Clinical Phase definition

Clinical Phase means the time period of an approved project where a trainee treats patients, supervised by an instructor, applying knowledge presented by an instructor.

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Clinical Phase means a human clinical trial conducted in any country that is intended to evaluate the safety and/or pharmacological effect and/or efficacy of a Licensed Product in human subjects, or that would otherwise satisfy the requirements of 21 CFR 312.21, or its foreign equivalent.

Clinical Phase means instructor supervised experience with a patient during which a 9/trainee applies knowledge presented by an instructor.

Examples of Clinical Phase in a sentence

• The Parties shall jointly work on the Development of such Product up to and including the Clinical Phase I Study and, unless the Program is terminated, GSK will conduct all subsequent Development activities, including activities to obtain Regulatory Approval for such Product, which CureVac shall support, including by the clinical supply of Products, all in accordance with this Agreement and the applicable R&D Plan.

• For the supply of Products to be used in Clinical Phase I Studies with respect to any other Pre-IND Program, the Parties will on a Product-by-Product basis negotiate an amendment to the Early Clinical Supply Agreement in good faith, subject to Section 6.2, whereby CureVac shall Manufacture or have Manufactured such Product on Genmab’s behalf.

• ADCT shall provide to the JSC a report of the progress and work performed during the Clinical Phase of the Development every [**], the first report being due [**] after Genmab’s 25% Election or Withdrawal.

• If Genmab accepts the proposal made by CureVac for supplies of Product for the first Clinical Phase II Study and is agreeable to appoint CureVac, the Parties shall within [*****] negotiate in good faith a master services agreement (“MSA”) and related quality agreement and a first work order for the Manufacture and supply of such Product quantities, Manufactured to the specifications specified by Genmab, and for payment [*****] on customary market-based terms.

• CureVac will complete preclinical validation and sponsor a Clinical Phase I Study of this First Product, unless the Parties agree on a different clinical Development approach within the JSC.

• For the supply of Products to be used in Clinical Phase I Studies with respect to the First Collaboration Program (including in relation to a Product based upon a Replacement Target Antibody), subject to Section 6.2, the Parties shall negotiate and enter into a clinical supply agreement under which CureVac shall Manufacture or have Manufactured such Products on Genmab’s behalf.

• Genmab consents to the appointment of CureVac’s Affiliate company CureVac Real Estate GmbH as a subcontractor of CureVac for the purpose of Manufacturing Products under this Agreement and the Early Clinical Supply Agreement for the supply of Products to be used in Clinical Phase I Studies with respect to the First Collaboration Program (as opposed to any future Manufacture under future supply agreements that might be agreed between the Parties).

• Genentech shall have the right in its sole discretion to decide whether or not the Parties shall continue the development of Licensed Product hereunder, after each of the reviews set forth in clauses (a), (b) and (c) above; as provided in Section 2.03 above, after a Genentech decision (if any) to proceed forward after the review under Section 4.05(c), both Parties shall have an equal vote in decisions affecting a U.S. Clinical Phase III Trial.

• Genmab shall provide to the JSC a report of the progress and work performed under the Pre-Clinical Work Plan, if applicable, and during the Clinical Phase of the Development every [**] months, the first report being due [**] months after ADCT’s Withdrawal.

• The parties may amend Exhibit D by mutual written agreement as may be necessary to reflect changes in the estimated cost of each antigen, which Exhibit will be appended to this Agreement prior to the Clinical Phase.

More Definitions of Clinical Phase

Clinical Phase means the activities, materials and budget for the clinical phase of the Development of the ADC.

Clinical Phase means the period during which human studies involving the Products are performed for the purpose of evaluating the safety, efficacy and appropriate dose ranges of Product (“Clinical Trials”), to secure marketing approval from a Regulatory Authority.

Clinical Phase has the meaning given to such term in Section 4.1 of this Agreement;

Clinical Phase has the meaning given in Schedule 1.

Clinical Phase means that portion of the Project during which regulatory approval to conduct human clinical trials of one or more Products will be sought in one or more territories and clinical trials will be conducted.

Clinical Phase means the period from the date the first patient is enrolled in the first human clinical trial involving the Product after the Effective Date until the grant of the first Health Registration Approval; (Confidential Treatment Requested)