Post-Approval Commitment Studies definition
Examples of Post-Approval Commitment Studies in a sentence
After transfer of the Regulatory Approval to Jazz, PharmaMar will provide completed clinical study reports (CSRs) and submission-ready analysis datasets to Jazz for any of the studies supporting the Regulatory Approval by the FDA for a Licensed Product in the SCLC Initial Indication (including the Atlantis Trial and the SCLC Post-Approval Commitment Studies) promptly after such reports and datasets are available.
Development Costs incurred by Jazz from the performance of the Jazz Canada SCLC Post-Approval Commitment Studies shall be creditable up to [***] of the Jazz Canada SCLC Post-Approval Commitment Studies Budget for any such Study solely against those Regulatory Milestone Payment, Sale Milestone Payments and royalty payments referred to Jazz Canada Territory thereafter due and payable pursuant to Section 8.4, Section 8.6 and Section 8.7, as applicable, as set forth in Section 8.3(b).
Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Jazz Canada SCLC Post-Approval Commitment Studies.
Upon the Closing, the Purchaser shall be responsible for any and all further developmental activities relating to the Product and Acquired Regulatory Approvals in or for the Territory, including any Post-Approval Commitment Studies and all obligations and expenses relating thereto.
In the event Jazz exercises its right to conduct the SCLC Post-Approval Commitment Studies itself in accordance with Section 4.1(b), then PharmaMar shall be responsible for one hundred percent (100%) of the Development Costs up to [***] of the SCLC Post-Approval Commitment Studies Budget.
In such event, Jazz shall prepare a proposed development plan and a proposed budget for such Jazz Canada SCLC Post-Approval Commitment Studies, including the number of FTEs to conduct such activities (each such development plan, a “Jazz Canada SCLC Post-Approval Commitment Studies Development Plan” and each such budget, a “Jazz Canada SCLC Post-Approval Commitment Studies Budget”), which shall each be reviewed, discussed and approved by the JDC.
Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Mutual Canada SCLC Post-Approval Commitment Studies.
Upon approval by the JDC, such plan shall be deemed the “SCLC Post-Approval Commitment Studies Development Plan”.
Except as set forth in this Section 4.1 with respect to the Atlantis Trial, the U.S. SCLC Post-Approval Commitment Studies and the Mutual Canada SCLC Post-Approval Commitment Studies, PharmaMar shall have no further obligation to conduct any pre-clinical or clinical Development activities with respect to any Licensed Products.
JDC approval shall not be required with regard to design, protocol and timeline of those SCLC Post-Approval Commitment Studies whose protocol has been submitted to FDA prior to the Effective Date of this Agreement.