Conducting Party definition

Conducting Party has the meaning set forth in Section 4.4(c)(i).

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Conducting Party means the Party that is (or the Party whose Affiliate, licensee or sublicensee is) conducting a Clinical Trial of a Product.

Conducting Party has the meaning set forth in Section 6.6.

Examples of Conducting Party in a sentence

• The Conducting Party shall promptly answer all reasonable questions posed by, and provide all additional documents reasonably requested by, the Non-Conducting Party with respect to the Opt-In Estimate.

• The Conducting Party shall provide such update on progress of the Combined Therapy Trials in writing to the Non-Conducting Party members of the JCS-WG on a [ * ] basis, which update shall contain information about overall progress, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Combined Therapy Trials.

• The Conducting Party shall be responsible for obtaining any necessary approvals from institutional review boards (each, an “IRB”) including, where applicable, obtaining approval of all Clinical Trial protocols, informed consents, investigator brochures, subject recruitment materials or plans, authorization of disclosure of confidential subject information, and any alterations to or waivers of the same, prior to commencement of any study.

• The Conducting Party shall accept, to the extent permitted by Applicable Law, responsibility for the retention of documentation and storage of samples of Licensed Products according to Applicable Law (provided, with respect to ▇▇▇▇▇▇▇ as the Conducting Party, the necessary documentation and samples have been transferred by Protagonist pursuant to this Agreement).

• Each Combined Therapy Trial shall be conducted under a combination IND unless a Regulatory Authority requires otherwise, for which the Conducting Party will be the sponsor of record (the “Combined Therapy IND”).

• With respect to any Additional Study or Incremental Study (for which either Party is the Conducting Party) that involves a New Form, the Conducting Party shall offer the Non-Conducting Party the opportunity to be the supplier of such New Form.

• Unless the Non-Conducting Party informs the Conducting Party that it is not interested in being, or is unable to be, the supplier of such New Form, the Parties shall negotiate in good faith and enter into a separate supply agreement that sets forth the terms and conditions under which the Non-Conducting Party will supply such New Form to the Conducting Party (in the event of an Incremental Study) or one or both Parties (in the event of an Additional Study).

• The Conducting Party shall be responsible for registering such Clinical Trial in the appropriate clinical study registry and reporting Clinical Trial results as may be required under Applicable Law.

• The Conducting Party shall not modify the protocol or the informed consent without the prior written agreement of the IRB.

• The Conducting Party shall have the authority to select the final clinical trial sites, CROs and investigators from the approved Site/CRO List.

More Definitions of Conducting Party

Conducting Party means, in the case of certain Third Party Proceedings, the party which has conduct of such proceedings or, as the case may be, the relevant part thereof in accordance with Clauses 5.2.6.1

Conducting Party means, for each Combined Therapy Study, the Party in the applicable Clinical Obligations Schedule that is expressly designated as the responsible Party with respect to a particular activity or obligation described in such Clinical Obligations Schedule in connection with the conduct of the Combined Therapy Study.

Conducting Party has the meaning set forth in Section 4.1(e)(ii) (Exception).

Conducting Party has the meaning set forth in Section 2.2.