1.122 Joint Review Committee has the meaning set forth in Section 2.9(b)(i).
1.123 Joint Steering Committee or JSC has the meaning set forth in Section 2.2(a).
1.124 Know-How means any data, results, and information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, discoveries, developments, specifications, formulations, formulae, articles of manufacture, materials (including biological or chemical) or compositions of matter of any type or kind, software, algorithms, marketing reports, pricing and distribution costs, forecasts, strategies, plans, clinical and non-clinical study reports, regulatory submission documents and summaries, expertise, stability, technology, test data including pharmacological, biological, chemical, biochemical, toxicological, and clinical test data, analytical and quality control data, stability data, studies and procedures, dosage regimens; in each case, whether or not patentable or copyrightable.
1.125 Knowledge with respect to a Party, means the actual knowledge of (a) with respect to Pfizer, [**], and (b) with respect to Arvinas, [**], in each case ((a) or (b)), at the relevant time, without any requirement to make any additional enquiries or investigation.
1.126 Lead Party has the meaning set forth in Section 4.1(b).
1.127 Lead Party Territory has the meaning set forth in Section 4.1(b).
1.128 Licensed Compound means Arvinas proprietary compound ARV-471, the structure of which is set forth on Appendix 1.128, and any stereoisomers, salts, esters as prodrugs, physical forms, and polymorphs thereof.
1.129 Licensed Product(s) means any product containing a Licensed Compound as an Active Ingredient, in any form, presentation, dosage or formulation form (including fixed dose combination).
1.130 Manufacture means, with respect to a Licensed Product, those manufacturing-related activities that support the Development (including the seeking and obtaining of Regulatory Approvals) and Commercialization of such Licensed Product, including manufacturing process development and scale-up, validation, qualification and audit of clinical and commercial manufacturing facilities, bulk production and fill/finish work, related quality assurance technical support activities and CMC Activities, and including, in the case of a clinical or commercial supply of such Licensed Product, the synthesis, manufacturing, processing, formulating, packaging, labeling, holding, quality control testing and release of such Licensed Product. Manufacturing and Manufactured have a correlative meaning.
1.131 Manufacturing Budget has the meaning set forth in Section 2.6(b)(xi).
1.132 Manufacturing Cost has the meaning set forth on Exhibit B.
1.133 Manufacturing-Specific Know-How means any Collaboration Know-How conceived, discovered, developed or otherwise made during Manufacturing of a Licensed Product and specifically related to process development, manufacture, formulating, but not formulations, packaging, labeling, analyzing or testing of such Licensed Product.
1.134 Manufacturing-Specific Patents means all Collaboration Patents that claim or disclose Manufacturing-Specific Know-How.