Clinical Development Plans Clause Samples

Clinical Development Plans. For each Product for which BI initiates a ***, BI shall prepare a clinical development plan outlining the major clinical Development activities that BI expects to undertake, including anticipated timescales, relating to the Product up to the submission of the initial NDA for the applicable Product (each, a “Clinical Development Plan”). It is understood that each Clinical Development Plan is intended to be a fluid document and is subject to change by BI based on, among other things, changes in the market, discussions with investigators and Regulatory Authorities and the results of studies undertaken. Subject to the provisions of ARTICLE VIII, during the Term, BI shall provide MacroGenics a copy of ***. The Clinical Development Plans will be created, approved, and amended according to BI’s then-current internal standards and processes for such Clinical Development Plans. The responsibility to provide a Clinical Development Plan for a particular Product shall terminate if BI ceases further Clinical Development of such Product.

Clinical Development Plans. The anticipated costs and timelines for activities under the Clinical Development Plans for the CNGA3 Product, the CNGB3 Product and the RPGR Product are attached hereto as parts of Exhibit 1.34. [***] with respect to the CNGA3 Product, CNGB3 Product and RPGR Product, the JDC shall develop and submit to the JSC for its review and approval, a Clinical Development Plan for each such Clinical IRD Product, and upon the JSC’s approval, each such initial Clinical Development Plan will be attached hereto and form a part of Exhibit 1.34. If ▇▇▇▇▇▇▇ elects to make the [***] Product a Clinical IRD Product in accordance with Section 2.1(b), no later than [***] following the [***] Product Opt-In Date, the JDC shall develop and submit to the JSC for its review and approval, a Clinical Development Plan for the [***] Product, and upon the JSC’s approval, such initial Clinical Development Plan shall be attached hereto and form a part of Exhibit 1.34. In the event that any Clinical Development Plan for a Clinical IRD Product conflicts with the anticipated costs and timelines set forth in Exhibit 1.34 for such Clinical IRD Product, the Clinical Development Plan shall control. Each Clinical Development Plan will set forth in reasonable detail at all times (i) all activities that are necessary or useful to be undertaken to achieve and maintain Regulatory Approval in the relevant Major Market Country for such Clinical IRD Product (the “Clinical Development Plan Activities”), (ii) an estimated timeline for completing such activities and the respective Clinical Development Plan Term, (iii) the respective deliverables for such activities and (iv) the allocation of responsibilities between the Parties for performance of each such activity. The terms of, and Clinical Development Plan Activities set forth in, each Clinical Development Plan will at all times be designed to expedite Regulatory Approval, reimbursement and Commercialization of the Clinical IRD Product that is the subject of such Clinical Development Plan, and to be in compliance with all Applicable Laws and in accordance with professional and ethical standards customary in the biopharmaceutical industry. From time to time, and at least on an annual basis, the JDC will develop, review and approve amendments or updates to each Clinical Development Plan for a Clinical IRD Product, subject to the remaining terms and conditions of this Agreement. Each such amended or updated Clinical Development Plan will automatically repla...

Clinical Development Plans. All Development of the Licensed Product shall be conducted pursuant to either the CDP or an IDP. The Initial Global Development Plan as of the Effective Date (attached hereto as Exhibit C) includes: (a) the Work Plan and Development Budget of the initial CDP for each of the Initial Studies; (b) the proposed Work Plan and Development Budget for Additional Studies which are US Studies intended as of the Execution Date to support the Regulatory Approval of a Licensed Product containing GRN163L in one or more Named Indications by the FDA and planned for future implementation depending on the Parties’ evaluation of clinical data and other results from ongoing studies;

Clinical Development Plans. All Development of the Licensed Products by or on behalf of either or both of the Parties after the Effective Date shall be conducted pursuant to the Global Development Plan. The Initial Global Development Plan as of the Effective Date (attached hereto as Exhibit C) includes: (a) the Work Plan for the Initial Study; (b) the Work Plan for each Ongoing Study that will continue (if any); (c) the Work Plan for each Ongoing Study that will be wound down; and (d) the Work Plan for any other clinical study of Licensed Products. The Parties acknowledge that the Initial Global Development Plan is preliminary and provides high-level Work Plans for initial Development activities. The Parties, through the JSC, shall use commercially reasonable efforts to update the Global Development Plan in due course after the Effective Date as further information develops, subject to Section 3.7.1.

Clinical Development Plans. The Manufacturing Costs incurred by or on behalf of either Party under the Clinical Development Plans shall be deemed Clinical Development Costs and shared equally between the Parties, subject to a Party’s Opt-Out, provided, however, in each case, that the costs have been included in the respective Development Plan or have otherwise been approved by both Parties.

Clinical Development Plans