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10-K
Dianthus Therapeutics, Inc. /DE/ · Mar 9, 7:21 AM ET
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Dianthus Therapeutics, Inc. /DE/ 10-K
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Contents
366
Article 1DEFINITIONS
1.1 “Accounting Standards” means with respect to a Selling Party (as defined below), (a) International Financial Reporting Standards of the International Accounting Standards Board, (b) the U.S. Generally Accepted Accounting Principles, or (c) applicable accounting standards followed by such Selling Party, in each case, consistently applied.
1.2 “Additional Active(s)” means any active pharmaceutical or biologic ingredient(s) in a Licensed Product that is not a Compound.
1.3 “Additional Cure Period” will have the meaning provided in Section 13.2(b).
1.4 “Affiliate” means any company or entity controlled by, controlling, or under common control with a Party or another entity for so long as such control exists. For the purpose of this definition, an entity will be deemed to “control” another entity, if it owns directly or indirectly, more than fifty percent (50%) of the outstanding voting securities, capital stock, or other comparable equity or ownership interest of such entity, or possession, direct or indirect, of the power to direct or cause the direction of the management or policies of an entity (whether through ownership of securities or other ownership interests, by contract or otherwise).
1.5 “Alliance Manager” will have the meaning provided in Section 3.8.
1.6 “Applicable Laws” means collectively the applicable provisions of any and all national, supranational, regional, state, provincial and local laws, treaties, statutes, rules, regulations, administrative codes, guidance, ordinances, judgments, decrees, directives, injunctions, orders, and any license, franchise, permit or similar right granted under any of the foregoing (including Regulatory Approvals) and any policies and other requirements of or from any court, arbitrator, Regulatory Authority or governmental agency or authority having jurisdiction over or related to the subject item or subject person, including, as applicable, Data Protection Laws.
1.7 “[***]” will have the meaning provided in Section 2.10.
1.8 “[***] Agreement” will have the meaning provided in Section 2.10.
1.9 “Back-Up Compounds” will mean, other than the Lead Compound, any [***].
1.10 “Basket Trial Indication” will have the meaning provided in Section 8.3.
1.11 “Biosimilar Product” means, with respect to a Licensed Product in a country, any generic, biosimilar or interchangeable product sold by a Third Party for the same indication for which such Licensed Product has Regulatory Approval in such country and that (a) received marketing approval for administration to humans based on an application that cited the Licensed Product as the reference product under Section 351(k) of the United States Public Health Service Act, as may be amended, or any subsequent or superseding law, statute or regulation (“PHSA”) and is “biosimilar” (as defined in Section 351(i)(2) of the PHSA) or “interchangeable” (as defined in Section 351(i)(3) of the PHSA) with the Licensed Product; (b) has been licensed as a similar biological medicinal product using such Licensed Product as the reference product pursuant to Article 10 of Directive 2001/83/EC, as may be amended, or any subsequent or superseding law, statute or regulation (“Directive 2001/83/EC”); or (c) has otherwise received Regulatory Approval as a generic, biosimilar or interchangeable product from another applicable Regulatory Authority in such country by referencing Regulatory Approvals (or data therein) of such Licensed Product. Any product (including any Licensed Product) licensed, marketed, or sold by or on behalf of a Party, its Affiliates or Sublicensees will not constitute a Biosimilar Product for purposes of the royalty reduction pursuant to Section 8.7(a).
1.12 “Breaching Party” will have the meaning provided in Section 13.2(b).
1.13 “Business Day” means any day that is not a Saturday, a Sunday or other day on which banks are required or authorized by law to close in New York City, New York, Nanjing, China or Hong Kong Special Administrative Region.
1.14 “Calendar Quarter” means each period of three (3) consecutive months commencing on January 1, April 1, July 1 or October 1 (or any portion thereof at the beginning or end of the Term or other relevant period); provided that the first Calendar Quarter of the Term will commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, July 1, or October 1 after the Effective Date and the last Calendar Quarter will end on the last day of the Term.
1.15 “Calendar Year” means each period of twelve (12) consecutive months commencing on January 1 and ending on December 31 (or any portion thereof at the beginning or end of the Term or other relevant period); provided that the first Calendar Year of the Term will commence on the Effective Date and end on December 31 of the year in which the Effective Date occurs and the last Calendar Year of the Term will commence on January 1 of the year in which the Term ends and end on the last day of the Term.
1.16 “CBDT Approval” means any approval, certificate or other clearance from the Cyberspace Administration of China, or any successor agency thereto, including formal acceptance and the assignment of filing numbers for any filing, that is necessary under applicable Data Protection Laws for a Party or any of its Affiliates or any Third Party acting on behalf of such Party or any of its Affiliates to disclose to, transfer to or share with the applicable entity (including, as applicable, Licensee or any of its Affiliates and Sublicensees or its or their designees) outside of mainland People’s Republic of China (for clarity, excluding for this purpose Hong Kong Special Administrative Region, Macau Special Administrative Region and Taiwan) any Personal Data subject to Data Protection Laws; provided, however, that if any such approval, certificate or other clearance is accompanied by any express or implied obligation to provide any further notices to or obtain any further consents from any data subjects (for clarity, including any such approval, certificate or other clearance based on any application including a template for obtaining any further consents from any subjects screened for or enrolled in any ongoing Clinical Trials), then such approval, certificate or other clearance will not constitute CBDT Approval unless and until all such further notices have been provided or all such further consents have been obtained as evidenced by signed further consents from data subjects.
1.17 “CBDT Filing” means any filing or submission for purposes of obtaining any CBDT Approval pursuant to Data Protection Laws.
1.18 “Central Development Costs”, means, collectively, with respect to any Shared Study, any and all out-of-pocket costs and expenses incurred in connection with such Shared Study by or on behalf of Licensee, its Affiliates or Sublicensees that benefit the Development of the Licensed Product subject to such Shared Study both inside and outside the Leads Bio Territory, including any and all out-of-pocket costs and expenses (a) for the clinical supply of the applicable Licensed Product and placebo for such Shared Study or (b) related to data management, statistics, electronic clinical outcome assessment (if applicable), central lab, investigational medical product depot, interactive response technology, and safety reporting and excluding, for clarity, costs and expenses solely for the benefit of the Leads Bio Territory or solely for the benefit of the Licensee Territory or Commercialization expenses, unless otherwise agreed by the Parties in writing.
1.19 “Cessation” will have the meaning provided in Section 13.2(e).
1.20 “Change of Control” means, with respect to either Party: (a) a transaction or series of transactions that results in more than 50% of the voting securities of such Party outstanding immediately prior thereto not being held by the holders of the outstanding voting securities of such Party immediately after such transaction(s); (b) a transaction or series of related transactions in which a Person or group of Persons, together with its Affiliates, becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the combined voting power of the
outstanding securities of such Party; or (c) a transfer to a Third Party of all or substantially all of its assets relating to this Agreement.
1.21 “Clinical Trial” means a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, Registrational Clinical Trial, or other human clinical trial, including any human clinical trial conducted before or after the Regulatory Approval of a product in a country, which trial may be conducted to enhance scientific knowledge of such product (e.g., for expansion of product labeling) or due to a request or requirement of a Regulatory Authority in such country.
1.22 “CMC” means chemistry, manufacturing and controls with respect to the Compound or Licensed Products.
1.23 “CMO” will have the meaning provided in Section 6.2.
1.24 “Combination Product” means a Licensed Product comprising a Compound and one or more Additional Active(s), where such Compound and the Additional Active(s) are (i) sold as a fixed dose/unit or otherwise co-formulated, or (ii) sold as separate doses/units in a single package or otherwise co-packaged for a single invoiced price.
1.25 “Commercialization” means, with respect to a product, all activities undertaken before and after obtaining Regulatory Approvals relating specifically to the pre-launch, launch, promotion, detailing, marketing, pricing, reimbursement, sale, and distribution of such product, including strategic marketing, sales force detailing, advertising, market access, medical education, and product support, all customer support, product distribution, and invoicing and sales activities, but excluding Development and Manufacturing. “Commercialize” and “Commercializing” will have the correlative meanings.
1.26 “Commercialization Plan” will have the meaning provided in Section 7.2.
1.27 “Commercialization Report” will have the meaning provided in Section 7.2.
1.28 “Commercially Reasonable Efforts” means, (a) where applied to carrying out specific tasks and obligations of a Party on its own, diligent and good faith efforts to accomplish such task or obligation as a similarly situated pharmaceutical company of comparable size and resources (as applicable) would use to accomplish a similar task or obligation under similar circumstances in accordance with Applicable Laws; and (b) where applied to the Development or Commercialization of the Licensed Products under this Agreement, efforts and resources that are consistent with the efforts and resources that a biotechnology company similarly situated to Licensee normally commits to its activities or products that it is Developing or Commercializing and that are of a similar potential value, stage of Development, life cycle and commercial potential, taking into account all relevant factors, including payments required to be made by Licensee to Leads Bio under this Agreement, the competitive environment, profitability, safety and efficacy, patent coverage, exclusivity, sales reimbursement, pricing, tariffs and the anticipated regulatory pathway. To the extent that the performance of Licensee’s obligations hereunder is adversely affected by Leads Bio’s failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether Licensee has used its Commercially Reasonable Efforts to perform any such affected obligations. Notwithstanding the
foregoing, it is anticipated that the level of effort with respect to each Licensed Product will change over time, including to reflect changes in the status of a particular Licensed Product in particular countries or markets in the Licensee Territory.
1.29 “Common Stock” will have the meaning provided in Section 8.2(a).
1.30 “Competing Product” means a product that contains any [***]that [***] as an intended primary mechanism of action.
1.31 “Compound” means (a) the compound known as LBL-047 as further defined on Schedule 1.31, a dual acting humanized fusion protein targeting BDCA2 fused with TACI-CRD2 (the “Lead Compound”), (b) all [***], and (c) all [***].
1.32 “Confidential Information” means, subject to Section 10.2, all Know-How and other proprietary scientific, technical, clinical, marketing, financial or commercial information or Data Controlled by a Party or its Affiliates, which one Party or any of its Affiliates has furnished or made available to the other Party or its Affiliates under or in connection with this Agreement or the Confidentiality Agreement, whether in oral, written or electronic form. The existence and terms of this Agreement will be deemed Confidential Information of each Party.
1.33 “Confidentiality Agreement” means the mutual confidentiality agreement executed between Leads Bio and Licensee dated as of [***].
1.34 “Control” (including any variations such as “Controlled” and “Controlling”) means, with respect to any Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials, possession by a Party or Third Party of the right, power and authority (whether by ownership, license or otherwise, other than by virtue of any rights granted under this Agreement) to grant access to, to grant use or reference of, or to grant a license or a sublicense to such Know-How, Patent Rights, intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials, without violating the terms of any agreement or other arrangement with any Third Party. Notwithstanding anything in this Agreement to the contrary, a Party and its Affiliates will not be deemed to Control any Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials (a) that are in-licensed or acquired by such Party or its Affiliates from a Third Party under an agreement, in the case of Licensee and its Affiliates, that is not a Licensee Third Party IP Agreement and, in the case of Leads Bio and its Affiliates, in an arrangement executed after the Effective Date that is not a Leads Bio Third Party IP Agreement, (b) that, prior to the consummation of a Change of Control of such Party, is owned, in-licensed or otherwise controlled by a Third Party that becomes an Affiliate of such Party after the Effective Date as a result of such Change of Control unless (i) prior to the consummation of such Change of Control, such Party or any of its Affiliates also Controlled such Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials, or (ii) the Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials owned, in-licensed or otherwise controlled by the applicable Third Party were not used by such Party in the performance of activities under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, such Party or any of its Affiliates determines to use or uses any such
Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases ((i) and (ii)), such Know-How, Patent Rights, other intellectual property rights, Regulatory Approvals, Regulatory Materials, or proprietary materials will be “Controlled” by such Party for purposes of this Agreement, or (c) that, following a consummation of a Change of Control of a Party, (i) is discovered, developed, invented, created, acquired, or in-licensed by such acquiring Person or its Affiliates (other than such Party or its pre-existing Affiliates) after the closing of such Change of Control without using or incorporating such Party’s or its pre-existing Affiliates’ Know-How, Patent Rights or any Confidential Information of either Party in existence as of the closing of such Change of Control, and (ii) is not used or practiced by or on behalf of such Party (or its successor) in the performance of its obligations or exercise of its rights under this Agreement.
1.35 “Cover” means, with respect to any Patent Right and a Licensed Product in a country, that the manufacture, use, sale, offer for sale, or importation of such Licensed Product by Licensee or a Third Party in such country, absent a license to such Patent Right, would infringe a Valid Claim of such Patent Right or in case of a Valid Claim in a patent application that has not yet issued, would infringe such Valid Claim if it were to issue without modification. “Covered” and “Covering” will have the correlative meanings.
1.36 “Data” means all data, including CMC data, non-clinical data, preclinical data and clinical data, generated by or on behalf of a Party or its Affiliates or their respective Sublicensees (in case of Licensee) and (sub)licensees (in the case of Leads Bio) pursuant to activities conducted under this Agreement; provided that Data does not include any data related to an Additional Active in a Combination Product or any Data arising from a Shared Study with respect to which Leads Bio has not provided a Participation Notice.
1.37 “Data Protection Laws” means all Applicable Laws relating to the processing, privacy and security of data in jurisdictions where any Data is generated or used, including, as applicable, the Data Security Program and PRC Data Protection Laws.
1.38 “Data Use Option” will have the meaning provided in Section 5.6(c).
1.39 “Derivative” means, with respect to the Lead Compound or a Back-Up Compound, a derivative, modification, or improvement to the Lead Compound or such Back-Up Compound, as applicable.
1.40 “Development” means, with respect to a product, all non-clinical and clinical drug development activities and processes, including toxicology, pharmacology, project management and other non-clinical efforts, statistical analysis, delivery system development, the performance of Clinical Trials (excluding the Manufacturing of such product for use in Clinical Trials) and other activities, in each case, which are reasonably necessary to prepare submissions for, and obtain or maintain, Regulatory Approval of such product, including lifecycle management studies and other activities. “Develop” and “Developing” will have the correlative meanings.
1.41 “Development Milestone Event” will have the meaning provided in Section 8.3.
1.42 “Development Plan” will have the meaning provided in Section 4.2(b).
1.43 “Disclosing Party” will have the meaning provided in Section 10.1.
1.44 “Divestiture” means (a) the divestiture of a Competing Product through (i) an outright sale or assignment of all material rights in such Competing Product to a Third Party or (ii) an exclusive out-license of all Development, Manufacture, and Commercialization rights with respect to such Competing Product, in each case in the Field, with no further material role, influence or authority of the applicable Party, directly or indirectly, with respect to such Competing Product or (b) the complete cessation of all Development, Manufacture, and Commercialization activities with respect to such Competing Product. For clarity, the right of the applicable Party to receive royalties, milestones, or other payments in connection with an acquiror, assignee or licensee’s Development or Commercialization of a Competing Product pursuant to clause (a) above or the right to enforce customary terms contained in the relevant agreements effectuating such transaction, will be permitted for any such Divestiture. When used as a verb, “Divest” and “Divested” means to cause a Divestiture.
1.45 “Dispute” will have the meaning provided in Section 15.1.
1.46 “Data Security Program” means U.S. DOJ Final Rule Implementing Executive Order 14117 of February 28, 2024 (Preventing Access to Americans’ Bulk Sensitive Personal data and United States Government-Related Data by Countries of Concern), 90 Fed. Reg. 1636, codified at 28 C.F.R. Part 202, as interpreted in rules, guidance, policies, statements, or otherwise from time to time.
1.47 “Effective Date” will have the meaning provided in the introductory paragraph of this Agreement.
1.48 “EMA” means the European Medicines Agency and any successor entity thereto.
1.49 “Equity Notice” will have the meaning provided in Section 8.2(a).
1.50 “European Major Markets” means Germany, France, Spain, Italy, and the United Kingdom.
1.51 “Executive Officers” means the Chief Executive Officer or her/his designee of Leads Bio and Chief Executive Officer or her/his designee of Licensee.
1.52 “Existing Leads Bio Third Party Agreement” means any agreement with a Third Party existing as of the Effective Date under which Leads Bio Controls any Licensed Intellectual Property, except for the [***] Agreement. Each Existing Leads Bio Third Party Agreement is listed on Schedule 1.52.
1.53 “Existing Licensee Third Party IP Agreement” means any Proposed Existing Licensee Third Party IP Agreement with respect to which Leads Bio has accepted a (sub)license under Section 2.10(b).
1.54 “Exploit” means, with respect to a product, to Research, Develop, Manufacture, use, sell, offer for sale, import, export, Commercialize, and otherwise fully exploit such product. “Exploitation” and “Exploiting” will have the correlative meanings.
1.55 “FDA” means the U.S. Food and Drug Administration and any successor entity thereto.
1.56 “Field” means all therapeutic, prophylactic and diagnostic applications, uses, and indications in humans.
1.57 “First Commercial Sale” means, with respect to a Licensed Product, the first sale by or on behalf of Licensee, its Affiliate or Sublicensee of the Licensed Product in a country in the Licensee Territory for use or consumption by an end user of such Licensed Product in such country after Regulatory Approvals for such Licensed Product have been obtained in such country. Sales of a Licensed Product in a country at or below cost, such as so-called “named patient sales” and “compassionate use sales,” will not be construed as a First Commercial Sale.
1.58 “Force Majeure Event” will have the meaning provided in Section 16.10.
1.59 “Fully Burdened Manufacturing Cost” means, with respect to any Licensed Product supplied by or on behalf of Leads Bio: (a) if such Licensed Product is Manufactured by one (1) or more Leads Bio CMOs, the amount paid by Leads Bio to such Leads Bio CMOs for the supply of such Licensed Product, plus a fixed markup of [***]([***]) to reflect supply chain management costs; and (b) to the extent such Licensed Product is Manufactured by Leads Bio or its Affiliates, the fully-burdened cost of such Manufacturing reasonably incurred by Leads Bio or its Affiliate, including the cost of raw materials, direct labor and benefits, a proportionate share of indirect Manufacturing costs (but excluding costs attributable to idle capacity) reasonably incurred by Leads Bio with respect to the Manufacture of such Licensed Product excluding any costs that are not reasonably related to a specific manufacturing activity such as charges for corporate overhead, plus a fixed markup of [***] ([***]) to reflect supply chain management costs. All components of Fully Burdened Manufacturing Costs will be allocated on a basis consistent with Accounting Standards and consistent with the cost accounting policy applied by Leads Bio to other similar products that it produces. A good faith estimate by Leads Bio of Fully Burdened Manufacturing Costs of the Licensed Product as of the Effective Date is set forth on Schedule 1.59.
1.60 “Future Leads Bio Third Party IP Agreement” means a Future Third Party IP Agreement entered into by Leads Bio or its Affiliates.
1.61 “Future Licensee Third Party IP Agreement” means a Future Third Party IP Agreement entered into by Licensee or its Affiliates.
1.62 “Future Third Party IP Agreement” means a Proposed Future Third Party IP Agreement for which a Party has elected to take a (sub)license under Section 2.11.
1.63 “GCP” means the then-current standards, practices and procedures for good clinical practices promulgated or endorsed by any applicable Regulatory Authority, as may be updated from time to time, including (a) the applicable revision of the ICH Guideline for good
clinical practice E6, (b) U.S. Code of Federal Regulations Title 21 parts 50, 54, 56, and 312, (c) NMPA Good Clinical Practice for Drug Clinical Trials (2020) and (d) Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.
1.64 “Global Development Plan” will have the meaning provided in Section 4.2(e).
1.65 “Global Study” means a Clinical Trial designed to obtain Regulatory Approvals for a Licensed Product in multiple countries through the conduct of a Clinical Trial in multiple countries, regions or medical institutions and conducted as part of one (1) unified Clinical Trial or separately but concurrently in accordance with a common Clinical Trial protocol, with at least one country or region within the Licensee Territory and at least one country or region within the Leads Bio Territory.
1.66 “GLP” means the then-current standards, practices and procedures for good laboratory practices promulgated or endorsed by any applicable Regulatory Authority, as may be updated from time to time, including (a) the Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice, (b) U.S. Code of Federal Regulations Title 21 part 58, (c) NMPA Good Laboratory Practice for Non-Clinical Laboratory Studies (2017), and (d) Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004.
1.67 “GMP” means the then-current standards, practices and procedures for good manufacturing practices promulgated or endorsed by any applicable Regulatory Authority, as may be updated from time to time, including (a) the ICH Guideline for Good Manufacturing Practice for Active Pharmaceutical Ingredients Q7, (b) U.S. Code of Federal Regulations Title 21 parts 210, 211, 600 and 610, (c) NMPA Good Manufacturing Practice for Drugs (2010) and the appendix for investigational drugs (2022), and (d) the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, as set out in Volume 4 of the European Commission’s Rules governing Medicinal Products in the European Union.
1.68 “Good Reason” will have the meaning provided in Section 13.2(e).
1.69 “Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial or other governmental authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.70 “Government Official” means (a) any elected or appointed government official (e.g., a member of a ministry of health), (b) any employee or person acting for or on behalf of a government official, Governmental Authority, or other enterprise performing a governmental function, (c) any political party, candidate for public office, officer, employee, or person acting for or on behalf of a political party or candidate for public office, and (d) any employee or person acting for or on behalf of a public international organization (e.g., the United Nations). For clarity, healthcare professionals or healthcare providers employed by government-owned hospitals will be considered Government Officials.
1.71 “HGR Approval” means any approval, certificate or other clearance from the HGR Regulatory Authority, that is necessary for Leads Bio or any of its Affiliates to collect, preserve,
utilize, or provide externally, including to disclose to, transfer to or share with a “foreign party” (as defined in the HGR Regulations) any HGR Information or HGR Materials. For clarity, HGR Approval includes any amendments to approvals for international collaborations and record filings for data transfer.
1.72 “HGR Filing” means any filing or submission for purposes of obtaining any HGR Approval, including any amendment to any HGR Approval for an international collaboration, data back-up confirmation and record filing for data transfer to a foreign party, or application to export HGR Materials.
1.73 “HGR Information” will have the meaning defined in the HGR Regulations.
1.74 “HGR Materials” will have the meaning defined in the HGR Regulations.
1.75 “HGR Regulations” means the PRC Regulation on the Administration of Human Genetic Resources (人类遗传资源管理条例) promulgated by the State Council of China and any implementing rules, guidelines or question and answer documents issued by the HGR Regulatory Authority.
1.76 “HGR Regulatory Authority” means the Ministry of Science and Technology or the National Health Commission, or any successor agency thereto, or any other Regulatory Authority having substantially the same function.
1.77 “Human Materials” means any human cell lines, tissue, human clinical isolates or similar human-derived materials.
1.78 “ICH” means the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use.
1.79 “IND” means an Investigational New Drug application, Clinical Trial Application, Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.
1.80 “Indemnitee” will have the meaning provided in Section 14.3.
1.81 “Indemnitor” will have the meaning provided in Section 14.3.
1.82 “Indication” means the diagnosis, treatment, prophylaxis or palliation of a discrete clinically recognized form of a disease or medical condition, and each of the following will be treated as the same Indication and not a distinct Indication: (a) the treatment of a disease, disorder or condition in a particular patient population and the treatment of the same disease, disorder or condition in another population (e.g., adult population and pediatric population); (b) different subtypes or lines of therapy for the same disease, disorder or condition; (c) initiating a Clinical Trial or obtaining Regulatory Approval for use of a pharmaceutical product in combination with another pharmaceutical product, where a Clinical Trial had been initiated or Regulatory Approval obtained for such first pharmaceutical product for use as monotherapy or in combination with a different pharmaceutical product, will not be considered to be a new Indication unless it is a
separate and distinct disease or medical condition in humans; (d) targeting patients with different levels of severity (e.g., moderate to severe patients, and mild patients); or (e) the pairing of two (2) or more different products for diagnosis and treatment uses in the same Clinical Trial or in separate Clinical Trials (or in the same filing for Regulatory Approval or in separate Regulatory Approvals) in each case of the foregoing targeting the same disease or medical condition.
1.83 “Indirect Taxes” means any import, export, excise, sales, use, value added, goods and services, gross receipts and similar taxes, together with any penalties and interest in respect thereof, that are imposed by any jurisdiction in the United States. For the avoidance of doubt, Indirect Taxes do not include any import, export, excise, sales, use value added, goods and services, gross receipt and similar taxes imposed by any jurisdiction outside the United States, including any VAT or VAT surcharges (such as urban maintenance and construction tax and education surcharge) imposed by any jurisdiction within the Leads Bio Territory.
1.84 “Inflation Reduction Act” means P.L. 117-169 (Aug. 16, 2022), as codified at 42 U.S.C. § 1320f, 42 U.S.C. § 1395w-3a and 42 U.S.C. § 1395w-114a (inter alia), as it may be amended from time to time or any substantially similar Applicable Law, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
1.85 “Initiation” means, with respect to a Clinical Trial, the first dosing of the first (1st) human subject in such Clinical Trial.
1.86 “Invention” means any inventions or discoveries, including processes, manufacture, compositions of matter, Know-How, Data, methods, assays, designs, protocols, and formulas, and improvements or modifications thereof, patentable or otherwise, that are generated, developed, conceived or reduced to practice (constructively or actually) by or on behalf of one Party or its Affiliates or their respective (sub)licensees (in case of Leads Bio) and Sublicensees (in case of Licensee) or the Parties jointly during the Term under this Agreement, including all rights, title and interest in and to the intellectual property rights therein and thereto.
1.87 “Jointly Owned Inventions” will have the meaning provided in Section 12.1(c).
1.88 “Jointly Owned Invention Patent Rights” will have the meaning provided in Section 12.1(c).
1.89 “JSC” means the joint steering committee to be established by the Parties pursuant to Section 3.1.
1.90 “Know-How” means any and all proprietary and non-public knowledge or technical information, including (a) information including trade secrets, inventions (whether patentable or not, and including data or descriptions contained in unpublished patent applications), methods, knowledge, skill, experience, research and development data and results (including medicinal chemistry data, preclinical data, pharmacological, toxicological and clinical test data and results (including investigator reports (both preliminary and final), statistical analyses, expert opinions and reports, safety and other electronic databases), chemical structure, sequences, processes, formulae, techniques, research data, reports, standard operating procedures and batch
records), product specifications, study designs and protocols, assays and biological methodology, analytical and quality control data, analytical methods (including applicable reference standards), full batch documentation, packaging records, release, stability, storage and shelf-life data, and manufacturing process information, results or descriptions, (b) databases, practices, techniques, specifications, formulations, formulae, software and algorithms, (c) if applicable, physical materials, reagents and compositions of matter, including chemical or biological materials, in each case, whether patentable or not, and (d) tangible manifestations of any of the foregoing.
1.91 “Lead Compound” will have the meaning set forth in Section 1.31.
1.92 “Leads Bio Development Plan” will have the meaning set forth in Section 4.2(b).
1.93 “Leads Bio Indemnitees” will have the meaning provided in Section 14.1.
1.94 “Leads Bio Prosecuted Divisionals” means one or a series of divisionals or continuing applications, as the case may be, of the Licensed BDCA2 Patent Rights filed by Leads Bio in the name of Leads Bio or any of its Affiliates that are not Licensee Prosecuted Divisionals.
1.95 “Leads Bio Solely Owned Inventions” will have the meaning provided in Section 12.1(b).
1.96 “Leads Bio Solely Owned Invention Patent Rights” will have the meaning provided in Section 12.1(b).
1.97 “Leads Bio Territory” means Mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan.
1.98 “Leads Bio Third Party IP Agreements” means all Existing Leads Bio Third Party Agreements and all Future Leads Bio Third Party IP Agreements.
1.99 “Leads US” means Leads Biolabs Inc., a Delaware corporation that as of the Effective Date has an address at 3500 S Dupont Hwy, Dover, DE 19901.
1.100 “License Payments” will have the meaning provided in Section 9.3(a).
1.101 “Licensed BDCA2 Linker Improvements” means any and all Inventions that constitute improvements, modifications, enhancements or derivatives of any Licensed BDCA2 Linker Know-How.
1.102 “Licensed BDCA2 Linker IP” means Licensed BDCA2 Linker Know-How or Licensed BDCA2 Linker Patent Rights.
1.103 “Licensed BDCA2 Linker Know-How” means any Licensed Know-How related to ([***]
1.104 “Licensed BDCA2 Linker Patent Rights” means any Licensed Patent Rights that [***].
1.105 “Licensed BDCA2 Patent Rights” means all Licensed Patent Rights identified as “Licensed BDCA2 Patent Rights” on Schedule 1.105.
1.106 “Licensed Intellectual Property” means the Licensed Know-How and Licensed Patent Rights.
1.107 “Licensed Know-How” means any Know-How that is Controlled by Leads Bio or any of its Affiliates as of the Effective Date or during the Term that is necessary or reasonably useful to (a) Exploit Compounds or Licensed Products in the Field in the Licensee Territory or (b) Manufacture any Compound or Licensed Product in the Leads Bio Territory. Notwithstanding the foregoing, Licensed Know-How will not include any Know-How that would be Licensed Know-How solely due to it being necessary or reasonably useful to Exploit any Additional Active or other proprietary compound or product Controlled by Leads Bio or any of its Affiliates that is not a Compound or a Licensed Product. A description of Licensed Know-How as of the Effective Date is attached hereto on Schedule 1.107; provided that the failure of Schedule 1.107 to include any Know-How will not mean that such Know-How is not Licensed Know-How as of the Effective Date.
1.108 “Licensed Patent Rights” means any Patent Rights Controlled by Leads Bio or any of its Affiliates as of the Effective Date or during the Term that are necessary or reasonably useful to (a) Exploit the Compounds or Licensed Products in the Field in the Licensee Territory or (b) Manufacture any Compound or Licensed Product in the Leads Bio Territory. Notwithstanding the foregoing, Licensed Patent Rights will not include any Patent Right that would be a Licensed Patent Right solely due to being necessary or reasonably useful to Exploit any Additional Active or other proprietary compound or product Controlled by Leads Bio or any of its Affiliates that is not a Compound or Licensed Product; provided that such Patent Right does not Cover the Compound. A list of all Licensed Patent Rights as of the Effective Date is attached hereto on Schedule 1.108; provided that the failure of Schedule 1.108 to include any Patent Right will not mean that such Patent Right is not a Licensed Patent Right as of the Effective Date.
1.109 “Licensed Platform Know-How” means any Licensed Know-How that is (a) related to any compound that is not a Compound, (b) generally related to the discovery, identification, creation, engineering, optimization, or manufacture of BDCA2 targeting fusion proteins or other compounds, (c) related to any molecule containing a BDCA2 antibody (or fragment, variant, derivative or part thereof) that is directed to a single target, including the discovery, identification, creation, optimization, or manufacture thereof, or (d) Licensed BDCA2 Linker Know-How.
1.110 “Licensed Platform Patent Rights” means (a) the Licensed BDCA2 Patent Rights, (b) Leads Bio Prosecuted Divisionals, and (c) any Licensed Patent Rights Covering or claiming any (i) compound that is not a Compound, (ii) Licensed Platform Know-How, or (iii) Licensed BDCA2 Linker Patent Rights, in each case, (i) through (iii), excluding Licensee Prosecuted Divisionals.
1.111 “Licensed Product” means any biological product containing a Compound as an active ingredient, whether alone or with one or more other active ingredients.
1.112 “Licensed Product Patent Rights” would mean all Licensed Patent Rights other than any Licensed Platform Patent Rights, including Licensee Prosecuted Divisionals and any Patent Rights with claims solely and specifically Covering [***].
1.113 “Licensee Development Plan” will have the meaning provided in Section 4.2(a).
1.114 “Licensee Indemnitees” will have the meaning provided in Section 14.2.
1.115 “Licensee Intellectual Property” means the Licensee Know-How and Licensee Patent Rights.
1.116 “Licensee Know-How” means any and all Know-How (a) that is an Invention and Controlled by Licensee or any of its Affiliates or (b) (i) Controlled by Licensee or any of its Affiliates as of the Effective Date or during the Term of this Agreement and (ii) used by or on behalf of Licensee or any of its Affiliates in the performance of activities under this Agreement during the Term, in each case (a) and (b) that is necessary or reasonably useful to Exploit the Compounds or Licensed Products in the Field in the Leads Bio Territory, excluding in each case any Know-How (x) owned by a Third Party and not subject to a Licensee Third Party IP Agreement, (y) that would be Licensee Know-How solely due to it being necessary or reasonably useful to Exploit any Additional Active or other proprietary compound or product Controlled by Licensee or any of its Affiliates that is not a Compound or Licensed Product or (z) that arose from or specifically relates to a Global Study that is not a Shared Study (e.g., data or the method of use for the Licensed Product as used in such Global Study).
1.117 “Licensee Patent Rights” means any and all Patent Rights that (a) Cover an Invention Controlled by Licensee or any of its Affiliates or (b) are (i) Controlled by Licensee or any of its Affiliates as of the Effective Date or during the Term of this Agreement, (ii) practiced by or on behalf of Licensee or any of its Affiliates in the performance of activities under this Agreement during the Term, and in each case (a) and (b) that are necessary or reasonably useful to Exploit the Compounds or Licensed Products in the Field in the Leads Bio Territory, excluding in each case any Patent Right (x) owned by a Third Party and not subject to a Licensee Third Party IP Agreement, (y) that would be Licensee Patent Right solely due to it being necessary or reasonably useful to Exploit any Additional Active or other proprietary compound or product Controlled by Licensee or any of its Affiliates that is not a Compound or Licensed Product or (z) to the extent Covering, claiming or describing any Know-How described in clause (z) of Section 1.116.
1.118 “Licensee Prosecuted Divisionals” means one or a series of divisionals or continuing applications, as the case may be, of the Licensed BDCA2 Patent Rights or Licensed Platform Patent Rights, and any Patent Rights granted therefrom with claims specifically Covering [***].
1.119 “Licensee Solely Owned Inventions” will have the meaning provided in Section 12.1(b).
1.120 “Licensee Solely Owned Invention Patent Rights” will have the meaning provided in Section 12.1(b).
1.121 “Licensee Third Party IP Agreement” means any Existing Licensee Third Party IP Agreement and Future Licensee Third Party IP Agreement.
1.122 “Licensee Territory” means worldwide, excluding the Leads Bio Territory.
1.123 “Local Development Costs” will have the meaning provided in Section 4.2(f).
1.124 “Losses” will have the meaning provided in Section 14.1.
1.125 “MAA” means an application for the authorization for marketing of a product, including New Drug Application and Biologics License Application, and will include all amendments and supplements thereto, filed with the applicable Regulatory Authority to gain approval to market such product in the applicable jurisdiction.
1.126 “Mainland China” means the mainland of the People’s Republic of China.
1.127 “Major Markets” means the European Major Markets, the United States, and Japan.
1.128 “Manufacture” means, with respect to a product, activities related to the manufacture and supply of the product, including manufacturing supplies for Development or Commercialization, packaging, labeling, in-process and finished product testing, release of product or any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of product, ongoing stability tests, storage, and shipment and regulatory activities directly related to any of the foregoing, but not including any Development or Commercialization activities. “Manufacturing” will have the correlative meanings.
1.129 “Manufacturing Technology Transfer” will have the meaning provided in Section 6.2.
1.130 “Maximum Fair Price” means a maximum fair price under the Inflation Reduction Act’s drug price negotiation program as defined in 42 U.S.C. § 1320f(c)(3) and all its subsequent amendments and replacements and guidance or regulations promulgated thereunder.
1.131 “Medicare Price” means, with respect to a Licensed Product, (a) for a Licensed Product that is a covered Part D drug, the average negotiated price (as defined in Section 42 U.S.C. 1395w-102(d)) under prescription drug plans or MA-PD plans for such Licensed Product minus the average rebate or other post-point of sale direct or indirect remuneration as described in 42 CFR 423.308 during the plan year immediately prior to the Price Applicability Period, (b) for a Licensed Product for which payment may be made under Part B of Title XVIII of the Social Security Act (42 U.S.C. Chapter 7, Subchapter XVIII), the average payment amount under 42 U.S.C. 1395w–3a(b)(4) across the four Calendar Quarters immediately prior to the Price Applicability Period, or (c) to the extent the Social Security Act is amended after the Effective Date, the most closely analogous price as those specified in clause (a) or (b).
1.132 “Milestone Shares” will have the meaning provided in Section 8.2(a).
1.133 “Minimum Patient Number” will have the meaning provided in Section 4.2(f).
1.134 “NMPA” means the China National Medical Products Administration (formerly known as the China Food and Drug Administration) and any successor agency thereto, or any Regulatory Authority having substantially the same function, including any functional subdivisions or centers thereof (e.g., Center for Drug Evaluation).
1.135 “Near Term Payment” will have the meaning provided in Section 8.1.
1.136 “Net Sales” means, with respect to a Licensed Product, the gross amounts invoiced in arm’s-length transactions by or on behalf of Licensee or any of its Affiliates or its or their Sublicensees (each, a “Selling Party”) from or on account of the sale of the Licensed Product by such Selling Party to Third Parties (including sales to any Third Party distributor, wholesaler, end user, or the like), less the sum of the following:
1.137 [***];
1.138 [***];
1.139 [***];
1.140 [***];
1.141 [***]; and
1.142 [***].
1.143 All of the foregoing deductions from the gross amount invoiced for such sales of the Licensed Product will be determined in accordance with the Accounting Standards. A Licensed Product transferred to Third Parties in connection with clinical and non-clinical research and trials, samples distributed to health care professionals, “named patient sales,” “compassionate use sales,” or any similar program or bona fide arrangement in which a Selling Party agrees to forego a normal profit margin will give rise to Net Sales of such Licensed Product only to the extent that any Selling Party invoices or receives amounts therefor in excess of the cost of goods thereof.
1.144 Licensed Products will be considered “sold” in accordance with the Accounting Standards. Net Sales will be determined from the books and records of the Selling Party.
1.145 It is understood that any accruals for individual items reflected in Net Sales are periodically trued up and adjusted by each Selling Party consistent with its customary practices and in accordance with the Accounting Standards.
1.146 Sale or transfer of any Licensed Product between any of the Selling Parties will not result in any Net Sales, and Net Sales will be calculated based on any subsequent sales or dispositions to a Third Party. To the extent that any Selling Party receives consideration other than or in addition to cash in consideration for the sale of the Licensed Product to a Third Party, Net Sales will include the fair market value of such non-cash consideration for such sale of Licensed Product. For clarity, sales by a Selling Party to a Third Party wholesaler or similar distributor, group purchasing organization, pharmacy benefit manager, or retail chain customer will be
considered sales to a Third Party and Net Sales hereunder and subsequent sales or transfers by such Third Party to a subsequent Person will not generate Net Sales.
1.147 Net Sales of any Combination Product for the purpose of calculating royalties due under this Agreement will be determined on a country-by-country basis for a given accounting period as follows: first, the applicable Selling Party will determine the actual Net Sales of such Combination Product (using the above provisions), and then: such Net Sales amount for the Combination Product will be multiplied by the fraction A/(A+B), where “A” is the net selling price in such country of the Licensed Product, if sold separately for the same dosage as contained in the Combination Product, and “B” is the net selling price in such country of the Additional Active(s) in the combination if sold separately for the same dosage as contained in the Combination Product. All net selling prices of the elements of such end-user product or service will be calculated as the weighted average net selling price of said elements during the applicable accounting period for which the Net Sales are being calculated. In the event that, in any country, no separate sale of either the Licensed Product or Additional Active(s) included in such Combination Product are made during the accounting period in which the sale was made or if the net selling price for an active ingredient cannot be determined for an accounting period, Net Sales allocable to the Licensed Product in each such country will be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining the same that takes into account, on a country-by-country basis, all relevant factors (including variations in potency, the relative contribution and value to the end user of the Licensed Product and the Additional Active(s) in the combination); provided that if the Parties cannot agree upon such appropriate consideration within sixty (60) days following the receipt of such written request, either Party may submit such matter to baseball arbitration in accordance with Schedule 15.3 for resolution.
1.148 “Non-Breaching Party” will have the meaning provided in Section 13.2(b).
1.149 “Paid Indication” will have the meaning provided in Section 8.3.
1.150 “Participation Notice” will have the meaning provided in Section 4.2(e).
1.151 “Party” means Licensee or Leads Bio individually, and “Parties” means Licensee and Leads Bio collectively.
1.152 “Patent Challenge” will have the meaning provided in Section 13.2(c).
1.153 “Patent Rights” means (a) patent applications filed in the applicable jurisdiction; (b) all patents, including supplemental protection certificates, that have issued or in the future issue from any of the foregoing, including utility models, design patents and certificates of invention; and (c) all divisionals, continuations, continuations-in-part, reissues, re-examination certificates, renewals, extensions or additions to any such patents and patent applications (as applicable).
1.154 “Patent Working Group” will have the meaning provided in Section 3.23.3.
1.155 “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.
1.156 “Personal Data” means (a) all information identifying, or in combination with other information, identifiable to, an individual, including pseudonymized (key-coded) clinical Data containing such information; and (b) any other information that is governed, regulated or protected by one or more Data Protection Laws.
1.157 “Pharmacovigilance Agreement” will have the meaning provided in Section 5.7.
1.158 “Phase I Clinical Trial” means a Clinical Trial of a Licensed Product that is described as a phase I clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. §312.21(a), as amended from time to time, or corresponding counterparts in any applicable jurisdiction.
1.159 “Phase II Basket Trial” will have the meaning provided in Section 8.3.
1.160 “Phase II Clinical Trial” means a Clinical Trial of a Licensed Product that is described as a phase II clinical trial in its protocol, or that would otherwise satisfy the requirements of 21 C.F.R. §312.21(b), as amended from time to time, or corresponding counterparts in any applicable jurisdiction. The phase II component as described in the applicable protocol of a Phase I/II Clinical Trial will be deemed to be a Phase II Clinical Trial for the purpose of this Agreement.
1.161 “Phase III Clinical Trial” means a Clinical Trial of a Licensed Product that is consistent with the requirements of US 21 C.F.R. § 312.21(c) (or the foreign equivalent thereof), as amended from time to time, or corresponding counterparts. The phase III component as described in the applicable protocol of a phase II/III study will be deemed to be a Phase III Clinical Trial for the purpose of this Agreement.
1.162 “PMDA” means the Pharmaceuticals and Medical Devices Agency in Japan, or any successor agency.
1.163 “PRC Data Protection Laws” means Applicable Laws in mainland China, rules and regulations related to privacy, data security and data protection, cross-border data transfer, direct marketing, cybersecurity, human genetic resources, or the interception or communication of electronic messages, including, to the extent applicable, the PRC Cybersecurity Law, the PRC Data Security Law, the PRC Personal Information Protection Law, the PRC Biosecurity Law and the Human Genetic Resources Regulation and their respective implementing regulations or any laws promulgated in relation thereto.
1.164 “Price Applicability Period” means, a price applicability period under the Inflation Reduction Act as defined in 42 U.S.C. § 1320f(b)(2).
1.165 “Pricing and Reimbursement Approval” means, with respect to a pharmaceutical product in any country where a Regulatory Authority authorizes reimbursement for, or approves or determines pricing or level of reimbursement for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such
reimbursement authorization or pricing approval or determination for such pharmaceutical product.
1.166 “Product Marks” will have the meaning provided in Section 7.5.
1.167 “Proposed Existing Licensee Third Party IP Agreement” will have the meaning provided in Section 2.10(b).
1.168 “Proposed Future Third Party IP Agreement” will have the meaning provided in Section 2.11.
1.169 “Proposed Publication” will have the meaning provided in Section 10.5.
1.170 “Prosecution and Maintenance” or “Prosecute and Maintain” or “Prosecuting and Maintaining” means, with regard to a Patent Right, the preparing, filing, prosecuting, extending, abandoning, and maintenance of such Patent Right, as well as handling re-examinations and reissues with respect to such Patent Right, together with the conduct of interferences, derivation proceedings, pre- and post-grant opposition proceedings, post-grant patent proceedings (such as inter partes review and post grant review) and other similar proceedings with respect to the particular Patent Right. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” or “Prosecuting and Maintaining” will not include any enforcement actions taken with respect to a Patent Right.
1.171 “Provider” will have the meaning provided in Section 11.2(y).
1.172 “Publication” will have the meaning provided in Section 10.5.
1.173 “Qualified Assignee” means [***].
1.174 “Receiving Party” will have the meaning provided in Section 10.1.
1.175 “Registrational Clinical Trial” means, with respect to a product, a human clinical trial (regardless of whether such clinical trial is referred to as a “Phase II Clinical Trial”, “Phase IIb Clinical Trial”, “Phase II/III Clinical Trial”, “Phase IIb/III Clinical Trial” or “Phase III Clinical Trial”) for such product, the results of which, together with prior information concerning such product, are determined by the sponsor to be intended to be sufficient to establish that such product is safe and effective for its intended Indication to support the filing of an MAA. If a clinical trial of a product is not initially designed as a Registrational Clinical Trial but is later re-designed, converted or expanded into such a trial, then it will be deemed to be a Registrational Clinical Trial hereunder as of the date it initiates the portion of the Clinical Trial that satisfies the criteria for a Registrational Clinical Trial (including any required written acknowledgement of such by a Regulatory Authority).
1.176 “Regulatory Approval” means any and all approvals, licenses, permits, registrations or authorizations of or from any Regulatory Authority that are necessary to market and sell a pharmaceutical product in any country, region or other jurisdiction, including Pricing and Reimbursement Approval where applicable. For clarity, unless it is required by the Applicable
Law to initiate marketing and selling of a product in a particular country, Regulatory Approval will not include Pricing and Reimbursement Approval.
1.177 “Regulatory Authority” means any country, federal, supranational, state or local regulatory agency, department, bureau or other governmental or regulatory authority having the administrative authority to regulate the development or marketing of pharmaceutical products in any country, region or jurisdiction.
1.178 “Regulatory Exclusivity” means, with respect to a pharmaceutical product and a country, region or jurisdiction, marketing or data exclusivity conferred by the applicable Regulatory Authority in such country, region or jurisdiction on the holder of a marketing approval to Commercialize a pharmaceutical product in such country, region or jurisdiction; provided that Regulatory Exclusivity will not include any marketing or data exclusivity conferred by an applicable Regulatory Authority in a country, region or jurisdiction if such Regulatory Exclusivity is for a certain population or indication only and the applicable product subject to such Regulatory Exclusivity is already commercially available in such country, region or jurisdiction for another population or indication.
1.179 “Regulatory Materials” means, with respect to a product, regulatory applications (including MAA), submissions, notifications, materials, communications, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Develop, Manufacture, market, sell or otherwise Commercialize such product in a particular country, region or jurisdiction.
1.180 “Remedial Action” will have the meaning provided in Section 5.8.
1.181 “Research” means, with respect to a product, conducting research activities to discover, identify, create, optimize, deliver and advance such product, including pre-clinical studies and optimization. “Researching” will have the correlative meaning.
1.182 “Review Period” will have the meaning provided in Section 10.5.
1.183 “Royalty Floor” will have the meaning provided in Section 8.7(e).
1.184 “Royalty Term” will have the meaning provided in Section 8.6.
1.185 “Rules” will have the meaning provided in Section 15.1.
1.186 “SEC” will have the meaning provided in Section 10.4(a)(i).
1.187 “Securities Act” will have the meaning provided in Section 8.2(b).
1.188 “Selected IRA Drug” means a drug that was selected for Medicare price negotiation under the Inflation Reduction Act, as described in 42 U.S.C. § 1320f-1(c).
1.189 “Separate” means, with respect to a Competing Product, as applicable, to use commercially reasonable technical and administrative safeguards to segregate activities directed to the Development, Manufacture, and Commercialization of such Competing Product from
activities directed to the Development, Manufacture, and Commercialization of the Compounds and Licensed Products under this Agreement, including applying commercially reasonable technical and administrative safeguards to ensure that: (a) no personnel involved in Developing, Manufacturing, or Commercializing such Competing Product have access to non-public plans or non-public information relating to the Development, Manufacture, or Commercialization of Compound and Licensed Products or any other Confidential Information of the applicable Party, (b) no personnel involved in Developing, Manufacturing, or Commercializing any Compound or Licensed Product have access to non-public plans or information relating to the Development, Manufacture, or Commercialization of such Competing Product, as applicable; provided that, in either case of (a) or (b), senior management personnel may review and evaluate plans and information regarding the Development, Manufacture, or Commercialization of such Competing Products, solely in connection with portfolio decision-making among product opportunities, and (c) no Licensed Intellectual Property, or Inventions are being used in connection with the Exploitation of such Competing Products.
1.190 “Shared Study” will have the meaning provided in Section 4.2(e).
1.191 “SIAC” will have the meaning provided in Section 15.1.
1.192 “Solely Owned Inventions” means Leads Bio Solely Owned Inventions and Licensee Solely Owned Inventions, as applicable.
1.193 “Solely Owned Invention Patent Rights” means Leads Bio Solely Owned Invention Patent Rights and Licensee Solely Owned Invention Patent Rights, as applicable.
1.194 “Sub-License/Assignment Revenue” means [***].
1.195 “Subcontractor” means a Third Party contractor engaged by a Party to perform certain obligations of such Party, or exercise certain rights of such Party in connection therewith, under this Agreement (including Third Party distributors, service providers, contract research organizations, and contract manufacturing organizations).
1.196 “Sublicense” means any license, sublicense, option agreements, right of first refusal agreements for a Sublicense, non-assertion agreements, covenant not to sue or other similar rights granted, directly or indirectly, by Licensee to a Third Party under the licenses or rights it receives from Leads Bio under clause (a) or clause (b) of Section 2.1 in accordance with Section 2.1, to Exploit a Compound or a Licensed Product in any way, but excluding any grant of rights to or agreement with any Subcontractor for such Party or its Affiliates, including any Third Party wholesaler, distributor, or the like.
1.197 “Sublicensee” means a Third Party that is receiving rights under a Sublicense.
1.198 “Tax Assignment” means, with respect to a Party, (a) an assignment of the obligations or rights of such Party under this Agreement to an Affiliate of such Party or a Third Party; (b) a Change of Control with respect to such Party; (c) any change with respect to such Party as a result of which such Party or the other Party ceases to be eligible for the benefits of any income tax treaty to which such Party is entitled as of the date hereof or on the entitlement to which a prior assignment hereunder was predicated; (d) the making or initiating of any payment pursuant to this
Agreement by such Party from a jurisdiction other than the jurisdiction in which such Party is a resident for income tax purposes; (e) the transfer of this Agreement by such Party to a branch, permanent establishment, office or place of business outside the jurisdiction in which such Party is organized; (f) a re-domiciliation of such Party for income tax purposes; (g) the entering by such Party or any of its Affiliates into any transactions or arrangements related to this Agreement or any License Payments as a result of which such License Payments to such Party are treated as (i) other than royalty payments or (ii) not beneficially owned by such Party.
1.199 “Tax Withholdings” will have the meaning provided in Section 9.3(b).
1.200 “Term” will have the meaning provided in Section 13.1.
1.201 “Territory” means (a) with respect to Leads Bio, the Leads Bio Territory and (b) with respect to Licensee, the Licensee Territory.
1.202 “Third Party” means any person or entity other than Licensee and its Affiliates and Leads Bio and its Affiliates.
1.203 “Third Party Claims” will have the meaning provided in Section 14.1.
1.204 “United States” or “U.S.” means the United States of America, including its territories and possessions as recognized by the United Nations from time to time, but in all cases including, for clarity, Puerto Rico.
1.205 “US$” or “U.S. Dollars” means U.S. dollars, the lawful currency of the U.S.
1.206 “Upfront Payment” will have the meaning provided in Section 8.1.
1.207 “Valid Claim” means a claim contained in (a) an issued and unexpired Patent Right within the Licensed Patent Rights that is solely owned by Leads Bio or its Affiliates and Covers a Licensed Product, which claim has not been found to be unpatentable, invalid, revocable or unenforceable by a decision of a court or other authority of competent jurisdiction in the subject country or jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal, and has not been admitted to be invalid or unenforceable through abandonment, reissue, disclaimer or otherwise, or (b) a patent application that has not been irretrievably cancelled, withdrawn, abandoned or rejected and that has not been pending for more than [***] from the priority date of the first filed priority document for such claim; provided that if a patent application that has been pending for more than [***] from the priority date is subsequently granted, it will be a Valid Claim from the date of such grant.
1.208 “VAT” means (a) any tax imposed in compliance with the Council Directive of November 28, 2006 on the common system of value added tax (EC Directive 2006/112) and (b) any other tax of a similar nature, including any value added taxes imposed in any jurisdiction within the Leads Bio Territory, in each case (a) and (b), including any tax imposed in substitution for, or in addition to, such tax referred to in clause (a) or (b) above, wherever imposed.
Article 2License
2.1 License Grant.
2.2 Sublicenses. Subject to the terms and conditions of this Agreement, Licensee will have the right to grant Sublicenses (through multiple tiers) to (i) an Affiliate of Licensee (for so long as it remains an Affiliate of Licensee), (ii) a Third Party to Manufacture of Licensed Products in the Field for Exploitation in the Licensee Territory or (iii) a Third Party to Develop or Commercialize Licensed Products in the Field in the Licensee Territory; provided that any proposed Sublicense of rights to Develop or Commercialize Licensed Products in the U.S. or European Major Markets to a Sublicensee with a market capitalization or enterprise value less than [***] will be subject to Leads Bio’s prior written consent (not to be unreasonably withheld, delayed, or conditioned).
2.4 No Implied Licenses; Retained Rights. No right or license under any Patent Rights or Know-How of either Party is granted or will be granted by implication. All such rights or licenses are or will be granted only as expressly provided in the terms of this Agreement. The license granted to Licensee under Section 2.1 will not include any right for Licensee to Exploit any Additional Active proprietary to Leads Bio other than the Compound in a Licensed Product without Leads Bio’s prior written consent. The license granted to Leads Bio under Section 2.5 will not include any right for Leads Bio to Exploit any Additional Active proprietary to or Controlled by Licensee or its Affiliates in a Licensed Product without Licensee’s prior written consent. Each Party hereby expressly reserves all rights not expressly licensed to Licensee in Section 2.1 (in the case of Leads Bio) and Section 2.5 (in the case of Licensee) and hereby expressly retains all rights to exercise its rights and perform its obligations under this Agreement, including with respect to Leads Bio participating in Shared Studies and Manufacturing and supplying Licensee with Compound or Licensed Products as set forth under this Agreement, including under Section 6.3 and Section 6.4. Leads Bio hereby expressly reserves (i) all rights under the Licensed Intellectual Property with respect to the Compounds and Licensed Products in the Leads Bio Territory (except to the extent any such rights are granted to Licensee in Section 2.1(b)), and (ii) all rights under the Licensed Intellectual Property to Exploit compounds and products that are not Compounds or Licensed Products, and Know-How and Patent Rights not included in Licensed Intellectual Property for any and all purposes.
2.5 License to Leads Bio. Subject to the terms and conditions of this Agreement (including Section 5.6(c)), Licensee hereby grants to Leads Bio (a) a non-exclusive, fully paid, royalty- and payment-free license under the Licensee Intellectual Property, to perform its obligations to Licensee under this Agreement and (b) an exclusive, fully paid, royalty- and payment-free license, with the right to sublicense through multiple tiers to any Affiliate of Leads Bio or any other Third Party as set forth in the last sentence in this Section 2.5, under the Licensee Intellectual Property, to Exploit (except to Manufacture and conduct Global Studies) the Compounds and Licensed Products in the Leads Bio Territory. Each of the licenses under clause (a) and (b) of this Section 2.5 are sublicensable through multiple tiers subject to the terms of this Agreement, including Section 2.6, and any applicable Licensee Third Party IP Agreement.
2.7 Know-How Transfer. By the later of: (a) [***] after the Effective Date and (b) Leads Bio’s receipt of the Upfront Payment, Leads Bio will provide to Licensee one (1) electronic copy of all tangible embodiments embodying Licensed Know-How Controlled by Leads Bio or any of its Affiliates that are reasonably necessary for Licensee to Exploit Compounds or Licensed Products or used by Leads Bio or its Affiliates to Exploit Compounds or Licensed Products, in each case as of the Effective Date (other than Regulatory Approvals and Regulatory Materials, which is addressed in Section 5.2, or Manufacturing related Licensed Know-How, which is addressed in Section 6.2), including the information set forth in Schedule 1.107 hereto. At Licensee’s request from time to time during the Term, Leads Bio will provide Licensee within [***] of such request, one (1) electronic copy of any tangible embodiments embodying Licensed Know-How that is necessary or useful for the Exploitation of Compounds or Licensed Product at no additional cost to Licensee; provided that Licensee will make such request no more than quarterly. Leads Bio will keep Licensee reasonably informed, including promptly upon Licensee’s request, of the existence of any additional Licensed Know-How that becomes Controlled by Leads Bio after the Effective Date and during the Term.
2.8 Non-Competition.
2.9 Assignment. Without the prior written consent of Leads Bio (not to be unreasonably withheld, delayed or conditioned), Licensee will not assign (including by novation but for clarity, excluding sublicensing or subcontracting) its rights or obligations under this Agreement, in whole or in part, to any Third Party that is not a Qualified Assignee if such assignment does not include all or substantially all of Licensee’s rights under the Licensed Intellectual Property and this Agreement with respect to at least one (1) Major Market.
2.10 Existing Third Party IP Agreements.
2.11 Future Third Party IP Agreements. During the Term, in the event that either Party or any of its Affiliates desires to enter into an agreement to obtain rights under any Know-How or Patent Rights from a Third Party (whether by acquisition or license) that may be necessary or reasonably useful to Exploit the Compounds or the Licensed Products in the Licensee Territory or the Leads
Bio Territory (a “Proposed Future Third Party IP Agreement”), such Party or its Affiliate will use commercially reasonable efforts to Control such Know-How or Patent Rights for purposes of granting a license to the other Party under this Agreement. Within [***] of the later of (i) execution of a Proposed Future Third Party IP Agreement by a Party or its Affiliate and (ii) a Party or its Affiliate’s determination to use Know-How or Patent Rights granted under a Proposed Future Third Party IP Agreement in the Exploitation of any Compounds or the Licensed Products any Know-How or Patent Rights, then, if such Party or its Affiliates Control such Know-How or Patent Rights, such Party will deliver a written notice to the other Party that includes a description of such Know-How or Patent Rights and such Proposed Future Third Party IP Agreement, which may be redacted to the extent not necessary for such other Party to understand the terms with which it would need to comply in order to receive a (sub)license thereunder, including any payments that such other Party would be obligated to pay in connection with the grant, maintenance, or exercise of a license or sublicense thereunder (as applicable) to such other Party and its Affiliates. The Party receiving such notice will have [***] to indicate as to whether it would like to receive a (sub)license under such Proposed Future Third Party IP Agreement and whether it agrees to (1) comply with the applicable terms and conditions of such Proposed Future Third Party IP Agreement; and (2) pay all amounts that the contracting Party would be obligated to pay in connection with the grant, maintenance and exercise of a sublicense as reasonably allocable to such Party for use in the Exploitation of the Compounds and Licensed Products in such Party’s territory. If a Party provides a written acceptance of such obligations within such [***] period, such Proposed Future Third Party IP Agreement will become a Future Third Party IP Agreement, such Party will be responsible for paying all amounts that the contracting Party would be obligated to pay in connection with the grant, maintenance and exercise of a sublicense as reasonably allocable to such Party for use in the Exploitation of Compounds and Licensed Products in such Party’s territory. Any payments made by Licensee as a result of accepting a (sub)license under a Future Leads Bio Third Party IP Agreement that are eligible for Licensee’s royalty reduction under Section 8.7(b) will be eligible for Licensee’s royalty reduction under Section 8.7(b). If a Party fails to provide such acceptance to the notifying Party within the applicable [***] period or informs the notifying Party of its intention not to receive a (sub)license under a Proposed Future Third Party IP Agreement, then such Party and its Affiliates will have no rights or obligations with respect to such Proposed Future Third Party IP Agreement.
Article 3GOVERNANCE
3.1 Joint Steering Committee. Within thirty (30) days following the Effective Date, the Parties will establish a joint steering committee comprised of an equal number of representatives from each Party to plan, coordinate, monitor and oversee the Parties’ activities in the Licensee Territory and Leads Bio Territory and facilitate information exchange between the Parties under this Agreement. The joint steering committee will in particular:
3.2 review and discuss the global strategy for the Development, Manufacture and Commercialization of the Licensed Products;
3.3 review and discuss Development activities in a Party’s Territory that will materially deviate from its then-current Development Plan (e.g., changes to the Indication such Party would pursue,
the Clinical Trial design or protocol) and any proposed amendments or revisions to the Development Plan(s);
3.4 review and discuss any study protocols relating to the Development Plan(s) (and any amendments thereto);
3.5 review, discuss and serve as a forum for the sharing of information between the Parties regarding the operation of any Development, Manufacturing or Commercialization activities by the Parties;
3.6 review and discuss any proposed Global Study;
3.7 review and discuss any exercise by Licensee or its Affiliates or Sublicensees of the license set forth in Section 2.1(b);
3.8 review and discuss supply chain and CMC matters related to the Compounds or Licensed Products;
3.9 review and discuss the Commercialization of the Licensed Products in the Field and branding strategies with a goal of consistent global marketing of the Licensed Products;
3.10 review and discuss Commercialization Plans in compliance with Applicable Law (including antitrust and competition laws); and
3.11 perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as determined by the Parties in writing.
3.12 Patent Working Group. Without limiting the generality of the foregoing, no later than thirty (30) days after the Effective Date, the JSC will establish a working group to coordinate on intellectual property matters (the “Patent Working Group”) comprised of an equal number of representatives from each Party. The Patent Working Group will not be considered a subcommittee of the JSC. The Patent Working Group will provide a forum for discussion of [***]The JSC will determine the desired membership of the Patent Working Group and once formed, the members of the Patent Working Group will determine the time, place and procedure of meetings.
3.13 Composition. The JSC will be composed of three (3) representatives from each Party (or such other lesser equal number of representatives of each of Licensee and Leads Bio as the JSC may determine), and each Party will notify the other Party of its initial JSC representatives within thirty (30) days after the Effective Date. Each Party will designate a representative to be the co-chairperson of the JSC, who will schedule meetings, prepare meeting agenda and meeting minutes and follow up on action items. These responsibilities will alternate between the Parties or each co-chairperson, as applicable, with Leads Bio’s co-chairperson taking the responsibility for the first meeting of the JSC. Each Party may change its representatives to the JSC from time to time in its sole discretion, effective upon notice to the other Party of such change. Each Party’s representatives in the JSC will possess appropriate experience with respect to the issues falling within the functions of the JSC and requisite seniority within such Party’s organization.
3.14 Non-Member Attendance. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend a meeting of the JSC (in a non-voting capacity) in the event that the planned agenda for the JSC meeting would require such participants’ expertise; provided that if either Party intends to have any Third Party other than a consultant attend such a meeting, such Party will provide prior written notice to the other Party and will obtain approval from such other Party for such Third Party to attend (such approval not to be unreasonably withheld, delayed or conditioned), and in all cases (including Third Party consultants), such Party will ensure that such Third Party is bound by confidentiality and non-use obligations consistent with the terms of this Agreement.
3.15 Limitations on Authority. The JSC will serve as a forum for discussion and alignment, but will not have any decision-making authority (including, without limitation, any authority to amend this Agreement or to override either Party’s decision-making authority with respect to matters within its respective areas of responsibility). The JSC will have only such powers as are expressly assigned to it in this Agreement, and such powers will be subject to the terms and conditions of this Agreement.
3.16 Meetings. The JSC will hold a meeting every [***] or as mutually otherwise agreed by the Parties. Such meetings may be in person, via videoconference, or via teleconference. The location of in-person meetings will be determined by the Parties. At least [***] prior to each JSC meeting, each Party will provide written notice to the other Party of agenda items proposed by such Party for discussion at such meeting, together with appropriate information related thereto. Reasonably detailed written minutes will be kept for all JSC meetings. Meeting minutes will be prepared on an alternating basis and sent to each member of the JSC for review and approval within [***] after the meeting. Minutes will be deemed approved unless a member of the JSC objects to the accuracy of such minutes within [***] of receipt.
3.17 Discontinuation of JSC. The JSC will continue to exist until the Parties mutually agree to disband the JSC. Once the JSC is disbanded, the JSC will have no further obligations under this Agreement and, thereafter, the Alliance Managers will be the points of contact for the exchange of information under this Agreement.
3.18 Alliance Managers. Each Party will appoint an individual, who is an employee of such Party, to act as its alliance manager under this Agreement within [***] after the Effective Date (the “Alliance Manager”). The Alliance Managers will: (a) serve as the primary points of contact between the Parties for the purpose of providing the other Party with information on the progress of a Party’s activities under this Agreement; (b) be responsible for facilitating the flow of information and otherwise promoting communication, coordination and collaboration between the Parties; (c) facilitate the prompt resolution of any disputes; and (d) attend JSC meetings. Alliance Managers may also serve as a Party’s representative on the JSC but is not required to so serve. An Alliance Manager may also bring any matter to the attention of the JSC, if such Alliance Manager reasonably believes that such matter warrants such attention. Each Party may replace its Alliance Manager at any time upon written notice to the other Party.
Article 4DEVELOPMENT
4.1 Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Licensee (itself and through its Affiliates and their respective Sublicensees) will have the sole right, at its own expense, to Develop the Licensed Products in the Field in the Licensee Territory. Without limiting the generality of the foregoing, Licensee will use Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [***] Licensed Product in the United States and [***] additional Major Markets in [***] Indication. Without limiting the foregoing, Licensee will Initiate a Phase I Clinical Trial, Phase II Clinical Trial, or Registrational Clinical Trial for a Licensed Product in the Licensee Territory within [***], and any failure to achieve the foregoing will give rise to Leads Bio’s ability to terminate this Agreement pursuant to Section 13.2(b); provided that, if any delay was caused (a) by events outside the reasonable control of Licensee, (b) a reasonable response by Licensee to a safety, efficacy or other issue related to the Phase I Clinical Trial conducted by or on behalf of Leads Bio or due to a reasonable reaction to guidance or a request from a Regulatory Authority, including a Force Majeure Event, in each case of (a) and (b), where such events have not been overcome, removed, or mitigated despite Licensee’s use of Commercially Reasonable Efforts to remove or mitigate such events, then Licensee’s failure to achieve the foregoing will not give rise to Leads Bio’s ability to terminate this Agreement pursuant to Section 13.2(b) solely for the period that such events persists. Licensee will provide Leads Bio with notice pursuant to Section 16.10 of any such event or reaction causing a delay and use Commercially Reasonable Efforts to overcome, remove, or mitigate the delay.
4.2 Development Plan.
4.3 Development Reports. Each Party will keep the other Party reasonably and timely informed of the progress and results of its and its Affiliates’ and Sublicensees’ work under the Development Plan(s) or Global Development Plan(s) through the JSC (including reporting of available pre-clinical and clinical Data at the JSC). Without limiting the generality of the foregoing, each Party will provide the other Party with a written report no later than [***] after the end of each Calendar Year setting forth a summary of the Development activities performed during such Calendar Year and the results thereof. Such reports prepared by Licensee will be provided at a level of detail reasonably sufficient to enable Leads Bio to determine Licensee’s compliance with its diligence obligations under Section 4.1. At each JSC meeting, the Parties will discuss the status, progress and results of the Development activities conducted by the Parties pursuant to this Agreement.
Article 5REGULATORY
5.1 Overview of Conduct of Regulatory Activities. As between the Parties, Licensee (itself and through its Affiliates and Sublicensees, as applicable) will have the sole right, at (as between the Parties) its cost and expense, for all regulatory activities (including the preparation, obtaining and maintaining of all Regulatory Approvals and Regulatory Materials) with respect to the Compounds and Licensed Products in the Licensee Territory. Licensee will be the holder of all Regulatory Approvals and Regulatory Materials for the Compounds and Licensed Products in the Licensee Territory.
5.2 Ownership of Existing Regulatory Approvals and Regulatory Materials. Promptly following the Effective Date, Leads Bio will transfer and assign, or will cause the transfer or assignment, to Licensee or its designee’s, or any of its Affiliates’, entire right, title, and interest in and to all Regulatory Approvals, if any, and other Regulatory Materials, with respect to the Compounds and Licensed Products in the Licensee Territory that are Controlled and possessed by Leads Bio or any of its Affiliates, unless the Parties agree otherwise. Prior to the completion of such transfer and assignment, Leads Bio will maintain or cause to be maintained using its current agent (or another agent designated by Licensee) all such Regulatory Materials in its name in accordance with Applicable Laws and will consult with Licensee with respect thereto, in each case subject to Licensee’s final decision-making authority.
5.3 Regulatory Materials. Each Party will notify the other Party of any material Regulatory Materials for the Licensed Product and any other material documents, comments or other correspondences related thereto submitted to or received from any Regulatory Authority in the Leads Bio Territory (with respect to Leads Bio as the notifying Party) and in the Major Markets (with respect to Licensee as the notifying Party) and will provide the other Party with copies thereof as soon as reasonably practicable, but in all events within [***] after submission or receipt thereof. Notwithstanding anything to the contrary in this Agreement, subject to the decision making as set forth in Section 4.2(g), to the extent that a Party, its Affiliate, (sub)licensee or their respective designee is required to submit any Regulatory Materials, including clinical trial submissions, to, or otherwise correspond with a Regulatory Authority in the Leads Bio Territory related to a Global Study, any such Regulatory Materials or correspondence will be submitted for review and comment to the other Party in advance, and the submitting Party will consider the non-submitting Party’s comments in good faith.
5.4 HGR, CBDT and Other Approvals.
5.5 Notice of Meetings and Regulatory Actions. Each Party will provide the other Party with notice of any material meeting or discussion with any Regulatory Authority in a Major Market (with respect to Licensee) or the Leads Bio Territory (with respect to Leads Bio) related to any Compound or Licensed Product, when possible, no later than [***] after receiving notice
thereof. At the notifying Party’s request, the other Party will reasonably cooperate with the notifying Party in preparing for any such meeting or discussion. The notifying Party will provide to the other Party a written summary of such meeting or discussion promptly following the issuance or approval of the corresponding official minutes by the applicable Regulatory Authority. If any Regulatory Authority takes, or gives notice of its intent to take, any regulatory action with respect to any Licensed Product, then such Party will notify the other Party of such action, to the extent practicable, within two Business Days after receipt of such notice (or, if action is taken without notice, within two Business Days of such Party becoming aware of such action).
5.6 Data Access; Right of Reference; Access to Regulatory Materials.
5.7 Pharmacovigilance. Prior to the start of participant enrollment into the first Clinical Trial of which Licensee or its applicable Affiliate acts as the sponsor in the Licensee Territory, the Parties will enter into a pharmacovigilance agreement regarding the Compounds and Licensed Products (the “Pharmacovigilance Agreement”), which will set forth standard operating procedures governing the collection, investigation, reporting, and exchange of safety information sufficient to permit each Party to comply with its regulatory and other legal obligations within the applicable timeframes. In the event of any inconsistency between the terms of this Agreement and the Pharmacovigilance Agreement, the terms of this Agreement will prevail and govern, except to the extent such conflicting terms relate directly to the pharmacovigilance responsibilities of the Parties (including the exchange of safety data), in which case the terms of the Pharmacovigilance Agreement will prevail and govern. Licensee will be responsible at its sole cost for establishing and managing the global safety database for the Licensed Products. Licensee will provide data access and a copy of applicable safety information to Leads Bio or its designee as set forth in the Pharmacovigilance Agreement.
5.8 Remedial Actions. Each Party will notify the other within [***], and promptly confirm such notice in writing, if it obtains information indicating that any Licensed Product is reasonably likely to be subject to any recall, corrective action or other regulatory action in the Licensee Territory or Leads Bio Territory by any Governmental Authority or Regulatory Authority (a “Remedial Action”). The Parties will assist each other in gathering and evaluating such information as is necessary to determine the necessity of conducting a Remedial Action. The Parties will collaborate in good faith and endeavor to reach an agreement on Remedial Action related decisions but each Party will have the right to make a final determination as to whether to voluntarily implement any recall, market suspension or market withdrawal of, or take any other Remedial Action with respect to, the Compounds or Licensed Products in its Territory. The costs and expenses of any Remedial Action in the Licensee Territory will be borne solely by Licensee, except in the event it is related to negligent Manufacturing by or on behalf of Leads Bio, its Affiliates or its or their (sub)licensees, in which case Leads Bio will bear such costs and expenses. The costs and expenses of any Remedial Action in the Leads Bio Territory will be borne solely by
Leads Bio, except in the event it is related to negligent Manufacturing by or on behalf of Licensee, its Affiliates or its or their Sublicensees or relates to a Development activity being conducted by or on behalf of Licensee, its Affiliates or its or their Sublicensees in the Leads Bio Territory for a Global Study that is not a Shared Study, in which case Licensee will bear such costs and expenses.
5.9 Data Security Program. Notwithstanding any other term or condition of this Agreement, neither Licensee nor any of its Affiliates or Sublicensees will have any obligation under this Agreement to transfer or provide access to any “government-related data” or “U.S. sensitive personal data” or “human biospecimens”, as defined in the Data Security Program, unless such transfer or provision of access is, as reasonably determined by Licensee (as advised by its external counsel), (a) exempt under 28 C.F.R. § 202.510 of the Data Security Program or (b) if with a foreign person non-covered person (as such terms are defined in the Data Security Program), compliant with the onward transfer requirements under 28 C.F.R. § 202.302 of the Data Security Program. Leads Bio will provide all assistance and cooperation as Licensee may reasonably request, including designation as Licensee’s data protection representative, to enable Licensee to comply with Licensee’s obligations under the Data Security Program.
Article 6MANUFACTURE & SUPPLY
6.1 Overview of Manufacturing Activities. Subject to the terms and conditions of Article 3, this Article 6 and the oversight of the JSC, Licensee will have the sole right (itself and through its Affiliates and Sublicensees or contractors, as applicable) to and sole control over, and sole decision-making authority with respect to, the Manufacturing and supply of the Compounds and the Licensed Products in the Field in or for the Licensee Territory during the Term.
6.2 Manufacturing Technology Transfer. At Licensee’s election at any time following the Effective Date, but no later than promptly following Licensee’s Initiation of any Phase II Clinical Trial, and subject to Licensee obtaining a separate cell line (sub)license from [***], upon Licensee’s reasonable advance request, Leads Bio will, and will cause the Third Party contract manufacturing organization(s) engaged by it to Manufacture the Compound(s) or Licensed Product(s) (each, a “CMO”) to transfer the Licensed Know-How that is necessary or reasonably useful for the Manufacture of the Compounds and Licensed Products to Licensee or its designee(s) in accordance with a manufacturing technology transfer plan mutually agreed by the Parties, and provide, and cause CMOs to provide, technical assistance to Licensee or its designee(s) in a timely manner to enable Licensee or its designee to Manufacture the Licensed Product, in each case, at Licensee’s reasonable cost (the “Manufacturing Technology Transfer”).
6.3 Initial Clinical Supply. Until completion of the Manufacturing Technology Transfer as set forth in Section 6.2, upon Licensee’s written request, Leads Bio will, by itself or through one or more Leads Bio CMO(s), supply to Licensee the Compounds or the Licensed Products for clinical use, including supplies for Phase II Clinical Trials, at its Fully Burdened Manufacturing Cost; provided that Licensee will be responsible for applicable taxes and all costs associated with shipping or insurance to the extent not already included in the Fully Burdened Manufacturing Cost. The Parties will negotiate in good faith a clinical supply agreement and related quality agreement with such negotiation to be commenced within [***] after the Effective Date and completed no later than [***]after the Effective Date unless mutually agreed by the Parties, which clinical supply
agreement will contain customary language regarding supply of the Licensed Products to Licensee. Leads Bio will, and will cause its Affiliates and use Commercially Reasonable Efforts to cause its CMO(s) to allow Licensee, its designees, and any Regulatory Authority (or representatives thereof), during normal business hours and upon reasonable notice, to have access and inspect the facilities where Licensed Products (including any component thereof) are Manufactured for the Licensee Territory, including any relevant books and records; provided that if such permission is not granted, Leads Bio will, and will permit any Regulatory Authority (or representatives thereof) to, access and inspect such CMO’s facilities upon Licensee’s request and ensure that any agreements with such CMOs permit such access and inspection. Leads Bio will inform Licensee promptly of any notices of inspection received by Leads Bio or its Affiliates related to the Manufacture of any Licensed Product (including any component thereof) and will allow and use Commercially Reasonable Efforts to cause its CMOs to allow representatives of Licensee to be present during such inspection, unless prohibited by Applicable Laws. Leads Bio will provide reasonable time to review and comment on any inspection submissions to be made by Leads Bio or its Affiliates, and Leads Bio will incorporate Licensee’s reasonable comments.
6.4 Licensee Manufacturing in Leads Bio Territory. In the event Licensee or any of its Affiliates intends to have one or more Third Parties (other than any Third Party with which Licensee or any of its Affiliates or Sublicensees has a prior or existing agreement or arrangement with respect to Manufacturing in the Leads Bio Territory) Manufacture the commercial drug substance of Licensed Products in the Leads Bio Territory for use, sale or distribution in the Licensee Territory, Licensee will grant, and hereby does grant, to Leads Bio the first right to negotiate an agreement for such rights to Manufacture or have Manufactured the Compounds and Licensed Products in the Leads Bio Territory at a cost-plus markup. Licensee will promptly provide Leads Bio with written notice of such intent. Leads Bio may exercise its right of first negotiation by providing written notice to Licensee within [***] following Leads Bio’s receipt of Licensee’s notice, and for a period of [***] following Leads Bios’ exercise notice, Leads Bio and Licensee will exclusively negotiate in good faith a definitive agreement for such Manufacturing rights on commercially reasonable terms, subject to Leads Bio being able to demonstrate by written evidence and audits (as requested by Licensee) during the [***] exercise period that its facilities have sufficient scale, capacity, and record of compliance with Applicable Laws, including GMP, for such activity and that all required regulatory approvals are in place. If the Parties fail to reach mutual agreement during such [***] negotiation period, Licensee will thereafter be free to Manufacture or have Manufactured the commercial drug substance of Compounds and Licensed Products in the Leads Bio Territory for the Licensee Territory. And, for clarity, if Licensee wishes to use a Subcontractor with which it has a prior or existing agreement or arrangement with respect to Manufacturing in the Leads Bio Territory to Manufacture commercial supply Licensed Product in the Leads Bio Territory for Commercialization in the Licensee Territory, Leads Bio will not have a first right to negotiate under this Section 6.4.
Article 7COMMERCIALIZATION MATTERS
7.1 Overview; Diligence. Subject to the terms and conditions of this Agreement (including the diligence obligations set forth below), Licensee (itself and through its Affiliates and Sublicensees, as applicable) will have the sole right to Commercialize the Licensed Products in the Field in the Licensee Territory, including, in its discretion: (i) developing and executing a commercial launch
and pre-launch plan, (ii) negotiating with applicable Governmental Authorities regarding the price and reimbursement statuses of the Licensed Products; (iii) marketing, advertising and promotion; (iv) booking sales and distribution and performance of related services; (v) handling all aspects of order processing, invoicing and collection, inventory and receivables; and (vi) providing customer support, and performing other related functions. As between the Parties, Licensee will bear all of the costs and expenses incurred in connection with such Commercialization activities. Licensee will use Commercially Reasonable Efforts to Commercialize one (1) Licensed Product in a Major Market in one Indication for which it has received Regulatory Approval (including Pricing and Reimbursement Approval, if applicable).
7.2 Commercialization Plan. No later than [***] before the anticipated date of the submission of the first MAA for a Licensed Product in such Party’s Territory, each Party will submit to the JSC for review and discussion a written Commercialization plan that includes a high-level summary of promotion and detailing planning, market research plans and assessments and pricing and market access strategies for such Licensed Product in, with respect to the Licensee, the Major Markets in the Licensee Territory and with respect to Leads Bio, the Leads Bio Territory (each, a “Commercialization Plan”). Thereafter, from time to time, but at least once every year, each Party will prepare updates or amendments to its Commercialization Plan and submit such updated or amended plan to the JSC for review and discussion.
7.3 Coordination of Commercialization Activities. The Parties recognize that they may benefit from the coordination of certain activities in support of the Commercialization of a Licensed Product across their Territories. As such, the Parties may coordinate such activities in each Party’s sole discretion where appropriate, including scientific and medical communication and Licensed Product positioning. For clarity, neither Party will conduct any Commercialization of any Licensed Product outside such Party’s Territory without the other Party’s express prior written consent.
7.4 Commercialization Reports. Each Party will update the JSC at each regularly scheduled JSC meeting regarding the Commercialization activities with respect to each Licensed Product in their respective Territory. Each such update will summarize Licensee’s, its Affiliates’ and Sublicensees’ significant Commercialization activities with respect to each Licensed Product in the Licensee Territory.
7.5 Trademarks. Each Party will have the right to brand the Licensed Products in its Territory using trademarks, logos and trade names that it determines appropriate for the Licensed Products (such trademarks, logos, and trade names, the “Product Marks”). Neither Party may use any trademark Controlled by the other Party or its Affiliates (including their corporate names) to brand the Licensed Products without such other Party’s prior written consent. Each Party will own all rights in the Product Marks in its Territory and will register and maintain the Product Marks in its Territory that it determines reasonably necessary. To the extent requested by a Party and commercially practicable, the Parties will cooperate with respect to developing and implementing a global branding strategy, subject to separate discussion and agreement. If the Parties do not agree upon a global branding strategy, then each Party will have the right to brand the Licensed Products in its Territory in a manner that it determines appropriate in its sole discretion.
7.6 Licensed Products Tracking in the Licensee Territory. Each Party will, and will ensure that its Affiliates and Sublicensees (in the case of Licensee) and (sub)licensees (in the case of Leads Bio), maintain adequate records to permit the Parties to trace the distribution, sale, and use of all Licensed Products to hospitals and pharmacies in its Territory.
7.7 No Diversion. Each Party hereby covenants and agrees that during the Term, and except as expressly permitted by this Agreement, it will not (and will cause its Affiliates and Sublicensees (in the case of Licensee), (sub)licensees (in the case of Leads Bio)and Subcontractors not to), either itself or through a Third Party, develop, use, market, promote, import, export, sell or actively offer for sale the Licensed Products in the other Party’s Territory. Without limiting the generality of the foregoing, except as expressly permitted by this Agreement and as mutually agreed by the Parties, each Party will not (a) engage in any advertising activities relating to the Licensed Products directed primarily to customers in the other Party’s Territory, or (b) actively or intentionally solicit orders from any prospective purchaser located in the other Party’s Territory. To the extent permitted by Applicable Laws, including applicable antitrust laws, if a Party receives any order for Licensed Products from a prospective purchaser located in a country or jurisdiction in the other Party’s Territory, such Party will immediately refer that order to the other Party and will not accept any such order or deliver or tender (or cause to be delivered or tendered) the Licensed Products under such order. If a Party should reasonably know that a customer or distributor is actively engaged itself or through a Third Party in the sale or distribution of the Licensed Products in the other Party’s Territory, then such first Party will (i) within [***] of gaining knowledge of such activities, notify the other Party regarding such activities and provide all information available to such Party that the other Party may reasonably request concerning such activities subject to Applicable Law and confidentiality and non-use obligations and (ii) use commercially reasonable efforts necessary to limit such sale or distribution in the other Party’s Territory, unless otherwise agreed in writing by the Parties.
Article 8FINANCIAL TERMS
8.1 Upfront Payment and Near Term Payment. In partial consideration of Leads Bio’s granting of the licenses and rights to Licensee hereunder, Licensee will make (a) a one-time, non‑refundable, non‑creditable payment to Leads Bio of twenty million U.S. Dollars (US$20,000,000) (the “Upfront Payment”) within [***] after the Effective Date, and (b) a one-time, non‑refundable, non‑creditable payment to Leads Bio of five million U.S. Dollars (US$5,000,000) (the “Near Term Payment”) within [***] after the Effective Date.
8.2 Equity Grant.
8.3 Development and Regulatory Milestone Payments. Subject to the terms and conditions of this Agreement, with respect to the milestone events set forth in the table below (each, a “Development Milestone Event”), promptly following the first achievement by Licensee, its Affiliates, or its or their Sublicensees (or Leads Bio or its Affiliates or (sub)licensees solely with respect to Development Milestone Event No. 1) of the corresponding Development Milestone Event, Licensee will notify Leads Bio of such achievement within [***] of becoming aware of such achievement except, solely with respect to Development Milestone Event No. 1, Leads Bio will notify Licensee within [***] of such achievement, and Licensee will pay to Leads Bio the corresponding non‑refundable, non‑creditable milestone payment within [***] after (a) the achievement of the applicable Development Milestone Event or (b) solely with respect to Development Milestone Event No. 1, the receipt by Licensee of the notice of the achievement of such Development Milestone Event:
8.4 Commercial Milestone Payments. Subject to the terms and conditions of this Agreement (including Section 8.6), Licensee will pay to Leads Bio the additional one-time, non-refundable,
non-creditable payments set forth in the table below after the first achievement of each commercial milestone event described below:
8.5 Royalties. Subject to the terms and conditions of this Agreement (including Section 8.6 and Section 8.7), on a Licensed Product-by-Licensed Product basis, Licensee will pay tiered royalties to Leads Bio on Net Sales of all Licensed Products in the Licensee Territory in each [***] (excluding Net Sales of any Licensed Product in any country in the Licensee Territory for which the Royalty Term has not commenced or has expired) at the rates set forth below, calculated by multiplying the applicable royalty rate by the corresponding portion of Net Sales of all Licensed Products in the Licensee Territory in such Calendar Year:
8.6 Royalty Term. Royalties under Section 8.5 will be payable, on a country-by-country basis and Licensed Product-by-Licensed Product basis, during the period beginning on the First Commercial Sale of such Licensed Product in such country and ending on the latest to occur of (a) the [***] ([***]) anniversary of the First Commercial Sale of such Licensed Product in such country; (b) expiration of the last-to-expire Valid Claim that [***]; or (c) expiration of the last-to-expire Regulatory Exclusivity for such Licensed Product in such country (the “Royalty Term”). Licensee will have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country in the Licensee Territory after the Royalty Term for such Licensed Product in such country has expired (including for sales of any such Licensed Product in such country held in inventory (determined in accordance with Accounting Standards) to the extent such sales do not result in Net Sales prior to the date of expiration of the applicable Royalty Term (in accordance with Accounting Standards)). From and after the expiration of such Royalty Term, Net Sales of such Licensed Product in such country shall be excluded for purposes of calculating the applicable royalty rate (or Net Sales thresholds therefor) set forth in Section 8.5.
8.7 Royalty Payment Reduction.
8.8 Sub-License/Assignment Revenue Payments. In partial consideration of Leads Bio’s granting of the licenses and rights to Licensee hereunder, Licensee will pay to Leads Bio a share of Sub-License/Assignment Revenue. Licensee will structure and negotiate any transaction involving a Sublicense or the assignment of its rights under the Licensed Intellectual Property and this Agreement in good faith. Licensee will notify Leads Bio in writing within [***]after receipt
of Sub-License/Assignment Revenue, and all Sub-License/Assignment Revenue payments will be paid to Leads Bio within [***] after the Sub-License/Assignment Revenue is received.
Article 9PAYMENT; RECORDS; AUDITS
9.1 Payment; Reports. Royalties will be calculated and reported for each [***] and will be paid within [***] after the end of each [***]. Each payment will be accompanied by a report of Net Sales of the Licensed Products by Licensee, its Affiliates and Sublicensees in sufficient detail to permit confirmation of the accuracy of the payment made, including gross sales and Net Sales of the Licensed Products on a country-by-country basis, the royalty payable, the method used to calculate the royalties, and the exchange rates used to calculate the royalties. Except as may otherwise be expressly provided herein, Licensee will not have the right to set off, withhold or make any deduction from any payment of royalties or other payments due to Leads Bio hereunder for any reason whatsoever.
9.2 Exchange Rate; Manner and Place of Payment. All payments hereunder will be payable in U.S. dollars. When conversion of payments from any foreign currency is required, such conversion will be at an exchange rate equal to the weighted average of the rates of exchange for the currency of the country from which such payments are payable as published by The Wall Street Journal, Western U.S. Edition during the Calendar Quarter for which a payment is due. All payments owed under this Agreement to Leads Bio will be made by wire transfer in immediately available funds to a bank and account designated in writing by Leads Bio, unless otherwise specified in writing by Leads Bio.
9.3 Taxes.
9.4 Blocked Currency. In the event that, by reason of Applicable Laws in any country or region, it becomes impossible or illegal, after reasonable efforts by Licensee to do so, for Licensee or its Affiliate to transfer, or have transferred on its behalf, payments owed Leads Bio hereunder, Licensee will promptly notify Leads Bio of the conditions preventing such transfer and such payments will be deposited in local currency in the relevant country or region to the credit of Leads Bio in a recognized banking institution designated by Leads Bio.
9.5 Records; Audits. Licensee will keep, and require its Affiliates and Sublicensees to keep, complete, fair and true books of accounts and records for the purpose of determining the amounts payable to Leads Bio pursuant to this Agreement. Such books and records will be kept for at least [***] ([***]) full Calendar Years following the end of the Calendar Year to which they pertain. Leads Bio will have the right to cause an independent, certified public accountant reasonably acceptable to Licensee to audit such records to the extent possessed by Licensee to confirm Net Sales, royalties and other payments for a period covering not more than the preceding [***] ([***]) full Calendar Years; provided that (a) such audit will not be more frequent than once in any [***] ([***]) month period, and (b) once such accountant has conducted a review and audit of any records pursuant to this Section 9.5 in respect of any given period, it may not subsequently re-inspect such records with respect to such period, unless, in each case of (a) and (b), for cause. Such audits may be exercised during normal business hours upon reasonable prior written notice to Licensee. Prompt adjustments will be made by the Parties to reflect the results of such audit. Leads Bio will bear the full cost of such audit unless such audit discloses an underpayment by Licensee of more than [***] of the amount of royalties or other payments due under this Agreement for any applicable Calendar Quarter, in which case, Licensee will bear the cost of such audit and will promptly remit to Leads Bio the amount of any underpayment. Any overpayment by Licensee revealed by an audit will be fully-creditable against future payments owed by Licensee to Leads Bio (and if no further payments are due, will be refunded by Leads Bio within [***] of Licensee’s request).
9.6 Late Payments. In the event that Licensee fails to make any undisputed payment due under this Agreement, simple interest will thereafter accrue on the sum due from the due date until the date of payment at [***]([***]) above the prime rate as reported in The Wall Street Journal; provided, however, that in no event will such rate exceed the maximum legal annual interest rate. The payment of such interest will not in itself limit Leads Bio from exercising any other rights it may have as a consequence of the lateness of any payment.
Article 10CONFIDENTIALITY
10.1 Confidential Information. Except to the extent expressly authorized by this Agreement or otherwise agreed in writing by the Parties, each Party (in such capacity, the “Receiving Party”) agrees that, during the Term and for [***] thereafter, it will keep confidential and will not publish or otherwise disclose to any Third Party, and will not use for any purpose other than as expressly provided for in this Agreement or any other written agreement between the Parties, any Confidential Information, including any Know-How, furnished or made available to it by or on behalf of the other Party (in such capacity, the “Disclosing Party”). The Receiving Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own (but in no event less than reasonable care) to ensure that its, and its Affiliates’, employees, agents, contractors, consultants and other representatives do not disclose or make any unauthorized use of the Confidential Information. The Receiving Party will promptly notify the Disclosing Party upon discovery of any unauthorized use or disclosure of the Disclosing Party’s Confidential Information. Notwithstanding anything to the contrary under this Agreement, all Licensed Know-How specific to a Compound or Licensed Product, along with the terms of this Agreement, will be the Confidential Information of each Party under this Agreement.
10.2 Exceptions. Confidential Information will not include any information which the Receiving Party can prove by competent evidence: (a) is at the time of disclosure, or thereafter becomes, through no act or failure to act on the part of the Receiving Party, generally known or available to the public or part of the public domain; (b) is known by the Receiving Party or any of its Affiliates at the time of receiving such information, as evidenced by its records; (c) is hereafter furnished to the Receiving Party or any of its Affiliates by a Third Party, as a matter of right and without restriction on disclosure; or (d) is independently discovered or developed by the Receiving Party or any of its Affiliates, without the use of or reference to Confidential Information of the Disclosing Party.
10.3 Authorized Disclosure. Notwithstanding the provisions of Section 10.1, the Receiving Party may disclose Confidential Information of the Disclosing Party as expressly permitted by this Agreement, or if and to the extent such disclosure is reasonably necessary in the following instances:
10.4 Public Announcements.
10.5 Publication. If either Party proposes to publicly present or publish any Clinical Trial data, non-clinical data or any associated results or conclusions related to the Compounds or Licensed Products that, in the case of Leads Bio, its Affiliate or (sub)licensee, it generated solely in the Leads Bio Territory (for clarity, not including a Global Study) or in the case of Licensee, its Affiliate or Sublicensee, it generated in the Licensee Territory or as part of a Global Study (each
such proposed presentation or publication, a “Proposed Publication”), it will share such Proposed Publication in accordance with this Section 10.5, subject to restrictions of applicable market abuse rules and securities laws. The proposing Party will provide the other Party with a copy of such Proposed Publication at least [***] prior to the earlier of its presentation or intended submission for publication; provided that in the case of abstracts, this period will be at least [***] and the other Party will have [***] to review any such publication and [***]to review any such abstract (such applicable period, the “Review Period”). The proposing Party agrees that it will not submit or present any Proposed Publication (i) until the other Party has provided written comments during such Review Period on the material in such Proposed Publication or (ii) until the applicable Review Period has elapsed without written comments from the other Party, in which case the proposing Party may proceed and the Proposed Publication will be considered approved in its entirety. If the proposing Party receives written comments from the other Party during the applicable Review Period, it will consider the comments of the other Party in good faith, but will retain the sole authority to submit the manuscript for such Proposed Publication; provided that the proposing Party agrees to (A) delete any Confidential Information of the other Party that is not specific to the Licensed Product or Compound that the other Party identifies for deletion in the other Party’s written comments, (B) delete any Clinical Trial data, non-clinical data, results, conclusions or other related information that is not specific to or resulting from any Clinical Trial conducted in the proposing Party’s Territory, and (C) delay such Proposed Publication for a period of up to an additional [***] (to the extent reasonably possible if such publication is contemplated under Section 10.6) after the end of the applicable Review Period to enable the other Party to draft and file patents with respect to any subject matter to be made public in such Proposed Publication and to which the other Party has the applicable intellectual property rights to file such patents. The proposing Party will provide the other Party a copy of the Proposed Publication at the time of the submission or presentation. Once a Party has made a Proposed Publication, the other Party will be permitted to re-publish the data, results or conclusions set forth in such Proposed Publication, subject to the process in this Section 10.5. The proposing Party will require its Affiliates, (sub)licensees (in case that Leads Bio is the proposing Party), Sublicensees (in case that Licensee is the proposing Party) and Subcontractors to comply with the obligations of this Section 10.5 as if they were the proposing Party, and will be liable for their non-compliance.
10.6 Publication and Listing of Clinical Trials. Each Party agrees to comply, with respect to the listing of Clinical Trials or the publication of Clinical Trial results with respect to Licensed Products and to the extent applicable to its activities conducted under this Agreement, with any Applicable Laws or applicable court order, stipulations, consent agreements and settlements entered into by such Party; provided that any listings or publications made pursuant to this Section 10.6 will be considered a publication hereunder and will be subject to Section 10.5.
10.7 Prior Non-Disclosure Agreement. As of the Effective Date, the terms of this Article 10 will supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties (or their Affiliates) to the extent dealing with the subject of this Agreement. Any information disclosed by a Party pursuant to any such prior agreement relating to the subject to this Agreement will be deemed Confidential Information of such Party for purposes of this Agreement subject to the exceptions of Section 10.2.
10.8 Equitable Relief. Given the nature of the Confidential Information and the competitive damage that could result to a Party upon unauthorized disclosure, use or transfer of its Confidential
Information to any Third Party, the Parties agree that monetary damages may not be a sufficient remedy for any breach of this Article 10. In addition to all other remedies, a Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any breach or threatened breach of this Article 10.
Article 11REPRESENTATIONS AND WARRANTIES; LIMITATION OF LIABILITY
11.1 Mutual Representations and Warranties. Each Party represents and warrants to the other that, as of the Effective Date:
11.2 Additional Leads Bio Representations, Warranties and Covenants. Except as set forth in Schedule 11.2, Leads Bio represents and warrants to Licensee, as of the Effective Date, and as applicable, covenants, as follows:
11.3 Additional Licensee Representations and Warranties. Licensee represents and warrants to Leads Bio, as of the Effective Date:
11.4 Mutual Covenants. In addition to any covenants made by the Parties elsewhere in this Agreement, each Party hereby covenants to the other that:
11.5 Performance by Affiliates, Sublicensees and Subcontractors. Each Party may perform some or all of its obligations under this Agreement through one or more Affiliates, Subcontractors or Sublicensees; provided, in each case, that (a) none of the other Party’s rights hereunder are diminished or otherwise adversely affected as a result of such delegation or subcontracting, and (b) each such Affiliate, Subcontractor or Sublicensee undertakes in writing obligations of confidentiality and non-use regarding Confidential Information and ownership of Inventions which are substantially the same as those set forth in Article 10 and Section 12.1; and provided, further, that each Party will at all times be fully responsible for the performance and payment of such Affiliate, subcontractor or Sublicensee.
11.6 Disclaimer. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY PATENT RIGHTS OR KNOW-HOW, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE AND NON-INFRINGEMENT OF ANY THIRD PARTY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHT.
Article 12INTELLECTUAL PROPERTY
12.1 Ownership.
12.2 Patent Right Prosecution and Maintenance.
12.3 Infringement by Third Parties.
12.4 Infringement of Third Party Rights. In the event that a claim is brought against either Party alleging the infringement, violation or misappropriation of any Third Party intellectual property right based on the Exploitation of the Licensed Products (“Third Party Infringement Claims”), each Party will promptly notify the other Party in writing of such Third Party Infringement Claim, and the Parties will promptly meet to discuss the defense of such Third Party Infringement Claim, and the Parties will, as appropriate, enter into a joint defense agreement with respect to the common interest privilege protecting communications regarding such Third Party Infringement Claim in a form reasonably acceptable to the Parties. Unless otherwise agreed in the joint defense agreement, each Party will have the right to defend any such Third Party Infringement Claims against it at its own expense as it reasonably determines appropriate; provided that the defending Party will not enter into any settlement, consent judgment or other disposition of any action or proceeding that would: (a) admit the invalidity of, or otherwise impair, any Licensed Intellectual Property without the prior written consent of Leads Bio or the Licensee Intellectual Property without the prior consent of Licensee, or (b) impose any liability or obligation on the other Party. Each Party will have the right, at its own respective expense, to be represented in any such action by counsel of its own respective choice.
12.5 Marking. To the extent required by law, Licensee will, and will cause its Affiliates and their Sublicensees to, mark the Licensed Products sold under this Agreement with the number of
each issued Licensed Product Patent Right and Jointly Owned Invention Patent Right that applies to the Licensed Products.
12.6 Patent Listings. On a Licensed Product-by-Licensed Product basis, as between the Parties, Licensee will have the sole right to make all patent listings of Licensed Product Patent Rights or Jointly Owned Invention Patent Rights with Regulatory Authorities with respect to such Licensed Product. Leads Bio will cooperate with Licensee’s reasonable requests in connection therewith, including meeting any submission deadlines, to the extent required or permitted by Applicable Laws.
12.7 Patent Right Term Extension. On a Licensed Product-by-Licensed Product basis, if elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in any country in the Licensee Territory with respect to any Licensed Product becomes available, upon Regulatory Approval or otherwise, then as between the Parties, Licensee will have the sole and exclusive right, but not the obligation, to file for patent term extension or supplemental protection certificates or their equivalents and to determine which issued patent to extend with respect to any Licensed Products in the Licensee Territory, except for Licensed Platform Patent Rights, for which Leads Bio will have the sole and exclusive right, but not the obligation, to file for such patent term extension or supplemental protection certificates. Leads Bio and its Affiliates will reasonably cooperate with Licensee so as to enable Licensee to exercise its rights under this Section 12.7.
Article 13TERM; TERMINATION
13.1 Term. The term of this Agreement (the “Term”) will commence on the Effective Date, and unless terminated earlier as provided in this Article 13, will expire upon the expiration of the final Royalty Term with respect to all Licensed Products.
13.2 Termination.
13.3 Alternative Remedy in Lieu of Termination. If Licensee has the right to terminate this Agreement pursuant to Section 13.2(b) for Leads Bio’s uncured material breach, then, in lieu of terminating this Agreement, Licensee may, in its sole discretion and as its sole remedy for the facts underlying the applicable uncured specific breach, exercise an alternative remedy for such uncured material breach as follows, which Leads Bio stipulates and agrees would be a reasonable remedy in such circumstance and not a penalty: Licensee may retain all of its licenses and other rights granted under this Agreement, subject to all of its payment and other obligations, except that to the extent not yet accrued, the commercial milestone payments, and the royalties payable thereafter under this Agreement, in each case, will be reduced by [***] effective from and after the delivery of the applicable notice of breach.
13.4 Effect of Expiration or Termination.
13.5 Accrued Obligations; Survival. Neither expiration nor any termination of this Agreement will relieve either Party of any obligation or liability accruing prior to such expiration or termination, nor will expiration or any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law or in equity, with respect to breach of this Agreement. In addition, the Parties’ rights and obligations under Sections 2.1(c) (Licensed BDCA2 Linker Improvements Grant), 2.4 (No Implied Licenses; Retained Rights), 2.5 (except clause (a) and solely to the extent provided in Section 13.4(c)(ii)), 2.6 (Sublicenses, Subcontractors, and Related Responsibility) (solely to the extent of any surviving license), 4.2(e) (Global Development Plan) and 4.2(f) (Shared Study) (solely with respect to any amounts accrued but not yet paid), 5.6(a), 5.9 (Data Security Program) (as related to any surviving license under Section 5.6(a)), 7.5 (Trademarks) (the third sentence only), 12.1 (Ownership), 12.2 (Patent Right Prosecution and Maintenance) and 12.3 (Infringement by Third Parties) (solely with respect to the Jointly Owned Invention Patent Rights), 13.5 (Accrued Obligations; Survival), 13.6 (Rights in Bankruptcy), 14.1 (Indemnification of Leads Bio), 14.2 (Indemnification of Licensee), 14.3 (Procedure), 14.4 (Insurance) (for the period set forth therein), 14.5 (Limitation of Liability), and Article 1 (to the extent necessary to construe the other surviving provisions), Article 9 (Payment; Records; Audits) (solely with respect to payments accrued prior to the effective date of such expiration or termination but not yet paid, except Section 9.5 (Records; Audits) (which will survive for the period set forth therein)), Article 10 (Confidentiality), Article 15 (Dispute Resolution), Article 16 (Miscellaneous) of this Agreement will survive expiration or any termination of this Agreement; Section 13.4(a) will survive only expiration of this Agreement; and Section 13.4(b) and 13.4(c) will survive only termination of this Agreement.
13.6 Rights Upon Bankruptcy.
Article 14INDEMNIFICATION
14.1 Indemnification of Leads Bio. Licensee will indemnify and hold harmless each of Leads Bio and its Affiliates and their respective directors, officers, employees, consultants, agents and successors and assigns of any of the foregoing (the “Leads Bio Indemnitees”) from and against any and all losses, damages, liabilities, expenses and costs, including reasonable legal expense and attorneys’ fees (“Losses”), incurred by any Leads Bio Indemnitee as a result of any claims, demands, actions, suits or proceedings brought by a Third Party (“Third Party Claims”) arising directly or indirectly out of: (a) the Exploitation of the Compounds or the Licensed Products by Licensee or its Affiliates or Sublicensees; (b) the gross negligence or willful misconduct of any Licensee Indemnitee; or (c) any breach of any representations, warranties or covenants by Licensee under this Agreement; except, in each case, to the extent such Third Party Claims fall within the scope of the indemnification obligations of Leads Bio set forth in Section 14.2.
14.2 Indemnification of Licensee. Leads Bio will indemnify and hold harmless each of Licensee and its Affiliates and their respective directors, officers, employees, consultants, agents and successors and assigns of any of the foregoing (the “Licensee Indemnitees”), from and against any and all Losses incurred by any Licensee Indemnitee as a result of any Third Party Claims arising directly or indirectly out of: (a) the Exploitation of the Compounds or Licensed Products by Leads Bio or its Affiliates; (b) the gross negligence or willful misconduct of any Leads Bio Indemnitee; or (c) any breach of any representations, warranties or covenants by Leads Bio under this Agreement; except, in each case, to the extent such Third Party Claims fall within the scope of the indemnification obligations of Licensee set forth in Section 14.1.
14.3 Procedure. If any Leads Bio Indemnitee or Licensee Indemnitee intends to claim indemnification under this Article 14 (the “Indemnitee”), Leads Bio or Licensee, as the case may be, will promptly notify the indemnifying Party (the “Indemnitor”) in writing of any Third Party Claim, in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor will have sole control of the defense or settlement thereof. The indemnity arrangement in this Article 14 will not apply to amounts paid in settlement of any action with respect to a Third Party Claim, if such settlement is effected without the consent of the Indemnitor, which consent will not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Third Party Claim will only relieve the Indemnitor of its indemnification obligations under this Article 14 if and to the extent the Indemnitor is actually prejudiced thereby. Leads Bio or Licensee, as the case may be, and the Indemnitee will cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Third Party Claim covered by
these indemnification provisions. The Indemnitor will not settle any Third Party Claim without the prior written consent of the Indemnitee if the settlement: (a) results in or imposes any obligation (including any payment obligation) on the Indemnitee, or (b) results in any admission of wrong-doing or fault by the Indemnitee.
14.4 Insurance. Each Party, at its own expense, will maintain product liability and other appropriate insurance in an amount consistent with sound business practice and reasonable in light of its obligations under this Agreement during the Term and for [***] thereafter. Each Party will provide a certificate of insurance (or evidence of self-insurance) evidencing such coverage to the other Party upon request.
14.5 Limitation of Liability. NEITHER PARTY WILL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 14.5 IS INTENDED TO OR WILL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 14.1 OR 14.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS CONFIDENTIALITY OR NON-USE OBLIGATIONS IN ARTICLE 10 OR A PARTY’S BREACH OF SECTION 2.8.
Article 15DISPUTE RESOLUTION
15.1 Disputes. Subject to Section 15.3, upon the written request of either Party to the other Party, any claim, dispute, or controversy as to the breach, enforcement, interpretation or validity of this Agreement (a “Dispute”) will be referred to the Executive Officers for resolution. In the event such executives are unable to resolve such Dispute within [***] after the initial written request, then, upon the written demand of either Party and subject to Section 15.3 below, the Dispute will be finally resolved by binding arbitration administered by the Singapore International Arbitration Centre (“SIAC”) (or any successor entity thereto) pursuant to its arbitration rules and procedures then in effect (the “Rules”), as modified by Section 15.2 below. Notwithstanding the foregoing, in the event of a dispute with respect to Section 1.136, the provisions of Section 15.3 will apply.
15.2 Arbitration.
15.3 Baseball Arbitration. Notwithstanding anything to the contrary herein, Section 15.2 will not apply with respect to disputes arising under Section [***], which will be resolved in accordance with the procedures set forth in Schedule 15.3.
15.4 Court Actions. Nothing contained in this Agreement will deny either Party the right to bring an action in any court of competent jurisdiction to resolve any dispute, controversy or claim that concerns (a) the validity, enforceability or infringement of any Patent Rights or other intellectual property rights, or (b) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory, and no such claim will be subject to arbitration as a Dispute pursuant to Section 15.2.
Article 16MISCELLANEOUS
16.1 Governing Law. This Agreement and any disputes, claims, or actions related thereto will be governed by and construed in accordance with the laws of Singapore, without regard to the conflicts of law provisions thereof.
16.2 Entire Agreement; Amendment. This Agreement, including the Schedules hereto, sets forth all of the agreements and understandings between the Parties with respect to the subject matter hereof and thereof, and supersedes and terminates all prior agreements and understandings between the Parties with respect to the subject matter hereof and thereof, including the Confidentiality Agreement. The Confidentiality Agreement is hereby terminated effective as of the Effective Date. Except as expressly set forth in this Agreement, no subsequent amendment, modification or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by the respective authorized officers of the Parties.
16.3 Further Assurances. Each Party will duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary or as any other Party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other Party its rights and remedies under this Agreement.
16.4 Relationship Between the Parties. The Parties’ relationship, as established by this Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture or similar business relationship or legal entity of any type between the Parties. Neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever. Neither Party will treat or report the relationship arising under this Agreement as a partnership for United States tax purposes unless otherwise required pursuant to a determination within the meaning of Section 1313 of the Internal Revenue Code of 1986, as amended.
16.5 Non-Waiver. The failure of a Party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement will neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a Party of a particular provision or right will be in writing, will be as to a particular matter and, if applicable, for a particular period of time and of a particular scope, and will be signed by such Party.
16.6 Assignment. Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned by a Party without the prior written consent of the other Party (which will not be unreasonably withheld, conditioned or delayed), except to (a) an Affiliate; provided that this Agreement will be assigned in whole, and the assigning Party will remain liable and responsible to the non‑assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate; (b) subject to Section 2.9 a Third Party in connection with the sale of all or substantially all of its assets to which this Agreement relates, whether in a sale of stock, sale of assets, business combination, reorganization, or other transaction or series of related transactions. Subject to Leads Bio’s obligations under this Agreement, including Section 11.2(s), Leads Bio may assign without the prior consent of Licensee its right to receive payments under this Agreement, or grant any security interest in its rights, title and interest in this Agreement, in whole or in part and in their entirety or in portions, to one or more Third Parties in connection with a financing transaction; provided that Leads Bio has given Licensee written notice regarding such assignment or financing transaction, and may disclose
without the consent of Licensee reports and notices relating to such payments to such Third Parties to the extent reasonably necessary to facilitate such transaction. The rights and obligations of the Parties under this Agreement will be binding upon and inure to the benefit of the permitted assigns of the Parties. Any assignment not in accordance with this Agreement will be void.
16.7 Third Party Beneficiaries. This Agreement is not intended to and will not be construed to give any Third Party any interest or rights (including any third party beneficiary rights) with respect to or in connection with any agreement or provision contained herein or contemplated hereby.
16.8 Severability. If, for any reason, any part of this Agreement is adjudicated invalid, unenforceable or illegal by a court of competent jurisdiction, such adjudication will not affect or impair, in whole or in part, the validity, enforceability or legality of any remaining portions of this Agreement. All remaining portions will remain in full force and effect as if the original Agreement had been executed without the invalidated, unenforceable or illegal part. The Parties will use their commercially reasonable efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) in a way that, to the extent practicable and legally permissible, implements the original intent of the Parties.
16.9 Notices. Any notice required or permitted to be given by a Party to the other Party (other than day-to-day communications) under this Agreement will be in writing and will be deemed given only (a)when delivered to the other Party personally (with receipt) or via overnight internationally recognized courier service (including Federal Express or DHL) charges prepaid with tracking capabilities, in each case at the applicable address as indicated below, or to such other address as provided in writing in accordance with this Section 16.9. Notices can also be transmitted via electronic mail but will not be deemed delivered until a hard copy has been provided in accordance with this Section 16.9, which hard copy will constitute notice hereunder.
16.10 Force Majeure. Each Party will be excused from liability for the failure or delay in performance of any obligation under this Agreement by reason of any event beyond such Party’s reasonable control including but not limited to acts of God, fire, flood, explosion, earthquake, or other natural forces, regional or worldwide epidemic, pandemic, war, civil unrest, acts of terrorism, labor disturbances (other than labor disturbances involving a Party’s own employees), government actions, accident, destruction or other casualty (a “Force Majeure Event”). Such excuse from liability will be effective only for so long as such failure or delay continues to be caused by or result from the Force Majeure Event and provided that the Party has not caused such event(s) to occur. The Party affected by a Force Majeure Event will notify the other Party of such circumstances, its anticipated duration, and any action being taken to avoid or minimize its effect as soon as reasonably practicable, use Commercially Reasonable Efforts to resume performance of its obligations, and will keep the other Party informed of actions related thereto.
16.11 Export Control. This Agreement is made subject to any restrictions concerning the export, reexport or transfer of items or technical data from the United States, China or other countries that may be applicable to either from time to time, including U.S. or China export control and sanctions laws and regulations. Neither Party will export, reexport or transfer, directly or indirectly, any items or technical data acquired from the other Party under this Agreement or any products using such items or technical data to a location, to an end use or end user or in a manner that requires a license or other governmental approval, without first obtaining such license or other governmental approval.
16.12 English Language. This Agreement was prepared in the English language, which language will govern the interpretation of, and any dispute regarding, the terms of this Agreement and will be the language of all communications under or in connection with this Agreement. Any translation into or communication in any other language will not be an official version thereof and in the event of any conflict in interpretation between the English version and another language, the English version will control.
16.13 Interpretation. The headings of clauses contained in this Agreement preceding the text of the sections, subsections and paragraphs hereof are inserted solely for convenience and ease of reference only and will not constitute any part of this Agreement, or have any effect on its interpretation or construction. All references in this Agreement to the singular will include the
plural where applicable. Unless otherwise specified, references in this Agreement to any Article will include all Sections, subsections and paragraphs in such Article, references to any Section will include all subsections and paragraphs in such Section, and references in this Agreement to any subsection will include all paragraphs in such subsection. The word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another. The word “including” and similar words means “including without limitation,” whether or not specifically stated. The word “or” means “and/or” unless the context dictates otherwise because the subject of the conjunction are mutually exclusive. The words “herein,” “hereof” and “hereunder” and other words of similar import refer to this Agreement as a whole and not to any particular Section or other subdivision. The words “pharmaceuticals” or “drugs” include biologics unless expressly indicated otherwise. All references to a “country” will include a region or jurisdiction as the context requires. All references to days in this Agreement means calendar days, unless otherwise specified. All references to any Applicable Laws in this Agreement means such Applicable Laws as amended, restated, supplanted or otherwise modified from time to time. Ambiguities and uncertainties in this Agreement, if any, will not be interpreted against either Party, irrespective of which Party may be deemed to have caused the ambiguity or uncertainty to exist.
16.14 Construction. The Parties hereto acknowledge and agree that: (a) each Party and its counsel reviewed and negotiated the terms and provisions of this Agreement and have contributed to its revision; (b) the rule of construction to the effect that any ambiguities are resolved against the drafting Party will not be employed in the interpretation of this Agreement; and (c) the terms and provisions of this Agreement will be construed fairly as to all Parties hereto and not in a favor of or against any Party, regardless of which Party was generally responsible for the preparation of this Agreement.
16.15 Counterparts; Electronic Signatures. This Agreement may be executed in two (2) or more counterparts, including by transmission of emailed or PDF copies of signature pages to the Parties or their representative legal counsel, each of which will be deemed an original document, and all of which, together with this writing, will be deemed one and the same instrument. Electronic or PDF image signatures will be treated as original signatures, with the understanding that each Party expressly agrees that such Party will be bound by its own electronically transmitted signature and will accept the electronically transmitted signature of the other Party (including through the use of eSignature platforms such as DocuSign®). No Party will raise the use of electronic delivery to transmit a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of electronic delivery as a defense to the formation of a contract.
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