As further described in this Section 8.3, the tactics and strategy for the Commercialization of each Product in the Territory will be described in a comprehensive plan (each such plan, a Joint Commercialization Plan) that describes the pre-launch, launch and subsequent Commercialization of such Product in the Shared Territory (including anticipated activities relating to messaging, branding, Pricing Matters (to the extent not prohibited by Applicable Law), advertising, planning, marketing, sales force training and allocation, detailing, and Distribution Matters), key tactics and strategies for implementing those activities and the associated budget for such activities (each such included budget, a Joint Commercialization Budget).
Joint Commercialization Plan. Any expenses incurred by a Party for Commercialization activities in the Shared Territory related to a Product that do not fall within the definitions of Joint Commercialization Costs will be borne solely by such Party unless the JCC determines otherwise. In addition, any expenditure or cost that exceeds the amount set forth in the applicable Joint Commercialization Plan by more than for a calendar year or any unbudgeted cost that is incurred by either Party will be borne by such Party; provided that the JCC will have the discretion to review such expenditures or costs and propose to the JSC that they be designated as Joint Commercialization Costs.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Patented Products in the Field. Notwithstanding the foregoing, Arcus is obligated to file an IND in the United States on a Patented Product no later than months from the Effective Date; provided that Stage 2 Technology Transfer, as defined in Section 3.3.1 below, is completed no later than days following the Effective Date. The deadline for Arcus to file an IND in the United States on a Patented Product shall be extended by one (1) day for each day that Abmuno is late in completing Stage 2 Technology Transfer. Any delay or postponement in the filing of an IND in the United States on a Patented Product beyond the deadline for such filing will be subject to approval by Abmuno, which approval shall not be unreasonably withheld, conditioned or delayed.
Development, Manufacturing and Commercialization. Regeneron shall have the right to grant one or more sublicenses under the licenses granted to Regeneron under Section 4.1, in full or in part, by means of written agreement to Affiliates or Third Parties (with the right to sublicense through multiple tiers), without the prior written consent of CytomX, for the performance of Regeneron’s Development, Manufacturing and Commercialization activities related to Licensed Products or for the performance of any other activities related to the Exploitation of a Licensed Product. As a condition precedent to and requirement of any such sublicense: # Regeneron shall furnish a redacted copy of such sublicense agreement to CytomX; # any such permitted sublicense shall be consistent with and subject to the terms and conditions of this Agreement (including for the avoidance of doubt, that if sales by such Sublicensee are included in Net Sales hereunder, such Sublicensee shall permit audit rights with respect to its reporting of Net Sales that are consistent with those given by Regeneron hereunder with respect to its sales included in Net Sales); # Regeneron will continue to be responsible for full performance of its obligations under this Agreement and will be responsible for all actions of such Sublicensee as if such Sublicensee were Regeneron hereunder; and # Regeneron’s grant of any sublicense will not relieve Regeneron or its Affiliates from any of its obligations under this Agreement.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Licensed Products. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of its requirements of packaged and labeled Licensed Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement. For so long as Arcus is conducting Development activities under this Agreement, Arcus shall provide to WuXi, no later than on June 30 and December 31 of each calendar year, with written summaries of the Development activities it performed, or caused to be performed, in respect of Licensed Products since the preceding report (or, with respect to the first such report, since the Effective Date), and the future Development activities it CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
On a Product-by-Product basis, each Party will use Commercially Reasonable Efforts to Commercialize such Product in the Shared Territory, and to carry out the tasks specified under the Joint Commercialization Plan in a timely and effective manner and in compliance in all material respects with Applicable Law and applicable codes of conduct.
Development and Commercialization Plans. Licensee shall perform, and shall ensure that its Affiliates, sublicensees, and Third Party contractors perform, the activities described in any Development Plan for the Licensed Product in a professional manner and in compliance with, to the extent applicable, Good Laboratory Practices, Good Clinical Practices and/or Good Manufacturing Practices and in compliance with all other applicable laws, rules, and regulations.
Regulatory, Manufacturing and Commercialization. After the Effective Date, # Zai Lab will be solely responsible for and control (at its own expense) all regulatory matters related to the Development and Commercialization of Compounds and/or Products in the Territory, including, without limitation, taking full responsibility for preparing and filing the relevant applications with the Regulatory Authorities for pre-clinical and clinical studies and for Regulatory Approval; and # Zai Lab will be solely responsible for and control (at its own expense) all aspects of Commercialization of Products and the Manufacturing and supply of Products (including, without limitation, the Manufacture and supply of related Compounds being Developed by Zai Lab) in the Territory and will have sole responsibility for all costs arising therefrom.
Commercialization shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall also include Commercialization Studies. Commercialize has a correlative meaning.
7 Commercialization
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