Development and Commercialization Clause Samples
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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 and Commercialization. Licensee shall have the sole right and obligation to develop and commercialize the Licensed Product in the Territory. NovaDel shall perform or cause to be performed, on behalf of Licensee, certain Development Activities in accordance with this Article 3. Except as set forth herein, Licensee shall be solely responsible for all costs and expenses in connection with all development and commercialization activities, including the Development Activities performed by NovaDel on behalf of Licensee.
Development and Commercialization. 8.01. CORPORATION undertakes to use continuous reasonable diligence to make and sell Licensed Products, including but not limited to, the performance of all efficacy, pharmaceutical, safety, toxicological and clinical tests, trials and studies and all other activities necessary in order to obtain the approval of the FDA for the production, use and sale of the Licensed Products, all as set forth in the Development Plan (annexed hereto as Appendix III and which is an integral part of this Agreement) and within all timetables set forth therein. CORPORATION further undertakes to exercise due diligence and to employ its reasonable diligence to obtain, the appropriate approvals of the health authorities for the production, use and sale of the Licensed Products, in each of the other countries of the world in which CORPORATION intend to produce, use, and/or sell Licensed Products.
8.02. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION shall carry out such tests, trials, studies and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products shall be produced in accordance with FDA Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified by the FDA as complying with GMP, provided that applicable laws, rules and regulations so require.
8.03. CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed Products in good faith in accordance with the Development Plan and to continue diligently thereafter to commercialize the Licensed Products.
8.04. CORPORATION shall provide NYU with written annual reports on all activities and actions undertaken by CORPORATION to develop and commercialize the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for the duration of this Agreement.
8.05. If CORPORATION shall not commercialize the Licensed Products within a reasonable time frame, unless such delay is necessitated by FDA or other regulatory agencies or unless NYU and CORPORATION have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU shall notify CORPORATION in writing of CORPO...
Development and Commercialization. Licensee shall use Diligent Efforts (and shall cause any sublicensees or subcontractors participating in the subject matter of this Agreement to use Diligent Efforts) to develop and introduce Licensed Product to commercial market and to market Licensed Product thereafter.
Development and Commercialization. 8.1. Within 1 (one) year of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM").
8.2. The Company undertakes, at its own expense, to use best efforts to commercialise the Products and, without derogating from the generality of the aforegoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical trials), tests and other works and activities, all as detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS") which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 (six) months; (iii) the Company's plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 6 (six) months; and (iv) projections of sales and marketing efforts. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.
8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agree...
Development and Commercialization. Pieris shall be solely responsible for development and commercialization of all Products under this Agreement, and shall have no obligation to consult with Enumeral regarding such development or commercialization activities.
Development and Commercialization. MERCK shall use reasonable efforts, consistent with the usual practice followed by MERCK in pursuing the commercialization and marketing of its other similar pharmaceutical products, at its own expense, to develop and commercialize a Product on a commercially reasonable basis in such countries in the Territory where in MERCK's opinion it is commercially viable to do so.
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plans, a copy of which is attached to this Agreement as Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans (the “Development Milestones”) shall be subject to Yissum’s prior written approval, not to be unreasonably conditioned, withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials con...
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plan approved by Yissum, a copy of which is attached to this Agreement as Appendix B. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above. In case of a need to modify dates of the achievement of the development milestones set forth in the Development Plan (the “Development Milestones”) a prior notice regarding the modification will be sent to Yissum by the Company. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.2. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per twelve (12) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Y▇▇▇▇▇ informed on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the twelve (12) month’ period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the twelve (12) month’ period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following twelve (12) months .
5.3. The Company, subject to its sole discretion, shall pursue the development and registration of all commercially reasonable indications or uses of the Licensed Technology in the Field.
5.4. If the Company shall not meet the Development Milestones or shall not commercialize the Products within a reasonable time frame, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accord...
Development and Commercialization. As between the Parties, Licensee will be solely responsible for the Development and Commercialization of POZEN Products in the Territory during the Term.