Aptalis Phase 4 Studies Sample Clauses

Aptalis Phase 4 Studies. Aptalis shall prepare a design and protocol(s) for any Phase 4 Study it or its sublicensees may propose (collectively, regardless of the preparer, including those prepared under Section 4.2.2, a “Protocol”) to carry out, and will submit each such Protocol to Strakan for its review, comment and approval. Aptalis shall, and shall use Commercially Reasonable Efforts to cause its sublicensees to, consider in good faith any comments submitted by Strakan, including comments regarding the impact of such Protocol on the regulatory and commercial status of the Product outside the Territory. Strakan shall provide its comments to Aptalis within fifteen (15) days after receiving a single Protocol for a Phase 4 Study and thirty (30) days after receiving multiple Protocols for a Phase 4 Study, and shall notify Aptalis within such time period(s) whether or not it approves the respective Protocol(s), provided that such approval will not be unreasonably withheld, conditioned or delayed. Aptalis shall use its Commercially Reasonable Efforts to cause its sublicensees to comply or carry out, as applicable, with such Protocol(s) as approved.