Mpex Development and Commercialization Diligence Sample Clauses

Mpex Development and Commercialization Diligence. (a) After the commencement of the Development Phase, and during the remainder of the term of this Agreement, Mpex agrees to use Commercially Reasonable Efforts to pursue the clinical development of and to obtain Marketing Approval for at least one (I) Drug Product intended for use in a Licensed Configuration in one (1) or more Major Countries, and after obtaining such Marketing Approval, to use Commercially Reasonable Efforts to market and sell such Drug Product and/or Licensed Configuration in all Major Countries in which it has been approved. Until such first Marketing Approval, provided that the license of Section 4.1.1 remains exclusive hereunder, Mpex shall provide PARI, at least annually through the JSC, with detailed reports of the progress of its development of Drug Products for use in Licensed Configurations and plans for its development and commercialization thereof in the upcoming year, and will provide PARI through the JSC quarterly updates thereto. The JSC shall discuss such reports and plans and Mpex shall duly consider any comments thereon provided by PARI, provided that the Parties agree that Mpex shall retain sole control of its development efforts hereunder and its plans therefor. For clarity, it is understood that the obligation to use Commercially Reasonable Efforts as set forth in this Section 7.1(a) shall apply to any Sublicensees who are responsible for development of Drug Products for Licensed Configurations, and to the extent Mpex has obtained reports and plans from such Sublicensees and are not restricted by confidentiality obligations, Mpex shall share such reports and plans with PARI at least annually through the JSC in the same manner as for reports and plans of its own development. This Section 7.1(a) shall also apply to any permitted successors or assigns of Mpex under this Agreement. The Parties acknowledge and agree that Mpex’ s material breach of this Section 7.1 (a) shall be deemed a material breach of this Agreement and the provisions of Section 15.2 hereof shall specifically apply to such material breach.
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Related to Mpex Development and Commercialization Diligence

  • 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 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 Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

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  • Development Plan As defined in Section 3.2(a).

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