-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, DqXJwHovF9s1fDjMYF2DcTr137AxlSuKDYV3G7dYRvw0HlwTziVT+a9N6k/1XQn0 yUyrcVi5C57ON1Eo9WXfSQ== 0001104659-08-001189.txt : 20080108 0001104659-08-001189.hdr.sgml : 20080108 20080108095830 ACCESSION NUMBER: 0001104659-08-001189 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080107 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080108 DATE AS OF CHANGE: 20080108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14680 FILM NUMBER: 08516757 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 8-K 1 a08-1446_18k.htm 8-K

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED):

January 7, 2008

 

GENZYME CORPORATION

(Exact name of registrant as specified in its charter)

 

Massachusetts

 

0-14680

 

06-1047163

(State or other jurisdiction of
incorporation or organization)

 

(Commission file number)

 

(IRS employer identification
number)

 

500 Kendall Street, Cambridge, Massachusetts  02142

(Address of Principal Executive Offices)  (Zip Code)

 

Registrant’s telephone number, including area code:

(617) 252-7500

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 1.01       Entry into a Material Definitive Agreement.

 

On January 7, 2008, Genzyme Corporation (“Genzyme”) and Isis Pharmaceuticals, Inc. (“Isis”) announced a major strategic alliance in which Genzyme will develop and commercialize mipomersen. Mipomersen, formerly ISIS 301012, is a lipid-lowering drug targeting apolipoprotein B-100. As part of the strategic relationship, Genzyme has exclusively licensed mipomersen from Isis and will also have preferred access to future Isis drugs for central nervous system and certain rare diseases. Genzyme will pay Isis $150 million to purchase five million shares of Isis common stock for $30 per share upon Hart-Scott-Rodino clearance. Upon completion of final contracts, Genzyme will pay Isis a $175 million up-front mipomersen license fee. In addition to this initial $325 million, Isis has the potential to receive significant milestone payments for mipomersen, which is currently in phase 3 trials. Once the product is launched, the two companies will share profits.

 

Isis will transition development responsibility for mipomersen to Genzyme over the next two years, and Isis will fund a portion of development costs over that time.  Genzyme will take over full development and commercialization responsibilities thereafter.

 

In addition to the up-front payment, Isis also has the opportunity to receive from Genzyme up to $825 million in development and regulatory milestone payments plus up to $750 million in commercial milestone payments.

 

Genzyme and Isis will share mipomersen profits 50/50 when annual worldwide revenues reach $2 billion or more. The profit share begins with a 70/30 Genzyme/Isis split and reaches 50/50 on a sliding scale as annual revenues ramp up to $2 billion.

 

Closure of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

 

The Company’s press release issued on January 7, 2008 related to the foregoing transactions is attached hereto as Exhibit 99.1.

 

Item 9.01

 

Financial Statements and Exhibits.

 

 

 

(d)

 

Exhibits.

 

 

 

 

 

99.1         Press Release, dated January 7, 2008.

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

GENZYME CORPORATION

 

 

 

 

 

 

Dated: January 8, 2008

By:

/s/ Thomas J. DesRosier

 

 

 

Thomas J. DesRosier

 

 

Senior Vice President; General Counsel

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press Release, dated January 7, 2008

 

4


EX-99.1 2 a08-1446_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

For Immediate Release: January 7, 2008, 4:01 pm EST

 

Media Contact, Genzyme

 

Investor Contact, Genzyme

Erin Emlock

 

Sally Curley

(617) 768-6923

 

(617) 768-6140

 

 

 

Contact, Isis

 

 

Kate Corcoran

 

 

(760) 603-2712

 

 

 

Genzyme and Isis Announce Strategic Alliance

Including Exclusive Worldwide License of Mipomersen

 


 

Breakthrough, Potential Blockbuster Product for

High Risk Cardiovascular Patients

 

CAMBRIDGE, Mass. and CARLSBAD, Calif. – Genzyme Corp. (Nasdaq: GENZ) and Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today that they have entered a major strategic alliance in which Genzyme will develop and commercialize mipomersen, Isis’ lipid-lowering treatment for high risk cardiovascular patients that utilizes novel antisense technology.  As part of the strategic relationship, Genzyme will also have preferred access to future Isis drugs for CNS and certain rare diseases.  The companies will host a webcast conference call today at 5:15 pm EST (2:15 pm PST) to discuss the transaction.

 

Genzyme will pay Isis $150 million to purchase five million shares of Isis common stock for $30 per share upon Hart-Scott-Rodino clearance.  Upon completion of final contracts, Genzyme will pay Isis a $175 million up-front mipomersen license fee.  In addition to this initial $325 million, Isis has the potential to receive significant milestone payments for mipomersen, which is currently in phase 3 trials.  Once the product is launched, the two companies will share profits.

 

“This alliance is an excellent strategic fit for Genzyme’s business model and culture,” said Henri A. Termeer, Genzyme’s chairman and chief executive officer.  “Mipomersen is an innovative approach to addressing a real unmet medical need, and we believe it could prove to be the most effective lipid-lowering agent for high risk  

 



 

patients for whom conventional therapies are not sufficient.  This potential blockbuster is a very Genzyme-like product.  It provides significant benefit over the standard of care, targets a well-defined and severely ill patient population, and offers meaningful revenue and earnings potential.”

 

“We feel that Genzyme is the perfect partner for Isis and for mipomersen,” said Stanley Crooke, chairman, president and chief executive officer of Isis.  “We have been very pleased with the quality and depth of interest in this flagship drug in our cardiovascular pipeline, and as we evaluated the licensing terms from various parties, we felt that Genzyme would value mipomersen appropriately as a pipeline-transforming product.  This commitment to mipomersen, along with Genzyme’s strength in drug development and marketing, made this relationship strategically compelling.”

 

Mipomersen License

 

Mipomersen, formerly ISIS 301012, is a lipid-lowering drug targeting apolipoprotein B-100.  Currently in phase 3 development, mipomersen has been shown in phase 2 trials to reduce cholesterol and other atherogenic lipids more than 40 percent beyond reductions achieved with current standard lipid-lowering drugs, enabling more patients to achieve lipid targets.  These trials have shown that the treatment is well-tolerated, has a strong safety profile, and works equally well in the presence and absence of other lipid lowering therapies including statins.   A weekly injectable therapeutic, mipomersen is being developed primarily for patients at significant cardiovascular risk who are unable to achieve target cholesterol levels with statins alone or who are intolerant of statins.  The drug has strong, broad patent protection.

 

Mipomersen’s initial indication will be for patients with familial hypercholesterolemia (FH), with an anticipated filing in 2009.  There are approximately 1.5 million people in the United States and Europe with FH, an inherited disorder that causes exceptionally high levels of LDL-cholesterol.  After appropriate clinical development, the next indication pursued for mipomersen will be for other patients with high cholesterol at high risk of cardiovascular events.

 

2



 

Deal Terms

 

Isis will transition development responsibility for mipomersen to Genzyme over the next two years.  In addition to the up-front payment, Isis also has the opportunity to receive from Genzyme up to $825 million in development and regulatory milestone payments plus up to $750 million in commercial milestone payments.

 

Genzyme and Isis will share mipomersen profits 50/50 when annual worldwide revenues reach $2 billion or more.  The profit share begins with a 70/30 Genzyme/Isis split and reaches 50/50 on a sliding scale as annual revenues ramp up to $2 billion.

 

“Genzyme is reconfirming its 2008 and five-year earnings guidance, and we will manage the financial impact of this agreement within our previously stated goal of 20 percent compound annual growth in non-GAAP earnings per share through 2011,” noted Mr. Termeer.

 

“We believe the profit sharing transaction we have structured with Genzyme is uniquely beneficial to Isis,” added Dr. Crooke.  “It allows us to benefit in the short term and over time through upfront licensing fees and milestones, while retaining substantial economic participation in the commercialization of the drug.  We look forward to working with Genzyme on mipomersen as well as potentially on drugs for CNS and certain rare diseases.”

 

Closure of the transaction is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

 

About Familial Hypercholesterolemia (FH)

 

FH patients have high blood concentrations of LDL-cholesterol due to a genetic disorder which prevents proper metabolism of LDL-cholesterol.  These patients experience a markedly increased risk of premature cardiovascular diseases (CVD) and CVD-related death.  Familial hypercholesterolemia can be present in two forms: homozygous (hoFH), where the same defective gene is inherited from both parents, or heterozygous (heFH), where the defective gene is inherited from only one parent so that some function is preserved. The homozygous form is a very rare condition estimated to affect approximately one in a million people.  Children with hoFH are at high risk for early coronary events and sudden death as young as age one.  HeFH is more common, with a prevalence of approximately one in 500, and patients with heFH also experience elevated LDL-cholesterol and are at high risk for early coronary events.  For undiagnosed or untreated heFH, the cumulative risk of a coronary heart disease (CHD) by age 60 years is 60-85% among men and 30-50% among women, with a mean age of onset of approximately 47 years.

 

3



 

About Genzyme

 

One of the world’s leading biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Since 1981, the company has grown from a small start-up to a diversified enterprise with more than 10,000 employees in locations spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was chosen to receive the National Medal of Technology, the highest honor awarded by the President of the United States for technological innovation. In 2006 and 2007, Genzyme was selected by FORTUNE as one of the “100 Best Companies to Work for” in the United States.

 

With many established products and services helping patients in nearly 90 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences. The company’s products and services are focused on rare inherited disorders, kidney disease, orthopaedics, cancer, transplant and diagnostic testing. Genzyme’s commitment to innovation continues today with a substantial development program focused on these fields, as well as immune disease, infectious disease and other areas of unmet medical need.

 

Genzyme’s press releases and other company information are available at www.genzyme.com and by calling Genzyme’s investor information line at 1-800-905-4369 within the United States or 1-678-999-4572 outside the United States.

 

About Isis Pharmaceuticals, Inc.

 

Isis is exploiting its expertise in RNA to discover and develop novel drugs for its product pipeline and for its partners.  The Company has successfully commercialized the world’s first antisense drug and has 18 drugs in development.  Isis’ drug development programs are focused on treating cardiovascular and metabolic diseases.  Isis’ partners are developing drugs for a wide variety of diseases.  Ibis Biosciences, Inc., Isis’ wholly owned subsidiary, is developing and commercializing the Ibis T5000™ Biosensor System, a revolutionary system to identify infectious organisms.  Isis is a joint owner of Regulus Therapeutics LLC, a joint venture focused on the discovery, development and commercialization of microRNA therapeutics.  As an innovator in RNA-based drug discovery and development, Isis is the owner or exclusive licensee of over 1,500 issued patents worldwide.  Additional information about Isis is available at www.isispharm.com.

 

Genzyme Safe Harbor Statement

 

This press release contains forward-looking statements, including the statements regarding anticipated approval under the Hart-Scott-Rodino Act and the anticipated completion of phase 3 development.  These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, the ability of the parties to receive approval for the transaction under the Hart-Scott-Rodino Act, the ability of the parties to complete phase 3 development and the risks and uncertainties described in reports filed by Genzyme with the Securities and

 

4



 

Exchange Commission under the Securities Exchange Act of 1934, as amended, including without limitation the information under the heading “Risk Factors” in the Management’s Discussion and Analysis of Financial Condition and Results of Operations section of the Genzyme Quarterly Report on Form 10-Q for the quarter ending September 30, 2007.  Genzyme cautions investors not to place substantial reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this press release, and Genzyme undertakes no obligation to update or revise the statements.

 

Genzyme® is a registered trademark of Genzyme Corporation. All rights reserved.

 

Isis Safe Harbor Statement

 

This release includes forward-looking statements regarding Isis’ strategic alliance with Genzyme Corp., the development and commercialization potential of mipomersen for cardiovascular disease, and Isis’ research and development opportunities in disease areas including CNS and certain rare diseases.  Any statement describing Isis’ goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement, including those statements that are described as Isis’ goals.  Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such products.  Isis’ forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.  Although Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis.  As a result, you are cautioned not to rely on these forward-looking statements.  These and other risks concerning Isis’ programs are described in additional detail in Isis’ annual report on Form 10-K for the year ended December 31, 2006, and its quarterly report on Form 10-Q for the quarter ended September 30, 2007, which are on file with the SEC.  Copies of these and other documents are available from the Company.

 

Isis Pharmaceuticals is a registered trademark of Isis Pharmaceuticals, Inc.  Ibis Biosciences and Ibis T5000 are trademarks of Ibis Biosciences, Inc.  Regulus Therapeutics is a trademark of Regulus Therapeutics LLC.

 

Conference Call Information

 

Genzyme and Isis will host a webcast conference call today at 5:15 pm EST (2:15 pm PST) to discuss the transaction.  To access the call, log on to either company’s web site or dial 888-323-5253 (U.S.) / 210-234-0009 (International) and reference passcode: Genzyme.  A replay of the webcast will be available until January 14th by dialing 203-369-3526.

 

# # #

 

5


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