Drug Product Candidate definition

Drug Product Candidate means any Development Candidate for which a Development Program has commenced under Section 3.1 hereunder.

Drug Product Candidate means any Development Candidate for which a Development Program has commenced under Section 3.1

Drug Product Candidate means any Compound as to which HMR has exercised its Development Option.

Examples of Drug Product Candidate in a sentence

• The Development Plan shall, among other things, detail, schedule and fully describe the proposed toxicology studies, clinical trials, regulatory plans, clinical trial and commercial material requirements, and process development and manufacturing plans for each Drug Product Candidate, along with relevant budget information for the described items, and will outline the key elements involved in obtaining Regulatory Approval in each country where the Drug Product is to be marketed.

• The JDC (or its successor organization, as designated by Vertex) will be the principal organization through which the development of a Drug Product Candidate is planned, administered, evaluated and completed, subject to appropriate review and approval at senior management levels as required by VERTEX from time to time.

• The JDC shall be responsible for review of the goals and strategy for development of each Drug Product Candidate and shall prepare and oversee the implementation of an overall Development Plan for each Drug Product Candidate.

• The JDC will typically meet at least quarterly, depending on the level of current development activity, and will be responsible for preparation and implementation of the Development Plan described in Section 3.2.2 below with respect to each Drug Product Candidate.

• In addition to the CFFT member, the JDC will typically have members from the various functional groups (e.g., research, preclinical safety, clinical, regulatory, marketing) which are or will be expected to be involved in development and launch of the Drug Product Candidate.

More Definitions of Drug Product Candidate

Drug Product Candidate means any Program Compound as to which SCHERING has exercised its Development Option under Article III hereof, and which has become the subject of a License Agreement in accordance with the provisions of Section 3.2 hereof.

Drug Product Candidate means any Program Compound listed from time to time on Schedule 1.12 hereof, as to which SCHERING has exercised its Development Option under Article III of the Research Agreement and which has become the subject of this License Agreement in accordance with the provisions of Section 3.2 of the Research Agreement.

Drug Product Candidate means any Development Candidate or Drug Product Candidate Back-up Candidate listed from time to time on Schedule

Drug Product Candidate means a Development Candidate which has been selected by NOVARTIS for development and commercialization under the License Agreement, pursuant to exercise of its Development Election under Section 4.1 hereof.

Drug Product Candidate means any Development Candidate or Drug Product Candidate Back-up Candidate listed from time to time on Schedule 1.12 hereof, as to which NOVARTIS has exercised the Development Election under the Research Agreement and which has become a subject of this License Agreement in accordance with the provisions thereof; and "Drug Product Candidate Back-up Candidate" shall have the meaning set forth in Section 7.4 of this Agreement.

Drug Product Candidate shall have the meaning as set forth in Section 3.3 of this Agreement.

Drug Product Candidate means a Compound as to which SERONO has exercised its Development Election under Article III hereof and which is therefore the subject of a License Agreement in accordance with the provisions of Sections 3.2, 3.3 or 3.4 hereof.