may consider releasing equipment if the Seller makes appropriate price adjustments. Delivery and Equipment output pricing adjustments may occur in tandum.
 
  14.1.3   Any late delivery price adjustments imposed by Unilife shall be deemed to be liquidated damages and not imposed as a penalty. These charges are in addition to any other rights and remedies Unilife may have under other sections of this Agreement or applicable law.
15.0   ASSIGNMENT AND SUBCONTRACTING. Seller agrees not to subcontract for any complete or substantially complete materials and/or supplies called for by this order without the prior written consent of Unilife, unless the purchase is from an acknowledged industry leader (Example: Feeder Bowls) Seller may not assign this order or any rights under this order without the written consent of Unilife, and no purported assignment by Seller shall be binding on Unilife without such consent. No consent shall be deemed to relieve Seller of its obligations to comply fully with the requirements of this order.
 
16.0   COMPLIANCE WITH LAWS. In performance of this order, Seller shall comply with all applicable Federal, state and local laws, rules, codes and regulations for violation of which Unilife may be liable including particularly the requirements of the Fair Labor Standards Act of 1938, as amended, and any requirements for packaging, labeling, crating and registering for transportation. Seller agrees to indemnify Unilife, its customers and agents for any loss, damage or award sustained because of Seller’s noncompliance with this paragraph.
 
17.0   EQUAL OPPORTUNITY. (The following clause is applicable unless this order is exempt under the rules and regulations of the Secretary of Labor.) During the performance of this order, the Seller agrees as follows: (i) The Seller will not discriminate against any employee or applicant for employment because of race, color, religion, sex or national origin. The Seller will take affirmative action to ensure that applicants are employed and that employees are treated during employment, without regard to their race, color, religion, sex or national origin. Such action shall include but not be limited to the following: employment, upgrading, demotion or transfer; recruitment or recruitment advertising; layoff or termination; rates of pay or other form of compensation; and selection for training, including apprenticeship. The Seller agrees to post in conspicuous places, available to employees and applicants for employment, notices to be provided by the Unilife of the cognizant Government Agency Contracting Officer setting forth the provisions of this nondiscrimination clause; (ii) the Seller will not discriminate against any employee or applicant for employment because of physical or mental

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
    handicap in regard to any position for which the employee or applicant for employment is qualified. The Seller agrees to take affirmative action to employ, advance in employment and otherwise treat qualified handicapped individuals without discrimination based upon their physical or mental handicap in all employment practices such as the following: employment upgrading, demotion or transfer, recruitment, advertising, layoff or termination; rates of pay or other forms of compensation, and selection for training, including apprenticeship; (iii) the Seller agrees to comply with the rules, regulations, and relevant orders the Secretary of Labor issued pursuant to applicable laws; (iv) the Seller will not discriminate against any employee or applicant for employment because he or she is a disabled veteran or veteran of the Vietnam era in regard to any position for which the employee or applicant for employment is qualified. The Seller agrees to take affirmative action to employ, advance in employment and otherwise treat qualified disabled veterans and veterans of the Vietnam era without discrimination based upon their disability or veterans status in all employment practices such as the following: employment upgrading, demotion or transfer, recruitment, advertising, layoff or termination, rates of pay or other forms of compensation, and selection for training, including apprenticeship.
 
18.0   EXCUSABLE DELAYS. Neither of the parties shall be held responsible for any delay or failure in performance hereunder caused by fire, embargoes, acts of the government in either its sovereign or contractual capacity, civil or military authorities, acts of God or by the public enemy, or other causes beyond their control and without their fault or negligence, provided, that Seller furnish written notice to Unilife within Ten (10) business days of the time Seller first receives knowledge of the occurrence of any such cause which will or may delay Seller’s performance.
 
19.0   MISCELLANEOUS. Whenever Seller shall have in its possession any property of Unilife, Seller shall be deemed an insurer thereof and responsible for its safe return to Unilife.
 
    Whenever Unilife has the right to demand of Seller adequate assurance of due performance, Unilife shall be the sole judge of the adequacy of assurance given by Seller. No delay or omission by Unilife in exercising any right or remedy hereunder shall be a waiver thereof of any other right or remedy. No single or partial waiver by Unilife thereof shall preclude any other or further exercise of any other right or remedy. All rights and remedies of Unilife hereunder are cumulative.
 
    No course of prior dealings between Unilife and Seller and no usage of the trade shall be relevant to supplement or explain this Agreement.
 
    This order and any agreement resulting herefrom cannot be modified or amended without the written consent of Unilife and Seller.

 

 


 

Exhibit 10.20
CONFIDENTIAL TREATMENT
REQUESTED PURSUANT TO RULE 24b-2
Certain portions of this exhibit have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The omitted materials have been filed separately with the Securities and Exchange Commission.
20.0   DISPUTES. The construction, interpretation and performance hereof and all transactions hereunder shall be governed by the domestic law of the Commonwealth of Pennsylvania. Seller hereby consents that all legal proceedings relating to the subject matter of this Agreement shall be maintained in the appropriate state or federal courts located within the city of Harrisburg, Pennsylvania, and consent that jurisdiction and venue for such proceedings shall be exclusively with such courts
 
21.0   CHANGE NOTIFICATION. Seller agrees that no deviations or changes in product, process, equipment, tooling or manufacturing locations will be made without prior written consent from Unilife.

 

 

EX-10.21 7 c93531exv10w21.htm EXHIBIT 10.21 Exhibit 10.21
Exhibit 10.21
PURCHASE AND MUTUAL INDEMNIFICATION AGREEMENT
THIS PURCHASE AND MUTUAL INDEMNIFICATION AGREEMENT (this “Agreement”) is effective as of the 16th day of November, 2009, by and among Greenspring Partners, LP, a Pennsylvania limited partnership with an address at P.O. Box 7289, York, PA 17404 (“Greenspring”), and Unilife Cross Farm LLC, a Delaware limited liability company with an address at 633 Lowther Road, Lewisberry, PA 17339 (“Unilife”).
BACKGROUND:
A. Greenspring desires to sell and Unilife desires to purchase that certain real estate known as 250 Cross Farm Lane, located in Conewago Township, York County, Pennsylvania (“Lot 1A”) on terms and conditions contained in that certain agreement of sale dated September 30, 2009, as amended, between Unilife Medical Solutions, Inc. and Greenspring (“Terminated Agreement”).
B. Certain other parcels of real estate are adjacent to Lot 1A, including a parcel known as 275 Cross Farm Lane currently owned by Exeter 275 Cross Farm, L.P. (“Lot 1B”) and a parcel known as 225 Cross Farm Lane currently owned by FR York Property Holdings, L.P. (“Lot 1”).
C. Lots 1A, 1B, and 1 are part of a single development (the “Development”) constructed by Greenspring.
D. Lot 1A on the one hand, and Lots 1B and 1 on the other hand, are separated by Cross Farm Lane (the “Road”).
E. A sedimentation basin (the “Basin”) is currently located on Lot 1A for the benefit of the Development. The Basin is subject to NPDES Permit No. PAG2006705054 (the “Permit”), currently in the name of Richard D. Poole, LLC (“Poole”, a former affiliate of Greenspring) and Greenspring (“Original Permittees”).
F. In connection with the sale of Lot 1A to Unilife, Unilife must become a co- permittee on the Permit.
G. In addition, two letters of credit are associated with the Development and obligations of Greenspring in connection therewith: (1) letter of credit no. 10002731221 from Susquehanna Bank PA in the face amount of $383,101.62 relating to certain improvements on Lot 1A (the “383 LC”); and (2) letter of credit no. 10001392561 from Susquehanna Bank PA with a face amount of $1,513,669 and a current balance of $122,950 relating to common improvements, including but not limited to the wearing course on, and traffic signaling relating to, the Road (the “123 LC”).

 

 


 

H. The parties hereto desire to confirm the agreement to purchase and assign responsibility for the various obligations relating to the Basin, the 383 LC and the 123 LC continuing after closing on the purchase.
NOW THEREFORE, for and in consideration of the mutual promises and covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows:
1. Incorporation of Recitals. The recitals set forth above are incorporated herein as if set forth at length below.
2. Agreement of Sale. Unilife Medical Solutions, Inc. and Greenspring hereby confirm that the Terminated Agreement has been terminated and is no longer of any force or effect. Greenspring hereby agrees to sell and Unilife agrees to purchase Lot 1A on the terms and conditions of the Terminated Agreement.
3. Indemnification.
A. Indemnification by Greenspring. Greenspring hereby agrees to indemnify, defend and save and hold harmless Unilife, its members, partners, shareholders, officers, agents, successors, affiliates and assigns from and against, and to reimburse such indemnified party with respect to, any and all claims, demands, causes of action, losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses, and court costs), direct and indirect, asserted against or incurred by such indemnified party by reason of, or arising in connection with: (1) the 123 LC and the obligations underlying it, including but not limited to the wearing course on the Road and the traffic signaling related to the Road; or (2) the Permit as it relates to Lots 1 or 1B.
B. Indemnification by Unilife. Unilife hereby agrees to indemnify, defend and save and hold harmless Poole, Greenspring, their respective members, partners, shareholders officers, agents, successors, affiliates and assigns from and against, and to reimburse such indemnified party with respect to, any and all claims, demands, causes of action, losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses, and court costs), direct and indirect, asserted against or incurred by such indemnified party by reason of, or arising in connection with: (1) the 383 LC and the obligations underlying it; or (2) the Permit as it relates to Lot 1A.
4. Covenant to Maintain Assets. Greenspring covenants and agrees to maintain sufficient liquid assets to satisfy its obligations described herein. Upon the reasonable request of Unilife, Greenspring shall deliver to Unilife financial or other information appropriate to confirm this undertaking.
5. No Proceedings or Threatened Proceedings.
A. Each party to this Agreement hereby represents that, as of the date hereof, to the knowledge of such party:

 

-2-


 

i. There is no litigation, arbitration, grievance or other proceeding before any court, arbitrator or governmental regulatory official, body or authority arising in connection with the Permit, the 123 LC, the 383 LC and/or the Development, and/or the transactions described in the recitals above (collectively, a “Proceeding”) pending.
ii. There is no Proceeding threatened.
iii. There has been no act, omission, circumstance or event that is reasonably likely to give rise to any Proceeding.
B. In the event of a breach of any representation contained in this Section 5 by a party to this Agreement (the “Breaching Party”), the Breaching Party agrees to indemnify, defend and save and hold harmless the other parties to this Agreement, their respective shareholders, members, officers, directors, agents, personal representatives, successors, and assigns from and against, and to reimburse such indemnified party with respect to, any and all claims, demands, causes of action, losses, damages, liabilities, costs and expenses (including reasonable attorneys’ fees and expenses, and court costs), direct and indirect, asserted against or incurred by the indemnified party, arising in connection with such breach.
6. Governing Law; Venue. This Agreement has been executed in and shall be construed and enforced in accordance with, and governed by, the laws of the Commonwealth of Pennsylvania without regard to conflict of law principles. Any action which in any way involves the rights, duties and/or obligations of the parties hereto shall be brought in the courts of the Commonwealth of Pennsylvania located in and for the County of York.
7. Entire Agreement. This Agreement sets forth the entire understanding of the parties hereto, supersedes any prior agreements, negotiations and understandings of the parties relating to the Permit, 123 LC or 383 LC. This Agreement may not be changed nor may any provision hereof be waived except by a writing signed by all of the parties hereto.
8. Counterparts. This Agreement may be executed in any number of counterparts, and each such counterpart hereof shall be deemed to be an original instrument, but all such counterparts together shall constitute but one agreement.
9. Headings. The headings of the sections of this Agreement are inserted for convenience of reference only, and shall not be considered a part hereof.
10. Binding Effect. This Agreement and all rights and powers granted hereby will bind and inure to the benefit of the parties hereto and their respective heirs, executors, administrators, personal representatives, trustees, successors and assigns.
11. Survival. The indemnification obligations and duties described herein shall survive any closing on Lot 1A and shall not be merged into the deed therefor.

 

-3-


 

IN WITNESS WHEREOF, the parties, intending to be legally bound hereby, have executed this Agreement as of the day and year first written above.
     
 
Greenspring Partners, LP
By: Greenspring Associates, LLC,
Sole General Partner
 
   
 
/s/ Richard D. Poole
 
 
 
By:  Richard D. Poole, Managing Member
     
 
Unilife Cross Farm LLC
By: Unilife Corporation, its sole member
 
   
 
By:  /s/ Cynthia M. Lighty
 
   
 
Name:  Cynthia M. Lighty
 
Title:  Assistant Secretary
Unilife Medical Solutions, Inc. hereby joins in this Agreement for the sole purpose of confirming the termination described in Section 2 above.
     
 
Unilife Medical Solutions, Inc.
 
   
 
By:  /s/ Cynthia M. Lighty
 
   
 
Name:  Cynthia M. Lighty
 
Title:  Assistant Secretary

 

-4-

EX-10.22 8 c93531exv10w22.htm EXHIBIT 10.22 Exhibit 10.22

Exhibit 10.22

October 16, 2009

Mr. Alan Shortall
Chief Executive Officer
Unilife Medical Solutions
633 Lowther Road
Lewisberry, PA 17339

REVISED

Dear Mr. Shortall:

The purpose of this letter is to provide an outline of the assistance the Commonwealth of Pennsylvania is prepared to offer Unilife Medical Solutions (Unilife) and its wholly-owned subsidiary company Integrated BioSciences (IBS), should Unilife choose to proceed with expanding its corporate headquarters and manufacturing operations in south central Pennsylvania. This offer of assistance replaces and supersedes our accepted offer letter dated November 12, 2008.

It is our understanding that Unilife wishes to enter into a build-to-suit agreement to construct a new building in south central Pennsylvania that will serve as its corporate headquarters and house its primary manufacturing operations. The proposed project is expected to create at least 241 new full-time jobs by December 31, 2012, and will retain 87 existing employees. The total cost of this project will be $86,000,000. Based upon this information, I am pleased to propose a significant economic development assistance package on behalf of the Commonwealth of Pennsylvania.

Please understand that if Unilife agrees to accept this offer of assistance from the Commonwealth, it also agrees to make no public announcement of the project without the prior approval of the Pennsylvania Department of Community and Economic Development (DCED). Unilife also agrees to formally apply with DCED for each of the programs described below, as necessary.

Opportunity Grant Program (OGP)

The Opportunity Grant program has the flexibility necessary to allow Pennsylvania to customize its assistance to the specific needs of your project. Based upon the project’s significant economic impact, the Commonwealth will provide a $500,000 Opportunity Grant to Unilife. This grant may be used for any eligible costs associated with the project.

 

1


 


Mr. Alan Shortall
October 16, 2009
Page 2

Job Creation Tax Credits (JCTC)

Job Creation Tax Credits are provided to businesses that create new, full-time jobs paying at least 150% of the federal minimum wage. For the 241 new jobs Unilife will create with this project, it will be eligible to receive tax credits of $482,000 over a period of years, based upon when the jobs are created. These credits can be applied to your company’s Pennsylvania Corporate Net Income Tax and/or its Capital Stock and Franchise Tax. In order to receive the full tax credit, all jobs must be created within three years of an agreed upon start date.

Job Training Assistance – Customized Job Training (CJT) and WEDnet

Based upon the information provided, the Commonwealth will provide Unilife up to $200,000 for eligible training costs through one or both of the following programs depending upon your company’s specific training needs. To be eligible for training funds, employees must be Pennsylvania residents and earn at least 150% of the federal minimum wage.

DCED provides Customized Job Training (CJT) grants, which can reimburse a company for up to 75% of eligible costs incurred in providing customized, advanced level training for new or existing employees. Eligible costs include trainer salaries and expenses, consumable training materials, and curriculum development.

WEDnet provides Guaranteed Free Training (GFT) grants, which can reimburse a company for up to $450 per employee receiving basic skills training and up to $850 per employee receiving information technology training. Any training under this program must take place during the fiscal year in which the application is made.

Unilife is required to apply for training funds within five (5) years from the date this offer is accepted. Should extraordinary circumstances delay your training, please advise us at your earliest convenience.

Pennsylvania Industrial Development Authority (PIDA)

The Pennsylvania Industrial Development Authority provides low-interest financing for land and building acquisition and for building construction or renovation. PIDA can finance up to 30% of the eligible real estate costs, up to a maximum of $2 million, whichever is less. Funds are loaned at a fixed rate for a term of up to fifteen years. The interest rate for PIDA loans in York County is currently 4.25%. Please be aware that the interest rate is subject to change in response to fluctuations in the 10-year Treasury note rate adjusted quarterly. You will receive the interest rate in effect at the time of application. Should your firm be designated as advanced technology, the interest rate will be 3.25%.

Pennsylvania Economic Development Financing Authority (PEDFA)

PEDFA is the state-wide conduit (pass through) issuer of taxable Revenue Bonds, both in pooled and stand-alone transactions, to be used to finance land, building, equipment, and working capital. PEDFA may finance up to 100% of project cost with a variable interest rate. The term is based upon a negotiated letter of credit. This offer is contingent upon qualifying your company’s expenses as eligible for the issuance of taxable bonds and negotiation of necessary financial documents. We will work closely with you to meet your timetable and other requirements.

 

2


 

Mr. Alan Shortall
October 16, 2009
Page 3

Redevelopment Assistance Capital Program (RACP)

The RACP program can provide grants to municipalities and redevelopment authorities for costs associated with major economic and community development projects in the Commonwealth. The RACP program is a component of the Commonwealth’s Capital Budget and, as such, projects that may potentially receive funding must first be authorized for a specific amount in a Capital Project Itemization Act. Additionally, the General Assembly must pass legislation raising the authorized debt level for the program. Projects are selected to receive RACP funding after a review by the Governor’s Office and the Office of the Budget of the project’s technical merits and compliance with minimum standards established by law and RACP policy. Based on information your firm has provided, I am proposing that an award up to $2,000,000 be made through the RACP program for this project. The funds would be provided to an appropriate public entity in the community and used towards the cost of construction of your new facility in Southcentral Pennsylvania.

Should the General Assembly not pass a new Capital Budget Itemization Act by December 31, 2009, I propose $2,000,000 in Infrastructure and Facilities Improvement Program (IFIP) be added to your economic development assistance package in lieu of the RACP funding. The RACP program will not be offered in conjunction with the IFIP program. A description of the IFIP program is listed below for your review.

Infrastructure and Facilities Improvement Program (IFIP)

The Infrastructure and Facilities Improvement Program can provide financial assistance in the form of multi-year grants, used by eligible applicants to service debt incurred for infrastructure and facilities improvement projects that enhance economic development in the Commonwealth. Based on the expected incremental increase in tax revenues (sales tax and personal income tax withholdings) and the annual debt service of the project financing, a maximum annual amount for the IFIP grant is established by the Department of Revenue and the Office of the Budget. The grant period can be up to ten years. Based on information provided about your project, the Commonwealth will provide $2,000,000 over 10 years for building renovations.

Governor Rendell is committed to making Pennsylvania an economic leader by investing in the growth of businesses like Unilife. In addition to the financing package outlined above, the Governor’s Action Team is prepared to provide Unilife with any assistance that may be required throughout the application process, as well as to coordinate the involvement of all other state agencies in your project. This would include assistance in securing any necessary environmental permits through the Department of Environmental Protection.

 

3


 

Mr. Alan Shortall
October 16, 2009
Page 4

Please be aware that the assistance proposed in this offer is based upon information that has been provided to us by your company regarding job creation projections, cost estimates, and project timing. All of the assistance outlined above is contingent upon Unilife submitting complete applications and meeting all program guidelines. Financial awards are also contingent upon availability of funds in any given budget year. If you have any questions regarding the application process for any of our financial assistance programs, please contact the Governor’s Action Team. This proposal will remain in effect for a period of 30 days from the date of this letter, unless extended in writing by the Commonwealth.

 

4


 

Mr. Alan Shortall
October 16, 2009
Page 5

I trust that this comprehensive offer of assistance from the Commonwealth will demonstrate our strong commitment to Unilife. I look forward to working with you to make this important project become a reality.

Sincerely,

/s/ George E. Cornelius
George E. Cornelius
Secretary

 

5


 

COMMONWEALTH OF PENNSYLVANIA
ACCEPTANCE OF OFFER

BY ACCEPTING THIS OFFER, UNILIFE AGREES TO MAKE NO PUBLIC ANNOUNCEMENT OF THE PROJECT WITHOUT THE PRIOR APPROVAL OF THE DCED PRESS OFFICE.

By accepting the attached offer of financial assistance, Unilife verifies that the information concerning job creation and retention and project cost is accurate, and understands that any changes could result in the Commonwealth revising or withdrawing this offer.

Should Unilife fail within the agreed timeframe to meet the commitments set forth above concerning job creation and retention or project cost, the Commonwealth reserves the right to withdraw all or part of this offer of assistance, and to seek repayment from Unilife of all or part of any assistance already disbursed.

Upon acceptance of this offer, Unilife will receive information regarding DCED’s Single Application for Financial Assistance, which will provide more specific information about the programs offered.

Unilife agrees to submit a Single Application for Financial Assistance for this project by January 30, 2010. Failure to do so may result in the loss or delay of funding.

If you have any questions regarding this offer or the application process, please contact Brian Ross at (717)720-1432.

     
Alan Shortall 
   
 
   
Printed Name
   
     
CEO 
   
 
   
Title
   
     
Unilife Medical Solutions 
   
 
   
Company Name
   
     
10/20/2009 
   
 
   
Date
   
     
11-3679944 
   
 
   
Company Federal ID Number (FEIN)
   
     

 

6


 

Please return this completed page, along with a copy of this letter, via facsimile and regular mail to:

Governor’s Action Team
Attn: Gilda Englander
Commonwealth Keystone Building
400 North Street, Plaza Level
Harrisburg, PA 17120
Fax: 717-772-5419

     
/s/ Alan Shortall 
10/20/2009   
 
 
 
Alan Shortall
Date   
     

 

7

EX-10.23 9 c93531exv10w23.htm EXHIBIT 10.23 Exhibit 10.23
Exhibit 10.23
     
(AIA LOGO)
  Document B101TM — 2007
Standard Form of Agreement Between Owner and Architect

AGREEMENT made as of the 29th day of  December in the year 2009
(In words; indicate day, month and year.)
BETWEEN the Architect’s client identified as the Owner:
(Name, legal status, address and other information)
Unilife Cross Farm LLC
633 Lowther Road
Lewisberry, PA 17339
and the Architect;
(Name, legal status, address and other information)
L2 Architecture
1717 Arch Street, Suite 3920
Philadelphia, PA 1910
for the following Project:
(Name, location and detailed description)
Unilife Medical Solutions
New World Headquarters Facility
250 Cross Farm Lane
York, Pennsylvania
The Owner and Architect agree as follows.
ADDITIONS AND DELETIONS:
The author of this document has added information needed for its completion. The author may also have revised the text of the original AIA standard form. An Additions and Deletions Report that notes added information as well as revisions to the standard form text is available from the author and should be reviewed. A vertical line in the left margin of this document indicates where the author has added necessary information and where the author has added to or deleted from the original AIA text.

This document has important legal consequences. Consultation with an attorney is encouraged with respect to its completion or modification.


 
     
Init.




/
  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

1


 

TABLE OF ARTICLES
         
1   INITIAL INFORMATION 2  
     
2   ARCHITECT’S RESPONSIBILITIES 3  
     
3   SCOPE OF ARCHITECT’S BASIC SERVICES 4  
     
4   ADDITIONAL SERVICES 10  
     
5   OWNER’S RESPONSIBILITIES 12  
     
6   COST OF THE WORK 13  
     
7   COPYRIGHTS AND LICENSES 14  
     
8   CLAIMS AND DISPUTES 15  
     
9   TERMINATION OR SUSPENSION 16  
     
10   MISCELLANEOUS PROVISIONS 16  
     
11   COMPENSATION 17  
     
12   SPECIAL TERMS AND CONDITIONS 19  
     
13   SCOPE OF THE AGREEMENT 19  
EXHIBIT A INITIAL INFORMATION
ARTICLE 1 INITIAL INFORMATION

§ 1.1 This Agreement is based on the Initial Information set forth in this Article 1 and in optional Exhibit A, initial information:
(Complete Exhibit A, Initial Information, and incorporate it into the Agreement at Section 13.2, or state below Initial Information such as details of the Project’s site and program, Owner’s contractors and consultants, Architect’s consultants, Owner’s budget for the Cost of the Work, authorized representatives, anticipated procurement method, and other information relevant to the Project.)
§ 1.2 The Owner’s anticipated dates for commencement of construction and Substantial Completion of the Work are set forth below:
  .1   Commencement of construction date:
 
      November 23, 2009. This shall be a fast-track project with construction commencing before completion of final design.
 
  .2   Substantial Completion date:
 
      September 10, 2010
§ 1.3 The Owner and Architect may rely on the Initial Information. Both parties, however, recognize that such information may materiallly change and, in that event, the Owner and the Architect may appropriately adjust the schedule, the Architect’s services and the Architect’s compensation.
 
     
Init.



/
  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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ARTICLE 2 ARCHITECT’S RESPONSIBILITIES

§ 2.1 The Architect shall provide the professional services as set forth in this Agreement.
§ 2.2 The Architect shall perform its services consistent with the professional skill and care ordinarily provided by architects practicing in the same or similar locality under the same or similar circumstances and with the same level of experience as the Architect. The Architect shall perform its services as expeditiously as is consistent with such professional skill and care and the orderly progress of the Project.
§ 2.3 The Architect shall identify a representative authorized to act on behalf of the Architect with respect to the Project. Architect’s Representative shall be John LaProcido.
§ 2.4 Except with the Owner’s knowledge and consent, the Architect shall not engage in any activity, or accept any employment, interest or contribution that would reasonably appear to compromise the Architect’s professional judgment with respect to this project.
§ 2.5 The Architect shall maintain the following insurance for the duration of this Agreement. If any of the requirements set forth below exceed the types and limits the Architect normally maintains, the Owner shall reimburse the Architect for any additional cost:
(Identify types and limits of insurance coverage, and other insurance requirements applicable to the Agreement, if any.)
  .1   General Liability
  (a)   Comprehensive or Commercial General Liability (including premises-operations independent contractors’ protective; products and competed operations; broad form property damage) written on an occurrence form that shall be no less comprehensive and no more restrictive than coverage provided by the standard Insurance Service Office (ISO) form CG 00 01 10 93:
     
Bodily Injury:
  $1,000,000 Each Occurrence
 
  $2,000,000 Aggregate
Property Damage:
  $1,000,000 Each Occurrence
 
  $2,000,000 Aggregate
  (b)   Products and completed operations to be maintained for four (4) years after final payment:
$2,000,000 Aggregate
  (c)   Properly damage liability insurance shall provide X, C and U coverage.
  (d)   Broad form property damage shall include completed operations.
  (e)   Contractual Liability:
     
Bodily Injury:
  $1,000,000 Each Occurrence
 
  $2,000,000 Aggregate
Property:
  $1,000,000 Each Occurrence
 
  $2,000,000 Aggregate
  (f)   Personal Injury with Employment Exclusion deleted:
$1,000,000 Aggregate
  (g)   If the General Liability coverages are provided by a Commercial Liability Policy the:
  (1)   General Aggregate shall not be less than $4,000,000
  (2)   Fire Damage Limit shall be not less than $50,000 on any one fire.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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  (3)   Medical Expense Limit shall be not less than $5,000 on any one person.
  (4)   Umbrella Excess Liability:
$1,000,000 over primary insurance
$1,000,000 retention for self-insured hazards each occurrence
  .2   Automobile Liability
  (a)   Business Auto Liability (including owned, non-owned, and hired vehicles):
     
Bodily Injury:
  $1,000,000 Each Person
 
  $1,000,000 Each Occurrence
Property Damage:
  $1,000,000 Each Occurrence
  .3   Workers’ Compensation
 
      State Statutory
     
Employer’s Liability:
  $100,000 Per Accident
 
  $500,000 Disease, Policy Limit
 
  $100,000 Disease, Each Employee
  .4   Professional Liability
(a) The Architect shall, at no additional cost to the Owner, provide professional liability insurance issued by a carrier licensed to provide such coverage in the Commonwealth of Pennsylvania for negligent acts, errors and omissions by the Architect, its firm, its agents, its employees and consultants, and to the extent arising out of this Agreement. Policy limits shall be in an amount not less than Two Million Dollars ($2,000,000.00) per occurrence. Provision of a valid Certificate of Insurance that meets these requirements is a condition precedent to the payment of any amounts due the Architect by the Owner. Such policy shall remain in effect during the course of the project and for a period of two (2) years after Substantial Completion.
(b) The Architect shall maintain all forms of insurance required by law by the Commonwealth of Pennsylvania. The Architect shall ensure that any and all consultants engaged or employed by the Architect carry and maintain insurance as set forth above. The Certificate of Insurance shall incorporate a provision requiring written notice to the Owner at least thirty (30) days prior to any cancellation, nonrenewal or material modification of the policies. The Owner shall be named an additional insured on the General Liability Policy.
ARTICLE 3 SCOPE OF ARCHITECT’S BASIC SERVICES

§ 3.1 The Architect’s basic services consist of those described in the project description and Articles 1 and 3 and include usual and customary structural, mechanical, and electrical engineering services. Services not set forth in the Project description and Articles 1 and 3 are Additional Services.
§ 3.1.1 The Architect shall manage the Architect’s services, consult with the Owner, research applicable design criteria, attend Project meetings, communicate with members of the Project team and report progress to the Owner.
§ 3.1.2 The Architect shall coordinate its services with those services provided by the Owner and the Owner’s consultants. The Architect shall be entitled to rely on the accuracy and completeness of services and information furnished by the Owner and the Owner’s consultants. The Architect shall provide prompt written notice to the Owner if the Architect becomes aware of any error, omission or inconsistency in such services or information.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.1.3 As soon as practicable after the date of this Agreement, the Architect shall submit for the Owner’s approval a schedule for the performance of the Architect’s services. The schedule initially shall include anticipated dates for the commencement of construction and for Substantial Completion of the Work as set forth in the Initial Information. The schedule shall include allowances for periods of time required for the Owner’s review, for the performance of the Owner’s consultants, and for approval of submissions by authorities having jurisdiction over the Project. Once approved by the Owner, time limits established by the schedule shall not, except for reasonable cause, be exceeded by the Architect or Owner. With the Owner’s written approval, the Architect shall adjust the schedule, if necessary as the Project proceeds until the commencement of construction.
§ 3.1.4 The Architect shall not be responsible for an Owner’s directive or substitution made without the Architect’s approval.
§ 3.1.5 The Architect shall, at appropriate times, contact the governmental authorities required to approve the Construction Documents and the entities providing utility services to the Project. In designing the Project, the Architect shall incorporate applicable design requirements imposed by such governmental authorities and by such entities providing utility services.
§ 3.1.6 The Architect shall assist the Owner in connection with the Owner’s responsibility for filing documents required for the approval of governmental authorities having jurisdiction over the Project.
§ 3.2 SCHEMATIC DESIGN PHASE SERVICES

§ 3.2.1 The Architect shall review the program and other information furnished by the Owner, and shall review laws, codes, and regulations applicable to the Architect’s services.
§ 3.2.2 The Architect shall prepare a preliminary evaluation of the Owner’s program, schedule, budget for the Cost of the Work, Project site, and the proposed procurement or delivery method and other Initial Information, each in terms of the other, to ascertain the requirements of the Project. The Architect shall notify the Owner of (1) any inconsistencies discovered in the information, and (2) other information or consulting services that may be reasonably needed for the Project. The Architect shall advise the Owner, in writing, of the need for any other consultants or testing.
§ 3.2.3 The Architect shall present its preliminary evaluation to the Owner and shall discuss with the Owner alternative approaches to design and construction of the Project, including the feasibility of incorporating environmentally responsible design approaches. The Architect shall reach an understanding with the Owner regarding the requirements of the Project.
§ 3.2.4 Based on the Project’s requirements agreed upon with the Owner, the Architect shall prepare and present for the Owner’s approval a preliminary design illustrating the scale and relationship of the Project components.
§ 3.2.5 Based on the Owner’s approval of the preliminary design, the Architect shall prepare Schematic Design Documents for the Owner’s approval. The Schematic Design Documents shall consist of drawings and other documents including a site plan, if appropriate, and preliminary building plans, sections and elevations; and may include some combination of study models, perspective sketches, or digital modeling. Preliminary selections of major building systems and construction materials shall be noted on the drawings or described in writing.
§ 3.2.5.1 The Architect shall consider environmentally responsible design alternatives, such as material choices and building orientation, together with other considerations based on program and aesthetics, in developing a design that is consistent with the Owner’s program, schedule and budget for the Cost of the Work. The Owner may obtain other environmentally responsible design services under Article 4.
§ 3.2.5.2 The Architect shall consider the value of alternative materials, price escalation, building systems and equipment, together with other considerations based on program and aesthetics in developing a design for the Project that is consistent with the Owner’s program, schedule and budget for the Cost of the Work.
§ 3.2.6 The Architect shall submit to the Owner an estimate of the Cost of the Work prepared in accordance with Section 6.3.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.2.7 The Architect shall submit the Schematic Design Documents to the Owner, and request the Owner’s approval.
§ 3.3 DESIGN DEVELOPMENT PHASE SERVICES

§ 3.3.1 Based on the Owner’s approval of the Schematic Design Documents, and on the Owner’s authorization of any adjustments in the Project requirements and the budget for the Cost of the Work, the Architect shall prepare Design Development Documents for the Owner’s approval. The Design Development Documents shall illustrate and describe the development of the approved Schematic Design Documents and shall consist of drawings and other documents including plans, sections, elevations, typical construction details, and diagrammatic layouts of building systems to fix and describe the size and character of the Project as to architectural, structural, mechanical and electrical systems, and such other elements as may be appropriate. The Design Development Documents shall also include outline specifications that identify major materials and systems and establish in general their quality levels.
§ 3.3.2 The Architect shall update the estimate of the Cost of the Work.
§ 3.3.3 The Architect shall submit the Design Development documents to the Owner, advise the Owner of any adjustments to the estimate of the Cost of the Work, and request the Owner’s approval.
§ 3.4 CONSTRUCTION DOCUMENTS PHASE SERVICES

§ 3.4.1 Based on the Owner’s approval of the Design Development Documents, and on the Owner’s authorization of any adjustments in the Project requirements and the budget for the Cost of the Work, the Architect shall prepare Construction Documents for the Owner’s approval. The Construction Documents shall illustrate and describe the further development of the approved Design Development Documents and shall consist of Drawings and Specifications setting forth in detail the quality levels of materials and systems and other requirements for the construction of the Work. The Owner and Architect acknowledge that in order to construct the Work the Contractor will provide additional information, including Shop Drawings, Product Data, Samples and other similar submittals, which the Architect shall review in accordance with Section 3.6.4. The Architect shall advise the Owner, in writing, of any material changes to the design from the Design Development Phase.
§ 3.4.2 The Architect shall incorporate into the Construction Documents the design requirements of governmental authorities having jurisdiction over the Project.
§ 3.4.3 During the development of the Construction Documents, the Architect shall assist the Owner in the development and preparation of (1) bidding and procurement information that describes the time, place and conditions of bidding, including bidding or proposal forms; (2) the form of agreement between the Owner and Contractor, as amended by Owner; and (3) the Conditions of the Contract for Construction (General, Supplementary and other Conditions). The Architect shall also compile a project manual that includes the Conditions of the Contract for Construction and Specifications and may include bidding requirements and sample forms.
§ 3.4.4 The Architect shall update the estimate for the Cost of the Work.
§ 3.4.5 The Architect shall submit the Construction Documents to the Owner, advise the Owner of any adjustments to the estimate of the Cost of the Work, take any action required under Section 6.5, and request the Owner’s approval.
§ 3.5 BIDDING OR NEGOTIATION PHASE SERVICES

§ 3.5.1 GENERAL

The Architect shall assist the Owner in establishing a list of prospective contractors. Following the Owner’s approval of the Construction Documents, the Architect shall assist the Owner in (1) obtaining either competitive bids or negotiated proposals; (2) confirming responsiveness of bids or proposals; (3) determining the successful bid or proposal, if any; and, (4) awarding and preparing contracts for construction.
§ 3.5.2 COMPETITIVE BIDDING

§ 3.5.2.1 Bidding Documents shall consist of bidding requirements and proposed Contract Documents.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.5.2.2 The Architect shall assist the Owner in bidding the Project by
  .1   procuring the reproduction of Bidding Documents for distribution to prospective bidders;
  .2   distributing the Bidding Documents to prospective bidders, requesting their return upon completion of the bidding process, and maintaining a log of distribution and retrieval and of the amounts of deposits, if any, received from and returned to prospective bidders;
  .3   organizing and conducting a pre-bid conference for prospective bidders;
  .4   preparing responses to questions from prospective bidders and providing clarifications and interpretations of the Bidding Documents to all prospective bidders in the form of addenda; and
  .5   organizing and conducting the opening of the bids, and subsequently documenting and distributing the bidding results, as directed by the Owner.
§ 3.5.2.3 The Architect shall consider requests for substitutions, if the Bidding Documents permit substitutions, and shall prepare and distribute addenda identifying approved substitutions to all prospective bidders.
§ 3.5.3 NEGOTIATED PROPOSALS

§ 3.5.3.1 Proposal Documents shall consist of proposal requirements and proposed Contract Documents.
§ 3.5.3.2 The Architect shall assist the Owner in obtaining proposals by
  .1   procuring the reproduction of Proposal Documents for distribution to prospective contractors, and requesting their return upon completion of the negotiation process;
  .2   organizing and participating in selection interviews with prospective contractors; and
  .3   participating in negotiations with prospective contractors, and subsequently preparing a summary report of the negotiation results, as directed by the Owner.
§ 3.5.3.3 The Architect shall consider requests for substitutions, if the Proposal Documents permit substitutions, and shall prepare and distribute addenda identifying approved substitutions to all prospective contractors.
§ 3.6 CONSTRUCTION PHASE SERVICES

§ 3.6.1 GENERAL

§ 3.6.1.1 The Architect shall provide administration of the Contract between the Owner and the Contractor as set forth below and in ALA Document A201™—2007, General Conditions of the Contract for Construction, as amended.
§ 3.6.1.2 The Architect shall advise and consult with the Owner during the Construction Phase Services. The Architect shall have authority to act on behalf of the Owner only to the extent provided in this Agreement. The Architect shall not have control over, charge of, or responsibility for the construction means, methods, techniques, sequences or procedures, or for safety precautions and programs in connection with the Work, nor shall the Architect be responsible for the Contractor’s failure to perform the Work in accordance with the requirements of the Contract Documents. The Architect shall be responsible for the Architect’s negligent acts or omissions, but shall not have control over or charge of, and shall not be responsible for, acts or omissions of the Contractor or of any other persons or entities performing portions of the Work. The Architect, by written notice, shall immediately bring any non-conformance, quality issue or delay in progress of the Work noted by the Architect to the attention of the Owner.
§ 3.6.1.3 Subject to Section 4.3, the Architect’s responsibility to provide Construction Phase Services commences with the award of the Contract for Construction and terminates on the date the Architect issues the final Certificate for Payment.
§ 3.6.2 EVALUATIONS OF THE WORK

§ 3.6.2.1 The Architect shall visit the site at intervals appropriate to the stage of construction, or as otherwise required in Section 4.3.3, to become generally familiar with the progress and quality of the portion of the Work completed, and to determine, in general, if the Work observed is being performed in a manner indicating that the Work, when fully completed, will be in accordance with the Contract Documents. However, the Architect shall not be required to make exhaustive or continuous on-site inspections to check the quality or quantity of the Work. On the basis of the site visits, the Architect shall keep the Owner reasonably informed about the progress and quality of the portion of the Work completed, and report to the Owner (1) known deviations from the Contract Documents and from the most recent construction schedule submitted by the Contractor, and (2) defects and deficiencies observed in the Work.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.6.2.2 The Architect has the authority to reject Work that does not conform to the Contract Documents. Whenever the Architect considers it necessary or advisable, the Architect shall have the authority to require inspection or testing of the Work in accordance with the provisions of the Contract Documents, whether or not such Work is fabricated, installed or completed. However, neither this authority of the Architect nor a decision made in good faith either to exercise or not to exercise such authority shall give rise to a duty or responsibility of the Architect to the Contractor, Subcontractors, material and equipment suppliers, their agents or employees or other persons or entities performing portions of the Work. The Architect shall advise the Owner, in writing, of the reasons for the rejection of any Work. Such shall be done in a timely fashion so as to allow the Owner to advise the Contractor.
§ 3.6.2.3 The Architect shall interpret and decide matters concerning performance under, and requirements of, the Contract Documents on written request of either the Owner or Contractor. The Architect’s response to such requests shall be made in writing within any time limits agreed upon or otherwise with reasonable promptness.
§ 3.6.2.4 Interpretations and decisions of the Architect shall be consistent with the intent of and reasonably inferable from the Contract Documents and shall be in writing or in the form of drawings. When making such interpretations and decisions, the Architect shall endeavor to secure faithful performance by both Owner and Contractor, and shall not show partiality to either. The Architect’s decisions on matters relating to aesthetic effect shall be final if consistent with the intent expressed in the Contract Documents.
§ 3.6.2.5 Unless the Owner and Contractor designate another person to serve as an Initial Decision Maker, as that term is defined in AIA Document A201—2007, the Architect shall render initial decisions on Claims between the Owner and Contractor as provided in the Contract Documents,
§ 3.6.3 CERTIFICATES FOR PAYMENT TO CONTRACTOR

§ 3.6.3.1 The Architect shall review and certify the amounts due the Contractor and shall issue certificates in such amounts. The Architect’s certification for payment shall constitute a representation to the Owner, based on the Architect’s evaluation of the Work as provided in Section 3.6.2 and on the data comprising the Contractor’s Application for Payment, that, to the best of the Architect’s knowledge, information and belief, the Work has progressed to the point indicated and that the quality of the Work is in accordance with the Contract Documents. The foregoing representations are subject (1) to an evaluation of the Work for conformance with the Contract Documents upon Substantial Completion, (2) to results of subsequent tests and inspections, (3) to correction of minor deviations from the Contract Documents prior to completion, and (4) to specific qualifications expressed by the Architect.
§ 3.6.3.2 The issuance of a Certificate for Payment shall not be a representation that the Architect has (1) made exhaustive or continuous on-site inspections to check the quality of the Work, (2) reviewed construction means, methods, techniques, sequences or procedures, (3) reviewed copies of requisitions received from Subcontractors and material suppliers and other data requested by the Owner to substantiate the Contractor’s right to payment, or (4) ascertained how or for what purpose the Contractor has used money previously paid on account of the Contract Sum.
§ 3.6.3.3 The Architect shall maintain a record of the Applications and Certificates for Payment.
§ 3.6.4 SUBMITTALS

§ 3.6.4.1 The Architect shall review the Contractor’s submittal schedule and shall not delay or withhold approval. The Architect’s action in reviewing submittals shall be taken in accordance with the approved submittal schedule or, in the absence of an approved submittal schedule, with reasonable promptness while allowing sufficient time in the Architect’s professional judgment to permit adequate review.
 
     
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  AIA Document B101™ -2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.6.4.2 In accordance with the Architect-approved submittal schedule, the Architect shall review and approve or take other appropriate action upon the Contractor’s submittals such as Shop Drawings, Product Data and Samples, but only for the limited purpose of checking for conformance with information given and the design concept expressed in the Contract Documents. Review of such submittals is not for the purpose of determining the accuracy and completeness of other information such as dimensions, quantities, and installation or performance of equipment or systems, which are the Contractor’s responsibility. The Architect’s review shall not constitute approval of safety precautions or, unless otherwise specifically stated by the Architect, of any construction means, methods, techniques, sequences or procedures. The Architect’s approval of a specific item shall not indicate approval of an assembly of which the item is a component.
§ 3.6.4.3 If the Contract Documents specifically require the Contractor to provide professional design services or certifications by a design professional related to systems, materials or equipment, the Architect shall specify the appropriate performance and design criteria that such services must satisfy. The Architect shall review shop drawings and other submittals related to the Work designed or certified by the design professional retained by the Contractor that bear such professional’s seal and signature when submitted to the Architect. The Architect shall be entitled to rely upon the adequacy, accuracy and completeness of the services, certifications and approvals performed or provided by such design professionals.
§ 3.6.4.4 Subject to the provisions of Section 4.3, the Architect shall review and respond to requests for information about the Contract Documents. The Architect shall set forth in the Contract Documents the requirements for requests for information. Requests for information shall include, at a minimum, a detailed written statement that indicates the specific Drawings or Specifications in need of clarification and the nature of the clarification requested. The Architect’s response to such requests shall be made in writing within any time limits agreed upon, or otherwise with reasonable promptness so as not to delay the progress of the Work. If appropriate, the Architect shall prepare and issue supplemental Drawings and Specifications in response to requests for information.
§ 3.6.4.5 The Architect shall maintain a record of submittals and copies of submittals supplied by the Contractor in accordance with the requirements of the Contract Documents.
§ 3.6.5 CHANGES IN THE WORK

§ 3.6.5.1 The Architect may authorize minor changes in the Work that are consistent with the intent of the Contract Documents and do not involve an adjustment in the Contract Sum or an extension of the Contract Time and shall advise the Owner of the same. Subject to the provisions of Section 4.3, the Architect shall prepare Change Orders and Construction Change Directives for the Owner’s approval and execution in accordance with the Contract Documents.
§ 3.6.5.2 The Architect shall maintain records relative to changes in the Work.
§ 3.6.6 PROJECT COMPLETION

§ 3.6.6.1 The Architect shall conduct inspections to determine the date or dates of Substantial Completion and the date of final completion; issue Certificates of Substantial Completion; receive from the Contractor and forward to the Owner, for the Owner’s review and records, written warranties and related documents required by the Contract Documents and assembled by the Contractor; and issue a final Certificate for Payment based upon a final inspection indicating the Work complies with the requirements of the Contract Documents.
§ 3.6.6.2 The Architect’s inspections shall be conducted with the Owner to check conformance of the Work with the requirements of the Contract Documents and to verify the accuracy and completeness of the list submitted by the Contractor of Work to be completed or corrected.
§ 3.6.6.3 When the Work is found to be substantially complete, the Architect shall inform the Owner about the balance of the Contract Sum remaining to be paid the Contractor, including the amount to be retained from the Contract Sum, if any, for final completion or correction of the Work. At Substantial Completion, the Architect shall assist the Owner in developing a punch list of incomplete and/or defective items, and the value of said items of Work. As a part of Basic Services, Architect shall return to the Project at ten (10) months following the date of Substantial Completion to conduct an inspection for warranty purposes.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 3.6.6.4 The Architect shall forward to the Owner the following information received from the Contractor: (1) consent of surety or sureties, if any, to reduction in or partial release of retainage or the making of final payment; (2) affidavits, receipts, releases and waivers of liens or bonds indemnifying the Owner against liens; and (3) any other documentation required of the Contractor under the Contract Documents.
§ 3.6.6.5 Upon request of the Owner, and prior to the expiration of one year from the date of Substantial Completion, the Architect shall, without additional compensation, conduct a meeting with the Owner to review the facility operations and performance.
ARTICLE 4 ADDITIONAL SERVICES

§ 4.1 Additional services listed below are not included in basic services but may be required for the project. The Architect shall provide the listed Additional Services only if specifically designated in the table below as the Architect’s responsibility, and the Owner shall compensate the Architect as provided in Section 11.2.
(Designate the Additional Services the Architect shall provide in the second column of the table below. In the third column indicate whether the service description is located in Section 4.2 or in an attached exhibit. If in an exhibit, identify the exhibit.)
         
    Responsibility   Location of Service Description
    (Architect, Owner   (Section 4.2 below or in an exhibit
    or   attached to this document and
Additional Services   Not Provided)   identified below)
§ 4.1.1 Programming
  Architect    
§ 4.1.2 Multiple preliminary designs
  Architect    
§ 4.1.3 Measured drawings
  Architect    
§ 4.1.4 Existing facilities surveys
  Architect    
§ 4.1.5 Site Evaluation and Planning (B203™ — 2007)
  Architect    
§ 4.1.6 Building information modeling
  Architect    
§ 4.1.7 Civil engineering
  Architect    
§ 4.1.8 Landscape design
  Architect    
§ 4.1.9 Architectural Interior Design (B252™ — 2007)
  Architect    
§ 4.1.10 Value Analysis (B204™ — 2007)
  Architect/Owner    
§ 4.1.11 Detailed cost estimating
  N/A    
§ 4.1.12 On-site project representation
  N/A    
§ 4.1.13 Conformed construction documents
  Architect   Included in Basic Services
§ 4.1.14 As-Designed Record drawings
  Architect    
§ 4.1.15 As-Constructed Record drawings
  N/A    
§ 4.1.16 Post occupancy evaluation
  N/A    
§ 4.1.17 Facility Support Services (B210™ — 2007)
  N/A    
§ 4.1.18 Tenant-related services
  N/A    
§ 4.1.19 Coordination of Owner’s consultants
  N/A    
§ 4.1.20 Telecommunications/data design
  Architect    
§ 4.1.21 Security Evaluation and Planning (B206™ — 2007)
  N/A    
§ 4.1.22 Commissioning (B211™ — 2007)
  N/A    
§ 4.1.23 Extensive environmentally responsible design
  N/A    
§ 4.1.24 LEED Certification (B214™ — 2007)
  N/A    
§ 4.1.25 Fast-track design services
  Architect    
§ 4.1.26 Historic Preservation (B205™ — 2007)
  N/A    
§ 4.1.27 Furniture, Furnishings, and Equipment Design (B253™ — 2007)
  Architect    
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 4.2 Insert a description of each additional service designated in Section 4.1 as the Architect’s responsibility, if not further described in an exhibit attached to this document.
§ 4.3 Additional Services may be provided after execution of this Agreement, without invalidating the Agreement. Except for services required due to the fault of the Architect, any Additional Services provided in accordance with this Section 4.3 shall entitle the Architect to compensation pursuant to Section 11.3 and an appropriate adjustment in the Architect’s schedule. The Architect shall provide Additional Services only if authorized and confirmed in writing by the Owner prior to the provision of such services and after the provision of a not-to-exceed estimate by the Architect.
§ 4.3.1 Upon recognizing the need to perform the following Additional Services, the Architect shall notify the Owner with reasonable promptness and explain the facts and circumstances giving rise to the need. The Architect shall not proceed to provide the following services until the Architect receives the Owner’s written authorization:
  .1   Services necessitated by a change in the Initial Information, previous instructions or approvals given by the Owner, or a material change in the Project including, but not limited to, size, quality, complexity, the Owner’s schedule or budget for Cost of the Work, or procurement or delivery method;
  .2   Services necessitated by the Owner’s request for extensive environmentally responsible design alternatives, such as unique system designs, in-depth material research, energy modeling, or LEED® certification;
  .3   Changing or editing previously prepared Instruments of Service necessitated by the enactment or revision of codes, laws or regulations or official interpretations;
  .4   Services necessitated by decisions of the Owner not rendered in a timely manner or any other failure of performance on the part of the Owner or the Owner’s consultants or contractors;
  .5   Preparing digital data for transmission to the Owner’s consultants and contractors, or to other Owner authorized recipients;
  .6   Preparation of design and documentation for alternate bid or proposal requests proposed by the Owner;
.7 Preparation for, and attendance at, a public presentation, meeting or hearing;
  .8   Preparation for, and attendance at a dispute resolution proceeding or legal proceeding, except where the Architect is party thereto, or which arises out of an alleged error or omission of the Architect;
  .9   .10 Consultation concerning replacement of Work resulting from fire or other cause during construction; or
  .11   Assistance to the Initial Decision Maker, if other than the Architect, unless in connection with an alleged error or omission of the Architect.
§ 4.3.2 To avoid delay in the Construction Phase, the Architect shall provide the following Additional Services, notify the Owner, in writing, with reasonable promptness, and explain the facts and circumstances giving rise to the need and a not-to-exceed estimate of the cost of such services. If the Owner subsequently determines that all or parts of those services are not required, the Owner shall give prompt written notice to the Architect, and the Owner shall have no further obligation to compensate the Architect for those services:
  .1   Reviewing an unreasonable number of Contractor’s submittal out of sequence from the submittal schedule agreed to by the Architect;
  .2   Responding to the Contractor’s requests for information that are not prepared in accordance with the Contract Documents or where such information is available to the Contractor from a careful study and comparison of the Contract Documents, field conditions, other Owner-provided information, Contractor-prepared coordination drawings, or prior Project correspondence or documentation;
  .3   Preparing Change Orders and Construction Change Directives that require evaluation of Contractor’s proposals and supporting data, or the preparation or revision of Instruments of Service;
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .4   Evaluating an extensive number of Claims as the Initial Decision Maker, unless in connection with an alleged error or omission of the Architect;
  .5   Evaluating substitutions proposed by the Owner or Contractor and making subsequent revisions to Instruments of Service resulting therefrom; or
  .6   To the extent the Architect’s Basic Services are affected, providing Construction Phase Services 90 days after (1) the date of Substantial Completion of the Work.
Notwithstanding anything to the contrary, in no event shall Architect be entitled to additional compensation if such service arises, in whole or in part, from an error, omission, inconsistency or lack of clarity in the Contract Documents.
§ 4.3.3 The Architect shall provide Construction Phase Services exceeding the limits set forth below as Additional Services. When the limits below are reached, the Architect shall notify the Owner:
  .1   three ( 3 ) reviews of each Shop Drawing, Product Data item, sample and similar submittal of the Contractor
  .2   weekly ( ) visits to the site by the Architect over the duration of the Project during construction
  .3   two ( 2 ) inspections for any portion of the Work to determine whether such portion of the Work is substantially complete in accordance with the requirements of the Contract Documents
  .4   two ( 2 ) inspections for any portion of the Work to determine final completion
§ 4.3.4 If the services covered by this Agreement have not been completed within such time frame to be mutually agreed upon by the parties upon final development of the full Project scope, through no fault of the Architect, extension of the Architect’s services beyond that time shall be compensated as Additional Services. The parties shall agree upon said time frame and execute a written Amendment to this Agreement reflecting said date.
ARTICLE 5 OWNER’S RESPONSIBILITIES

§ 5.1 Unless otherwise provided for under this Agreement, the Owner shall provide information in a timely manner regarding requirements for and limitations on the Project, including a written program which shall set forth the Owner’s objectives, schedule, constraints and criteria, including space requirements and relationships, flexibility, expandability, special equipment, systems and site requirements. Within 15 days after receipt of a written request from the Architect, the Owner shall furnish the requested information as necessary and relevant for the Architect to evaluate, give notice of or enforce lien rights.
§ 5.2 With the Architect’s assistance, the Owner shall establish and periodically update the Owner’s budget for the Project, including (1) the budget for the Cost of the Work as defined in Section 6.1; (2) the Owner’s other costs; and, (3) reasonable contingencies related to all of these costs. If the Owner significantly increases or decreases the Owner’s budget for the Cost of the Work, the Owner shall notify the Architect, the Owner and the Architect shall thereafter agree to a corresponding change in the Project’s scope and quality if the change in the Owner’s budget results in material changes in Architect’s work.
§ 5.3 The Owner shall identify a representative authorized to act on the Owner’s behalf with respect to the Project. The Owner shall render decisions and approve the Architect’s submittals in a timely manner in order to avoid unreasonable delay in the orderly and sequential progress of the Architect’s services.
§ 5.4 The Owner shall furnish surveys to describe physical characteristics, legal limitations and utility locations for the site of the Project, and a written legal description of the site. The surveys and legal information shall include, as applicable, grades and lines of streets, alleys, pavements and adjoining property and structures; designated wetlands; adjacent drainage; rights-of-way, restrictions, easements, encroachments, zoning, deed restrictions, boundaries and contours of the site; locations, dimensions and necessary data with respect to existing buildings, other improvements and trees; and information in its possession concerning available utility services and lines, both public and private, above and below grade, including inverts and depths. All the information on the survey shall be referenced to a Project benchmark.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 5.5 The Owner shall furnish services of geotechnical engineers, which may include but are not limited to test borings, test pits, determinations of soil bearing values, percolation tests, evaluations of hazardous materials, seismic evaluation, ground corrosion tests and resistivity tests, including necessary operations for anticipating subsoil conditions, with written reports and appropriate recommendations. The Architect shall advise the Owner of the need for any additional testing.
(Paragraph deleted)

§ 5.6 The Owner shall coordinate the services of its own consultants with those services provided by the Architect. Upon the Architect’s request, the Owner shall furnish copies of the scope of services in the contracts between the Owner and the Owner’s consultants. The Owner shall furnish the services of consultants other than those designated in this Agreement, or authorize the Architect to furnish them as an Additional Service, when the Architect requests such services and demonstrates that they are reasonably required by the scope of the Project. The Owner shall require that its consultants maintain professional liability insurance as appropriate to the services provided.
§ 5.7 The Owner shall furnish tests, inspections and reports required by law or the Contract Documents, such as structural, mechanical, and chemical tests, tests for air and water pollution, and tests for hazardous materials.
§ 5.8 The Owner shall furnish all legal, insurance and accounting services, including auditing services, that may be reasonably necessary at any time for the Project to meet the Owner’s needs and interests.
§ 5.9 The Owner shall provide reasonable notice to the Architect if the Owner becomes aware of any fault or defect in the Project, including errors, omissions or inconsistencies in the Architect’s Instruments of Service.
§ 5.10 Except as otherwise provided in this Agreement, or when direct communications have been specially authorized, the Owner shall endeavor to communicate with the Contractor and the Architect’s consultants through the Architect about matters arising out of or relating to the Contract Documents. The Owner shall promptly notify the Architect of any direct communications that may affect the Architect’s services.
§ 5.11 Before executing the Contract for Construction, the Owner shall coordinate the Architect’s duties and responsibilities set forth in the Contract for Construction with the Architect’s services set forth in this Agreement. The Owner shall provide the Architect a copy of the executed agreement between the Owner and Contractor, including the General Conditions of the Contract for Construction.
§ 5.12 The Owner shall provide the Architect access to the Project site prior to commencement of the Work and shall obligate the Contractor to provide the Architect access to the Work wherever it is in preparation or progress.
§ 5.13 Notwithstanding anything to the contrary, the Owner shall only be required to provide information if requested by the Architect, in writing, and such information is reasonably required for the Architect to perform its duties hereunder.
ARTICLE 6 COST OF THE WORK

§ 6.1 For purposes of this Agreement, the Cost of the Work shall be the total cost to the Owner to construct all elements of the Project designed or specified by the Architect and shall include contractors’ general conditions costs, overhead and profit, The Cost of the Work does not include the compensation of the Architect, the costs of the land, rights-of-way, financing, contingencies for changes in the Work or other costs that are the responsibility of the Owner.
§ 6.2 The Owner’s budget for the Cost of the Work is provided in Initial Information, and may be adjusted throughout the Project as required under Sections 5.2, 6.4 and 6.5. Evaluations of the Owner’s budget for the Cost of the Work, the preliminary estimate of the Cost of the Work and updated estimates of the Cost of the Work prepared by the Architect, represent the Architect’s judgment as a design professional. It is recognized, however, that neither the Architect nor the Owner has control over the cost of labor, materials or equipment; the Contractor’s methods of determining bid prices; or competitive bidding, market or negotiating conditions. Accordingly, the Architect cannot and does not warrant or represent that bids or negotiated prices will not vary from the Owner’s budget for the Cost of the Work or from any estimate of the Cost of the Work or evaluation prepared or agreed to by the Architect.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 6.3 In preparing estimates of the Cost of Work, the Architect shall be permitted to include contingencies for design, bidding and price escalation; to determine what materials, equipment, component systems and types of construction are to be included in the Contract Documents; to make reasonable adjustments in the program and scope of the Project; and to include in the Contract Documents alternate bids as may be necessary to adjust the estimated Cost of the Work to meet the Owner’s budget for the Cost of the Work. The Architect’s estimate of the Cost of the Work shall be based on current area, volume or similar conceptual estimating techniques. If the Owner requests detailed cost estimating services, the Architect shall provide such services as an Additional Service under Article 4.
§ 6.4 If the Bidding or Negotiation Phase has not commenced within 90 days per phase after the Architect submits the Construction Documents to the Owner, through no fault of the Architect, the Owner’s budget for the Cost of the Work shall be adjusted to reflect changes in the general level of prices in the applicable construction market.
§ 6.5 If at any time the Architect’s estimate of the Cost of the Work exceeds the Owner’s budget for the Cost of the Work, the Architect shall make appropriate recommendations to the Owner to adjust the Project’s size, quality or budget for the Cost of the Work, and the Owner shall cooperate with the Architect in making such adjustments.
§ 6.6 If the Owner’s budget for the Cost of the Work at the conclusion of the Construction Documents Phase Services is exceeded by the lowest bona fide bid or negotiated proposal, the Owner shall
  .1   give written approval of an increase in the budget for the Cost of the Work;
  .2   authorize rebidding or renegotiating of the Project within a reasonable time;
  .3   terminate in accordance with Section 9.5;
  .4   in consultation with the Architect, revise the Project program, scope, or quality as required to reduce the Cost of the Work; or
  .5   implement any other mutually acceptable alternative.
§ 6.7 If the Owner chooses to proceed under Section 6.6.4, the Architect, without additional compensation, shall modify the Construction Documents as necessary to comply with the Owner’s budget for the Cost of the Work at the conclusion of the Construction Documents Phase Services, or the budget as adjusted under Section 6.6.1. The Architect’s modification of the Construction Documents shall be the limit of the Architect’s responsibility under this Article 6.
ARTICLE 7 COPYRIGHTS AND LICENSES

§ 7.1 The Architect and the Owner warrant that in transmitting Installments of Service, or any other information, the transmitting party is the copyright owner of such information or has permission from the copyright owner to transmit such information for its use on the Project. If the Owner and Architect intend to transmit Instruments of Service or any other information or documentation in digital form, they shall endeavor to establish necessary protocols governing such transmissions.
§ 7.2 The Architect and the Architect’s consultants shall be deemed the authors and owners of their respective Instruments of Service, including the Drawings and Specifications, and shall retain all common law, statutory and other reserved rights, including copyrights. Submission or distribution of Instruments of Service to meet, official regulatory requirements or for similar purposes in connection with the Project is not to be construed as publication in derogation of the reserved rights of the Architect and the Architect’s consultants.
§ 7.3 Upon execution of this Agreement, the Architect grants to the Owner a nonexclusive license to use the Architect’s Instruments of Service solely and exclusively for purposes of constructing, using, maintaining, altering and adding to the Project, provided that the Owner substantially performs its obligations, including prompt payment of all sums when due, under this Agreement. The Architect shall obtain similar nonexclusive licenses from the Architect’s consultants consistent with this Agreement. The license granted under this section permits the Owner to authorize the Contractor, Subcontractors, Sub-subcontractors, and material or equipment suppliers, as well as the Owner’s consultants and separate contractors, to reproduce applicable portions of the Instruments of Service solely and exclusively for use in performing services or construction for the Project. If the Architect rightfully terminates this Agreement for cause as provided in Section 9.4, the license granted in this Section 7.3 shall terminate.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 7.3.1 In the event the Owner uses the Instruments of Service without retaining the author of the Instruments of Service, the Owner releases the Architect and Architect’s consultant(s) from all claims and causes of action arising from such uses. The Owner, to the extent permitted by law, further agrees to indemnify and hold harmless the Architect and its consultants from all costs and expenses, including the cost of defense, related to claims and causes of action asserted by any third person or entity to the extent such costs and expenses arise from the Owner’s use of the Instruments of Service under this Section 7.3.1. The terms of this Section 7.3.1 shall not apply if the Owner rightfully terminates this Agreement for cause under Section 9.4.
§ 7.4 Except for the licenses granted in this Article 7, no other license or right shall be deemed granted or implied under this Agreement. The Owner shall not assign, delegate, sublicense, pledge or otherwise transfer any license granted herein to another party without the prior written agreement of the Architect. Any unauthorized use of the Instruments of Service shall be at the Owner’s sole risk and without liability to the Architect and the Architect’s consultants.
ARTICLE 8 CLAIMS AND DISPUTES

§ 8.1 GENERAL

§ 8.1.1 The Owner and Architect shall commence all claims and causes of action, whether in contract, tort, or otherwise, against the other arising out of or related to this Agreement in accordance with the requirements of the method of binding dispute resolution selected in this Agreement within the period specified by applicable law. The Owner and Architect waive all claims and causes of action not commenced in accordance with this Section 8.1.1.
§ 8.1.2 To the extent damages are covered by property insurance, the Owner and Architect waive all rights against each other and against the contractors, consultants, agents and employees of the other for damages, except such rights as they may have to the proceeds of such insurance as set forth in AIA Document A201-2007, General Conditions of the Contract for Construction, as amended. The Owner or the Architect, as appropriate, shall require of the contractors, consultants, agents and employees of any of them similar waivers in favor of the other parties enumerated herein.
§ 8.1.3 The Architect and Owner waive consequential damages for claims, disputes or other matters in question arising out of or relating to this Agreement. This mutual waiver is applicable, without limitation, to all consequential damages due to either party’s termination of this Agreement.
§ 8.2 MEDIATION

§ 8.2.1 Any claim, dispute or other matter in question arising out of or related to this Agreement shall be subject to mediation as a condition precedent to binding dispute resolution. If such matter relates to or is the subject of a lien arising out of the Architect’s services, the Architect may proceed in accordance with applicable law to comply with the lien notice or filing deadlines prior to resolution of the matter by mediation or by binding dispute resolution.
§ 8.2.2 The Owner and Architect shall endeavor to resolve claims, disputes and other matters in question between them by mediation which, unless the parties mutually agree otherwise, shall be administered by the American Arbitration Association in accordance with its Construction Industry Mediation Procedures in effect on the date of the Agreement. A request for mediation shall be made in writing, delivered to the other party to the Agreement, and filed with the person or entity administering the mediation. The request may be made concurrently with the filing of a complaint or other appropriate demand for binding dispute resolution but, in such event, mediation shall proceed in advance of binding dispute resolution proceedings, which shall be stayed pending mediation for a period of 60 days from the date of filing, unless stayed for a longer period by agreement of the parties or court order.
§ 8.2.3 The parties shall share the mediator’s fee and any filing fees equally. The mediation shall be held in the place where the Project is located, unless another location is mutually agreed upon. Agreements reached in mediation shall be enforceable as settlement agreements in any court having jurisdiction thereof.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 8.2.4 If the parties do not resolve a dispute through mediation pursuant to this Section 8.2, the method of binding dispute resolution shall be the following:
(Check the appropriate box. If the Owner and Architect do not select a method of binding dispute resolution below, or do not subsequently agree in writing to a binding dispute resolution method other than litigation, the dispute will be resolved in a court of competent jurisdiction.)
o Arbitration pursuant to Section 8.3 of this Agreement
þ Litigation the Court of Common Pleas, York County, Pennsylvania, which shall have exclusive jurisdiction and venue.
o Other (Specify)
§ 8.3 ARBITRATION
(Paragraphs deleted)

§8.3.4 CONSOLIDATION OR JOINDER
(Paragraphs deleted)

ARTICLE 9 TERMINATION OR SUSPENSION

§ 9.1 If the Owner fails to make payments to the Architect in accordance with this Agreement, such failure shall be considered substantial nonperformance and cause for termination or, at the Architect’s option, cause for suspension of performance of services under this Agreement. If the Architect elects to suspend services, the Architect shall give fourteen days’ written notice to the Owner before suspending services. In the event of a suspension of services, the Architect shall have no liability to the Owner for delay or damage caused the Owner because of such suspension of services. Before resuming services, the Architect shall be paid all sums due prior to suspension and any expenses incurred in the interruption and resumption of the Architect’s services. The Architect’s fees for the remaining services and the time schedules may be equitably adjusted.
§ 9.2 If the Owner suspends the Project, the Architect shall be compensated for services performed prior to notice of such suspension. When the Project is resumed, the Architect shall be compensated for actual out-of-pocket expenses incurred in the interruption and resumption of the Architect’s services, the Architect’s fees for the remaining services and the time schedules shall be equitably adjusted.
§ 9.3 If the Owner suspends the Project for more than 90 cumulative days for reasons other than the fault of the Architect, the Architect may terminate this Agreement by giving not less than seven days’ written notice.
§ 9.4 Either party may terminate this Agreement upon not less than seven days’ written notice should the other party fail substantially to perform in accordance with the terms of this Agreement through no fault of the party initiating the termination.
§ 9.5 The Owner may terminate this Agreement upon not less than seven days’ written notice to the Architect for the Owner’s convenience and without cause.
§ 9.6 In the event of termination not the fault of the Architect, the Architect shall be compensated for services performed prior to termination, together with Reimbursable Expenses then due.
§ 9.7
§ 9.8 The Owner’s rights to use the Architect’s Instruments of Service in the event of a termination of this Agreement are set forth in Article 7 and Section 11.9.
ARTICLE 10 MISCELLANEOUS PROVISIONS

§ 10.1 This Agreement shall be governed by the law of the place where the Project is located.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 10.2 Terms in this Agreement shall have the same meaning as those in AIA Document A201-2007, General Conditions of the Contract for Construction, as amended.
§ 10.3 The Owner and Architect, respectively, bind themselves, their agents, successors, assigns and legal representatives to this Agreement. Neither the Owner nor the Architect shall assign this Agreement without the written consent of the other, except that the Owner may assign this Agreement to a lender providing financing for the Project if the lender agrees to assume the Owner’s rights and obligations under this Agreement.
§ 10.4 If the Owner requests the Architect to execute certificates, the proposed language of such certificates shall be submitted to the Architect for review at least 11 days prior to the requested dates of execution. If the Owner requests the Architect to execute consents reasonably required to facilitate assignment to a lender, the Architect shall execute all such consents that are consistent with (his Agreement, provided the proposed consent is submitted to the Architect for review at least 7 days prior to execution. The Architect shall not be required to execute certificates or consents that would require knowledge, services or responsibilities beyond the scope of this Agreement.
§ 10.5
§ 10.6 Unless otherwise required in this Agreement, the Architect shall have no responsibility for the discovery, presence, handling, removal or disposal of, or exposure of persons to, hazardous materials or toxic substances in any form at the Project site.
§ 10.7 The Architect shall have the right to include photographic or artistic representations of the design of the Project among the Architect’s promotional and professional materials. The Architect shall be given reasonable access to the completed Project to make such representations. However, the Architect’s materials shall not include the Owner’s confidential or proprietary information if the Owner has previously advised the Architect in writing of the specific information considered by the Owner to be confidential or proprietary. The Owner shall provide professional credit for the Architect in the Owner’s promotional materials for the Project.
§ 10.8 If the Architect or Owner receives information specifically designated by the other party as “confidential” or “business proprietary,” the receiving party shall keep such information strictly confidential and shall not disclose it to any other person except to (1) its employees, (2) those who need to know the content of such information in order to perform services or construction solely and exclusively for the Project, or (3) its consultants and contractors whose contracts include similar restrictions on the use of confidential information.
ARTICLE 11 COMPENSATION

§ 11.1 For the Architect’s Basic Services described under Article 3, the Owner shall compensate the Architect as follows:
(Insert amount of, or basis for, compensation.)
Architect’s Fee shall be a stipulated sum in the amount of One Million Five Hundred and Sixty Thousand Dollars ($1,560,000).
§ 11.2 For Additional Services designated in Section 4.1, the Owner shall compensate the Architect as follows:
(Insert amount of or basis for, compensation. If necessary, list specific services to which particular methods of compensation apply.)
Hourly Rates set forth on Exhibit B.
§ 11.3 For Additional Services that may arise during the course of the Project, including those under Section 4.3, the Owner shall compensate the Architect as follows:
(Insert amount of or basis for, compensation.)
Hourly Rates set forth on Exhibit B.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 11.4 Compensation for Additional Services of the Architect’s consultants when not included in Section 11.2 or 11.3, shall be the amount invoiced to the Architect plus ( ), or as otherwise stated below:
At cost
§ 11.5 Where compensation for Basic Services is based on a stipulated sum or percentage of the Cost of the Work, the compensation for each phase of services shall be as follows:
               
Schematic Design Phase
  Fifteen   percent   (15 %)
Design Development Phase
  Twenty   percent   (20 %)
Construction Documents Phase
  Forty   percent   (40 %)
Bidding or Negotiation Phase
  Five   percent   (5 %)
Construction Phase
  Twenty   percent   (20 %)
 
             
 
         
Total Basic Compensation
  one hundred   percent   (100 %)
 
             
§ 11.6 When compensation is based on a percentage of the Cost of the Work and any portions of the Project are deleted or otherwise not constructed, compensation for those portions of the Project shall be payable to the extent services are performed on those portions, in accordance with the schedule set forth in Section 11.5 based on (1) the lowest bona fide bid or negotiated proposal, or (2) if no such bid or proposal is received, the most recent estimate of the Cost of the Work for such portions of the Project. The Architect shall be entitled to compensation in accordance with this Agreement for all services performed whether or not the Construction Phase is commenced.
§ 11.7 The hourly billing rates for services of the Architect and the Architect’s consultants, if any, are set forth below. The rates shall be adjusted in accordance with the Architect’s and Architect’s consultants’ normal review practices.
(If applicable, attach an exhibit of hourly billing rates or insert them below.)
See Exhibit B.
Employee or Category     Rate
§ 11.8 COMPENSATION FOR REIMBURSABLE EXPENSES

§ 11.8.1 Reimbursable Expenses are in addition to compensation for Basic and Additional Services and include expenses incurred by the Architect and the Architect’s consultants directly related to the Project, as follows:
  .1   Transportation and authorized out-of-town travel and subsistence;
  .2   Long distance services, dedicated data and communication services, teleconferences, Project Web sites, and extranets;
  .3   Fees paid for securing approval of authorities having jurisdiction over the Project;
  .4   Printing, reproductions, plots, standard form documents;
  .5   Postage, handling and delivery;
  .6   Expense of overtime work requiring higher than regular rates, if authorized in advance by the Owner and not arising out of an alleged error or omission or failure to timely perform hereunder;
  .7   Renderings, models, mock-ups, professional photography, and presentation materials requested by the Owner;
  .8   Architect’s Consultant’s expense of professional liability insurance dedicated exclusively to this Project, or the expense of additional insurance coverage or limits if the Owner requests such insurance in excess of that normally carried by the Architect’s consultants;
  .9   All taxes levied on professional services and on reimbursable expenses;
  .10   Site office expenses; and
  .11   Other similar Project-related expenditures.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 11.8.2 For Reimbursable Expenses the compensation shall be the expenses incurred by the Architect and the Architect’s consultants plus one and one-tenth (1.1) of the expenses incurred.
§ 11.9 COMPENSATION FOR USE OF ARCHITECT’S INSTRUMENTS OF SERVICE

If the Owner terminates the Architect for its convenience under Section 9.5, or the Architect terminates this Agreement under Section 9.3, the Owner shall indemnify and hold Architect harmless from any charges to Architect’s Instruments of Service.
§ 11.10 PAYMENTS TO THE ARCHITECT

§ 11.10.1 An initial payment of zero dollars ($0.00) shall be made upon execution of this Agreement and is the minimum payment under this Agreement. It shall be credited to the Owner’s account in the final invoice.
§ 11.10.2 Unless otherwise agreed, payments for services shall be made monthly in proportion to services performed. Payments are due and payable upon presentation of the Architect’s invoice. Amounts unpaid ( ) days after the invoice date shall bear interest at the rate entered below, or in the absence thereof at the legal rate prevailing from time to time at the principal place of business of the Architect.

(Insert rate of monthly or annual interest agreed upon.)
per annum interest shall be prime rate as set forth in the (Money Section of The Wall Street Journal as of the date of execution of this Agreement or Owner’s cost of fund, whichever is lower.
§ 11.10.3 The Owner shall not withhold amounts from the Architect’s compensation to impose a penalty or liquidated damages on the Architect, or to offset sums requested by or paid to contractors for the cost of changes in the Work unless the Architect agrees or has been found liable for the amounts in a binding dispute resolution proceeding.
§ 11.10.4 Records of Reimbursable Expenses, expenses pertaining to Additional Services, and services performed on the basis of hourly rates shall be available to the Owner at mutually convenient times.
ARTICLE 12 SPECIAL TERMS AND CONDITIONS

Special terms and conditions that modify this Agreement are as follows:
§ 12.1 The Architect shall indemnify and hold harmless the Owner from and against any and all claims, damages, losses, expenses, including but not limited reasonable attorneys’ fees, to the extent arising out of the negligence, errors, omissions or failure to perform by the Architect, its employees, subconsultants or those for whom the Architect is responsible.
§ 12.2 In the event that a party fails or refuses to indemnify the other hereunder, in addition to all other obligations and upon an adjudication in favor of the prevailing party, the prevailing party shall be entitled to any and all costs associated with bringing such action, including, but not limited to, reasonable attorneys’ fees and all expert fees and costs.
§ 12.3 The Owner shall indemnify and hold harmless the Architect from and against any and all claims, damages, losses, expenses , including but not limited reasonable attorneys’ fees, to the extent arising out of the negligence of the Owner, its employees and those for whom the Owner is responsible.
ARTICLE 13 SCOPE OF THE AGREEMENT

§ 13.1 This Agreement represents the entire and integrated agreement between the Owner and the Architect and supersedes all prior negotiations, representations or agreements, either written or oral. This Agreement may be amended only by written instrument signed by both Owner and Architect.
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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§ 13.2 This Agreement is comprised of the following documents listed below:
  .1   AIA Document B101™—2007, Standard Form Agreement Between Owner and Architect, as amended
  .2   AIA Document A201™—2007, as amended.
  .3   Other documents: (List other documents, if any, including Exhibit A, Initial Information, and additional scopes of service, if any, forming part of the Agreement.)
This Agreement entered into as of the day and year first written above.
     
OWNER
  ARCHITECT
 
   
UNILIFE CROSS FARM LLC
  L2 ARCHITECTURE
 
/s/ Daniel Calvert
  /s/ John LaProcido 
 
   
      (Signature)
       (Signature)
Daniel Calvert CFO
  John LaProcido, Principal
 
   
     (Printed name and title)
       (Printed name and title)
 
     
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  AIA Document B101™ — 2007 (formerly B151™ — 1997). Copyright © 1974, 1978, 1987, 1997 and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA© Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this AIA© Document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:00:18 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (2052352336)

 

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AMENDMENT TO
AGREEMENT BETWEEN OWNER AND ARCHITECT
This Amendment is entered into this 29th day of December 2009 by and between Unilife Cross Farms, LLC (“Unilife”) and L2 Architecture (“L2”).
WHEREAS, on or about December 14, 2009, the parties entered into a B101-2007 Agreement between Owner and Architect, as modified (hereinafter the “Agreement”); and
WHEREAS, the parties agree that estimating services shall be provided by HSC Builders and Construction Managers (“HSC”),
NOW THEREFORE, for good and valuable consideration the receipt of which is hereby acknowledged the parties hereto agree as follows:
1. The preceding paragraphs are incorporated herein by reference as though set forth at length.
2. The Agreement is hereby amended to remove the responsibility to provide construction estimating services from the scope of Work of L2.
3. All other terms and conditions of the Agreement shall remain in effect.
With the intent to be legally bound hereby, this Amendment is executed the day first above written.
         
ATTEST:   Unilife Cross Farms, LLC
 
       
/s/ Cynthia M. Lighty
  By:   /s/ Daniel Calvert
 
       
       
 
       
ATTEST:   L2 Architecture
 
       
 
  By:   /s/ John LaProcido
 
       
 
      John LaProcido
 
      Principal

 

EX-10.24 10 c93531exv10w24.htm EXHIBIT 10.24 Exhibit 10.24
Exhibit 10.24
(AIA LOGO) Document A121™ CMc — 2003 and AGC Document 565
Standard Form of Agreement Between Owner and Construction Manager where the Construction Manager is Also the Constructor

AGREEMENT made as of the 14th day of Dec. in the year 2009 (In words, indicate day, month and year.)
BETWEEN the Owner:
(Name and address)
UNILIFE CROSS FARM LLC.
633 Lowther Road
Lewisberry, PA 17339
and the Construction Manager:
(Name and address)
HSC Builders & Construction Managers
304 New Mill Lane
Exton, PA 19341
The Project is:
(Name, address and brief description)
Unilife Medical Solutions
250 Cross Farm Lane
York, PA
New World Headquarters Facility
The Architect is:
(Name and address)
L2 Architecture
1717 Arch Street, Suite 3920
Philadelphia, PA 19103
The Owner and Construction Manager agree as set forth below:
ADDITIONS AND DELETIONS:
The author of this document has added information needed for its completion. The author may also have revised the text of the original AIA standard form. An Additions and Deletions Report that notes added information as well as revisions to the standard form text is available from the author and should be reviewed. A vertical line in the left margin of this document indicates where the author has added necessary information and where the author has added to or deleted from the original AIA text.
This document has important legal consequences. Consultation with an attorney is encouraged with respect to its completion or modification.
The 1997 Edition of AIA Document A201, General Conditions of the Contract for Construction, is referred to herein. This Agreement requires modification if other general conditions are utilized.


 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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TABLE OF CONTENTS
         
ARTICLE 1 GENERAL PROVISIONS
    3  
§ 1.1 Relationship of Parties
    3  
§ 1.2 General Conditions
    3  
 
       
ARTICLE 2 CONSTRUCTION MANAGER’S RESPONSIBILITIES
    3  
§ 2.1 Preconstruction Phase
    3  
§ 2.2 Guaranteed Maximum Price Proposal and Contract Time
    5  
§ 2.3 Construction Phase
    6  
§ 2.4 Professional Services
    7  
§ 2.5 Hazardous Materials
    7  
 
       
ARTICLE 3 OWNER’S RESPONSIBILITIES
    7  
§ 3.1 Information and Services
    7  
§ 3.2 Owner’s Designated Representative
    8  
§ 3.3 Architect
    8  
§ 3.4 Legal Requirements
    8  
 
       
ARTICLE 4 COMPENSATION AND PAYMENTS FOR PRECONSTRUCTION PHASE SERVICES
    8  
§ 4.1 Compensation
    8  
§ 4.2 Payments
    9  
 
       
ARTICLE 5 COMPENSATION FOR CONSTRUCTION PHASE SERVICES
    9  
§ 5.1 Compensation
    9  
§ 5.2 Guaranteed Maximum Price
    9  
§ 5.3 Changes in the Work
    10  
 
       
ARTICLE 6 COST OF THE WORK FOR CONSTRUCTION PHASE
    10  
§ 6.1 Costs to Be Reimbursed
    10  
§ 6.2 Costs Not to Be Reimbursed
    12  
§ 6.3 Discounts, Rebates and Refunds
    13  
§ 6.4 Accounting Records
    13  
 
       
ARTICLE 7 CONSTRUCTION PHASE
    13  
§ 7.1 Progress Payments
    13  
§ 7.2 Final Payment
    15  
 
       
ARTICLE 8 INSURANCE AND BONDS
    16  
§ 8.1 Insurance Required of the Construction Manager
    16  
§ 8.2 Insurance Required of the Owner
    16  
§ 8.3 Performance Bond and Payment Bond
    17  
 
       
ARTICLE 9 MISCELLANEOUS PROVISIONS
    17  
§ 9.1 Dispute Resolution
    17  
§ 9.2 Other Provisions
    17  
 
       
ARTICLE 10 TERMINATION OR SUSPENSION
    17  
§ 10.1 Termination Prior to Establishing Guaranteed Maximum Price
    17  
§ 10.2 Termination Subsequent to Establishing Guaranteed Maximum Price
    18  
§ 10.3 Suspension
    18  
 
       
ARTICLE 11 OTHER CONDITIONS AND SERVICES
    19  
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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ARTICLE 1 GENERAL PROVISIONS
§ 1.1 RELATIONSHIP OF PARTIES
The Construction Manager accepts the relationship of trust and confidence established with the Owner by this Agreement, and covenants with the Owner to furnish the Construction Manager’s reasonable skill and judgment and to cooperate with the Architect in furthering the interests of the Owner. The Construction Manager shall furnish construction administration and management services and use the Construction Manager’s best efforts to perform the Project in an expeditious and economical manner consistent with the interests of the Owner. The Owner shall endeavor to promote harmony and cooperation among the Owner, Architect, Construction Manager and other persons or entities employed by the Owner for the Project.
§ 1.2 GENERAL CONDITIONS
For the Construction Phase, the General Conditions of the contract shall be the AIA® Document A201™–2007, General Conditions of the Contract for Construction, as amended which is incorporated herein by reference. For the Preconstruction Phase, or in the event that the Preconstruction and Construction Phases proceed concurrently, A201™–2007, as amended shall apply to the Preconstruction Phase only as specifically provided in this Agreement. The term “Contractor” as used in A201™–2007, as amended shall mean the Construction Manager. When a Guaranteed Maximum Price has been agreed to between the parties, in instances where the term “Contract Sum” is used in the AIA Document A201 without any additional reference to the Guaranteed Maximum Price, the term “Contract Sum” shall nevertheless be determined to mean the Guaranteed Maximum Price or “GMP”.
ARTICLE 2 CONSTRUCTION MANAGER’S RESPONSIBILITIES
The Construction Manager shall perform the services described in this Article. The services to be provided under Sections 2.1 and 2.2 constitute the Preconstruction Phase services. If the Owner and Construction Manager agree, after consultation with the Architect, the Construction Phase may commence before the Preconstruction Phase is completed, in which case both phases will proceed concurrently.
§ 2.1 PRECONSTRUCTION PHASE
§ 2.1.1 PRELIMINARY EVALUATION
The Construction Manager shall provide a preliminary evaluation of the Owner’s program and Project budget requirements, each in terms of the other.
§ 2.1.2 CONSULTATION
The Construction Manager with the Architect shall jointly schedule and attend regular meetings with the Owner. The Construction Manager shall consult with the Owner and Architect regarding site use and improvements and the selection of materials, building systems and equipment. The Construction Manager shall provide recommendations on construction feasibility; actions designed to minimize adverse effects of labor or material shortages; time requirements for procurement, installation and construction completion; and factors related to construction cost, including estimates of alternative designs or materials, preliminary budgets and possible economies.
§ 2.1.3 PRELIMINARY PROJECT SCHEDULE
When Project requirements described in Section 3.1.1 have been sufficiently identified, the Construction Manager shall prepare, and periodically update, a preliminary Project schedule for the Architect’s review and the Owner’s approval. The Construction Manager shall obtain the Architect’s approval of the portion of the preliminary Project schedule relating to the performance of the Architect’s services. The Construction Manager shall coordinate and integrate the preliminary Project schedule with the services and activities of the Owner, Architect and Construction Manager. As design proceeds, the preliminary Project schedule shall be updated to indicate proposed activity sequences and durations, milestone dates for receipt and approval of pertinent information, submittal of a Guaranteed Maximum Price proposal, preparation and processing of shop drawings and samples, delivery of materials or equipment requiring long-lead-time procurement, Owner’s occupancy requirements showing portions of the Project having occupancy priority, and proposed date of Substantial Completion. If preliminary Project schedule updates indicate that previously approved schedules may not be met, the Construction Manager shall make appropriate recommendations to the Owner and Architect. A detailed Project Schedule in accordance with Article 3.10 of the General Conditions, as amended, shall be submitted with the GMP.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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§ 2.1.4 PHASED CONSTRUCTION
The Construction Manager shall make recommendations to the Owner and Architect regarding the phased issuance of Drawings and Specifications to facilitate phased construction of the Work, if such phased construction is appropriate for the Project, taking into consideration such factors as economies, time of performance, availability of labor and materials, and provisions for temporary facilities.
§ 2.1.5 PRELIMINARY COST ESTIMATES
§ 2.1.5.1 When the Owner has sufficiently identified the Project requirements and the Architect has prepared other basic design criteria, the Construction Manager shall prepare, for the review of the Architect and approval of the Owner, a preliminary cost estimate utilizing area, volume or similar conceptual estimating techniques.
§ 2.1.5.2 When Schematic Design Documents have been prepared by the Architect and approved by the Owner, the Construction Manager shall prepare, for the review of the Architect and approval of the Owner, a more detailed estimate with supporting data. During the preparation of the Design Development Documents, the Construction Manager shall update and refine this estimate at appropriate intervals agreed to by the Owner, Architect and Construction Manager.
§ 2.1.5.3 When Design Development Documents have been prepared by the Architect and approved by the Owner, the Construction Manager shall prepare a detailed estimate with supporting data for review by the Architect and approval by the Owner. During the preparation of the Construction Documents, the Construction Manager shall update and refine this estimate at appropriate intervals agreed to by the Owner, Architect and Construction Manager.
§ 2.1.5.4 If any estimate submitted to the Owner exceeds previously approved estimates or the Owner’s budget, the Construction Manager shall make appropriate recommendations to the Owner and Architect.
§ 2.1.6 SUBCONTRACTORS AND SUPPLIERS
The Construction Manager shall seek to develop subcontractor interest in the Project and shall furnish to the Owner and Architect for their information a list of possible subcontractors, including suppliers who are to furnish materials or equipment fabricated to a special design, from whom proposals will be requested for each principal portion of the Work. The Architect will promptly reply in writing to the Construction Manager if the Architect or Owner know of any objection to such subcontractor or supplier. The receipt of such list shall not require the Owner or Architect to investigate the qualifications of proposed subcontractors or suppliers, nor shall it waive the right of the Owner or Architect later to object to or reject any proposed subcontractor or supplier.
§ 2.1.7 LONG-LEAD-TIME ITEMS
The Construction Manager shall recommend to the Owner and Architect a schedule for procurement of long-lead-time items which will constitute part of the Work as required to meet the Project schedule. If such long-lead-time items are procured by the Owner, they shall be procured on terms and conditions acceptable to the Construction Manager. Upon the Owner’s acceptance of the Construction Manager’s Guaranteed Maximum Price proposal, all contracts for such items shall be assigned by the Owner to the Construction Manager, who shall accept responsibility for such items as if procured by the Construction Manager. The Construction Manager shall expedite the delivery of long-lead-time items.
§ 2.1.8 EXTENT OF RESPONSIBILITY
The Construction Manager does not warrant or guarantee estimates and schedules except as may be included as part of the Guaranteed Maximum Price. The recommendations and advice of the Construction Manager concerning design alternatives shall be subject to the review and approval of the Owner and the Owner’s professional consultants. It is not the Construction Manager’s responsibility to ascertain that the Drawings and Specifications are in accordance with applicable laws, statutes, ordinances, building codes, rules and regulations. The Construction Manager shall review the Drawings and Specifications with due care. If the Construction Manager recognizes that portions of the Drawings and Specifications are at variance therewith, the Construction Manager shall promptly notify the Architect and Owner in writing.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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§ 2.1.9 EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION
The Construction Manager shall comply with applicable laws, regulations and special requirements of the Contract Documents regarding equal employment opportunity and affirmative action programs.
§ 2.2 GUARANTEED MAXIMUM PRICE PROPOSAL AND CONTRACT TIME
§ 2.2.1 When the Drawings and Specifications are sufficiently complete, the Construction Manager shall propose a Guaranteed Maximum Price, which shall be the sum of the estimated Cost of the Work and the Construction Manager’s Fee.
§ 2.2.2 As the Drawings and Specifications may not be finished at the time the Guaranteed Maximum Price proposal is prepared, the Construction Manager shall provide in the Guaranteed Maximum Price for further development of the Drawings and Specifications by the Architect that is consistent with the Contract Documents and reasonably inferable therefrom. Such further development does not include such things as changes in scope, systems, kinds and quality of materials, finishes or equipment, all of which, if required, shall be incorporated by Change Order.
§ 2.2.3 The estimated Cost of the Work shall include the Construction Manager’s contingency, a sum established by the Construction Manager for the Construction Manager’s exclusive use to cover costs arising under Section 2.2.2 and other costs which are properly reimbursable as Cost of the Work but not the basis for a Change Order.
§ 2.2.4 BASIS OF GUARANTEED MAXIMUM PRICE
The Construction Manager shall include with the Guaranteed Maximum Price proposal a written statement of its basis, which shall include:
  .1   A list of the Drawings and Specifications, including all addenda thereto and the Conditions of the Contract, which were used in preparation of the Guaranteed Maximum Price proposal.
  .2   A list of allowances and a statement of their basis.
  .3   A list of the clarifications and assumptions made by the Construction Manager in the preparation of the Guaranteed Maximum Price proposal to supplement the information contained in the Drawings and Specifications.
  .4   The proposed Guaranteed Maximum Price, including a statement of the estimated cost organized by trade categories, allowances, contingency, and other items and the Fee that comprise the Guaranteed Maximum Price.
  .5   The Date of Substantial Completion upon which the proposed Guaranteed Maximum Price is based, and a schedule of the Construction Documents issuance dates upon which the date of Substantial Completion is based.
§ 2.2.5 The Construction Manager shall meet with the Owner and Architect to review the Guaranteed Maximum Price proposal and the written statement of its basis. In the event that the Owner or Architect discover any inconsistencies or inaccuracies in the information presented, they shall promptly notify the Construction Manager, who shall make appropriate adjustments to the Guaranteed Maximum Price proposal, its basis, or both.
§ 2.2.6 Unless the Owner accepts the Guaranteed Maximum Price proposal in writing on or before the date specified in the proposal for such acceptance and so notifies the Construction Manager, the Guaranteed Maximum Price proposal shall not be effective without written acceptance by the Construction Manager.
§ 2.2.7 Prior to the Owner’s acceptance of the Construction Manager’s Guaranteed Maximum Price proposal and issuance of a Notice to Proceed, the Construction Manager shall not incur any cost to be reimbursed as part of the Cost of the Work, except as the Owner may specifically authorize in writing.
§ 2.2.8 Upon acceptance by the Owner of the Guaranteed Maximum Price proposal, the Guaranteed Maximum Price and its basis shall be set forth in Amendment No. 1. The Guaranteed Maximum Price shall be subject to additions and deductions by a change in the Work as provided in the Contract Documents, and the Date of Substantial Completion shall be subject to adjustment as provided in the Contract Documents.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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§ 2.2.9 The Owner shall authorize and cause the Architect to revise the Drawings and Specifications to the extent necessary to reflect the agreed-upon assumptions and clarifications contained in Amendment No. 1. Such revised Drawings and Specifications shall be furnished to the Construction Manager in accordance with schedules agreed to by the Owner, Architect and Construction Manager. The Construction Manager shall promptly notify the Architect and Owner if such revised Drawings and Specifications are inconsistent with the agreed-upon assumptions and clarifications.
§ 2.2.10 The Guaranteed Maximum Price shall include in the Cost of the Work only those taxes which are enacted at the time the Guaranteed Maximum Price is established.
§ 2.3 CONSTRUCTION PHASE
§ 2.3.1 GENERAL
§ 2.3.1.1 The Construction Phase shall commence on the earlier of:
  (1)   the Owner’s acceptance of the Construction Manager’s Guaranteed Maximum Price proposal and issuance of a Notice to Proceed, or
  (2)   the Owner’s first authorization to the Construction Manager to:
(a) award a subcontract, or
(b) undertake construction Work with the Construction Manager’s own forces, or
(c) issue a purchase order for materials or equipment required for the Work.
§ 2.3.2 ADMINISTRATION
§ 2.3.2.1 Those portions of the Work that the Construction Manager does not customarily perform with the Construction Manager’s own personnel shall be performed under subcontracts or by other appropriate agreements with the Construction Manager. The Construction Manager shall obtain bids from Subcontractors and from suppliers of materials or equipment fabricated to a special design for the Work from the list previously reviewed and, after analyzing such bids, shall deliver such bids to the Owner and Architect. The Owner will then determine, with the advice of the Construction Manager and subject to the reasonable objection of the Architect, which bids will be accepted. The Owner may designate specific persons or entities from whom the Construction Manager shall obtain bids; however, if the Guaranteed Maximum Price has been established, the Owner may not prohibit the Construction Manager from obtaining bids from other qualified bidders. The Construction Manager shall not be required to contract with anyone to whom the Construction Manager has reasonable objection.
§ 2.3.2.2 If the Guaranteed Maximum Price has been established and a specific bidder among those whose bids are delivered by the Construction Manager to the Owner and Architect (1) is recommended to the Owner by the Construction Manager; (2) is qualified to perform that portion of the Work; and (3) has submitted a bid which conforms to the requirements of the Contract Documents without reservations or exceptions, but the Owner requires that another bid be accepted, then the Construction Manager may require that a change in the Work be issued to adjust the Contract Time and the Guaranteed Maximum Price by the difference between the bid of the person or entity recommended to the Owner by the Construction Manager and the amount of the subcontract or other agreement actually signed with the person or entity designated by the Owner.
§ 2.3.2.3 Subcontracts and agreements with suppliers furnishing materials or equipment fabricated to a special design shall conform to the payment provisions of Sections 7.1.8 and 7.1.9 and shall not be awarded on the basis of cost plus a fee without the prior consent of the Owner.
§ 2.3.2.4 The Construction Manager shall schedule and conduct meetings at which the Owner, Architect, Construction Manager and appropriate Subcontractors can discuss the status of the Work. The Construction Manager shall prepare and promptly distribute meeting minutes.
§ 2.3.2.5 Promptly after the Owner’s acceptance of the Guaranteed Maximum Price proposal, the Construction Manager shall prepare a schedule in accordance with Section 3.10 of A201™–2007, as amended including the Owner’s occupancy requirements.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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§ 2.3.2.6 The Construction Manager shall provide monthly written reports to the Owner and Architect on the progress of the entire Work. The Construction Manager shall maintain a daily log containing a record of weather, Subcontractors working on the site, number of workers, Work accomplished, problems encountered and other similar relevant data as the Owner may reasonably require. The log shall be available to the Owner and Architect.
§ 2.3.2.7 The Construction Manager shall develop a system of cost control for the Work, including regular monitoring of actual costs for activities in progress and estimates for uncompleted tasks and proposed changes. The Construction Manager shall identify variances between actual and estimated costs and report the variances to the Owner and Architect at regular intervals.
§ 2.3.2.8 The Construction Manager shall be responsible for preparing all Subcontractor bid packages and the distribution of bid documents to prospective bidders. The Construction Manager shall maintain a log of all solicitations of Subcontractors, a log of distribution, and retrieval of bid documents. The Construction Manager shall organize and conduct the opening of bids and shall distribute the results to the Owner and Architect.
§ 2.4 PROFESSIONAL SERVICES
Section 3.12.10 of A201™–2007, as amended shall apply to both the Preconstruction and Construction Phases.
§ 2.5 HAZARDOUS MATERIALS
Section 10.3 of A201™–2007, as amended shall apply to both the Preconstruction and Construction Phases.
ARTICLE 3 OWNER’S RESPONSIBILITIES
§ 3.1 INFORMATION AND SERVICES
§ 3.1.1 The Owner shall provide full information in a timely manner regarding the requirements of the Project, including a program which sets forth the Owner’s objectives, constraints and criteria, including space requirements and relationships, flexibility and expandability requirements, special equipment and systems, and site requirements.
§ 3.1.2 The Owner shall, at the written request of the Construction Manager prior to commencement of the Construction Phase and thereafter, furnish to the Construction Manager reasonable evidence that financial arrangements have been made to fulfill the Owner’s obligations under the Contract. Furnishing of such evidence shall be a condition precedent to commencement or continuation of the Work. After such evidence has been furnished, the Owner shall not materially vary such financial arrangements without prior notice to the Construction Manager.
§ 3.1.3 The Owner shall establish and update an overall budget for the Project, based on consultation with the Construction Manager and Architect, which shall include contingencies for changes in the Work and other costs which are the responsibility of the Owner.
§ 3.1.4 STRUCTURAL AND ENVIRONMENTAL TESTS, SURVEYS AND REPORTS
In the Preconstruction Phase, the Owner shall furnish the following with reasonable promptness and at the Owner’s expense. Except to the extent that the Construction Manager knows of any inaccuracy, the Construction Manager shall be entitled to rely upon the accuracy of any such information, reports, surveys, drawings and tests described in Sections 3.1.4.1 through 3.1.4.4 but shall exercise customary precautions relating to the performance of the Work.
§ 3.1.4.1 Reports, surveys, drawings and tests concerning the conditions of the site which are required by law.
§ 3.1.4.2 Surveys describing physical characteristics, legal limitations and utility locations for the site of the Project, and a written legal description of the site. The surveys and legal information shall include, as applicable, grades and lines of streets, alleys, pavements and adjoining property and structures; adjacent drainage; rights-of-way, restrictions, easements, encroachments, zoning, deed restrictions, boundaries and contours of the site; locations, dimensions and necessary data pertaining to existing buildings, other improvements and trees; and information concerning available utility services and lines, both public and private, above and below grade, including inverts and depths. All information on the survey shall be referenced to a project benchmark.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.1.4.3 The services of a geotechnical engineer when such services are requested by the Construction Manager. Such services may include but are not limited to test borings, test pits, determinations of soil bearing values, percolation tests, evaluations of hazardous materials, ground corrosion and resistivity tests, including necessary operations for anticipating subsoil conditions, with reports and appropriate professional recommendations.
§ 3.1.4.4 Structural, mechanical, chemical, air and water pollution tests, tests for hazardous materials, and other laboratory and environmental tests, inspections and reports which are required by law.
§ 3.1.4.5 The services of other consultants when such services are reasonably required by the scope of the Project and are requested by the Construction Manager. Any requests for such services shall be made in writing to the Owner.
§ 3.2 OWNER’S DESIGNATED REPRESENTATIVE
The Owner shall designate in writing a representative who shall have express authority to bind the Owner with respect to all matters requiring the Owner’s approval or authorization. This representative shall have the authority to make decisions on behalf of the Owner concerning estimates and schedules, construction budgets, and changes in the Work, and shall render such decisions promptly and furnish information expeditiously, so as to avoid unreasonable delay in the services or Work of the Construction Manager. Except as otherwise provided in Section 4.2.1 of A201™–2007, as amended, the Architect does not have such authority.
§ 3.3 ARCHITECT
The Owner shall retain an Architect to provide Basic Services, including normal structural, mechanical and electrical engineering services, other than cost estimating services, described in the edition of AIA® Document B101-2007, Standard Form of Agreement Between Owner and Architect, as amended. The Owner shall authorize and cause the Architect to provide those Additional Services described in B101-2007, as amended requested by the Construction Manager which must necessarily be provided by the Architect for the Preconstruction and Construction Phases of the Work. Such services shall be provided in accordance with time schedules agreed to by the Owner, Architect and Construction Manager. Upon request of the Construction Manager, the Owner shall furnish to the Construction Manager a copy of the Owner’s Agreement with the Architect, from which compensation provisions may be deleted.
§ 3.4 LEGAL REQUIREMENTS
The Owner shall determine and advise the Architect and Construction Manager of any special legal requirements relating specifically to the Project which differ from those generally applicable to construction in the jurisdiction of the Project. The Owner shall furnish such legal services as are necessary to provide the information and services required under Section 3.1.
ARTICLE 4 COMPENSATION AND PAYMENTS FOR PRECONSTRUCTION PHASE SERVICES
The Owner shall compensate and make payments to the Construction Manager for Preconstruction Phase services as follows:
§ 4.1 COMPENSATION
§ 4.1.1 For the services described in Sections 2.1 and 2.2, the Construction Manager’s compensation shall be calculated as follows:
(State basis of compensation, whether a stipulated sum, multiple of Direct Personnel Expense, actual cost, etc. Include a statement of reimbursable cost items as applicable.)
Preconstruction Fee is $42,900 with $25,000 to be credited toward the Construction Manager’s Fee for the construction phase.
§ 4.1.2 Compensation for Preconstruction Phase Services shall be equitably adjusted if such services extend beyond November 10, 1009 from the date of this Agreement or if the originally contemplated scope of services is significantly modified.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 4.1.3 If compensation is based on a multiple of Direct Personnel Expense, Direct Personnel Expense is defined as the direct salaries of the Construction Manager’s personnel engaged in the Project and the portion of the cost of their mandatory and customary contributions and benefits related thereto, such as employment taxes and other statutory employee benefits, insurance, sick leave, holidays, vacations, pensions and similar contributions and benefits.
§ 4.2 PAYMENTS
§ 4.2.1 Payments shall be made monthly following presentation of the Construction Manager’s invoice and, where applicable, shall be in proportion to services performed. Construction Manager and Owner shall establish a monthly draw meeting to review Construction Manager’s Application for Payment.
§ 4.2.2 Payments are due and payable thirty (30) days from the date the Construction Manager’s invoice is received by the Owner. Amounts unpaid after the date on which payment is due shall bear interest at the rate entered below, or in the absence thereof, at the legal rate prevailing from time to time at the place where the Project is located.
(Insert rate of interest agreed upon.)
per annum interest shall be Prime Rate as set forth in The Wall Street Journal as of the date of execution of this Agreement.
(Usury laws and requirements under the Federal Truth in Lending Act, similar state and local consumer credit laws and other regulations at the Owner’s and Contractor’s principal places of business, the location of the Project and elsewhere may affect the validity of this provision. Legal advice should be obtained with respect to deletions or modifications, and also regarding requirements such as written disclosures or waivers.)
ARTICLE 5 COMPENSATION FOR CONSTRUCTION PHASE SERVICES
The Owner shall compensate the Construction Manager for Construction Phase services as follows:
§ 5.1 COMPENSATION
§ 5.1.1 For the Construction Manager’s performance of the Work as described in Section 2.3, the Owner shall pay the Construction Manager in current funds the Contract Sum consisting of the Cost of the Work as defined in Article 6 and the Construction Manager’s Fee determined as follows:
(State a lump sum, percentage of actual Cost of the Work or other provision for determining the Construction Manager’s Fee, and explain how the Construction Manager’s Fee is to be adjusted for changes in the Work.)
Construction Manager’s Fee shall be one and one quarter percent (1 1/4%) of the cost of the Work.
§ 5.2 GUARANTEED MAXIMUM PRICE
§ 5.2.1 The sum of the Cost of the Work and the Construction Manager’s Fee are guaranteed by the Construction Manager not to exceed the amount provided in Amendment No. 1, subject to additions and deductions by changes in the Work as provided in the Contract Documents. Such maximum sum as adjusted by approved changes in the Work is referred to in the Contract Documents as the Guaranteed Maximum Price. Costs which would cause the Guaranteed Maximum Price to be exceeded shall be paid by the Construction Manager without reimbursement by the Owner.
At the end of the project, if the total Cost of the Work, including Construction Manager’s Fee is less than the GMP as adjusted by change orders, the remaining funds shall be deemed to be Savings. Savings shall include any Construction Manager’s contingency which remains unused. All Savings shall be split with eighty-five percent (85%) inuring to the benefit of the Owner and fifteen percent (15%) to the Construction Manager.
The parties further agree that as an incentive to the Construction Manager for completion, should the Construction Manager achieve the following Milestones, it shall be entitled to receive additional compensation which shall be calculated as a percentage of its Fee as set forth in 5.1.1 above;
     
April 15, 2010
  Completion of Utility Rooms for Equipment Installation
July 1, 2010
  Completion of Clean Rooms for Equipment Installation (15% of CM Fee)
August 1, 2010
  Temporary Occupancy Permit for Manufacturing/Warehouse
October 18, 2010
  Unrestricted Occupancy Permit for Manufacturing/Warehouse (15% of CM Fee)
December 15, 2010
  Unrestricted Occupancy Permit for Office
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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Should Construction Manager fail to achieve any Milestone by the date prescribed, but then achieve a later Milestone, it will not be entitled to the payment related to the failed Milestone.
(Insert specific provisions if the Construction Manager is to participate in any savings.)
§ 5.3 CHANGES IN THE WORK
§ 5.3.1 Adjustments to the Guaranteed Maximum Price on account of changes in the Work subsequent to the execution of Amendment No. 1 may be determined by any of the methods listed in Section 7.3.3 of A201-2007, as amended.
§ 5.3.2 In calculating adjustments to subcontracts (except those awarded with the Owner’s prior consent on the basis of cost plus a fee), the terms “cost” and “fee” as used in Section 7.3.3.3 of A201-2007, as amended and the terms “costs” and “a reasonable allowance for overhead and profit” as used in Section 7.3.6 of A201-2007, as amended shall have the meanings assigned to them in that document and shall not be modified by this Article 5. Adjustments to subcontracts awarded with the Owner’s prior consent on the basis of cost plus a fee shall be calculated in accordance with the terms of those subcontracts.
§ 5.3.3 In calculating adjustments to the Contract, the terms “cost” and “costs” as used in the above-referenced provisions of A201-2007, as amended shall mean the Cost of the Work as defined in Article 6 of this Agreement, and the term “and a reasonable allowance for overhead and profit” shall mean the Construction Manager’s Fee as defined in Section 5.1.1 of this Agreement.
§ 5.3.4 If no specific provision is made in Section 5.1.1 for adjustment of the Construction Manager’s Fee in the case of changes in the Work, or if the extent of such changes is such, in the aggregate, that application of the adjustment provisions of Section 5.1.1 will cause substantial inequity to the Owner or Construction Manager, the Construction Manager’s Fee shall be equitably adjusted on the basis of the Fee established for the original Work.
ARTICLE 6 COST OF THE WORK FOR CONSTRUCTION PHASE
§ 6.1 COSTS TO BE REIMBURSED
§ 6.1.1 The term “Cost of the Work” shall mean costs necessarily incurred by the Construction Manager in the proper performance of the Work. Such costs shall be at rates not higher than those customarily paid at the place of the Project except with prior consent of the Owner. The Cost of the Work shall include only the items set forth in this Article 6.
§ 6.1.2 LABOR COSTS
  .1   Wages of construction workers directly employed by the Construction Manager to perform the construction of the Work at the site or, with the Owner’s agreement, at off-site workshops.
  .2   Wages or salaries of the Construction Manager’s supervisory and administrative personnel when stationed at the site with the Owner’s agreement.
(If it is intended that the wages or salaries of certain personnel stationed at the Construction Manager’s principal office or offices other than the site office shall be included in the Cost of the Work, such personnel shall be identified below.)
         
 
  Classification   Name
See Exhibit “B”. Rates shall be fixed for the duration of the Project [NEED RATES].
  .3   Wages and salaries of the Construction Manager’s supervisory or administrative personnel engaged, at factories, workshops or on the road, in expediting the production or transportation of materials or equipment required for the Work, but only for that portion of their time required for the Work.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .4   Costs paid or incurred by the Construction Manager for taxes, insurance, contributions, assessments and benefits required by law or collective bargaining agreements, and, for personnel not covered by such agreements, customary benefits such as sick leave, medical and health benefits, holidays, vacations and pensions, provided that such costs are based on wages and salaries included in the Cost of the Work under Sections 6.1.2.1 through 6.1.2.3.
§ 6.1.3 SUBCONTRACT COSTS
Payments made by the Construction Manager to Subcontractors in accordance with the requirements of the subcontracts.
§ 6.1.4 COSTS OF MATERIALS AND EQUIPMENT INCORPORATED IN THE COMPLETED CONSTRUCTION
  .1   Costs, including transportation, of materials and equipment incorporated or to be incorporated in the completed construction.
  .2   Costs of materials described in the preceding Section 6.1.4.1 in excess of those actually installed but required to provide reasonable allowance for waste and for spoilage. Unused excess materials, if any, shall be handed over to the Owner at the completion of the Work or, at the Owner’s option, shall be sold by the Construction Manager; amounts realized, if any, from such sales shall be credited to the Owner as a deduction from the Cost of the Work.
§ 6.1.5 COSTS OF OTHER MATERIALS AND EQUIPMENT, TEMPORARY FACILITIES AND RELATED ITEMS
  .1   Costs, including transportation, installation, maintenance, dismantling and removal of materials, supplies, temporary facilities, machinery, equipment, and hand tools not customarily owned by the construction workers, which are provided by the Construction Manager at the site and fully consumed in the performance of the Work; and cost less salvage value on such items if not fully consumed, whether sold to others or retained by the Construction Manager. Cost for items previously used by the Construction Manager shall mean fair market value.
  .2   Rental charges for temporary facilities, machinery, equipment and hand tools not customarily owned by the construction workers, which are provided by the Construction Manager at the site, whether rented from the Construction Manager or others, and costs of transportation, installation, minor repairs and replacements, dismantling and removal thereof. Rates and quantities of equipment rented shall be subject to the Owner’s prior approval. Hourly rental rates for machinery and equipment rented from the Construction Manager or others shall not exceed eighty percent (80%) of the Dataquest’s Rental Rate Blue Book for Construction Equipment.
  .3   Costs of removal of debris from the site.
  .4   Reproduction costs, costs of telegrams, facsimile transmissions and long-distance telephone calls, postage and express delivery charges, telephone at the site and reasonable petty cash expenses of the site office.
  .5   That portion of the reasonable travel and subsistence expenses of the Construction Manager’s personnel incurred while traveling in discharge of duties connected with the Work.
§ 6.1.6 MISCELLANEOUS COSTS
  .1   That portion directly attributable to this Contract of premiums for insurance and bonds.
(If charges for self-insurance are to be included, specify the basis of reimbursement.)
  .2   Sales, use or similar taxes imposed by a governmental authority which are related to the Work and for which the Construction Manager is liable.
  .3   Fees and assessments for the building permit and for other permits, licenses and inspections for which the Construction Manager is required by the Contract Documents to pay.
  .4   Fees of testing laboratories for tests required by the Contract Documents, except those related to nonconforming Work other than that for which payment is permitted by Section 6.1.8.2.
  .5   Royalties and license fees paid for the use of a particular design, process or product required by the Contract Documents; the cost of defending suits or claims for infringement of patent or other intellectual property rights arising from such requirement by the Contract Documents; payments made in accordance with legal judgments against the Construction Manager resulting from such suits or claims and payments of settlements made with the Owner’s consent; provided, however, that such costs of legal defenses, judgment and settlements shall not be included in the calculation of the Construction Manager’s Fee or the Guaranteed Maximum Price and provided that such royalties, fees and costs are not excluded by the last sentence of Section 3.17.1 of A201™–1997 or other provisions of the Contract Documents.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .6   Data processing costs related to the Work.
  .7   Deposits lost for causes other than the Construction Manager’s negligence or failure to fulfill a specific responsibility to the Owner set forth in this Agreement.
  .8   Legal, mediation and arbitration costs, other than those arising from disputes between the Owner and Construction Manager, or alleged negligence on the part of the Construction Manager, reasonably incurred by the Construction Manager in the performance of the Work and with the Owner’s written permission, which permission shall not be unreasonably withheld.
  .9   Expenses incurred in accordance with Construction Manager’s standard personnel policy for relocation and temporary living allowances of personnel required for the Work, in case it is necessary to relocate such personnel from distant locations, with the Owner’s prior written approval.
§ 6.1.7 OTHER COSTS
  .1   Other costs incurred in the performance of the Work if and to the extent approved in advance in writing by the Owner.
§ 6.1.8 EMERGENCIES AND REPAIRS TO DAMAGED OR NONCONFORMING WORK
The Cost of the Work shall also include costs described in Section 6.1.1 which are incurred by the Construction Manager:
  .1   In taking action to prevent threatened damage, injury or loss in case of an emergency affecting the safety of persons and property, as provided in Section 10.6 of A201-2007, as amended.
  .2   In repairing or correcting damaged or nonconforming Work executed by the Construction Manager or the Construction Manager’s Subcontractors or suppliers, provided that such damaged or nonconforming Work was not caused by the negligence or failure to fulfill a specific responsibility to the Owner set forth in this agreement of the Construction Manager or the Construction Manager’s foremen, engineers or superintendents, or other supervisory, administrative or managerial personnel of the Construction Manager, or the failure of the Construction Manager’s personnel to supervise adequately the Work of the Subcontractors or suppliers, and only to the extent that the cost of repair or correction is not recoverable by the Construction Manager from insurance, Subcontractors or suppliers. In no event, and not withstanding anything to the contrary herein, shall the Cost of the Work include the cost of warranty items or the cost to repair or correct any defective or non-conforming Work.
§ 6.1.9 The costs described in Sections 6.1.1 through 6.1.8 shall be included in the Cost of the Work notwithstanding any provision of A201-2007, as amended or other Conditions of the Contract which may require the Construction Manager to pay such costs, unless such costs are excluded by the provisions of Section 6.2.
§ 6.2 COSTS NOT TO BE REIMBURSED
§ 6.2.1 The Cost of the Work shall not include:
  .1   Salaries and other compensation of the Construction Manager’s personnel stationed at the Construction Manager’s principal office or offices other than the site office, except as specifically provided in Sections 6.1.2.2 and 6.1.2.3.
  .2   Expenses of the Construction Manager’s principal office and offices other than the site office, except as specifically provided in Section 6.1.
  .3   Overhead and general expenses, except as may be expressly included in Section 6.1.
  .4   The Construction Manager’s capital expenses, including interest on the Construction Manager’s capital employed for the Work.
  .5   Rental costs of machinery and equipment, except as specifically provided in Section 6.1.5.2.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .6   Except as provided in Section 6.1.8.2, costs due to the negligence of the Construction Manager or to the failure of the Construction Manager to fulfill a specific responsibility to the Owner set forth in this Agreement.
  .7   Costs incurred in the performance of Preconstruction Phase Services.
 
  .8   Except as provided in Section 6.1.7.1, any cost not specifically and expressly described in Section 6.1.
 
  .9   Costs which would cause the Guaranteed Maximum Price to be exceeded.
§ 6.3 DISCOUNTS, REBATES AND REFUNDS
§ 6.3.1 Cash discounts obtained on payments made by the Construction Manager shall accrue to the Owner if (1) before making the payment, the Construction Manager included them in an Application for Payment and received payment therefor from the Owner, or (2) the Owner has deposited funds with the Construction Manager with which to make payments; otherwise, cash discounts shall accrue to the Construction Manager. Trade discounts, rebates, refunds and amounts received from sales of surplus materials and equipment shall accrue to the Owner, and the Construction Manager shall make provisions so that they can be secured.
§ 6.3.2 Amounts which accrue to the Owner in accordance with the provisions of Section 6.3.1 shall be credited to the Owner as a deduction from the Cost of the Work.
§ 6.4 ACCOUNTING RECORDS
§ 6.4.1 The Construction Manager shall keep full and detailed accounts and exercise such controls as may be necessary for proper financial management under this Contract; the accounting and control systems shall be satisfactory to the Owner. The Owner and the Owner’s accountants shall be afforded access to the Construction Manager’s records, books, correspondence, instructions, drawings, receipts, subcontracts, purchase orders, vouchers, memoranda and other data relating to this Project, and the Construction Manager shall preserve these for a period of three years after final payment, or for such longer period as may be required by law.
ARTICLE 7 CONSTRUCTION PHASE PAYMENTS
§ 7.1 PROGRESS PAYMENTS
§ 7.1.1 Based upon Applications for Payment submitted to the Architect by the Construction Manager and Certificates for Payment issued by the Architect, the Owner shall make progress payments on account of the Contract Sum to the Construction Manager as provided below and elsewhere in the Contract Documents.
§ 7.1.2 The period covered by each Application for Payment shall be one calendar month ending on the last day of the month, or as follows:
§ 7.1.3 Provided an Application for Payment is received by the Architect not later than the first (1st) day of a month, the Owner shall make payment to the Construction Manager not later than the thirtieth (30th) day of the same month. If an Application for Payment is received by the Architect after the application date fixed above, payment shall be made by the Owner not later than thirty (30) days after the Architect receives the Application for Payment.
§ 7.1.4 With each Application for Payment, the Construction Manager shall submit a billing detail report which identifies each expense incurred during the billing period, and payrolls, petty cash accounts, receipted invoices or invoices with check vouchers attached and any other evidence required by the Owner or Architect to demonstrate that cash disbursements already made by the Construction Manager on account of the Cost of the Work equal or exceed (1) progress payments already received by the Construction Manager; less (2) that portion of those payments attributable to the Construction Manager’s Fee; plus (3) payrolls for the period covered by the present Application for Payment.
§ 7.1.5 Each Application for Payment shall be based upon the most recent schedule of values submitted by the Construction Manager in accordance with the Contract Documents. The schedule of values shall allocate the entire Guaranteed Maximum Price among the various portions of the Work, except that the Construction Manager’s Fee shall be shown as a single separate item. The schedule of values shall be prepared in such form and supported by such data to substantiate its accuracy as the Architect may require. This schedule, unless objected to by the Architect, shall be used as a basis for reviewing the Construction Manager’s Applications for Payment. The schedule of values shall be adjusted as each trade contract is purchased to reflect the actual costs to be incurred under that line item.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 7.1.6 Applications for Payment shall show the percentage completion of each portion of the Work as of the end of the period covered by the Application for Payment. The percentage completion shall be the lesser of (1) the percentage of that portion of the Work which has actually been completed or (2) the percentage obtained by dividing (a) the expense which has actually been incurred by the Construction Manager on account of that portion of the Work for which the Construction Manager has made or intends to make actual payment prior to the next Application for Payment by (b) the share of the Guaranteed Maximum Price allocated to that portion of the Work in the schedule of values.
§ 7.1.7 Subject to other provisions of the Contract Documents, the amount of each progress payment shall be computed as follows:
  .1   Take that portion of the Guaranteed Maximum Price properly allocable to completed Work as determined by multiplying the percentage completion of each portion of the Work by the share of the Guaranteed Maximum Price allocated to that portion of the Work in the schedule of values. Pending final determination of cost to the Owner of changes in the Work, amounts not in dispute may be included as provided in Section 7.3.8 of A201-2007, as amended, even though the Guaranteed Maximum Price has not yet been adjusted by Change Order.
  .2   Add that portion of the Guaranteed Maximum Price properly allocable to materials and equipment delivered and suitably stored at the site for subsequent incorporation in the Work or, if approved in advance by the Owner, suitably stored off the site at a location agreed upon in writing.
  .3   Add the Construction Manager’s Fee, less retainage of ten (10%). The Construction Manager’s Fee shall be computed upon the Cost of the Work described in the two preceding Sections at the rate stated in Section 5.1.1 or, if the Construction Manager’s Fee is stated as a fixed sum in that Section, shall be an amount which bears the same ratio to that fixed-sum Fee as the Cost of the Work in the two preceding Sections bears to a reasonable estimate of the probable Cost of the Work upon its completion. The amount of retainage for each Application for Payment shall be limited to ten percent (10%) until fifty percent (50%) of the Work is complete; no additional retainage from subsequent payments will be withheld so the retainage is progressively reduced to five percent (5%) at the time of Substantial Completion. Notwithstanding anything to the contrary herein, in the event that the Owner reasonably determines that any portion of the Work is not being reasonably performed, or the Schedule is not being reasonably followed, the Owner shall have the absolute right to continue to make progress payments at the rate of only ninety percent (90%) of the amount due the Construction Manager and the amount due the Construction Manager shall not include the value of the Work disputed.
  .4   Subtract the aggregate of previous payments made by the Owner.
  .5   Subtract the shortfall, if any, indicated by the Construction Manager in the documentation required by Section 7.1.4 to substantiate prior Applications for Payment, or resulting from errors subsequently discovered by the Owner’s accountants in such documentation.
  .6   Subtract amounts, if any, for which the Architect has withheld or nullified a Certificate for Payment as provided in Section 9.5 of A201-2007, as amended.
§ 7.1.8 Except with the Owner’s prior approval, payments to Subcontractors shall be subject to retention of not less than ten (10%). The Owner and the Construction Manager shall agree upon a mutually acceptable procedure for review and approval of payments and retention for subcontracts.
§ 7.1.9 Except with the Owner’s prior approval, the Construction Manager shall not make advance payments to suppliers for materials or equipment which have not been delivered and stored at the site.
§ 7.1.10 In taking action on the Construction Manager’s Applications for Payment, the Architect shall be entitled to rely on the accuracy and completeness of the information furnished by the Construction Manager and shall not be deemed to represent that the Architect has made a detailed examination, audit or arithmetic verification of the documentation submitted in accordance with Section 7.1.4 or other supporting data, that the Architect has made exhaustive or continuous on-site inspections or that the Architect has made examinations to ascertain how or for what purposes the Construction Manager has used amounts previously paid on account of the Contract. Such examinations, audits and verifications, if required by the Owner, will be performed by the Owner’s accountants acting in the sole interest of the Owner.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 7.1.11 The payment or partial payment of any Application for Payment by the Owner, including the final Application for Payment, shall not constitute approval or acceptance of any Work or cost in such Application.
§ 7.2 FINAL PAYMENT
§ 7.2.1 Final payment shall be made by the Owner to the Construction Manager when (1) the Contract has been fully performed by the Construction Manager except for the Construction Manager’s responsibility to correct nonconforming Work, as provided in Section 12.2.2 of A201-2007, as amended, and to satisfy other requirements, if any, which necessarily survive final payment; (2) a final Application for Payment and a final accounting for the Cost of the Work have been submitted by the Construction Manager and reviewed by the Owner’s accountants; and (3) a final Certificate for Payment has then been issued by the Architect; such final payment shall be made by the Owner not more than 30 days after the issuance of the Architect’s final Certificate for Payment, or as follows:
§ 7.2.2 The amount of the final payment shall be calculated as follows:
  .1   Take the sum of the Cost of the Work substantiated by the Construction Manager’s final accounting and the Construction Manager’s Fee, but not more than the Guaranteed Maximum Price.
  .2   Subtract amounts, if any, for which the Architect withholds, in whole or in part, a final Certificate for Payment as provided in Section 9.5.1 of A201-2007, as amended or other provisions of the Contract Documents. At Substantial Completion, Owner shall develop a list of incomplete, defective or disputed items and shall retain funds as set forth in the General Conditions.
  .3   Subtract the aggregate of previous payments made by the Owner.
If the aggregate of previous payments made by the Owner exceeds the amount due the Construction Manager, the Construction Manager shall reimburse the difference to the Owner.
§ 7.2.3 The Owner’s accountants will review and report in writing on the Construction Manager’s final accounting within 30 days after delivery of the final accounting to the Architect by the Construction Manager. Based upon such Cost of the Work as the Owner’s accountants report to be substantiated by the Construction Manager’s final accounting, and provided the other conditions of Section 7.2.1 have been met, the Architect will, within seven days after receipt of the written report of the Owner’s accountants, either issue to the Owner a final Certificate for Payment with a copy to the Construction Manager or notify the Construction Manager and Owner in writing of the Architect’s reasons for withholding a certificate as provided in Section 9.5.1 of A201-2007, as amended. The time periods stated in this Section 7.2 supersede those stated in Section 9.4.1 of A201-2007, as amended.
§ 7.2.4 If the Owner’s accountants report the Cost of the Work as substantiated by the Construction Manager’s final accounting to be less than claimed by the Construction Manager, the Construction Manager shall be entitled to proceed in accordance with Article 9 without a further decision of the Architect. Unless agreed to otherwise, a demand for mediation or arbitration of the disputed amount shall be made by the Construction Manager within 60 days after the Construction Manager’s receipt of a copy of the Architect’s final Certificate for Payment. Failure to make such demand within this 60-day period shall result in the substantiated amount reported by the Owner’s accountants becoming binding on the Construction Manager. Pending a final resolution of the disputed amount, the Owner shall pay the Construction Manager the amount certified in the Architect’s final Certificate for Payment.
§ 7.2.5 If, subsequent to final payment and at the Owner’s request, the Construction Manager incurs costs described in Section 6.1 and not excluded by Section 6.2 (1) to correct nonconforming Work or (2) arising from the resolution of disputes, the Owner shall reimburse the Construction Manager such costs and the Construction Manager’s Fee, if any, related thereto on the same basis as if such costs had been incurred prior to final payment, but not in excess of the Guaranteed Maximum Price. If the Construction Manager has participated in savings, the amount of such savings shall be recalculated and appropriate credit given to the Owner in determining the net amount to be paid by the Owner to the Construction Manager.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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15


 

ARTICLE 8 INSURANCE AND BONDS
§ 8.1 INSURANCE REQUIRED OF THE CONSTRUCTION MANAGER
During both phases of the Project, the Construction Manager shall purchase and maintain insurance
as set forth in Section 11.1 of A201-2007, as amended. Such insurance shall be written for not
less than the following limits, or greater if required by law:
§ 8.1.1 Workers’ Compensation and Employers Liability meeting statutory limits mandated by state and federal laws. If (1) limits in excess of those required by statute are to be provided, or (2) the employer is not statutorily bound to obtain such insurance coverage or (3) additional coverages are required, additional coverages and limits for such insurance shall be as follows:
See Article 11 of A201-2007, as amended, for insurance requirements.
§ 8.1.2 Commercial General Liability including coverage for Premises-Operations, Independent Contractors’ Protective, Products-Completed Operations, Contractual Liability, Personal Injury and Broad Form Property Damage (including coverage for Explosion, Collapse and Underground hazards):
Each Occurrence
General Aggregate
Personal and Advertising Injury
Products-Completed Operations Aggregate
  .1   The policy shall be endorsed to have the General Aggregate apply to this Project only.
  .2   Products and Completed Operations insurance shall be maintained for a minimum period of at least (     ) year(s) after either 90 days following Substantial Completion or final payment, whichever is earlier.
  .3   The Contractual Liability insurance shall include coverage sufficient to meet the obligations in Section 3.18 of A201™–1997.
§ 8.1.3 Automobile Liability (owned, non-owned and hired vehicles) for bodily injury and property damage:
Each Accident
§ 8.1.4 Other coverage:
(If Umbrella Excess Liability coverage is required over the primary insurance or retention, insert the coverage limits. Commercial General Liability and Automobile Liability limits may be attained by individual policies or by a combination of primary policies and Umbrella and/or Excess Liability policies. If Project Management Protective Liability Insurance is to be provided, state the limits here.)
§ 8.2 INSURANCE REQUIRED OF THE OWNER
During both phases of the Project, the Owner shall purchase and maintain liability and property insurance, including waivers of subrogation, as set forth in Sections 11.2 and 11.4 of A201-2007, as amended. Such insurance shall be written for not less than the following limits, or greater if required by law:
§ 8.2.1 Property Insurance:
Deductible Per Occurrence
Aggregate Deductible
§ 8.2.2 Boiler and Machinery insurance with a limit of:
(If not a blanket policy, list the objects to be insured.)
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

16


 

§ 8.3 PERFORMANCE BOND AND PAYMENT BOND
§ 8.3.1 The Construction Manager shall (insert “shall” or “shall not”) furnish bonds covering faithful performance of the Contract and payment of obligations arising thereunder. Bonds may be obtained through the Construction Manager’s usual source, and the cost thereof shall be included in the Cost of the Work. The amount of each bond shall be equal to One Hundred Percent (100%) of the Contract Sum.
§ 8.3.2 The Construction Manager shall deliver the required bonds to the Owner at least three days before the commencement of any Work at the Project site.
ARTICLE 9 MISCELLANEOUS PROVISIONS
§ 9.1 DISPUTE RESOLUTION
§ 9.1.1 During both the Preconstruction and Construction Phases, Claims, disputes or other matters in question between the parties to this Agreement shall be resolved as provided in Sections 4.3 through 4.6 of A201-2007, as amended, except that, during the Preconstruction Phase, no decision by the Architect shall be a condition precedent to mediation or litigation.
§ 9.2 OTHER PROVISIONS
§ 9.2.1 Unless otherwise noted, the terms used in this Agreement shall have the same meaning as those in A201™–2007, General Conditions of the Contract for Construction, as amended.
§ 9.2.2 EXTENT OF CONTRACT
This Contract, which includes this Agreement and the other documents incorporated herein by reference, represents the entire and integrated agreement between the Owner and the Construction Manager and supersedes all prior negotiations, representations or agreements, either written or oral. This Agreement may be amended only by written instrument signed by both the Owner and Construction Manager. If anything in any document incorporated into this Agreement is inconsistent with this Agreement, this Agreement shall govern.
§ 9.2.3 OWNERSHIP AND USE OF DOCUMENTS
Article 1.6 of A201-2007, as amended shall apply to both the Preconstruction and Construction Phases.
§ 9.2.4 GOVERNING LAW
The Contract shall be governed by the law of the Commonwealth of Pennsylvania without application of its choice of law provisions.
§ 9.2.5 ASSIGNMENT
The Owner and Construction Manager respectively bind themselves, their partners, successors, assigns and legal representatives to the other party hereto and to partners, successors, assigns and legal representatives of such other party in respect to covenants, agreements and obligations contained in the Contract Documents. Except as provided in Section 13.2.2 of A201-2007, as amended, neither party to the Contract shall assign the Contract as a whole without written consent of the other. If either party attempts to make such an assignment without such consent, that party shall nevertheless remain legally responsible for all obligations under the Contract.
ARTICLE 10 TERMINATION OR SUSPENSION
§ 10.1 TERMINATION PRIOR TO ESTABLISHING GUARANTEED MAXIMUM PRICE
§ 10.1.1 Prior to execution by both parties of Amendment No. 1 establishing the Guaranteed Maximum Price, the Owner may terminate this Contract at any time without cause, and the Construction Manager may terminate this Contract for any of the reasons described in Section 14.1.1 of A201-2007, as amended.
§ 10.1.2 If the Owner or Construction Manager terminates this Contract pursuant to this Section 10.1 prior to commencement of the Construction Phase, the Construction Manager shall be equitably compensated for Preconstruction Phase Services performed prior to receipt of notice of termination; provided, however, that the compensation for such services shall not exceed the compensation set forth in Section 4.1.1.
(Paragraphs deleted)
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 10.2 TERMINATION SUBSEQUENT TO ESTABLISHING GUARANTEED MAXIMUM PRICE
Subsequent to execution by both parties of Amendment No. 1, the Contract may be terminated as provided in Article 14 of A201-2007, as amended.
§ 10.2.1 In the event of such termination by the Owner, the amount payable to the Construction Manager pursuant to Section 14.1.3 of A201-2007, as amended.
§ 10.2.2 In the event of such termination by the Construction Manager, the amount to be paid to the Construction Manager under Section 14.1.3 of A2017-2007, as amended.
§ 10.3 SUSPENSION
The Work may be suspended by the Owner as provided in Article 14 of A201-2007, as amended; in such case, the Guaranteed Maximum Price, if established, shall be increased as provided in Section 14.3.2 of A201-2007, as amended except that the term “cost of performance of the Contract” in that Section shall be understood to mean the Cost of the Work and the term “profit” shall be understood to mean the Construction Manager’s Fee as described in Sections 5.1.1 and 5.3.4 of this Agreement.
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

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ARTICLE 11 OTHER CONDITIONS AND SERVICES
This Agreement entered into as of the day and year first written above.
             
OWNER
      CONSTRUCTION MANAGER    
UNILIFE CROSS FARM LLC
      HSC BUILDERS AND CONSTRUCTION MANAGERS    
 
           
/s/ Daniel Calvert
      /s/ Mark R. Heim    
 
(Signature)
     
 
(Signature)
   
 
           
Daniel Calvert - CFO
      Mark R. Heim, President    
 
(Printed name and title)
     
 
(Printed name and title)
   
 
           
12/14/2009
      12/14/09    
 
Date
     
 
Date
   
 
           
/s/ Cynthia M. Lighty
      /s/ James E. Viner    
 
ATTEST
     
 
ATTEST
   
 
     
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  AIA Document A121™ CMc — 2003 and AGC Document 565. Copyright © 1991 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This Document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:50:12 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1195729238)

 

19


 

     
(LOGO)
  Document A201— 2007
General Conditions of the Contract for Construction

for the following PROJECT:
(Name and location or address)
Unilife Medical Solutions
250 Cross Farm Lane
York, PA
New World Headquarters Facility
THE OWNER:
(Name, legal status and address)
Unilife Cross Farm LLC
633 Lowther Road
Lewisberry, PA 17339
THE ARCHITECT:
(Name, legal status and address)
L2 Architecture
1717 Arch Street, Suite 3920
Philadelphia, PA 19103
ADDITIONS AND DELETIONS:
The author of this document has added information needed for its completion. The author may also have revised the text of the original AIA standard form. An Additions and Deletions Report that notes added information as well as revisions to the standard form text is available from the author and should be reviewed. A vertical line in the left margin of this document indicates where the author has added necessary information and where the author as added to or deleted from the original AIA text.

This document as important legal consequences. Consultation with an attorney is encouraged with respect to its completion or modification.


TABLE OF ARTICLES
1   GENERAL PROVISIONS 10
 
2   OWNER 12
 
3   CONTRACTOR 14
 
4   ARCHITECT 22
 
5   SUBCONTRACTORS 24
 
6   CONSTRUCTION BY OWNER OR BY SEPARATE CONTRACTORS 25
 
7   CHANGES IN THE WORK 26
 
8   TIME 28
 
9   PAYMENTS AND COMPLETION 29
 
10   PROTECTION OF PERSONS AND PROPERTY 35
 
11   INSURANCE AND BONDS 37
 
12   UNCOVERING AND CORRECTION OF WORK 41
 
13   MISCELLANEOUS PROVISIONS 42
 
14   TERMINATION OR SUSPENSION OF THE CONTRACT 44
 
15   CLAIMS AND DISPUTES 46
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes: A201-2007 Unilife Draft 12-11-09   (1262580089)

 

1


 

INDEX
(Numbers and Topics in Bold are Section Headings)
Acceptance of Nonconforming Work
9.6.6, 9.9.3, 12.3
Acceptance of Work
9.6.6, 9.8.2, 9.9.3, 9.10.1, 9.10.3, 12.3
Access to Work
3.16
,6.2.1, 12.1
Accident Prevention
10
Acts and Omissions
3.2, 3.3.2, 3.12.8, 3.18, 4.2.3, 8.3.1, 9.5.1, 10.2.5, 10.2.8, 13.4.2, 13.7.1, 14.1, 15.2
Addenda
1.1.1, 3.11.1
Additional Costs, Claims for
3.7.4,3.7.5,6.1.1,7.3.7.5, 10.3, 15.1.4
Additional Inspections and Testing
9.4.2, 9.8.3, 12.2.1, 13.5
Additional Insured
11.1.4
Additional Time, Claims for
3.2.4, 3.7.4, 3.7.5, 3.10.2, 8.3.2, 15.1.5
Administration of the Contract
3.1.3, 4.2, 9.4, 9.5
Advertisement or Invitation to Bid
1.1.1
Aesthetic Effect
4.2.13
Allowances
3.8
, 7.3.8
All-risk Insurance
11.3.1, 11.3.1.1
Applications for Payment
4.2.5, 7.3.9, 9.2, 9.3, 9.4, 9.5.1, 9.6.3, 9.7.1, 9.10, 11.1.3
Approvals
2.1.1, 2.2.2, 2.4, 3.1.3, 3.10.2, 3.12.8, 3.12.9, 3.12.10, 4.2.7, 9.3.2, 13.5.1
Arbitration
8.3.1, 11.3.10, 13.1.1, 15.3.2, 15.4
ARCHITECT
4
Architect, Definition of
4.1.1
Architect, Extent of Authority
2.4.1, 3.12.7, 4.1, 4.2, 5.2, 6.3.1, 7.1.2, 7.3.7, 7.4, 9.2.1, 9.3.1, 9.4, 9.5, 9.6.3, 9.8, 9.10.1, 9.10.3, 12.1, 12.2.1, 13.5.1, 13.5.2, 14.2.2, 14.2.4, 15.1.3, 15.2.1
Architect, Limitations of Authority and Responsibility
2.1.1, 3.12.4, 3.12.8, 3.12.10, 4.1.2, 4.2.1, 4.2.2, 4.2.3, 4.2.6, 4.2.7, 4.2.10, 4.2.12, 4.2.13, 5.2.1, 7.4.1, 9.4.2, 9.5.3, 9.6.4, 15.1.3, 15.2
Architect’s Additional Services and Expenses
2.4.1, 11.3.1.1, 12.2.1, 13.5.2, 13.5.3, 14.2.4
Architect’s Administration of the Contract
3.1.3, 4.2,3.7.4, 15.2, 9.4.1, 9.5
Architect’s Approvals
2.4.1, 3.1.3, 3.5.1, 3.10.2, 4.2.7
Architect’s Authority to Reject Work
3.5.1, 4.2.6, 12.1.2, 12.2.1
Architect’s Copyright
1.1.7, 1.5
Architect’s Decisions
3.7.4, 4.2.6, 4.2.7, 4.2.11, 4.2.12, 4.2.13, 4.2.14, 6.3.1, 7.3.7, 7.3.9, 8.1.3, 8.3.1, 9.2.1, 9.4.1, 9.5, 9.8.4, 9.9.1, 13.5.2, 15.2, 15.3
Architect’s Inspections
3.7.4, 4.2.2, 4.2.9, 9.4.2, 9.8.3, 9.9.2, 9.10.1, 13.5
Architect’s Instructions
3.2.4,3.3.1,4.2.6,4.2.7, 13.5.2
Architect’s Interpretations
4.2.11,4.2.12
Architect’s Project Representative
4.2.10
Architect’s Relationship with Contractor
1.1.2, 1.5, 3.1.3, 3.2.2, 3.2.3, 3.2.4, 3.3.1, 3.4.2, 3.5.1, 3.7.4, 3.7.5, 3.9.2, 3.9.3, 3.10, 3.11, 3.12, 3.16, 3.18, 4.1.2, 4.1.3, 4.2, 5.2, 6.2.2, 7, 8.3.1, 9.2, 9.3, 9.4, 9.5, 9.7, 9.8, 9.9, 10.2.6, 10.3, 11.3.7, 12, 13.4.2, 13.5, 15.2
Architect’s Relationship with Subcontractors
1.1.2, 4.2.3, 4.2.4, 4.2.6, 9.6.3, 9.6.4, 11.3.7
Architect’s Representations
9.4.2,9.5.1,9.10.1
Architect’s Site Visits
3.7.4, 4.2.2, 4.2.9, 9.4.2, 9.5.1, 9.9.2, 9.10.1, 13.5
Asbestos
10.3.1
Attorneys’ Fees
3.18.1,9.10.2,10.3.3
Award of Separate Contracts
6.1.1,6.1.2
Award of Subcontracts and Other Contracts for Portions of the Work
5.2
Basic Definitions
1.1
Bidding Requirements
1.1.1,5.2.1, 11.4.1
Binding Dispute Resolution
9.7.1, 11.3.9, 11.3.10, 13.1.1, 15.2.5, 15.2.6.1, 15.3.1, 15.3.2, 15.4.1
Boiler and Machinery Insurance
11.3.2

Bonds, Lien
7.3.7.4,9.10.2,9.10.3
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes: A201-2007 Unilife Draft 12-11-09   (1262580089)

 

2


 

Bonds, Performance, and Payment
7.3.7.4,9.6.7,9.10.3, 11.3.9, 11.4
Building Permit
3.7.1
Capitalization
1.3
Certificate of Substantial Completion
9.8.3,9.8.4,9.8.5
Certificates for Payment
4.2.1, 4.2.5, 4.2.9, 9.3.3, 9.4, 9.5, 9.6.1, 9.6.6, 9.7.1, 9.10.1,9.10.3, 14.1.1.3, 14.2.4, 15.1.3
Certificates of Inspection, Testing or Approval
13.5.4
Certificates of Insurance
9.10.2, 11.1.3
Change Orders
1.1.1, 2.4.1, 3.4.2, 3.7.4, 3.8.2.3, 3.11.1, 3.12.8, 4.2.8, 5.2.3, 7.1.2, 7.1.3, 7.2, 7.3.2, 7.3.6, 7.3.9, 7.3.10, 8.3.1, 9.3.1.1,9.10.3, 10.3.2, 11.3.1.2, 11.3.4, 11.3.9, 12.1.2, 15.1.3
Change Orders, Definition of
7.2.1
CHANGES IN THE WORK
2.2.1, 3.11, 4.2.8, 7, 7.2.1, 7.3.1, 7.4, 7.4.1, 8.3.1, 9.3.1.1, 11.3.9
Claims, Definition of
15.1.1
CLAIMS AND DISPUTES
3.2.4,6.1.1,6.3.1,7.3.9,9.3.3,9.10.4, 10.3.3, 15, 15.4
Claims and Timely Assertion of Claims
15.4.1
Claims for Additional Cost
3.2.4, 3.7.4, 6.1.1, 7.3.9, 10.3.2, 15.1.4
Claims for Additional Time
3.2.4, 3.7.46.1.1, 8.3.2, 10.3.2, 15.1.5
Concealed or Unknown Conditions, Claims for
3.7.4
Claims for Damages
3.2.4, 3.18, 6.1.1, 8.3.3, 9.5.1, 9.6.7, 10.3.3, 11.1.1, 11.3.5, 11.3.7, 14.1.3, 14.2.4, 15.1.6
Claims Subject to Arbitration
15.3.1, 15.4.1
Cleaning Up
3.15
, 6.3
Commencement of the Work, Conditions Relating to
2.2.1, 3.2.2, 3.4.1, 3.7.1, 3.10.1, 3.12.6, 5.2.1, 5.2.3, 6.2.2,8.1.2,8.2.2,8.3.1, 11.1, 11.3.1, 11.3.6, 11.4.1, 15.1.4
Commencement of the Work, Definition of
8.1.2
Communications Facilitating Contract Administration
3.9.1, 4.2.4
Completion, Conditions Relating to
3.4.1, 3.11, 3.15, 4.2.2, 4.2.9, 8.2, 9.4.2, 9.8, 9.9.1,
9.10, 12.2, 13.7, 14.1.2
COMPLETION, PAYMENTS AND
9
Completion, Substantial
4.2.9, 8.1.1, 8.1.3, 8.2.3, 9.4.2, 9.8, 9.9.1, 9.10.3, 12.2, 13.7
Compliance with Laws
1.6.1, 3.2.3, 3.6, 3.7, 3.12.10, 3.13, 4.1.1, 9.6.4, 10.2.2, 11.1, 11.3, 13.1, 13.4, 13.5.1, 13.5.2, 13.6, 14.1.1, 14.2.1.3, 15.2.8, 15.4.2, 15.4.3
Concealed or Unknown Conditions
3.7.4, 4.2.8, 8.3.1, 10.3
Conditions of the Contract
1.1.1, 6.1.1, 6.1.4
Consent, Written
3.4.2, 3.7.4, 3.12.8, 3.14.2, 4.1.2, 9.3.2, 9.8.5, 9.9.1, 9.10.2, 9.10.3, 11.3.1, 13.2, 13.4.2, 15.4.4.2
Consolidation or Joinder
15.4.4
CONSTRUCTION BY OWNER OR BY SEPARATE CONTRACTORS
1.1.4, 6
Construction Change Directive, Definition of
7.3.1
Construction Change Directives
1.1.1, 3.4.2, 3.12.8, 4.2.8, 7.1.1, 7.1.2, 7.1.3, 7.3, 9.3.1.1
Construction Schedules, Contractor’s
3.10, 3.12.1, 3.12.2, 6.1.3, 15.1.5.2
Contingent Assignment of Subcontracts
5.4
, 14.2.2.2
Continuing Contract Performance
15.1.3
Contract, Definition of
1.1.2
CONTRACT, TERMINATION OR SUSPENSION OF THE
5.4.1.1, 11.3.9, 14
Contract Administration
3.1.3, 4,9.4, 9.5
Contract Award and Execution, Conditions Relating to
3.7.1, 3.10, 5.2, 6.1, 11.1.3, 11.3.6, 11.4.1
Contract Documents, The
1.1.1
Contract Documents, Copies Furnished and Use of
1.5.2, 2.2.5, 5.3
Contract Documents, Definition of
1.1.1
Contract Sum
3.7.4, 3.8, 5.2.3, 7.2, 7.3, 7.4, 9.1, 9.4.2, 9.5.1.4, 9.6.7, 9.7, 10.3.2, 11.3.1, 14.2.4, 14.3.2, 15.1.4, 15.2.5
Contract Sum, Definition of
9.1
Contract Time
3.7.4, 3.7.5, 3.10.2, 5.2.3, 7.2.1.3, 7.3.1, 7.3.5, 7.4, 8.1.1, 8.2.1, 8.3.1, 9.5.1, 9.7.1, 10.3.2, 12.1.1, 14.3.2, 15.1.5.1, 15.2.5
 
     
Init.




/
  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes: A201-2007 Unilife Draft 12-11-09   (1262580089)

 

3


 

Contract Time, Definition of
8.1.1
CONTRACTOR
3
Contractor, Definition of
3.1, 6.1.2
Contractor’s Construction Schedules
3.10
, 3.12.1, 3.12.2, 6.1.3, 15.1.5.2
Contractor’s Employees
3.3.2, 3.4.3, 3.8.1, 3.9, 3.18.2, 4.2.3, 4.2.6, 10.2, 10.3, 11.1.1, 11.3.7, 14.1, 14.2.1.1,
Contractor’s Liability Insurance
11.1
Contractor’s Relationship with Separate Contractors and Owner’s Forces
3.12.5,3.14.2,4.2.4,6, 11.3.7, 12.1.2, 12.2.4
Contractor’s Relationship with Subcontractors
1.2.2, 3.3.2, 3.18.1, 3.18.2, 5, 9.6.2, 9.6.7, 9.10.2, 11.3.1.2, 11.3.7, 11.3.8
Contractor’s Relationship with the Architect 1.1.2, 1.5, 3.1.3, 3.2.2, 3.2.3, 3.2.4, 3.3.1, 3.4.2,
3.5.1, 3.7.4, 3.10, 3.11, 3.12, 3.16, 3.18, 4.1.3, 4.2, 5.2, 6.2.2, 7, 8.3.1, 9.2, 9.3, 9.4, 9.5,
9.7, 9.8, 9.9, 10.2.6, 10.3, 11.3.7, 12, 13.5, 15.1.2, 15.2.1
Contractor’s Representations
3.2.1, 3.2.2, 3.5.1, 3.12.6, 6.2.2, 8.2.1, 9.3.3, 9.8.2
Contractor’s Responsibility for Those Performing the Work
3.3.1, 3.18, 5.3.1, 6.1.3, 6.2, 9.5.1, 10.2.8 Contractor’s Review of Contract Documents
3.2
Contractor’s Right to Stop the Work
9.7
Contractor’s Right to Terminate the Contract
14.1, 15.1.6
Contractor’s Submittals
3.10, 3.11, 3.12.4, 4.2.7, 5.2.1, 5.2.3, 9.2, 9.3, 9.8.2,
9.8.3,9.9.1,9.10.2,9.10.3, 11.1.3, 11.4.2
Contractor’s Superintendent
3.9, 10.2.6
Contractor’s Supervision and Construction Procedures
1.2.2, 3.3, 3.4, 3.12.10, 4.2.2, 4.2.7, 6.1.3, 6.2.4, 7.1.3,
7.3.5,7.3.7,8.2, 10, 12, 14, 15.1.3
Contractual Liability Insurance
11.1.1.8, 11.2
Coordination and Correlation
1.2, 3.2.1, 3.3.1, 3.10, 3.12.6, 6.1.3, 6.2.1
Copies Furnished of Drawings and Specifications
1.5,2.2.5,3.11
Copyrights
1.5, 3.17
Correction of Work
2.3, 2.4, 3.7.3, 9.4.2, 9.8.2, 9.8.3, 9.9.1, 12.1.2, 12.2
Correlation and Intent of the Contract Documents
1.2
Cost, Definition of
7.3.7
Costs
2.4.1, 3.2.4, 3.7.3, 3.8.2, 3.15.2, 5.4.2, 6.1.1, 6.2.3, 7.3.3.3, 7.3.7, 7.3.8, 7.3.9, 9.10.2, 10.3.2, 10.3.6, 11.3, 12.1.2, 12.2.1, 12.2.4, 13.5, 14
Cutting and Patching
3.14,
6.2.5
Damage to Construction of Owner or Separate Contractors
3.14.2,6.2.4, 10.2.1.2, 10.2.5, 10.4, 11.1.1, 11.3, 12.2.4
Damage to the Work
3.14.2,9.9.1, 10.2.1.2, 10.2.5, 10.4.1, 11.3.1, 12.2.4
Damages, Claims for
3.2.4, 3.18, 6.1.1, 8.3.3, 9.5.1, 9.6.7, 10.3.3, 11.1.1, 11.3.5, 11.3.7, 14.1.3, 14.2.4, 15.1.6
Damages for Delay
6.1.1,8.3.3,9.5.1.6,9.7, 10.3.2
Date of Commencement of the Work, Definition of
8.1.2
Date of Substantial Completion, Definition of
8.1.3
Day, Definition of
8.1.4
Decisions of the Architect
3.7.4, 4.2.6, 4.2.7, 4.2.11, 4.2.12, 4.2.13, 15.2, 6.3, 7.3.7, 7.3.9, 8.1.3, 8.3.1, 9.2.1, 9.4, 9.5.1, 9.8.4, 9.9.1, 13.5.2, 14.2.2, 14.2.4, 15.1, 15.2
Decisions to Withhold Certification
9.4.1, 9.5, 9.7, 14.1.1.3
Defective or Nonconforming Work, Acceptance, Rejection and Correction of
2.3.1, 2.4.1, 3.5.1, 4.2.6, 6.2.5, 9.5.1, 9.5.2, 9.6.6, 9.8.2,9.9.3, 9.10.4,12.2.1
Defective Work, Definition of
3.5.1
Definitions
1.1, 2.1.1, 3.1.1, 3.5.1, 3.12.1, 3.12.2, 3.12.3, 4.1.1, 15.1.1, 5.1, 6.1.2, 7.2.1, 7.3.1, 8.1, 9.1, 9.8.1
Delays and Extensions of Time
3.2., 3.7.4, 5.2.3, 7.2.1, 7.3.1, 7.4.1, 8.3, 9.5.1, 9.7.1, 10.3.2, 10.4.1, 14.3.2, 15.1.5, 15.2.5
Disputes
6.3.1,7.3.9, 15.1, 15.2
Documents and Samples at the Site
3.11
Drawings, Definition of
1.1.5
Drawings and Specifications, Use and Ownership of
3.11
Effective Date of Insurance
8.2.2, 11.1.2
 
     
Init.




/
  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1262580089)

 

4


 

Emergencies
10.4
, 14.1.1.2, 15.1.4
Employees, Contractor’s
3.3.2, 3.4.3, 3.8.1, 3.9, 3.18.2, 4.2.3, 4.2.6, 10.2, 10.3.3, 11.1.1, 11.3.7, 14.1, 14.2.1.1
Equipment, Labor, Materials or
1.1.3, 1.1.6, 3.4, 3.5.1, 3.8.2, 3.8.3, 3.12, 3.13.1, 3.15.1, 4.2.6, 4.2.7, 5.2.1, 6.2.1, 7.3.7, 9.3.2, 9.3.3, 9.5.1.3, 9.10.2, 10.2.1, 10.2.4, 14.2.1.1, 14.2.1.2
Execution and Progress of the Work
1.1.3, 1.2.1, 1.2.2, 2.2.3, 2.2.5, 3.1, 3.3.1, 3.4.1, 3.5.1, 3.7.1, 3.10.1, 3.12, 3.14, 4.2, 6.2.2, 7.1.3, 7.3.5, 8.2, 9.5.1, 9.9.1, 10.2, 10.3, 12.2, 14.2, 14.3.1, 15.1.3
Extensions of Time
3.2.3, 3.7.4, 5.2.3, 7.2.1, 7.3, 7.4.1, 9.5.1, 9.7.1, 10.3.2, 10.4.1, 14.3, 15.1.5, 15.2.5
Failure of Payment
9.5.1.3, 9.7, 9.10.2, 13.6, 14.1.1.3, 14.2.1.2
Faulty Work
(See Defective or Nonconforming Work)
Final Completion and Final Payment
4.2.1, 4.2.9, 9.8.2, 9.10, 11.1.2, 11.1.3, 11.3.1, 11.3.5, 12.3.1, 14.2.4, 14.4.3
Financial Arrangements, Owner’s
2.2.1, 13.2.2, 14.1.1.4
Fire and Extended Coverage Insurance
11.3.1.1
GENERAL PROVISIONS
1
Governing Law
13.1

Guarantees (See Warranty)
Hazardous Materials
10.2.4, 10.3
Identification of Subcontractors and Suppliers
5.2.1
Indemnification
3.17.1, 3.18, 9.10.2, 10.3.3, 10.3.5, 10.3.6, 11.3.1.2, 11.3.7
Information and Services Required of the Owner
2.1.2, 2.2, 3.2.2, 3.12.4, 3.12.10, 6.1.3, 6.1.4, 6.2.5, 9.6.1, 9.6.4, 9.9.2, 9.10.3, 10.3.3, 11.2, 11.4, 13.5.1, 13.5.2, 14.1.1.4, 14.1.4, 15.1.3
Initial Decision
15.2
Initial Decision Maker, Definition of
1.1.8
Initial Decision Maker, Decisions
14.2.2, 14.2.4, 15.2.1, 15.2.2, 15.2.3, 15.2.4, 15.2.5
Initial Decision Maker, Extent of Authority
14.2.2, 14.2.4, 15.1.3, 15.2.1, 15.2.2, 15.2.3, 15.2.4, 15.2.5
Injury or Damage to Person or Property
10.2.8
, 10.4.1
Inspections
3.1.3, 3.3.3, 3.7.1, 4.2.2, 4.2.6, 4.2.9, 9.4.2, 9.8.3, 9.9.2,9.10.1, 12.2.1, 13.5
Instructions to Bidders
1.1.1
Instructions to the Contractor
3.2.4, 3.3.1, 3.8.1, 5.2.1, 7, 8.2.2, 12, 13.5.2
Instruments of Service, Definition of
1.1.7
Insurance
3.18.1, 6.1.1, 7.3.7, 9.3.2, 9.8.4, 9.9.1, 9.10.2, 11
Insurance, Boiler and Machinery
11.3.2
Insurance, Contractor’s Liability
11.1
Insurance, Effective Date of
8.2.2, 11.1.2
Insurance, Loss of Use
11.3.3
Insurance, Owner’s Liability
11.2
Insurance, Property
10.2.5, 11.3
Insurance, Stored Materials
9.3.2, 11.4.1.4
INSURANCE AND BONDS
11
Insurance Companies, Consent to Partial Occupancy
9.9.1, 11.4.1.5
Insurance Companies, Settlement with
11.4.10
Intent of the Contract Documents
1.2.1,4.2.7,4.2.12,4.2.13,7.4
Interest
13.6
Interpretation
1.2.3, 1.4, 4.1.1, 5.1, 6.1.2, 15.1.1
Interpretations, Written
4.2.11,4.2.12, 15.1.4
Judgment on Final Award
15.4.2
Labor and Materials, Equipment
1.1.3, 1.1.6, 3.4, 3.5.1, 3.8.2, 3.8.3, 3.12, 3.13, 3.15.1, 4.2.6, 4.2.7, 5.2.1, 6.2.1, 7.3.7, 9.3.2, 9.3.3, 9.5.1.3, 9.10.2, 10.2.1, 10.2.4, 14.2.1.1, 14.2.1.2
Labor Disputes
8.3.1
Laws and Regulations
1.5, 3.2.3, 3.6, 3.7, 3.12.10, 3.13.1, 4.1.1, 9.6.4, 9.9.1, 10.2.2, 11.1.1, 11.3, 13.1.1, 13.4, 13.5.1, 13.5.2, 13.6.1, 14, 15.2.8, 15.4
Liens
2.1.2,9.3.3,9.10.2,9.10.4,15.2.8
Limitations, Statutes of
12.2.5, 13.7, 15.4.1.1
 
     
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/
  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1262580089)

 

5


 

Limitations of Liability
2.3.1, 3.2.2, 3.5.1, 3.12.10, 3.17.1, 3.18.1, 4.2.6, 4.2.7, 4.2.12,6.2.2,9.4.2,9.6.4,9.6.7,10.2.5, 10.3.3, 11.1.2, 11.2, 11.3.7, 12.2.5, 13.4.2
Limitations of Time
2.1.2, 2.2, 2.4, 3.2.2, 3.10, 3.11, 3.12.5, 3.15.1, 4.2.7, 5.2, 5.3.1, 5.4.1, 6.2.4, 7.3, 7.4, 8.2, 9.2.1, 9.3.1, 9.3.3, 9.4.1, 9.5, 9.6, 9.7.1, 9.8, 9.9, 9.10, 11.1.3, 11.3.1.5, 11.3.6, 11.3.10, 12.2, 13.5, 13.7, 14, 15
Loss of Use Insurance
11.3.3
Material Suppliers
1.5, 3.12.1, 4.2.4, 4.2.6, 5.2.1, 9.3, 9.4.2, 9.6, 9.10.5
Materials, Hazardous
10.2.4, 10.3
Materials, Labor, Equipment and
1.1.3, 1.1.6, 1.5.1, 3.4.1, 3.5.1, 3.8.2, 3.8.3, 3.12, 3.13.1, 3.15.1, 4.2.6, 4.2.7, 5.2.1, 6.2.1, 7.3.7, 9.3.2, 9.3.3,9.5.1.3,9.10.2, 10.2.1.2, 10.2.4, 14.2.1.1, 14.2.1.2
Means, Methods, Techniques, Sequences and Procedures of Construction
3.3.1, 3.12.10, 4.2.2, 4.2.7, 9.4.2
Mechanic’s Lien
2.1.2, 15.2.8
Mediation
8.3.1, 10.3.5, 10.3.6, 15.2.1, 15.2.5, 15.2.6, 15.3, 15.4.1
Minor Changes in the Work
1.1.1, 3.12.8, 4.2.8,7.1, 7.4
MISCELLANEOUS PROVISIONS
13
Modifications, Definition of
1.1.1
Modifications to the Contract
1.1.1, 1.1.2, 3.11, 4.1.2, 4.2.1, 5.2.3, 7, 8.3.1, 9.7.1, 10.3.2, 11.3.1
Mutual Responsibility
6.2
Nonconforming Work, Acceptance of
9.6.6, 9.9.3, 12.3
Nonconforming Work, Rejection and Correction of
2.3.1, 2.4.1, 3.5.1, 4.2.6, 6.2.4, 9.5.1, 9.8.2, 9.9.3, 9.10.4, 12.2.1
Notice
2.2.1, 2.3.1, 2.4.1, 3.2.4, 3.3.1, 3.7.2, 3.12.9, 5.2.1, 9.7.1,9.10, 10.2.2, 11.1.3, 11.4.6, 12.2.2.1, 13.3, 13.5.1, 13.5.2, 14.1, 14.2, 15.2.8, 15.4.1
Notice, Written
2.3.1, 2.4.1, 3.3.1, 3.9.2, 3.12.9, 3.12.10, 5.2.1, 9.7.1, 9.10, 10.2.2, 10.3, 11.1.3, 11.3.6, 12.2.2.1, 13.3, 14, 15.2.8, 15.4.1
Notice of Claims
3.7.4,4.5, 10.2.8, 15.1.2, 15.4
Notice of Testing and Inspections
13.5.1, 13.5.2
Observations, Contractor’s
3.2, 3.7.4
Occupancy
2.2.2,9.6.6,9.8, 11.3.1.5
Orders, Written
1.1.1,2.3,3.9.2,7, 8.2.2, 11.3.9, 12.1, 12.2.2.1, 13.5.2,
14.3.1
OWNER
2
Owner, Definition of
2.1.1
Owner, Information and Services Required of the
2.1.2, 2.2, 3.2.2, 3.12.10, 6.1.3, 6.1.4, 6.2.5, 9.3.2, 9.6.1,9.6.4,9.9.2,9.10.3,10.3.3, 11.2, 11.3, 13.5.1, 13.5.2, 14.1.1.4, 14.1.4, 15.1.3
Owner’s Authority
1.5, 2.1.1, 2.3.1, 2.4.1, 3.4.2, 3.8.1, 3.12.10, 3.14.2, 4.1.2, 4.1.3, 4.2.4, 4.2.9, 5.2.1, 5.2.4, 5.4.1, 6.1, 6.3.1, 7.2.1, 7.3.1, 8.2.2, 8.3.1, 9.3.1, 9.3.2, 9.5.1, 9.6.4, 9.9.1,9.10.2, 10.3.2, 11.1.3,11.3.3, 11.3.10, 12.2.2, 12.3.1, 13.2.2, 14.3, 14.4, 15.2.7
Owner’s Financial Capability
2.2.1, 13.2.2, 14.1.1.4
Owner’s Liability Insurance
11.2
Owner’s Loss of Use Insurance
11.3.3
Owner’s Relationship with Subcontractors
1.1.2, 5.2, 5.3, 5.4, 9.6.4, 9.10.2, 14.2.2
Owner’s Right to Carry Out the Work
2.4
, 14.2.2
Owner’s Right to Clean Up
6.3
Owner’s Right to Perform Construction and to Award Separate Contracts
6.1
Owner’s Right to Stop the Work
2.3
Owner’s Right to Suspend the Work
14.3
Owner’s Right to Terminate the Contract
14.2
Ownership and Use of Drawings, Specifications and Other Instruments of Service
1.1.1, 1.1.6, 1.1.7, 1.5, 2.2.5, 3.2.2, 3.11.1, 3.17.1, 4.2.12, 5.3.1
Partial Occupancy or Use
9.6.6, 9.9, 11.3.1.5
Patching, Cutting and
3.14
, 6.2.5
Patents
3.17
Payment, Applications for
4.2.5, 7.3.9, 9.2.1, 9.3, 9.4, 9.5, 9.6.3, 9.7.1, 9.8.5, 9.10.1, 14.2.3,14.2.4,14.4.3
Payment, Certificates for
4.2.5, 4.2.9, 9.3.3, 9.4, 9.5, 9.6.1, 9.6.6, 9.7.1, 9.10.1, 9.10.3, 13.7, 14.1.1.3, 14.2.4
 
     
Init.




/
  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
User Notes:   (1262580089)

 

6


 

Payment, Failure of
9.5.1.3, 9.7, 9.10.2, 13.6, 14.1.1.3, 14.2.1.2
Payment, Final
4.2.1, 4.2.9, 9.8.2, 9.10, 11.1.2, 11.1.3, 11.4.1, 11.4.5, 12.3.1, 13.7, 14.2.4, 14.4.3
Payment Bond, Performance Bond and
7.3.7.4 ,9.6.7 ,9.10.3, 11.4.9, 11.4
Payments, Progress
9.3, 9.6, 9.8.5, 9.10.3, 13.6, 14.2.3, 15.1.3
PAYMENTS AND COMPLETION
9
Payments to Subcontractors
5.4.2, 9.5.1.3, 9.6.2, 9.6.3, 9.6.4, 9.6.7, 11.4.8, 14.2.1.2
PCB
10.3.1
Performance Bond and Payment Bond
7.3.7.4, 9.6.7, 9.10.3, 11.4.9, 11.4
Permits, Fees, Notices and Compliance with Laws
2.2.2, 3.7, 3.13, 7.3.7.4, 10.2.2
PERSONS AND PROPERTY, PROTECTION OF
10
Polychlorinated Biphenyl
10.3.1
Product Data, Definition of
3.12.2
Product Data and Samples, Shop Drawings
3.11, 3.12, 4.2.7
Progress and Completion
4.2.2, 8.2, 9.8, 9.9.1, 14.1.4, 15.1.3
Progress Payments
9.3, 9.6, 9.8.5, 9.10.3, 13.6, 14.2.3, 15.1.3
Project, Definition of the
1.1.4
Project Representatives
4.2.10
Property Insurance
10.2.5, 11.3
PROTECTION OF PERSONS AND PROPERTY
10
Regulations and Laws
1.5, 3.2.3, 3.6, 3.7, 3.12.10, 3.13, 4.1.1, 9.6.4, 9.9.1, 10.2.2, 11.1, 11.4, 13.1, 13.4, 13.5.1, 13.5.2, 13.6, 14, 15.2.8, 15.4
Rejection of Work
3.5.1, 4.2.6, 12.2.1
Releases and Waivers of Liens
9.10.2
Representations
3.2.1, 3.5.1, 3.12.6, 6.2.2, 8.2.1, 9.3.3, 9.4.2, 9.5.1, 9.8.2, 9.10.1
Representatives
2.1.1, 3.1.1, 3.9, 4.1.1, 4.2.1, 4.2.2, 4.2.10, 5.1.1, 5.1.2, 13.2.1
Responsibility for Those Performing the Work
3.3.2, 3.18, 4.2.3, 5.3.1, 6.1.3, 6.2, 6.3, 9.5.1, 10
Retainage
9.3.1, 9.6.2, 9.8.5, 9.9.1, 9.10.2, 9.10.3
Review of Contract Documents and Field Conditions by Contractor
3.2
, 3.12.7, 6.1.3
Review of Contractor’s Submittals by Owner and Architect
3.10.1, 3.10.2, 3.11, 3.12, 4.2, 5.2, 6.1.3, 9.2, 9.8.2
Review of Shop Drawings, Product Data and Samples by Contractor
3.12
Rights and Remedies
1.1.2, 2.3, 2.4, 3.5.1, 3.7.4, 3.15.2, 4.2.6, 4.5, 5.3, 5.4, 6.1, 6.3, 7.3.1, 8.3, 9.5.1, 9.7, 10.2.5, 10.3, 12.2.2, 12.2.4, 13.4, 14, 15.4
Royalties, Patents and Copyrights
3.17
Rules and Notices for Arbitration
15.4.1
Safety of Persons and Property
10.2
, 10.4
Safety Precautions and Programs
3.3.1, 4.2.2, 4.2.7, 5.3.1, 10.1, 10.2, 10.4
Samples, Definition of
3.12.3
Samples, Shop Drawings, Product Data and
3.11, 3.12, 4.2.7
Samples at the Site, Documents and
3.11
Schedule of Values
9.2
, 9.3.1
Schedules, Construction
3.10, 3.12.1, 3.12.2, 6.1.3, 15.1.5.2
Separate Contracts and Contractors
1.1.4, 3.12.5, 3.14.2, 4.2.4, 4.2.7, 6, 8.3.1, 11.4.7, 12.1.2
Shop Drawings, Definition of
3.12.1
Shop Drawings, Product Data and Samples
3.11, 3.12, 4.2.7
Site, Use of
3.13
, 6.1.1, 6.2.1
Site Inspections
3.2.2, 3.3.3, 3.7.1, 3.7.4, 4.2, 9.4.2, 9.10.1, 13.5
Site Visits, Architect’s
3.7.4, 4.2.2, 4.2.9, 9.4.2, 9.5.1, 9.9.2, 9.10.1, 13.5
Special Inspections and Testing
4.2.6, 12.2.1, 13.5
Specifications, Definition of the
1.1.6
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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Specifications, The
1.1.1, 1.1.6, 1.2.2, 1.5, 3.11, 3.12.10, 3.17, 4.2.14
Statute of Limitations
13.7, 15.4.1.1
Stopping the Work
2.3, 9.7, 10.3, 14.1
Stored Materials
6.2.1,9.3.2, 10.2.1.2, 10.2.4, 11.4.1.4
Subcontractor, Definition of
5.1.1
SUBCONTRACTORS
5
Subcontractors, Work by
1.2.2, 3.3.2, 3.12.1, 4.2.3, 5.2.3, 5.3, 5.4, 9.3.1.2, 9.6.7
Subcontractual Relations
5.3
, 5.4, 9.3.1.2, 9.6, 9.10, 10.2.1, 11.4.7, 11.4.8, 14.1, 14.2.1
Submittals
3.10, 3.11, 3.12, 4.2.7, 5.2.1, 5.2.3, 7.3.7, 9.2, 9.3, 9.8, 9.9.1,9.10.2,9.10.3, 11.1.3
Submittal Schedule
3.10.2,3.12.5,4.2.7
Subrogation, Waivers of
6.1.1, 11.4.5, 11.3.7
Substantial Completion
4.2.9, 8.1.1, 8.1.3, 8.2.3, 9.4.2, 9.8, 9.9.1, 9.10.3, 12.2, 13.7
Substantial Completion, Definition of
9.8.1
Substitution of Subcontractors
5.2.3, 5.2.4
Substitution of Architect
4.1.3
Substitutions of Materials
3.4.2, 3.5.1, 7.3.8
Sub-subcontractor, Definition of
5.1.2
Subsurface Conditions
3.7.4
Successors and Assigns
13.2
Superintendent
3.9
, 10.2.6
Supervision and Construction Procedures
1.2.2, 3.3, 3.4, 3.12.10, 4.2.2, 4.2.7, 6.1.3, 6.2.4, 7.1.3, 7.3.7, 8.2, 8.3.1, 9.4.2, 10, 12, 14, 15.1.3
Surety
5.4.1.2, 9.8.5, 9.10.2, 9.10.3, 14.2.2, 15.2.7
Surety, Consent of
9.10.2, 9.10.3
Surveys
2.2.3
Suspension by the Owner for Convenience
14.3
Suspension of the Work
5.4.2, 14.3
Suspension or Termination of the Contract
5.4.1.1, 11.4.9, 14
Taxes
3.6,3.8.2.1,7.3.7.4
Termination by the Contractor
14.1
, 15.1.6
Termination by the Owner for Cause
5.4.1.1, 14.2, 15.1.6
Termination by the Owner for Convenience
14.4
Termination of the Architect
4.1.3
Termination of the Contractor
14.2.2
TERMINATION OR SUSPENSION OF THE CONTRACT
14
Tests and Inspections
3.1.3, 3.3.3, 4.2.2, 4.2.6, 4.2.9, 9.4.2, 9.8.3, 9.9.2, 9.10.1, 10.3.2, 11.4.1.1, 12.2.1, 13.5
TIME
8
Time, Delays and Extensions of
3.2.4, 3.7.4, 5.2.3, 7.2.1, 7.3.1, 7.4.1, 8.3, 9.5.1, 9.7.1, 10.3.2, 10.4.1, 14.3.2, 15.1.5, 15.2.5
Time Limits
2.1.2, 2.2, 2.4, 3.2.2, 3.10, 3.11, 3.12.5, 3.15.1, 4.2, 4.4, 4.5, 5.2, 5.3, 5.4, 6.2.4, 7.3, 7.4, 8.2, 9.2, 9.3.1, 9.3.3, 9.4.1, 9.5, 9.6, 9.7, 9.8, 9.9, 9.10, 11.1.3, 11.4.1.5 , 11.4.6, 11.4.10, 12.2, 13.5, 13.7, 14, 15.1.2, 15.4
Time Limits on Claims
3.7.4, 10.2.8, 13.7, 15.1.2
Title to Work
9.3.2, 9.3.3
Transmission of Data in Digital Form
1.6
UNCOVERING AND CORRECTION OF WORK
12
Uncovering of Work
12.1
Unforeseen Conditions, Concealed or Unknown
3.7.4,8.3.1, 10.3
Unit Prices
7.3.3.2,7.3.4
Use of Documents
1.1.1, 1.5,2.2.5,3.12.6,5.3
Use of Site
3.13
, 6.1.1, 6.2.1
Values, Schedule of
9.2
, 9.3.1
Waiver of Claims by the Architect
13.4.2
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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Waiver of Claims by the Contractor
9.10.5, 11.4.7, 13.4.2, 15.1.6
Waiver of Claims by the Owner
9.9.3, 9.10.3, 9.10.4, 11.4.3, 11.4.5, 11.4.7, 12.2.2.1, 13.4.2, 14.2.4, 15.1.6
Waiver of Consequential Damages
14.2.4, 15.1.6
Waiver of Liens
9.10.2, 9.10.4
Waivers of Subrogation
6.1.1, 11.4.5, 11.3.7
Warranty
3.5, 4.2.9, 9.3.3, 9.8.4, 9.9.1, 9.10.4, 12.2.2, 13.7.1
Weather Delays
15.1.5.2
Work, Definition of
1.1.3
Written Consent
1.5.2, 3.4.2, 3.7.4, 3.12.8, 3.14.2, 4.1.2, 9.3.2, 9.8.5, 9.9.1,9.10.2,9.10.3, 11.4.1, 13.2, 13.4.2, 15.4.4.2
Written Interpretations
4.2.11,4.2.12
Written Notice
2.3, 2.4, 3.3.1, 3.9, 3.12.9, 3.12.10, 5.2.1, 8.2.2, 9.7, 9.10, 10.2.2, 10.3, 11.1.3, 11.4.6, 12.2.2, 12.2.4, 13.3, 14, 15.4.1
Written Orders
1.1.1, 2.3, 3.9, 7, 8.2.2, 11.4.9, 12.1, 12.2, 13.5.2, 14.3.1, 15.1.2
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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9


 

ARTICLE 1 GENERAL PROVISIONS

§ 1.1 BASIC DEFINITIONS

§ 1.1.1 THE CONTRACT DOCUMENTS
The Contract Documents are enumerated in the Agreement between the Owner and Contractor (as used herein “Contractor” shall mean “Construction Manager”)(hereinafter the Agreement) and consist of the Agreement, Conditions of the Contract (General, Supplementary and other Conditions), as amended, Drawings, Specifications, Addenda issued prior to execution of the Contract, other documents listed in the Agreement and Modifications issued after execution of the Contract. A Modification is (1) a written amendment to the Contract signed by both parties, (2) a Change Order, (3) a Construction Change Directive or (4) a written order for a minor change in the Work issued by the Architect. Unless specifically enumerated in the Agreement, the Contract Documents do not include the advertisement or invitation to bid, Instructions to Bidders, sample forms, other information furnished by the Owner in anticipation of receiving bids or proposals, the Contractor’s bid or proposal, or portions of Addenda relating to bidding requirements.
§ 1.1.2 THE CONTRACT
The Contract Documents form the Contract for Construction. The Contract represents the entire and integrated agreement between the parties hereto and supersedes prior negotiations, representations or agreements, either written or oral. The Contract may be amended or modified only by a Modification. The Contract Documents shall not be construed to create a contractual relationship of any kind (I) between the Contractor and the Architect or the Architect’s consultants, (2) between the Owner and a Subcontractor or a Sub-subcontractor, (3) between the Owner and the Architect or the Architect’s consultants or (4) between any persons or entities other than the Owner and the Contractor. The Architect shall, however, be entitled to performance and enforcement of obligations under the Contract intended to facilitate performance of the Architect’s duties.
§ 1.1.3 THE WORK
The term “Work” means the construction and services required by the Contract Documents, whether completed or partially completed, and includes all other labor, materials, equipment and services provided or to be provided by the Contractor to fulfill the Contractor’s obligations or reasonably inferable by the Contractor as necessary to produce the result intended by the Contract Documents. The Work may constitute the whole or a part of the Project.
§ 1.1.4 THE PROJECT
The Project is the total construction of which the Work performed under the Contract Documents may be the whole or a part and which may include construction by the Owner and by separate contractors.
§ 1.1.5 THE DRAWINGS
The Drawings are the graphic and pictorial portions of the Contract Documents showing the design, location and dimensions of the Work, generally including plans, elevations, sections, details, schedules and diagrams.
§ 1.1.6 THE SPECIFICATIONS
The Specifications are that portion of the Contract Documents consisting of the written requirements for materials, equipment, systems, standards and workmanship for the Work, and performance of related services.
§ 1.1.7 INSTRUMENTS OF SERVICE
Instruments of Service are representations, in any medium of expression now known or later developed, of the tangible and intangible creative work performed by the Architect and the Architect’s consultants under their respective professional services agreements. Instruments of Service may include, without limitation, studies, surveys, models, sketches, drawings, specifications, and other similar materials.
§ 1.1.8 THE PROJECT MANUAL
The Project Manual is a volume assembled for the Work which may include the bidding requirements, sample forms, Conditions of the Contract and Specifications.
§ 1.1.9 The term “Product” includes materials, systems, and equipment.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 1.1.10 The term “provide” includes furnishing and installing a product, complete in place, tested, approved and warranted.
§ 1.1.11 The term “Building Code” and the term “Code” refer to regulations of federal, state and local governmental agencies having jurisdiction over the Project.
§ 1.1.12 The terms “approved”, “required”, and “as directed” refer to and indicate the work or materials that may be approved, required or directed by Architect acting as the agent of the Owner.
§ 1.1.13 The term “similar” means in its general sense and not necessarily identical.
§ 1.1.14 The terms “shown”, indicated”, “detailed”, “noted”, “scheduled”, and terms of similar import, refer to requirements contained in the Contract Documents. Analogously, the expression “reasonably inferable” shall be interpreted to mean reasonably inferable by a contractor to the extent familiar with the Project and exercising the care, skill and diligence required by the Contract Documents.
§ 1.2 CORRELATION AND INTENT OF THE CONTRACT DOCUMENTS
§ 1.2.1 The intent of the Contract Documents is to include all items necessary for the proper execution and completion of the Work by the Contractor. The Contract Documents are complementary, and what is required by one shall be as binding as if required by all; performance by the Contractor shall be required only to the extent consistent with the Contract Documents and reasonably inferable from them as being necessary to produce the indicated results. In the event of inconsistencies within or between parts of the Contract Documents or between the Contract Documents and applicable standards, as well as those codes and ordinances which a competent contractor would generally be held accountable to, the Contractor shall (i) provide the better quality or greater quantity of Work or (ii) comply with the more stringent requirement; either or both in accordance with the Architect’s interpretation.
.1 On the Drawings, given dimensions shall take precedence over scaled measurements, and large scale drawings over small scale drawings.
.2 Before requesting the ordering of any material or doing any Work, the Contractor and each Subcontractor shall verify measurements at the Project site and shall be responsible for the correctness of such measurements. No extra charges or compensation will be allowed on account of differences between actual dimensions and the dimensions indicated on the Drawings.
.3 If a minor change in the Work is found to be necessary due to actual field conditions, the Contractor shall submit detailed drawings of such departure to the Architect for approval before making the change.
.4 Contractor shall thoroughly acquaint itself with and comply with the terms, statutes, rules and regulations governing excavation in the area of underground utilities.
§ 1.2.2 Organization of the Specifications into divisions, sections and articles, and arrangement of Drawings shall not control the Contractor in dividing the Work among Subcontractors or in establishing the extent of Work to be performed by any trade.
§ 1.2.3 Unless otherwise stated in the Contract Documents, words that have well-known technical or construction industry meanings are used in the Contract Documents in accordance with such recognized meanings.
§ 1.2.4 The Drawings are intended to show the general arrangement, design and extent of the Work and are partly diagrammatic. When the Project is completed, the Contractor shall mark-up a set of prints showing all changes and job conditions not shown on the Architect’s Drawings. This set of prints shall be delivered to the Architect’s office so record drawings can be prepared of the Project which are based on as-built information provided by the Contractor.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 1.2.5 If Work is required in such a manner as to make it impossible to produce first-class Work as defined by industry standards, or should discrepancies appear in the Contract Documents, Contractor shall request a written interpretation before proceeding with the Work. If Contractor fails to make such a request, Contractor shall not be excused for failure to carry out Work in a satisfactory manner. Should conflicts occur in the Contract Documents, the Contractor is deemed to have based its estimate on the acceptable standard trade practice for doing the Work, unless it shall have asked for and obtained a written decision before submission of its bid as to which method or materials will be required.
§ 1.3 CAPITALIZATION
Terms capitalized in these General Conditions include those that are (1) specifically defined, (2) the titles of numbered articles or (3) the titles of other documents published by the American Institute of Architects.
§ 1.4 INTERPRETATION
In the interest of brevity the Contract Documents frequently omit modifying words such as “all” and “any” and articles such as “the” and “an,” but the fact that a modifier or an article is absent from one statement and appears in another is not intended to affect the interpretation of either statement.
§ 1.5 OWNERSHIP AND USE OF DRAWINGS, SPECIFICATIONS AND OTHER INSTRUMENTS OF SERVICE
§ 1.5.1 The Architect and the Architect’s consultants shall be deemed the authors and owners of their respective Instruments of Service, including the Drawings and Specifications, and will retain all common law, statutory and other reserved rights, including copyrights. The Contractor, Subcontractors, Sub-subcontractors, and material or equipment suppliers shall not own or claim a copyright in the Instruments of Service. Submittal or distribution to meet official regulatory requirements or for other purposes in connection with this Project is not to be construed as publication in derogation of the Architect’s or Architect’s consultants’ reserved rights.
§ 1.5.2 The Contractor, Subcontractors, Sub-subcontractors and material or equipment suppliers are authorized to use and reproduce the Instruments of Service provided to them solely and exclusively for execution of the Work. All copies made under this authorization shall bear the copyright notice, if any, shown on the Instruments of Service. The Contractor, Subcontractors, Sub-subcontractors, and material or equipment suppliers may not use the Instruments of Service on other projects or for additions to this Project outside the scope of the Work without the specific written consent of the Owner, Architect and the Architect’s consultants.
§ 1.6 TRANSMISSION OF DATA IN DIGITAL FORM
If the parties intend to transmit Instruments of Service or any other information or documentation in digital form, they shall endeavor to establish necessary protocols governing such transmissions, unless otherwise already provided in the Agreement or the Contract Documents.
ARTICLE 2 OWNER

§ 2.1 GENERAL
§ 2.1.1 The Owner is the person or entity identified as such in the Agreement and is referred to throughout the Contract Documents as if singular in number. The Owner shall designate in writing a representative who shall have express authority to bind the Owner with respect to all matters requiring the Owner’s approval or authorization. Except as otherwise provided in Section 4.2.1, the Architect does not have such authority. The term “Owner” means the Owner or the Owner’s authorized representative.
§ 2.1.2 The Owner shall furnish to the Contractor within fifteen days after receipt of a written request, information necessary and relevant for the Contractor to evaluate, give notice of or enforce mechanic’s lien rights. Such information shall include a correct statement of the record legal title to the property on which the Project is located, usually referred to as the site, and the Owner’s interest therein.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 2.2 INFORMATION AND SERVICES REQUIRED OF THE OWNER
§ 2.2.1 Prior to commencement of the Work, the Contractor may request in writing that the Owner provide reasonable evidence that the Owner has made financial arrangements to fulfill the Owner’s obligations under the Contract. Thereafter, the Contractor may only request such evidence if (1) the Owner fails to make payments to the Contractor as the Contract Documents require; (2) a change in the Work materially changes the Contract Sum; or (3) the Contractor identifies in writing a reasonable concern regarding the Owner’s ability to make payment when due. The Owner shall furnish such evidence as a condition precedent to commencement or continuation of the Work or the portion of the Work affected by a material change. After the Owner furnishes the evidence, the Owner shall not materially vary such financial arrangements without prior notice to the Contractor.
§ 2.2.2 Except for permits and fees that are the responsibility of the Contractor under the Contract Documents, including those required under Section 3.7.1, the Owner shall secure and pay for necessary approvals, easements, assessments and charges required for construction, use or occupancy of permanent structures or for permanent changes in existing facilities.
§ 2.2.3 The Owner shall furnish surveys describing physical characteristics, legal limitations and utility locations for the site of the Project, and a legal description of the site. The Contractor shall be entitled to rely on the accuracy of information furnished by the Owner but shall exercise proper precautions relating to the safe performance of the Work.
§ 2.2.4 The Owner shall furnish information or services required of the Owner by the Contract Documents with reasonable promptness. The Owner shall also furnish any other information or services under the Owner’s control and relevant to the Contractor’s performance of the Work with reasonable promptness after receiving the Contractor’s written request for such information or services.
§ 2.2.5 Unless otherwise provided in the Contract Documents, the Owner shall furnish to the Contractor one copy of the Contract Documents for purposes of making reproductions pursuant to Section 1.5.2.
§ 2.3 OWNER’S RIGHT TO STOP THE WORK
If the Contractor fails to correct Work that is not in accordance with the requirements of the Contract Documents as required by Section 12.2 or repeatedly fails to carry out Work in accordance with the Contract Documents, the Owner may issue a written order to the Contractor to stop the Work, or any portion thereof, until the cause for such order has been eliminated; however, the right of the Owner to stop the Work shall not give rise to a duty on the part of the Owner to exercise this right for the benefit of the Contractor or any other person or entity, except to the extent required by Section 6.1.3.
§ 2.4 OWNER’S RIGHT TO CARRY OUT THE WORK
If the Contractor defaults or neglects to carry out the Work in accordance with the Contract Documents and fails within a seven-day period after receipt of written notice from the Owner to commence and continue correction of such default or neglect with diligence and promptness, the Owner may, without prejudice to other remedies the Owner may have, correct such deficiencies. In such case an appropriate Change Order shall be issued deducting from payments then or thereafter due the Contractor the reasonable cost of correcting such deficiencies, including Owner’s expenses and compensation for the Architect’s additional services made necessary by such default, neglect or failure, including Owner’s reasonable attorneys fees. Such action by the Owner and amounts charged to the Contractor are both subject to prior approval of the Architect. If payments then or thereafter due the Contractor are not sufficient to cover such amounts, the Contractor shall pay the difference to the Owner upon demand, including all interest and legal fees associated therewith and schedule delays incurred by the Owner.
§ 2.5 In no event shall the owner have control over, charge of, or any responsibility for construction means, methods, techniques, sequences or procedures or for safety precautions and programs in connection with the Work, notwithstanding any of the rights and authority granted the owner in the Contact Documents.
§ 2.6 The rights stated in this Article and elsewhere in the Contract Documents are cumulative and not in limitation of any rights of the Owner or Contractor (1) granted in the Contract Documents, (2) at law, or (3) in equity.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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ARTICLE 3 CONTRACTOR

§ 3.1 GENERAL
§ 3.1.1 The Contractor is the person or entity identified as such in the Agreement and is referred to throughout the Contract Documents as if singular in number. The Contractor shall be lawfully licensed, if required in the jurisdiction where the Project is located. The Contractor shall designate in writing a representative who shall have express authority to bind the Contractor with respect to all matters under this Contract. The term “Contractor” means the Contractor or the Contractor’s authorized representative.
§ 3.1.2 The Contractor shall perform the Work in accordance with the Contract Documents.
§ 3.1.3 The Contractor shall not be relieved of obligations to perform the Work in accordance with the Contract Documents either by activities or duties of the Architect in the Architect’s administration of the Contract, or by tests, inspections or approvals required or performed by persons or entities other than the Contractor.
§ 3.2 REVIEW OF CONTRACT DOCUMENTS AND FIELD CONDITIONS BY CONTRACTOR
§ 3.2.1 Execution of the Contract by the Contractor is a representation that the Contractor has visited the site, become generally familiar with local conditions under which the Work is to be performed and correlated personal observations with requirements of the Contract Documents. The Contractor and each Subcontractor shall evaluate and satisfy themselves as to the conditions and limitations under which the Work is to be performed, including, without limitation (1) the location, condition, layout and nature of the Project site and surrounding areas, (2) generally prevailing climatic conditions, (3) anticipated labor supply and costs, (4) availability and cost of materials, tools and equipment, and (5) other similar issues. The Owner shall not be required to make any adjustment in either the Contract Sum, Contract Time or any Milestone Date in connection with any failure by the Contractor or any Subcontractor to comply with the requirements of this paragraph. The Owner assumes no responsibility or liability for the safety of the Project site except that Owner’s personnel shall be responsible for complying with all safety regulations established while at the worksite.
§ 3.2.2 Because the Contract Documents are complementary, the Contractor shall, before starting each portion of the Work, carefully study and compare the various Contract Documents relative to that portion of the Work, as well as the information furnished by the Owner pursuant to Section 2.2.3, shall take field measurements of any existing conditions related to that portion of the Work, and shall observe any reasonably visible conditions at the site affecting it. The Contractor shall promptly report to the Architect any errors, inconsistencies or omissions discovered by or made known to the Contractor as a request for information in such form as the Architect may require. It is recognized that the Contractor’s review is made in the Contractor’s capacity as a contractor and not as a licensed design professional, unless otherwise specifically provided in the Contract Documents.
§ 3.2.3 The Contractor is not required to ascertain that the Contract Documents are in accordance with applicable laws, statutes, ordinances, codes, rules and regulations, or lawful orders of public authorities, unless they bear upon the performance of the Work, but the Contractor shall promptly report to the Architect any nonconformity discovered by or made known to the Contractor as a request for information in such form as the Architect may require.
§ 3.2.4 If the Contractor believes that additional cost or time is involved because of clarifications or instructions the Architect issues in response to the Contractor’s notices or requests for information pursuant to Sections 3.2.2 or 3.2.3, the Contractor shall make Claims as provided in Article 15. If the Contractor fails to perform the obligations of Sections 3.2.2 or 3.2.3, the Contractor shall pay such costs and damages to the Owner as would have been avoided if the Contractor had performed such obligations. If the Contractor performs those obligations, the Contractor shall not be liable to the Owner or Architect for damages resulting from errors, inconsistencies or omissions in the Contract Documents, for differences between field measurements or conditions and the Contract Documents, or for nonconformities of the Contract Documents to applicable laws, statutes, ordinances, codes, rules and regulations, and lawful orders of public authorities, unless the Contractor recognized or should have recognized such error, inconsistency, omission or difference and failed to report it to the Architect or Owner.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.2.5 The Drawings are intended to show the general arrangement, design and extent of the Work and are partly diagrammatic, they are not intended to be scaled for rough-in measurements or to serve as Shop Drawings.
§ 3.2.6 The Contractor shall consult with the Architect regarding any items which may through oversight be omitted from the Schedule, Drawings, or Specifications, or for which no symbol or other designation is given for identification. In the absence of any definite instruction from the Architect, such items shall be figured and furnished to correspond with similar items for which information is given.
§ 3.2.7 During the bidding period, any questions or discrepancies called to the Architect’s attention by a bidder will be answered by the Architect by a means of an “Addendum” issued to all bidders prior to receiving bids. All addenda shall become a part of the Contract Documents. If any items of Work is shown on the Drawings and not specified, or mentioned in the Specifications and not shown on the Drawings, the matter shall be brought to the attention of the Architect in writing during the bidding period so that an Addendum can be issued correcting the omission or clarification. If such correction is not made, then the work in question shall be considered to be required as if it had been specified and shown on the drawings.
§ 3.3 SUPERVISION AND CONSTRUCTION PROCEDURES
§ 3.3.1 The Contractor shall supervise and direct the Work, using the Contractor’s best skill and attention. The Contractor shall be solely responsible for, and have control over, construction means, methods, techniques, sequences and procedures and for coordinating all portions of the Work under the Contract, unless the Contract Documents give other specific instructions concerning these matters. If the Contract Documents give specific instructions concerning construction means, methods, techniques, sequences or procedures, the Contractor shall evaluate the jobsite safety thereof and, except as stated below, shall be fully and solely responsible for the jobsite safety of such means, methods, techniques, sequences or procedures. If the Contractor determines that such means, methods, techniques, sequences or procedures may not be safe, the Contractor shall give timely written notice to the Owner and Architect and shall not proceed with that portion of the Work without further written instructions from the Architect. If the Contractor is then instructed to proceed with the required means, methods, techniques, sequences or procedures without acceptance of changes proposed by the Contractor, the Owner shall be solely responsible for any loss or damage arising solely from those Owner-required means, methods, techniques, sequences or procedures.
§ 3.3.2 The Contractor shall be responsible to the Owner for acts and omissions of the Contractor’s employees, Subcontractors and their agents and employees, and other persons or entities performing portions of the Work for, or on behalf of, the Contractor or any of its Subcontractors.
§ 3.3.3 The Contractor shall be responsible for inspection of portions of Work already performed to determine that such portions are in proper condition to receive subsequent Work.
§ 3.3.4 The Contractor shall not be relieved of obligation to perform the Work in accordance with the Contract Documents either by activities or duties of the Owner in the Owner’s administration of the Contract, or by tests, inspections or approvals required or performed by persons other than the Contractor.
§ 3.4 LABOR AND MATERIALS
§ 3.4.1 Unless otherwise provided in the Contract Documents, the Contractor shall provide and pay for labor, materials, equipment, tools, construction equipment and machinery, water, heat, utilities, transportation, and other facilities and services necessary for proper execution and completion of the Work, whether temporary or permanent and whether or not incorporated or to be incorporated in the Work.
§ 3.4.1.1 The Contractor shall provide and pay for all costs of temporary heat, light, electrical power and water and off-site debris removal as required for the timely completion of the work, until the issuance of the Certificate for Substantial Completion, at which time the Owner will take over said costs.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.4.2 Except in the case of minor changes in the Work authorized by the Architect in accordance with Sections 3.12.8 or 7.4, the Contractor may make substitutions only with the consent of the Owner, after evaluation by the Architect and in accordance with a Change Order or Construction Change Directive.
§ 3.4.3 The Contractor shall enforce strict discipline and good order among the Contractor’s employees and other persons carrying out the Work. The Contractor shall not permit employment of unfit persons or persons not properly skilled in tasks assigned to them.
§ 3.4.4 The various products and materials mentioned in these Contract Documents are given to establish a standard of quality and price. It is not intended that the Contractor shall be limited to one product. It is the responsibility of the Architect to review or equal submittals. The judgment of the Architect shall be final as to where a substitute product is approved for use in place of the sole priority specified item.
§ 3.4.5 Where Specifications allow a material or operation to be “or equal” and “reviewed”, any substitutes shall be warranted by Contractor to be equal in quality, service and performance to items originally specified. Final determination and written approval for use of substitutes must be obtained from the Architect prior to ordering and installation.
§ 3.4.6 For use of material other than specified, Contractor shall assume the cost of and responsibility for satisfactorily accomplishing all changes in Work as required, and correction of any faults due to performance, quality or service failures.
§ 3.4.7 All materials used in this performance of the Work shall be handled with care, whether furnished by the Contractor or other parties. The Contractor shall account for the materials; inspect such materials as they are delivered at the Site; pile, store and handle same; protect them from injury; and insure delivery of materials at such times and in such quantities as will insure speedy, uninterrupted progress of the Work.
§ 3.5 WARRANTY
§ 3.5.1 The Contractor warrants to the Owner and Architect that materials and equipment furnished under the Contract will be of good quality and new unless the Contract Documents require or permit otherwise. The Contractor further warrants that the Work will conform to the requirements of the Contract Documents and will be free from defects, except for those inherent in the quality of the Work the Contract Documents require or permit. Work, materials, or equipment not conforming to these requirements may be considered defective. The Contractor’s warranty excludes remedy for damage or defect caused by abuse, alterations to the Work not executed by the Contractor, improper or insufficient maintenance, improper operation, or normal wear and tear and normal usage. If required by the Architect or Owner, the Contractor shall furnish satisfactory evidence as to the kind and quality of materials and equipment.
§ 3.5.2 Contractor expressly warrants its Work for one year after Final Completion. Contractor shall make any repair or replacement to the Work resulting from defective materials and/or workmanship or construction not in accordance with the Contract Documents. Contractor shall commence making the repairs or replacements required pursuant to this warranty promptly after Owner gives written notice to Contractor. In the event of Contractor’s failure to make timely corrections, Owner shall have the right to make corrections and Contractor shall be responsible for the immediate payment thereof.
§ 3.5.3 The Contractor agrees to assign to the Owner at the time of Substantial Completion of the Work any and all manufacturer’s warranties relating to materials and labor used in the Work and further agrees to perform the Work in such manner so as to preserve any and all such manufacturer’s warranties.
§ 3.6 TAXES
The Contractor shall pay sales, consumer, use and similar taxes for the Work provided by the Contractor that are legally enacted when bids are received or negotiations concluded, whether or not yet effective or merely scheduled to go into effect. The Contractor and its subcontractors shall be responsible for payment of Social Security and Unemployment taxes for their respective employees.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.7 PERMITS, FEES, NOTICES, AND COMPLIANCE WITH LAWS
§ 3.7.1 Unless otherwise provided in the Contract Documents, the Contractor shall secure and pay for the building permit as well as for other permits, fees, licenses, and inspections by government agencies necessary for proper execution and completion of the Work that are customarily secured after execution of the Contract and legally required at the time bids are received or negotiations concluded.
§ 3.7.2 The Contractor shall comply with and give notices required by applicable laws, statutes, ordinances, codes, rules and regulations, and lawful orders of public authorities applicable to performance of the Work.
§ 3.7.3 If the Contractor performs Work knowing it to be contrary to applicable laws, statutes, ordinances, codes, rules and regulations, or lawful orders of public authorities, the Contractor shall assume appropriate responsibility for such Work and shall bear the costs attributable to correction, and shall indemnify the Owner therefor, including reasonable professional fees.
§ 3.7.4 Concealed or Unknown Conditions. If the Contractor encounters conditions at the site that are (1) subsurface or otherwise concealed physical conditions that differ materially from those indicated in the Contract Documents or (2) unknown physical conditions of an unusual nature, that differ materially from those ordinarily found to exist and generally recognized as inherent in construction activities of the character provided for in the Contract Documents, the Contractor shall promptly provide notice to the Owner and the Architect before conditions are disturbed and in no event later than 21 days after first observance of the conditions. The Architect will promptly investigate such conditions and, if the Architect determines that they differ materially and cause an increase or decrease in the Contractor’s cost of, or time required for, performance of any part of the Work, will recommend an equitable adjustment in the Contract Sum or Contract Time, or both. If the Architect determines that the conditions at the site are not materially different from those indicated in the Contract Documents and that no change in the terms of the Contract is justified, the Architect shall promptly notify the Owner and Contractor in writing, stating the reasons. If either party disputes the Architect’s determination or recommendation, that party may proceed as provided in Article 15.
§ 3.7.5 If, in the course of the Work, the Contractor encounters human remains or recognizes the existence of burial markers, archaeological sites or wetlands not indicated in the Contract Documents, the Contractor shall immediately suspend any operations that would affect them and shall notify the Owner and Architect. Upon receipt of such notice, the Owner shall promptly take any action necessary to obtain governmental authorization required to resume the operations. The Contractor shall continue to suspend such operations until otherwise instructed by the Owner but shall continue with all other operations that do not affect those remains or features. Requests for adjustments in the Contract Sum and Contract Time arising from the existence of such remains or features may be made as provided in Article 15.
§ 3.8 ALLOWANCES
§ 3.8.1 The Contractor shall include in the Contract Sum all allowances stated in the Contract Documents. Items covered by allowances shall be supplied for such amounts and by such persons or entities as the Owner may direct, but the Contractor shall not be required to employ persons or entities to whom the Contractor has reasonable objection.
§ 3.8.2 Unless otherwise provided in the Contract Documents,
  .1   allowances shall cover the cost to the Contractor of materials and equipment delivered at the site and all required taxes, less applicable trade discounts;
  .2   Contractor’s costs for unloading and handling at the site, labor, installation costs, overhead, profit and other expenses contemplated for stated allowance amounts shall be included in the Contract Sum but not in the allowances; and
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .3   whenever costs are more than or less than allowances, the Contract Sum shall be adjusted accordingly by Change Order. The amount of the Change Order shall reflect (1) the difference between actual costs and the allowances under Section 3.8.2.1 and (2) changes in Contractor’s costs under Section 3.8.2.2.
§ 3.8.3 Materials and equipment under an allowance shall be selected by the Owner with reasonable promptness.
§ 3.9 SUPERINTENDENT
§ 3.9.1 The Contractor shall employ a competent superintendent satisfactory to the Owner and necessary assistants who shall be in attendance at the Project site during performance of the Work. The superintendent shall represent the Contractor, and communications given to the superintendent shall be as binding as if given to the Contractor. The Project Manager, Assistant Project Manager and Superintendent may not be removed without the prior written consent of the Owner. Owner reserves the right to have any employee of Contractor removed from the Project, upon reasonable cause.
§ 3.9.2 The Contractor, as soon as practicable after award of the Contract, shall furnish in writing to the Owner through the Architect the name and qualifications of a proposed superintendent. The Architect may reply within 14 days to the Contractor in writing stating (1) whether the Owner or the Architect has reasonable objection to the proposed superintendent or (2) that the Architect requires additional time to review. Failure of the Architect to reply within the 14 day period shall constitute notice of no reasonable objection.
§ 3.9.3 The Contractor shall not employ a proposed superintendent to whom the Owner or Architect has made reasonable and timely objection. The Contractor shall not change the superintendent without the Owner’s consent, which shall not unreasonably be withheld or delayed.
§ 3.10 CONTRACTOR’S CONSTRUCTION SCHEDULES
§ 3.10.1 The Contractor, promptly after being awarded the Contract, shall prepare and submit for the Owner’s and Architect’s information a Contractor’s construction schedule for the Work. The schedule shall not exceed time limits current under the Contract Documents, shall be revised at appropriate intervals as required by the conditions of the Work and Project, shall be related to the entire Project to the extent required by the Contract Documents, and shall provide for expeditious and practicable execution of the Work.
§ 3.10.2 The Contractor shall prepare a submittal schedule, promptly after being awarded the Contract and thereafter as necessary to maintain a current submittal schedule, and shall submit the schedule(s) for the Architect’s approval. The Architect’s approval shall not unreasonably be delayed or withheld. The submittal schedule shall (1) be coordinated with the Contractor’s construction schedule, and (2) allow the Architect reasonable time to review submittals. If the Contractor fails to submit a submittal schedule, the Contractor shall not be entitled to any increase in Contract Sum or extension of Contract Time based on the time required for review of submittals.
§ 3.10.3 The Contractor shall perform the Work in general accordance with the most recent schedules submitted to the Owner and Architect.
§ 3.10.4 The construction schedule shall be in a detailed precedence-style critical path method (CPM) or Primavera type format satisfactory to the Owner and Architect which shall also (1) provide a graphic representation of all activities and events that will occur during performance of the Work; (2) identify each phase of construction and occupancy; and (3) set forth dates that are critical in ensuring the timely and orderly completion of the Work in accordance with the requirements of the Contract Documents (hereinafter referred to as Milestone Dates). Upon review and acceptance by the Architect and Owner, the construction schedule shall be deemed part of the Contract Documents and attached to Amendment No. 1 as Exhibit D. The Contractor’s Schedule shall assume an amount of adverse weather conditions normal to the site of the Work for the seasons or season for the year involved. The Contractor shall monitor the progress of the Work for conformance with the requirements of the construction schedule and shall promptly advise the Owner and Architect of any delays or potential delays. The construction schedule shall be updated regularly to reflect actual conditions or if requested by the Owner. In the event any progress report indicates any delays, the Contractor shall propose an affirmative plan to correct the delay, including overtime and/or additional labor, if necessary. In no event shall any progress report constitute an adjustment in the Contract Time, any Milestone Date or the Contract Sum unless any such adjustment is agreed to by the Owner and authorized pursuant to a Change Order.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.10.5 The Contractor shall schedule and conduct construction and progress meetings, on a frequency required to effect coordination, to discuss such matters as procedures, progress, problems and scheduling. The Contractor shall prepare and distribute minutes within five working days of such meetings.
§ 3.10.6 The Contractor shall record the progress of the Project. Submit written progress reports not less frequently than monthly to the Owner and the Architect, including information on each Subcontractor and each Subcontractor’s Work, as well as the entire Project, showing percentages of completion and the number and amounts of Change Orders. Keep a daily log containing a record of weather, Subcontractor’s Work on the site, number of workers, Work accomplished, problems encountered and other similar relevant data as the Owner may require. Upon request, Contractor shall make the log available to the Owner and the Architect.
§ 3.10.7 In planning its construction schedule within the agreed contract time, it shall be assumed that the Contractor has anticipated the amount of adverse weather conditions normal to the site of the Work.
§ 3.10.8 In the event that the progress of the Work falls behind the most recent approved schedule of the Work, the Contractor shall prepare a recovery schedule depicting the strategy and means to recover all lost time, at no additional cost to the Owner if such delay is non-compensable, including, where approved by the Owner, working overtime and in multiple shifts. In cases of non-excusable delay, failure to timely prepare such a recovery schedule shall be a material breach of the Contract.
§ 3.11 DOCUMENTS AND SAMPLES AT THE SITE
The Contractor shall maintain at the site for the Owner one copy of the Drawings, Specifications, Project Manual, Addenda, Change Orders written Modifications, Construction Change Directives, Field Orders, and written interpretation and clarifications in good order and marked currently to indicate field changes and selections made during construction, and one copy of approved Shop Drawings, Product Data, Samples and similar required submittals. Annotations on the Drawings shall show changes in the Work occasioned by field conditions or Owner/Architect authorized changes to the Work. All notations shall be dimensioned where the location of the changed items different than that originally shown and shall show all underground utilities, sewer lines and the like which have been installed by the Contractor, giving accurate dimensions from column center lines and/or exterior building walls. These shall be available to the Architect and shall be delivered to the Architect for submittal to the Owner upon completion of the Work as a record of the Work as constructed.
§ 3.12 SHOP DRAWINGS, PRODUCT DATA AND SAMPLES
§ 3.12.1 Shop Drawings are drawings, diagrams, schedules and other data specially prepared for the Work by the Contractor or a Subcontractor, Sub-subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.
§ 3.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.
§ 3.12.3 Samples are physical examples that illustrate materials, equipment or workmanship and establish standards by which the Work will be judged.
§ 3.12.4 Shop Drawings, Product Data, Samples and similar submittals are not Contract Documents. Their purpose is to demonstrate the way by which the Contractor proposes to conform to the information given and the design concept expressed in the Contract Documents for those portions of the Work for which the Contract Documents require submittals. Review by the Architect is subject to the limitations of Section 4.2.7. Informational submittals upon which the Architect is not expected to take responsive action may be so identified in the Contract Documents. Submittals that are not required by the Contract Documents may be returned by the Architect without action. The Contractor’s review shall be noted on the submitted item or in its transmittal letter, together with written notice of any deviation in the submitted item from the requirements of the Work and of the Contract Documents. In collaboration with the Architect, Contractor shall establish and implement procedures for expediting the processing and approval of Shop Drawings, Product Date, Samples and other submittals.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.12.5 The Contractor shall review for compliance with the Contract Documents, approve and submit to the Architect Shop Drawings, Product Data, Samples and similar submittals required by the Contract Documents in accordance with the submittal schedule approved by the Architect or, in the absence of an approved submittal schedule, with reasonable promptness and in such sequence as to cause no delay in the Work or in the activities of the Owner or of separate contractors.
§ 3.12.6 By submitting Shop Drawings, Product Data, Samples and similar submittals, the Contractor represents to the Owner and Architect that the Contractor has (1) reviewed and approved them, (2) determined and verified materials, field measurements and field construction criteria related thereto, or will do so and (3) checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents.
§ 3.12.7 The Contractor shall perform no portion of the Work for which the Contract Documents require submittal and review of Shop Drawings, Product Data, Samples or similar submittals until the respective submittal has been approved by the Architect.
§ 3.12.8 The Work shall be in accordance with approved submittals except that the Contractor shall not be relieved of responsibility for deviations from requirements of the Contract Documents by the Architect’s approval of Shop Drawings, Product Data, Samples or similar submittals unless the Contractor has specifically informed the Architect in writing of such deviation at the time of submittal and (1) the Architect has given written approval to the specific deviation as a minor change in the Work, or (2) a Change Order or Construction Change Directive has been issued authorizing the deviation. The Contractor shall not be relieved of responsibility for errors or omissions in Shop Drawings, Product Data, Samples or similar submittals by the Architect’s approval thereof.
§ 3.12.9 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data, Samples or similar submittals, to revisions other than those requested by the Architect on previous submittals. In the absence of such written notice, the Architect’s approval of a resubmission shall not apply to such revisions.
§ 3.12.10 The Contractor shall not be required to provide professional services that constitute the practice of architecture or engineering unless such services are specifically required by the Contract Documents for a portion of the Work or unless the Contractor needs to provide such services in order to carry out the Contractor’s responsibilities for construction means, methods, techniques, sequences and procedures. The Contractor shall not be required to provide professional services in violation of applicable law. If professional design services or certifications by a design professional who shall have and maintain commercially reasonable limits of insurance related to systems, materials or equipment are specifically required of the Contractor by the Contract Documents, the Owner and the Architect will specify all performance and design criteria that such services must satisfy. The Contractor shall cause such services or certifications to be provided by a properly licensed design professional, whose signature and seal shall appear on all drawings, calculations, specifications, certifications, Shop Drawings and other submittals prepared by such professional. Shop Drawings and other submittals related to the Work designed or certified by such professional, if prepared by others, shall bear such professional’s written approval when submitted to the Architect. The Owner and the Architect shall be entitled to rely upon the adequacy, accuracy and completeness of the services, certifications and approvals performed or provided by such design professionals, provided the Owner and Architect have specified to the Contractor all performance and design criteria that such services must satisfy. Pursuant to this Section 3.12.10, the Architect will review, approve or take other appropriate action on submittals only for the limited purpose of checking for conformance with information given and the design concept expressed in the Contract Documents. The Contractor shall not be responsible for the adequacy of the performance and design criteria specified in the Contract Documents.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.12.11 All shop drawings shall be checked by the Contractor and shall bear its review stamp prior to submitting to the Architect.
§ 3.13 USE OF SITE
The Contractor shall confine operations at the site to areas permitted by applicable laws, statutes, ordinances, codes, rules and regulations, and lawful orders of public authorities and the Contract Documents and shall not unreasonably encumber the site with materials or equipment.
§ 3.13.2 Only materials and equipment that are to be used directly in the Work shall be brought to and stored on the Project site. Protection of construction materials and equipment stored at the Project site from weather, theft, damage and all other adversity is solely the responsibility of the Contractor.
§ 3.13.3 The Contractor and any entity for whom the Contractor is responsible shall not erect any sign on the Project site without the prior written consent of the Owner.
§ 3.14 CUTTING AND PATCHING
§ 3.14.1 The Contractor shall be responsible for cutting, fitting or patching required to complete the Work or to make its parts fit together properly. All areas requiring cutting, fitting and patching shall be restored to the condition existing prior to the cutting, fitting and patching, unless otherwise required by the Contract Documents.
§ 3.14.2 The Contractor shall not damage or endanger a portion of the Work or fully or partially completed construction of the Owner or separate contractors by cutting, patching or otherwise altering such construction, or by excavation. The Contractor shall not cut or otherwise alter such construction by the Owner or a separate contractor except with written consent of the Owner and of such separate contractor; such consent shall not be unreasonably withheld. The Contractor shall not unreasonably withhold from the Owner or a separate contractor the Contractor’s consent to cutting or otherwise altering the Work.
§ 3.15 CLEANING UP
§ 3.15.1 The Contractor shall keep the premises and surrounding area free from accumulation of waste materials or rubbish caused by operations under the Contract. On a regular basis, the Contractor shall remove waste materials, rubbish, the Contractor’s tools, construction equipment, machinery and surplus materials from and about the Project. At the completion of construction, a final clean-up including final glass cleaning, floor mopping, vacuuming, etc., shall be performed by the Contractor.
§ 3.15.2 If the Contractor fails to clean up as provided in the Contract Documents, the Owner may do so and Owner shall be entitled to reimbursement from the Contractor.
§ 3.16 ACCESS TO WORK
The Contractor shall provide the Owner and Architect access to the Work in preparation and progress wherever located.
§ 3.17 ROYALTIES, PATENTS AND COPYRIGHTS
The Contractor shall pay all royalties and license fees. The Contractor shall defend suits or claims for infringement of copyrights and patent rights and shall hold the Owner and Architect harmless from loss on account thereof, but shall not be responsible for such defense or loss when a particular design, process or product of a particular manufacturer or manufacturers is required by the Contract Documents, or where the copyright violations are contained in Drawings, Specifications or other documents prepared by the Owner or Architect. However, if the Contractor has reason to believe that the required design, process or product is an infringement of a copyright or a patent, the Contractor shall be responsible for such loss unless such information is promptly furnished to the Architect.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 3.18 INDEMNIFICATION
§ 3.18.1 To the fullest extent permitted by law the Contractor shall indemnify and hold harmless the Owner, its officers, directors, shareholders, affiliates, insurers, Architect, Architect’s consultants, and agents and employees of any of them from and against any and all claims, damages, losses and expenses, including but not limited to attorneys’ fees, arising out of or resulting from performance of the Work, provided that such claim, damage, loss or expense is attributable to bodily injury, sickness, disease or death, or to injury to or destruction of tangible property (other than the Work itself), but only to the extent caused by the negligent acts or omissions of the Contractor, a Subcontractor, anyone directly or indirectly employed by them or anyone for whose acts they may be liable, regardless of whether or not such claim, damage, loss or expense is caused in part by a party indemnified hereunder. Such obligation shall not be construed to negate, abridge, or reduce other rights or obligations of indemnity which would otherwise exist as to a party or person described in this Section 3.18.
§ 3.18.2 In claims against any person or entity indemnified under this Section 3.18 by an employee of the Contractor, a Subcontractor, anyone directly or indirectly employed by them or anyone for whose acts they may be liable, the indemnification obligation under Section 3.18.1 shall not be limited by a limitation on amount or type of damages, compensation or benefits payable by or for the Contractor or a Subcontractor under workers’ compensation acts, disability benefit acts or other employee benefit acts.
§ 3.18.3 In the event that the Contractor fails or refuses to indemnify an indemnitee hereunder, in addition to all other obligations and upon adjudication in favor of an indemnitee, Contractor shall be responsible for any and all costs associated with bringing such action, including reasonable attorneys’ fees. Owner may withhold from any payment an amount sufficient to protect the Owner.
§ 3.18.4 The Contractor’s indemnity obligations under this Paragraph 3.18 shall, but not by way of limitation, specifically include, without limitations, all fines, penalties and punitive damages arising out of, or in connection with, any (i) violation of or failure to comply with any governmental regulation or requirement by the Contractor or any person or entity for whom the Contractor is responsible, (ii) method of execution of the Work, or (iii) failure to obtain, or violation of, any permit or other approval of a public authority applicable to the Work by the Contractor or any entity for whom the Contractor is responsible.
ARTICLE 4 ARCHITECT

§ 4.1 GENERAL
§ 4.1.1 The Owner shall retain an architect lawfully licensed to practice architecture or an entity lawfully practicing architecture in the jurisdiction where the Project is located. That person or entity is identified as the Architect in the Agreement and is referred to throughout the Contract Documents as if singular in number.
§ 4.1.2 Duties, responsibilities and limitations of authority of the Architect as set forth in the Contract Documents shall not be restricted, modified or extended without written consent of the Owner, Contractor and Architect. Consent shall not be unreasonably withheld.
§ 4.1.3 If the employment of the Architect is terminated, the Owner shall employ a successor architect whose status under the Contract Documents shall be that of the Architect.
§ 4.2 ADMINISTRATION OF THE CONTRACT
§ 4.2.1 The Architect will provide administration of the Contract as described in the Contract Documents and the Architect and Owner’s Project Manager will be the Owner’s representative during construction until the date the Architect issues the final Certificate For Payment. The Architect will have authority to act on behalf of the Owner only to the extent provided in the Contract Documents.
§ 4.2.2 The Architect and Owner will visit the site at intervals appropriate to the stage of construction, or as otherwise agreed with the Owner, to become generally familiar with the progress and quality of the portion of the Work completed, and to determine in general if the Work observed is being performed in a manner indicating that the Work, when fully completed, will be in accordance with the Contract Documents. However, neither the Architect nor the Owner will be required to make exhaustive or continuous on-site inspections to check the quality or quantity of the Work. The Architect and the Owner will not have control over, charge of, or responsibility for, the construction means, methods, techniques, sequences or procedures, or for the safety precautions and programs in connection with the Work, since these are solely the Contractor’s rights and responsibilities under the Contract Documents, except as provided in Section 3.3.1.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 4.2.3 On the basis of the site visits, the Architect will keep the Owner reasonably informed about the progress and quality of the portion of the Work completed, and report to the Owner (1) known deviations from the Contract Documents and from the most recent construction schedule submitted by the Contractor, and (2) defects and deficiencies observed in the Work. The Architect and Owner will not be responsible for the Contractor’s failure to perform the Work in accordance with the requirements of the Contract Documents. The Architect will not have control over or charge of and will not be responsible for acts or omissions of the Contractor, Subcontractors, or their agents or employees, or any other persons or entities performing portions of the Work.
§ 4.2.4 COMMUNICATIONS FACILITATING CONTRACT ADMINISTRATION
Except as otherwise provided in the Contract Documents or when direct communications have been specially authorized, the Owner and Contractor shall endeavor to communicate with each other through the Architect about matters arising out of or relating to the Contract. Communications by and with the Architect’s consultants shall be through the Architect. Communications by and with Subcontractors and material suppliers shall be through the Contractor. Communications by and with separate contractors shall be through the Owner.
§ 4.2.5 Based on the Architect’s evaluations of the Contractor’s Applications for Payment, the Architect will review and certify the amounts due the Contractor and will issue Certificates for Payment in such amounts.
§ 4.2.6 The Architect and Owner have authority to reject Work that does not conform to the Contract Documents. Whenever the Architect or Owner considers it necessary or advisable, the Architect and Owner will have authority to require inspection or testing of the Work in accordance with Sections 13.5.2 and 13.5.3, whether or not such Work is fabricated, installed or completed. However, neither this authority of the Architect nor a decision made in good faith either to exercise or not to exercise such authority shall give rise to a duty or responsibility of the Architect or Owner to the Contractor, Subcontractors, material and equipment suppliers, their agents or employees, or other persons or entities performing portions of the Work.
§ 4.2.7 The Architect will review and approve, or take other appropriate action upon, the Contractor’s submittals such as Shop Drawings, Product Data and Samples, but only for the limited purpose of checking for conformance with information given and the design concept expressed in the Contract Documents. The Architect’s action will be taken in accordance with the submittal schedule approved by the Architect or, in the absence of an approved submittal schedule, with reasonable promptness while allowing sufficient time in the Architect’s professional judgment to permit adequate review. Review of such submittals is not conducted for the purpose of determining the accuracy and completeness of other details such as dimensions and quantities, or for substantiating instructions for installation or performance of equipment or systems, all of which remain the responsibility of the Contractor as required by the Contract Documents. The Architect’s review of the Contractor’s submittals shall not relieve the Contractor of the obligations under Sections 3.3, 3.5 and 3.12. The Architect’s review shall not constitute approval of safety precautions or, unless otherwise specifically stated by the Architect, of any construction means, methods, techniques, sequences or procedures. The Architect’s approval of a specific item shall not indicate approval of an assembly of which the item is a component.
§ 4.2.8 The Architect will prepare Change Orders and Construction Change Directives, and may authorize minor changes in the Work as provided in Section 7.4. The Architect will investigate and make determinations and recommendations regarding concealed and unknown conditions as provided in Section 3.7.4.
§ 4.2.9 The Architect and Owner will conduct inspections to determine the date or dates of Substantial Completion and the date of final completion; issue Certificates of Substantial Completion pursuant to Section 9.8; receive and forward to the Owner, for the Owner’s review and records, written warranties and related documents required by the Contract and assembled by the Contractor pursuant to Section 9.10; and issue a final Certificate for Payment pursuant to Section 9.10.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 4.2.10 If the Owner and Architect agree, the Architect will provide one or more project representatives to assist in carrying out the Architect’s responsibilities at the site. The duties, responsibilities and limitations of authority of such project representatives shall be as set forth in an exhibit to be incorporated in the Contract Documents.
§ 4.2.11 The Architect will interpret and decide matters concerning performance under, and requirements of, the Contract Documents on written request of either the Owner or Contractor. The Architect’s response to such requests will be made in writing within any time limits agreed upon or otherwise with reasonable promptness.
§ 4.2.12 Interpretations and decisions of the Architect will be consistent with the intent of, and reasonably inferable from, the Contract Documents and will be in writing or in the form of drawings. When making such interpretations and decisions, the Architect will endeavor to secure faithful performance by both Owner and Contractor, will not show partiality to either and will not be liable for results of interpretations or decisions rendered in good faith.
§ 4.2.13 The Architect’s decisions on matters relating to aesthetic effect will be final if consistent with the intent expressed in the Contract Documents.
§ 4.2.14 The Architect will review and respond to requests for information about the Contract Documents. The Architect’s response to such requests will be made in writing within any time limits agreed upon or otherwise with reasonable promptness. If appropriate, the Architect will prepare and issue supplemental Drawings and Specifications in response to the requests for information.
ARTICLE 5 SUBCONTRACTORS

§ 5.1 DEFINITIONS
§ 5.1.1 A Subcontractor is a person or entity who has a direct contract with the Contractor to perform a portion of the Work at the site. The term “Subcontractor” is referred to throughout the Contract Documents as if singular in number and means a Subcontractor or an authorized representative of the Subcontractor. The term “Subcontractor” does not include a separate contractor or subcontractors of a separate contractor.
§ 5.1.2 A Sub-subcontractor is a person or entity who has a direct or indirect contract with a Subcontractor to perform a portion of the Work at the site. The term “Sub-subcontractor” is referred to throughout the Contract Documents as if singular in number and means a Sub-subcontractor or an authorized representative of the Sub-subcontractor.
§ 5.2 AWARD OF SUBCONTRACTS AND OTHER CONTRACTS FOR PORTIONS OF THE WORK
§ 5.2.1 Unless otherwise stated in the Contract Documents or the bidding requirements, the Contractor, as soon as practicable after award of the Contract, shall furnish in writing to the Owner through the Architect the names of persons or entities (including those who are to furnish materials or equipment fabricated to a special design) proposed for each principal portion of the Work. The Architect may reply within 14 days to the Contractor in writing stating (1) whether the Owner or the Architect has reasonable objection to any such proposed person or entity or (2) that the Architect requires additional time for review. Failure of the Owner or Architect to reply within the 14 day period shall constitute notice of no reasonable objection.
§ 5.2.2 The Contractor shall not contract with a proposed person or entity to whom the Owner or Architect has made reasonable and timely objection. The Contractor shall not be required to contract with anyone to whom the Contractor has made reasonable objection.
§ 5.2.3 If the Owner or Architect has reasonable objection to a person or entity proposed by the Contractor, the Contractor shall propose another to whom the Owner or Architect has no reasonable objection. If the proposed but rejected Subcontractor was reasonably capable of performing the Work, the Contract Sum and Contract Time shall be increased or decreased by the difference, if any, occasioned by such change, and an appropriate Change Order shall be issued before commencement of the substitute Subcontractor’s Work. However, no increase in the Contract Sum or Contract Time shall be allowed for such substitution.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 5.2.4 The Contractor shall not substitute a Subcontractor, person or entity previously selected if the Owner or Architect makes reasonable objection to such substitution.
§ 5.3 SUBCONTRACTUAL RELATIONS
By appropriate written agreement, the Contractor shall require each Subcontractor, to the extent of the Work to be performed by the Subcontractor, to be bound to the Contractor by terms of the Contract Documents, and to assume toward the Contractor all the obligations and responsibilities, including the responsibility for safety of the Subcontractor’s Work, which the Contractor, by these Documents, assumes toward the Owner and Architect. Each subcontract agreement shall preserve and protect the rights of the Owner and Architect under the Contract Documents with respect to the Work to be performed by the Subcontractor so that subcontracting thereof will not prejudice such rights, and shall allow to the Subcontractor, unless specifically provided otherwise in the subcontract agreement, the benefit of all rights, remedies and redress against the Contractor that the Contractor, by the Contract Documents, has against the Owner. Where appropriate, the Contractor shall require each Subcontractor to enter into similar agreements with Sub-subcontractors. The Contractor shall make available to each proposed Subcontractor, prior to the execution of the subcontract agreement, copies of the Contract Documents to which the Subcontractor will be bound. Subcontractors will similarly make copies of applicable portions of such documents available to their respective proposed Sub-subcontractors.
§ 5.4 CONTINGENT ASSIGNMENT OF SUBCONTRACTS
§ 5.4.1 Each subcontract agreement for a portion of the Work is assigned by the Contractor to the Owner, provided that
  .1   assignment is effective only after termination of the Contract by the Owner for cause pursuant to Section 14.2 and only for those subcontract agreements that the Owner accepts by notifying the Subcontractor and Contractor in writing; and
  .2   assignment is subject to the prior rights of the surety, if any, obligated under bond relating to the Contract.
(Paragraph deleted)
§ 5.4.2 Each subcontract shall specifically provide that the Owner shall only be responsible to the subcontractor for those obligations that accrue subsequent to the Owner’s exercise of any rights under this conditional assignment.
§ 5.4.3 Upon such assignment to the Owner under this Section 5.4, the Owner may further assign the subcontract to a successor contractor or other entity.
ARTICLE 6 CONSTRUCTION BY OWNER OR BY SEPARATE CONTRACTORS

§ 6.1 OWNER’S RIGHT TO PERFORM CONSTRUCTION AND TO AWARD SEPARATE CONTRACTS
§ 6.1.1 The Owner reserves the right to perform construction or operations related to the Project with the Owner’s own forces, and to award separate contracts in connection with other portions of the Project or other construction or operations on the site under Conditions of the Contract identical or substantially similar to these including those portions related to insurance and waiver of subrogation. If the Contractor claims that delay or additional cost is involved because of such action by the Owner, the Contractor shall make such Claim as provided in Article 15.
§ 6.1.2 When separate contracts are awarded for different portions of the Project or other construction or operations on the site, the term “Contractor” in the Contract Documents in each case shall mean the Contractor who executes each separate Owner-Contractor Agreement.
§ 6.1.3 The Owner shall provide for coordination of the activities of the Owner’s own forces and of each separate contractor with the Work of the Contractor, who shall cooperate with them. The Contractor shall participate with other separate contractors and the Owner in reviewing their construction schedules. The Contractor shall make any revisions to the construction schedule deemed necessary after a joint review and mutual agreement. The construction schedules shall then constitute the schedules to be used by the Contractor, separate contractors and the Owner until subsequently revised.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 6.1.4 Unless otherwise provided in the Contract Documents, when the Owner performs construction or operations related to the Project with the Owner’s own forces, the Owner shall be deemed to be subject to the same obligations and to have the same rights that apply to the Contractor under the Conditions of the Contract, including, without excluding others, those stated in Article 3, this Article 6 and Articles 10, 11 and 12.
§ 6.2 MUTUAL RESPONSIBILITY
§ 6.2.1 The Contractor shall afford the Owner and separate contractors reasonable opportunity for introduction and storage of their materials and equipment and performance of their activities, and shall connect and coordinate the Contractor’s construction and operations with theirs as required by the Contract Documents.
§ 6.2.2 If part of the Contractor’s Work depends for proper execution or results upon construction or operations by the Owner or a separate contractor, the Contractor shall, prior to proceeding with that portion of the Work, promptly report to the Architect apparent discrepancies or defects in such other construction that would render it unsuitable for such proper execution and results. Failure of the Contractor so to report shall constitute an acknowledgment that the Owner’s or separate contractor’s completed or partially completed construction is fit and proper to receive the Contractor’s Work, except as to defects not then reasonably discoverable.
§ 6.2.3 The Contractor shall reimburse the Owner for costs the Owner incurs that are payable to a separate contractor because of the Contractor’s delays, improperly timed activities or defective construction. The Owner shall be responsible to the Contractor for costs the Contractor incurs because of a separate contractor’s delays, improperly timed activities, damage to the Work or defective construction of a separate contractor in accordance with Article 7 herein.
§ 6.2.4 The Contractor shall promptly remedy damage the Contractor wrongfully causes to completed or partially completed construction or to property of the Owner or separate contractors as provided in Section 10.2.5.
§ 6.2.5 The Owner and each separate contractor shall have the same responsibilities for cutting and patching as are described for the Contractor in Section 3.14.
§ 6.3 OWNER’S RIGHT TO CLEAN UP
If a dispute arises among the Contractor, separate contractors and the Owner as to the responsibility under their respective contracts for maintaining the premises and surrounding area free from waste materials and rubbish, the Owner may clean up and the Architect will allocate the cost among those responsible.
ARTICLE 7 CHANGES IN THE WORK

§ 7.1 GENERAL
§ 7.1.1 Changes in the Work may be accomplished after execution of the Contract, and without invalidating the Contract, by Change Order, Construction Change Directive or order for a minor change in the Work, subject to the limitations stated in this Article 7 and elsewhere in the Contract Documents.
§ 7.1.2 A Change Order shall be based upon agreement among the Owner, Contractor and Architect; a Construction Change Directive requires agreement by the Owner and Architect and may or may not be agreed to by the Contractor; an order for a minor change in the Work may be issued by the Architect alone.
§ 7.1.3 Changes in the Work shall be performed under applicable provisions of the Contract Documents, and the Contractor shall proceed promptly, unless otherwise provided in the Change Order, Construction Change Directive or order for a minor change in the Work.. Except as permitted in Paragraph 7.3 and 9.7.2, a change in the Contract Sum or the Contract Time shall be accomplished only by Change Order or written authorization. Accordingly, no course of conduct or dealings between the parties, nor express or implied acceptance of alterations or additions to the Work, and no claim that the Owner has been unjustly enriched by any alteration or addition to the Work, whether or not there is, in fact, any unjust enrichment, shall be the basis of any claim to an increase in any amounts due under the Contract Documents or a change in any time period provided for in the Contract Documents.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 7.2 CHANGE ORDERS
§ 7.2.1 A Change Order is a written instrument prepared by the Architect and signed by the Owner, Contractor and Architect stating their agreement upon all of the following:
  .1   The change in the Work;
 
  .2   The amount of the adjustment, if any, in the Contract Sum; and
 
  .3   The extent of the adjustment, if any, in the Contract Time.
§ 7.2.2 Agreement on any Change Order shall constitute a final settlement on all matters relating to the change in the Work that is the subject of the Change Order, including, but not limited to, all direct and indirect costs associated with such change and any and all adjustments to the Contract Sum, Contract Time and the construction schedule.
§ 7.3 CONSTRUCTION CHANGE DIRECTIVES
§ 7.3.1 A Construction Change Directive is a written order prepared by the Architect and signed by the Owner and Architect, directing a change in the Work prior to agreement on adjustment, if any, in the Contract Sum or Contract Time, or both. The Owner may by Construction Change Directive, without invalidating the Contract, order changes in the Work within the general scope of the Contract consisting of additions, deletions or other revisions, the Contract Sum and Contract Time being adjusted accordingly.
§ 7.3.2 A Construction Change Directive shall be used in the absence of total agreement on the terms of a Change Order.
§ 7.3.3 If the Construction Change Directive provides for an adjustment to the Contract Sum, the adjustment shall be based on one of the following methods:
  .1   Mutual acceptance of a lump sum properly itemized and supported by sufficient substantiating data to permit evaluation;
  .2   Unit prices stated in the Contract Documents or subsequently agreed upon;
  .3   Cost to be determined in a manner agreed upon by the parties and a mutually acceptable fixed or percentage fee; or
  .4   As provided in Section 7.3.7.
§ 7.3.4 If unit prices are stated in the Contract Documents or subsequently agreed upon, and if quantities originally contemplated are materially changed in a proposed Change Order or Construction Change Directive so that application of such unit prices to quantities of Work proposed will cause substantial inequity to the Owner or Contractor, the applicable unit prices shall be equitably adjusted.
§ 7.3.5 Upon receipt of a Construction Change Directive, the Contractor shall promptly proceed with the change in the Work involved and advise the Architect of the Contractor’s agreement or disagreement with the method, if any, provided in the Construction Change Directive for determining the proposed adjustment in the Contract Sum or Contract Time.
§ 7.3.6 A Construction Change Directive signed by the Contractor indicates the Contractor’s agreement therewith, including adjustment in Contract Sum and Contract Time or the method for determining them. Such agreement shall be effective immediately and shall be recorded as a Change Order.
§ 7.3.7 If the Contractor does not respond promptly or disagrees with the method for adjustment in the Contract Sum, the Architect shall determine the method and the adjustment on the basis of reasonable expenditures and savings of those performing the Work attributable to the change, including, in case of an increase in the Contract Sum, an amount for overhead and profit as set forth in the Agreement, or if no such amount is set forth in the Agreement, a reasonable amount. In such case, and also under Section 7.3.3.3, the Contractor shall keep and present, in such form as the Architect may prescribe, an itemized accounting together with appropriate supporting data. Unless otherwise provided in the Contract Documents, costs for the purposes of this Section 7.3.7 shall be limited to the following:
  .1   Costs of labor, including social security, old age and unemployment insurance, fringe benefits required by agreement or custom, and workers’ compensation insurance;
  .2   Costs of materials, supplies and equipment, including cost of transportation, whether incorporated or consumed;
  .3   Rental costs of machinery and equipment, exclusive of hand tools, whether rented from the Contractor or others;
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .4   Costs of premiums for all bonds and insurance, permit fees, and sales, use or similar taxes related to the Work; and
  .5   Additional costs of supervision and field office personnel directly attributable to the change.
§ 7.3.8 The amount of credit to be allowed by the Contractor to the Owner for a deletion or change that results in a net decrease in the Contract Sum shall be actual net cost as confirmed by the Architect. When both additions and credits covering related Work or substitutions are involved in a change, the allowance for overhead and profit shall be figured on the basis of net increase, if any, with respect to that change.
§ 7.3.9 Pending final determination of the total cost of a Construction Change Directive to the Owner, the Contractor may request payment for Work completed under the Construction Change Directive in Applications for Payment. The Architect will make an interim determination for purposes of monthly certification for payment for those costs and certify for payment the amount that the Architect determines, in the Architect’s professional judgment, to be reasonably justified. The Architect’s interim determination of cost shall adjust the Contract Sum on the same basis as a Change Order, subject to the right of either party to disagree and assert a Claim in accordance with Article 15.
§ 7.3.10 When the Owner and Contractor agree with a determination made by the Architect concerning the adjustments in the Contract Sum and Contract Time, or otherwise reach agreement upon the adjustments, such agreement shall be effective immediately and the Architect will prepare a Change Order. Change Orders may be issued for all or any part of a Construction Change Directive.
§ 7.4 MINOR CHANGES IN THE WORK
The Architect or Owner has authority to order minor changes in the Work not involving adjustment in the Contract Sum or extension of the Contract Time and not inconsistent with the intent of the Contract Documents. Such changes will be effected by written order signed by the Architect and shall be binding on the Owner and Contractor.
ARTICLE 8 TIME

§ 8.1 DEFINITIONS
§ 8.1.1 Unless otherwise provided, Contract Time is the period of time, including authorized adjustments, allotted in the Contract Documents for Substantial Completion of the Work.
§ 8.1.1.1 The Work to be completed under this Contract shall be completed within the calendar days stipulated in the schedule attached as Exhibit D to Amendment No. 1.
§ 8.1.2 The date of commencement of the Work is the date established in the Agreement.
§ 8.1.3 The date of Substantial Completion is the date certified by the Owner in accordance with Section 9.8.
§ 8.1.4 The term “day” as used in the Contract Documents shall mean calendar day unless otherwise specifically defined.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 8.2 PROGRESS AND COMPLETION
§ 8.2.1 Time limits stated in the Contract Documents are of the essence of the Contract. By executing the Agreement the Contractor confirms that the Contract Time is a reasonable period for performing the Work.
§ 8.2.2 The Contractor shall not knowingly, except by agreement or instruction of the Owner in writing, prematurely commence operations on the site or elsewhere prior to the effective date of insurance required by Article 11 to be furnished by the Contractor and Owner. The date of commencement of the Work shall not be changed by the effective date of such insurance.
§ 8.2.3 The Contractor shall proceed expeditiously with adequate forces and shall achieve Substantial Completion within the Contract Time.
§ 8.3 DELAYS AND EXTENSIONS OF TIME
§ 8.3.1 If the Contractor is delayed at any time in the commencement or progress of the Work by an act or neglect of the Owner or Architect, or of an employee of either, or of a separate contractor employed by the Owner; or by changes ordered in the Work; or by labor disputes, fire, unusual delay in deliveries, unavoidable casualties or other causes beyond the Contractor’s control; or by delay authorized by the Owner pending mediation and litigation; or by other causes that the Architect determines may justify delay, then the Contract Time shall be extended by Change Order to the extent such delay will prevent the Contractor from achieving Substantial Completion within the Contract Time and if the performance of the Work is not, was not, or would not have been delayed by any other cause for which the Contractor is not entitled to an extension in the Contract Time under the Contract Documents. The Contractor further acknowledges and agrees that adjustments in the Contract Time will be permitted for a delay only to the extent such delay (1) is not caused or could not have been anticipated by the Contractor, (2) could not be limited or avoided by contractor’s timely notice to the owner of the delay, and (3) is of a duration not less than one (1) day. In all cases, Contractor may utilize all available float in the project schedule as schedule contingency. Notwithstanding the foregoing, the float shall not adjust or modify any Milestone Date set forth in the Contract Documents.
§ 8.3.2 Claims relating to time shall be made in accordance with applicable provisions of Article 15.
§ 8.3.3 Notwithstanding anything to the contrary in the Contract Documents, the Contractor’s sole and exclusive remedy for any (i) delay in the commencement, prosecution or completion of the Work, (ii) hindrance or obstruction in the performance of the Work, (iii) loss of productivity, or (iv) other similar claims (collectively referred to as “Delays”) whether or not such Delays are foreseeable, shall be an extension of time in which to complete the Work if permitted under Subparagraph 8.3.1, and in the event of an Owner caused delay, direct costs only, in addition to an extension of time. In no event shall the Contractor be entitled to any other remedy or compensation or recovery of any damages, in connection with any Delay, including, without limitation, consequential damages, lost opportunity costs, impact damages or other similar remuneration.
ARTICLE 9 PAYMENTS AND COMPLETION

§ 9.1 CONTRACT SUM
The Contract Sum is stated in the Agreement and, including authorized adjustments, is the total amount payable by the Owner to the Contractor for performance of the Work under the Contract Documents.
§ 9.2 SCHEDULE OF VALUES
Where the Contract is based on a stipulated sum or Guaranteed Maximum Price, the Contractor shall submit to the Architect, before the first Application for Payment, a schedule of values allocating the entire Contract Sum to the various portions of the Work and prepared in such form and supported by such data to substantiate its accuracy as the Architect may require. This schedule, unless objected to by the Architect, shall be used as a basis for reviewing the Contractor’s Applications for Payment. The description of Work shall be sufficiently broken down to indicate labor and material costs associated with each area of Work. Any breakdown that fails to include sufficient detail, is unbalanced or exhibits “front-loading” of the value of the Work will be rejected.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.3 APPLICATIONS FOR PAYMENT
§ 9.3.1 At least ten days before the date established for each progress payment, the Contractor shall submit to the Architect an itemized Application for Payment prepared in accordance with the schedule of values, if required under Section 9.2., for completed portions of the Work. Such application shall be notarized, if required, and supported by such data substantiating the Contractor’s right to payment as the Owner or Architect may require, such as copies of requisitions from Subcontractors and material suppliers, and shall reflect retainage if provided for in the Contract Documents. The form of Application for Payment shall be AIA Document G702 “Application and Certificate for Payment”, supported by AIA Document G703, “Continuation Sheet” or sheets approved by the Architect, together with Partial Waivers.
§ 9.3.1.1 As provided in Section 7.3.9, such applications may include requests for payment on account of changes in the Work that have been properly authorized by Construction Change Directives, or by interim determinations of the Architect, but not yet included in Change Orders.
§ 9.3.1.2 Applications for Payment shall not include requests for payment for portions of the Work for which the Contractor does not intend to pay a Subcontractor or material supplier, unless such Work has been performed by others whom the Contractor intends to pay.
§ 9.3.1.3 Progress payments shall be made in accordance with the terms set forth in the Agreement between Owner and Contractor. Failure to submit all required documentation , including Waivers, shall be the basis for rejection of an Application for Payment.
§ 9.3.1.4 Applications for Payment shall cover the period of one month ending on the last day of the month.
§ 9.3.2 Unless otherwise provided in the Contract Documents, payments shall be made on account of materials and equipment delivered and suitably stored at the site for subsequent incorporation in the Work. If approved in advance by the Owner, payment may similarly be made for materials and equipment suitably stored off the site at a location agreed upon in writing. Payment for materials and equipment stored on or off the site shall be conditioned upon compliance by the Contractor with procedures satisfactory to the Owner to establish the Owner’s title to such materials and equipment or otherwise protect the Owner’s interest, and shall include the costs of applicable insurance, storage and transportation to the site for such materials and equipment stored off the site.
§ 9.3.3 The Contractor warrants that title to all Work covered by an Application for Payment will pass to the Owner no later than the time of payment. The Contractor further warrants that upon submittal of an Application for Payment all Work for which Certificates for Payment have been previously issued and payments received from the Owner shall be free and clear of liens, claims, security interests or encumbrances in favor of the Contractor, Subcontractors, material suppliers, or other persons or entities making a claim by reason of having provided labor, materials and equipment relating to the Work.
§ 9.3.4 To the extent permitted by law and to the extent payment has been made by the Owner for amounts due, Contractor hereby expressly waives, releases and relinquishes any and all right to maintain, or have filed or maintained, any mechanic’s lien or claim against the foresaid premises, or any part thereof, or any building or buildings thereon, for or on account of any work, labor and materials performed or furnished under this Agreement, and agrees that no such lien or claim shall be so filed or maintained by or on behalf of Contractor; and Contractor further agrees to save the Owner harmless from the lien or claim for liens against the aforesaid premises or any part thereof, or any buildings thereon, of any subcontractor, or any persons acting through or under the Contractor and agrees, that if at any time there shall be any evidence of the filing or maintenance of any such lien or claim for liens, the Owner shall have the right to deduct from the amount otherwise due to the Contractor hereunder, an amount sufficient to indemnify it for any or all loss or damages which may result from such lien or claim; and the Contractor further agrees that this waiver shall be an independent covenant, and shall operate and be effective, not only with respect to materials furnished or labor performed under any Agreement supplemental to this principal Agreement and under any Agreement for extra labor materials for the above described premises and buildings.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.3.5 To the extent payment has been made by the Owner for amounts due, Owner shall be entitled to withhold payment to Contactor upon receipt of notice of any intent to file a lien in an amount sufficient to protect the interests of the Owner. Owner shall allow Contractor a reasonable opportunity to bond off a lien. Owner shall have the right, on its own and without the Contractor’s consent, to resolve any lien claims and deduct the costs thereof from any amounts due Contractor. In the event sufficient funds are not due Contractor, Contractor shall immediately pay to Owner any sums paid by Owner to resolve lien claim(s) upon demand.
§ 9.4 CERTIFICATES FOR PAYMENT
§ 9.4.1 The Architect will, within seven days after receipt of the Contractor’s Application for Payment, either issue to the Owner a Certificate for Payment, with a copy to the Contractor, for such amount as the Architect determines is properly due, or notify the Contractor and Owner in writing of the Architect’s reasons for withholding certification in whole or in part as provided in Section 9.5.1.
§ 9.4.2 The issuance of a Certificate for Payment will constitute a representation by the Architect to the Owner, based on the Architect’s evaluation of the Work and the data comprising the Application for Payment, that, to the best of the Architect’s knowledge, information and belief, the Work has progressed to the point indicated and that the quality of the Work is in accordance with the Contract Documents. The foregoing representations are subject to an evaluation of the Work for conformance with the Contract Documents upon Substantial Completion, to results of subsequent tests and inspections, to correction of minor deviations from the Contract Documents prior to completion and to specific qualifications expressed by the Architect. The issuance of a Certificate for Payment will further constitute a representation that the Contractor is entitled to payment in the amount certified. However, the issuance of a Certificate for Payment will not be a representation that the Architect has (I) made exhaustive or continuous on-site inspections to check the quality or quantity of the Work, (2) reviewed construction means, methods, techniques, sequences or procedures, (3) reviewed copies of requisitions received from Subcontractors and material suppliers and other data requested by the Owner to substantiate the Contractor’s right to payment, or (4) made examination to ascertain how or for what purpose the Contractor has used money previously paid on account of the Contract Sum.
§ 9.5 DECISIONS TO WITHHOLD CERTIFICATION
§ 9.5.1 The Architect may withhold a Certificate for Payment in whole or in part, to the extent reasonably necessary to protect the Owner, if in the Architect’s opinion the representations to the Owner required by Section 9.4.2 cannot be made. If the Architect is unable to certify payment in the amount of the Application, the Architect will notify the Contractor and Owner as provided in Section 9.4.1. If the Contractor and Architect cannot agree on a revised amount, the Architect will promptly issue a Certificate for Payment for the amount for which the Architect is able to make such representations to the Owner. The Architect may also withhold a Certificate for Payment or, because of subsequently discovered evidence, may nullify the whole or a part of a Certificate for Payment previously issued, to such extent as may be necessary in the Architect’s opinion to protect the Owner from loss for which the Contractor is responsible, including loss resulting from acts and omissions described in Section 3.3.2, because of
  .1   defective Work not remedied;
  .2   third party claims filed or reasonable evidence indicating probable filing of such claims unless security acceptable to the Owner is provided by the Contractor;
  .3   failure of the Contractor to make payments properly to Subcontractors or for labor, materials or equipment;
  .4   reasonable evidence that the Work cannot be completed for the unpaid balance of the Contract Sum;
  .5   damage to the Owner or a separate contractor;
  .6   reasonable evidence that the Work will not be completed within the Contract Time, and that the unpaid balance would not be adequate to cover actual or liquidated damages for the anticipated delay; or
  .7   repeated failure to carry out the Work in accordance with the Contract Documents.
§ 9.5.2 When the above reasons for withholding certification are removed, certification will be made for amounts previously withheld.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.5.3 If the Architect withholds certification for payment under Section 9.5.1.3, the Owner may, at its sole option, issue joint checks to the Contractor and to any Subcontractor or material or equipment suppliers to whom the Contractor failed to make payment for Work properly performed or material or equipment suitably delivered. If the Owner makes payments by joint check, the Owner shall notify the Architect and the Architect will reflect such payment on the next Certificate for Payment.
§ 9.6 PROGRESS PAYMENTS
§ 9.6.1 After the Architect has issued a Certificate for Payment, the Owner shall make payment in the manner and within the time provided in the Contract Documents, and shall so notify the Architect.
§ 9.6.2 The Contractor shall pay each Subcontractor no later than seven days after receipt of payment from the Owner the amount to which the Subcontractor is entitled, reflecting percentages actually retained from payments to the Contractor on account of the Subcontractor’s portion of the Work. The Contractor shall, by appropriate agreement with each Subcontractor, require each Subcontractor to make payments to Sub-subcontractors in a similar manner.
§ 9.6.3 The Owner has the right to request written evidence from the Contractor that the Contractor has properly paid Subcontractors and material and equipment suppliers amounts paid by the Owner to the Contractor for subcontracted Work. If the Contractor fails to furnish such evidence within seven days, the Owner shall have the right to contact Subcontractors to ascertain whether they have been properly paid. Neither the Owner nor Architect shall have an obligation to pay or to see to the payment of money to a Subcontractor, except as may otherwise be required by law.
§ 9.6.4 Contractor payments to material and equipment suppliers shall be treated in a manner similar to that provided in Sections 9.6.2 and 9.6.3.
§ 9.6.5 A Certificate for Payment, a progress payment, or partial or entire use or occupancy of the Project by the Owner shall not constitute acceptance of Work not in accordance with the Contract Documents.
§ 9.6.6 Unless the Contractor provides the Owner with a payment bond in the full penal sum of the Contract Sum, payments received by the Contractor for Work properly performed by Subcontractors and suppliers shall be held by the Contractor for those Subcontractors or suppliers who performed Work or furnished materials, or both, under contract with the Contractor for which payment was made by the Owner. Nothing contained herein shall require money to be placed in a separate account and not commingled with money of the Contractor, shall create any fiduciary liability or tort liability on the part of the Contractor for breach of trust or shall entitle any person or entity to an award of punitive damages against the Contractor for breach of the requirements of this provision.
(Paragraph deleted)
§ 9.7 FAILURE OF PAYMENT
§ 9.7.1 If the Architect does not issue a Certificate for Payment, through no fault of the Contractor, within seven days after receipt of the Contractor’s Application for Payment, or if the Owner does not pay the Contractor within seven days after the date established in the Contract Documents the amount certified by the Architect or awarded by binding dispute resolution, then the Contractor may, upon seven additional days’ written notice to the Owner and Architect, stop the Work until payment of the amount owing has been received. The Contract Time shall be extended appropriately and the Contract Sum shall be increased by the amount of the Contractor’s reasonable costs of shut-down, delay and start-up, plus interest as provided for in the Contract Documents.
§ 9.7.2 Notwithstanding anything to the contrary, in no event shall the Contractor stop the Work in connection with any withholding of payment for an item or failure to make payment relating to an item made in connection with a good faith dispute.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.8 SUBSTANTIAL COMPLETION
§ 9.8.1 Substantial Completion is the stage in the progress of the Work when the Work or designated portion thereof is sufficiently complete in accordance with the Contract Documents so that the Owner can occupy or utilize the Work for its intended use. No portion of the Work will be considered substantially complete until all of the following requirements have been met for each phase:
  .1   all of the Project parts and systems are accessible, operable and usable by the Owner;
 
  .2   the Project is clean, as defined elsewhere in the Contract Documents;
 
  .3   preliminary operation and maintenance manuals have been submitted to the Architect;
  .4   preliminary training of the Owner’s personnel has taken place as required elsewhere in the Specifications;
  .5   annotated Record Drawings have been submitted to the Architect; and
  .6   all federal, state and local authorities having jurisdiction over the Project have issued the requisite certifications and/or approvals so that the Owner can occupy or utilize the Work for its intended purpose.
A Temporary or Conditional Certificate of Occupancy shall not be sufficient for the purposes of determining Substantial Completion.
For the purposes of establishing the commencement of any warranties, substantial completion shall be upon receipt of certificate of occupancy and use by the Owner.
§ 9.8.2 When the Contractor considers that the Work, or a portion thereof which the Owner agrees to accept separately, is substantially complete, the Contractor shall prepare and submit to the Architect a comprehensive list of items to be completed or corrected prior to final payment. Failure to include an item on such list does not alter the responsibility of the Contractor to complete all Work in accordance with the Contract Documents.
§ 9.8.3 Upon receipt of the Contractor’s list, the Architect and Owner will make an inspection to determine whether the Work or designated portion thereof is substantially complete. If the Architect’s or Owner’s inspection discloses any item, whether or not included on the Contractor’s list, which is not sufficiently complete in accordance with the Contract Documents so that the Owner can occupy or utilize the Work or designated portion thereof for its intended use, the Contractor shall, before issuance of the Certificate of Substantial Completion, complete or correct such item upon notification by the Architect or Owner. In such case, the Contractor shall then submit a request for another inspection by the Architect or Owner to determine Substantial Completion.
§ 9.8.4 When the Work or designated portion thereof is substantially complete, the Architect will prepare a Certificate of Substantial Completion that shall establish the date of Substantial Completion, shall establish responsibilities of the Owner and Contractor for security, maintenance, heat, utilities, damage to the Work and insurance, and shall fix the time within which the Contractor shall finish all items on the list accompanying the Certificate. Warranties required by the Contract Documents shall commence on the date of Substantial Completion of the Work or designated portion thereof unless otherwise provided in the Certificate of Substantial Completion.
§ 9.8.5 The Certificate of Substantial Completion shall be submitted to the Owner and Contractor for their written acceptance of responsibilities assigned to them in such Certificate. Upon such acceptance and consent of surety, if any, the Owner shall make payment of retainage applying to such Work or designated portion thereof. Such payment shall be adjusted for Work that is incomplete or not in accordance with the requirements of the Contract Documents.
§ 9.8.6 The Owner shall be entitled to withhold two (2) times the estimated cost of the items set forth on the list accompanying the Certificate of Substantial Completion as determined initially by the Contractor, subject to approval by the Architect and Owner. These amounts shall be deducted from any payments due and owing Contractor and held until all items have been completed to the satisfaction of the Owner and the Architect.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.9 PARTIAL OCCUPANCY OR USE
§ 9.9.1 The Owner may occupy or use any completed or partially completed portion of the Work at any stage when such portion is designated by separate agreement with the Contractor, provided such occupancy or use is consented to by the insurer as required under Section 11.3.1.5 and authorized by public authorities having jurisdiction over the Project. Such partial occupancy or use may commence whether or not the portion is substantially complete, provided the Owner and Contractor have accepted in writing the responsibilities assigned to each of them for payments, retainage, if any, security, maintenance, heat, utilities, damage to the Work and insurance, and have agreed in writing concerning the period for correction of the Work and commencement of warranties required by the Contract Documents. When the Contractor considers a portion substantially complete, the Contractor shall prepare and submit a list to the Architect as provided under Section 9.8.2. Consent of the Contractor to partial occupancy or use shall not be unreasonably withheld. The stage of the progress of the Work shall be determined by written agreement between the Owner and Contractor.
§ 9.9.2 Immediately prior to such partial occupancy or use, the Owner and Contractor shall jointly inspect the area to be occupied or portion of the Work to be used in order to determine and record the condition of the Work.
§ 9.9.3 Unless otherwise agreed upon, partial occupancy or use of a portion or portions of the Work shall not constitute acceptance of Work not complying with the requirements of the Contract Documents.
§ 9.10 FINAL COMPLETION AND FINAL PAYMENT
§ 9.10.1 Upon receipt of the Contractor’s written notice that the Work is ready for final inspection and acceptance and upon receipt of a final Application for Payment, the Architect will promptly make such inspection and, when the Architect finds the Work acceptable under the Contract Documents and the Contract fully performed, the Architect will promptly issue a final Certificate for Payment stating that to the best of the Architect’s knowledge, information and belief, and on the basis of the Architect’s on-site visits and inspections, the Work has been completed in accordance with terms and conditions of the Contract Documents and that the entire balance found to be due the Contractor and noted in the final Certificate is due and payable. The Architect’s final Certificate for Payment will constitute a further representation that conditions listed in Section 9.10.2 as precedent to the Contractor’s being entitled to final payment have been fulfilled. All warranties and guarantees required under or pursuant to the Contract Documents shall be assembled and delivered by the Contractor to the Owner as part of the final Application for Payment. The final payment will not be made by the Owner until all warranties and guarantees have been received and accepted by the Owner and the Owner has received all final Waivers.
§ 9.10.2 Neither final payment nor any remaining retained percentage shall become due until the Contractor submits to the Architect (I) an affidavit that payrolls, bills for materials and equipment, and other indebtedness connected with the Work for which the Owner or the Owner’s property might be responsible or encumbered (less amounts withheld by Owner) have been paid or otherwise satisfied, (2) a certificate evidencing that insurance required by the Contract Documents to remain in force after final payment is currently in effect and will not be canceled or allowed to expire until at least 30 days’ prior written notice has been given to the Owner, (3) a written statement that the Contractor knows of no substantial reason that the insurance will not be renewable to cover the period required by the Contract Documents, (4) consent of surety, if any, to final payment and (5) other data establishing payment or satisfaction of obligations, such as receipts, releases and waivers of liens, claims, security interests or encumbrances arising out of the Contract, to the extent and in such form as may be designated by the Owner. If a Subcontractor refuses to furnish a release or waiver required by the Owner, the Contractor may furnish a bond satisfactory to the Owner to indemnify the Owner against such lien. If such lien remains unsatisfied after payments are made, the Contractor shall refund to the Owner all money that the Owner may be compelled to pay in discharging such lien, including all costs and reasonable attorneys’ fees.
§ 9.10.3 If, after Substantial Completion of the Work, final completion thereof is materially delayed through no fault of the Contractor or by issuance of Change Orders affecting final completion, and the Architect so confirms, the Owner shall, upon application by the Contractor and certification by the Architect, and without terminating the Contract, make payment of the balance due for that portion of the Work fully completed and accepted. If the remaining balance for Work not fully completed or corrected is less than retainage stipulated in the Contract Documents, and if bonds have been furnished, the written consent of surety to payment of the balance due for that portion of the Work fully completed and accepted shall be submitted by the Contractor to the Architect prior to certification of such payment. Such payment shall be made under terms and conditions governing final payment, except that it shall not constitute a waiver of claims.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 9.10.4 The making of final payment shall constitute a waiver of Claims by the Owner except those arising from
  .1   liens, Claims, security interests or encumbrances arising out of the Contract and unsettled;
 
  .2   failure of the Work to comply with the requirements of the Contract Documents; or
 
  .3   terms of special warranties required by the Contract Documents; or
 
  .4   latent defects.
§ 9.10.5 Acceptance of final payment by the Contractor, a Subcontractor or material supplier shall constitute a waiver of claims by that payee except those previously made in writing and identified by that payee as unsettled at the time of final Application for Payment.
ARTICLE 10 PROTECTION OF PERSONS AND PROPERTY
§ 10.1 SAFETY PRECAUTIONS AND PROGRAMS
The Contractor shall be responsible for initiating, maintaining and supervising all safety precautions and programs in connection with the performance of the Contract. The Owner assumes no responsibility or liability for the safety of the Project site. Contractor shall be solely responsible for providing a safe place for the performance of the Work. Owner’s personnel shall be responsible for complying with all safety regulations established while at the worksite.
§ 10.1.1 The Contractor is reminded that all construction sites are subject to the Occupational Safety and Health Act (OSHA). As such, inspections of the workplace may be conducted by a Compliance Safety and Health Officer at any time. The Contractor is responsible for construction means, methods, techniques, sequences or procedures, and safety precautions and programs in connection with the Work. The Contractor shall bring work sites that are unsafe into compliance with the OSHA requirements. Failure to bring the workplace into compliance shall be sufficient cause for the Owner to reduce or withhold payment. Fines assessed to the Owner, the Architect or agents of either, as a result of an OSHA citation shall be deducted from payments to the Contractor.
§ 10.2 SAFETY OF PERSONS AND PROPERTY
§ 10.2.1 The Contractor shall take reasonable precautions for safety of, and shall provide reasonable protection to prevent damage, injury or loss to
  .1   employees on the Work and other persons who may be affected thereby;
  .2   the Work and materials and equipment to be incorporated therein, whether in storage on or off the site, under care, custody or control of the Contractor or the Contractor’s Subcontractors or Sub-subcontractors; and
  .3   other property at the site or adjacent thereto, such as trees, shrubs, lawns, walks, pavements, roadways, structures and utilities not designated for removal, relocation or replacement in the course of construction.
§ 10.2.2 The Contractor shall comply with and give notices required by applicable laws, statutes, ordinances, codes, rules and regulations, and lawful orders of public authorities bearing on safety of persons or property or their protection from damage, injury or loss.
§ 10.2.3 The Contractor shall erect and maintain, as required by existing conditions and performance of the Contract, reasonable safeguards for safety and protection, including posting danger signs and other warnings against hazards, promulgating safety regulations and notifying owners and users of adjacent sites and utilities.
§ 10.2.4 When use or storage of explosives or other hazardous materials or equipment or unusual methods are necessary for execution of the Work, the Contractor shall exercise utmost care and carry on such activities under supervision of properly qualified personnel. The Contractor shall give the Owner and Architect reasonable advance written notice of such use or storage.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 10.2.5 The Contractor shall promptly remedy damage and loss (other than damage or loss insured under property insurance required by the Contract Documents) to property referred to in Sections 10.2.1.2 and 10.2.1.3 caused in whole or in part by the Contractor, a Subcontractor, a Sub-subcontractor, or anyone directly or indirectly employed by any of them, or by anyone for whose acts they may be liable and for which the Contractor is responsible under Sections 10.2.1.2 and 10.2.1.3, except damage or loss attributable to acts or omissions of the Owner or Architect or anyone directly or indirectly employed by either of them, or by anyone for whose acts either of them may be liable, and not attributable to the fault or negligence of the Contractor. The foregoing obligations of the Contractor are in addition to the Contractor’s obligations under Section 3.18.
§ 10.2.6 The Contractor shall designate a responsible member of the Contractor’s organization at the site whose duty shall be the prevention of accidents. This person shall be the Contractor’s superintendent unless otherwise designated by the Contractor in writing to the Owner and Architect.
§ 10.2.7 The Contractor shall not permit any part of the construction or site to be loaded so as to cause damage or create an unsafe condition.
§ 10.2.7.1 The Contractor shall report in writing to the Owner and Architect all recordable accidents arising out of or in connection with the Work.
§ 10.2.7.2 Safety: The Contractor shall take all necessary steps or advisable precautions for the safety of all persons and property at, on, or near its Work. It shall comply with all applicable building codes and any safety regulations of the Owner, and all applicable provisions of Federal, State and Municipal safety laws. The Contractor shall erect and maintain all necessary or advisable safeguards as required by the conditions and progress of its Work for the protection of the workmen and public, and shall post danger signs warning against the hazards created by its Work, when required by OSHA regulation.
§ 10.2.7.3 In case of an emergency involving danger to life or property, the Contractor may act at its discretion to prevent injury or damage to the threatened life or property.
§ 10.3 INJURY OR DAMAGE TO PERSON OR PROPERTY
If either party suffers injury or damage to person or property because of an act or omission of the other party, or of others for whose acts such party is legally responsible, written notice of such injury or damage, whether or not insured, shall be given to the other party within a reasonable time not exceeding 21 days after discovery. The notice shall provide sufficient detail to enable the other party to investigate the matter.
§ 10.4 HAZARDOUS MATERIALS
§ 10.4.1 The Contractor is responsible for compliance with any requirements included in the Contract Documents regarding hazardous materials. If the Contractor encounters a hazardous material or substance not addressed in the Contract Documents and if reasonable precautions will be inadequate to prevent foreseeable bodily injury or death to persons resulting from a material or substance, including but not limited to asbestos or polychlorinated biphenyl (PCB), encountered on the site by the Contractor, the Contractor shall, upon recognizing the condition, immediately stop Work in the affected area and report the condition to the Owner and Architect in writing.
§ 10.4.2 Upon receipt of the Contractor’s written notice, the Owner shall obtain the services of a licensed laboratory to verify the presence or absence of the material or substance reported by the Contractor and, in the event such material or substance is found to be present, to cause it to be rendered harmless. Unless otherwise required by the Contract Documents, the Owner shall furnish in writing to the Contractor and Architect the names and qualifications of persons or entities who are to perform tests verifying the presence or absence of such material or substance or who are to perform the task of removal or safe containment of such material or substance. The Contractor and the Architect will promptly reply to the Owner in writing stating whether or not either has reasonable objection to the persons or entities proposed by the Owner. If either the Contractor or Architect has an objection to a person or entity proposed by the Owner, the Owner shall propose another to whom the Contractor and the Architect have no reasonable objection. When the material or substance has been rendered harmless, Work in the affected area shall resume upon written agreement of the Owner and Contractor. By Change Order, the Contract Time shall be extended appropriately and the Contract Sum shall be increased in the amount of the Contractor’s reasonable additional costs of shut-down, delay and start-up.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 10.3.3 To the fullest extent permitted by law, the Owner shall indemnify and hold harmless the Contractor, Subcontractors, Architect, Architect’s consultants and agents and employees of any of them from and against claims, damages, losses and expenses, including but not limited to attorneys’ fees, arising out of or resulting from performance of the Work in the affected area if in fact the material or substance presents the risk of bodily injury or death as described in Section 10.3.1 and has not been rendered harmless, provided that such claim, damage, loss or expense is attributable to bodily injury, sickness, disease or death, or to injury to or destruction of tangible property (other than the Work itself), except to the extent that such damage, loss or expense is due to the fault or negligence of the party seeking indemnity.
§ 10.3.4 The Owner shall not be responsible under this Section 10.3 for materials or substances the Contractor brings to the site unless such materials or substances are required by the Contract Documents. The Owner shall be responsible for materials or substances required by the Contract Documents, except to the extent of the Contractor’s fault or negligence in the use and handling of such materials or substances.
§ 10.3.5 The Contractor shall indemnify the Owner for the cost and expense the Owner incurs (1) for remediation of a material or substance the Contractor brings to the site and negligently handles, or (2) where the Contractor fails to perform its obligations under Section 10.3.1, except to the extent that the cost and expense are due to the Owner’s fault or negligence.
§ 10.3.6 If, without negligence on the part of the Contractor, the Contractor is held liable by a government agency for the cost of remediation of a hazardous material or substance solely by reason of performing Work as required by the Contract Documents, the Owner shall indemnify the Contractor for all cost and expense thereby incurred.
§ 10.4 EMERGENCIES
In an emergency affecting safety of persons or property, the Contractor shall act, at the Contractor’s discretion, to prevent threatened damage, injury or loss. Additional compensation or extension of time claimed by the Contractor on account of an emergency shall be determined as provided in Article 15 and Article 7.
ARTICLE 11 INSURANCE AND BONDS
§ 11.1 CONTRACTOR’S LIABILITY INSURANCE
§ 11.1.1 The Contractor shall purchase from and maintain in a company or companies lawfully authorized to do business in the jurisdiction in which the Project is located and shall name the Owner as an Additional Insured. Such insurance as will protect the Contractor and the Owner from claims set forth below which may arise out of or result from the Contractor’s operations and completed operations under the Contract and for which the Contractor may be legally liable, whether such operations be by the Contractor or by a Subcontractor or by anyone directly or indirectly employed by any of them, or by anyone for whose acts any of them may be liable:
  .1   Claims under workers’ compensation, disability benefit and other similar employee benefit acts that are applicable to the Work to be performed;
  .2   Claims for damages because of bodily injury, occupational sickness or disease, or death of the Contractor’s employees or persons or entities excluded by law from the requirements of Clause 11.1.1.1, but required by the Contract Documents to be insured;
  .3   Claims for damages because of bodily injury, sickness or disease, or death of any person other than the Contractor’s employees;
  .4   Claims for damages insured by usual personal injury liability coverage;
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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  .5   Claims for damages, other than to the Work itself, because of injury to or destruction of tangible property, including loss of use resulting therefrom;
  .6   Claims for damages because of bodily injury, death of a person or property damage arising out of ownership, maintenance or use of a motor vehicle;
  .7   Claims for bodily injury or property damage arising out of completed operations; and
  .8   Claims involving contractual liability insurance applicable to the Contractor’s obligations under Section 3.18.
The insurance required by Subparagraph 11.1.1 shall be written for not less than the following limits, or greater, if required by law:
Contractor shall maintain comprehensive general liability insurance in an amount not less than $2,000,000 against third party claims and other risks. All insurance to be maintained by Contractor shall contain no deductible amount in excess of $5,000, but shall be first-dollar coverage with no greater self-insurance allowable. Such coverage shall be obtained from a reputable, financially sound insurance company with a rating of “A-IX” or an equivalent rating from a nationally recognized rating agency. Commercial General Liability including coverage for Premises-Operations, Independent Contractors’ Protective, Products-Completed Operations, Contractual Liability, Personal Injury, and Broad Form Property Damage (including coverage for Explosion, Collapse and Underground Hazards):
$2,000,000 Each Occurrence
$2,000,000 General Aggregate
$1,000,000 Personal and Advertising Injury
$2,000,000 Products-Completed Operations Aggregate
$100,000 Fire Damage
Products and completed Operations insurance shall be maintained for a minimum period of at least four (4) year(s) after either ninety (90) days following Substantial Completion or final payment, whichever is earlier.
Automobile Liability (owned, non-owned and hired vehicles) for bodily injury and property damage:
$1,000,000 Each Accident
Umbrella Excess Liability Coverage:
$10,000,000 over primary insurance for each occurrence
Owner shall be listed as an additional insured and shall be provided with notice thirty (30) days prior to expiration or cancellation of any policy. Upon request, Owner shall be provided with copies of all policies upon execution of this Agreement.
The limits specified herein are minimum requirements and shall not be construed in any way as limits of liability or as constituting acceptance by Owner of responsibility for losses in excess of such limits. The Contractor shall be responsible for all deductibles applicable to any insurance. No acceptance and/or approval of any insurance by Owner shall be construed as relieving or excusing Contractor from any liability or obligation imposed by the provisions of the Contract Documents.
Each party shall give the other prompt notification of any claim with respect to any of the insurance to be provided hereunder, followed up with full details of the circumstances giving rise to such claim. Each party shall afford the other with assistance as may be necessary for the preparation and negotiation of insurance claims. The Contractor shall report to the Owner as soon as practicable all accidents or occurrences resulting in injuries to Contractor’s employees or third parties, or damage to property of third parties, arising out of or during the course of services by Contractor or on its behalf.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 11.1.2 Certificates of insurance acceptable to the Owner shall be filed with the Owner prior to commencement of the Work and thereafter upon renewal or replacement of each required policy of insurance. These certificates and the insurance policies required by this Section 11.1 shall contain a provision that coverages afforded under the policies will not be canceled or allowed to expire until at least 30 days’ prior written notice has been given to the Owner. An additional certificate evidencing continuation of liability coverage, including coverage for completed operations, shall be submitted with the final Application for Payment as required by Section 9.10.2 and thereafter upon renewal or replacement of such coverage until the expiration of the time required by Section 11.1.1. Information concerning reduction of coverage on account of revised limits or claims paid under the General Aggregate, or both, shall be furnished by the Contractor with reasonable promptness.
§ 11.1.3 The Contractor shall cause the commercial liability coverage required by the Contract Documents to include (1) the Owner, the Architect and the Architect’s Consultants as additional insureds for claims caused in whole or in part by the Contractor’s negligent acts or omissions during the Contractor’s operations; and (2) the Owner as an additional insured for claims caused in whole or in part by the Contractor’s negligent acts or omissions during the Contractor’s completed operations.
(Paragraph deleted)

§ 11.2 OWNER’S LIABILITY INSURANCE
The Owner shall be responsible for purchasing and maintaining the Owner’s usual liability insurance.
§ 11.3 PROPERTY INSURANCE
§ 11.3.1 Unless otherwise provided, the Owner shall purchase and maintain, in a company or companies lawfully authorized to do business in the jurisdiction in which the Project is located, property insurance written on a builder’s risk “all-risk” or equivalent policy form in the amount of the initial Contract Sum, plus value of subsequent Contract Modifications and cost of materials supplied or installed by others, comprising total value for the entire Project at the site on a replacement cost basis without optional deductibles. Such property insurance shall be maintained, unless otherwise provided in the Contract Documents or otherwise agreed in writing by all persons and entities who are beneficiaries of such insurance, until final payment has been made as provided in Section 9.10 or until no person or entity other than the Owner has an insurable interest in the property required by this Section 11.3 to be covered, whichever is later. This insurance shall include interests of the Owner, the Contractor, Subcontractors and Sub-subcontractors in the Project.
§ 11.3.1.1 Property insurance shall be on an “all-risk” or equivalent policy form and shall include, without limitation, insurance against the perils of fire (with extended coverage) and physical loss or damage including, without duplication of coverage, theft, vandalism, malicious mischief, collapse, earthquake, flood, windstorm, falsework, testing and startup, temporary buildings and debris removal including demolition occasioned by enforcement of any applicable legal requirements, and shall cover reasonable compensation for Architect’s and Contractor’s services and expenses required as a result of such insured loss.
§ 11.3.1.2 If the Owner does not intend to purchase such property insurance required by the Contract and with all of the coverages in the amount described above, the Owner shall so inform the Contractor in writing prior to commencement of the Work. The Contractor may then effect insurance that will protect the interests of the Contractor, Subcontractors and Sub-subcontractors in the Work, and by appropriate Change Order the cost thereof shall be charged to the Owner. If the Contractor is damaged by the failure or neglect of the Owner to purchase or maintain insurance as described above, without so notifying the Contractor in writing, then the Owner shall bear all reasonable costs properly attributable thereto.
§ 11.3.1.3 If the property insurance requires deductibles, the Owner shall pay costs not covered because of such deductibles. Notwithstanding, if the cause of any loss payment under such insurance is the fault of the Contractor, then the Contractor shall pay such deductible. Owner shall notify Contractor of the deductible amount for each policy when each policy is initiated and at each renewal.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 11.3.1.4 This property insurance shall cover portions of the Work stored off the site, and also portions of the Work in transit.
§ 11.3.1.5 Partial occupancy or use in accordance with Section 9.9 shall not commence until the insurance company or companies providing property insurance have consented to such partial occupancy or use by endorsement or otherwise. The Owner and the Contractor shall take reasonable steps to obtain consent of the insurance company or companies and shall, without mutual written consent, take no action with respect to partial occupancy or use that would cause cancellation, lapse or reduction of insurance.
§ 11.3.2 BOILER AND MACHINERY INSURANCE
The Owner shall purchase and maintain boiler and machinery insurance required by the Contract Documents or by law, which shall specifically cover such insured objects during installation and until final acceptance by the Owner; this insurance shall include interests of the Owner, Contractor, Subcontractors and Sub-subcontractors in the Work, and the Owner and Contractor shall be named insureds.
§ 11.3.3 LOSS OF USE INSURANCE
The Owner, at the Owner’s option, may purchase and maintain such insurance as will insure the Owner against loss of use of the Owner’s property due to fire or other hazards, however caused. The Owner waives all rights of action against the Contractor for loss of use of the Owner’s property, including consequential losses due to fire or other hazards however caused.
§ 11.3.4 If the Contractor requests in writing that insurance for risks other than those described herein or other special causes of loss be included in the property insurance policy, the Owner shall, if possible, include such insurance, and the cost thereof shall be charged to the Contractor by appropriate Change Order.
§ 11.3.5 If during the Project construction period the Owner insures properties, real or personal or both, at or adjacent to the site by property insurance under policies separate from those insuring the Project, or if after final payment property insurance is to be provided on the completed Project through a policy or policies other than those insuring the Project during the construction period, the Owner shall waive all rights in accordance with the terms of Section 11.3.7 for damages caused by fire or other causes of loss covered by this separate property insurance. All separate policies shall provide this waiver of subrogation by endorsement or otherwise.
§ 11.3.6 Before an exposure to loss may occur, the Owner shall file with the Contractor a copy of each policy that includes insurance coverages required by this Section 11.3. Each policy shall contain all generally applicable conditions, definitions, exclusions and endorsements related to this Project. Each policy shall contain a provision that the policy will not be canceled or allowed to expire, and that its limits will not be reduced, until at least 30 days’ prior written notice has been given to the Contractor.
§ 11.3.7 WAIVERS OF SUBROGATION
The Owner and Contractor waive all rights against (1) each other and any of their subcontractors, sub-subcontractors, agents and employees, each of the other, and (2) the Architect, Architect’s consultants, separate contractors described in Article 6, if any, and any of their subcontractors, sub-subcontractors, agents and employees, for damages caused by fire or other causes of loss to the extent covered by property insurance obtained pursuant to this Section 11.3 or other property insurance applicable to the Work, except such rights as they have to proceeds of such insurance held by the Owner as fiduciary. The Owner or Contractor, as appropriate, shall require of the Architect, Architect’s consultants, separate contractors described in Article 6, if any, and the subcontractors, sub-subcontractors, agents and employees of any of them, by appropriate agreements, written where legally required for validity, similar waivers each in favor of other parties enumerated herein. The policies shall provide such waivers of subrogation by endorsement or otherwise. A waiver of subrogation shall be effective as to a person or entity even though that person or entity would otherwise have a duty of indemnification, contractual or otherwise, did not pay the insurance premium directly or indirectly, and whether or not the person or entity had an insurable interest in the property damaged.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 11.3.8 A loss insured under the Owner’s property insurance shall be adjusted by the Owner as fiduciary and made payable to the Owner as fiduciary for the insureds, as their interests may appear, subject to requirements of any applicable mortgagee clause and of Section 11.3.10. The Contractor shall pay Subcontractors their just shares of insurance proceeds received by the Contractor, and by appropriate agreements, written where legally required for validity, shall require Subcontractors to make payments to their Sub-subcontractors in similar manner.
§ 11.3.9 If required in writing by a party in interest, the Owner as fiduciary shall, upon occurrence of an insured loss, give bond for proper performance of the Owner’s duties. The cost of required bonds shall be charged against proceeds received as fiduciary. The Owner shall deposit in a separate account proceeds so received, which the Owner shall distribute in accordance with such agreement as the parties in interest may reach, or as determined in accordance with the method of binding dispute resolution selected in the Agreement between the Owner and Contractor. If after such loss no other special agreement is made and unless the Owner terminates the Contract for convenience, replacement of damaged property shall be performed by the Contractor after notification of a Change in the Work in accordance with Article 7.
§ 11.3.10 The Owner as fiduciary shall have power to adjust and settle a loss with insurers unless one of the parties in interest shall object in writing within five days after occurrence of loss to the Owner’s exercise of this power; if such objection is made, the dispute shall be resolved in the manner selected by the Owner and Contractor as the method of binding dispute resolution in the Agreement. If the Owner and Contractor have selected arbitration as the method of binding dispute resolution, the Owner as fiduciary shall make settlement with insurers or, in the case of a dispute over distribution of insurance proceeds, in accordance with the directions of the arbitrators.
§ 11.4 PERFORMANCE BOND AND PAYMENT BOND
§ 11.4.1 The Owner shall have the right to require the Contractor to furnish bonds covering faithful performance of the Contract and payment of obligations arising thereunder as stipulated in bidding requirements or specifically required in the Contract Documents on the date of execution of the Contract. The surety, form and substance of the bond shall be satisfactory to the Owner. Surety companies executing bonds must appear on the Treasury Department’s most current list (Circular 570, as amended) and be authorized to transact business in the Commonwealth of Pennsylvania.
§ 11.4.2 Upon the request of any person or entity appearing to be a potential beneficiary of bonds covering payment of obligations arising under the Contract, the Contractor shall promptly furnish a copy of the bonds or shall authorize a copy to be furnished.
ARTICLE 12 UNCOVERING AND CORRECTION OF WORK

§ 12.1 UNCOVERING OF WORK
§ 12.1.1 If a portion of the Work is covered contrary to the Architect’s or Owner’s request or to requirements specifically expressed in the Contract Documents, it must, if requested in writing by the Architect or Owner, be uncovered for the Architect’s and/or Owner’s examination and be replaced at the Contractor’s expense without change in the Contract Time.
§ 12.1.2 If a portion of the Work has been covered that the Architect or Owner has not specifically requested to examine prior to its being covered, the Architect or Owner may request to see such Work and it shall be uncovered by the Contractor. If such Work is in accordance with the Contract Documents, costs of uncovering and replacement shall, by appropriate Change Order, be at the Owner’s expense. If such Work is not in accordance with the Contract Documents, such costs and the cost of correction shall be at the Contractor’s expense unless the condition was caused by the Owner or a separate contractor in which event the Owner shall be responsible for payment of such costs.
§ 12.2 CORRECTION OF WORK

§ 12.2.1 BEFORE OR AFTER SUBSTANTIAL COMPLETION
The Contractor shall promptly correct Work rejected by the Architect or Owner or failing to conform to the requirements of the Contract Documents, whether discovered before or after Substantial Completion and whether or not fabricated, installed or completed. Costs of correcting such rejected Work, including additional testing and inspections, the cost of uncovering and replacement, and compensation for the Architect’s services and expenses made necessary thereby, shall be at the Contractor’s expense.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 12.2.2 AFTER SUBSTANTIAL COMPLETION
§ 12.2.2.1 In addition to the Contractor’s obligations under Section 3.5, if, within one year after the date of Substantial Completion of the Work or designated portion thereof or after the date for commencement of warranties established under Section 9.9.1, or by terms of an applicable special warranty required by the Contract Documents, any of the Work is found to be not in accordance with the requirements of the Contract Documents, the Contractor shall correct it promptly after receipt of written notice from the Owner to do so unless the Owner has previously given the Contractor a written acceptance of such condition. The Owner shall give such notice promptly after discovery of the condition. During the one-year period for correction of Work, if the Owner fails to notify the Contractor and give the Contractor an opportunity to make the correction, the Owner waives the rights to require correction by the Contractor and to make a claim for breach of warranty. If the Contractor fails to correct nonconforming Work within a reasonable time during that period after receipt of notice from the Owner or Architect, the Owner may correct it in accordance with Section 2.4.
§ 12.2.2.2 The one-year period for correction of Work shall be extended with respect to portions of Work first performed after Substantial Completion by the period of time between Substantial Completion and the actual completion of that portion of the Work.
§ 12.2.2.3 The one-year period for correction of Work shall be extended by corrective Work performed by the Contractor pursuant to this Section 12.2 with the warranty period being renewed and recommencing for an additional year on the remedial Work only.
§ 12.2.3 The Contractor shall remove from the site portions of the Work that are not in accordance with the requirements of the Contract Documents and are neither corrected by the Contractor nor accepted by the Owner.
§ 12.2.4 The Contractor shall bear the cost of correcting destroyed or damaged construction, whether completed or partially completed, of the Owner or separate contractors caused by the Contractor’s correction or removal of Work that is not in accordance with the requirements of the Contract Documents.
§ 12.2.5 Nothing contained in this Section 12.2 shall be construed to establish a period of limitation with respect to other obligations the Contractor has under the Contract Documents. Establishment of the one-year period for correction of Work as described in Section 12.2.2 relates only to the specific obligation of the Contractor to correct the Work, and has no relationship to the time within which the obligation to comply with the Contract Documents may be sought to be enforced, nor to the time within which proceedings may be commenced to establish the Contractor’s liability with respect to the Contractor’s obligations other than specifically to correct the Work.
§ 12.3 ACCEPTANCE OF NONCONFORMING WORK
If the Owner prefers to accept Work that is not in accordance with the requirements of the Contract Documents, the Owner may do so instead of requiring its removal and correction, in which case the Contract Sum will be reduced as appropriate and equitable. Such adjustment shall be effected whether or not final payment has been made. The Architect shall have no authority to bind the Owner to accept work to which the Owner objects as being deficient or otherwise inconsistent with the requirements of the Contract Documents.
ARTICLE 13 MISCELLANEOUS PROVISIONS

§ 13.1 GOVERNING LAW
The Contract shall be governed by the laws of the Commonwealth of Pennsylvania without application of its choice of law provisions.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 13.2 SUCCESSORS AND ASSIGNS
§ 13.2.1 The Owner and Contractor respectively bind themselves, their partners, successors, assigns and legal representatives to covenants, agreements and obligations contained in the Contract Documents. Except as provided in Section 13.2.2 or set forth elsewhere in the Contract Documents, the Contractor shall not transfer, sell or assign the Contract as a whole or any portion thereof or its right, title or interest therein, without written consent of the Owner. The Contractor is expressly prohibited from assigning or selling any receivable hereunder. If The Contractor attempts to make such an assignment without such consent, that Contractor shall nevertheless remain legally responsible for all obligations under the Contract.
§ 13.2.2 The Owner may, without consent of the Contractor, assign the Contract to a lender or other entity providing construction financing for the Project, if the lender assumes the Owner’s rights and obligations under the Contract Documents. The Contractor shall execute all consents reasonably required to facilitate such assignment.
§ 13.3 WRITTEN NOTICE
Written notice shall be deemed to have been duly served if delivered in person to the individual, to a member of the firm or entity, or to an officer of the corporation for which it was intended; or if delivered at, or sent by registered or certified mail or by courier service providing proof of delivery to, the last business address known to the party giving notice.
§ 13.4 RIGHTS AND REMEDIES
§ 13.4.1 Except as provided in the Contract Documents, the duties and obligations imposed by the Contract Documents and rights and remedies available thereunder shall be in addition to and not a limitation of duties, obligations, rights and remedies otherwise imposed or available by law.
§ 13.4.2 No action or failure to act by the Owner, Architect or Contractor shall constitute a waiver of a right or duty afforded them under the Contract, nor shall such action or failure to act constitute approval of or acquiescence in a breach there under, except as may be specifically agreed in writing.
§ 13.5 TESTS AND INSPECTIONS
§ 13.5.1 Tests, inspections and approvals of portions of the Work shall be made as required by the Contract Documents and by applicable laws, statutes, ordinances, codes, rules and regulations or lawful orders of public authorities. Unless otherwise provided, the Contractor shall make arrangements for such tests, inspections and approvals with an independent testing laboratory or entity acceptable to the Owner, or with the appropriate public authority, and shall bear all related costs of tests, inspections and approvals. The Contractor shall give the Architect and Owner timely notice of when and where tests and inspections are to be made so that the Architect and Owner may be present for such procedures. The Owner shall bear costs of (1) tests, inspections or approvals that do not become requirements until after bids are received or negotiations concluded, and (2) tests, inspections or approvals where building codes or applicable laws or regulations prohibit the Owner from delegating their cost to the Contractor.
§ 13.5.2 If the Architect, Owner or public authorities having jurisdiction determine that portions of the Work require additional testing, inspection or approval not included under Section 13.5.1, the Architect will, upon written authorization from the Owner, instruct the Contractor to make arrangements for such additional testing, inspection or approval by an entity acceptable to the Owner, and the Contractor shall give timely notice to the Architect of when and where tests and inspections are to be made so that the Architect may be present for such procedures. Such costs, except as provided in Section 13.5.3, shall be at the Owner’s expense.
§ 13.5.3 If such procedures for testing, inspection or approval under Sections 13.5.1 and 13.5.2 reveal failure of the portions of the Work to comply with requirements established by the Contract Documents, all costs made necessary by such failure including those of repeated procedures and compensation for the Architect’s services and expenses shall be at the Contractor’s expense, including testing, professional fees and all costs related to the remedial work.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 13.5.4 Required certificates of testing, inspection or approval shall, unless otherwise required by the Contract Documents, be secured by the Contractor and promptly delivered to the Architect.
§ 13.5.5 If the Architect is to observe tests, inspections or approvals required by the Contract Documents, the Architect will do so promptly and, where practicable, at the normal place of testing.
§ 13.5.6 Tests or inspections conducted pursuant to the Contract Documents shall be made promptly to avoid unreasonable delay in the Work.
§ 13.6 INTEREST
Payments due and unpaid under the Contract Documents shall bear interest from the date payment is due at such rate as the parties may agree upon in writing or, in the absence thereof, at the legal rate prevailing from time to time at the place where the Project is located.
§ 13.7 TIME LIMITS ON CLAIMS AND SEVERABILITY
The Owner and Contractor shall commence all claims and causes of action, whether in contract, tort, breach of warranty or otherwise, against the other arising out of or related to the Contract within the time period specified by applicable law. Wherever possible each provision of this Agreement shall be interpreted in a manner as to be effective and valid under applicable law. If, however, any provision of this Agreement, or portion thereof, is prohibited by law or found invalid under any law, only such provision or portion thereof shall be ineffective, without in any manner invalidating or affecting the remaining provisions of this Agreement or valid portions of such provision, which are hereby deemed severable.
ARTICLE 14 TERMINATION OR SUSPENSION OF THE CONTRACT

§ 14.1 TERMINATION BY THE CONTRACTOR
§ 14.1.1 The Contractor may terminate the Contract if the Work is stopped for a period of 30 consecutive days through no act or fault of the Contractor or a Subcontractor, Sub-subcontractor or their agents or employees or any other persons or entities performing portions of the Work under direct or indirect contract with the Contractor, for any of the following reasons:
  .1   Issuance of an order of a court or other public authority having jurisdiction that requires all Work to be stopped;
  .2   An act of government, such as a declaration of national emergency that requires all Work to be stopped;
  .3   Because the Architect has not issued a Certificate for Payment and has not notified the Contractor of the reason for withholding certification as provided in Section 9.4.1, or because the Owner has not made payment on a Certificate for Payment within the time stated in the Contract Documents; or
  .4   The Owner has failed to furnish to the Contractor promptly, upon the Contractor’s request, reasonable evidence as required by Section 2.2.1.
§ 14.1.2 The Contractor may terminate the Contract if, through no act or fault of the Contractor or a Subcontractor, Sub-subcontractor or their agents or employees or any other persons or entities performing portions of the Work under direct or indirect contract with the Contractor, repeated suspensions, delays or interruptions of the entire Work by the Owner as described in Section 14.3 constitute in the aggregate more than 100 percent of the total number of days scheduled for completion, or 120 days in any 365-day period, whichever is less.
§ 14.1.3 If one of the reasons described in Section 14.1.1 or 14.1.2 exists, the Contractor may, upon seven days’ written notice to the Owner and Architect, terminate the Contract and recover from the Owner payment for Work executed, including reasonable overhead and profit, direct costs incurred by reason of such termination, and damages.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 14.1.4 If the Work is stopped for a period of 60 consecutive days through no act or fault of the Contractor or a Subcontractor or their agents or employees or any other persons performing portions of the Work under contract with the Contractor because the Owner has repeatedly failed to fulfill the Owner’s obligations under the Contract Documents with respect to matters important to the progress of the Work, the Contractor may, upon seven additional days’ written notice to the Owner and the Architect, terminate the Contract and recover from the Owner as provided in Section 14.1.3.
§ 14.2 TERMINATION BY THE OWNER FOR CAUSE
§ 14.2.1 The Owner may terminate the Contract if the Contractor
  .1   repeatedly refuses or fails to supply enough properly skilled workers or proper materials;
  .2   fails to make payment to Subcontractors for materials or labor in accordance with the respective agreements between the Contractor and the Subcontractors;
  .3   repeatedly disregards applicable laws, statutes, ordinances, codes, rules and regulations, or lawful orders of a public authority; or
  .4   otherwise is guilty of substantial breach of a provision of the Contract Documents.
§ 14.2.2 When any of the above reasons exist, the Owner, upon certification by the Initial Decision Maker that sufficient cause exists to justify such action, may without prejudice to any other rights or remedies of the Owner and after giving the Contractor and the Contractor’s surety, if any, seven days’ written notice, terminate employment of the Contractor and may, subject to any prior rights of the surety:
  .1   Exclude the Contractor from the site and take possession of all materials, equipment, tools, and construction equipment and machinery thereon owned by the Contractor;
  .2   Accept assignment of subcontracts pursuant to Section 5.4; and
  .3   Finish the Work by whatever reasonable method the Owner may deem expedient. Upon written request of the Contractor, the Owner shall furnish to the Contractor a detailed accounting of the costs incurred by the Owner in finishing the Work.
§ 14.2.3 When the Owner terminates the Contract for one of the reasons stated in Section 14.2.1, the Contractor shall not be entitled to receive further payment until the Work is finished.
§ 14.2.4 If such costs and damages incurred by the Owner, including attorneys fees and other professional fees and expenses exceeds the unpaid balance, the Contractor shall pay the difference to the Owner.
§ 14.2.5 In the event that the Owner terminates the Contract for cause, the Owner shall have the right at any time to convert the termination to a termination for convenience pursuant to Section 14.4 and the Contractor shall be limited to the compensation set forth in Section 14.4 and shall not be entitled to recover any other damages of any kind.
§ 14.3 SUSPENSION BY THE OWNER FOR CONVENIENCE
§ 14.3.1 The Owner may, without cause, order the Contractor in writing to suspend, delay or interrupt the Work in whole or in part for such period of time as the Owner may determine. In said event, the Owner shall equitably adjust the Contract Sum and Contract Time, if warranted.
§ 14.3.2 The Contract Sum and Contract Time shall be adjusted for increases in the cost and time caused by suspension, delay or interruption as described in Section 14.3.1. Adjustment of the Contract Sum shall include profit. No adjustment shall be made to the extent
  .1   that performance is, was or would have been so suspended, delayed or interrupted by another cause for which the Contractor is responsible; or
  .2   that an equitable adjustment is made or denied under another provision of the Contract.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 14.4 TERMINATION BY THE OWNER FOR CONVENIENCE
§ 14.4.1 The Owner may, at any time, terminate the Contract for the Owner’s convenience and without cause.
§ 14.4.2 Upon receipt of written notice from the Owner of such termination for the Owner’s convenience, the Contractor shall
  .1   cease operations as directed by the Owner in the notice;
  .2   take actions necessary, or that the Owner may direct, for the protection and preservation of the Work; and
  .3   except for Work directed to be performed prior to the effective date of termination stated in the notice, terminate all existing subcontracts and purchase orders and enter into no further subcontracts and purchase orders.
§ 14.4.3 Upon such termination, the Contractor shall recover as its sole remedy payment for Work properly performed in connection with the terminated portion of the Work prior to the effective date of termination, for items properly and timely fabricated off the Project site, delivered and stored in accordance with the Owner’s instructions. The contractor hereby waives and forfeits all other claims for payment and damages, including, without limitation, anticipated and/or unearned profits, consequential or indirect damages.
ARTICLE 15 CLAIMS AND DISPUTES

§ 15.1 CLAIMS

§ 15.1.1 DEFINITION
A Claim is a demand or assertion by one of the parties seeking, as a matter of right, payment of money, or other relief with respect to the terms of the Contract. The term “Claim” also includes other disputes and matters in question between the Owner and Contractor arising out of or relating to the Contract. The responsibility to substantiate Claims shall rest with the party making the Claim. The Owner shall not be required to assert a claim as a condition precedent to exercising any rights vested in it by the Contract Documents, by law or in equity
§ 15.1.2 NOTICE OF CLAIMS
Claims by either the Owner or Contractor must be initiated by written notice to the other party with a copy sent to the Architect. Claims by either party must be initiated within 21 days after occurrence of the event giving rise to such Claim or within 21 days after the claimant first recognizes the condition giving rise to the Claim, whichever is later.
§ 15.1.3 CONTINUING CONTRACT PERFORMANCE
Pending final resolution of a Claim, except as otherwise agreed in writing or as provided in Section 9.7 and Article 14, the Contractor shall proceed diligently with performance of the Contract and the Owner shall continue to make payments in accordance with the Contract Documents. The Owner shall have no obligation to make payments to the Contractor on or against such claims, disputes or other matters in question during the pendency of any mediation or other proceeding to resolve such matters except as provided by Article 7.3.9. The Owner shall make payment to the Contractor of all sums not in dispute.
§ 15.1.4 CLAIMS FOR ADDITIONAL COST
If the Contractor wishes to make a Claim for an increase in the Contract Sum, written notice as provided herein shall be given before proceeding to execute the Work. Prior notice is not required for Claims relating to an emergency endangering life or property arising under Section 10.4.
§ 15.1.5 CLAIMS FOR ADDITIONAL TIME
If the Contractor wishes to make a Claim for an increase in the Contract Time, written notice as provided herein shall be given. The Contractor’s Claim shall include an estimate of cost and of probable effect of delay on progress of the Work. In the case of a continuing delay, only one Claim is necessary.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 15.1.5.1 If adverse weather conditions which could not be reasonably anticipated and have an adverse affect on the critical path of constructions are the basis for a Claim for additional time, such Claim shall be documented by data substantiating that weather conditions were abnormal for the period of time, could not have been reasonably anticipated and had an adverse effect on the scheduled construction.
§ 15.1.5.2 Extensions of time will not be granted for delays caused by inadequate construction force or the failure to place orders for equipment or advise Owner for need for ordering of construction materials sufficiently in advance to insure delivery when needed.
§ 15.1.5.3 When the Contract Time has been extended, as provided herein, such extension of time shall not be considered as justifying extra compensation to the Contractor for administrative costs or other similar reasons.
§ 15.1.6 CLAIMS FOR CONSEQUENTIAL DAMAGES
The Contractor and Owner waive Claims against each other for consequential damages arising out of or relating to this Contract. This mutual waiver includes
  .1   damages incurred by the Owner for rental expenses, for losses of use, income, profit, financing, business and reputation, and for loss of management or employee productivity or of the services of such persons; and
  .2   damages incurred by the Contractor for principal office expenses including the compensation of personnel stationed there, for losses of financing, business and reputation, and for loss of profit except anticipated profit arising directly from the Work.
This mutual waiver is applicable, without limitation, to all consequential damages due to either party’s termination in accordance with Article 14. Nothing contained in this Section 15.1.6 shall be deemed to preclude an award of liquidated damages, when applicable, in accordance with the requirements of the Contract Documents.
§ 15.2 CLAIMS
§ 15.2.1 Either party may file for mediation.
§ 15.2.2 In the event of a Claim against the Contractor, the Owner may, but is not obligated to, notify the surety, if any, of the nature and amount of the Claim. If the Claim relates to a possibility of a Contractor’s default, the Owner may, but is not obligated to, notify the surety and request the surety’s assistance in resolving the controversy.
§ 15.2.3 If a Claim relates to or is the subject of a mechanic’s lien, the party asserting such Claim may proceed in accordance with applicable law to comply with the lien notice or filing deadlines.
(Paragraphs deleted)

§ 15.3 MEDIATION
§ 15.3.1 Claims, disputes, or other matters in controversy arising out of or related to the Contract except those waived as provided for in Sections 9.10.4 and 9.10.5, and 15.1.6 shall be subject to mediation as a condition precedent to litigation.
§ 15.3.2 The parties shall endeavor to resolve their Claims by mediation which, unless the parties mutually agree otherwise, shall be administered by the American Arbitration Association in accordance with its Construction Industry Mediation Procedures in effect on the date of the Agreement. A request for mediation shall be made in writing, delivered to the other party to the Contract, and filed with the person or entity administering the mediation. The request may be made concurrently with the filing of litigation proceedings but, in such event, mediation shall proceed in advance of litigation proceedings, which shall be stayed pending mediation for a period of 60 days from the date of filing, unless stayed for a longer period by agreement of the parties or court order.
§ 15.3.3 The parties shall share the mediator’s fee and any filing fees equally. The mediation shall be held in the general area where the Project is located, but not at either the Owner’s or Contractor’s facilities, and at a location that is mutually agreed upon. Agreements reached in mediation shall be enforceable as settlement agreements in any court having jurisdiction thereof.
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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§ 15.4 LITIGATION
§ 15.4.1 All claims, disputes and other matters in question between the Contractor and the Owner arising out of, or relating to this Agreement, the Project, the Work, the Contract Documents or the breach thereof shall be decided by litigation in the Court of Common Pleas of York County, which shall have exclusive jurisdiction and venue.
             
OWNER
UNILIFE CROSS FARM LLC
      CONSTRUCTION MANAGER
HSC BUILDERS AND CONSTRUCTION MANAGERS
   
 
           
/s/ Daniel Calvert
      /s/ Mark R. Heim    
 
(Signature)
     
 
(Signature)
   
 
           
Daniel Calvert CFO
      Mark R. Heim    
 
(Printed name and title)
     
 
(Printed name and title)
   
 
           
12/24/09
      12/23/09    
 
Date
     
 
Date
   
 
           
/s/ Cynthia M. Lighty
      /s/ Cassie J. Bosley    
 
ATTEST  Cynthia M. Lighty Assistant Secretary
     
 
ATTEST  Unilife Final 12/23/09 (A 1807516)
   
 
     
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  AIA Document A201™ — 2007. Copyright © 1911, 1915, 1918, 1925, 1937, 1951, 1958, 1961, 1936, 1966, 1970, 1976, 1987, 1997, and 2007 by The American Institute of Architects. All rights reserved. WARNING: This AIA™ Document is protected by U.S. Copyright Law and international Treaties. Unauthorized reproduction or distribution of this AIA™ Document, or any portion of it, may result in severe civil and criminal penalties and will be prosecuted to the maximum extend possible under the law. This document was produced by AIA software at 08:54:34 on 12/23/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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(AIA LOGO) Document A121TM CMc — 2003
Amendment No. 1
Amendment No. 1 to Agreement Between Owner and Construction Manager

Pursuant to Section 2.2 of the Agreement, dated 14/Dec/2009 between Unilife Cross Farm LLC. (Owner) and HSC Builders and Construction Managers (the Construction Manager), for New World Headquarters Facility (the Project), the Owner and Construction Manager establish a Guaranteed Maximum Price and Contract Time for the Work as set forth below.
ARTICLE I GUARANTEED MAXIMUM PRICE
The Construction Manager’s Guaranteed Maximum Price for the Work, including the estimated Cost of the Work as defined in Article 6 and the Construction Manager’s Fee as defined in Article 5, is one and one half percent (11/2%). This Price is for the performance of the Work in accordance with the Contract Documents listed and attached to this Amendment and marked Exhibits A through F, as follows:
         
 
  Exhibit A   Drawings, Specifications, addenda and General, Supplementary and other Conditions of the Contract on which the Guaranteed Maximum Price is based, pages __ through __, dated __. See Article III.
 
       
 
  Exhibit B   Allowance items, pages __ through __, dated __. See Article III.
 
       
 
  Exhibit C   Assumptions and Clarifications made in preparing the Guaranteed Maximum Price, pages __ through __, dated __. See Article III.
 
       
 
  Exhibit D   Completion Schedule, pages __ through __, dated __. See Article III.
 
       
 
  Exhibit E   Alternate Prices, pages __ through __, dated __. See Article III.
 
       
 
  Exhibit F   Unit Prices, pages __ through __, dated __. See Article III.
ADDITIONS AND DELETIONS: The author of this document has added information needed for its completion. The author may also have revised the text of the original AIA standard form. An Additions and Deletions Report that notes added information as well as revisions to the standard form text is available from the author and should be reviewed. A vertical line in the left margin of this document indicates where the author has added necessary information and where the author has added to or deleted from the original AIA text.
This document has important legal consequences. Consultation with an attorney is encouraged with respect to its completion or modification.


ARTICLE II CONTRACT TIME
The date of Substantial Completion established by this Amendment is:
     
April 15, 2010
  Completion of Utility Rooms for Equipment Installation
July 1, 2010
  Completion of Clean Rooms for Equipment Installation
August 1, 2010
  Temporary Occupancy Permit for Manufacturing/Warehouse
October 18, 2010
  Unrestricted Occupancy Permit for Manufacturing /Warehouse
December 15, 2010
  Unrestricted Occupancy Permit for Office
ARTICLE III – GUARANTEED MAXIMUM PRICE
The parties recognize and agree that this is a fast-track project with construction commencing before completion of design. The parties have agreed that the Guaranteed Maximum Price (“GMP”) shall be Twenty-One Million Seven Hundred Thousand Dollars ($21,700,000.00). The GMP is based on the following documents:
Schematic Design Report dated November 2, 2009
New Facility 2nd floor.pdf
 
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  AIA Document A121™ CMc — 2003 Amendment No. 1. Copyright © 1991, 1998 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:40:08 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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Production floor plan-110909.pdf
Base of Design (2) Estimate 11-9-2009.pdf
Unilife Project Milstone Schedule Updated 11-24-09.pdf
The GMP shall be revised upward or downward by Change Order.
             
OWNER
      CONSTRUCTION MANAGER    
UNILIFE CROSS FARM LLC
      HSC BUILDERS AND CONSTRUCTION MANAGERS    
/s/ Daniel Calvert
      /s/ Mark R. Heim    
 
(Signature)
     
 
(Signature)
   
Daniel Calvert
      Mark R. Heim, President    
 
(Printed name and title)
     
 
(Printed name and title)
   
12/14/2009
      12/14/09    
 
Date
     
 
Date
   
/s/ Cynthia M. Lighty
      /s/ James E. Viner    
 
ATTEST
     
 
ATTEST
   
 
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  AIA Document A121™ CMc — 2003 Amendment No. 1. Copyright © 1991, 1998 and 2003 by The American Institute of Architects and The Associated General Contractors of America. All rights reserved. WARNING: This document is protected by U.S. Copyright Law and International Treaties. Unauthorized reproduction or distribution of this document, or any portion of it, may result in severe civil and criminal penalties, and will be prosecuted to the maximum extent possible under the law. This document was produced by AIA software at 18:40:08 on 12/14/2009 under Order No. 1000385696_1 which expires on 01/23/2010, and is not for resale.
     
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2

EX-10.25 11 c93531exv10w25.htm EXHIBIT 10.25 Exhibit 10.25
Exhibit 10.25
DEVELOPMENT AGREEMENT
This DEVELOPMENT AGREEMENT (the “Agreement”), dated as of this 14 day of December, 2009 is made by and between Unilife Cross Farm, LLC, a Delaware limited liability company (the “Owner”), and Keystone Redevelopment Group, LLC, a Pennsylvania limited liability company (“Developer”).
RECITALS:
A. Owner has purchased in fee simple certain property located at 250 Cross Farm Lane, York County, Pennsylvania (the “Property”), containing approximately 35 acres, as more particularly described on Exhibit A attached hereto.
B. Owner desires to develop the Property by constructing an approximately 170,000 square foot office, manufacturing, warehousing and distribution building with related improvements (the “Improvements”).
C. Owner desires to retain the Developer for the purpose of assisting in overseeing the design and construction of the Property (collectively, the “Project”), and the Developer has agreed to perform such duties, pursuant to the provisions of this Agreement.
D. Owner also desires to retain the Developer for the purpose of assisting in securing financing for the Project, and the Developer has agreed to perform such duties, pursuant to the provisions of this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants herein contained and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto, intending to be legally bound, hereby agree as follows:
1. Definitions
1.1 As used herein:
Approved Plans” has the meaning set forth in Section 3.1(a) hereof.
Certificate of Occupancy” means a certificate of occupancy issued by Conewago Township, York County, Pennsylvania, evidencing permission to commence general occupancy of the Improvements and compliance with applicable building codes.
Commitments” has the meaning set forth in Section 3.2(b) hereof.
Completion Date” means the date of actual completion of the Improvements, as certified by the architect or engineer in charge of the Project retained by the Owner.
Construction Activities” means all of the various activities and duties of the Developer set forth in Section 3.1 hereof, including, but not limited to, those activities and duties enumerated in the various subsections of Section 3.1.

 

 


 

Construction Contract” has the meaning set forth in Section 3.1(b) hereof.
Consultants” has the meaning set forth in Section 3.1(a) hereof.
Contractors” has the meaning set forth in Section 3.1(b) hereof.
Development and Construction Budget” means the budget and completion schedule for the Project set forth as Exhibit B and more fully described in Section 3.1(a) hereof, as amended in accordance with terms hereof, from time to time.
Development Fee” has the meaning set forth in Section 5.1 hereof.
Factory Access” means the date that Owner has access to Improvements which have been completed sufficiently to allow commencement of the safe, secure installation of production equipment.
Force Majeure” means (i) any material labor disputes, fire, damage, unusual delay in transportation, adverse weather conditions not reasonably anticipatable or other Acts of God; (ii) any Untimely Consent by Owner.
Financing” has the meaning set forth in Section 3.2 hereof.
Improvements” has the meaning set forth in the recitals hereto.
Project” has the meaning set forth in the recitals hereto.
Project Completion Cost” means the projected cost of completing the Project as set forth in the Development and Construction Budget.
Project Financing” has the meaning set forth in Section 3.2(a) hereof.
Project Schedule” means the Project Schedule set forth as Exhibit C and which is more fully described in Section 3.1(a) hereof and which shall be in final form and approved by Owner, as the same may thereafter be amended in accordance with the terms hereof.
Project Team” has the meaning set forth in Section 2.3 hereof.
Property” has the meaning set forth in the recitals hereto.
Public Financing” has the meaning set forth in Section 3.2(a) hereof.
Untimely Consent” means any consent or approval required of Owner under the terms hereof, in connection with any matter, which consent is given on an untimely basis; provided, however, that no Untimely Consent shall have occurred hereunder if the consent of all other parties required in connection with such matter (other than parties affiliated with or under common control with Owner) has not been given.

 

2


 

2. Appointment of Developer
2.1 The Owner hereby appoints the Developer, and the Developer hereby accepts such appointment, on the terms and conditions, and subject to the limitations, hereinafter set forth, as the developer of the Project for and on behalf of the Owner to assist Owner in its efforts to develop the Project and assist Owner in its efforts to complete the Improvements as hereinafter provided. The Developer recognizes that a relationship of trust and confidence is created by this Agreement and shall perform those services that are set forth herein, together with such services as are reasonably incidental thereto, so as to effect the timely, efficient, and economic development and operation of the Project.
2.2 The appointment of the Developer shall be for a term commencing on the date hereof and ending on the Completion Date or the earlier termination of this Agreement pursuant to Article 6.
2.3 Developer shall designate a development team comprised of its personnel (“Project Team”) to enable it to perform its duties hereunder. The Project Team is listed on Exhibit D hereto.
3. Duties of the Developer
3.1 The Developer shall assist Owner in its efforts to cause the Improvements to be completed in a timely manner in accordance with the requirements of the Project Schedule, the Development and Construction Budget, and the Approved Plans. The services that the Developer shall perform, or cause to be performed, include, but are not limited to, the following:
(a) (i) The Developer shall assist the Owner in the selection of, negotiation of contracts with, and review of the services of, all architects, engineers, designers and other experts and consultants (collectively, the “Consultants”) necessary for the provision of architectural, engineering, design and other services for the Project, including the preparation of detailed plans, specifications, completion schedules, budgets and drawings (herein, as approved in writing by the Owner called the “Approved Plans”).
(ii) The Approved Plans, the Development and Construction Budget (as defined herein) and the Project Schedule (as defined herein) shall each be approved in writing by Owner.
(iii) The Development and Construction Budget shall set forth in reasonable detail the steps necessary to accomplish the completion of the Project in accordance with the Approved Plans and shall set forth the overall Project Completion Cost. The Development and Construction Budget described in this Section 3.1(a) shall be referred to herein as the “Development and Construction Budget.” The Developer shall assist Owner in preparing the Development and Construction Budget and in creating a schedule to be approved in writing by the Owner, based upon the Approved Plans and the Development and Construction Budget, setting forth anticipated project milestones and the target Completion Date (the “Project Schedule”).

 

3


 

(b) The Developer shall assist the Owner in the selection of contractors (the “Contractors”) for the Project, and in the negotiation of maximum fixed price construction contracts as determined by Owner (the “Construction Contracts”) for the Project, and Developer shall assist the Owner in supervising and coordinating the services of the Contractors.
(c) The Developer shall assist Owner in its efforts to administer and use all reasonable efforts to enforce all obligations of the Contractors, the Consultants, and other contractors under their respective contracts and shall advise Owner of any non-compliance by these parties on a timely basis. Developer shall maintain appropriate records with respect thereto.
(d) The Developer shall monitor all development and construction work as it progresses, shall review the work of subcontractors and materialmen by the Contractors, the Consultants, testing agents, and other consultants and review their inspection reports, shall assist Owner in its efforts to expedite completion of the Project as economically and as efficiently as possible, but in conformity with the Approved Plans, the Construction Contract and other contract documents, the Development and Construction Budget, and the Project Schedule.
(e) The Developer shall assist Owner in its efforts to require the Contractors, or other relevant contractors, to correct any defects in the construction of the Project, or in the installation, quality, or operation of any items, equipment, or fixtures therein.
(f) The Developer shall hold periodic meetings not less frequently than once every two weeks, with the Owner and any of its respective representatives, to review the progress of development and completion of the Project.
(g) The Developer shall consult with the Consultants and the Contractors and, in connection therewith, shall review conceptual designs and plans and specifications during development, and, after consultation with Owner, advise on site use and improvements, and provide recommendations on relative construction feasibility and factors relating to cost, all for the purpose of assisting Owner in its efforts to keep the progress of the development of the Project within the costs and timetable established by the Development and Construction Budget and the Project Schedule and for the purpose of assisting Owner in its efforts to obtain and maintain the quality of the construction of the Project established by the Approved Plans.
(h) The Developer shall use reasonable efforts to (singly, or with the assistance of the Consultants or the Contractors) assist the Owner in its efforts to obtain all necessary approvals, licenses, permits, certificates, and authorizations from all governmental authorities having jurisdiction over the Project in connection with the development and the completion and occupancy of the Project; and, Owner shall cooperate with Developer in connection with any necessary requirements applicable to Owner and related to obtaining such items.

 

4


 

(i) The Developer shall, in conjunction with the Consultants and the Contractors, obtain and provide the Owner with information in connection with any potential or anticipated Force Majeure and any proposed change, revision, supplementation, or updating of the Approved Plans, Development and Construction Budget, or Project Schedule. Such information shall, among other things, include updating estimates of the cost of development and timing of the completion of the Project, including a trade payment breakdown, and shall indicate, on a cash basis, the anticipated sources of funds to finance such development and completion and the anticipated dates when such funds will be required. Any and all change orders, regardless whether or not resulting from any such proposed revisions, shall only be effective with the written approval of the Owner.
(j) The Developer shall prepare and update, or assist the Owner in preparing and updating, cash flow projections and capital and income and expense budgets for the Project, which shall include proposed revisions and updates if reasonably necessary. All capital and income and expense budgets and all cash flow projects, together with all revisions and updates thereto, shall be subject to the written approval of Owner.
(k) The Developer shall promptly advise the Owner, of any known delays or anticipated delays in meeting the Project Schedule or the Development and Construction Budget and the reasons therefore.
(l) The Developer shall consult with the Owner regarding recommended insurance coverages and the terms of any policies. Owner shall procure and maintain in effect, or cause to be procured and maintained in effect, at all times during the course of construction, on behalf of the Owner and any lender, worker’s compensation insurance, comprehensive general liability insurance in all risk form, property damage insurance, and fire and extended coverage insurance carried in builder’s risk form on a completed value basis, all of which insurance shall be effected under valid and enforceable policies, from such insurers, in such forms, and in such amounts as shall be approved by the Owner, naming Developer as an additional insured. The Developer shall also assist the Owner in its attempts to require the Consultants and the Contractors to carry errors and omissions coverage acceptable to the Owner in addition to such Builder’s Risk all risk coverages required, naming Developer as an additional insured.
(m) The Developer shall promptly notify the Owner of any suit, proceeding, or other action commenced or taken against or threatened all or any portion of the Project or against the Owner of the Developer which may in any way be related to the Project or any portion thereof.
3.2 The Developer shall assist the Owner in its efforts to place Eighteen Million Dollars ($18,000,000) in financing, on terms and conditions satisfactory to Owner, for the Project (the “Financing”).
(a) The Developer shall assist Owner in its efforts to locate the Financing from commercial banks and other lending institutions (“Project Financing”) and/or from the Commonwealth of Pennsylvania in a manner more particularly described in that certain letter from the Department of Community and Economic Development to Owner dated October 16, 2009 (“Public Financing”).
(b) The Developer shall assist Owner in its efforts to deliver to Owner commitments for the Financing (the “Commitments”) on or before December 31, 2009.

 

5


 

(c) The amount of the Financing may be amended with the written consent of the parties; such consent shall not be unreasonably withheld where the reason for such amendment is to reflect actual or projected deviations from the projected costs associated with developing the Property and building the Facility and any and all activities associated therewith and such amendment will not materially impact the dates of Factory Access or issuance of a Certificate of Occupancy.
3.3 The Developer shall use reasonable efforts to accomplish the completion of the Project in accordance with the Approved Plans and at a cost within the Development and Construction Budget on or before the dates set forth in the Project Schedule.
3.4 Neither party shall be liable for damages or have the right to terminate this Agreement for any delay or default to the extent caused by an event of Force Majeure. Dates by which performance obligations are scheduled to be met will be extended for a period of time equal to the time lost because of the event of Force Majeure. Notwithstanding the foregoing, Owner may terminate this Agreement without any further obligation to Developer if the Commitments are not received on or before December 31, 2009, provided however, to the extent negotiations with a specific lender began prior to December 31, 2009, are actively and continuously occurring with the consent and participation of Owner, then such date shall be extended during the period of such active and continuous negotiation and Owner’s right to terminate shall expire if Commitments are received as a result of such active and continuous negotiation.
4. Limitations on the Developer’s Authority
Notwithstanding anything to the contrary contained in this Agreement:
4.1 No sum shall be expended by Developer which causes an overrun of any cost category set forth in the Development and Construction Budget unless the same has been approved in advance in writing by the Owner.
4.2 No contract, instrument, or document relating to the Project, and no modifications or amendment thereof, shall be entered into by the Developer unless approved in writing by the Owner.
4.3 No change order or any change to the: (a) Approved Plans, (b) Project Schedule, (c) Projected Completion Cost, (d) Development and Construction Budget, (e) Construction Contract, or (f) Project Schedule shall occur or be made without the prior written consent of Owner.
4.4 The Developer shall not exceed the scope of its authority under this Agreement.
5. Compensation
5.1 As payment for its services hereunder, the Developer shall be paid by Owner, an amount equal to Seven Hundred Fifty Four Thousand Dollars ($754,000) (the “Development Fee”). The Development Fee shall be subdivided into four components, which shall be payable as follows:
(a) Fifty Thousand Dollars ($50,000) shall be paid upon the execution of this Agreement (the “Initial Payment”).

 

6


 

(b) An amount equal to one third (1/3) of the Development Fee less the Initial Payment shall be paid in six (6) equal monthly installments, on the first day of every month, during the period beginning on January 1, 2010, and running through the projected date of Factory Access, June 1, 2010 (the “Progress Payments”).
(i) In the event that the actual date of Factory Access occurs before June 1, 2010, the remaining Progress Payments shall be accelerated and payable within thirty (30) days of the actual date of Factory Access.
(ii) In no event shall the Progress Payments continue beyond June 1, 2010, even if the actual date of Factory Access occurs thereafter.
(c) An amount equal to one third (1/3) of the Development Fee less the Initial Payment shall be paid on the date of Factory Access.
(d) The balance of the Development Fee shall be paid upon the issuance of the Certificate of Occupancy.
5.2 The Development Fee is intended to cover and the Owner shall have no obligation to reimburse Developer for, among other things, (i) any administrative costs, overhead, profit, or indirect costs of the Developer, (ii) salaries of personnel of the Developer, and (iii) any other costs or expenses incurred by Developer in the performance of its obligations hereunder; and no payment or other value, other than the Development Fee, shall be paid or provided by the Owner to the Developer in connection herewith except expenses expressly reimbursable by Owner in accordance with the terms hereof, except as provided for elsewhere in this Agreement.
5.3 Notwithstanding anything for the contrary contained herein, nothing in this Agreement shall obligate or require Developer or any party related to Developer to sign any contract including any contract relating to the Financing such as a loan, note, mortgage or guarantee.
6. Term
6.1 Subject to the terms hereof, the term of this Agreement shall commence as of the date hereof and shall terminate, unless extended or renewed in writing in accordance with Section 9.2 hereof, on the date of the issuance of the Certificate of Occupancy.
6.2 Owner may terminate this Agreement on December 31, 2009 if Developer has not delivered the Commitments to Owner pursuant to Developer’s duties under Section 3.2 hereof (subject to extension as set forth in Section 3.4). If this Agreement is terminated for any reason, Developer shall retain the Initial Payment.

 

7


 

7. Limitation of Liability; Indemnification
7.1 The Developer shall not be liable to the Owner on account of the acts (whether negligent or otherwise), omissions, errors or breaches of contract by the Contractors or subcontractor or materialmen, the Consultants and any other professionals or consultants engaged on the Project.
7.2 Owner shall indemnify, defend, and hold the Developer harmless from and against any liability, damages, costs, claims and expenses (including reasonable attorney’s fees) brought by any third parties (excluding the Owner and its affiliates) arising out of the Developer’s performance of this Agreement, except to the extent such liability, damages, costs, claims, and expenses arise as a result of Developer’s gross negligence, willful misconduct or intentionally tortious conduct.
7.3 Notwithstanding anything to the contrary contained herein, Owner’s sole and exclusive remedy against Developer for any breach of this Agreement by Developer or non-performance by Developer under this Agreement shall be to withhold the payments under Section 5.1(c), if Factory Access is not achieved because of such breach or nonperformance or to withhold payments under Section 5.1(d), if the Certificate of Occupancy is not achieved because of such breach or nonperformance. Otherwise, Developer shall have no liability to Owner under this Agreement.
8. Access
8.1 The Owner, shall during reasonable business hours at any time and from time to time during the term of this Agreement, have access to, and be permitted to inspect and copy, all records, financial statements, receipts, vouchers, and documents which are in the possession and control of the Developer relating to the development and the completion of the Project.
9. General Provisions
9.1 All notices or other communications which are required or permitted hereunder (collectively, “notices”) shall be in writing and shall be deemed sufficiently given if telescoped with confirmation from the sending machine of satisfactory receipt by the receiving machine, delivered personally, or sent by registered or certified mail, postage prepaid, to the party for whom intended, addressed as follows:
if to Owner:
Unilife Cross Farm, LLC
c/o Unilife Corporation
633 Lowther Road
Lewisberry, PA 17339
Telecopy: 717-932-9110

 

8


 

if to Developer:
Robert L. Ventresca
Keystone Redevelopment Group, LLC
242 Wood Street
Doylestown, PA 18901
Telecopy: 215-348-7532
or, as to either party, to such other person or address or number as such party may specify in a notice duly given to the other party as provided herein. All notices shall be deemed to have been given as of the date received if personally delivered, on the time of completion of the telecopy transmission, or three days after the date mailed.
9.2 This Agreement constitutes the entire Agreement between the Parties with respect to the subject matter hereof. No extension, renewal, waiver, or modification of the terms hereof shall be valid unless in writing signed by the party to be charged and only to the extent therein set forth.
9.3 This Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective successors and assigns.
9.4 All questions with respect to the construction of this Agreement and the rights and liabilities of the parties shall be determined in accordance with the applicable provisions of the laws of the Commonwealth of Pennsylvania, without regard to its conflicts of laws provisions.
9.5 If any term, covenant, or condition of this Agreement, shall, to any extent, be held invalid or unenforceable, the remainder of this Agreement shall not be affected thereby and each term, covenant, and condition of this Agreement shall be separately valid and enforceable to the fullest extent permitted by law.
9.6 All rights, privileges, and remedies afforded to the parties by this Agreement shall be cumulative and not exclusive, and the exercise of any one of such remedies shall not be deemed to be a waiver of any other rights, remedies, or privileges provided for herein or available at law or in equity.
9.7 The failure of either party to seek redress for violation, or to insist upon the strict performance, of any covenant, agreement, provision or condition of this Agreement shall not constitute a waiver thereof and such party shall have all remedies provided for herein or by applicable law with respect to the same or any subsequent act or omission which constitutes such violation or non-performance.
9.8 The captions appearing in this Agreement are inserted only as a matter of convenience and for reference and in no way define, limit or describe the scope and intent of this Agreement or any of the provisions hereof.
9.9 No consent, authorization, approval, waiver, or similar action of Owner hereunder shall be valid unless provided to Developer in a writing executed by the Owner.

 

9


 

9.10 This Agreement will be deemed to have been made and delivered in Pennsylvania and each of the undersigned hereby (i) agrees that any suit, action or proceeding arising out of or relating to this Agreement shall be instituted exclusively in Courts of Common Pleas or in the United States District Court located in the Commonwealth of Pennsylvania, and (ii) irrevocably consents to the jurisdiction of the Courts of Common Pleas and the United States District Courts of Pennsylvania in any such suit, action or proceeding.
IN WITNESS WHEREOF, and intending to be legally bound hereby, the parties hereto have duly executed this Agreement as of the day and year first above written.
                         
Keystone Redevelopment Group, LLC   Unilife Cross Farm, LLC    
 
                       
By:   /s/ Robert L. Ventresca   By:   /s/ Alan Shortall    
                 
 
  Printed Name:    Robert L. Ventresca       Printed Name:    Alan Shortall    
 
  Title:   Manager       Title:   CEO    

 

10


 

List of Exhibits
     
Exhibit A
  “Property”
Exhibit B
  Development and Construction Budget
Exhibit C
  Project Schedule
Exhibit D
  Project Team

 

Exhibits-1


 

Exhibit A
Property

 

Exhibits-2


 

EXHIBIT A
LEGAL DESCRIPTION
FOR
GREENSPRING PARTNERS, LP
All that certain tract of land situate in the Township of Conewago, County of York, Commonwealth of Pennsylvania, being a portion of lands now or formerly owned by Dale R. and Phyllis L Clymer, by Deed Book 82M, Page 764, being known as Lot 1A as shown on a Subdivision Plan, recorded at the Office; of the Recorder of Deeds for York County, Commonwealth of Pennsylvania, in Deed Book 1792, Page 6035, prepared by First Capital Engineering, drawing number 12135SD00, for Greenspring Partners, LP, said tract being more fully bounded and described as follows to wit:
BEGINNING at a point in the centerline of Susquehanna Trail (Township Road T-956) having a legal right-of-way of eighty and zero hundredths feet (80.00 Ft.), said point being the intersection of the centerline of Susquehanna Trail (T-956) and the centerline of Cross Farm Lane [to be constructed and to have a right-of-way of sixty and zero hundredths feet (60.00 Ft.)];
THENCE by the centerline of Susquehanna Trail (T-956) and on a curve to the loft having s radius of one-thousand, four-hundred thirty-eight and thirteen hundredths feel (1,438.13 Ft.), an arc length of one and thirty-six hundredths feet (1.36 Ft.), a chord bearing of South one degree, twenty-two minutes, and twenty-one seconds West (S 01° 22’ 21” W), and a chord length of one and thirty-six hundredths feet (1.36 Ft) to a point;
THENCE continuing by the centerline of Susquehanna Trail (T-9 56) South zero degress, forty-four minutes, and fifty-two seconds West (S 00° 44’ 52” W), eighty-seven and seventy-four hundredths feet (87.74 Ft.) to a point;
THENCE leaving Susquehanna Trail (T-956) in a westerly direction along lands now or formerly belonging to Richard C. and Patty L. Knisely North eighty-eight degrees, twenty-four minutes, and fifteen seconds West (N 88° 24’ 15” W), four-hundred two and forty-two hundredths feet (402.42 Ft.) to a concrete monument;

 

 


 

THENCE continuing by the Knisely property on a southwestern course of South twenty-five degrees, fifty-eight minutes, and six seconds West (S 25° 58’ 06” W), one-hundred sixty-seven and seventy-four hundredths feel (167.74 Ft.) to a concrete monument being the common corner of the aforesaid Knisely lands and property now or formerly belonging to Gerald R. Horst;
THENCE along the Horst properly the following three (3) courses and distances:
1. South twenty-six degrees, two minutes, and twenty-eight seconds West (S 26° 02’ 28” W), one-thousand, seven-hundred twelve and fifty-nine hundredths feet (1,712.59 Ft.) to a concrete monument;
2. North fifty-five degrees, fifteen minutes, and thirty-eight seconds West (N 55° 15’ 38” W), three-hundred sixteen and eighty-four hundredths feet (316.84 Ft.) to a concrete monument; and
3. South thirty-five degrees, twenty-nine minutes, and fifty-two seconds West (S 35° 29’ 52” W), four-hundred twenty-five and nine hundredths feet (425.09 Ft.) to a concrete monument at the common comer of lands of the aforementioned Gerald R. Horst and lands now or formerly belonging to Wellington Investment Group LLC;
THENCE in a northwesterly direction along the property of Wellington Investment Group LLC and lands now or formerly belonging to Scott T. and Tracey Heiland North thirty-three degrees, twenty-five minutes, and forty-three seconds West (N 33° 25’ 43” W), six-hundred twenty and fifty-one hundredths feet (520.51 Ft.) to a concrete monument being a common corner of lands now or formerly of the aforesaid Heiland property and lands of Dale R. and Phyllis L. Clymer;

 

 


 

THENCE along the property of Dale R. and Phyllis L. Clymer the next two (2) courses and distances:
1. North eighteen degrees, six minutes, and thirty-four seconds West (N 18° 06’ 34” W), four-hundred eighty-eight and zero hundredths feet (488.00 Ft.) to a concrete monument; and
2. North twelve degrees, twelve minutes, and forty-eight seconds Hast (N 12° 12’ 48” E), two-hundred seven and ninety-four hundredths feet (207.94 Ft.) to a point on the centerline of the aforementioned proposed Cross Farm Lane;
THENCE by the centerline of the proposed Cross Farm Lane the following five (5) courses and distances:
1. South seventy-seven degrees, forty-seven minutes, and twelve seconds East (S 77° 47’ 12” E), one-hundred twenty-one and seventy-right hundredths feet (121.78 Ft.) to a point;
2. On a curve to the left having a radius of two-hundred and zero hundredths feet (200.00 Ft.), an arc length of one-hundred forty-one and ninety-nine hundredths feet (141.99 Ft.), a chord bearing of North eighty-one degrees, fifty-two minutes, and thirty-one seconds East (N 81° 52’ 31” E), and a chord length of one-hundred thirty-nine and two hundredths feet (139.02 Ft.) to a point;
3. North sixty-one degrees, thirty-two minutes, and fourteen seconds East (N 61° 32’ 14” E) one-thousand, four-hundred ninety-two and fifty-eight hundredths feet (1,492.58 Ft.) to a point.

 

 


 

4. On a curve to the right having a radius of four-hundred fifty and zero hundredths feet (450.00 Ft.), an arc length of two-hundred thirty-six and seventy-two hundredths feet (236.72 Ft.), a chord bearing of North seventy-six degrees, thirty-six minutes, and twenty-six seconds East (N 76° 36’ 26” E), and a chord length of two-hundred thirty-four and zero hundredths feet (234.00 Ft.) to a point; and
5. South eighty-eight degrees, nineteen minutes, and twenty-one seconds East (S 88° 19’ 21” E), three-hundred eighty-nine and nineteen hundredths feet (389.19 Ft.) to the POINT OF BEGINNING.
Excepting and reserving to Metropolitan Edison a right-of-way easement of two-hundred and zero hundredths feet (200.00 Ft.) in width as described in Deed Book 57-I, Page 348. Also excepting and reserving to Edison Light and Power Company two (2) right-of-way easements, one of twelve and zero hundredths feet (12.00 Ft.) in width as described in Deed Book 30-W, Page 149 (in favor of Parcel 103G), and the other of twenty and zero hundredths feet (20.00 Ft.) in width as described in Deed Book 33-B, Page 180
     
CONTAINING:
  38.155 acres (Gross)
 
   
 
  36.417 acres (Net)

 

 


 

Exhibit B
Development and Construction Budget
         
Construction Cost
       
Site Improvements
    1,000,000  
Production Building Shell
    3,250,000  
Production Fit-out
    9,130,000  
Office Building Shell
    5,440,000  
Office Building Fit-out
    1,480,000  
Central Plant
    1,300,000  
Total Construction Cost
  $ 21,600,000  
 
       
Land Cost
  $ 2,034,791  
 
       
Architectural and Engineering Cost
  $ 1,500,000  
 
       
Total Development and Construction Budget
  $ 25,134,791  
 
     

 

Exhibits-3


 

Exhibit C
Project Schedule

 

Exhibits-4


 

Exhibit D
Project Team
Robert L. Ventresca
Robert G. Loughery
Gregory A. Ventresca
Charles A. Artillio
Jorden P. “Pete” Krauss
Such other person as designated by Developer from time to time.

 

 

EX-10.26 12 c93531exv10w26.htm EXHIBIT 10.26 Exhibit 10.26
Exhibit 10.26
AMENDED AND RESTATED OPERATING AGREEMENT
OF
UNILIFE CROSS FARM LLC
(A Delaware Limited Liability Company, Member Managed)

 

 


 

TABLE OF CONTENTS
         
    Page  
 
       
ARTICLE 1 DEFINITIONS
    1  
 
       
1.1 Definitions
    1  
 
       
ARTICLE 2 FORMATION AND PURPOSE
    6  
 
       
2.1 Formation
    6  
2.2 Name
    6  
2.3 Registered Office and Principal Place of Business
    6  
2.4 Purposes
    6  
2.5 Execution and Filing of the Certificate
    6  
2.6 Governing Act
    7  
2.7 Other Qualifications
    7  
 
       
ARTICLE 3 CAPITAL CONTRIBUTIONS
    7  
 
       
3.1 Initial Capital Contributions of Members
    7  
3.2 Capital Accounts
    7  
3.3 No Return of or Interest on Capital; No Partition
    8  
3.4 Additional Capital Contributions
    8  
3.5 Ownership Interests
    8  
 
       
ARTICLE 4 DISTRIBUTIONS TO MEMBERS AND ALLOCATIONS OF PROFITS AND LOSSES
    8  
 
       
4.1 Profits and Losses
    8  
4.2 Distributions
    9  
4.3 Special Allocations
    9  
4.4 Curative Allocations
    10  
4.5 Tax Allocations: Code Section 704(c)
    11  
4.6 Miscellaneous
    11  
4.7 Establishment of Reserve
    12  
4.8 Amounts Withheld
    12  
 
       
ARTICLE 5 MANAGEMENT
    12  
 
       
5.1 Rights and Duties of Members
    12  
5.2 Exculpation
    12  
5.3 Indemnification of the Members
    13  
5.4 Holding of Property
    13  
5.5 Loans
    13  
 
       
ARTICLE 6 RIGHTS AND OBLIGATIONS OF MEMBERS; MEETINGS
    13  
 
       
6.1 Liability of Members
    13  
6.2 Voting Rights
    14  
6.3 Company Meetings
    14  
6.4 Waiver of Fiduciary Duty; Company Opportunities
    14  
6.5 [Intentionally Deleted]
    15  
6.6 Additional Members
    15  

 

-i- 


 

TABLE OF CONTENTS
(continued)
         
    Page  
 
       
ARTICLE 7 ACCOUNTING
    15  
 
       
7.1 Books and Records
    15  
7.2 Fiscal Year
    15  
7.3 Tax and Financial Reports
    15  
7.4 Company’s Accounting Firm
    16  
7.5 Tax Matters Member
    16  
 
       
ARTICLE 8 TERM AND DISSOLUTION
    16  
 
       
8.1 Term
    16  
8.2 Events Causing Termination
    17  
8.3 Actions of Members
    17  
8.4 Distribution in Case of Termination
    17  
8.5 Rights of Members on Liquidation
    18  
 
       
ARTICLE 9 TRANSFER OF COMPANY INTERESTS
    18  
 
       
9.1 Transfer of Interests Generally
    18  
9.2 Sale or Liquidation of Percentage Interest
    18  
9.3 Transfer of Percentage Interests to Related Parties
    20  
9.4 Arbitration
    20  
9.5 Indemnity
    20  
9.6 Drag-Along Rights
    21  
9.7 Tag-Along Rights
    22  
 
       
ARTICLE 10 GENERAL PROVISIONS
    23  
 
       
10.1 Binding Effect and Benefit of This Agreement
    23  
10.2 Agreement
    23  
10.3 Notices, etc.
    24  
10.4 Integration; Termination
    24  
10.5 Interpretation
    24  
10.6 Counterparts
    24  
10.7 Severability of Provisions
    24  
10.8 Amendments
    24  
10.9 Subject to Purchase Agreement
    25  

 

-ii-


 

AMENDED AND RESTATED OPERATING AGREEMENT
OF
UNILIFE CROSS FARM LLC
(A Delaware Limited Liability Company, Member Managed)
THIS AMENDED AND RESTATED OPERATING AGREEMENT (this “Agreement”) is made as of the 14th day of December 2009, by and among the persons listed on Exhibit A attached hereto (each of the persons listed on Exhibit A is sometimes hereinafter referred to individually as a “Member” and collectively as the “Members”).
WITNESSETH:
WHEREAS, UNILIFE CROSS FARM LLC (the “Company”) was formed as a limited liability company under the Delaware Limited Liability Company Act on November 10, 2009;
WHEREAS, Cross Farm, LLC has entered into a Membership Interest Purchase Agreement (the “Purchase Agreement”) whereby Cross Farm, LLC will acquire a 1% interest in the Company;
WHEREAS, the Members desire to amend and restate the Operating Agreement in its entirety in order to set forth the terms of operation of the Company and the Business;
NOW, THEREFORE, in consideration of the mutual promises and covenants herein and intending to be legally bound, the Members agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Definitions.
For purposes of this Agreement, the following terms shall have the meanings set forth below, except as otherwise specified or as the context may otherwise require:
“Act” shall mean the Delaware Limited Liability Company Act, Title 6, Section 18-101 et seq., as amended from time to time.
“Adjusted Capital Account Deficit” shall mean, with respect to any Member, the deficit balance, if any, in such Member’s Capital Account as of the end of the relevant fiscal year, after giving effect to the following adjustments: (i) credit to such Capital Account any amounts which such Member is obligated to restore pursuant to the terms of such Member’s promissory note or otherwise or is deemed to be obligated to restore pursuant to Treasury Regulation Sections 1.704-2(g)(1) and 1.704-2(i)(5); and (ii) debit to such Capital Account the items described in Sections 1.704-1 (b)(2)(ii)(d)(4), 1.704-1 (b)(2)(ii)(d)(5) and 1.704-1 (b)(2)(ii)(d)(6) of the Regulations. The foregoing definition of Adjusted Capital Account Deficit is intended to comply with the provisions of Section 1.704-1 (b)(2)(ii)(d) of the Regulations and shall be interpreted consistently therewith.

 

1


 

“Adjusted Capital Contribution” shall mean, as of any day, a Member’s Capital Contributions reduced by the amount of cash and the Gross Asset Value of any Company property distributed to such Member pursuant to Sections 4.2 and 8.4 hereof.
“Agreement” shall mean this Operating Agreement, as amended from time to time.
“Bankruptcy” shall mean (i) the entry of a decree or order for relief by a court having jurisdiction in respect of a Person in an involuntary proceeding under any applicable bankruptcy, insolvency or other similar law now or hereafter in effect, or the appointment of a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of a Person or for any substantial part of such Person’s property or the entry of an order for the winding up or liquidation of its affairs, which decree or order remains unstayed and in effect for a period of ninety (90) consecutive days; (ii) the commencement by a Person of a voluntary proceeding under any applicable bankruptcy, insolvency or other similar law now or hereafter in effect, or consent to the entry of an order for relief in an involuntary case under any such law, or consent to the appointment or taking possession by a receiver, liquidator, assignee, custodian, trustee, sequestrator (or similar official) of a Person or for any substantial part of its property, or any general assignment by a Person for the benefit of creditors; or (iii) the attachment by a creditor of a Person’s interest in the Company, which attachment is not discharged or vacated within ninety (90) days from the date it becomes effective.
“Capital Account(s)” shall mean the individual account(s) maintained by the Company with respect to each Member as provided in Section 3.2 of this Agreement.
“Capital Contribution(s)” shall mean the amount of cash or the agreed value of the property or services (as determined by the Members and the Company) contributed by each Member to the Company as provided in Article 3 of this Agreement.
“Cash Flow” shall mean, for the fiscal year in which such determination is being made, the Company’s net income after taxes from operations, plus depreciation and amortization expense for such fiscal year (as computed for income tax purposes), less principal payments on scheduled indebtedness of the Company during the one-year period ending on the date upon which such determination is being made (excluding payments made under any subordinated promissory notes of the Company and payments scheduled to be made under Section 4.3(c) of this Agreement).
“Code” shall mean the Internal Revenue Code of 1986, as amended. All references to the Code or any regulations adopted thereunder, including Treasury Regulations or Temporary Treasury Regulations, are references to the Code or such regulations as they are in effect on the date hereof.

 

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“Company” shall mean the Delaware limited liability company governed by this Agreement.
“Company Minimum Gain” shall have the same meaning as Percentage Minimum Gain set forth in Treasury Regulation Sections 1 704-2(b)(2) and 1.704-2(d).
“Depreciation” shall mean, for each fiscal year or other period, an amount equal to the depreciation, amortization or other cost recovery deduction allowable with respect to an asset for such year or other period, except that if the Gross Asset Value of an asset differs from its adjusted basis for federal income tax purposes at the beginning of such year or other period, Depreciation shall be an amount which bears the same ratio to such beginning Gross Asset Value as the federal income tax depreciation, amortization, or other cost recovery deduction for such year or other period bears to such beginning adjusted tax basis; provided, however, that if the federal income tax depreciation, amortization, or other cost recovery deduction for such year is zero, Depreciation shall be determined with reference to such beginning Gross Asset Value using any reasonable method selected by the Tax Matters Member.
“Gross Asset Value” with respect to any asset shall mean the asset’s adjusted basis for federal income tax purposes, except as follows:
(i) The initial Gross Asset Value of any asset contributed by a Member to the Company shall be the gross fair market value of such asset, as determined by the Members;
(ii) The Gross Asset Values of all Company assets shall be adjusted to equal their respective gross fair market values, as determined by the Members, at the following times:
(a) the acquisition of an additional interest in the Company by any new or existing Member in exchange for more than a de minimis Capital Contribution;
(b) the distribution by the Company to a Member of more than a de minimis amount of Company property other than money as consideration for an interest in the Company; and
(c) the liquidation of the Company for federal income tax purposes within the meaning of Treasury Regulation Section l.704-I(b)(2)(ii)(9); provided, however, that the adjustments pursuant to clauses (a) and (b) above shall be made only if the Tax Matters Member reasonably determines that such adjustments are necessary or appropriate to reflect the relative economic interests of the Members in the Company.

 

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(iii) The Gross Asset Value of any Company asset distributed to any Member shall be the gross fair market value of such asset on the date of distribution;
(iv) The Gross Asset Values of Company assets shall be increased (or decreased) to reflect any adjustments to the adjusted basis of such assets pursuant to Code Section 734(b) or Code Section 743(b), but only to the extent that such adjustments are taken into account in determining Capital Accounts pursuant to Regulation Section 1.704-1 (b)(2)(iv)(m) and Section 4.3(g) hereof; provided, however, that Gross Asset Values shall not be adjusted pursuant to this clause (iv) to the extent the Tax Matters Member determines that an adjustment pursuant to clause (ii) hereof is necessary or appropriate in connection with a transaction that would otherwise result in an adjustment pursuant to this clause (iv); and
(v) If the Gross Asset Value of an asset has been determined pursuant to subparagraphs (i), (ii) or (iv) hereof, such Gross Asset Value shall thereafter be adjusted by the Depreciation taken into account with respect to such asset for purposes of computing Profits and Losses.
“Managing Member” shall have the meaning set forth in Sections 5.1 and 6.2 of this Agreement.
“Member” shall mean each person listed on attached Exhibit A, and anyone else admitted as a member of the Company. The term “Members” shall mean all of such persons.
“Member Nonrecourse Debt” shall have the same meaning as Member nonrecourse debt set forth in Sections 1.704-2(b)(4) and 1.704-2(i) of the Treasury Regulations.
“Member Nonrecourse Debt Minimum Gain” shall have the same meaning as Member nonrecourse debt minimum gain set forth in Treasury Regulation Section 1.704-2(i) and shall be determined in accordance with the principles of such Section of the Treasury Regulations.
“Member Nonrecourse Deductions” shall have the same meaning as Member nonrecourse deductions set forth in Sections 1.704-2(i)(1) and 1 704-(2)(i)(2) of the Treasury Regulations.
“Nonrecourse Deductions” shall mean deductions having the meaning set forth in Sections 1 704-2(b)(l) and 1.704-2(c) of the Treasury Regulations.
“Percentage Interest” shall mean a Member’s percentage interest on Exhibit A attached hereto and as amended from time to time.
“Person” shall mean any individual, person, corporation, trust or other entity.

 

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“Profits and Losses” shall mean, for each fiscal year or other period, an amount equal to the Company’s taxable income or loss for such year or period, determined in accordance with Code Section 703(a) (for these purposes, all items of income, gain, loss or deduction required to be stated separately pursuant to Code Section 703(a)(l) shall be included in taxable income or loss), with the following adjustments:
(i) Any income of the Company that is exempt from federal income tax and not otherwise taken into account in computing Profits or Losses pursuant to the foregoing shall be added to such taxable income or loss;
(ii) Any expenditures of the Company described in Code Section 705(a)(2)(B) or that are treated as Code Section 705(a)(2)(B) expenditures pursuant to Treasury Regulation Section 1.704-1 (b)(2)(iv)(i) and not otherwise taken into account in computing Profits or Losses pursuant to the foregoing shall be subtracted from such taxable income or loss;
(iii) In the event the Gross Asset Value of any Company asset is adjusted pursuant to clause (ii) or (iii) of the definition of Gross Asset Value, the amount of such adjustment shall be taken into account as gain or loss from the disposition of such asset for purposes of computing Profits or Losses;
(iv) Gain or loss resulting from any disposition of Company property with respect to which gain or loss is recognized for federal income tax purposes shall be computed by reference to the Gross Asset Value of the property disposed of, notwithstanding that the adjusted tax basis of such property differs from its Gross Asset Value;
(v) In lieu of depreciation amortization, and other cost recovery deductions taken into account in computing such taxable income or loss, there shall be taken into account Depreciation for such fiscal year or other period computed in accordance with the definition of Depreciation used herein;
(vi) To the extent an adjustment to the adjusted tax basis of any Company asset pursuant to Code Section 734(b) or Code Section 743(b) is required pursuant to Regulations Section 1.704-l(b)(2)(iv)(m)(4) to be taken into account in determining Capital Accounts as a result of a distribution other than in liquidation of a Member’s interest, the amount of such adjustment shall be treated as an item of gain (if the adjustment increases the basis of the asset) or loss (if the adjustment decreases the basis of the asset) from the disposition of the asset and shall be taken into account for purposes of computing Profits or Losses; and
(vii) Notwithstanding the above, any items that are specially allocated pursuant to Sections 4.3 or 4.4 hereof shall not be taken into account in computing Profits and Losses.

 

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ARTICLE 2
FORMATION AND PURPOSE
2.1 Formation.
The Members hereby form a limited liability company pursuant to the Act. The provisions of the Act shall apply and govern the formation and operation of the Company except to the extent otherwise expressly provided in this Agreement.
2.2 Name.
The name of the Company shall be UNILIFE CROSS FARM LLC. The Company may do business under that name and under any other name or names upon which the Members agree. If the Company does business under a name other than that set forth in its Certificate of Formation, then the Company shall file a fictitious name registration as required by law.
2.3 Registered Office and Principal Place of Business.
The registered office for the Company will be located at Corporation Trust Center, 1209 Orange Street, Wilmington, Delaware 19801 or at such other place within the State of Delaware as the Members may from time to time determine. The Company shall maintain such other offices as the Members shall determine. All correspondence for the Company shall be directed to Unilife Corporation, 633 Lowther Road, Lewisberry, Pennsylvania 17339.
2.4 Purposes.
The general purposes of the Company are to engage in any activity for which limited liability companies may be formed in the State of Delaware. The specific purpose of the Company shall be to purchase, own, operate, manage, mortgage, exchange and/or dispose of an interest in real property located at 250 Cross Farm Lane, Conewago Township, York County, Pennsylvania and to engage in all necessary or desirable activities in connection therewith. The Company shall possess and may exercise all of the powers and privileges granted by the Act, any other law or by this Agreement, together with any powers incidental thereto, so far as such powers and privileges are necessary or convenient to the conduct, promotion or attainment of the business purposes or activities of the Company.
2.5 Execution and Filing of the Certificate.
The Members have filed a Certificate of Formation for the Company (the “Certificate”) with the Delaware Secretary of State. Whenever it is necessary or advisable to amend or restate the Certificate, the Members may timely file an amended Certificate, and the Members shall do and continue to do all other things as may be required or advisable to maintain the Company as a limited liability company existing pursuant to Delaware law and as provided herein.

 

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2.6 Governing Act.
The Company under this Agreement shall be organized pursuant to the Act, as it may be amended from time to time.
2.7 Other Qualifications.
The Company shall exist under the laws of the State of Delaware and, to the extent that the business of the Company is conducted in any jurisdiction other than Delaware, shall obtain qualification to do business under the laws of such other jurisdiction(s) as determined by the Members.
ARTICLE 3
CAPITAL CONTRIBUTIONS
3.1 Initial Capital Contributions of Members.
Upon the execution of this Agreement, each Member shall contribute cash, tangible or intangible property, services rendered, or a promissory note or other obligation to contribute cash or property or to perform services to the Company in proportion to the Member’s Percentage Interest as shown on Exhibit A attached hereto. The initial capital contribution to the Company by the Members shall be One Hundred Dollars ($100.00), pro rata as per the Members’ interests.
3.2 Capital Accounts.
For tax purposes, a separate Capital Account shall be established and maintained for each Member in accordance with Code Section 704 and Treasury Regulation Section 1.704-1(b) and the following provisions:
(i) Generally, the Capital Account of a Member shall consist of the Member’s initial Capital Contribution increased by: (a) any additional Capital Contributions in cash; (b) the fair market value of any Capital Contribution of property in kind (net of liabilities securing such contributed property that the Company is considered to assume or take subject to, under Section 752 of the Code); and (c) such Member’s share of Company Profits (or items thereof allocated pursuant to Article 4), including income and gain exempt from tax, and decreased by (w) distributions in cash to such Member; (x) the fair market value of property distributed in kind to such Member (net of liabilities securing such distributed property that such Member is considered to assume or take subject to, under Section 752 of the Code); (y) such Member’s share of Company Losses allocated pursuant to Article 4; and (z) such Member’s share of expenditures of the Company described or treated as described in Section 705(a)(2)(B) of the Code.

 

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(ii) If any interest in the Company, or a portion thereof is transferred in accordance with this Agreement, the transferee shall succeed to the Capital Account of the transferor to the extent it relates to the transferred interest.
(iii) The foregoing provisions and other provisions of this Agreement relating to the maintenance of Capital Accounts are intended to comply with Treasury Regulation Section 1.704-1(b) and shall be interpreted and applied in a manner consistent with such Regulations.
3.3 No Return of or Interest on Capital; No Partition.
Except as specifically provided in this Agreement, no Member may withdraw any amount from his Capital Account or be paid interest on his Capital Contributions or his Capital Account. No Member shall have any personal liability for the repayment of any Capital Contributions of any other Member. Each Member waives any right to partition Company property. The foregoing shall not constitute a waiver of any Member’s rights upon dissolution of the Company.
3.4 Additional Capital Contributions.
No Member shall be required to make any additional capital contribution to the Company or to restore any deficit in such Member’s Capital Account, except as provided in this Agreement, and such deficit, if any, shall not be considered a debt owed to the Company or to any other person for any purpose.
3.5 Ownership Interests.
The interests of the Members in the Company shall be personal property for all purposes.
ARTICLE 4
DISTRIBUTIONS TO MEMBERS AND ALLOCATIONS OF PROFITS AND LOSSES
4.1 Profits and Losses.
(a) After giving effect to the special allocations set forth in Sections 4.3 and 4.4 hereof, Profits and Losses for any fiscal year shall be allocated in accordance with the Members’ respective Percentage Interests.
(b) Notwithstanding subsection (a) and after application of Treasury Regulation Section I.704-1 (b)(2)(ii)(d), no such Losses shall be allocated to a Member which would cause such Member to have an Adjusted Capital Account Deficit at the end of any fiscal year if, at the time, any other Member has a positive Capital Account balance. Any Losses not allocated to a Member due to the foregoing limitation shall be specially allocated to the Members with positive Capital Account balances in proportion to such Capital Account balances until all such Capital Account balances have been reduced to zero and any remainder shall be allocated to Members in accordance with their respective Percentage Interests.

 

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4.2 Distributions.
All existing net cash flow shall, after providing for a reserve as determined by the Members, be used to make a distribution in cash to the Members in proportion to their Percentage Interests, as set forth in Exhibit A, no less frequently than annually.
4.3 Special Allocations.
The following special allocations shall be made in the following order:
(a) Minimum Gain Chargeback. Notwithstanding any other provision of this Article 4, if there is a net decrease in Company Minimum Gain during any Company taxable year, each Member shall be specially allocated items of Company income and gain for such year (and, if necessary, subsequent years) in accordance with Treasury Regulation Section 1 704-2(f). Allocations pursuant to the previous sentence shall be made in proportion to the respective amounts required to be allocated to each of such Members pursuant thereto. The items to be so allocated shall be determined in accordance with Section 1.704-2(f) of the Treasury Regulations. This Section 4.3(a) is intended to comply with the minimum gain chargeback requirement in such Section of the Regulations and shall be interpreted consistently therewith.
(b) Member Minimum Gain Chargeback. Notwithstanding any other provision of this Article 4 except Section 4.3(a), if there is a net decrease in Member Nonrecourse Debt Minimum Gain attributable to a Member Nonrecourse Debt during any Company fiscal year, each Member who has a share of the Member Nonrecourse Debt Minimum Gain attributable to such Member Nonrecourse Debt, determined in accordance with Treasury Regulation Section 1.704-2(i)(5), shall be specially allocated items of Company income and gain for such year (and, if necessary, subsequent years) in accordance with Treasury Regulation Section 1.704-2(i)(4). Allocations pursuant to the previous sentence shall be made in proportion to the respective amounts required to be allocated to each of such Members pursuant thereto. The items to be so allocated shall be determined in accordance with Section 1.704-2(i)(4) of the Treasury Regulations. This Section 4.3(b) is intended to comply with the minimum gain chargeback requirement in such Section of the Regulations and shall be interpreted consistently therewith.
(c) Qualified Income Offset. In the event any Member who is not obligated (or treated as obligated) to restore a deficit balance in its Capital Account unexpectedly receives any adjustments, allocations, or distributions described in Regulation Section 1.704-1(b)(2)(ii)(d)(4), 1.704-1(b)(2)(ii)(d)(5) or I.704-l(b)(2)(ii)(d)(6), items of Company income and gain shall be specially allocated to each such Member in an amount and manner sufficient to eliminate, to the extent required by the Regulations, the Adjusted Capital Account Deficit of such Member as quickly as possible, provided that an allocation pursuant to this Section 4.3(c) shall be made if and only to the extent that such Member would have an Adjusted Capital Account Deficit after all other allocations provided for in this Article 4 have been tentatively made as if this Section 4.3(c) were not in this Agreement.

 

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(d) Gross Income Allocation. In the event any Member has a deficit Capital Account at the end of any Company fiscal year that is in excess of the sum of (i) the amount such Member is obligated to restore, and (ii) the amount such Member is deemed to be obligated to restore pursuant to Sections 1.704-2(g)(l) and 1.704-2(i)(5) of the Treasury Regulations, each such Member shall be specially allocated items of Company income and gain in the amount of such excess as quickly as possible, provided that an allocation pursuant to this Section 4.3(d) shall be made if and only to the extent that such Member would have a deficit Capital Account balance in excess of such sum after all other allocations provided for in this Article 4 have been tentatively made as if this Section 4.3(d) were not in this Agreement.
(e) Nonrecourse Deductions. Nonrecourse Deductions for any taxable year or other period shall be allocated among the Members in proportion to their respective Percentage Interests.
(f) Member Nonrecourse Deductions. Any Member Nonrecourse Deductions for any fiscal year or other period shall be specially allocated to the Member who bears the economic risk of loss with respect to the Member Nonrecourse Debt to which such Member Nonrecourse Deductions are attributable in accordance with Treasury Regulation Section 1.704-2(i).
(g) Section 754 Adjustment. To the extent an adjustment to the adjusted tax basis of any Company asset pursuant to Code Section 734(b) or Code Section 743(b) is required, pursuant to Treasury Regulation Section 1.704-1(b)(2)(iv)(m), to be taken into account in determining Capital Accounts, the amount of such adjustment to the Capital Accounts shall be treated as an item of gain (if the adjustment increases the basis of the asset) or loss (if the adjustment decreases such basis) and such gain or loss shall be specially allocated to the Members in a manner consistent with the manner in which their Capital Accounts are required to be adjusted pursuant to such Section of the Regulations.
4.4 Curative Allocations.
The allocations set forth in Sections 4.1(b) and 4.3 hereof (the “Regulatory Allocations”) are intended to comply with certain requirements of Treasury Regulation Section 1.704-1(b). It is the intent of the Members that, to the extent possible, all Regulatory Allocations shall be offset either with other Regulatory Allocations or with special allocations of other items of Company income, gain, loss or deduction pursuant to this Section 4.4. Therefore, notwithstanding any other provision of this Article 4 (other than the Regulatory Allocations), the Members shall make such offsetting special allocations of Company income, gain, loss and deduction in whatever manner they determine appropriate so that, after such offsetting allocations are made, each Members’ Capital Account balance is, to the extent possible, equal to the Capital Account balance such Member would have had if the Regulatory Allocations were not part of the Agreement and all Company items were allocated pursuant to Section 4.1(a) hereof. In exercising their discretion under this Section 4.4, the Members shall take into account future Regulatory Allocations under Sections 4.3(a) and 4.3(b) that, although not yet made, are likely to offset other Regulatory Allocations previously made under Sections 4.3(e) and 4.3(g).

 

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4.5 Tax Allocations: Code Section 704(c).
In accordance with Code Section 704(c) and the Regulations thereunder, income, gain, loss and deduction with respect to any property contributed to the capital of the Company shall, solely for tax purposes, be allocated among the Members so as to take account of any variation between the adjusted basis of such property to the Company for federal income tax purposes and its initial fair market value. Allocations pursuant to this Section 4.5 are solely for purposes of federal, state and local taxes and shall not affect, or in any way be taken into account in computing, any Member’s Capital Account or share of Profits, Losses, other items or distributions pursuant to any provision of this Agreement.
4.6 Miscellaneous.
(a) For purposes of determining the Profits, Losses or any other items allocable to any period, Profits, Losses and any such other items shall be determined on a daily, monthly or other basis, as determined by the Board using any permissible method under Code Section 706 and the Regulations promulgated thereunder.
(b) Except as otherwise provided in this Agreement, all items of Company income, gain, loss, deduction and any other allocations not otherwise provided for shall be divided among the Members in the same proportions as they share Profits or Losses, or, as the case may be, for the year.
(c) The Members are aware of the income tax consequences of the allocations made by this Article 4 and hereby agree to be bound by the provisions of this Article 4 in reporting their shares of Company income or loss for income tax purposes.
(d) Solely for the purpose of determining each Member’s share of excess nonrecourse liabilities pursuant to Treasury Regulation Section 1 752-3(a)(3), each Member’s interest in Company Profits is hereby specified to be such Member’s Percentage Interest.

 

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4.7 Establishment of Reserve.
The Members shall have the right and obligation to establish reasonable reserves based on generally accepted accounting principles for acquisitions, capital expenditures and other contingencies, such reserves to be funded with such portion of the revenues of the Company for any fiscal year as the Members may deem necessary or appropriate for that purpose.
4.8 Amounts Withheld.
All amounts withheld pursuant to the Code or any provision of any state or local tax law with respect to any payment, distribution or allocation to the Company or the Members shall be treated as amounts distributed to the Members pursuant to this Article 4 for all purposes under this Agreement. The Members agree to withhold from distributions, or with respect to allocations, to the Members and to pay over to any federal, state or local government any amounts required to be so withheld pursuant to Code or any provision of any other federal, state or local law and shall allocate any such amounts to the Members with respect to which such amount was withheld.
ARTICLE 5
MANAGEMENT
5.1 Rights and Duties of Members.
The Company shall be managed by the Members. The Members shall, from time to time, designate certain individuals as officers and authorize them to act on behalf of the Company, in accordance with the instructions of the Members. Such individuals need not be Members of the Company. Each Member shall designate an individual who shall be authorized to act on behalf of such Member with respect to the Company, and each Member shall, from time to time, advise the Company and each other Member of the names and offices of the persons authorized to act with respect to the Company on behalf of such Member. Until such time as otherwise directed by the Members in writing, Unilife Corporation shall be the “Managing Member” with the sole and exclusive authority to bind the Company. No other Member shall have the right to act for or bind the Company.
5.2 Exculpation.
No Member as such or any officer, employee or agent of any Member or the Company shall be liable to the Company or any Member for losses or liabilities arising from the conduct of the affairs of the Company or from the conduct of any employee or agent of the Company.

 

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5.3 Indemnification of the Members.
(a) The Company shall indemnify and hold harmless the Members and each person who shall serve at any time as a representative of a Member or an officer of the Company against all damages, losses, fines, costs and expenses (including attorneys’ fees and disbursements) resulting from or relating in any way to any claim or demand made or threatened, or any action, proceeding or investigation commenced or threatened, omitted to have been taken (or alleged to have been taken or omitted to have been taken) by such person in connection with the organization, business or other affairs of the Company (including any amounts paid or property transferred, and all costs and expenses, including attorneys’ fees and disbursements, incurred in connection with any settlement of any such claim, action, proceeding, or investigation), except that such indemnification shall be made only if such action or omission of such person satisfies the requirements of the Act with respect to the matter or matters as to which indemnity is sought.
(b) For the purposes of Section 5.3(a) hereof, the determination that the action or omission of any person satisfies the requirements of the Act shall be made by a court of competent jurisdiction or other body before which the relevant action, proceeding or investigation is pending. In the absence of a determination by such court or other body, such determination may be made by legal counsel to the Company in a written legal opinion to the Company.
5.4 Holding of Property.
Property owned by the Company shall be held in the name of the Company or in nominee name.
5.5 Loans.
Any person may, with the consent of the Members, lend or advance money to the Company. If any Member shall make any loan or loans to the Company or advance-money on its behalf, the amount of any such loan or advance shall not be treated as a Capital Contribution but shall be a debt due from the Company. The amount of any such loan or advance by a lending Member shall be repayable out of the Company’s cash and shall bear interest at such rate as the lending Member and other Members shall agree but not in excess of the maximum rate permitted by law. None of the Members shall be obligated to make any loan or advance to the Company.
ARTICLE 6
RIGHTS AND OBLIGATIONS OF MEMBERS; MEETINGS
6.1 Liability of Members.
(a) No Member shall have any personal liability with respect to the liabilities or obligations of the Company, except to the extent that such Member expressly and voluntarily assumes in writing any obligations of the Company; and
(b) No Member shall be personally liable or obligated, except as otherwise required by the Act, to return to the Company or to pay any creditor or any other Member the amount of any return of its Capital Contribution to it or other distribution made to it.

 

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6.2 Voting Rights.
The Members shall each have the number of votes corresponding to their respective Percentage Interests on any Company matter, except as otherwise specifically provided in this Agreement. Any action to be taken by the Members may be taken at a meeting held in accordance with Section 6.3 hereof or by consent in writing in accordance with this Section 6.2. Each Member who is entitled to vote or consent may vote or consent by a signed writing or a signed written consent directing the manner in which it desires that its vote be cast, except that any Member who fails to respond to any notice of meeting within twenty (20) days after hand delivery or the mailing thereof by certified or registered mail shall be deemed not to have consented to or approved any action proposed. Notwithstanding the foregoing, the Members authorize the Managing Member to act on behalf of and bind the Company in the ordinary course of business without the necessity of membership meeting, vote or further consent.
6.3 Company Meetings.
(a) Meetings of the Company may be called by a Member holding at least fifty percent of the aggregate Percentage Interests in the Company upon no less than five (5) days but no more than twenty (20) days notice in writing to the other Member(s).
(b) Members may participate in meetings by means of conference telephone calls in which all Members participating in the meeting can hear each other. Any vote may be cast in person, by telephone or by proxy. Proxies shall be valid only if in writing.
At any Company meeting, the presence in person or by telephone or proxy of Members representing at least fifty-one percent of the aggregate Percentage Interests in the Company shall constitute a quorum. Except as otherwise provided herein, the business of the Company presented at any meeting shall be decided by the vote of at least fifty-one percent of the aggregate Percentage Interests in the Company in favor of the action proposed. Alternatively, actions of the Company may be taken without a meeting by unanimous written consent of the Members.
6.4 Waiver of Fiduciary Duty; Company Opportunities.
This Agreement is not intended to, and does not, create or impose any fiduciary duty on the Managing Member or its respective Affiliates by virtue of its managing control or majority percentage interest. Further, all other Members hereby waive any and all fiduciary duties that, absent such waiver, may be implied by Law, and in doing so, recognizes, acknowledges and agrees that the duties and obligations of the Managing Member to the other Members and to the Company are only as expressly set forth in this Agreement. Each Member acknowledges that other Members own and/or manage other businesses, including businesses that may compete with the Company. Neither any Member nor its Affiliates, and their respective officers, directors, shareholders, partners, members, agents and employees, shall not in any way be prohibited or restricted from engaging or investing in, independently or with others, any business opportunity of any type or description, including, without limitation, those business opportunities that might be the same or similar to the Business and neither the Company, or any other Member and their Affiliates, and their respective officers, directors, shareholders, partners, members, agents and employees, shall have any right in or to such other business opportunities or to the income or proceeds derived therefrom.

 

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6.5 [Intentionally Deleted].
6.6 Additional Members.
Additional Members may be admitted to the Company upon receiving the consent of the existing Members. The terms of admission may provide for the creation of different classes or groups of Members having different rights, powers, and duties.
ARTICLE 7
ACCOUNTING
7.1 Books and Records.
The Managing Member shall keep, or cause to be kept, true, exact and complete books of account of the Company’s affairs, in which shall be entered fully and accurately each transaction of the Company and of each entity that it controls. The books of account shall be kept on a basis as determined by the Members. Such books of account, together with all correspondence, papers and other documents, shall be kept at the principal office of the Company and shall be, at all reasonable times, open to the examination of any of the Members or their duly authorized representatives. Except as otherwise provided herein, all financial books and records of the Company and of each entity which it controls shall be kept, and all financial statements furnished to the Members hereunder shall be prepared, in accordance with generally accepted accounting principles consistently applied as modified by tax basis accounting or such other basis as the Members may determine.
7.2 Fiscal Year.
The fiscal year and the taxable year of the Company shall end as of December 31 of each year.
7.3 Tax and Financial Reports.
(a) Not later than April 1 after the end of each fiscal year, each Member shall be provided with an information letter with respect to its distributive share of income, gain, deduction, losses and credits, as the case may be, for income tax reporting purposes for the previous fiscal year, together with any other information concerning the Company necessary for the preparation of a Member’s income tax return, including Form K-1 from the Company.

 

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(b) The Managing Member shall prepare or cause to be prepared all federal, state and local tax returns of the Company for each year for which such returns are required to be filed. The “Tax Matters Member” designated in Section 7.5 shall promptly notify all other Members of any Company audits by the US Internal Revenue Service or any state or local taxing authority.
(c) The Managing Member shall cause to be distributed to the Members, not later than April 1 after the end of each fiscal year, a balance sheet and income statement prepared for the prior calendar year in accordance with generally accepted accounting principles consistently applied.
7.4 Company’s Accounting Firm.
The Company’s accounting firm shall be such firm of independent certified public accountants as the Members may select from time to time.
7.5 Tax Matters Member.
To the extent necessary under the Code, the Managing Member is hereby designated as the “Tax Matters Member” in accordance with Section 6231(a)(7) of the Code and, in connection therewith and in addition to all other powers given thereunder, shall have all other powers needed to perform fully hereunder, including, without limitation, the power to retain all attorneys and accountants of its choice. The Tax Matters Member shall give notice to each other Member of a Company audit. The designation made in this Section 7.5 is hereby expressly consented to by each Member as an express condition to becoming a Member.
ARTICLE 8
TERM AND DISSOLUTION
8.1 Term.
The term of the Company shall commence as of the date of this Agreement and shall continue until termination pursuant to the provisions hereof.

 

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8.2 Events Causing Termination.
Except as otherwise provided herein, the Company shall be dissolved and shall terminate, and its affairs shall be wound up, upon the occurrence of any of the following:
(i) The vote of the Members;
(ii) The sale or other disposition of all or substantially all of the assets of the Company; or
(iii) An event of dissolution under the Act.
provided, however, that in the event there are no Members of the Company, the Personal Representative (as defined in the Act) shall have the right, within ninety (90) days after the event which terminated the continuing membership of the last remaining Member (the “Termination Date”), to agree in writing to continue the Company and to admit itself or some other Person as a Member effective as of the Termination Date, whereupon the Company shall not be dissolved and its affairs shall not be wound up.
8.3 Actions of Members.
No action of or event affecting a Member shall dissolve or terminate the Company unless specifically provided in Section 8.2 of this Agreement.
8.4 Distribution in Case of Termination.
Upon the termination of the Company, the Members, or such liquidating agent as such Members may appoint, shall proceed to wind up the affairs of the Company, unless within ninety (90) days after such event all of the remaining Members agree in writing to continue the Company, in the following order of priority:
(a) To the payment of the debts and liabilities of the Company and the expenses of liquidation in the order of priority as provided by the Act, and to the establishment of any reserves which the Members or liquidating agent shall deem reasonably necessary for any contingent or unforeseen liabilities or obligations of the Company. Said reserves may be paid over by the Members or liquidating agent to a bank or an attorney-at-law to be held in escrow for the purpose of paying any such contingent or unforeseen liabilities or obligations, and at the expiration of such period as the Members or liquidating agent shall deem advisable, such reserves shall be distributed to the Members or their assigns in the order of priority provided in this Section 8.4;
(b) To the Members in proportion to the credit balance in each of their Capital Accounts, after giving effect to all contributions, distributions and allocations for all periods.
Liquidation shall be conducted in accordance with the timing requirements of Section 1.704-1(b)(2) of the Treasury Regulations. No Member shall be liable to restore, or pay to the Company, any deficit in such Member’s Capital Account. The Company shall terminate when all property owned by Company shall have been disposed of and the net proceeds, after satisfaction of liabilities to creditors, shall have been distributed among the Members as aforesaid. The establishment of any reserves in accordance with the provisions of subsection 8.4(a) shall not have the effect of extending the term of the Company.

 

17


 

8.5 Rights of Members on Liquidation.
Except as otherwise provided in this Agreement, (i) each Member shall look solely to the assets of the Company for the return of its Capital Contributions and shall have no right or power to demand or receive property other than cash from the Company and (ii) no Member shall have priority over any other Member as to the return of its Capital Contributions, distributions or allocations.
ARTICLE 9
TRANSFER OF COMPANY INTERESTS
9.1 Transfer of Interests Generally.
Except as otherwise expressly provided herein, the Members shall not have the right to transfer or assign their interests in the Company and any such purported transfer or assignment shall be void ab initio, unless all of the Members agree to such transfer or assignment. A transfer shall include a voluntary or involuntary sale, exchange, assignment, gift, pledge, hypothecation, or other encumbrance or disposition. The Company shall not be required to transfer on its records any Company interest that has been purported to have been sold or transferred, but in violation of this Agreement, or to treat such purported owner, holder, or assignee as a Member or as having any economic rights in the Company. Each Member hereby acknowledges the reasonableness of the restrictions on the transfer of the interests in the Company imposed by this Agreement in view of the Company purposes and the relationship of the Members. Accordingly, the restrictions on transfer contained herein shall be specifically enforceable.
9.2 Sale or Liquidation of Percentage Interest.
A Member may sell or transfer his Percentage Interest subject to the following provisions:
(a) The remaining Members shall each have the first option to purchase a share of the Percentage Interest of the selling Member or to cause the Company to liquidate the Percentage Interest of the selling Member prior to said Percentage Interest being sold to a third party.
(b)(I) Each remaining Member may elect to purchase a share of the Percentage Interest of the selling Member equal to the ratio that his Percentage Interest bears to the total of the Percentage Interests of all remaining Members. If a remaining Member does not elect to purchase a portion of the Percentage Interest of the selling Member, the other remaining Members may elect to purchase that portion of the Percentage Interest of the selling Member in the ratio which the Percentage Interest of each such other remaining Member bears to the Percentage Interest of all such other remaining Members. Notwithstanding the foregoing, the remaining Members may elect to purchase such portion of the Percentage Interest of the selling Member as they may mutually agree upon.

 

18


 

(b)(2) A decision by the remaining Members to have the Company liquidate the Percentage Interest of the selling Member shall be in writing and signed by all remaining Members.
(c) The price for a Percentage Interest shall be the net fair market value of the Company property multiplied by the Percentage Interest of the selling Member or, if the selling Member has received a bona fide written third party offer to purchase his interest, then the purchase price stated in such offer. The net fair market value of the Company property shall be the net book value of the Company assets increased to reflect the fair market value of Company assets that have a fair market value greater than their cost less depreciation. The net fair market value of any Company real estate and equipment shall be determined by an appraiser selected by agreement of the Members or their authorized representatives.
(d) In the event any dispute should arise hereunder, such dispute shall be submitted to binding arbitration in accordance with the provisions of Section 9.4 hereof.
(e) The terms of any sale or liquidation hereunder shall be as follows:
(1) The Member who wishes to sell or transfer shall give written notice thereof to the other Members including, if applicable, a copy of the written offer of any third party purchaser.
(2) The other Members shall have a period of thirty (30) days after such notification within which to notify the selling Member of their intent to purchase or cause a liquidation of the Percentage Interest.
(3) Failure of the other Members to notify the selling Members within said thirty (30) day period shall render the Percentage Interest saleable to a third party for a period of sixty (60) days, and if not sold within that period, it shall once again become subject to this Agreement. Provided, however, that a Percentage Interest may not be sold or transferred to a third party without the written consent of the non-selling Members, which consent shall not be unreasonably withheld. Provided, further, that any sale to a third party shall be at a purchase price not less than that stated in a written offer communicated to the remaining Members pursuant to subparagraph (1) of this subsection (e) or, if no such offer was communicated to the remaining Members, the fair market value of the Percentage Interest.

 

19


 

(4) The purchase price of the Percentage Interest purchased by the Company and/or each of the remaining Members shall be paid as follows:
(i) The Company or purchasing Member shall pay in cash or by certified check an amount equal to one-sixth (1/6) of the purchase price at the time of Settlement. The Company’s or the purchasing Member’s obligation to pay the remaining purchase price shall be evidenced by a note, delivered at Settlement and payable to the selling Member, the principal amount of which shall equal the balance of the purchase price. The promissory note shall provide for five (5) equal installments of principal and interest, payable on the first through the fifth anniversary dates of the Settlement. The promissory note shall bear interest at a rate equal to the then-current prime rate of interest plus one percent per annum and may be prepaid without premium or penalty.
(ii) Settlement shall be held within sixty (60) days after the remaining Members receive notice of the intention to sell or transfer a Percentage Interest at a time and place agreed to by the parties.
(iii) Upon the delivery of the promissory note, the selling Member shall execute and deliver to the Company or purchasing Member(s) such documents as may be reasonably required to evidence the liquidation or transfer of his Percentage Interest.
(iv) Nothing contained in this subparagraph (4) shall prevent the Members from mutually agreeing upon some other terms of payment.
9.3 Transfer of Percentage Interests to Related Parties.
Notwithstanding the provisions of Section 9.1 of this Agreement or any other provisions hereof, a Member may, at any time, without the consent of and without creating a right of first refusal in the remaining Members or the Company, transfer all or any part of its Percentage Interest to an entity owned or controlled by the same persons owning or control such Member. Any Percentage Interest thus transferred shall, in the hands of each transferee, be subject to the terms and conditions of this Agreement.
9.4 Arbitration.
The parties agree that in the event any disagreement or dispute shall arise pertaining to the terms of Sections 9.1 and 9.2, all matters in controversy shall be submitted to a board of arbitrators consisting of three members, one of whom shall be chosen by the selling Member, one of whom shall be chosen by the remaining Members, and the third shall be chosen by the two designees. The parties to this Agreement, for themselves, their heirs, executors and assigns, agree to be bound by the decision of the board of arbitrators and accept its decision as a final determination.
9.5 Indemnity.
If a Member shall, or shall attempt to, sell, assign, transfer, pledge, subject to any security interest, or otherwise dispose of his/its Company interest, such Member shall indemnify and hold harmless the other Members and the Company against and from any and all liabilities, obligations, costs and expenses the other Member(s) or the Company may incur as a result of such failure.

 

20


 

9.6 Drag-Along Rights.
(a) Except as otherwise provided in this Agreement, if, at any time after the date hereof, the Managing Member (the “Drag-Along Transferring Member”) desires to Transfer a Percentage Interest owned by such Member to a third party (whether for cash, securities or a combination of both), then, if requested by the Drag-Along Transferring Member, each other Member (a “Drag-Along Participant”) shall be required to sell a percentage of its Percentage Interests equal to the percentage of Percentage Interests owned by the Drag-Along Transferring Member that are being sold by the Drag-Along Transferring Member.
(b) The consideration to be received by each Drag-Along Participant in the transaction contemplated by Section 9.6(a) (the “Drag Transaction”) shall be the same form and amount of consideration per Percentage Interest to be received by the Drag-Along Transferring Member(s), and the terms and conditions of such sale shall be the same as those upon which the Drag-Along Transferring Member(s) sells its Percentage Interests. If the Drag-Along Transferring Member(s) are given an option as to the form and amount of consideration to be received, all Drag-Along Participants will be given the same option.
(c) The Drag-Along Transferring Member(s) shall provide written notice (the “Drag-Along Notice”) to each Drag-Along Participant of any proposed Drag Transaction not less than 10 days prior to the consummation of the Drag Transaction. The Drag-Along Notice shall set forth the consideration to be paid by the purchaser for the Percentage Interests in the Drag Transaction, the name of the proposed purchaser and the other material terms of the Drag Transaction.
(d) In connection with the Drag Transaction, each Drag-Along Participant will agree to make the same customary representations, covenants, indemnities and agreements as the Drag-Along Transferring Member(s).
(e) At least 10 days prior to the anticipated consummation of the Drag Transaction, each Drag-Along Participant shall deliver to the Company to hold in escrow pending transfer of the consideration in respect thereof and the consummation of the Drag Transaction in accordance with its agreed terms and conditions (i) such documents as are necessary to convey to the applicable purchaser the Percentage Interests to be Transferred by such Drag-Along Participant, in form and substance reasonably satisfactory to such purchaser and (ii) a limited power-of-attorney authorizing the Company to take all actions necessary to Transfer such securities in such Drag Transaction. In the event that a Drag-Along Participant should fail to deliver such documents and power-of- attorney, the Company shall cause the books and records of the Company to show that such Percentage Interests are bound by the provisions of this Section 9.6 and that the Transfer of such Percentage Interests to the purchaser in such sale may be effected without such Drag-Along Participant’s consent.

 

21


 

(f) The closing of the Drag Transaction shall be held at such place and on such date as determined by the Drag-Along Transferring Member(s) and the proposed purchaser, but in no event later than 120 days (or longer, if the Hart-Scott-Rodino Act so requires) after delivery of the Drag-Along Notice required to be delivered pursuant to Section 9.6(c). Upon the consummation of the Drag Transaction, the purchaser shall remit directly to each Drag-Along Participant, by wire transfer if available and if requested by the Drag-Along Participant, the consideration for such Drag-Along Participant’s Percentage Interests sold pursuant thereto.
9.7 Tag-Along Rights.
(a) In the event that the Managing Member (the “Tag-Along Transferring Member(s)”) shall Transfer Percentage Interests then held by such Member (except for Transfers by the Managing Member not in the nature of a liquidation or realization of its investment, such as a transfer involving a Transfer to an Affiliate or in the context of a reorganization or the Managing Member’s investment in the Company, or transaction of a similar nature) (a “Tag-Along Sale”) to a third party or third parties, the other B Members (the “Tag-Along Participants”) shall have the right and option, but not the obligation, to sell the same percentage of the total number of Percentage Interests held by the respective Tag-Along Participants as the percentage of the total Percentage Interests held by the Tag-Along Transferring Member that are being sold, on the terms and conditions set forth in this Section 9.7.
(b) The consideration to be received by each Tag-Along Participant in the transaction contemplated by Section 9.7(a) (the “Tag Transaction”) shall be the same form and amount of consideration per Percentage Interest to be received by the Tag-Along Transferring Member(s), and the terms and conditions of such sale shall be the same as those upon which the Tag-Along Transferring Member(s) sells its Percentage Interests. If the Tag-Along Transferring Member(s) is given an option as to the form and amount of consideration to be received, all Tag-Along Participants will be given the same option.
(c) The Tag-Along Transferring Member(s) shall provide written notice (the “Tag-Along Notice”) to each Tag-Along Participant of any proposed Tag Transaction not less than 10 days prior to the consummation of the Tag Transaction. The Tag-Along Notice shall set forth the consideration to be paid by the purchaser for the Percentage Interests in the Tag Transaction, the name of the proposed purchaser and the other material terms of the Tag Transaction.

 

22


 

(d) In connection with the Tag Transaction, each Tag-Along Participant will agree to make the same customary representations, covenants, indemnities and agreements as the Tag-Along Transferring Member(s).
(e) At least 10 days prior to the anticipated consummation of the Tag Transaction, each Tag-Along Participant shall deliver to the Company to hold in escrow pending transfer of the consideration in respect thereof and the consummation of the Tag Transaction in accordance with its agreed terms and conditions (i) such documents as are necessary to convey to the applicable purchaser the Percentage Interests to be Transferred by such Tag-Along Participant, in form and substance reasonably satisfactory to such purchaser and (ii) a limited power-of-attorney authorizing the Company to take all actions necessary to Transfer such securities in such Tag Transaction. In the event that a Tag-Along Participant should fail to deliver such documents and power-of-attorney, the Company shall cause the books and records of the Company to show that such Percentage Interests are bound by the provisions of this Section 9.7 and that the Transfer of such Percentage Interests to the purchaser in such sale may be effected without such Tag-Along Participant’s consent.
(f) The closing of the Tag Transaction shall be held at such place and on such date as determined by the Tag-Along Transferring Member(s) and the proposed purchaser, but in no event later than 120 days (or longer, if the Hart-Scott-Rodino Act so requires) after delivery of the Tag-Along Notice required to be delivered pursuant to Section 9.7(c). Upon the consummation of the Tag Transaction, the purchaser shall remit directly to each Tag-Along Participant, by wire transfer if available and if requested by the Tag-Along Participant, the consideration for such Tag-Along Participant’s Percentage Interests sold pursuant thereto.
ARTICLE 10
GENERAL PROVISIONS
10.1 Binding Effect and Benefit of This Agreement.
This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns, as the case may be.
10.2 Agreement
The titles of the Articles and Sections herein have been inserted as a matter of convenience of reference only and shall not control or affect the meaning or construction of any of the terms or provisions hereof. At the expense of the Company, the Members shall promptly have prepared, executed and filed or recorded all legally required fictitious name or other applications, registrations, publications, certificates and affidavits for filing with the proper governmental authorities and have arranged for the proper advertisement, publication and filing of record thereof.

 

23


 

10.3 Notices, etc.
Except as otherwise expressly provided herein, all notices that are required or contemplated by this Agreement shall be in writing. Delivery of such notices shall be deemed to be made when the same are either personally served upon the person entitled thereto or sent by telecopy (fax) to such person (with receipt acknowledged by the person receiving such telecopy) or three (3) days after being deposited in the mails, by certified or registered mail, with postage prepaid, addressed to such person at its mailing address as shown on the Company’s records as changed by notice to parties hereto in accordance herewith.
10.4 Integration; Termination.
This Agreement represents the entire understanding of the parties with respect to the subject matter hereof. No termination, revocation or waiver of this Agreement shall be binding unless in writing and signed by all Members.
10.5 Interpretation.
This Agreement shall be interpreted and construed in accordance with the laws of the State of Delaware without regard to its conflicts of laws provisions, but shall not be construed against the drafter of this Agreement. As used in this Agreement, the neuter, masculine and/or feminine gender shall include the neuter, masculine or feminine gender as required by the context of the sentence and the plural shall include the singular wherever appropriate.
10.6 Counterparts.
The parties hereto may execute this Agreement in any number of counterparts, each of which, when executed and delivered, shall be an original; but all such counterparts shall constitute one and the same instrument.
10.7 Severability of Provisions.
Each provision of this Agreement shall be considered severable. If for any reason any provision or provisions hereof are determined to be illegal or invalid, such illegality or invalidity shall not impair the operation of or affect those portions of this Agreement that are valid and this Agreement shall be construed in all respects as if such invalid or illegal provision was omitted.
10.8 Amendments.
This Agreement may be amended by the unanimous vote of the Members and any such amendment approved in accordance with the foregoing shall be provided to all of the Members in written form; provided, however, this Agreement may not be amended without the unanimous written consent of each Member adversely affected thereby if such amendment would (i) modify the limited liability of a Member, or (ii) alter the interest of a Member in the Profits, Losses, or distributions of the Company.

 

24


 

10.9 Subject to Purchase Agreement.
Notwithstanding anything to the contrary contained in this Agreement, the Company is bound by the provisions of the Purchase Agreement and is authorized to take the actions set forth therein.
IN WITNESS WHEREOF, the parties have caused this Operating Agreement to be executed as of the day and year first above written.
         
WITNESS:
  MEMBERS:    
 
       
 
  Unilife Corporation    
 
       
 
  /s/ Alan Shortall    
 
 
 
By:    Alan Shortall
   
 
  Title: CEO    

 

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EXHIBIT A
         
Members   Percentage Interest  
 
       
Currently:
       
Unilife Corporation
    100 %
 
       
Upon performance of the Purchase Agreement:
       
Unilife Corporation
    99 %
Cross Farm, LLC
    1 %

 

26

EX-10.27 13 c93531exv10w27.htm EXHIBIT 10.27 Exhibit 10.27
Exhibit 10.27
UNILIFE MEDICAL SOLUTIONS LIMITED
SHARE PURCHASE AGREEMENT
                                         , 2009

 

 


 

UNILIFE MEDICAL SOLUTIONS LIMITED
SHARE PURCHASE AGREEMENT
THIS SHARE PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of                     , 2009, by and between UNILIFE MEDICAL SOLUTIONS LIMITED, a public company incorporated under the laws of Australia, and registered under ABN 14 008 071 403 (the “Company”), and the person whose name is set forth on Exhibit A attached hereto (the “Purchaser”).
Recitals
Whereas, the Company will seek to issue up to (i) 47,058,823 ordinary shares and (ii) 23,529,411 free unlisted attaching options in the Company to certain investors, including the Purchaser, in a private placement on the terms and conditions set out in this Agreement (the “Offering”) to raise up to A$40,000,000; and
Whereas, the Purchaser desires to purchase from the Company, and the Company desires to sell and issue to the Purchaser, certain number of shares and free unlisted attaching options in the Offering on the terms and subject to the conditions set forth herein.
Whereas, the Company is proposing to offer additional shares to existing shareholders at the Placement Price under a Share Purchase Plan to raise up to a further A$10 million.
Whereas, the Company announced on September 1, 2009 that it proposes to redomicile in the United States. Provided that the Conditions are fulfilled, it is intended that the Offering will be completed and the Placement Shares and Placement Options will be issued to the Purchaser prior to the redomiciliation occurring. Accordingly, if the Company proceeds with the redomiciliation:
  (a)  
the Placement Shares would participate in the scheme of arrangement which will be proposed to Unilife shareholders with the result that the Placement Shares would be replaced with common stock in the new United States parent company, Unilife Corporation; and
  (b)  
the Placement Options would be exchanged for equivalent options in Unilife Corporation.

 

 


 

Agreement
Now, Therefore, in consideration of the foregoing recitals and the mutual promises, representations, warranties and covenants hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1.  
DEFINITIONS
The following terms have the meaning ascribed to them below when used in this Agreement:
“Additional Shares means the further allocation of Placement Shares (as referred to on page 2) being the excess of the Company’s 15% placement capacity under ASX Listing Rule 7.1 which will be issued to investors upon satisfaction of the Conditions.
ASX Listing Rules” means the listing rules of ASX Limited (ACN 008 624 691).
Cancellation Deed” means the cancellation deed in the form set out in Exhibit D.
Cleansing Statement” means a statement meeting the requirements of section 708A(6) of the Corporations Act.
“Corporations Act” means the Corporations Act 2001 (Cth).
Conditions” means the conditions to which the issue of the Additional Shares and the Placement Options are subject namely, that the Company obtains Shareholder Approval for the issue of the Additional Shares and the Placement Options and with respect to the issue of the Placement Options, the investor providing a duly executed Cancellation Deed to the Company by 2 October, 2009.
“Firm Shares” means the initial allocation of Placement Shares (as referred to on page 2) which may be issued without Shareholder Approval under the Company’s 15% placement capacity under ASX Listing Rule 7.1.
Placement Price” means A$0.85 per Placement Share.
Placement Shares” Up to 47,058,023 fully paid ordinary shares in the Company to be issued under the Offering, at the Placement Price comprising the Firm Shares and the Additional Shares.
Placement Options” means two free unlisted options (a Tranche 1 option and a Tranche 2 option) to acquire one fully paid ordinary share in the Company for every four Placement Shares allotted to the investor, to be issued for nil cash consideration. Each option will entitle the investor to subscribe for one ordinary share in the Company.
The options will be issued with an exercise price of: Tranche 1 — A$1.25 and Tranche 2 - A$2.00 and otherwise on the terms and conditions set out in Exhibit B.
Redomiciliation” means the proposed redomiciliation of the Company in the United States which was announced on September 1, 2009.

 

 


 

Replacement Options” means the options over common stock in Unilife Corporation which will be issued to investors upon implementation of the Redomiciliation and which will be on substantially the same terms as the Placement Options as described in the Cancellation Deed.
Shareholder Approval” means the approval of shareholders of the Company for the issue of the Additional Shares and the Placement Options in accordance with ASX Listing Rule 7.1 at an extraordinary general meeting of the Company which is scheduled to occur in early November 2009 (“EGM”). The Company does not warrant that shareholder approval will be obtained for the placement of the Additional Shares and the Placement Options.
Underlying Shares” means the ordinary shares in the Company issued to investors on exercise of Placement Options and/or the shares of common stock in Unilife Corporation issued to investors on exercise of the Replacement Options (as applicable).
2.  
Agreement To Sell And Purchase.
  2.1  
Firm Shares. The issue of the Firm Shares does not require shareholder approval.
  2.2  
Authorization of the Additional Shares. The issue of the Additional Shares is subject to the Company obtaining Shareholder Approval for the issue of the Additional Shares.
  2.3  
Authorization of Placement Options. The issue of the Placement Options is subject to satisfaction of the Conditions.
  2.4  
Issue of the Additional Shares and Placement Options. The Board is fully committed to issuing the Additional Shares and Placement Options to investors subject to the terms and conditions hereof and will take all steps within its power to ensure that Shareholder Approval is obtained for the issue of the Additional Shares and the Placement Options.
  2.5  
Sale and Purchase. Subject to the terms and conditions hereof, at the Closing (as hereinafter defined) the Company hereby agrees to issue and sell to the Purchaser, and the Purchaser agrees to purchase from the Company the number of Placement Shares set forth opposite the Purchaser’s name on Exhibit A for the Purchase Price. Subject to satisfaction of the Conditions, the Company agrees to issue to the Purchaser and the Purchaser agrees to acquire the Placement Options for nil consideration. The parties hereby acknowledge and agree that the Purchaser shall not be entitled to, and any reference to the Placement Shares shall not include, any dividend or other distribution declared or paid on the ordinary shares in the share capital of the Company prior to the Closings.

 

 


 

  2.6  
Proposed Timetable. The proposed timetable for the Offering is as follows:
         
Return of Placement Application Form
  by 5.00pm 2 October 2009
Payment of subscription amount
  by 5.00pm 6 October 2009
Allotment of Firm Shares (not subject to Shareholder Approval being obtained)
  8 October 2009
Unilife Extraordinary General Meeting to consider resolution to approve issue of Additional Shares and Placement Options
  early November 2009
Allotment of Additional Shares and Placement Options (subject to Shareholder Approval being obtained)
  within 3 business days after the EGM
3.  
Payment of Purchase Price.
  3.1  
Upon the execution and return of this Agreement to the Company, the Purchaser shall pay, by wire transfer of immediately available funds or a certified or official bank check, the total Placement Price for the Placement Shares and such action shall constitute the Purchaser’s irrevocable application for the Placement Shares and Placement Options on the terms and conditions set out in this Agreement.
  3.2  
The Company reserves the right not to proceed with the Offering or any part of it at any time before the issue of Placement Shares and Placement Options to the Purchaser. If the Offering or any part of it does not proceed or is cancelled, all relevant amounts of the Placement Price will be refunded (without interest).
  3.3  
In order to confirm the Purchaser’s irrevocable application for the allotment and issue of the number of Placement Shares and Placement Options set out in Exhibit A to the Purchaser, on the terms set out in this Agreement and the Purchaser’s acceptance of the terms and conditions of the Offering as set out in this Agreement, the Purchase shall complete, sign and return a copy of this Agreement to the Company by fax on or before 5.00pm (US Eastern Time) 2 October 2009 to:
Unilife Medical Solutions Limited
Fax No: +1 717 938 9364
Attention: Alan Shortall
4.  
Closing; Delivery of Shares.
  4.1  
Closing of Placement Share issue. Upon the Purchaser complying with Section 2 of this Agreement and subject to Section 4.3 below, the Company agrees to allot and issue to the Purchaser the number of Placement Shares set out in Exhibit A. The closing of the sale and purchase of the Firm Shares under this Agreement (the “Closing”) shall take place on or about 2 October, 2009 (the “End Date”) electronically. The date on which the Closing occurs is hereinafter referred to as the “Closing Date”.

 

 


 

  4.2  
Closing of the Additional Shares and the Placement Option issue. Upon the Purchaser complying with Section 2 of this Agreement and subject to fulfillment of the Conditions, the Company agrees to allot and issue to the Purchaser the number of Additional Shares and Placement Options set out in Exhibit A. The Additional Shares and the Placement Options will be issued within 3 business days of the satisfaction of the Conditions. The Placement Options will be options to acquire fully paid ordinary shares on the terms set out in Exhibit B. The issue of Placement Options is conditional upon the Purchaser delivering to the Company a duly executed Cancellation Deed with respect to the Placement Options, under which the Placement Options will be replaced with Replacement Options upon implementation of the Company’s Redomiciliation.
  4.3  
Holding of Subscription Amounts for Additional Shares. The business day following the Closing Date, the Company shall transfer the subscription amounts received from investors for the Additional Shares (“Subscription Amounts ”) into the escrow account established and operated by its escrow agent. In the event that:
  (a)  
the Conditions are satisfied on or before 31 December 2009, the Company shall direct the escrow agent to release the Subscription Amounts to the Company promptly upon becoming aware that the Conditions have been satisfied;
  (b)  
Shareholder Approval is not obtained at the EGM (or at any deferral of the EGM) or the Conditions are not satisfied on or before 31 December 2009 2009, the Company shall direct the escrow agent to release the Subscription Amounts to the Company for refund to investors on the earliest business day after:
  (i)  
the EGM (if the resolution approving the Offering was not passed);
  (ii)  
the Company becomes aware that the Conditions are not capable of being satisfied; and
  (iii)  
31 December 2009.
  (c)  
Upon receipt of the Subscription Amounts from the escrow agent in accordance with clause 4.3(b), the Company shall promptly refund your Subscription Amount to you.
  (d)  
Any interest which accrues on the Subscription Amounts while in the escrow account shall follow the principal amount and shall be paid to the Company or refunded to investors (as the case may be) at the same time as payment of the corresponding principal.

 

 


 

  4.4  
Closing Conditions.
  (a)  
The Company’s obligation to proceed with the Closing shall be subject to the following conditions: (i) the representations and warranties made by the Purchaser are true and correct as of the Closing Date and the Purchaser has fulfilled those undertakings of the Purchaser to be fulfilled prior to the Closing; and (ii) the Company has simultaneously completed the purchases and sales of Placement Shares with the other investors in the Offering under share purchase agreements entered into separately with each of such other investors on substantially the same form as this Agreement; provided that any one or more of the conditions set forth in clauses (i) and (ii) immediately above may be waived by the Company.
  (b)  
The Purchaser’s obligation to proceed with the Closing shall be subject to the following conditions, which may be waived by the Purchaser: the representations and warranties made by the Company are true and correct in all material respects as of the Closing Date and the Company has fulfilled in all material respects those undertakings of the Company to be fulfilled prior to the Closing.
  4.5  
Delivery of Firm Shares. At the Closing, or as soon as reasonably practicable thereafter, subject to the terms and conditions hereof, the Company will deliver or procure the delivery by its registrar to the Purchaser, a holding statement evidencing the number of the Firm Shares issued to the Purchaser.
  4.6  
Delivery of Additional Shares. Within 3 business days following the satisfaction of the Conditions, subject to the terms and conditions hereof, the Company will issue the Additional Shares to the Purchaser and deliver or procure the delivery by its registrar to the Purchaser, a holding statement evidencing the number of Additional Shares issued to the Purchaser.
  4.7  
Delivery of Placement Options. Within 3 business days following the satisfaction of the Conditions, subject to the terms and conditions hereof, the Company will issue the Placement Options to the Purchaser and deliver or procure the delivery by its registrar to the Purchaser, a certificate evidencing the number of the Placement Options issued to the Purchaser.
  4.8  
Registration. The Company will seek approval for quotation of the Placement Shares on ASX promptly after the Closing or within 3 business days following satisfaction of the Conditions (as applicable). The Purchaser acknowledges that ASX Participating Organisations (as defined in the ASX Business Rules) cannot deal in the Placement Shares either as principal or agent until official quotation is granted in respect of the Placement Shares. The Company will not apply for quotation of the Placement Options on ASX or any other exchange.

 

 


 

5.  
Representations And Warranties Of The Company.
The Company hereby represents and warrants to the Purchaser as of the date of this Agreement as set forth below.
  5.1  
Organization and Qualification. The Company is a corporation duly organized and validly existing under the laws of Australia. Subject to the requisite shareholder approval as required under the ASX Listing Rules in relation to the Additional Shares and Placement Options, the Company has all requisite corporate power and authority to execute and deliver this Agreement, to issue and sell the Placement Shares and the Placement Options (subject to satisfaction of the Conditions) and to carry out the provisions of this Agreement.
  5.2  
Capitalization.
(a) The issued capital of Company, immediately prior to the signing of this Agreement comprises 221,374,809 ordinary shares, all of which are issued and outstanding.
(b) When issued in compliance with the provisions of this Agreement, the Placement Shares will be validly issued, fully paid ordinary shares , and will be free of any liens or encumbrances other than liens and encumbrances created by or imposed upon the Purchaser provided, however, that the Placement Shares may be subject to restrictions on transfer under state and/or federal securities laws as set forth herein or as otherwise required by such laws at the time a transfer is proposed. The sale of the Placement Shares is not and will not be subject to any preemptive rights that have not been properly waived or complied with prior to the Closing.
  5.3  
Authorization; Binding Obligations. All corporate action on the part of Company, its officers, directors and stockholders necessary for the authorization of the Agreement, the performance of all obligations of the Company hereunder at the Closing and the authorization, sale, issuance and delivery of the Placement Shares and the Placement Options (except for the Shareholder Approval) pursuant hereto has been duly taken. This Agreement, when executed and delivered, will be a valid and binding obligation of the Company enforceable in accordance with its terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights and (b) general principles of equity that restrict the availability of equitable remedies.
  5.4  
Compliance with Laws. To its knowledge, the Company is not in violation of any applicable statute, rule, regulation, order or restriction of any domestic or foreign government or any instrumentality or agency thereof in respect of the conduct of its business or the ownership of its properties, which violation of which would materially and adversely affect the business, assets, liabilities, financial condition or operations of the Company.
  5.5  
Compliance with Other Instruments. The Company is not in violation or default of any term of its Constitution or of any provision of any mortgage, indenture or contract to which it is a party and by which it is bound or of any judgment, decree, order or writ, other than such violation(s) that would not have a material adverse effect on the Company. The execution, delivery and performance of this Agreement, and the consummation of the transactions contemplated hereby will not result in any such material violation or be in conflict with, or constitute, with or without the passage of time and giving of notice, either a material default under any such provision, instrument, judgment, decree, order or writ or an event that results in the creation of any lien, charge or encumbrance upon any assets of the Company or the suspension, revocation, impairment, forfeiture, or nonrenewal of any material permit, license, authorization or approval applicable to the Company, its business or operations or any of its assets or properties.

 

 


 

  5.6  
Compliance with ASX Listing Rules. The Company is in compliance with the ASX Listing Rules, including its obligations to make periodic and continuous disclosure pursuant to the ASX Listing Rules, and has not received any notification that, and has no knowledge that, ASX is contemplating terminating such listing and, to the Company’s knowledge, there is no basis for it doing so. The issue and sale of the Placement Shares and the Placement Options to the Purchaser does not and will not contravene the ASX Listing Rules.
  5.7  
Filings. The Company is not required to make any filings with any Australian federal, state, local or other governmental authority in relation to the issue of the Placement Shares or the Placement Options other than the filing of a “Form 484 – Change of Company Details” with the Australian Securities & Investments Commission (“ASIC”) and the filing of an Appendix 3B with ASX after the issue of the Placement Shares and the Placement Options. The failure to file a “Form 484 – Change of Company Details” with the ASIC or an Appendix 3B with ASX does not prevent or otherwise affect the issue of the Placement Shares to the Purchaser.
5.8 Offering.
(a) Assuming the accuracy of the representations and warranties of the Purchaser contained in Section 5 hereof, the Company believes the offer, issue, and sale of the Placement Shares and the Placement Options is exempt from the registration requirements of the Securities Act of 1933, as amended (the “Act”).
(b) The offer, issue and sale of the Placement Shares and the Placement Options does not contravene any applicable statute, regulation, by-law or order of Australia or any State of Australia (“Australian Law”).
(c) The Company acknowledges that the Purchaser’s obligation to purchase the Placement Shares from Company under this Agreement is subject to the Company lodging a Cleansing Statement.

 

 


 

6.  
Representations And Warranties Of the Purchaser.
The Purchaser hereby represents and warrants to the Company as follows as of the date of this Agreement and as of the Closing:
  6.1  
Requisite Power and Authority. The Purchaser has all necessary power and authority to execute, deliver and perform this Agreement. All action on the Purchaser’s part required for the lawful execution and delivery of this Agreement has been taken. Upon execution and delivery by the Purchaser, this Agreement will be a valid and binding obligation of the Purchaser, enforceable in accordance with its terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights and (b) as limited by general principles of equity that restrict the availability of equitable remedies. The Purchaser agrees to be bound by the Company’s constitution from the Closing and authorizes its name to be placed on the register of members of the Company as the legal owner of the Placement Shares and on the Company’s option register as the legal owner of the Placement Options issued to the Purchaser.
  6.2  
Investment Representations.
(a) The Purchaser understands that the Placement Shares, Placement Options, Replacement Options and Underlying Shares have not been registered under the Act. The Purchaser also understands that the Placement Shares, the Placement Options, the Replacement Options and the Underlying Share are being or will be offered and sold pursuant to an exemption from registration contained in the Act based in part upon the Purchaser’s representations contained in this Agreement. The Purchaser further acknowledges and understands that the Placement Shares, Placement Options, Replacement Options and Underlying Shares must be held indefinitely unless they are subsequently registered under the Act or an exemption from registration is available. The Purchaser acknowledges and agrees that it is solely responsible for obtaining such legal, including tax, advice as it considers necessary and appropriate in connection with the execution, delivery and performance of this Agreement and the purchase by it of the Placement Shares and Placement Options.
(b) Purchaser hereby represents, warrants and undertakes as follows:
(i) Purchaser Bears Economic Risk. The Purchaser has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company so that it is capable of evaluating the merits and risks of its investment in the Company and has the capacity to protect its own interests. The Purchaser may be required to bear the economic risk of this investment indefinitely. The Purchaser understands that the Company has no present intention of registering the Placement Shares, Placement Options, Replacement Options or Underlying Shares in the United States pursuant to the Act.
(ii) Acquisition for Own Account. The Purchaser is acquiring the Placement Shares and the Placement Options in the ordinary course of its business and for the Purchaser’s own account for investment only, and not with a view towards their distribution or resale. The Purchaser has not acquired the Placement Shares or the Placement Options for the purpose of selling or transferring them, or granting, issuing or transferring interests in, or options over, them. The Purchaser has not entered into any arrangement or understanding with any other persons regarding the distribution of the Placement Shares or the Placement Options.

 

 


 

(iii) Purchaser Can Protect Its Interest. The Purchaser represents either that (i) by reason of its, or of its management’s, business or financial experience, the Purchaser has the capacity to protect its own interests in connection with the transactions contemplated by this Agreement; and (ii) the Purchaser has a preexisting personal or business relationship with the Company, Summer Street Research Partners (“Summer Street”) or any of their respective officers, directors or controlling persons. Further, the Purchaser is not aware of any general solicitation or publication of any advertisement, as such terms are defined in Regulation D under the Act, in connection with the transactions contemplated by the Agreement.
(iv) Accredited Investor. The Purchaser represents that (i) at the time of the Purchaser’s subscription originated, (ii) at the time of allotment of the Placement Shares and the Placement Options, (iii) at the time of the issuance of the Replacement Options and (iv) at the time of exercise of the Placement Options or the Replacement Options, as applicable, the Purchaser is an accredited investor, within the meaning of Regulation D under the Act. The Purchaser has completed or caused to be completed and delivered to the Company the Investor Questionnaire attached hereto as Exhibit C, which questionnaire is true, correct and complete in all material respects.
(v) Company Information. The Purchaser is aware of the Company’s business affairs and financial condition and has acquired sufficient information about the Company, including publicly available information concerning the Company, to reach an informed and knowledgeable decision to acquire the Placement Shares and Placement Options. The Purchaser has had an opportunity to discuss the Company’s business, management and financial affairs with directors, officers and management of the Company. The Purchaser has also had the opportunity to ask questions of and receive answers from, the Company and its management regarding the terms and conditions of this investment. The Purchaser has, in connection with its decisions to purchaser the Placement Shares and Placement Options, relied only upon the Company’s filings with the ASX and the representations and warranties of the Company contained herein.
(vi) Rule 144. The Purchaser acknowledges and agrees that the Placement Shares, Placement Options, Replacement Options and Underlying Shares are “restricted securities” as defined in Rule 144 promulgated under the Act as in effect from time to time.

 

 


 

(vii) No reliance. The Purchaser acknowledges and agrees that it has not relied on any representations made by the Company, Summer Street or any of their respective officers, employees, agents, advisers or affiliates except as set out in this Agreement. The Purchaser further acknowledges and agrees that it has not relied on any investigation that the Company, Summer Street or any of their respective officers, employees, agents, advisers or affiliates or any persons acting on their behalf may have conducted with respect to the Placement Shares and the Placement Options or the Company. None of such persons has made any representation to the Purchaser, express or implied, with respect to the Placement Shares and the Placement Options or the Company.
(viii) No securities recommendation . The Purchaser acknowledges and agrees that this Agreement does not constitute a securities recommendation or financial product advice and that the Company and Summer Street have not considered the Purchaser’s particular objectives, financial situation and needs.
(ix) No responsibility. The Purchaser acknowledges and agrees that except to the extent that liability cannot by law be excluded, none of the Company, Summer Street or any of their respective related bodies corporate or any officers, employees, agents, advisers or affiliates of the Company or Summer Street, accept any responsibility in relation to the Offering.
(x) Related party. The Purchaser represents and warrants that it is not a Related Party (as defined in the ASX Listing Rules) of the Company.
(xi) Indemnity. The Purchaser acknowledges that the Company or Summer Street and their affiliates will rely upon the truth and accuracy of the foregoing acknowledgments, representations, warranties and agreements and agree that if any such acknowledgments, representations or warranties are no longer accurate, the Purchaser will notify the Company immediately. The Purchaser shall indemnify the Company or Summer Street and their respective officers, employees, advisers and affiliates against any loss, damage or costs incurred and arising out of or in relation to any breach by the Purchaser of the acknowledgments, representations, warranties and agreements.
(xii) Insider trading. The Purchaser acknowledges that if it has material non-public information regarding the Company, insider trading restrictions may apply to it. The Purchaser agrees not to, and not to cause any other person to, acquire any of the Company’s securities after it has had access to material non-public information if doing so would be a breach of insider trading restrictions.

 

 


 

  6.3  
Transfer Restrictions. The Purchaser acknowledges and agrees that the Placement Shares, Placement Options, Replacement Options and Underlying Shares are subject to restrictions on transfer as set forth in this Agreement. The Purchaser shall not offer, sell, contract to sell or otherwise dispose of or deliver any of the Placement Shares and Underlying Shares unless: (i) the Placement Shares and Underlying Shares are sold on the ASX in compliance with Regulation S under the Act; or (ii) the Placement Shares and Underlying Shares are sold in a transaction that does not require registration under the Act or any applicable laws and regulations of the states of the United States governing the offer and sale of securities and, (iii) prior to and as a condition to the execution of the offer, sale or delivery described in clauses (i) and (ii) immediately above, the Purchaser has furnished to the Company an opinion of counsel satisfactory to the Company to such effect, unless the Company waives receipt of such opinion. The Purchaser further acknowledges that each Placement Option certificate and Replacement Option certificate will bear a legend that it and the Underlying Shares have not been registered under the Act or any applicable state securities laws and that such option may not be exercised unless registered under the Act and any applicable state securities laws, or an exemption therefrom is available.
7.  
Miscellaneous.
  7.1  
Governing Law. This Agreement shall be governed by and construed under the laws of the state of New South Wales, Australia in all respects as such laws are applied to agreements among Australian residents entered into and performed entirely within Australia, without giving effect to conflict of law principles thereof. The parties agree that any action brought by either party under or in relation to this Agreement, including without limitation to interpret or enforce any provision of this Agreement, shall exclusively be brought in, and each party agrees to and does hereby submit to the jurisdiction and venue of, any state or federal court located in the state of New South Wales, Australia.
  7.2  
Survival. The representations, warranties, covenants and agreements made herein shall survive the Closing for a one-year period.
  7.3  
Successors and Assigns. Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon the parties hereto and their respective successors, assigns, heirs, executors and administrators and shall inure to the benefit of and be enforceable by each person who shall be a holder of the Placement Shares and Placement Options from time to time; provided, however, that prior to the receipt by the Company of adequate written notice of the transfer of any Placement Shares and Placement Options specifying the full name and address of the transferee, the Company may deem and treat the person listed as the holder of such Placement Shares and Placement Options in its records as the absolute owner and holder of such Placement Shares or Placement Options (as the case may be) for all purposes.
  7.4  
Entire Agreement. This Agreement and the Exhibits hereto shall constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof.

 

 


 

  7.5  
Severability. In the event one or more of the provisions of this Agreement should, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein.
  7.6  
Amendment and Waiver. This Agreement may be amended, modified or waived only pursuant to a written instrument signed by the Company and (a) the investors in the Offering holding a majority of the ordinary shares issued and sold in the Offering, provided that such amendment, modification or waiver is made with respect to all such investors and does not adversely affect the Purchaser without adversely affecting all such investors in a similar manner; or (b) the Purchaser.
  7.7  
Delays or Omissions. It is agreed that no delay or omission to exercise any right, power or remedy accruing to any party, upon any breach, default or noncompliance by another party under this Agreement shall impair any such right, power or remedy, nor shall it be construed to be a waiver of any such breach, default or noncompliance, or any acquiescence therein, or of or in any similar breach, default or noncompliance thereafter occurring. It is further agreed that any waiver, permit, consent or approval of any kind or character on any party’s part of any breach, default or noncompliance under this Agreement or any waiver on such party’s part of any provisions or conditions of the Agreement must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement, by law, or otherwise afforded to any party, shall be cumulative and not alternative.
  7.8  
Notices. All notices required or permitted hereunder shall be in writing and shall be deemed effectively given: (a) upon personal delivery to the party to be notified, (b) when sent by confirmed electronic mail, telex or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, or (c) two (2) days after deposit with a nationally recognized overnight courier, specifying express delivery, with written verification of receipt. All communications shall be sent to the Company at the address as set forth on the signature page hereof and to the Purchaser at the addresses set forth on Exhibit A attached hereto or at such other addresses as the Company or the Purchaser may designate by ten (10) days advance written notice to the other party hereto.
  7.9  
Expenses. Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.
  7.10  
Attorneys’ Fees. In the event that any suit or action is instituted under or in relation to this Agreement, including without limitation to enforce any provision in this Agreement, the prevailing party in such dispute shall be entitled to recover from the losing party all fees, costs and expenses of enforcing any right of such prevailing party under or with respect to this Agreement, including without limitation, such reasonable fees and expenses of attorneys and accountants, which shall include, without limitation, all fees, costs and expenses of appeals.

 

 


 

  7.11  
Titles and Subtitles. The titles of the sections and subsections of the Agreement are for convenience of reference only and are not to be considered in construing this Agreement.
  7.12  
Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be an original, but all of which together shall constitute one instrument. This Agreement is binding on the parties on the exchange of counterparts. A copy of a counterpart sent by facsimile machine or other electronic means must be treated as an original counterpart, is sufficient evidence of the execution of the original and may be produced in evidence for all purposes in place of the original.
  7.13  
Broker’s Fees. Each party hereto represents and warrants that no agent, broker, investment banker, person or firm acting on behalf of or under the authority of such party hereto is or will be entitled to any broker’s or finder’s fee or any other commission directly or indirectly in connection with the transactions contemplated herein, except that the Company has agreed to pay the following aggregate commissions to brokers in connection with the Offering: a cash payment of up to 6.5% of the value of the Offering and the issue of options with an exercise price of A$0.85 per option totaling up to 6.5% of the value of the Offering. Each party hereto further agrees to indemnify each other party for any claims, losses or expenses incurred by such other party as a result of the representation in this Section 7.13 being untrue.
  7.14  
Further Assurance. The parties agree to take such further action(s) and execute such further documentation as may reasonably be necessary to carry out and consummate this Agreement and the subject matter hereof.
  7.15  
Currency. Except where otherwise expressly provided, all amounts set forth in this Agreement are stated in, and will be paid in, US dollars.
  7.16  
Pronouns. All pronouns contained herein, and any variations thereof, shall be deemed to refer to the masculine, feminine or neutral, singular or plural, as to the identity of the parties hereto may require.
[Signature Page Follows]

 

 


 

In Witness Whereof, the parties hereto have executed this Share Purchase Agreement as of the date set forth in the first paragraph hereof.
             
Executed by UNILIFE MEDICAL SOLUTIONS LIMITED acting by the following persons or, if the seal is affixed, witnessed by the following persons:
           
 
           
 
Signature of director
     
 
Signature of director/company secretary
   
 
           
 
Name of director (print)
     
 
Name of director/company secretary (print)
   
PURCHASER:
         
Signature:
       
 
 
 
   
Print Name:
       
 
 
 
   
Title:
       
 
 
 
   

 

 


 

Exhibit A
SCHEDULE OF INVESTOR
         
    Aggregate  
Name and Address of Purchaser   Purchase Price  
 
       
                     Placement shares comprising
-                      Firm Shares
-                      Additional Shares
                     Placement Options *
     
*  
The Purchaser will receive two Placement Options (a Tranche 1 option and a Tranche 2 option) for every four Placement Shares which the Purchaser purchases under the Offering.

 

 


 

Exhibit B
TERMS AND CONDITIONS OF PLACEMENT OPTIONS
1.  
Subject to satisfaction of the Conditions, the Placement Options shall be issued for nil cash consideration. Each Placement Option entitles the holder to subscribe for one fully paid ordinary share (Share) in Unilife Medical Solutions Limited (Company).The Placement Options granted to each subscriber under the Offering shall be issued in two equal tranches as follows:
  1.1  
Tranche 1: the exercise price for each Placement Option is A$1.25
 
  1.2  
Tranche 2: the exercise price for each Placement Option is A$2.00
The exercise price for any Placement Option shall be payable in full on exercise of the Placement Option.
2.  
The Placement Options shall be exercisable at any time from the date of grant until the third anniversary of the date of grant (Exercise Period).
3.  
If the Placement Option is not exercised on or prior to the expiry of the Exercise Period, the Placement Option will automatically lapse.
4.  
A certificate shall be issued for the Placement Options. Each certificate will bear a legend stating that it and the Underlying Shares have not been registered under the US Securities Act and that such option may not be exercised by or on behalf of any US person unless registered under the US Securities Act or if an exemption from registration is available and (ii) upon exercise of such option, the Optionholder will be required to give a written certification that he/she is outside the US and that he/she is not a US person and that the Placement Option is not being exercised on behalf of a US person.
5.  
Placement Options shall be exercisable by notice in writing to the registered office of the Company accompanied by the holder’s option certificate. The notice must state the number of Placement Options being exercised (in multiples of 20,000 or where the number of Placement Options held is less than 20,000 such lesser amount). If the notice does not state the number of Placement Options being exercised, the notice shall be void and the Company shall request the Optionholder to provide a further notice.
6.  
The Optionholder shall either:
  (a)  
include with the notice to the Company referred to in clause 5, a cheque payable to the Company; or
  (b)  
at the time of issuing the notice to the Company referred to in clause 5, arrange for an electronic funds transfer directly into an account nominated by the Company,
for the total exercise price of the Placement Options being exercised.
7.  
Upon receipt of a valid notice in accordance with clause 5 and subject to the Company receiving cleared funds from the Optionholder in accordance with clause 6, the Company must issue the requisite number of Shares in the name of the Optionholder and update its share register to record the Optionholder as the holder of that number of Shares equal to the number of Placement Options exercised within five (5) business days of the exercise of the Placement Option.

 

 


 

9.  
Shares issued pursuant to an exercise of Placement Options shall rank equally in all respects with existing Shares of the Company from the date of allotment.
10.  
An Optionholder may not sell, transfer, assign, give or otherwise dispose of, in equity or in law, the benefit of some or all of the Placement Options without the prior written consent of the Board.
11.  
If Shares of the class are quoted, the Company shall, in accordance with ASX Listing Rule 2.8, make application to have Shares issued pursuant to an exercise of Placement Options listed for official quotation.
12.  
If Placement Options are exercised before the record date of an entitlement, Optionholders can participate in a pro rata issue to the holders of Shares in the Company.
13.  
Optionholders do not have any right to participate in new issues of securities by the Company without exercising Placement Options.
14.  
In accordance with the ASX Listing Rules, in the event of any reorganisation of capital of the Company, the rights of the Optionholder will be changed to the extent necessary to comply with the ASX Listing Rules applying to a reorganisation of capital at the time of the reorganisation.
15.  
The Placement Options will not give any right to participate in dividends until Shares are allotted pursuant to the exercise of the relevant Placement Options.
16.  
In the event that an issue of Shares is made to the holders of securities in the Company (excluding a bonus issue), the exercise price of the Placement Options will be reduced in accordance with ASX Listing Rule 6.22.
17.  
The number of Shares to be issued pursuant to the exercise of Placement Options will be adjusted for bonus issues made prior to exercise of Placement Options. The effect will be that upon exercise of the Placement Options, the number of Shares received by the Optionholder will be increased by the number of bonus Shares that would have been issued to such holder if the Placement Options had been exercised prior to the record date for the bonus issue. The exercise price of the Placement Options will not change as a result of any such bonus issue.
18.  
If there has been a Change in Ownership or the Board concludes that the replacement of the majority of the Board is imminent, the Board must resolve to notify the Optionholder that all Placement Options may be exercised prior to 5pm (Sydney time) on the 90th day after the date of the notice (or by such earlier date as the Board determines).

 

 


 

19.  
Subject always to clause 21 below, a ‘Change in Ownership’ shall occur if:
(a) a person acquires a relevant interest (within the meaning of section 608 of the Corporations Act 2001) in more than fifty per cent (50%) of the Shares in the Company as a result of a takeover bid;
(b) a person acquires a relevant interest (within the meaning of section 608 of the Corporations Act 2001) in more than fifty per cent (50%) of the Shares in the Company as a result of a scheme of arrangement;
(c) through the acquisition of Shares in the Company a person is able to determine the majority composition of the Board; or
(d) any other event (including, but not limited to, a merger of the Company with another company) which the Board determines, in its absolute discretion, to be a Change in ownership.
20.  
A ‘Change in Ownership’ does not include, unless otherwise determined by the Board, either an internal restructure of the Company’s group or a transaction whereby the Company’s group is redomiciled by imposing a new parent company of the Company’s group (including where such transaction is effected by a scheme of arrangement under the Corporations Act 2001 (Cth)). This exception to a ‘Change in Ownership’ includes a scheme of arrangement pursuant to which:
(a) a subsidiary of the Company will become the new parent company of the Company; or
(b) the shareholders of the Company on the record date of the scheme of arrangement will be entitled to be issued shares equal to at least fifty per cent (50%) of the issued ordinary share capital of the new parent company of the Company on the implementation date of the scheme of arrangement.

 

 


 

Exhibit C
INVESTOR QUESTIONNAIRE

 

 


 

UNILIFE MEDICAL SOLUTIONS LIMITED
INVESTOR QUESTIONNAIRE
(ALL INFORMATION WILL BE TREATED CONFIDENTIALLY)
To:  
Unilife Medical Solutions Limited
Suite 3, Level 11,
1 Chifley Square,
Sydney 2000 NSW
Australia
This Investor Questionnaire (“Questionnaire”) must be completed by each potential investor in connection with the offer and sale of ordinary shares of Unilife Medical Solutions Limited (the “Shares”).  The Shares are being offered and sold by Unilife Medical Solutions Limited (the “Company”) without registration in the United States under the Securities Act of 1933, as amended (the “Act”), and the securities laws of certain states, in reliance on the exemptions contained in Section 4(2) of the Act and on Regulation D promulgated thereunder and in reliance on similar exemptions under applicable state laws.  The Company must determine that a potential investor meets certain suitability requirements before offering or selling the Shares to such investor.  The purpose of this Questionnaire is to assure the Company that each investor will meet the applicable suitability requirements.  The information supplied by you will be used in determining whether you meet such criteria, and reliance upon the private offering exemption from registration is based in part on the information herein supplied.
This Questionnaire does not constitute an offer to sell or a solicitation of an offer to buy any security.  Your answers will be kept strictly confidential.  However, by signing this Questionnaire you will be authorizing the Company to provide a completed copy of this Questionnaire to such parties as the Company deems appropriate in order to ensure that the offer and sale of the Shares will not result in a violation of the Act or the securities laws of any state and that you otherwise satisfy the suitability standards applicable to purchasers of the Shares.  All potential investors must answer all applicable questions and complete, date and sign this Questionnaire.  Please print or type your responses and attach additional sheets of paper if necessary to complete your answers to any item.  Capitalized terms used but not defined herein have the meaning given thereto in the Share Purchase Agreement to which this Questionnaire is attached (the “Share Purchase Agreement”).

 

 


 

A. BACKGROUND INFORMATION
Name [Exact Name as It will Appear on the Share Certificate or Holding Statement]:
 
Business Address:
 
(Number and Street)
 
(City, State and Zip Code)
 
(Telephone and Facsimile Numbers)
Residence Address [If Different from Business Address]:
 
(Number and Street)
 
(City, State and Zip Code)
 
(Telephone and Facsimile Numbers)
If an Individual:
 
(Age; Citizenship; Where Registered to Vote)
If an Existing Shareholder of the Company:
 
(Shareholder Registration Number)
 If a Corporation, Partnership, limited liability company, trust or other entity:
 
(Type of Entity; State and Date of Formation)
 
(Social Security or Taxpayer Identification No.)

 

 


 

Send all correspondence to (check one):                      Residence Address                      Business Address
Name and Email address of contact person:
 
B. STATUS AS ACCREDITED INVESTOR
The undersigned is an “accredited investor” as such term is defined in Regulation D under the Act, as at the time of the sale of the Shares the undersigned falls within one or more of the following categories (Please initial one or more, as applicable)1:
 _____ (1) a bank as defined in Section 3(a)(2) of the Act, or a savings and loan association or other institution as defined in Section 3(a)(5)(A) of the Act whether acting in its individual or fiduciary capacity; a broker or dealer registered pursuant to Section 15 of the Securities Exchange Act of 1934; an insurance company as defined in Section 2(13) of the Act; an investment company registered under the Investment Corporation Act of 1940 or a business development company as defined in Section 2(a)(48) of that Act; a Small Business Investment Corporation licensed by the U.S. Small Business Administration under Section 301(c) or (d) of the Small Business Investment Act of 1958; a plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions for the benefit of its employees, if such plan has total assets in excess of $5,000,000; an employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974 if the investment decision is made by a plan fiduciary, as defined in Section 3(21) of such Act, which is either a bank, savings and loan association, insurance company, or registered investment adviser, or if the employee benefit plan has total assets in excess of $5,000,000 or, if a self-directed plan, with the investment decisions made solely by persons that are accredited investors;
 _____ (2) a private business development company as defined in Section 202(a)(22) of the Investment Adviser Act of 1940;
 _____ (3) an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, corporation, Massachusetts or similar business trust, or partnership, not formed for the specific purpose of acquiring the Securities offered, with total assets in excess of $5,000,000;
 
     
1  
As used in this Questionnaire, the term “net worth” means the excess of total assets over total liabilities.  In computing net worth for the purpose of subsection (4), the principal residence of the investor must be valued at cost, including cost of improvements, or at recently appraised value by an institutional lender making a secured loan, net of encumbrances.  In determining income, the investor should add to the investor’s adjusted gross income any amounts attributable to tax exempt income received, losses claimed as a limited partner in any limited partnership, deductions claimed for depiction, contributions to an IRA or Keogh retirement plan, alimony payments, and any amount by which income from long-term capital gains has been reduced in arriving at adjusted gross income.

 

 


 

 _____  (4) a natural person whose individual net worth, or joint net worth with that person’s spouse, at the time of such person’s purchase of the Securities exceeds $1,000,000;
 _____  (5) a natural person who had an individual income in excess of $200,000 in each of the two most recent years or joint income with that person’s spouse in excess of $300,000 in each of those years and has a reasonable expectation of reaching the same income level in the current year;
 _____  (6) a trust, with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the Securities offered, whose purchase is directed by a sophisticated person as described in Rule 506(b)(2)(ii) of Regulation D; and
 _____  (7) an entity in which all of the equity owners are accredited investors (as defined above) (If the answer is yes, all shareholders, partners or other equity owners must complete an Individual Questionnaire).
C.  REPRESENTATIONS
The undersigned hereby represents and warrants to the Company as follows:
1.  
Any purchase of the Shares would be solely for the account of the undersigned and not for the account of any other person or with a view to any resale, fractionalization, division, or distribution thereof.
2.  
The information contained herein is complete and accurate and may be relied upon by the Company, and the undersigned will notify the Company immediately of any material change in any of such information occurring prior to the closing, if any, with respect to the purchase of the Shares by the undersigned or any co-purchaser.
3.  
There are no suits, pending litigation, or claims against the undersigned that could materially affect the net worth of the undersigned as reported in this Questionnaire.
4.  
The overall commitment of the undersigned to investments which are not readily marketable is not excessive in view of the undersigned’s net worth and financial circumstances, and any purchase of the Shares will not cause such commitment to become excessive.  The undersigned is able to bear the economic risk of an investment in the Shares.
5.  
The undersigned is aware of its obligations under applicable securities laws with respect to use and disclosure of non-public information regarding the Company.

 

 


 

6.  
The undersigned has carefully considered the potential risks relating to the Company and a purchase of the Shares, and fully understands that the Shares are speculative investments which involve a high degree of risk of loss of the undersigned’s entire investment.  Among others, the undersigned has carefully considered the Company’s filings with the ASX.
7.  
The undersigned understands that the Shares that it is acquiring are characterized as “restricted securities” under the federal securities laws of the United States inasmuch as they are being acquired in a transaction not involving a public offering, and that under such laws and applicable regulations such securities may be resold without registration under the Act, only in certain limited circumstances. In this connection, the undersigned represents that it is familiar with SEC Rule 144 or Regulation S, as presently in effect, and understands the resale limitations imposed thereby and by the Act.
IN WITNESS WHEREOF, the undersigned has executed this Questionnaire this  _____  day of                      2009, and declares under oath that it is truthful and correct.
             
         
    Print Name    
 
           
 
  By:        
 
     
 
Signature
   
 
           
 
     
 
Title (if an entity)
   

 

 


 

EXHIBIT D
CANCELLATION DEED

 

 


 

201 Elizabeth Street
Sydney NSW 2000
Australia
DX 107 Sydney
Tel +61 2 9286 8000
Fax +61 2 9283 4144
www.dlaphillipsfox.com
Standalone Option Cancellation Deed
Unilife Medical Solutions Limited
Unilife Corporation
[Standalone Option Holder]
DLA Phillips Fox is a member of
DLA Piper Group, an alliance of
independent legal practices. It is a
separate and distinct legal entity.
DLA Phillips Fox offices are located
in Adelaide Auckland Brisbane
Canberra Melbourne Perth Sydney
and Wellington.

 

 


 

(DLA PHILLIPS FOX LOGO)
Table of contents
         
Parties
    2  
 
       
Background
    2  
 
       
Operative provisions
    2  
 
       
1 Cancellation of Standalone Options
    2  
 
       
2 Issue of Unilife Corporation Standalone Options
    2  
Time of issue
    3  
 
       
3 Conditions
    3  
Cancellation and offer conditional
    3  
Effective Time
    3  
Termination
    3  
No waiver
    3  
 
       
4 Representations and warranties
    4  
 
       
5 Release
    5  
Release
    5  
 
       
6 Miscellaneous
    5  
Notices
    5  
Conflict of interest
    6  
Costs
    6  
Counterparts
    6  
Binding agreement
    7  
Further assurances
    7  
No merger
    7  
No rights
    7  
Publicity
    7  
Variation and waiver
    7  
 
       
7 Definitions and interpretation
    8  
Definitions
    8  
Interpretation
    9  
Headings
    10  
 
       
Schedule 1
    11  
 
       
Execution and date
    12  
 
       
Annexure A
    14  
Unilife Corporation Option Agreement
    14  

 

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Parties
Unilife Medical Solutions Limited ABN 14 008 071 403 of Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000 (Company)
Unilife Corporation a company incorporated in Delaware United States of 633 Lowther Road, Lewisberry, Pennsylvania 17339, United States (Unilife Corporation)
[insert name of Optionholder] (Standalone Option Holder)
Background
A   The Company has granted the Standalone Options to the Standalone Option Holder.
 
B   The Company and Unilife Corporation have entered into a Merger Implementation Agreement under which, amongst other things, the Company and Unilife Corporation have agreed to effect a transaction by means of a scheme of arrangement pursuant to Part 5.1 of the Corporations Act under which Unilife Corporation will acquire all of the issued share capital of the Company with the result that the Unilife group will be re-domiciled in the US.
 
C   The parties have agreed that in conjunction with the Share Scheme, the Standalone Options will be cancelled and, in consideration of the cancellation, Unilife Corporation will issue Unilife Corporation Standalone Options to the Standalone Option Holder.
Operative provisions
1   Cancellation of Standalone Options
1.1   Subject to clause 3.1, the Standalone Option Holder agrees to the cancellation of all, and not part only, of the Standalone Options held by it as at the date of this deed without any further action or consent on the part of the Company or the Standalone Option Holder.
2   Issue of Unilife Corporation Standalone Options
2.1   In consideration of, and subject to, the cancellation of its Standalone Options pursuant to clause 1.1 and subject to the satisfaction or waiver of the conditions set out in clause 3.1, Unilife Corporation will:
  2.1.1   issue the Unilife Corporation Standalone Options to the Standalone Option Holder;
  2.1.2   deliver to the Standalone Option Holder a duly executed counterpart of the Unilife Corporation Option Agreement;

 

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  2.1.3   enter the name of the Standalone Option Holder in its register of option holders; and
 
  2.1.4   no later than seven Business Days after the date of grant, despatch or procure the despatch to each Standalone Option Holder of a certificate representing the Unilife Corporation Standalone Options granted to it under this deed.
2.2   Subject to the satisfaction or waiver of the conditions set out in clause 3.1, the Standalone Option Holder will execute and deliver to the Company a counterpart of the Unilife Corporation Option Agreement.
Time of issue
2.3   Subject to the satisfaction of the conditions in clause 3.1, the Unilife Corporation Standalone Options must be issued by Unilife Corporation with effect from the Effective Time.
3   Conditions
Cancellation and offer conditional
3.1   The cancellation of the Standalone Options pursuant to clause 1.1 and the offer of Unilife Corporation Standalone Options pursuant to clause 2.1 is conditional upon:
  3.1.1   the Share Scheme becoming Effective; and
 
  3.1.2   the Company obtaining from ASX a waiver of any requirement under ASX Listing Rule 6.23.2 to obtain the approval of the Company’s shareholders to the cancellation of the Standalone Options.
Effective Time
3.2   Subject to the satisfaction of the conditions in clause 3.1, the Standalone Option Holder agrees to the cancellation of the Standalone Options with effect from the Effective Time, at which time the Standalone Options will have no further force or effect and the rights and entitlements of the Standalone Option Holder with respect to the Standalone Options will cease.
Termination
3.3   This deed will automatically terminate on the earlier of:
  3.3.1   the date on which the Merger Implementation Agreement is terminated; and
  3.3.2   30 June 2010 (or such other date and time agreed in writing between the Company and Unilife Corporation) if the conditions set out in clause 3.1 are not satisfied or waived before that date.
No waiver
3.4   The conditions precedent in clause 3.1 cannot be waived.

 

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4   Representations and warranties
4.1   The Standalone Option Holder represents and warrants to the Company and Unilife Corporation that as at the Effective Time:
  4.1.1   the number of Shares subject to, and the exercise price of, the Standalone Options, as set out in Schedule 1, is complete and accurate;
 
  4.1.2   it has read and understood the terms of this deed and the Unilife Corporation Option Agreement;
 
  4.1.3   it is not in breach of any provision or condition of the Standalone Options;
 
  4.1.4   it has full power and capacity to agree to the cancellation of the Standalone Options;
 
  4.1.5   it is the legal and beneficial holder of the Standalone Options;
 
  4.1.6   it will be taking the Unilife Corporation Standalone Options for investment purposes only and not with a view to distribution; and
 
  4.1.7   it is an accredited investor as defined in Regulation D promulgated by the SEC pursuant to the Securities Act of 1933.
4.2   The Standalone Option Holder acknowledges that the issue of the Unilife Corporation Standalone Options constitutes good and valuable consideration for the cancellation of the Standalone Options and the release in clause 5.1.
4.3   The Standalone Option Holder acknowledges that the issue of the Unilife Corporation Standalone Options in exchange for the cancellation of the Standalone Options may not be an economically equivalent exchange because of, among other things, the different tax laws that apply to the options.
4.4   The Standalone Optionholder acknowledges that the transfer of the Standalone Options and the securities issued on the exercise of the Standalone Options is restricted under applicable US securities laws.
4.5   The Standalone Option Holder acknowledges that the certificate or other instrument evidencing the Unilife Corporation Standalone Options and the securities issuable upon exercise of the Standalone Options will bear an appropriate legend reflecting the restrictions on transfer which will apply to the Unilife Corporation Standalone Options and such underlying securities under applicable US securities laws.

 

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5   Release
Release
5.1   Following cancellation of the Standalone Options:
  5.1.1   the Company releases the Standalone Option Holder and the Standalone Option Holder releases the Company and its officers, directors, shareholders, affiliates, successors, agents, attorneys, representatives, and any other person or entity that may have any liability for the Standalone Options (each a Released Party) from all actions, claims, losses, liabilities and expenses in respect of the cancellation and extinguishment of the Standalone Options, and all rights and entitlements attaching to the Standalone Options, with effect from the Effective Time; and
 
  5.1.2   the Company and the Standalone Option Holder agree not to make any claim or demand, or participate in any actions, claims, demands or proceedings against any Released Party inconsistent with clause 5.1.1 and agree that this deed may be pleaded as a bar to any such action, claim, proceeding or demand.
 
  5.1.3   the Standalone Option Holder agrees that, upon the issue of the Unilife Corporation Standalone Options, the Standalone Option Holder will have no further claim of right to purchase or receive Shares or any other securities or consideration for the Standalone Options, except as specifically set out in this deed.
6   Miscellaneous
Notices
6.1   Any notice, demand, consent or other communication (a Notice) given or made under this Agreement:
  6.1.1   must be in writing and signed by a person duly authorised by the sender;
 
  6.1.2   must be delivered to the intended recipient by prepaid post or by hand or fax to the address or fax number below or the address (being an address in Australia) or fax number last notified by the intended recipient to the sender:
Company:
     
Address:
  Level 11, 1 Chifley Square,
 
  Sydney NSW 2000
Fax:
  (02) 8346 6511
Attention:
  Mr Jeff Carter
 
Unilife Corporation:
 
   
Address:
  633 Lowther Road,
 
  Lewisberry, Pennsylvania 17339
Fax:
  +1 717 938 9364
Attention:
  Mr Alan Shortall
     
Standalone Optionholder:
 
   
Address:
  [                    ]
Fax:
  [                    ]
Attention:
  [                    ]

 

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  6.1.3   will be taken to be duly given or made:
  (a)   in the case of delivery in person, when delivered;
 
  (b)   in the case of delivery by post:
  (i)   within Australia to an Australian address, two Business Days after the date of posting; and
 
  (ii)   in any other case, 10 Business Days after the date of posting;
  (c)   in the case of fax, on receipt by the sender of a transmission control report from the dispatching machine showing the relevant number of pages and the correct destination fax machine number or name of recipient and indicating that the transmission has been made without error,
but if the result is that a Notice would be taken to be given or made on a day that is not a Business Day in the place to which the Notice is sent or is later than 4.00pm (local time) it will be taken to have been duly given or made at the commencement of business on the next Business Day in that place.
6.2   The Standalone Option Holder agrees to waive any right it may have under or arising from the Standalone Option to advance notice of the transactions contemplated under the Share Scheme, except as otherwise required under applicable law.
Conflict of interest
6.3   The parties’ rights and remedies under this deed may be exercised even if this involves a conflict of duty or a party has a personal interest in their exercise.
Costs
6.4   Each party shall pay their own legal and other costs and expenses in connection with the preparation, execution and completion of this deed and other related documentation.
Counterparts
6.5   This deed may be executed in counterparts. All counterparts when taken together are to be taken to constitute one instrument.

 

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Binding agreement
6.6   Each party agrees that this deed is binding on each party and their heirs, executors, administrators, and all persons claiming any right, benefit, or interest to the Standalone Options or the underlying Shares, and inures to the benefit of the Released Parties and their successors and assigns.
Further assurances
6.7   Each party agrees, at the Company’s expense, to do anything another party asks (such as obtaining consents, signing and producing documents and getting documents completed and signed):
  6.7.1   to bind the party and any other person intended to be bound under this deed;
 
  6.7.2   to enable the Company to cancel the Standalone Options;
 
  6.7.3   to show whether the party is complying with this deed; and
 
  6.7.4   to give full effect to this deed.
Governing law
6.8   This deed is governed by the laws of New South Wales. The Parties submit to the non-exclusive jurisdiction of its courts and courts of appeal from them. The Parties will not object to the exercise of jurisdiction by those courts on any basis.
No merger
6.9   This deed constitutes the entire understanding between the parties with respect the subject matter of this deed, except as otherwise set out in the Share Scheme. The warranties, undertakings and indemnities in this deed do not merge at the Effective Time.
No rights
6.10   The Standalone Option Holder agrees that the transactions contemplated under this deed do not result in the right to receive future grants of equity or other compensation other than the Unilife Corporation Standalone Options.
Publicity
6.11   The Standalone Option Holder may not make press or other announcements or releases relating to this deed or the transactions the subject of this deed.
Variation and waiver
6.12   A provision of this deed or a right created under it, may not be waived or varied except in writing, signed by the party or parties to be bound.

 

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7   Definitions and interpretation
Definitions
7.1   In this deed the following definitions apply:
ASX means ASX Limited (ABN 98 008 624 691).
Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Sydney, Australia.
Corporations Act means the Corporations Act 2001 (Cth).
Consolidation Ratio means the number of Shares in the Company which will be transferred to Unilife Corporation under the Share Scheme for every share of common stock in Unilife Corporation issued to Scheme Shareholders.
Court means the Federal Court of Australia.
Effective means, when used in relation to the Share Scheme, the coming into effect, pursuant to section 411(10) of the Corporations Act, of the Court order made under section 411(4)(b) of the Corporations Act in relation to the Share Scheme.
Effective Date means the date on which the Share Scheme becomes Effective.
Effective Time means 5:00pm on the Implementation Date.
Implementation Date means the third Business Day after the Scheme Record Date.
Merger Implementation Agreement means the merger implementation agreement dated 1 September 2009 between the Company and Unilife Corporation (as amended from time to time).
Related Body Corporate has the meaning given to that term in section 50 of the Corporations Act.
Scheme Record Date means 7.00pm on the fifth Business Day after the Effective Date.
Share means a fully paid ordinary share in the Company.
Share Scheme means the scheme of arrangement under Part 5.1 of the Corporations Act between the Company and Scheme Shareholders.
Scheme Shareholder means a Shareholder as at the Scheme Record Date.

 

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Standalone Options means the options issued to the Standalone Option Holder to subscribe for the Shares under a Share Purchase Agreement between the Company and the Standalone Option Holder dated on or around 1 October 2009, the key terms of which are set out in the second column of Schedule 1.
Unilife Corporation Standalone Options means the options to be issued to the Standalone Option Holder to subscribe for common stock in Unilife Corporation under the Unilife Corporation Option Agreement in substantially the form attached as Annexure A to this deed.
Interpretation
7.2   In the interpretation of this deed, the following provisions apply unless the context otherwise requires:
  7.2.1   The singular includes the plural and conversely.
 
  7.2.2   A gender includes all genders.
 
  7.2.3   If a word or phrase is defined, its other grammatical forms have a corresponding meaning.
 
  7.2.4   A reference to a person, corporation, trust, partnership, unincorporated body or other entity includes any of them.
 
  7.2.5   A reference to a clause, schedule or annexure is a reference to a clause of, or schedule or annexure to, this deed.
 
  7.2.6   A reference to an agreement or document (including a reference to this deed) is to the agreement or document as amended, varied, supplemented, novated or replaced, except to the extent prohibited by this deed or that other agreement or document.
 
  7.2.7   A reference to a person includes a reference to the person’s executors, administrators, successors, substitutes (including persons taking by novation) and assigns.
 
  7.2.8   A reference to legislation or to a provision of legislation includes a modification or re-enactment of it, a legislative provision substituted for it and a regulation or statutory instrument issued under it.
 
  7.2.9   A reference to $ is to the lawful currency of Australia.
 
  7.2.10   Words and phrases not specifically defined in this deed have the same meanings (if any) given to them in the Corporations Act.
 
  7.2.11   A reference to time is a reference to time in Sydney, Australia.

 

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  7.2.12   If the day on which any act, matter or thing is to be done is a day other than a Business Day, such act, matter or thing must be done on the immediately succeeding Business Day.
 
  7.2.13   The meaning of general words is not limited by specific examples introduced by including, or for example, or similar expressions.
Headings
7.3   Headings are for convenience only and do not affect the interpretation of this deed.

 

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(DLA PHILLIPS FOX LOGO)
Schedule 1
Standalone Options
         
        Number and key terms of
Name and address of   Number and key terms of   Unilife Corporation Standalone
Standalone Optionholder   Standalone Options   Options
 
[     ]
  Tranche 1

Number: [     ]

Exercise Price: A$1.25


Expiry date: Third anniversary of the date of grant of the Standalone Option.
  Tranche 1

Number: [     ] x the Consolidation Ratio

Exercise Price: A$1.25 x the Consolidation Ratio

Expiry date: Third anniversary of the date of grant of the Standalone Options the Unilife Corporation Standalone Option replaces.
 
       
 
  Tranche 2

Number: [     ]

Exercise Price: A$2.00


Expiry date: Third anniversary of the date of grant of the Standalone Option.
  Tranche 2

Number: [     ] x the Consolidation Ratio

Exercise Price: A$2.00 x the Consolidation Ratio

Expiry date: Third anniversary of the date of grant of the Standalone Options the Unilife Corporation Standalone Option replaces.

 

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(DLA PHILLIPS FOX LOGO)
Execution and date
Executed as a deed.
Date:

 

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(DLA PHILLIPS FOX LOGO)
         
Executed as a deed by Unilife Medical Solutions Limited acting by the following persons:
       
 
       
 
Signature of director
 
 
Signature of director/company secretary
   
 
       
 
Name of director (print)
 
 
Name of director/company secretary (print)
   
 
       
Executed as a deed by Unilife Corporation acting
by the following person:
       
 
       
 
Signature of duly authorised officer
       
 
       
 
Name of officer (print)
       
 
       
Executed as a deed by [insert name of Standalone Option Holder] acting by the following persons:
       
 
       
 
Signature of director/duly authorised officer
 
 
Signature of director/company secretary/ duly authorised officer
   
 
       
 
Name of director/officer (print)
 
 
Name of director/company secretary/officer (print)
   

 

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(DLA PHILLIPS FOX LOGO)   ??Standalone Option Cancellation Deed
Annexure A
Unilife Corporation Option Agreement

 

14


 

Exhibit 10.27
Option Agreement
Unilife Corporation
[insert name of Option Holder]

 

 


 

Table of contents
         
Parties
    3  
 
       
1 Grant of Options
    3  
 
       
2 Tranches
    3  
 
       
3 Exercise Period
    3  
 
       
4 Exercise Price
    3  
 
       
5 Notice of Exercise
    4  
 
       
6 Allotment of Unilife Corporation Shares
    4  
 
       
7 Quotation of Options and Shares
    4  
 
       
8 Shareholder approval
    5  
 
       
9 Shares rank equally
    5  
 
       
10 No participation in new issues
    5  
 
       
11 Reorganisation of capital
    5  
 
       
12 Options not transferable
    5  
 
       
13 Change of control
    6  
 
       
14 Option register
    6  
 
       
15 Governing Law
    6  
 
       
16 Notices
    6  
 
       
17 Definitions
    6  

 

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Parties
Unilife Corporation a company incorporated in Delaware United States of 633 Lowther Road, Lewisberry, Pennsylvania 17339, United States (Unilife Corporation)
 
[insert name of Optionholder] (Option Holder)
1   Grant of Options
 
1.1   Unilife Corporation grants the Option Holder [insert amount] Options to subscribe for Unilife Corporation Shares on the terms and conditions set out in this Agreement; and
 
1.2   Each Option entitles the Option Holder to acquire one Unilife Corporation Share.
 
2   Tranches
 
2.1   The Options are granted in two tranches:
  2.1.1   Tranche 1: [insert amount] Options; and
 
  2.1.2   Tranche 2: [insert amount] Options.
3   Exercise Period
 
3.1   Subject to clause 13, each Option is exercisable at any time in the period from the date of grant until the third anniversary of the Original Grant and if the Option is not exercised on or prior to the expiry of the relevant Option Period, the Option will automatically lapse.
 
4   Exercise Price
 
4.1   The exercise price for each Option is as follows:
  4.1.1   Tranche 1: [A$insert price equal to $1.25 x Consolidation Ratio] per Option
 
  4.1.2   Tranche 2: [A$insert price equal to $2.00 x Consolidation Ratio] per Option
    and is payable immediately on exercise by bank cheque or wire transfer to an account of the Unilife Corporation.

 

3


 

5   Notice of Exercise
 
5.1   The Options may be exercised wholly or in part by giving notice in writing to the Unilife Corporation at any time during the Option Period stating the number of Options being exercised. Options may only be exercised in multiples of 3,000 unless all of the then unexercised Options are being exercised under the relevant Notice of Exercise.
 
6   Allotment of Unilife Corporation Shares
 
6.1   Subject to clause 6.3, on receipt by Unilife Corporation of a valid Notice of Exercise in accordance with clause 5 and payment of the Exercise Price in accordance with clause 4, Unilife Corporation must, within two Business Days, issue and allot to the Option Holder the number of Unilife Corporation Shares set out in the Exercise Notice and despatch the relevant share certificate or other appropriate acknowledgment as soon as reasonably practicable thereafter.
 
6.2   Whilst Unilife Corporation remains listed on ASX, the Option Holder will be entitled to elect whether to receive Unilife Corporation Shares in the form of common stock of Unilife Corporation or as CDIs.
 
6.3   If at any time the Board determines that the delivery of Unilife Corporation Shares under this Agreement is or may be unlawful under Applicable Law, the Option Holder’s right to exercise the Option or receive the Unilife Corporation Shares pursuant to the Option shall be suspended until the Board determines that such delivery is lawful.
 
6.4   Unilife Corporation may require that the Option Holder, as a condition to exercise of the Option, and as a condition to the delivery of any share certificate, make such written representations (including representations to the effect that the Option Holder will not dispose of the Unilife Corporation Shares so acquired in violation of Applicable Law) and furnish such information as may, in the opinion of counsel for Unilife Corporation, be appropriate to permit Unilife Corporation to issue the Unilife Corporation Shares in compliance with Applicable Law.
 
7   Quotation of Options and Shares
 
7.1   The Options will not be listed for quotation on ASX or any other exchange.
 
7.2   As soon as reasonably practicable following the exercise of an Option:
  7.2.1   to the extent that the Option Holder elects to receive their Unilife Corporation Shares in the form of CDIs, Unilife Corporation shall apply for the CDIs to be admitted for quotation on the Official List of ASX (so long as CDIs are quoted on the Official List of the ASX at that time); or
 
  7.2.2   to the extent that the Option Holder elects to receive their Unilife Corporation Shares in the form of common stock, Unilife Corporation shall apply for the Unilife Corporation Shares to be admitted for quotation on NASDAQ (so long as the Unilife Corporation shares are quoted on NASDAQ at that time).

 

4


 

8   Shareholder approval
 
8.1   If, for any reason, an issue of Unilife Corporation Shares to the Option Holder in accordance with this Agreement would require approval of Shareholders, Unilife Corporation must convene the necessary meeting as soon as reasonably practicable and at its own cost.
 
9   Shares rank equally
 
9.1   Unilife Corporation Shares issued on the exercise of Options will rank equally in all respects with the other Unilife Corporation Shares on issue at the date of allotment and will be subject to the provisions of Unilife Corporation’s certificate of incorporation.
 
10   No participation in new issues
 
10.1   An Option does not confer a right to participate in new issues of securities of Unilife Corporation, unless the Option Holder has first exercised the Option and such exercise took place on or before the record date for determining entitlements to the issue.
 
10.2   In the event that a pro rata issue of Unilife Corporation shares is made to the holders of securities in Unilife Corporation, the exercise price of the Options shall be reduced in accordance with the ASX Listing Rules (so long as CDIs are quoted on ASX at that time).
 
11   Reorganisation of capital
 
11.1   In the event of any reorganisation (including consolidation (reverse split), sub-division (stock split), split-up, spin-off or similar transaction, recapitalisation, reduction or return, merger or share exchange) of the issued capital of Unilife Corporation, the rights of the Option Holder including the number of Options or the Exercise Price or both shall be reorganised (as appropriate);
  11.1.1   while CDIs are quoted on the Official List of ASX, to the extent necessary to comply with the Listing Rules applying to a reorganisation of capital at the time of the reorganisation; or
 
  11.1.2   if CDIs are no longer quoted on the Official List of ASX, as otherwise determined by the Board to be appropriate to reflect the reorganisation.
12   Options not transferable
 
12.1   Subject to clause 12.2 below, the Options are not transferable without the prior written consent of Unilife Corporation, except to a family member, family trust or estate of a shareholder or officer of the Option Holder,
 
12.2   Transfers to a partner, shareholder, officer, subsidiary, affiliate, affiliated partnership or other affiliated entity are not permitted without the prior written consent of Unilife Corporation, such permission to be granted by Unilife Corporation only after the Option Holder provides satisfactory assurances to Unilife Corporation that there is an available exemption from registration under which Unilife Corporation will be able to issue Unilife Corporation Shares upon exercise of the Options by the transferee.

 

5


 

13   Change of control
 
13.1   Each outstanding Option shall lapse upon the effective time of a Change of Control Event unless the transaction the subject of the Change of Control Event provides for the continuation or assumption of outstanding Options by the surviving or successor entity or a parent company of that entity, or for the substitution of equivalent awards, as determined in the sole discretion of the Board, of the surviving or successor entity or a parent of that entity. This is subject to the proviso that holders of Options that lapse under this clause 13.1 are permitted to exercise all of their Options immediately before the Change of Control Event.
 
14   Option register
 
14.1   Unless otherwise determined by the Board of Directors of Unilife Corporation (or a committee of the Board), Unilife Corporation’s share registry will maintain a register of the Options.
 
15   Governing Law
 
15.1   The Options and this Agreement shall in all respects be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict of laws principles.
 
15.2   Any suit with respect to an Option will be brought in the federal or state courts in the State of Delaware, and the Option Holder, by accepting the Options, irrevocably and unconditionally agrees and submits to the personal jurisdiction and venue thereof.
 
16   Notices
 
16.1   Notices may be given by Unilife Corporation to the Option Holder in writing and to the address set out above or such new address as is notified from time to time by the Option Holder to Unilife Corporation.
 
17   Definitions
 
17.1   In these Rules, unless the context otherwise requires:
 
    A$ means Australian currency.
 
    Applicable Law means any one or more or all, as the context requires, of:
  (a)   the Corporations Act and any regulations to it;
 
  (b)   the ASX Listing Rules;
 
  (c)   the certificate of incorporation of the Unilife Corporation;

 

6


 

  (d)   the United States Securities Act of 1933, as amended (including the rules thereunder), Exchange Act and any other applicable United States federal or state law, including without limitation the Delaware General Corporation Law;
 
  (e)   the Internal Revenue Code of 1986, as amended, and any regulations to it;
 
  (f)   the NASDAQ Rules; and
 
  (g)   any practice note, policy statement, class order, declaration, guideline, policy or procedure pursuant to the provisions of which any of the SEC, ASIC or ASX is authorised or entitled to regulate, implement or enforce, either directly or indirectly, the provisions of any of the foregoing statutes, regulations or rules or any conduct of any duly authorised person, pursuant to any of the abovementioned statutes, regulations or rules.
    ASIC means the Australian Securities and Investments Commission.
 
    ASX means ASX Limited (ACN 008 624 691) and any successor body corporate or the financial market it operates (as the context requires).
 
    ASX Listing Rules means the Listing Rules published by ASX from time to time.
 
    Board means all or some of the directors of Unilife Corporation acting as a board from time to time.
 
    Business Day means any day, other than a Saturday, Sunday or public holiday in New York, United States of America.
 
    CDI means a CHESS Depositary Interest over [insert fraction] of a share of Unilife Corporation common stock.
 
    Change of Control Event means the occurrence of any of the following events:
  (a)   a change of Ownership of Unilife Corporation;
 
  (b)   a change of Effective Control of Unilife Corporation; or
 
  (c)   a change of Ownership of Assets of Unilife Corporation; or
    as described in these Rules and construed consistent with Section 409A of the Code. For the purposes of a Change of Control Event, fair market value is determined by the Board, and share ownership is determined under section 318(a) of the Code. A Change of Control Event excludes any transfer to a related person as described in Section 409A of the Code or a public offering of the Shares.
 
    Change of Effective Control of Unilife Corporation means the date on which a majority of members of Unilife Corporation’s full board of directors is replaced during any 12-month period by directors whose appointment or election is not endorsed by a majority of the members of Unilife Corporation’s full board of directors before the date of the appointment or election.

 

7


 

    Change of Ownership of Assets of Unilife Corporation means the date on which any one person acquires, or Persons Acting as a Group acquire (or has or have acquired during the 12 month period ending on the date of the most recent acquisition by such Person or Persons), assets from Unilife Corporation that have a total gross fair market value more than 50% of the total gross fair market value of all of the assets of Unilife Corporation immediately before such acquisitions. For this purpose, gross fair market value means the value of the assets of Unilife Corporation, or the value of the assets being disposed of, determined without regard to any liabilities associated with such assets.
 
    Change of Ownership of Unilife Corporation means the date on which any one Person acquires, or Persons Acting as a Group acquire, ownership of Shares that, together with the Shares held by such Person or Persons Acting as Group, constitutes more than 50% of the total fair market value or total voting power of the Shares of Unilife Corporation. However, if any one Person is, or Persons Acting as a Group are, considered to own more than 50% of the total fair market value or total voting power of the Shares of Unilife Corporation, the acquisition of additional Shares by the same Person or Persons Acting as a Group is not considered to cause a Change of Ownership of Unilife Corporation or to cause a Change of Effective Control of Unilife Corporation. An increase in the percentage of Shares owned by any one Person, or Persons Acting as a Group, as a result of a transaction in which Unilife Corporation acquires its Shares in exchange for property will be treated as an acquisition of Shares.
 
    Corporations Act means the Corporations Act 2001 (Cth).
 
    Exchange Act means the United States Securities Exchange Act of 1934, as amended, including the rules promulgated thereunder.
 
    Exercise Price means the exercise price payable to acquire one Share pursuant to the exercise of each Option.
 
    NASDAQ Rules means the Nasdaq Listing Rules as published by The Nasdaq Stock Market from time to time.
 
    Notice of Exercise means the notice provided to Unilife Corporation by the Option Holder in respect of the exercise of the Options.
 
    Option Period means the date from which the Options become exerciseable until the date on which the Options lapse.
 
    Options means the options granted to the Option Holder under this Agreement.
 
    Original Grant means the date of grant of the Original Option.
 
    Original Option means the Unilife Medical Solutions Limited options granted to the Option Holder which the Option replaces.
 
    Person means any individual, entity or group within the meaning of section 13(d)(3) or 14(d)(2) of the Exchange Act, other than employee benefit plans sponsored or maintained by the Company and by entities controlled by the Company or an underwriter of the Shares of the Company in a registered public offering;

 

8


 

    Persons Acting as a Group means persons who are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of shares, or similar business transaction with the corporation. If a Person owns shares in both corporations that enter into a merger, consolidation, purchase or acquisition of shares, or similar transaction, such shareholder is considered to be a Person Acting as a Group with other shareholders only with respect to the ownership in that corporation before the transaction giving rise to the change and not with respect to the ownership interest in the other corporation. Persons will not be considered to be Persons Acting as a Group solely because they purchase assets of the same corporation at the same time or purchase or own shares of the same corporation at the same time, or as a result of the same public offering;
 
    Unilife Corporation Shares means shares of fully paid common stock in the capital of Unilife Corporation.
 
    Unilife Medical Solutions Limited means Unilife Medical Solutions Limited (ABN 14 008 071 403).
 
    SEC means the United States Securities and Exchange Commission.

 

9


 

Date:
THESE OPTIONS AND THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (US SECURITIES ACT) AND THE OPTIONS MAY NOT BE EXERCISED BY OR ON BEHALF OF ANY U.S. PERSON, AS SUCH TERM IS DEFINED IN REGULATION S OF THE US SECURITIES ACT, UNLESS A REGISTRATION STATEMENT UNDER THE SECURITIES ACT IS FILED AND MADE EFFECTIVE, OR AN OPINION OF COUNSEL SATISFACTORY TO THE UNILIFE CORPORATION TO THE EFFECT THAT REGISTRATION UNDER THE US SECURITIES ACT IS NOT REQUIRED. NEITHER THE OPTIONS NOR THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE MAY BE TRANSFERRED, SOLD OR OTHERWISE DISPOSED OF IN THE ABSENCE OF (I) AN EFFECTIVE REGISTRATION STATEMENT WITH RESPECT TO THE OPTIONS OR THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE, OR (II) AN EXEMPTION FROM REGISTRATION UNDER THE US SECURITIES ACT AND AN OPINION OF COUNSEL SATISFACTORY TO THE UNILIFE CORPORATION TO THE EFFECT THAT REGISTRATION UNDER THE US SECURITIES ACT IS NOT REQUIRED.
     
Executed by Unilife Corporation acting by the following person:
   
 
   
 
Signature of duly authorised officer
   
 
   
 
Name of officer (print)
   
 
   
Executed by [insert name of Option Holder]
in the presence of:
   
 
   
 
Signature of duly authorised officer
   
 
   
 
Name of officer (print)
   

 

10

EX-10.28 14 c93531exv10w28.htm EXHIBIT 10.28 Exhibit 10.28
Exhibit 10.28
(UNILIFE LOGO)
Private and Confidential
1 October 2009
     
[name]
  URGENT
[company]
   
[address]
  FAX CONFIRMATION REQUIRED BY
[address]
  5.00PM (AEST)
 
  2 October 2009
Email: [  ]
   
Dear [name]
UNILIFE MEDICAL SOLUTIONS LIMITED – PLACEMENT OFFERS & ALLOCATION FOR NON-US PERSONS
Unilife Medical Solutions Limited (“Unilife”) is pleased to invite you and/or your clients to subscribe for shares and free unlisted attaching options in Unilife under a placement to raise up to A$40 million in Australia and the US (“Placement”) on the terms set out in this letter (“Subscription Agreement”). Details of the shares and free unlisted attaching options in Unilife for which you are invited to subscribe (conditional upon satisfaction of the Conditions) are set out in Section 2.
Unilife is also proposing to offer additional shares to existing shareholders at the Placement Price under a Share Purchase Plan to raise up to a further A$10 million.
Unilife announced on 1 September 2009 that it proposes to redomicile in the United States. Provided that the Conditions are fulfilled, it is intended that the Placement will be completed and the Placement Shares and Placement Options will be issued prior to the redomiciliation occurring. Accordingly, if Unilife proceeds with the redomiciliation:
  (a)   the Placement Shares would participate in the scheme of arrangement which will be proposed to Unilife shareholders with the result that the Placement Shares would be replaced with common stock in the new United States parent company, Unilife Corporation; and
 
  (b)   the Placement Options would be exchanged for equivalent options in Unilife Corporation.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

 


 

Non-US Subscription Agreement for Unilife Placement
1.   Details of the Placement
The following are the principal details of the Placement and defined terms used in this Subscription Agreement:
     
Company or Unilife
  Unilife Medical Solutions Limited (ABN 14 008 071 403)
 
   
Placement
  The proposed issue by the Company of (i) the Placement Shares at the Placement Price and (ii) the Placement Options to investors in the US and Australia.
 
   
Amount of Placement
  Up to A$40 million
 
   
Placement Shares
  Up to 47,058,823 fully paid ordinary shares in the Company to be issued under the Placement, at the Placement Price comprising the Firm Shares and the Additional Shares.
 
   
Placement Price
  A$0.85 per Placement Share
 
   
Firm Shares
  The initial allocation of Placement Shares (as referred to on page 1), which may be issued without shareholder approval under the Company’s 15% placement capacity under Listing Rule 7.1.
 
   
Additional Shares
  The further allocation of Placement Shares (as referred to on page 1), being the excess over the Company’s 15% placement capacity under ASX Listing Rule 7.1 which will be issued to investors upon satisfaction of the Conditions.
 
   
Placement Options
  For every four Placement Shares allotted, the Placees will be issued for nil cash consideration, two free unlisted options (a Tranche 1 option and a Tranche 2 option) in the Company. Each option will entitle the Placee to subscribe for one ordinary share in the Company.
 
   
 
  The options will be issued with an exercise price of: Tranche 1 — A$1.25, Tranche 2 — A$2.00, and otherwise on the terms and conditions set out in Schedule 1
 
   
Redomiciliation
  The proposed redomiciliation of the Company in the United States which was announced on 1 September 2009.
 
   
Replacement Options
  The options over common stock in Unilife Corporation which will be issued to investors by Unilife Corporation upon implementation of the Redomiciliation and which will be on substantially the same terms as the Placement Options as described in the Cancellation Deed.
 
   
Conditions
  The issue of the Additional Shares and the Placement Options is subject to the Company obtaining Shareholder Approval for their issue. The issue of the Placement Options is also conditional upon the placee providing a duly executed Cancellation Deed to the Company by 2 October 2009.
 
   
Cancellation Deed
  The cancellation deed in the form set out in Schedule 2.
 
   
Shareholder Approval
  The Placement is conditional upon the approval of Unilife shareholders for the issue of the Additional Shares and the Placement Options in accordance with ASX Listing Rule 7.1 at an extraordinary general meeting of the Company which is scheduled to occur in early November 2009 (“EGM”).
 
   
  Unilife does not warrant that shareholder approval will be obtained for the placement of the Additional Shares or the Placement Options.
 
   
Underlying Shares
  The ordinary shares in the Company issued to investors on exercise of Placement Options and/or the shares of common stock in Unilife Corporation issued to investors on exercise of the Replacement Options (as applicable).
 
   
Use of Proceeds
  Unilife intends to use the proceeds raised from the Placement in the expansion of its operational capabilities in the United States, for the continued industrialisation of the Unilife Ready-to-Fill Syringe, and for the development of other pipeline products.
 
   
  Notwithstanding the above, the Company reserves the right to change the use of proceeds in its sole discretion, from time to time.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

Page 2


 

Non-US Subscription Agreement for Unilife Placement
2.   Your Allocation
Unilife is pleased to confirm that you, as the addressee of this Subscription Agreement (“you”), are invited to subscribe for or procure your clients to subscribe for the number of Placement Shares and Placement Options set out below.
         
[  ] Placement Shares
comprising:
  A$[  ]   5:00pm, Tuesday, 6 October 2009
(Australian Eastern Standard Time)
 
       
    [  ] Firm Shares; and
       
 
       
    [  ] Additional Shares
       
 
       
[  ] Placement Options*
       
 
     
*   You will receive two Placement Options (a Tranche 1 option and a Tranche 2 option) for every four Placement Shares which you subscribe for under the Placement.
This offer is made to you on the terms and conditions set out in this Subscription Agreement. The term “you” shall include any person or entity which applies for Placement Shares and Placement Options on your behalf, including as nominee or custodian.
By returning the completed Placement Application Form (attached to this Subscription Agreement) including the making of your investor representations in this Subscription Agreement and the Placement Application Form and providing payment of the subscription price for your Placement Shares (“Subscription Amount”) to the Company in cleared funds by no later than 5:00pm Tuesday 6 October 2009, you are irrevocably applying for the allotment and issue to you of the number of Placement Shares and Placement Options set out above on the terms set out in this Subscription Agreement without the need for any separate instrument of application by you.
Upon receipt of the completed Placement Application Form, together with payment of the above Subscription Amount in cleared funds the Company agrees to allot and issue to you the number of Placement Shares set out above and, if the Conditions are satisfied, agrees to issue to you the number of Placement Options set out above.
Upon the allotment of Placement Shares and Placement Options to you, you agree to:
  (a)   accept the Placement Shares and Placement Options issued to you on the terms of the offer as set out in this Subscription Agreement;
 
  (b)   to be bound by the Company’s constitution; and
 
  (c)   authorise your name to be placed on the register of members of the Company as the legal owner of the Placement Shares and on the Company’s option register as the legal owner of the Placement Options issued to you.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

Page 3


 

Non-US Subscription Agreement for Unilife Placement
Pursuant to the terms of the Placement Application Form and this Subscription Agreement, you acknowledge that the Placement Shares, Placement Options, the Replacement Options and the Underlying Shares have been or will be offered and sold to you (upon the satisfaction of the Conditions in the case of the Placement Options), in reliance on Regulation S of the United States Securities Act of 1933, as amended (the “US Securities Act”) and therefore you covenant and agree not to sell the Placement Shares, the Placement Options, the Replacement Options or the Underlying Shares except as permitted under the US Securities Act pursuant to registration or to an exemption from registration. You also covenant and agree that you will not exercise the Placement Options or the Replacement Options unless at the time of exercise (i) you are outside the United States and (ii) you are not a US person, as defined in Regulation S (and are not acquiring the Underlying Shares on behalf of or for the account of or benefit of, a US person).
3.   Timetable
The proposed timetable for the Placement is as follows:
     
Return of Placement Application Form
  by 5.00pm 2 October 2009
Payment of subscription amount
  by 5.00pm 6 October 2009
Allotment of Firm Shares (not subject to Shareholder Approval being obtained)
  8 October 2009
Unilife Extraordinary General Meeting to consider resolution to approve issue of Additional Shares and Placement Options
  early November 2009
Allotment of Additional Shares and Placement Options (subject to Shareholder Approval being obtained)
  within 3 business days after the EGM
     
*   All times above are references to Sydney time.
Quotation of Placement Shares (on ASX) will occur following allotment of the relevant Placement Shares. The Company will not apply for listing of the Placement Options on ASX or any other exchange.
Please note that the above timetable may change without consultation with you and you are bound by your Subscription Agreement, notwithstanding any such changes to the timetable.
The Company reserves the right not to proceed with the Placement or any part of it at any time before the allotment of Placement Shares and Placement Options to you. If the Placement or any part of it does not proceed or is cancelled, all relevant Subscription Amounts relating to the cancelled part of the Placement will be refunded (without interest).
4.   Rights and Restrictions attaching to the Placement Shares, the Placement Options, the Replacement Options and the Underlying Shares
The Placement Shares will be fully paid ordinary shares and will rank pari passu in all respects with the ordinary shares of Unilife on issue as at the date of their allotment. With respect to the transferability of the Placement Shares, the Placement Shares are being offered pursuant to the Regulation S exemption from registration under the US Securities Act, and as such, cannot be offered or sold to “US persons” (as defined under Regulation S of the US Securities Act).
The Placement Options will be options to acquire ordinary shares in Unilife on the key terms set out in Schedule 1. The Placement Options will not be listed on ASX. The issue of the Placement Options is conditional upon you delivering to the Company a duly executed Cancellation Deed with respect to the Placement Options, under which the Placement Options will be replaced with equivalent options in Unilife Corporation, upon implementation of the Unilife Group’s redomiciliation in the United States. The terms of the Replacement Options are set out in the Option Deed attached to the Cancellation Deed attached as Schedule 2.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

Page 4


 

Non-US Subscription Agreement for Unilife Placement
Allotment of the Placement Options will only take place once the Conditions have been satisfied.
Upon allotment, Unilife will apply to ASX for official quotation of the Placement Shares on the ASX. Please note that ASX Participating Organisations (as defined in the ASX Business Rules) cannot deal in the Placement Shares either as principal or agent until official quotation is granted in respect of the Placement Shares. The Placement Options, the Replacement Options and the Underlying Shares are being or will be offered pursuant to the Regulation S exemption from registration under the US Securities Act and as such cannot be offered or sold to ‘US’ persons as defined under Regulation S of the US Securities Act.
5.   Issue of Placement Shares and Placement Options
Subject to the Company receiving payment in full in cleared funds for the Placement Price, the Firm Shares will be issued on or about 8 October 2009.
The Additional Shares and the Placement Options will be issued to Applicants within 3 business days of the satisfaction of the Conditions.
6.   Holding of Subscription Amounts for Additional Shares
(a)   The business day following the date that the Company closes the Placement, the Company shall transfer the subscription amounts received from investors for the Additional Shares (“Escrow Amounts”) into the escrow account established and operated by its escrow agent.
 
(b)   In the event that:
  (i)   the Conditions are satisfied on or before 31 December 2009, Unilife shall direct the escrow agent to release the Escrow Amounts to the Company promptly upon becoming aware that the Conditions have been satisfied;
 
  (ii)   Shareholder Approval is not obtained at the EGM (or at any deferral of the EGM) or the Conditions are not satisfied on or before 31 December 2009. Unilife shall direct the escrow agent to release the Escrow Amounts to the Company for refund to investors on the earliest of the business day after:
    the EGM (if the resolution approving the Placement was not passed);
 
    the Company becomes aware that the Conditions are not capable of being satisfied; and
 
    31 December 2009.
(c)   Upon receipt of the Escrow Amounts from the escrow agent in accordance with clause 6(b)(ii), the Company shall promptly refund your Subscription Amount to you.
(d)   Any interest which accrues on the Escrow Amounts while in the Escrow Account shall follow the principal amount and shall be paid to the Company or refunded to investors (as the case may be) at the same time as payment of the corresponding principal.
7.   Offer Personal
The invitation for you to subscribe for Placement Shares and Placement Options on the terms and conditions set out in this Subscription Agreement is personal to you. You may not, prior to allotment of the Placement Shares and Placement Options, assign, transfer or deal in any other manner, with Placement Shares and Placement Options, or your rights or obligations under this Subscription Agreement without the prior written agreement of Unilife.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

Page 5


 

Non-US Subscription Agreement for Unilife Placement
8.   Representations, Warranties and Agreements
By accepting this invitation (by returning the completed Placement Application Form and Subscription Amount to the Company) you represent, warrant and agree for the benefit of Unilife and Inteq Limited and their respective related bodies corporate and any officers, employees, agents or advisers of any of them (“affiliates”) that:
(a)   If you are in Australia you are:
  (i)   a “Sophisticated Investor” under section 708(8) of the Corporations Act 2001 (Cth) (Corporations Act); or
 
  (ii)   a “Professional Investor” under section 708(11) of the Corporations Act.
(b)   If you are outside Australia, you are a person to whom an invitation or offer to subscribe for Placement Shares in the manner contemplated by this Subscription Agreement is permitted by the laws of the jurisdiction in which you are situated, and to whom Placement Shares can lawfully be issued under all applicable laws, without the need for any registration, filing or lodgement. This Subscription Agreement does not constitute an offer to subscribe for Placement Shares in any jurisdiction in which, or to any person to whom, such an offer would be illegal.
(c)   You confirm that you are in compliance with all relevant laws and regulations and will not cease to be in compliance if you apply for Placement Shares and Placement Options on the terms set out in this Subscription Agreement.
(d)   In accepting this offer to apply for Placement Shares and Placement Options on the terms set out in this Subscription Agreement you are not subscribing for Placement Shares and Placement Options for the purpose of selling or transferring the Placement Shares and Placement Options issued to you or granting, issuing or transferring interests in, or options over the Placement Shares and Placement Options within 12 months of their date of issue. This confirmation is understood to be a statement by you of present intention only but not an undertaking not to sell, particularly where your investment objectives or market conditions change.
(e)   You acknowledge that no disclosure document has been prepared under the Corporations Act in connection with the offer of the Placement Shares or the Placement Options.
(f)   You have such knowledge and experience in financial and business matters that you are capable of evaluating the merits and risks of a subscription for Placement Shares and Placement Options and you acknowledge that an investment in Placement Shares and Placement Options involves a degree of risk.
(g)   You have the financial ability to bear the economic risk of an investment in Placement Shares and Placement Options.
(h)   You are aware that publicly available information about Unilife can be obtained from ASX (including its web site http://www.asx.com.au), and that certain publicly available information about Unilife can be obtained free of charge from Unilife‘s web site: www.unilife.com.
(i)   You have had access to all information that you believe is necessary or appropriate in connection with your application for Placement Shares and Placement Options. You acknowledge and agree that you will not hold Unilife, Inteq Limited or any of their respective officers, employees, agents, advisers or affiliates responsible for any misstatements in, or omissions from, any publicly available information concerning Unilife.
(j)   You have made and relied upon your own assessment of Unilife and have conducted your own investigation with respect to the Placement Shares and Placement Options and Unilife including, without limitation, the particular tax consequences of subscribing, owning or disposing of Placement Shares and Placement Options in light of your particular situation as well as any consequences arising under the laws of any other taxing jurisdiction.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

Page 6


 

Non-US Subscription Agreement for Unilife Placement
(k)   You have not relied on any representations made by Unilife, Inteq Limited or any of their respective officers, employees, agents, advisers or affiliates except as set out in this Subscription Agreement.
(l)   You have not relied on any investigation that Unilife, Inteq Limited or any of their respective officers, employees, agents, advisers or affiliates or any persons acting on their behalf may have conducted with respect to the Placement Shares and the Placement Options or Unilife. None of such persons has made any representation to you, express or implied, with respect to the Placement Shares and the Placement Options or Unilife.
(m)   You acknowledge that this Subscription Agreement does not constitute a securities recommendation or financial product advice and that Unilife and Inteq Limited have not considered your particular objectives, financial situation and needs.
(n)   You agree to be bound by the provisions of the constitution of Unilife upon allotment of Placement Shares to you (and upon any subsequent issue of Placement Options to you).
(o)   Except to the extent that liability cannot by law be excluded, you acknowledge that none of Inteq Limited, Unilife or any of their respective related bodies corporate or any officers, employees, agents, advisers or affiliates of Inteq Limited or Unilife, accept any responsibility in relation to the Placement.
 
(p)   You are not a Related Party (as defined in the ASX Listing Rules) of Unilife.
(q)   You understand and agree that the offer and sale to you of the Placement Shares, the Placement Options, the Replacement Options and the Underlying Shares have not been and will not be registered under the US Securities Act or the laws of any state or other jurisdiction in the United States but rather the issue of the Placement Shares, the Placement Options and the Replacement Options under this Subscription Agreement and the issue of the Underlying Shares on exercise of the Placement Options or the Replacement Options will be made in reliance on an exemption from registration contained in Regulation S under the US Securities Act for offers and sales made outside of the US. Therefore, you agree that you may not and will not offer, sell, pledge, transfer or otherwise dispose of any Placement Shares, any Placement Options, any Replacement Options or any Underlying Securities in the United States or for the account or benefit of a U.S. person (as defined in Regulation S of the US Securities Act) (“US Person”) unless and until the Placement Shares, the Placement Options, the Replacement Options or the Underlying Shares (as applicable) are registered under the US Securities Act (which you acknowledge Unilife has no obligation to do) or offered, sold, pledged, transferred or otherwise disposed of in a transaction exempt from, or not subject to, the registration requirements of the US Securities Act or the laws of any state or other jurisdiction in the United States. You further acknowledge that (i) each Placement Option certificate and Replacement Option certificate will bear a legend stating that it and the Underlying Shares have not been registered under the US Securities Act and that such option may not be exercised by or on behalf of any US person unless registered under the US Securities Act or an exemption from registration is available and (ii) upon exercise of such option, you will be required to give a written certification that you are outside the US and that you are not a US person and that the Placement Option or Replacement Option is not being exercised on behalf of a US person.
(r)   You represent that (i) at the time that you submit your Placement Application Form to the Company, (ii) at the time of allotment of the Placement Shares and the Placement Options, (iii) at the time of the issue of the Replacement Options and (iv) at the time of exercise of the Placement Options or the Replacement Options, as applicable, you are and will be (i) outside the United States and (ii) not a US person, as defined in Regulation S and are not and will not be acquiring the Placement Shares, the Placement Options, the Replacement Options or the Underlying Shares on behalf of or for the account of or benefit of, a US person.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
(s)   You will not engage in hedging transactions with regard to either the Placement Shares, the Placement Options, the Replacement Options or the Underlying Shares unless in compliance with the US Securities Act
(t)   You have full corporate power and lawful authority to execute and deliver this Subscription Agreement and to perform, or cause to be performed, your obligations under this Subscription Agreement.
(u)   This Subscription Agreement constitutes a legal, valid and binding obligation on you, enforceable in accordance with its terms.
(v)   If you are acquiring any Placement Shares and Placement Options for an account of one or more persons, you have full power to make the foregoing acknowledgments, representations, warranties and agreements on behalf of each such person and you will take reasonable steps to ensure that each such person will comply with its obligations herein.
(w)   You acknowledge that Unilife, Inteq Limited and their affiliates will rely upon the truth and accuracy of the foregoing acknowledgments, representations, warranties and agreements and agree that if any such acknowledgments, representations or warranties are no longer accurate, you will notify Unilife immediately. You indemnify Unilife, Inteq Limited and their respective officers, employees, advisers and affiliates against any loss, damage or costs incurred and arising out of or in relation to any breach by you of the acknowledgments, representations, warranties and agreements.
(x)   You acknowledge that if you have material non-public information regarding the Company insider trading restrictions may apply to you. You agree not to, and not to cause any other person to, acquire any of the Company’s securities after you have had access to material non-public information if doing so would be a breach of insider trading restrictions.
9.   Announcements
You may not make any public announcement or communication concerning the transactions referred to in this Subscription Agreement without obtaining the prior written consent of Unilife except as required by law or a regulation of a stock exchange.
10.   Governing Law and Jurisdiction
This Subscription Agreement between us arising out of your acceptance of the terms of this invitation to apply for Placement Shares shall be governed by the laws of New South Wales, Australia and you agree to submit to the exclusive jurisdiction of the courts of that State and the Commonwealth of Australia.
11.   Entire Agreement
The terms contained in this Subscription Agreement including, without limitation, your executed Placement Application Form, constitute the entire agreement among you and Unilife and your participation in the Placement to the exclusion of all prior representations, understandings and agreements among you and Unilife. Any variation of the terms of this Subscription Agreement must be in writing signed by Unilife and you.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
12.   Notices
Any notice to be given relating to the offer of Placement Shares and Placement Options or this Subscription Agreement may be sent by mail or by facsimile to the facsimile number of the party to whom the notice is sent and will be deemed to have been given one business day after being mailed or upon the successful transmission to that facsimile number.
13.   Commission
The Company has agreed to pay the following aggregate commissions to brokers in connection with the Placement:
(a)   a cash payment of up to 6.5% of the value of the Placement; and
 
(b)   the issue of options with an exercise price of A$0.85 per option totalling up to 6.5% of the number of shares allotted to subscribers under the Placement.
14.   Placement Application Form & Payment Details
To confirm your irrevocable application for the allotment and issue of the number of Placement Shares and Placement Options set out in Section 2 above to you, on the terms set out in this Subscription Agreement and your acceptance of the terms and conditions of the Placement as set out in this Subscription Agreement, please complete, sign and return a copy of the Placement Application Form to Unilife Medical Solutions Limited by fax on or before 5.00pm (Australian Eastern Standard Time) 2 October 2009 to:
Unilife Medical Solutions Limited
     
Fax No:
  +612 8346 6511
Attention:
  Jeff Carter, Company Secretary
Cheque Payment:
Please make cheques payable to Unilife Medical Solutions Limited – Subscription Account in Australian currency, cross it and mark it “Not Negotiable”. Cheques must be made in Australian currency, and cheques must be drawn on an Australian Bank.
Electronic Funds Transfers:
Electronic funds transfers must be made in Australian currency and all transfer fees and bank charges must be deducted from the sending bank. Transfers should be directed as follows:
     
Account Holder:
   Unilife Medical Solutions Limited
Account Name:
   Unilife Medical Solutions Limited — Subscription Account
Bank Name:
   Westpac Banking Corporation
Branch:
   Royal Exchange
BSB (Australian transfers):
   032-002
SWIFT Ref (International transferees):
   WPACAU2S
Account Number:
   494645
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
Any questions relating to settlement should be directed to Jeff Carter on +61 2 8346 6511. Please note that while this settlement is being undertaken via CHESS it is not covered by the National Guarantee Fund.
Yours faithfully,
Mr Jeff Carter
Company Secretary
Unilife Medical Solutions Limited
Enclosures: Placement Application Form
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
SCHEDULE 1
TERMS AND CONDITIONS OF PLACEMENT OPTIONS
1.   Subject to satisfaction of the Conditions, the Placement Options shall be issued for nil cash consideration. Each Placement Option entitles the holder to subscribe for one fully paid ordinary share (Share) in Unilife Medical Solutions Limited (Company).The Placement Options granted to each subscriber under the Placement shall be issued in two equal tranches as follows:
  1.1   Tranche 1: the exercise price for each Placement Option is A$1.25
 
  1.2   Tranche 2: the exercise price for each Placement Option is A$2.00
The exercise price for any Placement Option shall be payable in full on exercise of the Placement Option.
2.   The Placement Options shall be exercisable at any time from the date of grant until the third anniversary of the date of grant (Exercise Period).
3.   If the Placement Option is not exercised on or prior to the expiry of the Exercise Period, the Placement Option will automatically lapse.
4.   A certificate shall be issued for the Placement Options. Each certificate will bear a legend stating that it and the Underlying Shares have not been registered under the US Securities Act and that such option may not be exercised by or on behalf of any US person unless registered under the US Securities Act or if an exemption from registration is available and (ii) upon exercise of such option, the Optionholder will be required to give a written certification that he/she is outside the US and that he/she is not a US person and that the Placement Option is not being exercised on behalf of a US person.
5.   Placement Options shall be exercisable by notice in writing to the registered office of the Company accompanied by the holder’s option certificate. The notice must state the number of Placement Options being exercised (in multiples of 20,000 or where the number of Placement Options held is less than 20,000 such lesser amount). If the notice does not state the number of Placement Options being exercised, the notice shall be void and the Company shall request the Optionholder to provide a further notice.
 
6.   The Optionholder shall either:
  (a)   include with the notice to the Company referred to in clause 5, a cheque payable to the Company; or
 
  (b)   at the time of issuing the notice to the Company referred to in clause 5, arrange for an electronic funds transfer directly into an account nominated by the Company,
for the total exercise price of the Placement Options being exercised.
7.   Upon receipt of a valid notice in accordance with clause 5 and subject to the Company receiving cleared funds from the Optionholder in accordance with clause 6, the Company must issue the requisite number of Shares in the name of the Optionholder and update its share register to record the Optionholder as the holder of that number of Shares equal to the number of Placement Options exercised within five (5) business days of the exercise of the Placement Option.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
9.   Shares issued pursuant to an exercise of Placement Options shall rank equally in all respects with existing Shares of the Company from the date of allotment.
10.   An Optionholder may not sell, transfer, assign, give or otherwise dispose of, in equity or in law, the benefit of some or all of the Placement Options without the prior written consent of the Board.
11.   If Shares of the class are quoted, the Company shall, in accordance with ASX Listing Rule 2.8, make application to have Shares issued pursuant to an exercise of Placement Options listed for official quotation.
12.   If Placement Options are exercised before the record date of an entitlement, Optionholders can participate in a pro rata issue to the holders of Shares in the Company.
13.   Optionholders do not have any right to participate in new issues of securities by the Company without exercising Placement Options.
14.   In accordance with the ASX Listing Rules, in the event of any reorganisation of capital of the Company, the rights of the Optionholder will be changed to the extent necessary to comply with the ASX Listing Rules applying to a reorganisation of capital at the time of the reorganisation.
15.   The Placement Options will not give any right to participate in dividends until Shares are allotted pursuant to the exercise of the relevant Placement Options.
16.   In the event that an issue of Shares is made to the holders of securities in the Company (excluding a bonus issue), the exercise price of the Placement Options will be reduced in accordance with ASX Listing Rule 6.22.
17.   The number of Shares to be issued pursuant to the exercise of Placement Options will be adjusted for bonus issues made prior to exercise of Placement Options. The effect will be that upon exercise of the Placement Options, the number of Shares received by the Optionholder will be increased by the number of bonus Shares that would have been issued to such holder if the Placement Options had been exercised prior to the record date for the bonus issue. The exercise price of the Placement Options will not change as a result of any such bonus issue.
18.   If there has been a Change in Ownership or the Board concludes that the replacement of the majority of the Board is imminent, the Board must resolve to notify the Optionholder that all Placement Options may be exercised prior to 5pm (Sydney time) on the 90th day after the date of the notice (or by such earlier date as the Board determines).
 
19.   Subject always to clause 21 below, a ‘Change in Ownership’ shall occur if:
  (a)   a person acquires a relevant interest (within the meaning of section 608 of the Corporations Act 2001) in more than fifty per cent (50%) of the Shares in the Company as a result of a takeover bid;
 
  (b)   a person acquires a relevant interest (within the meaning of section 608 of the Corporations Act 2001) in more than fifty per cent (50%) of the Shares in the Company as a result of a scheme of arrangement;
 
  (c)   through the acquisition of Shares in the Company a person is able to determine the majority composition of the Board; or
 
  (d)   any other event (including, but not limited to, a merger of the Company with another company) which the Board determines, in its absolute discretion, to be a Change in ownership.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
20.   A ‘Change in Ownership’ does not include, unless otherwise determined by the Board, either an internal restructure of the Company’s group or a transaction whereby the Company’s group is redomiciled by imposing a new parent company of the Company’s group (including where such transaction is effected by a scheme of arrangement under the Corporations Act 2001 (Cth)). This exception to a ‘Change in Ownership’ includes a scheme of arrangement pursuant to which:
  (a)   a subsidiary of the Company will become the new parent company of the Company; or
 
  (b)   the shareholders of the Company on the record date of the scheme of arrangement will be entitled to be issued shares equal to at least fifty per cent (50%) of the issued ordinary share capital of the new parent company of the Company on the implementation date of the scheme of arrangement.
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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Non-US Subscription Agreement for Unilife Placement
SCHEDULE 2
CANCELLATION DEED
Unilife Medical Solutions Limited, Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000, Australia T +61 2 8346 6500 F +61 2 8346 6511
W www.unilife.com

 

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(DLA PHILLIPS FOX LOGO)
  201 Elizabeth Street
Sydney NSW 2000
Australia
DX 107 Sydney
Tel +61 2 9286 8000
Fax +61 2 9283 4144
www.dlaphillipsfox.com
Standalone Option Cancellation Deed
Unilife Medical Solutions Limited
Unilife Corporation
DLA Phillips Fox is a member of
DLA Piper Group, an alliance of
independent legal practices. It is a
separate and distinct legal entity.
DLA Phillips Fox offices are located
in Adelaide Auckland Brisbane
Canberra Melbourne Perth Sydney
and Wellington.

 

 


 

(DLA PHILLIPS FOX LOGO)
Table of contents
         
Parties
    2  
 
       
Background
    2  
 
       
Operative provisions
    2  
 
       
1 Cancellation of Standalone Options
    2  
 
       
2 Issue of Unilife Corporation Standalone Options
    2  
Time of issue
    3  
 
       
3 Conditions
    3  
Cancellation and offer conditional
    3  
Effective Time
    3  
Termination
    3  
No waiver
    3  
 
       
4 Representations and warranties
    4  
 
       
5 Release
    4  
Release
    4  
 
       
6 Miscellaneous
    5  
Notices
    5  
Conflict of interest
    6  
Costs
    6  
Counterparts
    6  
Binding agreement
    6  
Further assurances
    6  
No merger
    7  
No rights
    7  
Publicity
    7  
Variation and waiver
    7  
 
       
7 Definitions and interpretation
    7  
Definitions
    7  
Interpretation
    8  
Headings
    9  
 
       
Schedule 1
    10  
 
       
Execution and date
    11  
 
       
Annexure A
    12  
Unilife Corporation Option Agreement
    12  

 

1


 

(DLA PHILLIPS FOX LOGO)
Parties
Unilife Medical Solutions Limited ABN 14 008 071 403 of Suite 3, Level 11, 1 Chifley Square, Sydney NSW 2000 (Company)
Unilife Corporation a company incorporated in Delaware United States of 633 Lowther Road, Lewisberry, Pennsylvania 17339, United States (Unilife Corporation)
(Standalone Option Holder)
Background
     
A
  The Company has granted the Standalone Options to the Standalone Option Holder.
 
   
B
  The Company and Unilife Corporation have entered into a Merger Implementation Agreement under which, amongst other things, the Company and Unilife Corporation have agreed to effect a transaction by means of a scheme of arrangement pursuant to Part 5.1 of the Corporations Act under which Unilife Corporation will acquire all of the issued share capital of the Company with the result that the Unilife group will be re-domiciled in the US.
 
   
C
  The parties have agreed that in conjunction with the Share Scheme, the Standalone Options will be cancelled and, in consideration of the cancellation, Unilife Corporation will issue Unilife Corporation Standalone Options to the Standalone Option Holder.
Operative provisions
1   Cancellation of Standalone Options
1.1   Subject to clause 3.1, the Standalone Option Holder agrees to the cancellation of all, and not part only, of the Standalone Options held by it as at the date of this deed without any further action or consent on the part of the Company or the Standalone Option Holder.
2   Issue of Unilife Corporation Standalone Options
2.1   In consideration of, and subject to, the cancellation of its Standalone Options pursuant to clause 1.1 and subject to the satisfaction or waiver of the conditions set out in clause 3.1, Unilife Corporation will:
  2.1.1   issue the Unilife Corporation Standalone Options to the Standalone Option Holder;
  2.1.2   deliver to the Standalone Option Holder a duly executed counterpart of the Unilife Corporation Option Agreement;
  2.1.3   enter the name of the Standalone Option Holder in its register of option holders; and

 

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(DLA PHILLIPS FOX LOGO)
  2.1.4   no later than seven Business Days after the date of grant, despatch or procure the despatch to each Standalone Option Holder of a certificate representing the Unilife Corporation Standalone Options granted to it under this deed.
2.2   Subject to the satisfaction or waiver of the conditions set out in clause 3.1, the Standalone Option Holder will execute and deliver to the Company a counterpart of the Unilife Corporation Option Agreement.
Time of issue
2.3   Subject to the satisfaction of the conditions in clause 3.1, the Unilife Corporation Standalone Options must be issued by Unilife Corporation with effect from the Effective Time.
3   Conditions
Cancellation and offer conditional
3.1   The cancellation of the Standalone Options pursuant to clause 1.1 and the offer of Unilife Corporation Standalone Options pursuant to clause 2.1 is conditional upon:
  3.1.1   the Share Scheme becoming Effective; and
  3.1.2   the Company obtaining from ASX a waiver of any requirement under ASX Listing Rule 6.23.2 to obtain the approval of the Company’s shareholders to the cancellation of the Standalone Options.
Effective Time
3.2   Subject to the satisfaction of the conditions in clause 3.1, the Standalone Option Holder agrees to the cancellation of the Standalone Options with effect from the Effective Time, at which time the Standalone Options will have no further force or effect and the rights and entitlements of the Standalone Option Holder with respect to the Standalone Options will cease.
Termination
3.3   This deed will automatically terminate on the earlier of:
  3.3.1   the date on which the Merger Implementation Agreement is terminated; and
  3.3.2   30 June 2010 (or such other date and time agreed in writing between the Company and Unilife Corporation) if the conditions set out in clause 3.1 are not satisfied or waived before that date.
No waiver
3.4   The conditions precedent in clause 3.1 cannot be waived.

 

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(DLA PHILLIPS FOX LOGO)
4   Representations and warranties
4.1   The Standalone Option Holder represents and warrants to the Company and Unilife Corporation that as at the Effective Time:
  4.1.1   the number of Shares subject to, and the exercise price of, the Standalone Options, as set out in Schedule 1, is complete and accurate;
 
  4.1.2   it has read and understood the terms of this deed and the Unilife Corporation Option Agreement;
 
  4.1.3   it is not in breach of any provision or condition of the Standalone Options;
 
  4.1.4   it has full power and capacity to agree to the cancellation of the Standalone Options;
 
  4.1.5   it is the legal and beneficial holder of the Standalone Options;
 
  4.1.6   it will be taking the Unilife Corporation Standalone Options for investment purposes only and not with a view to distribution; and
 
  4.1.7   it is a sophisticated or professional investor within the meaning of section 708 of the Corporations Act 2001(Cth)
4.2   The Standalone Option Holder acknowledges that the issue of the Unilife Corporation Standalone Options constitutes good and valuable consideration for the cancellation of the Standalone Options and the release in clause 5.1.
4.3   The Standalone Option Holder acknowledges that the issue of the Unilife Corporation Standalone Options in exchange for the cancellation of the Standalone Options may not be an economically equivalent exchange because of, among other things, the different tax laws that apply to the options.
4.4   The Standalone Optionholder acknowledges that the transfer of the Standalone Options and the securities issued on the exercise of the Standalone Options is restricted under applicable US securities laws.
4.5   The Standalone Option Holder acknowledges that the certificate or other instrument evidencing the Unilife Corporation Standalone Options and the securities issuable upon exercise of the Standalone Options will bear an appropriate legend reflecting the restrictions on transfer which will apply to the Unilife Corporation Standalone Options and such underlying securities under applicable US securities laws.
 
5   Release
Release
5.1   Following cancellation of the Standalone Options:
  5.1.1   the Company releases the Standalone Option Holder and the Standalone Option Holder releases the Company and its officers, directors, shareholders, affiliates, successors, agents, attorneys, representatives, and any other person or entity that may have any liability for the Standalone Options (each a Released Party) from all actions, claims, losses, liabilities and expenses in respect of the cancellation and extinguishment of the Standalone Options, and all rights and entitlements attaching to the Standalone Options, with effect from the Effective Time; and

 

4


 

(DLA PHILLIPS FOX LOGO)
  5.1.2   the Company and the Standalone Option Holder agree not to make any claim or demand, or participate in any actions, claims, demands or proceedings against any Released Party inconsistent with clause 5.1.1 and agree that this deed may be pleaded as a bar to any such action, claim, proceeding or demand.
  5.1.3   the Standalone Option Holder agrees that, upon the issue of the Unilife Corporation Standalone Options, the Standalone Option Holder will have no further claim of right to purchase or receive Shares or any other securities or consideration for the Standalone Options, except as specifically set out in this deed.
6   Miscellaneous
Notices
6.1   Any notice, demand, consent or other communication (a Notice) given or made under this Agreement:
  6.1.1   must be in writing and signed by a person duly authorised by the sender;
  6.1.2   must be delivered to the intended recipient by prepaid post or by hand or fax to the address or fax number below or the address (being an address in Australia) or fax number last notified by the intended recipient to the sender:
Company:
         
 
  Address:   Level 11, 1 Chifley Square,
Sydney NSW 2000
 
  Fax:
Attention:
  (02) 8346 6511
Mr Jeff Carter
 
       
    Unilife Corporation:
 
       
 
  Address:   633 Lowther Road,
Lewisberry, Pennsylvania 17339
 
  Fax:
Attention:
  +1 717 938 9364
Mr Alan Shortall
 
       
    Standalone Optionholder:
 
       
 
  Address:    
 
  Fax:    
 
  Attention:    

 

5


 

(DLA PHILLIPS FOX LOGO)
  6.1.3   will be taken to be duly given or made:
  (a)   in the case of delivery in person, when delivered;
 
  (b)   in the case of delivery by post:
  (i)   within Australia to an Australian address, two Business Days after the date of posting; and
 
  (ii)   in any other case, 10 Business Days after the date of posting;
  (c)   in the case of fax, on receipt by the sender of a transmission control report from the dispatching machine showing the relevant number of pages and the correct destination fax machine number or name of recipient and indicating that the transmission has been made without error,
but if the result is that a Notice would be taken to be given or made on a day that is not a Business Day in the place to which the Notice is sent or is later than 4.00pm (local time) it will be taken to have been duly given or made at the commencement of business on the next Business Day in that place.
6.2   The Standalone Option Holder agrees to waive any right it may have under or arising from the Standalone Option to advance notice of the transactions contemplated under the Share Scheme, except as otherwise required under applicable law.
Conflict of interest
6.3   The parties’ rights and remedies under this deed may be exercised even if this involves a conflict of duty or a party has a personal interest in their exercise.
Costs
6.4   Each party shall pay their own legal and other costs and expenses in connection with the preparation, execution and completion of this deed and other related documentation.
Counterparts
6.5   This deed may be executed in counterparts. All counterparts when taken together are to be taken to constitute one instrument.
Binding agreement
6.6   Each party agrees that this deed is binding on each party and their heirs, executors, administrators, and all persons claiming any right, benefit, or interest to the Standalone Options or the underlying Shares, and inures to the benefit of the Released Parties and their successors and assigns.
Further assurances
6.7   Each party agrees, at the Company’s expense, to do anything another party asks (such as obtaining consents, signing and producing documents and getting documents completed and signed):
  6.7.1   to bind the party and any other person intended to be bound under this deed;
 
  6.7.2   to enable the Company to cancel the Standalone Options;
 
  6.7.3   to show whether the party is complying with this deed; and
 
  6.7.4   to give full effect to this deed.

 

6


 

(DLA PHILLIPS FOX LOGO)
Governing law
6.8   This deed is governed by the laws of New South Wales. The Parties submit to the non-exclusive jurisdiction of its courts and courts of appeal from them. The Parties will not object to the exercise of jurisdiction by those courts on any basis.
No merger
6.9   This deed constitutes the entire understanding between the parties with respect the subject matter of this deed, except as otherwise set out in the Share Scheme. The warranties, undertakings and indemnities in this deed do not merge at the Effective Time.
No rights
6.10   The Standalone Option Holder agrees that the transactions contemplated under this deed do not result in the right to receive future grants of equity or other compensation other than the Unilife Corporation Standalone Options.
Publicity
6.11   The Standalone Option Holder may not make press or other announcements or releases relating to this deed or the transactions the subject of this deed.
Variation and waiver
6.12   A provision of this deed or a right created under it, may not be waived or varied except in writing, signed by the party or parties to be bound.
 
7   Definitions and interpretation
Definitions
7.1   In this deed the following definitions apply:
ASX means ASX Limited (ABN 98 008 624 691).
Business Day means a day that is not a Saturday, Sunday, public holiday or bank holiday in Sydney, Australia.
Corporations Act means the Corporations Act 2001 (Cth).
Consolidation Ratio means the number of Shares in the Company which will be transferred to Unilife Corporation under the Share Scheme for every share of common stock in Unilife Corporation issued to Scheme Shareholders.
Court means the Federal Court of Australia.
Effective means, when used in relation to the Share Scheme, the coming into effect, pursuant to section 411(10) of the Corporations Act, of the Court order made under section 411(4)(b) of the Corporations Act in relation to the Share Scheme.

 

7


 

(DLA PHILLIPS FOX LOGO)
Effective Date means the date on which the Share Scheme becomes Effective.
Effective Time means 5:00pm on the Implementation Date.
Implementation Date means the third Business Day after the Scheme Record Date.
Merger Implementation Agreement means the merger implementation agreement dated 1 September 2009 between the Company and Unilife Corporation (as amended from time to time).
Related Body Corporate has the meaning given to that term in section 50 of the Corporations Act.
Scheme Record Date means 7.00pm on the fifth Business Day after the Effective Date.
Share means a fully paid ordinary share in the Company.
Share Scheme means the scheme of arrangement under Part 5.1 of the Corporations Act between the Company and Scheme Shareholders.
Scheme Shareholder means a Shareholder as at the Scheme Record Date.
Standalone Options means the options issued to the Standalone Option Holder to subscribe for the Shares under a Subscription Agreement between the Company and the Standalone Option Holder dated on or around 2 October 2009, the key terms of which are set out in the second column of Schedule 1.
Unilife Corporation Standalone Options means the options to be issued to the Standalone Option Holder to subscribe for common stock in Unilife Corporation under the Unilife Corporation Option Agreement in substantially the form attached as Annexure A to this deed.
Interpretation
7.2   In the interpretation of this deed, the following provisions apply unless the context otherwise requires:
  7.2.1   The singular includes the plural and conversely.
 
  7.2.2   A gender includes all genders.
  7.2.3   If a word or phrase is defined, its other grammatical forms have a corresponding meaning.
  7.2.4   A reference to a person, corporation, trust, partnership, unincorporated body or other entity includes any of them.
  7.2.5   A reference to a clause, schedule or annexure is a reference to a clause of, or schedule or annexure to, this deed.
  7.2.6   A reference to an agreement or document (including a reference to this deed) is to the agreement or document as amended, varied, supplemented, novated or replaced, except to the extent prohibited by this deed or that other agreement or document.

 

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(DLA PHILLIPS FOX LOGO)
  7.2.7   A reference to a person includes a reference to the person’s executors, administrators, successors, substitutes (including persons taking by novation) and assigns.
  7.2.8   A reference to legislation or to a provision of legislation includes a modification or re-enactment of it, a legislative provision substituted for it and a regulation or statutory instrument issued under it.
 
  7.2.9   A reference to $ is to the lawful currency of Australia.
  7.2.10   Words and phrases not specifically defined in this deed have the same meanings (if any) given to them in the Corporations Act.
 
  7.2.11   A reference to time is a reference to time in Sydney, Australia.
  7.2.12   If the day on which any act, matter or thing is to be done is a day other than a Business Day, such act, matter or thing must be done on the immediately succeeding Business Day.
  7.2.13   The meaning of general words is not limited by specific examples introduced by including, or for example, or similar expressions.
Headings
7.3   Headings are for convenience only and do not affect the interpretation of this deed.

 

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(DLA PHILLIPS FOX LOGO)
Schedule 1
Standalone Options
         
        Number and key terms of
Name and address of   Number and key terms of   Unilife Corporation
Standalone Optionholder   Standalone Options   Standalone Options
 
       
 
  Tranche 1

Number:

Exercise Price: A$1.25


Expiry date: Third anniversary of the date of grant of the Standalone Option.
  Tranche 1

Number: __ x the Consolidation Ratio

Exercise Price: A$1.25 x the Consolidation Ratio

Expiry date: Third anniversary of the date of grant of the Standalone Options the Unilife Corporation Standalone Option replaces.
 
       
 
  Tranche 2

Number:

  Tranche 2

Number: __ x the Consolidation Ratio
 
  Exercise Price: A$2.00


Expiry date: Third anniversary of the date of grant of the Standalone Option.
  Exercise Price: A$2.00 x the Consolidation Ratio

Expiry date: Third anniversary of the date of grant of the Standalone Options the Unilife Corporation Standalone Option replaces.

 

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(DLA PHILLIPS FOX LOGO)
Execution and date
Executed as a deed.
Date:
             
Executed as a deed by Unilife Medical Solutions
Limited
acting by the following persons:
           
 
           
 
Signature of director
     
 
Signature of director/company secretary
   
 
           
 
Name of director (print)
     
 
Name of director/company secretary (print)
   
 
           
Executed as a deed by Unilife Corporation acting by the following person:
           
 
           
 
Signature of duly authorised officer
           
 
           
 
Name of officer (print)
           
 
           
Executed as a deed by in the presence of:
           
 
           
 
Signature of witness
     
 
Signature of
   
 
           
 
Name of witness (print)
           

 

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(DLA PHILLIPS FOX LOGO)
Annexure A
Unilife Corporation Option Agreement

 

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Exhibit 10.28
Option Agreement
Unilife Corporation
[insert name of Option Holder]

 

 


 

Table of contents
         
Parties
    3  
 
       
1 Grant of Options
    3  
 
       
2 Tranches
    3  
 
       
3 Exercise Period
    3  
 
       
4 Exercise Price
    3  
 
       
5 Notice of Exercise
    4  
 
       
6 Allotment of Unilife Corporation Shares
    4  
 
       
7 Quotation of Options and Shares
    4  
 
       
8 Shareholder approval
    5  
 
       
9 Shares rank equally
    5  
 
       
10 No participation in new issues
    5  
 
       
11 Reorganisation of capital
    5  
 
       
12 Options not transferable
    5  
 
       
13 Change of control
    6  
 
       
14 Option register
    6  
 
       
15 Governing Law
    6  
 
       
16 Notices
    6  
 
       
17 Definitions
    6  

 

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Parties
Unilife Corporation a company incorporated in Delaware United States of 633 Lowther Road, Lewisberry, Pennsylvania 17339, United States (Unilife Corporation)
[insert name of Optionholder] (Option Holder)
1   Grant of Options
1.1   Unilife Corporation grants the Option Holder [insert amount] Options to subscribe for Unilife Corporation Shares on the terms and conditions set out in this Agreement; and
1.2   Each Option entitles the Option Holder to acquire one Unilife Corporation Share.
 
2   Tranches
 
2.1   The Options are granted in two tranches:
  2.1.1   Tranche 1: [insert amount] Options; and
 
  2.1.2   Tranche 2: [insert amount] Options.
3   Exercise Period
3.1   Subject to clause 13, each Option is exercisable at any time in the period from the date of grant until the third anniversary of the Original Grant and if the Option is not exercised on or prior to the expiry of the relevant Option Period, the Option will automatically lapse.
4   Exercise Price
 
4.1   The exercise price for each Option is as follows:
  4.1.1   Tranche 1: [A$insert price equal to $1.25 x Consolidation Ratio] per Option
 
  4.1.2   Tranche 2: [A$insert price equal to $2.00 x Consolidation Ratio] per Option
and is payable immediately on exercise by bank cheque or wire transfer to an account of the Unilife Corporation.

 

3


 

5   Notice of Exercise
5.1   The Options may be exercised wholly or in part by giving notice in writing to the Unilife Corporation at any time during the Option Period stating the number of Options being exercised. Options may only be exercised in multiples of 3,000 unless all of the then unexercised Options are being exercised under the relevant Notice of Exercise.
6   Allotment of Unilife Corporation Shares
6.1   Subject to clause 6.3, on receipt by Unilife Corporation of a valid Notice of Exercise in accordance with clause 5 and payment of the Exercise Price in accordance with clause 4, Unilife Corporation must, within two Business Days, issue and allot to the Option Holder the number of Unilife Corporation Shares set out in the Exercise Notice and despatch the relevant share certificate or other appropriate acknowledgment as soon as reasonably practicable thereafter.
6.2   Whilst Unilife Corporation remains listed on ASX, the Option Holder will be entitled to elect whether to receive Unilife Corporation Shares in the form of common stock of Unilife Corporation or as CDIs.
6.3   If at any time the Board determines that the delivery of Unilife Corporation Shares under this Agreement is or may be unlawful under Applicable Law, the Option Holder’s right to exercise the Option or receive the Unilife Corporation Shares pursuant to the Option shall be suspended until the Board determines that such delivery is lawful.
6.4   Unilife Corporation may require that the Option Holder, as a condition to exercise of the Option, and as a condition to the delivery of any share certificate, make such written representations (including representations to the effect that the Option Holder will not dispose of the Unilife Corporation Shares so acquired in violation of Applicable Law) and furnish such information as may, in the opinion of counsel for Unilife Corporation, be appropriate to permit Unilife Corporation to issue the Unilife Corporation Shares in compliance with Applicable Law.
7   Quotation of Options and Shares
7.1   The Options will not be listed for quotation on ASX or any other exchange.
 
7.2   As soon as reasonably practicable following the exercise of an Option:
  7.2.1   to the extent that the Option Holder elects to receive their Unilife Corporation Shares in the form of CDIs, Unilife Corporation shall apply for the CDIs to be admitted for quotation on the Official List of ASX (so long as CDIs are quoted on the Official List of the ASX at that time); or
  7.2.2   to the extent that the Option Holder elects to receive their Unilife Corporation Shares in the form of common stock, Unilife Corporation shall apply for the Unilife Corporation Shares to be admitted for quotation on NASDAQ (so long as the Unilife Corporation shares are quoted on NASDAQ at that time).

 

4


 

8   Shareholder approval
8.1   If, for any reason, an issue of Unilife Corporation Shares to the Option Holder in accordance with this Agreement would require approval of Shareholders, Unilife Corporation must convene the necessary meeting as soon as reasonably practicable and at its own cost.
9   Shares rank equally
9.1   Unilife Corporation Shares issued on the exercise of Options will rank equally in all respects with the other Unilife Corporation Shares on issue at the date of allotment and will be subject to the provisions of Unilife Corporation’s certificate of incorporation.
10   No participation in new issues
10.1   An Option does not confer a right to participate in new issues of securities of Unilife Corporation, unless the Option Holder has first exercised the Option and such exercise took place on or before the record date for determining entitlements to the issue.
10.2   In the event that a pro rata issue of Unilife Corporation shares is made to the holders of securities in Unilife Corporation, the exercise price of the Options shall be reduced in accordance with the ASX Listing Rules (so long as CDIs are quoted on ASX at that time).
11   Reorganisation of capital
11.1   In the event of any reorganisation (including consolidation (reverse split), sub-division (stock split), split-up, spin-off or similar transaction, recapitalisation, reduction or return, merger or share exchange) of the issued capital of Unilife Corporation, the rights of the Option Holder including the number of Options or the Exercise Price or both shall be reorganised (as appropriate);
  11.1.1   while CDIs are quoted on the Official List of ASX, to the extent necessary to comply with the Listing Rules applying to a reorganisation of capital at the time of the reorganisation; or
 
  11.1.2   if CDIs are no longer quoted on the Official List of ASX, as otherwise determined by the Board to be appropriate to reflect the reorganisation.
12   Options not transferable
12.1   Subject to clause 12.2 below, the Options are not transferable without the prior written consent of Unilife Corporation, except to a family member, family trust or estate of a shareholder or officer of the Option Holder,
12.2   Transfers to a partner, shareholder, officer, subsidiary, affiliate, affiliated partnership or other affiliated entity are not permitted without the prior written consent of Unilife Corporation, such permission to be granted by Unilife Corporation only after the Option Holder provides satisfactory assurances to Unilife Corporation that there is an available exemption from registration under which Unilife Corporation will be able to issue Unilife Corporation Shares upon exercise of the Options by the transferee.

 

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13   Change of control
13.1   Each outstanding Option shall lapse upon the effective time of a Change of Control Event unless the transaction the subject of the Change of Control Event provides for the continuation or assumption of outstanding Options by the surviving or successor entity or a parent company of that entity, or for the substitution of equivalent awards, as determined in the sole discretion of the Board, of the surviving or successor entity or a parent of that entity. This is subject to the proviso that holders of Options that lapse under this clause 13.1 are permitted to exercise all of their Options immediately before the Change of Control Event.
14   Option register
14.1   Unless otherwise determined by the Board of Directors of Unilife Corporation (or a committee of the Board), Unilife Corporation’s share registry will maintain a register of the Options.
15   Governing Law
15.1   The Options and this Agreement shall in all respects be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict of laws principles.
15.2   Any suit with respect to an Option will be brought in the federal or state courts in the State of Delaware, and the Option Holder, by accepting the Options, irrevocably and unconditionally agrees and submits to the personal jurisdiction and venue thereof.
16   Notices
16.1   Notices may be given by Unilife Corporation to the Option Holder in writing and to the address set out above or such new address as is notified from time to time by the Option Holder to Unilife Corporation.
17   Definitions
17.1 In these Rules, unless the context otherwise requires:
A$ means Australian currency.
Applicable Law means any one or more or all, as the context requires, of:
  (a)   the Corporations Act and any regulations to it;
 
  (b)   the ASX Listing Rules;
 
  (c)   the certificate of incorporation of the Unilife Corporation;

 

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  (d)   the United States Securities Act of 1933, as amended (including the rules thereunder), Exchange Act and any other applicable United States federal or state law, including without limitation the Delaware General Corporation Law;
 
  (e)   the Internal Revenue Code of 1986, as amended, and any regulations to it;
 
  (f)   the NASDAQ Rules; and
 
  (g)   any practice note, policy statement, class order, declaration, guideline, policy or procedure pursuant to the provisions of which any of the SEC, ASIC or ASX is authorised or entitled to regulate, implement or enforce, either directly or indirectly, the provisions of any of the foregoing statutes, regulations or rules or any conduct of any duly authorised person, pursuant to any of the abovementioned statutes, regulations or rules.
ASIC means the Australian Securities and Investments Commission.
ASX means ASX Limited (ACN 008 624 691) and any successor body corporate or the financial market it operates (as the context requires).
ASX Listing Rules means the Listing Rules published by ASX from time to time.
Board means all or some of the directors of Unilife Corporation acting as a board from time to time.
Business Day means any day, other than a Saturday, Sunday or public holiday in New York, United States of America.
CDI means a CHESS Depositary Interest over [insert fraction] of a share of Unilife Corporation common stock.
Change of Control Event means the occurrence of any of the following events:
  (a)   a change of Ownership of Unilife Corporation;
 
  (b)   a change of Effective Control of Unilife Corporation; or
 
  (c)   a change of Ownership of Assets of Unilife Corporation; or
as described in these Rules and construed consistent with Section 409A of the Code. For the purposes of a Change of Control Event, fair market value is determined by the Board, and share ownership is determined under section 318(a) of the Code. A Change of Control Event excludes any transfer to a related person as described in Section 409A of the Code or a public offering of the Shares.
Change of Effective Control of Unilife Corporation means the date on which a majority of members of Unilife Corporation’s full board of directors is replaced during any 12-month period by directors whose appointment or election is not endorsed by a majority of the members of Unilife Corporation’s full board of directors before the date of the appointment or election.

 

7


 

Change of Ownership of Assets of Unilife Corporation means the date on which any one person acquires, or Persons Acting as a Group acquire (or has or have acquired during the 12 month period ending on the date of the most recent acquisition by such Person or Persons), assets from Unilife Corporation that have a total gross fair market value more than 50% of the total gross fair market value of all of the assets of Unilife Corporation immediately before such acquisitions. For this purpose, gross fair market value means the value of the assets of Unilife Corporation, or the value of the assets being disposed of, determined without regard to any liabilities associated with such assets.
Change of Ownership of Unilife Corporation means the date on which any one Person acquires, or Persons Acting as a Group acquire, ownership of Shares that, together with the Shares held by such Person or Persons Acting as Group, constitutes more than 50% of the total fair market value or total voting power of the Shares of Unilife Corporation. However, if any one Person is, or Persons Acting as a Group are, considered to own more than 50% of the total fair market value or total voting power of the Shares of Unilife Corporation, the acquisition of additional Shares by the same Person or Persons Acting as a Group is not considered to cause a Change of Ownership of Unilife Corporation or to cause a Change of Effective Control of Unilife Corporation. An increase in the percentage of Shares owned by any one Person, or Persons Acting as a Group, as a result of a transaction in which Unilife Corporation acquires its Shares in exchange for property will be treated as an acquisition of Shares.
Corporations Act means the Corporations Act 2001 (Cth).
Exchange Act means the United States Securities Exchange Act of 1934, as amended, including the rules promulgated thereunder.
Exercise Price means the exercise price payable to acquire one Share pursuant to the exercise of each Option.
NASDAQ Rules means the Nasdaq Listing Rules as published by The Nasdaq Stock Market from time to time.
Notice of Exercise means the notice provided to Unilife Corporation by the Option Holder in respect of the exercise of the Options.
Option Period means the date from which the Options become exerciseable until the date on which the Options lapse.
Options means the options granted to the Option Holder under this Agreement.
Original Grant means the date of grant of the Original Option.
Original Option means the Unilife Medical Solutions Limited options granted to the Option Holder which the Option replaces.
Person means any individual, entity or group within the meaning of section 13(d)(3) or 14(d)(2) of the Exchange Act, other than employee benefit plans sponsored or maintained by the Company and by entities controlled by the Company or an underwriter of the Shares of the Company in a registered public offering;

 

8


 

Persons Acting as a Group means persons who are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of shares, or similar business transaction with the corporation. If a Person owns shares in both corporations that enter into a merger, consolidation, purchase or acquisition of shares, or similar transaction, such shareholder is considered to be a Person Acting as a Group with other shareholders only with respect to the ownership in that corporation before the transaction giving rise to the change and not with respect to the ownership interest in the other corporation. Persons will not be considered to be Persons Acting as a Group solely because they purchase assets of the same corporation at the same time or purchase or own shares of the same corporation at the same time, or as a result of the same public offering;
Unilife Corporation Shares means shares of fully paid common stock in the capital of Unilife Corporation.
Unilife Medical Solutions Limited means Unilife Medical Solutions Limited (ABN 14 008 071 403).
SEC means the United States Securities and Exchange Commission.

 

9


 

Date:
THESE OPTIONS AND THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE HAVE NOT BEEN REGISTERED UNDER THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (US SECURITIES ACT) AND THE OPTIONS MAY NOT BE EXERCISED BY OR ON BEHALF OF ANY U.S. PERSON, AS SUCH TERM IS DEFINED IN REGULATION S OF THE US SECURITIES ACT, UNLESS A REGISTRATION STATEMENT UNDER THE SECURITIES ACT IS FILED AND MADE EFFECTIVE, OR AN OPINION OF COUNSEL SATISFACTORY TO THE UNILIFE CORPORATION TO THE EFFECT THAT REGISTRATION UNDER THE US SECURITIES ACT IS NOT REQUIRED. NEITHER THE OPTIONS NOR THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE MAY BE TRANSFERRED, SOLD OR OTHERWISE DISPOSED OF IN THE ABSENCE OF (I) AN EFFECTIVE REGISTRATION STATEMENT WITH RESPECT TO THE OPTIONS OR THE SECURITIES TO BE ISSUED UPON THEIR EXERCISE, OR (II) AN EXEMPTION FROM REGISTRATION UNDER THE US SECURITIES ACT AND AN OPINION OF COUNSEL SATISFACTORY TO THE UNILIFE CORPORATION TO THE EFFECT THAT REGISTRATION UNDER THE US SECURITIES ACT IS NOT REQUIRED.
     
Executed by Unilife Corporation acting by the following person:
   
 
   
 
Signature of duly authorised officer
   
 
   
 
Name of officer (print)
   
 
   
Executed by [insert name of Option Holder]
in the presence of:
   
 
   
 
Signature of duly authorised officer
   
 
   
 
Name of officer (print)
   

 

10

EX-10.29 15 c93531exv10w29.htm EXHIBIT 10.29 Exhibit 10.29
Exhibit 10.29
(UNILIFE LOGO)
UNILIFE MEDICAL SOLUTIONS LIMITED
ABN 14 008 071 403
2009 SHARE PURCHASE PLAN TERMS AND
CONDITIONS

 

 


 

Unilife Medical Solutions Limited 2009 Share Purchase Plan
The Unilife Medical Solutions Limited 2009 Share Purchase Plan (SPP) being offered by Unilife Medical Solutions Limited (Unilife or the Company) provides Eligible Shareholders (refer to 2 below) with the opportunity to purchase additional shares in the Company without incurring brokerage and other transaction costs.
The Company has recently received commitments from sophisticated and professional investors in Australia and accredited investors in the United States of America for 37,749,209 shares to raise approximately A$32 million (Placement) from the placement of fully paid ordinary shares in the Company (Shares) at an issue price of A$0.85. The Company now wishes to extend an offer under the SPP to existing shareholders to allow them to acquire Shares at the same issue price of A$0.85.
Details of the offer and how to participate are set out below.
1. What is the timetable for the SPP?
The key dates for the SPP are set out below:
     
Date   Event
 
   
5.00pm on 9 October 2009
  Record date for SPP
 
   
14 October 2009
  SPP Opening Date
 
   
5.00pm on 30 October 2009
  SPP Closing Date
 
   
12 November 2009
  Allotment Date
 
   
16 November 2009
  Despatch of holding statements
     
*   Note: All times referred to are Sydney time
The Company reserves the right to change the Closing Date or the proposed allotment date at any time by making an announcement to the ASX. The Company also reserves the right to terminate the SPP at any time prior to the issue of Shares pursuant to the SPP. If the Company terminates the SPP, it will refund application monies (without interest).
2. Who is an Eligible Shareholder?
Registered holders of shares in the Company at 5.00pm Sydney time on 9 October 2009 (Record Date) having a registered address in either Australia or New Zealand are eligible to participate in the SPP (Eligible Shareholders).
The Company has determined that the SPP may only be accepted by residents of Australia and New Zealand. This is due to regulations restricting the SPP offer to persons in places in which it is lawful and practical for the Company to offer and issue shares under the SPP, in the reasonable opinion of the Company. To the extent that you hold Shares on behalf of another person resident outside Australia or New Zealand, it is your responsibility to ensure that acceptance of the offer complies with all applicable laws.

 

 


 

3. Participation by single holders
If you are an Eligible Shareholder and you have received more than one offer under the SPP (for example, because you hold more than one shareholding under separate share accounts), you may not apply for more than 17,647 Shares under the SPP. This is because the maximum amount that may be raised by law under a share purchase plan from each eligible holder in any 12 month period is A$15,000. By applying for Shares under the SPP, you certify that you have not exceeded this limit. The Company reserves the right to reject any application for Shares where it believes there has not been compliance with this requirement.
4. Participation by joint holders
If two or more persons are recorded in the register of members as jointly holding Shares, they will be taken to be a single registered holder for the purposes of the SPP. Joint holders are only entitled to participate in the SPP in respect of that single holding.
5. Participation on behalf of beneficial owners by custodians, trustees or nominees
If you are a custodian, trustee or nominee within the definition of “custodian” in ASIC Class Order CO 09/425 (Custodian) and hold Shares on behalf of one or more persons (each a Participating Beneficiary), you may apply for up to a maximum of A$15,000 worth of Shares for each Participating Beneficiary, subject to providing a notice in writing to Unilife (the Custodian Certificate) certifying the following:
(a)   that you hold Shares on behalf of Participating Beneficiaries who have instructed you to apply for Unilife Shares on their behalf under the SPP;
 
(b)   the number of Participating Beneficiaries;
 
(c)   the name and address of each Participating Beneficiary;
 
(d)   the number of Unilife Shares that you hold on behalf of each Participating Beneficiary;
 
(e)   the number or dollar amount of Shares which each Participating Beneficiary has instructed you to apply for on their behalf;
 
(f)   that there are no Participating Beneficiaries in respect of which the total of the application price exceeds A$15,000 worth of Shares, calculated by reference to Shares applied for by you as Custodian on their behalf under the SPP, as a result of an instruction given by them to you as Custodian to apply for Shares on their behalf; and
 
(g)   any such additional or varied information as might be required under any more specific ASIC relief that might be granted to Unilife in relation to the SPP.
For the purposes of ASIC Class Order CO 09/425 you are a “custodian” if you are a registered holder that:
(a)   holds an Australian financial services licence that:
  (i)   covers the provision of a “custodial or depository service” (as defined in section 766E of the Corporations Act); or
 
  (ii)   includes a condition requiring the holder to comply with ASIC Class Order CO 02/294; or

 

 


 

(b)   is exempt under:
  (i)   paragraph 7.6.01(1)(k) of the Corporations Regulations 2001; or
 
  (ii)   under ASIC Class Order CO 05/1270 to the extent that it relates to ASIC Class Order CO 03/184,
from the requirement to hold an Australian financial services licence for the provision of a custodial or depository service.
If you hold Shares as a trustee, custodian or nominee for another person, but are not a Custodian as defined above, you cannot participate for beneficiaries in the manner described above. In this case, the rules for multiple single holdings (above) apply.
Custodians who wish to apply on behalf of more than one Participating Beneficiary should contact Computershare Investor Services Pty Limited on +61 3 9415 4647.
6. Are Eligible Shareholders required to participate in the SPP?
No. Participation in the SPP is entirely optional. The offer to acquire Shares under the SPP is not a recommendation to acquire shares or financial product advice.
Before deciding on whether to participate in the SPP, you should consider the Company’s latest financial statements and recent announcements to ASX (ASX code: UNI) and, if you are in any doubt, consult your independent financial and taxation advisers.
7. What are the Shares being offered under the SPP?
Shares issued under the SPP are fully paid ordinary shares in the Company which will rank equally in all respects with the existing fully paid ordinary shares of the Company, carrying the same voting rights, dividend rights and other entitlements.
8. What is the issue price?
The issue price for each Share under the SPP is A$0.85. This price is the same price at which shares were offered under the recent Placement and is approximately 31.5% lower than the volume weighted average market price of the Company’s Shares as traded on ASX over the last 5 days on which sales in the Company’s Shares were recorded before the SPP was announced on 7 October 2009.
You should note that the Share price may rise or fall between the date of this offer and the date when Shares are allotted and issued to you under the SPP. This means that the price you pay per Share pursuant to this offer may be either higher or lower than the Share price at the time of the offer or at the time the Shares are issued and allotted to you under the SPP.
9. How much can you invest under the SPP?
Eligible Shareholders may apply under one of the alternatives below:
  1,500 Shares at an aggregate purchase price of A$1,275.00;
 
  6,000 Shares at an aggregate purchase price of A$5,100.00;
 
  12,000 Shares at an aggregate purchase price of A$10,200.00; or
 
  17,647 Shares at an aggregate purchase price of A$14,999.95.

 

 


 

The offer under the SPP needs to comply with the limit in ASIC Class Order CO 09/425. Under this class order, Eligible Shareholders may only acquire a maximum of A$15,000 worth of Shares under a share purchase plan in any 12-month period. This means that Eligible Shareholders must not acquire more than A$15,000 worth of Shares, in aggregate, under this SPP. These limitations apply even if you receive more than one Application Form or if you hold Shares in more than one capacity, e.g. if you are both a sole and joint holder of Shares as described above.
10. Applications may be scaled back
The maximum number of Shares to be issued under the SPP is intended to be 11,764,705 (raising up to A$10 million). If subscriptions under the SPP exceed A$10 million, the Company may scale back applications received under the SPP. If applications are scaled back, any excess application monies will be refunded without interest.
However, if applications are received for in excess of A$10 million, the Board retains the discretion to issue more than 11,764,705 Shares to satisfy all or part of such applications, subject to a maximum number of Shares equal to 30% of the issued share capital of the Company at the date of issue.
11. How do I apply for shares under the SPP?
You may apply for Shares by:
  completing the enclosed Application Form and returning it together with your cheque, bank draft or money order drawn on an Australian bank and in Australian dollars to the Company’s Share Registry in accordance with the instructions on the Application Form; or
 
  by making a BPAY® payment using the customer reference number shown on your Application Form, in which case you do not need to return your Application Form.
Please do not forward cash. Receipts for payment will not be issued. Applications must be received by 5.00pm (Sydney time) on 30 October 2009. Applications received after that time will not be accepted.
Applications and payments under the SPP may not be withdrawn once they have been received by Unilife. Application money will not bear interest as against Unilife under any circumstances.
Please read the enclosed SPP Application Form for further details of how to apply for Shares under the SPP.
If you apply to participate in the SPP by submitting a BPAY® payment or completing and returning the Application Form, you will be deemed to have represented on behalf of each person on whose account you are acting that:
(a)   you are an Eligible Shareholder;
 
(b)   you acknowledge that the Shares have not, and will not be, registered under the Securities Act or the securities laws of any state or other jurisdictions in the United States, or in any other jurisdiction outside Australia or New Zealand, and accordingly, the Shares may not be offered, sold or otherwise transferred except in accordance with an available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws; and
 
(c)   you have not and will not send any materials relating to the SPP to any person in the United States or that is, or is acting for the account or benefit of, a US Person.
By accepting an offer to acquire Shares under the SPP, you agree to be bound by these SPP Terms and Conditions and by Unilife’s’ constitution.
12. Can the offer under the SPP be transferred to a third party?
No. The offer is non-renounceable and cannot be transferred to any other person.

 

 


 

13. Is the SPP underwritten?
No, the SPP will not be underwritten. However, to the extent that less than A$10 million is raised from Eligible Shareholders under the SPP, YBR Securities Pty Limited has been appointed to place any such shortfall in subscriptions. Based on the level of support received from sophisticated and professional investors under the recent Placement, YBR Securities Pty Limited has indicated to the Company that it is confident of being able to place the full amount of any shortfall that may arise under the SPP.
14. Certification by Eligible Shareholders
By submitting the Application Form (together with a cheque, bank draft or money order) or making a BPAY® payment, you certify that the aggregate of the application price paid by you for:
(a)   the Shares the subject of such Application Form; and
 
(b)   any other Shares applied for by you, or which you have instructed a Custodian to acquire on your behalf, under the SPP or any similar offer by the Company,
does not exceed A$15,000, unless you are applying as a custodian on behalf of one or more Participating Beneficiaries.
The A$15,000 limit applies irrespective of the number of Shares you hold on the Record Date. Unilife reserves the right, and in certain circumstances may be required by ASIC Class Order CO 09/425 or other conditions, to reject any application for Shares under the SPP to the extent it considers, or is reasonably satisfied, that the application (whether alone or in conjunction with other applications) does not comply with these requirements.
15. Will I receive notification of my allotment?
Yes. You will be sent a holding statement or confirmation of allotment on or around 16 November 2009.
16. When can I sell shares purchased under the SPP?
Shares issued under the SPP may be sold or transferred on ASX at any time after quotation, which is expected to commence on or around 12 November 2009.
17. Foreign securities restrictions
As noted above, the SPP is only being extended to shareholders with a registered address in Australia or New Zealand. This document (and the accompanying Application Form) does not constitute an offer of securities in Unilife in any jurisdiction in which such an offer would be illegal.
To the extent that a shareholder holds Shares on behalf of another person resident outside Australia or New Zealand, it is that shareholder’s responsibility to ensure that any acceptance complies with all applicable foreign laws.
Neither this document nor the Application Form constitutes an offer of securities in the United States or to, or for the account or benefit of any US person.
The Shares to be issued under this SPP have not been and will not be registered under the US Securities Act of 1933, as amended (the Securities Act), or the securities laws of any state or other jurisdiction of the United States.
In order to comply with relevant securities laws, the Shares to be issued under this SPP may not be offered to shareholders located in the “United States” or to shareholders who are, or who are acting for the account or benefit of, “US persons”. As used herein, the terms “United States” and “US persons” are as defined in Regulation S under the Securities Act.

 

 


 

Because of these legal restrictions, you must not send copies of the SPP Terms and Conditions or any other material relating to the SPP to any person resident in the United States or any person who is, or is acting for the account or benefit of, “US persons”.
Consistent with the warranties contained in these SPP Terms and Conditions and the accompanying Application Form, you may not submit any completed Application Forms for any person resident in the United States or who is, or is acting for the account or benefit of, “US persons”. Failure to comply with these restrictions may result in violations of applicable securities laws.
18. Class Order compliance
This offer of securities under the SPP is made in accordance with ASIC Class Order CO 09/425 which grants relief from the requirement to prepare a prospectus for the offer of the Shares under the SPP.
19. Withdrawal, suspension, termination, anomalies and disputes
Unilife reserves the right to waive strict compliance with any provision of these terms and conditions, to amend or vary these terms and conditions and to suspend or terminate the SPP at any time. Any such amendment, variation, suspension or termination will be binding on all Eligible Shareholders even where Unilife does not notify you of that event. Unilife may make determinations in any manner it thinks fit, including in relation to any difficulties, anomalies or disputes which may arise in connection with or by reason of the operation of the SPP, whether generally or in relation to any participant or application. Any determinations by Unilife will be conclusive and binding on all Eligible Shareholders and other persons to whom the determination relates.
20. Governing law
This offer is governed by the law in force in New South Wales. By accepting this offer, you submit to the non-exclusive jurisdiction of the courts of New South Wales.
21. Contact us
If you have any questions about the SPP, please call the Unilife Shareholder Information Line on 1800 243 240 (in Australia) or +61 2 8256 3371 (from outside Australia).

 

 

EX-21 16 c93531exv21.htm EXHIBIT 21 Exhibit 21
Exhibit 21
     
Entity   Jurisdiction of Formation
 
   
Unilife Medical Solutions, Inc.
  Delaware
Unitract Syringe Pty Limited
  Australia
Unilife Medical Solutions Limited
  Australia
Unilife Cross Farm LLC
  Delaware

 

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  DLA Piper LLP (US)
 
  1251 Avenue of the Americas, 27th Floor
 
  New York, New York 10020-1104
 
  www.dlapiper.com
 
   
 
  Marjorie Sybul Adams
 
  marjorie.adams@dlapiper.com
 
  T 212.335.4517
 
  F 212.884.8517
January 5, 2010
VIA EDGAR
Mr. Russell Mancuso
Branch Chief
Mail Stop 3030
Division of Corporate Finance
Securities and Exchange Commission
100 F Street NE
Washington, D.C. 20549
  Re:   Unilife Corporation
Registration Statement on Form 10
Filed November 12, 2009
File No. 1-34540
Dear Mr. Mancuso:
On behalf of our client Unilife Corporation (the “Company”), the undersigned is transmitting this letter in response to the written comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) contained in your letter dated December 9, 2009 (the “Comment Letter”), with respect to the above-referenced filing.  In connection with this response to the Comment Letter, the Company is filing electronically with the Commission today Amendment No. 1 (the “Amendment”) to the Registration Statement on Form 10 (the “Registration Statement”). In order to expedite your review, we have enclosed a courtesy package that includes four copies of the Amendment, which has been black-lined to show changes from the original filing.
The following responses to the Staff’s comments are numbered to correspond to the numbered items and headings of the paragraphs set forth in your Comment Letter. Please note that page numbers in our responses are references to the page numbers in the Amendment. For the convenience of the Staff, each of the comments from the Comment Letter is restated in bold italics prior to the Company’s response. Capitalized terms used herein and not otherwise defined shall have the meanings given to them in the Registration Statement or in the Amendment, as applicable.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 2
Presentation of Information, page 3
1.   Please tell us why you believe it is appropriate to present information in your registration statement about your company assuming the completion of a transaction that has not yet occurred.
 
    Response: The redomiciliation of the Company from Australia to Delaware pursuant to a share scheme of arrangement and an option scheme of arrangement under Australian law (collectively, the “Schemes”) will be completed before the Registration Statement becomes effective. The Company will not submit a request to accelerate effectiveness of the Registration Statement until on or after the implementation date of the Schemes. The Company’s goal is to obtain a Nasdaq listing for its common stock as contemporaneously as practicable with the implementation of the Schemes and thus the Company and not Unilife Medical Solutions Limited will be the entity whose shares are registered. The Schemes are discussed in greater detail in response to the Staff’s Comment 18 below. In order to be able to achieve that goal, it was necessary to file the Registration Statement in advance of such implementation to allow time for Staff review and response by the Company to the Staff’s comments. The Company believes that there are a number of other similar scenarios in which a registration statement is filed that assumes completion of a transaction that has not yet occurred. For example, in a spinoff transaction, the company being spun off files its registration statement prior to the effectiveness of the transaction and while it is still a subsidiary of the parent.
 
2.   Please tell us the nature and timing of Form 8-K filings that you intend to make when the “redomiciling” transaction is complete.
 
    Response: As outlined in the response to the Staff’s Comment 1 above, the implementation date of the Schemes will occur prior to the time that the Registration Statement becomes effective. The Company intends to amend the Registration Statement as soon as practicable after the implementation date and prior to effectiveness of the Registration Statement to reflect the fact that the Schemes will have been implemented. Thus, the Company does not believe that a Form 8-K filing will be necessary to reflect the completion of the redomiciliation because the Company will not become subject to the reporting obligations under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), until after the Registration Statement becomes effective and the Schemes have been implemented.
 
3.   Please tell us the purpose of filing this registration statement before you completed the “redomiciling” transaction.
 
    Response: See the response to the Staff’s Comment 1 above. The Company filed the Registration Statement with the SEC simultaneously with the lodgement of an information memorandum relating to the redomiciliation to be effected by the Schemes (the “Information Memorandum”) with the Australian Securities and Investments Commission (“ASIC”) to allow for concurrent reviews of the Registration Statement by the Staff and the Information Memorandum by ASIC and the Federal Court of Australia (the “Court”).

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 3
The Information Memorandum is the Australian equivalent of a merger proxy and also serves as a listing application for the CDIs of Unilife Corporation on the Australian Securities Exchange. ASIC completed its review of the Information Memorandum on November 27, 2009. Thereafter, on December 4, 2009, the Court approved the Information Memorandum and ordered the Scheme meetings. The Scheme meetings are scheduled to occur on January 8, 2010. The Court hearing to approve the Schemes is scheduled to occur on January 14, 2010 with implementation scheduled for January 27, 2010.
Market Opportunity, page 5
4.   Please provide us with copies of the sources of the third-party data that appears on page 5. Please mark the materials so that they are keyed to the disclosure. Also, tell us about any other relationship between you and the sources of the data used in your document.
 
    Response: The Company is providing supplementally as Annex A to the hard copy of this letter marked copies of the sources of the third-party data that appears on page 5. An index has been included, listing the various data on page 5 and cross-referencing to the third-party sources that support such data. The Company advises the Staff that the third-party sources are independent from the Company and that none of the third-party data was prepared for use in this filing.
Manufacture medical devices under contract, page 8
5.   Please ensure that the description of your business throughout your document does not disproportionately present planned products relative to the business that has historically contributed material revenue. In this regard, please tell us why you describe in this section only one example of the devices manufactured under contract. What risks and liabilities have been created by this business? When do the contracts end? Also, it is unclear why you do not describe the business related to the terminated license mentioned on page 29 as well as the reasons for the termination.
 
    Response: The Company advises the Staff that the Company currently has one customer, B. Braun Medical, Inc., in the contract manufacturing business, which, during its fiscal year ended June 30, 2009, contributed approximately 15.6% of its revenues. The Company is currently concentrating substantially all its commercial and operational efforts towards the commercialization of its own proprietary devices, namely the Unifill syringe and the Unitract 1mL syringe, and does not expect contract manufacturing to represent a significant portion of its business going forward. The Company has revised its disclosures to remove contract manufacturing from its business strategy discussion and has also added additional disclosure on pages 4 and 14 regarding this business.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 4
    The Company further advises the Staff that the terminated license mentioned on page 29 was not related to the contract manufacturing business. Instead, the terminated agreement related to a proposed licensing arrangement with MedPro Safety Products LLC, which the Company subsequently determined not to be consist with its business strategies and elected to terminate. The Company repaid $2.3 million of the $3.0 million that it had originally received in 2008 from MedPro as a final settlement with MedPro. The Company has revised the disclosure on page 29 to address the termination of the MedPro agreement.
6.   Please provide us your analysis supporting your conclusion regarding whether the contract mentioned in this section must be filed per regulation S-K Item 601(b)(10).
    Response: The Company advises the Staff that the Company entered into a supply agreement with B. Braun Medical, Inc. on September 15, 2003 and amendments thereto on January 20, 2005 and March 2, 2009, respectively (collectively, the “B. Braun Contract”), which is the sole contractual arrangement of the Company involved in the contract manufacturing business. The B.Braun Contract was filed as Exhibit 10.5 to the original filing of the Registration Statement and, in response to the Staff’s Comment 49 below, has been re-filed with the Amendment together with all the exhibits thereto that were omitted from the original filing.
Our Products, page 8
7.   Please clarify how the Unilife and Unitract products differ.
 
    Response: We have revised the disclosures on page 8 of the Registration Statement in response to the Staff’s comment.
Strategic Partnership with sanofi-aventis, page 9
8.   With a view toward clarified disclosure, please tell us what, hurdles remain, until “industrialization” is complete.
    Response: The Company has revised the disclosure on page 9 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 5
9.   Please tell us with specificity the provision of the agreement in which sanofi-aventis will retain full exclusivity across all therapeutic classes only until June 30, 2012. We note the penultimate sentence of the penultimate paragraph on page 9.
    Response: The Company advises the Staff that Article 2 of the First Amendment to the Exclusivity Agreement, in Section 2.3, provides that “[s]hould the parties be unable to agree upon a final list of therapeutic classes within the timeline defined hereinabove, an exclusive licence of the UNILIFE Intellectual Property shall be granted to SWIND for all therapeutic areas ..., for a limited period of three years from the Execution Date of the First Amendment (“Default Licence”)”. The first amendment was executed on June 29, 2009 and therefore sanofi-aventis’ exclusivity across all therapeutic areas expires on June 29, 2012. The Company has revised the disclosure on page 9 accordingly.
10.   Please tell us why this section does not describe section 7.4 of exhibit 10.1.
    Response: The Company advises the Staff that the Company will not be obligated to repay the industrialization costs under Section 7.4 of the Exclusive Agreement, since the parties signed the Industrialization Agreement within 12 months from the date of the Exclusive Agreement and therefore the termination condition under Section 7.2.3 was not met.
Manufacturing, page 10
11.   We note the disclosure in the last paragraph of this section about specialized sources. Please disclose the extent to which your products incorporate components purchased from single sources of supply. Also, disclose the availability of the products and components. In addition, clarify whether you have written agreements with any of the suppliers, and, if applicable, disclose the material terms of the agreements. File as exhibits material contracts as required by Regulation S-K Item 601(b)(10).
    Response: The Company advises the Staff that, due to an initial requirement for only limited production volumes of components which comprise the Unifill syringe, the Company currently receives the majority, or in some cases all, of its components such as rubber seals and glass barrel from a single source supplier. As commercial-scale production of the Unifill syringe commences, the Company intends to appoint, as a minimum, a dual source supply system for all components and related services. The Company has revised the disclosures on page 10 accordingly. The Company does not believe that the written agreements with its suppliers (other than the agreement entered into with Mikron as described in the response to the Staff’s Comment 15 below) are material within the meaning of Regulation S-K Item 601(b)(10).
Intellectual Property, page 11
12.   Please disclose the effect of granted patents.
    Response: The Company has revised the disclosures on page 12 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 6
Government Regulation, page 12
13.   Please tell us, with a view to disclosure, why you do not disclose the material Australian government regulations applicable to your business.
    Response: The Company has revised the disclosure on page 12 to include discussions of applicable Australian regulations.
14.   Please provide a more complete explanation of the Food and Drug Administration’s regulation of your intended business to describe fully the potential scope of the FDA’s statutory and regulatory requirements for approval of devices. You should describe possible requirements to submit a pre-market approval application to the FDA for review that is supported by extensive data, including technical, preclinical, clinical trials, manufacturing, and labeling to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device.
 
    Include in your disclosure a description of the following regulatory issues:
    device classification information;
 
    pre-market approval application requirements and conditions of approval;
 
    the status of your products within the process;
 
    the date and nature of approvals received;
 
    registration and labeling requirements;
 
    advertising and promotion; and
 
    post-market reporting and record-keeping requirements, including medical device reporting and reports of corrections or removals.
Also, clarify what you mean by “ANDA and NDA applications,” including an explanation of the nature and duration of that application process.
Response: The Company has the revised the disclosure on page 12 in response to the Staff’s comment and has deleted the references to ANDA and NDA applications.
Corporate History, page 14
15.   Please briefly describe the business of Integrated BioSciences at the time of the acquisition in January 2007.
    Response: The Company has revised the disclosures on page 14 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 7
We have outsourced the development of automated assembly systems, page 17
16.   Please tell us which exhibit represents the agreement mentioned in this risk factor.
 
    Response: The Company advises the Staff that the agreement entered into between the Company and Mikron Assembly Technology on November 12, 2009 represents the agreement mentioned in this risk factor and has been filed with the Amendment as Exhibit 10.20 with certain confidential information redacted pursuant to a confidential treatment request made in accordance with Rule 24b-2 under the Exchange Act.
If there are substantial sales of our shares of common stock, page 22
17.   Please provide us your analysis of applicable authority for your statements regarding when your securities may be resold.
 
    Response: The Company advises the Staff that, upon the implementation of the schemes of arrangement, the Company will issue shares of common stock to UMSL shareholders in exchange for their ordinary shares in UMSL pursuant to the share scheme of arrangement. As explained in detail in the response to the Staff’s Comment 18 below, we are of the view that the Company’s issuance of its shares of common stock pursuant to the share scheme will be exempt from registration under Section 3(a)(10) of the Securities Act of 1933, as amended (the “Securities Act”). In SLB No. 3A (as defined in the response to the Staff’s Comment 18 below), the Staff states that “securities received in a Rule 145(a) transaction not involving a shell company that was exempt under Section 3(a)(10) may generally be resold without regard to Rule 144 if the sellers are not affiliates of the issuer of the Section 3(a)(10) securities and have not been affiliates within 90 days of the date of the Section 3(a)(10)-exempt transaction, as such securities would not constitute “restricted securities” within the meaning of Rule 144(a)(3) under the Securities Act. In the event that the securities are held by affiliates of the issuer, those holders may be able to resell the securities in accordance with the provisions of Rule 144.”
Management’s Discussion and Analysis of Financial Condition, page 23
Redomiciliation, page 24
18.   Please provide us your analysis supporting your conclusion that the transaction will be exempt from registration under Section 3(a)(10) of the Securities Act.
 
    Response: Section 3(a)(10) of the Securities Act provides an exemption from the registration requirements of the Securities Act for, in relevant part, “... any security which is issued in exchange for one or more bona fide outstanding securities, claims or property interests, or partly in such exchange and partly for cash, where the terms and conditions of such issuance and exchange are approved, after a hearing upon the fairness of such terms and conditions at which all persons to whom it is proposed to issue securities in such exchange shall have the right to appear, by any court ... expressly authorized by law to grant such approval.”

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 8
In Staff Legal Bulletin No. 3A (June 18, 2008) (“SLB No. 3A”), the Staff identified the following conditions that must be met before reliance may be made upon the exemption provided in Section 3(a)(10) of the Securities Act: (1) the securities must be issued in exchange for securities, claims, or property interests; they cannot be offered for cash; (2) a court or authorized governmental entity must approve the fairness of the terms and conditions of the exchange; (3) the reviewing court or authorized governmental entity must (a) find, before approving the transaction, that the terms and conditions of the exchange are fair to those to whom securities will be issued, and (b) be advised before the hearing that the issuer will rely on the Section 3(a)(10) exemption based on the court’s or authorized governmental entity’s approval of the transaction; (4) the court or authorized governmental entity must hold a hearing before approving the fairness of the terms and conditions of the transaction; (5) a governmental entity must be expressly authorized by law to hold the hearing, although it is not necessary that the law require the hearing; (6) the fairness hearing must be open to everyone to whom securities would be issued in the proposed exchange; (7) adequate notice must be given to all those persons; and (8) there cannot be any improper impediments to the appearance by those persons at the hearing.
The redomiciliation transaction will be conducted by way of Schemes. The issuance of the common stock and stock options of the Company under the Schemes would satisfy the conditions set forth in SLB No. 3A, as explained in the following paragraphs:
1. The Exchange. Under the Schemes, each holder of the ordinary shares of Unilife Medical Solutions Limited (“UMSL”) or share options issued under the UMSL Employee Share Option Plan will exchange its ordinary shares or share options (and no other consideration) for the common stock or stock options offered by the Company, respectively, and will not be offered any cash except that, in order to reduce the transaction costs associated with compliance with the potential securities law restrictions in every country, ineligible overseas shareholders of UMSL (being those shareholders whose address is in a place outside Australia and its external territories, New Zealand, the United States, Hong Kong, United Kingdom, Ireland, France, Croatia and Malta or such other country agreed to by UMSL or the Company) will receive the cash proceeds from the sale of the Chess Depositary Interests (“CDIs”, each representing one-sixth of a share of the Company’s common stock) allotted to a nominee in respect of such ineligible overseas shareholder. Accordingly, the exchange satisfies the view of the Staff set forth in Footnote 6 to SLB No. 3A that UMSL security holders must exchange predominantly securities for the consideration being offered by the Company. Furthermore, the Staff in the past has not recommended enforcement action to the Commission in business combination transactions effected pursuant to Section 3(a)(10) where the consideration offered by the acquiror consisted of cash and securities, but cash constituted a majority of such consideration. See, e.g., BTR plc (available September 5, 1995), SC Acquisition Corp. (available July 12, 1996) and Constellation Brands, Inc. (available January 29, 2003).

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 9
2. Court Approval. The Staff stated in Section 4.B.4 of SLB No. 3A that the term “any court” in Section 3(a)(10) includes a foreign court. The Federal Court of Australia (the “Court”), which will conduct a hearing on the fairness of the terms and conditions of the exchange, is a foreign court. Therefore, the fact that the judicial proceeding with respect to the Schemes will occur in an Australia court should not affect the availability of the Section 3(a)(10) exemption, and the Staff has previously so indicated. See ForBio Inc. (available September 23, 1998) and Constellation Brands, Inc., supra.
3. Determination of Fairness and Advice of Section 3(a)(10) Reliance. The Company has been advised by DLA Phillips Fox, its Australian counsel, that, under Section 411 of the Corporations Act 2001 (Cth) of Australia (the “Corporations Act”), the Schemes cannot take effect unless they have been approved by the requisite majorities of shareholders and optionholders and have been approved by an order of the Court. In considering whether to approve the Schemes, the Court has an obligation to consider the fairness of the Schemes, both procedurally and substantively, with regard to the interests of all holders even if all of the other statutory requirements have been met. The Company has been further advised by its Australian counsel that, in determining whether to exercise its discretion and approve the Schemes, the Court “must be satisfied that the proposal was at least so far fair and reasonable, as that an intelligent and honest man, who is a member of that class, and acting alone in respect of his interest as such a member, might approve of it.” See Re Dorman, Long and Company Limited (1934) Ch. 635, Maugham J., at page 657. In prior no-action letters, the Staff has indicated that this criteria (or equivalent fairness criteria) satisfies the Section 3(a)(10) requirement that a court approve the terms and conditions of the issuance and exchange, after a hearing upon the fairness of such terms and conditions. See, e.g., Weatherford International Ltd. (available January 14, 2009), SanDisk Corporation (available September 21, 2006), Constellation Brands, Inc., supra, John Wood Group PLC (available March 1, 2002), Galen Holdings PLC (available August 7, 2000), The Development Bank of Singapore Ltd. (available August 12, 1999), ADC Telecommunications, Inc. (available July 30, 1999), Lason Inc. (available June 7, 1999), and Omnicom Group Inc. (available January 28, 1999).
The Company has also been advised by its Australian counsel that, pursuant to Section 411 of the Corporations Act, each of the Schemes derives its force from the Court’s sanction and not only from the approval of such Scheme at the meeting of the holders of UMSL ordinary shares or share options, as applicable, to consider and vote on such Scheme (collectively, the “Scheme Meetings”) . Therefore, the Court will take particular care to scrutinize the Schemes before approving them. The Court is not bound to approve the Schemes simply because it has previously made an order for the convening of the Scheme meetings and the Schemes have been passed by the prescribed majorities at the Scheme meetings.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 10
UMSL advised the Court at the First Court Hearing (as defined below) on December 4, 2009 that, if the Court approves each Scheme, its sanctioning of each such Scheme will constitute the basis for the issuance of the common stock or stock options, as applicable, under the respective Scheme, without registration under the Securities Act, in reliance on the exemption from registration provided by Securities Act Section 3(a)(10).
4. Court Hearings. Each of the Schemes involves two Court hearings, one to convene a Scheme Meeting with respect to such Scheme (the “First Court Hearing”) which occurred on December 4, 2009, and the other to approve such Schemes (the “Second Court Hearing” and, together with the First Court Hearing, the “Court Hearings”). At the Second Court Hearing with respect to each Scheme, any and all holders of UMSL ordinary shares or share options, as applicable, may appear and be heard. The Court Hearings will be held before the Court approves the fairness of the terms and conditions of each Scheme.
5. Authorization of Governmental Entity. Section 411 of the Corporations Act authorizes the Court to hold a hearing on each Scheme and to approve the fairness of the terms and conditions of each Scheme to the holders of the UMSL ordinary shares or share options, as applicable.
6. Open Hearing. The Court Hearings will be open to attendance by any and all holders of UMSL ordinary shares or share options, as applicable.
7. Notice. The Company has been advised by its Australian counsel that on December 4, 2009, the Court ordered that an advertisement regarding the Second Court Hearing (pursuant to which approval of the Court is sought in relation to a Scheme) be placed in a newspaper of national circulation. Notice of the Second Court Hearing will also be published in the Commonwealth Gazette of the Australian government. The advertisements will indicate that the relevant holders may appear at the hearing and may support or oppose the relevant Scheme. A description of the procedure for objecting to a Scheme has been included in the information memorandum mailed to the holders of UMSL ordinary shares and share options. In addition, the information memorandum, which contains a timetable of the transaction including the expected date of the Second Court Hearing with respect to each Scheme, has been mailed to holders of UMSL ordinary shares and share options. In the event that the actual date of the Second Court Hearings differs from the expected date contained in the information memorandum, UMSL will be required to announce through the ASX notice of the actual date of the Second Court Hearings promptly after such actual date has been determined, and the information memorandum has advised holders of UMSL ordinary shares and share options of this possibility and the fact that such announcement is required to be made.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 11
8. No Improper Impediments. The Company has been advised by its Australian counsel that there will be no improper impediments to appearance at either the First Court Hearing or Second Court Hearing by any holder of UMSL ordinary shares or share options. The Court Hearings will be open to everyone who is proposed to be issued securities in the exchange and adequate notice will be given to all those persons. Notice is required to be given by anyone wanting to object to the approval of the Schemes no later than one day prior to the Second Court Hearing, consisting of a notice of appearance together with an affidavit setting out the grounds of objection. If a holder of UMSL ordinary shares or share options does not object within this prescribed timeframe, such holder may not have a right to appear at the Second Court Hearing, although the Court in its discretion could, and likely would, permit such a holder to state objections to the Court if the holder made a personal appearance at the Second Court Hearing.
Based upon the foregoing, we are of the view that the issuance of the Company’s common stock and stock options under the Schemes will satisfy the conditions set forth in SLB No. 3A and will be exempt from registration under Section 3(a)(10) of the Securities Act.
Recent Equity Financing, page 24
19.   Please clarify when the private placement will close.
 
    Response: The Company has revised the disclosures on page 24 in response to the Staff’s comment.
 
20.   Please clarify how you determined which shareholders are eligible to participate in the share purchase plan. Also disclose the terms and material provisions of the plan.
Response: The Company advises the Staff that, in conjunction with the private placement, all Unilife Medical Solutions Limited shareholders resident in Australia and New Zealand were eligible to participate in the share purchase plan, which, like a rights offering in the United States, is a way to raise capital by allowing an issuer’s existing shareholders to purchase shares from the issuer. The Company has revised the disclosure on page 24 and filed the share purchase plan terms and conditions as Exhibit 10.29 to the Amendment.
21.   Please tell us which exhibits to your registration statement govern the agreements mentioned in this section.
Response: The Company has filed with the Amendment the following exhibits related to the private placement and the share purchase plan: (1) Exhibit 10.27, Form of Share Purchase Agreement (including exhibits thereto) between the Company and each of the US investors in the private placement; (2) Exhibit 10.28, Form of Subscription Agreement (including exhibits thereto) between the Company and each of the Australian investors in the private placement; (3) Exhibit 10.29, the 2009 share purchase plan terms and conditions.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 12
Critical Accounting Policies, page 25
Pennsylvania Economic Development Assistance, page 25
22.   Please file as exhibits any written agreements between you and the Commonwealth of Pennsylvania concerning the offer of assistance.
Response: The Company has filed with the Amendment as Exhibit 10.22 the written offer and acceptance related to the assistance from the Commonwealth of Pennsylvania, which is the only written agreement concerning the offer of assistance.
23.   Please replace the vague term “certain”‘ with specific disclosure regarding the material terms of the agreement. Include when the government is obligated to provide you the funds and the circumstances under which the offer can be cancelled or the funds must be returned.
Response: The Company has revised the disclosures on page 25 in response to the Staff’s comment.
Goodwill, page 25
24.   We note your disclosures here are the same as the disclosures regarding goodwill in Note 2 to your financial statements. We further note that goodwill comprises a substantial portion of your assets as of June 30, 2009. In light of the significant amount of goodwill reported on your consolidated balance sheet, please revise the discussion here to address the following:
    Clearly disclose the number of reporting units you have identified for purposes of your annual goodwill impairment testing.
    Discuss in greater detail the methodologies you utilize to determine the fair value of the reporting units and quantify and discuss any significant assumptions utilized in your evaluation.
    Here and in the notes to the consolidated financial statements, disclose in greater detail your policy for testing goodwill for impairment, including a more detailed description of the two-step impairment testing process outlined in FASB Accounting Standards Codification 350-20-35.
Response: The Company has revised the disclosures on page 25 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 13
Fiscal Year 2008 Compared to Fiscal Year 2007, page 27
25.   Please expand the references on page 27 to the acquisition in January 2007 to clarify the specific reasons for the increased revenues and expenses. For example, what products did you begin to sell as a result of the acquisition?
Response: The Company has revised the disclosures on page 27 in response to the Staff’s comment.
Introduction, page 34
26.   Please disclose how you define your “industry group.” Also identify the companies that participate in the survey.
Response: The Company advises the Staff that it has further reviewed its executive compensation practices and substantially revised the Compensation Discussion and Analysis on pages 34 through 43. Among other changes, the Company has deleted the references to the “industry group” and the “Radford Survey”. As revised, the Compensation Discussion and Analysis discloses that the current compensation packages for its named executive officers were not determined with regard to the Radford Survey or any other particular benchmarking. The Company has, however, retained a compensation consulting firm, Strategic Apex Group, LLC to assist its compensation committee in developing an appropriate comparator group for benchmarking following the redomiciliation transaction. The Company expects that this comparator group will consist of companies in the health care industry as well as companies in the mid-Atlantic region of the United States.
Base Salary, page 36
27.   Please disclose to the extent to which salaries paid varied from those disclosed 50th percentile target. Discuss the reasons for the differences.
Response: The Company has revised the disclosures on page 36 in response to the Staff’s comment in regard to how salaries were determined historically. The Company advises the Staff that the salaries that are currently being paid were not determined with regard to the Radford survey.
28.   Here and in other appropriate sections of your Compensation Discussion and Analysis, disclose the reasons for the changes between the compensation reported in your Summary Compensation table and the compensation mentioned in the agreements beginning on page 39.
Response: The Company has revised the disclosure in the Summary Compensation Table and the “Employment Offer Letters, Employment Agreements and Consultancy Agreements” section on pages 43 through 48.
Annual Cash Incentive Compensation, page 36
29.   Please specify how you define the term “successful” as you use it several times in the second paragraph of this section. Also describe when these definitions were established relative to the period during which the executive earned the bonus.
Response: The Company has revised the disclosures on pages 36.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 14
30.   Please describe how the specific dollar amounts of the incentive compensation were determined. Discuss reasons for the differing amounts among the named executive officers.
Response: The Company has revised the disclosures on pages 36.
31.   Please reconcile your statements in the third paragraph that the compensation committee will make future bonus decisions with your disclosure on pages 40-42 indicating that the bonuses will be paid at the discretion of the CEO.
Response: The Company has revised the disclosures on page 37 in response to the Staff’s comment.
32.   Please expand your description of your Incentive Bonus Plan to permit investors to understand how you calculated the related amounts in the table on page 47. Also, please file the plan as an exhibit to the registration statement.
Response: The Company advises the Staff that the Company does not have a formal Incentive Bonus Plan. The Company has deleted the reference to the initial capitalized term “Incentive Bonus Plan.” The employment agreements with each of the named executive officers provide for a maximum percentage of the executive’s base salary or a stated amount as bonus. The Company has revised the disclosures accordingly.
Long-Term Incentive Compensation, page 37
33.   Please discuss how the amount of each award reported in your compensation tables was determined. Include the specific factors that determined the different size of the awards paid to the named executive officers.
Response: The Company has revised the disclosures on page 37 in response to the Staff’s comment.
Savings Plans, page 38
34.   Please tell us how the summary compensation table reflects the 9% pension contribution mentioned in the first paragraph of this section. Also describe the “superannuation” program.
Response: The Company has revised the summary compensation table disclosures on pages 43 and 44 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 15
Compensation Committee Interlocks and Insider Participation, page 46
35.   Please clearly and directly address under this caption the items required to be addressed by Regulation S-K Item 407(e)(4).
Response: The Company has revised the disclosures on page 43 in response to the Staff’s comment.
Summary Compensation Table, page 46
36.   Please show us how the salary of Mr. Carter mentioned in the summary compensation table adjusted as indicated by footnote 6 reflects his salary mentioned on page 6 in exhibit 10.9.
Response: The Company advises the Staff that the salary amount of Mr. Carter as reported in the summary compensation table includes the amount earned under his employment agreement from July 2008 through January 2009 and the amount earned under his consulting agreement from February 2009 through June 2009.
37.   Please tell us how the bonus of Mr. Carter mentioned in the summary compensation table adjusted as indicated by footnote 6 reflects his bonus mentioned on page 6 of exhibit 10.9.
Response: The Company advises the Staff that the bonus amount of Mr. Carter as reported in the summary compensation table reflects the discretionary bonus Mr. Carter received. The bonus amount set forth in his employment agreement has been reported in the non-equity incentive plan compensation column of the summary compensation table.
38.   We note your statement that the disclosure “includes” the item identified in footnote (13). Please tell us the nature of the balance of the “other compensation” and the authority on which you rely to exclude from your disclosure a description of that compensation.
Response: The Company has revised the disclosure on page 44 to describe the nature of the balance of the other compensation.
Director Compensation, page 53
39. Please provide the disclosure required by Item 402(k)(3) of Regulation S-K.
Response: The Company has revised the disclosures on page 54 in response to the Staff’s comment.
Certain Relationships and Related Transactions, page 54
40.   Please expand this section to disclose the consulting agreement with Mr. Carter.
Response: The Company has revised the disclosures on page 55 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 16
Market Information, page 54
41.   Please tell us how the second paragraph after the table reflects the transfer restrictions mentioned in footnote (3) on page 32. File any related agreement as an exhibit to the registration statement.
Response: The Company has revised the disclosures on page 56 to reflect the transfer restrictions mentioned in footnote (3) on page 32. These transfer restrictions are contained in the employment agreement with Mr. Alan Shortall, which has been filed with the Registration Statement as Exhibit 10.8.
Recent Sales of Unregistered Securities, page 55
42.   Please expand this section to provide the disclosure required by Item 701 of Regulation S-K as to all sales of Unilife Medical Solutions Limited securities within the last three years that were not registered under the Securities Act.
Response: The Company has revised the disclosures on pages 57 and 58 in response to the Staff’s comment.
43.   Please tell us why the options mentioned in the last paragraph of this section will be issued in the “redomiciliation” in a manner that differs from the options mentioned in the penultimate paragraph of this section.
Response: The Company advises the Staff that it will issue the options to purchase its shares of common stock mentioned in the last paragraph of this section in exchange for those options to purchase ordinary shares of UMSL that were issued by UMSL to certain consultants and advisors outside its employee share option plan. Pursuant to Australian law, these share options will be exchanged outside the option scheme of arrangement. As a result, the issuance of the stock options in exchange for these share options will not be exempt under Section 3(a)(10) of the Securities Act but will be exempt under Section 4(2) of the Securities Act and Regulation D, Regulation S and/or Rule 701 thereunder. The Company has, however, deleted the last three paragraphs of this section, since the securities described therein have not been issued yet. The Company will update the disclosures when the securities are issued in connection with the completion of the redomiciliation transaction.
Description of Registrant’s Securities to be Registered, page 56
44.   Your disclosure may not be qualified by reference to state law. Please revise accordingly.
Response: The Company has revised the disclosures on page 59 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 17
Anti-Takeover Effects of Certain Provisions of Delaware Law, page 57
45. Please tell us why this section does not describe section 7.2 of your bylaws.
Response: The Company has revised the disclosures on page 60 in response to the Staff’s comment.
Financial Statements and Exhibits, page 58
46.   We note your reference to an application for confidential treatment. We will issue any comments on your application separately.
Response: The Company acknowledges the Staff’s comment.
47.   We note the first footnote to the exhibit index. Please file the list required by the last sentence of Regulation S-K Item 601(b)(2).
 
    Response: The Company has filed the list required by the last sentence of Regulation S-K Item 601(b)(2) with the Amendment.
48.   Please tell us why you believe that the document that you filed as exhibit 2.2 is properly filed under Regulation S-K Item 601(b)(2) rather than another subsection of Item 601. From your description of the agreement, is unclear whether this document represents the January 2007 transaction mentioned on page 14 and whether omission of schedules and similar attachments is appropriate.
Response: The Company advises the Staff that Exhibit 2.2 was the share purchase agreement entered into among UMSL and certain major shareholders of Integrated BioSciences, Inc. for the acquisition by UMSL of all of the equity interests of Integrated BioSciences, Inc., which acquisition was completed in January 2007. As a result, the Company believes that this agreement was properly filed as Exhibit 2.2 under Item 601(b)(2) rather than another subsection of Item 601 and that the omission of schedules and similar attachments thereto is permissible under Item 601(b)(2).

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 18
Exhibit 10.5
49.   Please file the complete exhibit. We note exhibits A through F are missing.
Response: The Company has filed the complete exhibit with the Amendment.
Financial Statements, page F-l
50.   Please amend the filing to update the financial statements and other related disclosures of the registrant in accordance with Rule 3-12 of Regulation S-X. This updating requirement also applies to information provided in Management’s Discussion and Analysis and elsewhere in the filing.
Response: The Company has updated the financial statements and other related disclosures in the Registration Statement, including the Management’s Discussion and Analysis.
51.   Please note that the FASB Accounting Standards Codification is effective for interim and annual periods ending after September 15, 2009. As a result, all non-SEC accounting and financial reporting standards have been superseded. In future filings, when yon update your financial statements, please also revise any references to accounting standards accordingly.
Response: The Company has revised the references to accounting standards in response to the Staff’s comment.
Consolidated Statements of Operations, page F-4
52.   We note the line item “Share-based compensation expense” presented on the face of this statements. Please revise the statements of operations to present expense for stock-based compensation in the same line or lines as cash compensation paid to the same employees in accordance with SAB Topic 14F.
Response: The Company has revised the statements of operations on pages F-3 and F-15 in response to the Staff’s comment.

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 19
Note 3, Equity and Share-based Compensation, page F-12
53.   We note the significant increase in share-based compensation recorded in fiscal year 2009 over fiscal year 2008. According to your accounting policy, the fair value of stock options is determined using the Black-Scholes option pricing model “with the exception of market-based performance grants, which are valued based on a Barrier pricing model.” Please tell us whether or not the increase is primarily attributable to the application of the latter model and if so, disclose the amount and identify the market-based performance grants.
Response: The increase in share based compensation expense was attributable to an increase in the number of stock options and common stock granted as compensation during fiscal 2009. During fiscal 2009 and 2008, a total of 3,850,000 and 1,208,333 options were granted to employees, directors and consultants, respectively. Total share-based compensation expense recorded related to stock options during fiscal 2009 and 2008 was $1.4 million and $0.8 million, respectively. Additionally, during fiscal 2009, 1,666,667 shares of common stock were issued to the CEO resulting in a charge to operations of approximately $1.5 million. The increase in share based compensation expense was not attributable to the use of the Barrier pricing model which was applied in valuing the options with market-based vesting criteria.
*     *     *
At your request, the Company further acknowledges that:
    the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
    Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the filing; and
    the Company may not assert Staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
*     *     *

 

 


 

Russell Mancuso
Division of Corporation Finance
Securities and Exchange Commission
January 5, 2010
Page 20
Please call the undersigned at (212)335-4517, or Alan Shortall, CEO of the Company, at (717) 938-9323, if you have any questions or comments regarding the foregoing or need any additional information. Thank you.
         
    Very truly yours,
 
 
    /s/ Marjorie Sybul Adams   
    Marjorie Sybul Adams   
cc:   Thomas A. Jones
Division of Corporation Finance
Securities and Exchange Commission

Alan Shortall
Unilife Corporation

 

 

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