CELGENE Territory Sample Clauses

CELGENE Territory. CELGENE and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to the Licensed Products in the CELGENE Territory. CELGENE shall consult with EPIZYME through the JCC with respect to pricing and reimbursement approvals in the CELGENE Territory.
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CELGENE Territory. Subject to CELGENE’s reasonable discretion, EPIZYME 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 in the EMA and in the Major EU Countries, Canada, China, India, Japan and Mexico (such countries being referred to hereinafter as “Major License Countries”) upon prior reasonable written request, and in all other countries of the CELGENE Territory upon mutual agreement of the Parties, in each case, on a Licensed Product-by-Licensed Product basis, from and after Achievement of Proof of Concept of such Licensed Product. CELGENE shall provide EPIZYME 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. CELGENE and EPIZYME shall discuss any material documents or other material correspondence that CELGENE is planning to submit in connection with Regulatory Approvals from the Major License Countries including the proposed labeling for the Licensed Products and related Diagnostic Products. Upon EPIZYME’s reasonable written request therefor, CELGENE shall provide EPIZYME with drafts of such documents or correspondence sufficiently in advance of submission so that EPIZYME 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 CELGENE. EPIZYME 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 in the CELGENE Territory. CELGENE shall promptly provide to EPIZYME copies of any material documents or other material correspondence pertaining to the Licensed Product or related Diagnostic Product in the EMA or the Major License Countries and shall promptly provide to EPIZYME all proposed labeling, in each case received from the Regulatory Authorities in the Major License Countries. Upon EPIZYME’s reasonable written request, CELGENE shall provide EPIZYME with any English translations of the documents and correspondence describe...
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CELGENE Territory. Following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, CELGENE 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 such Licensed Compounds, Licensed Products and related Diagnostic Products in the Field in the CELGENE Territory. CELGENE shall own all such regulatory filings and Regulatory Approvals relating to such Licensed Compounds, Licensed Products and related Diagnostic Products in the CELGENE Territory. Subject to Sections 2.7.3(c) and 6.6, to the extent permitted by applicable Laws and following Achievement of Proof of Concept of a Licensed Compound or Licensed Product, EPIZYME shall assign and transfer to CELGENE all regulatory filings and Regulatory Approvals in the CELGENE Territory that relate to such Licensed Compound, Licensed Product and related Diagnostic Product.
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CELGENE Territory. As between the Parties, subject to the terms of the Agreement, CELGENE shall have the sole right and responsibility for the development and related manufacturing activities (subject to Sections 4.5 and 6.1.1) in connection with such Development Candidate and its corresponding Licensed Products and Diagnostic Products in the Field in the CELGENE Territory and, with respect to Non-[*] DCs, in the SUTRO Territory through U.S. IND Clearance. CELGENE will, itself or through its Affiliates or Sublicensees, exercise Commercially Reasonable Efforts to clinically develop each such Development Candidate, Licensed Products and Diagnostic Products in the Field in the CELGENE Territory; it being understood and agreed that, as of any time during the Term, the exercise of Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to any Development Candidate and its corresponding Licensed Products and Diagnostic Products included in any BAC/ADC Program shall be deemed to satisfy the requirement to exercise Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to each other Development Candidate and its corresponding Licensed Products and Diagnostic Products included in each such Program. In addition to the reporting requirements set forth in Section 3.1.3, at least once per Calendar Year, CELGENE shall provide to SUTRO a reasonably detailed report regarding CELGENE’s development activities, which shall include with respect to the prior twelve (12) month-period an update of any Clinical Trials conducted by CELGENE, its Affiliates or Sublicensees with respect to all Development Candidates and a description of INDs and XXXx filed and Regulatory Approvals obtained by CELGENE, its Affiliates or Sublicensees for all Development Candidates and Licensed Products. Notwithstanding the foregoing, CELGENE’s reporting obligations under this Section 3.1.1 shall terminate upon a Business Combination of SUTRO.
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CELGENE Territory. As between the Parties, subject to the terms of the Agreement, CELGENE shall have the sole right and responsibility for the commercialization and related manufacturing activities (subject to Article 6) in connection with such Development Candidate and its corresponding Licensed Products and Diagnostic Products in the Field in the CELGENE Territory. CELGENE will, itself or through its Affiliates or Sublicensees, exercise Commercially Reasonable Efforts to commercialize such Development Candidate, Licensed Products and Diagnostic Products in the Field in the CELGENE Territory; it being understood and agreed that, as of any time during the Term, the exercise of Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to any Development Candidate and its corresponding Licensed Products and Diagnostic Products included in any BAC/ADC Program shall be deemed to satisfy the requirement to exercise Commercially Reasonable Efforts by CELGENE (itself or through its Affiliates or Sublicensees) with respect to each other Development Candidate and its corresponding Licensed Products and Diagnostic Products included in each such Program. In addition to the reporting requirements set forth in Section 3.2.3, at least once per Calendar Year, CELGENE shall provide to SUTRO a reasonably detailed report regarding CELGENE’s commercialization activities for such prior twelve (12) month-period, including notice of the First Commercial Sale of any Licensed Product by CELGENE, its Affiliates or Sublicensees on a country-by-country basis in the CELGENE Territory.
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CELGENE Territory. Unless otherwise expressly authorized by CELGENE in writing, SUTRO shall not (i) actively seek prospective purchasers for any Licensed Product for use in the CELGENE Territory, (ii) engage in any advertising or promotional activities relating to any Licensed Product directed primarily to prospective purchasers for use in the CELGENE Territory, or (iii) solicit orders from any prospective purchaser for sale and use in the CELGENE Territory. If SUTRO receives any unauthorized order from a prospective purchaser for the CELGENE Territory, SUTRO shall promptly refer that order to CELGENE and shall not accept any such orders. SUTRO shall not sell any Licensed Product to a purchaser if SUTRO knows that such purchaser intends to resell or otherwise distribute or provide such Licensed Product to a prospective purchaser for use in the CELGENE Territory.
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CELGENE Territory. Following IND Clearance for a Development Candidate anywhere in the CELGENE Territory, CELGENE shall have the sole right to prepare, file and maintain all Regulatory Materials (including pricing and reimbursement approvals) necessary for the development, manufacture or commercialization of such Development Candidate, its corresponding Licensed Products and Diagnostic Products, in the Field in the CELGENE Territory, provided, however, that SUTRO shall have the sole right to prepare, file and maintain any SUTRO Expression DMF. CELGENE shall own all such Regulatory Materials relating to such Development Candidate, Licensed Products and Diagnostic Products in the CELGENE Territory (excluding for clarity any SUTRO Expression DMF).
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CELGENE Territory. From and after the completion of the first Phase 1 Clinical Trial for a Licensed Compound Directed to DOT1L, or if EPIZYME exercises a EPIZYME Post-EOP1 Clinical Opt-Out pursuant to Section 2.5, CELGENE 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 CELGENE Territory, and to the extent permitted by applicable Laws and to the extent not assigned and transferred as of the Effective Date, EPIZYME shall assign and transfer to CELGENE, within [**] days after the completion of such Phase 1 Clinical Trial or after such EPIZYME Post-EOP1 Clinical Opt-Out or such EPIZYME Late Stage Opt-Out, all regulatory filings and Regulatory Approvals in the CELGENE Territory that relate to any and all Licensed Compounds and Licensed Products directed to DOT1L and all related Diagnostic Products. From and after the completion of the first Phase 1 Clinical Trial for a Licensed Compound Directed to DOT1L, or after such EPIZYME Post-EOP1 Clinical Opt-Out or such EPIZYME Late Stage Opt-Out, CELGENE shall own all such regulatory filings and Regulatory Approvals necessary for the Development, Manufacture or Commercialization of Licensed Compounds, Licensed Products and related Diagnostic Products in the CELGENE Territory.
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Related to CELGENE Territory

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

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

  • 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.

  • 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.

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

  • 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.

  • Licensed Patents Immune Design, at its expense, shall have the first right to file, prosecute and maintain all Licensed Patents for which Immune Design has any exclusive rights under this Agreement using patent counsel reasonably approved by IDRI, including conducting any interferences, reexaminations, reissues, oppositions, or request for patent term extension relating thereto. Immune Design shall conduct such filing, prosecution and maintenance in good faith, taking into consideration IDRI’s retained rights hereunder, and consistent with reasonable business judgment, provide IDRI with all relevant or material documentation and proposed filing in the Territory so that IDRI may be concurrently and promptly informed of the continuing prosecution, and consult with IDRI with regards to Immune Design’s patent strategy with the Licensed Patents for which Immune Design has any exclusive rights under this Agreement. Licensed Patents in the name of IDRI shall remain in the name of IDRI. Immune Design shall use commercially reasonable efforts to ***, as applicable. To the extent such ***, Immune Design shall provide IDRI reasonable opportunity to review and comment on such prosecution efforts regarding such Licensed Patents in the Territory, and any IDRI comments will be reasonably considered in such prosecution efforts, and included to the extent affecting the IDRI Exclusive Field or IDRI Territory, as the case may be. If Immune Design determines in its sole discretion to abandon or not maintain any Licensed Patent for which Immune Design has any exclusive rights under this Agreement in the Territory, then Immune Design shall promptly provide IDRI with written notice of such determination at least sixty (60) days before any deadline for taking action to avoid abandonment and shall provide IDRI with the right, opportunity and reasonable assistance to prepare, file, prosecute and maintain such Licensed Patent in the applicable jurisdiction in IDRI’s sole discretion and at IDRI’s expense, provided that Immune Design shall provide such reasonable assistance at its *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. own costs and expenses. If IDRI elects to prepare, file, prosecute and maintain such Licensed Patent in such jurisdiction for which Immune Design has any exclusive rights, then Immune Design’s license rights to such Licensed Patent in such country will become nonexclusive in such country under such Licensed Patent (and/or patent application). If IDRI desires Immune Design to file, in a particular jurisdiction, a Licensed Patent for which Immune Design has any exclusive rights under this Agreement that claims priority to another Licensed Patent for which Immune Design has any exclusive rights under this Agreement, IDRI shall provide written notice to Immune Design requesting that Immune Design file such patent application in such jurisdiction. If IDRI provides such written notice to Immune Design, Immune Design shall either (i) file and prosecute such patent application and maintain any patent issuing thereon in such jurisdiction and the Parties shall share the related costs and expenses (A) in countries *** on the basis of *** percent (***%) Immune Design: *** percent (***%) IDRI or (B) in countries within the IDRI Territory equally; or (ii) notify IDRI that Immune Design does not desire to file such patent application in such jurisdiction and provide IDRI with the opportunity to file and prosecute such patent application, provided that if IDRI files and prosecutes such patent application in such jurisdiction, then Immune Design’s license rights to such License Patent in such country will become nonexclusive in such country under such Licensed GLA Patent (and/or patent application). Immune Design shall be responsible for the costs and expenses incurred in connection with its own activities for filing, prosecuting and maintaining the Licensed Patents; IDRI shall be responsible for monitoring of such activities by IDRI.

  • 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.

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