Post-Approval Commitment Studies definition

Post-Approval Commitment Studies means clinical studies mandated by FDA (or other Regulatory Authorities) to be performed after approval of a Licensed Product or Combination Product, as a condition of such approval.
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Post-Approval Commitment Studies means any study or data collection effort in respect of the Licensed Products which is requested, mandated or required by an Agency following an Approval for the Licensed Products in the Territory.
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Post-Approval Commitment Studies means any studies that are required by the applicable Regulatory Authority to maintain a first Marketing Approval for a product in any of the United States, [*] or by the European Commission.
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Examples of Post-Approval Commitment Studies in a sentence

  • Upon approval by the JDC, such plan shall be deemed the “SCLC Post-Approval Commitment Studies Development Plan”.

  • After transfer of the Regulatory Approval to Jazz, PharmaMar will provide completed clinical study reports (CSRs) and submission-ready analysis datasets to Jazz for any of the studies supporting the Regulatory Approval by the FDA for a Licensed Product in the SCLC Initial Indication (including the Atlantis Trial and the SCLC Post-Approval Commitment Studies) promptly after such reports and datasets are available.

  • Jazz shall conduct and be responsible, at its expense, for regulatory communications with the FDA regarding the SCLC Post-Approval Commitment Studies once Regulatory Approval by the FDA for Licensed Product in the SCLC Initial Indication has been transferred to Jazz pursuant to Section 5.2.

  • In such event, Jazz shall prepare a proposed development plan and a proposed budget for such Jazz Canada SCLC Post-Approval Commitment Studies, including the number of FTEs to conduct such activities (each such development plan, a “Jazz Canada SCLC Post-Approval Commitment Studies Development Plan” and each such budget, a “Jazz Canada SCLC Post-Approval Commitment Studies Budget”), which shall each be reviewed, discussed and approved by the JDC.

  • Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Jazz Canada SCLC Post-Approval Commitment Studies.

  • JDC approval shall not be required with regard to design, protocol and timeline of those SCLC Post-Approval Commitment Studies whose protocol has been submitted to FDA prior to the Effective Date of this Agreement.

  • Except as set forth in this Section 4.1 with respect to the Atlantis Trial, the U.S. SCLC Post-Approval Commitment Studies and the Mutual Canada SCLC Post-Approval Commitment Studies, PharmaMar shall have no further obligation to conduct any pre-clinical or clinical Development activities with respect to any Licensed Products.

  • Upon approval by the JDC, such plan shall be deemed the “Mutual Canada SCLC Post-Approval Commitment Studies Development Plan”.

  • Except as set forth in this Section 4.1 with respect to the Atlantis Trial and the SCLC Post-Approval Commitment Studies, PharmaMar shall have no further obligation to conduct any pre-clinical or clinical Development activities with respect to any Licensed Products.

  • Jazz shall conduct and be responsible, at its expense, for regulatory communications with Health Canada regarding the Mutual Canada SCLC Post-Approval Commitment Studies.


More Definitions of Post-Approval Commitment Studies

Post-Approval Commitment Studies means clinical studies either mandated by the FDA (or other Regulatory Authorities) to be performed after approval of the Product, committed to be done during the NDA review for NDA number 212157, included in the NDA approval letter, or otherwise required to be completed as a condition of such approval. Post-Approval Commitment Studies related to the Product as of the Effective Date are set forth on Exhibit J.
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Post-Approval Commitment Studies means clinical studies mandated by FDA (or other Regulatory Authorities) to be performed after
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Related to Post-Approval Commitment Studies

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Development approval means any written authorization from a

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Initial Commitment means, in relation to an Initial Senior Noteholder, the amount set out in the relevant Senior Noteholder Fee Letter.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Incremental Commitment Agreement means each Incremental Commitment Agreement in the form of Exhibit R (appropriately completed) executed and delivered in accordance with Section 2.14.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Non-Approval Event means, in respect of the Benchmark:

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Additional Commitment means any commitment hereunder added pursuant to Sections 2.22, 2.23 or 9.02(c).

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Additional Commitments means any commitments hereunder added pursuant to Section 2.22, 2.23 or 9.02(c).

  • 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).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • 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.

  • 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. [***]

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.