Regulatory Approval and Commercialization Clause Samples

The "Regulatory Approval and Commercialization" clause outlines the obligations and procedures related to obtaining necessary governmental or regulatory approvals before a product or service can be marketed and sold. Typically, this clause specifies which party is responsible for seeking approvals, the timelines involved, and any cooperation required between the parties during the approval process. It may also address the steps to be taken once approval is granted, such as launching the product or dividing commercialization responsibilities. The core function of this clause is to ensure that all legal and regulatory requirements are met before commercial activities begin, thereby reducing legal risk and clarifying each party’s responsibilities in bringing a product to market.
Regulatory Approval and Commercialization. T2 Bio shall use commercially reasonable efforts to seek regulatory approval of the Developed Products from the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the applicable regulatory authority in all other jurisdictions identified in the Project Plan. Upon receiving regulatory approval for a Developed Product, T2 Bio shall promptly notify Allergan in writing of such approval and use commercially reasonable efforts to commercialize such Developed Product in such jurisdictions where such approval has been obtained. In connection with seeking regulatory approval of the Developed Products and upon T2 Bio’s reasonable request, Allergan shall provide T2 Bio reasonable access to data generated in Allergan-sponsored clinical trials in which a Developed Product has been used.
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Regulatory Approval and Commercialization. 6.1 Efforts by Sanofi. Subject to this Section 6.1, Sanofi shall *** to obtain Regulatory Approval and Commercialize *** in the Field ***; provided, that if Sanofi, in its sole discretion, elects to *** to obtain Regulatory Approval and Commercialize *** in the Field in *** (the “*** Major Markets”), then Sanofi’s obligation to *** to obtain Regulatory Approval and Commercialize *** in the Field in *** shall be suspended until Sanofi either (a) stops *** to obtain Regulatory Approval in the *** Major Markets, or (b) receives Regulatory Approval for any Licensed Product in any of the *** Major Markets. For the purposes of this Agreement, “***” with regards to Sanofi means that Sanofi shall ***. Except as otherwise provided in this Agreement, Sanofi shall be solely responsible for (i) all Development and Commercialization activities related to Licensed Products (excluding the Manufacturing rights of IMDZ set forth in Article 9), including without limitation all pre-marketing activities and all post-approval clinical studies, and (ii) booking all sales of Licensed Products in the Territory.
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Regulatory Approval and Commercialization. 5.1 Best Efforts for Regulatory Approval: Licensor and Licensee shall collaborate to achieve U.S. and international regulatory approvals for the Commercialization of the Licensed Products. This includes performing clinical trials on the Licensed Products.
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Regulatory Approval and Commercialization 
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Related to Regulatory Approval and Commercialization

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

  • Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.