Joint Commercialization Plans Sample Clauses

Joint Commercialization Plans. On a Licensed Product-by-Licensed Product basis, if Protagonist has not exercised the Rusfertide Opt-Out Right or a Partial Opt-Out Right with respect to a Licensed Product other than Rusfertide, the Parties will Commercialize such Licensed Product in the U.S. pursuant to a commercialization plan and detailed budget (each such plan, a “Joint Commercialization Plan”) that describes: (i) the material pre-launch, launch and subsequent Commercialization activities for such Licensed Product in the U.S., including the field force size, structure, allocation and deployment, patient support size and structure, branding strategy (including brand name, positioning, product positioning, messages, timing, logo, colors, and other visual branding elements) for such Licensed Product, market access plans, Promotional [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Materials, Distribution Matters, Scientific Exchange Activities, CMC Activities and the quantities of Licensed Product to be supplied to the Parties for the U.S. and the estimated delivery date therefor; Phase 4 Clinical Trials; and the key tactics and strategies for implementing the foregoing activities; (ii) the strategic manufacturing decisions to be implemented to ensure continued and adequate commercial supply of such Licensed Product for such Commercialization activities and the associated estimated Manufacturing Costs; and (iii) (A) the detailed associated budget of the [***] and [***] anticipated to be incurred in the performance of such Commercialization activities, including a [***] rolling budget and the annual budget for the first year (the second and third year annual budgets will be mutually agreed at the JCC based on the [***] rolling budget), and (B) a budget of the Detail Costs anticipated to be incurred for such Licensed Product (each such included budget, a “Shared Commercialization Budget”)). The initial Joint Commercialization Plan (and Shared Commercialization Budget) for Xxxxxxxxxx as agreed upon by the Parties is attached hereto as Schedule ‎7.3(a). Provided Protagonist has not exercised the Rusfertide Opt-Out Right, then, for any other Licensed Product for which Xxxxxxxxxx has not already exercised a Partial Opt-Out Right, Takeda will prepare a proposed draft Joint Commercialization Plan (inclusive of a proposed Shared C...
Sample 1
AutoNDA by SimpleDocs
Joint Commercialization Plans. At an appropriate time to be determined by the JSC (but in any event at least [***] prior to commercial launch of the applicable Shared Product for the applicable Indication in the Territory), the JSC shall formulate and approve an initial joint plan for commercialization of such Shared Product for the Territory (the “Joint Commercialization Plan”). The Joint Commercialization Plan may be amended or updated from time to time by the JSC, including any amendments or updates to any anticipated timelines or to the then-current budget. The Joint Commercialization Plan shall encompass the planned commercialization strategy in the Territory for the applicable Shared Product and shall set forth the corresponding budget of Shared Commercialization Costs, anticipated timelines, commercialization activities to be performed by each Party, commercial supply forecasts, and the other matters described below. The initial Joint Commercialization Plan shall include the budgeted Shared Commercialization Costs for pre-launch commercialization activities in the Territory and for commercialization activities through at least two Calendar Years after the First Commercial Sale of the Shared Product in the Territory. The Joint Commercialization Plan shall be updated by the JSC on an annual or more frequent basis. The responsibilities allocated to each of the Parties shall be based on their respective capabilities and geographic scope. Initially, the Parties anticipate that [***], which will be reflected in the Joint Commercialization Plans.
Sample 1
Joint Commercialization Plans 
Sample 1

Related to Joint Commercialization Plans

  • Commercialization Plan The JCC will oversee the Commercialization of Shared Products by the Parties in the Field in the Territory. No later than [***] prior to the anticipated launch of the Shared Product in the first country in the Territory, the JCC will develop and submit to the JSC for approval, a Commercialization plan (the “Commercialization Plan”) that sets forth the Commercialization activities to be undertaken by the Parties with respect to the Commercialization of the Shared Product in the Territory. The Commercialization Plan may include activities on a region-by-region or country-by-country basis, as determined by the JCC. The JCC will update the Commercialization Plan on [***] (or more frequently as needed) and submit it to the JSC for approval. The Commercialization Plan will include (a) the Global Branding Strategy, (b) a marketing strategy, (c) a communications strategy that includes plans for public relations, conferences and exhibitions and other external meetings, internal meetings and communications, publications and symposia, internet activities and core brand package, (d) a high level operating plan for the implementation of such strategies on [***], including information related to Shared Product positioning, core messages to be communicated and pricing strategies, (e) a detailing strategy, (f) a pricing strategy, (g) all other material activities to be conducted in connection with the Commercialization of the Shared Product in the Field in the Territory and (h) a budget for activities conducted under the Commercialization Plan (the “Commercialization Budget”). The Commercialization Plan will include a meaningful role for both Parties. In allocating responsibilities between the Parties, the JCC will take into consideration each Party’s expertise, capabilities, staffing and available resources to take on such activities, as well as the Parties’ intention to provide CRISPR an opportunity to build and expand its expertise, capabilities, staffing and available resources in connection with performing Commercialization activities allocated to it. CRISPR shall be the Commercializing lead for Shared Products in the United States and Vertex shall be the Commercializing lead for Shared Products outside of the United States. The Commercializing lead, with respect to the United States or outside of the United States, respectively, shall be referred to herein as the “Lead Commercialization Party” for such jurisdiction (as applicable, the “Lead Commercialization Party” Unless otherwise specified in the Commercialization Plan, the Parties will jointly be responsible for conducting all Commercialization activities outside of the United States, such activities to be determined by the JSC.

  • Joint Commercialization Committee The Parties shall establish a joint commercialization committee (the “Joint Commercialization Committee” or “JCC”) at an appropriate time, reasonably in advance of the first potential Marketing Approval of a CoDev Product and reasonably in advance of the time required for the Global Commercialization Strategy to be prepared as set forth in Section 6.1.

  • Development Plans 4.3.1 For each Licensed Indication and corresponding Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for each Licensed Indication will be delivered within […***…] after the Grant Date for such Licensed Indication.

  • 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 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 Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • 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 xxxxx; 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.

Time is Money Join Law Insider Premium to draft better contracts faster.