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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 3 contracts
Samples: License Agreement (Bionano Genomics, Inc.), License Agreement (BioNano Genomics, Inc), License Agreement (BioNano Genomics, Inc)
Development and Commercialization. 8.01. CORPORATION undertakes EOS shall use its commercially reasonable efforts and diligence in developing and commercializing Product(s) related 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 AgreementExclusive Antigen(s) 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 its business, legal, medical and scientific judgment, and in a manner acceptable undertaking investigations and actions required to obtain appropriate Regulatory Approval(s) necessary to market such Products that EOS determines in its sole discretion to pursue in the relevant health authoritiesTerritory, CORPORATION shall carry out such tests, trials, studies reasonable efforts and other activities in accordance with FDA Good Laboratory Practices and in a manner acceptable diligence 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 efforts and resources EOS would use for product(s) owned by it or to continue diligently which it has rights, which is of similar market potential at a similar stage in development as the Products directed towards the applicable Exclusive Antigen taking into account the competitiveness of the marketplace, the proprietary position of the Product(s) that EOS determines in its sole discretion to pursue, the relative potential safety and efficacy of such Product(s), the regulatory requirements involved in such Products' development, commercialization and Regulatory Approval, the Cost of Goods and availability of capacity to ---------- [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. manufacture and supply such Product(s) at commercial scale, the profitability of such Product(s), and other relevant factors including technical, legal, scientific or medical factors. As to between the Parties, EOS shall be solely responsible for funding all costs of the development and commercialization of each Product EOS determines in its sole discretion to pursue. EOS shall keep SGI informed in a timely manner as to the progress of the development of Products EOS determines, from time to time, to pursue. Beginning on January 1, 2002 and thereafter to commercialize within thirty (30) days following the Licensed Products.
8.04. CORPORATION end of each calendar year, EOS shall provide NYU SGI with a written annual reports report summarizing EOS's activities related to research and development of Products and status of clinical trials and government approvals necessary for marketing Products. Beginning on all activities January 1, 2002 and actions undertaken by CORPORATION to develop and commercialize the Licensed Products; such reports shall be made thereafter within sixty thirty (6030) days after following the end of each June 30th for the duration of this Agreementcalendar year, SGI shall provide EOS with a written report summarizing SGI's activities related to preparing ADCs and developing new Drug Conjugation Technology.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 2 contracts
Samples: Collaboration Agreement (Pharmacopeia Inc), Collaboration Agreement (Pharmacopeia Inc)
Development and Commercialization. 8.01(a) It shall be within the judgment of CORPORATION in what manner to proceed with the development of Licensed Products for commercialization; provided that CORPORATION shall use efforts, consistent with its sound and reasonable business practices and technical judgment, to effect introduction of Licensed Products into the commercial market. CORPORATION undertakes shall be deemed to use continuous reasonable satisfy the due diligence to make and sell Licensed Products, including but not limited to, the performance requirements 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 this Section 10(a) by: *** *** *** *** *** *** *** *** *** *** *** *** . Corporation's Development Plan (is 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 ProductsIII.
8.02. (b) Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 required by subsection (a) above shall be carried out in accordance with FDA current Good Laboratory Practices, current Good Manufacturing Practices and current Good Clinical 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 such Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products shall be produced in accordance with FDA current Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified licensed by the FDA as complying with GMPto manufacture such Licensed Products, provided that applicable laws, rules and regulations so require.
8.03. (c) CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Products in good faith each counted in accordance with the Development Plan which approve has been received (as described in Section 10(a)) and to continue diligently thereafter to commercialize the Licensed ProductsProducts in each such country in a manner consistent with sound and reasonable business practices.
8.04. (d) 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. (e) If CORPORATION shall not commercialize satisfy the Licensed Products within a reasonable time frame, requirements set forth in Section 10(a) (unless such delay or failure 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 CORPORATION’s 's failure to commercialize and shall allow CORPORATION sixty (60) days *** to cure such failure Upon receiving such notice, CORPORATION may elect to extend such diligence period and all subsequent diligence periods relating to such Licensed Product for *** upon written certification to NYU that CORPORATION is continuing product development work with respect to a Licensed Product and payment to NYU of a *** *** . After the expiration of any such *** CORPORATION may elect to further extend its failure diligence obligations under Section 10(a) with respect to commercializesuch Licensed Product for successive *** upon (i) written notice to NYU, (ii) certification by CORPORATION that it is continuing to diligently develop such Licensed Product and, together with its sublicensee(s), will spend no less than *** *** in each Calendar Year on development of such Product and (iii) payment to NYU prior to the beginning of such year of an amount equal to *** representing *** *** . CORPORATION’s 's failure to cure such a delay in the diligence requirements to NYU’s 's reasonable satisfaction or elect and satisfy the requirements of one of the options set forth above within such 60-day period *** shall be a material breach of this Agreement. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
Appears in 2 contracts
Samples: Research & License Agreement (Collateral Therapeutics Inc), Research & License Agreement (Collateral Therapeutics Inc)
Development and Commercialization. 8.01. CORPORATION undertakes to a. Cell-Matrix shall use continuous reasonable efforts and due diligence to make and sell develop Licensed Products, including but not limited toas promptly as is reasonably and commercially feasible, the performance of and to perform 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 Cell-Matrix further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees 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 Cell-Matrix or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. b. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection a. above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION Cell-Matrix 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 for commercial sale shall be produced in accordance with FDA Good Manufacturing Practice (“"GMP”") procedures in a facility which that 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 c. Cell-Matrix shall provide NYU with written annual reports on all significant activities and actions undertaken by CORPORATION Cell-Matrix to develop and commercialize the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for twelve (12) months of the duration of this Agreement, commencing twelve months after the Effective Date.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Cancervax Corp), License Agreement (Cancervax Corp)
Development and Commercialization. 8.01. CORPORATION (a) It is understood and agreed that subject to termination of this Agreement and the Licence thereunder pursuant to Paragraph 3(d) above or to the other provisions of this Agreement, should the Corporation wish to have further research (beyond that to be performed at the Institute and to be funded pursuant to Paragraph 3 above) conducted outside the Corporation's own facilities with respect to all or any part of the Licenced Technology then such additional research shall be performed at the Institute, (to the extent that Yeda confirms the availability of the necessary facilities) under the supervision of *****, should he declare himself available, willing and able to perform such further research, provided that the cost of performing such research at the Institute (including the cost of acquisition of any necessary equipment), shall not be substantially more than such cost at a reputable institution which has declared itself willing to undertake the performance of such further research.
(b) The Corporation undertakes to use continuous reasonable diligence act diligently and to make reasonable efforts to expedite the commencement of commercial sale of the Products and sell Licensed Products, including but not limited tocommercial provision of the Services and without derogating from the generality of the aforegoing, the performance of all efficacy, pharmaceutical, safetynecessary research, toxicological tests, pharmacological and efficacy tests, pre-clinical tests, trials clinical trials, the steps required for obtaining regulatory approvals from the US Food and studies Drug Administration and all other activities necessary in order to obtain regulatory authorities and the approval development of procedures and facilities for large-scale commercial production of the FDA for the production, use Products and sale provision 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 thereinServices. CORPORATION The Corporation further undertakes to continue to act diligently in the exercise due diligence of the Licence and to employ take all reasonable steps to maximize such exercise throughout the period of the Licence.
(i) Should Yeda be of the opinion that the Corporation is in breach of its reasonable diligence obligations pursuant to obtainParagraph 8(b) above with respect to the research, development and commercialization activities relating to any Product or Service, it may so advise the Corporation and notify the Corporation that unless certain steps are taken by the Corporation within a certain time as specified in the said notice, the appropriate approvals Licence shall lapse. Should the Corporation not refer the matter to arbitration pursuant to subparagraph (ii) below nor take the said specified steps within the said specified time, the Licence and this Agreement shall thereupon terminate.
(ii) Should the Corporation not accept the terms of Yeda’s said notice, it shall be entitled, within 30 days of receipt of Yeda’s said notice, to advise Yeda that it does not accept the terms 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 said notice and to continue diligently thereafter refer the dispute for resolution by arbitration pursuant to commercialize the Licensed ProductsParagraph 14 below.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 2 contracts
Samples: Research and License Agreement (XTL Biopharmaceuticals LTD), Research and License Agreement (XTL Biopharmaceuticals LTD)
Development and Commercialization. 8.01a. AMICUS shall use its commercially reasonable efforts to bring one or more Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Patent Rights in the Field. CORPORATION undertakes AMICUS shall not, however, be required to use continuous reasonable diligence pursue the development of more than one Licensed Product at a time, nor shall AMICUS be required to make and sell pursue every possible Licensed ProductsProduct.
b. Attached as Appendix A to this Agreement is the current development plan of AMICUS for the forthcoming period of twelve months (such plan, including but not limited toas updated from time to time as described in clause (c) below, the performance of all "Plan"). As and when appropriate, future Plans will incorporate efficacy, pharmaceutical, pharmaceutical safety, toxicological and and/ or clinical tests, trials and studies and all tests or any other activities necessary in order to obtain the approval of the FDA and counterpart foreign regulatory agencies for the production, use and sale of Licensed Products, as well as marketing plans to commercialize Licensed Products that have obtained such approvals.
c. On the earlier of thirty (30) days prior to the first anniversary of the Effective Date or the end of AMICUS's first fiscal year, and thereafter on each successive anniversary of such date, AMICUS shall deliver to MSSM a report setting forth in reasonable detail progress and problems with the implementation of the Plan and, providing an update on its efforts to commercialize Licensed Products, including a forecast and schedule of major events required to market the Licensed Products. Such report shall also include any amendments proposed by AMICUS to the Plan based upon the progress made and then current scientific, all as set forth regulatory and commercial exigencies relating to Licensed Products. Within forty-five (45) days following the delivery of such a report (a "Diligence Report") representatives of MSSM may request a meeting with AMICUS to review the Diligence Report, the status of the efforts of AMICUS under the Plan and any proposed amendments to the Plan. Any such proposed amendments to the Plan shall be subject to approval by MSSM, which approval shall not be unreasonably withheld or delayed. Upon approval of any such amendments, they shall be deemed amendments to the Plan, added to Appendix A and deemed incorporated into this Agreement.
d. AMICUS will use its commercially reasonable efforts to accomplish the milestones described 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 ProductsPlan.
8.02. e. Provided that applicable laws, rules and regulations require that so require, the manufacture of Licensed Products shall be carried out by AMICUS or its agents in accordance [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. with FDA Good Laboratory Practices and FDA Good Manufacturing Practice ("GMP") procedures in a facility which has been certified by the FDA and the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 above the Plan shall be carried out so performed by AMICUS or its agents in accordance with FDA Good Laboratory Practices clinical trial procedures. MSSM shall have no responsibility for the actual production, distribution, sale or use of any Licensed Product.
f. If at any time AMICUS abandons or suspends its efforts to commercialize all Licensed Products for a period exceeding ninety (90) days, AMICUS shall immediately notify MSSM giving reasons and in a manner acceptable statement of its intended actions. MSSM shall be entitled to the relevant health authorities, CORPORATION shall carry out such tests, trials, studies and other activities terminate this Agreement for "Cause" 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 requireSection 11 upon any such abandonement.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 2 contracts
Samples: License Agreement (Amicus Therapeutics Inc), License Agreement (Amicus Therapeutics Inc)
Development and Commercialization. 8.01. CORPORATION a. Orthogen undertakes to use continuous reasonable diligence to make and sell Licensed Productscarry out a development plan, 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 Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. sale of the Licensed Products, all as set forth in the Development Plan (annexed hereto as Appendix III Products and which is an integral part of this Agreement) and within all timetables set forth thereinServices. CORPORATION Orthogen further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees 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 Orthogen or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. b. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection a. above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION Orthogen 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 and Services 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 c. Orthogen undertakes to begin the regular commercial production, use, and sale of the Licensed Products and Services in good faith and as soon as is practicable in accordance with the Development Plan development plan and to continue diligently thereafter to commercialize the Licensed ProductsProducts and Services.
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. d. If CORPORATION Orthogen shall not commercialize the Licensed Products or Services 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 circumstancesagencies, NYU HJD shall notify CORPORATION Orthogen in writing of CORPORATIONOrthogen’s failure to Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. commercialize and shall allow CORPORATION Orthogen sixty (60) days to cure its failure to commercialize. CORPORATIONOrthogen’s failure to cure such delay to NYUHJD’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 2 contracts
Samples: License Agreement (BioHorizons, Inc.), License Agreement (BioHorizons, Inc.)
Development and Commercialization. 8.01. CORPORATION undertakes 6.1 The Licensee undertakes, at its own expense, to use continuous reasonable diligence carry out the Licensee Development Plan as detailed in Schedule 1.5.5, and which may be reasonably amended by the Licensee from time 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 time - and all other activities steps and actions 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 Commercialize the Licensed Products.
8.04. CORPORATION 6.2 Without derogating from the provisions of Section 6.1 above, the Licensee shall provide NYU with written annual reports on all activities and actions undertaken by CORPORATION exert Commercially Reasonable Efforts to develop and commercialize to introduce the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for Products into the duration commercial markets as soon as practicable and thereafter, until the expiration of this Agreement.
8.05. If CORPORATION shall not commercialize , to make all Commercially Reasonable Efforts and endeavors to keep the Licensed Products reasonably available to the public.
6.3 The Licensee shall provide the Licensor with annual written reports, which shall detail the development results and other related work performed by the Licensee during the twelve months prior to the report. Such report shall also set forth a general assessment regarding the development of the Licensed Product and the marketing thereof. Notwithstanding the above, during the first 24 months as of the Effective Date, the reports subject of this Section 6.3 shall be provided on a semi-annual basis (i.e. once every six months commencing on the Effective Date) and the Parties shall in good faith discuss such reports and future actions of the Licensee, and the Licensee shall take into reasonable consideration the reasonable suggestions of Licensor, as shall be communicated during such good faith discussions.
6.4 The Licensee shall submit to Licensor a written notice with regard to the First Commercial Sale 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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty thirty (6030) days thereafter specifying its date, the country in which such sale took place and the type of Licensed Product sold. The Licensee shall also submit to cure its failure the Licensor a written notice with regard to commercialize. CORPORATION’s failure to cure the first achievement of an aggregated annual amount of USD $50,000 from sales of Licensed Products (together by all Licensee Parties), within thirty (30) days from the date of such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreementachievement.
Appears in 2 contracts
Samples: License Agreement (Graphite Corp), License Agreement (Graphite Corp)
Development and Commercialization. 8.01Subject to the terms of this Agreement and the Ancillary Agreements (including Fluidigm’s rights and obligations under the Collaboration Agreement with respect to the Collaboration Activities), Novartis shall have the sole right to conduct and decide all matters with respect to the development (except as otherwise provided in the Collaboration Agreement) and commercialization of the Novartis Licensed Products (including conduct of clinical trials, distribution, pricing and selection and use of trademarks) in the Primary Field and Secondary Field in the Territory. CORPORATION undertakes Notwithstanding the foregoing, Novartis shall use at least commercially reasonable efforts to develop and [***] Information has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. commercialize Novartis Licensed Products in the Primary Field consistent with Novartis’ typical development and commercialization of similar products with similar market potential and at similar stages in development and commercialization. If Novartis does not use continuous commercially reasonable diligence efforts to make and sell launch a Novartis Licensed ProductsProduct in any of China, including but not limited toIndia, Hong Kong, Korea, Singapore or Taiwan, then all rights granted to Novartis by Fluidigm, to the extent reasonably required to effect commercialization of such Novartis Licensed Product in such country, shall revert back to Fluidigm (i.e., the performance licenses granted hereunder to Novartis and Novartis’ rights under the Supply Agreement shall become co-exclusive with Fluidigm with respect to commercialization of all efficacysuch Novartis Licensed Product in such country, pharmaceuticaland for clarity Novartis shall retain the right to otherwise Exploit (in the case of manufacturing, safety, toxicological only to the extent that Novartis is permitted to manufacture under this Agreement and clinical tests, trials and studies and all other activities necessary the Supply Agreement) such Novartis Licensed Product in such country in order to obtain develop and commercialize such Novartis Licensed Product in the approval countries retained by Novartis). Such reversion shall not be effected unless and until Fluidigm provides written notice to Novartis of its intent to effect such reversion of such rights and provides Novartis a period of one year, from the FDA time of such notice, to cure such deficiency and Novartis does not do so within such period. In the case of such a reversion, for the productionclarity, use and sale of the Licensed Products(i) royalties may be due to Novartis, all as set forth in the Development Plan Collaboration Agreement; and (annexed hereto as Appendix III ii) notwithstanding this co-exclusivity, Fluidigm (and which is an integral part of this Agreementits Affiliates) 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 entitled to Exploit all products and services subject to such co-exclusivity, itself or with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authoritiesor through (sub)licensees, CORPORATION shall carry out such testscommercialization partners, trialsdistributors, 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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this AgreementThird Parties.
Appears in 1 contract
Samples: License Agreement (Fluidigm Corp)
Development and Commercialization. 8.01a. COMPANY shall use all commercially reasonable efforts to bring one or more Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Patent Rights in the Field. CORPORATION undertakes COMPANY shall not, however, be required to use continuous reasonable diligence pursue the development of more than one Licensed Product at a time, nor shall COMPANY be required to make and sell pursue every possible Licensed ProductsProduct.
b. Attached as Appendix A to this Agreement is the current development plan of COMPANY for the forthcoming period of twelve months (such plan, including but not limited toas updated from time to time as described in clause (c) below, the performance of all "Plan"). As and when appropriate, future Plans will incorporate efficacy, pharmaceutical, pharmaceutical safety, toxicological and and/ or clinical tests, trials and studies and all tests or any other activities necessary in order to obtain the approval of the FDA and counterpart foreign regulatory agencies for the production, use and sale of Licensed Products, as well as marketing plans to commercialize Licensed Products that have obtained such approvals.
c. On the earlier of thirty (30) days prior to the first anniversary of the Effective Date or the end of COMPANY'S first fiscal year, and thereafter on each successive anniversary of such date, COMPANY shall deliver to MSSM a report setting forth in reasonable detail progress and problems with the implementation of the Plan and, providing an update on its efforts to commercialize Licensed Products, including a forecast and schedule of major events required to market the Licensed Products. Such report shall also include any amendments proposed by COMPANY to the Plan based upon the progress made and then current scientific, regulatory and commercial exigencies relating to Licensed Products. Within forty-five (45) days following the delivery of such a report (a "Diligence Report") representatives of MSSM may request a meeting with COMPANY to review the Diligence Report, the status of the efforts of COMPANY under the Plan and any proposed amendments to the Plan. Any such proposed amendments to the Plan shall be subject to approval by MSSM, which approval shall not be unreasonably withheld or delayed. Upon approval of any such amendments, they shall be deemed amendments to the Plan, added to Appendix A and deemed incorporated Into this Agreement. d COMPANY will use all as set forth commercially reasonable efforts to accomplish the milestones described 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 ProductsPlan.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01. 8.01 CORPORATION undertakes to use continuous reasonable diligence [***] to make carry out the Development Plan (annexed hereto as Appendix III and sell Licensed Productswhich is an integral part of this Agreement, as such Development Plan may be updated from time-to-time by mutual agreement of the parties), 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 updated from time-to-time by mutual agreement of this Agreementthe parties) and within all timetables set forth therein. CORPORATION further undertakes to exercise due diligence [***], and to employ its reasonable diligence include in each sublicense agreement an obligation of such sublicensee, to obtain[***], 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. 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. 8.03 CORPORATION undertakes agrees to use [***] 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. 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 six (6) months during the duration term of this Agreement.
8.05, commencing six (6) months after the Effective Date. If CORPORATION shall not commercialize the Licensed Products within a reasonable time frame, unless include sufficient details in such delay is necessitated by FDA or other regulatory agencies or unless reports for NYU and CORPORATION have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU shall notify CORPORATION in writing of ascertain CORPORATION’s failure to commercialize progress in developing and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreementcommercializing Licensed Products.
Appears in 1 contract
Development and Commercialization. 8.01Subject to the terms of this Agreement and the Ancillary Agreements (including Fluidigm’s rights and obligations under the Collaboration Agreement with respect to the Collaboration Activities), Novartis shall have the sole right to conduct and decide all matters with respect to the development (except as otherwise provided in the Collaboration Agreement) and commercialization of the Novartis Licensed Products (including conduct of clinical trials, distribution, pricing and selection and use of trademarks) in the Primary Field and Secondary Field in the Territory. CORPORATION undertakes Notwithstanding the foregoing, Novartis shall use at least commercially reasonable efforts to develop and commercialize Novartis Licensed Products in the Primary Field consistent with Novartis’ typical development and commercialization of similar products with similar market potential and at similar stages in development and commercialization. If Novartis does not use continuous commercially reasonable diligence efforts to make launch a Novartis Licensed Product in any of [***], then all rights granted [***] Information has been omitted and sell filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. to Novartis by Fluidigm, to the extent reasonably required to effect commercialization of such Novartis Licensed ProductsProduct in such country, including but not limited toshall revert back to Fluidigm (i.e., the performance licenses granted hereunder to Novartis and Novartis’ rights under the Supply Agreement shall become co-exclusive with Fluidigm with respect to commercialization of all efficacysuch Novartis Licensed Product in such country, pharmaceuticaland for clarity Novartis shall retain the right to otherwise Exploit (in the case of manufacturing, safety, toxicological only to the extent that Novartis is permitted to manufacture under this Agreement and clinical tests, trials and studies and all other activities necessary the Supply Agreement) such Novartis Licensed Product in such country in order to obtain develop and commercialize such Novartis Licensed Product in the approval countries retained by Novartis). Such reversion shall not be effected unless and until Fluidigm provides written notice to Novartis of its intent to effect such reversion of such rights and provides Novartis a period of one year, from the FDA time of such notice, to cure such deficiency and Novartis does not do so within such period. In the case of such a reversion, for the productionclarity, use and sale of the Licensed Products(i) royalties may be due to Novartis, all as set forth in the Development Plan Collaboration Agreement; and (annexed hereto as Appendix III ii) notwithstanding this co-exclusivity, Fluidigm (and which is an integral part of this Agreementits Affiliates) 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 entitled to Exploit all products and services subject to such co-exclusivity, itself or with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authoritiesor through (sub)licensees, CORPORATION shall carry out such testscommercialization partners, trialsdistributors, 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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this AgreementThird Parties.
Appears in 1 contract
Samples: License Agreement (Fluidigm Corp)
Development and Commercialization. 8.01. CORPORATION CPP undertakes to use continuous reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix I and sell Licensed Productswhich is an integral part of this Agreement), 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 CPP further undertakes to exercise due reasonable diligence and to employ its reasonable diligence to obtain or to cause its sublicensees 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 CPP or its sublicensees 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 CPP 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 CPP 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 CPP shall provide NYU LICENSORS with written annual reports on all activities and actions undertaken by CORPORATION CPP to develop and commercialize the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. If CORPORATION CPP 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 LICENSORS and CORPORATION CPP have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU LICENSORS shall notify CORPORATION CPP in writing of CORPORATIONCPP’s failure to commercialize and shall allow CORPORATION CPP sixty (60) days to cure its failure to commercialize. CORPORATIONCPP’s failure to cure such delay to NYULICENSORS’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: License Agreement (Catalyst Pharmaceutical Partners, Inc.)
Development and Commercialization. 8.01. (a) CORPORATION undertakes to use continuous reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix - and sell Licensed Productswhich is an integral part of this Agreement), 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 or to cause its sublicensees 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. (b) Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection (a) 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. (c) 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. (d) 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. (e) 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 CORPORATION’s 's failure to commercialize and shall allow CORPORATION sixty ninety (6090) days to cure its failure to commercialize. CORPORATION’s 's failure to cure such delay to NYU’s 's reasonable satisfaction within such 60-day ninety (90)-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01As soon as practicable after the Effective Date, the parties will mutually agree upon and implement a commercially reasonable transition plan pursuant to which further development and commercialization activities will be transitioned from Isis to Lilly. CORPORATION undertakes The transition plan will provide for transfer to use continuous Lilly of relevant data and records, ownership of regulatory filings, and transition of Third Party arrangements (e.g., manufacturing, CRO and similar agreements), and a process for sharing class specific safety data related to the Product. Isis will not be entitled to any compensation or reimbursement for the costs of the first [***] hours of its personnel incurred in transitioning activities to Lilly. Lilly will reimburse Isis for its reasonable diligence direct Third Party costs incurred in connection with transition activities. If Isis and Lilly agree that Isis will continue some of the development of the Product, Isis and Lilly will agree upon a plan and budget to make reimburse Isis for such development activities. Following transition of activities to Xxxxx, Xxxxx will be solely responsible for all development and sell Licensed Productscommercialization of the Product, including but not limited totoxicology, clinical development (including taking over and becoming the performance IND sponsor of all efficacyclinical trials that are ongoing as of the Effective Date), pharmaceuticalregulatory, safetymanufacturing and commercialization efforts, toxicological except as agreed otherwise by the Parties. Lilly and clinical tests, trials its Sublicensees will have the sole right and studies and all other activities necessary responsibility for the preparation of any regulatory filings required in order to obtain the approval of the FDA for the production, use and sale of the Licensed Products, all as set forth conduct clinical trials on Product 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 obtainTerritory, 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 together with the Development Plan preparation of suitable applications for marketing approval in the Territory and to continue diligently thereafter to commercialize will be the Licensed Productsowner and party of record of all such regulatory filings. Isis will cooperate with Lilly, at Lilly’s expense, as Lilly reasonably requires in preparing such regulatory filings including, without limitation, any and all data contained therein.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: Drug Development and License Option Agreement (Isis Pharmaceuticals Inc)
Development and Commercialization. 8.01. a. CORPORATION undertakes to use continuous reasonable diligence to make and sell Licensed Productscarry out the Development Plan, 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 or to cause its sublicensees 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. b. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection a. 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. c. 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. d. 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. e. 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 CORPORATION’s 's failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure If CORPORATION falls to cure such delay to NYU’s 's reasonable satisfaction within satisfaction, NYU shall have the right, upon written notice to CORPORATION, solely at NYU's discretion, either to terminate this Agreement or to convert the License granted herein to a non-exclusive license.
f. CORPORATION shall deliver to NYU a sample of each BPI Product developed by CORPORATION promptly after its development. NYU shall use such 60-day period samples only for research purposes and shall be a material breach of this Agreementnot give them to others, unless and until such BPI Products are in the public domain or unless authorized by CORPORATION in writing.
Appears in 1 contract
Development and Commercialization. 8.01(a) It shall be within the judgment of CORPORATION in what manner to proceed with the development of Licensed Products for commercialization; provided that CORPORATION shall use efforts, consistent with its sound and reasonable business practices and technical judgment, to effect introduction of Licensed Products into the commercial market. CORPORATION undertakes shall be deemed to use continuous reasonable satisfy the due diligence to make requirements of this Section 10(a) by: (i) preparing and sell filing an Investigational New Drug Application for a Licensed Products, including but not limited to, Product within three (3) years following the performance of all efficacy, pharmaceutical, safety, toxicological Effective Date; (ii) preparing and clinical tests, trials and studies and all other activities necessary in order to obtain the filing an application for marketing approval of the FDA for the production, use and sale of the a Licensed Products, all as set forth Product in the United States, Canada, or a country within the European Union within six (6) years following the Effective Date; and (iii) obtaining marketing approval of a Licensed Product in the United State, Canada, or a country within the European Union within eight (8) years following the Effective Date. Corporation’s Development Plan (is 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 ProductsIII.
8.02. (b) Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 required by subsection (a) above shall be carried out in accordance with FDA current Good Laboratory Practices, current Good Manufacturing Practices and current Good Clinical 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 such Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products shall be produced in accordance with FDA current Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified licensed by the FDA as complying with GMPto manufacture such Licensed Products, provided that applicable laws, rules and regulations so require.
8.03. (c) CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed Products in good faith each country in accordance with the Development Plan which approval has been received (as described in Section 10(a)) and to continue diligently thereafter to commercialize the Licensed ProductsProducts in each such country in a manner consistent with sound and reasonable business practices.
8.04. (d) 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. (e) If CORPORATION shall not commercialize satisfy the Licensed Products within a reasonable time frame, requirements set forth in Section 10(a) (unless such delay or failure 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 CORPORATION’s ’S failure to commercialize and shall allow CORPORATION sixty (60) days to cure such failure. Upon receiving such notice, CORPORATION may elect to extend such diligence period and all subsequent diligence periods relating to such Licensed Product for one twelve (12) month period upon written certification to NYU that CORPORATION is continuing product development work with respect to a Licensed Product and payment to NYU of a fee equal to $100,000. After the expiration of any such twelve-month period, CORPORATION may elect to further extend its failure diligence obligations under Section 10(a) with respect to commercializesuch Licensed Product for successive one-year periods upon (i) written notice to NYU, (ii) certification by CORPORATION that it is continuing to diligently develop such Licensed Product and, together with its sublicensee(s), will spend no less than three million dollars ($3,000,000) in each Calendar Year on development of such Product and (iii) payment to NYU prior to the beginning of such year of an amount equal to $500,000, representing minimum annual royalties with respect to such Product. CORPORATION’s failure to cure such a delay in the diligence requirements to NYU’s reasonable satisfaction or elect and satisfy the requirements of one of the options set forth above within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01Himalaya (itself or through its Affiliates, Licensees or other Selling Parties) shall be responsible, at its, or their, sole cost and expense, for all (i) development activities with respect to licensed, or sublicensed, CAB Antibodies and Products in the Territory, and (ii) commercialization activities with respect to Products in the Territory. CORPORATION undertakes Himalaya shall use, and shall cause its Affiliates, Third Party Service Providers, Licensees and/or other Selling Parties to use continuous reasonable diligence Commercially Reasonable Efforts to make diligently develop all CAB Antibodies and sell Licensed Productsall Products in the Territory, including but not limited toto diligently file for and obtain Regulatory Approval of Products in the Territory, and, after such Regulatory Approval is obtained, to diligently commercialize applicable Products in the Territory. The development activities shall comprise, at a minimum, the performance following activities:
(i) Provide BioAtla with annual forecasts 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 funding required for the productiondevelopment, use manufacture and sale of Products beginning on the Licensed Products, first anniversary of the Effective Date;
(ii) Fully fund the development of Products for Regulatory Approval as set forth under each Development Plan and each Commercialization Plan;
(iii) Timely pay all patent prosecution and maintenance costs in the Territory; and
(iv) If Himalaya fails to perform any of its obligations as specified herein with respect to any particular CAB Antibody on the timelines set forth in the Development Plan (annexed hereto and/or Commercialization Plans as Appendix III applicable, then BioAtla shall have the right and which is an integral part option to either terminate this Agreement or change the grant of this Agreement) rights to Himalaya to any such CAB Antibody from exclusive to non-exclusive if it has notified Himalaya of its intent to do so and within all timetables set forth therein. CORPORATION further undertakes to exercise due diligence the reason 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 Himalaya has not cured 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 failure within sixty (60) days after each June 30th for days. This right, if exercised by BioAtla, supersedes the duration rights granted in Paragraph 4.1 below. Upon such event, Himalaya hereby covenants and agrees to assign to BioAtla all right and title to all data and information generated and related to the CAB Antibody and all Intellectual Property Rights related thereto developed by or on behalf of this AgreementHimalaya and the other Selling Parties.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01(a) It shall be within the judgment of CORPORATION in what manner to proceed with the development of Licensed Products for commercialization; provided that CORPORATION shall use efforts, consistent with its sound and reasonable business practices and technical judgment, to effect introduction of Licensed Products into the commercial market. CORPORATION undertakes shall be deemed to use continuous reasonable satisfy the due diligence to make and sell Licensed Products, including but not limited to, the performance requirements 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 this Section 10(a) by: *** *** *** *** *** *** *** *** *** *** *** *** . Corporation's Development Plan (is 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 ProductsIII.
8.02. (b) Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 required by subsection (a) above shall be carried out in accordance with FDA current Good Laboratory Practices, current Good Manufacturing Practices and current Good Clinical 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 such Practices and in a manner acceptable to the relevant health authorities. Furthermore, the Licensed Products shall be produced in accordance with FDA current Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified licensed by the FDA as complying with GMPto manufacture such Licensed Products, provided that applicable laws, rules and regulations so require.
8.03. (c) CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Products in good faith each counted in accordance with the Development Plan which approve has been received (as described in Section 10(a)) and to continue diligently thereafter to commercialize the Licensed ProductsProducts in each such country in a manner consistent with sound and reasonable business practices.
8.04. (d) 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. (e) If CORPORATION shall not commercialize satisfy the Licensed Products within a reasonable time frame, requirements set forth in Section 10(a) (unless such delay or failure 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 CORPORATION’s 's failure to commercialize and shall allow CORPORATION sixty (60) days to cure such failure Upon receiving such notice, CORPORATION may elect to extend such diligence period and all subsequent diligence periods relating to such Licensed Product for one twelve (12) month period upon written certification to NYU that CORPORATION is continuing product development work with respect to a Licensed Product and payment to NYU of a fee equal to $100,000. After the expiration of any such twelve-month period CORPORATION may elect to further extend its failure diligence obligations under Section 10(a) with respect to commercializesuch Licensed Product for successive one-year periods upon (i) written notice to NYU, (ii) certification by CORPORATION that it is continuing to diligently develop such Licensed Product and, together with its sublicensee(s), will spend no less than three million dollars ($3,000,000) in each Calendar Year on development of such Product and (iii) payment to NYU prior to the beginning of such year of an amount equal to $500,000 representing minimum annual royalties with respect to such Product. CORPORATION’s 's failure to cure such a delay in the diligence requirements to NYU’s 's reasonable satisfaction or elect and satisfy the requirements of one of the options set forth above within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: Research & License Agreement (Collateral Therapeutics Inc)
Development and Commercialization. 8.01a. AMICUS shall use its commercially reasonable efforts to bring one or more Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Patent Rights in the Field. CORPORATION undertakes AMICUS shall not, however, be required to use continuous reasonable diligence pursue the development of more than one Licensed Product at a time, nor shall AMICUS be required to make and sell pursue every possible Licensed ProductsProduct.
b. Attached as Appendix A to this Agreement is the current development plan of AMICUS for the forthcoming period of twelve months (such plan, including but not limited toas updated from time to time as described in clause (c) below, the performance of all “Plan”). As and when appropriate, future Plans will incorporate efficacy, pharmaceutical, pharmaceutical safety, toxicological and and/ or clinical tests, trials and studies and all tests or any other activities necessary in order to obtain the approval of the FDA and counterpart foreign regulatory agencies for the production, use and sale of Licensed Products, as well as marketing plans to commercialize Licensed Products that have obtained such approvals.
c. On the earlier of thirty (30) days prior to the first anniversary of the Effective Date or the end of AMICUS’s first fiscal year, and thereafter on each successive anniversary of such date, AMICUS shall deliver to MSSM a report setting forth in reasonable detail progress and problems with the implementation of the Plan and, providing an update on its efforts to commercialize Licensed Products, including a forecast and schedule of major events required to market the Licensed Products. Such report shall also include any amendments proposed by AMICUS to the Plan based upon the progress made and then current scientific, all as set forth regulatory and commercial exigencies relating to Licensed Products. Within forty-five (45) days following the delivery of such a report (a “Diligence Report”) representatives of MSSM may request a meeting with AMICUS to review the Diligence Report, the status of the efforts of AMICUS under the Plan and any proposed amendments to the Plan. Any such proposed amendments to the Plan shall be subject to approval by MSSM, which approval shall not be unreasonably withheld or delayed. Upon approval of any such amendments, they shall be deemed amendments to the Plan, added to Appendix A and deemed incorporated into this Agreement.
d. AMICUS will use its commercially reasonable efforts to accomplish the milestones described 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 ProductsPlan.
8.02. e. Provided that applicable laws, rules and regulations require that so require, the manufacture of Licensed Products shall be carried out by AMICUS or its agents in accordance with FDA Good Laboratory Practices and FDA Good Manufacturing Practice (“GMP”) procedures in a facility which has been certified by the FDA and the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 above the Plan shall be so performed by AMICUS or its agents in accordance with FDA clinical trial procedures. MSSM shall have no responsibility for the actual production, distribution, sale or use of any Licensed Product.
f. If at any time AMICUS abandons or suspends its efforts to commercialize all Licensed Products for a period exceeding ninety (90) days, AMICUS shall immediately notify MSSM giving reasons and a statement of its intended actions. MSSM shall be entitled to terminate this Agreement for “Cause” in accordance with Section 11 upon any such abandonment.
g. MSSM shall also be entitled to terminate this Agreement for “Cause” in accordance with Section 11 if AMICUS shall fail to deliver any Diligence Report on a timely basis, or fail to use commercially reasonable efforts to implement the Plan, and such failure is not cured within the sixty (60) day period set by the notice provided pursuant to Section 11, unless such failure is excused by:
i) causes beyond AMICUS’s direct control; or
ii) MSSM’s failure to meet its obligations hereunder; or
iii) inaction of any federal or state agency whose approval is required for commercial sales of Licensed Products.
h. Provided that applicable laws, rules and regulations so require, the performance of the tests, trials, studies and other activities specified in subsection b, 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 MSSM shall have no responsibility for the regular commercial actual production, usedistribution, and sale or use of the any Licensed Products in good faith in accordance with the Development Plan and to continue diligently thereafter to commercialize the Licensed ProductsProduct.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01. 8.01 CORPORATION undertakes to use continuous reasonable diligence [***] to make carry out the Development Plan (annexed hereto as Appendix III and sell Licensed Productswhich is an integral part of this Agreement, as such Development Plan may be updated from time-to-time by mutual agreement of the parties), 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 updated from time-to-time by mutual agreement of this Agreementthe parties) and within all timetables set forth therein. CORPORATION further undertakes to exercise due diligence [***], and to employ its reasonable diligence include in each sublicense agreement an obligation of such sublicensee, to obtain[***], 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. 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. 8.03 CORPORATION undertakes agrees to [***] 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. 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 six (6) months during the duration term of this Agreement.
8.05, commencing six (6) months after the Effective Date. If CORPORATION shall not commercialize the Licensed Products within a reasonable time frame, unless include sufficient details in such delay is necessitated by FDA or other regulatory agencies or unless reports for NYU and CORPORATION have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU shall notify CORPORATION in writing of ascertain CORPORATION’s failure to commercialize progress in developing and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreementcommercializing Licensed Products.
Appears in 1 contract
Development and Commercialization. 8.01. CORPORATION undertakes to use continuous reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix I and sell Licensed Productswhich is an integral part of this Agreement), 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 or to cause its sublicensees 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 or its sublicensees 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 anniversary of the duration Effective Date of this Agreement, commencing one year after the Effective Date.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01. CORPORATION undertakes to use continuous reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix II and sell Licensed Productswhich is an integral part of this Agreement), 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 or to cause its sublicensees 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 or its sublicensees 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 Section 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 significant 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 [**] of the duration of this Agreement, commencing [**] after the Effective Date.
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 CORPORATION’s failure to commercialize and shall allow CORPORATION sixty (60) days [**] to cure its failure to commercialize. CORPORATION’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day [**] period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: License Agreement (Sesen Bio, Inc.)
Development and Commercialization. 8.01. CORPORATION (a) LICENSEE undertakes to use continuous reasonable diligence to make and sell Licensed Products, carry out the Commercial Development Plan 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 Commercial Development Plan (annexed hereto as Appendix III and which is an integral part of this Agreement) and within all timetables set forth therein. CORPORATION LICENSEE further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sub-licensees 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 LICENSEE or its sub-licensees intend to produce, use, and/or sell Licensed Products.
8.02. (b) Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection (a) above shall be carried out in accordance with U.S. FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION LICENSEE shall carry out such tests, trials, studies and other activities in accordance with U.S. FDA Good Laboratory Practices and or in a manner acceptable to the relevant foreign health authorities. Furthermore, the Licensed Products shall be produced in accordance with U.S. 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 (c) LICENSEE undertakes to begin the regular commercial production, use, and sale of the Licensed Products in good faith in accordance with the Commercial Development Plan and to continue diligently thereafter to commercialize the Licensed ProductsProducts and/or Licensed Processes.
8.04. CORPORATION (d) LICENSEE shall provide NYU CURE with written annual reports on all activities and actions undertaken by CORPORATION LICENSEE to develop and commercialize the Licensed Products; such reports (the Half-Year Commercialization Reports) shall be made within sixty forty-five (6045) days after each June 30th for six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. (e) If CORPORATION LICENSEE 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 CURE and CORPORATION LICENSEE have mutually agreed to amend the Commercial Development Plan Plan, or because of unforeseen circumstances, NYU including manufacturing delays out of LICENSEE's control, CURE shall notify CORPORATION LICENSEE in writing of CORPORATION’s LICENSEE's failure to commercialize and shall allow CORPORATION sixty (60) days LICENSEE a reasonable period of time thereafter to cure its failure to commercialize. CORPORATION’s LICENSEE's failure to cure such delay to NYU’s CURE's reasonable satisfaction within such 60-day reasonable period of time shall be a material breach of this Agreement.
Appears in 1 contract
Samples: License Agreement (Axonyx Inc)
Development and Commercialization. 8.01. a. CORPORATION undertakes to use continuous reasonable diligence its best efforts to make carry out the development and sell commercialization of the 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 or to cause its sublicensees 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. b. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 subsection a. 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. c. CORPORATION undertakes to begin the regular commercial production, use, and sale of the Licensed Products in good faith in accordance with the Development Plan development plan to be provided to NSUH by the end of the Research Period and to continue diligently thereafter to commercialize the Licensed Products.
8.04. d. CORPORATION shall provide NYU NSUH 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 six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.05. e. 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 NSUH and CORPORATION have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU NSUH shall notify CORPORATION in writing of CORPORATION’s 's failure to commercialize and shall allow CORPORATION sixty (60) days to cure its failure to commercialize. CORPORATION’s 's failure to cure such delay to NYU’s NSUH's reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Development and Commercialization. 8.01. 10.01 CORPORATION undertakes will undertake to use continuous commercially reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix III and sell Licensed Productswhich is an integral part of this Agreement), 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 commercially reasonable diligence to obtain or to cause its sublicensees 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 or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.02. 10.02 Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 Section 10.01 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. 10.03 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. 10.04 Upon written request of NYU, 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 [***] of the duration of this Agreement, commencing [***] after the Effective Date.
8.05. 10.05 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 circumstancesagencies, NYU shall notify CORPORATION in writing of CORPORATION’s ’S failure to commercialize and shall allow CORPORATION sixty (60) days [***] to cure its failure to commercialize. CORPORATION’s ’S failure to cure such delay to NYU’s reasonable satisfaction within such 60-day [***] period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: Research and License Agreement (PureTech Health PLC)
Development and Commercialization. 8.0110.01. CORPORATION INI undertakes to use continuous reasonable diligence to make carry out the Development Plan (annexed hereto as Appendix III and sell Licensed Productswhich is an integral part of this Agreement), 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 INI further undertakes to exercise due diligence and to employ its reasonable diligence to obtain or to cause its sublicensees 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 INI or its sublicensees intend to produce, use, and/or sell Licensed Products.
8.0210.02. Provided that applicable laws, rules and regulations require that the performance of the tests, trials, studies and other activities specified in Paragraph 8.01 10.01 above shall be carried out in accordance with FDA Good Laboratory Practices and in a manner acceptable to the relevant health authorities, CORPORATION INI 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.
8.0310.03. CORPORATION INI 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.
8.0410.04. CORPORATION INI shall provide NYU with written annual reports on all activities and actions undertaken by CORPORATION INI to develop and commercialize the Licensed Products; such reports shall be made within sixty (60) days after each June 30th for six (6) months of the duration of this Agreement, commencing six months after the Effective Date.
8.0510.05. If CORPORATION INI 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 NY U and CORPORATION INI have mutually agreed to amend the Development Plan because of unforeseen circumstances, NYU shall notify CORPORATION INI in writing of CORPORATIONINI’s failure to commercialize and shall allow CORPORATION INI sixty (60) days to cure its failure to commercialize. CORPORATIONINI’s failure to cure such delay to NYU’s reasonable satisfaction within such 60-day period shall be a material breach of this Agreement.
Appears in 1 contract
Samples: Research and License Agreement (Intellect Neurosciences, Inc.)