Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum’s approval, which shall not be unreasonably denied, conditioned or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. 5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every six (6) months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include a summary of the Development Results and any other related work performed by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the six month period prior to the report. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; a description of any corporate transaction involving the Products or the Licensed Technology; and shall detail all proposed changes to the Development Plan, including the reasons therefore. 5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Product. 5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, below, shall not release the Company from its obligation as stated in this section. If the Company shall not commercialize the Products within a reasonable time frame, unless such delay is caused by (i) the requirements of a regulatory authority; (ii) force majeure; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's failure to meet its obligations of diligence and shall allow the Company ninety (90) days to cure its failure of diligence. The Company's failure to cure within such ninety (90) day period to Yissum's reasonable satisfaction shall be a material breach of this Agreement.
Appears in 1 contract
Sources: Research and License Agreement (Immune Pharmaceuticals Inc)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products Development Plan approved by Yissum, a copy of which is shall be attached to this Agreement as Appendix C. C within sixty (60) days of the Effective Date. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum’s prior written approval, which shall not be unreasonably denied, conditioned or delayedbut without derogating from the dates of the achievement of the Milestones set forth in this Section 5. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet all of the following milestones identified in Section 7.3 below for at least one Product (the “Development Milestones”).
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the Research, Research program and the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least once every six (6) monthstwice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's ’s Committee Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable ’s request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall detail all proposed changes prepare a modified Development Plan for Yissum’s review and approval. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum reasonably requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the of, at least one Product in the Field. In US for the event that indications set forth in the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the ProductDevelopment Plan.
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, Section 7 below, shall not release the Company from its obligation as stated in this sectionSection.
5.5. If the Company shall not meet the Development Milestones or shall not commercialize the Products within a reasonable time frame, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company ninety one hundred eighty (90180) days to cure its such failure of diligence. The Company's ’s failure to cure within such ninety one hundred eighty (90180) day period to Yissum's ’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. The Company agrees to provide Yissum or the University (for no consideration) a defined number of units of any Product developed or manufactured under this Agreement at cost, for academic research purposes only.
Appears in 1 contract
Sources: Research and License Agreement (Virpax Pharmaceuticals, Inc.)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products Development Plan, a copy of which is attached to this Agreement as Appendix C. B. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth abovein the Development Plan; provided, upon however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plan (the “Development Milestones”) shall be subject to Yissum’s prior written approval, which shall not to be unreasonably deniedconditioned, conditioned withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every six (6) months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing mattersexercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis via the Committee concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable ’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the six 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; and . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall detail all proposed changes explain, in its Development Report. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Product.[RESERVED]
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, below, shall not release the Company from its obligation as stated in this section[RESERVED]
5.5. If the Company shall not commercialize meet the Products within a reasonable time framemilestones set forth in the Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company ninety (90) 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of diligenceup to sixty (60) days. The Company's ’s failure to cure within such ninety the aforementioned cure period (90or extended cure period) day period to Yissum's ’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.
Appears in 1 contract
Sources: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.16.1. The Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan (with milestones, timetable and timetable budgeting), for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the "Development Plan") a copy of which is which, that meets Yissum’s reasonable approval, shall be finalized by the Company and attached to this Agreement as Appendix C. D within 120 (one hundred twenty) days from the end of the Research Program that is described in Appendix C of this Agreement and contemplated to be completed within 4 (four) months. The parties agree that the Development Plan will not cover REPEL-CV Products given the funding, development and commercialization by the Company of REPEL-CV Products. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon Yissum’s prior written approval, which shall such approval not to be unreasonably delayed or denied, conditioned or delayedbut without derogating from the dates of the achievement of the significant milestones set forth in the Development Plan. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.26.2. The Parties parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every six (6) monthstwice per calendar year. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the six month period prior to the report, (ii) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 (twelve) months; and (iii) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason for that and shall detail all proposed changes to the prepare a modified Development Plan, including the reasons therefore.
5.3Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder.
6.3. The Company shall use reasonable commercial efforts to pursue the development and registration of all commercially reasonable indications or uses of the Product Licensed Technology in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Product.
5.46.4. Upon completion of the development of any Product, the Company undertakes to perform all use commercially reasonable actions efforts necessary to maximize Net Sales of such Product on a regular and consistent basis.
6.5. Payments of The Development Plan shall contain certain milestones designated therein as essential milestones (“Essential Milestone/s”). Failure to meet an Essential Milestone by the License Maintenance Fee as date set forth out in the Development Plan for achieving such Essential Milestone (or any modified date pursuant to section 7, 6.1 above or this section 6.5 below), shall not release the Company from its obligation as stated entitle Yissum to termination rights in this sectionaccordance with section 16 below. If the The Company shall not commercialize be entitled to extend the Products within period for meeting an Essential Milestone (“Milestone Extension”) in accordance with the following:
a. The Company shall be entitled to a reasonable time frame, unless such delay is caused by (i) Milestone Extension of six months for each Essential Milestone
b. The Company shall be entitled to a Milestone Extension for the requirements period of a regulatory authority; (ii) force majeure; or (iii) unless majeure and any period for which the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's failure to meet its obligations of diligence and shall allow the Company ninety (90) days to cure its failure of diligence. The Company's failure to cure within such ninety (90) day period to Yissum's reasonable satisfaction meet the date set for an Essential Milestone together with the relevant Milestone Extension shall be a material breach of this Agreement entitling Yissum to immediate termination under section 16.2 of this Agreement.
6.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
6.7. The Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number units of any Product developed and/or manufactured under this Agreement, for academic research purposes only.
Appears in 1 contract
Sources: Research and License Agreement (Pathfinder Cell Therapy, Inc.)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products Development Plans, a copy of which is attached to this Agreement as Appendix C. B. The Development Plan Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth abovein the Development Plans; provided, upon however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans (the “Development Milestones”) shall be subject to Yissum’s prior written approval, which shall not to be unreasonably deniedconditioned, conditioned withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every six (6) months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing mattersexercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis via the Committee concerning all material activities and changes to the a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable ’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the six 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; and . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall detail all proposed changes explain, in its Development Report. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Product.[RESERVED]
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, below, shall not release the Company from its obligation as stated in this section[RESERVED]
5.5. If the Company shall not commercialize meet the Products within milestones set forth in a reasonable time frameDevelopment Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company ninety (90) 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of diligenceup to sixty (60) days. The Company's ’s failure to cure within such ninety the aforementioned cure period (90or extended cure period) day period to Yissum's ’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.
Appears in 1 contract
Sources: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products Development Plan, a copy of which is attached to this Agreement as Appendix C. B. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth abovein the Development Plan; provided, upon however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plan (the “Development Milestones”) shall be subject to Yissum’s prior written approval, which shall not to be unreasonably deniedconditioned, conditioned withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every six (6) months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing mattersexercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis via the Committee concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's reasonable ’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the six 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; and . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall detail all proposed changes explain, in its Development Report. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Product.[RESERVED]
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, below, shall not release the Company from its obligation as stated in this section[RESERVED]
5.5. If the Company shall not commercialize meet the Products within a reasonable time framemilestones set forth in the Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company ninety (90) 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of diligenceup to sixty (60) days. The Company's ’s failure to cure within such ninety the aforementioned cure period (90or extended cure period) day period to Yissum's ’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.
Appears in 1 contract
Sources: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its best commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and Development Plan (including the commercialization of Products Essential Development Milestones defined below) agreed by Yissum, a copy of which is attached to shall be incorporated into this Agreement as Appendix C. The C within 45 (forty-five) days of the Effective Date, as such Development Plan may be amended, modified or replaced from time to time as determined by the Board of Directors of the Company as reasonably required (the “Board”), in order to achieve its sole and absolute discretion, provided however that the commercialization goals Company shall amend any of the milestones set forth above, upon Yissum’s approval, which shall not be unreasonably denied, conditioned or delayedin Appendix C under the heading ‘Essential Development Milestone’ (”Essential Development Milestones”) only if the Company first receives the written approval of Yissum for the particular amendment. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. In the event that there is no Development Plan (including the Essential Development Milestones) prepared by the Company that meets Yissum’s approval and is incorporated into this Agreement within 45 (forty-five) days of the Effective Date, then Yissum shall be entitled, at its sole discretion, to terminate without cause, with immediate effect, this Agreement and all rights of the Company hereunder, upon written notice to the Company of such termination.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least once every six (6) monthstwice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's ’s Committee Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall shall, for the period of the License, (i) prepare and provide to Yissum via Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed via Yissum's Representatives on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum's ’s reasonable request, from time to time, provide Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company's business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall detail all proposed changes to the prepare a modified Development Plan, including the reasons therefore.
5.3Plan for Yissum’s review. The Company shall pursue also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the development and registration of commercially reasonable indications or uses performance of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use its best commercial efforts to sublicense the particular indication or use of the Producthereunder.
5.45.3. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in section 7, below, shall not release the Company from its obligation as stated in this section.
5.4. If the Company shall not commercialize meet one of the Products Essential Development Milestones within a reasonable time framethe timeframe set out in the Development Plan for the attainment of the said Essential Development Milestone, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 18.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company ninety one hundred and twenty (90120) days to cure its such failure of diligence. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of up to sixty (60) days. The Company's ’s failure to cure within such ninety (90) day period failure, to Yissum's ’s reasonable satisfaction satisfaction, within the aforementioned cure period (or extended cure period) shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 16.3 below.
5.5. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
Appears in 1 contract
Sources: Research and License Agreement (Therapix Biosciences Ltd.)