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.
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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.
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Examples of Sarcoma Program in a sentence

  • 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.

  • 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.

  • 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.

  • Improvements in biomechanics, metallurgy and engineering have allowed for the development of advanced, modular prostheses that provide a more durable, long-lasting reconstruction for patients who are candidates for limb salvage surgery.Osteosarcoma Research at Penn and the Future of Sarcoma TreatmentThe vision for the Sarcoma Program is multifaceted, starting with the development of a strong foundation of basic and translational research in Sarcoma at Penn.

  • The prospect that patients at the Sarcoma Program at Penn Medicine will have access to these therapies is greatly increased by the Program’s affiliation with the Abramson Cancer Center, home to advanced genetic research and conduit for Penn patients to advanced clinical trials across the nation.

  • 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.

  • A dedicated radiologist who specializes in musculoskeletal imaging is integrated with Hoag’s Bone & Soft Tissue Sarcoma Program .

  • L.M.F. supported by GERRAF, Siemens Medical Systems, SCBT/MR Young Investigator Award, Johns Hopkins Sarcoma Program Pilot Grant, and William M.G. Gatewood Fellowship.

  • The goal is to see if sarcoma treatment should occur in a centralized model of care, as opposed to a de-centralized model by determining which model provides the most beneficial health outcomes for patients.This panel will provide expert input, guidance and direction throughout the course of the Sarcoma Program Review Project.

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.

  • 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.

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • Pilot program means the pilot program identified and funded through the Funding Agreement and described in that Funding Agreement and its attachments.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • CRAF Program means the Civil Reserve Air Fleet Program authorized under 10 U.S.C. Section 9511 et seq. or any similar or substitute program under the laws of the United States.

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Number of Students Who Began Program means the number of students who began the program who are scheduled to complete the program within the reporting calendar year.

  • Development Plan has the meaning set forth in Section 3.2.

  • Educational program means a program for educating and preparing physician assistants which is approved by the board.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Collaborative pharmacy practice agreement means a written and signed

  • Flexi Plan means any individual indemnity hospital insurance plan under the VHIS framework with enhancement(s) to any or all of the protections or terms and benefits that the Standard Plan provides to the Policy Holder and the Insured Person, subject to certification by the Government. Such plan shall not contain terms and benefits which are less favourable than those in the Standard Plan, save for the exception as may be approved by the Government from time to time.

  • Basic health plan model plan means a health plan as required in RCW 70.47.060(2)(e).

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Loan Program means the State Treasurer’s Interest-Free Loan Program for Colorado School Districts authorized pursuant to the Loan Program Statutes.

  • Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.

  • Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.

  • Research Program has the meaning set forth in Section 3.1.

  • Education program means any program that is principally engaged in the provision of education, including, but not limited to, early childhood education, elementary and secondary education, postsecondary education, special education, job training, career and technical education, and adult education, and any program that is administered by an educational agency or institution.

  • Opioid treatment program means a detoxification or maintenance treatment program which is required to report patient identifying information to the central registry and which is located in the state.