Collaboration Agreement has the meaning set forth in the Recitals.
Commercialization Plan has the meaning set forth in Section 6.2.
CMPPA Agreement means the CMPPA Agreement between the SSA and CHHS.
Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.
Development Plan has the meaning set forth in Section 3.2.
Development Schedule shall have the meaning set forth in Section 1.1.
Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).
Development Agreement has the meaning set forth in the Recitals.
MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;
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.
Phase I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.
Collaborative agreement means a voluntary, written, or electronic arrangement between one
DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
Clinical Supply Agreement has the meaning set forth in Section 4.2.
Joint Development Agreement has the meaning provided in Section 5.3.
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.
Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.
Pharmacovigilance Agreement has the meaning set forth in Section 5.1.
Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
Quality Agreement has the meaning set forth in Section 9.6.
Tri-Party Agreement shall have the meaning set forth in Section 6.4 hereof.
Mediation agreement means a written agreement between the parties to a mediation meeting.
Development Agreements means all development, utility or similar agreements included in the Permitted Encumbrances.
Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.
Clinical Trial means any human clinical trial of a Product.