Development and Commercialization. 8.1. Within 1 (one) year of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"). 8.2. The Company undertakes, at its own expense, to use best efforts to commercialise the Products and, without derogating from the generality of the aforegoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical trials), tests and other works and activities, all as detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence. 8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS") which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 (six) months; (iii) the Company's plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 6 (six) months; and (iv) projections of sales and marketing efforts. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder. 8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. 8.5. Without derogating from the obligations of the Company pursuant to this clause 8 above or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall inform Yeda in writing, of a further Development Program in respect of such additional Products and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis. 8.6. The Company shall ▇▇▇▇, and cause all its Sublicensees to ▇▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 2 contracts
Sources: Research and Licensing Agreement (Tissera Inc), Research and License Agreement (Bert Logic Inc)
Development and Commercialization. 8.1. Within 1 18 (oneeighteen) year months of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"“the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, to use best efforts take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the aforegoingforegoing, to use its best commercially reasonable efforts to expedite the commencement of the commercial sale of the ProductsProducts and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) shall carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical the trials), tests and other works and activities, all as activities detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works Program and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS"“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 12 (sixtwelve) months; and (iii) the Company's ’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 6 12 (sixtwelve) months; and (iv) projections of sales and marketing effortsefforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda’s review subject to and without derogating from the milestones set in 13.2 below. The Company shall also make reasonable efforts to provide Yeda with any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.
8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims or any other results and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. Furthermore, the Company makes no representation to the effect that the commercialization of the Product(s), or any part thereof, will succeed.
8.5. Without derogating from the obligations of the Company pursuant to this clause 8 above or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall inform Yeda in writingsubmit to Yeda, of for its written approval (not to be unreasonably withheld), a further Development Program in respect of such additional Products and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis.
8.6. The Company agrees to lend (for no consideration) Yeda and/or the Institute one unit of the Product developed and/or manufactured under this Agreement, for academic research purposes only.
8.7. The Company shall ▇▇▇▇, and cause all its Sublicensees to ▇▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 2 contracts
Sources: Research and License Agreement (Brainsway Ltd.), Research and License Agreement (Brainsway Ltd.)
Development and Commercialization. 8.1. Within 1 18 (oneeighteen) year months of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"“the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, to use best efforts take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the aforegoingforegoing, to use its best commercially reasonable efforts to expedite the commencement of the commercial sale of the ProductsProducts and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) shall carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical the trials), tests and other works and activities, all as activities detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works Program and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS"“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 12 (sixtwelve) months; and (iii) the Company's ’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 6 12 (sixtwelve) months; and (iv) projections of sales and marketing effortsefforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda’s review subject to and without derogating from the milestones set in 13.2 below. The Company shall also make reasonable efforts to provide Yeda with any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.
8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims or any other results and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program. Furthermore, the Company makes no representation to the effect that the commercialization of the Product(s), or any part thereof, will succeed.
8.5. Without derogating from the obligations of the Company pursuant to this clause 8 above or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall inform Yeda in writingsubmit to Yeda, of for its written approval (not to be unreasonably withheld), a further Development Program in respect of such additional Products and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis. Ref.: 05-2595-04-4 L/88017/4000/407949/1 No.: 60604-001
8.6. The Company agrees to lend (for no consideration) Yeda and/or the Institute one unit of the Product developed and/or manufactured under this Agreement, for academic research purposes only.
8.68.7. The Company shall ▇▇▇▇, and cause all its Sublicensees to ▇▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 1 contract
Development and Commercialization. 8.1. Within 1 (one) year [***]of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"“the Initial Development Program”).
8.2. The Company undertakes, at its own expense, [***] to use best efforts take all necessary steps to develop and commercialise the Products and, without derogating from the generality of the aforegoingforegoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For [***] Omitted pursuant to a confidential treatment request. The confidential portion has been filed separately with the Securities and Exchange Commission. such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) shall carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical the trials), tests and other works and activities, all as activities detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works Program and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence. Without prejudice to the foregoing, the Company undertakes to comply with all the requirements of the Magneton Approval, including that it will perform all development activities necessary in order to meet any milestones set out therein.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, shall provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS"“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials (if applicable) conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 12 (sixtwelve) months; (iii) the Company's ’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 6 12 (sixtwelve) months; and (iv) projections of sales and marketing efforts; and (v) a summary of all protocols or minutes of meetings with the FDA, EMEA or any other regulatory authority in connection with any Product and copies of any opinions, decisions, and approvals issued by any of the aforementioned authorities. If the Company has provided a Development Program for more than 1 (one) Product, then such Progress Report shall provide such information separately for each such Product. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda’s review. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.
8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program.
8.5. Without derogating from the obligations of the Company pursuant to this clause 8 above or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program or to update the Initial Development Program, the Company shall inform submit to Yeda in writing, of a further Development Program in respect of such additional Products or updates and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis.
8.6. The Company agrees to supply to Yeda and/or the Institute, for (and in quantities customary for) academic research purposes, any Products developed and/or manufactured and/or produced under this Agreement at no cost to Yeda, the Institute or the Scientists.
8.7. The Company shall ▇m▇▇▇, and cause all its Sublicensees and Further Sublicensees to ▇m▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 1 contract
Development and Commercialization. 8.1. Within 1 (one) year [***]of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"“the Initial Development Program”).
8.2. The Company undertakes, at its own expense, [***] to use best efforts take all necessary steps to develop and commercialise the Products and, without derogating from the generality of the aforegoingforegoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For [***] Portions of this exhibit were omitted and filed separately with the Secretary of the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment under Rule 24b-2 of the Exchange Act. such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) shall carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical the trials), tests and other works and activities, all as activities detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works Program and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence. Without prejudice to the foregoing, the Company undertakes to comply with all the requirements of the Magneton Approval, including that it will perform all development activities necessary in order to meet any milestones set out therein.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, shall provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS"“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials (if applicable) conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 12 (sixtwelve) months; (iii) the Company's ’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 6 12 (sixtwelve) months; and (iv) projections of sales and marketing efforts; and (v) a summary of all protocols or minutes of meetings with the FDA, EMEA or any other regulatory authority in connection with any Product and copies of any opinions, decisions, and approvals issued by any of the aforementioned authorities. If the Company has provided a Development Program for more than 1 (one) Product, then such Progress Report shall provide such information separately for each such Product. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda’s review. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder.
8.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 or of clause 13.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program.
8.5. Without derogating from the obligations of the Company pursuant to this clause 8 above or from the provisions of clause 13.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program or to update the Initial Development Program, the Company shall inform submit to Yeda in writing, of a further Development Program in respect of such additional Products or updates and the provisions of this clause 8 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis.
8.6. The Company agrees to supply to Yeda and/or the Institute, for (and in quantities customary for) academic research purposes, any Products developed and/or manufactured and/or produced under this Agreement at no cost to Yeda, the Institute or the Scientists.
8.7. The Company shall ▇m▇▇▇, and cause all its Sublicensees and Further Sublicensees to ▇m▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 1 contract
Sources: Research and License Agreement (Protalix BioTherapeutics, Inc.)
Development and Commercialization. 8.1. Within 1 (one) year of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM").
8.25.1. The Company undertakes, at its own expense, to use best commercially reasonable efforts to commercialise the Products and, without derogating from the generality of the aforegoingforegoing, to use its best commercially reasonable efforts to expedite the commencement of the commercial sale of the Products, in accordance with the development program (the “Initial Development Program”) which shall be attached as Appendix B hereto within 90 (ninety) days of the date of signature of this Agreement, in such form to be proposed by the Company and approved by Yeda. For such purpose and without derogating from the generality of the aforegoingforegoing nor from the Company’s discretion, under the terms of this Agreement, as to development and commercialisation of any Product, the Company shall: (i) invest in those research and development activities; and (ii) shall use commercially reasonable efforts to carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II and III clinical the trials), tests and other works and activities, all as activities detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works Program and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, 5.4 below in accordance with the respective timetables timetable included therein. The Company further undertakes to continue use commercially reasonable efforts in continuing with commercialisation of the Products diligently throughout the period of the Licence.
8.35.2. The Company shallshall provide Yeda, after the delivery to, and approval by, Yeda on each anniversary of the Initial Development Program under clause 8.1 abovedate of this Agreement, provide Yeda on June 30 and December 31 of each calendar year with a written progress reports report ("PROGRESS REPORTS") “Progress Report”), which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials (if applicable) conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 belowProgram; (ii) manufacturing, sublicensing, marketing and sales during the preceding 6 12 (sixtwelve) months; (iii) the Company's ’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 6 12 (sixtwelve) months; and (iv) projections of sales and marketing efforts; and (v) the amount of money raised, if any, by the Company in any manner during the preceding 12 (twelve) months; and (vi) a summary of all protocols or minutes of meetings with the FDA, EMEA or any other regulatory authority in connection with any Product and copies of any opinions, decisions, and approvals issued by any of the aforementioned authorities. If the Company has provided a Development Program for more than 1 (one) Product, and to the extent that the Initial Development Program relates to more than 1 (one) Product, then such Progress Report shall provide such information separately for each such Product. The Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance of the Company hereunder. Ref.: 05-2753-09-18 22 No.: 113177-004 If progress in respect of a Product differs in a material respect or detail from that anticipated in the Initial Development Program or a Development Program relating to such Product, or a preceding Progress Report, then the Company shall modify the Initial Development Program or Development Program, as the case may be, for Yeda’s review and approval (not to be unreasonably withheld).
8.45.3. For ▇▇▇▇ acknowledges and agrees that the removal Initial Development Program or any Development Program include forecasts, based on assumptions and facts and dependent on future conditions, which are beyond the Company’s control and ability to anticipate, and that the commercialisation of doubtProducts requires additional extensive research and investment, which despite the Company’s efforts may not bear fruit or become available. Therefore, without derogating from the remaining provisions of this clause 8 5 (including without limitation the Company’s undertakings to use commercially reasonable efforts to commercialise, and to expedite the commencement of the commercial sale of, the Products, and to perform the Development Program) or of clause 13.2 11 below, nothing contained in this Agreement shall be construed as a warranty by the Company that the Initial Development Program or any Development Program to be carried out by it as aforesaid will actually materialize or achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out respect of any such Development Program or to any forecast contained therein, including without limitation, the production of any Product and/or the commercialisation thereof. Except as provided in clause 11 below, the Company shall not be subject to any liability or other adverse consequences solely due to the failure to reach any milestone, provided that it shall fulfill its undertakings to use commercially reasonable efforts to commercialise, and to expedite the commencement of the commercial sale of, the Products, and to perform the Development Program.
8.55.4. Without derogating from the obligations of the Company pursuant to this clause 8 above 5 or from the provisions of clause 13.2 11 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall inform Yeda in writingsubmit to Yeda, of for its written approval (not to be unreasonably withheld), a further Development Program in respect of such additional Products and the provisions of this clause 8 5 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis. Ref.: 05-2753-09-18 23 No.: 113177-004
5.5. For the removal of doubt, nothing contained in this Agreement shall prevent Yeda or the Institute from using the Licensed Information for academic research or other scholarly purposes, subject to the provisions of clause 7.6 hereinafter.
8.65.6. The Company shall ▇▇▇▇mark, and cause shall include in all its Sublicensees agreements with Sublicensees, the obligation to ▇▇▇▇, mark all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
5.7. Without derogating from the foregoing in this clause 5, the Company undertakes to use commercially reasonable efforts to achieve each of the milestones set forth below with respect to the Product specified in sub-clause 1.2.8(iv) above (“the Milestones”):
(a) within 2 (two) years from the signature of this Agreement to commence pre-clinical activities directed toward the submission of an IND with respect to a Product;
(b) within 3 (three) years from the commencement of pre- clinical activities, to file an IND (or any equivalent application) with respect to a Product;
(c) within 3 (three) years from IND filing, to commence a phase I clinical trial;
(d) within 4 (four) years from the commencement of a phase I clinical trial, to commence a phase III clinical trial;
(e) within 4 (four) years from the commencement of a phase III clinical trial, to receive regulatory approval for commencement of sales;
Appears in 1 contract
Development and Commercialization. 8.16.1. Within 1 (one) year of the date of signature of this Agreement, the The Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a has submitted an initial Development Program for the development of Products (such to Yeda, for its approval. The Development Program, as approved by Yeda, "THE INITIAL DEVELOPMENT PROGRAM"is attached hereto as Appendix B (“the initial Development Program”).
8.26.2. The Company undertakes, at its own expense, to use best efforts take all necessary steps to commercialise the Products and, without derogating from the generality of the aforegoing, to use its best efforts to expedite the commencement of the commercial sale of the Products. For such purpose and without derogating from the generality of the aforegoing, the Company shall: (i) invest in those research and development activities; and (ii) shall carry out and/or have a third party carry out on its behalf the performance of those trials (including phases I, II II, and III clinical trials), tests and other works and activities, all as detailed in the Initial Development Program, in accordance with the timetable specified therein. The Company also undertakes to perform all such other tests, works and activities as are detailed in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 6.5 below, in accordance with the respective timetables included therein, as may be amended by the Company from time to time, subject to Yeda’s prior written consent which should not be withheld unreasonably. The Company further undertakes to continue with commercialisation of the Products diligently throughout the period of the Licence.
8.36.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, shall provide Yeda on June 30 and December 31 of each calendar year with written progress reports ("PROGRESS REPORTS"“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 6.5 below; (ii) manufacturing, sublicensing, marketing and and. sales during the preceding 6 (six) months; (iii) the Company's ’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 6 (six) months; and (iv) projections of sales and marketing efforts. The ; and (v) the amount of money raised, if any, by the Company shall also provide any reasonable additional data that Yeda requires to evaluate the performance by way of the Company hereunderissuance of any irredeemable share capital during the preceding 6 (six) months.
8.46.4. For the removal of doubt, without derogating from the remaining provisions of this clause 8 6 or of clause 13.2 10.2 below, nothing contained in this Agreement shall be construed as a warranty by the Company that any Development Program to be carried out by it as aforesaid will actually achieve its aims and the Company makes no warranties whatsoever as to any results to be achieved in consequence of the carrying out of any such Development Program.
8.56.5. Without derogating from the obligations of the Company pursuant to this clause 8 6 above or from the provisions of clause 13.2 10.2 below, in the event that the Company shall wish to develop and/or commercialise Products in addition to those specified in the Initial Development Program, the Company shall inform Yeda in writingsubmit to Yeda, of for its written approval (not to be unreasonably withheld), a further Development Program in respect of such additional Products and the provisions of this clause 8 6 shall apply also with respect to such further Development Program and to the development and commercialisation of such additional Products, mutatis mutandis.
8.66.6. The Company shall ▇▇▇▇, and cause all its Sublicensees to ▇▇▇▇, all Products that are manufactured or sold under this Agreement with the number or numbers of each Patent applicable to such Product.
Appears in 1 contract
Sources: Licensing Agreement (BiondVax Pharmaceuticals Ltd.)