FOR COMBINATION PRODUCT Sample Clauses
FOR COMBINATION PRODUCT. FOREST shall pay to ALMIRALL non-refundable milestone payments to accrue on the following events for the Combination Product: - Feasibility of the formulation of the Combination Product (feasibility meaning delivery by ALMIRALL of data that shows that [***] or if clinical Development is undertaken - [***] following the receipt by FOREST of top line data from completed Phase Ill clinical trials provided by the Development Plan where the [***] corresponding primary endpoint is achieved with statistical significance and safety and efficacy data obtained are sufficient for use as pivotal trials for filing an NDA with a reasonable expectation of FDA Approval [***] it being understood that in the event this milestone is not due FOREST shall not be obliged to submit the corresponding NDA - Combination Product Final Approval: [***] In total [***]
FOR COMBINATION PRODUCT. General and legal responsibility for combination product requirements in accordance with CFR, including, but not limited to, the use of the Product with any other medical products, components, devices (including the pen device), labels or otherwise [*] [*] Responsibilities of Management (§ 820.20 CFR), with executive responsibility at the Facility of ▇▇▇▇▇▇ Pharma, are well defined and documented in the quality system in effect at the Facility of ▇▇▇▇▇▇ Pharma where the Product is Manufactured. Radius shall review ▇▇▇▇▇▇ Pharma’s quality system during initial and periodic audits, to verify compliance with the management responsibility requirements [*] [*] Ensure compliance of the Product with the requirements of 21 CFR 820.30 [*] [*] Transfer the design, as referred to under 21 CFR 820.30, section (g), of the Pen (the combination device) to ▇▇▇▇▇▇ Pharma, to be in accordance with the Specifications [*] [*] Document acceptance of such design transfer and incorporation into the Specifications [*] [*] Provide to ▇▇▇▇▇▇ Pharma, and accept responsibility for, the technical and functional requirement specifications [*] [*] Propose selective, specific design input requirements, based on the technical and functional requirement specifications [*] [*] Review and approve ▇▇▇▇▇▇ Pharma-proposed design input requirements, if acceptable [*] [*] Validate, and accept responsibility for, the design, as referred to under section 21 CFR 820.30, section (g), including assessment and verification that the design output meets the Radius design input (according to Radius’ design validation procedures) [*] [*] Upon request by Radius and in accordance with separate written agreement, perform testing of the design output to support Radius’ design verification [*] [*] Approve, adopt and accept responsibility for, design changes, as referred to under 21 CFR 820.30, section (i) [*] [*] Communicate any changes to the design to ▇▇▇▇▇▇ Pharma, via revision of the Specifications to be implemented via the change control provisions of this QA [*] [*] Retain, and accept responsibility for, the design history file and the development plan, including as referred to under 21 CFR 820.30, section (j) [*] [*] APPENDIX 5: DELINEATION OF RESPONSIBILITIES (6/6) , Revison 01
FOR COMBINATION PRODUCT. (continued)