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. 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. 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 a written plan and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. 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, upon BNS’ approval, which shall not be unreasonably denied, conditioned or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 6 months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNS, via BNS’ Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to BNS via BNS’ Representatives with periodic written reports (“Development Reports”) not less than once per every 6 months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS informed via BNS’ Representatives 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 BNS’ reasonable request, from time to time, provide BNS with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include a summary of the Development Results and any other related work performed by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the 6 month period prior to the report. Development Reports shall also set forth a general assessment regarding the achievement of ...
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. 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. 8.1. Within 18 (eighteen) months 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”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, to take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein.
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 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 12 (twelve) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the rea...
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.
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercial reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in the PCB Field 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, inter alia, to achieve the commercialization goals set forth above, upon Yissum’s prior written approval (not to be unreasonable withheld), but without derogating from the dates of the achievement of the milestones set forth in this Section 5. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and PCB Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercial reasonable efforts to meet all of the milestones set forth in Appendix B attached hereto (the “PCB Development Milestones”).
5.2. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum 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 PCB Development Results and other Development Results, as relevant, and any other related work effected by the Company or by any Affiliate or Sub-Licensee during the six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing and commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – co...
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. 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.
