Development and Commercialization. The Clinical Development and Collaboration Agreement shall, among other things, require that Company and the Transferee establish a Joint Steering Committee (“Joint Steering Committee” or “JSC”) to oversee Development of Covered Products until the First Commercial Sale of a Covered Product in the Territory, unless otherwise agreed in writing by Company and the Transferee. The JSC will be comprised of an equal number of members appointed by the Transferee and by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions of this Agreement, the Clinical Development and Collaboration Agreement and Law. The JDC will be responsible for coordinating amendments to any plan for Development in respect of a Covered Product for use in the Field in the Territory for review and approval by the JSC, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunder.
Appears in 1 contract
Samples: Technology Transfer Agreement
Development and Commercialization. 6.1. The Clinical Development Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and Collaboration Agreement shallmarketing work necessary to develop and commercialize Products in accordance with a written plan (with milestones, among other thingstimetable and budgeting), require that for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the Transferee "Development Plan") a copy of which, that meets Yissum’s reasonable approval, shall be finalized by the Company and attached to this Agreement as Appendix 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, such approval not to be unreasonably delayed or denied, but 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.
6.2. The parties shall establish a Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) to oversee the exercise of the License. Each party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least twice 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 with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months concerning all material activities undertaken in respect of Covered the exercise of the License, (ii) keep Yissum informed 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 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 effected by the Company or by any Affiliate or 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 until for the following 12 (twelve) months; and (iii) projections of sales and marketing efforts following the First Commercial Sale 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 Covered Product in the Territory, unless otherwise agreed in writing by Company and the Transferee. The JSC will be comprised marketing thereof; as well as a description of an equal number of members appointed by any corporate transaction involving the Transferee and by Company. The JSC shall oversee Products or the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one voteLicensed Technology. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions of this Agreement, the Clinical Development and Collaboration Agreement and Law. The JDC will be responsible for coordinating amendments to any plan for Development progress in respect of a Covered 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 prepare a modified Development Plan 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 Licensed Technology in the Field Field.
6.4. Upon completion of the development of any Product, the Company undertakes to use commercially reasonable efforts necessary to maximize Net Sales of such Product on a regular and consistent basis.
6.5. The Development Plan shall contain certain milestones designated therein as essential milestones (“Essential Milestone/s”). Failure to meet an Essential Milestone by the date set out in the Territory Development Plan for review achieving such Essential Milestone (or any modified date pursuant to section 6.1 above or this section 6.5 below), shall entitle Yissum to termination rights in accordance with section 16 below. The Company shall be entitled to extend the period for meeting an Essential Milestone (“Milestone Extension”) in accordance with the following:
a. The Company shall be entitled to a Milestone Extension of six months for each Essential Milestone
b. The Company shall be entitled to a Milestone Extension for the period of force majeure and approval by any period for which the JSC, for overseeing such Development work, Company and for making operational decisions related to such Development work. Unless otherwise Yissum have agreed in writing by to amend the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration AgreementPlan. The Clinical Development and Collaboration Agreement shall, among other things, require that Company's failure to meet the date set for so long as an Essential Milestone together with the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work relevant Milestone Extension shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions 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 Lawregulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder.
6.7. Prior The Company agrees to provide Yissum and/or the First Commercial Sale University (for no consideration) a reasonable number units of a Covered any Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territorydeveloped and/or manufactured under this Agreement, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunderacademic research purposes only.
Appears in 1 contract
Samples: Research and License Agreement (Pathfinder Cell Therapy, Inc.)
Development and Commercialization. 5.1. The Clinical Company undertakes, at its own expense, to use commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plan approved by Yissum, a copy of which shall be attached to this Agreement as Appendix 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, but without derogating from the dates of the achievement of the Milestones set forth in this Section 5. All terms and Collaboration conditions of the License and this Agreement shallshall apply to the modified Development Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, among other things, require that the Company and undertakes to use commercially reasonable efforts to meet all of the Transferee following milestones identified in Section 7.3 below for at least one Product (the “Development Milestones”).
5.2. The Parties shall establish a Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) to oversee the Research, Research program and the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least twice 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 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) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months concerning all material activities undertaken in respect of Covered the exercise of the License, (ii) keep Yissum informed 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 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 effected by the Company or by 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 until for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale 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 Covered Product and the marketing thereof; 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 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 performance of the Company hereunder.
5.3. The Company shall pursue the development and registration of, at least one Product in the TerritoryUS for the indications set forth in the Development 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 below, shall not release the Company from its obligation as stated in this Section.
5.5. If the Company shall not meet the Development Milestones or shall not commercialize the Products within a reasonable time frame, unless otherwise such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing by 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 TransfereeCompany one hundred eighty (180) days to cure such failure of diligence. The JSC will be comprised of an equal number of members appointed by the Transferee and by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having ’s failure to cure within such one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable hundred eighty (180) day period to decide or resolve unanimously any matter properly presented to it for action, then such matter Yissum’s reasonable satisfaction shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions material breach of this Agreement, the Clinical Development and Collaboration Agreement and Lawentitling Yissum to immediate termination under Section 15.2 below.
5.6. The JDC will be responsible 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 coordinating amendments 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 plan for Development in respect of a Covered Product for use in the Field in the Territory for review and approval by the JSCdeveloped or manufactured under this Agreement at cost, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunderacademic research purposes only.
Appears in 1 contract
Samples: Research and License Agreement (Virpax Pharmaceuticals, Inc.)
Development and Commercialization. 5.1. The Clinical Company undertakes, at its own expense, to use commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plan (including the Essential Development Milestones defined below) agreed by Yissum, a copy of which shall be incorporated into this Agreement as Appendix 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 (the "Board"), in its sole and Collaboration absolute discretion, provided however that the Company shall amend any of the milestones set forth in 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 shallshall 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, among other thingsthen Yissum shall be entitled, require that at its sole discretion, to terminate without cause, with immediate effect, this Agreement and all rights of the Company and hereunder, upon written notice to the Transferee Company of such termination.
5.2. The Parties shall establish a Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least twice 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 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, for the period of the License, (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months concerning all material activities undertaken in respect of Covered the exercise of the License, (ii) keep Yissum informed 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: (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 effected by the Company or by any Affiliate or 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 until for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale 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 Covered Product in the Territory, unless otherwise agreed in writing by Company and the Transfereemarketing thereof; 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 prepare a modified Development Plan for Yissum’s review. The JSC will be comprised Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of an equal number the Company hereunder.
5.3. Upon completion of members appointed by the Transferee 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 by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one voteconsistent basis.
5.4. If the JSC Company shall not meet one of the Essential Development Milestones within the timeframe set out in the Development Plan for the attainment of the said Essential Development Milestone, unless such delay is unable caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 18.9, below; Yissum shall notify the Company in writing of the Company's failure to decide meet its obligations of diligence and shall allow the Company one hundred and twenty (120) days to cure 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 failure to cure such failure, to Yissum's reasonable satisfaction, within the aforementioned cure period (or resolve unanimously any matter properly presented to it for action, then such matter extended cure period) shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions material breach of this Agreement, the Clinical Development and Collaboration Agreement and Lawentitling Yissum to immediate termination under Section 16.3 below.
5.5. The JDC will be responsible for coordinating amendments to any plan for Development Company shall perform all its activities hereunder in respect of a Covered Product for use in the Field in the Territory for review accordance with all applicable laws and approval by the JSC, for overseeing such Development workregulations, and shall procure the receipt of all approvals and consents necessary for making operational decisions related to such Development work. Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities its obligations hereunder.
Appears in 1 contract
Development and Commercialization. 5.1. The Clinical Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development and Collaboration Plans, a copy of which is attached to this Agreement shallas Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, among other thingshowever, require that Company and changes to the Transferee establish a Joint Steering Committee specified dates for the achievement of the Milestones set forth in the Development Plans (the “Joint Steering Committee” or “JSCDevelopment Milestones”) shall be subject to oversee Development of Covered Products until the First Commercial Sale of a Covered Product in the TerritoryYissum’s prior written approval, unless otherwise agreed in writing by Company and the Transferee. The JSC will not to be comprised of an equal number of members appointed by the Transferee and by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territoryunreasonably conditioned, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development planwithheld or delayed. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions of the License and this Agreement shall apply to the modified Development 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 be a forum for the exchange of information between the Parties with respect to the exercise 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 Clinical Development Committee shall act only in an advisory capacity and Collaboration Agreement and Lawshall not have decision-making powers. The JDC will be responsible Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’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 effected by the Company or by any Affiliate or Sublicensee during the 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 coordinating amendments to 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 plan for Development milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Covered Product for use differs from that anticipated in its Development Plan or a preceding Development Report, the Field Company shall 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 Territory for review performance of the Company hereunder.
5.3. [RESERVED]
5.4. [RESERVED]
5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and approval by the JSC, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise Yissum have agreed in writing by to amend the Transferee Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and Companyshall allow the Company 120 days to cure such failure. If, until the First Commercial Sale of a Covered Product in the Territoryto Yissum’s reasonable satisfaction, the JDC will meet on a regular basisCompany 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 times and in such manner as provided in Clinical Development and Collaboration Agreementfailure by an additional period of up to sixty (60) days. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as Company’s failure to cure within the Transferee aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a Permitted Transferee) is preparing material breach of this Agreement, entitling Yissum to Commercialize a Covered Product(s) 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 Territoryreceipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. Where legally permissible, the day-to-day Commercialization preparation work shall be conducted under Company agrees to provide Yissum and/or the direction of University (for no consideration) a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal reasonable number of representatives from units of any Product developed and/or manufactured under this Agreement, at the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory’s discretion, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunderinternal academic research purposes only.
Appears in 1 contract
Samples: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.1. The Clinical Company undertakes, at its own expense, to use commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plan (including the Essential Development Milestones defined below) agreed by Yissum, a copy of which shall be incorporated into this Agreement as Appendix 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 (the “Board”), in its sole and Collaboration absolute discretion, provided however that the Company shall amend any of the milestones set forth in 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 shallshall 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, among other thingsthen Yissum shall be entitled, require that at its sole discretion, to terminate without cause, with immediate effect, this Agreement and all rights of the Company and hereunder, upon written notice to the Transferee Company of such termination.
5.2. The Parties shall establish a Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least twice 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 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, for the period of the License, (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months concerning all material activities undertaken in respect of Covered the exercise of the License, (ii) keep Yissum informed 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: (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 effected by the Company or by any Affiliate or 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 until for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale 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 Covered Product in the Territory, unless otherwise agreed in writing by Company and the Transfereemarketing thereof; 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 prepare a modified Development Plan for Yissum’s review. The JSC will be comprised Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of an equal number the Company hereunder.
5.3. Upon completion of members appointed by the Transferee 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 by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one voteconsistent basis.
5.4. If the JSC Company shall not meet one of the Essential Development Milestones within the timeframe set out in the Development Plan for the attainment of the said Essential Development Milestone, unless such delay is unable caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 18.9, below; Yissum shall notify the Company in writing of the Company’s failure to decide meet its obligations of diligence and shall allow the Company one hundred and twenty (120) days to cure 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 failure to cure such failure, to Yissum’s reasonable satisfaction, within the aforementioned cure period (or resolve unanimously any matter properly presented to it for action, then such matter extended cure period) shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions material breach of this Agreement, the Clinical Development and Collaboration Agreement and Lawentitling Yissum to immediate termination under Section 16.3 below.
5.5. The JDC will be responsible for coordinating amendments to any plan for Development Company shall perform all its activities hereunder in respect of a Covered Product for use in the Field in the Territory for review accordance with all applicable laws and approval by the JSC, for overseeing such Development workregulations, and shall procure the receipt of all approvals and consents necessary for making operational decisions related to such Development work. Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities its obligations hereunder.
Appears in 1 contract
Samples: Research and License Agreement (Therapix Biosciences Ltd.)
Development and Commercialization. 5.1. The Clinical Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development and Collaboration Plans, a copy of which is attached to this Agreement shallas Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, among other thingshowever, require that Company and changes to the Transferee establish a Joint Steering Committee specified dates for the achievement of the Milestones set forth in the Development Plans (the “Joint Steering Committee” or “JSCDevelopment Milestones”) shall be subject to oversee Development of Covered Products until the First Commercial Sale of a Covered Product in the TerritoryYissum’s prior written approval, unless otherwise agreed in writing by Company and the Transferee. The JSC will not to be comprised of an equal number of members appointed by the Transferee and by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territoryunreasonably conditioned, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development planwithheld or delayed. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance with the terms and conditions of the License and this Agreement shall apply to the modified Development 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 be a forum for the exchange of information between the Parties with respect to the exercise 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 Clinical Development Committee shall act only in an advisory capacity and Collaboration Agreement and Lawshall not have decision-making powers. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. The JDC will be responsible Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’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 effected by the Company or by any Affiliate or Sublicensee during the 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 coordinating amendments to 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 plan for Development milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Covered Product for use differs from that anticipated in its Development Plan or a preceding Development Report, the Field Company shall 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 Territory for review performance of the Company hereunder.
5.3. [RESERVED]
5.4. [RESERVED]
5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and approval by the JSC, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise Yissum have agreed in writing by to amend the Transferee Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and Companyshall allow the Company 120 days to cure such failure. If, until the First Commercial Sale of a Covered Product in the Territoryto Yissum’s reasonable satisfaction, the JDC will meet on a regular basisCompany 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 times and in such manner as provided in Clinical Development and Collaboration Agreementfailure by an additional period of up to sixty (60) days. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as Company’s failure to cure within the Transferee aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a Permitted Transferee) is preparing material breach of this Agreement, entitling Yissum to Commercialize a Covered Product(s) immediate termination under Section 15.2 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the Territoryreceipt of all approvals and consents necessary for the performance of its obligations hereunder.
5.7. Where legally permissible, the day-to-day Commercialization preparation work shall be conducted under Company agrees to provide Yissum and/or the direction of University (for no consideration) a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal reasonable number of representatives from units of any Product developed and/or manufactured under this Agreement, at the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory’s discretion, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunderinternal academic research purposes only.
Appears in 1 contract
Samples: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.1. The Clinical Development Company undertakes, at its own expense, to use its best efforts to carry out the development, regulatory, manufacturing and Collaboration Agreement shall, among other things, require that Company marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the Transferee 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 Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) to oversee Development the exercise of Covered Products until the First Commercial Sale of a Covered Product in License including the TerritoryCompany’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), unless otherwise agreed in writing by Company and the Transfereewhich shall meet at least once every six (6) months. The JSC will Representatives shall be comprised of an equal number of members appointed bound by the Transferee and by Company. The JSC shall oversee the Development of Covered Products confidentiality arrangements set out in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, then such matter shall be resolved as provided in the definitive Clinical Development and Collaboration this Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final and shall be in compliance consult with the terms and conditions of this AgreementYissum, the Clinical Development and Collaboration Agreement and Law. The JDC will be responsible for coordinating amendments to any plan for Development via Yissum's Representatives, in respect of a Covered Product for use in the Field in the Territory for review and approval by the JSC, for overseeing such Development work, and for making operational significant decisions related to such Development workthe exercise of the License. Unless otherwise agreed in writing by For the Transferee and Company, until the First Commercial Sale avoidance of a Covered Product in the Territorydoubt, the JDC will meet on Committee shall be a regular basisforum for the exchange of information between the Parties with respect to the foregoing matters, at such times shall act only in an advisory capacity and in such manner as provided in Clinical Development and Collaboration Agreementshall not have decision-making powers. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee Company shall (or a Permitted Transfereei) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party 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 least 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 Calendar Quarter basis 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 report, via e-mail, general assessment regarding the status achievement of Commercialization activities hereunderany 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
Samples: Research and License Agreement (Immune Pharmaceuticals Inc)
Development and Commercialization. 5.1. The Clinical Development Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and Collaboration Agreement shall, among other things, require that Company marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the Transferee 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 BNS’ 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 Joint Steering Committee steering committee (the “Joint Steering Committee” or “JSC”) 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 6 months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNS, via BNS’ 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 BNS via BNS’ Representatives with periodic written reports (“Development Reports”) not less than once per every 6 months from the Effective Date concerning all material activities undertaken in respect of Covered Products until the First Commercial Sale exercise of the License, (ii) keep BNS informed via BNS’ 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 BNS’ reasonable request, from time to time, provide BNS 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 6 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 Covered 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 TerritoryField. 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 commercial reasonable efforts to sublicense the particular indication or use of the Product provided the sublicense has no negative economic or regulatory impact on the overall development and commercialization 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 6, 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 timeframe in major markets (US, EU), unless otherwise such delay is caused by (i) the requirements of a regulatory authority; (ii) force majeure; (iii) unfavorable economic conditions or (iv) unless the Company and BNS have agreed in writing by to amend the Development Plan, BNS shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the TransfereeCompany 90 days to cure its failure of diligence. The JSC will be comprised of an equal number of members appointed by the Transferee and by Company. The JSC shall oversee the Development of Covered Products in the Field in the Territory, and shall plan, implement, and oversee activities relating thereto, including the preparation and implementation of a development plan. All JSC decisions will be made by unanimous vote, with the JSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable ’s failure to decide or resolve unanimously any matter properly presented cure within such 90 day period to it for action, then such matter BNS’ reasonable satisfaction shall be resolved as provided in the definitive Clinical Development and Collaboration a material breach of this Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Joint Development Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be final entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and shall be in compliance with the all material terms and conditions of this Agreementthe Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the Clinical Development and Collaboration Agreement and Law. The JDC will be responsible for coordinating amendments avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to any plan for Development in respect make use of a Covered Product for use in the Field in Licensed Technology on behalf of the Territory for review and approval by the JSC, for overseeing such Development workCompany, and for making operational decisions related which use the Company is required to such Development workpay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Unless otherwise agreed in writing by Upon submission of its request to obtain the Transferee written consent of BNS to a Sublicense, the Company shall fully disclose and Companysubmit to BNS all documentation relating to the Sublicense, until the First Commercial Sale of a Covered Product adequately disclose to BNS any other business connection which it now has or is in the Territory, process of forming with the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that for so long as the Transferee (or a Permitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the day-to-day Commercialization preparation work shall be conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The JCC shall be comprised of an equal number of representatives from the Transferee and Company. All JCC decisions will be made by unanimous vote. If the JCC is unable to decide or resolve any matter properly presented to it for action, then Sublicensee which may reasonably effect the decision of the Transferee shall be final and in compliance with the Company regarding terms and conditions of the Sublicense; and shall notify BNS in writing, whether a proposed Sublicensee is an Affiliate or is otherwise related to the Company. In addition, the Company shall provide BNS with an executed copy of the Sublicense (or Sublicense amendment, as the case may be) within 10 days of its execution.
5.6. If the Company is unable or unwilling to serve or develop a potential market or market territory for which there is another party willing to be a sublicensee, the Company will, at BNS’ request, negotiate in good faith a sublicense with such party, unless such a sublicense would negatively impact from economic or regulatory standpoint the global development and commercialization of the product.
5.7. Any Sublicense shall be dependent on the validity of the License and shall terminate upon termination of the License.
5.8. The Company shall ensure that any Sublicense shall include material terms that bind the Sublicensee to observe the terms of this Agreement, including, but not limited to, Section 14, below, the breach of which terms shall be a material breach resulting in the prompt termination of the Sublicense. In such an event, the Company undertakes to take all reasonable steps to enforce such terms upon the Sublicensee, including the termination of the Sublicense. In all cases, the Company shall immediately notify BNS of any breach of the material terms of a Sublicense, and shall copy BNS on all correspondence with regard to such breach.
5.9. The Company shall require any Sublicensee to provide it with royalty reports that include at least the detail that the Company is required to produce pursuant to Section 7.2, below. Upon request, the Company shall produce such reports to BNS.
5.10. Any act or omission of the Sublicensee which is not promptly remedied by the Company or the Sublicensee and which would have constituted a breach of this Agreement and Law. Prior to by the First Commercial Sale of a Covered Product (Company had it been an act or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance omission of the Commercialization programCompany, and for making operational decisions related which the Company has not used commercially reasonable efforts to that program. Periodicallypromptly cure, a member including termination of the JCC for each party Sublicense, shall provide constitute a breach of this Agreement by the Company.
5.11. For the avoidance of any doubt it is hereby declared that under no circumstance whatsoever shall a Sublicensee be entitled to grant the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide Sublicense or any part thereof to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunderany third party.
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Samples: Research and License Agreement (Immune Pharmaceuticals Inc)