Common use of CELGENE Territory Clause in Contracts

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 described in this Section 2.7.3(b)(i) that are produced for its own use.

CELGENE Territory. Subject With respect to Licensed Products Directed to DOT1L or [**], 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, (x) in the case of a Licensed Product Directed to [**], from and after Achievement CELGENE’s exercise of Proof of Concept of the Phase 1 Option with respect to such Licensed Product, and (y) in the case of a Licensed Product Directed to DOT1L, from and after the Effective Date. 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 United States (if within the CELGENE Territory), the EMA or and the Major License Countries and shall promptly provide to EPIZYME all proposed labeling, in each case received from the Regulatory Authorities in the United States (if within the CELGENE Territory), the EMA and the Major License Countries. Upon EPIZYME’s reasonable written request, CELGENE shall provide EPIZYME with any English translations of the documents and correspondence described in this Section 2.7.3(b)(i2.12.3(b)(i) that are produced for its own use.