Joint Commercialization Committee or “JCC” has the meaning set forth in Section 3.4 (Joint Commercialization Committee).
Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.
Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.
Technical Committee means the body established in accordance with article VII;
Manufacturing Agreement has the meaning set forth in Section 4.3.
Commercialization Plan has the meaning set forth in Section 6.2.
Technical Advisory Committee means a committee established under section 12;
Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.
Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.
Screening Committee means the State level Screening Committee constituted in terms of sub-rule (2) of rule 123 of these rules.
Project Steering Committee or “PSC” means the committee referred to in Section I.B of Schedule 2 to this Agreement;
Quality Assurance Plan or “QAP” shall have the meaning set forth in Clause 11.2;
Joint Steering Committee or “JSC” has the meaning set forth in Section 3.1.
Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.
Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.
Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.
Commercial Development Plan means the written commercialization plan attached as Appendix E.
Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.
Steering Committee shall have the meaning set forth in Section 3.1.
Joint Development Committee or “JDC” has the meaning set forth in Section 3.10.
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.
JCC has the meaning set forth in Section 3.1.
Procurement Committee means a Committee constituted by the Employer to perform the functions as such under the terms and conditions of Contract.
Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.
Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.
Development Program means the implementation of the development plan.