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12.18 Counterparts ....................................................................................................... 72 |
EXHIBITS AND SCHEDULES |
Exhibit A CollPlant Collagen |
Exhibit B Sterile 20 Project Development Plan |
Exhibit C Sterile 50 Project Development Plan |
Exhibit D Lyophilized Low Bioburden Project Development Plan |
Exhibit E Specifications |
Schedule 1.26 CollPlant Patents |
Schedule 2.5 Supply Agreement Term Sheet |
Schedule 9.2 CollPlant Disclosure Schedule |
Schedule 9.2.3 Existing Patent Rights |
Schedule 9.2.10 Disputes |
Schedule 9.2.16 Use of Academic Facilities and Personnel |
Schedule 12.2.2 ADR |
DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT |
This DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT (this "Agreement") is entered into and made effective as of February 5, 2021 (the "Effective Date"), by and between, on the one hand, CollPlant Ltd., an Israeli company, having its principal place of business at Oppenheimer 4 Rehovot, Israel ("CollPlant"), and... |
RECITALS |
WHEREAS, CollPlant is a regenerative and aesthetic medicine company developing technologies and products for tissue regeneration, including the CollPlant Collagen; |
WHEREAS, AbbVie and its Affiliates possess expertise in the research, development, manufacturing and commercialization of human pharmaceuticals and devices, including medical aesthetics; |
WHEREAS, CollPlant and AbbVie desire to engage in a collaborative effort in which CollPlant will carry out certain development activities set forth in the Development Plans (as defined herein); |
WHEREAS, AbbVie desires to acquire from CollPlant and CollPlant desires to grant to AbbVie the Exclusivity Rights (as defined herein), and CollPlant desires to grant to AbbVie a right of first negotiation for Option Products (as defined herein), in each case as set forth in, and subject to the terms of, this Agreement;... |
WHEREAS, the Parties will enter into the Supply Agreement (as defined herein) in accordance with the terms of this Agreement, and CollPlant will supply CollPlant Collagen to AbbVie in accordance with the terms of the Supply Agreement. |
NOW, THEREFORE, in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows: |
ARTICLE 1 - DEFINITIONS |
As used in this Agreement, the following terms will have the meanings set forth in this Article 1 - (Definitions) unless context dictates otherwise: |
1.1 "AbbVie" has the meaning set forth in the Preamble. |
1.2 "Accounting Standards" means, with respect to a Party or its Affiliates or its or their (sub)licensees, United States generally accepted accounting principles or International Financial Reporting Standards as issued by the International Accounting Standards Board, as applicable, in each case consistently applied. |
1.3 "ADR" has the meaning set forth in Section 12.2.1 (General). |
1.4 "Adverse Ruling" has the meaning set forth in Section 11.2.1(a) (Material Breach). |
1.5 "Affiliate" means, with respect to a Person, any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such first Person for so long as such Person controls, is controlled by or is under common control with such first Person, regardless of... |
1.6 "Agreement" has the meaning set forth in the Preamble. |
1.7 "APIL" has the meaning set forth in the Preamble. |
1.8 "Audit Arbitrator" has the meaning set forth in Section 6.10.2 (Audit Dispute). |
1.9 "Board of Directors" has the meaning set forth in Section 1.16.1 (Change of Control). |
1.10 "Breaching Party" has the meaning set forth in Section 11.2.1(a) (Material Breach). |
1.11 "Business Day" means a day other than a Friday, Saturday or Sunday on which banking institutions in Chicago, Illinois and Tel Aviv, Israel are open for business. |
1.12 "Calendar Quarter" means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively, except that the first Calendar Quarter of the Term shall commence on the Effective Date and end on the day immediately prior to the first to occur of January 1, April 1, Ju... |
1.13 "Calendar Year" means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31, except that the first Calendar Year of the Term shall 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 shall ... |
1.14 "CDA" has the meaning set forth in Section 12.12 (Entire Agreement; Amendments). |
1.15 "cGMP" means the current Good Manufacturing Practices as provided for (and as amended from time to time) as applicable in the International Standard ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes in the ISO 13485, MDSAP requirements and rest of world GMP requirem... |
1.16 "Change of Control" with respect to a Party, shall be deemed to have occurred if any of the following occurs after the Effective Date: |
1.16.1 any "person" or "group" (as such terms are defined below) (a) is or becomes the "beneficial owner" (as defined below), directly or indirectly, of shares of capital stock or other interests (including partnership interests) of such Party then outstanding and normally entitled (without regard to the occurrence of ... |
1.16.2 such Party enters into a merger, consolidation or similar transaction with another Person (whether or not such Party is the surviving entity) and as a result of such merger, consolidation or similar transaction (a) the members of the Board of Directors of such Party immediately prior to such transaction constitu... |
1.16.3 the holders of capital stock of such Party approve a plan or proposal for the liquidation or dissolution of such Party. |
1.16.4 For the purpose of this definition of Change of Control, (a) "person" and "group" have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term "group" includes any group acting for the purpose of acquiring, holding or disposing of securities w... |
1.17 "Clinical Data" means all Know-How with respect to any Exclusive Product, which Know-How is made, collected, or otherwise generated under or in connection with Clinical Trials or Phase 4 Clinical Trial, including any data (including raw data), reports, and results of analysis with respect thereto. |
1.18 "Clinical Trial" means a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial, Pivotal Clinical Trial, or any other study in which human subjects or patients are dosed with a drug or given a medical device, whether approved or investigational. |
1.19 "Code" means the Internal Revenue Code of 1986, as amended. |
1.20 "CollPlant" has the meaning set forth in the Preamble. |
1.21 "CollPlant Collagen" means (a) CollPlant's proprietary type I recombinant human collagen produced in genetically engineered tobacco plants, as detailed in Exhibit A (CollPlant Collagen) ("rhCollagen") and any altered, modified or improved forms thereof that are developed by or on behalf of CollPlant or its Affilia... |
1.22 "CollPlant Know-How" means all Know-How that (a) is Controlled by CollPlant or any of its Affiliates as of the Effective Date or at any time during the Term, (b) is not generally known and (c) is related to CollPlant Collagen (including analytical methods related thereto) and is reasonably necessary or useful for ... |
1.23 "CollPlant Option Product Know-How" means, with respect to an Option Product, all Know-How that (a) is Controlled by CollPlant or any of its Affiliates as of the effective date of the applicable definitive agreement entered into pursuant to Section 2.3 (Right of First Negotiation for Option Products) or at any tim... |
1.24 "CollPlant Option Product Patents" means, with respect to an Option Product, all Patent Rights Controlled by CollPlant or any of its Affiliates as of the effective date of the applicable definitive agreement entered into pursuant to Section 2.3 (Right of First Negotiation for Option Products) or at any time during... |
1.25 "CollPlant Option Product Technology" means the CollPlant Option Product Know-How and CollPlant Option Product Patents. |
1.26 "CollPlant Patents" means (a) all Patent Rights set forth on Schedule 1.26 (CollPlant Patents), and (b) all Patent Rights Controlled by CollPlant or any of its Affiliates as of the Effective Date or at any time during the Term that (i) claim the CollPlant Collagen or components thereof, or a composition containing... |
1.27 "CollPlant Other Proprietary Technology" means (a) CollPlant's proprietary formulations for (i) 3D Bioprinting and (ii) anti-viral agents to treat COVID-19; (b) CollPlant's proprietary products, including Vergenix™ STR and Vergenix™ FG (Flowable Gel); (c) any formulation of resilin proprietary to CollPlant; and (d... |
1.28 "CollPlant Technology" means the CollPlant Know-How, CollPlant Patents and CollPlant Inventions. |
1.29 "Combination Product" means an Exclusive Product that contains (a) one or more applicable Primary Component(s) for such Exclusive Product and (b) one (1) or more other active ingredients or medical devices that are not Primary Components (each of such other active ingredients and medical devices, an "Other Compone... |
1.30 "Commercialization" and "Commercialize" means any and all activities related to the preparation for sale of, offering for sale of, or sale of a product, including activities related to marketing, promoting, distributing, importing and exporting such product, and, for purposes of setting forth the rights and obliga... |
1.31 "Commercially Reasonable Efforts" means, (a) with respect to the efforts and resources to be expended by AbbVie with respect to any objective, activity or decision to be undertaken with respect to the Development or Commercialization of an Exclusive Product, the reasonable efforts and resources to accomplish such ... |
1.32 "Committee" has the meaning set forth in Section 3.2(d) (Responsibilities). |
1.33 "Competitive Infringement" has the meaning set forth in Section 7.3.1 (Enforcement of CollPlant Technology). |
1.34 "Confidential Information" means any information or data provided orally, visually, in writing or other form by or on behalf of one (1) Party (or an Affiliate or representative of such Party) to the other Party (or to an Affiliate or representative of such Party) in connection with this Agreement, whether prior to... |
1.35 "Contingent Payment Trigger Event" has the meaning set forth in Section 6.3 (Contingent Payments). |
1.36 "Control" means, subject to Section 12.3.2 (Assignment), with respect to a Person and any Regulatory Filings, material, Know-How, Patent Right or other intellectual property right, the possession by such Person or any of its Affiliates of the right, whether through ownership, agreement or license (other than by a ... |
1.37 "Data Security and Privacy Laws" means all applicable Laws relating to the privacy, Processing and security of Personal Data. |
1.38 "Default Notice" has the meaning set forth in Section 11.2.1(a) (Material Breach). |
1.39 "Delivery System" has the meaning set forth in Section 1.87.6 (Net Sales). |
1.40 "Development" means all activities related to research, pre-clinical and other non-clinical testing, test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Trials, including Manuf... |
1.41 "Development Plan" means each of the (a) Sterile 20 Project Development Plan, (b) Sterile 50 Project Development Plan, (c) Lyophilized Low Bioburden Project Development Plan, (d) Sterile 50 Work Plan, and (e) LLB Work Plan. |
1.42 "Development Program" means a program of Development activities conducted under a Development Plan. |
1.43 "Dispute" has the meaning set forth in Section 12.2 (Dispute Resolution). |
1.44 "Distributor" means any Person appointed by AbbVie or any of its Affiliates or its or their Third Party Transferees to distribute, market and sell an Exclusive Product with or without packaging rights, in one or more countries in the Territory, in circumstances where such Person purchases its requirements of such ... |
1.45 "Dollars" or "$" means the legal tender of the U.S. |
1.46 "Effective Date" has the meaning set forth in the Preamble. |
1.47 "EMA" means the European Medicines Agency, and any successor entity thereto. |
1.48 "EP Trigger Product" means, with respect to an Exclusive Product and a country, a product containing type I recombinant human collagen product (other than CollPlant Collagen) that has received Regulatory Approval for Commercialization in a country in any indication for which the Exclusive Product has received Regu... |
1.49 "EU" or "European Union" means the economic, scientific and political organization of European Union member states as it may be constituted from time to time. |
1.50 "Exclusive Product" means any product which is a: |
1.50.1 dermal or soft tissue filler product which is injected into the head (including the face or lips), neck or décolletage that contains CollPlant Collagen (or any altered form thereof developed by or on behalf of AbbVie, with the explicit exclusion of any chemical modification to the core structure of the CollPlant... |
1.50.2 dermal or soft tissue filler product which is injected anywhere in the body (other than the head, neck or décolletage) that contains CollPlant Collagen (or any altered form thereof developed by or on behalf of AbbVie, with the explicit exclusion of any chemical modification to the core structure of the CollPlant... |
1.50.3 topical product that is either distributed or sold through physicians, or the Amazon.com Professional Beauty channel or any website or digital platform owned or licensed by AbbVie or any of its Affiliates and is branded in the name of AbbVie or any of its Affiliates and in each case, that contains CollPlant Coll... |
For clarity and notwithstanding anything to the contrary in the forgoing, the term "Exclusive Product" shall not include: over the counter topical skincare products (other than any product included in the definition of "Exclusive Product" under Section 1.50.3); 3D printed products, anywhere in the body, including 3D pr... |
1.51 "Exclusive Product Milestone Event" has the meaning set forth in Section 6.4.1 (Exclusive Product Milestones). |
1.52 "Exclusive Product Milestone Payment" has the meaning set forth in Section 6.4.1 (Exclusive Product Milestones). |
1.53 "Exclusivity Rights" has the meaning set forth in Section 4.1 (Grant of Exclusive Rights to AbbVie). |
1.54 "Executive Officers" means the Chief Executive Officer, or his or her designee, in the case of CollPlant, and the Senior Vice President, Allergan Aesthetics R&D, or his or her designee, in the case of AbbVie. |
1.55 "Exploit" or "Exploitation" means to make, have made, import, export, use, have used, sell, have sold, or offer for sale, including to research, Develop, Commercialize, register, modify, enhance, improve, Manufacture, have Manufactured, hold, or keep (whether for disposal or otherwise), formulate, optimize, have u... |
1.56 "Extracellular Matrix Components" means any of proteoglycans, non-proteoglycans polysaccharides, and cell adhesion proteins. |
1.57 "FDA" means the United States Food and Drug Administration, and any successor entity thereto. |
1.58 "FFDCA" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., as amended from time to time, together with any rules, regulations and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto). |
1.59 "Field" means medical aesthetics and reconstruction for medical aesthetics applications or aesthetic outcomes. |
1.60 "First Application Milestone" has the meaning set forth in Section 6.4.1 (Exclusive Product Milestones). |
1.61 "First Commercial Sale" means, with respect to a product and a country in the Territory, the first sale for monetary value and for end use or consumption of such product in such country after all Regulatory Approvals and Pricing Approvals legally required for such sale have been granted by the applicable Regulator... |
1.62 "First Stability Study" has the meaning set forth in Section 2.2.1 (Sterile 20 Project). |
1.63 "Governmental Authority" means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal exercising executive, judicial, legislative, police, reg... |
1.64 "IIA Terms" means the provisions of the Law for the Encouragement of Research, Development and Technological Innovation in the Industry, 1984 (the "Innovation Law") and all the regulations, directives and guidelines promulgated thereunder, and including the terms of the Israel Innovation Authority's grant approval... |
1.65 "Independent Affiliate" has the meaning set forth in Section 12.3.2 (Assignment). |
1.66 "Injectable Breast Implant Favorable Terms Offer Notice" has the meaning set forth in Section 2.3.1 (Injectable Breast Implant Product Option). |
1.67 "Injectable Breast Implant Product" means any injectable breast implant product Developed or Manufactured by or on behalf of CollPlant or its Affiliates utilizing CollPlant Collagen in combination with any other ingredients or compounds, including fat, fat cells, Extracellular Matrix Components, structural protein... |
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