Provision Language
Definitions
“Licensed Territory” means India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives and Sri Lanka.
“Option Territory” means all countries and territories in the world excluding the Licensed Territory and the Retained Territory.
“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.
“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.
“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.
“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.
“SIIL Technology” means the SIIL Patents and SIIL Know-How.
“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.
“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 aso f 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.
“Visterra Technology” means the Visterra Patents and Visterra Know-How.
“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. LICENSES AND TERRITORY OPTION
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 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 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.
2.3. Rights of Reference.
(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.
2.4. Negative Covenant; No Implied License. SIIL covenants that it shall not, and it shall not permit any of its Affiliates to, use or practice any Visterra Technology outside the scope of the license granted to it under Section 2.1 above. Visterra covenants that it shall not, and it shall not permit any of its Affiliates to, use or practice any SIIL Technology outside the scope of the license granted to it under Section 2.2. Except as set forth herein, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, under any trademarks or Patents owned or Controlled by the other Party.
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2.6. Other Products. During the Term, except pursuant to and in accordance with the terms of this Agreement, neither SIIL nor any of its Affiliates shall directly or indirectly develop, manufacture or commercialize any therapeutic product containing an antibody as an active ingredient in the Licensed Territory that is indicated for the treatment of Dengue Fever infections in humans. Visterra acknowledges that SIIL, as of the Effective Date, has existing development programs and activities with respect to treatments of Dengue Fever, and, notwithstanding anything to the contrary herein, except as set forth above in this Section 2.6, this Agreement shall not in any way restrict SIIL’s freedom to exploit any product opportunities or to conduct development or commercialization activities, now and in future, against Dengue Fever either by way of preventive products, curative products or therapeutic treatments.
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2.9. Option Territory.
(a) Grant of Option. During the Term and subject to the other terms and conditions of this Agreement, Visterra hereby grants SIIL an exclusive option during the Option Period, exercisable in accordance with Section 2.9(b), for SIIL to obtain a non-exclusive, royalty-bearing license, under the Visterra Technology, to research, Develop, make, have made, use, sell, offer for sale, have sold, import, export and otherwise Commercialize and exploit the Product in the Field in the Option Territory (the “Option”).
(b) Exercise of Option.
(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 OptionExercise 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
(c) Option Acceleration.
(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.
(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 4. PRODUCT DEVELOPMENT
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4.3. Diligence. Each Party shall use Commercially Reasonable Efforts to conduct the Development activities assigned to it in the Research and Development Plan. In addition, SIIL shall: [**].
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.
ARTICLE 6. COMMERCIALIZATION
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6.2. SIIL Performance.
(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.
6.3. Trademark. SIIL shall have the sole and exclusive right to brand the Product in the Licensed Territory using names, trademarks and trade dress it determines appropriate for the Product, which may vary by country or within a country (“Product Marks”). SIIL shall own all rights and goodwill in the Product Marks and register and maintain the Product Marks in the countries and regions it determines reasonably necessary.