IND-Enabling Studies Sample Clauses
The IND-Enabling Studies clause defines the requirements and responsibilities related to conducting studies necessary to support the filing of an Investigational New Drug (IND) application with regulatory authorities. Typically, this clause outlines which party is responsible for designing, funding, and performing preclinical studies such as toxicology, pharmacology, and safety assessments that are prerequisites for IND submission. By clearly allocating these obligations, the clause ensures that all necessary data is generated to meet regulatory standards, thereby facilitating the timely advancement of a drug candidate into clinical trials and reducing the risk of delays due to incomplete or inadequate study results.
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IND-Enabling Studies. The term “IND-Enabling Studies” shall mean GLP toxicology studies intended to support the filing of an application with Regulatory Authorities to initiate a Phase I Study on a molecule directed toward a Development Target selected by MAGENTA in its sole discretion.
IND-Enabling Studies. At the request of Celgene, Array shall use Diligent Efforts to perform continued IND-Enabling Studies for one (1) Development Back-Up Compound per Target during the Option Term for such Target. For purposes of this Section 3.7.4, “IND-Enabling Studies” shall mean studies which are specifically required for an IND filing with the FDA, including without limitation, ADME and GLP toxicology studies, or studies required for the preparation of the CMC section of such IND including studies relating to analytical methods and purity analysis, and formulation and manufacturing development studies, all as necessary to obtain the permission of regulatory authorities to begin human clinical testing.
IND-Enabling Studies. InnoCare shall use Commercially Reasonable Efforts to complete the IND enabling activities for each ICP Preclinical Compound (the “IND Enabling Activities”) set forth in a plan mutually agreed by the Parties (the “IND Enabling Plan”). InnoCare shall deliver the proposed IND Enabling Plan within [***] after the Effective Date for ▇▇▇▇▇’s review and approval, which plan shall set forth the scope, budget and other details of the IND enabling activities to be performed by InnoCare. Any changes, amendments or revisions to the initial IND Enabling Plan shall be mutually agreed upon by the Parties. InnoCare shall provide Zenas an update of InnoCare’s activities and the Results under the IND Enabling Plan on a Calendar Quarterly basis at each JSC meeting for review and discussion. InnoCare shall perform all activities under the IND Enabling Plan in good scientific manner and in material compliance with Applicable Law and in accordance with the IND Enabling Plan, and such activities shall be considered part of Zenas’s Development efforts, included as part of the Zenas Development Plan, and taken into account when considering whether ▇▇▇▇▇ has used Commercially Reasonable Efforts to Develop the ICP Preclinical Compounds as required under this Agreement. Zenas shall reimburse InnoCare for the IND Enabling Activities performed by or on behalf of InnoCare (a) with respect to the TYK2 Program, (i) [***] of all [***] expenses incurred by or on behalf of InnoCare or its Affiliates prior to the Effective Date as set forth on Schedule 4.1.1(A) (Pre-Effective Date TYK2 Program Expenses), and (ii) [***] of all [***] and [***] of all [***] expenses [***] incurred by or on behalf of InnoCare or its Affiliates under the IND Enabling Plan after the Effective Date in accordance with the budget set forth in Schedule 4.1.1(B) (TYK2 Program Budget); and (b) with respect to the IL-17 Program, (i) [***] of all [***] expenses incurred by or on behalf of InnoCare or its Affiliates prior to the Effective Date as set forth on Schedule 4.1.1(C) (Pre-Effective Date IL-17 Program Expenses); and (ii) [***] of all [***] and [***] of all [***] expenses [***] incurred by or on behalf of InnoCare or its Affiliates under the IND Enabling Plan after the Effective Date in accordance with the budget set forth in Schedule 4.1.1(D) (IL-17 Program Budget). [***] Notwithstanding anything to the contrary in this Section 4.1.1 (IND-Enabling Studies), ▇▇▇▇▇ shall have the right, exercisable in its sole discr...
IND-Enabling Studies. 3.7.1 For each Research Plan, after Fate completes the activities described in Step 5 in Exhibit 3.3.3, Fate shall promptly prepare and deliver to ▇▇▇▇▇▇▇ a complete DC Data Package for the Collaboration Candidates that the JRC is considering for further development (such Collaboration Candidates, the “DC Collaboration Candidates”). The “DC Data Package” means a collection of all then-available information, data, and results arising from the completion of such activities by Fate for such DC Collaboration Candidates so that a determination may be made as to whether any of such DC Collaboration Candidates should be further developed in IND Enabling Studies. Any cells (including Collaboration Candidates) that are generated in the course of generating the DC Collaboration Candidates included in a particular DC Data Package, but not included in such DC Data Package, will be deemed to be “Rejected Candidates.”