Development and Regulatory Approvals Sample Clauses
The DEVELOPMENT AND REGULATORY APPROVALS clause outlines the responsibilities and procedures related to the development of a product and obtaining the necessary regulatory approvals for its commercialization. Typically, this clause specifies which party is responsible for conducting development activities, preparing regulatory submissions, and interacting with regulatory authorities. For example, it may detail timelines for clinical trials, requirements for data collection, and obligations to report progress. Its core function is to ensure that both parties understand their roles in bringing a product to market and to allocate responsibility for navigating the regulatory landscape, thereby reducing the risk of delays or non-compliance.
Development and Regulatory Approvals. King shall have sole control over the development of the Thrombin-JMI® incorporated in or included in combination with the Products. VSI shall use commercially reasonable efforts to obtain Regulatory Approval and/or CE ▇▇▇▇ approval as required for the marketing and sale of the Products in the Selected Countries. VSI shall be the sole owner of such Regulatory Approvals obtained hereunder. King shall reimburse VSI the reasonable costs incurred after the Effective Date for obtaining such Regulatory Approval for Products hereunder. If after undertaking and completing the Development Plans pursuant to Article 3 with respect to each of the Products identified below in (a) and (b) respectively, such development and regulatory efforts have not resulted in the Regulatory Approval identified below, VSI agrees to make the following one-time, non-refundable, non-creditable payments to King within thirty (30) days following the completion of the applicable Development Plan(s):
(a) $2,500,000 (two million five hundred thousand dollars) if the FDA has not approved each and every one of ThrombiGel 10, ThrombiGel 40 and ThrombiGel 100 for surgical use in the U.S.A.; and
(b) $2,500,000 (two million five hundred thousand dollars) if the FDA has not approved ThrombiGel Paste for surgical use in the U.S.A.
Development and Regulatory Approvals