Joint Medical Affairs Plan Sample Clauses

Joint Medical Affairs Plan. As further described in this Section 5.2, the Medical Affairs Activities in support of each Product in the Shared Territory shall be described in a comprehensive plan (each such plan, a “Joint Medical Affairs Plan”) that describes the pre-launch activities, launch activities and subsequent Medical Affairs Activities for such Product in the Shared Territory (including without limitation anticipated Voluntary Phase 4 Clinical Trials, scientific presentations and publications, and medical education), key tactics and strategies for implementing those activities, the relative responsibilities of the Parties and the associated budget for such activities (each such included budget, a “Joint Medical Affairs Budget”). The Parties shall agree upon the initial Joint Medical Affairs Plan (including the corresponding Joint Medical Affairs Budget), which shall be approved by the JMAC, no later than [*] after the Effective Date. All Joint Medical Affairs Plans, including corresponding Joint Medical Affairs Budgets, with respect to a Product in the Shared Territory and subsequent revisions thereto will contain such information as the JMAC believes necessary for the successful medical affairs support of such Product in the Shared Territory, both pre- and post-launch, and shall generally conform to the level of detail utilized by Astellas in preparation of its own plans for product Medical Affairs Activities. On an annual basis (no later than [*] of the preceding calendar year), or more often as the Parties deem appropriate, the JMAC shall prepare amendments to the then-current Joint Medical Affairs Plan(s), including the corresponding Joint Medical Affairs Budget(s). In the event of any inconsistency between a Joint Medical Affairs Plan and this Agreement, the terms of this Agreement shall prevail.
Sample 1Sample 2
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Joint Medical Affairs Plan. The Parties, through JSC, shall collaborate with respect to the Medical Affairs Activities in support of the Products in the Field in the Territory. The JSC will review and discuss a joint medical affairs plan and its amendments (“Joint Medical Affairs Plan”) under which the Parties shall decide (a) whether and when to initiate or discontinue any joint voluntary Phase 4 studies for the Products and, if applicable, the sharing of costs relating thereto, and (b) review, discuss, and coordinate the Parties’ scientific presentation and publication strategy relating to the Products in the Field in the Territory. The JSC shall approve those portions of the Joint Medical Affairs Plan which relate to global activities, but shall only review, and shall not approve, those portions of the Joint Medical Affairs Plan which relate only to activities specifically for the Licensed Territory or the Retained Territory.
Sample 1
Joint Medical Affairs Plan. All Medical Affairs Activities and objectives in support of Licensed Products in the Territory shall be described in a comprehensive plan (such plan, a “Joint Medical Affairs Plan”) that describes for [***], the pre-launch activities, launch activities, and subsequent Medical Affairs Activities for such Licensed Product in the Territory, including [***]. The budget set forth in the Joint Medical Affairs Plan shall be allocated between (i) the Joint Operational Costs for the portion of the Medical Affairs Activities in support of Commercialization of Licensed Products in the Shared Territory, (ii) the Joint Development Costs or Joint Early Program Development Costs, as applicable, for the portion of Medical Affairs Activities in support of Development of Licensed Products in the Territory, subject to any overages permitted pursuant to Section 3.6, as applicable, and (iii) the budget within the Roche Operational Plan for the portion of Medical Affairs Activities in support of Commercialization in the Roche Territory, subject to any overages permitted pursuant to Section 5.7(b). The JMAC shall discuss and coordinate with the JCC and JDC the allocation of the budget set forth in the Joint Medical Affairs Plan. The JMAC shall prepare and approve the initial Joint Medical Affairs Plan. The Joint Medical Affairs Plan with respect to a Licensed Product and subsequent revisions thereto shall contain such information as the JMAC believes necessary for the successful medical affairs support of such Licensed Product, both pre- and post-launch. On an annual Calendar Year basis, or more often as the Parties deem appropriate, the JMAC shall prepare and approve the Joint Medical Affairs Plan and any amendments thereto in consultation with the JDC and JCC with respect to the associated budgets for the Joint Operational Costs, Joint Development Costs and Joint Early Program Development Costs. In the event of any inconsistency between a Joint Medical Affairs Plan and this Agreement, the terms of this Agreement shall prevail.
Sample 1
Joint Medical Affairs Plan. All Medical Affairs Activities and objectives in support of Licensed Products in the Shared Territory shall be described in a comprehensive plan (such plan, a “Joint Medical Affairs Plan”) that describes for [**], the pre-launch activities, launch activities, and subsequent Medical Affairs Activities for such Licensed Product in the Shared Territory, including evidence generation strategy, expanded access/compassionate use, investigator-initiated studies, real world evidence, health economics and outcomes research, publication planning, advisory board planning, managed care communications, medical information, and key tactics and strategies for implementing those activities, the relative responsibilities of the Parties, and the associated budget for such activities [**]. The JMAC shall prepare and submit to the JSC for approval of the initial Joint Medical Affairs Plan and the Joint Medical Affairs Budget. The Joint Medical Affairs Plan with respect to a Licensed Product and subsequent revisions thereto shall contain such information as the JMAC believes necessary for the successful medical affairs support of such Licensed Product, both pre- and post-launch. On an annual Calendar Year basis, or more often as the Parties deem appropriate, the JMAC shall prepare and approve the Joint Medical Affairs Plan (including the associated Joint Medical Affairs Budget) and any amendments thereto. In the event of any inconsistency between a Joint Medical Affairs Plan and this Agreement, the terms of this Agreement shall prevail.
Sample 1
Joint Medical Affairs Plan. An annual joint medical plan for each Product in the Field for the Co-Promotion Territory (each, “Joint Medical Affairs Plan”) shall be prepared by and approved by the applicable JMDRC, and shall constitute a part of the applicable Joint Medical Affairs and Development Plan and Budget. The initial version of the Joint Medical Affairs Plan for the WH Product in the WH Field and the initial version of the Joint Medical Affairs Plan for the Oncology Product in the Oncology Field are set out in [***]. In coordination with the branding for the Products in the Field in the Co-Promotion Territory, each Joint Medical Affairs Plan shall include:
Sample 1

Related to Joint Medical Affairs 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:

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

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

  • Collaboration Management Promptly after the Effective Date, each Party will appoint a person who will oversee day-to-day contact between the Parties for all matters related to the management of the Collaboration Activities in between meetings of the JSC and will have such other responsibilities as the Parties may agree in writing after the Effective Date. One person will be designated by Merck (the “Merck Program Director”) and one person will be designated by Moderna (the “Moderna Program Director,”) together will be the “Program Directors”. Each Party may replace its Program Director at any time by notice in writing to the other Party. Any Program Director may designate a substitute to temporarily perform the functions of that Program Director by written notice to the other Party. The initial Program Directors will be: For Moderna: [***] For Merck: [***]

  • 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.

  • Joint Development Committee The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • 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).

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