DUE DILIGENCE IN COMMERCIALIZATION Sample Clauses

DUE DILIGENCE IN COMMERCIALIZATION. Licensee shall use commercially reasonable efforts to bring Licensed Products to market through a diligent program for the development, regulatory approval, and commercialization of Licensed Products to generate Net Sales Revenue during the term of this Agreement. Licensee shall be responsible for all reasonable expenses which may be incurred in connection with regulatory filings and clinical trials in support of market approval for the Licensed Products. Licensee shall provide Licensor with a progress report on [***] basis, beginning on the [***] anniversary of the Effective Date, setting forth Licensee’s development, regulatory, clinical, and commercialization efforts regarding the Licensed Products under this Agreement.
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DUE DILIGENCE IN COMMERCIALIZATION. 8.1 LICENSEE shall plan and implement appropriate research and development, testing and production efforts directed toward commercialization of the LICENSED PRODUCTS at the earliest practicable date consistent with sound scientific and business judgment, and shall provide to YALE a copy of such plan. Such a plan will include provisions for testing and evaluations of activity of the INVENTIONS listed in Exhibit B against a) tumors characterized as multi-drug resistant, b) tumors characterized as metastatic, and c) other tumor types. Such a plan will include provision for testing and evaluation of activity of the INVENTIONS listed in Exhibit C in at least one animal model of human disease. 8.2 LICENSEE shall implement as soon as practicable following the date of this Agreement the plan for developing and commercializing the LICENSED PRODUCTS, including tests and evaluations contained in the plan described in 8.1. YALE shall be entitled to terminate this Agreement in accordance with Article XI if LICENSEE shall fail A) to implement the plan or to conduct tests and trials involving the INVENTIONS as part of a bona fide intention to develop and market products within five years in regard to any or all INVENTIONS listed in Exhibit B, and two years in regard to any or all INVENTIONS listed in Exhibit C, following the date of this Agreement, and B) to have expended at least $250,000 in the aggregate in research and development directed to the development of products in the fields of the INVENTIONS, less legal costs and funds supplied for research to YALE faculty, and such failure is not excused by (i) causes beyond LICENSEE's direct control; (ii) YALE's failure to meet its obligations hereunder; (iii) infringement of third party patents or proprietary rights; or (iv) actions or inaction of any federal or state agency whose approval is required for commercial sales. 8.3 LICENSEE shall provide periodic status reports to YALE, at least annually, indicating progress and problems to date in commercialization, and a forecast and schedule of major events required to market the LICENSED PRODUCTS. 8.4 If at any time LICENSEE abandons or suspends its marketing or its intent to market the LICENSED PRODUCTS for a period exceeding ninety (90) days, LICENSEE shall immediately notify YALE giving reasons and a statement of its intended actions.
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DUE DILIGENCE IN COMMERCIALIZATION. LICENSEE shall conduct research, development, manufacturing or sublicense programs, as appropriate, directed toward expeditious commercialization of technology based on the Invention, and make annual reports to YALE of progress in these programs. If in YALE's reasonable judgment taking into account the normal course of such programs conducted with sound and reasonable business practices, LICENSEE has failed to conduct such programs for any period of six months after the Effective Date, YALE may request a plan from LICENSEE indicating its schedule for reinstituting such a program. If LICENSEE fails to provide a satisfactory plan to YALE within thirty (30) days, YALE shall have the right to terminate this Agreement. YALE shall have the right to terminate this Agreement after six (6) years from the Effective Date if LICENSEE has not filed an IND for a product with the FDA, either directly or through a sublicensee.
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DUE DILIGENCE IN COMMERCIALIZATION. LICENSEE shall conduct research, development, manufacturing or sublicense programs, as appropriate, directed toward expeditious commercialization of technology based on the Invention, and make annual reports to YALE of progress in these programs, which reports to be held in confidence by YALE. If in YALE's reasonable judgment taking into account the normal course of such programs conducted with sound and reasonable business practices, LICENSEE has failed to conduct such programs for any period of six months after the Effective Date, YALE may request a plan from LICENSEE indicating its schedule for reinstituting such a program. If LICENSEE fails to provide a satisfactory plan to YALE within thirty (30) days, YALE shall have the right to terminate this Agreement.
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DUE DILIGENCE IN COMMERCIALIZATION. 8.01 LICENSEE shall plan and implement appropriate research and development, testing and production efforts directed toward commercialization of the LICENSED * CONFIDENTIAL TREATMENT REQUESTED PRODUCTS in the FIELD OF USE at a commercially practicable date and shall provide to YALE a copy of such plan. 8.02 LICENSEE shall implement in reasonable commercial fashion following the date of this agreement the plan for developing and commercializing the LICENSED PRODUCTS in the FIELD OF USE. YALE shall be entitled to terminate this Agreement in accordance with Article XI in the event that either: a) YALE gives written notice to LICENSEE that it intends to elect to terminate the license because of LICENSEE'S failure to implement the plan in any material respect and LICENSEE, after such written notice from YALE as provided in Section 11.01, fails to provide written evidence to YALE of present, attempted or anticipated commercialization in a manner and on a schedule reasonably commensurate with the scope of the country or countries in question and LICENSEE's resources. YALE agrees that: evidence provided by LICENSEE that it has an ongoing and active or anticipated research, development, manufacturing, marketing or licensing program as appropriate, directed toward production and sale of a LICENSED PRODUCT shall be deemed satisfactory evidence; in the discretion of LICENSEE commercialization efforts may be directed first to industrialized nations of the world commencing with the United States of America, and only subsequently to other regions as reasonably and commercially practicable for LICENSEE given its strategies and resources; certain countries may, in the discretion of LICENSEE, best be commercialized by sublicense; and that LICENSEE may in the exercise of prudent business judgment elect to defer commercialization efforts in particular fields until the LICENSED PRODUCT has undergone substantial and appropriate further development; or b) LICENSEE shall fail to make the first commercial sale within two years from the receipt of approval from the United States Food and Drug Administration ("FDA") for a LICENSED PRODUCT, if such approval is required for the LICENSED PRODUCT, or within one year from the completion of the LICENSED PRODUCT if FDA approval is not required for the LICENSED PRODUCT, and such failure is not excused by (i) causes beyond LICENSEE's direct control; (ii) YALE's failure to meet its obligations hereunder; (iii) infringement of third party pate...
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DUE DILIGENCE IN COMMERCIALIZATION 
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Related to DUE DILIGENCE IN COMMERCIALIZATION

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Development Diligence Pfizer will use its Commercially Reasonable Efforts to Develop and seek Regulatory Approval for [ * ] Product [ * ] in the Field [ * ]. Pfizer will [ * ] with respect to the Development or Regulatory Approval of Products under this Agreement.

  • 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).

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Commercialization Efforts The RECIPIENT shall, including whether through its own efforts or the efforts of a licensee under a License Agreement allowed by the terms of this Attachment, use diligent and commercially reasonable efforts to commercialize at least one Commercial Product or Commercial Service or otherwise bring to practical application the Project Results in accordance with the commercial development plan submitted with the Application and including any changes to such commercial development plan in accordance with Section D3.01. For the avoidance of doubt, partnering or licensing activities shall be considered to be efforts to commercialize.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Research Program The term “Research Program” shall mean the research program to be undertaken by TSRI under the direction and control of the Principal Investigator as expressly set forth on Exhibit A hereto.

  • Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.

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