Development Regulatory and Commercialization Clause Samples
The DEVELOPMENT, REGULATORY, AND COMMERCIALIZATION clause outlines the responsibilities and processes related to the creation, approval, and marketing of a product or service under an agreement. It typically specifies which party is responsible for conducting research and development activities, obtaining necessary regulatory approvals, and executing commercialization strategies such as manufacturing, distribution, and sales. This clause ensures that all parties understand their roles and obligations throughout the product lifecycle, thereby facilitating efficient progress from development to market launch and addressing potential disputes over responsibilities.
Development Regulatory and Commercialization. [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.
2.1. The first sentence of Section 3.1.1(c) of the Agreement is hereby deleted in its entirety and replaced with the following: “The JDC’s responsibilities will include, among others: (i) preparing and approving the Development Plan and any amendments to such plan, (ii) approving (or establishing procedures to approve) protocols for pre-clinical or clinical studies (including Post- Approval Research), (iii) making modifications to and performing quarterly monitoring of progress of pre-clinical and clinical studies and proposing additional studies for the Product, (iv) facilitating the exchange of all data, information, material or results relating to the development of the Product, (v) solely with respect to the [**], reviewing and commenting on Regulatory Submissions relating to the Product, and (vi) solely with respect to the [**] and the [**], reviewing Partner’s budget for Developing the Product. Notwithstanding anything to the contrary in this Section 3.1 and the definition of Development, the JDC’s rights and responsibilities under this Agreement will not extend to reviewing or commenting on Regulatory Submissions relating to the Product in the [**] or otherwise handling regulatory affairs with respect to the [**] (but for clarity, the initiation and design of pre-clinical or clinical studies for the Licensed Compound or the Product shall not be deemed to be regulatory affairs and shall remain subject to the approval of the JDC; provided, that following a decision by the JDC to initiate, and approval by the JDC of the design of, any pre-clinical or clinical studies for the Licensed Compound or the Product (including approval of an amendment to the Development Plan for such studies) for purposes of Regulatory Approval in any country(ies) in the [**], Partner shall have [**] over conduct of such studies; provided, however, that Partner shall [**] of any such studies following the initiation thereof without the prior written approval of the JDC).”
2.2. Section 3.1.1(f) of the Agreement is hereby deleted in its entirety and replaced with the following: “Elevation and Dispute Resolution. Each Party’s representatives on the JDC will collectively have one vote on all matters that are within the responsibility of such committee. The members of each committee will use reasonable ef...
Development Regulatory and Commercialization