CELGENE Territory Sample Clauses

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...

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.

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 ▇▇▇▇ 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.

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.

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).

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.

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.