Voyager Diligence Sample Clauses
The Voyager Diligence clause establishes the obligation for one or both parties to conduct thorough investigations or assessments related to the Voyager agreement. In practice, this may involve reviewing financial records, operational procedures, or compliance with relevant regulations before finalizing the transaction or partnership. The core function of this clause is to ensure that all parties have sufficient information to make informed decisions, thereby reducing the risk of unforeseen issues and promoting transparency in the agreement.
Voyager Diligence. (a) If Voyager elects to proceed with Clinical Trials for the Product, Voyager shall use Commercially Reasonable Efforts to conduct all required Clinical Trials and obtain the Regulatory Approvals necessary to Exploit the Product in the United States as soon as reasonably practicable. Voyager shall use Commercially Reasonable Efforts to commercialize the Product in the United States during the term of this Agreement commencing as soon as reasonably practicable after receipt of required Regulatory Approvals. At the same time as Voyager provides SBS with written notice of its intent to conduct Clinical Trials pursuant to Section 4.1, Voyager shall provide SBS with a written outline of its Clinical Trial strategy and timeline to support Regulatory Approval in the United States (the “Clinical Trial Plan”). The Clinical Trial Plan will include Voyager’s good faith estimate as to the target dates for (i) IND filing, (ii) start of Phase III and (iii) NDA filing to support Regulatory Approval in the United States (each, a “Clinical Milestone Target Date”). Voyager shall review the Clinical Trial Plan at least on a quarterly basis and may in its reasonable discretion change such plan and any Clinical Milestone Target Date therein at any time. Voyager promptly shall notify SBS in writing in the event of any material change to the Clinical Trial Plan or in the event that any Clinical Milestone Target Date is delayed by one calendar quarter or more. At SBS’s request, Voyager shall provide SBS the reasons for such change. If Voyager defaults in the performance of any of its material obligations under this Section 4.2(a), which default has not been cured by Voyager within sixty (60) days after receiving written notice thereof from SBS, then SBS may, in its sole discretion, terminate this Agreement by providing immediate written notice to Voyager.
(b) If Voyager has not applied for Regulatory Approval in (i) each other Major Market within [**] after obtaining Regulatory Approval for the Product in the United States or (ii) in each country in the Territory other than a Major Market within [**] after obtaining Regulatory Approval for the Product in the United States, or has not made the First Commercial Sale in any country [**] after receipt of Regulatory Approval in such country, then SBS may, upon [**] days prior written notice to Voyager (unless Voyager applies for such Regulatory Approval or makes such First Commercial Sale within such [**] day period), terminate the r...
Voyager Diligence. Voyager shall use Commercially Reasonable Efforts to (a) Develop each Split Territory Licensed Product and obtain Regulatory Approval therefor by the FDA in the United States; and (b) perform the Development activities allocated to it under each applicable Split Territory Global Development Plan, as each such Split Territory Global Development Plan may be amended in accordance with this Agreement.
Voyager Diligence. During the Option Period for each Collaboration Program, Voyager shall use Commercially Reasonable Efforts to Develop Collaboration Products under each Collaboration Program in accordance with the Collaboration R&D Plan for such Collaboration Products through achievement of Human POP Study Completion.