EX-10 15 filename15.htm Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. License and Collaboration Agreement Between Visterra, Inc. and Serum Institute of India Ltd....
Exhibit 10.15
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Double asterisks denote omissions.
License and Collaboration Agreement
Between
Visterra, Inc.
and
Serum Institute of India Ltd.
August 7, 2015
LICENSE AND COLLABORATION AGREEMENT
This LICENSE AND COLLABORATION AGREEMENT (the “Agreement”) is entered into on August 7, 2015 (the “Effective Date”) between VISTERRA, INC., a Delaware corporation with its principal place of business at Xxx Xxxxxxx Xxxxxx, Xxxxx X0000, Xxxxxxxxx, XX 00000 (“Visterra”), and SERUM INSTITUTE OF INDIA LTD., a company incorporated under the Companies Xxx, 0000, and having its Registered Office at 212/2, Off Soli Xxxxxxxxxx Xxxx, Xxxxxxxx, Xxxx 000000, Xxxxx (“SIIL”). Visterra and SIIL are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
ARTICLE 1
As used in this Agreement, the following initially capitalized terms, whether used in the singular or plural form, shall have the meanings set forth in this Article 1.
1.1. “Adverse Event” means any side effect, injury, toxicity or sensitivity reaction, or any unexpected incident, and the severity thereof, whether or not determined to be attributable to any Product, including, without limitation, a medical occurrence temporarily associated with the use of a medicinal product but not necessarily causally related.
1.2. “Affiliate” means, with respect to a particular Party, a person, corporation, partnership, or other entity that controls, is controlled by or is under common control with such
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1.3. “Business Day” means a day other than (a) a Saturday or a Sunday, (b) a bank or other public holiday in Boston, MA, USA, (c) a bank or other public holiday in Pune, India, or (d) with respect to administrative matters, but not the calculation and payment of amounts to be paid in connection with this Agreement, the nine (9) consecutive days beginning on December 24th and continuing through January 1st and the five (5) consecutive days of Diwali (as celebrated in Pune, India) to the extent not already covered in (a), (b) or (c).
1.4. “Calendar Quarter” means each of the three (3)-month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year, or the applicable portion of such period.
1.5. “Calendar Year” means each twelve (12)-month period commencing on January 1, and ending on December 31, or the applicable portion of such period; provided, that the first Calendar Year commences on the Effective Date and ends on December 31, 2015.
1.6. “Caribbean” means Antigua and Barbuda, Aruba, the Bahamas, Barbados, Cuba, Curacao, Dominica, Dominican Republic, Grenada, Haiti, Jamaica, Saint Kitts and Nevis, Saint Lucia, Saint Xxxxxxx and the Grenadines and Trinidad and Tobago.
1.7. “Central America” means Belize, Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua and Panama.
1.8. “Commercialization” means all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, detailing, medical education and medical liaison activities, Manufacturing for commercial purposes, marketing, pricing, reimbursement, sale, and distribution of the Product, including: (a) strategic marketing, sales force detailing, advertising, medical education and liaison, and market and Product support; (b) any post-marketing clinical studies for use in generating data to be submitted to Regulatory Authorities (and all associated reporting requirements); and (c) all customer support, Product distribution, invoicing and sales activities. “Commercialize” and “Commercializing” shall have correlative meanings.
1.9. “Commercially Reasonable Efforts” means: (a) where applied to carrying out specific tasks and obligations of a Party under this Agreement, expending reasonable, diligent, good faith efforts and resources to accomplish such task or obligation as such Party (on its own or acting through any of its Affiliates, sublicensees or subcontractors) would normally use to accomplish a similar task or obligation under similar circumstances; and (b) where applied to Development, Manufacture or Commercialization of a Product, the use of reasonable, diligent, good faith efforts and resources, in an active and ongoing program, as normally used by similarly-situated companies with respect to a company product having comparable commercial potential, stage of development, medical/scientific, technical and regulatory profile, and
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intellectual property protection, taking into account all Commercially Relevant Factors at the time such efforts are to be expended.
1.10. “Commercially Relevant Factors” means, with respect to a Product, including as applicable to such Product, all relevant factors that may affect the Development, Regulatory Approval or Commercialization of such Product, including (as applicable): safety, efficacy, quality or stability; product profile (including product modality, category and mechanism of action); stage of Development or life cycle status; Development, Regulatory Approval, manufacturing, and Commercialization costs and risk; feasibility of manufacture; the likelihood of obtaining Regulatory Approvals (including satisfactory price approvals) and the timing of such approvals; the current guidance and requirements for Regulatory Approval and the current and projected regulatory status; labeling or anticipated labeling; the then-current competitive environment external to the Parties and the likely competitive environment external to the Parties at the time of projected entry into the market (i.e., not taking into consideration any other Products or other products of the Parties); past performance; present and future market potential; existing or projected pricing, sales, reimbursement and profitability; pricing or reimbursement changes in relevant countries; proprietary position, strength and duration of patent protection and anticipated exclusivity; and other scientific, technical, regulatory, and commercial factors that the decision-making Party reasonably believes to be relevant to such Product.
1.11. “Confidential Information” means, with respect to a Party, all non-public, confidential or proprietary Information of such Party that is disclosed to the other Party (or its employees, consultants, Affiliates, officers, directors, attorneys, accountants, advisors or agents) on or after the Effective Date, whether in oral, written, graphic, or electronic form, together with other Information which a reasonable person would conclude is intended to remain confidential due to its nature or the circumstances under which it is disclosed. All Information disclosed by either Party pursuant to the Confidential Disclosure Agreement between the Parties dated June 10, 2013, as amended as of June 10, 2014, shall be deemed to be such Party’s Confidential Information disclosed hereunder.
1.12. “Control” means, with respect to any material, Information, or intellectual property right, that a Party or its Affiliates owns or has a license or right to such material, Information, or intellectual property right and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other arrangement with, or obtaining the consent of, any Third Party. Notwithstanding the foregoing, material, Information or intellectual property rights subject to a Third Party payment obligation (other than payment obligations arising under the MIT Agreement) as a result of the grant of a license to the other Party or arising out of the practice or use of such material, Information or intellectual property right by the other Party shall only be deemed to be “Controlled” by a Party if the other Party agrees in writing to reimburse the granting Party for all such payments to the relevant Third Party.
1.13. “Develop” or “Development” means all activities relating to preparing and conducting preclinical testing, toxicology testing, human clinical studies, and regulatory activities (e.g., Regulatory Approval Applications) with respect to the Product and post-Regulatory Approval regulatory activities in connection with a Product, together with the
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Manufacturing of the Product for the purpose of conducting the foregoing activities.
1.14. “Dollar” means a U.S. dollar, and “$” shall be interpreted accordingly.
1.15. “European Union” or “EU” means the countries of the European Union as constituted on the Effective Date and as it may be expanded or contracted from time to time after the Effective Date and their respective territories and possessions.
1.16. “Field” means the treatment and prevention of Dengue Fever infections in humans.
1.17. “First Commercial Sale” means the first sale to a Third Party of a Product in a given regulatory jurisdiction after Regulatory Approval has been obtained in such jurisdiction.
1.18. “GAVI Alliance” means the Global Alliance for Vaccines and Immunization (GAVI), an independent non-profit organization established under the laws of Switzerland, with the purpose of providing support for improvements of vaccinations and immunization in the poorest countries of the world.
1.19. “GAVI-Eligible Countries” means all countries in the Licensed Territory which are deemed GAVI-eligible countries by the GAVI Alliance, as such GAVI-eligible countries may be added or deleted by the GAVI Alliance from time to time, and any other country that may be added as a “Developing Country” under the MIT Agreement. As of the Effective Date, India and Sri Lanka are the only GAVI-Eligible Countries in the Licensed Territory.
1.20. Generic Product” means, with respect to a Product in the Field in a particular country in the Licensed Territory, another pharmaceutical product that is: (a) a Product; (b) approved for use in such country by the relevant Regulatory Authority; and (c) commercialized by a Third Party who has not obtained the right or access to such product (through sublicense, subcontract or chain of distribution) from SIIL or its Affiliates or sublicensees.
1.21. “Good Manufacturing Practice” means all applicable then-current standards for Manufacturing, including, as applicable, (a) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820, (b) European Directive 2003/94/EC and Eudralex 4, (c) the principles detailed in the ICH Q7 guidelines, and (d) the equivalent applicable Laws in any relevant country, each as may be amended and applicable from time to time.
1.22. “Information” means any data, results, technology, business information and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, tools, methods, methodologies, designs, prototypes, processes, drawings, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, source code, personnel information, marketing reports, customer lists, pricing information, financial information, marketing plans, development plans, expertise, technology, models, clinical trial designs, test data (including pharmacological, biological, chemical, biochemical,
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toxicological, preclinical and clinical test data), analytical and quality control data, stability data, other study data, databases and procedures.
1.23. “Initiation” means, with respect to a clinical study of a Product, the first dosing of the first human subject for such clinical study with the Product.
1.24. “Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, city or other political subdivision, domestic or foreign.
1.25. “Licensed Antibody” means Visterra’s proprietary engineered monoclonal antibody known as VIS513 having the amino acid sequence set forth on Exhibit A attached hereto.
1.26. “Licensed Territory” means India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives and Sri Lanka.
1.27. “Manufacture” or “Manufacturing” means any and all activities directed to producing, manufacturing, scaling-up, processing, filling, finishing, packaging, labeling, quality assurance testing and release, shipping and storage of a pharmaceutical product or any component or form thereof (including production of drug substance and drug product, in bulk form, for preclinical and clinical studies and for Commercialization).
1.28. “MIT Agreement” means that certain Exclusive Patent License Agreement between the Massachusetts Institute of Technology (“MIT”) and Visterra dated November 15, 2013, as amended from time to time.
1.29. “MIT Patents” means the Patents licensed to Visterra pursuant to the MIT Agreement.
1.30. “Net Sales” means the gross amount billed by SIIL and its Affiliates, excluding distributors and wholesalers, for any Product sold to Third Parties other than sublicensees as determined in accordance with SIIL’s accounting standards as consistently applied, less a deduction of the following, in each case, to the extent actually accrued, discounted or credited, as applicable, and without duplication:
(a) customary trade, quantity, or cash discounts to the extent actually allowed and taken;
(b) amounts repaid or credited by reason of defects, rejections, recalls or returns;
(c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, delivery, or use of a Product which is paid by or on behalf of SIIL;
(d) outbound transportation costs prepaid or allowed and costs of insurance in transit;
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(e) rebates and chargebacks to customers and third parties;
(f) sales, transfers or other dispositions of Product for test marketing, sampling, promotional, charitable, compassionate use (or similar programs), donations (for example, to non-profit institutions or government agencies), pre-clinical, clinical or regulatory purposes; and
(g) amounts provided or credited to customers through coupons and other discount programs.
Net Sales shall occur on the earlier of the receipt of payment or ninety (90) days after the date of billing for a Product. If a Product is distributed at a discounted price that is substantially lower than the customary price charged by SIIL (taking into account customary pricing for a governmental entity), or distributed for non-cash consideration (whether or not at a discount), Net Sales shall be calculated based on the non-discounted amount of the Product charged to an independent Third Party during the same Calendar Quarter or, in the absence of such sales, on the fair market value of the Product.
Non-monetary consideration shall be valued based on the fair market value of such non-monetary consideration, including all relevant and material elements of such consideration, as agreed by the Parties in good faith.
Net Sales shall be calculated only once with respect to each Product sold by SIIL or its Affiliates, even if such Product is sold more than once in the course of its transfer to the ultimate end-user. The foregoing notwithstanding, Net Sales shall not include transfers among SIIL and any Affiliate unless the recipient does not intend to further sell or transfer the Product and is the end user thereof.
1.31. “North America” means Canada, the United States and Mexico and their respective territories and possessions.
1.32. “Option Period” means the period beginning on the Effective Date and ending on the date that is [**] days following SIIL’s generation of top line clinical data from the first Phase 2 Clinical Study of the Product in lab-confirmed Dengue Fever patients; provided, that the Option Period may be earlier terminated as set forth in Section 2.9(c).
1.33. “Option Territory” means all countries and territories in the world excluding the Licensed Territory and the Retained Territory.
1.34. “Patents” means (a) pending patent applications, issued patents, utility models and designs, (b) provisionals, nonprovisionals, reissues, substitutions, confirmations, registrations, validations, re-examinations, revalidations, extensions, additions, continuations, continued prosecution applications, supplementary protection certificates, PCTs, continuations-in-part, or divisions of or to any patents, patent applications, utility models or designs, and all patents issued on any of the foregoing and (c) any foreign equivalent or counterpart of the foregoing.
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1.35. “Phase 1 Clinical Study” means a clinical study in humans which provides for the first introduction into humans of a pharmaceutical product, conducted in normal subjects or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, as further defined by Indian Regulatory Authorities.
1.36. “Phase 2 Clinical Study” means a clinical study in humans of the safety, dose ranging and efficacy of a pharmaceutical product, as further defined by Indian Regulatory Authorities, Federal Regulation 21 C.F.R. § 312.21(b) or its foreign equivalents.
1.37. “Phase 3 Clinical Study” means a controlled clinical study, or a portion of a controlled study, in humans of the efficacy and safety of a pharmaceutical product, which study (in its entirety or portion, as applicable), is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to file an application to obtain Regulatory Approval, as further defined by Indian Regulatory Authorities.
1.38. “Product” means any product for the Field comprising or containing the Licensed Antibody, alone or in combination with other active pharmaceutical ingredients or agents, in any and all forms, in current and future formulations, dosage forms and strengths, and delivery modes; provided, however, that Product shall not include another therapeutically-active compound or antibody (other than a Licensed Antibody) that is Covered by or embodies any Patents or Information and that are, in either case, Controlled by Visterra or any of its Affiliates, without Visterra’s prior written consent.
1.39. “Regulatory Approval” means, with respect to a Product in any country or jurisdiction, all approvals, registrations, licenses or authorizations from the relevant Regulatory Authority in a country or jurisdiction that is specific to Product and necessary to market and sell such Product in such country or jurisdiction and related pricing and reimbursement approvals, to the extent such approvals would be obtained in the ordinary course.
1.40. “Regulatory Approval Application” means an application to the appropriate Regulatory Authority for Regulatory Approval in any particular country or jurisdiction (e.g., an NDA or BLA).
1.41. “Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other governmental entity involved in granting Regulatory Approval or, to the extent required in such country or regulatory jurisdiction, pricing or reimbursement approval of a Product in such country or regulatory jurisdiction.
1.42. “Regulatory Exclusivity” means market or data exclusivity granted by a governmental authority to prevent the entry of Generic Products onto the market, including new chemical entity exclusivity, new use or indication exclusivity, new formulation exclusivity, orphan drug exclusivity, pediatric exclusivity and 180-day generic product exclusivity, or any equivalent of the foregoing in the Licensed Territory.
1.43. “Regulatory Filings” means, with respect to the Product, any submission to a Regulatory Authority of any appropriate regulatory application specific to the Product, and shall
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include any submission to a regulatory advisory board and any supplement or amendment thereto.
1.44. “Retained Territory” means all countries and territories in North America, Central America, the Caribbean, South America and the EU and Australia, Japan, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.
1.45. “Serious Adverse Events” means an Adverse Event which results in death or is immediately life-threatening or results in persistent and significant disability/incapacity or results in congenital abnormally and medically important event or requires in-patient hospitalization or prolongation of existing hospitalization.
1.46. “SIIL Know-How” means all Information Controlled by SIIL and used by or on behalf of SIIL to make, use and sell Product. For clarity, SIIL Know-How excludes rights granted under the SIIL Patents.
1.47. “SIIL Manufacturing Technology” means SIIL Know How and those SIIL Patents utilized by SIIL in the manufacture of a product containing the Licensed Antibody Products.
1.48. “SIIL Patent” means all Patents that (a) are Controlled by SIIL or its Affiliates as of the Effective Date or at any time during the Term (excluding SIIL’s interest in any Joint Patents), and (b) but for the licenses granted herein and assuming the issuance of the claims in any unissued claims part of a Valid Claim of any such Patent, would be infringed by the developing, making, using, offering for sale, selling or importing of the Product in the territory contemplated by any relevant license herein.
1.49. “SIIL Technology” means the SIIL Patents and SIIL Know-How.
1.50. “South America” means Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Guyana, Paraguay, Peru, Suriname, Uruguay and Venezuela.
1.51. “Taxes” means taxes (other than income taxes), duties, tariffs or other governmental charges levied on the sale of Products, including consumption taxes.
1.52. “Third Party” means any person or entity other than Visterra or SIIL or their respective Affiliates.
1.53. “Valid Claim” means, with respect to any country: (a) a claim of an issued and unexpired patent (as may be extended through supplementary protection certificate or patent term extension or the like) to the extent such claim has not been revoked, held invalid or unenforceable by a patent office, tribunal, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) and which claim has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, post grant opposition, revocation, re-examination or disclaimer or otherwise; and (b) a claim of a pending patent application in such country covering the applicable product, in each case that has been pending less than [**] years from the earliest date on which such patent application claims priority and which claim
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was filed and is being prosecuted in good faith and has not been cancelled, withdrawn or abandoned or finally rejected by an administrative agency action from which no appeal can be taken.
1.54. “Visterra Know-How” means all Information that is Controlled by Visterra or its Affiliates as of the Effective Date or during the Term and is necessary or reasonably useful for the Development, Manufacture or Commercialization of the Licensed Antibody or Product in the Field. Without limiting the foregoing, except as set forth below, Visterra Know-How includes all data, results and other Information generated from or obtained by clinical studies and other tests Controlled by Visterra or its Affiliates and any Information described in Regulatory Filings filed with any Regulatory Authority in the Visterra Territory with respect to the Product to the extent Controlled by Visterra or its Affiliates. Notwithstanding the foregoing, Visterra Know-How shall not include Information controlled by a Third Party that acquires Visterra pursuant to an Acquisition and such Information (a) existed as of the date of closing of such acquisition or merger or (b) was developed after the date of closing of such acquisition or merger without using Visterra Know-How or inventions claimed in Visterra Patents. For clarity, Visterra Know-How excludes rights granted under the Visterra Patents and SIIL Technology.
1.55. “Visterra Patents” means all Patents in the Licensed Territory that (a) are Controlled by Visterra or its Affiliates as of the Effective Date or at any time during the Term (excluding Visterra’s interest in any Joint Patents), and (b) but for the licenses granted herein, would be infringed by the developing, making, using, offering for sale, selling or importing of the Licensed Antibody or Product by SIIL or its Affiliates in the Field in the Licensed Territory. Notwithstanding the foregoing, Visterra Patents shall not include Patents controlled by a Third Party that acquires Visterra pursuant to an Acquisition if such Patents (a) existed as of the date of closing of such acquisition or merger or (b) was developed after the date of closing of such acquisition or merger without using Visterra Know-How or inventions claimed in Visterra Patents. The Visterra Patents existing as of the Effective Date in the Licensed Territory are set forth on Exhibit B attached hereto. For clarity, Visterra Patents exclude rights granted under the Visterra Know-How and SIIL Technology.
1.56. “Visterra Technology” means the Visterra Patents and Visterra Know-How.
1.57. “Visterra Territory” means (a) prior to the execution of an Option Amendment, the Retained Territory and the Option Territory and (b) after the execution of an Option Amendment, the Retained Territory.
ARTICLE 2
2.1. License to SIIL under Visterra Technology.
(a) License. Subject to the terms of this Agreement, Visterra hereby grants SIIL and its Affiliates during the Term (i) an exclusive (even as to Visterra), non-sublicensable, royalty-bearing license and, as the case may be, sublicense subject to Section 2.1(b), under the Visterra Technology and Visterra’s interest in the Joint Patents, to research, Develop, have
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Developed, make, have made, use, sell, offer for sale, have sold, import, export and otherwise Commercialize and exploit the Product in the Field in the Licensed Territory and (ii) a non-exclusive, non-sublicensable, royalty-bearing license under the Visterra Technology to make and have made the Licensed Antibody and Product in the Netherlands, solely for export to, use or sale of the Product in the Licensed Territory.
(b) Visterra Retained Rights. Visterra and its Affiliates hereby retain the exclusive right under the Visterra Technology to: (i) practice Visterra Technology to exercise its rights and perform its obligations under this Agreement, whether directly or through one or more licensees; and (ii) practice and license Visterra Technology outside the scope of the licenses granted to SIIL under Section 2.1(a), including to Develop Products for the purpose of obtaining Regulatory Approval outside the Licensed Territory, to make and have made Products for use outside the Licensed Territory, and to use, import, offer for sale, sell and otherwise Commercialize Products but solely for end use outside of the Licensed Territory.
(c) MIT Retained Rights. SIIL acknowledges that MIT retains the right on behalf of itself and all other non-profit research institutions to practice under the MIT Patents for research, teaching, and educational purposes to the extent specifically set forth in the MIT Agreement.
2.2. License to Visterra. SIIL hereby grants Visterra:
(a) during the Term, a non-exclusive, fully-paid, royalty free license, with the right to grant sublicenses to Third Party service providers acting on Visterra’s behalf (subject to the restrictions set forth below), under the SIIL Technology solely to perform Visterra’s obligations under this Agreement;
(b) a perpetual, royalty-free, fully-paid, non-exclusive license, with the right to grant sublicenses, under SIIL’s interest in the Joint Patents to research, Develop, make, have made, use, sell, offer for sale, import and otherwise Commercialize Products in the Visterra Territory;
(c) a perpetual, non-exclusive or exclusive (to be mutually agreed by the Parties in good faith) license, with the right to grant sublicenses (through multiple tiers), under the SIIL Manufacturing Technology to research, Develop, make, have made, use, sell, offer for sale, import and otherwise Commercialize products containing the Licensed Antibody for the Field in the Visterra Territory, such license under this subsection (c) shall bear commercially reasonable consideration to be negotiated in good faith by the Parties, taking into account the commercial value of such SIIL Manufacturing Technology and scope of license granted to Visterra; and
(d) a perpetual, non-exclusive license, with the right to grant sublicenses (through multiple tiers), under the SIIL Technology (other than SIIL Manufacturing Technology) to research, Develop, make, have made, use, sell, offer for sale, import and otherwise Commercialize products containing the Licensed Antibody in the Field in the Visterra Territory, which license shall (i) with respect to SIIL Technology that (A) covers or claims the composition, manufacture, use or sale of the Licensed Antibody or (B) was generated by or on
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behalf of SIIL under this Agreement with respect to the Licensed Antibody, be royalty-free and fully-paid, and (ii) with respect to SIIL Technology that is not covered by subsection (d)(i) above, bear commercially reasonable consideration to be negotiated in good faith by the Parties, which consideration shall be determined by the Parties taking into account the commercial value of such SIIL Technology and scope of license granted to Visterra.
(a) Visterra hereby grants to SIIL and its Affiliates a “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, to any Regulatory Filings Controlled by Visterra or any of its Affiliates on the Effective Date and during the Term and all data contained therein, in each case, that are necessary or useful to Develop, Manufacture or Commercialize the Licensed Antibody or Product in the Field in the Licensed Territory in accordance with this Agreement.
(b) SIIL hereby grants to Visterra a freely-sublicensable “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) and any foreign counterpart to such regulation, to any Regulatory Filings Controlled by SIIL or any of its Affiliates on the Effective Date and during the Term and all data contained therein, in each case, that are necessary or useful to Develop, Manufacture or Commercialize the Licensed Antibody or Product in the Visterra Territory.
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way of preventive products, curative products or therapeutic treatments.
(a) If Visterra or any of its Affiliates receives, or if MIT notifies Visterra that it has received, a bona fide request from a capable Third Party for a license under the MIT Patents to Develop and Commercialize a Product at affordable prices in India or Sri Lanka and the Product is not being sold (including without limitation sufficient supply to meet market demand at reasonable costs) or diligently developed for sale by SIIL or an Affiliate for end use in India or Sri Lanka, as applicable, then Visterra shall promptly notify SIIL of such inquiry (an “Inquiry Notice”). So long as SIIL is not in material breach of its relevant obligations hereunder, Visterra shall use its best efforts to respond to MIT in connection with the Inquiry Notice in a manner agreed upon by the Parties, provided that any response shall, to the extent consistent with Visterra’s reasonable good faith belief, include confirmation of SIIL’s compliance with its obligations hereunder and Visterra’s belief that exclusivity should be maintained with respect to the license grants under Section 2.1 of the MIT Agreement.
(b) Within [**] months of such Inquiry Notice, Visterra may enter into a non-exclusive sublicense agreement containing commercially reasonable terms and conditions with such Third Party for the requested Product in India or Sri Lanka, as applicable. SIIL acknowledges that if Visterra does not grant a sublicense under the MIT Patents to the Third Party within [**] months of such Inquiry Notice, and MIT, at its sole discretion, determines that a sublicense to the Third Party is reasonable under the totality of the circumstances (taking into account development efforts of SIIL and its Affiliates) to make Products available in India or Sri Lanka, as applicable, then MIT shall have the right to grant a non-exclusive license under the MIT Patents to such Third Party in such territory. For clarity, the foregoing non-exclusive licenses contemplated under this Section 2.7(b) shall not apply to any Visterra Patents (other than the MIT Patents) licensed to SIIL hereunder.
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(i) Subject to Section 2.9(c), SIIL may exercise the Option at any time during the Option Period upon delivery of written notice to Visterra (the “Option Exercise Notice”). If SIIL does not exercise the Option by the end of the Option Period, or if SIIL provides Visterra with written notification at any time prior to the end of the Option Period that it will not exercise the Option, then the Option shall expire without being exercised, and Visterra shall have the right to, either by itself or with a Third Party, research, Develop, Manufacture and Commercialize the Product in the Option Territory without further obligation to SIIL.
(ii) If SIIL exercises its Option within the Option Period then, promptly after Visterra’s receipt of the Option Exercise Notice, the Parties shall negotiate in good faith, for a period of [**] days after Visterra’s receipt of such Option Exercise Notice (the “Negotiation Period”), an amendment to this Agreement pursuant to which the Licensed Territory would be expanded to include the Option Territory on a non-exclusive basis and SIIL would agree to meet certain agreed upon Development and Commercialization diligence milestones within an agreed upon time period (the “Option Amendment”). Within [**] days after the execution of the Option Amendment by both Parties, SIIL shall pay to Visterra a one-time, non-refundable and non-creditable upfront fee of [**] Dollars ($[**]). The Option Amendment shall only be effective upon Visterra’s receipt of such payment. If the Parties, despite good faith negotiations, are unable to enter into such Option Amendment within the Negotiation Period, then Visterra shall have the right to, either by itself or with a Third Party, research, Develop, Manufacture and Commercialize the Product in the Option Territory without further obligation to SIIL
(i) If, any time during the Option Period, Visterra receives a bona fide request from a Third Party to discuss or negotiate an agreement pursuant to which such Third Party would Develop and Commercialize the Product in the Option Territory (or one or more countries therein), Visterra shall so notify SIIL. SIIL shall have [**] days after its receipt of such notice to exercise the Option as provided in Section 2.9(b). If SIIL does not exercise the Option by the end of such [**] day period, or if SIIL provides Visterra with written notification at any time prior to the end of such [**] day period that it does not wish to exercise the Option, then the Option Period shall terminate, the Option shall expire without being exercised, and Visterra shall have the right to, either by itself or with a Third Party, research, Develop, Manufacture and Commercialize the Product in the Option Territory without further obligation to SIIL.
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(ii) If, at any time during the Option Period, SIIL elects to make reference in any Regulatory Filing to any top-line clinical data from a Phase 2 Clinical Study of the Product in lab-confirmed Dengue Fever patients that was conducted by Visterra or a Third Party licensee, collaborator or contractor of Visterra, SIIL shall promptly notify Visterra of such election. SIIL shall have [**] days after delivery of such notice to exercise the Option as provided in Section 2.9(b). If SIIL does not exercise the Option by the end of such [**] day period, or if SIIL provides Visterra with written notification at any time prior to the end of such [**] day period that it does not wish to exercise the Option, then the Option Period shall terminate, the Option shall expire without being exercised, and Visterra shall have the right to, either by itself or with a Third Party, research, Develop, Manufacture and Commercialize the Product in the Option Territory without further obligation to SIIL.
ARTICLE 3
3.1. Joint Steering Committee.
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(d) JSC Responsibilities. The JSC shall:
(i) perform its designated roll regarding the Parties’ conduct under the Research and Development Plan and the Development of the Product in the Field in the Licensed Territory by SIIL (provided that the JSC shall not be involved in the day-to-day management of the Development, Manufacture or Commercialization of the Product) as further set forth in this Agreement;
(ii) prepare and approve annual or interim amendments to the Research and Development Plan;
(iii) discuss and endeavor to resolve any disputes arising out of this Agreement;
(iv) review and comment upon the Commercialization Plan presented to the JSC by SIIL in accordance with Section 6.1;
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(v) appointment of alliance managers;
(vi) review and discuss the Publication Strategy for the Products;
(vii) review and discuss proposed protocols for clinical trials to be conducted by SIIL in the Licensed Territory; and
(viii) consider and act on such other matters that are specifically delegated to the JSC as specified in this Agreement.
(i) Disbanding of JSC. The Parties may disband the JSC upon mutual written agreement.
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be held at a mutually agreeable location or alternating each meeting between a location selected by Visterra and by SIIL. The Parties shall discuss and agree upon an agenda in advance for each meeting of the Key Scientific Representatives and determine the appropriate representatives from each Party to be included in such meeting. Meetings of the Key Scientific Representatives shall be for information-exchanging and collaboration purposes only and the Key Scientific Representatives shall have no decision-making authority. The Key Scientific Representatives shall continue to meet as provided in this Section 3.2 until [**] or until such time as otherwise mutually agreed upon by the Parties.
ARTICLE 4
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such Research Plan to the extent necessary. The then-current Research and Development Plan shall at all times contain at least that level of detail and cover at least the same matters (to the extent applicable) as the initial Research and Development Plan.
[**].
Any failure by SIIL to achieve such Development milestones within the relevant timeframes shall be deemed to be a breach of SIIL’s obligations under this Section 4.3, provided that SIIL’s failure to achieve such Development milestone to the extent such failure solely results from Regulatory Authority inaction that is outside SIIL’s control (and not otherwise due to the action or inaction of SIIL, its Affiliate or anyone acting in its behalf) and solely for the duration of such inaction by such Regulatory Authority, provided that SIIL continues to use Commercially Reasonable Efforts to meet such milestones accordingly. Without limiting the foregoing, SIIL shall use diligent efforts to Develop the Product in GAVI-Eligible Countries in the Licensed Territory in a manner that is designed to enable availability and accessibility at reasonable cost.
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appropriate for regulatory purposes. Each Party shall have the right to review all records maintained by the other Party or its Affiliates or sublicensees at reasonable times, upon the reviewing Party’s written request.
ARTICLE 5
5.1. SIIL Regulatory Responsibilities.
(a) SIIL shall own all Regulatory Filings, all pre-clinical data, clinical data generated from SIIL sponsored clinical trials and Regulatory Approvals for the Product in the Licensed Territory, and shall be solely responsible for preparing any and all Regulatory Filings for the Product in the Licensed Territory at its sole expense, provided that Visterra will provide SIIL with any Information or rights of reference in accordance with Section 2.3(a) as reasonably requested by SIIL in connection with the Licensed Antibody. The JSC shall review and comment on all such Regulatory Filings. SIIL shall keep Visterra informed of regulatory developments specific to the Product throughout the Licensed Territory and shall reasonably consider any input from Visterra with respect to SIIL’s interactions with Regulatory Authorities in the Licensed Territory.
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(b) SIIL shall ensure, at its sole expense, that the Development, Manufacture and Commercialization of the Product in the Licensed Territory including any export or import of any Licensed Antibody or Product into or from the Licensed Territory is in compliance with all applicable Laws.
(c) To the extent permitted by the applicable Regulatory Authority and as requested by Visterra, SIIL shall allow representatives of Visterra to participate, at Visterra’s sole expense, in any scheduled conference calls and meetings between SIIL and any Regulatory Authority to the extent the call or meeting is specific to the Licensed Antibody. If Visterra elects not to participate in such calls or meetings, SIIL shall provide Visterra with written summaries to the extent available of such calls and meetings as soon as practicable after they become available.
(d) SIIL shall provide Visterra with copies of all final submissions and correspondence to and from all Regulatory Authorities relating to the Product in the Field within thirty (30) days of submission or receipt, as applicable, and shall provide Visterra a summary of each significant submission (such as application for approval for clinical trials, Regulatory Approval and fast track or orphan drug designation, the protocol for clinical trials and any modifications thereof) as soon as practicable but in any event within thirty (30) Business Days after such submission.
(a) Within [**], the Parties shall discuss in good faith and enter into a pharmacovigilance and adverse event reporting agreement setting forth the worldwide pharmacovigilance procedures for the Parties with respect to the Product, such as safety data sharing, adverse events reporting and prescription events monitoring (the “Pharmacovigilance Agreement”). Such Pharmacovigilance Agreement shall govern the global pharmacovigilance procedures to be agreed upon by SIIL, Visterra and the commercial partners of each Party.
(b) Prior to the execution of such Pharmacovigilance Agreement, the Parties agree to coordinate the pharmacovigilance procedures in connection with the Development of the Product, SIIL shall submit to Visterra all SIIL safety information and reporting in a manner that, to the extent practicable, meets the reporting requirements in the Visterra Territory for such information and Visterra shall submit to SIIL all of Visterra’s (including its sublicensees’ and Affiliate’s) safety information and reporting in a manner that meets the reporting requirements in the Licensed Territory. SIIL shall own all the safety information, including any safety databases for the Product, generated by or on behalf of SIIL in the Licensed Territory. Each Party shall notify the other Party within twenty-four (24) hours of such Party’s learning of any Serious Adverse Events that is attributed to or potentially attributable to the use of the Product. Each Party shall also provide the other Party, on an annual basis and more frequently as reasonably requested by the other Party, a summary report of Adverse Events, as well as those Serious Adverse Events that are not attributable to the use of the Product.
(c) After the execution of the Pharmacovigilance Agreement, the Parties shall comply with the Pharmacovigilance Agreement with respect to all aspects of pharmacovigilance
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activities with respect to the Product, and Section 5.2(b) shall be of no further effect.
ARTICLE 6
COMMERCIALIZATION
6.1. Overview of Commercialization in the Licensed Territory. SIIL shall be solely responsible for all aspects of the Commercialization of the Product in the Field in the Licensed Territory, in compliance with all applicable Laws in accordance with a commercialization plan to
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be prepared by SIIL and provided to JSC for its review and comment prior to the First Commercial Sale of the Product in the Licensed Territory (the “Commercialization Plan”). Such Commercialization Plan shall include, to the extent permitted by applicable Law, the activities to be conducted and the overall timelines therefor in preparation for the launch of the Product and after such Product launch in the respective countries and marketing materials, which shall be updated on [**] basis during the [**]-month period prior to the First Commercial Sale of the Product and thereafter on [**] basis by SIIL and provided to the JSC for its review and comment. SIIL shall book sales for the Product in the Licensed Territory and shall be responsible for all order processing, invoicing, collection, distribution, inventory, and returns necessary in connection therewith.
(a) SIIL shall use Commercially Reasonable Efforts to Commercialize the Product in the Licensed Territory. Without limiting the foregoing, SIIL shall use diligent efforts to Commercialize the Product in GAVI-Eligible Countries in the Licensed Territory in a manner that is designed to enable availability and accessibility at reasonable price.
(b) If a Product has been approved for commercial sale in any country (either in the Licensed Territory or Visterra Territory), but has not been approved for commercial sale in one or more GAVI-Eligible Countries in the Licensed Territory, the Parties shall promptly meet to discuss, and SIIL shall commit to Visterra, in writing with mutually agreed upon timelines (such timelines to be enforceable under this Agreement), that it or an Affiliate shall, (A) promptly apply for approval for commercial sale of such Product in such GAVI-Eligible Countries in the Licensed Territory, and (B) promptly after receiving approval, begin and continue to sell such Product in such GAVI-Eligible Countries in Licensed Territory at reasonably affordable prices in sufficient volume to meet market demand in such countries.
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facilitate Visterra’s reporting obligations to upstream licensors.
ARTICLE 7
ARTICLE 8
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for the earlier milestone shall be due and payable simultaneously with the payment for achievement of the later milestone event.
Milestone Event | Milestone Payment | |
Regulatory Milestones | ||
[**] | [**] | |
[**] | [**] | |
[**] | [**] | |
The aggregate Net Sales of all Products in the Licensed Territory during four (4) consecutive Calendar Quarters during the Term equal or exceed $[**] | [**] | |
The aggregate Net Sales of all Products in the Licensed Territory during four (4) consecutive Calendar Quarters during the Term equal or exceed $[**] | [**] |
Aggregate Annual Net Sales of all Products in the Licensed Territory for a Particular Calendar Year | Royalty Rate | |||
For that portion of aggregate annual Net Sales of Products in the Licensed Territory less than $[**] | [ | **] | ||
For that portion of aggregate annual Net Sales of Products in the Licensed Territory equal to or greater than $[**] but less than $[**] | [ | **] | ||
For that portion of aggregate annual Net Sales of Products in the Licensed Territory equal to or greater than $[**] | [ | **] |
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(b) Royalty Term. Royalties under Section 8.3(a) shall be due, on a country-by-country basis and Product-by-Product basis, during the period beginning on the First Commercial Sale of the Product in such country, and ending upon the later of (i) the expiration of the last-to-expire Valid Claim in the country covering the Product sold in such country; (ii) the expiration of Regulatory Exclusivity covering the Product sold in such country, where such Regulatory Exclusivity is provided under the law; and (iii) the tenth (10th) anniversary after the First Commercial Sale of the Product in such country (the “Royalty Term”).
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8.4. Foreign Exchange. Net Sales will be made in both Dollars and other currencies. To the extent Net Sales are made in currencies other than the Dollar, the amount payable to Visterra in respect of such Net Sales shall be converted to Dollars on the date of remittance at the foreign exchange rate determined by Reserve Bank Of India. All payments from a Party to the other Party shall be made by wire transfer in immediately available funds in Dollars to the credit of such bank account as may be designated by the other Party in this Agreement or in writing to such Party. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day. When conversion of payments from any foreign currency is required to be undertaken by a Party, the Dollar equivalent shall be calculated using such Party’s then-current standard exchange rate conversion methodology as applied in its external reporting, which shall be in accordance with applicable accounting standards.
(b) Indirect Taxes. The Parties shall cooperate in accordance with applicable
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Law to minimize indirect taxes (such as service tax levy, value added tax, sales tax, consumption tax and other similar taxes (“Indirect Taxes”)) in connection with this Agreement. Notwithstanding anything contained in Section 8.7(a), this Section 8.7(b) shall apply with respect to Indirect Taxes. All payments required to be paid to Visterra hereunder are exclusive of Indirect Taxes as may be applicable under Indian Laws. If any Indirect Taxes are chargeable in respect of any payments as may be applicable under Indian Laws, SIIL shall pay such Indirect Taxes in addition to the amounts agreed under this Agreement to Visterra at the applicable rate in respect of any such payments following the receipt, where applicable, of an Indirect Taxes invoice in the appropriate form issued by Visterra in respect of those payments. The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. For clarity, under this Section 8.7(b), if Visterra is required by Law to pay any Indirect Taxes under relevant Indian Tax Laws, then SIIL will reimburse Visterra for any Indirect Taxes required to be paid by Visterra accordingly.
ARTICLE 9
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exploit (including through the grant of licenses and covenants not to xxx) the Joint Inventions without a duty of accounting or seeking consent from the other Party.
(i) Subject to Sections 9.3(a)(ii) and 9.3(a)(iii) and below, Visterra shall have the sole right to prepare, file, prosecute and maintain Visterra Patents and Joint Patents (collectively, the “Visterra Prosecuted Patents”). Visterra shall provide SIIL reasonable opportunity to review and comment on such prosecution efforts regarding such Visterra Prosecuted Patents in the Licensed Territory. Visterra shall provide SIIL with a copy of material communications from any patent authority in the Licensed Territory regarding such Visterra Prosecuted Patents, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses for SIIL’s review and comment. Visterra shall reasonably consider such comments by SIIL and shall include them unless Visterra has a reasonable objection in connection with the prosecution of Visterra Prosecuted Patents in the Licensed Territory.
(ii) The costs and expenses incurred after December 17, 2014, by Visterra in connection with the preparation, filing, prosecution and maintenance of Visterra Patents and Joint Patents under Section 9.3(a)(i) shall be allocated between the Parties as follows: (A) SIIL shall reimburse Visterra for all actual out-of-pocket costs (including reasonable attorneys’ fees) incurred by Visterra in connection with the preparation, filing, prosecution and maintenance of the Visterra Prosecuted Patents in the Licensed Territory and (B) Visterra shall bear all other fees and expenses.
(iii) If Visterra wishes to cease the prosecution or maintenance of any Visterra Prosecuted Patents in the Licensed Territory, it shall notify SIIL to that effect in writing, and SIIL may, at its discretion, assume the rights to the prosecution or maintenance of such Visterra Prosecuted Patents, at SIIL’s sole expense, by informing Visterra in writing within sixty (60) days after receiving such notification from Visterra.
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(iv) Except with respect to commercially reasonable actions/inactions taken by Visterra with respect to the filing and maintenance of Joint Patents, if Visterra does not otherwise initiate actions for filing a Joint Patent in the Licensed Territory within [**] days of communication by SIIL or refuses to file the application for grant of a patent for any other reasons, then SIIL may initiate actions at its own cost to file a patent application, in which case, provided that such patent application/Joint Patent does not contain claims specific to the Product, such patent application/Joint Patent will then be a SIIL Patent solely owned and controlled by SIIL.
9.4. Infringement of Patents by Third Parties.
(i) For any Product Infringement in the Field in the Licensed Territory, each Party shall share with the other Party all Information available to it regarding such existing or threatened infringement. SIIL shall have the first right, but not the obligation, to bring an appropriate suit or other action against any person or entity engaged in such Product Infringement, subject to Section 9.4(b)(ii) through 9.4(b)(v). If SIIL fails to institute and prosecute an action or proceeding to xxxxx such Product Infringement within a period of [**] days after the first notice under Section 9.4(a), then Visterra shall have the right, but not the obligation to, commence a suit or take action to enforce the applicable Visterra Patent or Joint Patent against such Third Party perpetrating such Product Infringement in the Licensed Territory at its own cost and expense. In this case, SIIL shall take appropriate actions, if any, in order to enable Visterra to commence a suit or take the actions set forth in the preceding sentence.
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(ii) Each Party shall provide to the Party enforcing the Visterra Patent or Joint Patent under this Section 9.4(b) reasonable assistance in such enforcement, at such enforcing Party’s request and expense, including joining such action as a party plaintiff if required by applicable Law to pursue such action. If any suit brought by SIIL must be brought in MIT’s name or MIT is joined as a party-plaintiff to any suit brought by SIIL, SIIL shall hold MIT harmless from and indemnify MIT against any costs, expenses or liability that MIT incurs in connection with such action on Visterra’s behalf. The enforcing Party with respect to any action under this Section 9.4(b) shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Party’s comments on any such efforts, and shall seek consent of the other Party in any important aspects of such enforcement including determination of litigation strategy, filing of important papers to the competent court, which shall not be unreasonably withheld or delayed. If SIIL brings any action under this Section 9.4(b) involving existing or threatened infringement of the MIT Patents, SIIL shall consult with Visterra to seek input from MIT and shall consider the views of MIT regarding the advisability of the proposed action and its effect on the public interest, including without limitation, the availability and accessibility of Products at a reasonable price to people most in need within GAVI-Eligible Countries. Visterra shall cooperate with SIIL in facilitating all correspondence with MIT required under this Section 9.4(b)(ii).
(iii) If SIIL commences a Product Infringement action, it shall bear all internal and out-of-pocket costs and expenses incurred by both Parties in connection with such action. In the event that Visterra commences a Product Infringement action, it shall bear all internal and out-of-pocket costs and expenses incurred by both Parties in connection with such action.
(iv) The Party not bringing an action with respect to Product Infringement under this Section 9.4(b) shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the Party bringing such action.
(v) Notwithstanding anything to the contrary contained herein, MIT shall have the first right to defend any Product Infringement involving a Patent Challenge with respect to the MIT Patents as set forth in Section 7.3 of the MIT Agreement, and Visterra shall consult with and keep SIIL reasonably informed with respect thereto.
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consent shall not be unreasonably withheld, conditioned or delayed. Nothing in this Article 9 shall require Visterra to consent to any settlement that is reasonably anticipated by Visterra to have a substantially adverse impact upon any Visterra Patent or Joint Patent in the Visterra Territory, or to the Development, Manufacture, Commercialization, use, importation, offer for sale or sale of the Product in the Visterra Territory. SIIL shall not enter into any settlement, consent judgment, or other voluntary final disposition of any infringement action involving existing or threatened infringement of the MIT Patents without the prior written consent of MIT. Visterra shall cooperate with SIIL in facilitating all correspondence with MIT required under this Section 9.4(d).
ARTICLE 10
REPRESENTATIONS AND WARRANTIES; COVENANTS
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(a) Corporate Existence and Power. It is a company or corporation duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is incorporated, and has full corporate power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as contemplated in this Agreement, including the right to grant the licenses granted by it hereunder.
(a) Subject to the rights of the U.S. federal government with respect to any government-funded invention claimed in any MIT Patent as set forth in 35 U.S.C. §§ 201-211, and the regulations promulgated thereunder, Visterra has the right under the Visterra Technology to grant the licenses to SIIL as purported to be granted pursuant to this Agreement.
(b) The MIT Agreement is in full force and effect as modified or amended prior to the Effective Date, and Visterra has provided to SIIL true and complete copies of such agreement, and any redacted portions thereof are not material to SIIL’s decision to enter into or assert its rights and perform its obligation under this Agreement. Neither Visterra nor, to Visterra’s knowledge, MIT is in default with respect to a material obligation under, and neither Visterra nor MIT has claimed or, to Visterra’s knowledge, has grounds upon which to claim, that the other party is in default with respect to a material obligation under the MIT Agreement.
(c) No Third Party other than MIT has granted Visterra a license to Patents or Information that are not Controlled by Visterra or its Affiliates but that would, if Controlled by Visterra or its Affiliates, be within the definition of Visterra Patents or Visterra Know-How.
(d) Visterra owns or Controls all of the Visterra Patents and Visterra Know-How free from encumbrances and is listed in the records of the appropriate governmental authorities as the owner of record or licensee for each registration, grant and application included in the Visterra Patents.
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(e) (i) Visterra has, with respect to Patents or Know-How owned by it, obtained from all individuals who participated in any respect in the invention or authorship of any such Patents or Know-How, effective assignments of all ownership rights of such individuals in such Patents or Know-How, and (ii) to the knowledge of Visterra, with respect to Patents or Know-How licensed to Visterra under the MIT Agreement, MIT has obtained from all individuals who participated in any respect in the invention or authorship of any such Patents or Know-How, effective assignments of all ownership rights of such individuals in such Patents or Know-How, in the case of each of (i) and (ii), to the extent that any such Patents or Know-How would constitute Visterra Patents or Visterra Know-How, as applicable, if Controlled by Visterra, either pursuant to written agreement or by operation of law.
(f) All of Visterra’s and its Affiliates’ employees, officers, and consultants engaged in the Development or Commercialization of the Product have executed agreements or have existing obligations under applicable Law requiring assignment to Visterra or its Affiliates, as applicable, of all inventions made during the course of and as the result of their association with Visterra and obligating the individual to maintain as confidential Visterra’s Confidential Information as well as confidential information of other parties (including SIIL and its Affiliates) which such individual may receive, to the extent required to support Visterra’s obligations under this Agreement.
(g) All application, registration, maintenance and renewal fees in respect of Visterra Patents as of the Effective Date have been, with respect to Visterra Patents owned by Visterra and, to Visterra’s knowledge, with respect to Visterra Patents licensed to Visterra, paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining Visterra Patents.
(h) Other than the MIT Agreement, there are no agreements or arrangements to which Visterra or any of its Affiliates is a party relating to the Licensed Antibody, Product, Visterra Patents, or Visterra Know-How that would limit the rights granted to SIIL under this Agreement or that restrict or will result in a restriction on the Parties’ ability to Develop, Manufacture, use or Commercialize the Licensed Antibody or Product in the Field in the Territory;
(i) Neither Visterra nor any of its Affiliates, nor any of its or their respective officers, employees, representatives or agents has made an untrue statement of material fact or fraudulent statement to the United States Food and Drug Administration (the “FDA”) or any other Regulatory Authority with respect to the Development of the Licensed Antibody, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority with respect to the Development of the Licensed Antibody, or committed an act, made a statement, or failed to make a statement with respect to the Development of the Licensed Antibody.
(j) In the course of the Development of the Licensed Antibody, neither Visterra nor any of its Affiliates has used prior to the Effective Date any employee, agent or independent contractor who has been debarred or excluded from participation in government healthcare programs by any Regulatory Authority, or, to Visterra’s knowledge, is the subject of
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debarment or exclusion proceedings by a Regulatory Authority or has been convicted pursuant to § 306 of the Food, Drug, and Cosmetic Act.
(k) Visterra has not received any written notice from any Third Party asserting or alleging that any research or Development of any Product by Visterra prior to the Effective Date infringed or misappropriated the intellectual property rights of such Third Party.
(l) To Visterra’s knowledge, the Development, Manufacture and Commercialization of the Product in the Licensed Territory pursuant to this Agreement will not infringe any Third Party’s valid intellectual property rights.
(m) There are no actual, pending, alleged or threatened adverse actions, suits, claims, interferences or formal governmental investigations involving the Product or the Visterra Technology relating to the Product by or against Visterra or any of its Affiliates or licensees in or before any court, Regulatory Authority or other governmental authority.
(a) During the Term, Visterra shall (i) maintain the MIT Agreement in full force and effect; (ii) promptly provide SIIL with a party’s notice of any default under the MIT Agreement; (iii) to the extent within Visterra’s reasonable control, not take any action, fail to take any action or allow any event to occur that would give MIT the right to terminate the MIT Agreement without the written consent of SIIL; (iv) not amend or modify the MIT Agreement in a manner that will adversely affect SIIL’s rights under this Agreement or the MIT Agreement, without SIIL’s prior written consent; (v) not exercise any right to itself terminate or waive any material right under the MIT Agreement, which waiver would adversely affect SIIL’s rights under this Agreement or the MIT Agreement without the prior written consent of SIIL; and (vi) to the extent practicable, notify SIIL prior to any termination of the MIT Agreement. In addition, Visterra shall promptly provide SIIL with a copy of any amendments to the MIT Agreement made after the Effective Date.
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FITNESS FOR A PARTICULAR PURPOSE, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES OTHER THAN THOSE EXPRESSLY STATED IN THIS AGREEMENT, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
ARTICLE 11
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not apply to the extent that any such Losses are subject to indemnification by Visterra pursuant to Section 11.1.
ARTICLE 12
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shall not publish or otherwise disclose and shall not use for any purpose other than as provided for in this Agreement (which includes the exercise of any rights or the performance of any obligations hereunder) any Confidential Information of the other Party pursuant to this Agreement. The foregoing confidentiality and non-use obligations shall not apply to any portion of the Confidential Information that the receiving Party can demonstrate by competent written proof:
(a) was already known to the receiving Party or its Affiliate, other than under an obligation of confidentiality, at the time of disclosure by the other Party;
(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;
(d) is subsequently disclosed to the receiving Party or its Affiliate by a Third Party who has a legal right to make such disclosure; or
(e) is subsequently independently discovered or developed by the receiving Party or its Affiliate without the aid, application, or use of the disclosing Party’s Confidential Information, as evidenced by a contemporaneous writing.
(a) such disclosure: (i) is reasonably necessary for the filing or prosecuting patent rights as contemplated by this Agreement; or (ii) is reasonably necessary for the prosecuting or defending litigation as contemplated by this Agreement;
(b) such disclosure is reasonably necessary: (i) to such Party’s directors, attorneys, independent accountants or financial advisors for the sole purpose of enabling such directors, attorneys, independent accountants or financial advisors to provide advice to the receiving Party; provided that in each such case on the condition that such directors, attorneys, independent accountants and financial advisors are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; or (ii) to actual or potential investors or acquirers solely for the purpose of evaluating an actual or potential investment or acquisition; provided that in each such case on the condition that such actual or potential investors or acquirers are bound by confidentiality and non-use obligations consistent with those contained in this Agreement;
(c) such disclosure is required by judicial or administrative process; provided that in such event such Party shall promptly inform the other Party such required disclosure and provide the other Party an opportunity to challenge or limit the disclosure obligations. Confidential Information that is disclosed by judicial or administrative process shall remain otherwise subject to the confidentiality and non-use provisions of this Article 12, and the Party
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 37 |
disclosing Confidential Information pursuant to law or court order shall take all steps reasonably necessary, including seeking of confidential treatment or a protective order to ensure the continued confidential treatment of such Confidential Information;
(d) such disclosure is reasonably necessary to its collaborators in its respective territory (including contract research organizations, hospitals, doctors, consultants, subcontractors and Affiliates) for the purpose of the Development, Manufacture or Commercialization of the Products, solely for the purpose of carrying out such collaboration, on the condition that such collaborators are bound by confidentiality and non-use obligations consistent with those contained in this Agreement;
(e) such disclosure is reasonably necessary to its potential collaborators to have such potential collaborators to evaluate the possibility of entering into an agreement with the disclosing Party on condition that such potential collaborators are bound by confidentiality and non-use obligations consistent with those contained in this Agreement; or
(f) in the case of disclosure of SIIL’s Confidential Information by Visterra, such disclosure is made to MIT as required by the terms of the MIT Agreement.
(a) Visterra shall develop and present to the JSC for its review and comment a global branding strategy for Products in the Field throughout the world, including a life cycle plan, brand vision, positioning, key messaging, concept and imagery, brand public relations and supporting market research (a “Publication Strategy”).
(b) SIIL shall deliver to Visterra a copy of any proposed publication or presentation relating to the Product for Visterra’s review and approval. Visterra shall have the right to require modifications of the proposed publication or presentation for reasons such as: (a) to protect Visterra’s Confidential Information; (b) for trade secret reasons or business reasons; or (c) to delay such submission for an additional ninety (90) days as may be reasonably necessary to seek patent protection for any Sole Inventions owned by Visterra or any Joint Invention disclosed in such proposed submission. Any publication or presentation by SIIL relating to the Product shall be consistent with the Publication Strategy. Visterra shall be free to publish/present with respect to the Product in its discretion and without review or approval of SIIL, provided that such publication/presentation does not include Confidential Information of SIIL without SIIL’s written consent (not to be unreasonably withheld).
(a) A Party may disclose this Agreement and its terms in filings with the Securities Exchange Commission (or equivalent foreign agency) (“SEC”), tax authorities, bankers (in connection with payments from SIIL), governmental authorities or other regulatory
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 38 |
agencies to the extent required by law after complying with the procedures set forth in this Section 12.4. In such event, the Party seeking such disclosure shall prepare a draft confidential treatment request and a proposed redacted version of this Agreement to request confidential treatment for this Agreement, and the other Party agrees to promptly (and in any event, no less than [**] Business Days after receipt of such confidential treatment request and proposed redactions) give its input in a reasonable manner in order to allow the Party seeking disclosure to file its request within the time lines proscribed by applicable regulations. The Party seeking such disclosure shall exercise Commercially Reasonable Efforts to obtain confidential treatment of this Agreement from the SEC or other regulatory agency as represented by the redacted version reviewed by the other Party.
(b) Further, each Party acknowledges that the other Party may be legally required to make public disclosures (including in filings with the SEC or other agency) of certain material developments or material information generated under this Agreement and agrees that each Party may make such disclosures as required by law; provided that, where possible, the Party seeking such disclosure first provides the other Party a copy of the proposed disclosure; and provided further that (except to the extent that the Party seeking disclosure is required to disclose such information to comply with applicable Laws) if the other Party demonstrates to the reasonable satisfaction of the Party seeking disclosure, within [**] Business Days of such Party’s providing the copy, that the public disclosure of previously undisclosed information shall materially adversely affect the Development or Commercialization of a Product being developed or commercialized, the Party seeking disclosure shall remove from the disclosure such specific previously undisclosed information as the other Party shall reasonably request to be removed.
(c) Notwithstanding the foregoing, the Parties will agree on language of a press release announcing the collaboration no later than thirty (30) days after the execution of this Agreement by both Parties and shall issue such press release promptly thereafter.
(d) The Parties agree that after a disclosure pursuant to Sections 12.4(a) or 12.4(b) has been reviewed and approved by the other Party, the disclosing Party may make subsequent public disclosures or issue a press release disclosing the same content without having to obtain the other Party’s prior consent and approval.
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 39 |
ARTICLE 13
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 40 |
termination was proper, then such termination shall be deemed to be effective on the date of termination based on the original termination notice prior to the initiation of the related dispute or, if later, [**] days following the resolution of the relevant dispute. If as a result of such dispute resolution process it is determined that the notice of termination was improper, then no termination shall have occurred and this Agreement shall remain in effect.
(i) terminate this Agreement in accordance with Section 13.2 (in addition to pursuing any remedy that may be available to SIIL at law or in equity as a result of Visterra’s breach of this Agreement); or
(ii) elect (A) not to terminate this Agreement, (B) to retain the license granted under Section 2.1, subject to all terms and conditions hereof, and (C) pursue any remedy that may be available to SIIL at law or in equity as a result of Visterra’s breach of this Agreement, without prejudice to SIIL’s right to terminate this Agreement at a later date pursuant to Section 13.2 (for that uncured material breach or any other uncured material breach of this Agreement by Visterra). If SIIL so elects not to terminate this Agreement and such breach is undisputed or it is finally determined pursuant to Section 13.2(b) that such notice was proper, thereafter (x) the JSC shall be disbanded and, in lieu thereof, within [**] days after the end of each Calendar Year, SIIL shall deliver a written report to Visterra summarizing in reasonable detail SIIL’s efforts to Develop the Product during the just-ended Calendar Year and (y) the royalty rates set forth in Section 8.3(a) shall be reduced by [**] percent ([**]%) with respect to Net Sales occurring after the date of such notice.
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 41 |
termination of this Agreement, the following shall apply (in addition to any other rights and obligations otherwise under this Agreement with respect to such termination):
(d) If this Agreement is terminated by Visterra under Section 13.2(a) solely with respect to the Manufacture of the Licensed Antibody or Product by SIIL, the provisions of this Section 13.5 shall apply solely with respect to such terminated rights and all other rights and obligations of SIIL hereunder shall survive.
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 42 |
13.4, Visterra may seek to recover such amounts as part of any dispute resolution proceeding brought by Visterra with respect to the breach or Patent Challenge giving rise to such termination.
ARTICLE 14
ARTICLE 15
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 43 |
subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized representative of each Party.
If to Visterra: | Visterra, Inc. | |
Xxx Xxxxxxx Xxxxxx, Xxxxx X0000 | ||
Xxxxxxxxx, XX 00000 | ||
Attention: Chief Executive Officer | ||
Fax: 000 000-0000 | ||
With a copy to: | Visterra, Inc. | |
Xxx Xxxxxxx Xxxxxx, Xxxxx X0000 | ||
Xxxxxxxxx, XX 00000 | ||
Attention: Legal Department | ||
Fax: 000 000-0000 | ||
And a copy to: | Xxxxxx LLP | |
One Freedom Square | ||
Reston Town Center | ||
00000 Xxxxxxx Xxxxx | ||
Xxxxxx, XX 00000-0000 | ||
Attn: Xxxxxxx X. Xxxxxx | ||
Fax: 000-000-0000 |
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 44 |
If to SIIL: | Serum Institute of India Ltd. | |
000, Xxxxxx Xxxxxx | ||
16-B/1 Dr. Xxxxxxxx Xxxx | ||
Xxxx 000000, XXXXX | ||
Attention: Xxxxxxxx Xxxxxxx, Company Secretary | ||
Fax: x00 00 00000000 |
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 45 |
invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
15.11. Governing Law. This Agreement and all disputes arising out of or related to this Agreement or any breach hereof shall be governed by and construed under the laws of the State of New York, without giving effect to any choice of law principles that would require the application of the laws of a different state.
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 46 |
agreement, letter, approved minutes or otherwise, (g) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof and (h) the term “or” shall be interpreted in the inclusive sense commonly associated with the term “and/or”, (i) words of any gender include each other gender, (j) words such as “herein”, “hereof” and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (k) words using the singular shall include the plural, and vice versa, (l) the words “include,” “includes” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia” or words of similar import and (m) unless “Business Days” is specified, “days” shall mean “calendar days.”
[Signature Page Follows]
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 47 |
VISTERRA, INC. | SERUM INSTITUTE OF INDIA LTD. | |||||||
By: | /s/ Xxxxx X. X. Xxxxxxx | By: | /s/ Xxxx X. Xxxxxxxxxx | |||||
Name: | Xxxxx X. X. Xxxxxxx | Name: | Xxxx X. Xxxxxxxxxx | |||||
Title: | CEO | Title: | CEO and Executive Director |
License Agreement SIIL-Visterra – EXECUTION VERSION | Page 48 |
Exhibit A
Licensed Antibody
VH amino acid sequence
[**]
VL amino acid sequence
[**]
License Agreement SIIL-Visterra – EXECUTION VERSION | Exhibit A |
Exhibit B
Visterra Patents
Client Matter | Type | Status | App. No. | File Date | Country | Client Ref. | Title | |||||||||||||||||||
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] | |||||||||||||||||||
[**] | [**] | [**] | [**] | [**] | [**] | [**] | [**] |
License Agreement SIIL-Visterra – EXECUTION VERSION | Exhibit B |
Exhibit C
Research and Development Plan
Research and Development Plan for
Dengue Monoclonal Antibody (VIS513)
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of five pages were omitted. [**]
License Agreement SIIL-Visterra – EXECUTION VERSION | Exhibit C |
Schedule 2.8
Technology Transfer
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. [**].
License Agreement SIIL-Visterra – EXECUTION VERSION | Schedule 2.8 |