Specified Studies definition

Specified Studies means, with respect to a Licensed Product, (i) all clinical trials currently underway in the Territory for such Licensed Product in the applicable Development Plan and (ii) all clinical trials in the applicable Development Plan to be Initiated after the Effective Date which are global in nature, including Phase 3b Clinical Trials.
View Source
Specified Studies has the meaning set forth in Section 4.2.2. 1.164 “Subcommittee” has the meaning set forth in Section 2.2.
View Source
Specified Studies means the preclinical and clinical studies, the details of which are set forth in Schedule F.
View Source

Examples of Specified Studies in a sentence

  • In performing the Specified Studies, IDEA shall consult with ALPHARMA and shall keep ALPHARMA promptly informed on an ongoing basis regarding all aspects of the Specified Studies.

  • ALPHARMA shall assist IDEA, as reasonably requested by IDEA, in connection with any regulatory approval application filings or other regulatory matters or submissions relating to the Specified Studies outside the Territory at IDEA's cost (other than internal personnel costs of ALPHARMA).

  • IDEA shall assist ALPHARMA, as reasonably requested by ALPHARMA, in connection with any NDA filings or other regulatory matters or submissions relating to the Specified Studies in the Territory at ALPHARMA's cost (other than internal personnel costs of IDEA).

  • In the event the Parties amend the Research Plan for the initial Research Program with respect to the Specified Studies, then notwithstanding Section 2.1.5(a), the Parties shall mutually agree on [***].

  • If IDEA is in breach of any of its obligations under this Section 5.1 and such breach remains uncured for [**] days after ALPHARMA gives written notice to IDEA of such breach, ALPHARMA shall have the right to step-in and take over the management and direction of the Specified Studies (including without limitation the right to manage and direct the activities of all third party contractors engaged to perform any aspects of the Specified Studies).

  • IDEA shall cooperate, at its own expense, with the exercise of ALPHARMA's step-in right (including without limitation procuring the cooperation of its employees and contractors and providing all relevant information), and all costs and expenses of conducting the Specified Studies will remain IDEA's sole responsibility.

  • IDEA shall not be required to accept any change proposed by ALPHARMA that materially increases the scope of any of the Specified Studies.

  • IDEA will provide ALPHARMA promptly with a copy of all interim and final reports prepared by or on behalf of IDEA with respect to the Specified Studies.

  • In carrying out the Specified Studies, IDEA shall, and shall obtain agreement from any third party contractors engaged by it to perform the Specified Studies to, perform all aspects of the Specified Studies in a good and professional manner, in accordance with cGCP and all laws and regulations applicable to studies the results of which are intended to be used to support NDAs in the Territory.

  • As of the Execution Date, the IND for the Specified Studies is held by IDEA and ALPHARMA hereby authorizes IDEA, until ALPHARMA instructs it otherwise, to continue to be the owner of such IND and, until IDEA no longer holds such IND, to communicate with the FDA regarding such regulatory issues, subject to the prior approval of ALPHARMA in relation to each communication, which will not be unreasonably withheld or delayed.


More Definitions of Specified Studies

Specified Studies is defined in Section 2.2.1.
View Source

Related to Specified Studies

  • Qualified student means a resident of this state who:

  • Specified Sales means (a) the sale, transfer, lease or other disposition of inventory and materials in the ordinary course of business and (b) the conversion of cash into Cash Equivalents and Cash Equivalents into cash.

  • Specified sexual activities means any of the following:

  • Occupied structure means any building, vehicle, or other place suitable for human occupancy or

  • Specified Subsidiaries means any of (i) Intermediate, (ii) Dell, (iii) Denali Finance, (iv) Dell International (until such time as the MD Stockholders and the SLP Stockholders otherwise agree), (v) EMC, (vi) any successors and assigns of any of Intermediate, Dell, Denali Finance, Dell International (until such time as the MD Stockholders and the SLP Stockholders otherwise agree) and EMC, (vii) any other borrowers under the senior secured indebtedness and/or issuer of the debt securities, in each case, incurred or issued to finance the Merger and the transactions contemplated thereby and by the related transactions entered into in connection therewith and (viii) each intermediate entity or Subsidiary between the Corporation and any of the foregoing.