Exhibit 4.14
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
LICENSE AGREEMENT
between
OBSEVA SA
and
THERAMEX HQ UK Limited
Dated as of 10 February 2022
LICENSE AGREEMENT
This License and Distribution Agreement (the “Agreement”) is made and entered into effective as of 10 February 2022 (the “Effective Date”) by and between:
(2) | Theramex HQ UK Limited a limited liability company incorporated in England and Wales with a registered address at Sloane Square House, 1 Holbein Place, London SW1W 8NS, UK (“Licensee”). |
ObsEva and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Recitals
(C) | NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
| 1.1 | “Accounting Standards” means International Financial Reporting Standards (IFRS) or accounting principles generally accepted in the United States of America (US GAAP), which standards or principles are used at the relevant time and consistently applied by the applicable Party. |
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| 1.2 | “Affiliate” means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, “control” and, with correlative meanings, the terms “controlled by” and “under common control with” means (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise; or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person (or, with respect to a limited partnership or other similar entity, its general partner or controlling entity) provided however that Affiliate shall exclude: (i) any funds or vehicles (“CVC Funds”) advised by CVC Capital Partners Limited and/or its affiliates; and (ii) any portfolio companies in which any CVC Fund holds an interest or investment from time to time. The Parties acknowledge that in the case of certain entities organized under the laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management or policies of such entity. |
| 1.4 | “Agreed Prosecution” has the meaning given to it in Section 9.4. |
| 1.5 | “Annual Net Sales-Based Milestone Payment” has the meaning given to it in Section 7.3.1. |
| 1.6 | “Annual Net Sales Milestone Threshold” has the meaning given to it in Section 7.3.1. |
| 1.7 | “Applicable Law” means federal, state, local, national and supra-national laws, statutes, rules, and regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, major national securities exchanges or major securities listing organizations, that may be in effect from time to time during |
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| the Term and applicable to a particular activity or country or other jurisdiction hereunder. |
| 1.11 | “Breaching Party” has the meaning given to it in Section 14.2. |
| 1.12 | “Business Day” means a day other than a Saturday, Sunday or public holiday in Switzerland or England. |
| 1.13 | “Challenged Patent” has the meaning given to it in Section 14.3. |
| 1.14 | “Change of Control” means, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party that results in the voting securities of such Party outstanding immediately prior thereto, or any securities into which such voting securities have been converted or exchanged, ceasing to represent more than fifty percent (50%) of the combined voting power of the surviving entity or the parent of the surviving entity immediately after such merger or consolidation, or (b) a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of more than fifty percent (50%) of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s business or assets to which this Agreement relates. |
| 1.15 | “Claims” has the meaning given to it in Section 13.1. |
| 1.16 | “Clinical Trial” means studies in humans designed to generate data in support or maintenance of a Regulatory Approval in any country. |
| 1.17 | “Commercialization” means applying for a Marketing Authorization and, as applicable, Pricing or Reimbursement Approval, and activities taken before and |
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| 1.20 | “Confidential Information” means all Information, including trade secrets, processes, formulae, data, know-how, improvements, inventions, chemical or biological materials, assays, techniques, marketing plans, strategies, customer lists, |
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| or other information that has been disclosed by or on behalf of one Party to the other Party or any of its Affiliates under this Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated in oral, written, graphic, or electronic form, or by visual inspection |
| 1.22 | “Covers” means, with respect to a Patent and a Licensed Product, that, but for the licenses granted in this Agreement, the making, use, sale, offer for sale or importation of the Licensed Product would infringe such Patent. |
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| 1.23 | “Default Notice” has the meaning given to it in Section 14.2. |
| 1.24 | “Disclosing Party” has the meaning given to it in Section 11.1. |
| 1.25 | “Dispute” has the meaning given to it in Section 15.6. |
| 1.26 | “Distributor” means any person who purchases Licensed Products from the Licensee and promotes, markets, and sells such Licensed Products on behalf of Licensee in countries where Licensee is the holder of the Marketing Authorization. |
| 1.28 | “EMA” means the European Medicines Agency, or any successor organization thereto and, with respect to the grant of a Marketing Authorization, includes the European Commission. |
| 1.30 | “EUR” means Euros (€). |
| 1.32 | “Excess Quantities” has the meaning given to it in Schedule 1.102. |
| 1.33 | “Exploit” or “Exploitation” means to develop, use, make, have made, offer for sale, sell, have sold, import, Commercialize or otherwise exploit and “Exploiting” has the corollary meaning. |
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| 1.34 | "FCS Longstop Date" is the date calculated according to the following formula: [*] plus the number of days between (i) [*], and (ii) [*]. |
| 1.35 | “FDA” means the United States Food and Drug Administration and any successor agency or authority having substantially the same function. |
| 1.36 | “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
| 1.38 | “First Commercial Sale” means, with respect to any Licensed Product and country in the Territory, the first sale of such Licensed Product in such country after receipt of Marketing Authorization for such Licensed Product for such country. |
| 1.39 | “Generic Competition” means, with respect to a given Licensed Product in a given country or region in the Territory, that the unit sales of such Licensed Product in such country or region reduce in any two consecutive calendar quarters [*] or more from the calendar quarter that was prior to the launch of the first to be launched Generic Product of such Licensed Product in such country or region. |
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| statutes. A Licensed Product authorized by the Licensee or any of its Affiliates, Sublicensees, or Distributors as an authorized generic product whether or not marketed by Licensee or a Third Party will not constitute a Generic Product. |
| 1.41 | “Good Clinical Practice” means all applicable current good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of Clinical Trials, including, as applicable, (a) as set forth in the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Harmonized Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other applicable guidelines for good clinical practice for trials on medicinal products anywhere in the world, (b) the Declaration of Helsinki (2013) as last amended at the 64th World Medical Association in October 2013 and any further amendments or clarifications thereto and (c) any equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time, and, in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate, and protect the rights, integrity, and confidentiality of trial subjects. |
| 1.42 | “Good Laboratory Practices” means all applicable current good laboratory practice standards, including, as applicable, as set forth in the then-current good laboratory practice standards promulgated or endorsed by the FDA, as defined in 21 C.F.R. Part 58, and any equivalent Applicable Law in any relevant country or region, each as may be amended and applicable from time to time. |
| 1.43 | “ICC” has the meaning given to it in Section 15.6.2. |
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| 1.47 | “Initiation” means, in relation to a Clinical Trial, the first dosing of the first subject to be dosed in such Clinical Trial and “Initiating” shall take the corollary meaning. |
| 1.48 | “Intellectual Property” has the meaning given to it in Section 14.6. |
| 1.49 | “Intentional Failure to Supply” means [*]; and (B) the period over which there has been such an intentional refusal for [*] consecutive orders notwithstanding that (i) ObsEva has the available manufacturing capacity to manufacture the amount of Licensed Product ordered by Licensee in addition to the amounts required for any country outside the Territory; and (ii) ObsEva has received sufficient quantities of Licensed Compound from Kissei for the manufacture of Licensed Product ordered by Licensee in addition to the amounts required for any country outside the Territory. There shall be no Intentional Failure to Supply if (w) Licensee has failed to provide forecasts in accordance with the Supply Agreement; (x) Licensee is in material breach of either this Agreement or the Supply Agreement at any time between the forecast for the relevant delivery of Licensed Product becoming firm pursuant to the Supply Agreement and the date for delivery of the relevant Licensed Product; (y) there are due and payable invoices outstanding for payment by the Licensee; and/or (z) there is a force majeure event that prevents ObsEva from making such supply. For the avoidance of doubt, a failure to supply Licensed Compound or Licensed Products to Licensee on the basis of a failure by any of Kissei or any Third Party contracted to supply Licensed Product to ObsEva shall not constitute an Intentional Failure to Supply on the part of ObsEva. |
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| 1.52 | “Kissei Agreement” means the license agreement relating to the Licensed Compound between ObsEva and Kissei on 19 November 2015. |
| 1.54 | “Kissei Patents” means the Patents listed in Schedule 1.53. |
| 1.55 | “Know-How” means all present and future scientific, technical, or commercial information, results and data of any type whatsoever developed or generated in relation to the Licensed Compound or Licensed Product, in any tangible or intangible form, whether patentable or not, including know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, discoveries, inventions, Improvements, drawings, assembly procedures, computer programs, specifications, data, results, and other biological, chemical, pharmacological, toxicological, pharmaceutical, pharmacokinetic, metabolic, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and information, study designs and protocols, reagents and other information relating thereto. |
| 1.57 | “Licensed Product” means each finished pharmaceutical product that includes or incorporates the Licensed Compound as an active ingredient. |
| 1.58 | “Licensee Indemnitees” has the meaning given to it in Section 13.2. |
| 1.60 | “Licensee Supply Price” has the meaning given to it in Section 14.9.3. |
| 1.61 | “Losses” has the meaning given to it in Section 13.1. |
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| Territory, including all additions, deletions or supplements thereto, and as any and all such requirements may be amended, or supplanted, at any time. |
| 1.63 | “MA Longstop Date” has the meaning set out in Section 14.5.1(a). |
| 1.65 | “Margin Saving” has the meaning given to it in Section 14.9.3. |
| 1.66 | “Marketing Authorization” means, with respect to a particular country or other regulatory jurisdiction, any MAA approval or other approval, product or establishment license, registration, or authorization of any Regulatory Authority necessary for the commercial sale of a Licensed Product in such country or other regulatory jurisdiction. For clarity, Marketing Authorization does not include any Pricing or Reimbursement Approval. |
| 1.68.1 | customary trade, quantity, and cash discounts or rebates actually allowed on the Licensed Product; |
| 1.68.2 | credits or allowances given to customers for rejections or returns of the Licensed Product or on account of retroactive price reductions affecting such Licensed Product; |
| 1.68.3 | amounts debited on account of bad debts with respect to Net Sales previously invoiced (provided that the net amount of any such bad debts subsequently collected shall be counted as sales); |
| 1.68.4 | sales taxes, excise taxes, use taxes, import/export duties or other governmental charges actually due or incurred with respect to the production, importation, use or sale of the Licensed Product to Third Parties; |
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| 1.68.5 | postage, shipping, and transportation charges to the extent that they are included in the price or otherwise paid by the purchaser, including insurance, for transporting the Licensed Product; and |
| 1.68.6 | Licensed Product rebates and Licensed Product chargebacks including those granted to managed-care entities and government agencies. |
Sales or transfers of the Licensed Product among Licensee and its Affiliates, and from Licensee and/or its Affiliates to Sublicensees and/or their Affiliates shall be excluded from the computation of Net Sales, and no royalties will be payable on such sales and such sales shall not count towards determining whether an Annual Net Sales Milestone Threshold has been reached.
| 1.69 | “New Drug Application” or “NDA” means a New Drug Application as defined in the FFDCA. |
| 1.70 | “Non-Breaching Party” has the meaning given to it in Section 14.2. |
| 1.71 | “ObsEva Indemnitees” has the meaning given to it in Section 13.1. |
| 1.74 | “ObsEva Promotional Materials” has the meaning given to it in Section 5.5.1. |
| 1.75 | “ObsEva Territory” means all countries other than those in the Territory. |
| 1.76 | “Oncology Indication” means an Indication in the range C00-C97. |
| 1.77 | “Package”, “Packaged”, or “Packaging” means placing Licensed Compound into primary and secondary packaging and preparing and utilizing labeling (including |
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| the Regulatory Authority-approved Licensed Product labeling) for such packaging, including written, printed or graphic matter upon a container, wrapper or any package insert or outsert utilized with or for Licensed Product, for purposes of producing Licensed Product in its finished form, ready for commercial sale to the market. |
| 1.78 | “PASS” means, in respect of a Marketing Authorization, a post-authorization safety study required by a Regulatory Authority as a condition of granting or maintaining such Marketing Authorization. |
| 1.79 | “Patent Challenge” has the meaning given to it in Section 14.3. |
| 1.80 | “Patents” means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed from such patents, patent applications or provisional applications, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (c) any and all patents that have issued or in the future issue from the foregoing patent applications ((a) and (b)), including utility models, petty patents and design patents and certificates of invention, and (d) any and all extensions or restorations of (a), (b) or (c) by existing or future extension or restoration mechanisms, including, without limitation, patent term extension, supplementary protection certificate or pediatric extension. |
| 1.81 | “Person” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. |
| 1.83 | “Prior CDA” has the meaning given to it in Section 11.5. |
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| 1.86 | “Receiving Party” has the meaning given to it in Section 11.1. |
| 1.87 | “Regulatory Approval” means, with respect to a country or other jurisdiction, any and all approvals (including MAAs), licenses, registrations, or authorizations of any Regulatory Authority necessary to market and sell a Licensed Compound or Licensed Product in such country or other jurisdiction, including, where applicable, (a) Pricing or Reimbursement Approval in such country or other jurisdiction, (b) pre- and post-approval marketing authorizations, and (c) approval of product labeling. |
| 1.88 | “Regulatory Authority” means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including but not limited to the Commercialization and the Exploitation of the Licensed Compound or Licensed Products. |
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| relied upon in any of the foregoing, in each case ((a), (b), and (c)) relating to a Licensed Compound or Licensed Product. |
| 1.90 | “Regulatory Exclusivity” means any exclusive marketing rights or data protection or other exclusivity rights conferred by any competent Regulatory Authority with respect to a drug or biological product that prevent: (i) such Regulatory Authority from granting any NDA in respect of a product containing the Licensed Compound; and/or (ii) a third party from making a cross reference to data held by such Regulatory Authority, or rights similar thereto in other countries or regulatory jurisdictions. If a Regulatory Authority confers more than one type of exclusivity with respect to a product in the Territory (e.g., the FDA grants both biologic drug reference product exclusivity and orphan drug exclusivity with respect to such biological product), “Regulatory Exclusivity” will be deemed to apply to such product so long as any exclusivity granted to such product prevents such Regulatory Authority from granting any Regulatory Approval of a product containing the Licensed Compound or making any cross reference to data held by such Regulatory Authority. |
| 1.91 | “Representatives” has the meaning given to it in Section 11.1. |
| 1.92 | “Royalty Surplus” has the meaning given to it in Section 7.4.1(a). |
| 1.94 | “Safety Data Exchange Agreement” has the meaning given to it in Section 10.1. |
| 1.95 | “Senior Officer” means, with respect to ObsEva, its Chief Executive Officer or his/her designee, and with respect to Licensee, its Chief Executive Officer or his/her designee. |
| 1.96 | “Specifications” means the Licensed Product specifications set out in the Marketing Authorization, as may be amended from time to time in accordance with this Agreement. |
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| 1.99 | “Substitution Agreement” has the meaning given to it in Section 14.9.1. |
| 1.100 | “Supply Agreement” has the meaning given to it in Section 6.1. |
| 1.101 | “Supply Price” has the meaning given to it in Section 6.3.1. |
| 1.102 | “Supply Terms” means the terms of the supply agreement to be entered into by the Parties on terms that are substantially similar to those set out in Schedule 1.102. |
| 1.103 | “Substantive Office Action” has the meaning given to it in Section 9.2.1. |
| 1.104 | “Term” has the meaning given to it in Section 14.1. |
| 1.105 | “Territory” means all countries other than the Excluded Territories, Puerto Rico, the United States of America, and Canada. |
| 1.107 | “Third Party Payments” shall mean the aggregate of all payments (including for royalties, lump sum payments, upfront payments, reasonable costs, reasonable damages, and any judgements and awards) which Licensee, its Affiliates or its Sublicensees pay to a Third Party for a license under Patents owned or controlled by such Third Party that would, but for such license, be infringed by the Commercialization of Licensed Product supplied by ObsEva to the Licensee |
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| pursuant to the Supply Agreement in the Field, in the Territory, in accordance with this Agreement. |
| 1.108 | “Third Party Provider” has the meaning given to it in Section 4.5. |
| 1.109 | “United States” or “U.S.” means the United States of America and its territories and possessions (including the District of Columbia and Puerto Rico). |
| 1.110 | “Upfront Payment” has the meaning given to it in Section 7.1. |
| 1.111 | “Valid Claim” means, on a country-by-country basis, any claim of a patent or patent application that has not, as applicable, (a) refused, lapsed, expired, been formally disclaimed by written submission to any United States or foreign patent office, withdrawn, cancelled or abandoned within the patent or patent application, or been pending in a patent application for more than [*] since the date of its first substantive office action; (b) been held, within the patent or patent application, to be permanently revoked, invalid or unenforceable in an unappealable or unappealed within the time allowed for appeal decision of a court or other governmental body of competent jurisdiction; or (c) been admitted by the owner or applicant to be invalid or unenforceable within the patent or patent application, respectively. For clarity, a claim of an issued patent that ceased to be a Valid Claim before it issued because it had been pending too long, but subsequently issues and is otherwise described above, shall again be considered to be a Valid Claim once it issues. The same principle shall apply in similar circumstances such as if, for example (but without limitation), a final rejection of a claim is overcome. |
| 1.112 | “Withholding Trigger Event” has the meaning given to it in Section 7.6. |
| 1.113.1 | Uterine Fibroids, Endometriosis, and Menopause, and |
| 1.113.2 | to the extent the treatment is authorized for use in women, fertility, contraception, osteoporosis and rheumatoid arthritis. |
For the avoidance of doubt Women's Health Conditions expressly excludes the treatment of any cancer.
| 2.1 | Grant to Licensee. Subject to the terms and conditions of this Agreement, ObsEva hereby grants to Licensee: |
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| (b) | to (i) develop (in accordance with the terms of this Agreement) and (ii) Commercialize the Licensed Product, in each case ((i) and (ii)) in the Field, in each country of the Territory either directly or via its Affiliates, Sublicensees or Distributors. |
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| (a) | ObsEva shall take reasonable steps to remedy any such breach; and |
3. | COLLABORATION MANAGEMENT |
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| (b) | Clinical Trials of the Licensed Product in the Field conducted by ObsEva outside of the Territory, provided that the JMC shall have no decision-making authority in relation to such matters. |
| 3.2.2 | The JMC shall have the power, by unanimous agreement of the representatives of the Parties, to appoint working groups to ensure the collaboration between the Parties in respect of the further development and Commercialization of the Licensed Product. |
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| (a) | ObsEva shall have final decision-making authority regarding: |
| (i) | whether to approve the Licensee’s conduct of any clinical studies of the Licensed Product; |
| (ii) | any matter which ObsEva reasonably believes will have a negative impact upon the safety, the efficacy profile or the label of a Licensed Compound or a Licensed Product in each case outside of the Field and/or outside of the Territory; and |
| (iii) | any matter which would reasonably be expected to primarily influence the Exploitation of a Licensed Product outside of the Territory (as opposed to the Exploitation of such Licensed Product in the Territory). |
| (b) | Licensee shall have final decision-making authority in all other cases. |
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| 3.6 | Procedural Rules. The JMC shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of the JMC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Representatives of the Parties on the JMC may attend a meeting either in person or by telephone, video conference or similar means in which each participant can hear what is said by, and be heard by, the other participants. Representation by proxy shall be allowed. The JMC shall be a forum for the discussion of the development and Commercialization of the Licensed Compound and Licensed Product. Both (i) employees or consultants of either Party that are not representatives of the Parties on the JMC, and (ii) representatives of Kissei as required in the Kissei Agreement may attend meetings of the JMC; provided, that such attendees are bound by obligations of confidentiality and non-disclosure equivalent to those set forth in Article 11. |
| 3.7 | Expenses. Each Party shall be responsible for all travel and related costs and expenses for its members and other representatives to attend meetings of the JMC. |
| 3.8 | Kissei Meeting Attendance. |
| 4.1 | Conduct of Development by ObsEva. ObsEva will use its Commercially Reasonable Efforts, at its own costs, to (a) undertake any clinical and non-clinical |
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| 4.3.1 | cooperate in good faith to ensure consistency between the protocols for such PASS to the extent practicable; |
| 4.3.2 | cooperate in the sharing of data arising from such PASS in accordance with Section 4.8; and |
| 4.3.3 | each be responsible for their respective costs and expenses of conducting such PASS in their Field and Territory. |
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| 4.4.1 | In any event: |
| (a) | the Parties shall submit all recommended proposals for any clinical studies of the Licensed Product to be undertaken in the Territory, in accordance with this Article 4, by a Third Party to the JMC for review and consideration; and |
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| 4.6.1 | MA in European Union. |
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| (ii) | Any further support shall be provided by ObsEva on terms to be negotiated between the Parties. |
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| and shall consider in good faith the comments of the other Party to such correspondence. |
| 4.8 | Cooperation; Information Sharing. The Parties shall at all times cooperate in good faith with respect to any and all regulatory activities. Each Party will provide |
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| 4.9 | Translations. Each Party shall provide any Information shared under this Agreement in English if such Information is reasonably available in English. If such Information is not reasonably available in English, such Party shall provide a summary of such document in the English language and the following provisions shall apply: |
| (b) | the other Party shall be solely responsible for translation, at its own cost and expense, of all documents that such Party requires to be translated other than those referenced in Section 4.9(a). |
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| to Commercialize Licensed Compounds and Licensed Products outside the Territory at its own cost and expense. |
| 5.2 | Commercialization Diligence. Licensee shall use Commercially Reasonable Efforts to Commercialize a Licensed Product in the Territory. In undertaking such Commercialization Licensee shall: |
| 5.2.1 | promptly following the Effective Date, establish and/or maintain a sales force appointed and trained in accordance with good industry practice to promote the Licensed Products throughout the Major Markets; |
| 5.2.2 | seek Pricing or Reimbursement Approvals for the Licensed Product in each Major Market in the Territory promptly [*] following the grant of Marketing Authorization in such country; |
| 5.2.3 | [*] |
| (b) | [*] |
| (c) | [*] |
[*]
| (d) | [*] |
| (e) | [*] |
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| (b) | an overview of the marketing activities and the medical activities undertaken in the previous quarter. |
| 5.2.8 | promptly inform ObsEva in writing of the occurrence of the First Commercial Sale of each Licensed Product in each country in the Territory; |
| 5.2.10 | establish and maintain a scientific service for scientific information relating to the Licensed Products in the Major Markets and shall liaise with ObsEva in relation to any material enquiries made to such service; |
| 5.2.12 | keep ObsEva informed in a timely manner of any information brought to Licensee’s attention which in Licensee’s reasonable judgment could lead to |
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| a variation of any Regulatory Approval or the Packaging of the Licensed Product (subject to any overriding provisions of the pharmacovigilance procedures to be set out in the pharmacovigilance agreement entered into pursuant to Section 10.1). For the avoidance of doubt it is declared and agreed that all decisions relating to the Specification and methods of manufacturing Licensed Product shall be subject to the provisions of the Supply Agreement; |
| 5.2.13 | comply at all times with all Applicable Laws pertaining to the Commercialization of the Licensed Products in the Territory; |
| 5.3.1 | Licensee shall not: |
| (a) | make any statements, representations, warranties or guarantees concerning any Licensed Product which are contrary to the appropriate MA for the Licensed Product or Applicable Laws; |
| (b) | use any misleading or deceptive marketing practices or any other promotional activities that would reasonably be expected to materially harm or otherwise damage ObsEva’s, Kissei’s or their Affiliates’ image or reputation or the reputation of the Product Marks or such other trade marks that Licensee uses pursuant to Section 8.1 or the OBSEVA trademark, whether within the Territory or outside the Territory; |
| (c) | advertise any Licensed Product outside the Territory, canvass or solicit orders for the Licensed Product outside the Territory, or |
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| (d) | open branches for the sale of any Licensed Product outside the Territory; or |
| (e) | maintain distribution depots for distribution of any Licensed Product outside the Territory. |
| 5.3.2 | ObsEva shall not: |
| (a) | make any statements, representations, warranties or guarantees concerning any Licensed Product which are contrary to the appropriate MA for the Licensed Product or Applicable Laws; |
| (b) | use any misleading or deceptive marketing practices or any other promotional activities that may materially harm or otherwise damage Licensee or its Affiliates’ image or reputation or the reputation of Licensee’s THERAMEX trademark, whether within the Territory or outside the Territory; |
| (c) | advertise any Licensed Product in the Field inside the Territory, canvass or solicit orders for the Licensed Product in the Field inside the Territory, or supply the Licensed Product to Third Parties located inside of the Territory or located outside the Territory who Licensee or its Affiliates reasonably believe will export the relevant Licensed Product into the Territory for use in the Field; or |
| (d) | open branches for the sale of any Licensed Product in the Field inside the Territory. |
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| establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products outside the Territory and to perform or cause to be performed all related services. |
| 5.5 | Promotional Materials. |
| (a) | at the first meeting of the JMC; and |
| (b) | on each occasion that Licensee wishes to materially change its branding and/or marketing strategies, at a meeting of the JMC that precedes the intended date of implementation of such change. |
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| 6.3.1 | Supply Price. The Supply Price for each Licensed Product shall be as set out in the Supply Agreement. |
| 6.3.2 | Exchange Rate. For the purpose of calculating the Supply Price under this Agreement or under any Supply Agreement where the input costs are in a currency other than Euro, ObsEva shall convert such amounts into Euro using its standard conversion methodology used in preparing its financial statements applied on a consistent basis and consistent with applicable Accounting Standards. |
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| any of Licensee’s Affiliates or Sublicensees [*] of each of the following milestones, calculated as follows: |
Development Milestone Event | Amount payable (EUR) |
[*] | [*] |
[*] | [*] |
[*] | [*] |
[*] | [*] |
Each milestone payment in this Section 7.2 shall be payable only upon the first achievement of such milestone for each Licensed Product, whether by or on behalf of Licensee or any of Licensee’s Affiliates or Sublicensees, or in respect of [*].
| 7.3 | Sales-Based Milestones. |
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| (i) | in the case of Licensed Product supplied to the Licensee or its Affiliates by ObsEva, the total Supply Price paid by |
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| Licensee in respect of the Licensed Products the sale of which constituted the relevant Net Sales; and |
| (ii) | in circumstances where Licensee has Licensed Product manufactured by a Third Party, [*]. |
(such amount the "Royalty Surplus"); and
| (b) | the total Supply Price paid by Licensee in respect of such Licensed Products sold in that country that the sale of which constituted the relevant Net Sales for the calculation set out in 7.4.1(a). |
| (a) | with respect to any Licensed Product in any calendar quarter, the operation the provisions of Sections 7.4.2 and 7.4.3 individually or in combination, shall not reduce the Royalty Surplus by more than |
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| [*] of the Royalty Surplus that would otherwise have been due under Section 7.4.1 with respect to Net Sales of such Licensed Product in the applicable country(ies) during such calendar quarter; and |
| (b) | in no event shall the Supply Price be reduced pursuant to Section 7.4.2 or 7.4.3. |
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| Supply Price shall be payable if and to the extent not already paid pursuant to the Supply Agreement). |
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| withholding tax been imposed or increased due to such Withholding Trigger Event. All payments due pursuant to this Agreement shall be paid exclusive of any value-added tax, sales tax or other consumption taxes required to be paid to tax authorities in connection with such payment. |
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| and registrations for the Product Marks and all costs and maintenance associated with the Product Marks for the duration of the Term. |
| (a) | [*] |
| (b) | [*] |
| (c) | [*] |
| (d) | [*] |
| 8.4.3 | For the avoidance of doubt, the Agreed Litigation Assistance shall not obligate ObsEva to construct or draft any document not already available to ObsEva. |
| 8.4.4 | Neither Party may settle an action it commences hereunder that admits any wrongdoing of, or requires any payment by the other Party without the other Party’s prior written consent, such consent not to be unreasonably withheld, delayed or conditioned. The enforcing Party shall keep the other Party |
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| regularly informed of the status and progress of such enforcement efforts and the Parties agree that, irrespective of which Party brings an action pursuant to this Section 8.4, the Parties shall discuss and reasonably consider the views of the other Party in the choice of counsel with respect to such action and strategic decisions and their implementation in connection with such action shall be managed by consensus of the Parties each acting reasonably. The Party not bringing an enforcement action under this Section 8.4 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. |
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| 9.2.2 | If Licensee starts to consider abandoning any part of Licensee’s Patents or electing not to file, prosecute or maintain an Licensee Patent outside the |
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|
| (a) | file or continue the prosecution or maintenance of such Kissei Patent in such country at its cost and in its name instead of assigning such Kissei Patent to ObsEva; |
such rights the "Maintenance Election Rights".
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| way that would subject ObsEva to an injunction or an admission of liability by ObsEva or that would result in ObsEva being required to pay damages without ObsEva’s prior written consent. The leading Party of any action contemplated in this Section 9.6 shall keep the other Party regularly informed of all material actions and correspondences in connection with any claim, suit or proceeding under this Section 9.6, including providing copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. |
| 9.8.3 | Enforcement of Kissei Patents. In the event of any infringement of the Kissei Patents by a Third Party in the Territory, ObsEva shall use |
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|
10. | PHARMACOVIGILANCE AND SAFETY |
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| performing work on the Licensed Compounds or Licensed Products to comply with such obligations. |
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| 11.2 | Exceptions. The obligations in Section 11.2 shall not apply with respect to any portion of the Confidential Information that the Receiving Party can show by contemporaneous proof: |
| 11.2.1 | was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party; |
| 11.2.2 | was generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; |
| 11.2.3 | 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; |
| 11.2.4 | is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use; or |
| 11.2.5 | has been independently developed by employees or contractors of the Receiving Party or any of its Affiliates without the aid, application or use of Confidential Information of the Disclosing Party. |
| 11.3 | Authorized Disclosure. The Receiving Party may disclose Confidential Information belonging to the Disclosing Party to the extent (and only to the extent) such disclosure is reasonably necessary in the following instances: |
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|
| 11.3.2 | complying with Applicable Law and with judicial process, if in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance, provided that, if legally permissible, the Receiving Party shall promptly notify the other Party of such required disclosure so that the Disclosing Party can seek a protective order or other appropriate remedies and, at the Disclosing Party’s request and expense, reasonably assist the Disclosing Party in seeking such protective order or other reasonable remedies; and |
| 11.4 | Terms of this Agreement. The Parties acknowledge that the terms of this Agreement shall be treated as Confidential Information of both Parties and kept confidential by each of the Parties in accordance with this Article 11. |
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| provide such other Party with a copy of relevant portions of the proposed filing not less than [*] prior to such filing (and any revisions to such portions of the proposed filing a reasonable time prior to the filing thereof), including any exhibits thereto relating to this Agreement, and shall use reasonable efforts to obtain confidential treatment of any information concerning this Agreement that such other Party requests be kept confidential, and shall only disclose Confidential Information of the Disclosing Party which it is advised by counsel is legally required or advisable to be disclosed. No such notice shall be required under this Section 11.6 if the substance of the description of or reference to this Agreement contained in the proposed filing has been included in any previous filing made by the other Party hereunder or otherwise approved by the other Party. |
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| Party’s Confidential Information without prior written consent by the other Party such consent not to be unreasonably withheld, delayed or conditioned. |
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| business, provided that in each case such retained Confidential Information shall continue to be held subject to the terms of this Agreement. |
12. | REPRESENTATIONS AND WARRANTIES |
| 12.1 | Mutual Representations and Warranties. ObsEva and Licensee each represents and warrants to the other, as of the Effective Date, as follows: |
| 12.1.2 | Authorization. The execution and delivery of this Agreement and the performance by it of the transactions contemplated hereby have been duly authorized by all necessary corporate action, and do not violate (a) in any material respect, any agreement to which such Party is bound, (b) any requirement of any Applicable Law, or (c) any order, writ, judgment, injunction, decree, determination, or award of any court or governmental agency presently in effect applicable to such Party. |
| 12.1.3 | Binding Agreement. This Agreement is a legal, valid, and binding obligation of such Party enforceable against it in accordance with its terms and conditions, subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor rights, judicial principles affecting the availability of specific performance, and general principles of equity (whether enforceability is considered a proceeding at law or equity). |
| 12.1.4 | No Conflicts. It is not under any obligation, contractual or otherwise, to any Person that conflicts in any material respect with the terms of this Agreement. |
| 12.1.5 | No Debarment. Neither Party nor any of its Affiliates (a) has ever been debarred or subject to debarment or has received notice from the FDA of an intent to debar or has been convicted of a crime for which an entity or person could be debarred under 21 U.S.C. §335a; or (b) has ever been under indictment for a crime for which a person or entity could be debarred under 21 U.S.C. §335a. If during the Term a Party has reason to believe that it or |
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| any of its employees, officers, independent contractors, consultants or agents rendering services relating to the Licensed Products: (x) is or will be debarred or convicted of a crime for which a person or entity could be debarred under 21 U.S.C. §335a; or (y) is or will be under indictment for a crime for which a person or entity could be debarred under 21 U.S.C. §335a, then such Party shall immediately notify the other Party of same in writing. |
| 12.2 | Additional Representations and Warranties of ObsEva. ObsEva further represents and warrants to Licensee, as of the Effective Date, as follows: |
| 12.2.1 | ObsEva has the right to grant the rights to Licensee contained in this Agreement, including but not limited to Article 2 of this Agreement and has not previously assigned, transferred, conveyed, or granted any license or other rights under the ObsEva Patents, ObsEva Know-How, Kissei Patents or Kissei Know-How that would conflict with or limit the scope of any of the rights or licenses granted to Licensee hereunder; |
| 12.2.2 | to the best of its knowledge, the Regulatory Documentation and the Dossier provided by ObsEva to the Licensee are at the Effective Date, and were at the time of filing, true, complete and accurate in all material respects; |
| 12.2.3 | ObsEva has not breached the Kissei Agreement and it has not received any written notice from Kissei that it is in breach of the Kissei Agreement; |
| 12.2.4 | it has not served notice on Kissei alleging that it is in material breach of the Kissei Agreement; |
| 12.2.5 | to the best of its knowledge there is no repudiatory or material breach of the Kissei Agreement by Kissei; |
| 12.2.7 | ObsEva has not received any written notice that the manufacture, Exploitation, or Commercialization of Licensed Products infringes upon any intellectual property right of any Third Party in any country; |
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| 12.2.8 | ObsEva and its Affiliates have complied with all Applicable Laws, Good Clinical Practice and Good Laboratory Practice in connection with the development of the Licensed Compound and the Licensed Product that has been carried out by or on behalf of ObsEva; |
| 12.2.9 | neither ObsEva nor any of its Affiliates has received written notice of any claim, demand, proceedings, investigation, or other legal action of any nature pending or threatened by any Regulatory Authority or other Third Party with respect to the Licensed Compound, Licensed Product, or any facility where the Licensed Products are manufactured, or the transactions contemplated by this Agreement, and there is no judgment or settlement against or owed by ObsEva or its Affiliate related to any of the foregoing; |
| 12.2.10 | neither ObsEva nor any of its Affiliates has received any warning letters or written correspondence from any Regulatory Authority requiring the termination, suspension or material modification of any clinical or pre-clinical studies or tests with respect to the Licensed Compound or the Licensed Product; |
| 12.2.11 | to the best of its knowledge no Third Party has infringed the ObsEva Patents, ObsEva Know-How, Kissei Patents or Kissei Know-How; |
| 12.2.12 | there is no pending, and neither ObsEva nor its Affiliates have received any written notice of any pending, alleged or threatened, re-examination, opposition, interference, or litigation, or any written communication alleging that any ObsEva Patent or Kissei Patent is invalid or unenforceable anywhere in the world; |
| 12.2.13 | ObsEva has obtained assignment of all right, title and interest in the ObsEva Patents in the Territory, and all inventors who should have been listed as inventors have been listed, except as would not have a material adverse effect on commercialization of Licensed Products; and |
| 12.2.14 | ObsEva has taken commercially reasonable measures to protect the secrecy, confidentiality and value of the unpublished ObsEva Know-How. |
| 12.3 | Additional Covenants of ObsEva. |
| 12.3.1 | ObsEva shall not make any false or misleading representations to Third Parties regarding Licensee or the Licensed Products; and |
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| 12.3.2 | all preclinical and clinical trials of the Licensed Product that have been or will be conducted by or on behalf of ObsEva have been or will be conducted in compliance in all material respects with Applicable Law (including Good Clinical Practices and Good Laboratory Practices, as applicable). |
| 12.4 | Additional Covenants of Licensee. Licensee further covenants to ObsEva, as of the Effective Date, as follows: |
| 12.4.2 | Licensee shall not market the Licensed Products for any use not approved by the applicable Regulatory Authority or otherwise not permitted under Applicable Law; |
| 12.4.3 | Licensee shall not make any false or misleading representations to customers or others regarding ObsEva or the Licensed Products; and |
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| 12.6 | Modern Slavery. In performing its obligations under this Agreement and the Supply Agreement, both the Parties shall: |
| 12.6.1 | comply with all Applicable Law and applicable codes from time to time in force including but not limited to the Modern Slavery Act 2015; and |
| 12.6.2 | not engage in any activity, practice or conduct that would constitute an offence under sections 1, 2 or 4, of the Modern Slavery Act 2015 if such activity, practice or conduct were carried out in the UK. |
| 12.8 | Disclaimer of Warranties. Except for the express warranties set out in this Agreement, neither Party makes any representations or grants any warranties, express or implied, either in fact or by operation of law, by statute or otherwise, and each Party specifically disclaims any other warranties, whether written or oral, or express or implied, including any warranty of quality, merchantability, or fitness for a particular use or purpose or any warranty as to the validity of any Patents or the non-infringement of any intellectual property rights of Third Parties. |
13. | Indemnification and insurance |
| 13.1 | Indemnification by Licensee. Licensee shall defend, hold harmless and indemnify ObsEva and its Affiliates and their respective directors, officers, employees and |
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| 13.3 | Indemnification Procedure. The indemnified Party shall provide the indemnifying Party with prompt notice of the claim giving rise to the |
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| Party with written evidence of such insurance upon request. Each Party shall provide the other Party with written notice at least [*] prior to the cancellation, non-renewal or material change in such insurance which materially adversely affects the rights of the other Party hereunder. |
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| 14.3.1 | where such challenge was initiated by a Third Party which subsequently becomes an Affiliate of Licensee as a result of Licensee acquiring such Third Party, Licensee causes such Third Party to file a motion to dismiss with prejudice such challenge within [*] after such Third Party becomes an Affiliate of Licensee; or |
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For clarity, this Section 14.3 shall not apply to arguments made by Licensee or its Affiliates that (x) distinguish the inventions claimed in Patents from those claimed in the patent applications owned or controlled by Licensee or any of its Affiliates in the ordinary course of ex parte prosecution of such patent applications or (y) inventorship disputes where Licensee seeks to correct inventorship, and does not explicitly seek to invalidate the Patent.
| (a) | in the event that ObsEva does not receive a Marketing Authorization in the European Union in the uterine fibroids Indication substantially in accordance with the label agreed by the Committee |
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| for Medicinal Products for Human Use's opinion as given on 16 December 2021 by [*] (the "MA Longstop Date"); |
| (b) | in the event that ObsEva receives a Marketing Authorization in the European Union in the uterine fibroids Indication where such Marketing Authorization: |
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| refund of the Upfront Payment due pursuant to Section 14.5.3 shall be the exclusive remedy of Licensee and in lieu of any and all other remedies of Licensee under this Agreement, the Supply Agreement. |
| 14.5.4 | For the avoidance of doubt, prior to any such termination under this Section 14.5, Licensee’s obligations under Article 5 shall not be suspended and Licensee shall submit purchase orders in accordance with the Supply Agreement in anticipation of and in sufficient quantities for launch of the Licensed Product in Germany. |
| 14.7 | Effects of Expiry. In the event that this Agreement expires in relation to a particular country: |
| 14.7.1 | Licensee shall continue to hold the relevant Regulatory Approvals; |
| 14.7.2 | to the extent that the ObsEva Know-How is owned by ObsEva, the licenses set out in Section 2.1.2 and Section 2.1.3 shall continue on a royalty free, non-exclusive, irrevocable, perpetual basis; and |
| 14.7.3 | ObsEva shall not enforce any of the terms of the Kissei Agreement and/or the Kissei Supply Agreement to the extent that to do so would prevent Licensee from acquiring Licensed Compound from Kissei. |
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| 14.8.1 | all rights and licenses granted by ObsEva hereunder shall immediately terminate with respect to the Territory as a whole or the applicable country of the Territory; |
| 14.8.2 | all licenses granted by Licensee to ObsEva outside the Territory (including under Sections 4.4.3, 4.7, and 4.10.2) shall survive and shall be extended to include the Territory; |
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| 14.9 | Intentional Failure to Supply. In the event of an Intentional Failure to Supply the Licensee shall have the following rights: |
| 14.9.2 | Subject to the Licensee, Kissei and ObsEva entering into a Substitution Agreement: |
| (b) | Licensee shall be responsible for adding any Third Party supplier to the Marketing Authorizations in the Territory and shall be responsible for the costs incurred by Licensee to qualify any such Third Party supplier. |
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| (a) | all obligations of ObsEva under this Agreement and the Supply Agreement for the supply of Licensed Product shall cease. |
| (b) | Licensee’s obligation to pay royalties to ObsEva pursuant to Section 7.4 shall be reduced to a royalty of the greater of: |
| (i) | [*] |
| (ii) | [*]. |
[*]
| 14.9.4 | Upon the earlier of (i) the entry into force of a Substitution Agreement and a supply agreement with a third party supplier in accordance with this Section 14.9, and (ii) the expiry of a [*] period commencing on the date that Licensee notifies ObsEva of its intention to exercise its rights under this Section 14.9, the Supply Agreement shall terminate in its entirety and all obligations of ObsEva under this Agreement and the Supply Agreement with respect to the manufacture and supply of Licensed Product shall terminate, including the obligations of ObsEva under Article 6 of this Agreement and ObsEva shall have no liability or obligation under this Agreement or otherwise for Licensed Compound or Licensed Product supplied to Licensee or its Sublicensees by any Third Party. |
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| 14.9.5 | If Licensee exercises its rights under this Section 14.9 such exercise shall be the exclusive remedy of Licensee and in lieu of any and all other remedies of Licensee under this Agreement, the Supply Agreement and/or otherwise for any Intentional Failure to Supply by ObsEva. |
| 14.9.6 | Subject to this Section 14.9, the terms of this Agreement shall remain in full force and effect after the exercise by Licensee of its rights under this Section 14.9. |
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| 15.2 | Export Control. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party under this Agreement or any products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate agency or other governmental entity in accordance with Applicable Law. |
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| binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of ObsEva or Licensee, as the case may be. The permitted assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement. |
| 15.4 | Severability. If any provision of this Agreement is held to be illegal, invalid, or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid, or unenforceable provision had never comprised a part hereof, and (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid, or unenforceable provision or by its severance herefrom. |
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| purposes of having the matter settled. Such matter shall be finally resolved by binding arbitration administered by the International Chamber of Commerce (“ICC”) pursuant its arbitration rules, and judgment on the arbitration award may be entered in any court having jurisdiction thereof. The Parties agree that: |
| (a) | The arbitration shall be conducted by three arbitrators appointed by the ICC, who shall be experienced in the pharmaceutical business in the Territory. The place of arbitration shall be London, England, and all proceedings and communications shall be in English, unless otherwise agreed by all Parties involved in such dispute. |
| (b) | Any Party may apply to the arbitrators for interim injunctive relief until the arbitration award is rendered or the controversy is otherwise resolved. Any Party also may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any injunctive or provisional relief necessary to protect the rights or property of that Party pending the arbitration award. |
| (c) | The arbitrators shall have no authority to award punitive or any other type of damages not measured by a Party’s compensatory damage. The prevailing Party shall be entitled to recover from the other Party its own costs and expenses and attorneys’ fees reasonably incurred by such prevailing Party. |
| (d) | Except to the extent necessary to confirm an award or as may be required by law, neither a Party nor the arbitrators may disclose the existence, content, or results of an arbitration without the prior written consent of all Parties. In no event shall an arbitration be initiated after the date when commencement of a legal or equitable proceeding, based on the dispute, controversy or claim, would have been barred by the applicable statute of limitations. |
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| agreed by the Parties in writing, such Dispute shall not be submitted to arbitration in accordance with Section 15.6.2 and instead, either Party may initiate litigation in a court of competent jurisdiction, notwithstanding Section 15.5, in any country or other jurisdiction in which such rights apply. |
| 15.6.4 | Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 15.6 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dispute, if necessary to protect the interests of such Party. This Section shall be specifically enforceable. |
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|
If to Licensee, to:
General Counsel
Theramex HQ UK Limited
Sloane Square House
London
SW1W 8NS
[*]
with a copy (which shall not constitute notice) to:
Latham & Watkins
99 Bishopsgate
London EC2M 3XF
[*]
If to ObsEva, to:
Chemin des Aulx 12,
1228 Plan-Les-Ouates,
Switzerland
Attention: Chief Executive Officer
with a copy (which shall not constitute notice) to:
ObsEva SA
Chemin des Aulx 12,
1228 Plan-Les-Ouates,
Switzerland
Attention: Chief Administrative Officer
| 15.9 | Equitable Relief. Each Party acknowledges and agrees that the rights and restrictions set forth in Article 9 and Article 11 are reasonable and necessary to |
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| protect the legitimate interests of the other Party, and that any breach or threatened breach of any provision included in such Article may result in irreparable injury to such other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision in such Articles, the non-breaching Party shall be authorized and entitled to equitable relief, including an injunction, specific performance and any other relief that may be available from a court of competent jurisdiction. |
| 15.11 | Third Parties. Except as provided in Article 13, covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. The rights of the Parties to terminate, rescind or agree any variation, waiver or settlement under this Agreement are not subject to the consent of any other person. |
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| 15.15 | Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by electronically transmitted signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures. |
| 15.17 | Schedule. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control. |
| 15.18 | Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word “or” is used in the inclusive sense (and/or). The headings and captions of this Agreement are for convenience of reference only. |
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| The term “including,” “include,” or “includes” as used herein shall mean “including, but not limited to,” and shall not limit the generality of any description preceding such term. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will apply against the Party which drafted such terms and provisions. |
[SIGNATURE PAGE FOLLOWS]
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THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date.
OBSEVA SA | THERAMEX HQ UK Limited |
By:/s/ Brian O’Callaghan Name:Brian O’Callaghan Title:Chief Executive Officer | By:/s/ Matthew Frankel Name:Matthew Frankel Title:Director |
Schedule 1.10
Brand Plan
[*]
Schedule 1.53
Kissei Patents
[*]
Schedule 1.56
[*]
Schedule 1.73
ObsEva Patents
[*]
Schedule 1.84
Product Marks
[*]
Schedule 1.102
Supply Terms
[*]
Schedule 12.7
Data Protection
[*]