-----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, M/SB/nGo7Uz1nskdqQnN/PWoHOoEhg4vLsIaWFFUfm4aiWQT+0F7tz32YDTM/KGE rSU8TqNB+Cduw4jF1QrtYA== 0001193125-10-136879.txt : 20100610 0001193125-10-136879.hdr.sgml : 20100610 20100610130637 ACCESSION NUMBER: 0001193125-10-136879 CONFORMED SUBMISSION TYPE: 10-K PUBLIC DOCUMENT COUNT: 8 CONFORMED PERIOD OF REPORT: 20100331 FILED AS OF DATE: 20100610 DATE AS OF CHANGE: 20100610 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIGEN CORP CENTRAL INDEX KEY: 0000730272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042729386 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 10-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14656 FILM NUMBER: 10889728 BUSINESS ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 BUSINESS PHONE: 7814499560 MAIL ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 10-K 1 d10k.htm FORM 10-K Form 10-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-K

 

 

 

x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended March 31, 2010

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from              to             

Commission file number: 000-14656

 

 

REPLIGEN CORPORATION

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   04-2729386

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

41 Seyon Street, Bldg. 1, Suite 100

Waltham, MA

  02453
(Address of Principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (781) 250-0111

 

 

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class

Common Stock, $0.01 Par Value Per Share

Series A Junior Participating Preferred Stock Purchase Rights

Name of Each Exchange on Which Registered

The NASDAQ Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Title of Each Class

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ¨    No  x.

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    Yes  ¨    No  x.

Indicate by checkmark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  x    No  ¨.

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ¨    No  ¨.

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.   ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer  ¨    Accelerated filer  x    Non-accelerated filer  ¨    Smaller reporting company  ¨
     

(Do not check if a smaller

reporting company)

  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).    Yes  ¨    No  x.

The aggregate market value of the voting and non-voting common equity held by non-affiliates as of September 30, 2009, the last business day of the registrant’s most recently completed second fiscal quarter, was approximately $154,098,617.

The number of shares of outstanding of the registrant’s common stock as of May 31, 2010 was 30,766,807.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the Company’s definitive Proxy Statement in connection with the 2010 annual meeting of Stockholders are incorporated by reference into Part III of this Form 10-K.

 

 

 


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Table of Contents

 

         PAGE

PART I

    

Item 1.

 

Business

   3

Item 1A.

 

Risk Factors

   11

Item 1B.

 

Unresolved Staff Comments

   18

Item 2.

 

Properties

   18

Item 3.

 

Legal Proceedings

   18

Item 4.

 

Removed and Reserved

   19

PART II

    

Item 5.

 

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

   20

Item 6.

 

Selected Financial Data

   22

Item 7.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   23

Item 7A.

 

Quantitative and Qualitative Disclosures About Market Risk

   34

Item 8.

 

Financial Statements and Supplementary Data

   34

Item 9.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

   34

Item 9A.

 

Controls and Procedures

   34

Item 9B.

 

Other Information

   37

PART III

    

PART IV

    

Item 15.

 

Exhibits and Financial Statement Schedules

   39

SIGNATURES

   42

 

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PART I

 

Item 1. BUSINESS

The following discussion of our business contains forward-looking statements that involve risks and uncertainties. When used in this report, the words “intend,” “anticipate,” “believe,” “estimate,” “plan” and “expect” and similar expressions as they relate to us are included to identify forward-looking statements. Our actual results could differ materially from those anticipated in these forward-looking statements and are a result of certain factors, including those set forth under “Risk Factors” and elsewhere in this Annual Report on Form 10-K.

Repligen Corporation (“Repligen,” the “Company” or “we”) is a biopharmaceutical company focused on the development and commercialization of innovative therapies that harness biological pathways and deliver value to patients and clinicians in neurology, gastroenterology and orphan diseases. We are currently conducting a number of drug development programs for diseases such as pancreatitis, bipolar disorder, Friedreich’s ataxia and spinal muscular atrophy. We also have a bioprocessing business that focuses on the development and commercialization of products that are used for the production of biopharmaceuticals. In addition, we receive royalties from Bristol-Myers Squibb Company (“Bristol”) on their net sales in the United States of their product Orencia®. We seek to invest the profits from our current commercial products, royalty and other revenues, as well as use our existing financial resources to advance the development of our therapeutic product candidates and our bioprocessing business.

We were incorporated in May 1981, under the laws of the State of Delaware. Our principal executive offices are at 41 Seyon Street, Waltham, Massachusetts 02453 and our telephone number is (781) 250-0111.

Currently Marketed Products

We currently sell a line of commercial bioprocessing products based on Protein A, as well as single or limited campaign use pre-packed chromatography columns, which are used in the production of monoclonal antibodies and other biopharmaceutical manufacturing applications.

Protein A Products for Antibody Manufacturing

Protein A is widely used in the purification of therapeutic monoclonal antibodies. Most therapeutic monoclonal antibodies are manufactured by the fermentation of mammalian cells that express the monoclonal antibody. The monoclonal antibody is typically produced by a process in which an impure fermentation broth containing the desired monoclonal antibody is passed over a solid support to which Protein A has been chemically attached or “immobilized.” The immobilized Protein A binds the monoclonal antibody while other impurities are washed away. The monoclonal antibody is then recovered from the support in a substantially purified form.

We manufacture and market several products based on recombinant forms of Protein A. Our primary customers incorporate our Protein A products into their proprietary monoclonal antibody purification products that they sell directly to the biopharmaceutical industry. We primarily supply Protein A products to GE Healthcare (“GEHC”) under a supply agreement which extends through 2015. The majority of our product sales for the last three years have been sales of Protein A products and related detection assays.

The global monoclonal antibody market was valued at approximately $40 billion in 2009 and is expected to exceed $65 billion by 2015. Examples of therapeutic antibodies include Enbrel® and Remicade® for rheumatoid arthritis and other inflammatory disorders, and Rituxan® for rheumatoid arthritis and Non-Hodgkin’s Lymphoma, among others. There are more than 200 additional monoclonal antibodies in various stages of clinical testing which may lead to additional growth of the antibody market and in turn, increased demand for Protein A.

 

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SecreFlo® for Pancreatic Diagnosis

We discontinued distribution of SecreFlo® in the second quarter of fiscal year 2009 due to the expiration of our agreement with ChiRhoClin, Inc. Previously, we recorded sales of SecreFlo®, a synthetic form of porcine (pig-derived) secretin. SecreFlo® is approved by the U.S. Food and Drug Administration (“FDA”) as an aid in the diagnosis of chronic pancreatitis and gastrinoma (a form of cancer) and as an aid during endoscopic retrograde cholangiopancreatography (“ERCP”), a gastrointestinal procedure.

Intellectual Property on Monoclonal Antibody and Antibody Fusion Products

Orencia® (CTLA4-Ig) Royalties

CTLA4 is a key regulator of the activity of the immune system. CTLA4 “turns off” the immune system after it has successfully cleared a bacterial or viral infection by blocking the activation of T-cells, the immune cells responsible for initiating an immune response. CTLA4-Ig’s mechanism of action is different from the current therapies for autoimmune disease or organ transplant rejection, thus it may provide a treatment for patients who are refractory to existing therapies. In the 1990’s, our collaborators at the University of Michigan and the U.S. Navy demonstrated in animal models that a fusion protein consisting of fragments of CTLA4 and an antibody (“CTLA4-Ig”) could be used to treat certain autoimmune diseases. This research finding resulted in the granting of U.S. patent No. 6,685,941 (“the ‘941 Patent”) covering the treatment of certain autoimmune disorders including rheumatoid arthritis with CTLA4-Ig.

In December 2005, the FDA approved Bristol’s application to market CTLA4-Ig, under the brand name Orencia®, for treatment of rheumatoid arthritis. In January 2006, Repligen and the University of Michigan jointly filed a lawsuit against Bristol in the United States District Court for the Eastern District of Texas for infringement of the ‘941 Patent. In April 2008, Repligen and the University of Michigan entered into a settlement agreement with Bristol pursuant to which, Bristol made an initial payment of $5 million to Repligen and agreed to pay us royalties on the U.S. net sales of Orencia® for any clinical indication at a rate of 1.8% for the first $500 million of annual sales, 2.0% for the next $500 million and 4.0% of annual sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013.

The ‘941 Patent is owned by the University of Michigan and exclusively licensed to Repligen. In consideration of this exclusive license, Repligen agreed to pay the University of Michigan 15% of all royalty income received, after deducting legal expenses. There are no annual or other fees associated with this agreement. Under this agreement, since its inception through fiscal year 2010, Repligen has paid approximately $2,438,000 to the University of Michigan.

Erbitux®

Erbitux® is a monoclonal antibody developed by ImClone Systems Incorporated (“ImClone”) which was approved by the FDA in February 2004 for the treatment of certain forms of colon cancer and in March 2006 for the treatment of head and neck cancer. Erbitux® is manufactured with a cell line which contains certain genetic technologies (“DNA enhancers”) which increase the productivity of a cell line. A U.S. patent covering the use of DNA enhancers, which expired in May of 2004, was assigned to The Massachusetts Institute of Technology (“MIT”) and exclusively licensed to Repligen. In May 2004, Repligen and MIT jointly filed a lawsuit against ImClone in U.S. District Court for Massachusetts alleging that ImClone had infringed our patent rights in its production of Erbitux®. In September 2007, Repligen and MIT entered into a settlement agreement under which ImClone was granted a license to the DNA enhancer patent and certain other intellectual property in exchange for a payment of $65,000,000.

Research and Development

For the past three years, we have devoted substantial resources to the research and development of therapeutic product candidates and our commercial products and product candidates discussed herein. We spent

 

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$14,160,000, $12,772,000 and $7,241,000 in fiscal years 2010, 2009 and 2008, respectively, on company-sponsored research and development activities.

Development Stage Products

Secretin for MRI Imaging of the Pancreas

Secretin is a well-known gastrointestinal hormone produced in the small intestine that regulates the function of the pancreas as part of the process of digestion. We are currently evaluating the sensitivity and specificity of secretin in combination with MRI to improve the detection of structural abnormalities of the pancreas relative to MRI alone. Detailed visual assessment of the pancreatic ducts and identification of structural abnormalities is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. The use of secretin during MRI harnesses the natural biologic properties of secretin, which signals the release of water-rich fluids into the ducts of the pancreas. Improvement in the detection and delineation of normal and abnormal structures with MRI is attractive for patient care as it can obviate the need for more invasive endoscopic procedures.

We initiated a Phase 2 clinical trial in June 2006 to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging of the pancreas. This was a multi-center, baseline controlled, single dose study in which 76 patients with a history of pancreatitis received an RG1068-MRI and an MRI alone of the pancreas. In May 2007, we announced positive results from this Phase 2 clinical trial. The study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity. In addition, the study showed highly significant increases in the following three assessments: physician confidence in their ability to identify structural abnormalities, the number of pancreatic duct segments visualized, and improvement in the overall quality of the MRI images. Our Phase 2 data was reviewed by the FDA and served as the basis for a pivotal, Phase 3 study.

This Phase 3 clinical trial was initiated in March 2008 and completed in December 2009. This was a multi-center, baseline controlled, single dose study in which 258 patients with a history of pancreatitis at 23 clinical sites within the United States and Canada received an MRI of the pancreas with and without RG1068. The primary objectives of the Phase 3 study were to demonstrate that RG1068 increases the sensitivity in detecting structural abnormalities of the pancreas by MRI, with minimal loss of specificity. The predetermined criteria for a successful study included the achievement of a statistically significant improvement in sensitivity with minimal loss in specificity from two of the three central radiologists reading the MRI images. In this study, one radiologist achieved a statistically significant improvement in sensitivity with RG1068, while a second radiologist showed a trend but did not achieve statistical significance. There was minimal loss in specificity for all radiologists.

Based on numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 trial data, we submitted a request to the FDA and the European Medicines Agency (“EMA”) to re-analyze the Phase 3 data set (“Phase 3 re-read”). In May 2010, the FDA and EMA approved our plan for a re-analysis of images obtained from the Phase 3 trial and we anticipate that preliminary results will be available by the end of fiscal year 2011, ending on March 31, 2011. We believe that a successful Phase 3 re-read may provide the basis for filing a New Drug Application (“NDA”) with the FDA for approval to market RG1068 for this use in the United States.

We have received an Orphan Drug designation from the FDA covering the use of RG1068 in MRI which, provided we are the first company to receive FDA approval for this use of secretin, will provide seven years of marketing exclusivity in the United States following approval of the NDA. We also have received “fast track” designation from the FDA which may provide the basis for an expedited review of this NDA by the FDA.

 

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Uridine for Bipolar Depression

Uridine is a biological compound essential for multiple biosynthetic processes including the synthesis of DNA and RNA, the basic hereditary material found in all cells and numerous other factors essential for cell metabolism. Uridine is synthesized by the power plant of the human cell known as the mitochondria. The rationale for uridine therapy in central nervous system (“CNS”) disorders is supported by pre-clinical and clinical research. Researchers at McLean Hospital previously demonstrated that uridine is active in a well-validated animal model of depression. Literature reports indicate that certain genes that encode for mitochondrial proteins are significantly down-regulated in the brains of bipolar patients. This insight suggests that the symptoms of bipolar disorder may be linked to dysregulation of energy metabolism in the brain.

Bipolar disorder, also known as manic depression, is a chronic illness marked by extreme changes in mood, thought, energy and behavior in which a person’s mood alternates between the “poles” of mania (highs) and depression (lows). Bipolar disorder affects more than 5 million adults worldwide and is usually diagnosed in late adolescence or early adulthood. Bipolar disorder is associated with substantial morbidity and mortality, ranking worldwide behind only unipolar depression and alcohol abuse among psychiatric illnesses for related disabilities and overall economic burden of illness. The average lifetime financial burden of bipolar disorder in the United States is more than $600,000 per patient. Although lithium and anticonvulsants such as valproic acid have substantially improved the prognosis of bipolar disorder, many individuals are unable to tolerate treatment-related side effects, and incomplete clinical response, lack of compliance in taking medication, and relapse remain common clinical problems.

In March 2006, we initiated a Phase 2a clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This was a multi-center, dose escalating study in 83 patients which compared daily, oral dosing with either RG2417 or a placebo for six weeks. Patients were evaluated weekly for the safety and effectiveness of RG2417 on the symptoms of bipolar depression. The study showed a statistically significant improvement in the symptoms of depression over the six-week course of treatment in the patients treated with RG2417 when compared to placebo as measured by the Montgomery-Asberg Depression Rating Scale. RG2417 was well tolerated by patients with a safety profile similar to those treated with a placebo. Our Phase 2a data was reviewed by the FDA and served as the basis for a Phase 2b study.

In November 2008, we initiated this Phase 2b proof-of-concept clinical trial for RG2417 as a potential treatment for the depressive symptoms associated with bipolar disorder. This study, currently in progress, is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or placebo twice daily for eight weeks. We anticipate that preliminary results from this Phase 2b clinical trial will be available by the end of fiscal year 2011, ending on March 31, 2011.

Histone Deacetylase Inhibitors for Friedreich’s Ataxia

Friedreich’s ataxia is an inherited neurodegenerative disease caused by a single gene defect that results in inadequate production of the protein frataxin. Low levels of frataxin lead to degeneration of both the nerves controlling muscle movements in the arms and legs and the nerve tissue in the spinal cord. Symptoms of Friedreich’s ataxia typically emerge between the ages of five and fifteen and often progress to severe disability, incapacitation or loss of life in early adulthood. There are approximately 15,000 patients worldwide with Friedreich’s ataxia. There is currently no treatment for Friedreich’s ataxia.

In April 2007, we entered into an exclusive commercial license (the “Scripps License Agreement”) with The Scripps Research Institute (“Scripps”) for intellectual property covering compounds which may have utility in treating Friedreich’s ataxia. Our preclinical studies with several chemically synthesized libraries of compounds have identified selective HDAC inhibitors. Some of these compounds increase production of the protein frataxin which may have the potential to arrest disease progression in patients with Friedreich’s ataxia. Repligen is currently developing RG2833, a selective histone deacetylase 3 (“HDAC-3”) inhibitor for the treatment of

 

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Friedreich’s ataxia. We recently filed an Investigational New Drug (“IND”) application with the FDA for a Phase 1 study for a double-blind, single ascending dose study in healthy volunteers to evaluate the pharmacokinetic and safety profile of RG2833 in up to 40 subjects. This study will also evaluate the pharmacodynamic response of various biomarkers in peripheral blood to RG2833. We have received an Orphan Drug designation from the FDA for RG2833, which, if we are the first company to obtain market approval for RG2833 for Friedreich’s ataxia, will provide seven years of marketing exclusivity in the United States following NDA approval.

DcpS Inhibitors for Spinal Muscular Atrophy

We are pursuing development of a drug that targets the scavenger mRNA decapping enzyme, DcpS, for treatment of patients with spinal muscular atrophy (“SMA”). Our inhibitors have the potential to be the first in class treatment for this disease. SMA is an inherited neurodegenerative disease in which a defect in the survival motor neuron gene (“SMN”) results in low levels of the protein SMN and leads to progressive damage to motor neurons, loss of muscle function and, in many patients, early death.

On October 22, 2009, we entered into an exclusive worldwide commercial license agreement (“FSMA License Agreement”) with Families of Spinal Muscular Atrophy (“FSMA”). Pursuant to the FSMA License Agreement, we obtained an exclusive license to develop and commercialize certain patented technology and improvements thereon, owned or licensed by FSMA, relating to compounds which may have utility in treating SMA. If all milestones are achieved, total financial obligations under this agreement, including milestone payments, sublicense fees, and other charges, could total approximately $16,000,000.

Repligen’s compounds, known as DcpS inhibitors, increase the production of SMN in preclinical studies of cells derived from patients. Further preclinical testing of these compounds in models of SMA has demonstrated significantly increased survival, suggesting potential clinical utility. Repligen is currently evaluating a lead DcpS inhibitor in preclinical studies for future clinical trials in patients with SMA.

Sales and Marketing

We sell our bioprocessing products primarily through value-added resellers such as GEHC as well as through distributors in certain foreign markets. Prior to its discontinuation in the second quarter of fiscal year 2009, we marketed SecreFlo® directly to hospital-based gastroenterologists in the United States.

Significant Customers and Geographic Reporting

Customers for our bioprocessing products include chromatography companies, diagnostics companies, biopharmaceutical companies and laboratory researchers. In April 2008, we settled our litigation with Bristol regarding their sales of Orencia® for which we now receive a royalty. For fiscal years 2010 and 2009, royalty revenue from Bristol represented 43% and 46% of total revenues, respectively. Our largest bioprocessing customer accounted for 36%, 36% and 72% of total revenues in fiscal years 2010, 2009 and 2008, respectively. In fiscal year 2008, another bioprocessing customer also represented 16% of total revenue.

In fiscal years 2010, 2009 and 2008, total revenues from sales to customers in the United States were approximately 57%, 59% and 32%, respectively. During the same fiscal periods, total revenues generated though sales to customers in Sweden were 36%, 37% and 61%, respectively.

Employees

As of May 6, 2010, we had 68 employees. Of those employees, 50 were engaged in research, development and manufacturing and 18 were in administrative and marketing functions. Thirty-one of our employees hold doctorates or other advanced degrees. Each of our employees has signed a confidentiality agreement. None of our employees are covered by collective bargaining agreements.

 

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Patents, Licenses and Proprietary Rights

Repligen actively pursues patent protection in the United States and in major countries abroad and believes that patents are an important element in the protection of our competitive and proprietary position. Other forms of protection, including trade secrets, orphan drug status and know-how, are also considered important elements of our proprietary strategy. As further described below, Repligen owns or has exclusive rights to a number of U.S. patents and U.S. pending patent applications as well as corresponding foreign patents and patent applications. The expiration of key patents owned or licensed by us or the failure of patents to issue on pending patent applications could create increased competition, with potential adverse effects on our business prospects. For each of our license agreements where we license the rights to patents or patent applications, the license will terminate on the day that the last to expire patent covered by each such license agreement expires.

We also rely upon trade secret protection for our confidential and proprietary information. Our policy is to require each of our employees, consultants, business partners and significant scientific collaborators to execute confidentiality agreements upon the commencement of an employment, consulting or business relationship with us. These agreements provide that all confidential information developed or made known to the individual during the course of the individual’s relationship with us is to be kept confidential and not disclosed to third parties except in specific circumstances. In the case of employees and consultants, the agreements generally provide that all inventions conceived by the individual in the course of rendering services to Repligen shall be our exclusive property.

CTLA4-Ig

The ‘941 patent was issued in February 2004, covering the use of CTLA4-Ig to treat specific autoimmune disorders including rheumatoid arthritis and multiple sclerosis. The patent is assigned to the University of Michigan and the U.S. Navy and is exclusively licensed to Repligen. In April 2008, Repligen granted Bristol an exclusive sublicense to this patent (see “Legal Proceedings”).

Uridine

In 2009, Repligen entered into an exclusive license agreement with McLean Hospital for the worldwide rights to an internationally filed patent application which covers the use of uridine in the treatment of patients with bipolar disorder. Repligen has recently received a Notice of Allowance from the U.S. Patent and Trademark Office for this patent which, upon issue, will remain in force until 2025 prior to any regulatory extensions. Under the terms of the license agreement, McLean received an upfront payment, and is eligible to receive payments upon certain product development milestones and royalties upon successful commercialization of uridine for bipolar disorder. Foreign equivalents of this patent are being prosecuted outside of the United States.

Protein A

We own a broad U.S. patent covering recombinant Protein A, which expired in September 2009, as well as significant know-how in the manufacture of high-purity Protein A. We recently were granted U.S. Patent No. 7,691,608 B2, “Nucleic Acids Encoding Recombinant Protein A,” which claims a recombinant gene that encodes a Protein A molecule with an amino acid sequence identical to that of the natural Protein A molecule which has long been commercialized for bioprocessing applications. This U.S. patent will remain in effect until 2028. Foreign equivalents of this patent are being prosecuted outside of the United States.

Histone Deacetylase Inhibitors

Repligen has entered into an exclusive license agreement with The Scripps Research Institute for worldwide rights to a patent application claiming compounds and methods for treating Friedreich’s ataxia with inhibitors of histone deacetylase (“HDAC”). We have identified the specific HDAC that is the target of these inhibitors and have filed additional patent applications claiming methods and compositions for treating Friedreich’s ataxia. These patent applications are currently being prosecuted in the United States and abroad.

 

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Spinal Muscular Atrophy

In 2009, Repligen entered into an exclusive license agreement with a non-profit organization, the Families of Spinal Muscular Atrophy (“FSMA”), for worldwide rights to patent applications related to compositions and methods for the treatment of spinal muscular atrophy. FSMA had funded the development of these compounds and identified a novel enzyme target (“DcpS”) that these compounds inhibit. Repligen is prosecuting these patent applications in the U.S. and abroad.

Competition

Our bioprocessing products compete on the basis of quality, performance, cost effectiveness, and application suitability with numerous established technologies. Additional products using new technologies that may be competitive with our products may also be introduced. Many of the companies selling or developing competitive products have financial, manufacturing and distribution resources significantly greater than ours.

The field of drug development is characterized by rapid technological change. New developments are expected to continue at a rapid pace in both industry and academia. There are many companies, both public and private, including large pharmaceutical companies, chemical companies and specialized biotechnology companies, engaged in developing products competitive with products that we have under development. Many of these companies have greater capital, human resources, research and development, manufacturing and marketing experience than we do. They may succeed in developing products that are more effective or less costly than any that we may develop. These competitors may also prove to be more successful than we are in production and marketing. In addition, academic, government and industry-based research groups compete intensely with us in recruiting qualified research personnel, in submitting patent filings for protection of intellectual property rights and in establishing corporate strategic alliances. We cannot be certain that research, discoveries and commercial developments by others will not render any of our programs or potential products noncompetitive.

Manufacturing

Protein A for Antibody Manufacturing

We manufacture Protein A bioprocessing products from recombinant strains of bacteria. We manufacture Protein A for GEHC under a supply agreement which extends through 2015. We purchase raw materials from more than one commercially established company and believe that the necessary raw materials are currently commercially available in sufficient quantities necessary to meet market demand. We utilize our own facility and third parties to carry out certain fermentation and recovery operations, while the purification, immobilization, packaging and quality control testing of our Protein A bioprocessing products are conducted at our facilities. We are ISO 9001 certified and utilize a formal quality system to maintain process control, traceability, and product conformance. We also practice continuous improvement initiatives based on routine internal audits, customer feedback and audits performed by our partners and customers. In addition, our business continuity management system focuses on key areas such as contingency planning, security stocks and off-site storage of raw materials and finished goods to ensure continuous supply of our products.

Therapeutic Product Candidates

We currently rely, and will continue to rely for at least the next few years, upon contract manufacturers for both the procurement of raw materials and the production of our product candidates for use in our clinical trials. Our product candidates will need to be manufactured in a facility and by processes that comply with the FDA’s good manufacturing practices and other similar regulations. It may take a substantial period of time to begin manufacturing our products in compliance with such regulations. If we are unable to establish and maintain relationships with third parties for manufacturing sufficient quantities of our product candidates and their components that meet our planned time and cost parameters, the development and timing of our clinical trials may be adversely affected.

 

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Government Regulation

The development of drug candidates is subject to regulation in the United States by the FDA and abroad by foreign equivalents. Product development and approval within the FDA regulatory framework usually takes a significant number of years and involves the expenditure of substantial capital resources. Timelines for development are uncertain.

Before clinical testing in the United States of any drug candidate may begin, FDA requirements for preclinical efficacy and safety must be completed. Required toxicity testing typically involves characterization of the drug candidate in several animal species. Safety and efficacy data are submitted to the FDA as part of an Investigational New Drug application and are reviewed by the FDA prior to the commencement of human clinical trials.

Clinical trials involve the administration of the drug to human volunteers or patients under the supervision of a qualified investigator, usually a physician, with an FDA-approved protocol. Human clinical trials are typically conducted in three sequential phases:

 

   

Phase 1 clinical trials represent the initial administration of the investigational drug to a small group of human subjects to test for safety (pharmacovigilance), dose tolerability, absorption, biodistribution, metabolism, excretion and clinical pharmacology and, if possible, to gain early evidence regarding efficacy and potential biomarkers.

 

   

Phase 2 clinical trials typically involve a small sample of the actual intended patient population and seek to assess the efficacy of the drug for specific targeted indications, to determine dose tolerance and the optimal dose range, and to gather additional information relating to safety and potential adverse effects.

 

   

Once an investigational drug is found to have some efficacy and an acceptable safety profile in the targeted patient population, Phase 3 clinical trials are initiated to establish further clinical safety and efficacy of the investigational drug in a broader sample of the general patient population at multiple study sites in order to determine the overall risk-benefit ratio of the drug and to provide an adequate basis for product approval. The Phase 3 clinical development program consists of expanded, large-scale studies of patients with the target disease or disorder to obtain definitive statistical evidence of the efficacy and safety of the proposed product.

All data obtained from a comprehensive development program are submitted in an NDA to the FDA and the corresponding agencies in other countries for review and approval. The NDA includes information pertaining to clinical studies and the manufacture of the new drug. Review of an NDA by the FDA can be a time-consuming process and the FDA may request that we submit additional data or carry out additional studies.

Available Information

We maintain a website with the address www.repligen.com. We are not including the information contained on our website as a part of, or incorporating it by reference into, this annual report on Form 10-K. We make available free of charge through our website our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, and amendments to these reports, as soon as reasonably practicable after we electronically file such materials with, or furnish such materials to, the Securities and Exchange Commission. Our Code of Business Conduct and Ethics is also available free of charge through our website.

In addition, the public may read and copy any materials that we file with the Securities and Exchange Commission at the Securities and Exchange Commission’s Public Reference Room at 100 F Street, NE, Washington, D.C. 20549. The public may obtain information on the operation of the Public Reference Room by calling the Securities and Exchange Commission at 1-800-SEC-0330. Also, our filings with the Securities and Exchange Commission may be accessed through the Securities and Exchange Commission’s Electronic Data Gathering, Analysis and Retrieval (EDGAR) system at www.sec.gov.

 

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Item 1A. RISK FACTORS

Investors should carefully consider the risk factors described below before making an investment decision.

If any of the events described in the following risk factors occur, our business, financial condition or results of operations could be materially harmed. In that case the trading price of our common stock could decline, and investors may lose all or part of their investment. Additional risks and uncertainties that we are unaware of or that we currently deem immaterial may also become important factors that affect Repligen.

This annual report on Form 10-K contains forward looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward looking statements as a result of certain factors, including the risks faced by us described below and elsewhere in this annual report on Form 10-K.

We are dependent on others to develop, conduct clinical trials for, manufacture, market and sell our principal products.

We conduct some of our development activities, and conduct most of our commercialization activities, through collaborations. These collaborations include academic researchers as well as contracts with vendors. Our collaborations are heavily dependent on the efforts and activities of our collaborative partners. Our existing and any future collaborations may not be technically or commercially successful. For example, if any of our collaborative partners were to breach or terminate an agreement with us, reduce its funding or otherwise fail to conduct the collaboration successfully, we may need to devote additional internal resources to the program that is the subject of the collaboration, scale back or terminate the program or seek an alternative partner, any of which could lead to delays in development and/or commercialization of our products.

We depend on, and expect to continue to depend on, a limited number of customers for a high percentage of our revenues.

As a result, the loss of, or a significant reduction in orders from, any of these customers would significantly reduce our revenues and harm our results of operations. If a large customer purchases fewer of our products, defers orders or fails to place additional orders with us, our revenue could decline, and our operating results may not meet market expectations. In addition, if those customers order our products, but fail to pay on time or at all, our liquidity and operating results could be materially and adversely affected.

Royalty revenue from Bristol-Myers Squibb Company for sales of Orencia® could fail to materialize.

Our royalty agreement with Bristol provides for us to receive payments from Bristol based on their net sales of their Orencia® product in the United States. We have no control over Bristol’s sales and marketing practices for Orencia® and Bristol has no obligation to use commercially reasonable efforts to sell Orencia®. Bristol’s sales could be significantly impacted by regulatory and market influences beyond our control, resulting in low or even no royalty revenue for us.

Our research activities may not identify a clinical candidate with appropriate efficacy, safety and pharmacology to support clinical trials in humans.

In order to conduct phase 1 clinical trials in humans, we must first demonstrate suitable efficacy, safety and pharmacology characteristics of any potential drug candidates. If we are unsuccessful in these efforts, we may be forced to identify alternative drug candidates at substantial cost, or possibly abandon certain pre-clinical research activities.

 

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Our clinical trials may not be successful and we may not be able to develop and commercialize related products.

In order to obtain regulatory approvals for the commercial sale of our future therapeutic products, we and our collaborative partners will be required to complete extensive clinical trials in humans to demonstrate the safety and efficacy of the products. We have limited experience in conducting clinical trials.

The submission of an IND application may not result in FDA authorization to commence clinical trials. If clinical trials begin, we or our collaborative partners may not complete testing successfully within any specific time period, if at all, with respect to any of our products. Furthermore, we, our collaborative partners, or the FDA, may suspend clinical trials at any time on various grounds, including a finding that the subjects or patients are being exposed to unacceptable health risks. Clinical trials, if completed, may not show any potential product to be safe or effective. Thus, the FDA and other regulatory authorities may not approve any of our potential products for any indication.

The rate of completion of clinical trials is dependent in part upon the rate of enrollment of patients. Patient enrollment is a function of many factors, including the size of the patient population, the proximity of patients to clinical sites, the eligibility criteria for the study, and the existence of competitive clinical trials. Delays in planned patient enrollment may result in increased costs and delays in completion of clinical trials.

We may not obtain regulatory approvals; the approval process is costly and lengthy.

We must obtain regulatory approval for our ongoing development activities and before marketing or selling any of our future therapeutic products. We may not receive regulatory approvals to conduct clinical trials of our products or to manufacture or market our products. In addition, regulatory agencies may not grant such approvals on a timely basis or may revoke previously granted approvals.

The process of obtaining FDA and other required regulatory approvals is lengthy and may be expensive. The time required for FDA and other clearances or approvals is uncertain and typically takes a number of years, depending on the complexity and novelty of the product. Our analysis of data obtained from preclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. Any delay in obtaining or failure to obtain required clearance or approvals could materially adversely affect our ability to generate revenues from the affected product. We have only limited experience in filing and prosecuting applications necessary to gain regulatory approvals.

We are also subject to numerous foreign regulatory requirements governing the design and conduct of the clinical trials and the manufacturing and marketing of our future products. The approval procedure varies among countries. The time required to obtain foreign approvals often differs from that required to obtain FDA approvals. Moreover, approval by the FDA does not ensure approval by regulatory authorities in other countries (or vice versa).

All of the foregoing regulatory risks also are applicable to development, manufacturing and marketing undertaken by our collaborative partners or other third parties.

Even if we obtain marketing approval, our therapeutic products will be subject to ongoing regulatory review, which may be expensive and may affect our ability to successfully commercialize our products.

Even if we or our collaborative partners receive regulatory approval of a product, such approval may be subject to limitations on the indicated uses for which the product may be marketed, which may limit the size of the market for the product or contain requirements for costly post-marketing follow-up studies. The manufacturers of our products for which we or our collaborative partners have obtained marketing approval will be subject to continued review and periodic inspections by the FDA and other regulatory authorities. The

 

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subsequent discovery of previously unknown problems with the product, clinical trial subjects, or with a manufacturer or facility may result in restrictions on the product or manufacturer, including withdrawal of the product from the market.

If we or our collaborative partners fail to comply with applicable regulatory requirements, we may be subject to fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions, and criminal prosecution.

If we are unable to obtain, maintain and enforce patents or regulatory exclusivity (orphan drug or new chemical entity exclusivity) for our products, we may not be able to succeed commercially.

We endeavor to obtain and maintain patent and trade secret protection for our products and processes when available in order to protect them from unauthorized use and to produce a financial return consistent with the significant time and expense required to bring our products to market. Our success will depend, in part, on our ability to:

 

   

obtain and maintain patent protection for our products and manufacturing processes;

 

   

preserve our trade secrets;

 

   

operate without infringing the proprietary rights of third parties; and

 

   

secure licenses from others on acceptable terms.

We cannot be sure that any patent applications relating to our products that we will file in the future or that any currently pending applications will issue on a timely basis, if ever. Since patent applications in the United States filed prior to November 2000 are maintained in secrecy until patents issue and since publication of discoveries in the scientific or patent literature often lag behind actual discoveries, we cannot be certain that we were the first to make the inventions covered by each of our pending patent applications or that we were the first to file patent applications for such inventions. Even if patents are issued, the degree of protection afforded by such patents will depend upon the:

 

   

scope of the patent claims;

 

   

validity and enforceability of the claims obtained in such patents; and

 

   

our willingness and financial ability to enforce and/or defend them.

The patent position of biotechnology and pharmaceutical firms is often highly uncertain and usually involves complex legal and scientific questions. Moreover, no consistent policy has emerged in the United States or in many other countries regarding the breadth of claims allowed in biotechnology patents. Patents which may be granted to us in certain foreign countries may be subject to opposition proceedings brought by third parties or result in suits by us, which may be costly and result in adverse consequences for us.

In some cases, litigation or other proceedings may be necessary to assert claims of infringement, to enforce patents issued to us or our licensors, to protect trade secrets, know-how or other intellectual property rights we own or to determine the scope and validity of the proprietary rights of third parties. Such litigation could result in substantial cost to us and diversion of our resources. An adverse outcome in any such litigation or proceeding could have a material adverse effect on our business, financial condition and results of operations.

If our competitors prepare and file patent applications in the United States that claim technology also claimed by us, we may be required to participate in interference proceedings declared by the U.S. Patent and Trademark Office to determine priority of invention, which would result in substantial costs to us.

 

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Since some of our U.S. patents covering recombinant Protein A have expired, we may face increased competition which could harm our results of operations, financial condition, cash flow and future prospects.

Other companies could begin manufacturing and selling recombinant Protein A in the U.S. and may directly compete with us on certain Protein A products. This may induce us to sell Protein A at lower prices and may erode our market share which could adversely affect our results of operations, financial condition, cash flow and future prospects.

Our freedom to develop our product candidates may be challenged by others and we may have to engage in litigation to determine the scope and validity of competitors’ patents and proprietary rights, which, if we do not prevail, could harm our business, results of operations, financial condition, cash flow and future prospects.

There has been substantial litigation and other proceedings regarding the complex patent and other intellectual property rights in the pharmaceutical and biotechnology industries. We have been a party to, and in the future may become a party to, patent litigation or other proceedings regarding intellectual property rights.

Other types of situations in which we may become involved in patent litigation or other intellectual property proceedings include:

 

   

We may initiate litigation or other proceedings against third parties to seek to invalidate the patents held by such third parties or to obtain a judgment that our products or services do not infringe such third parties’ patents.

 

   

We may initiate litigation or other proceedings against third parties to seek to enforce our patents against infringement.

 

   

If our competitors file patent applications that claim technology also claimed by us, we may participate in interference or opposition proceedings to determine the priority of invention.

 

   

If third parties initiate litigation claiming that our processes or products infringe their patent or other intellectual property rights, we will need to defend against such claims.

The cost to us of any patent litigation or other proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the cost of such litigation or proceedings more effectively than we can because of their substantially greater financial resources. If a patent litigation or other intellectual property proceeding is resolved unfavorably to us, we or our collaborative partners may be enjoined from manufacturing or selling our products and services without a license from the other party and be held liable for significant damages. The failure to obtain any required license on commercially acceptable terms or at all may harm our business, results of operations, financial condition, cash flow and future prospects.

Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time, attention and resources.

For more information about the legal proceedings in which we were involved but which have been settled, please see “Legal Proceedings.”

We may become involved in litigation or other proceedings with collaborative partners, which may be time consuming, costly and could result in delays in our development and commercialization efforts.

We conduct some of our development activities, and conduct most of our commercialization activities, through collaborations with collaborative partners. Therefore, any disputes with such partners that lead to

 

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litigation or similar proceedings may result in us incurring legal expenses, as well as facing potential legal liability. Such disputes, litigation or other proceedings are also time consuming and may cause delays in our development and commercialization efforts.

We have limited sales and marketing experience and capabilities.

We have limited sales, marketing and distribution experience and capabilities. We may, in some instances, rely significantly on sales, marketing and distribution arrangements with our collaborative partners and other third parties. In these instances, our future revenues will be materially dependent upon the success of the efforts of these third parties.

If in the future we determine to perform sales, marketing and distribution functions ourselves, we would face a number of additional risks, including:

 

   

we may not be able to attract and build a significant marketing staff or sales force;

 

   

the cost of establishing a marketing staff or sales force may not be justifiable in light of any product revenues; and

 

   

our direct sales and marketing efforts may not be successful.

We have limited pharmaceutical manufacturing capabilities and will be dependent on third party manufacturers.

We have limited pharmaceutical manufacturing experience and no commercial or pilot scale manufacturing facilities for the production of pharmaceuticals. In order to continue to develop pharmaceutical products, apply for regulatory approvals and, ultimately, commercialize any products, we may need to develop, contract for, or otherwise arrange for the necessary manufacturing capabilities.

We currently rely upon third parties to produce material for preclinical and clinical testing purposes and expect to continue to do so in the future. We also expect to rely upon third parties, including our collaborative partners, to produce materials required for the commercial production of certain of our products if we succeed in obtaining the necessary regulatory approvals. We believe that there is no proprietary aspect to the manufacture of our product candidates. However, there are only a limited number of manufacturers that operate under the FDA’s regulations for good manufacturing practices which are capable of and/or approved to manufacture our product candidates. Timing for the initiation of new manufacturers is uncertain, and, if we are unable to arrange for third party manufacturing of our product candidates on a timely basis, or to do so on commercially reasonable terms, we may not be able to complete development of our product candidates or market them, if they are approved.

The manufacture of products by us and our collaborative partners and suppliers is subject to regulation by the FDA and comparable agencies in foreign countries. Delay in complying or failure to comply with such manufacturing requirements could materially adversely affect the marketing of our products.

If we are unable to continue to hire and retain skilled personnel, then we will have trouble developing and marketing our products.

Our success depends largely upon the continued service of our management and scientific staff and our ability to attract, retain and motivate highly skilled technical, scientific, management, regulatory, clinical and marketing personnel. Potential employees with an expertise in the field of molecular biology, biochemistry, regulatory affairs and/or clinical development of new drug and biopharmaceutical manufacturing are not generally available in the market and are difficult to attract and retain. We also face significant competition for such personnel from other companies, research and academic institutions, government and other organizations who have superior funding and resources to be able to attract such personnel. The loss of key personnel or our

 

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inability to hire and retain personnel who have technical, scientific or regulatory compliance backgrounds could materially adversely affect our product development efforts and our business.

The market may not be receptive to our products upon their introduction.

The commercial success of our therapeutic products that are approved for marketing will depend upon their acceptance by the medical community and third party payors as being clinically useful, cost effective and safe. All of the products that we are developing are based upon new technologies or therapeutic approaches. As a result, it is hard to predict market acceptance of our products.

Other factors that we believe will materially affect market acceptance of our products and services include:

 

   

the timing of receipt of marketing approvals and the countries in which such approvals are obtained;

 

   

the safety, efficacy and ease of administration of our products;

 

   

the success of physician education programs;

 

   

the availability of government and third party payor reimbursement of our products; and

 

   

competition from products which may offer better safety, efficacy or lower cost.

Healthcare reform measures could adversely affect our business.

The efforts of governmental and third-party payors to contain or reduce the costs of healthcare may adversely affect the business and financial condition of pharmaceutical and biotechnology companies. Specifically, in both the United States and some foreign jurisdictions, there have been a number of legislative and regulatory proposals to change the health care system in ways that could affect our ability to sell our products profitably. The U.S. Congress has just passed the America Affordable Health Choices Act of 2009 and is considering a number of proposals that are intended to reduce or limit the growth of health care costs and which could significantly transform the market for pharmaceuticals products. We expect further federal and state proposals and health care reforms to continue to be proposed by legislators, which could limit the prices that can be charged for the products we develop and may limit our commercial opportunity. In the United States, the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, also called the Medicare Modernization Act, or MMA, changed the way Medicare covers and pays for pharmaceutical products. These cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for any approved products and could seriously harm our business. While the MMA applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and any reduction in reimbursement that results from the MMA may result in a similar reduction in payments from private payors. The continuing efforts of government and other third-party payors to contain or reduce the costs of health care through various means may limit our commercial opportunity. In addition, the pendency or approval of such proposals could result in a decrease in the price of Repligen’s common stock or limit our ability to raise capital or to enter into collaborations or license rights to our products.

We compete with pharmaceutical and biotechnology companies who are capable of developing new approaches that could make our products and technology obsolete.

The market for therapeutic and commercial products is intensely competitive, rapidly evolving and subject to rapid technological change. Pharmaceutical and biotechnology companies may have substantially greater financial, manufacturing, marketing, and research and development resources than we have. New approaches by these competitors may make our products and technologies obsolete or noncompetitive.

 

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We have incurred substantial losses, we may continue to incur operating losses and we will not be successful until we reverse this trend.

Although the company had significant net income in fiscal years 2009 and 2008 as a result of the ImClone and Bristol settlements, we have historically incurred operating losses since our founding in 1981. We incurred a loss for fiscal 2010 and we expect to incur operating losses for the foreseeable future.

While we generate revenue from bioprocessing product sales and began receiving royalty payments in fiscal year 2009 from Bristol for the net sales of their Orencia® product in the United States, this revenue may not be sufficient to cover the costs of our clinical trials and drug development programs. We plan to continue to invest in key research and development activities. As a result, we will need to generate significant revenues in order to achieve profitability. We cannot be certain whether or when this will occur because of the significant uncertainties that affect our business.

We may need to obtain additional capital resources for our drug development programs, or we may be unable to develop or discover new drugs.

We may need additional long-term financing to develop our drug development programs through the clinical trial process as required by the FDA and to develop our commercial products business. We also may need additional long-term financing to support future operations and capital expenditures, including capital for additional personnel and facilities. If we spend more money than currently expected for our drug development programs and our commercial products business, we may need to raise additional capital by selling debt or equity securities, by entering into strategic relationships or through other arrangements. We may be unable to raise any additional amounts on reasonable terms or when they are needed due to the volatile nature of the biotechnology marketplace. If we are unable to raise this additional capital, we may have to delay or postpone critical clinical studies or abandon other development programs.

Our stock price could be volatile, which could cause you to lose part or all of your investment.

The market price of our common stock, like that of the common stock of many other development stage biotechnology companies, is highly volatile. In addition, the stock market has experienced extreme price and volume fluctuations. This volatility has significantly affected the market prices of securities of many biotechnology and pharmaceutical companies for reasons frequently unrelated to or disproportionate to the operating performance of the specific companies. These broad market fluctuations may adversely affect the market price of our common stock.

Provisions in our certificate of incorporation and by-laws and of Delaware law may prevent or delay an acquisition of our Company, which could decrease the trading price of our common stock.

Our certificate of incorporation, by-laws and Delaware law contain provisions that are intended to deter coercive takeover practices and inadequate takeover bids by making such practices or bids unacceptably expensive to the raider and to encourage prospective acquirors to negotiate with our Board of Directors rather than to attempt a hostile takeover. These provisions include our Board of Directors’ ability to issue preferred stock without stockholder approval and Delaware law’s various restrictions on mergers and other business combinations between us and any holder of 15% or more of our outstanding common stock. In addition, we maintain a shareholder rights plan which may deter a potential acquiror from pursuing an offer for our company.

We believe these provisions protect our stockholders from coercive or otherwise unfair takeover tactics by requiring potential acquirors to negotiate with our Board of Directors and by providing our Board of Directors with more time to assess any acquisition proposal. These provisions are not intended to make our company immune from takeovers. However, these provisions apply even if the offer may be considered beneficial by some stockholders and could delay or prevent an acquisition that our Board of Directors determines is not in the best interests of our company and our stockholders.

 

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Item 1B. UNRESOLVED STAFF COMMENTS

None.

 

Item 2. PROPERTIES

We lease approximately 25,000 square feet of space located in Waltham, Massachusetts which serves as our corporate headquarters. We also conduct manufacturing, research and development, marketing and administrative operations at this facility. In addition, we lease approximately 10,000 square feet of space at a second location in Waltham for expanded manufacturing and administrative operations. Both of these leases expire in 2012. During fiscal 2010, we incurred total rental costs for both facilities of approximately $689,000.

 

Item 3. LEGAL PROCEEDINGS

ImClone Systems

In May 2004, Repligen and the Massachusetts Institute of Technology (“MIT”) filed an action in the United States District Court for the District of Massachusetts against ImClone Systems, Incorporated (“ImClone”) for infringement of U.S. Patent No. 4,663,281 (the “‘281 patent”) based on ImClone’s manufacture and sale of Erbitux®. The ‘281 patent, which covers the use of certain genetic elements that increase protein production in a mammalian cell, is assigned to MIT and exclusively licensed to Repligen.

On September 10, 2007, the Company and MIT entered into a settlement agreement (the “ImClone Settlement”) with ImClone relating to the lawsuit against ImClone for infringement of the ‘281 patent. Pursuant to the ImClone Settlement, ImClone made a payment of $65 million to Repligen and MIT that resulted in net proceeds to Repligen of $40.17 million, as follows:

 

Gross proceeds from ImClone Settlement agreement

   $ 65,000,000   

Less: Amounts paid to MIT

     (11,000,000

Less: Legal fees and other costs

     (13,830,000
        

Net gain on litigation settlement

   $ 40,170,000   
        

The ImClone Settlement served as the basis for the Company and MIT to dismiss the lawsuit against ImClone and for the Company to grant ImClone a non-exclusive sublicense to the ‘281 patent and certain other intellectual property. There are no further obligations to the Company with respect to the sublicenses. The net gain on the litigation settlement was recorded as a separate component of operating expenses in the Company’s statement of operations in fiscal 2008.

Bristol-Myers Squibb Company

In January 2006, Repligen and the University of Michigan jointly filed a complaint against Bristol in the United States District Court for the Eastern District of Texas for infringement of U.S. Patent No. 6,685,941 (the “‘941 patent”) for the commercial sale of Orencia®. The ‘941 patent, entitled “Methods of Treating Autoimmune Disease via CTLA4-Ig,” covers methods of using CTLA4-Ig to treat rheumatoid arthritis, as well as other therapeutic methods. Repligen has exclusive rights to this patent from its owners, the University of Michigan and the U.S. Navy. In February 2006, Bristol answered the complaint and counterclaimed seeking a declaratory judgment that the ‘941 patent is invalid and unenforceable and that Bristol does not infringe the patent.

On April 7, 2008, Repligen and the University of Michigan entered into a settlement agreement (the “Bristol Settlement”) with Bristol relating to the lawsuit against Bristol for infringement of the ‘941 patent. Pursuant to the Bristol Settlement, Bristol made an initial payment of $5 million to Repligen. The Bristol Settlement further provides for Bristol to pay royalties on the United States net sales of Orencia® for any clinical indication at a rate of 1.8% for the first $500 million of annual net sales, 2.0% for the next $500 million of annual net sales and 4%

 

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of annual net sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The Bristol Settlement served as the basis for Repligen and the University of Michigan to dismiss the lawsuit against Bristol and for Repligen and the University of Michigan to grant to Bristol an exclusive license to the ‘941 patent and certain other intellectual property. Repligen has no continuing obligations to Bristol as a result of this settlement. Pursuant to the Bristol Settlement, Repligen has recognized $8,980,000 and $13,383,000 in fiscal years 2010 and 2009, respectively. The $9.0 million recognized in fiscal year 2010 was for sales of Orencia® from January 1, 2009 through December 31, 2009. The $13.4 million recognized in fiscal year 2009 was comprised of a $5 million initial payment, $1.3 million for sales of Orencia® from January 1, 2008 through December 31, 2008, and $7.1 million for sales in fiscal year 2009 (see Note 2).

Repligen must also remit to the University of Michigan 15% of all royalty revenue received from Bristol, after deducting certain legal and other costs incurred related to the Bristol Settlement. Repligen incurred approximately $6.1 million in such legal costs. Royalty expense for fiscal years 2010 and 2009 was $1,347,000 and $1,091,000, respectively. This operating expense has been included on the statements of operations under the line item “Cost of royalty and other revenue.”

Other

From time to time, we may be subject to other legal proceedings and claims in the ordinary course of business. We are not currently aware of any such proceedings or claims that we believe will have, individually or in the aggregate, a material adverse effect on our business, financial condition or results of operations.

 

Item 4. (REMOVED AND RESERVED)

 

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PART II

 

Item 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES

Market Information

Our common stock is traded on the Nasdaq Global Market under the symbol “RGEN.” The quarterly high and low closing prices for our common stock are shown in the following table.

 

     Fiscal Year 2010    Fiscal Year 2009
     High    Low    High    Low

First Quarter

   $ 5.50    $ 3.92    $ 6.23    $ 4.72

Second Quarter

   $ 5.55    $ 4.96    $ 5.58    $ 4.51

Third Quarter

   $ 5.13    $ 3.74    $ 4.78    $ 3.30

Fourth Quarter

   $ 4.06    $ 3.35    $ 4.79    $ 3.56

Stockholders and Dividends

As of June 2, 2010, there were approximately 666 stockholders of record of our common stock. We have not paid any dividends since our inception and do not intend to pay any dividends on our common stock in the foreseeable future. We anticipate that we will retain all earnings, if any, to support our operations and our proprietary drug development programs. Any future determination as to the payment of dividends will be at the sole discretion of our board of directors and will depend on our financial condition, results of operations, capital requirements and other factors our board of directors deems relevant.

Equity Compensation Plan Information

See Part III, Item 12 for information regarding securities authorized for issuance under our equity compensation plans.

Issuer Purchases of Equity Securities

In June 2008, the Board of Directors authorized a program to repurchase up to 1.25 million shares of our common stock to be repurchased at the discretion of management from time to time in the open market or through privately negotiated transactions. The repurchase program has no set expiration date and may be suspended or discontinued at any time. For the twelve-month period ended March 31, 2009, the Company repurchased 492,827 shares of common stock, for an aggregate purchase price of $1,969,240, leaving 757,173 shares remaining under this authorization.

 

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LOGO

The information contained in the performance graph shall not be deemed to be “soliciting material” or to be “filed” with the Securities and Exchange Commission, and such information shall not be incorporated by reference into any future filing under the Securities Act or Exchange Act, except to the extent that Repligen specifically incorporates it by reference into such filing.

 

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Item 6. SELECTED FINANCIAL DATA

The following selected financial data are derived from the audited financial statements of Repligen. The selected financial data set forth below should be read in conjunction with our financial statements and the related notes thereto and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included elsewhere in this report and our Annual Report on Form 10-K for the years ended March 31, 2009, 2008, 2007 and 2006.

 

     Years ended March 31,  
     2010     2009     2008     2007     2006  
     (In thousands except per share amounts)  

Revenue:

          

Product revenue

   $ 10,305      $ 14,529      $ 18,587      $ 13,074      $ 12,529   

Royalty and other revenue

     10,666        14,833        709        1,000        382   
                                        

Total revenue

     20,971        29,362        19,296        14,074        12,911   

Operating expenses:

          

Cost of product revenue

     4,159        5,686        6,160        3,615        3,551   

Cost of royalty and other revenue

     1,347        1,091        —          —          —     

Research and development

     14,160        12,772        7,241        5,924        5,163   

Selling, general and administrative

     7,072        5,933        10,173        6,360        5,417   

Net gain from litigation settlement

     —          —          (40,170     —          —     
                                        

Total operating expenses

     26,738        25,482        (16,596     15,899        14,131   

(Loss) income from operations

     (5,767     3,880        35,892        (1,825     (1,220
                                        

Interest expense

     (2     (3     (9     (11     (3

Investment income

     870        1,896        2,051        947        750   

Other income

     —          —          —          —          1,170   
                                        

(Loss) income before taxes

     (4,899     5,773        37,934        (889     697   

Income tax (benefit) provision

     (835     27        827        —          —     
                                        

Net (loss) income

   $ (4,064   $ 5,746      $ 37,107      $ (889   $ 697   
                                        

Earnings per share:

          

Basic

   $ (0.13   $ 0.19      $ 1.20      $ (0.03   $ 0.02   
                                        

Diluted

   $ (0.13   $ 0.18      $ 1.18      $ (0.03   $ 0.02   
                                        

Weighted average shares outstanding:

          

Basic

     30,752        30,958        30,834        30,379        30,125   
                                        

Diluted

     30,752        31,290        31,321        30,379        30,691   
                                        
     As of March 31,  
     2010     2009     2008     2007     2006  
     (In thousands)  

Balance Sheet Data:

          

Cash and marketable securities (1)

   $ 59,146      $ 63,961      $ 60,589      $ 22,627      $ 23,408   

Working capital

     55,024        50,235        49,831        22,394        18,575   

Total assets

     71,420        73,755        68,840        29,076        28,599   

Long-term obligations

     642        82        143        200        231   

Accumulated deficit

     (117,921     (113,857     (120,577     (157,683     (156,794

Stockholders’ equity

     66,120        69,123        64,107        25,538        25,433   

 

(1) Excludes restricted cash of $200 related to our headquarters’ lease arrangement for all years presented.

 

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Item 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This annual report on Form 10-K contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The forward-looking statements in this annual report on Form 10-K do not constitute guarantees of future performance. Investors are cautioned that statements in this annual report on Form 10-K that are not strictly historical statements, including, without limitation, statements regarding current or future financial performance, potential impairment of future earnings, management’s strategy, plans and objectives for future operations and product candidate acquisition, clinical trials and results, litigation strategy, product research and development, selling, general and administrative expenditures, intellectual property, development and manufacturing plans, availability of materials and product and adequacy of capital resources and financing plans constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, the risks identified under the caption “Risk Factors” and other risks detailed in this annual report on Form 10-K and our other filings with the Securities and Exchange Commission. We assume no obligation to update any forward-looking information contained in this annual report on Form 10-K.

Overview

We are a biopharmaceutical company focused on the development and commercialization of innovative therapies that harness biological pathways and deliver value to patients and clinicians in neurology, gastroenterology and orphan diseases. We are currently conducting a number of drug development programs for diseases such as pancreatitis, bipolar disorder, Friedreich’s ataxia and spinal muscular atrophy. We also have a bioprocessing business that focuses on the development and commercialization of products that are used for the production of biopharmaceuticals. In addition, we receive royalties from Bristol-Myers Squibb Company (“Bristol”) on their net sales in the United States of their product Orencia®. Total revenue in fiscal 2010 decreased significantly as compared to fiscal 2009 due to a decrease in our bioprocessing product sales as we experienced lower customer demand for our Protein A products due to the current economic environment and a one-time royalty payment from Bristol recognized as revenue in the prior year. We seek to invest the profits from our current commercial products and royalty and other revenues, as well as use our existing financial resources, to advance the development of our therapeutic product candidates and our bioprocessing business.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

While our significant accounting polices are more fully described in the notes to our financial statements, we have identified the policies and estimates below as critical to our business operations and the understanding of our results of operations. The impact of and any associated risks related to these policies on our business operations are discussed throughout “Management’s Discussion and Analysis of Financial Condition” and “Results of Operations” where such policies affect our reported and expected financial results.

Revenue recognition

We generate product revenues from the sale of bioprocessing products to customers in the pharmaceutical and process chromatography industries. We recognize revenue related to product sales upon delivery of the product to the customer as long as there is persuasive evidence of an arrangement, the sales price is fixed or determinable and collection of the related receivable is reasonably assured. Determination of whether these criteria have been met are based on management’s judgments primarily regarding the fixed nature of the fee charged for product delivered, and the collectability of those fees. We have a few longstanding customers who comprise the majority of revenue and have excellent payment history and therefore we do not require collateral. We have had no significant write-offs of uncollectible invoices in the periods presented.

 

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At the time of sale, we also evaluate the need to accrue for warranty and sales returns. The supply agreements we have with our customers and related purchase orders identify the terms and conditions of each sale and the price of the goods ordered. Due to the nature of the sales arrangements, inventory produced for sale is tested for quality specifications prior to shipment. Since the product is manufactured to order and in compliance with required specifications prior to shipment, the likelihood of sales return, warranty or other issues is largely diminished. Sales returns and warranty issues are infrequent and have had nominal impact on our financial statements historically.

In April 2008, we settled our outstanding litigation with Bristol and began recognizing royalty revenue in fiscal year 2009 for Bristol’s net sales in the United States of Orencia® which is used in the treatment of rheumatoid arthritis. Pursuant to the Bristol Settlement, we recognized $13,383,000 in royalty revenue in fiscal 2009, which included a $5.0 million initial payment and $1.3 million for sales of Orencia® prior to fiscal 2009, in addition to royalties earned on sales of Orencia® during our fiscal 2009. We recognized $8,980,000 in royalty revenue for sales of Orencia® in fiscal 2010. Revenue earned from Bristol royalties is recorded in the periods when it is earned based on royalty reports sent by Bristol to us. We have no continuing obligations to Bristol as a result of this settlement.

Additionally, during fiscal years 2010, 2009 and 2008, we earned and recognized approximately $1,009,000, $776,000 and $244,000, respectively in royalty revenue from ChiRhoClin for their sales of secretin. Revenue earned from ChiRhoClin royalties is recorded in the periods when it is earned based on royalty reports sent by ChiRhoClin to us. As of December 31, 2009, ChiRhoClin has fulfilled its royalty obligations to us for its sales of secretin. We do not expect to recognize any further royalty revenue from ChiRhoClin.

In fiscal 2010, we recognized $552,000 and $125,000 of revenue from sponsored research and development projects under agreements with the Muscular Dystrophy Association (“MDA”) and jointly with the Friedreich’s Ataxia Research Alliance and the National Ataxia Foundation, respectively. During fiscal 2009, we recognized approximately $564,000 and $110,000 of revenue from sponsored research and development projects under agreements with the Muscular Dystrophy Association (“MDA”) and Comitato RUDI onlus—GoFAR (“GoFAR”), respectively. During the fiscal year ended March 31, 2008, we recognized $365,000 of revenue from a sponsored research and development project under an agreement with the Stanley Medical Research Institute.

Research revenue is recognized when the expense has been incurred and services have been performed. Determination of which incurred costs qualify for reimbursement under the terms of our contractual agreements and the timing of when such costs were incurred involves the judgment of management. Our calculations are based upon the agreed-upon terms as stated in the arrangements. However, should the estimated calculations change or be challenged by other parties to the agreements, research revenue may be adjusted in subsequent periods. The calculations have not historically changed or been challenged and we do not anticipate any subsequent change in revenue related to sponsored research and development projects.

There have been no material changes to our initial estimates related to revenue recognition in any periods presented in the accompanying financial statements.

Inventories

Inventories relate to our bioprocessing business. We value inventory at cost or, if lower, fair market value using the first-in, first-out method. We review our inventory at least quarterly and record a provision for excess and obsolete inventory based on our estimates of expected sales volume, production capacity and expiration dates of raw materials, work-in process and finished products. Expected sales volumes are determined based on supply forecasts provided by key customers for the next three to twelve months. We write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value, and inventory in excess of expected requirements to cost of product revenue. Manufacturing of bioprocessing finished goods is done to order and tested for quality specifications prior to shipment.

 

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A change in the estimated timing or amount of demand for our products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. During all periods presented in the accompanying financial statements, there have been no material adjustments related to a revised estimate of inventory valuations.

Business Combinations

Amounts paid for acquisitions are allocated to the assets acquired and liabilities assumed, if any, based on their fair values at the dates of acquisition. The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions determined by management. Any excess of purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. The fair value of contingent consideration includes estimates and judgments made by management regarding the extent of royalties to be earned in excess of the defined minimum royalties. Management will update these estimates and the related fair value of contingent consideration at each reporting period.

Accrued liabilities

We estimate accrued liabilities by identifying services performed on our behalf, estimating the level of service performed and determining the associated cost incurred for such service as of each balance sheet date. Examples of estimated accrued expenses include:

 

   

Fees paid to contract manufacturers in conjunction with the production of clinical materials. These expenses are normally determined through a contract or purchase order issued by us;

 

   

Service fees paid to organizations for their performance in conducting clinical trials. These expenses are determined by contracts in place for those services and communications with project managers on costs which have been incurred as of each reporting date;

 

   

Professional and consulting fees incurred with law firms, audit and accounting service providers and other third party consultants. These expenses are determined by either requesting those service providers to estimate unbilled services at each reporting date for services incurred, or tracking costs incurred by service providers under fixed fee arrangements.

We have processes in place to estimate the appropriate amounts to record for accrued liabilities, which principally involve the applicable personnel reviewing the services provided. In the event that we do not identify certain costs which have begun to be incurred or we under or over-estimate the level of services performed or the costs of such services, the reported expenses for that period may be too low or too high. The date on which certain services commence, the level of services performed on or before a given date, and the cost of such services are often judgmental. We make these judgments based upon the facts and circumstances known at the date of the financial statements.

A change in the estimated cost or volume of services provided could result in additional accrued liabilities. Any significant unanticipated changes in such estimates could have a significant impact on our accrued liabilities and reported operating results. There have been no material adjustments to our accrued liabilities in any of the periods presented in the accompanying financial statements.

Stock-based compensation

We use the Black-Scholes option pricing model to calculate the fair value of share-based awards on the grant date.

The expected term of options granted represents the period of time for which the options are expected to be outstanding and is derived from our historical stock option exercise experience and option expiration data. The

 

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expected life of stock options granted is based on the simplified method. Accordingly, the expected term is presumed to be the midpoint between the vesting date and the end of the contractual term. In addition, for purposes of estimating the expected term, we have aggregated all individual option awards into one group as we do not expect substantial differences in exercise behavior among its employees. The expected volatility is a measure of the amount by which our stock price is expected to fluctuate during the expected term of options granted. We determined the expected volatility based upon the historical volatility of our common stock over a period commensurate with the option’s expected term, exclusive of any events not reasonably anticipated to recur over the option’s expected term. The risk-free interest rate is the implied yield available on U.S. Treasury zero-coupon issues with a remaining term equal to the option’s expected term on the grant date. We have never declared or paid any cash dividends on any of our capital stock and do not expect to do so in the foreseeable future. Accordingly, we use an expected dividend yield of zero to calculate the grant-date fair value of a stock option.

We recognize compensation expense on a straight-line basis over the requisite service period based upon options that are ultimately expected to vest, and accordingly, such compensation expense has been adjusted by an amount of estimated forfeitures. Forfeitures represent only the unvested portion of a surrendered option. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Based on an analysis of historical data, we have calculated an 8% annual forfeiture rate for non-executive level employees, a 3% annual forfeiture rate for executive level employees, and a 0% forfeiture rate for non-employee members of the Board of Directors, which we believe is a reasonable assumption to estimate forfeitures. However, the estimation of forfeitures requires significant judgment, and to the extent actual results or updated estimates differ from our current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised.

For the years ended March 31, 2010, 2009 and 2008, we recorded stock-based compensation expense of approximately $1,007,000, $823,000 and $524,000, respectively, for stock options granted under the Second Amended and Restated 2001 Repligen Corporation Stock Plan (the “2001 Plan”).

As of March 31, 2010, there was $1,919,119 of total unrecognized compensation cost related to unvested share-based awards. This cost is expected to be recognized over a weighted average remaining requisite service period of 3.11 years. We expect 823,294 in unvested options to vest over the next five years.

RESULTS OF OPERATIONS

The following discussion of the financial condition and results of operations should be read in conjunction with the accompanying financial statements and the related footnotes thereto.

Revenues

Total revenues for fiscal 2010, 2009 and 2008 were $20,971,000, $29,362,000, and $19,296,000, respectively, and were primarily comprised of sales of our bioprocessing products and royalties. Our total revenue was comprised of:

 

     Year ended March 31,    % Change  
     2010    2009    2008    2010 vs. 2009     2009 vs. 2008  
     (in thousands, except percentages)             

Bioprocessing

   $ 10,305    $ 14,361    $ 16,321    (28 %)    (12 %) 

SecreFlo®

     —        168      2,266    (100 %)    (93 %) 
                                 

Product revenue

   $ 10,305    $ 14,529    $ 18,587    (29 %)    (22 %) 

Royalty and other revenue

     10,666      14,833      709    (28 %)    1992
                                 

Total revenue

   $ 20,971    $ 29,362    $ 19,296    (29 %)    52
                                 

 

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Substantially all of our bioprocessing products are based on recombinant Protein A and are sold to customers who incorporate our manufactured products into their proprietary antibody purification systems to be sold directly to the pharmaceutical industry. Monoclonal antibodies are a well-established class of drug with applications in rheumatoid arthritis, asthma and a variety of cancers. Sales of our bioprocessing products are therefore impacted by the timing of large-scale production orders and the regulatory approvals for such antibodies, which may result in significant quarterly fluctuations.

During fiscal 2010, bioprocessing product sales decreased by $4,056,000 or 28% as compared to fiscal 2009. Volume decreased 26% due to decreased demand from certain key customers in reaction to current economic conditions and other business events. Changes in the mix of products sold in fiscal 2010 as compared to fiscal 2009 comprised the remaining 2% decrease. We sell various bioprocessing products at various price points. The mix of products sold varies and impacts the fluctuations in total product revenue and cost of product revenues from period to period.

During fiscal 2009, bioprocessing product sales decreased by $1,960,000 or 12% as compared to fiscal 2008. Volume decreased 5% due to decreased demand from certain key customers in reaction to the current credit crisis and other business events. Changes in the mix of products sold in fiscal 2009 as compared to fiscal 2008 comprised the remaining 7% decrease.

We anticipate that bioprocessing product sales will increase in fiscal 2011 as our customers respond to an anticipated economic recovery during the year. In addition, our bioprocessing product sales may be subject to quarterly fluctuations due to the timing of large-scale production orders.

Sales of SecreFlo® decreased $2,098,000 in fiscal 2009 as we discontinued selling this product in the second quarter of fiscal 2009. The settlement in fiscal 2005 with our sole supplier of SecreFlo®, ChiRhoClin, provided for a certain amount of vials of product that we could ultimately ship. The final shipment of SecreFlo® to us from ChiRhoClin was received in fiscal 2008 and we discontinued selling SecreFlo® in the second quarter of fiscal 2009.

Pursuant to the Bristol Settlement (as defined in Note 10), we recognized royalty revenue of approximately $8,980,000 and $13,383,000 in fiscal years 2010 and 2009, respectively. The $13,383,000 recognized in fiscal 2009 included an initial $5.0 million royalty payment, $1.3 million in royalties for sales of Orencia® from January 1, 2008 to March 31, 2008, as well as $7.1 million for sales in fiscal year 2009. For fiscal 2011, we expect royalty revenues to increase moderately over fiscal 2010 as Bristol’s Orencia® continues to penetrate the market.

Also, during fiscal years 2010, 2009 and 2008, we earned and recognized approximately $1,009,000, $776,000 and $244,000, respectively, in royalty revenue from ChiRhoClin. As of December 31, 2009, ChiRhoClin has fulfilled its royalty obligations to us for its sales of our secretin. We do not expect to recognize any further royalty revenue from ChiRhoClin.

In fiscal 2010, we recognized $552,000 and $125,000 of revenue from sponsored research and development projects under agreements with the Muscular Dystrophy Association (“MDA”) and jointly with the Friedreich’s Ataxia Research Alliance and the National Ataxia Foundation, respectively. During fiscal 2009, we recognized approximately $564,000 and $110,000 of revenue from sponsored research and development projects under agreements with the MDA and Comitato RUDI onlus—GoFAR (“GoFAR”), respectively. During the fiscal year ended March 31, 2008, we recognized $365,000 of revenue from a sponsored research and development project under an agreement with the Stanley Medical Research Institute.

We expect research and license revenues will remain relatively consistent in fiscal 2011 as the MDA grant related effort continues.

 

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Costs and operating expenses

Total costs and operating expenses for fiscal 2010, 2009 and 2008 consist of the following:

 

     Year ended March 31,     % Change  
     2010    2009    2008     2010 vs. 2009     2009 vs. 2008  
(In thousands)                             

Costs and operating expenses:

            

Cost of product revenue

   $ 4,159    $ 5,686    $ 6,160      (27 %)    (8 %) 

Cost of royalty and other revenue

     1,347      1,091      —        23   —     

Research and development

     14,160      12,772      7,241      11   76

Selling, general and administrative

     7,072      5,933      10,173      19   (42 %) 

Net gain from litigation settlement

     —        —        (40,170   —        —     
                                  

Total costs and operating expenses

   $ 26,738    $ 25,482    $ (16,596   5   254
                                  

The decrease in cost of product revenue of $1,527,000 or 27% in fiscal 2010 as compared to fiscal 2009 is primarily due to a 29% decrease in bioprocessing product sales as well as favorable manufacturing variances. This decrease is partially offset by higher depreciation costs of approximately $156,000 related to investments in our manufacturing facilities.

The decrease in cost of product revenue of $474,000 or 8% in fiscal 2009 as compared to fiscal 2008 was primarily due to a 12% decrease in bioprocessing sales. This decrease was partially offset by increased direct labor costs of approximately $193,000 due primarily to additional quality assurance and control personnel hired to meet growing customer demand for increased product quality assurance efforts and to support ISO 9001 certification. It was also partially offset by higher depreciation and occupancy costs of approximately $357,000 primarily associated with our manufacturing and administrative expansion at a second site located in Waltham, MA.

Pursuant to the Bristol Settlement, we must remit 15% of royalty revenue received through the expiration of the agreement in December 2013, after deducting certain allowable legal and other costs, to the University of Michigan. For fiscal 2010 and 2009, this cost of royalty revenue was approximately $1,347,000 and $1,091,000, respectively. This increase is directly related to the increase in Bristol royalty revenue noted above.

Research and development costs primarily include costs of internal personnel, external pharmacology and toxicology research, clinical trials and the costs associated with the manufacturing and testing of clinical materials. We currently have ongoing clinically enabled research and development programs that support our secretin and uridine product candidates. In addition, we are pursuing pre-clinical activities in Friedreich’s ataxia and spinal muscular atrophy that may or may not be further developed. Due to the small size of the Company and the fact that these various programs share personnel and fixed costs, we do not track all our expenses or allocate any fixed costs by program, and therefore, have not provided an estimate of historical costs incurred by project.

Each of our therapeutic research and development programs is subject to risks and uncertainties, including the requirement to seek regulatory approvals that are outside of our control. For example, our clinical trials may be subject to delays based on our inability to enroll patients at the rate that we expect to meet the schedule for our planned clinical trials. Moreover, the product candidates identified in these research programs, particularly in our early stage programs must overcome significant technological, manufacturing and marketing challenges before they can be successfully commercialized. For example, results from our preclinical animal models may not be replicated in our clinical trials with humans. As a result of these risks and uncertainties, we are unable to predict with any certainty the period in which material net cash inflows from such projects could be expected to commence or the completion date of these programs.

These risks and uncertainties also prevent us from estimating with any certainty the specific timing and future costs of our research and development programs, although historical trends within the industry suggest that

 

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expenses tend to increase in later stages of development. Collaborations with commercial vendors and academic researchers accounted for 51%, 59%, and 45% of our research and development expenses for fiscal 2010, 2009, and 2008, respectively. The outsourcing of such services provides us flexibility to discontinue or increase spending depending on the success of our research and development programs.

During fiscal 2010, research and development expenses increased by $1,388,000 or 11% as compared to fiscal 2009. This increase is comprised primarily of 1) $909,000 related to our new DcpS program to develop a drug for the treatment of patients with spinal muscular atrophy, 2) $891,000 related to Friedreich’s ataxia as we identified a clinical candidate and began preparing for a phase 1 clinical trial and 3) $236,000 related to increased personnel expenses primarily due to headcount additions in clinical and regulatory areas. These increases were partially offset by a $746,000 decrease as we approached the end of our phase 3 clinical trial for RG1068, evaluating the use of human secretin in aiding pancreatic imaging.

During fiscal 2009, research and development expenses increased by $5,531,000 or 76% as compared to fiscal 2008. This increase was comprised primarily of 1) $1,869,000 related to the continued phase 3 clinical trial for RG1068, evaluating the use of human secretin in pancreatic imaging, 2) $1,500,000 related to the phase 2b clinical trial for RG2417, evaluating the use of uridine to treat bipolar depression and 3) $1,388,000 related to Friedreich’s ataxia as we continued to search for a clinical candidate. Additionally, there were increased personnel expenses of $724,000 primarily due to headcount additions in clinical, regulatory and research and development areas.

Future research and development expenses are dependent on a number of variables, including the cost and design of clinical trials and external costs such as manufacturing of clinical materials. We expect our research and development expenses in fiscal 2011 to decrease moderately primarily due to the secretin clinical trial ending in fiscal 2010, the timing of certain expenditures associated with our Friedreich’s ataxia program for which we recently filed an IND application with the FDA, partially offset by increased spending on our DcpS program for treatment of patients with spinal muscular atrophy. In addition, we will have a re-analysis performed on the images obtained from our Phase 3 clinical trial for secretin to improve pancreatic diagnostic imaging and anticipate that preliminary results will be available by the end of fiscal year 2011, ending on March 31, 2011. We will continue our Phase 2b clinical trial for uridine to treat bipolar depression and anticipate that preliminary results will also be available by the end of fiscal year 2011. There may be further increases in expenses if we acquire additional product candidates.

Selling, general and administrative (“SG&A”) expenses include the associated costs with selling our commercial products and costs required to support our research and development efforts including legal, accounting, patent, shareholder services and other administrative functions. In addition, SG&A expenses have historically included costs associated with various litigation matters.

In fiscal 2010, SG&A costs increased by $1,139,000 or 19% as compared to fiscal 2009. This increase is primarily due to increased personnel expenses of $1,001,000 primarily due to headcount increases in marketing and business development including salaries and stock-based compensation.

During fiscal 2009, SG&A costs decreased by $4,240,000 or 42% as compared to fiscal 2008. This decrease is primarily due to $4,841,000 of litigation costs incurred in fiscal 2008 relating to the Bristol and ImClone settlements, and a $238,000 decrease in recruiting and relocation costs as certain key board and management positions were filled in fiscal 2008. These decreases are partially offset by increased personnel expenses of $899,000 primarily due to headcount increases in marketing and business development including salaries and stock-based compensation.

We expect SG&A expenses to increase moderately in fiscal 2011 primarily due to slightly higher headcount and related personnel expenses.

 

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Net gain from litigation settlement

On September 10, 2007, Repligen and MIT entered into the ImClone Settlement relating to the lawsuit against ImClone for infringement of the ‘281 patent. Pursuant to the ImClone Settlement, ImClone made a payment of $65 million to Repligen and MIT that resulted in net proceeds to Repligen of $40,170,000 after litigation costs of $13,830,000 and proceeds to MIT of $11,000,000. The ImClone Settlement served as the basis to dismiss the lawsuit against ImClone and for Repligen to grant ImClone a non-exclusive sublicense to the ‘281 patent and certain other intellectual property.

Investment income

Investment income includes income earned on invested cash balances. Investment income for fiscal 2010, 2009 and 2008 was approximately $870,000, $1,896,000 and $2,051,000, respectively. The decrease of $1,026,000 or 54% in fiscal 2010 compared to fiscal 2009 and the decrease of $155,000 or 8% in fiscal 2009 compared to fiscal 2008 are primarily attributable to lower interest rates resulting from overall economic conditions. We expect interest income to vary based on changes in the amount of funds invested and fluctuation of interest rates.

Benefit from income taxes

In fiscal year 2010, we recorded a tax benefit of approximately $835,000 primarily due to the “Worker, Homeownership, and Business Assistance Act of 2009” (the “Act”) that was enacted in November 2009. Among other things, the Act suspended the limitation on the use of net operating losses to offset alternative minimum tax liabilities, which we expect will enable us to recover $835,000 of alternative minimum taxes paid in prior years. As a result, the Company had an effective tax rate of negative 17.0%.

Liquidity and capital resources

We have financed our operations primarily through sales of equity securities, revenues derived from product sales, and research grants, as well as proceeds and royalties from litigation settlements. Our revenue for the foreseeable future will be limited to our bioprocessing product revenue, royalties from Bristol, and research and development grants. Given the uncertainties related to pharmaceutical product development, we are currently unable to reliably estimate when, if ever, our therapeutic product candidates will generate revenue and cash flows.

At March 31, 2010, we had cash and marketable securities of $59,146,000 compared to $63,961,000 at March 31, 2009. Deposits for leased office space of $200,000 is classified as restricted cash and is not included in cash and marketable securities total for either 2010 or 2009.

Cash flows

 

(In thousands)    Year ended March 31,  

Cash provided by (used in)

   2010     Increase /
(Decrease)
    2009     Increase /
(Decrease)
    2008  

Operating activities

   $ (2,448   $ (8,755   $ 6,307      $ (32,160   $ 38,467   

Investing activities

     9,921        42,153        (32,232     (18,003     (14,229

Financing activities

     12        1,608        (1,596     (2,194     598   

Operating activities

In fiscal 2010, our operating activities consumed $2,448,000 of cash which reflects a net loss of approximately $4,064,000 and non-cash charges totaling approximately $2,386,000 including depreciation, amortization, and stock-based compensation charges. The remaining cash flow used in operations resulted from unfavorable changes in various working capital accounts.

 

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In fiscal 2009, our operating activities provided cash of $6,307,000 reflecting net income of approximately $5,746,000 which includes non-cash charges totaling approximately $1,907,000 including depreciation, amortization, and stock-based compensation charges. The remaining cash flow used in operations resulted from unfavorable changes in various working capital accounts.

In fiscal 2008, our operating activities provided cash of $38,467,000 reflecting net income of approximately $37,107,000 which includes non-cash charges totaling approximately $1,659,000 including depreciation, amortization, and stock-based compensation charges. The remaining cash flow used in operations resulted from unfavorable changes in various working capital accounts.

Investing activities

In fiscal 2010, our investing activities generated $9,921,000 of cash, which is primarily due to net maturities of marketable debt securities of $12,299,000 partially offset by $1,780,000 of cash used to acquire the assets of BioFlash Partners, LLC (see Note 13) and $597,000 for capital expenditures. In fiscal 2009, our investing activities consumed $32,232,000 of cash, which is primarily due to net purchases of marketable debt securities of $30,892,000. Also in fiscal 2009, we spent $1,340,000 on capital expenditures as we continued to upgrade both our research and development and manufacturing capabilities. We place our marketable security investments in high quality credit instruments as specified in our investment policy guidelines.

Financing activities

In fiscal 2010, exercises of stock options provided cash receipts of $54,000. In fiscal 2009, the repurchase of common stock consumed $1,954,000 and exercises of stock options provided cash receipts of $402,000.

Off-balance sheet arrangements

We do not have any special purpose entities or off-balance sheet financing arrangements.

Contractual obligations

As of March 31, 2010, we had the following fixed obligations and commitments:

 

     Payments Due By Period
     Total    Less than 1
Year
   1 – 3 Years    3 – 5 Years    More than 5
Years
     (In thousands)

Operating lease obligations

   $ 1,005    $ 572    $ 424    $ 9    $ —  

Purchase obligations

     1,212      1,212      —        —        —  

Contractual obligations (1)

     1,776      1,011      115      190      460
                                  

Total

   $ 3,993    $ 2,795    $ 539    $ 199    $ 460
                                  

 

(1) These amounts include obligations for minimum contingent consideration from acquisitions as well as for license, supply and consulting agreements.

Capital requirements

Our future capital requirements will depend on many factors, including the following:

 

   

the success of our clinical studies;

 

   

the scope of and progress made in our research and development activities;

 

   

our ability to acquire additional products or product candidates;

 

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the extent of any share repurchase activity;

 

   

the success of any proposed financing efforts; and

 

   

the ability to sustain sales and profits of our bioprocessing products; and

 

   

the amount of royalty revenues we receive from Bristol.

Absent acquisitions of additional products, product candidates or intellectual property, we believe our current cash balances are adequate to meet our cash needs for at least the next twenty-four months. We expect to incur moderately increased expenses in fiscal 2011 compared to fiscal 2010. This is primarily due to increases in cost of product revenue associated with higher anticipated product revenue, increased personnel expenses, offset by moderately lower research and development costs. Our future capital requirements include, but are not limited to, continued investment in our research and development programs, the acquisition of additional products and technologies to complement our manufacturing capabilities, capital expenditures primarily associated with purchases of equipment and continued investment in our intellectual property portfolio.

We plan to continue to invest in key research and development activities. We actively evaluate various strategic transactions on an ongoing basis, including licensing or acquiring complementary products, technologies or businesses that would complement our existing portfolio of development programs. We continue to seek to acquire such potential assets that may offer us the best opportunity to create value for our shareholders. In order to acquire such assets, we may need to seek additional financing to fund these investments. This may require the issuance or sale of additional equity or debt securities. The sale of additional equity may result in additional dilution to our stockholders. Should we need to secure additional financing to acquire a product, fund future investment in research and development, or meet our future liquidity requirements, we may not be able to secure such financing, or obtain such financing on favorable terms because of the volatile nature of the biotechnology marketplace.

Net operating loss carryforwards

At March 31, 2010, we had net operating loss carryforwards of approximately $63,903,000 and business tax credits carryforwards of approximately $2,118,000 available to reduce future federal income taxes, if any. Additionally, at March 31, 2010, we had net operating loss carryforwards of approximately $3,061,000 and business tax credits carryforwards of approximately $5,615,000 available to reduce future state income taxes, if any. The net operating loss and business tax credits carryforwards will continue to expire at various dates through March 2030. Net operating loss carryforwards and available tax credits are subject to review and possible adjustment by the Internal Revenue Service and may be limited in the event of certain changes in the ownership interest of significant stockholders.

In fiscal year 2010, we recorded a tax benefit of approximately ($835,000) primarily due to the “Worker, Homeownership, and Business Assistance Act of 2009” (the “Act”) that was enacted in November 2009. Among other things, the Act suspended the limitation on the use of net operating losses to offset alternative minimum tax liabilities, and will enable us to receive a refund of $835,000 for alternative minimum taxes paid in prior years. In fiscal 2009 and 2008, we utilized our net operating loss carryforwards to reduce our income tax provision.

Effects of inflation

Our assets are primarily monetary, consisting of cash, cash equivalents and marketable securities. Because of their liquidity, these assets are not directly affected by inflation. Since we intend to retain and continue to use our equipment, furniture and fixtures and leasehold improvements, we believe that the incremental inflation related to replacement costs of such items will not materially affect our operations. However, the rate of inflation affects our expenses, such as those for employee compensation and contract services, which could increase our level of expenses and the rate at which we use our resources.

 

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Recent accounting pronouncements

In October 2009, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2009-13, “Multiple-Deliverable Arrangements—a consensus of the FASB Emerging Issues Task Force” (“ASU 2009-13”). This ASU establishes the accounting and reporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of this update address how to separate deliverables and how to measure and allocate arrangement consideration to one or more units of accounting. This update is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted. We have not yet completed our evaluation of ASU 2009-13, but we do not currently believe that adoption will have a material impact on our results of operations, financial position or cash flows.

In January 2010, the FASB issued ASU No. 2010-06, “Improving Disclosures about Fair Value Measurements“ (“ASU 2010-06”). This ASU requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, “Fair Value Measurements and Disclosures,” including significant transfers into and out of Level 1 and Level 2 investments of the fair value hierarchy. ASU 2010-06 also requires additional information in the roll forward of Level 3 investments including presentation of purchases, sales, issuances, and settlements on a gross basis. Further clarification for existing disclosure requirements provides for the disaggregation of assets and liabilities presented, and the enhancement of disclosures around inputs and valuation techniques. This update is effective for the first interim or annual reporting period beginning after December 15, 2009, except for the additional information in the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods within those fiscal years. We adopted ASU 2010-06 in January 2010. The adoption of this update did not have a material impact on our results of operations, financial position or cash flows.

In April 2010, the FASB issued ASU No. 2010-17, “Milestone Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task Force” (“ASU 2010-17”). This ASU provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions. ASU 2010-17 is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. We have not yet completed our evaluation of ASU 2010-17, but we do not currently believe that adoption will have a material impact on our results of operations, financial position or cash flows.

 

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Item 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Interest rate risk

We have investments in commercial paper, U.S. Government and agency securities as well as corporate bonds and other debt securities. As a result, we are exposed to potential loss from market risks that may occur as a result of changes in interest rates, changes in credit quality of the issuer or otherwise.

We generally place our marketable security investments in high quality credit instruments, as specified in our investment policy guidelines. A hypothetical 100 basis point decrease in interest rates would result in an approximate $254,000 decrease in the fair value of our investments as of March 31, 2010. We believe, however, that the conservative nature of our investments mitigates our interest rate exposure, and our investment policy limits the amount of our credit exposure to any one issue, issuer (with the exception of U.S. agency obligations) and type of instrument. We do not expect any material loss from our marketable security investments and therefore believe that our potential interest rate exposure is limited. We intend to hold the majority of our investments to maturity, in accordance with our business plans.

 

Item 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

Financial statements and supplementary data required by Item 8 are set forth at the pages indicated in Item 15(a) below and are incorporated herein by reference.

 

Item 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.

None.

 

Item 9A. CONTROLS AND PROCEDURES

(a) Disclosure Controls and Procedures.

The Company’s management, with the participation of our chief executive officer and principal financial officer, has evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based on such evaluation, our chief executive officer and principal financial officer have concluded that, as of the end of such period, the Company’s disclosure controls and procedures were effective in ensuring that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, on a timely basis, and is accumulated and communicated to the Company’s management, including the Company’s chief executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

(b) Management’s Annual Report on Internal Control Over Financial Reporting.

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board of directors, management and other personnel to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles and includes those policies and procedures that:

 

   

pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;

 

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provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and

 

   

provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Projections of any evaluation of effectiveness to future periods are subject to the risks that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

Management assessed the effectiveness of the Company’s internal control over financial reporting as of March 31, 2010. In making this assessment, management used the criteria established in Internal Control—Integrated Framework, issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on this assessment, our management concluded that, as of March 31, 2010, our internal control over financial reporting is effective based on those criteria. Ernst & Young LLP, the independent registered public accounting firm that audited our financial statements included in this annual report on Form 10-K, has issued an attestation report on our internal control over financial reporting as of March 31, 2010. Please see Item 9A of this Form 10-K.

/s/ REPLIGEN CORPORATION

June 10, 2010

 

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(c) Attestation Report of the Independent Registered Public Accounting Firm.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of Repligen Corporation:

We have audited Repligen Corporation’s internal control over financial reporting as of March 31, 2010, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Repligen Corporation’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.

We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.

A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.

Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

In our opinion, Repligen Corporation maintained, in all material respects, effective internal control over financial reporting as of March 31, 2010, based on the COSO criteria.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the balance sheets of Repligen Corporation as of March 31, 2010 and 2009, and the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended March 31, 2010 of Repligen Corporation and our report dated June 10, 2010 expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Boston, Massachusetts

June 10, 2010

 

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(d) Changes in Internal Control Over Financial Reporting.

There have not been any changes in the Company’s internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended March 31, 2010 that have material affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

Item 9B. OTHER INFORMATION

None.

 

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PART III

Pursuant to General Instructions G to Form 10-K, the information required for Part III, Items 10, 11, 12, 13 and 14, is incorporated herein by reference from the Company’s proxy statement for the 2010 Annual Meeting of Stockholders.

 

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PART IV

 

Item 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

The following documents are filed as part of this Annual Report on Form 10-K:

(a) (1) Financial Statements:

The financial statements required by this item are submitted in a separate section beginning on page 38 of this Report, as follows:

 

     Page

Report of Independent Registered Public Accounting Firm

   46

Balance Sheets as of March 31, 2010 and 2009

   47

Statements of Operations for the Years Ended March 31, 2010, 2009 and 2008

   48

Statements of Stockholders’ Equity for the Years Ended March 31, 2010, 2009 and 2008

   49

Statements of Cash Flows for the Years Ended March 31, 2010, 2009 and 2008

   50

Notes to Financial Statements

   51

(a) (2) Financial Statement Schedules:

None.

(a) (3) Exhibits:

The Exhibits which are filed as part of this Annual Report or which are incorporated by reference are set forth in the Exhibit Index hereto.

EXHIBIT INDEX

 

Exhibit
Number

  

Document Description

    3.1    Restated Certificate of Incorporation dated June 30, 1992 and amended September 17, 1999 (filed as Exhibit 3.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1999 and incorporated herein by reference) (SEC File No. 000-14656).
    3.2    Certificate of Designation of Series A Junior Participating Preferred Stock dated March 4, 2003 (filed as Exhibit A of Exhibit 1 to Repligen Corporation’s Registration Statement on Form 8-A filed March 4, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
    3.3    Amended and Restated By-laws (filed as Exhibit 3.2 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
    4.1    Specimen Stock Certificate (filed as Exhibit 4.1 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
    4.2    Rights Agreement, dated as of March 3, 2003, between Repligen Corporation and American Stock Transfer & Trust Company (filed as Exhibit 4.1 to Repligen Corporation’s Current Report on Form 8-K filed March 4, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
  10.1*    Consulting Agreement, dated November 1, 1981, between Dr. Alexander Rich and Repligen Corporation. (filed as Exhibit 10.2 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).

 

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Exhibit
Number

  

Document Description

  10.2*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and Walter C. Herlihy (filed as Exhibit 10.3 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.3*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and James R. Rusche (filed as Exhibit 10.4 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.4*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and Daniel P. Witt (filed as Exhibit 10.5 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.5*    Employment Offer Letter dated February 29, 2008 by and between Repligen Corporation and William Kelly (filed as Exhibit 10.20 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2008 and incorporated herein by reference).
  10.6*    Repligen Executive Incentive Compensation Plan (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on form 8-K filed on December 14, 2005 and incorporated herein by reference).
  10.7*    The Amended 1992 Repligen Corporation Stock Option Plan, as amended (filed as Exhibit 4.2 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000 and incorporated herein by reference) (SEC File No. 000-14656).
  10.8*    The Second Amended and Restated 2001 Repligen Corporation Stock Plan (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on Form 8-K filed on September 18, 2008 and incorporated herein by reference).
  10.8.1*    The Second Amended and Restated 2001 Repligen Corporation Stock Option Plan, Form of Incentive Stock Option Plan (filed as Exhibit 10.14 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2005 and incorporated herein by reference).
  10.8.2*    The Amended and Restated 2001 Repligen Corporation Stock Plan, Form of Restricted Stock Agreement (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on Form 8-K filed on January 9, 2006 and incorporated herein by reference).
  10.9    Common Stock Purchase Warrant dated April 6, 2007 (filed as Exhibit 4.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and incorporated herein by reference).
  10.10#    Manufacturing Transfer Agreement dated as of December 17, 1998 among the Company and Amersham Pharmacia Biotech AB (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended December 31, 1998 and incorporated herein by reference) (SEC File No. 000-14656).
  10.11#    License Agreement dated as of July 24, 2000 with University of Michigan (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000 and incorporated herein by reference) (SEC File No. 000-14656).
  10.12    Lease Between Repligen Corporation as Tenant and West Seyon LLC as Landlord, 35 Seyon Street, Waltham, MA (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2001 and incorporated herein by reference) (SEC File No. 000-14656).
  10.13#    Settlement Agreement by and between ChiRhoClin, Inc. and Repligen Corporation, and dated as of May 9, 2005 (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 and incorporated herein by reference).

 

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Exhibit
Number

  

Document Description

  10.14#    License Agreement by and between The Scripps Research Institute and Repligen Corporation dated April 6, 2007 (filed as Exhibit 10.18 to Repligen Corporation’s Annual Report on
Form 10-K for the year ended March 31, 2007 and incorporated herein by reference).
  10.15#    Settlement Agreement and Releases dated September 10, 2007 by and among Repligen Corporation, Massachusetts Institute of Technology and ImClone Systems Incorporated (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and incorporated herein by reference).
  10.16#    Settlement and Release Agreement dated April 7, 2008 by and among Repligen Corporation, The Regents of the University of Michigan and Bristol-Myers Squibb Company (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and incorporated herein by reference).
  10.17#+    Strategic Supplier Alliance Agreement dated January 28, 2010 by and between Repligen Corporation and GE Healthcare Bio-Sciences AB.
  23.1+    Consent of Ernst & Young LLP.
  24.1+    Power of Attorney (included on signature page).
  31.1+    Rule 13a-14(a)/15d-14(a) Certification.
  31.2+    Rule 13a-14(a)/15d-14(a) Certification.
  32.1+    Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

# Confidential treatment obtained as to certain portions.
* Management contract or compensatory plan or arrangement.
+ Filed herewith.

The exhibits listed above are not contained in the copy of the Annual Report on Form 10-K distributed to stockholders. Upon the request of any stockholder entitled to vote at the 2010 annual meeting, the Registrant will furnish that person without charge a copy of any exhibits listed above. Requests should be addressed to Repligen Corporation, 41 Seyon Street, Waltham, MA 02453.

 

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SIGNATURES

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 thereunto duly authorized.

 

    REPLIGEN CORPORATION
Date: June 10, 2010     By:   /S/    WALTER C. HERLIHY        
     

Walter C. Herlihy

President and Chief Executive Officer

POWER OF ATTORNEY

KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below hereby makes, constitutes and appoints Walter C. Herlihy and William J. Kelly with full power to act without the other, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities to sign any or all amendments to this Form 10-K, and to file the same with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agents of any of them, or any substitute or substitutes, lawfully do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.

 

Signature

  

Title

 

Date

/s/    WALTER HERLIHY        

Walter C. Herlihy, Ph.d.

   President, Chief Executive Officer and Director
(Principal executive officer)
  June 10, 2010

/s/    WILLIAM J. KELLY        

William J. Kelly

   Chief Financial Officer
(Principal financial and accounting
officer)
  June 10, 2010

/s/    ALEXANDER RICH        

Alexander Rich, M.D.

   Chairman of the Board   June 10, 2010

/s/    KAREN DAWES        

Karen Dawes

   Director   June 10, 2010

/s/    ALFRED L. GOLDBERG        

Alfred L. Goldberg, Ph.D.

   Director   June 10, 2010

/s/    EARL W. HENRY        

Earl W. Henry, M.D.

   Director   June 10, 2010

/s/    THOMAS F. RYAN, JR.        

Thomas F. Ryan, Jr.

   Director   June 10, 2010

/s/    GLENN L. COOPER

Glenn L. Cooper, M.D.

   Director   June 10, 2010

 

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EXHIBIT INDEX

 

Exhibit
Number

  

Document Description

    3.1    Restated Certificate of Incorporation dated June 30, 1992 and amended September 17, 1999 (filed as Exhibit 3.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 1999 and incorporated herein by reference) (SEC File No. 000-14656).
    3.2    Certificate of Designation of Series A Junior Participating Preferred Stock dated March 4, 2003 (filed as Exhibit A of Exhibit 1 to Repligen Corporation’s Registration Statement on Form 8-A filed March 4, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
    3.3    Amended and Restated By-laws (filed as Exhibit 3.2 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
    4.1    Specimen Stock Certificate (filed as Exhibit 4.1 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
    4.2    Rights Agreement, dated as of March 3, 2003, between Repligen Corporation and American Stock Transfer & Trust Company (filed as Exhibit 4.1 to Repligen Corporation’s Current Report on Form 8-K filed March 4, 2003 and incorporated herein by reference) (SEC File No. 000-14656).
  10.1*    Consulting Agreement, dated November 1, 1981, between Dr. Alexander Rich and Repligen Corporation. (filed as Exhibit 10.2 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.2*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and Walter C. Herlihy (filed as Exhibit 10.3 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.3*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and James R. Rusche (filed as Exhibit 10.4 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.4*    Employment Agreement, dated March 14, 1996, between Repligen Corporation and Daniel P. Witt (filed as Exhibit 10.5 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2002 and incorporated herein by reference) (SEC File No. 000-14656).
  10.5*    Employment Offer Letter dated February 29, 2008 by and between Repligen Corporation and William Kelly (filed as Exhibit 10.20 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2008 and incorporated herein by reference).
  10.6*    Repligen Executive Incentive Compensation Plan (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on form 8-K filed on December 14, 2005 and incorporated herein by reference).
  10.7*    The Amended 1992 Repligen Corporation Stock Option Plan, as amended (filed as Exhibit 4.2 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000 and incorporated herein by reference) (SEC File No. 000-14656).
  10.8*    The Second Amended and Restated 2001 Repligen Corporation Stock Plan (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on Form 8-K filed on September 18, 2008 and incorporated herein by reference).
  10.8.1*    The Second Amended and Restated 2001 Repligen Corporation Stock Option Plan, Form of Incentive Stock Option Plan (filed as Exhibit 10.14 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2005 and incorporated herein by reference).
  10.8.2*    The Amended and Restated 2001 Repligen Corporation Stock Plan, Form of Restricted Stock Agreement (filed as Exhibit 10.1 to Repligen Corporation’s Current Report on Form 8-K filed on January 9, 2006 and incorporated herein by reference).

 

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Exhibit
Number

  

Document Description

  10.9    Common Stock Purchase Warrant dated April 6, 2007 (filed as Exhibit 4.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 and incorporated herein by reference).
  10.10#    Manufacturing Transfer Agreement dated as of December 17, 1998 among the Company and Amersham Pharmacia Biotech AB (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended December 31, 1998 and incorporated herein by reference) (SEC File No. 000-14656).
  10.11#    License Agreement dated as of July 24, 2000 with University of Michigan (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2000 and incorporated herein by reference) (SEC File No. 000-14656).
  10.12    Lease Between Repligen Corporation as Tenant and West Seyon LLC as Landlord, 35 Seyon Street, Waltham, MA (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2001 and incorporated herein by reference) (SEC File No. 000-14656).
  10.13#    Settlement Agreement by and between ChiRhoClin, Inc. and Repligen Corporation, and dated as of May 9, 2005 (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2005 and incorporated herein by reference).
  10.14#    License Agreement by and between The Scripps Research Institute and Repligen Corporation dated April 6, 2007 (filed as Exhibit 10.18 to Repligen Corporation’s Annual Report on Form 10-K for the year ended March 31, 2007 and incorporated herein by reference).
  10.15#    Settlement Agreement and Releases dated September 10, 2007 by and among Repligen Corporation, Massachusetts Institute of Technology and ImClone Systems Incorporated (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 and incorporated herein by reference).
  10.16#    Settlement and Release Agreement dated April 7, 2008 by and among Repligen Corporation, The Regents of the University of Michigan and Bristol-Myers Squibb Company (filed as Exhibit 10.1 to Repligen Corporation’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and incorporated herein by reference).
  10.17#+    Strategic Supplier Alliance Agreement dated January 28, 2010 by and between Repligen Corporation and GE Healthcare Bio-Sciences AB.
  23.1+    Consent of Ernst & Young LLP.
  24.1+    Power of Attorney (included on signature page).
  31.1+    Rule 13a-14(a)/15d-14(a) Certification.
  31.2+    Rule 13a-14(a)/15d-14(a) Certification.
  32.1+    Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

 

# Confidential treatment obtained as to certain portions.
* Management contract or compensatory plan or arrangement.
+ Filed herewith.

 

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INDEX TO FINANCIAL STATEMENTS

 

     Page

Report of Independent Registered Public Accounting Firm

   46

Balance Sheets as of March 31, 2010 and 2009

   47

Statements of Operations for the Years Ended March 31, 2010, 2009 and 2008

   48

Statements of Stockholders’ Equity for the Years Ended March 31, 2010, 2009 and 2008

   49

Statements of Cash Flows for the Years Ended March 31, 2010, 2009 and 2008

   50

Notes to Financial Statements

   51

 

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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of Repligen Corporation:

We have audited the accompanying balance sheets of Repligen Corporation as of March 31, 2010 and 2009, and the related statements of operations, stockholders’ equity, and cash flows for each of the three years in the period ended March 31, 2010. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Repligen Corporation at March 31, 2010 and 2009, and the results of its operations, and its cash flows for each of the three years in the period ended March 31, 2010, in conformity with U.S. generally accepted accounting principles.

We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Repligen Corporation’s internal control over financial reporting as of March 31, 2010, based on criteria established in Internal Control-Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated June 10, 2010 expressed an unqualified opinion thereon.

/s/ Ernst & Young LLP

Boston, Massachusetts

June 10, 2010

 

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REPLIGEN CORPORATION

BALANCE SHEETS

 

     March 31, 2010     March 31, 2009  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 12,526,040      $ 5,041,410   

Marketable securities

     40,608,710        43,817,915   

Accounts receivable, less reserve for doubtful accounts of $10,000

     570,038        540,779   

Royalties receivable

     2,296,000        2,036,800   

Inventories

     2,201,140        2,413,227   

Prepaid expenses and other current assets

     1,479,107        933,585   
                

Total current assets

     59,681,035        54,783,716   

Property, plant and equipment, at cost:

    

Leasehold improvements

     3,855,616        3,845,247   

Equipment

     4,176,281        3,527,469   

Furniture and fixtures

     567,480        513,501   
                

Total property, plant and equipment, at cost

     8,599,377        7,886,217   

Less: Accumulated depreciation

     (5,466,354     (4,216,430
                

Property, plant and equipment, net

     3,133,023        3,669,787   

Long-term marketable securities

     6,011,697        15,101,239   

Intangible assets, net

     1,400,208        —     

Goodwill

     994,000        —     

Restricted cash

     200,000        200,000   
                

Total assets

   $ 71,419,963      $ 73,754,742   
                

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

   $ 991,005      $ 1,922,572   

Accrued liabilities

     3,666,135        2,626,341   
                

Total current liabilities

     4,657,140        4,548,913   

Long-term liabilities

     642,447        82,398   
                

Total liabilities

     5,299,587        4,631,311   

Commitments and contingencies (Notes 5, 10, 11 and 12)

    

Stockholders’ equity:

    

Preferred stock, $.01 par value, 5,000,000 shares authorized, no shares issued or outstanding

     —          —     

Common stock, $.01 par value, 40,000,000 shares authorized; issued and outstanding 30,761,807 shares at March 31, 2010 and 30,741,707 shares at March 31, 2009

     307,618        307,417   

Additional paid-in capital

     183,733,863        182,673,275   

Accumulated deficit

     (117,921,105     (113,857,261
                

Total stockholders’ equity

     66,120,376        69,123,431   
                

Total liabilities and stockholders’ equity

   $ 71,419,963      $ 73,754,742   
                

The accompanying notes are an integral part of these financial statements.

 

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REPLIGEN CORPORATION

STATEMENTS OF OPERATIONS

 

     Years ended March 31,  
     2010     2009     2008  

Revenue:

      

Product revenue

   $ 10,304,727      $ 14,528,916      $ 18,587,376   

Royalty and other revenue

     10,666,342        14,832,605        708,905   
                        

Total revenue

     20,971,069        29,361,521        19,296,281   

Operating expenses: (1)

      

Cost of product revenue

     4,159,002        5,685,577        6,147,745   

Cost of royalty and other revenue

     1,347,168        1,091,297        12,500   

Research and development

     14,159,721        12,771,573        7,240,812   

Selling, general and administrative

     7,071,859        5,933,090        10,173,400   

Net gain from litigation settlement

     —          —          (40,170,000
                        

Total operating expenses

     26,737,750        25,481,537        (16,595,543

(Loss) income from operations

     (5,766,681     3,879,984        35,891,824   

Investment income

     870,043        1,895,706        2,051,258   

Interest expense

     (1,972     (2,963     (9,097
                        

(Loss) income before taxes

     (4,898,610     5,772,727        37,933,985   

Income tax (benefit) provision

     (834,766     26,699        827,471   
                        

Net (loss) income

   $ (4,063,844   $ 5,746,028      $ 37,106,514   
                        

Earnings per share:

      

Basic

   $ (0.13   $ 0.19      $ 1.20   
                        

Diluted

   $ (0.13   $ 0.18      $ 1.18   
                        

Weighted average shares outstanding:

      

Basic

     30,752,041        30,957,957        30,834,491   
                        

Diluted

     30,752,041        31,290,233        31,320,997   
                        

 

      

(1)    Includes non-cash stock-based compensation as follows:

      

Cost of product revenue

   $ 40,941      $ 47,686      $ 28,134   

Research and development

     209,335        172,872        106,870   

Selling, general and administrative

     756,522        602,687        389,383   

The accompanying notes are an integral part of these financial statements.

 

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REPLIGEN CORPORATION

STATEMENTS OF STOCKHOLDERS’ EQUITY

 

     Common Stock     Additional
Paid-in Capital
    Accumulated
Deficit
    Stockholders’
Equity
 
     Number of Shares     Amount        

Balance, March 31, 2007

   30,477,635      $ 304,776      $ 182,916,856      $ (157,683,334   $ 25,538,298   
                                      

Share-based compensation expense

         524,387          524,387   

Issuance of common stock for license

   87,464        875        299,125          300,000   

Exercise of stock options

   507,835        5,078        632,577          637,655   

Net income

           37,106,514        37,106,514   
                                      

Balance, March 31, 2008

   31,072,934      $ 310,729      $ 184,372,945      $ (120,576,820   $ 64,106,854   
                                      

Share-based compensation expense

         823,245          823,245   

Repurchase and retirement of treasury stock

   (492,827     (4,928     (2,923,058     973,530        (1,954,456

Exercise of stock options

   161,600        1,616        400,143          401,759   

Net income

           5,746,028        5,746,028   
                                      

Balance, March 31, 2009

   30,741,707      $ 307,417      $ 182,673,275      $ (113,857,261   $ 69,123,431   
                                      

Share-based compensation expense

         1,006,798          1,006,798   

Exercise of stock options

   20,100        201        53,790          53,991   

Net loss

           (4,063,844     (4,063,844
                                      

Balance, March 31, 2010

   30,761,807      $ 307,618      $ 183,733,863      $ (117,921,105   $ 66,120,376   
                                      

 

The accompanying notes are an integral part of these financial statements.

 

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REPLIGEN CORPORATION

STATEMENTS OF CASH FLOWS

 

     Years ended March 31,  
     2010     2009     2008  

Cash flows from operating activities:

      

Net (loss) income:

   $ (4,063,844   $ 5,746,028      $ 37,106,514   

Adjustments to reconcile net (loss) income to net cash
(used in) provided by operating activities:

      

Issuance of common stock for license

     —          —          300,000   

Depreciation and amortization

     1,378,999        1,077,347        824,626   

Stock-based compensation expense

     1,006,798        823,245        524,387   

Loss on disposal of assets

     905        6,123        9,559   

Changes in assets and liabilities:

      

Accounts receivable

     (29,259     520,822        260,528   

Royalties receivable

     (259,200     (1,972,600     (242,635

Inventories

     212,087        391,020        (1,289,676

Prepaid expenses and other current assets

     (545,522     (226,238     (261,932

Accounts payable

     (931,567     (799,337     1,560,405   

Accrued liabilities

     782,200        801,379        (267,876

Long-term liabilities

     49        (60,645     (57,299
                        

Net cash (used in) provided by operating activities

     (2,448,354     6,307,144        38,466,601   
                        

Cash flows from investing activities:

      

Purchases of marketable securities

     (47,038,060     (56,865,473     (54,797,953

Redemptions of marketable securities

     59,336,807        25,973,235        41,671,877   

Acquisition of assets of BioFlash Partners, LLC

     (1,780,000     —          —     

Purchases of property, plant and equipment

     (597,349     (1,339,999     (1,102,585
                        

Net cash provided by (used in) investing activities

     9,921,398        (32,232,237     (14,228,661
                        

Cash flows from financing activities:

      

Exercise of stock options

     53,991        401,759        637,655   

Repurchase of common stock

     —          (1,954,456     —     

Principal payments under capital lease obligations

     (42,405     (42,938     (39,962
                        

Net cash provided by (used in) financing activities

     11,586        (1,595,635     597,693   
                        

Net increase (decrease) in cash and cash equivalents

     7,484,630        (27,520,728     24,835,633   

Cash and cash equivalents, beginning of period

     5,041,410        32,562,138        7,726,505   
                        

Cash and cash equivalents, end of period

   $ 12,526,040      $ 5,041,410      $ 32,562,138   
                        

Supplemental disclosure of non-cash investing activities:

      

Consideration transferred in acquisition of BioFlash Partners, LLC

   $ 560,000      $ —        $ —     
                        

Supplemental disclosure of cash flow information:

      

Income taxes (refunded) paid

   $ (135,157   $ 166,000      $ 800,000   
                        

Non-cash tender of common stock to exercise stock options

   $ —        $ —        $ 564,003   
                        

The accompanying notes are an integral part of these financial statements.

 

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REPLIGEN CORPORATION

NOTES TO FINANCIAL STATEMENTS

 

1. Organization and Nature of Business

Repligen Corporation (“Repligen” or the “Company”) is a biopharmaceutical company focused on the development and commercialization of innovative therapies that harness biological pathways and deliver value to patients and clinicians in neurology, gastroenterology and orphan diseases. The Company is currently conducting a number of drug development programs for diseases such as pancreatitis, bipolar disorder, Friedreich’s ataxia and spinal muscular atrophy. Repligen also has a bioprocessing business that focuses on the development and commercialization of products that are used for the production of biopharmaceuticals. In addition, the Company receives royalties from Bristol-Myers Squibb Company (“Bristol”) on their net sales in the United States of their product Orencia®.

The Company’s business strategy is to invest the profits from current bioprocessing products sales and royalty and other revenues, as well as use existing financial resources to advance the development of its therapeutic product candidates and our bioprocessing business.

The Company is subject to a number of risks typically associated with companies in the biotechnology industry. Principally those risks include the Company’s dependence on collaborative arrangements, development by the Company or its competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with the U.S. Food and Drug Administration and other governmental regulations and approval requirements, as well as the ability to grow the Company’s business and obtain adequate funding to finance this growth.

 

2. Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.

Revenue Recognition

The Company generates product revenues from the sale of bioprocessing products to customers in the pharmaceutical and process chromatography industries. The Company recognizes revenue related to product sales upon delivery of the product to the customer as long as there is persuasive evidence of an arrangement, the sales price is fixed or determinable and collection of the related receivable is reasonably assured. Determination of whether these criteria have been met is based on management’s judgments primarily regarding the fixed nature of the fee charged for product delivered, and the collectability of those fees. The Company has a few longstanding customers who comprise the majority of revenue and have excellent payment history and therefore the Company does not require collateral. The Company has had no significant write-offs of uncollectible invoices in the periods presented.

At the time of sale, the Company also evaluates the need to accrue for warranty and sales returns. The supply agreements the Company has with its customers and related purchase orders identify the terms and conditions of each sale and the price of the goods ordered. Due to the nature of the sales arrangements, inventory produced for sale is tested for quality specifications prior to shipment. Since the product is manufactured to order and in compliance with required specifications prior to shipment, the likelihood of sales return, warranty or other

 

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issues is largely diminished. Sales returns and warranty issues are infrequent and have had nominal impact on the Company’s financial statements historically.

In April 2008, the Company settled its outstanding litigation with Bristol and began recognizing royalty revenue in fiscal year 2009 for Bristol’s net sales in the United States of Orencia® which is used in the treatment of rheumatoid arthritis. Pursuant to the Bristol Settlement (as defined in Note 10), the Company recognized royalty revenue of approximately $8,980,000 and $13,383,000 in fiscal years 2010 and 2009, respectively. The $13,383,000 recognized in fiscal 2009 included an initial $5.0 million royalty payment, $1.3 million in royalties for sales of Orencia® from January 1, 2008 to March 31, 2008, as well as $7.1 million for sales in fiscal year 2009. Revenue earned from Bristol royalties is recorded in the periods when it is earned based on royalty reports sent by Bristol to the Company. The Company has no continuing obligations to Bristol as a result of this settlement.

Additionally, the Company earned and recognized approximately $1,009,000, $776,000 and $244,000 in fiscal years 2010, 2009 and 2008, respectively, in royalty revenue from ChiRhoClin for their sales of secretin. Revenue earned from ChiRhoClin royalties is recorded in the periods when it is earned based on royalty reports sent by ChiRhoClin to the Company. In December 2009, ChiRhoClin fulfilled its royalty obligations to the Company for its sales of secretin. The Company does not expect to recognize any further royalty revenue from ChiRhoClin.

In fiscal years 2010 and 2009, the Company recognized approximately $552,000 and $564,000, respectively, of revenue from a sponsored research and development project under an agreement with the Muscular Dystrophy Association. In addition, the Company recognized approximately $125,000 and $110,000 in fiscal years 2010 and 2009, respectively, under other sponsored research and development projects. During fiscal 2008, the Company recognized approximately $365,000 under an agreement with the Stanley Medical Research Institute and $100,000 under another sponsored research and development project.

Research revenue is recognized when the expense has been incurred and services have been performed. Determination of which costs incurred qualify for reimbursement under the terms of the Company’s contractual agreements and the timing of when such costs were incurred involves the judgment of management. The Company’s calculations are based upon the agreed-upon terms as stated in the arrangements. However, should the estimated calculations change or be challenged by other parties to the agreements, research revenue may be adjusted in subsequent periods. The calculations have not historically changed or been challenged and the Company does not anticipate any subsequent change in its revenue related to sponsored research and development projects.

There have been no material changes to the Company’s initial estimates related to revenue recognition in any periods presented in the accompanying financial statements.

Risks and Uncertainties

The Company evaluates its operations periodically to determine if any risks and uncertainties exist that could impact its operations in the near term. The Company does not believe that there are any significant risks which have not already been disclosed in the financial statements. A loss of certain suppliers could temporarily disrupt operations, although alternate sources of supply exist for these items. The Company has mitigated these risks by working closely with key suppliers, identifying alternate sources and developing contingency plans.

Comprehensive Income (Loss)

Comprehensive income is defined as the change in equity of a business enterprise during a period resulting from transactions and other events and circumstances from non-owner sources. The Company’s comprehensive income/loss is equal to the reported net income/loss for all periods presented.

 

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Cash, Cash Equivalents and Marketable Securities

At March 31, 2010, the Company’s investments included money market funds as well as short-term and long-term marketable securities, which are classified as held-to-maturity investments as the Company has the positive intent and ability to hold the investments to maturity. These investments are therefore recorded on an amortized cost basis. Marketable securities are investments with original maturities of greater than 90 days. Long-term marketable securities are securities with maturities of greater than one year.

Cash, cash equivalents and marketable securities consist of the following:

 

     As of March 31,
     2010    2009

Cash and cash equivalents

   $ 12,526,040    $ 5,041,410
             

Marketable securities:

     

U.S. Government and agency securities

     23,009,237      20,871,059

Corporate and other debt securities

     17,599,473      22,946,856
             
   $ 40,608,710    $ 43,817,915
             

Long-term marketable securities:

     

U.S. Government and agency securities

     3,261,524      5,032,385

Corporate and other debt securities

     2,750,173      10,068,854
             
   $ 6,011,697    $ 15,101,239
             

Total

   $ 59,146,447    $ 63,960,564
             

The average remaining maturity of marketable securities at March 31, 2010 is approximately 6.5 months.

Management reviewed the Company’s investments as of March 31, 2010 and concluded that there are no securities with other than temporary impairments in the investment portfolio. The Company does not intend to sell any investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases at maturity. There were no realized gains or losses on the investments for the years ended March 31, 2010, 2009 and 2008.

Investments in held-to-maturity debt securities consisted of the following at March 31, 2010:

 

     March 31, 2010
     Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
    Fair Value

Marketable securities:

          

U.S. Government and agency securities

   $ 23,009,237    $ 25,883    $ (1,748   $ 23,033,372

Corporate and other debt securities

     17,599,473      82,760      —          17,682,233
                            
     40,608,710      108,643      (1,748     40,715,605

Long-term marketable securities:

          

U.S. Government and agency securities

     3,261,524      10,849      (8,546     3,263,827

Corporate and other debt securities

     2,750,173      28,105      —          2,778,278
                            
     6,011,697      38,954      (8,546     6,042,105
                            

Total

   $ 46,620,407    $ 147,597    $ (10,294   $ 46,757,710
                            

All investments in held-to-maturity debt securities with gross unrealized losses have been in unrealized loss positions for less than 12 months.

 

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Investments in held-to-maturity debt securities consisted of the following at March 31, 2009:

 

     March 31, 2009
     Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
    Fair Value

Marketable securities:

          

U.S. Government and agency securities

   $ 20,871,059    $ 113,154    $ (1,051   $ 20,983,162

Corporate and other debt securities

     22,946,856      77,916      (82,088     22,942,684
                            
     43,817,915      191,070      (83,139     43,925,846

Long-term marketable securities:

          

U.S. Government and agency securities

     5,032,385      21,835      —          5,054,220

Corporate and other debt securities

     10,068,854      56,742      (20,714     10,104,882
                            
     15,101,239      78,577      (20,714     15,159,102
                            

Total

   $ 58,919,154    $ 269,647    $ (103,853   $ 59,084,948
                            

The contractual maturities of held-to-maturity debt securities at March 31, 2010 were as follows:

 

     Amortized
Cost
   Fair Value

Due in 1 year or less

   $ 40,608,710    $ 40,715,605

Due in 1 to 2 years

     6,011,697      6,042,105
             
   $ 46,620,407    $ 46,757,710
             

Fair Value Measurement

In determining the fair value of its assets and liabilities, the Company uses various valuation approaches. The Company employs a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows:

 

Level 1     Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access
Level 2     Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly
Level 3     Valuations based on inputs that are unobservable and significant to the overall fair value measurement

The availability of observable inputs can vary among the various types of financial assets and liabilities. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, for financial statement disclosure purposes, the level in the fair value hierarchy within which the fair value measurement is categorized is based on the lowest level input that is significant to the overall fair value measurement.

 

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The Company’s held-to-maturity securities, which are fixed income investments, are comprised of obligations of U.S. government agencies, corporate debt securities and other interest bearing securities. These held-to-maturity securities are recorded at amortized cost and are therefore not included in the Company’s market value measurement disclosure. Money market funds are valued using quoted market prices with no valuation adjustments applied. Accordingly, these securities are categorized in Level 1. The Company has no other assets or liabilities for which fair value measurement is either required or has been elected to be applied, other than the liability for contingent consideration recorded in connection with the acquisition of BioFlash Partners, LLC (“BioFlash”) (See Note 13). The contingent consideration is valued using management’s estimates of royalties to be paid to the former shareholders of BioFlash based on sales of the acquired assets. This valuation is a Level 3 valuation as the primary inputs are unobservable. The following table provides a roll forward of the fair value of the contingent consideration:

 

Balance at April 1, 2009

   $ —  

Additions

     560,000

Changes in Fair Value

     —  
      

Balance at March 31, 2010

   $ 560,000
      

The following fair value hierarchy table presents information about each major category of the Company’s assets and liabilities measured at fair value on a recurring basis as of March 31, 2010:

 

     Fair value measurement at reporting date using:
     Quoted prices in
active markets for
identical assets
(Level 1)
   Significant other
observable
inputs
(Level 2)
   Significant
unobservable
inputs
(Level 3)
   Balance as of
March 31,
2010

Assets:

           

Money market funds

   $ 8,237,402          $ 8,237,402

There were no remeasurements to fair value during the year ended March 31, 2010 of financial assets and liabilities that are not measured at fair value on a recurring basis.

Inventories

Inventories relate to the Company’s bioprocessing business. The Company values inventory at cost or, if lower, fair market value using the first-in, first-out method. The Company reviews its inventories at least quarterly and records a provision for excess and obsolete inventory based on its estimates of expected sales volume, production capacity and expiration dates of raw materials, work-in process and finished products. Expected sales volumes are determined based on supply forecasts provided by key customers for the next three to twelve months. The Company writes down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value, and inventory in excess of expected requirements to cost of product revenue. Manufacturing of bioprocessing finished goods is done to order and tested for quality specifications prior to shipment.

A change in the estimated timing or amount of demand for the Company’s products could result in additional provisions for excess inventory quantities on hand. Any significant unanticipated changes in demand or unexpected quality failures could have a significant impact on the value of inventory and reported operating results. During all periods presented in the accompanying financial statements, there has been no material adjustments related to a revised estimate of inventory valuations.

 

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Work-in-process and finished products inventories consist of material, labor, outside processing costs and manufacturing overhead. Inventories consist of the following:

 

     As of March 31,
     2010    2009

Raw Materials

   $ 1,067,823    $ 1,400,408

Work-in-process

     395,088      791,465

Finished products

     738,229      221,354
             

Total

   $ 2,201,140    $ 2,413,227
             

Accrued Liabilities

The Company estimates accrued liabilities by identifying services performed on the Company’s behalf, estimating the level of service performed and determining the associated cost incurred for such service as of each balance sheet date. Examples of estimated accrued expenses include: 1) Fees paid to contract manufacturers in conjunction with the production of clinical materials. These expenses are normally determined through a contract or purchase order issued by the Company; 2) Service fees paid to organizations for their performance in conducting clinical trials. These expenses are determined by contracts in place for those services and communications with project managers on costs which have been incurred as of each reporting date; 3) Professional and consulting fees incurred with law firms, audit and accounting service providers and other third party consultants. These expenses are determined by either requesting those service providers to estimate unbilled services at each reporting date for services incurred, or tracking costs incurred by service providers under fixed fee arrangements.

The Company has processes in place to estimate the appropriate amounts to record for accrued liabilities, which principally involve the applicable personnel reviewing the services provided. In the event that the Company does not identify certain costs which have begun to be incurred or the Company under or over-estimates the level of services performed or the costs of such services, the reported expenses for that period may be too low or too high. The date on which certain services commence, the level of services performed on or before a given date, and the cost of such services are often judgmental. The Company makes these judgments based upon the facts and circumstances known at the date of the financial statements.

Depreciation

Depreciation is calculated using the straight-line method over the estimated useful life of the asset as follows:

 

Classification

  

Estimated Useful Life

Leasehold improvements

   Shorter of the term of the lease or estimated useful life

Equipment

   Three to five years

Furniture and fixtures

   Three years

For depreciation of property and equipment, the Company expensed approximately $1,349,000, $1,077,000, and $825,000 in fiscal 2010, 2009, and 2008, respectively. These amounts include depreciation of assets recorded under capitalized lease agreements of approximately $34,000, $38,000, and $43,000 in 2010, 2009, and 2008, respectively.

Earnings (Loss) Per Share

Basic earnings (loss) per share for the years ended March 31, 2010, 2009 and 2008 were computed on the basis of the weighted average number of shares of common stock outstanding during the period. Diluted earnings

 

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(loss) per share is computed on the basis of the weighted average number of shares of common stock plus the effect of dilutive potential common shares outstanding during the period using the treasury stock method. Dilutive potential common shares include outstanding stock options, restricted stock and warrants.

Basic and diluted weighted average shares outstanding were as follows:

 

     Year Ended March 31,
     2010    2009    2008

Weighted average common shares

   30,752,041    30,957,957    30,834,491

Dilutive common stock options

   —      332,276    486,506
              

Weighted average common shares, assuming dilution

   30,752,041    31,290,233    31,320,997
              

Diluted weighted average shares outstanding for the year ended March 31, 2010 does not include the impact of 2,318,650 outstanding potential common shares for stock options as they would be anti-dilutive. Accordingly, basic and diluted net losses per share are the same for the year ended March 31, 2010.

For years ended March 31, 2009 and 2008, options to purchase 938,000 and 443,000 shares were excluded from the calculation of diluted earnings per share because the exercise prices of the stock options were greater than or equal to the average price of the common shares.

Segment Reporting

The Company views its operations, makes decisions regarding how to allocate resources and manages the business as one operating segment. As a result, the financial information disclosed herein represents all of the material financial information related to the Company’s principal operating segment.

The following table represents the Company’s total revenue by geographic area (based on the location of the customer):

 

     Year ended March 31,  
         2010             2009             2008      

US

   57   60   32

Sweden

   36   36   61

Other

   7   4   7
                  

Total

   100   100   100
                  

The following table represents the Company’s total revenue by product type:

 

     Year ended March 31
     2010    2009    2008

Bioprocessing

   $ 10,304,727    $ 14,361,025    $ 16,321,065

SecreFlo®

     —        167,891      2,266,311
                    

Product revenue

   $ 10,304,727    $ 14,528,916    $ 18,587,376

Royalty and other revenue

     10,666,342      14,832,605      708,905
                    

Total revenue

   $ 20,971,069    $ 29,361,521    $ 19,296,281
                    

All of the Company’s assets are located in the United States for fiscal years ended March 31, 2010, 2009 and 2008.

 

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Concentrations of Credit Risk and Significant Customers

Financial instruments that subject the Company to significant concentrations of credit risk primarily consist of cash and equivalents, marketable securities and accounts receivable. Per the Company’s investment policy, cash equivalents and marketable securities are invested in financial instruments with high credit ratings and credit exposure to any one issue, issuer (with the exception of U.S. treasury obligations) and type of instrument is limited. At March 31, 2010 and 2009, the Company had no investments associated with foreign exchange contracts, options contracts or other foreign hedging arrangements.

Concentration of credit risk with respect to accounts receivable is limited to customers to whom the Company makes significant sales. While a reserve for the potential write-off of accounts receivable is maintained, the Company has not written off any significant accounts to date. To control credit risk, the Company performs regular credit evaluations of its customers’ financial condition.

Revenue from significant customers as a percentage of the Company’s total revenue is as follows:

 

     Years Ended March 31,  
         2010             2009             2008      

Orencia® Royalties from Bristol

   43   46   —     

Bioprocessing Customer A

   36   36   61

Bioprocessing Customer B

   1   4   14

Significant accounts receivable balances as a percentage of the Company’s total trade accounts receivable and royalties receivable balances are as follows:

 

     As of March 31,  
         2010             2009      

Orencia® Royalties from Bristol

   80   70

Bioprocessing Customer B

   2   12

Bioprocessing Customer C

   13   —     

Business Combinations

Amounts paid for acquisitions are allocated to the assets acquired and liabilities assumed, if any, based on their fair values at the dates of acquisition. The fair value of identifiable intangible assets is based on detailed valuations that use information and assumptions determined by management. Any excess of purchase price over the fair value of the net tangible and intangible assets acquired is allocated to goodwill. The fair value of contingent consideration includes estimates and judgments made by management regarding the extent of royalties to be earned in excess of the defined minimum royalties. Management will update these estimates and the related fair value of contingent consideration at each reporting period.

Goodwill and Intangible Assets

Intangible assets are amortized over their useful lives using the estimated economic benefit method, as applicable.

Goodwill is not amortized. Instead goodwill is reviewed for impairment at least annually. There was no evidence of impairment to goodwill for fiscal year 2010.

Intangible assets and their related useful lives are reviewed at least annually to determine if any adverse conditions exist that would indicate the carrying value of these assets may not be recoverable. More frequent impairment assessments are conducted if certain conditions exist, including: a change in the competitive

 

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landscape, any internal decisions to pursue new or different technology strategies, a loss of a significant customer, or a significant change in the market place including changes in the prices paid for our products or changes in the size of the market for our products. An impairment results if the carrying value of the asset exceeds the estimated fair value of the asset based on the sum of the future undiscounted cash flows expected to result from the use and disposition of the asset. If the estimate of an intangible asset’s remaining useful life is changed, the remaining carrying amount of the intangible asset is amortized prospectively over the revised remaining useful life. There were no indicators of impairment in fiscal year 2010.

Stock Based Compensation

The Company uses the Black-Scholes option pricing model to calculate the fair value of share-based awards on the grant date. The following assumptions are used in calculating the fair value of share-based awards:

Expected term—The expected term of options granted represents the period of time for which the options are expected to be outstanding and is derived from the Company’s historical stock option exercise experience and option expiration data. The expected term is presumed to be the midpoint between the vesting date and the end of the contractual term. In addition, for purposes of estimating the expected term, the Company has aggregated all individual option awards into one group as the Company does not expect substantial differences in exercise behavior among its employees.

Expected volatility—The expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate during the expected term of options granted. The Company determines the expected volatility based primarily upon the historical volatility of the Company’s common stock over a period commensurate with the option’s expected term, exclusive of any events not reasonably anticipated to recur over the option’s expected term.

Risk-free interest rate—The risk-free interest rate is the implied yield available on U.S. Treasury zero-coupon issues with a remaining term equal to the option’s expected term on the grant date.

Expected dividend yield—The Company has never declared or paid any cash dividends on any of its capital stock and does not expect to do so in the foreseeable future. Accordingly, the Company uses an expected dividend yield of zero to calculate the grant-date fair value of a stock option.

Estimated forfeiture rates—The Company has applied, based on an analysis of its historical forfeitures, annual forfeiture rates of 8% for awards granted to non-executive level employees and 3% for awards granted to executive level employees to all unvested stock options as of March 31, 2010. The Company reevaluates this analysis periodically and adjusts these estimated forfeiture rates as necessary. Ultimately, the Company will only recognize expense for those shares that vest.

Recent Accounting Pronouncements

In October 2009, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2009-13, “Multiple-Deliverable Arrangements—a consensus of the FASB Emerging Issues Task Force” (“ASU 2009-13”). This ASU establishes the accounting and reporting guidance for arrangements under which a vendor will perform multiple revenue-generating activities. Specifically, the provisions of this update address how to separate deliverables and how to measure and allocate arrangement consideration to one or more units of accounting. This update is effective prospectively for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. Early adoption is permitted. The Company has not yet completed its evaluation of ASU 2009-13, but does not currently believe that adoption will have a material impact on its results of operations, financial position or cash flows.

 

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In January 2010, the FASB issued ASU No. 2010-06, “Improving Disclosures about Fair Value Measurements“ (“ASU 2010-06”). This ASU requires new disclosures and clarifies some existing disclosure requirements about fair value measurements codified within ASC 820, “Fair Value Measurements and Disclosures,” including significant transfers into and out of Level 1 and Level 2 investments of the fair value hierarchy. ASU 2010-06 also requires additional information in the roll forward of Level 3 investments including presentation of purchases, sales, issuances, and settlements on a gross basis. Further clarification for existing disclosure requirements provides for the disaggregation of assets and liabilities presented, and the enhancement of disclosures around inputs and valuation techniques. This update is effective for the first interim or annual reporting period beginning after December 15, 2009, except for the additional information in the roll forward of Level 3 investments. Those disclosures are effective for fiscal years beginning after December 15, 2010, and for interim reporting periods within those fiscal years. The Company adopted ASU 2010-06 in January 2010. The adoption of this update did not have a material impact on its results of operations, financial position or cash flows.

In April 2010, the FASB issued ASU No. 2010-17, “Milestone Method of Revenue Recognition—a consensus of the FASB Emerging Issues Task Force” (“ASU 2010-17”). This ASU provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions. ASU 2010-17 is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Early adoption is permitted. The Company has not yet completed its evaluation of ASU 2010-17, but does not currently believe that adoption will have a material impact on its results of operations, financial position or cash flows.

 

3. Income Taxes

The tax benefit of ($834,766) for the year ended March 31, 2010 is comprised of a current benefit for federal income taxes of ($834,766). The benefit for federal income taxes is due to the “Worker, Homeownership, and Business Assistance Act of 2009” (the “Act”) that was enacted in November 2009. Among other things, the Act suspended the limitation on the use of net operating losses to offset alternative minimum tax liabilities. The Company paid a total of approximately $835,000 of alternative minimum taxes in the fiscal years ended March 31, 2009 and 2008 combined. The Company expects to receive a refund of approximately $835,000 upon filing its tax return for the year ended March 31, 2010. This refundable tax amount is included in prepaid expenses and other current assets on the balance sheet at March 31, 2010. For the year ended March 31, 2009, the tax provision of $26,699 is comprised of a current provision for federal income taxes of $29,557 and a current benefit for state income taxes of ($2,858). For the year ended March 31, 2008, the tax provision of $827,471 is comprised of a current provision for federal income taxes of $736,805 and a current provision for state income taxes of $90,666.

At March 31, 2010, the Company had net operating loss carryforwards of approximately $63,903,000 and business tax credits carryforwards of approximately $2,118,000 available to reduce future federal income taxes, if any. Additionally, at March 31, 2010, we had net operating loss carryforwards of approximately $3,061,000 and business tax credits carryforwards of approximately $5,615,000 available to reduce future state income taxes, if any. The net operating loss and business tax credits carryforwards will continue to expire at various dates through March 2030. The net operating loss and business tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and may be limited in the event of certain changes in the ownership interest of significant stockholders.

 

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Our deferred tax assets consist of the following:

 

     As of March 31,  
     2010     2009  

Temporary timing differences

   $ 4,700,000      $ 4,716,000   

Net operating loss carryforwards

     21,919,000        19,957,000   

Tax business credits carryforwards

     4,157,000        4,646,000   
                

Total deferred tax assets

     30,776,000        29,319,000   

Valuation allowance

     (30,776,000     (29,319,000
                

Net deferred tax asset

   $ —        $ —     
                

At March 31, 2010 and 2009, a full valuation allowance has been provided against the deferred tax assets, as it is uncertain if the Company will realize the benefits of such deferred tax assets.

The reconciliation of the federal statutory rate to the effective income tax rate for the years ended March 31, 2010, 2009 and 2008 is as follows:

 

     Years Ended March 31,  
     2010     2009     2008  

Income (loss) before income taxes

   $ (4,898,610   %      $ 5,772,727      %      $ 37,933,985      %   
                                          

Expected tax (recovery) at statutory rate

     (1,665,527   (34.0 )%      1,962,727      34.0     12,897,555      34.0

Adjustments due to:

            

State income and franchise taxes

     (80,151   (1.6 )%      287,822      5.0     1,620,725      4.3

Utilization of loss carryforwards and business tax credits

     (934,659   (19.1 )%      (1,891,597   (32.8 )%      (13,987,955   (36.9 )% 

Alternative minimum tax

     —        —          96,540      1.7     732,817      1.9

Permanent differences

     255,766      5.2     207,508      3.6     191,459      0.5

Change in valuation allowance

     1,589,805      32.5     (636,301   (11.0 )%      (627,130   (1.6 )% 
                                          

(Benefit) provision for income taxes

   $ (834,766   (17.0 )%    $ 26,699      0.5   $ 827,471      2.2
                                          

At March 31, 2010, 2009 and 2008, the Company had no material unrecognized tax benefits.

The Company recognizes interest and penalties related to uncertain tax positions in income tax expense. No interest and penalties have been recognized by the Company to date.

Fiscal years 2006 through 2010 are subject to examination by the federal and state taxing authorities. There are no income tax examinations currently in process.

 

4. Stockholders’ Equity

Common Stock and Warrants

At March 31, 2010, the Company has reserved 2,893,859 shares of common stock pursuant to the Plans. As discussed in Note 11 below, on April 6, 2007, the Company issued warrants to an individual at Scripps to purchase up to 150,000 shares of common stock. The warrants have a 7-year term and are exercisable based on performance criteria as detailed in the warrant agreement. At this time, the Company does not believe that the performance criteria are probable of being achieved in the near future.

 

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Shareholder Rights Plan

In March 2003, the Company adopted a Shareholder Rights Agreement (the “Rights Agreement”). Under the Rights Agreement, the Company distributed certain rights to acquire shares of the Company’s Series A junior participating preferred stock (the “Rights”) as a dividend for each share of common stock held of record as of March 17, 2003. Each share of common stock issued after the March 17, 2003 record date has an attached Right. Under certain conditions involving an acquisition by any person or group of 15% or more of the common stock (20% in the case of a certain stockholder) (“the 15% holder”), each Right permits the holder (other than the 15% holder) to purchase common stock having a value equal to twice the exercise price of the Right, upon payment of the exercise price of the Right. In addition, in the event of certain business combinations after an acquisition by a person or group of 15% or more of the common stock (20% in the case of a certain stockholder), each Right entitles the holder (other than the 15% holder) to receive, upon payment of the exercise price, common stock having a value equal to twice the exercise price of the Right. The Rights have no voting privileges and, unless and until they become exercisable, are attached to, and automatically trade with, the Company’s common stock. The Rights will terminate upon the earlier of the date of their redemption or March 2013.

Stock Based Compensation

For fiscal years ended March 31, 2010, 2009 and 2008, the Company recorded stock-based compensation expense of approximately $1,007,000, $823,000 and $524,000, respectively, for stock options granted under the Second Amended and Restated 2001 Repligen Corporation Stock Plan (the “2001 Plan”).

The 2001 Plan allows for the granting of incentive and nonqualified options and restricted stock and other equity awards to purchase shares of common stock. Incentive options granted to employees under the 2001 Plan generally vest over a four to five-year period, with 20%-25% vesting on the first anniversary of the date of grant and the remainder vesting in equal yearly installments thereafter. Nonqualified options issued to non-employee directors and consultants under the 2001 Plan generally vest over one year. Options granted under the 2001 Plan have a maximum term of ten years from the date of grant and generally, the exercise price of the stock options equals the fair market value of the Company’s common stock on the date of grant. At March 31, 2010, options to purchase 2,318,650 shares were outstanding under the 2001 Plan and the 1992 Repligen Corporation Stock Option Plan (collectively with the 2001 Plan, the “Plans”). At March 31, 2010, 575,209 shares were available for future grant under the 2001 Plan.

The Company uses the Black-Scholes option pricing model to calculate the fair value of share-based awards on the grant date. The fair value of share-based awards granted during the fiscal years ended March 31, 2010, 2009 and 2008 were calculated using the following estimated weighted-average assumptions:

 

     Years Ended March 31,
     2010    2009    2008

Expected term (years)

   6.5    6.5    6.5

Volatility

   58.12% - 65.14%    60.47% - 64.07%    64.46% - 76.85%

Risk-free interest rate

   2.54% - 3.14%    1.88% - 3.71%    2.81% - 4.97%

Expected dividend yield

        

The Company recognizes stock-based compensation expense on a straight-line basis over the requisite service period based upon options that are ultimately expected to vest, and accordingly, such compensation expense has been adjusted by an amount of estimated forfeitures.

 

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Information regarding option activity for the year ended March 31, 2010 under the Plans is summarized below:

 

     Options
Outstanding
    Weighted-
Average
Exercise
Price Per
Share
   Weighted-
Average
Remaining
Contractual
Term
(in years)
   Aggregate
Intrinsic
Value

Options outstanding at April 1, 2009

   2,213,550      $ 4.37      

Granted

   247,000        4.55      

Exercised

   (20,100     2.69      

Forfeited/Cancelled

   (121,800     4.99      
              

Options outstanding at March 31, 2010

   2,318,650      $ 4.37    6.14    $ 1,174,676
              

Options exercisable at March 31, 2010

   1,371,250      $ 4.09    4.61    $ 1,020,881
              

Vested and expected to vest at March 31, 2010 (1)

   2,194,544      $ 4.35    6.02    $ 1,147,354
              

 

(1) This represents the number of vested options as of March 31, 2010 plus the number of unvested options expected to vest as of March 31, 2010 based on the unvested outstanding options at March 31, 2010 adjusted for estimated forfeitures.

The aggregate intrinsic value in the table above represents the total pre-tax intrinsic value (the difference between the closing price of the common stock on March 31, 2010 of $4.06 and the exercise price of each in-the-money option) that would have been received by the option holders had all option holders exercised their options on March 31, 2010.

The weighted average grant date fair value of options granted during the fiscal years ended March 31, 2010 and 2009 was $2.71 and $3.17, respectively. The total fair value of stock options that vested during fiscal years ended March 31, 2010, 2009 and 2008 was approximately $1,067,000, $655,000 and $494,000, respectively. The total intrinsic value of options exercised during the years ended March 31, 2010, 2009 and 2008 was $43,875, $418,366 and $1,672,260, respectively, determined as of the date of exercise. The Company received $53,991, $401,759 and $637,655 from stock option exercises during the years ended March 31, 2010, 2009 and 2008, respectively.

As of March 31, 2010, there was $1,919,119 of total unrecognized compensation cost related to unvested share-based awards. This cost is expected to be recognized over a weighted average remaining requisite service period of 3.11 years. The Company expects 823,294 in unvested options to vest over the next five years.

 

5. Commitments and Contingencies

Lease Commitments

In 2001, the Company entered into a ten-year lease agreement for approximately 25,000 square feet of space located in Waltham, Massachusetts to be used for its corporate headquarters, manufacturing, research and development, and marketing and administrative operations. In connection with this lease agreement, the Company issued a letter of credit in the amount of $200,000 to the lessor. The letter of credit is collateralized by a certificate of deposit held by the bank that issued the letter of credit. The certificate of deposit is classified as restricted cash in the accompanying balance sheet as of March 31, 2010 and 2009. In 2007, the Company entered into a five-year lease agreement for approximately 2,500 square feet of space in Waltham, Massachusetts to provide for expanded manufacturing operations. Adjacent to this space, the Company entered into a two-year lease in 2008 for approximately 7,350 square feet of additional space to be used for expanded manufacturing and administrative operations.

 

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In fiscal 2006, Repligen entered into a capital lease agreement to provide the Company with manufacturing equipment over a five-year period. In fiscal 2005, the Company entered into two capital lease agreements to provide us with two pieces of office equipment for approximately $33,000. The lease terms were three and five years beginning in June and October of 2004, respectively. As of March 31, 2010, the Company has no remaining capital lease obligations.

Obligations under non-cancelable operating leases, including the facility leases discussed above, as of March 31, 2010 are as follows:

 

Years Ending

   Operating Leases

March 31, 2011

   $ 572,079

March 31, 2012

     423,948

March 31, 2013

     9,264
      

Minimum lease payments

   $ 1,005,291
      

Rent expense charged to operations under operating leases was approximately $689,000, $631,000 and $512,000 for the years ended March 31, 2010, 2009 and 2008, respectively. As of March 31, 2010, 2009 and 2008, the Company had a deferred rent liability of $64,000, $100,600 and $118,900, respectively related to the escalating rent provisions for the Waltham headquarters.

Licensing and Research Agreements

The Company licenses certain technologies that are, or may be, incorporated into its technology under several agreements and also has entered into several clinical research agreements which require the Company to fund certain research projects. Generally, the license agreements require the Company to pay annual maintenance fees and royalties on product sales once a product has been established using the technologies.

In October 2009, the Company entered into an exclusive worldwide commercial license agreement with Families of Spinal Muscular Atrophy (see Note 12). The initial license fee of $500,000 and a related sublicense fee of $175,000 have been charged to research and development expenses in fiscal 2010. In April 2007 the Company entered into an exclusive license agreement with the Scripps Research Institute (see Note 11). The initial license fee under this agreement aggregated $600,000 in a combination of cash and Company common stock and was charged to research and development expenses in fiscal 2008. The Company has recorded research and development expenses associated with license agreements of approximately $643,000, $326,000, and $681,000 for fiscal years 2010, 2009 and 2008, respectively.

Purchase Orders, Supply Agreements and Other Contractual Obligations

In the normal course of business, the Company has entered into purchase orders and other agreement with manufacturers, distributors and others. Outstanding obligations at March 31, 2010 are approximately $1,933,000 where approximately $1,908,000 is expected to be completed within one year and the remaining amount to be substantially completed within two years.

 

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6. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consist of the following:

 

     As of March 31,
     2010    2009

Interest receivable

   $ 223,290    $ 354,416

Prepaid taxes

     882,439      182,830

Prepaid insurance

     169,829      155,321

Clinical and research expenses

     80,031      133,133

Equipment and services

     109,358      93,725

Other

     14,160      14,160
             

Total

   $ 1,479,107    $ 933,585
             

 

7. Accrued Liabilities

Accrued liabilities consist of the following:

 

     As of March 31,
     2010    2009

Employee compensation

   $ 1,285,172    $ 1,040,529

Research and development

     787,267      769,793

Royalty and license fees

     881,900      269,850

Unearned revenue

     306,794      125,000

Professional fees

     216,086      94,572

Other accrued expenses

     133,554      110,059

Other current liabilities

     55,362      216,538
             

Total

   $ 3,666,135    $ 2,626,341
             

 

8. Employee Benefit Plan

The Repligen Corporation 401(k) Savings and Retirement Plan (the “401(k) Plan”) is a qualified defined contribution plan in accordance with Section 401(k) of the Internal Revenue Code. All employees over the age of 21 are eligible to make pre-tax contributions up to a specified percentage of their compensation. Under the 401(k) Plan, the Company may, but is not obligated to match a portion of the employees’ contributions up to a defined maximum. The match is calculated on a calendar year basis. The Company matched approximately $117,000, $85,278, and $56,647 for the fiscal years ended March 31, 2010, 2009, and 2008 respectively.

 

9. Related Party Transactions

The Company paid Dr. Alexander Rich, Chairman of the Board of Directors, $47,400 and $43,200 in fiscal years 2009 and 2008, respectively, per a consulting agreement that automatically extended for successive one-year terms unless terminated by either party at least 90 days prior to the next anniversary date. Effective January 2009, this consulting agreement was terminated and Dr. Rich is now paid a monthly retainer similar to the Company’s other directors. Dr. Rich received no additional cash compensation for attendance at Board of Directors meetings or otherwise as director.

The Company paid Dr. Paul Schimmel, former Co-Chairman of the Board of Directors, $32,800 in fiscal year 2008 pursuant to a consulting agreement. This agreement automatically extended for successive one-year terms unless terminated by either party at least 90 days prior to the next anniversary date. Dr. Schimmel retired from the Board of Directors as of the Company’s annual meeting in September 2007, and accordingly, the consulting agreement with Dr. Schimmel was terminated at that time. Dr. Schimmel received no additional cash compensation for attendance at Board of Directors meetings or otherwise as director.

 

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10. Legal Proceedings

ImClone Systems

In May 2004, Repligen and the Massachusetts Institute of Technology (“MIT”) filed an action in the United States District Court for the District of Massachusetts against ImClone Systems, Incorporated (“ImClone”) for infringement of U.S. Patent No. 4,663,281 (“the ‘281 patent”) based on ImClone’s manufacture and sale of Erbitux®. The ‘281 patent, which covers the use of certain genetic elements that increase protein production in a mammalian cell, is assigned to MIT and exclusively licensed to Repligen.

On September 10, 2007, Repligen and MIT entered into a settlement agreement (the “ImClone Settlement”) with ImClone relating to the lawsuit against ImClone for infringement of the ‘281 patent. Pursuant to the ImClone Settlement, ImClone made a payment of $65 million to Repligen and MIT that resulted in net proceeds to Repligen of $40.17 million, as follows:

 

Gross proceeds from Settlement Agreement

   $ 65,000,000   

Less: Amounts paid to MIT

     (11,000,000

Less: Legal fees and other costs

     (13,830,000
        

Net gain on litigation settlement

   $ 40,170,000   
        

The ImClone Settlement served as the basis for the Company and MIT to dismiss the lawsuit against ImClone and for the Company to grant ImClone a non-exclusive sublicense to the ‘281 patent and certain other intellectual property. There are no further obligations to the Company with respect to the sublicenses. The net gain on litigation settlement was recorded as a separate component of operating expenses in the statement of operations in fiscal 2008.

Bristol-Myers Squibb Company (“Bristol”)

In January 2006, Repligen and the University of Michigan jointly filed a complaint against Bristol in the United States District Court for the Eastern District of Texas for infringement of U.S. Patent No. 6,685,941 (“the ‘941 patent”) for the commercial sale of Orencia®. The ‘941 patent, entitled “Methods of Treating Autoimmune Disease via CTLA4-Ig,” covers methods of using CTLA4-Ig to treat rheumatoid arthritis, as well as other therapeutic methods. Repligen has exclusive rights to this patent from its owners, the University of Michigan and the U.S. Navy. In February 2006, Bristol answered the complaint and counterclaimed seeking a declaratory judgment that the ‘941 patent is invalid and unenforceable and that Bristol does not infringe the patent.

On April 7, 2008, Repligen and the University of Michigan entered into a settlement agreement (the “Bristol Settlement”) with Bristol relating to the lawsuit against Bristol for infringement of the ‘941 patent. Pursuant to the Bristol Settlement, Bristol made an initial payment of $5 million to Repligen. The settlement further provides for Bristol to pay royalties on the United States net sales of Orencia® for any clinical indication at a rate of 1.8% for the first $500 million of annual net sales, 2.0% for the next $500 million of annual net sales and 4% of annual net sales in excess of $1 billion for each year from January 1, 2008 until December 31, 2013. The Bristol Settlement served as the basis for Repligen and the University of Michigan to dismiss the lawsuit against Bristol and for Repligen and the University of Michigan to grant to Bristol an exclusive worldwide license to the ‘941 patent and certain other intellectual property.

Pursuant to the Bristol Settlement, the Company recognized royalty revenue in fiscal years 2010 and 2009 of approximately $8,980,000 and $13,383,000, respectively. The $13,383,000 recognized in fiscal 2009 included an initial $5.0 million royalty payment, $1.3 million in royalties for sales of Orencia® from January 1, 2008 to March 31, 2008, as well as $7.1 million for sales in fiscal year 2009 (see Note 2).

Repligen must also remit to the University of Michigan 15% of all royalty revenue received from Bristol, after deducting certain legal and other costs incurred related to the Bristol Settlement. The Company incurred

 

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approximately $6.1 million in such legal costs. Royalty expense for fiscal years 2010 and 2009 was approximately $1,347,000 and $1,091,000, respectively. This operating expense has been included on the statements of operations under the line item “Cost of royalty and other revenue.”

 

11. Scripps Agreements

License Agreement

On April 6, 2007, the Company entered into an exclusive worldwide commercial license agreement (“License Agreement”) with The Scripps Research Institute (“Scripps”). Pursuant to the License Agreement, the Company obtained a license to use, commercialize and sublicense certain patented technology and improvements thereon, owned or licensed by Scripps, relating to compounds which may have utility in treating Friedreich’s ataxia, an inherited neurodegenerative disease. Research in tissues derived from patients, as well as, in mice, indicates that the licensed compounds increase production of the protein frataxin, which suggests potential utility of these compounds in slowing or stopping progression of the disease. There are currently no approved treatments for Friedreich’s ataxia in the U.S.

Pursuant to the License Agreement, the Company agreed to pay Scripps an initial license fee of $300,000, certain royalty and sublicense fees and, in the event that the Company achieves specified developmental and commercial milestones, certain additional milestone payments. Total future milestone payments, were all milestones achieved, would be approximately $4.3 million. In addition, the Company issued Scripps and certain of its designees 87,464 shares of the Company’s common stock which had a value of $300,000 on the date of issuance. The Company recorded the initial license payment and the value of the shares issued as research and development costs in the statements of operations in fiscal 2008.

In connection with the License Agreement, the Company issued warrants to an individual at Scripps to purchase up to 150,000 shares of common stock. The warrants have a 7-year term and are exercisable based on performance criteria as detailed in the warrant agreement. No expense has been recorded related to these warrants through March 31, 2010, as none of the performance criteria have been achieved. At this time, the Company does not believe that the performance criteria are probable of being achieved in the near future.

The License Agreement with Scripps expires or may be terminated (i) when all of the royalty obligations under the License Agreement expire; (ii) at any time by mutual written consent; (iii) by Scripps if the Company (a) fails to make payments under the License Agreement, (b) fails to achieve certain developmental and commercial objectives, (c) becomes insolvent, (d) is convicted of a felony relating to the manufacture, use or sale of the licensed technology, or (e) defaults in its performance under the License Agreement; or (iv) by the Company upon 90 days written notice.

Research Funding and Option Agreement

On October 26, 2007, the Company entered into a research funding and option agreement (“Funding Agreement”) with Scripps to fund a research program for the research and development of compounds that may have utility in the treatment of Friedreich’s ataxia. Pursuant to the Funding Agreement, the Company is required to fund approximately $35,000 per quarter which is recorded as research and development expenses. In exchange for funding the research, Scripps will grant an exclusive option to the Company to acquire a sole, worldwide license, including the right to sublicense, manufacture and sell products, and services that result from the research program. There are no guaranties or warranties that products or services may result from the research program and the Company has therefore ascribed no value to the license. The Funding Agreement expires or may be terminated (i) when all of the royalty obligations under the Funding Agreement expire; (ii) at any time by mutual written consent; (iii) by Scripps if the Company (a) fails to make payments under the Funding Agreement, (b) fails to achieve certain developmental and commercial objectives, (c) becomes insolvent, (d) is convicted of a felony relating the manufacture, use or sale of the licensed technology, or (e) defaults in its performance under the Funding Agreement; or (iv) by the Company upon 90 days written notice.

 

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The Company made payments to Scripps of approximately $123,000, $133,000 and $105,000 for fiscal years 2010, 2009 and 2008, respectively, in connection with the Funding Agreement, as amended.

 

12. FSMA License Agreement

On October 22, 2009, the Company entered into an exclusive worldwide commercial license agreement (“FSMA License Agreement”) with Families of Spinal Muscular Atrophy (“FSMA”). Pursuant to the FSMA License Agreement, the Company obtained an exclusive license to develop and commercialize certain patented technology and improvements thereon, owned or licensed by FSMA, relating to compounds which may have utility in treating spinal muscular atrophy (“SMA”). SMA is an inherited neurodegenerative disease in which a defect in the survival motor neuron gene (“SMN”) results in low levels of the protein SMN and leads to progressive damage to motor neurons, loss of muscle function and, in many patients, early death.

Pursuant to the License Agreement, the Company paid FSMA an initial license fee of $500,000 and a related sublicense fee of $175,000 which have been recorded as research and development expense in the statements of operations in fiscal 2010. If all milestones are achieved, total financial obligations under this agreement, including milestone payments, sublicense fees, and other charges, could total approximately $16,000,000. Given the uncertain nature of such a development program, the likelihood that products or services will result from the research program is not known at this time. The Company has therefore ascribed no value to the license or the related liability.

The License Agreement with FSMA expires or may be terminated (i) on the later of: (a) when all related patents have expired or been abandoned, or (b) 10 years following the first commercial sale of a licensed product; (ii) by FSMA if the Company (a) fails to make payments under the License Agreement, (b) fails to use commercially reasonable efforts towards development and commercial objectives, (c) fails to maintain the required insurance or becomes insolvent, or (d) defaults in its performance under the License Agreement; or (iii) by the Company upon 30 days written notice.

 

13. BioFlash Acquisition

On January 29, 2010, the Company acquired the assets of BioFlash including a technology platform for the production of pre-packed, “plug and play” chromatography columns for total consideration transferred of $2.6 million. This patented technology enables economical production of chromatography columns in a format that is ready for use in the production of a broad range of biopharmaceuticals including monoclonal antibodies, vaccines and recombinant proteins. The terms of the acquisition include an upfront payment of $1.8 million, a milestone payment of $300,000 payable the earlier of (i) the date on which Repligen receives an acknowledgment executed by a specific customer or (ii) the second anniversary of the acquisition date, and future royalties based on product sales.

The Company will manufacture and sell these pre-packed columns under the brand name OpusTM. Opus TM pre-packed chromatography columns have the potential to improve the speed of process development and reduce the cost of biopharmaceutical manufacturing by decreasing the time associated with set-up, cleaning and validation of traditional manufacturing technologies.

Consideration Transferred

The Company has accounted for the acquisition of the assets of BioFlash as the purchase of a business under U.S. Generally Accepted Accounting Principles. Under the acquisition method of accounting, the assets of BioFlash were recorded as of the acquisition date, at their respective fair values, and consolidated with those of Repligen. The purchase price is based upon estimates of the fair value of assets acquired. The preparation of the valuation required the use of significant assumptions and estimates. Critical estimates included, but were not limited to, future expected cash flows, including projected revenues and expenses, and the applicable discount

 

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rates. These estimates were based on assumptions that the Company believes to be reasonable. However, actual results may differ from these estimates. The Company incurred transaction costs of $90,707 associated with the acquisition of the assets of BioFlash.

The total consideration transferred is as follows:

 

Cash consideration

   $ 1,780,000

Liability for additional payment

     300,000

Estimated fair value of contingent consideration

     560,000
      

Total consideration transferred

   $ 2,640,000
      

The fair value of contingent consideration was determined based upon a probability weighted analysis of expected future royalty payments (and the fair value of a time-based additional payment) to be made to former shareholders of BioFlash. The liability for contingent consideration is included in long-term liabilities on the balance sheet at March 31, 2010 and will be remeasured at each reporting period until the contingency is resolved.

Allocation of Consideration Transferred

The following chart summarizes the allocation of consideration transferred:

 

Intangible assets subject to amortization

   $ 1,430,000

Goodwill

     994,000

Equipment

     216,000
      

Total

   $ 2,640,000
      

The excess of the consideration transferred over the fair value of net tangible assets acquired was allocated to specific intangible asset categories as follows:

 

     Amount
Assigned
   Amortization
Period
   Accumulated
Amortization
March 31, 2010

Amortizable intangible assets

        

Technology – developed

   $ 760,000    8 years    $ 15,834

Patents

     240,000    8 years      5,000

Customer relationships

     430,000    8 years      8,958
                
   $ 1,430,000       $ 29,792

Goodwill

     994,000      

The Company believes that the intangible assets are recorded at fair value at the date of acquisition and do not exceed the amount a third party would pay for the assets. The Company used the income approach to determine the fair value of the amortizable intangible assets. The Company expects to record amortization expense of $178,750 in each of the next five years.

Various factors contributed to the establishment of goodwill, including the expected business plans and opportunities to introduce future products to BioFlash’s customer base.

 

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14. Valuation and Qualifying Accounts

 

     Balance at
Beginning of
Period
   Additions    Reversal
without
Utilization
   Balance at
End of
Period

Allowance for Doubtful Accounts:

           

2008

   $ 10,000    $ 5,000    $ 5,000    $ 10,000

2009

   $ 10,000      —        —      $ 10,000

2010

   $ 10,000      —        —      $ 10,000

 

15. Selected Quarterly Financial Data (Unaudited)

The following table contains statements of operations information for each quarter of fiscal 2010 and 2009. The Company believes that the following information reflects all normal recurring adjustments necessary for a fair presentation of the information for the periods presented. The operating results for any quarter are not necessarily indicative of results for any future period.

 

    Q4 FY10     Q3 FY10     Q2 FY10     Q1 FY10     Q4 FY09     Q3 FY09     Q2 FY09     Q1 FY09  
    (in thousands, except per share amounts)  

Revenue:

               

Product revenue

  $ 2,225      $ 2,865      $ 2,742      $ 2,473      $ 2,558      $ 3,294      $ 2,984      $ 5,693   

Royalty and other revenue

    2,647        2,752        2,679        2,588        2,036        2,724        2,106        7,967   
                                                               

Total revenue

    4,872        5,617        5,421        5,061        4,594        6,018        5,090        13,660   

Operating expenses:

               

Cost of product revenue

    885        1,085        918        1,271        1,342        1,287        1,211        1,846   

Cost of royalty and other revenue

    345        343        341        318        270        286        210        325   

Research and development

    3,453        3,845        3,479        3,383        4,645        3,579        2,463        2,084   

Selling, general and administrative

    1,952        1,714        1,889        1,517        1,552        1,404        1,530        1,447   
                                                               

Total operating expenses

    6,635        6,987        6,627        6,489        7,809        6,556        5,414        5,702   

Income (loss) from operations

    (1,763     (1,370     (1,206     (1,428     (3,215     (538     (324     7,958   

Investment income

    134        187        227        322        375        473        515        533   

Interest income (expense)

    —          (1     (1     —          (1     (1     1        (2
                                                               

Income (loss) before taxes

    (1,629     (1,184     (980     (1,106     (2,841     (66     192        8,489   

Income tax (benefit) provision

    —          (835     —          —          148        84        (50     (210
                                                               

Net income (loss)

  $ (1,629   $ (349   $ (980   $ (1,106   $ (2,693   $ 18      $ 142      $ 8,279   
                                                               

Earning per share:

               

Basic

  $ (0.05   $ (0.01   $ (0.03   $ (0.04   $ (0.09   $ 0.00      $ 0.00      $ 0.27   
                                                               

Diluted

  $ (0.05   $ (0.01   $ (0.03   $ (0.04   $ (0.09   $ 0.00      $ 0.00      $ 0.26   
                                                               

Weighted average shares outstanding:

               

Basic

    30,752        30,759        30,746        30,742        30,698        30,809        31,173        31,153   
                                                               

Diluted

    30,752        30,759        30,746        30,742        30,962        31,025        31,556        31,585   
                                                               

 

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EX-10.17 2 dex1017.htm STRATEGIC SUPPLIER ALLIANCE AGREEMENT Strategic Supplier Alliance Agreement

Exhibit 10.17

STRATEGIC SUPPLIER ALLIANCE AGREEMENT – CONTRACT MANUFACTURING EMEA

GE HEALTHCARE

 

GE Healthcare entity (“GEHC”)    Other Party (the “Supplier”)
GE Healthcare Bio-Sciences AB    Repligen Corporation
Address    Address
Björkgatan 30, 751 84 Uppsala, Sweden    41 Seyon Street Building #1 suite 100
Registration number    Waltham, MA 02453 USA
556108-1919    Registration number
AGREEMENT    GEHC REF:

The Parties hereby agree that the following terms and conditions shall apply:

 

  A. Purpose

GEHC and the Supplier are entering into this Agreement for the outsourcing by GEHC of the manufacture of the Products by the Supplier. Pursuant to the terms and condition of this Agreement, the Supplier shall manufacture and sell to GEHC, and GEHC shall purchase from the Supplier the Products meeting the specifications referred to in Attachment C (the “Products”) in such amounts as GEHC may order from time to time on the terms and conditions set out in this Agreement. GEHC shall pay the price of the Products specified in Attachment C (the “Prices”).

 

  B. Documents

The following attachments are an integral part of this Agreement (the “Attachments”). The provisions of each Attachment shall be incorporated by reference into and deemed to be part of this Agreement. The order of precedence shall be as follows, unless otherwise agreed:

QUALITY & INTEGRITY TERMS

Attachment A - Supplier Quality Requirements

Attachment B - Supplier Integrity Statement

BUSINESS TERMS

Attachment C - Products, Prices, Specifications (if any),

Attachment D - Business Terms

GENERAL TERMS

Attachment E - General Terms and Conditions

TECHNICAL TERMS

Attachment F - GEHC Production Know-How

 

  C. Term

Effective Date: 2010-01-01

Agreement Term: This Agreement shall commence on the Effective Date and, subject to the rights of termination in clause 16 of Attachment E, shall continue for a period of five (5) years. The Parties shall negotiate eighteen (18) months prior to the expiration of the Term to decide whether to renew this Agreement.

This Agreement has been duly executed by each of the Parties

 

Signed for and on behalf of GEHC      Signed for and on behalf of the Supplier
Signature   

/s/ Peter Ehrenheim

     Signature   

/s/ Walter C. Herlihy

Name (capitals)   

PETER EHRENHEIM

     Name (capitals)   

WALTER C. HERLIHY

Title   

President and CEO

     Title   

President and CEO

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment A

Purchased Material Quality Terms

Supplier Name:    Repligen Corporation

Version No.:

The Parties are committed to quality in the performance of this Agreement. Accordingly, all Products shall conform to the Purchased Material Quality Requirements set forth below.

Applicable To All Suppliers:

Section 1 - Quality Systems: The Supplier shall maintain a documented quality system, and the Supplier shall be in compliance with ISO 9001 or equivalent. Key components of a robust quality system are properly implemented quality procedures for collection and processing defects (parts or services), appropriate statistical techniques to analyze defects and identifying opportunities for corrective and preventive actions, along with evidence of validation that actions are effective in eliminating and preventing further defects. Upon request from GE Healthcare, the Supplier shall provide documented corrective action plans to prevent future deviations from the specification within thirty (30) days from receiving a corrective action request from GE Healthcare.

To ensure products and services provided to GE Healthcare shall meet or exceed GE Healthcare requirements, GE Healthcare may audit the Supplier’s quality system at periodic intervals upon 30 days written advance notification, to inspect and observe the Supplier’s manufacture of Products, to audit the Supplier’s quality control and inspection procedures, and to have access to all data and documentation from such control of the Products and to take samples and make such other investigations as GEHC deems necessary. The Supplier shall reserve the right for GEHC to perform such inspections on the premises of subcontractors engaged by the Supplier, such inspections to be scheduled by the Supplier following reasonable prior notice by GEHC and to be carried out jointly by representatives of both Parties and at the sole expense of GEHC. GEHC’s right of inspection under this head shall not diminish the Supplier’s obligation to deliver Products which comply with the specifications of this Agreement. GE Healthcare may also request periodic, joint quality assurance meetings at the Supplier’s facility to discuss and resolve product quality and reliability issues.

Section 2 - Quality Record Retention: If the Supplier is required to perform acceptance activities per GE Healthcare written agreement or purchase specification, the Supplier shall maintain records of the acceptance activities for the services performed and/or products and services delivered to GE Healthcare. These records may include as appropriate test/inspection criteria, revision level of documents/equipment/software used, operating procedures (planning, routing or traveler sheets), dates of test/inspection, and the results. The records required shall be retained until GE Healthcare notifies the Supplier that the product life has ended or for a minimum of ten (10) years, whichever is longer, unless the required records are submitted to GE Healthcare by written agreement or purchase specification.

Section 3 - Compliance: The Supplier shall comply with the terms of the Purchase Order or purchase agreement with GE Healthcare (“Agreement”). The Supplier shall maintain compliance with any and all laws and government regulations that apply in the manufacturing and delivery of its products or services. Such laws may include, but are not limited to, regulations and directives, labor laws, environmental laws, Custom Trade Partnership Against Terrorism (CTPAT) and product safety laws. The Supplier shall provide GE Healthcare all information requested that is necessary to enable GE Healthcare to comply with the laws and regulations applicable to the GE Healthcare sale and use of GE Healthcare products. As per GE Healthcare

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    2 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


purchase specifications or for OEM (Original Equipment Manufacturer) items, the Supplier shall maintain compliance to industry standards and product listings for all Products delivered to GE Healthcare.

Section 4 - Change Notification: Changes proposed by Supplier, both material and process or software changes, which may affect form, fit, function, reliability, serviceability, performance, functional interchangeability, regulatory compliance, safety, options or spare parts interchangeability or interface capability with GE Healthcare Product must be submitted along with a written change notice, for GE Healthcare approval. This includes, but is not limited to, changes of sources of material and parts, changes in manufacturing processes, test procedures, manufacturing locations, relocation or replacement of equipment and any similar changes that are anticipated by Sub-Suppliers. Items affected by such changes may not be delivered to GE Healthcare until the Supplier has received written approval for the changes from GE Healthcare. At minimum, the change notice must include the Supplier’s affected part number or software revision, date of implementation, serial number effectivity of the assembly that is changed, reason for the change, specific details of the change and, if available, supporting data that demonstrates that part reliability has not been impacted negatively. The change must not be implemented without prior written consent from GE Healthcare, which shall not be unreasonably withheld. In addition, GE Healthcare has the right to request samples for evaluation prior to approval by GE Healthcare of such changes.

Section 5 - Specifications: The Supplier is responsible to meet or exceed the part requirements and Specifications as referenced in the Agreement. The Supplier is accountable to ensure that delivered items meet the requirements of the revisions and/or versions specified on the applicable Agreement.

The Supplier shall ensure that GE Healthcare documentation is controlled and distributed with the correct revision level to the appropriate personnel that produce the product for GE Healthcare. The Supplier shall also ensure that all GE Healthcare documentation is treated as proprietary and confidential.

For GE Healthcare designed Products, the Supplier is responsible for ensuring that all applicable GE Healthcare documentation is provided to all of the Supplier’s Sub-Suppliers involved in the supply of product for GE Healthcare. The Supplier shall ensure that both they and their Sub-Suppliers that use GE Healthcare engineering documentation are maintained in compliance with all accepted Engineering Change Requests/Engineering Change Orders issued by GE Healthcare.

Upon request from GE Healthcare, the Supplier shall ensure that part qualification is conducted and documents are submitted as required. The part qualification requirements shall be determined by GE Healthcare and shall consist of at a minimum a part layout plan, capability study, and a process control plan.

Section 6 - Electrostatic Discharge: IF ELECTROSTATIC DISCHARGE (ESD) SENSITIVE DEVICES ARE SUPPLIED TO GE HEALTHCARE, THE SUPPLIER MUST HAVE AN ACTIVE ESD PROGRAM AND USE PROPER ESD HANDLING AND PACKAGING PROCEDURES. APPLICABLE COMPONENTS INCLUDE CIRCUIT BOARDS, ELECTRONIC ASSEMBLIES WITH EXPOSED COMPONENTS OR CONNECTORS, SEMI-CONDUCTORS AND ANY OTHER DEVICES THAT MAY REQUIRE ESD PROTECTION. SUPPLIERS MUST MAINTAIN RECORDS OF THE TESTING DONE AND TRAINING PROVIDED.

Section 7 - Packaging and Shipping Methods: The Supplier shall provide packaging and shipping methods to prevent cosmetic, mechanical and electrical damage to the Product. The Supplier shall meet or exceed the detailed specifications of the GE Healthcare packaging requirements found in the Specification

Section 8 - Order of Precedence: This attachment A shall be an addendum to the Strategic Supplier Alliance Agreement (SSAA) between Supplier and GE Healthcare. Any conflict between this Attachment A and the other Attachments of the SSAA regarding the minimum material quality requirements shall be resolved pursuant to the latter. Any conflict between this Attachment A and the Purchase Order regarding the minimum material quality requirements shall be resolved pursuant to the terms of this Attachment A.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    3 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


By signing below, you agree to the terms hereof and consent to meet all requirements that apply for any and all products and services provided to GE Healthcare.

 

Agreed to and Accepted by Supplier
Signature:  

/s/ Daniel P. Witt, PhD

Printed Name:  

Daniel P. Witt, PhD

Title:  

Vice President, Operations

Date:  

2/2/2010

Supplier Name:  

Repligen Corporation

Agreed to and Accepted by the General Electric Company on Behalf of its Division, GE Healthcare

Signature:  

/s/ Peter Ehrenheim

Printed Name:  

Peter Ehrenheim

Title:  

President and CEO

Date:  

1/27/2010

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    4 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment B

Supplier Integrity Statement

Supplier Integrity, Business Conduct, and Compliance Requirements

 

A. Supplier agrees (a) to comply with all applicable legal, as well as GEHC policy, requirements (including those relating to labor, the environment, health and safety, wages, hours and conditions of employment, occupational safety, discrimination, sexual harassment, immigration, minority owned businesses, intellectual property rights and improper payments); (b) that Supplier is responsible for ensuring that Supplier’s employees, contractors, representatives and sub-suppliers understand and comply with the same legal and GEHC policy requirements; and (c) that the requirements referenced in (a) and (b) above include the following:

 

(1) Code of Conduct. Maintain and enforce written company policies requiring high ethical conduct and strict adherence to lawful business practices, including a prohibition against bribery of government officials.

 

(2) Labor Matters.

 

  (i) Employ only workers above the applicable minimum age requirement or the age of 16 whichever is higher.

 

  (ii) No use of forced, prison or indentured labor, workers subject to any form of compulsion or coercion, or labor in violation of minimum wage, hour of service, or overtime laws in the country of manufacture, and prohibit physical, sexual or psychological harassment or coercion.

 

  (iii) Allow workers to freely choose whether to organize or join associations for the purpose of collective bargaining as provided by local law.

 

  (iv) Assure that workers are hired, paid and otherwise subject to terms and conditions of employment based on their ability to do the job, not on the basis of their personal characteristics such as race, national origin, sex, religion, ethnicity, disability, maternity, age, and other characteristics protected by local law; provided, however, that the foregoing does not bar compliance with affirmative preferences that may be required by local law.

 

(3) Environmental Compliance. Comply with all applicable environmental laws and regulations, including: (i) maintaining and enforcing written and comprehensive environmental management programs that are subject to periodic audit by GEHC or its representatives; (ii) continuing compliance with all required environmental permits; and (iii) strictly not negligently permitting any discharge to the environment in violation of law, or that would otherwise have an adverse impact on the environment.

 

(4) Health & Safety. Provide workers with a safe workplace that complies with applicable health and safety standards as well as appropriate living conditions.

 

(5) Improper Payments and Business Dealings. Not offer or provide, directly or indirectly, anything of value (including cash, illegal political contributions, bribes or kickbacks or other improper payments) to any GEHC employee, representative, customer, government official, or other third party in connection with any GEHC procurement, transaction or business dealing. Prohibitions include offering or providing (directly or indirectly): (i) any consulting, employment or similar position to any GEHC employee (or their family member or significant other) involved with a GEHC procurement; (ii) GEHC employees and representatives with any gifts, other than gifts of nominal value to commemorate or recognize a particular GEHC-supplier business transaction or activity; and/or (iii) GEHC employees and/or representatives with the opportunity to participate in any contest, game or promotion. In addition to the foregoing, comply with all applicable laws of the United States and other countries relating to such matters.

 

(6) Business Entertainment of GEHC Employees and Representatives. Comply with the business entertainment (including travel and living) policies established by GEHC and which govern GEHC employees and representatives, including understanding those business entertainment policies of the applicable GEHC component or operation before offering or providing any GEHC employee or representative any form of business entertainment. Never offer to a GEHC employee or representative any form of business entertainment under circumstances that would create the appearance of an impropriety.

 

(7) Collusive Conduct and GEHC Procurements. Comply with all applicable competition laws, including, but not limited to: (i) not engage in prohibited communications or enter into agreements with competitors that can affect competition; (ii) not share or exchange any price, cost or other competitive information, nor engage in any other collusive conduct with any other third party supplier or bidder to GEHC with respect to any proposed, pending or current GEHC procurement; and (iii) avoid even the appearance of improper conduct.

 

(8) Intellectual & Other Property Rights. Respect the intellectual and other property rights of others, including GEHC’s. Only use GEHC information and property (including tools, drawings and specifications) for the purpose for which they are expressly provided and for no other purposes. Take all necessary steps to safeguard and maintain the confidentiality of GEHC proprietary information, including maintaining it in confidence, only in secure work areas, and not disclose it to any third parties without the prior written permission of GEHC. Only transmit GEHC information over the Internet on an encrypted basis. Observe and respect all GEHC patents, trademarks, trade secrets, and copyrights, as well as comply with such restrictions or prohibitions on their use as GEHC may from time to time establish.

 

(9)

Export and International Trade Controls & Customs Matters. Comply with all applicable import and export control laws and regulations, including those of the United States, and not transfer GEHC technical information to any third party

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    5 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  without the express prior written permission of GEHC. Without limitation to the foregoing: (i) comply with all applicable export controls laws and regulations in the export or re-export of GEHC technical information, including any restrictions on access and use applicable to non-U.S. nationals; (ii) ensure that all invoices and any customs or similar documentation submitted to GEHC or governmental authorities in connection with transactions involving GEHC accurately describe the goods and services provided or delivered and the price thereof; and (iii) not participate in any boycotts or restrictive trade practices prohibited by U.S. laws. Supplier will also obtain all applicable permits and licenses necessary to perform its obligations under this Agreement, and upon GEHC’s request, will provide GEHC with copies of such permits and licenses. Where Products contain United States components, Supplier will also provide GEHC with details of the United States content value as a percentage of the Product price upon GEHC’s request. Additionally and upon request, Supplier will provide ECCN and Harmonized Tariff numbers assigned to Products.

 

(10) Privacy. With respect to data and personal information (including information of GEHC employees, its customers, suppliers, business partners, and patient health information handled and processed on behalf of its customers) (collectively, “PI”): (i) comply with all applicable privacy and data protection laws globally, or generally acceptable privacy principles where comprehensive privacy laws are not available; (ii) report any improper use or disclosure of PI, as well as successful security breaches, immediately upon becoming aware; (iii) ensure that any employees, contractors, representatives and sub-suppliers to whom it provides PI and/or access to information systems, agree to the same restrictions and conditions set forth herein; (iv) facilitate audits by making its internal practices, books and records relating to the use and disclosure of PI available to GEHC and government agencies (including, the Secretary of the Department of Health and Human Services) for purposes of determining compliance with applicable laws, rules, and regulations; (v) when requested by GEHC, promptly return or destroy, as well as certify in writing to the return and destruction of, all PI and information in any form that allows access to GEHC information systems, and retain no copies of such PI and information; (vi) safeguard PI upon taking possession or exposure to employees and all third parties; (vii) ensure that formal security management systems are employed that eliminates the risk of PI-related security breaches; and (viii) notify GEHC in writing whenever PI will be exported from jurisdictions with data transfer restrictions, or transfer PI to countries without comprehensive data protections laws.

 

(11) Money Laundering Prevention. Comply with all applicable anti-money laundering laws and regulations and GEHC policies established for money laundering prevention.

 

(12) Prohibition of Use of Sub-Suppliers or Third Parties to Evade Requirements. Not use sub-suppliers or other third parties to evade any applicable legal and/or GEHC policy requirements, including those enumerated above.

 

(13) Security Measures. Supplier warrants and represents that it will review and adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable. Supplier furthermore agree that it will make reasonable efforts to become a member of C-TPAT, or any similar EU/other organization aimed at strengthening and improving supply chain security, in a timely manner if it is eligible to do so.

 

(14) Country of Origin. In accordance with and as required by applicable trade and customs laws, Supplier will mark each Product, as well as Product packaging, containers, labels, and invoices, with the country of origin for the Product. Supplier will also provide acceptable and auditable documentation that establishes the country of origin for all Products, including, without limitation and as applicable, certifications of origin for Products qualifying for EFTA/EU and other preferential duty provisions, as applicable. Without limitation to the foregoing and in marking the Products, Supplier will comply with the requirements of the custom authorities of the country of receipt.

GEHC policy requirements, including those enumerated above, are subject to modification by GEHC at any time. Supplier agrees to contact its GEHC representative if Supplier has any questions about the foregoing and/or their application to particular circumstances.

 

B. Products provided by Supplier may be subject to environmental, health and safety laws and regulations. As a result, Supplier agrees to the following without limitation:

 

(1) Supplier represents, warrants, certifies and covenants that Supplier shall perform all activities required under this Agreement in compliance with all applicable national, EU, state/provincial and local labor, environmental, health and safety laws and regulations.

 

(2) Supplier represents, warrants, certifies and covenants that each chemical substance constituting or contained in Products sold or otherwise transferred to GEHC hereunder is on the list of chemical substances compiled and published by (a) the Administrator of the Environmental Protection Agency pursuant to the Toxic Substances Control Act (15 USC Section 2601 et seq.) as amended; and (b) the equivalent lists in the other jurisdictions to which GEHC informs Supplier or Supplier knows the Products will likely be shipped to or through; or is exempt from the foregoing lists, in which case Supplier shall provide adequate documentation of the validity of the claimed exemption if so requested by GEHC;

 

(3) Supplier will, when relevant, timely provide GEHC with supporting documentation, including without limitation, (a) the exact weight by weight percentage of any REACH candidate list substance constituting or contained in the Products, (b) all relevant information that GEHC requires to meet the obligations under REACH to communicate safe use to GEHC’s customers.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    6 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


(4) Supplier represents, warrants, certifies and covenants that none of the Products supplied under this Agreement contain any above limits stated in law: (i) lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) or any other hazardous substances the use of which is restricted under EU Directive 2002/95/EC (27 January 2003) (RoHS Directive), as amended; (ii) arsenic, asbestos, benzene, polychlorinated biphenyls (PCBs), or carbon tetrachloride; (iii) any chemical restricted under the Montreal Protocol on ozone-depleting substances; or (iv) any other chemical or hazardous material the use of which is restricted in any other jurisdictions to which GEHC informs Supplier or Supplier knows the Products are likely to be shipped to or through, unless GEHC expressly agrees otherwise in writing to Supplier referencing this Agreement and Supplier identifies an applicable exemption from any relevant legal restriction on the inclusion of such chemicals or hazardous materials in the Products sold or transferred to GEHC. Upon GEHC’s request and subject to the confidentiality provisions of this Agreement and GEHC’s ability to meet its compliance obligations, Supplier will provide GEHC with the chemical composition, including proportions, of any substance, preparation, mixture, alloy or goods supplied under this Agreement and any other relevant information or data regarding the properties, including, without limitation, test data and hazard information.

 

(5) Supplier will use all commercially reasonable efforts to establish and maintain an effective program to ensure that the activities of any suppliers it utilizes to provide any chemicals, substances, goods or services that will be incorporated into the Products supplied under this Agreement will be conducted in conformance with Sections B(1) to B(4) above.

 

(6) With respect to any Products or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall provide all relevant information, including without limitation, safety data sheets in the language and the legally required format of the location to which the Products will be shipped and mandated labeling information, required pursuant to applicable requirements such as: (i) the Occupational Safety and Health Act (OSHA) regulations codified at 29 CFR 1910.1200; or (ii) REACH or EU Directive 67/548/EEC, as amended, if applicable, and (iii) any other applicable law, rule or regulation or any similar requirements in any other jurisdictions to which GEHC informs Supplier that the Products are likely to be shipped.

 

(7) With respect to any Products or other materials sold or otherwise transferred to GEHC hereunder, Supplier shall notify GEHC in writing of the presence of any nanoscale material (defined for these purposes as any substance with at least one dimension of such substance known to be less than 100 nano meters in length). With respect to all such nanoscale materials, Supplier shall provide a description of its legal status in the relevant jurisdiction, and any safety data or other notifications that are appropriate in the EU, US and the relevant jurisdiction.

 

AGREED TO AND ACCEPTED BY SUPPLIER
BY:  

Daniel P. Witt, PhD

TITLE:  

Vice President, Operations

DATE:  

/s/ Daniel P. Witt, PhD 2/2/2010

SUPPLIER NAME:  

Repligen Corporation

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    7 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment C

Products, Prices and Specifications

 

Currency:    USD
Delivery term:    FCA Waltham, Massachusetts
Revision date:    22 January 2010

A.

Product Name    Zäta
GEHC Article number    28-4048-76

Supplier Article Number/unit size

 

20-2501-00      [*]
20-2501-01      [*]
20-2501-02      [*]
20-2501-03      [*]
20-2501-04      [*]

 

[*]   
Lead time (PO):    [*]
Lead Times for Safety Stock Replenishment
Requirement    Lead time Zata
[*]   

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling Forecast distributed by GEHC and the prior [*] by GEHC of each of the Products based on [*].

 

Shelf life    [*]

B.

Product Name    rPA
GEHC Article number    30-6000-60

Supplier Article Number/unit

 

20-1501-00      [*]
20-1501-01      [*]
20-1501-02      [*]
20-1501-03      [*]

[*]

 

Lead time (PO):    [*]

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    8 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Lead Times for Safety Stock Replenishment

 

Requirement    Lead time rPA

[*]

  

Level of Supplier’s Safety Stock

[*] based on the average of the [*] of the then current [*] rolling forecast distributed by GEHC and the prior [*] by GEHC of each of the Products based on [*].

 

Shelf life

   [*]

C. General Price Terms

All prices above are per gram and shall be set [*] based on the [*] in each of the [*] for the Products that corresponds to the [*] of each of the Products based on the [*]. The price for each of the Products shall be set on the [*] of each [*] and shall remain fixed for that [*]. Example:

[*]

The prices agreed herein do not include the costs of transportation, packaging, shipping or taxes (including VAT) for the Products and will be paid by GEHC. The costs of packaging will be charged to GEHC by Supplier directly and shall be clearly specified on the invoice.

Additional charges: Unless otherwise agreed in this Agreement the Prices include all costs relating to the supply of the Products and GEHC shall not be obliged to reimburse the Supplier for any additional charges or any other costs relating to the supply of the Products that are not specified herein or otherwise agreed in writing by the Parties.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    9 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Specifications

 

LOGO

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

30-6000-60 Ed. AG

Issued by

QA/ A Elb-Jorde

  

Established by

R&D/ J Daicic

  

Valid from

2008-10-17

  

Supersedes

30-6000-60 Ed. AF

  

Page

1 (2)

rProtein A

Code No: 30-6000-60

 

1       Packaging instruction

  
   The package shall be suitable for storage of the material.

2       Terms of transportation

  
   At -18 °C or below

3       Storage conditions

  
   Preserve in a well-closed container at or below -18 °C.

4       Shelf life

  
  

Estimated shelf life is [*] from the date of manufacture.

Final shelf life is to be decided from stability studies.

5       Other name(s)

  
   rPa – GE Healthcare

6       Formula and mass

  
   Theoretical Mr. 34 318 Dalton calculated from amino acid sequence.

7       Description

  
   rProtein A is a recombinant engineered form of Staphylococcus aureus Protein A, produced by fermentation of Escherichia coil. The protein is produced with chemicals and materials of non-animal origin.
   The product is supplied as a clear, amber frozen liquid free from particulates.

70-5043-16 / AB Valid from 2007-01-24

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    10 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


LOGO

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

30-6000-60 Ed. AG

                   

Page

2 (2)

8       Requirements on properties

    

Characteristic

  

Tolerance limit

  

Test method

  

Remark

  

1       Visual examination

   [*]    45-2006-68   
  

2       igG-binding activity: %

   [*]    04-0008-64   
  

3       Purity by size exclusion chromatography: %

  

[*]

   04-0008-66   
  

4       SDS-PAGE

  

[*]

   04-0008-65   
  

5       Protein concentration  (A275); mg/ml

  

[*]

   QCP-1156    1
  

6       Microbial contamination CFU/ml

  

[*]

   M-QCP-1003    1
  

7       Endotoxin activity EU/mg rProtein A

  

[*]

   M-QCP-1017    1

Comment:

1) Supplier method, to be available by the supplier on request from GE Healthcare.

 

GE and GE monogram are trademarks of General Electric Company.

© 1999- 2008 General Electric Company - All rights reserved.

GE Healthcare Bio-Sciences AB, a General Electric Company.

   70-5043-16 /AB

 

Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


LOGO

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

14-0037-84 Ed. AC

 

Issued by

QA/ A Elb-Jorde

  

Established by

R&D/ J Daicic

  

Valid from

2008-08-19

  

Supersedes

14-0037-84 Ed. AB

  

Page

1 (2)

ZätA protein 905

Code No: 28-4048-76

 

1       Packaging instruction

  
   The package shall be suitable for storage of the material.

2       Terms of transportation

  
   At or below -18 °C

3       Storage conditions

  
   Preserve in a well-closed container at or below -18 °C.

4       Shelf life

  
  

Estimated shelf life is [*] from the date of manufacture.

Final shelf life is to be decided from stability studies.

5       Formula and mass

  
   Theoretical Mr: 26 748 Dalton calculated from amino acid sequence.

6       Description

  
  

ZätA protein is a recombinant protein produced by a Genetically Modified Organism (GMO) in a fermentation process.

The substance is a clear, yellowish frozen liquid free from particulates, supplied in a buffer:

20 mM potassium phosphate

150 mM sodium chloride

2 mM EDTA

pH 7.0

  

The bulk is to be manufactured according to our Base Method, number 14-0040-44.

The protein is produced with chemicals and materials of non-animal origin.

70-5043-16/AB Valid from 2007-01-24


LOGO

  

ANALYTICAL SPECIFICATION RAW MATERIAL

 

14-0037-84 ED. AC

                   

Page

2 (2)

7       Requirements on properties

    

Characteristic

  

Tolerance limit

  

Test method

  

Remark

  

1       Visual examination

   [*]    45-2006-68   
  

2       IgG-binding activity; %

   [*]    04-0008-64   
  

3       Purity by size exclusion chromatography; %

   [*]    04-0008-66   
  

4       SDS – PAGE

   [*]    04-0008-65   
  

5       Quantification; mg/ml

   [*]    04-0013-21   
  

6       Microbial contamination

CFU/ml

   [*]    M-QCP-1003    1
  

7       Endotoxin activity

EU/mg ZatA Protein

   [*]    M-QCP-1166    1

Comment:

1) Supplier method, to be available by the supplier on request from GE Healthcare.

 

GE and GE monogram are trademarks of General Electric Company.

© 2006-2008 General Electric Company – All rights reserved.

GE Health Bio-Sciences AB, a General Electric Company.

   70-5043-16 / AB


Annual Business Attachment / Performance Goals

The purpose of the performance goals are primarily for the Supplier to plan the operations at the Supplier’s site and take preventive initiatives so that the set performance goals can be achieved. The results of the Supplier’s performance in below areas should be a part of the business updates between the two Parties. While the performance goals are targets and non-achievement of such goals shall not be considered as material breach of contract the Suppler agrees to use all commercially reasonable efforts to achieve the performance goals.

Performance goals:

 

1. Deliveries within Specification, agreed lead times and quantities; performance goal is [*] according to the terms in Attachment C)

 

2. Number of complaint reports sent to the Supplier by GEHC; performance goal is [*]

 

3. Business contingency plan and or Quality audits performed and with the result approved; performance goal is [*].

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    14 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment D

Business Terms

 

1. Specifications

The Products to be supplied in accordance with the terms of this Agreement are set forth in Products and Prices, Attachment C. A technical specification in relation to a specific Product is referred to as the “Specification” as set forth in Attachment C.

 

2. Delivery documentation

With each shipment the Supplier shall deliver the following documents to GEHC:

Certificate of Analysis, Packing slip and the Commercial Invoice.

With each shipment the Supplier shall issue a Shipper’s Letter of Instructions and an Export Declaration as applicable.

 

3. Prices and Payment Terms

 

  a. Firm Prices. The Prices of the Products are firm for the Term of this Agreement.

 

  b. Taxes. Unless prohibited by law, the Supplier will separately indicate on its Invoice any tax that is required to be imposed on the sale of Products.

 

  c. Payment Terms. GEHC shall settle any undisputed invoices arising under this Agreement [*] ([*]) days after receiving an Invoice prepared in accordance with the terms of this Agreement. All sums to be paid by GEHC under this Agreement shall be in the currency specified in Attachment C. Interest for late payments shall not apply to payments that GEHC contests in good faith and shall in no event exceed applicable statutory interest rate.

 

  d. Productivity improvement. In the event the Parties have jointly contributed to productivity improvements or cost savings achieved by the Supplier the Parties agree to negotiate in good faith a reasonable price adjustment. Price conditions will be changed only upon mutual agreement.

 

  e. Invoicing requirements. The Supplier’s Invoices shall contain the GEHC Purchase Order number and other such information as may be required by law or requested from time to time by GEHC. Each cost item shall be specified in the invoice. Invoices shall be addressed to GEHC or the GEHC affiliate who has placed the purchase order with the Supplier.

 

  f. GEHC mandated changes. It is recognized and agreed by the Parties that GEHC mandated changes in the manufacturing process, quality requirements or standard or in the components and materials used in the process or any other changes in the requirements for the Products may result in an increase in the cost of the Products. The Parties agree to negotiate in good faith to adjust the prices accordingly, provided that the Supplier notifies GEHC in writing of any possible cost increases in advance of the initiation of any such changes.

 

4. Components and Materials

At GEHC’s option, GEHC may instruct the Supplier to procure or provide all materials and components necessary for the manufacture of the Products from an approved supplier, in which case an approved suppliers list shall be maintained by the Supplier. GEHC confirms its approval of the currently used suppliers as notified to GEHC in approved raw material specifications. Any new suppliers selected by the Supplier in connection with the Agreement must be approved by GEHC, whereupon they may be

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    15 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


added to such approved suppliers list. The Parties may from time to time agree on materials that can be sourced by the Supplier from different sub-suppliers without GEHC’s consent.

 

5. Additional Suppliers

The Supplier shall, at GEHC’s written request, provide reasonable assistance to GEHC with regard to GEHC’s efforts to have a designated alternative supplier for the Products (i) by providing GEHC or such designee with copies of all written SOP’s and access at Suppliers facility to completed batch records or other tangible forms of recorded manufacturing documentation of the Products, that are reasonably necessary for the manufacture of the Product, and (ii) by making relevant personnel available within reason for consultation on the phone or at Supplier’s facility with respect to clauses (i) above.

 

6. Forecast and Commitment

 

  a. Forecasting. [*] ([*]) days before the end of each quarter, GEHC shall submit to the Supplier in writing a [*] ([*]) month rolling quarterly forecast (“Forecast”) for its estimated needs of the Products during the subsequent [*] ([*]) month period. Supplier shall use the Forecast as the basis for its production planning and shall adjust the Safety Stock according to the new Forecast within the agreed lead times. In the event that GEHC does not timely submit a Forecast to the Supplier, Supplier will notify GEHC in writing and GEHC will have [*] ([*]) business days to provide the Supplier with the updated Forecast or if GEHC fails to provide the updated Forecast, the Forecast will revert to [*] ([*]).

 

  b. The Forecast. The [*] of every Forecast provided by GEHC for Products shall be [*] on GEHC and the Supplier. [*]. The Supplier agrees to use all commercially reasonable efforts to be responsive and supply Product in excess of any firm and binding [*] if so requested by GEHC, provided such excess shall not exceed [*]% of the then firm and binding [*].

 

  c. General Supply Commitment. The Supplier represents and warrants that it has the capacity and expertise necessary to [*]. In the event that the market demand exceeds this volume, GEHC and Supplier will work together and make best efforts to meet the market demand.

 

  d. Purchase Commitment. As a result of this Agreement, the Supplier will become one of the preferred suppliers of GEHC for the Products. GEHC agrees that the [*] shall include quantities of the Products, which corresponds to at least [*] ([*]) percent of GEHC’s total actual requirements in [*] for the Products. For any year thereafter the requirement in the [*] shall be at least [*] ([*]) percent of GEHC’s total actual requirements in [*] for the Products per year and at least [*] ([*]) percent of GEHC’s actual requirements in [*] of each of the Products. While GEHC has to adjust its production levels to market changes GEHC shall use all reasonable efforts to distribute orders evenly during the year and to avoid to have quarters without any orders at all. Further, GEHC agrees to purchase at least [*] ([*]) percent of its total requirements in [*] of the Products during the years [*] of this Agreement or any shortened period of [*] in the event this Agreement is terminated in accordance with 16.6 and 16.7 in Attachment E. In the event GEHC should fail to fulfill its purchase obligations hereunder it shall as its sole liability immediately issue a purchase order for the missing quantities upon the Supplier’s written request thereto. The Supplier agrees to maintain the equivalent ability to manufacture the Products for GEHC. The Parties may from time to time mutually agree in writing on separate arrangements for certain time periods in order to accommodate specific requirement and planning needs which may deviate from the above commitment. GEHC shall be free to decide on the mix between Products under the above purchase obligations and in the [*] forecast, provided that the binding part of the forecast shall be fixed. In the event there is a requirement in excess of [*]% of the firm and committed [*] and the Supplier is unable to deliver within the agreed lead times as specified in Attachment C then GEHC shall be free to purchase any such additional quantities as Supplier is unable to deliver that [*] from other suppliers.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    16 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


If the Supplier during a certain [*] is unable to timely supply Products complying with agreed quality standards in quantities specified in GEHC’s committed Forecast, then GEHC’s purchasing commitment hereunder shall be reduced with a quantity corresponding to the quantity to which such inability relates.

 

  e. No Obligation. Other than as set out in subsection b) and d) above, it is the express understanding of the Parties that GEHC shall have no obligation to purchase Products exclusively from the Supplier or to purchase any minimum amount of Products, and may use other suppliers for any and all Products, or similar products.

 

7. Contract Managers and Communication

 

  a. Contract Manager. Both the Supplier and GEHC will appoint a contract manager to manage their respective obligations under this Agreement, to act as focal points between the two organizations and review progress on a quarterly basis. The contract manager shall be as specified below or such other person as subsequently communicated to the other Party.

 

GEHC:

   [*]

Supplier:

   [*]

 

  b. Legal Notices (as set forth in Section 18 in Attachment E).

 

GEHC:

   Björkgatan 30
   751 84 Uppsala, Sweden
   Fax No. [*]

Supplier:

   41 Seyon Street Bldg #1 suite 100
   Waltham, MA 02453 USA
   Phone: 781 250-0111 (main)
   Fax: 781 250-0115

 

  c. Crisis Communication. The Supplier must maintain the ability to contact or receive contact from GEHC on a twenty-four (24) hour per day, seven (7) days per week basis in order to communicate and manage crisis situations that threaten to or interrupt the supply chain.

 

8. Insurance and Liability

 

  a. The Supplier undertakes to maintain a comprehensive liability insurance policy with a reputable insurer including cover for third party liability and product liability on terms customary to the business. Such insurance shall be for an insured sum of not less than USD [*] ([*])[*] and the Supplier shall supply GEHC with a copy of the relevant policy on request.

 

  b. The Supplier shall be liable to compensate GEHC for direct and indirect damage and loss it has caused GEHC under this Agreement up to USD [*] ([*])[*]. In the event of any loss or damage in excess of this amount the Supplier shall not be liable to compensate for such excess damage or loss, unless: (i) caused by its gross negligence or willful misconduct, (ii) caused by its breach of confidentiality obligations under this Agreement, or (iii) relating to its intellectual property indemnification obligations under this Agreement.

 

9. Safety Stock and Consignment Stock

The Supplier shall keep a Safety Stock at the Supplier’s premises, corresponding to the minimum set inventory values and the replenishment times in Attachment C.

The inventory levels stated in Attachment C shall be based on the latest [*] Forecast distributed by GEHC. In case a new Forecast leads to replenishment actions for the safety stock the Supplier shall use

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    17 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


all commercially reasonable efforts to replenish the Safety Stock as soon as practical and always within the agreed lead times set forth in Attachment C.

GEHC is reviewing the possibility to introduce a consignment stock arrangement, ie having the Supplier to own certain stock of Product at GEHC premises. The Supplier agrees to negotiate the terms and conditions in good faith.

 

10. Manufacturing Process

For clarity it is stated that all written manufacturing or production documentation relating solely to the Products, including without limitation the manufacturing documents specified in Attachment F shall be the sole property of GEHC. The Supplier shall document and GEHC shall have access to review all written manufacturing or production records relating to any of the Products at Suppliers facility and upon request from GEHC, the Supplier is obliged to send GEHC copies of the requested manufacturing or production documents (including SOP’s and records) and such a request shall not be unreasonably withheld by the Supplier.

The Supplier shall keep a master list of production documents showing the name, identity and version number for each of the production documents that is used in the production of the Products. The Supplier shall always keep and maintain the master list of production documentation and shall send upon GEHC’s request an update of any of the documents included in the master list of production documentation.

 

11. Business interruption

The Supplier undertakes to keep GEHC informed about any circumstances that might reasonably impact on the Supplier’s ability to supply the Products, timely and in accordance with applicable quality standards, including any plans to close or divest the business relating to all or any of the Products. If such circumstance should arise or may reasonably be possible to arise the Supplier shall immediately inform GEHC and propose a plan on how to mitigate the consequences thereof. The Parties shall then in good faith conduct negotiations concerning the actions to be taken and the costs to avoid or mitigate the risks.

 

12. Reports

GEHC will provide Supplier within [*] of the close of each [*] period a report of the total quantity of each of the Products purchased by GEHC from all suppliers during the period.

The Supplier will provide GEHC with finished goods inventory and Safety Stock levels of Products within [*] of the close of each [*] period.

 

13. Audit

Supplier shall have the right to have an independent third party reasonably acceptable to GEHC, such as one of the global auditing firms, to conduct an annual audit of GEHC’s records to ensure compliance with GEHC’s commitments according to Section 6 d in this Section of the Agreement.

 

14. Supply of GEHC products for the manufacture of Products

During the term of this agreement the Supplier shall have the right to purchase the following products from GEHC at following price conditions:

 

Name

  

Article No:

  

Price:

[*]      

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    18 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Delivery conditions: CIF

Lead time: [*]

Credit term: [*] days from date of invoice

Order handling: all order shall be submitted to the Contract Manager, together with a declaration of the intended use for the Products.

The sale of the goods to the Supplier shall be subject to GEHC Conditions of Sale.

The products ordered in accordance with this Clause 15 may only be used in the manufacture of the Products for delivery to GEHC. Any other use of the products ordered is strictly forbidden.

 

15. ELISA Kits

GEHC acknowledges that the Supplier manufactures and sells ELISA analytic kits for protein leakage testing. During the term of this Agreement Repligen shall have the right to use MabSelect SuRe™ ligands and the MabSelect SuRe trademark, but only in connection with the manufacture, sale and marketing of ELISA analytical kits for protein leakage testing. The Supplier agrees to use the GEHC trademarks in accordance with GEHC’s written instructions from time to time.

 

16. Cell banks

The biological starting material used in the fermentation process originates from the cell banks kept and owned by GEHC. Such material may only be used in connection with the manufacture of the Products and shall be returned to GEHC, alternatively destroyed upon termination of this agreement for what ever reason. Supplier shall not disclose or provide such material to any third parties, unless GEHC has given its prior written consent thereto. The Supplier agrees not to sequence, extract or in any other way use the plasmid, the chromosome or any of the DNA codes present in the cell banks.

The supplier may order starting material according to the following conditions:

 

  a) Lead time: [*] days, unless otherwise agreed.

 

  b) Orders: written orders in accordance with form provided by GEHC specifying product, campaign, numbers of vials and requested delivery date. The order will be sent to:

 

GE Healthcare Bio-Sciences AB

Att: [*]

BL3-2

Björkgatan 30

751 84 UPPSALA

Sweden

tel:    [*]
fax:    [*]

 

  c) GEHC will confirm order without delay and provide a notice two weeks before the estimated delivery date.

 

  d) Supplier shall confirm receipt of the cell bank.

 

  e) Transportation: GEHC will coordinate with Repligen to ensure appropriate delivery time and arrangements for the cell banks and will arrange and pay for transportation.

Documentation: The cell banks will be accompanied by a Certificate of Analysis in accordance with the documents listed in Attachment F.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    19 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  f) Repligen shall provide GEHC at the beginning of every [*] a report of the total quantity of seed stock for each of the Products as well as the planned consumption of the seed stock for the following [*] months. GEHC shall use this information for their internal planning purposes.

 

17. Other products

The Parties have agreed to enter into a separate agreement covering the Supplier´s supply of [*]. The Parties intend to enter into a separate agreement concerning supply of [*].

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    20 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment E – General Terms and Conditions

ORDER AND SUPPLY

 

1. Purchase Orders

 

1.1 Purchase Order Contents. GEHC shall issue purchase orders to the Supplier stating the quantity and delivery date for Products (a “Purchase Order”). The Purchase Orders shall be written and sent through an electronic purchasing system or by fax, e-mail or other agreed method.

 

1.2 Orders from Affiliates. From time to time Affiliates of GEHC may also issue purchase orders for Products and, if requested by such GEHC Affiliate, the Supplier agrees to supply Products to such affiliate on the terms of this Agreement. The ordering GEHC Affiliate entity shall be solely contractually liable for such order.

 

1.3 Acceptance of Purchase Order. The Supplier shall be deemed to have accepted a Purchase Order upon receipt from GEHC so long as the terms are consistent with those stated in this Agreement. The Supplier shall confirm compliance with the Purchase Order in writing within [*] ([*]) business days of the receipt of Purchase Order.

 

2. Transportation; Title and Risk of Loss

 

2.1 Unless otherwise agreed, Products shall be delivered according to the Incoterms FCA (ICC Incoterms 2000) at the address set out in Attachment D. This means that the possession and title will transfer upon delivery to the carrier. The Supplier will be responsible for export declaration and shall arrange for transportation at GEHC’s cost and in accordance with GEHC’s instructions. GEHC will take care of the import declaration.

 

2.2 If the delivery term agreed in Products and Prices in Attachment C or Purchase Order, if any, is an Incoterm such term of delivery shall be construed according to the edition of Incoterms in force at the Effective Date.

 

3. Delivery

 

3.1 The Supplier shall deliver the Products on the date and in quantity set forth in the Purchase Order. The Supplier may only deliver prior to the agreed delivery date with the written consent of GEHC.

 

3.2 Deliveries shall not be regarded as completed until the Delivery Documentation in Specific Requirements Attachment D has been provided.

 

3.3 The lead time as specified in Attachment C for the Product shall count from the date of issue of the Purchase Order to receipt of the Products at GEHC premises, including receipt of any agreed documentation.

 

3.4 In the event that the Supplier anticipates or expects a delay in delivery it shall immediately notify GEHC and at the same time explain the causes and the steps that it is taking to minimize the delay. GEHC may, acting reasonably, require the Supplier to take
  further or other steps, including the deployment of additional resources, at the Supplier’s cost, to minimize the said delay. If unless otherwise mutually agreed by the Parties, the delivery is delayed by more than [*] days then GEHC may: (i) terminate the delayed Purchase Order and, if applicable, return to the Supplier some or all of the Products that relate to such order at the expense of the Supplier; and/or either to (ii) purchase substitute Products elsewhere and charge the Supplier with the increased cost thereof (if any) or (iii) claim as liquidated damages for such default [*] per cent of the total value of the delivery for each calendar day delivery is delayed limited to a maximum of [*] per cent of the total value of the delivery in aggregate. Such rights are without prejudice to any other rights that GEHC may have in respect of late delivery by the Supplier.

 

4. Inspection Period

All Products delivered to GEHC by the Supplier must meet the terms and conditions of this Agreement and the related Purchase Order. All Products shall be received subject to GEHC’s acceptance or rejection on or before the end of the Inspection Period. GEHC may reject an entire order based upon a reasonable sampling of Products. “Inspection Period” means [*] ([*]) business days. Partial or total payment by GEHC for Products under this Agreement prior to the end of the Inspection Period shall not constitute its acceptance thereof, nor shall such payment remove the Supplier’s responsibility for any non-conforming items.

The Supplier acknowledges that GEHC’s inspection of the goods may be based on the review of the Certificate of Analysis issued by the Supplier and that GEHC shall not be prevented from raising any claims under the warranty in clause 11 after the expiration of the Inspection Period.

 

5. Safety Stock

Supplier shall maintain at its’ own cost and risk the safety stock agreed as set forth in Attachment C. The safety stock shall be managed in accordance with first in - first out principle.

 

6. Changes to Products

 

6.1 GEHC Proposed Changes. GEHC may [*] per year propose changes to the Specification or the manufacturing method for the Products by submitting the proposed changes to the Supplier. The Supplier agrees to use all commercially reasonable efforts to accommodate any such proposals of GEHC and shall respond in writing to GEHC within [*] ([*]) days after receipt of such changes with the following information, as

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    21 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  applicable: (a) time required to implement proposed changes; (b) impact of proposed changes on pricing of Product; and (c) impact of proposed changes on the lead time of the Product. If the Parties agree on the changes to the Specification they shall amend this Agreement accordingly. If the Parties fail to agree on the amendments to be made to the Agreement to reflect the changes to the Specification the terms in effect prior to commencement of the negotiations shall remain in full force and effect and the Supplier shall continue to supply the Product to the existing Specification.

 

6.2 Supplier’s Proposed Changes. The Supplier may [*] per year propose, a change to the Specifications (including, but not limited to, changes which may affect quality, form, fit, function, reliability, regulatory compliance, safety or interface capability with GEHC products) or a change in its manufacturing method (including, but not limited to changes of sources of materials and changes in manufacturing processes or locations) but the Supplier shall not implement such change without the prior written consent of GEHC, which shall not be unreasonably withheld. The Supplier shall make such proposals in writing explaining the reason for the changes and providing reasonable detail sufficient for GEHC to evaluate the proposal. GEHC agrees to use all commercially reasonable efforts to accommodate any such proposals. Upon request of GEHC, the Supplier shall provide samples of the Products manufactured according to the proposed new specification or manufacturing method for evaluation purposes.

 

7. Packaging and marking

The Supplier shall be responsible for the safe and suitable packaging and labeling of the Products, for complying with the packaging and marking requirements in the Specifications, if any, and all applicable laws and regulations relating to the packaging, marking and transport of the Products.

 

8. Health and Safety

 

8.1 The Supplier shall ensure that all information held by or reasonably available to it regarding any changes occurring after the Effective Date with regard to potential hazards known or believed to exist in the transport, handling, or use of any Products and/or performance of any services shall be received by GEHC in writing prior to delivery of the Products and/or performance of the services.

 

8.2 Employees, agents and representatives of the Supplier visiting any of GEHC’s sites shall be subject to such safety and security regulations as may be in force on that site.

 

9. Business Contingency Planning

 

9.1 Business Contingency Plan. Upon GEHC’s request, the Supplier shall provide to GEHC a summary of Suppliers Business Contingency Plan that outlines the Supplier’s internal contingency arrangements to ensure GEHC continuity of supply if the Supplier or
  any of the Supplier’s suppliers are unable to provide Products or components to such Products to GEHC.

 

9.2 GEHC shall have the right to carry out audits of the Supplier’s Business Contingency Plan on a regular [*] basis with [*] ([*]) days prior notice.

 

10. Compliance

 

10.1 Applicable Laws. The Supplier represents and warrants that its performance under this Agreement and its manufacture of the Products will comply with all applicable laws and regulations, and all conventions and standards issued by relevant authorities and that the Supplier has obtained all applicable permits and licenses necessary to perform its obligations under this Agreement

 

10.2 Assistance. The Supplier shall at GEHC’s request give reasonable assistance necessary to obtain any licenses required by GEHC with respect to the importation, exportation, marketing and use of the Products and provide GEHC with all information in relation to the Products which may be required by any regulatory authority.

 

10.3 Regulatory Approvals and other Governmental Registrations. GEHC shall be responsible for identifying, obtaining, and maintaining at its sole cost and expense all FDA and other applicable clearances and approvals and corresponding approvals in other countries that are required for the development, manufacture, or sale of any Product. The Supplier shall provide GEHC with reasonable support and assistance in obtaining any such approvals, which may include providing test reports and data necessary to meet the country specific regulatory requirements.

 

10.4 Regulatory Agency Inquiries. If the FDA or any other regulatory body with authority over the end products to which the Products form part, provides written notice to the Supplier to inquire about or investigate any Product or conduct any audit or inspection of facilities used for the manufacture, storage or distribution of Products or request any information related to the manufacture of any Product, the Supplier shall give notice thereof to GEHC within one working day of receipt of such contact from the FDA or other body.

 

10.5 Security Measures. The Supplier agrees that it will adopt industry standard security measures which are consistent with accepted programs including the US Customs-Trade Partnership Against Terrorism (“C-TPAT”), the European Union’s Authorized Economic Operator program and other similar programs where applicable.

 

10.6 Export Restrictions. If any Products are subject to export restrictions in the country of manufacture or shipment the Supplier shall supply GEHC prior to dispatch with any relevant ECCN and ECN numbers and copies of any export licenses or other certificates required in the country of manufacture or shipment and, where Products contain US components, details of the value as a percentage of the Products price.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    22 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


10.7 Country of Origin. In accordance with GEHC´s request the Supplier will mark each Product, and, as appropriate, Product packaging, labels, or invoices with the country of origin for the Product, in accordance with the applicable trade and customs laws. The Supplier will also upon request from GEHC provide acceptable and auditable documentation that establishes the country of origin for a Product and including the raw materials used to manufacture such Product for the whole supply chain, including without limitation, certifications of origin for Products qualifying for NAFTA or EEA preferential duty provisions, as applicable.

 

10.8 Personal Data Protection. With regard to personal data received from GEHC, the Supplier agrees (i) not to use it other than for its intended purpose, (ii) not to disclose it to any third parties, and (iii) not to transfer it to any countries outside the European Union , unless GEHC has given its prior written consent thereto. The Supplier shall use appropriate measures to ensure security and confidentiality of GEHC personal data. Supplier shall notify GEHC in the most expedient time possible and without unreasonable delay of any Security Breach involving any GEHC personal data where “Security Breach” is defined as any event involving an actual, potential or threatened compromise of the security, confidentiality or integrity of the data, including but not limited to any unauthorized access or use. GEHC shall have the right to use personal data received from the Supplier in conformity with applicable data protection laws. Upon termination of this Agreement, for whatsoever reason, Supplier shall stop the Processing of GEHC Personal, unless otherwise agreed by GEHC, and these undertakings shall remain in force until such time as Supplier no longer possesses GEHC Personal Data. For the purpose of this provision the definition of “personal data” is that provided in EU Directive 95/46/EC.

WARRANTY, INDEMNIFICATION AND LIABILITY

 

11. Warranty

 

11.1 Product Warranty. The Supplier represents and warrants that the Products will:

 

  (a) conform strictly to and be manufactured in accordance with the Specifications referred to in Attachment C;

 

  (b) be free from defects in title, material, and workmanship, whether latent or otherwise;

 

11.2 Supplier Intellectual Property Warranty. The Supplier represents and warrants as follows: (i) it owns or has the right to use all of its Process-Related Technology existing as of the Effective Date that it will use to manufacture the Products and to sell the Products to GEHC; and (ii) neither the Supplier’s equipment nor any of its Process-Related Technology used to manufacture the Products infringes or is alleged to infringe any patent or other proprietary right of any other person.

 

11.3 GEHC Intellectual Property Warranty. GEHC represents and warrants as follows: (i) GEHC owns
  or has the right to use all of the Product-Related Technology; and (ii) the Product-Related Technology does not infringe and is not alleged to infringe any patent or other proprietary right of any other person.

 

11.4 Execution and Performance of Agreement. The Supplier represents and warrants that it has the full right, power, and authority to enter into and perform its obligations under this Agreement. The Supplier further represents and warrants that the performance of its obligations under this Agreement will not result in a violation or breach of, and will not conflict with or constitute a default under any agreement, contract, commitment, or obligation to which Supplier or any of its affiliates are a party or by which it is bound and that it has not granted and will not grant during the term of this Agreement or any renewal thereof any conflicting rights, license, consent, or privilege with respect to the rights granted herein.

 

11.5 Survival of Warranties. The Supplier agrees that (i) the warranties set forth in this section shall survive the inspection, acceptance, and use of the Products by GEHC, its distributors and sub-distributors for a period of the shorter of either [*] ([*]) months from completion of delivery of the Purchase Order or the shelf life as specified in Attachment C (“Warranty Period”) and that they (ii) are for the benefit of GEHC and its successors and assigns; and (iii) are in addition to any warranties and remedies to which the Supplier may otherwise agree or which are provided by law. The Supplier agrees to extend to GEHC any warranties received from the Supplier’s suppliers. The Supplier warrants Products only as set forth in this Agreement and disclaims all other warranties.

 

11.6 Returns. GEHC may return to the Supplier any Product that does not conform to the representations and warranties. Any such Product shall be returned to the Supplier and then once replaced returned to GEHC at Supplier’s expense (including all transportation and insurance). The Supplier will, at its cost, and as soon as reasonably practicable replace the returned Product to bring the Product in conformance with the warranty, and will return the replacement Product as soon as possible, but in any event within thirty (30) days, after receipt of the non-conforming or defective Product. If the Supplier is unable to return the Product within thirty (30) days, the Supplier shall at GEHC´s request provide GEHC a refund as defined in section 11.8 below.

 

11.7 Complaints. Any complaint shall be regarded as having been timely lodged if GEHC notifies the Supplier of the fault at any time during the warranty period. Within [*] weeks after any complaint lodged by GEHC concerning a defective Product the Supplier shall make a reasonably detailed report to GEHC on the corrective and preventive action that has been initiated according to the Suppliers standard operating procedure.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    23 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


11.8 Credits/Refunds. In accordance with this Section 11, the Supplier shall promptly refund GEHC by wire transfer or check for any payment GEHC made with respect to such Product. GEHC may elect, at its sole discretion, to take such credit on any open invoices of the Supplier in the place of such refund.

 

11.9 Set-off. GEHC may set-off any amount owed from the Supplier or any of Supplier’s affiliates against any amount payable at any time by GEHC.

 

11.10 Remedies. The remedies contained in this Section 11 are in addition to all other remedies available at law or in equity.

 

11.11 Recalls and Field Corrections. If any recall, product withdrawal or field correction of any Product is required by a governmental agency or by GEHC for safety or efficacy reasons resulting from (a) the supply by the Supplier of any Product not complying with the terms and conditions of the Agreement (including all warranties included in the Agreement) or (b) the negligent or intentionally wrongful act or omission of the Supplier or its affiliates or their representatives, then the Supplier shall bear all costs and expenses, including but not limited to the costs and expenses related to such recall or field correction, communications and meetings with all required regulatory agencies, replacement stock, service labor, installation, travel, notifying customers of such recall and any replacement product to be delivered to those same customers, including shipping costs. To the extent that any such recall or field correction is due in part to the negligent or intentional acts or omissions of GEHC, GEHC shall be responsible for such costs and expenses equitably in proportion to its fault.

 

11.12 Testing In the case of disagreement between the Parties concerning the quality of Products delivered and such disagreement relates to the provisions in this Section 11, a sample shall be submitted to an independent laboratory to be agreed upon by the Parties and the report from such laboratory shall finally settle whether or not the delivery has met the specification or not. The cost for the laboratory shall be borne by the failing party.

 

12. Indemnification

 

12.1 Supplier Indemnity. Subject to Section 14 below, the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and GEHC’s Affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by the Supplier of any term of this Agreement or any term contained in any Attachments or (ii) any negligent act or omission, or willful misconduct of the Supplier or its agents, employees, or subcontractors. GEHC shall notify the Supplier of any such claim, suit, or proceeding, and Supplier will assist (at the Supplier’s expense) in the defense of the same.

 

12.2 GEHC Indemnity. Subject to Section 14 below, GEHC agrees to defend, indemnify, protect, and hold harmless the Supplier and its Affiliates, employees,
  agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, arising out of or relating to: (i) the breach by GEHC of any term of this Agreement or any term contained in any Attachments or (ii) any negligent act or omission, or willful misconduct of GEHC or its agents, employees, or subcontractors. Supplier shall notify GEHC of any such claim, suit, or proceeding, and GEHC will assist (at GEHC expense) in the defense of the same.

 

12.3 Intellectual Property Indemnity. With the exclusion of any GEHC Technology, the Supplier agrees to defend, indemnify, protect, and hold harmless GEHC and GEHC’s affiliates, employees, agents, servants, and representatives from and against any and all claims, damages, losses, liabilities, and expenses of whatever nature, resulting from a claim or allegation that the use (for uses made known to the Supplier) or sale of a Product infringes or otherwise violates an intellectual property right of any third party. If GEHC has reason to believe that (i) the use of any Supplier Process-Related Technology is enjoined by a court, the Supplier will first use best efforts to either procure the necessary licenses to continue manufacturing under the Supplier Process-Related Technology or adjust the manufacturing process at its sole-cost to avoid infringing such other party’s intellectual property (provided that such an adjustment can be made by the Supplier without otherwise breaching the Agreement); and (ii) if after using best efforts, the first two options are not commercially reasonable, the Supplier may terminate the Agreement, refund to GEHC any amounts paid thereunder for Products that cannot be sold by GE as a result of the injunction and reimburse GEHC for any related costs incurred.

CONFIDENTIALITY AND GE PROPERTY

 

13. Confidentiality

 

13.1 During the Term of this Agreement and the supply agreements preceding this Agreement, each Party (the “Recipient”) may have received or will receive or have access to certain information of the other Party (the “Discloser”) that is Confidential Information of the Discloser. For purposes of this Agreement, “Confidential Information” shall mean any information disclosed by the Discloser to the Recipient, whether technology-related or business-related, whether furnished before or after the Effective Date and irrespective of the form of communication, ; provided, however, that in order for oral information to be treated as Confidential Information, it must be identified as confidential and proprietary at the time of disclosure, and the substance of the disclosure must be provided in writing within [*] ([*]) days of the oral disclosure of such information. All written information must be clearly marked using words such as “confidential” or “proprietary” in order to be treated as Confidential Information, unless of apparent

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    24 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  confidential nature. The Recipient will protect the Confidential Information with the same degree of care as the Recipient uses for its own similar information, but no less than a reasonable degree of care. Confidential Information may only be used by those employees, contractors and advisors of the Recipient and its affiliates (“Representatives”) who have a need to know such information for the purposes related to this Agreement and who are bound by equivalent confidentiality obligations, and the Recipient shall inform such Representatives of the confidential nature of such Confidential Information and the obligations of the Recipient hereunder. The Recipient shall be responsible for any breach of this Agreement by it or any Representative to the same extent as though such Representatives were Parties hereto. The Parties acknowledge that trade secrets are deemed Confidential Information to be protected indefinitely. The Parties also agree that all other information, including but not limited to technical information (which is not intellectual property rights) and forecasts disclosed during the Term or prior to the formation of this Agreement are deemed Confidential Information to be protected during the term and for a period of [*] ([*]) years thereafter.

 

13.2 Exclusions The undertakings in clause 13.1 shall not apply to information which:

 

  (a) is publicly available through no fault of the Recipient;

 

  (b) the Recipient can show by reasonable written record was in his possession at the time of disclosure and which was not acquired directly or indirectly from the Discloser;

 

  (c) is rightfully received from a third party with no duty of confidentiality;

 

  (d) has been developed by the Recipient independently of the Confidential Information received from the Discloser; or

 

  (e) the Recipient notifies the Discloser is required to be disclosed by the Recipient pursuant to a legally enforceable order, direction or other regulation but any disclosure shall only be so far as necessary to give effect thereto.

 

13.3 Return of Confidential Information. All Confidential Information supplied to or acquired by each Party and all copies thereof shall be returned to the other Party within [*] ([*]) days after termination of this Agreement All information consisting of documents, notes and other writings prepared by one Party based on non-public data of the other Party shall be destroyed.

 

13.4 Development. The confidentiality terms in this Clause shall not be construed to limit GEHC’s or Suppliers right to independently develop or acquire products without use of the other Parties Confidential Information.

 

13.5 Restrictions on Use of Design Materials and Know How. During and after the Term the Supplier shall be prohibited from selling to any third party any Product or equivalent product that is either (i)
  developed for GEHC under this Agreement; (ii) incorporates any GEHC Confidential Information; or (iii) is specifically designed or configured for use with GEHC’s products using information received or know how developed in connection with this Agreement.

 

13.6 Previous undertakings of confidentiality. The Parties agree that the provisions in this Clause 13 shall replace all previous undertakings of confidentiality and shall apply to all Confidential Information whether disclosed in connection with this Agreement or any preceding supply agreement between the Parties concerning any of the Products.

 

14. Indirect Loss

In no event shall GEHC be liable for any indirect or consequential loss or damage in connection with this Agreement. The Supplier shall not be liable for any indirect or consequential loss or damage other than what is set forth in Clause 8 in Attachment D.

 

15. Technology

 

15.1 Definitions.

 

  (a) “Technology” means any idea, invention, technique, modification, process, or improvement (whether patentable or not), trade secret, industrial design (whether registerable or not), patent, copyright or work of authorship (whether or not copyright protection may be obtained for it), excluding, however, any of the foregoing that is within the public domain.

 

  (b) “Product-Related Technology” means any Technology owned at any time during the Term (whether owned as of the Effective Date or thereafter acquired or developed) by either of the parties that is related directly and solely to the structure of the Products.

 

  (c) “Process-Related Technology” means any Technology owned at any time during the Term (whether owned as of the Effective Date or thereafter acquired or developed) by either of the parties that is required for the manufacture of the Products.

 

15.2 Licenses.

 

  (a) During the Term and only for the purpose of fulfilling its duties and obligations under the Agreement, GEHC hereby grants to the Supplier a royalty-free and nonexclusive right and license to use any Product-Related Technology or Process-Related Technology owned by GEHC that is necessary or useful to the Supplier for manufacture of the Products. Supplier acknowledges and agrees that no other use shall be made by the Supplier, its affiliates or authorized contractors of the GEHC Technology without the express written authorization of GEHC.

 

  (b) During and after the Term, the Supplier hereby grants to GEHC a royalty-free and nonexclusive right and license to use any Process-Related Technology owned by the Supplier that is necessary to GEHC for the manufacture, either directly or

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    25 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  through a third party manufacturer, sale, distribution, and use of the Products. GEHC acknowledges and agrees that no other use shall be made by GEHC, its affiliates or authorized contractors of the Process-Related Technology of the Supplier, without the express written authorization of the Supplier.

 

15.3 Ownership of Technology.

 

  (a) GEHC Property. All tools, dies, drawings, plans, manufacturing aids, testing or other equipment or materials, and all intellectual property rights in the foregoing, which GEHC furnishes to the Supplier, or which is developed or acquired at GEHC’s expense or at its direction in the performance of work hereunder, shall be GEHC’s property (the “GEHC Property”). The Supplier hereby assigns and agrees to assign to GEHC, all such property. All such GEHC Property shall be safely maintained separate from the Supplier’s property, and marked “Property of General Electric Company.” The Supplier agrees not to substitute any property for GEHC Property and not to use such property except for performance of work hereunder or as authorized in writing by GEHC. The Supplier also agrees to insure any GEHC Property at full replacement cost. GEHC Property will be held at the Supplier’s own risk, and subject to removal by GEHC at its written request.

 

  (b) GEHC Technology. Including, but not limited to such GEHC Technology listed in Attachment F, all GEHC Technology (i) that is provided to the Supplier by and/or on behalf of GEHC or that is used by the Supplier with respect to the performance of its obligations hereunder and (ii) that was owned by GEHC prior to being provided to the Supplier shall be and remain the property of GEHC. The Supplier shall acquire no right, title or interest in the GEHC Technology as a result of its performance of its obligations hereunder. At GEHC’s request or upon termination or expiration of the Agreement for any reason, the Supplier shall return to GEHC any and all copies of GEHC Technology and remove all copies of such GEHC Technology from the computers and computer networks of the Supplier, save for one copy which may be retained for the purpose of monitoring the Supplier´s compliance with this provision.

 

  (c) Supplier Technology. All Supplier Technology that is both (i) provided to GEHC by and/or on behalf of the Supplier or that is used by the Supplier with respect to the performance of its obligations under the Agreement and (ii) owned by the Supplier prior to the performance of any of its obligations under the Agreement or acquired by the Supplier thereafter shall remain the property of the Supplier. GEHC shall acquire no right, title or interest in any such existing Supplier
  Technology as a result of the Supplier’s performance of its obligations hereunder.

 

  (d) Newly Created Works. All Technology, that is either Product-Related Technology or Process-Related Technology, developed by the Supplier as a result of the Supplier’s manufacture and supply of the Products or otherwise derived from GEHC Technology (collectively, the “Works”) shall also be deemed GEHC Technology and solely owned by GEHC. Such Works shall be considered “works made for hire” pursuant to the Copyright Act of 1976, as amended, and all intellectual property rights in and to such Works, including any copyright, trade secret and patent rights, shall be solely and exclusively owned by GEHC. The Supplier shall disclose to GEHC in a timely manner any and all Works, and such disclosures by the Supplier shall include a reasonably detailed written description of such Works. To the extent that all applicable intellectual property rights in the Works are not deemed “works made for hire” and transferred and assigned to GEHC by operation of law, the Supplier hereby does and will transfer and assign, and cause its employees and agents to transfer and assign, now and in the future, all right, title and interest in the Works to GEHC. GEHC may transfer such Works to any third party or use the Works for any purpose without further payment to the Supplier. In the event GEHC decides to file one or more patent applications covering any such Works, the Supplier shall at GEHC’s request and expense assist GEHC in the preparation and prosecution of such patent application(s) and shall execute all documents (and cause its employees or agents to execute all documents) deemed necessary by GEHC for the filing thereof and/or the vesting in GEHC of all title thereto. Such Works shall be deemed GEHC Confidential Information under the Agreement.

 

15.4 No Rights. The Supplier shall acquire no right, title or interest in any of the trademarks, patents, trade secrets, service marks or copyrights belonging to GEHC except as otherwise stated in Exhibit D Section 15 herein. No rights are granted to the Supplier under any GEHC patents, copyrights, trade secrets, or other property rights except as may be expressly agreed to by GEHC in writing. The Supplier shall not use or incorporate into Products any intellectual property of others without their prior written permission.

 

15.5 Removal of Marks. Subject to clause 16 in Attachment D the Supplier agrees not to sell, transfer, distribute or otherwise convey any part, component, Product or service bearing or incorporating any GEHC trademark, trade name or service mark, part numbers or other identifiers, including any GEHC packaging, copyrights or code (“GEHC Marks”), to any party other than to GEHC or any affiliate of GEHC except as otherwise stated in

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    26 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  Exhibit D Section 15 herein. The Supplier shall not have the right to sell rejected, returned or unpurchased Products to any third parties. The Supplier will defend and indemnify GEHC against any claims, losses, liabilities, costs or expenses that GEHC may incur as a result of the Supplier’s breach of this obligation.

 

15.6 Co-operation. The Supplier shall reasonably cooperate with GEHC to secure any intellectual property rights developed under this Agreement by, for example, assisting in the filing and prosecution of patent applications, and executing such documents as GEHC may reasonably request at GE expense.

 

15.7 Survival. The obligations under this Clause shall survive the termination of this Agreement.

TERMINATION

 

16. Termination

 

16.1 Mutual Termination. Either Party may terminate this Agreement:

 

  (a) at any time upon written notice if the other Party (the “Defaulting Party”) materially defaults in the performance of one or more of its obligations hereunder and the Defaulting Party fails to cure the default within thirty (30) days after receiving written notice of such, provided that if the default is not reasonably susceptible to cure within such period, then the non-defaulting Party shall have the right to terminate this Agreement immediately upon written notice; or

 

  (b) immediately if any proceeding under the bankruptcy or insolvency laws is brought against the Defaulting Party, a receiver is appointed for the Defaulting Party or the Defaulting Party makes an assignment for the benefit of creditors, except as provided otherwise under applicable law.

 

16.2 GEHC Termination for cause. GEHC shall have the right to terminate this agreement and/or, at GEHC’s discretion, relevant Purchase Orders, with immediate effect in the event of (i) material breach by the Supplier of the Minimum Purchased Material Quality Requirements set forth in Attachment A (ii) a repeated breach of any term of this Agreement, (iii) consistent failure by the Supplier to meet required delivery dates, (iv) a delay in delivery that has exceeded more than [*] ([*]) days, (iv) material breach by the Supplier of the Supplier Integrity Statement set forth in Attachment B.

 

16.3 Purchase Orders. If GEHC terminates this Agreement in accordance with clause 16.1 or 16.2 it may also terminate all unfulfilled Purchase Orders without any liability except for the price of any Products previously delivered and accepted by GEHC (subject to any set-off available to GEHC). If GEHC terminates this Agreement in accordance with clause 16.3 or if the Agreement expires, GEHC and the Supplier agree that any unfulfilled Purchase Orders issued prior to such termination or expiry
  but not yet delivered shall survive until fully performed.

 

16.4 Any advance termination of this Agreement shall not relieve the Defaulting Party of its obligations and the non-defaulting Party shall retain all legal and equitable remedies after such termination.

 

16.5 In the event of termination whether for cause or otherwise, unless attributable to Suppliers material breach of contract as set forth in Clause 16.1 and 16.2, GEHC shall purchase the remaining Product in the Suppliers Safety stock and with regard to any other finished goods inventory of the Supplier, up to three months consumption of each of the Products according to the latest Forecast., provided the Products comply with at least [*] remaining shelf life and otherwise fully complies with the applicable specifications.

 

16.6 GEHC shall have the right to terminate the Agreement with eighteen (18) months written notice if the Supplier or any of its Affiliates markets or sells any immobilized chromatography products that is functionally substitutable (based on technical performance) with GEHC’s chromatography products containing the Products (as exemplified by MabSelect and MabSelect SuRe), provided that GEHC prior to termination shall give Repligen thirty (30) days written notice of its intent to terminate the agreement and should Repligen provide reasonable explanation of compliance or stop selling or marketing such product during the thirty day period, as certified by Repligen to GEHC in writing, then GEHC shall not have the right to terminate the agreement referring to such circumstances.

 

16.7 GEHC shall have the right to terminate the Agreement with twelve (12) months written notice if the control of the Supplier or its non-therapeutic protein A business is acquired by a company, which is a direct competitor to GEHC in the field of chromatography media or bioprocess hardware products.

COMMUNICATION AND MISCELLANEOUS

 

17. Electronic Data Interchange

 

17.1 Access. GEHC, in its sole discretion, may permit the Supplier to have online access to designated computer systems of GEHC in order to facilitate the Supplier’s ability to perform its obligations under this Agreement. If such access is granted, the Supplier shall give to GEHC the names of the Supplier’s employees who have a legitimate business need for such access to GEHC’s computer systems, and GEHC shall provide a separate user identification code for each person. The Supplier, at its own expense, shall provide and maintain any hardware, telecommunications services and software not furnished by GEHC, which are needed to communicate reliably with GEHC’s computer systems. GEHC, in its sole discretion, may terminate the Supplier’s access to GEHC’s computer network at any time.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    27 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


17.2 Use Restrictions. The Supplier shall ensure that: (i) computer access is limited to those employees with a legitimate business need whose names have been furnished to GEHC; and (ii) such employees with access agree to keep any information so obtained strictly confidential, to use such information only to perform the Supplier’s contract obligations to GEHC and to cease accessing GEHC’s computer systems when no longer required to perform work under this Agreement. The Supplier shall promptly notify GEHC if it becomes aware of any unauthorized access to GEHC’s computer systems or unauthorized use of the information on the systems.

 

18. Notices

 

18.1 All notices expressly required to be in writing (Legal notices) shall be, if required by either party, in English or at least accompanied by a translation into English, and shall be sufficiently served if delivered by hand (including by courier) or if sent by pre-paid first class post, special delivery, registered mail, or pre-paid air mail or by fax. In all cases notices shall be delivered to the respective Parties at the addresses specified on the front page of this Agreement.

 

18.2 A notice shall be deemed to have been received:

 

  (a) if delivered by hand, at the time of delivery;

 

  (b) in the case of pre-paid first class post, special delivery or registered mail, two business days after the date of posting;

 

  (c) in the case of pre-paid airmail, four business days after the date of posting.

 

  (d) in the case of fax, upon completion of transmission

 

18.3 For the avoidance of doubt, notices under this Agreement may not be served by email, unless the Parties agree at the time of service.

 

19. Miscellaneous

 

19.1 Independent Contractor. The relationship of the Parties hereunder shall be that of independent contractors. Nothing in this Agreement shall be deemed to create a partnership, joint venture, or similar relationship between the Parties, and no Party shall be deemed to be an agent of the other Party.

 

19.2 Subcontractors. None of the obligations to be performed by the Supplier under this Agreement shall be performed by any subcontractor or other third party unless such performance shall have been approved by GEHC in writing.

 

19.3 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of State of New York without giving effect to the conflict of law principles thereof. The United Nations Convention on Contracts for International Sales of Goods shall not apply to this Agreement.

 

19.4 Arbitration. The Parties will attempt to resolve any dispute, controversy or claim relating to this Agreement through good faith negotiations within [*] ([*]) days, failing which the dispute shall be finally settled by arbitration in accordance with the Rules of the International Chamber of Commerce,
  which Rules are deemed to be incorporated by reference into this Clause. The seat of the arbitration shall be Boston in the event the Supplier is the defendant and Uppsala if GEHC is the defendant. The language of the arbitration shall be English, if requested by either Party. The cost of the arbitration will be shared equally by the Parties. The arbitrator will have the authority to apportion liability between the Parties, but will not have the authority to award any damages or remedies not available under the express terms of this Agreement. With regards to any action for breach of confidentiality or intellectual property obligations, nothing in this section shall preclude either party from seeking interim equitable relief but such request shall not be deemed a waiver of the obligation to arbitrate hereunder.

 

19.5 Force Majeure.

 

  (a) The obligations of either Party hereunder shall be excused or suspended to the extent performance is prevented or delayed by any future condition, which (i) is beyond the reasonable control, and without the fault or negligence, of the Party affected thereby, (ii) was not foreseeable by such Party at the time this Agreement was entered into, and (iii) could not have been prevented by such Party taking reasonable steps. Such conditions shall include, but not be limited to, war mobilisation, riots, fire, explosion, flood, insurrection, embargo, currency restriction, and acts or omissions of governments in their sovereign capacity.

 

  (b) The Party invoking relief hereunder, shall, within seven (7) days after commencement of the event of force majeure, give written notice thereof and of the anticipated consequences thereof, to the other Party.

 

  (c) In the event of any case of force majeure, the Party affected thereby shall take all reasonable measures to mitigate and minimise the effect of such case, and to resume as promptly as possible the diligent performance of its obligations under this Agreement, however GEHC shall be permitted during such time to acquire substitute or replacement items from one or more alternative sources. If the delay lasts more than thirty (30) days GEHC may terminate this Agreement and any applicable Purchase Orders.

 

  (d) Notwithstanding anything in this Agreement to the contrary, no delay or failure of a Party to perform its obligations hereunder shall be excused if and to the extent that it is caused by labour problems of such Party, its subcontractors’ and/or its suppliers such as strikes.

 

19.6 Assignment. This Agreement is personal to the Parties and no Party shall without the prior written consent of the other Party, assign this Agreement or any part of it. Any such action shall be declared null and void. No Party shall sub-contract or

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    28 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


  delegate in any manner any or all of its obligations under this Agreement to a third party or agent without the other Party’s consent. Notwithstanding the foregoing, GEHC may assign its rights and obligations under this Agreement without the Supplier’s consent: to an affiliate and in conjunction with the transfer of all or substantially all of its business or that part to which this Agreement relates. This Agreement shall be binding upon and shall inure to the benefit of the Parties hereto and their respective heirs, successors, and permitted assigns. The Supplier may not assign this Agreement to any third parties unless GEHC gives its written consent thereto in writing.

 

19.7 Publicity. The Supplier shall not issue any press release or announcement, use any of GEHC’s products or its name or trademarks in promotional activity, or otherwise publicly announce or comment on this Agreement without GEHC’s prior written consent except as provided for in Exhibit D section 15 herein or as may be otherwise required by law. Repligen has right to issue a press release on completion of this Agreement subject to prior review and approval by GEHC.

 

19.8 Amendment; Waiver; Survival. This Agreement may be modified only by a writing signed by both Parties. Any failure to enforce any provision of this Agreement is not a waiver of that provision or of either Party’s right to later enforce each and every provision. The terms of this Agreement that by their nature are intended to survive its expiration will continue in full force and effect after its expiration.

 

19.9 Severability. If any provision of this Agreement is determined to be legally unenforceable or invalid, it shall not affect the validity or enforceability of the remainder of the Agreement, and the remaining provisions will continue in full force and effect. The Parties will substitute a provision that most closely approximates the economic intent of the invalid provision.

 

19.10 Battle of Forms. This Agreement contains the entire agreement and understanding of the Parties and supersedes all prior agreements, understandings or arrangements (both oral and written) relating to the subject matter of this Agreement. For the avoidance of doubt, the Supply Agreement between the Parties dated May 26, 1999 as amended and the License Agreement between the Parties dated May 1, 1999 as amended are both hereby terminated. Any Orders placed under this Agreement shall be solely governed by the terms and conditions of this Agreement. No general terms and conditions of either Party referred to in purchase orders, order confirmations or elsewhere shall apply, unless expressly agreed in writing.

 

19.11 Affiliate. For the purposes of this Agreement, an Affiliate of a party shall mean any company controlled by or under common control with the relevant party where “control” means direct or indirect ownership of at least 50 percent of the
  voting stock or interest in a company or control of the composition of the board of directors.

 

19.12 Interpretation. In this Agreement, reference to a clause, section or Attachment are, except where otherwise stated, a reference to an Attachment of this Agreement and a clause or section of the relevant Attachment. Clause, section or Attachment headings in this Agreement and any descriptive notes in brackets are for convenience only and shall not affect the construction or interpretation of this Agreement. References to the words “include(s)” or “including” shall be construed without limitation to the generality of the preceding words. Unless the context otherwise requires, references to the singular include the plural and vice versa, references to any gender include all other genders and references to “persons” shall include individuals, bodies corporate, unincorporated associations, businesses and partnerships. Any reference to a day shall be to a calendar day unless specified otherwise. Any reference to a Business Day shall mean any day which is not a Saturday, Sunday or public holiday in the country in which GEHC or its relevant Affiliate or the Supplier is located unless specified otherwise.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    29 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.


Attachment F

GE Technology

Production know-how covering [*] with regard to rPA and ZätA protein, in particular as described in the following documentation.

 

Documentation – title

  

GEHC Doc No. (when applicable)

rPA

[*]

  

ZätA

[*]

  

For avoidance of doubt, the above is not an exhaustive list of GE Technology, but describes certain key elements of the manufacturing process and test methods relating to the Products.

 

Strategic Supplier Alliance Agreement - GEHC Directs EMEA Contract Manufacturing / Version Supply 1.0    30 (30)
Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act; [*] denotes omissions.
EX-23.1 3 dex231.htm CONSENT OF ERNST & YOUNG LLP Consent of Ernst & Young LLP

Exhibit 23.1

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

We consent to the incorporation by reference in the following Registration Statements:

 

  (1) Registration Statements (Form S-8 Nos. 333-157168, 333-89140 and 33-62796) pertaining to the Second Amended and Restated 2001 Repligen Corporation Stock Plan, the 2001 Repligen Corporation Stock Option Plan, and the 1992 Repligen Corporation Stock Plan

 

  (2) Registration Statements (Form S-3 Nos. 333-106109, 333-30383, 333-57951, 333-76005, 333-79611, 333-95641, 333-31728, 333-35056 and 333-36280) of Repligen Corporation

of our reports dated June 10, 2010 with respect to the financial statements of Repligen Corporation and the effectiveness of internal control over financial reporting of Repligen Corporation, included in this Annual Report (Form 10-K) for the year ended March 31, 2010.

/s/ Ernst & Young LLP

Boston, Massachusetts

June 10, 2010

EX-31.1 4 dex311.htm SECTION 302 CEO CERTIFICATION Section 302 CEO Certification

Exhibit 31.1

CERTIFICATION

I, Walter Herlihy, certify that:

1. I have reviewed this Annual Report on Form 10-K of Repligen Corporation;

2. Based on my knowledge, this Annual Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an Annual Report ) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: June 10, 2010
/s/    WALTER C. HERLIHY        
Walter C. Herlihy
Chief Executive Officer and President
(Principal executive officer)
EX-31.2 5 dex312.htm SECTION 302 CFO CERTIFICATION Section 302 CFO Certification

Exhibit 31.2

CERTIFICATION

I, William J. Kelly, certify that:

1. I have reviewed this Annual Report on Form 10-K of Repligen Corporation;

2. Based on my knowledge, this Annual Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this Annual Report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an Annual Report ) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: June 10, 2010
/s/    WILLIAM J. KELLY        
William J. Kelly
Chief Financial Officer
(Principal accounting and financial officer)
EX-32.1 6 dex321.htm SECTION 906 CEO & CFO CERTIFICATION Section 906 CEO & CFO Certification

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Annual Report of Repligen Corporation (the “Company”) on Form 10-K for the period ending March 31, 2010 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned officers of the Company hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to my knowledge, that:

 

  (1) The Report fully complies with the requirements of section 13(a) or 15(d) as applicable of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date: June 10, 2010     By:   /S/    WALTER C. HERLIHY        
      Walter C. Herlihy
     

Chief Executive Officer and President

(Principal executive officer)

Date: June 10, 2010     By:   /S/    WILLIAM J. KELLY        
      William J. Kelly
     

Chief Financial Officer

(Principal financial and accounting officer)

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