Sarcoma Program definition

Sarcoma Program means Development of the Licensed Product in the STS Indication for Regulatory Approval in the US consistent with the special protocol assessment (“SPA”) as agreed by the FDA, including, without limitation, the Development activities described in Schedule 1.97.
View Source
Sarcoma Program means Development of the Licensed Product in the STS Indication for Regulatory Approval in the US consistent with the special protocol assessment (“SPA”) as agreed by the FDA, including, without limitation, the Development activities described inSchedule 1.97.
View Source

Examples of Sarcoma Program in a sentence

  • The Parties shall use Commercially Reasonable Efforts to diligently Develop the Licensed Product in accordance with the Development Plan and the other terms of this Agreement, it being understood that Threshold will be responsible for the Sarcoma Program as set forth in Article 4.6.

  • Except as otherwise agreed by the JSC, or as set forth in Article 4.6 as regards the Sarcoma Program, Merck shall prepare, make, own and maintain all regulatory filings and Regulatory Approvals for the Licensed Products, including all INDs and NDAs. Each Responsible Party shall act in consultation with the other Party.

  • Notwithstanding anything to the contrary in the Development Plan, Threshold shall be responsible for Development activities within the Sarcoma Program, including continuing the ongoing Phase III Trial and any additional mandated Clinical Trials for the Sarcoma Program, [* * *].

  • Notwithstanding the foregoing, material issues, such as but not limited to label scope, in communications with Regulatory Authorities shall be discussed by the Parties and approved at JSC prior to actual implementation, except that final determination with respect to the Sarcoma Program shall be made by Threshold acting reasonably and in good faith and in furtherance of the Parties’ joint interest to successfully Develop and Commercialize the Licensed Product in the Field in the Territory.

  • Such right shall be exclusive with respect to Commercial Supply and with respect to Clinical Supply, except that Licensor shall be allowed to continue to procure stability and validation batches and Clinical Supply for the Clinical Trials and the NDA within the Sarcoma Program including active pharmaceutical ingredient and drug product, and other Clinical Trials for which Threshold is responsible, under the existing agreement with Syngene, Inc.

Related to Sarcoma Program

  • PEBB program means the program within the HCA that administers insurance and other benefits for eligible employees (as described in WAC 182-12-114), eligible retired employees (as described in WAC 182-12-171 and 182-12-180), eligible survivors (as described in WAC 182-12-180, 182-12-250, and 182-12-265), eligible dependents (as de- scribed in WAC 182-12-250 and 182-12-260) and others as defined in RCW 41.05.011.

  • Development Program means the implementation of the development plan.

  • AML Program has the meaning ascribed thereto in Schedule 2.1(F)(8) hereof.

  • MPA Program means the global emergency multiphase programmatic approach program designed to assist countries to prevent, detect and respond to the threat posed by COVID-19 and strengthen national systems for public health preparedness.

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.