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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... |
1.68 "Injectable Breast Implant Product Milestone Event" has the meaning set forth in Section 6.4.2 (Injectable Breast Implant Product Milestones). |
1.69 "Injectable Breast Implant Product Milestone Payment" has the meaning set forth in Section 6.4.2 (Injectable Breast Implant Product Milestones). |
1.70 "Injectable Breast Implant Product Negotiation Period" has the meaning set forth in Section 2.3.1 (Injectable Breast Implant Product Option). |
1.71 "Injectable Breast Implant Product Option" means AbbVie's right to first negotiate a definitive license agreement with CollPlant with respect to Injectable Breast Implant Products pursuant to Section 2.3.1 (Injectable Breast Implant Product Option). |
1.72 "Injectable Breast Implant Product Option Data Package" means a data package that includes the following, in each case as applicable to Injectable Breast Implant Products: physical and mechanical characterization and properties (e.g. extrusion force, rheology, etc.), biocompatibility package, large animal implanta... |
1.73 "In-License Agreement" means any agreement between CollPlant or its Affiliate and a Third Party under which CollPlant or its Affiliate is granted a license or other right to any intellectual property within the CollPlant Technology or that otherwise relates to the CollPlant Collagen. |
1.74 "Israel Innovation Authority" means the Israel Innovation Authority, formerly known as the Office of the Chief Scientist of the Ministry of Economy and Industry of the State of Israel, and any successor agency or authority having substantially the same function. |
1.75 "Japan PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency or authority having substantially the same function. |
1.76 "JGC" has the meaning set forth in Section 3.1 (Joint Governance Committee). |
1.77 "Know-How" means all knowledge, materials and information of a technical, scientific, business and other nature, including inventions, know-how, technology, means, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, ass... |
1.78 "Knowledge" means, with respect to CollPlant, the actual knowledge of the chief executive officer, chief financial officer, deputy chief executive officer, chief operations officer, chief scientist, president, any executive vice-president, any vice president (including the vice president of R&D), the head of regul... |
1.79 "Law" means (a) any federal, state, local, national and supra-national laws, statutes, standards, ordinances, codes, rules, regulations, regulatory guidelines, resolutions or promulgations (including written governmental interpretations thereof, the guidance related thereto), (b) any judicial, governmental or admi... |
1.80 "LLB Work Plan" has the meaning set forth in Section 2.2.4 (Next Generation CollPlant Collagen Feasibility Studies). |
1.81 "Lyophilized Low Bioburden Project" means the Development Program conducted pursuant to the Lyophilized Low Bioburden Project Development Plan. |
1.82 "Lyophilized Low Bioburden Project Development Plan" means the Development Plan attached as Exhibit D (Lyophilized Low Bioburden Project Development Plan) hereto, as may be amended in accordance with the terms of this Agreement. |
1.83 "Major Market Country" means each of the United States, the United Kingdom, Germany, France, Italy and Spain. |
1.84 "Manufacture" and "Manufacturing" means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, labeling, transporting, shipping, storing and holding of any product, or any intermediate thereof, including process development, process qualifica... |
1.85 "Medical Affairs Activities" means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Exclusive Products, including activities of medical scientific liaisons and the provision of medical i... |
1.86 "Mono Product" has the meaning set forth in Section 1.87(a) (Net Sales). |
1.87 "Net Sales" means with respect to an Exclusive Product, the gross amount invoiced by AbbVie, any of its Affiliates or any Third Party Transferee (each, a "Selling Party") to a Third Party (including a customer, Distributor, wholesaler or end user) that is not a Third Party Transferee in bona fide arm's length tran... |
1.87.1 trade, cash and quantity discounts; |
1.87.2 price reductions or rebates, retroactive or otherwise, imposed by, negotiated with or otherwise paid to Governmental Authorities or other payees; |
1.87.3 taxes on sales (such as sales, value added, or use taxes) to the extent added to the sale price and set forth separately as such in the total amount invoiced; |
1.87.4 amounts repaid or credited by reason of rejections, defects, return goods allowance, recalls or returns, or because of retroactive price reductions, including rebates or wholesaler charge backs; |
1.87.5 the portion of administrative fees paid during the relevant time period to group purchasing organizations, pharmaceutical benefit managers or Medicare Prescription Drug Plans relating to such Exclusive Product; |
1.87.6 any consideration actually paid or payable for any Delivery System related to a billed or invoiced sale of such Exclusive Product, and separately itemized on such invoice, where for purposes of this Net Sales definition, a "Delivery System" means any delivery system designed to assist in the administration of su... |
1.87.7 any invoiced amounts from a prior period which are not collected and are written off by AbbVie or its Affiliates, including bad debts, provided that such amounts shall be included in Net Sales if and when actually received; |
1.87.8 that portion of the annual fee on prescription drug manufacturers imposed by the Patient Protection and Affordable Care Act, Pub. L. No. 111-148 (as amended) and reasonably allocable to sales of the Exclusive Products; |
1.87.9 freight, insurance, import/export, and other transportation charges to the extent added to the sale price and set forth separately as such in the total amount invoiced, as well as any fees for services provided by wholesalers and warehousing chains related to the distribution of such Exclusive Product; and |
1.87.10 any other similar and customary deductions that are consistent with Accounting Standards, but which may not be duplicative of the deductions specified in Sections 1.87.1-1.87.9 above. |
Net Sales shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory, or governmental purposes. Net Sales shall include the amount or fair market value of all other consideration received by AbbVie, its Affiliates or Third Party Transferees in respect of the Exclusive Pr... |
Subject to the above, Net Sales shall be calculated in accordance with the standard internal policies and procedures of AbbVie, its Affiliates, or Third Party Transferees, consistently applied, which must be in accordance with Accounting Standards. |
For purposes of calculating Net Sales, all Net Sales shall be converted into Dollars in accordance with Section 6.11 (Methods of Payments; Offsets). |
In the event an Exclusive Product is a Combination Product, the Net Sales for such Combination Product shall be calculated as follows: |
(a) If a Selling Party separately sells in such country or other jurisdiction, (i) a product containing as its sole active ingredients the Primary Components contained in such Combination Product and containing no Other Components contained in the Combination Product (the "Mono Product") and (ii) products containing as... |
(b) If a Selling Party separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the Other Components in such Combination Product and not containing any Primary Components contained in s... |
(c) If a Selling Party does not separately sell in such country or other jurisdiction the Mono Product but does separately sell products containing as their sole active ingredients the Other Components in such Combination Product and not containing any Primary Components contained in such Combination Product, then the ... |
(d) If a Selling Party does not separately sell in such country or other jurisdiction both the Mono Product and the Other Components in such Combination Product, the Net Sales attributable to such Combination Product shall be reasonably determined by the Parties based on the relative fair market value of such Mono Prod... |
If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option), such definitive license agreement will provide, unless otherwise agreed upon by the Parties in writing, that the Combination Product terms set forth in this Agreement will apply to the a... |
1.88 "Next Generation Studies Option Period" means the period commencing on the date of the later of (a) the completion of the activities under the Sterile 50 Project Development Plan and CollPlant's delivery to AbbVie of the successful outcomes specified in Work Plan II under the Sterile 50 Project Development Plan an... |
1.89 "Non-Breaching Party" has the meaning set forth in Section 11.2.1(a) (Material Breach). |
1.90 "OP Trigger Product" means, with respect to an Option Product and a country, a generic version of such Option Product in such country. |
1.91 "Opt-In" means opting into the jurisdiction of Unified Patent Court, such as through withdrawal under Article 83(4) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01) of the Opt-Out of a Patent Right. |
1.92 "Opt-Out" means opting out of the jurisdiction of Unified Patent Court, such as the opt-out of a Patent Right from the exclusive competence of the Unified Patent Court under Article 83(3) of the Agreement on a Unified Patent Court between the participating Member States of the European Union (2013/C 175/01). |
1.93 "Option Product" means either of (a) an Injectable Breast Implant Product and (b) a Photocurable Dermal Filler Product. |
1.94 "Other Component" has the meaning set forth in Section 1.29 (Combination Product). |
1.95 "Party" and "Parties" have the meanings set forth in the Preamble. |
1.96 "Patent Right" means (a) all national, regional and international patents and patent applications, including provisional patent applications and rights to claim priority from any of these patents or applications, (b) all patent applications filed either from such patents, patent applications or provisional applica... |
1.97 "Person" means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, Governmental Authority, or any other entity not specifically listed in this Section 1.97 (Person). |
1.98 "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 Security and Priv... |
1.99 "Phase 1 Clinical Trial" means a human clinical trial of a product that provides for the first introduction into humans of a pharmaceutical or biological product with the principal purpose of a preliminary determination of safety, tolerability, pharmacological activity or pharmacokinetics in healthy individuals or... |
1.100 "Phase 2 Clinical Trial" means a human clinical trial of a product, the principal purpose of which is a determination of safety and efficacy in the target patient population, which is prospectively designed to generate sufficient data that may permit commencement of a Pivotal Clinical Trial, or a similar clinical... |
1.101 "Phase 3 Clinical Trial" means a human clinical trial of a product on a sufficient number of subjects in an indicated patient population that is designed to establish that a product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reac... |
1.102 "Phase 4 Clinical Trial" means a post-marketing human clinical study for a product with respect to any indication as to which Regulatory Approval has been received or for a use that is the subject of an investigator-initiated study program. |
1.103 "Photocurable Dermal Filler Favorable Terms Offer Notice" has the meaning set forth in Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.104 "Photocurable Dermal Filler Product" means any photocurable dermal or soft tissue filler product Developed or Manufactured by or on behalf of CollPlant or its Affiliates that is injected into the head (including face or lips), neck or décolletage and that contains CollPlant Collagen, alone or in combination with ... |
1.105 "Photocurable Dermal Filler Product Milestone Event" has the meaning set forth in Section 6.4.3 (Photocurable Dermal Filler Product Milestones). |
1.106 "Photocurable Dermal Filler Product Milestone Payment" has the meaning set forth in Section 6.4.3 (Photocurable Dermal Filler Product Milestones). |
1.107 "Photocurable Dermal Filler Product Negotiation Period" has the meaning set forth in Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.108 "Photocurable Dermal Filler Product Option" means AbbVie's right of first negotiation of a definitive license agreement with CollPlant with respect to Photocurable Dermal Filler Products pursuant to Section 2.3.2 (Photocurable Dermal Filler Product Option). |
1.109 "Photocurable Dermal Filler Product Option Data Package" means a data package that includes the following, in each case as applicable to Photocurable Dermal Filler Products: physical characterization and properties (e.g. extrusion force, rheology, etc.), biocompatibility package, implantation studies with histolo... |
1.110 "Pivotal Clinical Trial" means any (a) Phase 3 Clinical Trial or (b) other Clinical Trial (or any arm thereof) of a product on a sufficient number of patients, the results of which, together with prior data and information concerning such product, are intended to be or otherwise are sufficient, without any additi... |
1.111 "Pricing Approval" means such approval, agreement, determination or decision establishing prices for a product that can be charged to consumers or will be reimbursed by Governmental Authorities in a country in the Territory where Governmental Authorities of such country approve or determine pricing for pharmaceut... |
1.112 "Primary Component" means, with respect to an Exclusive Product, each of (a) the CollPlant Collagen and (b) (i) the filler product described in Section 1.50.1 or 1.50.2 or (ii) the topical product described in Section 1.50.3 that, in each case ((a) and (b)), is included in such Exclusive Product. |
1.113 "Privacy and Security Obligations" has the meaning set forth in Section 9.2.21 (Representations, Warranties and Covenants, as applicable, of CollPlant). |
1.114 "Processing" (or its conjugates) means any operation or set of operations that is performed upon Personal Data, whether or not by automatic means, such as collection, recording, organization, storage, adaptation or alternation, retrieval, consultation, use, disclosure by transmission, discrimination or otherwise ... |
1.115 "Product Information" has the meaning set forth in Section 8.1 (Product Information). |
1.116 "Product Trademarks" has the meaning set forth in Section 7.6.1 (Ownership of Product Trademarks). |
1.117 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals of the applicable Regulatory Authority necessary for the commercial marketing and sale of a product in such country or jurisdiction, including, where applicable, (a) pre- and post-approval marketing author... |
1.118 "Regulatory Approval Application" means any application in the Territory to seek Regulatory Approval of a product in any country or multinational jurisdiction, as defined in applicable Laws and filed with the relevant Regulatory Authorities of such country or jurisdiction. |
1.119 "Regulatory Authority" means any applicable supra-national, federal, national, regional, state, provincial, or local governmental or regulatory authority, agency, department, bureau, commission, council, or other entities (e.g., the FDA, EMA, Notified Body and Japan PMDA) regulating or otherwise exercising author... |
1.120 "Regulatory Filing" means all (a) applications (including all Regulatory Approval Applications), registrations, licenses, authorizations, and approvals (including Regulatory Approvals), (b) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact repo... |
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