Preparation of Commercialization Plan Sample Clauses

Preparation of Commercialization Plan. Promptly, but in no event later than [ * ] after the [ * ] of the first [ * ] with respect to each Collaboration Product, the JSC shall prepare and approve an initial Commercialization Plan for such Collaboration Product for the balance of the then current calendar year plus the following [ * ].
Sample 1Sample 2See All (5)
AutoNDA by SimpleDocs
Preparation of Commercialization Plan. Promptly, but in no event later than [***] after the initiation of the first [***] with respect to a Collaboration Product: (i) the JSC shall prepare and approve an initial Commercialization Plan for a duration to be decided by the JSC but for not less than the balance of the then current Calendar Year plus the following Calendar Year for review and final written approval by the Parties. Thereafter, the JSC shall prepare a Commercialization Plan for each Calendar Year during which Commercialization activities are anticipated to occur at least [***] prior to the commencement of such Calendar Year. Each Commercialization Plan shall contain the specific Commercialization objectives to be achieved during the applicable period, the specific activities to be performed by each of the Parties in connection with the Commercialization of the Collaboration Products (including promotion, distribution, detailing and marketing activities), as well as a detailed budget for performing such activities. Each Commercialization Plan shall be consistent with the terms and conditions of both this Agreement and the Co-Promotion Agreement (if applicable). [***] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Sample 1
Preparation of Commercialization Plan. A Commercialization Plan will be prepared by Clementia with respect to each Licensed Product. Clementia shall provide Galderma with the first Commercialization Plan within [*****] and thereafter shall provide Galderma with updates of such plan at least [*****]. Any amendments or modifications to the Commercialization Plan for any Licensed Product shall be prepared by Clementia and delivered promptly to Galderma.
Sample 1
Preparation of Commercialization Plan. MTTR will prepare the plan for the Commercialization of each Product in the Field in the Territory (“Commercialization Plan”) and any updates thereto, in accordance with this Section 7.2. MTTR shall submit the initial Commercialization Plan to the JSC for review and approval by the JSC, no later than [***] prior to the expected date of First Commercial Sale of such Product. MTTR will incorporate all feedback provided by Oncobiologics (after any reasonable discussion requested by MTTR) with respect to such Commercialization Plan, and the Parties will communicate, cooperate and share information with each other on an ongoing basis through the Term to keep each other informed as to the Commercialization of the Product and in order to enable MTTR to revise the Commercialization Plan to reflect Oncobiologics’s then-current plans for Commercialization of Products in the Field in the Territory. The Commercialization Plan shall reflect at least the use of Commercially Reasonable Efforts to market and sell the Product in the Field [***]. MTTR shall provide any material updates to the Commercialization Plan to the JSC at least [***] each [***] for review and approval by the JSC in accordance with Article 3. The Commercialization Plan and updates thereto shall contain a reasonably detailed summary of (a) all major Commercialization activities conducted with respect to Products in the Field in the Territory since the last Commercialization Plan and (b) and all major Commercialization activities proposed to be conducted with respect to Products in the Fxxx in the Territory, including the anticipated timelines for achieving such activities. Subject to Section 4.3(b), Oncobiologics will use Commercially Reasonable Efforts to execute the Commercialization Plan and maximize sales of Products for the Field in the Territory. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1
Preparation of Commercialization Plan. As soon as practicable and in any event *** prior to the date of filing of the first application for Marketing Authorization with respect to any Product that is not an Out-Licensed Product, ArQule shall prepare and provide to the JSC for its review a Commercialization Plan with respect to such Product which shall set forth the Commercialization activities to be conducted with respect to such Product. Each Commercialization Plan shall be updated by ArQule and reviewed by the JSC at such times as the JSC may determine, not less than once each Calendar Year.
Sample 1

Related to Preparation of Commercialization 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.

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

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

  • 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 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.

  • 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.

  • Marketing Plan The Contractor shall have a Marketing Plan, that has been prior-approved by the SDOH and/or LDSS, that describes the Marketing activities the Contractor will undertake within the local district during the term of this Agreement. The Marketing Plan and all marketing activities must be consistent with the Marketing Guidelines which are set forth in Appendix D, which is hereby made a part of this Agreement as if set forth fully herein. The Marketing Plan shall be kept on file in the offices of the Contractor, LDSS, and the SDOH. The Marketing Plan may be modified by the Contractor subject to prior written approval by the SDOH and/or the LDSS. The LDSS or SDOH must take action on the changes submitted within sixty (60) calendar days of submission or the Contractor may deem the changes approved.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Development Program A. Development Activities to be Undertaken (Please break activities into subunits with the date of completion of major milestones)

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