Responsibility for Commercialization of Products Sample Clauses

The "Responsibility for Commercialization of Products" clause defines which party is obligated to bring a product to market and manage its commercial activities. Typically, this clause outlines the specific roles, such as marketing, sales, distribution, and regulatory compliance, that the responsible party must undertake. For example, in a licensing agreement, the licensee may be tasked with launching and selling the product in designated territories. The core function of this clause is to ensure clarity regarding which party is accountable for the product’s commercial success, thereby preventing disputes and aligning expectations between the parties.
Responsibility for Commercialization of Products. Subject to the exercise by Enanta of a Co-Development and Profit Share Option and unless otherwise set forth in any Marketing and Sales Plan, ▇▇▇▇▇▇ shall have the sole right and responsibility for all aspects of the Commercialization of Products, in accordance with the applicable Marketing and Sales Plan in the Field. Without limiting the foregoing, ▇▇▇▇▇▇ shall have the sole right and responsibility for (a) the conduct of: (i) all activities relating to the manufacture and supply of Products (including all required process development and scale up work with respect thereto); and (ii) all pre-marketing, marketing, promotion, FDA DDMAC interactions, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance or maintaining databases), subject to the oversight of the JSC and (b) for: (i) subject to Section 4.5.5, making all Regulatory Filings for Candidates and filing all Drug Approval Applications and otherwise seeking all Regulatory Approvals for Products, as well as all correspondence and communications with Regulatory Authorities regarding such matters; (ii) reporting all Adverse Events to Regulatory Authorities if and to the extent required by Applicable Laws; and (iii) subject to making the Co-Development Payments to Enanta for Co-Developed Products contemplated by Section 6.4.1(b). ▇▇▇▇▇▇ shall own all Regulatory Approvals for Products, subject to Section 11.3.
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Responsibility for Commercialization of Products. Subject to Section 5.11 below, ILDONG shall have the primary right and responsibility for, and shall have primary control and authority over, at its sole cost and expense, (a) all aspects of the Commercialization of Products in the Field in the Territory including the sole responsibility for booking sales of Product and for all returns, charge-backs and rebates with respect to Products; and (b) the conduct of all pre-marketing, marketing, Branding, promotion, sales, distribution, import and export activities (including securing pricing, reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance and maintaining databases) applicable to the Commercialization of Products in the Field and in the Territory.
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Responsibility for Commercialization of Products. MERCK shall be the Responsible Party and have the sole right and responsibility for all aspects of the Commercialization of Products for all Cancer Indications in both the U.S. Territory and the ROW Territory in accordance with the Product Commercialization Plans, shall book all sales in both the U.S. Territory and the ROW Territory, and shall have responsibility for Manufacturing all Product, including Clinical Product, and API (after transfer of such responsibility pursuant to the Manufacturing Transition Plan as set forth in Section 3.5.1). Without limiting the foregoing, MERCK shall have the right and responsibility for the conduct of all pre-marketing, marketing, medical affairs, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance or maintaining databases). MERCK will provide ARIAD with a draft or update of the MERCK ROW Product Commercialization Plan annually, in line with MERCK’s global planning calendar timelines at a meeting of the JCC and will give good faith consideration to ARIAD’s comments on such draft.
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Responsibility for Commercialization of Products. Except as expressly set forth in Exhibit A or otherwise in this Agreement with respect to Commercialization-related Services to be conducted by MTTR, Oncobiologics will have the sole right and responsibility for, and final decision-making authority with respect to, the Commercialization of Products in the Field in the Territory, including (a) the conduct of all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including the securing of reimbursement, sales and marketing and any post-marketing trials or databases and post-marketing safety surveillance); (b) the submission of applications for reimbursement with respect to any Product in any country in the Territory; (c) the identification and registration of all tradenames for any Product in the Field in the Territory; (d) the out-licensing of intellectual property owned or controlled by Oncobiologics that Covers any Product in the Field in the Territory; and (e) the booking of all sales of Products in the Field in the Territory, in each case in accordance with the Commercialization Plan. During the Term, MTTR shall, through the Consultants, provide Services to Oncobiologics with respect to the Commercialization of Products in the Field in the Territory for all Approved Indications. Any promotion of the Product by any Active HCP shall be subject to the prior approval of Oncobiologics. [***].
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Responsibility for Commercialization of Products. Consistent with the remaining terms and conditions of this Agreement, each Party shall be solely responsible for Commercialization of Products in the Field in its Territory. For clarity, Ocugen shall be solely responsible for the Commercialization of Products in the Field in the Ocugen Territory, and ▇▇▇▇▇▇▇ shall be solely responsible for the Commercialization of Products in the Field in the ▇▇▇▇▇▇▇ Territory, in each case including all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance), maintaining all issued Marketing Authorizations, maintaining all pharmacovigilance systems and activities as required by Applicable Laws and the timing and launch of all Products. Each Party shall, and shall cause its Affiliates, to market and promote the Products only in the Field in its Territory.
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Responsibility for Commercialization of Products. Subject to Section 5.11 below, TG shall have the primary right and responsibility for, and shall have primary control and authority over, at its sole cost and expense, (a) all aspects of the Commercialization of Products in the Field in the Territory including the sole responsibility for booking sales of Product and for all returns, charge-backs and rebates with respect to Products; and (b) the conduct of all pre-marketing, marketing, Branding, promotion, sales, distribution, import and export activities (including securing pricing, reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance and maintaining databases) applicable to the Commercialization of Products in the Field and in the Territory.
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Responsibility for Commercialization of Products. Subject to the exercise by a Party of an Opt-Out Right pursuant to Section 3.4 and unless otherwise set forth in any Product Commercialization Plan (a) ARIAD shall be the Responsible Party and MERCK will be the Participating Party for all Sarcoma Indications in the U.S. Territory other than budgets, Pricing and Branding and the Parties shall jointly be the Responsible Party and have the right and responsibility for all aspects of the Commercialization of Products for all Major Cancer Indications and Other Cancer Indications in the U.S. Territory and for budgets, Pricing and Branding for all Indications in the U.S. Territory in accordance with the applicable Product Commercialization Plan; provided that ARIAD shall have responsibility for Manufacturing all API for Product under the Supply Agreement and Clinical Product (prior to Clinical Product Transfer) and for order fulfillment and distribution of Product in the U.S. Territory and shall book all sales in the U.S. Territory; and (b) MERCK shall be the Responsible Party and have the sole right and responsibility for all aspects of the Commercialization of Products for all Cancer Indications in the ROW Territory in accordance with the applicable MERCK ROW Product Commercialization Plan and shall book all sales in the ROW Territory and shall have responsibility for Manufacturing all Product, including Clinical Product (after Clinical Product Transfer), under the Supply Agreement. Without limiting the foregoing, the Responsible Party (or Parties) shall have the right and responsibility for the conduct of all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or post-marketing safety surveillance or maintaining databases), subject to the oversight of the JSC with respect to Co-Promoted Products. MERCK will provide ARIAD with a draft or update of the MERCK ROW Product Commercialization Plan annually, not later than March 31 of each Calendar Year and will give good faith consideration to ARIAD’s comments on such draft. MERCK will review the MERCK ROW Product Commercialization Plan with ARIAD at a meeting of the JCC and will provide ARIAD with an annual roll-up of the MERCK ROW Product Commercialization Plan.
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Responsibility for Commercialization of Products. As between the Parties, Lilly shall be solely responsible, at its sole cost and expense, for the conduct of all aspects of the Commercialization of Products in the Territory, including (a) the conduct of: (i) all activities related to Clinical Trials and (ii) all pre-marketing, marketing, promotion, sales, distribution, import and export activities (including securing reimbursement, sales and marketing and conducting any post-marketing trials or databases and post-marketing safety surveillance); (b) the timing for the launch of Products and for submitting applications for reimbursement with respect to Products in any country in the Territory; and [***].
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Responsibility for Commercialization of Products 
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Related to Responsibility for Commercialization of Products

  • 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.

  • 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).

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection ▇▇▇▇▇; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Collaboration activities 4.1 The Collaboration Suppliers will perform the Collaboration Activities and all other obligations of this Agreement in accordance with the Detailed Collaboration Plan. 4.2 The Collaboration Suppliers will provide all additional cooperation and assistance as is reasonably required by the Buyer to ensure the continuous delivery of the services under the Call-Off Contract. 4.3 The Collaboration Suppliers will ensure that their respective subcontractors provide all cooperation and assistance as set out in the Detailed Collaboration Plan.

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.