Development and Commercialization Program Sample Clauses

The DEVELOPMENT AND COMMERCIALIZATION PROGRAM clause defines the framework and obligations for how the parties will collaborate to develop and bring a product or technology to market. It typically outlines the roles and responsibilities of each party, sets milestones or deliverables, and may establish timelines, budgets, and reporting requirements. By clearly delineating the process and expectations for both development and commercialization, this clause ensures coordinated efforts and helps prevent misunderstandings or disputes over each party’s contributions and rights.
Development and Commercialization Program. 2.1 Commencing on the Effective Date, the parties shall collaborate in the development and commercialization of the Licensed Product in the Licensed Field. The program of activities to be conducted by each of Corixa and ZKC during the term of the Agreement is set forth on Exhibit C (the "Development and Commercialization Program"), which shall be amended on an annual basis by mutual agreement of the parties, effective upon each anniversary of the Effective Date. The Development and Commercialization Program shall include a development plan setting forth the activities currently contemplated by the parties to be performed in developing the Licensed Product, as well as a description of each party's responsibilities in connection with the development and commercialization of the Licensed Product. Anything herein to the contrary notwithstanding, the timelines included in the development plan are non-binding and shall function as guidelines only for the development of Licensed Product and may be modified from time to time by the Development Steering Committee. The parties agree that the end goal of the Development and Commercialization Program shall be the expeditious clinical development and regulatory approval of the Licensed Product as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter and scope of such Development and Commercialization Program shall be made without the mutual written agreement of both parties. 2.2 On the Effective Date, ZKC agrees to diligently undertake, [*], pre-clinical and clinical development and commercialization of the Licensed Product within the Territory as determined by the Development Steering Committee or Commercialization Steering Committee, as applicable. ZKC shall have the right, subject to the terms and conditions of this Agreement, including, without limitation, Section 3 hereof, to determine the clinical development and commercialization plan for the Licensed Product in the Territory. 2.3 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner Corixa's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field [*] or any of its Third Party [*], provided, however, Corixa shall not during the term of this Agreement conduct any clinical trial in the Territory in respect of the Licensed Product or sell, market or distribute the Licensed Product in the L...
View SourceView Similar (6)
Development and Commercialization Program. 2.1 Commencing on the Effective Date, the parties shall collaborate in the development and commercialization of the Licensed Product in the Licensed Field. The program of activities to be conducted by each of Corixa and Medicis during the term of the Agreement as set forth on Exhibit D to be attached hereto prior to the Effective Date (the “Development and Commercialization Program”), which may be reviewed no less often than on an annual basis by the Development Steering Committee or the Commercialization Steering Committee, as applicable, and, if necessary and appropriate, amended by the written agreement of the parties after recommendation by the Development Steering Committee or the Commercialization Steering Committee, as appropriate, effective upon the next anniversary of the Effective Date. The Development and Commercialization Program shall include a development plan setting forth the activities and timelines currently contemplated by the parties to be performed in developing the Licensed Products, as well as a description of each party’s responsibilities in connection with the development and commercialization of the Licensed Products. The timelines included in the Development and Commercialization Program may be modified from time to time by the Development Steering Committee or the Commercialization Steering Committee, as appropriate. The parties agree that the end goal of the Development and Commercialization Program shall be the expeditious clinical development and regulatory approval of the Licensed Products and optimization for successful commercialization as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter, scope and timeline of such Development and Commercialization Program shall be made without the written agreement of the parties. 2.2 Subject to the terms and conditions of this Agreement, the parties acknowledge and agree that nothing in this Agreement shall restrict Corixa’s ability to conduct clinical trials of any nature related to the Licensed Products using good clinical practice either inside or outside of the Licensed Field at Corixa’s or any of its Third Party Partners’ own cost and expense, provided that [***]. Notwithstanding the foregoing, Corixa shall provide Medicis access to and permit use of clinical data and regulatory filings controlled by Corixa related to the Licensed Products in the Licensed Field, and shall also use...
View SourceView Similar (3)
Development and Commercialization Program a. UT shall be responsible for all costs and expenses for obtaining regulatory approval and commercializing Products for treatment of the Indication, including all costs of clinical trials. UT will solely and exclusively own all regulatory applications and approvals obtained by UT with respect to Products. UT will closely consult with Toray with regard to its participation in important clinical development meetings.
View Source
Development and Commercialization Program. 4.1 Initial Assessment Period. 4.1.1 The parties acknowledge that it will be beneficial to UP to work closely with AltaRex for a period of time following the Effective Date in order to (i) perform a top-to-bottom assessment of all aspects of the development of the Licensed Technology conducted by or on behalf of AltaRex prior to the Effective Date so that UP may be fully informed of all development progress, status, issues, concerns, assumptions, strategies, trade-offs, limitations, decisions and similar elements and factors bearing on the state of the Licensed Technology as of the Effective Date, and (ii) to reengineer, redesign, develop, propose and optimize turnkey solutions and strategies going forward with respect to all aspects of the successful development of the Licensed Technology including, without limitation, manufacturing, clinical trial design including a pivotal trial design for OvaRex®, intellectual property strategies, and market and competitive assessments, the foregoing period referred to as the “Initial Assessment Period”. 4.1.2 UP shall provide written notice to AltaRex when it has substantially completed the Initial Assessment Period to its satisfaction and is prepared to proceed with the UP Development Program in accordance with Section 4.2 below or determines not to proceed with the UP Development Program (the date of such notice being the last day of the Initial Assessment Period if not earlier delivered in writing to AltaRex); provided, however, that the Initial Assessment Period shall be no longer than 240 days following the Effective Date. UP’s conclusions, recommendations and strategies going forward that result from the Initial Assessment Period shall be presented to the Advisory Committee for evaluation and discussion. 4.1.3 From the Effective Date, UP, at its sole expense, shall fund all reasonable and direct ongoing development costs incurred by either AltaRex or UP in accordance with this Agreement and with respect to developing the Licensed Technology in the Territory during the Initial Assessment Period only; provided, however, that AltaRex shall not incur any such development expenses (the “AltaRex Expenses”) following the Effective Date that are not (i) in accordance with a budget approved by UP (the “AltaRex Expense Budget”), which approval shall not be unreasonably withheld or delayed, or (ii) with the prior written approval of UP, which approval shall not be unreasonably withheld or delayed. 4.1.3.1 AltaRex shall pro...
View Source
Development and Commercialization Program 
View SourceView Similar (8)

Related to Development and Commercialization Program

  • 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 Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones) B. Estimated total development time

  • 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.

  • 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 ▇▇▇▇▇; 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.