Combined Therapy Trial definition

Combined Therapy Trial or “Combined Therapy Trials” shall have the meaning set forth in Section 2.1(a) of this Agreement.
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Combined Therapy Trial has the meaning set forth in Section 2.1.
Sample 1

Examples of Combined Therapy Trial in a sentence

  • BMS will provide Five Prime with Nivolumab country-specific customs valuations initially prior to study start initiation of Combined Therapy Trial(s) and at the end of each Quarter during the conduct of the Combined Therapy Trial.

  • Five Prime will provide BMS in writing with a list of all countries participating in a Combined Therapy Trial prior to study start initiation of such Combined Therapy Trial.

  • Therefore, as between the Parties, BMS will report payments or other transfers of value (“POTV”) made by Five Prime or the CRO related to the conduct of the Combined Therapy Trials and any applicable associated contractor engagements as required under the Sunshine Laws, for each Combined Therapy Trial initiated prior to such date that Five Prime becomes responsible for reporting POTV for studies sponsored by it.

  • Each Combined Therapy Trial shall be conducted in accordance with a protocol (each, a “Protocol”) to be drafted by BioXcel (in consultation with Nektar) and mutually agreed upon by the Parties at a meeting of the JDC.

  • During the conduct of such Combined Therapy Trial, Five Prime will send in writing any changes to the list of participating countries to BMS one month prior to the end of each Quarter.

  • The Parties shall use diligent efforts to define and finalize the processes the Parties shall employ to protect patients and promote their well-being in connection with the use of the Combined Therapy, and to execute a written pharmacovigilance agreement (the “Pharmacovigilance Agreement”) within *** after the Effective Date, and prior to the dosing of the first patient in the first Combined Therapy Trial under the Development Plan.

  • Aggregate Safety Information shall be provided by a Party to the other in the same format as is contained in the investigators’ brochures prepared by such Party for its Compound in each country where a Combined Therapy Trial will be conducted.

  • Five Prime shall use Commercially Reasonable Efforts to Manufacture or have Manufactured the Five Prime Compound in drug product or drug substance form (as necessary) in reasonable quantities and at the points in time as agreed by the JDC for each Combined Therapy Trial.

  • The cost of Manufacture and supply (including shipping, insurance, taxes and duty, if applicable) of Five Prime Compound for the performance of the Development Plan (i) with respect to any Phase 1a Combined Therapy Trial, shall be borne solely by Five Prime, and (ii) with respect to any Phase 1b or later Combined Therapy Trial, fifty percent (50%) shall be borne by Five Prime and fifty percent (50%) shall be borne by BMS, and Five Prime shall bear the risk of loss for the Five Prime Compound.

  • After completion of a Combined Therapy Trial in a Developed Tumor Type, the Parties agree to discuss in good faith additional clinical trials (other than clinical trials contemplated by Section 2.1(a)) of the Combined Therapy in such Developed Tumor Type for a period of up to *** after such Developed Tumor Type ceases being a Restricted Tumor Type.

Related to Combined Therapy Trial

  • Step therapy means a protocol or

  • Step therapy protocol means a protocol or program that establishes the specific

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • 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)).

  • Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • Diagnostic mammography means a method of screening that

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Gene Therapy means a product or service for the treatment or prevention of a disease that utilizes ex vivo or in vivo delivery (via viral or nonviral gene transfer methods or systems) of Genetic Material, including any cell incorporating Genetic Material.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Therapeutic diet means meals served that are soft, low-fat, low-sodium or controlled calorie.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • 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.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;

  • Participating Home Infusion Therapy Provider means a Home Infusion Therapy Provider who has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Pivotal Trial means a controlled pivotal clinical trial of Licensed Technology that is prospectively designed to demonstrate statistically whether such Licensed Technology is effective and safe for use in a particular indication in a manner sufficient to obtain regulatory approval to market such product in the United States, European Union, or other foreign jurisdiction.

  • Endpoint means any Federal Reserve Bank, financial institution, local clearing house, courier or other entity or location for the delivery of cash letters or other presentment of Imaged Items or Substitute Checks.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]