Additional Studies definition

Additional Studies means any biomarker, manufacturing, purity, toxicology, imaging or combination studies, or any other exploratory or pre-clinical in vitro or in vivo studies commenced after the Effective Date and associated with any part of the Product, or carried out in support of the clinical trial conducted pursuant to this Agreement, where such studies are performed by or on behalf of the Charity, including those described in Schedule 9 (as the same may be amended from time to time by the Charity).

Additional Studies means the [***] collaborative research agreements currently under negotiation or recently executed between AstraZeneca or its Affiliates and [***], in each case which relate to the Compounds and which will be entered into prior to or after the Effective Date pursuant to Section 5.6, as further described in Part 1 of Schedule 1.3.

Additional Studies means, other than the Currently Ongoing Studies, Licensed Territory Specific Studies, Extraterritorial Studies, and studies that can be both an Extraterritorial Study and a Licensed Territory Specific Study agreed to be conducted by the Parties as part of the Development Plan under the terms and conditions of this Agreement.

Examples of Additional Studies in a sentence

• BettsAssociate Professor of Old Testament Interpretation (2001) B.S.Ed., Wright State University; M.Div., Ph.D., The Southern Baptist Theological Seminary; Additional Studies: Jerusalem University College Dr. Betts is a fifth generation Southern Baptist minister who has pastored fourteen years in Ohio and Indiana.

• Interested firms meeting all the pre-qualification criteria as mentioned in Point-3 above may submit their offer in the prescribed Annexure / sub-Annexure of this tender.

• As of the Execution Date, Aptose has received an additional fifteen grams (15g) of CG’806 (the “Additional Materials”) to conduct the Additional Studies.

• Each Party will maintain, or cause to be maintained, records of its activities under the Additional Research Programs, Joint Development Programs and Independent Additional Studies (as applicable) in sufficient detail and in good scientific manner appropriate for scientific, Patent and regulatory purposes, that will properly reflect all work performed therein, for a period consistent with such Party’s record retention policies, but in no event less than required by applicable Laws.

• Each Party shall conduct the Internal SAV Programs, POC Programs, Additional Research Programs, Joint Development Programs and Independent Additional Studies and other activities under the Internal SAV Program Plans, POC Plans, Additional Research Plans, Joint Development Plan and Budget for the applicable Program or Independent Additional Study Development Plans in compliance with all applicable Laws.

More Definitions of Additional Studies

Additional Studies has the meaning set forth in Section 2.3 (Activities During Evaluation Period).

Additional Studies means [***].

Additional Studies means, collectively, (a) a Phase III Clinical Trial for a Product that is focused on the treatment of cirrhotic patients (adult F4cc) and (b) any Phase III Clinical Trials for a Product that are focused on the treatment of pediatric patients.

Additional Studies means, collectively, (a) a Phase III Clinical Trial for a Product that is focused on the treatment of cirrhotic patients (adult F4cc) conducted in or for the Profit-Share Territory, (b) any Phase III Clinical Trials for a Product that are focused on the treatment of pediatric patients conducted in or for the Profit-Share Territory, and (c) any other Clinical Trial that (i) is intended to support the Regulatory Approval of a Product for the treatment of cirrhotic patients or pediatric patients and (ii) is included under the Co-Funded Development Plan. For clarity, the [***] to be performed by Takeda is an Additional Study.

Additional Studies is defined in Subsection 4.1.6.

Additional Studies means all Non-Clinical Studies and clinical studies other than the VITAL Studies or the Currently Ongoing Studies, whether conducted prior to or following Regulatory Approval of the Product, pertaining to the use of the Product in the Field for the Licensed Territory, including: Phase 1, 2, 3 or 4 Clinical Studies or pivotal studies (including studies for additional indications or label expansion); investigator-sponsored trials, safety or surveillance studies; pharmacoeconomic studies; pharmacoepidemiology studies; reimbursement studies; and other studies.

Additional Studies shall have the meaning set forth in Section 4.7.