Full Press Release Details
Aeterna Zentaris GmbH
Sinopharm A-think Pharmaceuticals Co., Ltd.
Dated as of 1 December 2014
| LICENSE AGREEMENT | 1 | |
| ARTICLE 1 DEFINITIONS | 1 | |
| ARTICLE 2 GRANT OF RIGHTS | 7 | |
| ARTICLE 3 DEVELOPMENT AND REGULATOR | 8 | |
| ARTICLE 4 COMMERCIALIZATION | 11 | |
| ARTICLE 5 MANUFACTURE AND SUPPLY | 12 | |
| ARTICLE 6 MILESTONE PAYMENTS; ROYALTIES | 12 | |
| ARTICLE 7 INTELLECTUAL PROPERTY | 15 | |
| ARTICLE 8 PHARMACOVIGILANCE AND SAFETY | 18 | |
| ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE | 19 | |
| ARTICLE 10 REPRESENTATIONS AND WARRANTIES | 21 | |
| ARTICLE 11 INDEMNITY | 23 | |
| ARTICLE 12 TERM AND TERMINATION | 24 | |
| ARTICLE 13 MISCELLANEOUS | 25 | |
| EXHIBIT A | 30 | |
| EXHIBIT B | 42 | |
| EXHIBIT C | 43 | |
| EXHIBIT D | 44 | |
| EXHIBIT E | 45 | |
| EXHIBIT F | 47 |
This License Agreement (this "Agreement") is entered into as of 1 December 2014 (the "Effective Date") by and between Aeterna Zentaris GmbH, a limited liability company organized under the laws of the Federal Republic of Germany, with its principal place of business at Weism llerstrasse 50, 60314 Frankfurt Germany ("AEZS"), and Sinopharm A-think Pharmaceuticals Co., Ltd., a company organized under the laws of the People's Republic of China with its registered address at No. 1, Yi Xin Road, Shuangyang Economic Development Zone, Changchun, Jilin Province, China ("Sinopharm"). AEZS and Sinopharm are sometimes referred to herein individually as a "Party" and collectively as the "Parties".
WHEREAS, the Tulane Educational Fund ("Tulane"), a Louisiana non-profit corporation is the proprietor of the Licensed Patents (as defined herein) under which AEZS is licensed, with the right to grant sub-licenses;
WHEREAS, AEZS controls certain intellectual property rights with respect to the Licensed Compounds (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein);
WHEREAS, AEZS wishes to grant to Sinopharm, and Sinopharm wishes to take, a license under such intellectual property rights to Develop (as defined herein) and Manufacture (as defined herein) the Licensed Compounds and the Licensed Products in the Territory, and to Commercialize (as defined herein) the Licensed Products in the Territory, in each case in accordance with the terms and conditions set forth below; and
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1 "Adverse Event" and "Adverse Experience" have the meaning set forth in Section 8.1. Such terms are synonyms and are used interchangeably in this Agreement.
1.2 "Adverse Reaction" has the meaning set forth in Section 8.2.
1.3 "Affiliate" means, with respect to a Party, any Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes of this definition, "control" and, with correlative meanings, the terms "controlled by" and "under common control with" means (a) the possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the ownership of voting securities, by contract relating to voting rights or corporate governance, or otherwise, or (b) the ownership, directly or indirectly, of more than 50% of the voting securities or other ownership interest of a business entity (or, with respect to a limited partnership or other similar entity, its controlling entity).
1.4 "Agreement" has the meaning set forth in the preamble hereto.
1.5 "Applicable Law" means applicable laws, rules and regulations, including any rules, regulations, guidelines or other requirements of the Regulatory Authorities that may be in effect from time to time.
1.6 "Accountant" has the meaning set forth in Section 6.9.
1.7 "AEZS" has the meaning set forth in the preamble hereto.
1.8 "Alliance Manager" has the meaning set forth in Section 3.1.2.
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1.9 "Approval Milestone" has the meaning set forth in Section 6.1.
1.10 "Business Day" means a day other than a Saturday or Sunday on which banking institutions in Beijing, China, Frankfurt, Germany or New York, USA are not closed.
1.11 "Calendar Quarter" means each successive period of three calendar months commencing on January 1, April 1, July 1 and October 1.
1.12 "Calendar Year" means each successive period of 12 calendar months commencing on January 1 and ending on December 31.
1.13 "CFDA" shall mean the China Food and Drug Administration in the PRC and any successor governmental authority having substantially the same function.
1.14 "Clinical Data" means all data, reports and results with respect to the Licensed Compounds and the Licensed Products made, collected or otherwise generated under or in connection with the Clinical Studies.
1.15 "Clinical Studies" means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.
1.16 "Combination Product" means a Licensed Product that consists of or contains a Licensed Compound as an active ingredient together with (a) one or more other active ingredients and is sold either as a fixed dose or as separate doses in a single package; or (b) a delivery device where such delivery device is sold with the Licensed Product as a single package (such other active ingredient(s) and/or delivery device).
1.17 "Commercial Milestone" has the meaning set forth in Section 6.2.
1.18 "Commercialization" means, with respect to a Licensed Product, any and all activities (whether before or after Regulatory Approval) directed to the marketing, promotion and sale of such Licensed Product in the Field in the Territory after all the Regulatory Approvals for commercial sale have been obtained, including pre-launch and post-launch marketing, promoting, marketing research, distributing, offering to commercially sell and commercially selling such Licensed Product, importing, exporting or transporting such Licensed Product for commercial sale, medical education activities with respect to such Licensed Product, conducting Clinical Studies that are not required to obtain or maintain Regulatory Approval for such Licensed Product for an indication, which may include epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored studies and health economics studies and regulatory affairs (including interacting with Regulatory Authorities) with respect to the foregoing. When used as a verb, "Commercializing" means to engage in Commercialization and "Commercialize" and "Commercialized" shall have corresponding meanings.
1.19 "Commercially Reasonable Efforts" means the level of efforts and resources comparable to the efforts and resources commonly used in the research-based biopharmaceutical industry by companies in the Territory with resources and expertise similar to those of Sinopharm (including its Affiliates) for compounds or products of similar market potential as the Licensed Products and at a similar stage in development or product life as the Licensed Products, taking into consideration market exclusivity, profitability, market potential, potential competition and other relevant factors. "Commercially Reasonable Efforts" shall be determined on a product-by-product and an indication-by- indication basis.
1.20 "Confidential Information" has the meaning set forth in Section 9.1.
1.21 "Controlled" means, with respect to any Information and Invention, Regulatory Documentation, Patent or other intellectual property right, that the Party or one or more of its Affiliates owns or has a license to such Information and Invention, Regulatory Documentation, Patent or intellectual property right and has the ability to grant to the other Party access, a license or a sublicense (as applicable) thereto as provided for herein without violating the terms of any agreement or other arrangements with any Third Party existing at the time such Party would be first required hereunder to grant the other Party such access, license or sublicense.
[*] Confidential Treatment Requested
1.22 "DAL" shall mean the Drug Administration Law of the PRC, as amended from time to time.
1.23 "Development" means, with respect to a Licensed Product, all activities related to research, preclinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, Manufacture Process Development, Clinical Studies, including Manufacturing in support thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications, regulatory affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval for the Licensed Compounds and/or Licensed Products. When used as a verb, "Develop" means to engage in Development.
1.24 "Development Plan" means the plan for the Development of the Licensed Compounds and the Licensed Products as described in Section 3.1.3, as updated from time to time by the Parties pursuant to Section 3.1.3.
1.25 "Disclosing Party" has the meaning set forth in Section 9.1.
1.26 "DMF" shall mean a Drug Master File maintained with the FDA or its equivalent maintained with any Regulatory Authority.
1.27 "DOH" shall mean the Drug Office of the Department of Health in Hong Kong and any successor governmental authority having substantially the same function.
1.28 "Dollars" or "$" means United States Dollars.
1.29 "Drug Approval Application" means a New Drug Application (an "NDA") as defined in the DAL or the US Food, Drug and Cosmetic Act and the regulations promulgated thereunder (including all additions, supplements, extensions and modifications thereto), or any corresponding substantially equivalent application in the Territory, including, with respect to the European Union, a Marketing Authorization Application (an "MAA") filed with the EMA pursuant to the centralized approval procedure or with the applicable Regulatory Authority of a country in Europe with respect to the mutual recognition or any other national approval procedure.
1.30 "Effective Date" has the meaning set forth in the preamble hereto.
1.31 "Expansion Indication" has the meaning set forth in Section 2.3.
1.32 "Exploit" means, (a) with respect to a Licensed Product, to import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture, have Manufactured (provided that Sinopharm procures that each third party manufacturer shall enter into a confidentiality and non-disclosure agreement directly with AEZS on terms at least as restrictive as those set out in Article 9), distribute, promote or market, such Licensed Product, and (b) with respect to a Licensed Compound, to research, Develop, register, Manufacture or use such Licensed Compound.
1.33 "Exploitation" means the act of Exploiting a Licensed Product or a Licensed Compound.
1.34 "FDA" means the United States Food and Drug Administration and any successor agency thereto.
1.35 "Field" means all human use of the Licensed Products, including in the Initial Indication and in any Expansion Indications.
1.36 "First Commercial Sale" means, with respect to a Licensed Product in the Territory, the first commercial sale in the Territory for monetary value for use or consumption by the general public of such Licensed Product in the Territory after all the Regulatory Approvals from the relevant Regulatory Authorities have been obtained for the Licensed Compound and such Licensed Product in the Territory, including the approval of the Drug Approval Application and the pricing and reimbursement approval by the relevant Regulatory Authority. Sales prior to the approval
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of the applicable Drug Approval Application, such as so-called "treatment IND sales", "named patient sales" and "compassionate use sales", shall not constitute a First Commercial Sale.
1.37 "Improvements" has the meaning set forth in Section 7.2.
1.38 "HB" shall mean the Health Bureau in Macau and any successor governmental authority having substantially the same function.
1.39 "IND" means an investigational new drug application filed with the CFDA, the FDA or other Regulatory Authorities for authorization to commence Clinical Studies in the applicable jurisdiction (including all additions, supplements, extensions and modifications thereto).
1.40 "Indemnified Party" has the meaning set forth in Section 11.3.
1.41 "Indemnifying Party" means the Party from whom indemnification is sought pursuant to Section 11.3.
1.42 "Indication" means the Initial Indication or an Expansion Indication.
1.43 "Information and Inventions" means all technical, scientific and other know- how and information, trade secrets, knowledge, technology, means, methods, protocols, assays, structures, sequences, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including pre-clinical trial results and Clinical Study results, Manufacturing procedures, test procedures, and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing.
1.44 "Initial Indication" means the use for endometrial cancer.
1.45 "Joint Information and Inventions" has the meaning set forth in Section 7.2.
1.46 "Joint Steering Committee" or "JSC" has the meaning set forth in Section 3.2.1.
1.47 "LIBOR" means the London Interbank Offered Rate for deposits in Dollars having a maturity of one month published by the British Bankers' Association, as adjusted from time to time on the first London business day of each month.
1.48 "Licensed Compounds" means: Zoptarelin doxorubicin acetate (AEZS-108), with the structure described in Exhibit D attached hereto, or any of its metabolites, polymorphs, salts, esters, free acid forms, free base forms, pro drug forms, racemates or optically active forms, collectively.
1.49 "Licensed Know-How" shall mean, whether patentable or not, all the research and development information or data related to the use or Manufacture of a Licensed Compound, or those related to the Manufacture, formulation, marketing, use, sale or distribution of a Licensed Product, which are not generally known and are Controlled by AEZS or its Affiliates as of the Effective Date or thereafter become Controlled by AEZS or its Affiliates including but not limited to those items listed on Exhibit A.
1.50 "Licensed Patents" means (a) the national, regional and international patents and patent applications relating to the Licensed Compounds and Licensed Products, including provisional patent applications which are Controlled by AEZS or one or more of its Affiliates as of the Effective Date, or which thereafter become Controlled by AEZS or its Affiliates, including but not limited to those set forth on Exhibit B, (b) all patent applications filed from any of the foregoing provisional patent applications in clause (a), (c) all patent applications that claim priority to any patent or patent applications in clause (a) or clause (b), including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications, (d) any and all patents that have issued or in the future issue from any of foregoing patent applications in clause (a), clause (b) or clause (c), including utility models, petty patents and design patents and certificates of invention, and (e) any and all extensions or restorations
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by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of any of the foregoing patents or patent applications in clause (a), clause (b), clause (c) or clause (d).
1.51 "Licensed Product" means any pharmaceutical product containing a Licensed Compound, alone or in the form of a Combination Product, including but not limited to those listed in Exhibit E.
1.52 "Losses" has the meaning set forth in Section 11.1.
1.53 "Manufacture" and "Manufacturing" means, with respect to a Licensed Compound or a Licensed Product, all activities related to the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, holding, Manufacture Process Development, stability testing, quality assurance or quality control of such Licensed Compound or a Licensed Product or any intermediate thereof.
1.54 "Manufacture Process Development" means the process development, process qualification and validation and scale-up of the process to manufacture a Licensed Compound or a Licensed Product and analytic development and product characterization with respect thereto, which includes both clinical process and commercial process development.
1.55 "Markings" has the meaning set forth in Section 4.6.
1.56 "Milestone Event" means any of the Approval Milestones and Commercial Milestones.
1.57 "NDA" has the meaning set forth in the definition of "Drug Approval Application."
1.58 "Net Sales" means [*] [Exclusion of confidential information related to calculation of the royalty]
Net Sales will be adjusted according to Section 6.3.2 if the Licensed Product is sold in the form of a Combination Product.
For clarity, sales by Sinopharm or its Affiliate or Sublicensee to any distributor, wholesaler, purchasing entity, hospitals, pharmacy or the like will be included in the Net Sales calculations, but further sales by any distributor, wholesaler, purchasing entity, hospitals, pharmacy or the like will not be included in the Net Sales calculation.
1.59 "On-going Clinical Trials" means those Clinical Studies listed on Exhibit F hereto.
1.60 "Option Compounds" means any compound developed by AEZS or its Affiliates to reach the same target in human cells as any Licensed Compound, by using a different structure to any Licensed Compound, but excluding the Licensed Compounds.
1.61 "Party" and "Parties" each has the meaning set forth in the preamble hereto.
1.62 "Patents" means (a) all national, regional and international patents and patent applications, including provisional patent applications, (b) all patent applications filed from any of the foregoing provisional patent applications in clause (a), (c) all patent applications that claim priority to any patent or patent applications in clause (a) or clause (b), including divisionals, continuations, continuations-in-part, provisionals, converted provisionals and continued prosecution applications, (d) any and all patents that have issued or in the future issue from any of foregoing patent applications in clause (a), clause (b) or clause (c), including utility models, petty patents and design patents and certificates of invention, and (e) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of any of the foregoing patents or patent applications in clause (a), clause (b), clause (c) or clause (d).
1.63 "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.
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1.64 "Product Infringement" has the meaning set forth in Section 7.6.1.
1.65 "Product Labeling" means, with respect to a Licensed Product, (a) the full prescribing information approved by the CFDA for such Licensed Product in the Territory, including any required patient information and (b) all labels and other written, printed or graphic matter upon an container, wrapper or any package insert utilized with or for such Licensed Product in the Territory.
1.66 "Product Trademarks" means the Trademark(s) to be used by Sinopharm or its Related Parties for the Commercialization of the Licensed Products in the Field in the Territory and any registrations thereof or any pending applications relating thereto in the Territory.
1.67 "Receiving Party" has the meaning set forth in Section 9.1.
1.68 "Regulatory Approval" means:with respect to a Licensed Product, any and all approvals (including Drug Approval Applications), licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market such Licensed Product in the Territory when used with reference to Sinopharm, or outside the Territory when used with reference to AEZS, including, where applicable, (a) pricing or reimbursement approval in the Territory, (b) pre- and post-approval marketing authorizations, (c) any prerequisite Manufacturing approval or authorization for the Licensed Product and the Licensed Compound for the Licensed Product), and (d) Product Labeling approval;
1.69 "Regulatory Authority" means any applicable supra-national, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of a Licensed Compound or a Licensed Product in the Territory when used in the context of Sinopharm, or outside the Territory when used with reference to AEZS.
1.70 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including all Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files and (c) Clinical Data and any other data contained in any of the foregoing, in each case ((a), (b) and (c)), relating to the Licensed Compounds or the Licensed Products.
1.71 "Related Party" shall mean any Affiliate of a Party and any licensee or Sublicensee of such Party, but excluding distributors.
1.72 "ROFR" has the meaning set forth in Section 2.4.
1.73 "Royalty Term" means, with respect to each Licensed Product, the period beginning on the [][Exclusion of confidential information related to calculation of the royalty], and ending on the latter to occur of: [] [Exclusion of confidential information related to calculation of the royalty].
1.74 "Serious" has the meaning set forth in Section 8.3.
1.75 "Sinopharm" has the meaning set forth in the preamble hereto.
1.76 "Sinopharm Indemnitee" has the meaning set forth in Section 11.1.
1.77 "Sublicensee" means a Person, other than an Affiliate of Sinopharm, that is granted a sublicense by Sinopharm under and in accordance and compliance with this Agreement.
1.78 "Territory" means the People's Republic of China including Hong Kong and Macao.
1.79 "Third Party" means any Person other than AEZS, Sinopharm and their respective Affiliates.
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1.80 "Third Party License" has the meaning set forth in Section 6.3.3.