Exhibit 10.9
COLLABORATION AGREEMENT
by and between
MICROBIA, INC.
and
FOREST LABORATORIES, INC.
SEPTEMBER 12, 2007
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
TABLE OF CONTENTS
1. |
DEFINITIONS |
1 |
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2. |
SCOPE OF COLLABORATION AND GRANT OF LICENSES |
15 |
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2.1. |
Scope of Collaboration |
15 |
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2.2. |
License to Forest |
15 |
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2.3. |
License to Microbia |
15 |
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2.4. |
Restrictions |
16 |
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2.5. |
Joint Technology |
16 |
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2.6. |
Sublicensing |
16 |
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2.7. |
Right of Reference |
16 |
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2.8. |
No Other Rights |
17 |
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2.9. |
Section 365(n) |
17 |
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3. |
DECISION MAKING AND DISPUTE RESOLUTION |
17 |
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3.1. |
Overview |
17 |
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3.2. |
Joint Development Committee |
17 |
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3.3. |
Joint Commercialization Committee |
18 |
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3.4. |
Joint Responsibilities of the JDC and JCC |
20 |
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3.5. |
Other Committees |
20 |
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3.6. |
Elevation and Dispute Resolution |
20 |
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4. |
DEVELOPMENT, REGULATORY, COMMERCIALIZATION |
21 |
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4.1. |
Development |
21 |
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4.2. |
Regulatory Matters |
23 |
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4.3. |
Adverse Events |
23 |
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4.4. |
Manufacture and Supply of Products |
24 |
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4.5. |
Commercialization in the Territory |
24 |
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4.6. |
Phase IV and Publication Strategy |
27 |
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5. |
CONSIDERATION |
28 |
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5.1. |
Upfront Payments |
28 |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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5.2. |
Milestones |
28 |
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5.3. |
Royalties |
30 |
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5.4. |
Program Expenses |
30 |
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5.5. |
Interest |
33 |
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6. |
MUTUAL COVENANTS |
34 |
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6.1. |
Confidentiality |
34 |
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6.2. |
Restrictions |
36 |
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6.3. |
Compliance with Law |
37 |
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6.4. |
Nonsolicitation of Employees |
37 |
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6.5. |
Standstill Agreement |
37 |
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7. |
REPRESENTATIONS AND WARRANTIES |
39 |
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7.1. |
Representations and Warranties of Each Party |
39 |
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7.2. |
Additional Representations and Warranties of Microbia |
40 |
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7.3. |
Additional Representations and Warranties of Forest |
40 |
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7.4. |
Representation by Legal Counsel |
41 |
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7.5. |
No Inconsistent Agreements |
41 |
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7.6. |
Disclaimer |
41 |
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8. |
INTELLECTUAL PROPERTY |
42 |
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8.1. |
Disclosure |
42 |
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8.2. |
Ownership |
42 |
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8.3. |
Intellectual Property Working Group |
42 |
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8.4. |
Prosecution and Maintenance of Patent Rights |
42 |
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8.5. |
Trademarks |
44 |
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8.6. |
Enforcement of Technology Rights |
44 |
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8.7. |
Third Party Claims |
46 |
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8.8. |
Third Party Licenses |
46 |
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8.9. |
Patent Marking |
46 |
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8.10. |
Patent Certifications |
46 |
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8.11. |
No Implied Licenses |
47 |
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8.12. |
Privileged Communications |
47 |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
9. |
INTENTIONALLY OMITTED |
47 |
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10. |
TERM AND TERMINATION |
47 |
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10.1. |
Term |
47 |
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10.2. |
Termination for Cause |
47 |
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10.3. |
Change of Control |
52 |
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10.4. |
Survival of Certain Obligations |
54 |
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11. |
PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE |
54 |
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11.1. |
Sharing of Liability Expenses |
54 |
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11.2. |
Indemnification by Microbia |
54 |
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11.3. |
Indemnification by Forest |
55 |
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11.4. |
Procedure |
55 |
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11.5. |
Insurance |
56 |
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11.6. |
Liability Limitations |
56 |
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12. |
MISCELLANEOUS |
56 |
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12.1. |
Governing Law, Jurisdiction; Dispute Resolution |
56 |
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12.2. |
Force Majeure |
58 |
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12.3. |
Additional Approvals |
59 |
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12.4. |
Waiver and Non-Exclusion of Remedies |
59 |
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12.5. |
Notices |
59 |
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12.6. |
Entire Agreement |
60 |
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12.7. |
Amendment |
60 |
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12.8. |
Assignment |
60 |
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12.9. |
No Benefit to Others |
60 |
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12.10. |
Counterparts |
61 |
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12.11. |
Severability |
61 |
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12.12. |
Further Assurance |
61 |
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12.13. |
Publicity |
61 |
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12.14. |
Relationship of the Parties |
61 |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
MASTER COLLABORATION AGREEMENT
This MASTER COLLABORATION AGREEMENT (the “Agreement”) is entered into on this 12th day of September, 2007 (the “Effective Date”), by and among Microbia, Inc., a Delaware corporation (“Microbia”) and Forest Laboratories, Inc. (“Forest”). Microbia and Forest may each be referred to herein individually as a “Party” and collectively as the “Parties.”
BACKGROUND
Microbia is developing certain pharmaceutical compounds which have uses or potential uses in the treatment and prevention of disease in humans.
Forest is engaged in the research, development and commercialization of human pharmaceutical products.
Microbia and Forest desire to collaborate on the development and commercialization of Microbia’s pharmaceutical compounds on the terms and conditions set forth in this Agreement.
AGREEMENT
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1.1. “Affiliate(s)” means, with respect to a Person, any Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, “control” means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting securities or other ownership interests of such Person.
1.2. “Adjunctive Product” has the meaning set forth in Section 6.2.1.
1.3. “API Manufacturing” means the Manufacture and supply of the active pharmaceutical ingredient of a Collaboration Compound that is included in a Product Developed and Commercialized hereunder.
1.4. “Applicable Laws” means all applicable statutes, ordinances, regulations, rules, or orders of any kind whatsoever of any Regulatory Authority, including, without limitation, the FD&C Act, Prescription Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a et seq.), and Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.), all as amended from time to time in the Territory.
1.5. “Backup Compound” means [**].
1.6. “Calendar Quarter” means each of the three (3) consecutive month periods ending on March 31, June 30, September 30, and December 31.
1.7. “Change of Control” means any of the following: (a) the sale or disposition of all or substantially all of the assets of a Party to a Third Party, (b) the acquisition by a Third Party, other than an employee benefit plan (or related trust) sponsored or maintained by a Party or any of its Affiliates, of more than fifty percent (50%) of such Party’s outstanding shares of voting capital stock (e.g., capital stock entitled to vote generally for the election of directors), (c) the appointment or election to the Board of Directors of a Party of members constituting a majority of such Board who were not appointed, approved or recommended for election by the Board of Directors as constituted immediately prior to the appointment or election of such majority, or (d) the merger or consolidation of a Party with or into another corporation, other than, in the case of (b) or (c) of this Section, an acquisition or a merger or consolidation of a Party in which holders of shares of such Party’s voting capital stock immediately prior to the acquisition, merger or consolidation have at least fifty percent (50%) of the ownership of voting capital stock of the acquiring Third Party or the surviving corporation in such merger or consolidation, as the case may be, immediately after the merger or consolidation. Notwithstanding the foregoing, a Change of Control shall not be deemed to occur on account of an initial public offering, the acquisition of securities of a Party by an institutional investor, or Affiliate thereof, that acquires a Party’s securities in a transaction or series of related transactions as a passive investment which does not affect the management of such Party, or a sale of assets, merger or other transaction effected exclusively for the purpose of changing the corporate domicile of a Party.
1.8. “CC” means chronic constipation.
1.9. “Collaboration Compound” means (i) the Initial Compound or (ii) any Backup Compound, in each case including any analogs, homologues, derivatives, salts, metabolites, esters, isomers, enantiomers, polymorphs and pro-drugs of such compound. Forest’s right to [**] hereunder will expire upon [**], provided, however, that (i) [**], then Forest’s right to [**], (ii) any compound that is [**], and (iii) with respect to a [**] which may reasonably be expected [**] for which a Collaboration Compound is, at the time such [**], such right shall not expire until [**].
1.10. “Collaboration Know-How” means Know-How that is invented, conceived or developed by or on behalf of either or both Parties’ (or their Affiliates’) employees or Third Parties acting on such Parties’ behalf, in each case in the course of such Party’s performance under this Agreement.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.11. “Collaboration Patent Rights” means Patent Rights claiming Collaboration Know-How.
1.12. “Collaboration Technology” means Collaboration Know-How and Collaboration Patent Rights, and all other intellectual property rights in any of the foregoing.
1.13. “Commercial Launch” means the first commercial sale of a Product in the United States following Regulatory Approval in the United States.
1.14. “Commercialization” means any and all activities of using, importing, marketing, promoting, distributing, offering for sale or selling a Product, including for example pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of Product, seeking pricing and reimbursement approvals for Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Phase IV clinical trials. Commercialization includes Promotion but does not include Development or Manufacturing. When used as a verb, “Commercialize” means to engage in Commercialization.
1.15. “Commercialization Budget” means the budget approved by the JCC for conducting Commercialization pursuant to the Commercialization Plan.
1.16. “Commercialization Expenses” means all costs and expenses associated with Commercialization activities pursuant to the Commercialization Plan, including without limitation, FTE Costs, selling expenses, or other direct and indirect costs and expenses associated with marketing, shipping, packaging, storage and distribution of the Product for Commercialization in the Field, costs of warehousing, transportation, order entry, billing, shipping, credit and collection and other such activities in connection with Product distribution; costs for preparing and reproducing detailing aids, Product promotional materials and other promotional materials, costs of professional education, product related public relations, relationships with opinion leaders and professional societies, market research (before and after product approval), healthcare economics studies, Phase IV clinical trials, and other similar activities directly related to the Products and, in each case, to the extent not previously deducted from gross invoiced amounts in determining Net Sales hereunder, the cost of activities related to obtaining reimbursement from payers, costs of sales and marketing data, costs associated with sales representatives and training of the sales representatives, sales meetings, details, samples, sales call reporting, work on managed care accounts, in each case to the extent not included in FTE Costs, costs related to customer service and other sales and customer service-related expenses, in each case as included in the Commercialization Plan and Commercialization Budget. Such costs may also include actual out-of-pocket costs for outside services and expenses (e.g.,
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
consultants, agency fees, meeting costs, etc.). For purposes of this definition, FTE Costs shall be charged [**] and the costs of sales representatives (other than the cost of acquiring samples) shall be based entirely upon the [**]. Notwithstanding the foregoing, Commercialization Expenses shall not include [**]. In furtherance of the Parties’ interest in maximizing the profitability of the collaboration, the Parties agree that the Commercialization Plan shall allocate activities to the Parties so as to avoid duplicative costs and to maximize cost efficiency to the extent practicable. In furtherance of that objective, the Commercialization Budget will include a separate amount for Commercialization support expenses, which shall be for Commercialization-related marketing, sales and administrative support costs and associated overheads not specifically attributable to activities designated under the Commercialization Plan (as used in this Section, the “Support Expenses”). Unless otherwise agreed by the Parties, the Support Expenses shall not exceed [**] of the total Commercialization Budget before Commercial Launch and [**] after Commercial Launch. Each Party shall be allocated a portion of the budgeted Support Expenses in proportion to its share of Promotional activities being conducted pursuant to the Commercialization Plan (e.g. 35% to Microbia and 65% to Forest, if Microbia is performing 35% and Forest is performing 65% of the Detailing). Commercialization Expenses will include each Party’s allocated portion of the Support Expenses but, without the consent of the other Party (which may be withheld in its sole discretion), Commercialization Expenses will not include any Support Expenses of a Party that exceed such Party’s allocated portion of the Support Expenses.
1.17. “Commercialization Plan” has the meaning set forth in Section 4.5.1.
1.18. “Commercially Reasonable Efforts” means those efforts and resources normally used by a Party for a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account, without limitation, issues of safety and efficacy, product profile, the proprietary position of the product or compound, the regulatory environment and status of the compound, and other relevant scientific factors, market conditions then prevailing, including the competitive environment (but without regard to other products or compounds being developed or commercialized by such Party outside of this Agreement), profitability, the extent of market exclusivity, the cost to develop the compound or product, health economic claims, and other similar factors reasonably determined by the Party to be relevant. Without limiting the foregoing, Commercially Reasonable Efforts as it applies to the clinical development of the Collaboration Compound and Product hereunder means adherence to the activities and time lines (to the extent adherence to such activities and time lines is controllable by the Party responsible for performing such activities) set forth in the Development Plan, as may be amended from time to time based on the results of studies conducted with a
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Collaboration Compound and Product, and regulatory factors. “Commercially Reasonable” as used herein shall be interpreted in a corresponding manner.
1.19. “Commercial Year” has the meaning set forth in Section 5.2.3.
1.20. “Confidential Information” means, with respect to a Party, all information (and all tangible and intangible embodiments thereof), which is Controlled by such Party, is disclosed by such Party to the other Party pursuant to this Agreement, and is designated as confidential in writing by the disclosing Party whether by letter or by use of an appropriate stamp or legend, prior to or at the time any such information is disclosed by the disclosing Party to the other Party. In addition, any information which is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information if the disclosing Party, within [**] after such disclosure, delivers to the receiving Party a written document or documents describing the information disclosed and referencing the place and date of such oral, visual, electronic or written disclosure and the names of the person(s) to whom such disclosure was made, provided, however, that any technical information disclosed at a meeting of the JDC, JCC or any other committee established pursuant to this Agreement shall constitute Confidential Information unless otherwise specified.
1.21. “Control” or “Controlled” means, with respect to any intellectual property right of a Party, that the Party or its Affiliate owns or has a license to such intellectual property right and has the ability to grant access, a license, or a sublicense to such intellectual property right to the other Party as provided in this Agreement without violating an agreement with or other rights of any Third Party.
1.22. “Covered Product” has the meaning set forth in Section 6.2.2.
1.23. “Detail” means a one-on-one, face-to-face meeting, in an individual or group practice setting, between one or more physician prescribers and one Forest or Microbia sales representative during which product information is communicated as either the leading product (i.e., “first position”) or the second product (i.e., “second position”). When used as a verb, “Detail” or “Detailing” shall mean to engage in a Detail.
1.24. “Detail Election” has the meaning set forth in Section 4.5.3.
1.25. “Detail Rate” as applicable to both Parties, means the [**]. The “Detail Rate” shall be established based upon [**]. Each Detail shall be [**] as follows: (i) during the [**], and (ii) after the earlier of the [**].
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.26. “Detail Reports” means a report of Details performed by a Party during the quarter covered by such report containing such information and in such format as determined by the JCC.
1.27. “Development” means all activities performed by or on behalf of either Party in the performance of any Development Plan for the Product in the Field in the Territory. Development shall include, without limitation, all activities related to research (including, without limitation, Post-Approval Research) preclinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, quality assurance/quality control, clinical studies, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis and report writing performed pursuant to the Development Plan with respect to the Product. Development shall not include Manufacturing or Commercialization. When used as a verb, “Develop” means to engage in Development.
1.28. “Development Budget” means the budget approved by the JDC for conducting Development pursuant to the Development Plan which budget will be updated and amended concurrently with the Development Plan.
1.29. “Development Expense” means the costs incurred by a Party in connection with studies or activities performed under the Development Plan in order to obtain, maintain or expand the relevant Regulatory Approval to manufacture, use or sell Product in the Field in the Territory to the extent included in the Development Budget. Development Expense shall include, without limitation, (a) all out-of-pocket costs and expenses actually incurred by Forest or Microbia in conducting such studies or activities including without limitation costs of studies on the toxicological, pharmacological, metabolic or clinical aspects of a Product conducted internally or by individual investigators or consultants and necessary for the purpose of obtaining, maintaining and/or expanding Regulatory Approval of the Product, process development, process improvement and scale-up costs, validation costs, including qualification lots, (b) the costs of internal personnel engaged in the performance of such studies or activities, including the activities described below in this Section (such costs shall be included in the Development Budget [**]), (c) all costs of developing data for Regulatory Submissions and all costs associated with making such submissions, (d) all costs related to pharmacovigilance activities, and (e) any other costs that are designated as Development Expenses herein, in each case as included in the Development Plan and the Development Budget.
1.30. “Development Plan” means the plan for the Development of the Collaboration Compound for Regulatory Approval prepared and approved by the JDC and as amended or updated from time to time, but in no event less frequently than once a year, in accordance with this Agreement. The initial Development Plan is attached hereto as Exhibit 1.30.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.31. “Effective Date” means the date of this Agreement first set forth above.
1.32. “Fair Market Value” means with respect to a valuation required by any provision hereof, the price which a willing buyer would pay, on an arm’s length basis, for all rights and related intellectual property assets which comprise the assets, data or rights being valued, in light of the status of development and reasonably anticipated risks and costs of further development and the market potential for the commercialization of such assets, data or rights. In any case where Fair Market Value must be determined but is not determined by good faith negotiations between the Parties, pursuant to Section 10.3.2(b), [**]. In addition, as the Parties wish to assure that Fair Market Value will be determined without regard to [**], Fair Market Value will be based upon [**] excluding any payment made pursuant to Section 5.1 this Agreement.
1.33. “FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder.
1.34. “FDA” means the United States Food and Drug Administration or any successor agency thereto, and in Canada and Mexico shall mean regulatory authorities having similar jurisdiction.
1.35. “Field” means all human diagnostic, prophylactic, and therapeutic uses of a product in any oral formulation or oral dosage form for any and all indications, including but not limited to IBS-C, CC and OIC.
1.36. “First Commercial Sale” means, with respect to the Product and any country of the Territory, the first sale of such Product under this Agreement for use in the Field to a Third Party in such country, after such Product has been granted Regulatory Approval for use in the Field by the competent Regulatory Authorities in such country.
1.37. “Forest Know-How” means (i) Know-How that Forest Controls as of the Effective Date or that comes into the Control of Forest during the Term (other than Joint Know-How or Know-How which is Microbia Know-How licensed to Forest pursuant to this Agreement) to the extent necessary or useful in the Territory to Manufacture, Develop or Commercialize any Collaboration Compound or Product, including without limitation any method of making any Collaboration Compound or Product, any composition or formulations of any Collaboration Compound or Products, or any method of using or administering any Collaboration Compound or Product, and (ii) Collaboration Know-How (other than Joint Know-How) that is invented, conceived or developed by employees of Forest or its Affiliates, or Third Parties acting on behalf of Forest or its Affiliates.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.38. “Forest Patent Rights” means any Patent Right that Forest Controls as of the Effective Date or that come into the Control of Forest during the Term (other than Joint Patent Rights or Patent Rights which are Microbia Patent Rights licensed to Forest pursuant to this Agreement) to the extent such rights cover or recite any Collaboration Compound or Product, any method of making any Collaboration Compound or Product, any composition or formulations of any Collaboration Compound or Products, or any method of using or administering any Collaboration Compound or Products.
1.39. “Forest Technology” means Forest’s interest in (a) the Forest Know-How, and (b) the Forest Patent Rights, and all other intellectual property rights in any of the foregoing.
1.40. “FTE Costs” means, (i) with respect to costs associated with [**] in any Calendar Quarter pursuant to this Agreement, the [**] pursuant to this Agreement in any Calendar Quarter, the [**].
1.41. “FTE Other Rate” means the [**]. The JDC and the JCC will arrange for the finance departments of each Party to discuss and agree upon appropriate FTE Other Rates for the various functional areas of this collaboration and to periodically review the appropriateness of and to adjust such rates.
1.42. “FTE Rate” means (i) [**] and (ii) [**], as applied.
1.43. “GAAP” means United States generally accepted accounting principles, as in effect from time to time.
1.44. “Good Clinical Practice” or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by other governmental agencies in countries in which the Products are intended to be sold, to the extent such standards are not less stringent than United States GCP.
1.45. “Good Laboratory Practice” or “GLP” means the then current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good laboratory practice as are required by other governmental agencies in countries in which the Products are intended to be sold, to the extent such standards are not less stringent than United States GLP.
1.46. “Good Manufacturing Practice” or “GMP” means the then current standards for manufacturing activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good manufacturing practice as are
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
required by other governmental agencies in countries in which the Products are intended to be manufactured or sold, to the extent such standards are not less stringent than United States GMP.
1.47. “Initial Compound” means Microbia’s proprietary guanylate cyclase C agonist polypeptide known as “Linaclotide Acetate,” having the chemical structure set forth on Schedule 1.47.
1.48. “IBS-C” means irritable bowel syndrome with the primary manifestation of constipation.
1.49. “Initial Development Plan” has the meaning set forth in Section 4.1.1.
1.50. “JCC” has the meaning set forth in Section 3.3.
1.51. “JDC” has the meaning set forth in Section 3.2.
1.52. “Joint Know-How” means any Collaboration Know-How that is invented, conceived or developed jointly by an employee of Microbia or its Affiliates (or a Third Party acting on any of their behalf) and an employee of Forest or its Affiliates (or a Third Party acting on any of their behalf).
1.53. “Joint Patent Right” means any Patent Right that claims Joint Know-How and names as the inventors one or more employees or agents of Microbia or its Affiliates together with one or more employees or agents of Forest or its Affiliates, as determined by U.S. law.
1.54. “Joint Technology” means Joint Know-How, Joint Patent Rights, and all other intellectual property rights therein.
1.55. “Know-How” means all inventions, discoveries, data, information (including scientific, technical or regulatory information), processes, methods, techniques, materials, technology, results, analyses, laboratory, pre-clinical and clinical data, or other know-how, whether or not patentable, including without limitation pharmacology, toxicology, drug stability, manufacturing and formulation methodologies and techniques, clinical and non-clinical safety and efficacy studies, marketing studies, absorption, distribution, metabolism and excretion studies.
1.56. “Manufacture,” “Manufactured” or “Manufacturing” means all activities involved in the production of a Collaboration Compound or Product to be Developed and/or Commercialized under this Agreement.
1.57. “Manufacturing Costs” means the cost to produce the Collaboration Compound and the Product for use pursuant to the Development Plan and, as applicable, the Commercialization Plan. Manufacturing Costs will
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
include without limitation, labor and material cost, allocable depreciation and amortization, product quality assurance/control costs, allocable facilities costs (e.g., sewer, water, property taxes), Third Party royalties, insurance, other costs borne by the Manufacturing Party for transport, customs and duty clearance and storage of the Collaboration Compound and Product, actual costs for API Manufacturing, and actual amounts paid to Third Parties for Manufacturing services (if applicable). Allocations shall be made assuming full capacity operation of the relevant facility, adjusted for changeovers in production runs, with the portion actually attributable to the Product Manufacture allocated to Manufacturing Costs. For administrative efficiency, the Parties’ respective finance departments will meet from time to time to agree upon a fixed percentage of Net Sales to determine (by approximation or other means, as mutually agreed) the Manufacturing Costs comprising distribution costs, including costs associated with shipping, storage, warehousing, transportation and distribution of the Product and billing. Such percentage shall be subject to periodic review and adjustment as necessary to assure that it continues to approximate such costs. For the avoidance of doubt, to the extent that any costs described in the preceding sentence are included in the percentage described in such sentence and deducted from Manufacturing Costs, such costs shall not be included in Commercialization Expenses. To the extent Manufacturing Costs include a Party’s internal costs, such amounts shall include directly related overheads but not corporate or general overheads. All Manufacturing Costs will be determined in accordance with GAAP.
1.58. “Microbia Know-How” means (i) Know-How Microbia Controls as of the Effective Date or that comes into the Control of Microbia during the Term (other than Joint Know-How and Know-How which is Forest Know-How licensed to Microbia pursuant to this Agreement) to the extent necessary or useful in the Territory to Manufacture, Develop or Commercialize any Collaboration Compound or Product, including without limitation any method of making any Collaboration Compound or Product, any composition or formulations of any Collaboration Compound or Products, or any method of using or administering any Collaboration Compound or Product, and (ii) Collaboration Know-How (other than Joint Know-How) that is invented, conceived or developed by employees of Microbia or its Affiliates, or Third Parties acting on behalf of Microbia or its Affiliates.
1.59. “Microbia Patent Rights” means any Patent Right that Microbia Controls as of the Effective Date or that comes into the Control of Microbia during the term of this Agreement (other than Joint Patent Rights and Patent Rights which are Forest Patent Rights licensed to Microbia pursuant to this Agreement) to the extent such rights cover or recite any Collaboration Compound or Product, any method of making the Collaboration Compound or Product, any composition or formulations of the Collaboration Compound or Products, or the method of using or administering the Collaboration Compound or Product.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.60. “Microbia Technology” means Microbia’s interest in (i) the Microbia Know-How, (ii) the Microbia Patent Rights, and all other intellectual property rights in any of the foregoing.
1.61. “Net Loss” means Net Sales [**] less Program Expenses, where the result is a negative number.
1.62. “Net Profit” means Net Sales [**] less Program Expenses, where the result is a positive number.
1.63. “Net Sales” means, on a country-by-country basis, with respect to any period for each country in the Territory, the gross amounts invoiced by Forest or its Affiliates, as applicable, to unrelated Third Parties for sales of the Product in the Field in such country, less the following deductions to the extent included in the gross invoiced sales price for the Product or otherwise directly paid or incurred by Forest or its Affiliates with respect to the sale of the Product in such country: (i) trade, quantity or cash discounts credits, adjustments or allowances, including without limitation, those granted on account of price adjustments, billing errors, rejected goods, or damaged goods; (ii) rebates and chargebacks allowed, given or accrued (including, but not limited to, cash, governmental and managed care rebates, hospital or other buying group chargebacks, and governmental taxes in the nature of a rebate based on usage levels or sales of the Product); (iii) sales, excise, turnover, inventory, value-added, and similar taxes assessed on the sale of the Product; (iv) bad debts reserved for on the basis utilized by Forest in its branded pharmaceutical business generally or, if greater, bad debts actually written off, in each case which are attributable to sales of Product; (v) freight and insurance charges; (vi) amounts paid or credited to customers for inventory management services; and (vii) the portion of any management or administrative fees paid during the relevant time period to group purchasing organizations, wholesalers and managed care organizations to the extent determined by sales or utilization of the Product. Net Sales will be determined in accordance with GAAP. Without limiting the generality of the foregoing, sales, transfers or dispositions of Product for charitable, promotional (including samples), pre-clinical, clinical, or regulatory purposes will be excluded from Net Sales, as will sales or transfers of Product among a Party and its Affiliates.
1.64. “New Drug Application” or “NDA” means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the U.S.
1.65. “OIC” means opioid induced constipation.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.66. “Operational Rights” means a Party’s right to representation on the JDC and JCC, the Party’s decision-making authority under the JCC and JDC, and its right to perform Detailing pursuant to the Commercialization Plan.
1.67. “Other Out-of-Pocket Costs” means (i) [**], costs incurred in [**] of this Agreement, (ii) costs incurred in [**] of this Agreement, and (iii) costs incurred by the Parties pursuant to Section [**].
1.68. “P&L Statement” has the meaning set forth in Section 5.4.2.
1.69. “Patent Right” means any and all (a) U.S. or foreign patent applications, including, without limitation, all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (b) all U.S. or foreign patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including, without limitation, supplementary protection certificates or the equivalent thereof, and (c) any other form of government-issued right substantially similar to any of the foregoing.
1.70. “Phase II” in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any foreign equivalent thereto.
1.71. “Phase III” in reference to a clinical trial means a trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.
1.72. “Phase IV” in reference to a clinical trial means a trial conducted for purposes of further characterizing and supporting the Product for marketing but not for purposes of seeking Regulatory Approval or otherwise fulfilling a requirement of a Regulatory Authority.
1.73. “Post-Approval Research” means ongoing research and development of a Product after such Product has received Regulatory Approval in a country of the Territory, including, without limitation, Phase IV clinical studies and clinical studies in support of indications within the Field or labeling changes for such Product within the field in such country during the term of this Agreement.
1.74. “Product” means any pharmaceutical product in finished oral form that contains a Collaboration Compound either as the sole active ingredient or in combination with one or more other active ingredients and all present and future oral formulations, oral dosages, and oral dosage forms thereof. For the avoidance of doubt and unless otherwise mutually agreed by the Parties, each in its sole discretion, “Product” excludes non-oral formulations, non-oral dosages and non-
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
oral dosage forms, including without limitation intravenous and inhalable forms, including any such formulations that are combination products.
1.75. “Program Expenses” means the Commercialization Expenses, Development Expenses, Manufacturing Costs, and Other Out of Pocket Costs.
1.76. “Promotion” means those activities normally undertaken by a pharmaceutical company’s sales force to implement marketing plans and strategies aimed at encouraging the appropriate use of a particular prescription or other pharmaceutical product, including Detailing. When used as a verb, “Promote” means to engage in such activities.
1.77. “Quality Agreement” means the agreement entered into pursuant to Section 4.2.3.
1.78. “Reconciliation Report” has the meaning set forth in Section 5.4.4.
1.79. “Regulatory Approval” means the approval and authorization of a Regulatory Authority in a country necessary to develop, manufacture, distribute, sell or market a Product in that country, including pricing and reimbursement approval, where required.
1.80. “Regulatory Authority” means any national (e.g., the FDA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the world involved in the granting of Regulatory Approval for a Product in the Territory.
1.81. “Regulatory Submissions” means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize the Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigative new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for the Product in the Territory.
1.82. “Restricted Period” has the meaning set forth in Section 6.2.1.
1.83. “Right of Reference” has the meaning set forth in Section 2.7.
1.84. “Senior Management” of a Party includes, at a minimum, each of the Chief Executive Officer, Head of Research and Development, Head of
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Marketing, and President or Chief Operating Officer of the pharmaceutical business or division.
1.85. “Share Adjustment” has the meaning set forth in Section 5.4.1.
1.86. “Sublicensee” means an Affiliate or Third Party that is granted a license, sublicense, covenant not to sue or other grant of rights under this Agreement pursuant to Section 2.6 of this Agreement. “Sublicense” means an agreement or arrangement pursuant to which such a sublicense or distribution right has been granted.
1.87. “Sublicense Income” means all payments that Forest or an Affiliate receives from a Third Party Sublicensee in connection with any grant of rights that includes the rights granted to Forest under Section 2.2, including without limitation license fees, milestone payments, license maintenance fees, royalties and other payments, [**].
1.88. “Target Party” has the meaning set forth in Section 10.3.2(b).
1.89. “Technology” means Know-How and Patent Rights.
1.90. “Term” is defined in Section 10.1.
1.91. “Territory” means the countries of North America, consisting of the United States, Canada and Mexico, and their respective territories and possessions (including Puerto Rico, irrespective of political status).
1.92. “Third Part(y/ies)” means any person(s) or entit(y/ies) other than Microbia and its Affiliates and Forest and its Affiliates.
1.93. “Trademark” means any trademark under which the Product is sold, other than the Parties’ trade names and trademarks used by the Parties to identify their companies generally.
1.94. “United States” or “U.S.” means the United States of America, its territories and possessions (including Puerto Rico, irrespective of political Status).
1.95. “Valid Claim” means a claim of an issued and unexpired Patent Right in the Territory, which claim has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which is not appealable or has not been appealed within the time allowed for appeal, and which has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
1.96. “Valuation Panel” means a panel of [**]. In the event the Parties are required by the terms hereof to select a Valuation Panel, each Party shall [**]. Each Party shall [**]. The decision of [**] entered into shall be deemed the decision of the Valuation Panel. The Parties shall instruct the Valuation Panel to reach its decision as promptly as practicable, and if possible within [**]. The costs of this Valuation Panel shall be [**] by the Parties.
1.97. “Year” means each twelve (12) month period ending December 31st.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
The Parties will also coordinate worldwide publication strategy involving the Product and activities involving the Product related to scientific conferences inside and outside the Territory, including through delegation to appropriate working groups of the Parties. Each Party shall be afforded the opportunity to review and approve any scientific paper or presentation with respect to the Product proposed for publication, presentation or distribution by the other Party or its Affiliates and licensees or Sublicensees and shall have no more than [**] to complete such review and approval or such shorter period as may reasonably be required by applicable publication deadlines promptly communicated to such Party. The Party proposing publication or presentation shall not unreasonably reject comments furnished by the other Party, will comply with the other Party’s request to delete references to its Confidential Information in any such publication or presentation and will delay publication for such reasonable period requested by the other Party to permit the filing of patent applications concerning any Forest Technology, Microbia Technology or Joint Technology disclosed in material proposed for such publication or presentation. In no event will Confidential Information of a Party be published without the consent of such Party.
The Parties will coordinate the disclosure of the initiation and results of clinical studies performed pursuant to the Development Plan or clinical studies performed by either Party’s licensees or Sublicensees with respect to any Collaboration Compound or Product, whether within or outside of the Territory, to the extent required by law or best industry practices; provided that all proposed disclosures and publications will be submitted for expeditious review by the JDC and due regard will be given to the comments of each Party, the maintenance of confidentiality of Confidential Information of each Party and allowing time for intellectual property registrations. Nothing set forth herein shall be deemed to limit or restrict either Party from disclosing the results of clinical trials (whether performed by the Parties or by Third Parties) to the extent required by law or best industry practices. The Parties intend that the provisions of this Section 4.6 shall apply to the Parties and their respective Affiliates, licensees and Sublicensees.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
EVENT |
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MILESTONE PAYMENT |
Dosing the first patient in the first Phase III clinical trial for purposes of obtaining Regulatory Approval in the United States using a Product in treating or preventing IBS-C |
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$25,000,000 equity investment as further described in Section 5.2.2 below. |
Dosing the first patient in the first Phase III clinical trial for purposes of obtaining Regulatory Approval in the United States using a Product in treating or preventing CC |
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$[**] |
Acceptance of the first NDA by a Regulatory Authority in the United States for use of a Product in treating or preventing IBS-C |
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$[**] |
Acceptance of the first NDA by a Regulatory Authority in the United States for use of a Product in treating or preventing CC |
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$[**] |
The first Regulatory Approval of an NDA by a Regulatory Authority in the United States for use of a Product in treating or preventing IBS-C |
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$[**] |
The first Regulatory Approval of an NDA by a Regulatory Authority in the United States for use of a Product in treating or preventing CC |
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$[**] |
Notwithstanding the preceding, in the event Forest provides notice of termination of this Agreement to Microbia pursuant to Section 10.2.2 prior to the occurrence of a milestone event set forth above, Forest shall not be obligated to make any such or subsequent Development Milestone payment (including the equity investment referred to above and further described
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
under 5.2.2 below), provided that if Forest provides notice of termination within [**] days of the achievement of the first NDA approval Milestone for either CC or IBS-C based upon Forest’s determination that such approval provides for labeling or is subject to conditions which would make it not Commercially Reasonable to Commercialize the Product as contemplated by this Agreement, in lieu of paying the associated NDA approval Milestones, Forest shall be obligated to pay Microbia $[**] within [**] days of such approval, unless Microbia has determined at that time not to Commercialize the Product, or to discontinue such Commercialization, in which case no such payment or further payment shall be required pursuant to this Section, and provided that notwithstanding the foregoing, Forest shall otherwise continue to perform all of its obligations under this Agreement until any such termination becomes effective in accordance with this Agreement. Forest shall make any such determination in a Commercially Reasonable manner.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
EVENT |
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MILESTONE PAYMENT |
End of first Commercial Year in which aggregate annual Net Sales of Products in the United States are at least $1,000,000,000, if such Commercial Year occurs within the first eight (8) Commercial Years of Commercialization. |
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$[**] |
End of first Commercial Year in which aggregate annual Net Sales of Products in the United States are at least $1,000,000,000, if such Commercial Year occurs after the first eight Commercial Years but within the first ten (10) Commercial Years of Commercialization, provided that at such time, the Product is expected to have at least four (4) years of legal or regulatory market exclusivity in the United States. |
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$[**] |
For purposes of this Section 5.2.3 and Section 5.4.1 below, a “Commercial Year” shall refer to the twelve (12) month period beginning on the first day of the first full month following the Commercial Launch of the Product and each consecutive twelve (12) month period thereafter.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Notwithstanding the foregoing, the provisions of this Section 6.5 shall not apply to (i) the exercise by any of the Forest Related Parties of any rights available to shareholders generally pursuant to any transaction described in Section 6.5.1(a) above, provided that such Forest Related Party has not then either directly or as a member of a Group made, effected, initiated or caused such transaction to occur, or (ii) any activity by any of the Forest Related Parties after Microbia or any other Third Party unrelated to any of the Forest Related Parties has made any public announcement of its intent to solicit or engage in any transaction of the type referred to in this Section 6.5.1(a) above, provided however, with respect to subpart (ii), if any of the Forest Related Parties or such Third Party terminates or announces its intent to terminate such transaction and such Forest Related Party (A) has not previously made any public announcement of its intent to solicit or engage in any transaction of the type referred to in this Section 6.5.1(a) above, or (B) in the event that such public announcement has been made by any of the Forest Related Parties, such Forest Related Party has terminated or announced its intent to terminate such transaction, then the provisions of this Section 6.5 shall again be applicable.
For purposes of this Section, “Representatives” of a Party will be deemed to include each person or entity that is or becomes (i) an Affiliate of such Party, or (ii) an officer, director, employee, partner, attorney, advisor, accountant, agent or representative of such Party or of any of such Party’s Affiliates, provided such person is acting on behalf of such Party or such Party’s Affiliate. “Group” means two or more persons acting as a partnership, limited partnership, syndicate or other group for the purpose of acquiring, holding or disposing of securities of Microbia.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
except in each case, to the extent caused by the gross negligence or willful misconduct of Forest or any Forest Indemnified Party, or by breach of this Agreement by Forest.
except in each case, to the extent caused by the gross negligence or willful misconduct of Microbia or any Microbia Indemnified Party, or by breach of this Agreement by Microbia.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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For Microbia: |
its Chief Executive Officer or his designate |
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For Forest: |
its Chief Executive Officer or his designate |
In the event the designated executive officers do not resolve such dispute within the allotted thirty (30) days, either Party may, after the expiration of the thirty (30) day period, seek to resolve the dispute through arbitration in accordance with this Section 12.1.2. Notwithstanding the preceding, the Parties acknowledge that the failure of the JCC or JDC to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, shall not be deemed a dispute which may be referred for resolution by arbitration hereunder.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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For: |
Microbia, Inc. |
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320 Bent Street |
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Cambridge, MA 02141 |
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Fax: 617-494-0908 |
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Attn: Vice President, Business Development |
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With a copy to: |
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Ropes & Gray LLP |
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One International Place |
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Boston, MA 02110 |
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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Fax: 617-951-7050 |
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Attn: Marc Rubenstein |
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For: |
Forest Laboratories, Inc. |
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909 Third Avenue |
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New York, NY 10022 |
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Fax: 212-224-6740 |
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Attn: Chief Executive Officer |
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With a copy to: |
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Forest Laboratories, Inc. |
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909 Third Avenue |
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New York, NY 10022 |
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Fax: 212-224-6740 |
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Attn: General Counsel |
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective Date.
FOREST LABORATORIES, INC. |
MICROBIA, INC. |
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By: |
/s/ Howard Solomon |
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By: |
/s/ Peter Hecht |
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Name: Howard Solomon |
Name: Peter Hecht |
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Title: Chairman |
Title: CEO |
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
EXHIBIT 1.30
Development Plan
Linaclotide Development Plan — Final 8/20/07
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Duration |
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Status |
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Timing in Relation to Clinical |
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General Program Assumptions: The plans described here reflect the current view for the major studies and program activities that are to be completed for the development of linaclotide. This plan does not reflect all the studies that are to be done to support the program, since data, regulatory requirements and mutual objectives for the development and commercialization of linaclotide may drive the need for additional studies.
[**]
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SCHEDULE 1.5
Existing Backup Compounds
[**]
SCHEDULE 1.47
Initial Compound
[**]
SCHEDULE 4.1.1
Certain Clinical and
Non-Clinical Development and
Regulatory Responsibilities for Forest-Microbia Development of the Product in
the Field in the Territory
[**]
SCHEDULE 4.5.3
Promotional Obligations
[**]
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SCHEDULE 5.2.2(i)
Stock Purchase Agreement
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
FORM OF SERIES G CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT
BY AND AMONG
MICROBIA, INC.
AND
THE SEVERAL PURCHASERS NAMED IN EXHIBIT A
[Date]
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SERIES G CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT
This SERIES G CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of [Date], by and among MICROBIA, INC., a Delaware corporation (the “Company”), and each of those persons and entities, severally and not jointly, whose names are set forth on the Schedule of Purchasers attached hereto as Exhibit A (which persons and entities are hereinafter collectively referred to as “Purchasers” and each individually as a “Purchaser”).
RECITALS
WHEREAS, the Company has authorized the sale and issuance of an aggregate of up to [·] shares of its Series G Convertible Preferred Stock (the “Series G Stock”);
WHEREAS, the Purchasers desire to purchase the Shares on the terms and conditions set forth herein; and
WHEREAS, the Company desires to issue and sell such Shares to Purchasers on the terms and conditions set forth herein.
AGREEMENT
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises hereinafter set forth, the parties hereto agree as follows:
1. AGREEMENT TO SELL AND PURCHASE.
1.1 Authorization of Shares. On or prior to the Initial Closing (as defined in Section 2.1 below), the Company shall have duly authorized (a) the sale and issuance to Purchasers of up to [·] shares of its Series G Stock (the “Shares”) and (b) the issuance of such shares of Common Stock to be issued upon conversion of the Shares (the “Conversion Shares”). The Shares and the Conversion Shares shall have the rights, preferences, privileges and restrictions set forth in the Eighth Amended and Restated Certificate of Incorporation of the Company, in the form attached hereto as Exhibit B (the “Restated Charter”). The Company has, or prior to the Initial Closing will have, adopted and filed the Restated Charter with the Secretary of State of the State of Delaware.
1.2 Sale and Purchase.
(a) Initial Shares. Subject to the terms and conditions hereof, at the Initial Closing (as defined in Section 2.1) the Company hereby agrees to issue and sell to each Purchaser listed in Part I of Exhibit A (the “Initial Purchasers”), severally and not jointly, and each such Purchaser agrees to purchase from the Company, severally and not jointly, the number of Shares (the “Initial Shares”) set forth opposite such Purchaser’s name on Exhibit A, at a purchase price of [twelve dollars] ($[12.00]) per share. The Company’s agreement with each of the Purchasers is a separate agreement, and the sale of Shares to each of the Purchasers is a separate sale.
(b) Additional Shares. If less than all of the authorized number of shares of Series G Stock are sold at the Initial Closing, then, subject to the terms of this Agreement, at one or more Additional Closings (as defined in Section 2.2), the Company may
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
issue and sell up to the balance of the authorized but unissued shares of Series G Stock (the “Additional Shares”) at a purchase price of [twelve dollars] ($[12.00]) per share to such additional purchasers (the “Additional Purchasers”) as the majority of the Board of Directors may approve. The Company and each Additional Purchaser shall execute the counterpart signature page for Additional Closings attached hereto, and upon such execution and delivery, each such counterpart shall be deemed a part of this Agreement and Exhibit A shall automatically be amended to reflect the Additional Shares purchased in such Additional Closing.
The Initial Shares and the Additional Shares are collectively referred to hereinafter as the “Shares.” The Initial Purchasers and the Additional Purchasers are collectively referred to hereinafter as the “Purchasers.”
2. CLOSING, DELIVERY AND PAYMENT.
2.1 Initial Closing. The closing of the sale and purchase of the Initial Shares under this Agreement (the “Initial Closing”) shall take place at 10:00 a.m. on the date hereof, upon the satisfaction of the closing conditions set forth in Section 5.1 below, at the offices of Ropes & Gray LLP, One International Place, Boston, Massachusetts 02110, or at such other time or place as the Company and Purchasers may mutually agree (such date is hereinafter referred to as the “Initial Closing Date”). If at the Initial Closing any of the conditions specified in Section 5.1 shall not have been fulfilled, each of the Initial Purchasers shall, at his, her or its election, be relieved of all of his, her or its obligations under this Agreement without thereby waiving any other rights such Initial Purchaser may have by reason of such failure or such non-fulfillment.
2.2 Additional Closings. The closing of the sale and purchase of any Additional Shares under this Agreement (each, an “Additional Closing”), shall take place at such time, date, and place as the Company and each Additional Purchaser may mutually agree (each such date is hereinafter referred to as an “Additional Closing Date”); provided, however, that any Additional Closings under the terms of this Agreement shall occur no later than sixty days after the date of the Initial Closing (the “Additional Closing Deadline”), provided further that, the Additional Closing Deadline may be extended by mutual agreement between the Company and the holders of a majority of the then outstanding shares of Series G Stock with respect to the issuance of any Additional Shares under this Agreement or otherwise. If at any Additional Closing any of the conditions specified in Section 5.1 shall not have been fulfilled, each of the Additional Purchasers shall, at his, her or its election, be relieved of all of his, her or its obligations under this Agreement without thereby waiving any other rights such Additional Purchaser may have by reason of such failure or such non-fulfillment.
2.3 Delivery. At the Initial Closing and each Additional Closing (the Initial Closing and each Additional Closing, a “Closing”), subject to the terms and conditions hereof, the Company will deliver to each Purchaser a certificate representing the number of Shares to be purchased at such Closing by such Purchaser, against payment of the purchase price therefor by check, wire transfer made payable to the order of the Company, or any combination of the foregoing.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
2.4 Use of Proceeds. The Company shall use the proceeds from the sale of the Shares for product development and for general working capital purposes.
3. REPRESENTATIONS AND WARRANTIES OF THE COMPANY.
Except as set forth in the Schedule of Exceptions attached hereto as Exhibit E delivered by the Company to the Purchasers at the Initial Closing and at any Additional Closing, the Company hereby represents and warrants to each Purchaser as of the date of this Agreement as follows:
3.1 Organization, Good Standing and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware. The Company has all requisite corporate power and authority to own and operate its properties and assets, to carry on its business as presently conducted and as presently proposed to be conducted, to execute and deliver this Agreement, the Seventh Amended and Restated Investors’ Rights Agreement in the form attached hereto as Exhibit C (the “Investors’ Rights Agreement”), the Fourth Amended and Restated Voting Agreement in the form attached hereto as Exhibit D (the “Voting Agreement” and together with the Investors’ Rights Agreement, the “Related Agreements”), to issue and sell the Shares and the Conversion Shares, and to carry out the provisions of this Agreement, the Related Agreements and the Restated Charter. The Company is duly qualified and is authorized to do business as a foreign corporation and is in good standing in all jurisdictions listed in the Schedule of Exceptions in which the nature of its activities and of its properties (both owned and leased) makes such qualification necessary, except for those jurisdictions in which failure to so qualify would not have a material adverse effect on the business, assets, properties, operations, prospects or financial condition of the Company (a “Material Adverse Effect”). The Company has furnished to each Purchaser who has so requested in writing, true and complete copies of its Seventh Amended and Restated Certificate of Incorporation (the “Certificate of Incorporation”) and By-Laws as presently in effect.
3.2 Subsidiaries. Except as set forth in the Schedule of Exceptions, the Company has no subsidiaries and does not own or control, directly or indirectly, any equity security of any corporation or any other interest in any other corporation, general or limited partnership, joint venture association, business trust or other business entity. The Company is not a participant in any joint venture, partnership or similar arrangement.
3.3 Capitalization; Voting Rights.(1)
The authorized capital stock of the Company, immediately prior to the Initial Closing after giving effect to the Restated Charter, will consist of [80,932,230] shares of Common Stock, par value $0.001 per share, 6,934,807 shares of which are issued and outstanding and 9,677,915 shares of which are reserved for future issuance to employees pursuant to the Company’s 1998
(1) Capitalization figures are current as of the date of the Master Collaboration Agreement between the Company and Forest Laboratories.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Stock Option Plan, 2002 Stock Incentive Plan, 2002 California Stock Incentive Plan and 2005 Stock Incentive Plan (collectively, the “Stock Incentive Plans”) and [63,843,741] shares of Preferred Stock, par value $0.001 per share, 8,904,567 of which are designated Series A Preferred Stock, all of which are issued and outstanding 7,419,355 of which are designated Series B Preferred Stock, all of which are issued and outstanding, 6,401,523 of which are designated Series C Stock, all of which are issued and outstanding, 12,618,296 of which are designated as Series D Stock, all of which are issued and outstanding, 20,500,000 of which are designated as Series E Stock, 19,633,531 of which are issued and outstanding, 8,000,000 of which are designated as Series F Stock, 8,000,000 of which are issued and outstanding, and [·] of which are designated as Series G Stock, none of which are issued and outstanding (collectively, the “Preferred Stock”). All issued and outstanding shares of the Company’s capital stock (a) have been duly authorized and validly issued, (b) are fully paid and non-assessable, and (c) were offered, issued, sold and delivered in compliance with all applicable federal and state securities laws. The rights, preferences, privileges and restrictions of the Shares are as stated in the Restated Charter. Each series of Preferred Stock is convertible into Common Stock on a one-for-one basis. The Conversion Shares have been duly and validly reserved for issuance.
(a) Other than the 9,677,915 shares reserved for issuance under the Company’s Stock Incentive Plans, and except as provided in the Restated Charter and the Investors’ Rights Agreement or as set forth in the Schedule of Exceptions, (i) no subscriptions, warrants, options, convertible securities or other rights (contingent or otherwise) to purchase or acquire (including conversion or preemptive rights and rights of first refusal) any shares of capital stock of the Company are authorized or outstanding, (ii) the Company has no obligation (contingent or otherwise) to issue any subscription, warrant, option, convertible security or other such right (including conversion or preemptive rights and rights of first refusal) or to issue or distribute to holders of any shares of its capital stock any evidences of indebtedness or assets of the Company, and (iii) the Company has no obligation (contingent or otherwise) to purchase, redeem or otherwise acquire any shares of its capital stock or any interest therein or to pay any dividend or make any other distribution in respect thereof, and (iv) no stock appreciation, phantom stock or similar rights with respect to the Company are authorized or outstanding. Except as contemplated by this Agreement, the Related Agreements or in the Schedule of Exceptions, there are no agreements or proxies, written or oral, between the Company and any holder of its capital stock, or, to the best knowledge of the Company, among any holders of its capital stock, relating to the acquisition, disposition or voting of the capital stock of the Company.
(b) When issued in compliance with the provisions of this Agreement and the Restated Charter, the Shares and the Conversion Shares will be validly issued, fully paid and nonassessable, and will be free of any liens or encumbrances (other than liens and encumbrances created by the Purchasers); provided, however, that the Shares and the Conversion 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 Shares and the subsequent conversion of the Shares into Conversion Shares are not and will not be subject to any preemptive rights or rights of first refusal that have not been properly waived or complied with on or prior to the Initial Closing.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(c) Attached as Exhibit G hereto is a true and complete list of the securityholders of the Company, showing the number of shares of Common Stock, Preferred Stock or other securities of the Company held by each securityholder as of the date of this Agreement and, in the case of options, warrants and other convertible securities, the exercise price thereof and the number and type of securities issuable thereunder.
3.4 Authorization; Binding Obligations. All corporate action on the part of the Company, its officers, directors and stockholders necessary for the authorization of this Agreement and the Related Agreements, the performance of all obligations of the Company hereunder and thereunder at each Closing and the authorization, sale, issuance and delivery of the Shares pursuant hereto and the Conversion Shares pursuant to the Restated Charter has been taken or will be taken prior to the Initial Closing. This Agreement and the Related Agreements have been duly executed and delivered by the Company and constitute the valid and binding obligations of the Company enforceable in accordance with their respective terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights, (b) general principles of equity that restrict the availability of equitable remedies, and (c) to the extent that the enforceability of the indemnification provisions in Section 2.9 of the Investors’ Rights Agreement may be limited by applicable laws.
3.5 Financial Statements. The Company has made available to each Purchaser a complete and correct copy of (i) the audited balance sheet of the Company as of December 31, 200_, and the related, audited statements of income, changes in stockholders’ equity and cash flows for the fiscal year then ended, and (ii) the unaudited balance sheet of the Company as of (the “Statement Date”), and the related, unaudited statements of income and cash flows for the fiscal year then ended (collectively, the “Financial Statements”). The Financial Statements, together with the notes thereto, were prepared in accordance with generally accepted accounting principles applied on a basis consistent with prior periods, are complete and correct in all material respects and present fairly the financial condition and position of the Company as of their respective dates; provided, however, that the unaudited Financial Statements are subject to normal recurring year-end audit adjustments (which will not be material), and do not contain all footnotes required under generally accepted accounting principles.
3.6 Liabilities. Except as set forth in the Schedule of Exceptions, the Company has no material liabilities and, to the best of its knowledge, knows of no material contingent liabilities not disclosed in the Financial Statements, except current liabilities incurred in the ordinary course of business which are not, either individually or in the aggregate, material to the business, assets, properties, operations, prospects or financial condition of the Company.
3.7 Absence of Changes. Except as set forth in the Schedule of Exceptions, since the Statement Date, there has not been:
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(a) any change in the business, assets, properties, operations, prospects or financial condition of the Company, except changes in ordinary course of business that have not been, either individually or in the aggregate, materially adverse;
(b) any change (individually or in the aggregate) in the contingent obligations of the Company by way of guaranty, endorsement (other than endorsement of drafts in the ordinary course of business for the purpose of collection), indemnity, warranty (other than in the ordinary course of business), or otherwise.
(c) any material loss, destruction or damage to any property of the Company, whether or not insured;
(d) any waiver by the Company of any valuable right or of any material debt or claim owed to it;
(e) any satisfaction or discharge of any lien, claim or encumbrance or payment of any obligation by the Company, except in the ordinary course of business or that is not material to the business, assets, properties, operations, prospects or financial condition of the Company;
(f) any material change or amendment to a material contract or arrangement by which the Company or any of its assets or properties is bound;
(g) any change in the compensation paid or payable to any officer, director, employee, consultant, agent or stockholder of the Company (other than compensation increases in the ordinary course of business consistent with past practice, which, individually and in the aggregate, are not material);
(h) any resignation or termination of any executive officer or other key employee of the Company or material change in the terms and conditions of their employment;
(i) any loans or advances made to any person, other than ordinary advances for travel expenses;
(j) any direct or indirect redemption or acquisition of, any capital stock in the Company;
(k) declared or paid any dividends, or authorized or made any distribution in cash or in kind upon or with respect to any class or series of its capital stock;
(l) to the Company’s knowledge, any other event or condition of any character that has affected, or may affect, materially and adversely, the Company’s business or prospects; or
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(m) any agreement or understanding, whether in writing or otherwise, for the Company to take or become subject to any of the actions specified in paragraphs (a) through (l).
3.8 Agreements; Action.
(a) Except for agreements explicitly contemplated hereby, agreements between the Company and its employees with respect to the sale of the Company’s Common Stock under the Stock Incentive Plans, and except as set forth in the Schedule of Exceptions, there are no agreements, understandings or proposed transactions between the Company and any of its officers, directors, affiliates or any affiliate thereof.
(b) The Schedule of Exceptions sets forth a list of all agreements, or commitments of any nature (whether written or oral) to which the Company is a party by which it is bound, including without limitation (i) any agreement which requires future expenditures by the Company in excess of $1,000,000, (ii) the transfer or license of any patent, trademark, copyright, trade secret or other proprietary right to or from the Company (other than licenses arising from the purchase of “off the shelf” or other standard products), (iii) any employment or consulting agreement in excess of $100,000, employee benefit, bonus, pension, profit-sharing, stock option, stock purchase or similar plan or arrangement, (iv) any distributor, sales representative or similar agreement, (v) any agreement with any current or former stockholder, officer or director of the Company, or any “affiliate” or “associate” of such persons (as such terms are defined in the rules and regulations promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including without limitation any agreement or other arrangement providing for the furnishing of services by, rental of real or personal property from, or otherwise requiring payments to, any such person or entity, (vi) provisions restricting the development, manufacture or distribution of the Company’s products or services, or (vii) indemnification by the Company with respect to infringements of proprietary rights (other than indemnification obligations arising from purchase or sale or license agreements entered into in the ordinary course of business), (viii) provisions restricting the development, manufacture or distribution of the Company’s products or services, (ix) any agreement relating to indebtedness for borrowed money, (x) any agreement for the disposition of a material portion of the Company’s assets (other than in the ordinary course of business) and (xi) any agreement for the acquisition of the business or shares of another party.
(c) Except as set forth in the Schedule of Exceptions, the Company has not (i) declared or paid any dividends, or authorized or made any distribution upon or with respect to any class or series of its capital stock or (ii) made any loans or advances to any person, other than ordinary advances for travel expenses.
(d) For the purposes of subsection (b) above, all indebtedness, liabilities, agreements, understandings, instruments, contracts and proposed transactions involving the same person or entity (including persons or entities the Company has reason to
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
believe are affiliated therewith) shall be aggregated for the purpose of meeting the individual minimum dollar amounts of such subsection.
(e) All of the contracts, agreements and instruments to which the Company is a party are valid, binding and enforceable in accordance with their respective terms, except for those contracts, agreements and instruments the lack of validity, binding effect or enforceability of which would not have a Material Adverse Effect. The Company has performed all obligations required to be performed by it and is not in default under, or in breach of, nor in receipt of any claim of default or breach under any contract, agreement or instrument, except for such breaches or defaults, which either individually or in the aggregate, would not have a Material Adverse Effect, and the Company does not have any present expectation or intention of not fully performing all such obligations. To the Company’s knowledge, no event has occurred which with the passage of time or the giving of notice or both would reasonably be expected to result in a default, breach or event of noncompliance by the Company under any contract, agreement or instrument. The Company has no knowledge of any breach or anticipated breach by the other parties to any contract, agreement or instrument.
(f) Each Purchaser who has so requested in writing has been supplied with a true and correct copy of each of the written instruments, plans, contracts and agreements and an accurate description of each of the oral arrangements, contracts and agreements that are referred to on the Schedule of Exceptions pursuant to this Section 3.8, together with all amendments, waivers or other changes thereto.
(g) The Company is not a party to and is not bound by any contract, agreement or instrument, or subject to any restriction under its Certificate of Incorporation or By-laws that, to its knowledge, adversely affects in any material respect, its business as currently conducted or as proposed to be conducted, or its properties or its financial condition.
(h) The Company has not engaged in the past three months in any discussion (i) with any representative of any corporation or entity regarding the consolidation or merger of the Company with or into any such corporation or entity or the sale, conveyance or disposition of all or substantially all of the assets of the Company or a transaction or series of related transactions in which more than fifty percent of the voting power of the Company would be disposed of, or (ii) regarding any other form of acquisition, liquidation, dissolution or winding up to the Company.
3.9 Obligations to Related Parties. There are no obligations of the Company to officers, directors, stockholders, or employees of the Company other than (a) for payment of salary for services rendered, (b) reimbursement for reasonable expenses incurred on behalf of the Company, and (c) for other standard employee benefits made generally available to all employees (including stock option agreements outstanding under any Stock Incentive Plans). The Company is not a guarantor or indemnitor of any indebtedness of any other person, firm or corporation.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
3.10 Title to Properties and Assets; Liens, etc. Except as set forth in the Schedule of Exceptions, the Company has good and marketable title to its properties and assets and good title to its leasehold estates, in each case subject to no mortgage, pledge, lien, lease, encumbrance or charge, other than (a) those resulting from taxes which have not yet become delinquent, (b) minor liens and encumbrances which do not materially detract from the value of the property subject thereto or materially impair the operations of the Company, and (c) those that have otherwise arisen in the ordinary course of business. The Company is in compliance with all material terms of each lease to which it is a party or is otherwise bound.
3.11 Patents and Trademarks.
(a) As used in this Agreement, the term “Intellectual Property Rights” with respect to a party means all: (i) patents, patent applications, inventions and designs, and any registration thereof with any agency or authority; (ii) trademarks, service marks, trade names, franchises and copyrights and all registrations and applications to register any of the foregoing with any agency or authority; (iii) trade secrets including all formulae, processes, know-how, technical data, shop rights, and any media or other tangible embodiment thereof and all descriptions thereof; (iv) all other technology and intangible property, including without limitation computer programs in object code or source code form, databases, and documentation and flow charts; and (v) with respect to the Company, any licenses and other rights granted to or by the Company with respect to any of the foregoing, excluding licenses or agreements arising from the purchase of “off the shelf” or standard products.
(b) The Schedule of Exceptions contains a complete and accurate list of all (i) patents, patent applications, trademarks, copyrights and service marks owned by the Company, identifying the title, name(s) of inventors or author(s), if applicable, filing dates, issue dates, docket or serial numbers, status and countries of issuance, and (ii) licenses granted to or by the Company with respect to any of the Intellectual Property Rights owned or used by the Company. The Company owns or possesses sufficient legal rights to all Intellectual Property Rights necessary for its business as now conducted and as presently proposed to be conducted. To the Company’s knowledge, none of the activities conducted by the Company or proposed to be conducted by the Company infringes, violates or constitutes a misappropriation of the Intellectual Property Rights of any other person or entity. In addition, to the Company’s knowledge, no other person or entity is infringing, violating or misappropriating any of the Intellectual Property Rights that the Company owns or has licensed. The Company has not received any communications alleging that the Company has violated or, by conducting its business as presently conducted and as proposed to be conducted, would violate any of the Intellectual Property Rights of any other person or entity. To the Company’s knowledge, no directors, officers or employees are obligated under any contract (including licenses, covenants or commitments of any nature) or other agreement, or subject to any judgment, decree or order of any court or administrative agency, that would interfere with their duties to the Company or that would conflict with the Company’s business as presently conducted and as proposed to be conducted. Neither the execution nor delivery of this Agreement or the Related Agreements, nor the carrying on of the Company’s business by the employees of the Company, nor the conduct of
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
the Company’s business as presently conducted and as proposed to be conducted, will, to the Company’s knowledge, conflict with or result in a breach of the terms, conditions or provisions of, or constitute a default under, any contract, covenant or instrument under which any director, officer or employee, is now obligated. The Company does not believe it is or will be necessary to utilize any inventions, trade secrets or proprietary information of any of its employees made prior to their employment by the Company, except for inventions, trade secrets or proprietary information that have been assigned to the Company and which are disclosed in the Schedule of Exceptions hereto.
(c) The Company has taken commercially reasonable precautions (i) to protect its rights in its Intellectual Property Rights, and (ii) to maintain the confidentiality of its trade secrets, know-how and other confidential Intellectual Property Rights, and to the Company’s knowledge, there have been no acts or omissions by the officers, directors, stockholders, employees, consultants and advisors of the Company the result of which would be to materially compromise the rights of the Company to apply for, enforce and otherwise ensure the Company’s legal and equitable rights to all its Intellectual Property. Each employee and officer of the Company has executed the Proprietary Information and Inventions Agreement, substantially in the form attached hereto as Exhibit H (the “Proprietary Information and Inventions Agreement”). Each of the Company’s consultants has executed a consulting agreement containing provisions relating to proprietary information and inventions substantially similar to those contained in the Proprietary Information and Inventions Agreement.
3.12 Compliance with Other Instruments. The Company is not in violation or default of any term of its Certificate of Incorporation or Bylaws, or of any provision of any mortgage, indenture, agreement, instrument or contract to which it is party or by which it is bound or of any judgment, decree, order, writ. The execution of and performance of the transactions contemplated by this Agreement and the Related Agreements, and compliance with their respective provisions by the Company, will not (a) conflict with or violate any provision of the Certificate of Incorporation or By-laws of the Company; (b) require on the part of the Company any filing with, or any permit, authorization, consent or approval of, any court, arbitrational tribunal, administrative agency or commission or other governmental or regulatory authority or agency (each of the foregoing is hereafter referred to as a “Governmental Entity”); (c) conflict with, result in a breach of, constitute (with or without due notice or lapse of time or both) a default under, result in the acceleration of, create in any party the right to accelerate, terminate, modify or cancel, or require any notice, consent or waiver under, any contract, lease, sublease, license, sublicense, franchise, permit, indenture, agreement or mortgage for borrowed money, instrument of indebtedness, or other arrangement to which the Company is a party or by which the Company is bound or to which its assets are subject; (d) result in the imposition of any mortgage, pledge, security interest, encumbrance, charge, or other lien (whether arising by contract or by operation of law) upon any assets of the Company; or (e) violate any order, writ, injunction, decree, statute, rule or regulation applicable to the Company or any of its properties or assets.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
3.13 Litigation. There is no action, suit, proceeding or investigation pending or, to the Company’s knowledge, currently threatened against the Company that questions the validity of this Agreement, the Related Agreements or the right of the Company to enter into any of such agreements, or to consummate the transactions contemplated hereby or thereby, or which might result, either individually or in the aggregate, in any material adverse change in the business, assets, properties, operations, prospects or financial condition of the Company, financially or otherwise, or any change in the current equity ownership of the Company, nor is the Company aware that there is any basis for any of the foregoing. The foregoing includes, without limitation, actions pending or threatened (or any basis therefor known to the Company) involving the prior employment of any of the Company’s employees, their use in connection with the Company’s business of any information or techniques allegedly proprietary to any of their former employers, or their obligations under any agreements with prior employers. The Company is not a party or subject to the provisions of any order, writ, injunction, judgment or decree of any court or government agency or instrumentality. There is no action, suit, proceeding or investigation by the Company currently pending or which the Company intends to initiate.
3.14 Tax Returns and Payments. The Company has timely filed all foreign, federal, state, county and local income, excise or franchise tax returns, real estate and personal property tax returns, sales and use tax returns and other tax returns and reports required to be filed by it and such returns and reports are true and correct in all material respects. All taxes shown to be due and payable on such returns, any assessments imposed, and to the Company’s knowledge all other taxes due and payable by the Company on or before the Closing, have been paid or will be paid prior to the time they become delinquent. The Company has no knowledge of any liability of any tax to be imposed upon its properties or assets as of the date of this Agreement that is not adequately provided for in the Financial Statements. With regard to the income tax returns of the Company, the Company has not received notice of any audit or of any proposed deficiencies from any taxing authority, and no controversy with respect to taxes of any type is pending or, to the knowledge of the Company, threatened. There are in effect no waivers of applicable statutes of limitations with respect to any taxes owed by the Company for any year. There is no tax lien (other than for current taxes not yet due and payable), whether imposed by any federal, state or other taxing authority, outstanding against the assets, properties or business of the Company. The Company has not elected pursuant to the Internal Revenue Code of 1986, as amended (the “Code”) to be treated as an S corporation pursuant to Section 1362(a) of the Code or a collapsible corporation pursuant to Section 341(f) of the Code, nor has it made any other elections pursuant to the Code (other than elections that relate solely to methods of accounting, depreciation, or amortization) that would have a Material Adverse Effect.
3.15 Employees. The Company has no collective bargaining agreements with any of its employees. There is no labor union organizing activity pending or, to the Company’s knowledge, threatened with respect to the Company. To the Company’s knowledge, no employee of the Company, nor any consultant with whom the Company has contracted, is in violation of any term of any employment contract, proprietary information agreement or any other agreement relating to the right of any such individual to be employed by, or to contract
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
with, the Company because of the nature of the business to be conducted by the Company; and to the Company’s knowledge the continued employment by the Company of its present employees, and the performance of the Company’s contracts with its independent contractors, will not result in any such violation. The Company has not received any notice alleging that any such violation has occurred. No employee of the Company has been granted the right to continued employment by the Company or to any severance or other material compensation following termination of employment with the Company. The Company is not aware that any officer or key employee, or that any group of key employees, intends to terminate his, her or their employment with the Company, nor does the Company have a present intention to terminate the employment of any officer, key employee or group of key employees. The Company has complied in all material respects with all applicable laws relating to the employment of its personnel, including provisions relating to hours worked, wages, equal opportunity, collective bargaining and the payment of social security and other taxes.
3.16 Scientific Advisory Board. Each member of the Company’s Scientific Advisory Board has executed a Consulting Agreement, substantially in the form attached hereto as Exhibit I.
3.17 Registration Rights. Except as required pursuant to the Investors’ Rights Agreement, the Company is presently not under any obligation, and has not granted or agreed to grant any rights, to register (as defined in Section 1.1 of the Investors’ Rights Agreement) any of the Company’s presently outstanding securities or any of its securities that may hereafter be issued.
3.18 Compliance with Laws; Permits. 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 (including, without limitation, laws relating to the environment, ERISA and occupational health and safety) in respect of the conduct of its business or the ownership of its properties which violation would have a Material Adverse Effect. No governmental orders, permissions, consents, approvals or authorizations are required to be obtained and no registrations or declarations are required to be filed in connection with the execution and delivery of this Agreement and the issuance of the Shares or the Conversion Shares, except such as have been duly and validly obtained or filed, or with respect to any filings that must be made after the Closing, as will be filed in a timely manner. The Company has all franchises, permits, licenses and any similar authorizations necessary for the conduct of its business as now being conducted by it, except for those franchises, permits, licenses or authorizations the lack of which could not have a Material Adverse Effect and which the Company believes it can obtain, without undue burden or expense.
3.19 Environment and Safety Laws. To its knowledge, the Company is not in violation of any applicable statute, law or regulation relating to the environment or occupational health and safety, and no material expenditures are required in order to comply with any such existing statute, law or regulation with respect to the operations of the Company as presently conducted. To the Company’s knowledge, no Hazardous Materials (as defined below) are used
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
or have been used, stored, or disposed of by the Company in violation of applicable law. For purposes of the preceding sentence, “Hazardous Materials” shall mean (a) materials which are listed or otherwise defined as “hazardous” or “toxic” under any applicable local, state, federal and/or foreign laws and regulations that govern the existence and/or remedy of contamination on property, the protection of the environment from contamination, the control of hazardous wastes, or other activities involving hazardous substances, including building materials, or (b) any petroleum products or nuclear materials.
3.20 Offering Valid. Assuming the accuracy of the representations and warranties of the Purchasers contained in Section 4.2 hereof, the offer, sale and issuance of the Shares and the Conversion Shares will be exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), and will have been registered or qualified (or are exempt from registration and qualification) under the registration, permit or qualification requirements of all applicable state securities laws. Neither the Company nor any agent on its behalf has solicited or will solicit any offers to sell or has offered to sell or will offer to sell all or any part of the Shares to any person or persons so as to bring the sale of such Shares by the Company within the registration provisions of the Securities Act.
3.21 Insurance. The Company maintains valid policies of workers’ compensation insurance and of insurance with respect to its properties and business of the kinds and in the amounts customarily maintained by companies engaged in the same or similar business and similarly situated, including, without limitation, insurance against loss, damage, fire, casualty, theft, general public liability and other risks.
3.22 Brokerage. There are no claims for brokerage commissions, finders fees or similar compensation in connection with the transactions contemplated by this Agreement based on any arrangement or agreement made by or on behalf of the Company.
3.23 Disclosure. Neither this Agreement nor any exhibits hereto, nor any report, certificate, or instrument furnished to any of the Purchasers or their special counsel in connection with the transactions contemplated by this Agreement, when read together, contains any untrue statement of a material fact or omits to state a material fact necessary in order to make the statement contained herein or therein, in light of the circumstances under which they were made, not misleading. Each projection and budget furnished to the Purchasers by the Company was prepared in good faith based on assumptions believed by the Company to be reasonable and represents the Company’s good faith estimate of future results based on information available as of the respective dates of the presentations and the budget; provided that no representation is made as to whether the financial results reflected in such projections or budget will in fact be achieved.
3.24 ERISA. Except as set forth on the Schedule of Exceptions, the Company does not maintain any employee benefit plans (as defined in Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”)). To the extent that the Company does maintain any such employee benefit plans, each plan complies in all material
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
respects with (i) all applicable requirements of ERISA, and (ii) all applicable requirements of the Code.
3.25 Books and Records. The minute books of the Company contain complete and accurate records of all meetings and other corporate actions of its stockholders and its Board of Directors and committees thereof. The stock ledger of the Company is complete and reflects all issuances, transfers, repurchases and cancellations of shares of capital stock of the Company.
3.26 Qualified Small Business. The Company represents and warrants to the Purchasers that, to the best of its knowledge, the Company is a “qualified small business” within the meaning of Section 1202(d) of the Code, as of the date hereof and the Shares should qualify as “qualified small business stock” as defined in Section 1202(c) of the Code as of the date hereof. The Company further represents and warrants that, as of the date hereof, it meets the “active business requirement” of Section 1202(e) of the Code, and it has made no “significant redemptions” within the meaning of Section 1202(c)(3)(B) of the Code.
3.27 Real Property Holding Company. The Company is not a real property holding company within the meaning of Section 897 of the Code.
3.28 Investment Company. The Company is not an “investment company” within the meaning of the Investment Company Act of 1940, as amended, and will not, as a result of the transactions contemplated hereby, become an “investment company”.
4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASERS.
Each Purchaser severally and not jointly hereby represents and warrants to the Company as follows (such representations and warranties do not lessen or obviate the representations and warranties of the Company set forth in this Agreement):
4.1 Requisite Power and Authority. Purchaser has all necessary power and authority under all applicable provisions of law to execute and deliver this Agreement and the Related Agreements and to carry out their respective provisions. All action on such Purchaser’s part required for the lawful execution and delivery of this Agreement and the Related Agreements have been or will be effectively taken prior to the Closing. Upon their execution and delivery, this Agreement and the Related Agreements will be valid and binding obligations of such Purchaser, enforceable in accordance with their respective terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights, (b) general principles of equity that restrict the availability of equitable remedies, and (c) to the extent that the enforceability of the indemnification provisions of Section 2.9 of the Investors’ Rights Agreement may be limited by applicable laws.
4.2 Investment Representations. Purchaser understands that neither the Shares nor the Conversion Shares have been registered under the Securities Act. Purchaser also understands that the Shares are being offered and sold pursuant to an exemption from registration
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
contained in the Securities Act based in part upon such Purchaser’s representations contained in this Agreement. Purchaser hereby represents and warrants as follows:
(a) Purchaser Bears Economic Risk. Purchaser has substantial experience in evaluating and investing in private placement transactions of securities in companies similar to the Company so that he, she or it is capable of evaluating the merits and risks of the investment in the Company and has the capacity to protect his, her or its own interests. Purchaser must bear the economic risk of this investment indefinitely unless the Shares (or the Conversion Shares) are registered pursuant to the Securities Act, or an exemption from registration is available. Purchaser understands that the Company has no present intention of registering the Shares, the Conversion Shares or any shares of its Common Stock. Purchaser also understands that there is no assurance that any exemption from registration under the Securities Act will be available and that, even if available, such exemption may not allow Purchaser to transfer all or any portion of the Shares or the Conversion Shares under the circumstances, in the amounts or at the times Purchaser might propose.
(b) Acquisition for Own Account. Purchaser is acquiring the Shares and the Conversion Shares for Purchaser’s own account for investment only, and not with a view towards their distribution.
(c) Purchaser Can Protect Its Interest. Purchaser has, by reason of its, or of its management’s, business or financial experience, the capacity to protect his, her or its own interests in connection with the transactions contemplated in this Agreement and the Related Agreements. Further, Purchaser is aware of no publication of any advertisement in connection with the transactions contemplated in this Agreement.
(d) Accredited Investor. Purchaser is an accredited investor within the meaning of Regulation D under the Securities Act.
(e) Company Information. Purchaser has had an opportunity to discuss the Company’s business, management and financial affairs with directors, officers and management of the Company and has had the opportunity to review the Company’s operations and facilities. 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.
(f) Rule 144. Purchaser acknowledges and agrees that the Shares, and, if issued, the Conversion Shares, must be held indefinitely unless they are subsequently registered under the Securities Act or an exemption from such registration is available.
(g) Residence. If the Purchaser is an individual, then the Purchaser resides in the state or province identified in the address of the Purchaser set forth on Exhibit A; if the Purchaser is a partnership, corporation, limited liability company or other entity, then the office or offices of the Purchaser in which its investment decision was made is located at the address or addresses of such Purchaser as set forth on Exhibit A.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
4.3 Transfer Restrictions. Each Purchaser acknowledges and agrees that the Shares and, if issued, the Conversion Shares are subject to restrictions on transfer as set forth in the Investors’ Rights Agreement.
4.4 Brokerage. There are no claims for brokerage commissions, finders fees or similar compensation in connection with the transactions contemplated by this Agreement based on any arrangement or agreement made by or on behalf of the Purchaser.
5. CONDITIONS TO CLOSING.
5.1 Conditions to Purchasers’ Obligations at Each Closing. Purchasers’ obligations to purchase the Shares at the Initial Closing and at any Additional Closing are subject to the satisfaction or waiver, at or prior to such Closing Date, of the following conditions:
(a) Representations and Warranties True. The representations and warranties made by the Company in Section 3 hereof shall be true and correct in all material respects (except for those representations and warranties that are qualified as to materiality, Material Adverse Effect or any similar materiality qualifier which shall be true and correct in all respects) on and as of the Initial Closing Date with the same force and effect as if they had been made on and as of such Closing Date, except for the representations and warranties that are made as of a certain date which shall be true and correct as of that certain date.
(b) Performance of Obligations. The Company shall have performed and complied with all agreements, obligations and conditions contained herein required to be performed or complied with by it on or prior to such Closing.
(c) Consents, Permits, and Waivers. The Company shall have obtained any and all consents, permits and waivers necessary or appropriate for consummation of the transactions contemplated by this Agreement and the Related Agreements (except for such as may be properly obtained subsequent to such Closing).
(d) Filing of Restated Charter. The Restated Charter shall have been filed with the Secretary of State of the State of Delaware and shall continue to be in full force and effect as of such Closing Date.
(e) Corporate Documents. The Company shall have delivered to Purchasers or their counsel, copies of all corporate documents of the Company as Purchasers shall reasonably request.
(f) Reservation of Conversion Shares. The Conversion Shares issuable upon conversion of the Shares shall have been duly authorized and reserved for issuance upon such conversion.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
(g) Certificates and Documents. Prior to the Initial Closing, and at each Additional Closing upon the request of an Additional Purchaser, the Company shall have delivered to each of the Purchasers:
(i) Certificates, dated no more than five days prior to the date of such Closing, as to the corporate good standing of the Company issued by the Secretary of State of Delaware and the Secretary of the Commonwealth of Massachusetts;
(ii) Compliance Certificate executed by the Chief Executive Officer of the Company, dated as of the date of such Closing, certifying as to the fulfillment of the conditions specified in Sections 5.1(a) through 5.1(f) of this Agreement.
(iii) Certificate of the Secretary of the Company, dated as of the date of such Closing certifying as to (A) the incumbency of the Company’s principal officers, (B) a copy of the Certificate of Incorporation, certified by the Secretary of State of the State of Delaware, as in effect immediately prior to such Closing Date, (C) a copy of the By-laws of the Company, as in effect on and as of such Closing Date, and (D) a copy of the resolutions of the Board of Directors and the stockholders of the Company, authorizing and approving all matters in connection with this Agreement, the Related Agreements and the transactions contemplated hereby and thereby.
(h) Investors’ Rights Agreement. A Seventh Amended and Restated Investors’ Rights Agreement substantially in the form attached hereto as Exhibit C shall have been executed and delivered by the Company and the parties thereto.
(i) Voting Agreement. A Fourth Amended and Restated Voting Agreement substantially in the form attached hereto as Exhibit D shall have been executed and delivered by the Company and the parties thereto.
(j) Proceedings and Documents. All corporate and other proceedings in connection with the transactions contemplated at the Initial Closing hereby and all documents and instruments incident to such transactions shall be reasonably satisfactory in substance and form to the Purchasers and their special counsel, and the Purchasers and their special counsel shall have received all such counterpart originals or certified or other copies of such documents as they may reasonably request.
(k) Legal Opinion. The Purchasers shall have received from Company counsel an opinion addressed to them, dated as of the Initial Closing Date, in substantially the form attached hereto as Exhibit F.
(l) Minimum Investment. The Initial Purchasers identified on Exhibit A shall purchase at least $25,000,000 in shares of Series G Stock at the Initial Closing.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
5.2 Conditions to Obligations of the Company. The Company’s obligation to issue and sell the Shares at the Initial Closing and at any Additional Closing is subject to the satisfaction, on or prior to such Closing, of the following conditions:
(a) Representations and Warranties True. The representations and warranties made by such Purchasers in Section 4 hereof shall be true and correct on and as of such Closing, with the same force and effect as if they had been made on and as of such Closing Date.
(b) Performance of Obligations. Such Purchasers shall have performed and complied with all agreements, obligations and conditions contained herein required to be performed or complied with by such Purchasers on or prior to such Closing.
(c) Investors’ Rights Agreement. A Seventh Amended and Restated Investors’ Rights Agreement substantially in the form attached hereto as Exhibit C shall have been executed and delivered by the Purchasers.
(d) Voting Agreement. A Fourth Amended and Restated Voting Agreement substantially in the form attached hereto as Exhibit D shall have been executed and delivered by the Investors named therein.
(e) Consents, Permits, and Waivers. The Company shall have obtained any and all consents, permits and waivers necessary or appropriate for consummation of the transactions contemplated by this Agreement and the Related Agreements (except for such as may be properly obtained subsequent to the Closing).
6. MISCELLANEOUS.
6.1 Governing Law. Except to the extent that any provision of this Agreement is contrary to any mandatory provision of the Delaware General Corporation Law (in which case such mandatory statutory provision shall apply), this Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts and the laws of the United States applicable therein (without giving effect to any choice or conflict of laws provision or rule that would cause the application of the laws of any other jurisdiction) and shall be treated in all respects as a Massachusetts contract. Any action, suit or proceeding arising out of or relating to this Agreement shall be brought in the courts of the Commonwealth of Massachusetts and each of the parties hereto hereby irrevocably submits (i) in the case of a suit or proceeding to which the Company is a party, to the exclusive jurisdiction of such courts and (ii) in the case of a suit or proceeding to which the Company is not a party, to the non-exclusive jurisdiction of such courts.
6.2 Survival. The representations, warranties, covenants and agreements made herein shall survive any investigation made by any Purchaser and the execution and delivery of this Agreement and the closing of the transactions contemplated hereby for a period of three (3) years following the Initial Closing. All statements as to factual matters contained in
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
any certificate or other instrument delivered by or on behalf of the Company pursuant hereto in connection with the transactions contemplated hereby shall be deemed to be representations and warranties by the Company hereunder solely as of the date of such certificate or instrument.
6.3 Successors and Assigns. Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors and administrators of the parties hereto and shall inure to the benefit of and be enforceable by each person who shall be a holder of the Shares from time to time. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and assigns any rights, remedies, obligations, or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement.
6.4 Entire Agreement. This Agreement, the Exhibits and Schedules hereto, the Related Agreements and the other documents delivered pursuant hereto or thereto constitute the full and entire understanding and agreement between the parties with regard to the subjects hereof and supersede all prior agreements and understandings among the parties, written or oral, with respect thereto. No party shall be liable or bound to any other in any manner by any representations, warranties, covenants and agreements except as specifically set forth herein and therein.
6.5 Severability. In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.
6.6 Amendment and Waiver.
(a) This Agreement may be amended or modified only upon the written consent of the Company and holders of at least a majority of the then outstanding Shares (treated as if converted and including any Conversion Shares into which the Shares have been converted that have not been sold to the public).
(b) The obligations of the Company and the rights of the holders of the Shares and the Conversion Shares under this Agreement may be waived (either generally or in a particular instance and either retroactively or prospectively) only with the written consent of the holders of at least a majority of the then outstanding Shares (treated as if converted and including any Conversion Shares into which the Shares have been converted that have not been sold to the public); provided, however, that no condition set forth in Section 5 may be waived with respect to any Purchaser who does not consent thereto. No waivers of or exceptions to any term, condition or provision of this Agreement, in any one or more instances, shall be deemed to be, or construed as, a further or continuing waiver of any such term, condition or provision.
6.7 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, the Related Agreements or the Restated Charter, shall impair any such right, power or remedy, nor shall it be construed to be a waiver of any such
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
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 Purchaser’s part of any breach, default or noncompliance under this Agreement, the Related Agreements or under the Restated Charter or any waiver on such party’s part of any provisions or conditions of this Agreement, the Related Agreements or the Restated Charter must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies, either under this Agreement, the Related Agreements and the Restated Charter, by law, or otherwise afforded to any party, shall be cumulative and not alternative.
6.8 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 telex or facsimile if sent during normal business hours of the recipient, if not, then on the next business day, (c) five (5) days after having been sent by registered or certified mail, return receipt requested, postage prepaid, or (d) one (1) day after deposit with a nationally recognized overnight courier, specifying next day delivery, with written verification of receipt. All communications shall be sent to the party at such party’s address as set forth below or as subsequently modified by ten (10) days advance written notice to the other parties hereto, as follows:
(i) if to the Company, to:
Microbia, Inc.
320 Bent Street
Cambridge, MA 02141
Telephone: (617) 621-7722
Facsimile: (617) 494-0908
or at such other address or addresses as may have been furnished in writing by the Company to the Purchasers,
(ii) if to any Purchaser, at such Purchaser’s respective address set forth on Exhibit A.
6.9 Expenses. Each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement; provided, however, that the Company shall, at the Initial Closing, reimburse the reasonable fees of and expenses of one (1) counsel for the Purchasers, not to exceed $25,000.
6.10 Attorneys’ Fees. In the event that any suit or action is instituted 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.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
6.11 Titles and Subtitles. The titles of the sections and subsections of this Agreement are for convenience of reference only and are not to be considered in construing this Agreement.
6.12 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 may be executed by facsimile signatures.
6.13 Exculpation Among Purchasers. Each Purchaser acknowledges that it is not relying upon any person, firm, or corporation, other than the Company, in making its investment or decision to invest in the Company. Each Purchaser agrees that no Purchaser nor the respective controlling persons, officers, directors, partners, agents, or employees of any Purchaser shall be liable to any other Purchaser for any action heretofore or hereafter taken or omitted to be taken by any of them in connection with the Shares and Conversion Shares.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
6.14 Confidentiality. Each party hereto agrees that, except with the prior written consent of the other party, it shall at all times keep confidential and not divulge, furnish or make accessible to anyone any confidential information, knowledge or data concerning or relating to the business or financial affairs of the other parties to which such party has been or shall become privy by reason of this Agreement or the Related Agreements, discussions or negotiations relating to this Agreement or the Related Agreements, the performance of its obligations hereunder or the ownership of the Shares purchased hereunder; provided, however, that a Purchaser may disclose confidential information, knowledge or data concerning or relating to the business or financial affairs of the Company (i) to its attorneys, accountants and consultants, to the extent necessary to obtain their services in connection with monitoring its investment in the Company, provided that such attorney, accountant or consultant is legally obligated not to use or disclose any such information, knowledge or data or (ii) as may otherwise be required by law, provided that the Purchaser takes reasonable steps to minimize the extent of any such required disclosure. The provisions of this Section 6.14 shall be in addition to, and not in substitution for, the provisions of any separate nondisclosure agreement executed by the parties hereto.
6.15 Pronouns. All pronouns contained herein, and any variations thereof, shall be deemed to refer to the masculine, feminine or neutral, singular or plural, as the identity of the parties hereto may require.
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
IN WITNESS WHEREOF, the parties hereto have executed the SERIES G CONVERTIBLE PREFERRED STOCK PURCHASE AGREEMENT as of the date set forth in the first paragraph hereof.
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
MICROBIA, INC.
PURCHASER SIGNATURE PAGE
(for Designated Offering Investors)
Initial Closing
By his, her or its execution and delivery of this signature page, the undersigned Purchaser hereby joins in and agrees to be bound by the terms and conditions of the:
(i) Series G Convertible Preferred Stock Purchase Agreement dated as of the date set forth in the first paragraph thereof (the “Purchase Agreement”) by and among Microbia, Inc. (the “Company”) and the Purchasers listed on Exhibit A thereto, as to the number of shares of Series G Stock set forth below;
(ii) Seventh Amended and Restated Investors’ Rights Agreement dated as of the date set forth in the first paragraph thereof, by and among the Company and the Investors listed on Exhibit A thereto (the “Investors’ Rights Agreement”), as an “Investor” thereunder;
(iii) Fourth Amended and Restated Voting Agreement dated as of the date set forth in the first paragraph thereof, by and among the Company and the Stockholders listed on Exhibit A thereto (the “Voting Agreement”), as a “Stockholder” thereunder; and
authorizes this signature page to be attached to the Purchase Agreement, the Investors’ Rights Agreement and the Voting Agreement, or counterparts thereof.
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
MICROBIA, INC.
PURCHASER SIGNATURE PAGE
(for Non-Designated Offering Investors)
Initial Closing
By his, her or its execution and delivery of this signature page, the undersigned Purchaser hereby joins in and agrees to be bound by the terms and conditions of the:
(i) Series G Convertible Preferred Stock Purchase Agreement dated as of the date set forth in the first paragraph thereof (the “Purchase Agreement”) by and among Microbia, Inc. (the “Company”) and the Purchasers listed on Exhibit A thereto, as to the number of shares of Series G Stock set forth below;
(ii) Seventh Amended and Restated Investors’ Rights Agreement dated as of the date set forth in the first paragraph thereof, by and among the Company and the Investors listed on Exhibit A thereto (the “Investors’ Rights Agreement”), as an “Investor” thereunder; and
(iii) Fourth Amended and Restated Voting Agreement dated as of the date set forth in the first paragraph thereof, by and among the Company and the Stockholders listed on Exhibit A thereto (the “Voting Agreement”), as a “Stockholder” thereunder; and
authorizes this signature page to be attached to the Purchase Agreement, the Investors’ Rights Agreement and the Voting Agreement, or counterparts thereof.
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
MICROBIA, INC.
PURCHASER SIGNATURE PAGE
(for Designated Offering Investors)
Additional Closing
By his, her or its execution and delivery of this signature page, the undersigned Purchaser hereby joins in and agrees to be bound by the terms and conditions of the:
(i) Series G Convertible Preferred Stock Purchase Agreement dated as of [·] (the “Purchase Agreement”) by and among Microbia, Inc. (the “Company”) and the Purchasers listed on Part II of Exhibit A thereto, as to the number of shares of Series G Stock set forth below;
(ii) Seventh Amended and Restated Investors’ Rights Agreement dated as of [·], by and among the Company and the Investors listed on Exhibit A thereto (the “Investors’ Rights Agreement”), as an “Investor” thereunder; and
(iii) Fourth Amended and Restated Voting Agreement dated as of [·], by and among the Company and the Stockholders listed on Exhibit A thereto (the “Voting Agreement”), as an “Stockholder” thereunder; and
authorizes this signature page to be attached to the Purchase Agreement, the Investors’ Rights Agreement and the Voting Agreement, or counterparts thereof.
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
MICROBIA, INC.
PURCHASER SIGNATURE PAGE
(for Non-Designated Offering Investors)
Additional Closing
By his, her or its execution and delivery of this signature page, the undersigned Purchaser hereby joins in and agrees to be bound by the terms and conditions of the:
(i) Series G Convertible Preferred Stock Purchase Agreement dated as of [·] (the “Purchase Agreement”) by and among Microbia, Inc. (the “Company”) and the Purchasers listed on Exhibit A thereto, as to the number of shares of Series G Stock set forth below;
(ii) Seventh Amended and Restated Investors’ Rights Agreement dated as of [·], by and among the Company and the Investors listed on Exhibit A thereto (the “Investors’ Rights Agreement”), as an “Investor” thereunder;
(iii) Fourth Amended and Restated Voting Agreement dated as of [·], by and among the Company and the Stockholders listed on Exhibit A thereto (the “Voting Agreement”), as a “Stockholder” thereunder; and
authorizes this signature page to be attached to the Purchase Agreement, the Investors’ Rights Agreement and the Voting Agreement, or counterparts thereof.
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SCHEDULE 5.2.2(ii)
PIPE Term Sheet
MICROBIA, INC.
FOREST LABORATORIES, INC. $25M PRIVATE PLACEMENT
TERM SHEET
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Microbia, Inc., a Delaware corporation (the “Company”). |
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Purchaser: |
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Forest Laboratories, Inc., a Delaware corporation (the “Purchaser”). |
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Type of Securities: |
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2,083,334 shares of the Company’s common stock, at $12.00 per share, as may be adjusted pursuant to Section 5.2.2 of the Collaboration Agreement dated September 12, 2007, by and between the Company and the Purchaser, the “Collaboration Agreement”). |
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Amount of Offering: |
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$25 million |
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Closing Date: |
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The date described in Section 5.2.2 of the Collaboration Agreement. |
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Use of Proceeds: |
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The Company will use the proceeds it receives from the sale of the Common Stock for general corporate purposes. |
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Registration Rights: |
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The Company shall file a shelf registration statement for the shares of Common Stock on Form S-3 or such other form as the Company is eligible to use (the “Registration Statement”). Such Registration Statement shall be filed as soon as practicable but in any event within 30 days of the Closing Date. The Company shall use commercially reasonable efforts to cause the Registration Statement to be declared effective by the Securities and Exchange Commission (the “SEC”) as soon as practicable and, in any event, within 90 days after the Closing Date, or, in the event of a review of the Registration Statement by the SEC, within 120 days after the Closing Date. Should the Registration Statement not be filed within 30 days of the Closing Date or declared effective within the 90-day or 120-day period, as applicable, following the Closing Date, the Company shall pay each Purchaser liquidated damages of 1.25% per month for a maximum of 12 months, in cash, based on the principal amount invested by each such Purchaser. Such Registration Statement shall remain effective until the earlier of (i) the date all securities registered have been sold or (ii) the date when all shares held by the Purchaser can be sold under Rule 144 in a 90 day period. The Registration Statement will be effected pursuant to an agreement with registration rights terms substantially in the form of those in the form of Investors’ Rights Agreement attached to the form of Stock Purchase Agreement. |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
Confidentiality: |
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This document and the documents associated with the transaction (and the subject matter hereof and thereof) will not be disclosed to any persons other than the Company, the Purchaser and their respective advisors without the prior written consent of the non-disclosing parties, except as may be required by law or regulation. |
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Nature of Document: |
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The closing of the transactions contemplated by this Term Sheet will be subject to a number of standard conditions. Accordingly, except as provided above under the caption “Confidentiality,” this Term Sheet does not constitute a legally binding obligation of the parties hereto. |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SCHEDULE 7.2(a)
Microbia Patent Rights
The following are those patent applications and patents Controlled by Microbia which, Microbia, as of the Effective Date, has identified as potentially being useful in connection with the Product in the Field and Territory.
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Application Serial Number |
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Filing Date |
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Status |
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PCT |
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PCT/US2004/002390 |
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01/28/04 |
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NAT PHASE |
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US |
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10/766,735 |
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01/28/04 |
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non-final office action (05/01/07) |
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CA |
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2514507 |
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01/28/04 |
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PENDING |
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MX |
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PA/A/2005/008097 |
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01/28/04 |
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PENDING |
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US |
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10/796,719 |
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03/09/04 |
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notice of allowance (08/22/07) |
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US |
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10/845,895 |
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05/14/04 |
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non-final office action (07/13/07) |
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PCT |
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PCT/US2004/018751 |
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06/14/04 |
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NAT PHASE |
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US |
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10/868,744 |
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06/14/04 |
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non-final office action (03/22/07) |
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CA |
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2529307 |
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06/14/04 |
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PENDING |
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US |
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10/899,806 |
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07/27/04 |
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non-final office action (07/13/07) |
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PCT |
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PCT/US2005/002941 |
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01/31/05 |
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PUBLISHED |
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US |
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10/587,450 |
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01/31/05 |
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no substantive office actions |
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US |
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11/054,071 |
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02/08/05 |
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no substantive office actions |
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US |
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11/054,072 |
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02/08/05 |
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non-final office action (07/5/07) |
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PCT |
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PCT/US2005/007752 |
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03/08/05 |
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PUBLISHED |
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CA |
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2558050 |
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03/08/05 |
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PENDING |
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MX |
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PA/A/2006/010205 |
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03/08/05 |
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PENDING |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
PCT |
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PCT/US2006/004768 |
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02/08/06 |
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NAT PHASE |
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PCT |
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PCT/US2006/009696 |
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03/17/06 |
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PUBLISHED |
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PCT |
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PCT/US2006/032719 |
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08/21/06 |
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PUBLISHED |
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[**] |
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[**] |
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[**] |
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PCT |
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PCT/US2007/062820 |
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02/26/07 |
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PENDING |
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US |
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PCT/US2007/062815 |
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02/26/07 |
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PENDING |
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US |
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60/891,626 |
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02/26/07 |
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PENDING |
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US |
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60/916,257 |
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05/04/07 |
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PENDING |
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US |
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60/941,255 |
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05/31/07 |
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PENDING |
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PCT |
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PCT/US2007/72223 |
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06/27/07 |
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PENDING |
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
SCHEDULE 7.2(c)
Microbia Patent Rights developed with Government Funding
None
SCHEDULE 7.2(d)
Microbia Agreements with Third Parties Relating to Microbia Patent Rights
None
SCHEDULE 7.3(a)
Forest Patent Rights
None
SCHEDULE 7.3(c)
Forest Patent Rights developed with Government Funding
None
SCHEDULE 7.3(e)
Forest Products in Development
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
AMENDMENT NO. 1 TO MASTER COLLABORATION AGREEMENT
This AMENDMENT NO. 1 TO MASTER COLLABORATION AGREEMENT (the “Amendment”) is entered into on this 3rd day of November, 2009 (the “Amendment Effective Date”), by and among Ironwood Pharmaceuticals, a Delaware corporation (formerly Microbia, Inc.) (“Ironwood”) and Forest Laboratories, Inc. (“Forest”). Ironwood and Forest may each be referred to herein individually as a “Party” and collectively as the “Parties.”
BACKGROUND
Ironwood and Forest entered into a Master Collaboration Agreement dated as of September 12, 2007 (the “Agreement”).
Ironwood and Forest now desire to make certain clarifying changes to the Agreement in order to better reflect the intent of the Parties.
AGREEMENT
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
I. LICENSE AMENDMENT.
A. Section 2.2(i) of the Agreement is hereby deleted in its entirety and replaced with the following:
“(i) under Microbia’s interest in the Microbia Technology and the Joint Technology to Develop pursuant to the Development Plan and Manufacture the Product anywhere in the world solely for purposes of Commercialization in the Field in the Territory and to Commercialize the Product in the Field in the Territory, and”
B. Section 2.3(ii)(x) of the Agreement is hereby deleted in its entirety and replaced with the following:
“(x) under Forest’s interest in the Forest Technology and the Joint Technology to develop, manufacture and commercialize the Collaboration Compound and Product in the Field outside of the Territory and to develop (subject to the proviso in the final sentence of Section 2.2 above) and manufacture the Product in the Territory for purposes of commercialization in the Field outside the Territory and”
[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
II. GENERAL.
A. Except as amended by this Amendment, the Agreement shall remain in full force and effect in accordance with the terms thereof. Amendments made pursuant to this Amendment shall be effective as of the Effective Date.
B. This Amendment may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument. An executed signature page of this Amendment delivered by facsimile transmission shall be as effective as an original executed signature page.
[The remainder of this page has been intentionally left blank.]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Amendment to be effective as of the Effective Date.
FOREST LABORATORIES, INC. |
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IRONWOOD PHARMACEUTICALS, INC. |
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By: |
/s/ David Solomon |
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By: |
/s/ James O’Mara |
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Name: David Solomon |
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Name: James O’Mara |
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Title: Vice President |
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Title: Vice President |
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[**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.