Commercialization Plan Sample Clauses
A Commercialization Plan clause outlines the strategy and steps that parties will follow to bring a product, service, or intellectual property to market. It typically details responsibilities, timelines, milestones, and resource commitments required for successful commercialization, and may specify performance metrics or reporting obligations. This clause ensures that all parties are aligned on the process and expectations for turning an innovation or asset into a marketable offering, thereby reducing misunderstandings and increasing the likelihood of commercial success.
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Commercialization Plan. (i) The initial plan for the Commercialization of the Product in the Field in the Partner Territory is attached to this Agreement as Exhibit 5.1 (the “Initial Commercialization Plan”), and includes in reasonable detail: the number of sales representatives to be deployed, an account/physician target-specific detail and coverage plan (including, “call points”), the dollar amount and allocation of planned promotional and marketing expenses, the projected dates for the First Commercial Sale of the Product in the Partner Territory, as well as an outline regarding the price and brand positioning of the Product, which shall be consistent with the minimum commercial diligences set forth in Section 5.2(b). The Initial Commercialization Plan can be adjusted by the JSC.
(ii) Partner shall prepare for the JSC’s review updates of the Commercialization Plan on an ongoing basis, and in any event, the JSC shall review the then-current Commercialization Plan in the sixth (6th) and twelfth (12th) month of each calendar year.
(iii) Partner shall carry out and manage, and shall cause its Affiliates and Sublicensees to carry out and manage, the Commercialization of the Product in the Partner Territory in material accordance with the then-current Commercialization Plan and the provisions of this Agreement.
(iv) If, after taking into account all potential opportunities with respect to the Product in a comprehensive analysis of the relevant clinical science, clinical need, published data and commercial considerations, the JSC determines that Partner should develop and present to Bioprojet a go-to-market Commercialization plan for the OSA Target Indication (the “OSA Proposal”), then Partner shall do so within ninety (90) days of such determination. The OSA Proposal shall take into account the Parties’ mutual agreement that the Product’s optimal brand positioning and pricing strategy in the Partner Territory are the Narcolepsy with Cataplexy and EDS Target Indications and include, among other things, (i) analysis of potential regulatory options for the Product in the Partner Territory for the Narcolepsy with Cataplexy, EDT and OSA Target Indications, including an assessment of the viability of different brand names, and simultaneous Commercialization of the same compound, for such three (3) Target Indications, (ii) commercial payor/pricing analysis for potential managed care contracting strategies for the OSA Target Indication and (iii) a full medical affairs development program to...
Commercialization Plan. (a) Not later than three [***] after submission of Regulatory Filings for each Product in each country of the Territory, Licensee will provide to the JCC for review its initial Commercialization Plan for each Product for each country in the Territory. Such initial Commercialization Plan will describe Licensee’s plans for activities to be conducted for such Product for such country. Each Commercialization Plan shall include the details of obligations to be performed by Licensee to achieve the specific activities that are applicable to the stage of [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Commercialization (e.g., pre-launch, launch planning, launch, or post-launch) of the applicable Product during the time period covered by such Commercialization Plan and subsequent time periods.
(b) Prior to the First Commercial Sale for such Product in such country, Licensee will provide to the JCC for review an updated Commercialization Plan for such Product for such country. Such updated Commercialization Plan will include, but not be limited to, Licensee’s updated plans for activities to be conducted for such Product for such country prior to launch as well as activities to be conducted in connection with such launch.
(c) Promptly after each anniversary of the First Commercial Sale of such Product during the Term, Licensee will provide to the JCC for review updated Commercialization Plans for such Product for such country. Such further updated Commercialization Plan will include, but not be limited to, Licensee’s plans for Commercialization activities for such Product and such country for the twelve (12) month period following the date of delivery of such Commercialization Plan. No Commercialization Plan may be implemented by Licensee if [***]. Each Commercialization Plan shall be consistent with and shall not contradict the terms of this Agreement [***], and in the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail. Notwithstanding the foregoing, if a [***], Licensee shall [***] and shall promptly [***].
Commercialization Plan. Licensee is a start-up venture having the strategic commitment to commercialize the Licensed Products and/or Licensed Processes in the Field of Use in the Territory, as appropriate, and Licensee has provided to the University a copy of its most recent Commercialization Plan;
Commercialization Plan. The Commercialization Plan shall contain in reasonable detail the significant Commercialization activities and the projected timelines for achieving such activities, including [***] in the Territories. Zai shall deliver an initial Commercialization Plan to the JSC for review and discussion no later than [***] of the first Regulatory Approval Application for a Product in the Territory. Thereafter, from time to time, but at least once every [***] months, Zai shall propose updates or amendments to the Commercialization Plan to reflect changes in such plans, including those in response to changes in the marketplace, relative success of the Products, and other relevant factors influencing such plan and activities, and submit such proposed updated or amended Commercialization Plan to the JSC. In preparing the initial Commercialization Plan and any updates or amendments thereto, Zai shall provide TPTX with an opportunity to comment and Zai shall consider any TPTX’s comments in good faith in finalizing the initial Commercialization Plan and any updates or amendments thereto.
Commercialization Plan. Abbott shall use Commercially Reasonable Efforts to make the Diagnostic Test commercially available in each country in which Regulatory Approval is obtained pursuant to the Regulatory Plan and, with Epizyme’s cooperation as appropriate and agreed by Epizyme in Epizyme’s reasonable discretion, shall commercialize the Diagnostic Test pursuant to the provisions of a joint commercialization plan (the “Commercialization Plan”), which shall include the following:
(a) the activities to be performed by each Party (and, in the case of Epizyme, if Epizyme has licensed to or is otherwise collaborating with a Third Party with respect to the development or commercialization of the Epizyme Product in any country or territory, the activities to be performed by such Third Party) and the deliverables related thereto;
(b) the timelines for each activity under the Commercialization Plan;
(c) the overarching commercialization strategy and commercial goals for the Diagnostic Test, including the availability and distribution of the Diagnostic Test in each country for which Regulatory Approval is sought pursuant to the Regulatory Plan;
(d) customer service;
(e) responsibilities for and restrictions on public relations activity/Direct-To-Consumer and other promotional advertising activity;
(f) coordination of the pre-launch/launch and post launch of Abbott/Epizyme (and Third Party, if applicable) sales teams and scientific teams;
(g) forecasting and measurement of sales and distribution data, including reporting of sales units of the Diagnostic Test to Epizyme and the Epizyme Product to Abbott;
(h) the establishment of “launch success factors” for each market. Such launch success factors shall be agreed upon by the Parties prior to any launch;
(i) activities to be performed post-launch to ensure ongoing alignment of the Diagnostic Test Intended Use and Epizyme Product Indication, including fulfilling any commitment(s) imposed by Regulatory Authorities;
(j) plans for manufacturing and supplying the Diagnostic Test; and
(k) plans for maintaining acceptable levels of regulatory and GMP/GLP compliance during development, manufacture and marketing of the Diagnostic Test. (as amended from time to time, the “Commercialization Plan”). The initial Commercialization Plan is attached hereto as Exhibit D. The Parties acknowledge that the initial Commercialization Plan does not address all of the items set forth above, but the Parties agree that, as soon as practicable following the Effective...
Commercialization Plan. Prior to signing this AGREEMENT, LICENSEE has provided to UNIVERSITY a written plan (hereinafter “COMMERCIALIZATION PLAN”) for the LICENSED PRODUCT within the respective LICENSED FIELD and within the LICENSED TERRITORY to be introduced by LICENSEE into commercial use. The COMMERCIALIZATION PLAN shall include, without limitation: (a) planned research and development activities and (b) milestones and evidence of sufficient financial resources to successfully implement the COMMERCIALIZATION PLAN and ensure that LICENSED PRODUCT will be kept reasonably available to the public. Such COMMERCIALIZATION PLAN is incorporated as Appendix B.
Commercialization Plan. Commercialization of Licensed Product under this Agreement shall be governed by a written Commercialization Plan that describes the anticipated commercialization activities (including promotional, marketing and sales activities) to be performed with respect to Licensed Product in the Territory by Licensee, its Affiliates, or it permitted Sublicensees, as well as projected timelines and annual budgets for such activities (the “Commercialization Plan”). The initial Commercialization Plan shall be drafted by Licensee no later than ***. On an annual basis thereafter (no later than *** of each Calendar Year), or more often as the Parties deem appropriate, the Licensee shall update and amend, as appropriate, the then-current Commercialization Plan. Such updates and amendments shall reflect any changes, re-prioritization of, or additions to the anticipated commercialization activities. Once provided to the JSC, each updated or amended Commercialization Plan shall become effective and supersede the previous Commercialization Plan as of the date of such provision or at such other time as decided by the JSC. In the event of any inconsistency between the Commercialization Plan and this Agreement, the terms of this Agreement shall prevail.
Commercialization Plan. Partner shall be responsible for the creation and implementation of an annual plan and budget for the commercialization of Products in the Field in the Territory, which will include any Post Marketing Studies (as defined below) of Products in the Field in the Territory (the “Commercialization Plan”), which Commercialization Plan shall include, without limitation, identification of, and proposed plans to address, potential challenges with respect to commercialization of Products in the Field in the Territory. Partner shall prepare and submit to Optimer the initial Commercialization Plan no later than […***…] after the first submission of a MAA for Product in the Territory for review and discussion through the JSC. Subsequent updated Commercialization Plans shall be submitted by Partner to Optimer on an annual basis on or before the end of February each Calendar Year for review and discussion through the JSC. Through the JSC, Partner shall regularly consult with and provide updates to Optimer regarding the commercialization strategy and the commercialization of Products in the Field in the Territory. Partner shall consider in good faith Optimer’s input regarding such commercialization strategy and the Commercialization Plan; provided, however, that Partner shall have final decision-making authority with respect to commercialization of Products in the Field in the Territory, including the right to set the terms of sales and book all sales of Products in the Field in the Territory, subject to Section 5.1(c) below. Partner shall provide Optimer with access to KOLs as may reasonably be requested by Optimer, where “KOLs” means all healthcare providers in the Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Partner, its Affiliates and Sublicensees, as the case may be, as a key opinion leader for a Product in the Territory. Optimer shall provide Partner with access to KOLs as may reasonably be requested by Partner, where “KOLs” means all healthcare providers outside the Territory and ▇▇▇▇ Territory that have administered a Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by Optimer, its Affiliates and Sublicensees, as the case may be, as a key opinion leader for a Product outside the Territory and ▇▇▇▇ Territory.
Commercialization Plan. As soon as the information is available, but not later than [*] prior to the anticipated date of Commercialization for a Licensed Product, Celgene will prepare and provide to the JRC (for review but not approval) a summary of a plan that is a continuation of the Development Plan for such Licensed Product that summarizes the Commercialization activities for such Licensed Product (each, a “Commercialization Plan”). The Commercialization Plan shall include summary information related to marketing plans, publication planning, and launch plans and such other details agreed to by the Parties. Celgene will provide the JRC with annual updates and revisions to each Commercialization Plan and related budgets for the JRC’s review but not approval.
Commercialization Plan. The Parties shall annually update their part of the Commercialization Plan for the following Calendar Year before a mutually agreeable date prior to December 31 in the preceding year. The JCC shall consider and discuss the revised plans, and ARIAD SWISSCO shall consider in good faith the input of ARIAD US on the ARIAD SWISSCO part of the Commercialization Plan for the Territory. ARIAD SWISSCO shall use Commercially Reasonable Efforts to implement its part of the then current Commercialization Plan.