Confidential 1.4 “Clinical Trial and Manufacturing Activities Fee” means the amount of Twenty Million Dollars (USD $20,000,000.00). 1.5 “Commercialize” or “Commercialization” means all activities undertaken relating to use for commercial purposes,...
Confidential 1.4 “Clinical Trial and Manufacturing Activities Fee” means the amount of Twenty Million Dollars (USD $20,000,000.00). 1.5 “Commercialize” or “Commercialization” means all activities undertaken relating to use for commercial purposes, including pre-marketing, marketing, distribution, sale, offering for sale, sampling, securing market access, pricing, medical affairs support and educational activities. 1.6 “Commercialization Condition” means that: (a) Bayer notifies Daré of Bayer’s intention to pay the Clinical Trial and Manufacturing Activities Fee pursuant to Section 2.2; (b) the agreement relating to the supply of Product described in Section 8.1 is concluded prior to the expiration of the [***] period described in Section 2.1 (as such period may be extended in accordance therewith); and (c) Daré has received the Clinical Trial and Manufacturing Activities Fee from Bayer, all in accordance with the process and timelines set forth in Article 2. 1.7 “Commercialization Date” means the date that the Commercialization Condition is performed. 1.8 “Commercially Reasonable Efforts” means the level of effort, budget and resources normally used by a Party for a product owned or controlled by it, which is of similar projected profitability and at a similar stage in its development or product life, taking into account with respect to a product any issues of patent coverage, safety and efficacy, product profile, the proprietary position of the product, the then-current competitive environment for the product and the likely timing of the product(s) entry into the market, the regulatory environment of the product and other relevant scientific, technical, economic and commercial factors. 1.9 “Confidential Information” has the meaning set forth in Section 11.1 below. 1.10 “Control” means, with respect to any material, information, or other intellectual property right, that a Party (a) owns or has a license to such material, information, or other intellectual property right and (b) has the ability to grant to the other Party access, a license or a sublicense (as applicable) to such material, information, or other intellectual property right as provided for herein without (i) requiring the consent of a Third Party, (ii) incurring cost to a Third Party (other than royalties or other revenue share requirements contemplated pursuant to a license agreement), or (iii) violating the terms of any agreement or other arrangement with any Third Party. 1.11 “Daré License” means that certain License Agreement entered into by and between Daré and ATI effective July 19th, 2017. 1.12 “Develop” or “Development” means to engage in research and development activities (including preclinical studies, clinical trials, CMC development and regulatory activities). 1.13 “FDA” means the United States Food and Drug Administration or any successor agency thereto. 1.14 “Field” means human contraception. 1.15 “First Commercial Sale” means the first commercial sale of a Product by Bayer or an Affiliate or sublicensee of Bayer to a person or entity who is not Bayer or an Affiliate or sublicensee of Bayer in the Territory after grant of a Marketing Approval. For the avoidance of doubt, supply of Product as samples or to patients for compassionate use, named patient use, clinical trials or other similar development purposes shall not be considered a First Commercial Sale. 2 4838-6408-4913, v. 3
Confidential 1.16 “Indirect Tax” means any sales, use, value added taxes, excise taxes or other similar taxes, duties, or charges (but excluding taxes on income or similar taxes) that may be imposed by any taxing authority within the Territory. 1.17 “Know How” means all know-how, including all proprietary and confidential commercial, technical, scientific and other information, inventions (whether patentable or not), trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and know-how, including study designs and protocols), in all cases whether in written, electronic or any other tangible form, including information related to materials, samples, assays, compounds, compositions or formulations. For the avoidance of doubt, any individual piece of Know How ceases to be covered by this definition once it has been publicly disclosed or if any of the exclusions set forth in Section 11.2 apply. 1.18 “Laws” means all applicable laws (including anti-corruption Laws), statutes, rules, regulations (including cGCP, cGLP and cGMP), orders, judgments and/or ordinances of any Regulatory Authority or court having effect from time to time in the Territory. 1.19 “Licensed Know How” means any Know How Controlled by Daré or any of its Affiliates as of the Execution Date or at any time during the Term, that is necessary to Commercialize the Product or that is useful exclusively in relation to Commercializing the Product, in each case, within the Field. Know-How that is owned or controlled by an entity that becomes an Affiliate of Daré after the Execution Date and that is not used by Daré in the development or commercialization of the Product shall not constitute Licensed Know How. 1.20 “Licensed Xxxx” means any Xxxx Controlled by Daré or any of its Affiliates, as of the Execution Date or at any time during the Term within the Territory, specifically related to the Product, including Ovaprene. Marks that are owned or controlled by an entity that becomes an Affiliate of Daré after the Execution Date and that are not used by Daré in the development or commercialization of the Product in the Field and Territory shall not constitute Licensed Marks. 1.21 “Licensed Patent Rights” means any of the following: 1.21.1 the Patent Rights listed in Exhibit 1.21 hereto, and 1.21.2 any Patent Rights Controlled by Daré or any of its Affiliates as of the Execution Date or at any time during the Term that are necessary to Commercialize the Product or that are useful exclusively in relation to Commercializing the Product, in each case in the Field (and Patent Rights that are owned or controlled by an entity that becomes an Affiliate of Daré after the Execution Date and that are not used by Daré in the development or commercialization of the Product shall not constitute Licensed Patent Rights). 1.22 “Licensed Technology” means the Licensed Patent Rights and Licensed Know How. 1.23 “Manufacture” and “Manufacturing” means all operations required to manufacture, test, release, handle, package, store and destroy a Product. 1.24 “Xxxx” means any word, name, symbol, color, designation or device or any combination thereof for use in the course of trade, including all trademarks, service marks, brand xxxx, trade dress, 3 4838-6408-4913, v. 3
Confidential logos, slogans, designs, brand names, trade names, business symbols, domain names, social media handles, and all other indicia of origin, together with all translations, adaptations, derivations, and combinations thereof, and all registrations, applications for registration thereof and social media handles associated therewith, together with any extensions and renewals thereof and all goodwill associated therewith. 1.25 “Marketing Approval” means any approval, license, registration or authorization, including a Premarket Approval, required from the relevant Regulatory Authority to market and sell the Product in the Territory. 1.26 “Net Sales” means the aggregate gross invoiced sales prices from the sale of Products sold by Bayer and its Affiliates and sublicensees, less the following deductions, actually incurred, paid or accrued by Bayer or its Affiliate or sublicensee: (i) normal trade, quantity and cash discounts, rebates, or similar payments actually granted or given to wholesalers or other distributors, buying groups, health care insurance carriers, managed care entities or other institutions, including any government-mandated rebates; (ii) returns, rejections or recalls (due to spoilage, damage, expiration of useful life or otherwise); (iii) reasonable freight, packing, shipping and postage charges; and (iv) customs or excise taxes on the sale of a Product required by Laws, including import duties, value added, sales and use tax and other taxes (except income taxes) or duties relating to importation, use or sales of a Product. In the event of any sale or other disposal for value, such as barter or counter-trade, of a Product, other than an arms’-length transaction for cash, Net Sales shall be calculated as above based on the value of the non-cash consideration received or the fair market price of such Product in the country of sale or disposal. In no event shall any particular amount of deduction identified above be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). All discounts, allowances, credits, rebates, and other deductions shall be fairly and equitably allocated between Products and other products of Bayer and its Affiliates and sublicensees bundled or sold with such Products such that the Product does not bear a disproportionate portion of such deductions. 1.27 “Patent Challenge” has the meaning contained in Section 12.8. 1.28 “Patent Rights” mean: 1.28.1 all national, regional and international patents, patent applications, utility models, design patents and design rights filed in any country of the world including provisional patent applications; 1.28.2 all patents, patent applications, utility models, design patents and design rights filed either from such patents, patent applications, utility models, design patents, design rights or provisional patent applications or claiming priority from either of these, including any continuation, continuation-in part, division, provisional, converted provisional and continued prosecution applications, or any substitute application; 1.28.3 any patent issued with respect to or in the future issued from any such patent applications; 1.28.4 any and all extensions or restorations by existing or future extension or restoration mechanisms, including reissues, re-examinations, and extensions (including any supplementary protection certificates and the like) of the foregoing patents, patent applications, utility models, design patents and design rights; and 1.28.5 any foreign counterparts of the foregoing. 4 4838-6408-4913, v. 3
Confidential 1.29 “Pivotal Trial” means the pivotal clinical trial or trials to be conducted in the US for the purpose of obtaining Premarket Approval of the Product known as Ovaprene. 1.30 “PMI” means Poly-Med, Inc. 1.31 “Premarket Approval” or “PMA” means a premarket approval application filed with the FDA, for approval by such agency for the marketing and sale of Products in the US pursuant to 21 CFR 814, as such regulations may be amended from time to time. 1.32 “Product” means the monthly, non-absorbable silicone-based, non-hormonal (which releases ferrous gluconate and ascorbic acid), ring-based vaginal contraceptive device, wherein the ringed- mesh comprises a composite ring comprising a flexible matrix containing one or more bioactive agent or agents and needed excipients or modulators, which encircles a fluid-permeable mesh material, currently known as Ovaprene. Product shall include any improvement or modification to the Product that is made or introduced by or on behalf of either Party during the Term; provided that Bayer shall acquire no rights to any improvement or modification to the Product that is not Controlled by Daré. 1.33 “Promotional Materials” means all sales representative training materials and all written, printed, graphic, digital, electronic, audio or video matter, intended for use or used by or on behalf of Bayer, any of its Affiliates or sublicensees, and any of their respective sales forces, sales managers and other sales personnel, in connection with promotion of the Product, which may include without limitation journal advertisements, sales visual aids, leave-behind items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements. 1.34 “Regulatory Authority” means the FDA or any national or local agency, authority, department, inspectorate, official, or public or statutory person having jurisdiction over any of the activities contemplated by this Agreement or the Parties, or any successor bodies thereto. 1.35 “Regulatory Documentation” means all applications, registrations, licenses, authorizations and approvals, all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, in each case specifically addressing the Product, and all data included in the foregoing, including all IDEs, PMAs, Marketing Approvals, adverse events files and complaints files. 1.36 “Results Package” has the meaning stated in Section 2.1. 1.37 “Side Letter” means that letter sent by PMI to Daré dated March 18, 2017 in which PMI agrees with Daré certain undertakings in the event of a breach of the Daré License or the insolvency of ATI. 1.38 “Sublicense Revenue” means all cash payments, the fair market cash value of any equity consideration (less any amounts paid for such equity consideration), and forgivable loans (to the extent actually forgiven) received by Bayer or its Affiliates in consideration for and directly attributable to the grant of a sublicense hereunder, including without limitation upfront payments, license maintenance fees, royalties, milestone payments or the like, subject to the following provisions: 5 4838-6408-4913, v. 3
Confidential manner as agreed with the FDA. Any changes to the protocol or other aspects of the Pivotal Trial shall be made only following notice to Bayer of the proposed change. Such notice will be given in sufficient time in advance of the implementation of the change to allow Bayer to properly consider the change and to discuss it with Daré. Daré agrees to take reasonable account of any reasonable suggestions or objections made by Bayer, recognizing that the data to be generated will be used by Bayer to make an informed decision on whether to perform the Commercialization Condition. ARTICLE 4: LICENSE GRANT 4.1 License Grant by Daré. Commencing upon the Commercialization Date and subject to the terms of this Agreement, Daré grants to Bayer a royalty-bearing, irrevocable (but terminable pursuant to Article 12: license (including the right to grant sublicenses pursuant to Section 4.2 below) under Daré’s interest in the Licensed Technology to Develop and Commercialize the Product, where the manufacture, use, sale or import of the Product is covered by the Licensed Technology, in the Field in the Territory. Such license shall be exclusive with regard to Commercialization and co-exclusive with Daré with regard to Development. 4.2 Sublicensing. Subject to the terms of this Agreement, Bayer may sublicense (but with no right to grant further sublicenses) the rights granted to Bayer under Section 4.1 to any Bayer Affiliate or Third Party. 4.2.1 Bayer Responsibility. Any sublicense granted by Bayer hereunder shall not relieve Bayer from any of its obligations under the Agreement and Bayer will be responsible for all actions of its sublicensee in connection with such sublicense. 4.2.2 Consent of Daré. Any sublicense to a Third Party shall require the prior written consent of Daré, such consent not to be unreasonably withheld, delayed or conditioned. In considering the reasonableness of withholding any such consent, it is acknowledged that Daré has selected Bayer as a licensee hereunder due to its expertise and presence in the Field and in the Territory, including its capacity and resource to successfully Commercialize the Product. It is intended by Daré that any non-Affiliate sublicensee should have expertise, presence, capacity and resource in the Field in the Territory that is comparable to Bayer’s. 4.2.3 Requirements. Each sublicense shall be in writing and consistent with and subject to the terms and conditions of this Agreement, including granting Daré and its licensors the audit rights stated in Article 10. Bayer shall provide Daré a copy of each sublicense agreement, and each amendment thereto or extension thereof (redacted as appropriate regarding information on products unrelated to the Product and unrelated to the Licensed Technology), within [***] days of execution, and Bayer acknowledges that Daré may disclose such copies to its licensors as necessary. All sublicenses granted by Bayer shall terminate automatically and immediately upon expiration or termination of this Agreement. Bayer shall terminate a sublicense if the sublicensee commits any action or omits to take any action that would constitute a material breach of this Agreement if committed by Bayer, and if such sublicensee fails to cure such action or omission within the corresponding cure period provided in this Agreement. 4.3 Retained Rights. Daré and its licensors shall have and retain the rights to use the Licensed Technology to further Develop the Product in the Territory, and shall retain all rights to Develop 8 4838-6408-4913, v. 3
Confidential Above $[***] [***]% provided, however, that upon the expiration of (1) the last to expire Valid Claim within the Licensed Patent Rights covering the manufacture, use, sale and import of the Product in the Territory; or (2) the last to expire marketing, data or similar exclusivity for the Product conferred by a Regulatory Authority that provides an exclusive commercialization period during which Bayer, its Affiliates or its sublicensees have the exclusive right to market and sell the Product in any region in the Territory (excluding any rights conferred by or based on any Licensed Patent Rights); whichever is later, each royalty rate set forth above shall be reduced by [***] percent ([***]%). 9.3.2 Royalties not Cumulative. In determining the applicable royalty rate, the Net Sales stated above are not cumulative and the relevant royalty rate will be calculated on a calendar year- by-calendar year basis. 9.3.3 Blended Rates. With respect to the royalty rates for the Product, the Parties acknowledge and agree that the Licensed Patent Rights and Licensed Know-How licensed pursuant to this Agreement justify royalty rates of differing amounts with respect to sales of the Product, which rates could be applied separately to the Product involving the exercise of such Licensed Patent Rights and/or the use or incorporation of such Licensed Know-How, and that if such royalties were calculated separately, royalties relating to Licensed Patent Rights and royalties relating to Licensed Know-How would last for different terms. The Parties have determined in light of such considerations and for reasons of convenience that blended royalty rates for the Patent Rights and the Know-How licensed hereunder will apply during the Term (which blended royalty rates would be advantageous to both Parties), subject to the royalty reduction calculation set forth in Section 9.3.1. Consequently, the Parties have agreed to adopt the royalty rates set forth in this Section 9.3. 9.3.4 Royalty Stacking. If during the Term Bayer becomes aware of a Third Party Patent Right and where Bayer reasonably determines, in the absence of a license to such Third Party Patent Right, such Third Party Patent Right would be infringed by Bayer’s Commercialization of the Product in the Field and in the Territory as permitted herein, Bayer (itself or through any other Bayer Affiliate) may obtain a license to such Third Party Patent Right in the Territory. In the event that Bayer pays royalties to such Third Party for the acquisition of a license to such Third Party Patent Rights, Bayer shall deduct from the royalty payable by Bayer to Daré pursuant to this Section 9.3 in a given calendar quarter all royalties paid to such Third Party in such quarter under such agreement, provided that in no event shall Bayer reduce the royalties payable to Daré hereunder by more than [***] percent ([***]%) of the royalties otherwise payable. Royalties payable in respect of Net Sales made by a Bayer sublicensee may be reduced by operation of this Section 9.3.4 only where the operative Third Party license agreement is entered into by Bayer and such Third Party. 9.3.5 Quarterly Royalty Reporting and Royalty Payment. All royalty payments shall be made at quarterly intervals. Within [***] days of the end of each quarter after the First Commercial Sale of the Product, Bayer shall submit a statement which shall show for that quarter: (i) Net Sales, (ii) a calculation of the royalty payment due on such Net Sales, (iii) offsets made pursuant to Section 9.3.4, and (iv) such other relevant details as Daré may reasonably 13 4838-6408-4913, v. 3
Confidential the Affiliate does not withdraw or cause to be withdrawn such challenge within ninety (90) days of receipt of such notice, in which case Daré shall have the right to terminate this Agreement by providing written notice thereof to Bayer. The foregoing right to terminate shall not apply with respect to any Patent Challenge where the Patent Challenge is made in defense of an assertion of the relevant Patent Right that is first brought by Daré against Bayer. 12.9 Consequences of Termination of Agreement. In the event of the termination of this Agreement, the following provisions shall apply, as applicable: 12.9.1 If this Agreement is terminated by Bayer pursuant to Section 12.3 or Section 12.7: (a) All licenses and rights granted by Daré to Bayer, including all licenses granted to Bayer pursuant to Section 4.1, shall immediately terminate. (b) Bayer shall cease to use any Marketing Approval obtained in accordance with the Agreement. (c) Bayer shall cease to conduct any activity related to the Development and/or Commercialization of the Product. (d) Each Party shall promptly return all Confidential Information of the other Party that are not subject to a continuing license hereunder; provided, that, each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder. (e) Bayer shall, and shall cause its Affiliates and sublicensees, to provide reasonable assistance, at no cost to Daré, as may be reasonably necessary or useful for Daré or its designee to commence or continue commercializing Products in the Territory and to generally effect a smooth and orderly transition of commercialization activities with respect to the Product, for a period of up to one hundred eighty (180) days after the effective date of termination (the “Transition Period”), including transferring or amending as appropriate, upon request of Daré, any agreements or arrangements with Third Parties to commercialize the Products in the Territory, and domain names as described in Section 16.7.8. To the extent that any such contract between Bayer or its Affiliate or sublicensee and a Third Party is not assignable to Daré or its designee, then, to the extent reasonably practicable, Bayer shall reasonably cooperate with Daré (but without Bayer retaining any liability under such contract or incurring expense or cost to the Third Party) to arrange to continue to and provide such services from such entity. (f) Bayer and its Affiliates and sublicensees shall: (A) transfer or assign, or cause to be transferred or assigned, to Daré or its designee (or to the extent transfer or assignment is not permitted by Law, take all reasonable actions to make available to Daré or its designee) the full benefits (including the right of reference, to the extent consistent with Law) of all Regulatory Applications, Regulatory Approvals, Regulatory Materials, regulatory dossiers, applications for Pricing Approval, and Pricing Approvals, for the Product, all as existing at the date of termination whether held in the name of Bayer or its Affiliate; (B) provide to Daré or its designee originals of all of the foregoing documents, as well as copies of all correspondence with relevant Regulatory Authorities or Pricing Authorities 19 4838-6408-4913, v. 3
Confidential pertaining to Products; and (C) take such other reasonable actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this Section to Daré or its designee, at Daré’s cost and expense. Notwithstanding the above, if Bayer cannot complete (A) through (C) as set forth above due to Law or contracts that prohibit the same, Bayer will take all reasonable actions to make the above available to Daré or Daré’s designee, at Daré’s cost and expense. (g) Daré shall have the right, but not the obligation, to purchase from Bayer and its Affiliates and sublicensees any or all of the usable inventory of any Product in Bayer’s or its Affiliates’ and sublicensees’ possession as of the date of termination, at a purchase price equal to the price paid by Bayer for such inventory. Any packaging, transport, insurance and other costs relating to delivery shall be borne by Daré. In addition, if Daré does not purchase the inventory, Bayer and its Affiliates and sublicensees may sell, have sold and offer to sell any inventory of Product in its or their possession as of the termination date during the 180-day period beginning on the termination date, or if applicable, complete performance of any and all bid and tender agreements that had been entered into prior to the termination date. Notwithstanding the above, Bayer may not sell off any inventory at a price less than the fair market value. (h) Bayer shall, if requested by Daré, deliver to Daré all Promotional Materials in Bayer’s and its Affiliates’ and sublicensees’ possession (including electronic files of all Promotional Materials), and Daré will reimburse Bayer for its out-of-pocket cost for printing and delivering such materials. Notwithstanding the foregoing, Daré shall retain no rights to use the Bayer name or the Bayer cross following termination of this Agreement. (i) To the extent permissible by Law Bayer and its Affiliates and sublicensees shall transfer to Daré any and all data exclusivity rights for the Product as existing at the date of termination, including regulatory or statutory exclusivity periods. (j) Subject to any obligations of confidentiality owed to Third Parties and to the extent they relate specifically to the Product, Bayer shall promptly provide to Daré a list of all agreements in effect between Bayer and its Affiliates and sublicensees on the one hand, and any distributors on the other hand, of Products in the Territory, including the identity of and contact information for each such Third Party, and will use Commercially Reasonable Efforts to facilitate introductions between Daré and such Third Parties, and Bayer will disclose copies of such agreements to Daré to the extent permitted by the relevant Third Party (either through the agreement itself, or through the Third Party’s written consent). Bayer shall use Commercially Reasonable Efforts to include in each such agreement a provision allowing it to assign such agreement to Daré in the event of termination of this Agreement. (k) Each Party shall promptly return all Confidential Information of the other Party that is not subject to a continuing license hereunder; provided, that, each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder. 20 4838-6408-4913, v. 3
Confidential 12.9.2 If this Agreement is terminated by either Party on any grounds except by Bayer pursuant to Section 12.3: (a) All licenses and rights granted by Daré to Bayer, including all licenses granted to Bayer pursuant to Section 4.1, shall immediately terminate; (b) Bayer shall cease to use any Marketing Approval obtained in accordance with the Agreement; (c) Bayer shall cease to conduct any activity related to the Development and/or Commercialization of the Product; (d) Each Party shall promptly return all Confidential Information of the other Party that is not subject to a continuing license hereunder; provided, that, each Party may retain one copy of the Confidential Information of the other Party in its archives solely for the purpose of establishing the contents thereof and ensuring compliance with its obligations hereunder (e) Bayer and its Affiliates and sublicensees shall: (A) transfer or assign, or cause to be transferred or assigned, to Daré or its designee (or to the extent transfer or assignment is not permitted by Law, take all reasonable actions to make available to Daré or its designee) the full benefits (including the right of reference, to the extent consistent with Law) of all Regulatory Applications, Regulatory Approvals, Regulatory Materials, regulatory dossiers, applications for Pricing Approval, and Pricing Approvals, for the Product, all as existing at the date of termination whether held in the name of Bayer or its Affiliate; (B) provide to Daré or its designee originals of all of the foregoing documents, as well as copies of all correspondence with relevant Regulatory Authorities or Pricing Authorities pertaining to Products; and (C) take such other reasonable actions and execute such other instruments, assignments and documents as may be necessary to effect, evidence, register and record the transfer, assignment or other conveyance of rights under this Section to Daré or its designee, at Daré’s cost and expense. Notwithstanding the above, if Bayer cannot complete (A) through (C) as set forth above due to Law or contracts that prohibit the same, Bayer will take all reasonable actions to make the above available to Daré or Daré’s designee, at Daré’s cost and expense; (f) Daré shall have the right, but not the obligation, to purchase from Bayer and its Affiliates and sublicensees any or all of the usable inventory of any Product in Bayer’s or its Affiliates’ and sublicensees’ possession as of the date of termination, at a purchase price equal to the price paid by Bayer for such inventory. Any packaging, transport, insurance and other costs relating to delivery shall be borne by Daré. In addition, if Daré does not purchase the inventory, Bayer and its Affiliates and sublicensees may sell, have sold and offer to sell any inventory of Product in its or their possession as of the termination date during the 180-day period beginning on the termination date, or if applicable, complete performance of any and all bid and tender agreements that had been entered into prior to the termination date. Notwithstanding the above, Bayer may not sell off any inventory at a price less than the fair market value; 21 4838-6408-4913, v. 3
Confidential ARTICLE 18: DISPUTE RESOLUTION If the Parties are unable to resolve a dispute, despite their good faith efforts, either Party may refer the dispute to the CEO of Daré and the Head of the Bayer business unit responsible for the Commercialization of the Product. In the event that no agreement is reached by the said CEO and Head (or other designees) with respect to such dispute within thirty (30) days after its referral to them, either Party may pursue any and all remedies available at law or in equity. ARTICLE 19: GENERAL PROVISIONS 19.1 Interpretation. 19.1.1 the headings of sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference only and shall not constitute any part of the Agreement or have any effect on its interpretation or construction. 19.1.2 All references in the Agreement to the singular shall include the plural where applicable. 19.1.3 The use of any gender is applicable to all genders. 19.1.4 Unless otherwise specified, references in the Agreement to any section shall include all subsections and paragraphs in such section, and references in the Agreement to any subsection shall include all paragraphs in such subsection. 19.1.5 Any list or examples following the word “including” shall be interpreted without prejudice to the generality of the preceding words. 19.1.6 All references to days or years in the Agreement shall mean calendar days or years, as the case may be, unless otherwise specified. 19.2 Applicable Law. The Agreement and any disputes, claims, or actions related thereto shall be governed by and construed in accordance with the Laws of the State of New York without giving effect to any choice or conflict of law provisions; provided, however, the foregoing shall not apply to disputes arising out of or relating to intellectual property which shall be governed by applicable federal laws and/or laws of the State of New York (without regard for principles of conflicts of laws) as they apply to the given situation. The Parties further expressly agree that the exclusive venue for the resolution of any such disputes (including intellectual property) shall be the state and federal courts located in New York, New York or the federal courts located in the Southern District of New York, and that such courts shall have exclusive jurisdiction. The Parties hereby submit themselves to the jurisdiction of such courts for such purposes. EACH PARTY HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES, TO THE FULLEST EXTENT IT MAY LEGALLY AND EFFECTIVELY DO SO, TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING HEREUNDER AND ANY CLAIM OF INCONVENIENT FORUM OF ANY COURT IN THE SOUTHERN DISTRICT OF NEW YORK. The prevailing Party in any dispute is entitled to recover its reasonable attorneys’ fees. 19.3 Notices. Any notice, consent, or other formal or legal communication required or permitted by this Agreement shall be in writing and shall be sent (a) by prepaid registered or certified mail, return receipt requested, or (b) by express delivery service by an internationally recognized courier, addressed to the other Party at the address shown below or at such other address for which such Party gives notice hereunder: 31 4838-6408-4913, v. 3
Confidential U.S. Department of Commerce and/or other appropriate governmental agencies of the United States. 19.15.2 Bayer shall not (i) export, reexport, or transfer any Product to any country that is at the time of export, reexport or transfer subject to an embargo by the U.S. government; (ii) export, reexport, or transfer any Product to any instrumentality, agent, entity, or individual that is acting on behalf of, or directly or indirectly owned or controlled by, any governmental entity that is subject to an embargo by the U.S. government; (iii) export, reexport or transfer any Product to a national of a country that is subject to an embargo of the U.S. government; and (iv) engage in any transactions or dealings with any organization, entity, or individual identified on the List of Specially Designated Nationals and Blocked Persons (“SDNs”) or the Foreign Sanctions Evaders List, which are both maintained by the Office of Foreign Assets Control of the U.S. Treasury Department, or the Entity List, Denied Persons List, or Unverified List, which are maintained by the Bureau of Industry and Security of the U.S. Commerce Department; in each case to the extent such export, reexport or transfer violates Applicable Laws. Notwithstanding the above and for the avoidance of doubt, Bayer may export, reexport, or transfer any Product as permitted by applicable Law or based upon specific or general licenses allowed by applicable Law at the export, reexport or transfer of the Product. The Parties acknowledge that the above prohibitions do change from time to time, and any changes in the above can be discussed by the Parties. 19.15.3 Either Party will immediately report to the other Party (i) any concerns, suspicions, or actual knowledge of violations of the Export Control Laws or any other similar applicable export control law in performance of this Agreement, or (ii) if either Party becomes the subject of any formal or informal investigation, prosecution, or government or judicial determination related to a violation of Export Control Laws or any other similar applicable export control law, in performance of this Agreement. 19.15.4 Each Party will fully cooperate and cause its relevant personnel to cooperate with the other Party in the other Party’s review or investigation in relation to an actual or potential violation of any applicable export law or regulation in performance of this Agreement. 19.15.5 Each Party understands and acknowledges that, notwithstanding any provision contained herein, (i) an intentional violation of this Section 19.15 as applicable to the Product by any either Party shall be deemed a material breach of this Agreement and will entitle the other Party to (i) terminate this Agreement immediately upon notice for cause, and (ii) be indemnified for and held harmless against any and all damages, fines, penalties, disgorgements, settlements, determinations, or claims faced by or imposed on the non-breaching Party or any of its representatives to the extent attributable to the material breach of this Section by the breaching Party or any of its respective directors, officers, employees, consultants, agents, sublicensees, subcontractors, distributors, subdistributors or other representatives’ and (ii) a non-intentional violation of this Section 19.15 as applicable to the Product by either Party shall be deemed a non-material breach of this Agreement. Such a breach may be cured by reporting as soon as practicable the basis of the breach to the regulatory agency responsible for the applicable export control laws. In addition each Party 35 4838-6408-4913, v. 3
Confidential must thereafter cooperate with said agency during any investigation and with any subsequent fines or remediation imposed by said agency. [SIGNATURES ON FOLLOWING PAGE] 36 4838-6408-4913, v. 3