{"component": "definition", "props": {"groups": [{"size": 8, "samples": [{"hash": "a2k40dq4tuE", "uri": "/contracts/a2k40dq4tuE#generic-version", "label": "Research Collaboration and License Agreement (HOOKIPA Pharma Inc.)", "score": 33.1615333557, "published": true}, {"hash": "9fLy2LKWdcf", "uri": "/contracts/9fLy2LKWdcf#generic-version", "label": "Research Collaboration and License Agreement (HOOKIPA Pharma Inc.)", "score": 32.2087593079, "published": true}, {"hash": "5ndDYSQGzbc", "uri": "/contracts/5ndDYSQGzbc#generic-version", "label": "Research Collaboration and License Agreement (HOOKIPA Pharma Inc.)", "score": 31.2121829987, "published": true}], "snippet": "means, with respect to a Licensed Product, a product (including a \u201cbiogeneric,\u201d \u201cfollow-on biologic,\u201d \u201cfollow-on biological medicine or product,\u201d \u201cfollow-on protein product,\u201d \u201csimilar biological medicine or product,\u201d or \u201cbiosimilar product\u201d) that: (a) within the U.S., is \u201cbiosimilar\u201d or \u201cinterchangeable,\u201d with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be \u201csimilar,\u201d \u201ccomparable,\u201d \u201cinterchangeable,\u201d \u201cbioequivalent,\u201d or \u201cbiosimilar\u201d to such Licensed Product. For clarity, a Biosimilar of a Licensed Product shall constitute a Generic Version of such Licensed Product.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "licensed-product", "type": "clause", "offset": [25, 41]}, {"key": "protein-product", "type": "definition", "offset": [157, 172]}, {"key": "biosimilar-product", "type": "clause", "offset": [221, 239]}, {"key": "the-us", "type": "clause", "offset": [259, 266]}, {"key": "the-fda", "type": "clause", "offset": [361, 368]}, {"key": "applicable-law", "type": "definition", "offset": [396, 410]}, {"key": "in-the-row", "type": "clause", "offset": [419, 429]}, {"key": "applicable-regulatory-authority", "type": "definition", "offset": [452, 483]}, {"key": "for-clarity", "type": "clause", "offset": [614, 625]}], "hash": "8348454047ef0cda5aafa555df2d94f3", "id": 1}, {"size": 6, "samples": [{"hash": "gi8NqCGkHFo", "uri": "/contracts/gi8NqCGkHFo#generic-version", "label": "Collaboration and Option Agreement (Globeimmune Inc)", "score": 24.4544830322, "published": true}, {"hash": "9Uop5UAinMB", "uri": "/contracts/9Uop5UAinMB#generic-version", "label": "Collaboration and Option Agreement (Globeimmune Inc)", "score": 24.421628952, "published": true}, {"hash": "6Dh96ZdWGv", "uri": "/contracts/6Dh96ZdWGv#generic-version", "label": "Collaboration and Option Agreement (Globeimmune Inc)", "score": 24.3832988739, "published": true}], "snippet": "means, with respect to a Licensed Product, a second or subsequent product (including a \u201cbiogeneric,\u201d \u201cfollow-on biologic,\u201d \u201cfollow-on biological product,\u201d \u201cfollow-on protein product,\u201d \u201csimilar biological medicinal product,\u201d or \u201cbiosimilar product\u201d) that is (a) in the United States, \u201ctherapeutically equivalent,\u201d \u201ccomparable,\u201d \u201cbiosimilar,\u201d or \u201cinterchangeable,\u201d as evaluated by the FDA, applying the definition of \u201ctherapeutically equivalent\u201d set forth in the preface to the then-current edition of the FDA publication \u201cApproved Drug Products With Therapeutic Equivalence Evaluations\u201d or any other definitions set forth in the U.S. Code, FDA regulations, or other source of U.S. Law, FDA regulations, or guidelines and, outside the United States, such equivalent determination by the applicable Regulatory Authorities (including a determination that the second product is \u201ccomparable,\u201d \u201cinterchangeable,\u201d \u201cbioequivalent,\u201d or \u201cbiosimilar\u201d with respect to the Licensed Product), in each case, as is necessary to permit pharmacists or other individuals authorized to dispense pharmaceuticals under Law to substitute one product for another product in the absence of specific instruction from a physician or other authorized prescriber under Law, and (b) is not an Authorized Generic Version of such Licensed Product; where \u201cAuthorized Generic Version\u201d means any pharmaceutical product that (i) is sold under the Drug Approval Application for such [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Licensed Product, (ii) is sold under a different Trademark than such Licensed Product, and (iii) has a National Drug Code (\u201cNDC\u201d) number that differs from the NDC number for such Licensed Product (other than on a temporary basis as may be necessary to launch such Licensed Product in the applicable market).", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "licensed-product", "type": "clause", "offset": [25, 41]}, {"key": "subsequent-product", "type": "definition", "offset": [55, 73]}, {"key": "biological-product", "type": "definition", "offset": [134, 152]}, {"key": "protein-product", "type": "definition", "offset": [166, 181]}, {"key": "medicinal-product", "type": "clause", "offset": [204, 221]}, {"key": "biosimilar-product", "type": "clause", "offset": [228, 246]}, {"key": "in-the-united-states", "type": "clause", "offset": [261, 281]}, {"key": "therapeutically-equivalent", "type": "definition", "offset": [284, 310]}, {"key": "the-fda", "type": "clause", "offset": [379, 386]}, {"key": "the-definition-of", "type": "definition", "offset": [397, 414]}, {"key": "current-edition", "type": "definition", "offset": [481, 496]}, {"key": "drug-products", "type": "definition", "offset": [530, 543]}, {"key": "other-definitions", "type": "definition", "offset": [593, 610]}, {"key": "the-us", "type": "clause", "offset": [624, 631]}, {"key": "fda-regulations", "type": "clause", "offset": [639, 654]}, {"key": "source-of", "type": "definition", "offset": [665, 674]}, {"key": "outside-the-united-states", "type": "definition", "offset": [721, 746]}, {"key": "applicable-regulatory-authorities", "type": "definition", "offset": [785, 818]}, {"key": "second-product", "type": "clause", "offset": [855, 869]}, {"key": "each-case", "type": "definition", "offset": [981, 990]}, {"key": "other-individuals", "type": "clause", "offset": [1033, 1050]}, {"key": "specific-instruction", "type": "definition", "offset": [1164, 1184]}, {"key": "authorized-prescriber", "type": "definition", "offset": [1211, 1232]}, {"key": "authorized-generic-version", "type": "definition", "offset": [1262, 1288]}, {"key": "pharmaceutical-product", "type": "clause", "offset": [1360, 1382]}, {"key": "drug-approval-application", "type": "definition", "offset": [1410, 1435]}, {"key": "certain-confidential-information", "type": "clause", "offset": [1451, 1483]}, {"key": "contained-in", "type": "definition", "offset": [1484, 1496]}, {"key": "the-securities-and-exchange-commission", "type": "clause", "offset": [1546, 1584]}, {"key": "pursuant-to-rule", "type": "clause", "offset": [1585, 1601]}, {"key": "securities-act-of-1933", "type": "definition", "offset": [1613, 1635]}, {"key": "as-amended", "type": "definition", "offset": [1637, 1647]}, {"key": "national-drug-code", "type": "definition", "offset": [1752, 1770]}, {"key": "ndc-number", "type": "definition", "offset": [1808, 1818]}, {"key": "temporary-basis", "type": "definition", "offset": [1862, 1877]}, {"key": "applicable-market", "type": "definition", "offset": [1937, 1954]}], "hash": "93a4266244450e3f864008aa99bee4cd", "id": 2}, {"size": 6, "samples": [{"hash": "dyNtwV5j8S8", "uri": "/contracts/dyNtwV5j8S8#generic-version", "label": "License and Collaboration Agreement (Globeimmune Inc)", "score": 25.3832988739, "published": true}, {"hash": "jRAp8GQuEZr", "uri": "/contracts/jRAp8GQuEZr#generic-version", "label": "License and Collaboration Agreement (Globeimmune Inc)", "score": 25.2053394318, "published": true}, {"hash": "bUNjJBBp5cE", "uri": "/contracts/bUNjJBBp5cE#generic-version", "label": "License and Collaboration Agreement (Globeimmune Inc)", "score": 23.6228618622, "published": true}], "snippet": "means, with respect to a Licensed Product, a product (including a \u201cbiogeneric,\u201d \u201cfollow-on biologic,\u201d \u201cfollow-on biological product,\u201d \u201cfollow-on protein product,\u201d \u201csimilar biological medicinal product,\u201d or \u201cbiosimilar product\u201d) that (a) (i) is \u201csimilar\u201d or \u201cinterchangeable,\u201d with respect to such Licensed Product as evaluated by the FDA, (ii) outside the United States, is determined by the applicable Regulatory Authorities to be", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "licensed-product", "type": "clause", "offset": [25, 41]}, {"key": "biological-product", "type": "definition", "offset": [113, 131]}, {"key": "protein-product", "type": "definition", "offset": [145, 160]}, {"key": "medicinal-product", "type": "clause", "offset": [183, 200]}, {"key": "biosimilar-product", "type": "clause", "offset": [207, 225]}, {"key": "the-fda", "type": "clause", "offset": [330, 337]}, {"key": "outside-the-united-states", "type": "definition", "offset": [344, 369]}, {"key": "applicable-regulatory-authorities", "type": "definition", "offset": [392, 425]}], "hash": "cd48c56c1248cd20c88bf0fcd21d8599", "id": 3}, {"size": 6, "samples": [{"hash": "8plxskSEnlj", "uri": "/contracts/8plxskSEnlj#generic-version", "label": "Marketing and Supply Agreement (Arena Pharmaceuticals Inc)", "score": 23.6036968231, "published": true}, {"hash": "jD28Edln0w", "uri": "https://invest.arenapharm.com/static-files/752e2913-344b-4f2a-99b8-b6d5fa0e19a7", "label": "invest.arenapharm.com", "score": 9.9637231827, "published": false}, {"hash": "929Ne3gFXAG", "uri": "https://invest.arenapharm.com/static-files/885e89d6-bee4-4031-8a67-820e1c8cae29", "label": "invest.arenapharm.com", "score": 9.0533876419, "published": false}], "snippet": "means, with respect to a particular Product, a product sold (i) by a Third Party (who is not authorized by Eisai or any of its Affiliates and who neither Arena nor any of its Affiliates has authorized at Eisai\u2019s request) or (ii) by Arena, any of its Affiliates or any Third Party authorized by Arena or any of its Affiliates (provided that the foregoing shall in no way be deemed or construed to limit Arena\u2019s obligations under Section 2.3(a)) that, in each case ((i) or (ii)), (a) contains as an active pharmaceutical agent the same Compound or Related Compound that such Product contains as an active pharmaceutical agent, and (b) (1) if sold in the United States, has been approved for sales introduction into commerce in the United States by reference to the Regulatory Approval for such Product in the United States pursuant to Section 505(b)(2) or 505(j) of the FFDCA (or the successor thereof) or (2) if sold in a country in the Additional Territory, has been approved for sale in such country pursuant to an equivalent regulatory law or regulation, but excluding for clarity any Products sold by Eisai or any of its Affiliates or Sub-distributors during the Term.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "particular-product", "type": "definition", "offset": [25, 43]}, {"key": "by-a-third-party", "type": "clause", "offset": [64, 80]}, {"key": "authorized-by", "type": "definition", "offset": [93, 106]}, {"key": "provided-that", "type": "definition", "offset": [326, 339]}, {"key": "the-foregoing", "type": "definition", "offset": [340, 353]}, {"key": "each-case", "type": "definition", "offset": [453, 462]}, {"key": "pharmaceutical-agent", "type": "definition", "offset": [504, 524]}, {"key": "related-compound", "type": "definition", "offset": [546, 562]}, {"key": "in-the-united-states", "type": "clause", "offset": [645, 665]}, {"key": "reference-to", "type": "definition", "offset": [746, 758]}, {"key": "regulatory-approval", "type": "definition", "offset": [763, 782]}, {"key": "pursuant-to-section", "type": "definition", "offset": [821, 840]}, {"key": "additional-territory", "type": "definition", "offset": [936, 956]}, {"key": "for-sale", "type": "clause", "offset": [976, 984]}, {"key": "law-or-regulation", "type": "definition", "offset": [1038, 1055]}, {"key": "but-excluding", "type": "clause", "offset": [1057, 1070]}, {"key": "for-clarity", "type": "clause", "offset": [1071, 1082]}, {"key": "products-sold", "type": "clause", "offset": [1087, 1100]}, {"key": "during-the-term", "type": "clause", "offset": [1155, 1170]}], "hash": "796f19da640775dfb2289c37f3a48705", "id": 4}, {"size": 6, "samples": [{"hash": "3QyANbAdDNa", "uri": "/contracts/3QyANbAdDNa#generic-version", "label": "Asset Purchase Agreement (Aralez Pharmaceuticals Inc.)", "score": 27.9267616272, "published": true}, {"hash": "4ge171x3wAn", "uri": "/contracts/4ge171x3wAn#generic-version", "label": "Asset Purchase Agreement (Aralez Pharmaceuticals Inc.)", "score": 27.6858310699, "published": true}], "snippet": "means, with respect to any Subject Product, any other pharmaceutical product that (a) references the Purchased Regulatory Approvals for such Subject Product or any supplement or amendment thereto and (b) is sold under a different Trademark than such Subject Product.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "subject-product", "type": "definition", "offset": [27, 42]}, {"key": "pharmaceutical-product", "type": "clause", "offset": [54, 76]}, {"key": "purchased-regulatory-approvals", "type": "definition", "offset": [101, 131]}, {"key": "or-amendment", "type": "definition", "offset": [175, 187]}], "hash": "014488f75102fbfbb980475409a53dc8", "id": 5}, {"size": 5, "samples": [{"hash": "ahixGb5o3mb", "uri": "/contracts/ahixGb5o3mb#generic-version", "label": "Amendment and Restatement Agreement (Mereo BioPharma Group PLC)", "score": 36.2306632996, "published": true}, {"hash": "e7rGI7d7pxV", "uri": "/contracts/e7rGI7d7pxV#generic-version", "label": "Exclusive License and Option Agreement", "score": 31.3408622742, "published": true}, {"hash": "ilVo8UqONaQ", "uri": "/contracts/ilVo8UqONaQ#generic-version", "label": "Exclusive License and Option Agreement (Mereo Biopharma Group PLC)", "score": 30.0650234222, "published": true}], "snippet": "means, with respect to [***] a Product, any other prescription pharmaceutical product sold by a Third Party that is not a Sublicensee, or distributor of Mereo, its Affiliate, or their Sublicensees, that (i) contains the same API(s) as such Product, (ii) has the same [***] as such Product and (ii) is \u201ctherapeutically equivalent\u201d as evaluated by the FDA, applying the definition of \u201ctherapeutically equivalent\u201d set forth in the preface to the FDA\u2019s Orange Book (or, with respect to any country in the Territory outside the United States, is similarly substitutable under equivalent Applicable Law in such country), with respect to such [***], as such Product.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "pharmaceutical-product", "type": "clause", "offset": [63, 85]}, {"key": "by-a-third-party", "type": "clause", "offset": [91, 107]}, {"key": "therapeutically-equivalent", "type": "definition", "offset": [302, 328]}, {"key": "the-fda", "type": "clause", "offset": [346, 353]}, {"key": "the-definition-of", "type": "definition", "offset": [364, 381]}, {"key": "orange-book", "type": "definition", "offset": [449, 460]}, {"key": "in-the-territory", "type": "clause", "offset": [494, 510]}, {"key": "outside-the-united-states", "type": "definition", "offset": [511, 536]}, {"key": "applicable-law", "type": "definition", "offset": [582, 596]}], "hash": "199500ffcc78ba602974fab3f40daa0e", "id": 6}, {"size": 5, "samples": [{"hash": "k6ioPFDpuhr", "uri": "/contracts/k6ioPFDpuhr#generic-version", "label": "Collaboration, License and Option Agreement (Curis Inc)", "score": 32.2032852173, "published": true}, {"hash": "a2jP81icHKG", "uri": "/contracts/a2jP81icHKG#generic-version", "label": "Collaboration, License and Option Agreement", "score": 31.3408622742, "published": true}, {"hash": "dO0MNV8xez7", "uri": "/contracts/dO0MNV8xez7#generic-version", "label": "Collaboration, License and Option Agreement (Curis Inc)", "score": 26.1471595764, "published": true}], "snippet": "means, with respect to a Product, on a country-by-country basis, a pharmaceutical product that: (a) is sold in a given country by a Third Party, other than Curis, any of its Affiliates or any Sublicensee, or any other Third Party in a chain of distribution originating from Curis, any of its Affiliates or any Sublicensee; (b) contains the same Program Compound (and, if such Product is a fixed-dose combination that also contains any other active pharmaceutical ingredient that is not a Program Compound, the same other active ingredient(s)) as such Product in the same dosage form, strength (for each active ingredient and route of administration) as such Product; and (c) has been approved for marketing by the relevant Regulatory Authority in such country in reliance on the Marketing Approval for such Product in such country, including any such pharmaceutical product that has been approved for marketing (i) in the US, pursuant to Section 505(b)(2) or Section 505(j) of the Act (21 U.S.C. \u00a7355(b)(2) or 21 U.S.C. \u00a7355(j), respectively), (ii) in the EU or an EU member state, as a \u201cgeneric medicinal product\u201d pursuant to Article 10 of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (iii) in any other country or jurisdiction, pursuant to any equivalent of the foregoing laws, regulations or directives, wherein the approval of such pharmaceutical product is based on reference to the Marketing Approval for such Product in such country and a demonstration of bio-equivalence to such Product and, in each case, which may be substituted for the Product without any action by the physician or health care practitioner.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "pharmaceutical-product", "type": "clause", "offset": [67, 89]}, {"key": "by-a-third-party", "type": "clause", "offset": [127, 143]}, {"key": "other-third-party", "type": "definition", "offset": [212, 229]}, {"key": "program-compound", "type": "definition", "offset": [345, 361]}, {"key": "a-fixed", "type": "clause", "offset": [387, 394]}, {"key": "active-pharmaceutical-ingredient", "type": "definition", "offset": [441, 473]}, {"key": "active-ingredient", "type": "clause", "offset": [521, 538]}, {"key": "dosage-form", "type": "definition", "offset": [571, 582]}, {"key": "route-of-administration", "type": "definition", "offset": [625, 648]}, {"key": "relevant-regulatory-authority", "type": "definition", "offset": [714, 743]}, {"key": "reliance-on", "type": "clause", "offset": [763, 774]}, {"key": "marketing-approval", "type": "clause", "offset": [779, 797]}, {"key": "pursuant-to-section", "type": "definition", "offset": [926, 945]}, {"key": "the-act", "type": "clause", "offset": [977, 984]}, {"key": "the-eu", "type": "clause", "offset": [1052, 1058]}, {"key": "eu-member-state", "type": "definition", "offset": [1065, 1080]}, {"key": "medicinal-product", "type": "clause", "offset": [1096, 1113]}, {"key": "article-10", "type": "definition", "offset": [1127, 1137]}, {"key": "directive-2001-83", "type": "definition", "offset": [1164, 1181]}, {"key": "as-amended", "type": "definition", "offset": [1185, 1195]}, {"key": "under-article", "type": "definition", "offset": [1222, 1235]}, {"key": "council-regulation", "type": "definition", "offset": [1258, 1276]}, {"key": "the-foregoing", "type": "definition", "offset": [1423, 1436]}, {"key": "approval-of", "type": "definition", "offset": [1482, 1493]}, {"key": "based-on", "type": "definition", "offset": [1525, 1533]}, {"key": "reference-to", "type": "definition", "offset": [1534, 1546]}, {"key": "each-case", "type": "definition", "offset": [1666, 1675]}, {"key": "the-product", "type": "clause", "offset": [1706, 1717]}, {"key": "action-by-the", "type": "clause", "offset": [1730, 1743]}, {"key": "health-care-practitioner", "type": "definition", "offset": [1757, 1781]}], "hash": "bd344498d41045acd2bc8fed50e19dd8", "id": 7}, {"size": 4, "samples": [{"hash": "bCtBnHWh8eH", "uri": "/contracts/bCtBnHWh8eH#generic-version", "label": "Purchase and Sale Agreement (Galera Therapeutics, Inc.)", "score": 30.7741279602, "published": true}, {"hash": "lsmYQLURqGp", "uri": "/contracts/lsmYQLURqGp#generic-version", "label": "Purchase and Sale Agreement (Galera Therapeutics, Inc.)", "score": 30.3059539795, "published": true}, {"hash": "bM1XihSid9E", "uri": "/contracts/bM1XihSid9E#generic-version", "label": "Purchase and Sale Agreement", "score": 26.1704311371, "published": true}], "snippet": "means, as to a Product, another product that is not owned, controlled or authorized by Seller or its Affiliates, or Seller\u2019s sublicensees and licensees (acting pursuant to a license or sublicense under the Product Patent Rights) and that has received Regulatory Approval through a regulatory process by which the sponsor of the application for such Regulatory Approval for such other product or the Regulatory Authority approving such application relies, in whole or in part, on data included in the DAA for such Product.", "snippet_links": [{"key": "by-seller", "type": "clause", "offset": [84, 93]}, {"key": "pursuant-to-a", "type": "definition", "offset": [160, 173]}, {"key": "product-patent-rights", "type": "definition", "offset": [206, 227]}, {"key": "regulatory-approval", "type": "definition", "offset": [251, 270]}, {"key": "regulatory-process", "type": "clause", "offset": [281, 299]}, {"key": "the-sponsor", "type": "clause", "offset": [309, 320]}, {"key": "the-application", "type": "clause", "offset": [324, 339]}, {"key": "other-product", "type": "definition", "offset": [378, 391]}, {"key": "regulatory-authority", "type": "definition", "offset": [399, 419]}], "hash": "195b9b212c94085032e0a7d171df8aa6", "id": 8}, {"size": 4, "samples": [{"hash": "gKH6Rukubqs", "uri": 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product or (ii) that is not a Sublicensee of Licensee (or any of its Affiliates) authorized to market and sell such product and that has not otherwise been authorized, directly or indirectly, by Licensee (or any of its Affiliates or Sublicensees) to market and sell such product.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "licensed-product", "type": "clause", "offset": [25, 41]}, {"key": "by-licensee", "type": "clause", "offset": [47, 58]}, {"key": "in-the-field", "type": "clause", "offset": [102, 114]}, {"key": "in-the-territory", "type": "clause", "offset": [139, 155]}, {"key": "for-sale", "type": "clause", "offset": [190, 198]}, {"key": "reliance-on", "type": "clause", "offset": [218, 229]}, {"key": "approval-of", "type": "definition", "offset": [240, 251]}, {"key": "applicable-regulatory-authority", "type": "definition", "offset": [295, 326]}, {"key": "by-a-third-party", "type": "clause", "offset": [344, 360]}, {"key": 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relating to medicinal products for human use, each as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), and (iii) in any other country or jurisdiction pursuant to Applicable Law that is equivalent to such provisions, but excluding for clarity any \u201cauthorized generic\u201d that is authorized or permitted by Astellas or a Related Party.", "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "pharmaceutical-product", "type": "clause", "offset": [60, 82]}, {"key": "active-ingredient", "type": "clause", "offset": [109, 126]}, {"key": "licensed-compound", "type": "definition", "offset": [131, 148]}, {"key": "sale-and-use", "type": "clause", "offset": [259, 271]}, {"key": "the-country", "type": "definition", "offset": [275, 286]}, {"key": "basis-of", "type": "clause", "offset": [294, 302]}, {"key": "marketing-authorization", "type": "clause", 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biologic,\u201d \u201cfollow-on biological medicine or product,\u201d \u201cfollow-on protein product,\u201d \u201csimilar biological medicine or product,\u201d or \u201cbiosimilar product\u201d) that: (a) within the U.S., is \u201cbiosimilar\u201d or \u201cinterchangeable,\u201d with respect to such Licensed Product as evaluated by the FDA or otherwise determined by Applicable Law; or (b) in the ROW, is determined by the applicable Regulatory Authority or by Applicable Law to be \u201csimilar,\u201d \u201ccomparable,\u201d \u201cinterchangeable,\u201d \u201cbioequivalent,\u201d or \u201cbiosimilar\u201d to such Licensed Product. 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