Section 1.26. Clinical Development Plan has the meaning set forth in Section 4.01 (Joint Development in the Field in the Territory) hereof.
Section 1.27. CMC has the meaning set forth in Section 2.04(b) (Ongoing Transfer) hereof.
Section 1.28. CMO has the meaning set forth in Section 3.04(c) (Joint Manufacturing Committee) hereof.
Section 1.29. Collaboration IP has the meaning set forth in Section 10.01 (Ownership) hereof.
Section 1.30. Combination Product has the meaning set forth in Section 1.107 (Net Sales) hereof.
Section 1.31. Commercialization or Commercialize means, with respect to a pharmaceutical product, any and all activities directed to the marketing, promotion, importation, distribution, pricing, Reimbursement Approval, offering for sale, or sale of such pharmaceutical product, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall exclude Development and Manufacturing.
Section 1.32. Commercialization Plan and Report means, with respect to a Licensed Product in an indication in the Field, a written report including the following: [***], in each case with respect to the Commercialization of such Licensed Product in such indication in, with respect to Astellas, the Major Asian Countries and the Major European Countries and, with respect to Frequency, the U.S.
Section 1.33. Commercially Reasonable Efforts means, with respect to the efforts to be expended by a Party with respect to any objective, [***]. With respect to any efforts [***]. Commercially Reasonable Efforts shall be determined [***]. Further, to the extent that the performance of a Partys obligations hereunder is [***].
Section 1.34. Committee has the meaning set forth in Section 3.01 (General) hereof.
Section 1.35. Confidential Information means, subject to Section 13.02 (Exceptions), Know-How and any technical, scientific, trade, research, manufacturing, business, financial, compliance, marketing, product, supplier, intellectual property or other information that may be disclosed by one Party or any of its Affiliates to the other Party or any of its Affiliates during the Term, regardless of whether such information is specifically designated as confidential and regardless of whether such information is in written, oral, electronic or other form. In addition, subject to Section 13.02 (Exceptions), all information that (a) was disclosed prior to the Effective Date by or on behalf of either Party or any of its Affiliates under, and subject to, [***] (Confidentiality Agreement) and (b) is Confidential Information as defined in the Confidentiality Agreement, shall be deemed Confidential Information hereunder.
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.