SUTRO Territory Clause Samples
SUTRO Territory. As between the Parties, subject to the terms of the Agreement, upon U.S. IND Clearance, SUTRO shall have the sole right and responsibility for the development and related manufacturing activities in connection with any Non-[*] DC and its corresponding Licensed Products and Diagnostic Products in the Field in the SUTRO Territory. SUTRO may, itself or through its Affiliates or licensees, clinically develop such Non-[*] DCs, Licensed Products and Diagnostic Products in the Field in the SUTRO Territory. SUTRO will be subject to the reporting requirements set forth in Section 3.1.3.
SUTRO Territory. CELGENE may participate in all material meetings and other material contact with Regulatory Authorities pertaining to the development, manufacture and commercialization of a Collaboration BAC, Collaboration ADC or Development Candidate and its corresponding Licensed Products and Diagnostic Products, or Regulatory Approvals thereof, (a) worldwide (prior to Nomination of such Collaboration BAC or Collaboration ADC as a Development Candidate) and (b) in the SUTRO Territory, on a Non-[*] DC-by-Non-[*] DC basis (after IND Clearance for such Development Candidate in the SUTRO Territory). SUTRO 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 37 *Confidential Treatment Requested. relating to such meetings or such other contact. SUTRO and CELGENE shall discuss any material documents or other material correspondence that SUTRO is planning to submit in connection with (i) Regulatory Approvals worldwide (prior to Nomination of such Collaboration BAC or Collaboration ADC as a Development Candidate) and (ii) Regulatory Approvals in the SUTRO Territory, on a Non-[*] DC-by-Non-[*] DC basis (after IND Clearance for such Development Candidate in the SUTRO Territory), including in each case the proposed labeling for the corresponding Licensed Products and Diagnostic Products. SUTRO 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, which comments shall be considered in good faith by SUTRO. CELGENE shall not have the right to approve the proposed labeling or any other regulatory filings or submissions for the corresponding Licensed Products and Diagnostic Products (A) worldwide (prior to Nomination of such BAC or ADC as a Development Candidate) and (B) in the SUTRO Territory, on a Non-[*] DC-by-Non-[*] DC basis (after IND Clearance for such Development Candidate in the SUTRO Territory). SUTRO shall promptly provide to CELGENE copies of any material documents or other material correspondence pertaining to the corresponding Licensed Products and Diagnostic Products (I) worldwide (prior to Nomination of such Collaboration BAC or Collaboration ADC as a Development Candidate) and (II) in the SUTRO Territory, on a Non-[*] DC-by-Non-[*] DC basis (after IND Clearance for such Development Candidate i...
SUTRO Territory. Unless otherwise expressly authorized by SUTRO in writing, CELGENE shall not (i) actively seek prospective purchasers for any Licensed Product for use in the SUTRO Territory, (ii) engage in any advertising or promotional activities relating to any Licensed Product directed primarily to prospective purchasers for use in the SUTRO Territory, or (iii) solicit orders from any prospective purchaser for sale and use in the SUTRO Territory. If CELGENE receives any unauthorized order from a prospective purchaser for the SUTRO Territory, CELGENE shall promptly refer that order to SUTRO and shall not accept any such orders. CELGENE shall not sell any Licensed Product to a purchaser if CELGENE knows that such purchaser intends to resell or otherwise distribute or provide such Licensed Product to a prospective purchaser for use in the SUTRO Territory.
SUTRO Territory. Following IND Clearance for a Non-[*] DC in the SUTRO Territory, SUTRO shall have the sole right to prepare, file and maintain all Regulatory Materials (including pricing and reimbursement approvals) in the SUTRO Territory necessary for the development, manufacture or commercialization of such Non-[*] DC, its corresponding Licensed Products and Diagnostic Products, in the Field in the SUTRO Territory. SUTRO shall own all such Regulatory Materials in the SUTRO Territory. To the extent permitted by applicable Laws and following IND Clearance for such Non-[*] DC in the SUTRO Territory, CELGENE shall assign and transfer to SUTRO all Regulatory Materials for the SUTRO Territory that solely relate to such Non-[*] DC and its corresponding Licensed Products and Diagnostic Products.
SUTRO Territory. SUTRO and its Affiliates shall take the lead in all pricing and reimbursement approval proceedings relating to Licensed Products comprising or containing Non-[*] DCs in the SUTRO Territory. SUTRO shall consult with CELGENE through the JSC with respect to pricing and reimbursement approvals in the SUTRO Territory with respect to Licensed Products comprising or containing Non-[*] DCs.