EPIZYME Territory Sample Clauses

The "EPIZYME Territory" clause defines the specific geographic regions or countries where EPIZYME, as a party to the agreement, is granted rights to develop, market, or sell certain products or technologies. This clause typically outlines the boundaries of EPIZYME's commercial activities, such as limiting their rights to North America, Europe, or other designated territories, and may also specify any excluded regions. By clearly delineating the territory, the clause prevents overlap or conflict with other parties' rights and ensures that each party understands the scope of their permitted activities, thereby reducing the risk of disputes over market access.
EPIZYME Territory. EPIZYME and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to the Licensed Products in the EPIZYME Territory. EPIZYME shall consult with CELGENE through the JCC with respect to pricing and reimbursement approvals in the EPIZYME Territory.
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EPIZYME Territory. Subject to EPIZYME’s reasonable discretion, CELGENE will have the right to fully participate in all material meetings and other material contact with Regulatory Authorities pertaining to the Development, Manufacture and Commercialization of the Licensed Products and related Diagnostic Products or Regulatory Approvals worldwide (prior to Achievement of Proof of Concept) and in the EPIZYME Territory (after Achievement of Proof of Concept) upon prior reasonable written request, in each case, on a Licensed Product-by-Licensed Product basis. EPIZYME shall provide CELGENE with reasonable advance written notice of all such meetings and other contact and advance copies of all material related documents and other material relevant information relating to such meetings or such other contact. EPIZYME and CELGENE shall discuss any material documents or other material correspondence that EPIZYME is planning to submit in connection with Regulatory Approvals worldwide (prior to Achievement of Proof of Concept) or in the EPIZYME Territory (after Achievement of Proof of Concept), including the proposed labeling for the Licensed Products and related Diagnostic Products. Upon CELGENE’s reasonable written request therefor, EPIZYME shall provide CELGENE with drafts of such documents or correspondence sufficiently in advance of submission so that CELGENE may review and comment on such documents and such other correspondence and have a reasonable opportunity to influence the substance of such submissions in a manner consistent with the goal of obtaining optimal Regulatory Approvals as quickly as reasonably practicable, which comments shall be considered in good faith by EPIZYME. CELGENE shall not have the right to approve the proposed labeling or any other regulatory filings or submissions for the Licensed Products and related Diagnostic Products worldwide (prior to Achievement of Proof of Concept) or in the EPIZYME Territory (after Achievement of Proof of Concept). EPIZYME shall promptly provide to CELGENE copies of any material documents or other material correspondence pertaining to the Licensed Product or related Diagnostic Product worldwide (prior to Achievement of Proof of Concept) or in the EPIZYME Territory (after Achievement of Proof of Concept) and shall promptly provide to CELGENE all proposed labeling, in each case received from the Regulatory Authorities worldwide (prior to Achievement of Proof of Concept) or in the EPIZYME Territory (after Achievement of Proof of C...
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EPIZYME Territory. Following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, EPIZYME shall continue to have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field in the EPIZYME Territory. EPIZYME shall own all such regulatory filings and Regulatory Approvals in the EPIZYME Territory.
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EPIZYME Territory. Following CELGENE’s exercise of the Phase 1 Option for an Available Target in accordance with Section 2.9.3, except as provided in Sections 2.4, 2.5 and 2.6, EPIZYME shall have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of all Licensed Compounds and Licensed Products Directed to such Available Target and all related Diagnostic Products in the Field in the EPIZYME Territory. EPIZYME shall own all such regulatory filings and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of Licensed Compounds and Licensed Products and related Diagnostic Products in the EPIZYME Territory.
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EPIZYME Territory. Except as provided in Sections 2.5 and 2.6, EPIZYME shall have the sole right to prepare, file and maintain all regulatory filings (including pricing and reimbursement approvals) and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of all Licensed Compounds and Licensed Products Directed to DOT1L and all related Diagnostic Products in the Field in the EPIZYME Territory. EPIZYME shall own all such regulatory filings and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of Licensed Compounds and Licensed Products and related Diagnostic Products in the EPIZYME Territory.
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Related to EPIZYME Territory

  • Licensed Product The term “Licensed Product” shall mean any product (a) the manufacture, use, importation, sale or offer for sale of which would, in the absence of the license granted by this Agreement, infringe a Valid Claim of any of the Licensed Patent Rights, or (b) that is comprised of, utilizes or incorporates Licensed Biological Materials, or (c) that is discovered, developed or made using a Licensed Process.

  • Territory 33.1 This Agreement applies to the territory in which CenturyLink operates as an ILEC in the State. CenturyLink shall be obligated to provide services under this Agreement only within this territory. 33.2 Notwithstanding any other provision of this Agreement, CenturyLink may terminate this Agreement as to a specific operating territory or portion thereof pursuant to Section 6.7 of this Agreement.

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.