Development and Commercialization. 8.1. Within 18 (eighteen) months of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, “the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1 8.2. The Company undertakes, at its own expense, to take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. 8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on December 31 of each calendar year with written progress reports (“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 12 (twelve) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the 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 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 submit to Yeda, 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 xxxx, and cause all its Sublicensees to xxxx, 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
Samples: Research and License Agreement (Brainsway Ltd.), Research and License Agreement (Brainsway Ltd.)
Development and Commercialization. 8.1. Within 18 1 (eighteenone) months 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”"THE INITIAL DEVELOPMENT PROGRAM"). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, to take all commercially reasonable steps use best efforts to commercialise the Products and, without derogating from the generality of the foregoingaforegoing, to use commercially reasonable its best efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the LicenceProducts. For such purpose and without derogating from the generality of the aforegoing, the Company shall 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 the those trials (including phases I, II and III clinical trials), tests and other works and activities activities, all as detailed in the Initial Development Program 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”"PROGRESS REPORTS") which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 12 6 (twelvesix) months; and (iii) the Company’s 's plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 6 (twelvesix) months; and (iv) projections of sales and marketing efforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the reason therefor and prepare a modified Development Program for Yeda’s review subject to and without derogating from the milestones set in 13.2 belowefforts. 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 submit to Yedainform Yeda in writing, for its written approval (not to be unreasonably withheld), 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 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 xxxx, and cause all its Sublicensees to xxxx, 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
Samples: Research and License Agreement (Bert Logic Inc), Research and Licensing Agreement (Tissera Inc)
Development and Commercialization. 8.1. Within 18 (eighteen) months [***]of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda a Development Program for the development of Products (such Development Program, as approved by Yeda, “the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, [***] to take all commercially reasonable necessary steps to develop and commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable its best efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the LicenceProducts. 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 carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. 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 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 (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 12 (twelve) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following efforts; and (v) a summary of all protocols or minutes of meetings with the First Commercial SaleFDA, 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 subject to and without derogating from the milestones set in 13.2 belowreview. 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 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 submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda 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 lend (for no consideration) supply to Yeda and/or the Institute one unit of the Product Institute, for (and in quantities customary for) academic research purposes, any Products developed and/or manufactured and/or produced under this AgreementAgreement at no cost to Yeda, for academic research purposes onlythe Institute or the Scientists.
8.7. The Company shall xxxxmxxx, and cause all its Sublicensees and Further Sublicensees to xxxxmxxx, 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. 8.16.1. Within 18 (eighteen) months 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, is attached hereto as Appendix B (“the Initial 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
8.26.2. The Company undertakes, at its own expense, to take all commercially reasonable necessary steps to commercialise the Products and, without derogating from the generality of the foregoingaforegoing, to use commercially reasonable its best efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the LicenceProducts. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the those trials (including phases I, II, and III clinical trials), tests and other works and activities activities, all as detailed in the Initial Development Program 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.
8.3, 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 shall, after the delivery to, and approval by, Yeda further undertakes to continue with commercialisation of the Initial Development Program under clause 8.1 above, Products diligently throughout the period of the Licence.
6.3. The Company shall 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 6.5 below; (ii) manufacturing, sublicensing, marketing and and. sales during the preceding 12 6 (twelvesix) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 6 (twelvesix) months; and (iv) projections of sales and marketing efforts following efforts; and (v) the First Commercial Sale. If progress in respect amount of a Product differs from that anticipated in its Development Program or preceding Progress Reportmoney raised, then if any, by 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 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 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.
8.56.5. 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 submit to Yeda, 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.
8.6. 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.
8.76.6. The Company shall xxxx, and cause all its Sublicensees to xxxx, 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
Samples: Licensing Agreement (BiondVax Pharmaceuticals Ltd.)
Development and Commercialization. 8.1. Within 18 (eighteen) months of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), a Development Program for the development of Products (such Development Program, as approved by Yeda, “the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, to take all commercially reasonable steps to commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable efforts to expedite the commencement of the commercial sale of the Products and use commercially reasonable efforts to continue with marketing and sale of the Products throughout the term of the Licence. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein.
8.3. The Company shall, after the delivery to, and approval by, Yeda of the Initial Development Program under clause 8.1 above, provide Yeda on December 31 of each calendar year with written progress reports (“Progress Reports”) which shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Initial Development Program or any other Development Program delivered and approved pursuant to clause 8.5 below; (ii) manufacturing, sublicensing, marketing and sales during the preceding 12 (twelve) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following the First Commercial Sale. If progress in respect of a Product differs from that anticipated in its Development Program or preceding Progress Report, then the Company shall explain, in its Progress Report, the 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 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 submit to Yeda, 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.
8.7. The Company shall xxxx, and cause all its Sublicensees to xxxx, 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 18 (eighteen) months [***]of the date of signature of this Agreement, the Company shall submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda a Development Program for the development of Products (such Development Program, as approved by Yeda, “the Initial Development Program”). Such Initial Development Program may be updated by the Company from time to time based on reasonable grounds to be notified to Yeda in writing, subject to the Company’s discretion and without derogating from the milestones set in 13.2.1 below. Ref: 05-2595-04-4 No.: 60604-001 L/88017/4000/407949/1
8.2. The Company undertakes, at its own expense, [***] to take all commercially reasonable necessary steps to develop and commercialise the Products and, without derogating from the generality of the foregoing, to use commercially reasonable its best efforts to expedite the commencement of the commercial sale of the Products Products. For [***] Portions of this exhibit were omitted and use commercially reasonable efforts to continue filed separately with marketing and sale the Secretary of the Products throughout Securities and Exchange Commission pursuant to the term Registrant’s application requesting confidential treatment under Rule 24b-2 of the LicenceExchange Act. For such purpose and without derogating from the generality of the aforegoing, the Company shall carry out and/or have a third party carry out on its behalf the performance of the trials, tests and other works and activities detailed in the Initial Development Program and in all further Development Programs (if any) submitted and approved pursuant to clause 8.5 below, in accordance with the respective timetables included therein. 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 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 (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 12 (twelve) months; and (iii) the Company’s plans in respect of the testing, undertaking of trials (if applicable) or commercialisation of Products for the following 12 (twelve) months; and (iv) projections of sales and marketing efforts following efforts; and (v) a summary of all protocols or minutes of meetings with the First Commercial SaleFDA, 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 subject to and without derogating from the milestones set in 13.2 belowreview. 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 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 submit to Yeda, for its written approval (not to be unreasonably withheld), Yeda 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 lend (for no consideration) supply to Yeda and/or the Institute one unit of the Product Institute, for (and in quantities customary for) academic research purposes, any Products developed and/or manufactured and/or produced under this AgreementAgreement at no cost to Yeda, for academic research purposes onlythe Institute or the Scientists.
8.7. The Company shall xxxxmxxx, and cause all its Sublicensees and Further Sublicensees to xxxxmxxx, 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
Samples: Research and License Agreement (Protalix BioTherapeutics, Inc.)