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.
Licensed Technology The term "Licensed Technology" shall mean the ------------------- Licensed Patents, plus all improvements thereto developed by Licensor, and all related data, know-how and technology.
Background Technology List here prior contracts to assign Inventions that are now in existence between any other person or entity and you. [ ] List here previous Inventions which you desire to have specifically excluded from the operation of this Agreement. Continue on reverse side if necessary.
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:
Intellectual Property, Inventions and Patents Executive acknowledges that all discoveries, concepts, ideas, inventions, innovations, improvements, developments, methods, designs, analyses, drawings, reports, patent applications, copyrightable work and mask work (whether or not including any confidential information) and all registrations or applications related thereto, all other proprietary information and all similar or related information (whether or not patentable) which relate to Parent’s or any of its Subsidiaries’ actual or anticipated business, research and development or existing or future products or services and which are conceived, developed or made by Executive (whether alone or jointly with others) while employed by the Company and its Subsidiaries, whether before or after the date of this Agreement (“Work Product”), belong to Parent, the Company or such Subsidiary. Executive shall promptly disclose such Work Product to the Board and, at the Company’s expense, perform all actions reasonably requested by the Board (whether during or after the Employment Period) to establish and confirm such ownership (including, without limitation, assignments, consents, powers of attorney and other instruments).
Patent Rights The term “
Technology For purposes of this Agreement, “Technology” means all Software, information, designs, formulae, algorithms, procedures, methods, techniques, ideas, know-how, research and development, technical data, programs, subroutines, tools, materials, specifications, processes, inventions (whether or not patentable and whether or not reduced to practice), apparatus, creations, improvements and other similar materials, and all recordings, graphs, drawings, reports, analyses, and other writings, and other embodiments of any of the foregoing, in any form or media whether or not specifically listed herein. Further, for purposes of this Agreement, “Software” means any and all computer programs, whether in source code or object code; databases and compilations, whether machine readable or otherwise; descriptions, flow-charts and other work product used to design, plan, organize and develop any of the foregoing; and all documentation, including user manuals and other training documentation, related to any of the foregoing.
Patents and Patent Applications To the Company’s knowledge, all patents and patent applications owned by or licensed to the Company or under which the Company has rights have been duly and properly filed and maintained; to the knowledge of the Company, the parties prosecuting such applications have complied with their duty of candor and disclosure to the USPTO in connection with such applications; and the Company is not aware of any facts required to be disclosed to the USPTO that were not disclosed to the USPTO and which could reasonably be expected to preclude the grant of a patent in connection with any such application or could reasonably be expected to form the basis of a finding of invalidity with respect to any patents that have issued with respect to such applications.
Licensed Patents Immune Design, at its expense, shall have the first right to file, prosecute and maintain all Licensed Patents for which Immune Design has any exclusive rights under this Agreement using patent counsel reasonably approved by IDRI, including conducting any interferences, reexaminations, reissues, oppositions, or request for patent term extension relating thereto. Immune Design shall conduct such filing, prosecution and maintenance in good faith, taking into consideration IDRI’s retained rights hereunder, and consistent with reasonable business judgment, provide IDRI with all relevant or material documentation and proposed filing in the Territory so that IDRI may be concurrently and promptly informed of the continuing prosecution, and consult with IDRI with regards to Immune Design’s patent strategy with the Licensed Patents for which Immune Design has any exclusive rights under this Agreement. Licensed Patents in the name of IDRI shall remain in the name of IDRI. Immune Design shall use commercially reasonable efforts to ***, as applicable. To the extent such ***, Immune Design shall provide IDRI reasonable opportunity to review and comment on such prosecution efforts regarding such Licensed Patents in the Territory, and any IDRI comments will be reasonably considered in such prosecution efforts, and included to the extent affecting the IDRI Exclusive Field or IDRI Territory, as the case may be. If Immune Design determines in its sole discretion to abandon or not maintain any Licensed Patent for which Immune Design has any exclusive rights under this Agreement in the Territory, then Immune Design shall promptly provide IDRI with written notice of such determination at least sixty (60) days before any deadline for taking action to avoid abandonment and shall provide IDRI with the right, opportunity and reasonable assistance to prepare, file, prosecute and maintain such Licensed Patent in the applicable jurisdiction in IDRI’s sole discretion and at IDRI’s expense, provided that Immune Design shall provide such reasonable assistance at its *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. own costs and expenses. If IDRI elects to prepare, file, prosecute and maintain such Licensed Patent in such jurisdiction for which Immune Design has any exclusive rights, then Immune Design’s license rights to such Licensed Patent in such country will become nonexclusive in such country under such Licensed Patent (and/or patent application). If IDRI desires Immune Design to file, in a particular jurisdiction, a Licensed Patent for which Immune Design has any exclusive rights under this Agreement that claims priority to another Licensed Patent for which Immune Design has any exclusive rights under this Agreement, IDRI shall provide written notice to Immune Design requesting that Immune Design file such patent application in such jurisdiction. If IDRI provides such written notice to Immune Design, Immune Design shall either (i) file and prosecute such patent application and maintain any patent issuing thereon in such jurisdiction and the Parties shall share the related costs and expenses (A) in countries *** on the basis of *** percent (***%) Immune Design: *** percent (***%) IDRI or (B) in countries within the IDRI Territory equally; or (ii) notify IDRI that Immune Design does not desire to file such patent application in such jurisdiction and provide IDRI with the opportunity to file and prosecute such patent application, provided that if IDRI files and prosecutes such patent application in such jurisdiction, then Immune Design’s license rights to such License Patent in such country will become nonexclusive in such country under such Licensed GLA Patent (and/or patent application). Immune Design shall be responsible for the costs and expenses incurred in connection with its own activities for filing, prosecuting and maintaining the Licensed Patents; IDRI shall be responsible for monitoring of such activities by IDRI.
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.
