system: You are a contract-analysis assistant performing a span-extraction task. You are given an excerpt from a commercial contract and the name of a clause type to locate within it.

Return the exact text of the requested clause, copied verbatim from the excerpt — identical wording and punctuation, with no paraphrasing, summarising, explanation, or added commentary.

The excerpt is one window of a much longer contract and often will not contain the requested clause. If the requested clause does not appear in this excerpt, respond with exactly: Not found.

Output only the extracted clause text, or the exact string `Not found.` — nothing else.

user: Contract excerpt:
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Licensed Product incorporating dose escalation and cohort expansion studies as described in the Initial Development Plan (as it may be amended from time to time in accordance with Section 3.1.1). 1.122 "Phase II" means a human clinical trial of a Licensed Compound or Licensed 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 pivotal clinical trials, or a similar clinical study prescribed by the Regulatory Authorities, from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(b), as amended. 1.123 "Phase III" means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended. 1.124 "PHSA" means the United States Public Health Service Act, as amended from time to time. 1.125 "PMDA" means Japan's Pharmaceuticals and Medical Devices Agency and any successor agency(ies) or authority having substantially the same function. 1.126 "Post CSR Option Period" has the meaning set forth in Section 12.6.3(e). 1.127 "Prior NDA" has the meaning set forth in Section 13.9. 1.128 "Product Information" has the meaning set forth in Section 9.1. 1.129 "Product Infringement" has the meaning set forth in Section 7.3.1. 1.130 "Product Labeling" means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the full prescribing information for such Licensed Product as approved by the Regulatory Authority for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction. 1.131 "Product-Specific Claims" has the meaning set forth in Section 7.2.1(a). 1.132 "Product-Specific Patents" has the meaning set forth in Section 7.2.1(b). 1.133 "Product Trademarks" means the Trademark(s) to be used by AbbVie or its Affiliates or its or their respective Sublicensees for the Development, Commercialization or Exploitation of Licensed Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, any trademarks, service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates). 1.134 "Proposed Future In-Licensed Rights" has the meaning set forth in Section 5.9. 1.135 "Regulatory Approval" means, with respect to a country or other jurisdiction in the Territory, all approvals (including Drug Approval Applications), licenses, registrations, or authorizations of - 15 - Source: HARPOON THERAPEUTICS, INC., 10-K, 3/12/2020 any Regulatory Authority necessary to Commercialize a Licensed Compound or Licensed Product in such country or other jurisdiction, including, where applicable, pricing or reimbursement approval in such country or other jurisdiction. 1.136 "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 and PMDA) regulating or otherwise exercising authority with respect to activities contemplated in this Agreement, including the Exploitation of the Licensed Compound or Licensed Products in the Territory. 1.137 "Regulatory Documentation" means all (a) applications (including all INDs and Drug Approval Applications and other Major Regulatory Filings), registrations, licenses, authorizations, and approvals (including 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 data contained or relied upon in any of the foregoing, in each case ((a), (b), and (c)) to the extent relating to a Licensed Compound or Licensed Product. 1.138 "Regulatory Exclusivity" means, with respect to any country or other jurisdiction in the Territory, an additional market protection, other than Patent protection, granted by a Regulatory Authority in such
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Extract the exact clause related to "Governing Law" from the excerpt above.