EPIZYME Territory Sample Clauses

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. 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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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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Related to EPIZYME Territory

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • 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.

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Joint Patent Rights If not already established under the Research Collaboration Agreement, prior to either Party filing any Patent Right disclosing Joint Program Technology or Joint TAP Platform Improvements, the Parties shall establish a patent committee (the “Patent Committee”) comprised of at least one (1) representative of each Party for the purpose of facilitating the preparation, filing, prosecution, maintenance and defense of Joint Patent Rights. As agreed upon by the Parties, meetings of the Patent Committee may be face-to-face or may be conducted by teleconferences or videoconferences, from time to time as needed. The Patent Committee will be the forum through which the Parties coordinate their respective obligations to each other described in Sections 5.2.2 and 5.2.3 hereof and in this Section. In the event the Parties conceive or generate any Joint Program [***] Certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Confidential Treatment Requested by CytomX Therapeutics, Inc. Technology or Joint TAP Platform Improvements, the Parties shall promptly meet to discuss and determine, based on mutual consent, whether to seek patent protection thereon, which Party will control filing, prosecution and maintenance of such patents and how to pay for the filing, prosecution and maintenance of such patents. It is presumed that CytomX will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint Program Technology or Joint Unconjugated Probody Platform Improvements, and that ImmunoGen will control filing, prosecution and maintenance of Joint Patent Rights claiming Joint TAP Platform Improvements or Joint Conjugation Probody Platform Improvements. Neither Party will file any Joint Patent Right without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed. The Party controlling filing and prosecution of any such Joint Patent Right (a) shall keep the other Party informed regarding each Patent Right, (b) shall consider in good faith any recommendations made by the other Party in regard to the filing, prosecution or maintenance of any such Patent Right and (c) shall not unreasonably refuse to incorporate any recommendations made by the other Party in regard to such filing, prosecution or maintenance.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Licensed Patent Rights The term “Licensed Patent Rights” shall mean rights arising out of or resulting from:

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