Non-[*] DC definition
Examples of Non-[*] DC in a sentence
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.
On a Non-[*] DC-by-Non-[*] DC basis, after IND Clearance for such Non-[*] DC in the SUTRO Territory, SUTRO may participate in material meetings with Regulatory Authorities pertaining to the development, manufacture and commercialization of such Non-[*] DC and its corresponding Licensed Products and Diagnostic Products, or Regulatory Approvals thereof, in the CELGENE Territory.
With respect to any (a) Collaboration BAC or Collaboration ADC that is not a Development Candidate or (b) Non-[*] DC, in each case CELGENE shall provide to SUTRO for review written copies of any such publication or presentation at least thirty (30) days prior to submission for publication or presentation, and SUTRO shall provide its comments, if any, within thirty (30) days from CELGENE’s submission.
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.
Notwithstanding Section 9.4.1(b), in the event that a Non-[*] DC becomes an Abandoned Non-[*] DC pursuant to Section 2.2.6(b)(iii), CELGENE shall assign to SUTRO, at the time such Non-[*] DC becomes an Abandoned Non-[*] DC, all rights under Section 9.4.1(b)(iii) that were previously assigned by SUTRO to CELGENE pursuant to Section 9.4.1(c) with respect to the Abandoned Non-[*] DC.
For clarity, subject to Section 3.1.1, a Non-[*] DC may only be clinically developed or commercialized by SUTRO upon IND Clearance in the SUTRO Territory in accordance with this Agreement, and except as expressly permitted herein, SUTRO shall not initiate any IND-Enabling Study or file an IND for any Development Candidate.
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 may, itself or through its Affiliates or licensees, commercialize such Non-[*] DC, Licensed Products and Diagnostic Products in the Field in the SUTRO Territory.
On a Non-[*] DC-by-Non-[*] DC basis, after IND Clearance for such Development Candidate in the SUTRO Territory, the JSC shall continue to perform the functions set forth in this Section 5.2, solely with respect to such Non-[*] DC.
As between the Parties, subject to the terms of the Agreement, SUTRO shall have the sole right and responsibility for the commercialization and related manufacturing activities in connection with such Development Candidate if it is a Non-[*] DC and its corresponding Licensed Products and Diagnostic Products in the Field in the SUTRO Territory.