Commercialization Diligence. Novartis shall dedicate commercially reasonable efforts, during each [**] month period, necessary to commercialize a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries. If Novartis commercializes a Licensed Product for a Profile, after receipt of Regulatory Approval therefor, in any of the U.S., Japan or the EU Major Market Countries, Novartis will be deemed to satisfy all diligence obligations with respect to such Profile.
Commercialization Diligence. Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].
Commercialization Diligence. 7.4.1 Upon Regulatory Approval in a country in the Licensee Territory for a Licensed Product, Licensee shall use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such country.
Commercialization Diligence. (a) Program 1 Product. Merus shall use Commercially Reasonable Efforts to Commercialize the Program 1 Product for at least one Indication in the United States after receipt of Regulatory Approval therefor. Incyte shall use Commercially Reasonable Efforts to Commercialize the Program 1 Product for at least one Indication in the Non-U.S. Major Markets after receipt of Regulatory Approval therefor.
Commercialization Diligence. (a) Prior to Submission of First BLA. For each Product under Development, prior to the submission of the first BLA to the first Regulatory Authority in the Territory, Green Cross shall submit to the JSC a written summary plan for the Commercialization for each such Product under Development. Thereafter, Green Cross shall regularly report on its Commercialization activities at meetings of the JSC or, if formed, the Joint Commercialization Committee. Such reports shall cover subject matter at a level of detail similar to that which Green Cross affords to its senior executives with respect to similar Green Cross products. All such plans and information shall be presented for discussion purposes, and Green Cross agrees to consider in good faith any comments or suggestions MacroGenics may make with respect to Commercialization of Products.
Commercialization Diligence. Subject to Cardiome’s receipt of access to a complete electronic copy of SteadyMed’s New Drug Application for Product and Infusion set in the Field as filed with the FDA and the required stability data for Product described below in this Section 6.3, Cardiome shall use Commercially Reasonable Efforts: (a) to obtain and maintain Regulatory Approvals in at least the Major Markets; (b) to obtain and maintain required Pricing Approvals in at least the Major Markets; (c) to initiate commercial sale of Supplied Items in each Major Market within six (6) months after receipt of Regulatory Approval and any required Pricing Approvals in such Major Market, and thereafter to Commercialize, and maximize Net Sales of, Supplied Items in the Field in such Major Market; and (d) otherwise to conduct material Commercialization Plan activities substantially in accordance with the timeline set forth in the Commercialization Plan. Without limiting the generality of the foregoing, no later than six (6) months after the later of (i) Cardiome’s receipt of access to a complete electronic copy of SteadyMed’s New Drug Application for Product as filed with the FDA and (ii) Cardiome’s receipt from SteadyMed of 12 months of stability data for Product, Cardiome shall file a Regulatory Application with each of the EMA and the applicable national Regulatory Authority in Canada. For clarity, SteadyMed shall be solely responsible for conducting the activities necessary to generate 12 months of stability data for Product, at SteadyMed’s sole cost.
Commercialization Diligence. Dermavant shall, and shall ensure that each Responsible Party shall, use Commercially Reasonable Efforts to Commercialize the Product in the United States and each other jurisdiction in which Marketing Approval has been obtained and for each Indication for which Marketing Approval has been obtained, in each case taking into account the CRE Considerations.
Commercialization Diligence. ILDONG shall use Commercially Reasonable Efforts during the Term to Commercialize Products for all approved Indications in the Field and in the Territory. Without limiting the foregoing, (a) commencing no later than * (*) days prior to the estimated date of First Commercial Sale of the Product, ILDONG shall conduct pre-marketing activities in the Territory with respect to the Product and (b) following receipt of Marketing Authorization with respect to the Product in the Territory, ILDONG shall initiate and conduct such promotional activities determined by ILDONG as may be required to develop a commercial market for, launch and Commercialize the Product (including through direct conduct with key opinion leaders) in the Territory. In addition, ILDONG, shall establish and maintain a well-trained sales force for the Product, (together with a well-trained support staff) adequate to service all the customers of ILDONG and to keep the sales force knowledgeable and fully informed as to the Product; maintain an effective distribution system for the Product in the Territory; transport and store the Product to preserve its quality in accordance with pre-determined QA requirements; obtain and maintain all licenses, approvals and permits in the Territory necessary for ILDONG to perform its obligations under this Agreement; establish and maintain suitable systems and records to enable a recall of Product in a timely, efficient and accurate manner and otherwise in accordance with applicable laws and regulations in the Territory; abide by all applicable rules and regulations relating to sales, marketing and reimbursement; ensure that no Product shipped by ILDONG is adulterated or misbranded; maintain adequate control over the physical security of the Product; Cause all Affiliates, sublicensees and subcontractors of ILDONG to comply with the above.
Commercialization Diligence. Licensee, from and after the Effective Date, shall use all reasonable and diligent efforts to develop, test, and obtain regulatory approvals required, if any, and manufacture, market and sell Licensed Products in the Territory, and shall, within a reasonable time after obtaining requisite regulatory approvals, earnestly and diligently endeavor to market and sell the same in quantities sufficient to meet the market demands therefor.
Commercialization Diligence. Licensee shall be responsible for, and shall use Commercially Reasonable Efforts to Commercialize each Licensed Product in the Field in the Territory, including the timely performance of all activities set forth in the Commercialization Plan for such Licensed Product, at its sole cost and expense.
