{"component": "definition", "props": {"groups": [{"size": 4, "snippet_links": [{"key": "pharmaceutical-product", "type": "definition", "offset": [10, 32]}, {"key": "by-a-third-party", "type": "clause", "offset": [50, 66]}, {"key": "granted-by", "type": "definition", "offset": [208, 218]}, {"key": "authority-to", "type": "definition", "offset": [232, 244]}, {"key": "active-pharmaceutical-ingredient", "type": "definition", "offset": [305, 337]}, {"key": "relevant-product", "type": "definition", "offset": [345, 361]}, {"key": "for-purposes-of-the", "type": "clause", "offset": [370, 389]}, {"key": "reliance-on", "type": "clause", "offset": [420, 431]}, {"key": "approval-of", "type": "definition", "offset": [442, 453]}, {"key": "the-fda", "type": "clause", "offset": [481, 488]}, {"key": "outside-the-united-states", "type": "definition", "offset": [523, 548]}, {"key": "applicable-regulatory-authority", "type": "clause", "offset": [630, 661]}, {"key": "authorized-generic-product", "type": "definition", "offset": [744, 770]}], "samples": [{"hash": "9PkX3sp1HCc", "uri": "/contracts/9PkX3sp1HCc#generic-products", "label": "Collaboration Agreement (Neurocrine Biosciences Inc)", "score": 32.3401794434, "published": true}, {"hash": "eN66l4ukCPr", "uri": "/contracts/eN66l4ukCPr#generic-products", "label": "Collaboration Agreement", "score": 31.3408622742, "published": true}, {"hash": "aki2fvNJHqz", "uri": "/contracts/aki2fvNJHqz#generic-products", "label": "Collaboration Agreement (Neurocrine Biosciences Inc)", "score": 27.1108837128, "published": true}], "snippet": "means any pharmaceutical product that (i) is sold by a Third Party that is not a licensee or Sublicensee of Abbott or its Affiliates, or any of their licensees or Sublicensees under a marketing authorization granted by a Regulatory Authority to such Third Party, and (ii) contains the same Compound as an active pharmaceutical ingredient as the relevant Product and (x) for purposes of the United States, is approved in reliance on the prior approval of a Product as determined by the FDA, or (y) for purposes of a country outside the United States, is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority. On a country by country basis, a Product licensed or produced by Abbott (e.g. an authorized generic product) will not constitute a Generic Product.", "hash": "7313a068096fa50df6e87e50744368bb", "id": 1}, {"size": 4, "snippet_links": [{"key": "a-third-party", "type": "clause", "offset": [6, 19]}, {"key": "third-parties", "type": "definition", "offset": [36, 49]}, {"key": "active-pharmaceutical-ingredient", "type": "definition", "offset": [106, 138]}, {"key": "regulatory-approval-process", "type": "clause", "offset": [184, 211]}, {"key": "the-applicant", "type": "definition", "offset": [233, 246]}, {"key": "regulatory-authority", "type": "definition", "offset": [293, 313]}, {"key": "submitted-by", "type": "clause", "offset": [384, 396]}, {"key": "on-behalf-of", "type": "definition", "offset": [401, 413]}, {"key": "approval-of", "type": "definition", "offset": [501, 512]}], "samples": [{"hash": "dD10JSz0mAA", "uri": "/contracts/dD10JSz0mAA#generic-products", "label": "Collaboration and License Agreement (Regulus Therapeutics Inc.)", "score": 25.1587944031, "published": true}, {"hash": "9JdAev0aghH", "uri": "/contracts/9JdAev0aghH#generic-products", "label": "Collaboration and License Agreement (Regulus Therapeutics Inc.)", "score": 23.6255989075, "published": true}, {"hash": "hhXgm1l3uUC", "uri": "https://www.sec.gov/Archives/edgar/data/1505512/000119312512360813/d392345dex992.htm", "label": "Regulus Therapeutics Inc.", "score": 7.6255989075, "published": false}], "snippet": "means a Third Party\u2019s product(s) or Third Parties\u2019 product(s) that has the same or substantially the same active pharmaceutical ingredient as a Product and receives Approval through a regulatory approval process in which either: (i) the applicant for, or sponsor of such Approval; or (ii) the Regulatory Authority that granted such Approval, relied, in whole or in part, upon [\u2026***\u2026] submitted by, or on behalf of, Sanofi (or its Affiliate or sublicensee), to any Regulatory Authority, to support the Approval of a Product.", "hash": "9d1557e9eb5fb7d04f1cc5e6ac1e6d25", "id": 2}, {"size": 4, "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "particular-product", "type": "definition", "offset": [25, 43]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [176, 202]}, {"key": "or-equivalent", "type": "definition", "offset": [266, 279]}, {"key": "regulatory-authority", "type": "definition", "offset": [330, 350]}, {"key": "dosage-form", "type": "definition", "offset": [386, 397]}, {"key": "a-third-party", "type": "clause", "offset": [431, 444]}, {"key": "regulatory-approval", "type": "clause", "offset": [458, 477]}, {"key": "laws-governing", "type": "clause", "offset": [514, 528]}, {"key": "approval-of", "type": "definition", "offset": [529, 540]}, {"key": "biological-products", "type": "definition", "offset": [541, 560]}, {"key": "application-for-approval", "type": "definition", "offset": [568, 592]}], "samples": [{"hash": "ShdpLe1cF9", "uri": "/contracts/ShdpLe1cF9#generic-products", "label": "Collaboration and License Agreement (Macrogenics Inc)", "score": 24.7563304901, "published": true}, {"hash": "fcThE8OhHhx", "uri": "/contracts/fcThE8OhHhx#generic-products", "label": "Collaboration and License Agreement (Macrogenics Inc)", "score": 24.6741962433, "published": true}], "snippet": "means, with respect to a particular Product commercialized by BI in a particular country, any product (other than Products commercialized by BI, its Affiliates or Sublicensees pursuant to this Agreement) that either (a) is a \u201cfollow-on biologic\u201d (FOB) or biosimilar or equivalent version to a Product, as defined by the competent Regulatory Authority, and administered in an equivalent dosage form as such Product or (b) for which a Third Party has received Regulatory Approval (based upon then-current applicable Laws governing approval of biological products) whose application for approval relies to a large extent (but not exclusively) on data generated by BI, including Regulatory Approval under section 505(b)(2) of the Federal Food Drug, and Cosmetic Act.", "hash": "cbfc4336c3f6bb6e176100daf8248138", "id": 3}, {"size": 4, "snippet_links": [{"key": "product-or-products", "type": "definition", "offset": [8, 27]}, {"key": "active-ingredient", "type": "definition", "offset": [42, 59]}, {"key": "the-applicable", "type": "clause", "offset": [124, 138]}, {"key": "contained-in", "type": "definition", "offset": [148, 160]}, {"key": "applicable-product", "type": "definition", "offset": [165, 183]}, {"key": "regulatory-authority", "type": "definition", "offset": [299, 319]}, {"key": "within-the-territory", "type": "definition", "offset": [320, 340]}], "samples": [{"hash": "42PzU8R5xKe", "uri": "/contracts/42PzU8R5xKe#generic-products", "label": "Collaboration and License Agreement (Isis Pharmaceuticals Inc)", "score": 21.0, "published": true}, {"hash": "fIsu5cWfb6r", "uri": "https://ir.ionispharma.com/static-files/39cb9d65-9320-411c-876c-1f62e4016741", "label": "ir.ionispharma.com", "score": 9.965092659, "published": false}], "snippet": "means a product or products containing an active ingredient having the same or substantially the same chemical structure as the applicable Compound contained in the applicable Product, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority within the Territory.", "hash": "98890c454d6eb9d30b46ce61d3aed975", "id": 4}, {"size": 3, "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [6, 21]}, {"key": "licensed-product", "type": "definition", "offset": [35, 51]}, {"key": "pharmaceutical-product", "type": "definition", "offset": [68, 90]}, {"key": "applicable-regulatory-authority", "type": "clause", "offset": [238, 269]}, {"key": "authority-and", "type": "clause", "offset": [396, 409]}, {"key": "third-party", "type": "clause", "offset": [474, 485]}], "samples": [{"hash": "hIlKh1dZMqc", "uri": "/contracts/hIlKh1dZMqc#generic-products", "label": "License Agreement (Immunome Inc.)", "score": 34.2313499451, "published": true}, {"hash": "cJOB1h3RMai", "uri": "/contracts/cJOB1h3RMai#generic-products", "label": "License Agreement (Ayala Pharmaceuticals, Inc.)", "score": 30.3381252289, "published": true}, {"hash": "8sDIsmoJhzj", "uri": "/contracts/8sDIsmoJhzj#generic-products", "label": "License Agreement (Ayala Pharmaceuticals, Inc.)", "score": 30.1765918732, "published": true}], "snippet": "means with respect to a particular Licensed Product in a country, a pharmaceutical product that (a) contains the same or substantially the same active ingredient(s) as such Licensed Product, (b) is approved for use in such country by the applicable Regulatory Authority, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority and (c) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee of Company or its Affiliates and did not purchase such product in a chain of distribution that included any of Company or any of its Affiliates or its Sublicensees.", "hash": "c7bfec23b05657a55c9d383735e7ca2e", "id": 5}, {"size": 3, "snippet_links": [{"key": "commercial-product", "type": "definition", "offset": [8, 26]}, {"key": "distribution-of", "type": "clause", "offset": [44, 59]}, {"key": "licensed-technology", "type": "definition", "offset": [75, 94]}, {"key": "not-covered", "type": "definition", "offset": [103, 114]}, {"key": "a-valid-claim", "type": "clause", "offset": [138, 151]}, {"key": "licensed-patents", "type": "clause", "offset": [159, 175]}, {"key": "clinical-trial", "type": "clause", "offset": [250, 264]}], "samples": [{"hash": "mJhkpgXipU", "uri": "/contracts/mJhkpgXipU#generic-products", "label": "Exclusive License Agreement (GTX Inc/Tn)", "score": 18.0, "published": true}, {"hash": "hL2VJREMk2L", "uri": "/contracts/hL2VJREMk2L#generic-products", "label": "Exclusive License Agreement (GTX Inc/Tn)", "score": 18.0, "published": true}, {"hash": "3voIUxkmYLd", "uri": "/contracts/3voIUxkmYLd#generic-products", "label": "Exclusive License Agreement (GTX Inc/Tn)", "score": 18.0, "published": true}], "snippet": "means a commercial product the use, sale or distribution of which utilizes Licensed Technology that is not covered in whole or in part by a Valid Claim of the Licensed Patents. A product that is sold, distributed or used for testing, development, or clinical trial purposes shall not be considered a commercial product.", "hash": "2e42a2e94208ca957868002512c7a305", "id": 6}, {"size": 3, "snippet_links": [{"key": "pharmaceutical-products", "type": "clause", "offset": [10, 33]}, {"key": "the-product", "type": "clause", "offset": [46, 57]}, {"key": "pursuant-to-this-agreement", "type": "clause", "offset": [95, 121]}], "samples": [{"hash": "fGdw7534kPd", "uri": "/contracts/fGdw7534kPd#generic-products", "label": "License and Collaboration Agreement", "score": 33.7089920044, "published": true}, {"hash": "p1p2PXo5qi", "uri": "/contracts/p1p2PXo5qi#generic-products", "label": "License and Collaboration Agreement (Akzo Nobel Nv)", "score": 18.0, "published": true}], "snippet": "means any pharmaceutical products (other than the Product commercialized by Organon and Pfizer pursuant to this Agreement) that contain the Compound and can reasonably be or are reasonably used for the same indication or indications as the Product.", "hash": "8ccbc76eba41623fb3458088c72c2106", "id": 7}, {"size": 3, "snippet_links": [{"key": "product-or-products", "type": "definition", "offset": [8, 27]}, {"key": "active-ingredient", "type": "definition", "offset": [42, 59]}, {"key": "the-applicable", "type": "clause", "offset": [124, 138]}, {"key": "contained-in", "type": "definition", "offset": [193, 205]}, {"key": "applicable-product", "type": "definition", "offset": [210, 228]}, {"key": "regulatory-authority", "type": "definition", "offset": [344, 364]}, {"key": "applicable-country", "type": "clause", "offset": [376, 394]}, {"key": "head-office", "type": "definition", "offset": [438, 449]}], "samples": [{"hash": "6mjSIVQ31xy", "uri": "/contracts/6mjSIVQ31xy#generic-products", "label": "License Agreement (Isis Pharmaceuticals Inc)", "score": 19.0, "published": true}, {"hash": "3IFUhmTnZjj", "uri": "/contracts/3IFUhmTnZjj#generic-products", "label": "License Agreement (Oncogenex Pharmaceuticals, Inc.)", "score": 19.0, "published": true}], "snippet": "means a product or products containing an active ingredient having the same or substantially the same chemical structure as the applicable ASO targeting Clusterin that is the active ingredient contained in the applicable Product, whether approved under an NDA, ANDA, an application under 505(b)(2), or any equivalent thereof, or otherwise by a Regulatory Authority within the applicable country. [***] means [***], a biotech company with head office in [***]. [***] [***] means those patents listed in Appendix B.", "hash": "2d6ece91298925919eafbfff9abb0607", "id": 8}, {"size": 2, "snippet_links": [{"key": "group-a", "type": "definition", "offset": [23, 30]}, {"key": "group-b", "type": "clause", "offset": [53, 60]}, {"key": "group-c", "type": "clause", "offset": [86, 93]}], "samples": [{"hash": "2MZh1NMcvTu", "uri": "/contracts/2MZh1NMcvTu#generic-products", "label": "Development and Marketing Agreement (Spectrum Pharmaceuticals Inc)", "score": 21.0, "published": true}, {"hash": "hLeKnQPhoiV", "uri": "https://investor.sppirx.com/index.php/static-files/0ba61d13-1933-4fa8-97ad-aa34a8a34af0", "label": "Amendment", "score": 13.965092659, "published": false}], "snippet": "means collectively the Group A Generic Products, the Group B Generic Products and the Group C Generic Products.", "hash": "9afcf016704f28aeece486ea0a986782", "id": 9}, {"size": 2, "snippet_links": [{"key": "with-respect-to", "type": "clause", "offset": [7, 22]}, {"key": "regulatory-approval", "type": "clause", "offset": [51, 70]}, {"key": "granted-by", "type": "definition", "offset": [71, 81]}, {"key": "governmental-authority", "type": "definition", "offset": [84, 106]}, {"key": "pharmaceutical-product", "type": "definition", "offset": [140, 162]}, {"key": "contained-in", "type": "definition", "offset": [254, 266]}, {"key": "reference-product", "type": "definition", "offset": [269, 286]}, {"key": "clinically-inactive", "type": "definition", "offset": [325, 344]}, {"key": "an-applicant-for", "type": "clause", "offset": [367, 383]}, {"key": "refer-to", "type": "clause", "offset": [410, 418]}, {"key": "information-regarding", "type": "clause", "offset": [461, 482]}, {"key": "the-safety", "type": "clause", "offset": [483, 493]}, {"key": "in-order-to", "type": "clause", "offset": [552, 563]}, {"key": "to-receive", "type": "definition", "offset": [598, 608]}, {"key": "any-jurisdiction", "type": "definition", "offset": [632, 648]}, {"key": "within-the-territory", "type": "definition", "offset": [649, 669]}, {"key": "for-sale", "type": "clause", "offset": [759, 767]}, {"key": "by-a-third-party", "type": "clause", "offset": [784, 800]}, {"key": "pursuant-to", "type": "definition", "offset": [812, 823]}, {"key": "rights-granted", "type": "definition", "offset": [828, 842]}, {"key": "by-licensee", "type": "clause", "offset": [843, 854]}], "samples": [{"hash": "aY6QkjlNBj4", "uri": "/contracts/aY6QkjlNBj4#generic-products", "label": "License and Collaboration Agreement (Ocuphire Pharma, Inc.)", "score": 33.8487319946, "published": true}, {"hash": "44sqNvaa7yv", "uri": "https://ir.opusgtx.com/sec-filings/all-sec-filings/content/0001140361-22-040303/0001140361-22-040303.pdf", "label": "ir.opusgtx.com", "score": 17.8328683116, "published": false}], "snippet": "means, with respect to a Product that has received Regulatory Approval granted by a Governmental Authority in a country in the Territory, a pharmaceutical product which contains any phentolamine salt which is highly similar, or similar enough to the one contained in a reference Product, notwithstanding minor differences in clinically inactive components, to permit an applicant for Governmental Authority to refer to and rely on clinical and other scientific information regarding the safety, purity, potency and/or efficacy of the reference Product in order to allow such pharmaceutical product to receive Regulatory Approval in any jurisdiction within the Territory through an abbreviated, expedited, or other similar regulatory pathway, that is marketed for sale in such country by a Third Party other than pursuant to any rights granted by Licensee or their Affiliates.", "hash": "33b94b2da726f2a70794b43e202175a5", "id": 10}], "next_curs": "Cl0SV2oVc35sYXdpbnNpZGVyY29udHJhY3RzcjkLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIZZ2VuZXJpYy1wcm9kdWN0cyMwMDAwMDAwYQyiAQJlbhgAIAA=", "definition": {"size": 69, "title": "Generic Product(s)", "snippet": "means any pharmaceutical product that (i) is sold by a Third Party that is not a licensee or Sublicensee of Abbott or its Affiliates, or any of their licensees or Sublicensees under a marketing authorization granted by a Regulatory Authority to such Third Party, and (ii) contains the same Compound as an active pharmaceutical ingredient as the relevant Product and (x) for purposes of the United States, is approved in reliance on the prior approval of a Product as determined by the FDA, or (y) for purposes of a country outside the United States, is approved in reliance on the prior approval of a Product as determined by the applicable Regulatory Authority. On a country by country basis, a Product licensed or produced by Abbott (e.g. an authorized generic product) will not constitute a Generic Product.", "id": "generic-products", "examples": ["The Contractor must maintain prices for Brand Name and Generic Products for the first year of the Contract as proposed in the Products List.", "Where no Generic Market Data is available for a particular geographical region, the Parties will determine the level of sales of Generic Products in such region in good faith based on the totality of the information then available for global sales of Licensed Products and Generic Products.", "Respondents shall provide a Price Proposal for statewide coverage and provide a discount off MSRP for all Product Categories, including Brand Name and Generic Products, for the initial and renewal terms.", "The term of this Agreement, as to a particular Licensed Product in a particular country, shall expire (on a country-by-country basis) upon the earlier of: (i) the expiration of the Royalty Term for such Licensed Product in such country, or (ii) the end of calendar quarter in which sales in such country of Generic Products exceed [***]% (on a \u201cper unit\u201d basis) of the sales of the Licensed Product in such country.", "Product Group specific to this RFP (Brand Name or Generic Products).", "Generic Products may also be referred to as private label Products.", "Such reduction shall be first applied with respect to such country starting with sales in the calendar quarter following the first calendar quarter where the sales of the <strong>Generic Product(s)</strong> in such country exceed [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of the unit sales volume of the applicable Licensed Product.", "The royalty rates specified in Sections 5.5(a) and 5.5(b) shall be reduced by [CONFIDENTIAL TREATMENT REQUESTED] /*/ ([CONFIDENTIAL TREATMENT REQUESTED] /*/) on a country-by-country basis at any such time where the sale of one or more <strong>Generic Product(s)</strong> in such country exceeds [CONFIDENTIAL TREATMENT REQUESTED] /*/ percent ([CONFIDENTIAL TREATMENT REQUESTED] /*/%) of the unit sales volume for the applicable Licensed Product in that country, as measured by IMS Health or its successor.", "If no data is commercially available, then the Parties shall agree upon a methodology for estimating the percentage unit-based market share of Generic Products in such country.", "Market share shall be based on the aggregate market in such country of such Shared Product and all applicable Generic Products (based on sales of units of such Shared Product and such <strong>Generic Product(s)</strong> in the aggregate, as reported by IMS International, or if such data are not available, such other reliable data source as reasonably agreed by the Parties)."], "related": [["generic-product", "Generic Product", "Generic Product"], ["licensed-products", "Licensed Products", "Licensed Products"], ["licensed-product", "Licensed Product", "Licensed Product"], ["hemp-products", "Hemp products", "Hemp products"], ["hemp-product", "Hemp product", "Hemp product"]], "related_snippets": [], "updated": "2025-07-10T05:58:13+00:00"}, "json": true, "cursor": ""}}