Third-party supply or other failures, business interruptions, or natural disasters affecting our manufacturing facilities in Rensselaer, New York could adversely affect our ability to
`supply our products.
`
`We manufacture all of our bulk drug materials at our manufacturing facilities in Rensselaer, New York. We would be unable to manufacture these materials if our Rensselaer facilities were to
`cease production due to regulatory requirements or action, business interruptions, labor shortages or disputes, contaminations, fire, natural disasters, or other problems at the facilities.
`
`Certain raw materials necessary for the manufacture and formulation of ARCAL YST® and of our product candidates, including VEGF Trap-Eye and ZALTRAPTM, are provided by single(cid:173)
`source unaffiliated third-party suppliers. In addition, we rely on certain third parties to perform filling, finishing, distribution, laboratory testing, and other services related to the manufacture of
`AR CAL YST® and our product candidates. We would be unable to obtain these raw materials or services for an indeterminate period of time if any of these third parties were to cease or interrupt
`production or otherwise fail to supply these materials, products, or services to us for any reason, including due to regulatory requirements or action, adverse financial developments at or
`affecting the supplier, failure by the supplier to comply with GMPs, business interruptions, or labor shortages or disputes. This, in tum, could materially and adversely affect our ability to
`manufacture or supply ARCAL YST® or our product candidates for use in clinical trials or commercial supply, which could materially and adversely affect our business and future prospects.
`
`Also, certain of the raw materials required in the manufacture and the formulation of our product candidates may be derived from biological sources, including mammalian tissues, bovine
`serum, and human serum albumin. There are certain European regulatory restrictions on using these biological source materials. If we are required to substitute for these sources to comply with
`European regulatory requirements, our clinical development activities may be delayed or interrupted.
`
`Risks Related to Commercialization of Products
`
`Even ifwe receive regulatory approval to market our products, we may be unsuccessful in commercializing them, which would materially harm our business, results of operations, and
`financial condition.
`
`Even if clinical trials demonstrate the safety and effectiveness of any of our product candidates for a specific disease and the necessary regulatory approvals are obtained, the commercial
`success of any of our product candidates will depend upon, among other things, their acceptance by patients, the medical community, and third-party payers and on our and our collaborators'
`ability to successfully manufacture and commercialize those products. Even if we obtain regulatory approval for our product candidates, if they are not successfully commercialized, we will not
`be able to recover the significant investment we have made in developing such products and our business, results of operations, and financial condition would be severely harmed.
`
`If we are unable to establish sales, marketing, and distribution capabilities, or to enter into agreements with third parties to do so, we will be unable to successfully market and sell our
`products.
`
`We are selling ARCAL YST® for the treatment of CAPS ourselves in the U.S., primarily through third-party service providers. We have no sales or distribution personnel in the U.S. and have
`only a small staff with commercial capabilities. If we are unable to obtain those capabilities, either by developing our own organizations or entering into agreements with service providers, even
`if our current or future product candidates receive marketing approval, we will not be able to successfully sell those products. In that event, we will not be able to generate significant revenue,
`even if our product candidates receive regulatory approval. We cannot guarantee that we will be able to hire the qualified sales and marketing personnel we need or that we will be able to enter
`into marketing or distribution agreements with third-party providers on acceptable terms, if at all.
`
`We currently have no sales, marketing, commercial, or distribution capabilities outside the U.S. Under the terms of our collaboration agreement with sanofi-aventis, we will rely on sanofi(cid:173)
`aventis for sales, marketing, and distribution of ZALTRAP™ in cancer indications, should it be approved in the future by regulatory authorities for marketing. Under the terms of our license
`and collaboration agreement with Bayer HealthCare, we will rely on Bayer HealthCare for sales, marketing, and distribution of VEGF Trap-Eye in countries outside the U.S. should it be approved
`for marketing in such countries.
`
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`We will have to rely on a third party or devote significant resources to develop our own sales, marketing, and distribution capabilities for our other product candidates, including VEGF
`Trap-Eye in the U.S. and ARCAL YST® for patients with gout initiating uric acid-lowering drug therapy if such products receive regulatory approval. Though we are currently actively pursuing
`establishing our own sales, marketing, and distribution organization in anticipation of receiving regulatory approval to market and sell in the U.S. VEGF Trap-Eye for the treatment of wet AMD,
`and in anticipation of filing for and receiving regulatory approval to market and sell in the U.S. VEGF Trap-Eye for the treatment of CRVO and ARCAL YST® for the prevention of gout flares in
`patients initiating uric acid-lowering treatment, we may be unsuccessful in doing so.
`
`We have no experience in sales, marketing, or distribution of products in substantial commercial quantities or in establishing and managing the required infrastructure to do so, including
`large-scale information technology systems and a large-scale distribution network, and we may be unable to establish such infrastructure on a timely basis. In building a sales force in
`anticipation of the possible approval and launch in the U.S. of VEGF Trap-Eye in wet AMD and other ophthalmologic indications for which it is currently in Phase 3 clinical trials and of
`ARCAL YST® for the prevention of gout flares, we may be unable to successfully recruit and retain within the required time frame an adequate number of qualified sales representatives and may
`encounter difficulties in retaining third parties to provide sales, marketing, or distribution resources. Even if we hire the qualified sales and marketing personnel, and establish the required
`infrastructure we need to support our objectives, or enter into marketing and distribution agreements with third parties on acceptable terms, we may not do so in an efficient manner or on a
`timely basis. We may not be able to correctly judge the size and experience of the sales and marketing force and the scale of distribution capabilities necessary to successfully market and sell in
`the U.S. VEGF Trap-Eye, ARCAL YST® for the prevention of gout flares, or any of our other product candidates, if they receive regulatory approval. Establishing and maintaining sales,
`marketing, and distribution capabilities are expensive and time-consuming. Our expenses associated with building up and maintaining the sales force and distribution capabilities may be
`disproportional, particularly in the near term, compared to the revenues we may be able to generate on sales in the U.S. of VEGF Trap-Eye or ARCALYST® for the prevention of gout flares. We
`cannot guarantee that we will be successful in commercializing VEGF Trap-Eye, ARCAL YST® for the prevention of gout flares, or any of our other product candidates.
`
`Even if our product candidates are approved for marketing, their commercial success is highly uncertain given their method of administration, and because our competitors have
`received approval for and may be marketing products with a similar mechanism of action or may enter the marketplace with better or lower cost drugs.
`
`Our product candidates are delivered either by intravenous infusion or by intravitreal or subcutaneous injections, which are generally less well received by patients than tablet or capsule
`delivery and this could adversely affect the commercial success of those products if they receive marketing approval.
`
`There is substantial competition in the biotechnology and pharmaceutical industries from pharmaceutical, biotechnology, and chemical companies. Many of our competitors have
`substantially greater research, preclinical and clinical product development and manufacturing capabilities, and financial, marketing, and human resources than we do. Our smaller competitors
`may also enhance their competitive position if they acquire or discover patentable inventions, form collaborative arrangements, or merge with large pharmaceutical companies. Even if we
`achieve product commercialization, our competitors have achieved, and may continue to achieve, product commercialization before our products are approved for marketing and sale.
`
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`Genentech has an approved VEGF antagonist, Avastin®, on the market for treating certain cancers and many different pharmaceutical and biotechnology companies are working to develop
`competing VEGF antagonists, including Novartis, Amgen, Imclone LLC/Eli Lilly and Company, Pfizer, AstraZeneca, and GlaxoSmithKline. Many of these molecules are farther along in
`development than ZALTRAP™ and may offer competitive advantages over our molecule. Each of ffizer, Onyx Pharmaceuticals, Inc. (together with its partner Bayer HealthCare), and
`GlaxoSmithKline are marketing and selling oral medications that target tumor cell growth and new vasculature formation that fuels the growth of tumors. The marketing approvals for
`Genentech's VEGF antagonist, Avastin®, and their extensive, ongoing clinical development plan for Avastin® in other cancer indications, make it more difficult for us to enroll patients in clinical
`trials to support ZALTRAPTM and to obtain regulatory approval of ZALTRAPTM in these cancer settings. This may delay or impair our ability to successfully develop and commercialize
`ZAL TRAP™. In addition, even if ZAL TRAP™ is ever approved for sale for the treatment of certain cancers, it will be difficult for our drug to compete against Avastin® and the FD A approved
`kinase inhibitors, because doctors and patients will have significant experience using these medicines. In addition, an oral medication may be considerably less expensive for patients than a
`biologic medication, providing a competitive advantage to companies that market such products.
`
`The market for eye disease products is also very competitive. Novartis and Genentech are collaborating on the commercialization and further development of a VEGF antibody fragment,
`Lucentis® for the treatment of wet AMD, DME, and other eye indications. Lucentis® was approved by the FDA in June 2006 for the treatment of wet AMD and in June 2010 for the treatment of
`macular edema following RVO. Lucentis® was also approved by the EMA for wet AMD in January 2007 and for DME in January 2011. Many other companies are working on the development of
`product candidates for the potential treatment of wet AMD and DME including those that act by blocking VEGF and VEGF receptors, as well as siRNAs that modulate gene expression. In
`addition, ophthalmologists are using off-label, with success for the treatment of wet AMD, DME, and RVO, a third-party repackaged version of Genentech's approved VEGF antagonist,
`Avastin®.
`
`The NE! and others are conducting long-term, controlled clinical trials comparing Lucentis® to Avastin® in the treatment of wet AMD. One-year data from the Comparison of Age-Related
`Macular Degeneration Treatments Trial (CATT), were reported in April 2011 and indicated that Avastin® dosed monthly was non-inferior to Lucentis® dosed monthly in the primary efficacy
`endpoint of mean visual acuity gain at 52 weeks. Even if our ELA for VEGF Trap-Eye for the treatment of wet AMD which was filed in February 2011 is approved, it may be difficult for VEGF
`Trap-Eye in this or other eye indications for which it may be approved to compete against Lucentis®, because doctors and patients have had significant experience using this medicine.
`Moreover, the recently reported results of the CATT study, combined with the relatively low cost of Avastin® in treating patients with wet AMD, may well exacerbate the competitive challenge
`which VEGF Trap-Eye will face in this or other eye indications for which it may be approved. In addition, while we believe that ZAL TRAP™ would not be well tolerated if administered directly
`to the eye, if ZALTRAP™ is approved for the treatment of certain cancers, there is a risk that third parties will attempt to repackage ZAL TRAP™ for use and sale for the treatment of wet AMD
`and other diseases of the eye, which would present a potential low-cost competitive threat to VEGF Trap-Eye if it is ever approved for wet AMD or other eye indications.
`
`The availability of highly effective FDA approved TNF-antagonists such as Enbrel®, Remicade®, Humira® (adalimumab), a registered trademark of Abbott Laboratories, Simponi®
`(golimumab), a registered trademark of Centocor, the IL-I receptor antagonist Kineret®, Haris®, and other marketed therapies makes it more difficult to successfully develop and commercialize
`ARCAL YST® in other indications, and this is one of the reasons we discontinued the development of AR CAL YST® in adult rheumatoid arthritis. In addition, even if ARCAL YST® is ever
`approved for sale in indications where TNF-antagonists are approved, it will be difficult for our drug to compete against these FDA approved TNF-antagonists because doctors and patients
`have had significant experience using these effective medicines. Moreover, in such indications these approved therapeutics may offer competitive advantages over ARCALYST®, such as
`requiring fewer injections.
`
`There are both small molecules and antibodies in development by other companies that are designed to block the synthesis of IL-I or inhibit the signaling of IL-I. For example, Eli Lilly,
`Xoma Ltd. (in collaboration with Servier), and Novartis are each developing antibodies to IL-I and both Amgen and Medlmmune are developing antibodies to the IL-I receptor. In 2009,
`Novartis received regulatory approval in the U.S. and Europe for canakinumab, a fully human anti-interleukin-IL!Jl antibody, for the treatment of CAPS. Canakinumab is also in development for
`atherosclerosis and a number of other inflammatory diseases. Novartis' IL-I antibody and these other drug candidates could offer competitive advantages over ARCAL YST®. For example,
`canakinumab is dosed once every eight weeks compared to the once-weekly dosing regimen for ARCAL YST®. The successful development and/or commercialization of these competing
`molecules could adversely affect sales of ARCAL YST® for CAPS and delay or impair our ability to commercialize ARCAL YST® for indications other than CAPS.
`
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`We are developing ARCALYST® for the prevention of gout flares in patients initiating uric acid-lowering therapy and plan to submit a ELA for U.S. regulatory approval in mid-2011. In
`January 2011, Novartis announced that the results of two Phase 3 studies with canakinumab focused on reducing pain and preventing recurrent attacks or "flares" in patients with hard-to-treat
`gout were positive. Novartis has also reported that regulatory filings for the use of canakinumab in gouty arthritis have been completed in the European Union in 2010 and in the U.S. in the first
`quarter of 2011, based on the results of these two Phase 3 studies. Canakinumab is dosed less frequently for the treatment of CAPS and may be perceived as offering competitive advantages
`over ARCAL YST® in gout by some physicians, which would make it difficult for us to successfully commercialize ARCAL YST® in that disease.
`
`Currently, inexpensive, oral therapies such as analgesics and other Nonsteroidal anti-inflammatory drugs (NSAIDS), are used as the standard of care to treat the symptoms of gout diseases.
`These established, inexpensive, orally delivered drugs will make it difficult for us to successfully commercialize AR CAL YST® in these diseases.
`
`Our early-stage clinical candidates in development are all fully human monoclonal antibodies, which were generated using our Ve/oclmmune® technology. Our antibody generation
`technologies and early-stage clinical candidates face competition from many pharmaceutical and biotechnology companies using various technologies.
`
`Numerous other companies are developing therapeutic antibody products. Companies such as Pfizer, Johnson & Johnson, AstraZeneca, Amgen, Biogen Idec, Novartis, Genentech/Roche,
`Bristol-Myers Squib, Abbott, and GlaxoSmithKline have generated therapeutic products that are currently in development or on the market that are derived from recombinant DNA that comprise
`human antibody sequences.
`
`We are aware of several pharmaceutical and biotechnology companies actively engaged in the research and development of antibody products against targets that are also the targets of
`our early-stage product candidates. For example, Pfizer, Johnson & Johnson, and Abbott are developing antibody product candidates against NGF. Genentech/Roche is marketing an antibody
`against IL-6R (tocilizumab) for the treatment of rheumatoid arthritis, and several other companies, including Centocor, and Bristol-Myers Squibb, have antibodies against IL-6 in clinical
`development for this disease. GlaxoSmithKline, in partnership with OncoMed Pharmaceuticals, has a Dll4 antibody in clinical development for the treatment of solid tumors. Aerovance has two
`formulations of a biologic directed against IL-4 in clinical development. Amgen previously had an antibody against IL-4R in clinical development for the treatment of asthma. We believe that
`several companies, including Amgen and Pfizer, have development programs for antibodies against PCSK9. Amgen, Pfizer, and AstraZeneca have development programs underway for
`antibodies against ANG2. If any of these or other competitors announces a successful clinical study involving a product that may be competitive with one of our product candidates or the
`grant of marketing approval by a regulatory agency for a competitive product, such developments may have an adverse effect on our operations or future prospects.
`
`The successful commercialization of our product candidates will depend on obtaining coverage and reimbursement for use of these products from third-party payers and these payers
`may not agree to cover or reimburse for use of our products, and we may be unable to profitably commercialize ARCALYST® for CAPS.
`
`Our product candidates, if commercialized, may be significantly more expensive than traditional drug treatments. For example, we are developing ARCAL YST® for the prevention of gout
`flares in patients initiating uric acid-lowering drug therapy. Patients suffering from this gout indication are currently treated with inexpensive therapies, including NSAIDS. These existing
`treatment options are likely to be considerably less expensive and may be preferable to a biologic medication for some patients. Our future revenues and profitability will be adversely affected if
`U.S. and foreign governmental, private third-party insurers and payers, and other third-party payers, including Medicare and Medicaid, do not agree to defray or reimburse the cost of our
`products to the patients. If these entities refuse to provide coverage and reimbursement with respect to our products or provide an insufficient level of coverage and reimbursement, our
`products may be too costly for many patients to afford them, and physicians may not prescribe them. Many third-party payers cover only selected drugs, making drugs that are not preferred by
`such payers more expensive for patients, and require prior authorization or failure on another type of treatment before covering a particular drug. In particular, payers may impose these
`obstacles to coverage on higher-priced drugs, as our product candidates are likely to be.
`
`We maiket and sell ARCAL YST® in the U.S. for the treatment of a group of rare genetic disorders called CAPS. We have received European Union marketing authorization for rilonacept for
`the treatment of CAPS. There may be too few patients with CAPS to profitably commercialize ARCAL YST®. Physicians may not prescribe ARCAL YST®, and CAPS patients may not be able to
`afford ARCAL YST®, if third-party payers do not agree to reimburse the cost of ARCALYST® therapy and this would adversely affect our ability to commercialize ARCAL YST® profitably.
`
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`In addition to potential restrictions on coverage, the amount of reimbursement for our products may also reduce our profitability. Government and other third-party payers are challenging
`the prices charged for healthcare products and increasingly limiting, and attempting to limit, both coverage and level of reimbursement for prescription drugs. In March 2010, the PPACA and a
`related reconciliation bill were enacted in the U.S. This legislation imposes cost contaimnent measures that are likely to adversely affect the amount of reimbursement for our future products.
`The full effects of this legislation are unknown at this time and will not be known until regulations and guidance are issued by the Centers for Medicare and Medicaid Services and other federal
`and state agencies. Some states are also considering legislation that would control the prices of drugs, and state Medicaid programs are increasingly requesting manufacturers to pay
`supplemental rebates and requiring prior authorization by the state program for use of any drug for which supplemental rebates are not being paid. It is likely that federal and state legislatures
`and health agencies will continue to focus on additional health care reform in the future that will impose additional constraints on prices and reimbursements for our products.
`
`Since ARCAL YST® and our product candidates will likely be too expensive for most patients to afford without health insurance coverage, if our products are unable to obtain adequate
`coverage and reimbursement by third-party payers, our ability to successfully commercialize our product candidates may be adversely impacted. Any limitation on the use of our products or
`any decrease in the price of our products will have a material negative effect on our ability to achieve profitability.
`
`In certain foreign countries, pricing, coverage, and level of reimbursement of prescription drugs are subject to governmental control, and we may be unable to negotiate coverage, pricing,
`and reimbursement on terms that are favorable to us. In some foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The requirements
`governing drug pricing vary widely from country to country. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their
`national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product
`or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. Our results of operations may suffer if we are
`unable to market our products in foreign countries or if coverage and reimbursement for our products in foreign countries is limited or delayed.
`
`Regulatory and Litigation Risks
`
`If we fail to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates, we could incur substantial remedial costs, delays in
`the development or approval of our product candidates and/or in their commercial launch if they obtain regulatory approval, and a reduction in sales.
`
`We and our third-party providers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable agencies in other jurisdictions to confirm such
`compliance. Changes of suppliers or modifications of methods of manufacturing may require amending our application(s) to the FDA and acceptance of the change by the FDA prior to release
`of product(s). Because we produce multiple product candidates at our facility in Rensselaer, New York, including ARCAL YST®, VEGF Trap-Eye, and ZAL TRAPTM, there are increased risks
`associated with cGMP compliance. Our inability, or the inability of our third-party fill/finish or other service providers, to demonstrate ongoing cGMP compliance could require us to engage in
`lengthy and expensive remediation efforts, withdraw or recall product, halt or interrupt clinical trials, and/or interrupt commercial supply of any marketed products, and could also delay or
`prevent our obtaining regulatory approval for our late-stage product candidates. Any delay, interruption or other issues that arise in the manufacture, fill/finish, packaging, or storage of any
`drug products or product candidates as a result of a failure of our facilities or the facilities or operations of third parties to pass any regulatory agency inspection or maintain cGMP compliance
`could significantly impair our ability to develop, obtain approval for, and successfully commercialize our products, which would substantially harm our business and prospects. Any finding of
`non-compliance could also increase our costs, cause us to delay the development of our product candidates, and cause us to lose revenue from our marketed product, which could be seriously
`detrimental to our business and financial condition.
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`If the testing or use of our products harms people, we could be subject to costly and damaging product liability claims.
`
`The testing, manufacturing, marketing, and sale of drugs for use in people expose us to product liability risk. Any informed consent or waivers obtained from people who enroll in our clinical
`trials may not protect us from liability or the cost of litigation. We may also be subject to claims by patients who use our approved product, ARCAL YST® for the treatment of CAPS, that they
`have been injured by a side effect associated with the drug. We may face product liability claims and be found responsible even if injury arises from the acts or omissions of our third-party
`fill/finish or other providers. Our product liability insurance may not cover all potential liabilities or may not completely cover any liability arising from any such litigation. Moreover, in the
`future we may not have access to liability insurance or be able to maintain our insurance on acceptable terms.
`
`If we market and sell approved products in the future, in a way that violates federal or state fraud and abuse laws, we may be subject to civil or criminal penalties.
`
`In addition to FDA and related regulatory requirements, we are subject to health care "fraud and abuse" laws, such as the federal False Claims Act, the anti-kickback provisions of the
`federal Social Security Act, and other state and federal laws and regulations. Federal and state anti-kickback laws prohibit, among other things, payments or other remuneration to induce or
`reward someone to purchase, prescribe, endorse or recommend a product that is reimbursed under federal or state healthcare programs. If we provide payments or other remuneration to a
`healthcare professional to induce the prescribing of our products, we could face liability under state and federal anti-kickback laws.
`
`Federal false claims laws prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal goverurnent, or knowingly making, or causing to
`be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as
`allegedly providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices
`that were then used by federal programs to set reimbursement rates; engaging in promotion for uses that the FDA has not approved, known as off-label uses, that caused claims to be submitted
`to Medicaid for non-covered off-label uses, and submitting inflated best price information to the Medicaid Rebate program.
`
`The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other
`state programs, or, in several states, apply regardless of the payer. Sanctions under these federal and state laws may include civil monetary penalties, exclusion of a manufacturer's products
`from reimbursement under goverurnent programs, criminal fines, and imprisonment.
`
`Even if it is determined that we have not violated these laws, government investigations into these issues typically require the expenditure of significant resources and generate negative
`publicity, which would harm our business and financial results and condition. Because of the breadth of these laws and the narrowness of the safe harbors, it is possible that some of our
`business activities could be challenged under one or more of such laws.
`
`In recent years, several states and localities, including California, the District of Columbia, Massachusetts, Maine, Minnesota, Nevada, New Mexico, Vermont, and West Virginia, have
`enacted legislation requiring pharmaceutical companies to establish marketing compliance programs, and file periodic reports with the state or make periodic public disclosures on sales,
`marketing, pricing, clinical trials, and other activities. Similar requirements are being considered in other states. In addition, as part of the federal Patient Protection and Affordable Care Act, or
`PPACA, pharmaceutical companies will be required to file reports with the federal government regarding payments made to healthcare professionals. Many of these requirements are new and
`uncertain, and the penalties for failure to comply with these requirements are unclear. Nonetheless, if we are found not to be in full compliance with these laws, we could face enforcement
`actions, fines, and other penalties, and could receive adverse publicity, which would harm our business and financial results and condition.
`
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`Our operations may involve hazardous materials and are subject to environmental, health, and safety laws and regulations. We may incur substantial liability arising from our activities
`involving the use of hazardous materials.
`
`As a biopharmaceutical company with significant manufacturing operations, we are subject to extensive environmental, health, and safety laws and regulations, including those governing
`the use of hazardous materials. Our research and development and manufacturing activities involve the controlled use of chemicals, viruses, radioactive compounds, and other hazardous
`materials. The cost of compliance with environmental, health, and safety regulations is substantial. If an accident involving these materials or an environmental discharge were to occur, we
`could be held liable for any resulting damages, or face regulatory actions, which could exceed our resources or insurance coverage.
`
`Our business is subject to increasingly complex corporate governance, public disclosure, and accounting requirements and regulations that could adversely affect our business and
`financial results and condition.
`
`We are subject to changing rules and regulations of various federal and state governmental authorities as well as the stock exchange on which our Common Stock is listed. These entities,
`including the Public Company Accounting Oversight Board (PCAOB), the SEC and The NASDAQ Stock Market LLC, have issued a significant number of new and increasingly complex
`requirements and regulation