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.
Appears in 1 contract
Sources: Collaboration and License Agreement (Sutro Biopharma Inc)
CELGENE Territory. As between On a Non-[*] DC-by-Non-[*] DC basis, after IND Clearance for such Non-[*] DC in the PartiesSUTRO Territory, subject SUTRO may participate in material meetings with Regulatory Authorities pertaining to the terms development, manufacture and commercialization of such Non-[*] DC and its corresponding Licensed Products and Diagnostic Products, or Regulatory Approvals thereof, in the Agreement, CELGENE Territory. CELGENE shall have the sole right provide SUTRO with reasonable advance written notice of all such meetings and responsibility for the development other contact and advance copies of all material related manufacturing activities (subject documents and other material relevant information relating to Sections 4.5 such meetings or such other contact. SUTRO and 6.1.1) CELGENE shall discuss any material documents or other material correspondence that CELGENE is planning to submit in connection with Regulatory Approvals in the CELGENE Territory sufficiently in advance of submission so that SUTRO may review and comment on such documents and such other correspondence including in each case the proposed labeling for the corresponding Licensed Products and Diagnostic Products. SUTRO 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 except with respect to (A) worldwide, for all BACs and ADCs prior to Nomination as a Development Candidate and its (B) in the SUTRO Territory, limited to Non-[*] DCs following IND Clearance. CELGENE shall promptly provide to SUTRO copies of any material documents or other material correspondence pertaining to the corresponding Licensed Products and Diagnostic Products in the Field in the CELGENE Territory andTerritory, with respect to on a Non-[*] DCsDC-by-Non-[*] DC basis, and shall promptly provide to SUTRO all proposed labeling, in each case received from 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 Regulatory Authorities 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, SUTRO’s rights, and CELGENE’s reporting obligations obligations, under this Section 3.1.1 4.2.1 shall terminate upon a Business Combination of SUTRO.
Appears in 1 contract
Sources: Collaboration and License Agreement (Sutro Biopharma Inc)