Clinical Hold definition

Clinical Hold means that: (i) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Initial Trial or such Party’s Compound in the United States or (ii) a Regulatory Authority other than the FDA has issued an equivalent order to the order in any other country or group of countries.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedSchedule a Demo

Clinical Hold means that (a) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries.

Clinical Hold means a clinical hold issued by the FDA (or other Regulatory Authority) in accordance with 21 CFR 312.42 (or a similar foreign counterpart law or regulation) to delay a proposed clinical investigation of a Product or to suspend an ongoing clinical investigation of a Product.

Examples of Clinical Hold in a sentence

• If an ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇ Clinical Trial is put on Clinical Hold, the Joint Development Committee shall modify the budget to appropriately reflect the costs associated with the wind-down of activities associated with the applicable ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇ Clinical Trial.

• Each party will immediately notify the other Party of any event materially-related to a Product including any starting/stopping of a Clinical Trial, any Clinical Hold, clinical data or results, material regulatory discussions, filings, Approval or Akcea’s sales projections (each a “Significant Event”) so the Parties may analyze the need for or desirability of publicly disclosing or reporting such event and mutually agree on a communications strategy for such Significant Event.

• If, after [ ]* of discussions following the Clinical Hold, either Party reasonably concludes that the issue adversely impacts the Combined Therapy Clinical Trial and is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Clinical Trial, then such Party may immediately terminate this Agreement.

• Following receipt of a Clinical Hold, neither VGX itself, its Subsidiaries nor any third party acting on its behalf, has continued or will continue to provide investigational drug products to any of the human subjects enrolled in the study for which the Clinical Hold was received.

• If, after [**] of discussions following the Clinical Hold, either Party reasonably concludes that the issue adversely impacts the Combined Therapy Clinical Trial and is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Clinical Trial, then such Party may immediately terminate this Agreement.

More Definitions of Clinical Hold

Clinical Hold means that (a) the applicable Clinical Trial is put on clinical hold by the applicable Regulatory Authorities and remains on hold for at least one year, (b) the IND or other regulatory approval for the applicable Clinical Trial has been suspended, terminated, or withdrawn by the applicable Regulatory Authorities and remains suspended, terminated, or withdrawn for at least one year, (c) the applicable Clinical Trial has been suspended due to potential toxicity or safety findings or side effects that the Joint Development Committee (with the consent of both Parties) reasonably believes justify suspension of such Clinical Trial, or (d) due to potential toxicity or safety findings or side effects, the independent data monitoring committee recommends termination of such Clinical Trial.

Clinical Hold means the FDA requires Amylin to stop, or Amylin agrees to stop, dosing patients with Compound in all Amigo Trials, prior to completion of the Amigo Trials in accordance with their protocols.

Clinical Hold as used in this Section 12.7, shall mean a bona fide decision of the developing Party or a decision of a regulatory authority or another governmental body to suspend a clinical trial or other study when it does not believe that such clinical trial or other study can be conducted without unreasonable risk to the subjects in such clinical trial or study, and the existence of such circumstances shall be subject to arbitration in accordance with Section 21.14.

Clinical Hold means that there are regulatory restrictions in place from FDA preventing the sale and distribution of OpenBiome FMT Product by Seller under enforcement discretion.

Clinical Hold means (i) an order issued by the FDA to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. States or (ii) an equivalent order to that set forth in (i) issued by a Regulatory Authority other than the FDA in any other country or group of countries.

Clinical Hold. Clinical Hold shall mean a complete or partial clinical hold as described in the “Guidance for Industry: Submitting and Reviewing Complete Responses to Clinical Holds”, dated October 2000, revision 1, as available at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/RegulatoryInformation/Guidances/▇▇▇▇▇▇▇▇▇.htm as of the Effective Date.

Clinical Hold means that (a) the applicable Clinical Trial is put on clinical hold by the applicable Regulatory Authorities and remains on hold for at least one year, (b) the IND or other regulatory approval for the applicable Clinical Trial has been suspended, terminated, or withdrawn by the applicable Regulatory Authorities and remains suspended, terminated, or withdrawn for at least one year, (c) the applicable Clinical Trial has been suspended due to potential toxicity or safety findings or side effects that the Joint Development Committee (with the consent of both Parties) reasonably believes justify suspension of such Clinical Trial, or