1.39 “Licensed Know-How” means all Technical Information and Regulatory Documentation Controlled as of the Effective Date or thereafter during the Term by Kayla or any of its Affiliates that is necessary for the Exploitation of any Licensed Compounds in any Licensed Product in the Field in the Territory. The Licensed Know-How existing as of the Effective Date is listed on Exhibit B.
1.40 “Licensed Method” means any method that (a) uses Licensed Know-How, or (b) the use, practice or performance of which is covered by a Valid Claim of any Licensed Patent.
1.41 “Licensed Patents” means (a) [***] and [***]; (b) any and all provisionals, nonprovisionals, substitutions, continuations, continuations-in-part or divisionals or the patents or patent applications listed in subsection (a) or any other patent application claiming priority directly or indirectly to (i) any of the patents or patent applications in subsection (a) or (ii) any patent or patent application from which the patents or patent applications in subsection (a) claim direct or indirect priority, (c) all patents issuing on any of the foregoing in (a)-(b), (d) all foreign and other counterparts of any of the foregoing in (a)-(c), whether pending or issued, including any patent applications filed under the Patent Cooperation Treaty and (e) all other continuing applications, extensions or restorations by existing or future extension or restoration mechanisms, including patent term extension, supplementary protection certificates (or the equivalent), renewals, letters patent, reissues, reexaminations, extensions, confirmations, registrations and patents of addition, or any other existing or future extension or restoration mechanisms or patent term adjustments, on any of the foregoing in subsections (a)-(d).
1.42 “Licensed Product” means any product containing a Licensed Compound administered in, on or together with an Exosome. Licensed Product shall include all dosage forms, formulations, preparations and line extensions of any such product, including a Combination Product, except for calculation of Net Sales in Section 1.37.
1.43 “Losses” has the meaning set forth in Section 8.1.
1.44 “Management Committee” has the meaning set forth in Section 2.1.
1.45 “Manufacture” means, with respect to a Licensed Product or component thereof, those manufacturing-related activities that support the research, development, 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 commercial supply of such Licensed Product, the synthesis, manufacturing, processing, formulating, packaging, labeling, holding, quality control testing and release of such Licensed Product.
1.46 “Material Breach” has the meaning set forth in Section 11.3.
1.47 “NDA” means a New Drug Application, as defined in the U.S. Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, filed with the FDA required for marketing approval for the applicable Licensed Product in the U.S, and any equivalent application submitted in any country in the Territory.
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