Common use of Development and Commercialization Clause in Contracts

Development and Commercialization. 5.1. The 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 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 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. 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 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 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; 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 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. 5.3. 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. 5.4. If the 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 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 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 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: License Agreement (Therapix Biosciences Ltd.)

Development and Commercialization. 5.1. 5.1 The Company undertakes, at its own expense, to use commercially reasonable 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 or subsequent results of any commercial development (the “Development Plan (including the Essential Development Milestones defined below) agreed by YissumPlan”), a copy of which shall be incorporated into is annexed to this Agreement as Appendix C within 45 (forty-five) days of the Effective Date, as such C. The Development Plan may be amended, modified or replaced from time to time as determined by the Board of Directors of Company as reasonably required in order to achieve the Company (the "Board"), in its sole and absolute discretion, provided however that the Company shall amend any of the milestones commercialization goals 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 amendmentabove, upon Yissum’s approval, which shall not be unreasonably withheld, conditioned or delayed. 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. 5.2 The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which who shall meet at least twice per calendar year. year unless the Parties agree otherwise, 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 ’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. It is agreed that any and all expenses incurred in by Yissum’s Representatives as a result of their participation in the Committee shall be borne and paid by the Company. The Parties further agree that the Company shallshall be entitled to convene Committee meetings by telephone or video conference. Notwithstanding anything to the contrary, for including any reports regarding the period of Research, the License, Company shall (ia) provide Yissum via Yissum’s Representatives with periodic written reports in the OCS format (“Development Reports”) not less than once per every six twelve (612) months concerning all material activities undertaken in respect of the exercise of the License, (iib) keep Yissum informed via Yissum’s Representatives substantially on a timely basis concerning all material activities and changes to the Development Plan undertaken in respect of the exercise of the License, and (iiic) 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 elated 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 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; as well as 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. 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 detail all proposed changes to the 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 Plan, including the performance of the Company hereunderreasons therefor. 5.3. 5.3 Upon completion of the development of any ProductProduct as defined in Section 1.1(aa)(y), the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. 5.4. 5.4 If the Company shall not meet one of commercialize the Essential Development Milestones Products, as defined m Section 1 1(aa)(y), within the timeframe set out in the Development Plan for the attainment of the said Essential Development Milestonea reasonable time frame, unless such delay is caused by (ia) the requirements of a regulatory or other governmental authority; (iib) force majeure majeure; (c) lack of commercial viability caused by factors external to the Company, provided that the Company shall make commercially reasonable efforts to remove such factors; or (d) unless the Company and Yissum have agreed in accordance with Section 18.9writing to amend the Development Plan, below; Yissum shall notify the Company in writing of the Company's ’s failure to meet its obligations of diligence and shall allow the Company one hundred and twenty ninety (12090) days to cure such its failure of diligence. If, The Company’s failure to clue within such ninety (90) day period to Yissum’s reasonable satisfaction, satisfaction shall give Yissum the Company is diligently taking measures right to cure such failure, Yissum may, at terminate this Agreement as its sole discretion, notify the Company remedy 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 extended cure period) shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 16.3 belowevent. 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: License and Sponsored Research Agreement (Environmental Impact Acquisition Corp)

Development and Commercialization. 5.1. The 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 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 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. 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 ’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 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 ’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 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; 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 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. 5.3. 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. 5.4. If the 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 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 ’s failure to 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 ’s failure to cure such failure, to Yissum's ’s reasonable 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.)

Development and Commercialization. 5.1The 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 Company undertakes, at its own expense, to use commercially reasonable efforts to carry out JSC will be comprised of an equal number of members appointed by the development, regulatory, manufacturing Transferee and marketing work necessary to develop and commercialize by Company. The JSC shall oversee the Development of Covered Products in accordance 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 Development Plan (including JSC representatives of Company collectively having one vote and the Essential Development Milestones defined below) agreed by YissumJSC 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, a copy of which then such matter shall be incorporated into this 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 Appendix C within 45 the Transferee (fortyand/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the Field in the Territory, the day-five) days to-day Development work shall be conducted under the direction of the Effective DateJoint 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, as such Development Plan may be amended, modified or replaced from time to time as determined by then the Board decision of Directors of the Company (the "Board"), in its sole and absolute discretion, provided however that the Company shall amend any of be final and shall be in compliance with 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 this Agreement, the License Clinical Development 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 Collaboration Agreement and all rights of the Company hereunder, upon written notice to the Company of such termination. 5.2Law. The Parties shall establish a steering committee (the “Committee”) JDC will be responsible for coordinating amendments 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 any plan 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 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 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; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Covered Product differs from 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 anticipated in its Development Plan for so long as the Transferee (or a preceding Development ReportPermitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the Company day-to-day Commercialization preparation work shall explainbe 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 its Development Reportcompliance 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 reason therefor and shall prepare a modified Development Plan JCC will be responsible for Yissum’s review. The Company shall also make reasonable efforts coordinating any amendments to provide Yissum with any reasonable additional data that Yissum requires to evaluate the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Company 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. 5.3. 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. 5.4. If the 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 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 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 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: Technology Transfer Agreement

Development and Commercialization. 5.16.1. The Company undertakes, at its own expense, to use commercially reasonable 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 budgeting), for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the "Development Plan (including the Essential Development Milestones defined belowPlan") agreed by Yissum, a copy of which which, that meets Yissum’s reasonable approval, shall be incorporated into finalized by the Company and attached to this Agreement as Appendix C D within 45 120 (forty-fiveone hundred twenty) days from the end of the Effective DateResearch 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, as such development and commercialization by the Company of REPEL-CV Products. The Development Plan may be amended, modified or replaced from time to time as determined by the Board of Directors 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 Company (the "Board"), in its sole and absolute discretion, provided however that the Company shall amend any achievement of the significant 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 amendmentPlan. 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. 5.26.2. The Parties parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License. Each Party 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 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, 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 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: (ai) 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; (cii) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six 12 (6twelve) months; and (diii) 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; 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 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. 5.36.3. 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. 6.4. 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. 5.46.5. If The Development Plan shall contain certain milestones designated therein as essential milestones (“Essential Milestone/s”). Failure to meet an Essential Milestone by the Company shall not meet one of the Essential Development Milestones within the timeframe date set out in the Development Plan for the attainment of the said achieving such Essential Development MilestoneMilestone (or any modified date pursuant to section 6.1 above or this section 6.5 below), unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure shall entitle Yissum to termination rights in accordance with Section 18.9, section 16 below; Yissum . The Company shall notify 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 any period for which the Company and Yissum have agreed in writing of to amend the Company's failure to 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) daysDevelopment Plan. The Company's failure to cure such failure, to Yissum's reasonable satisfaction, within meet the aforementioned cure period (or extended cure period) date set for an Essential Milestone together with the relevant Milestone Extension shall be a material breach of this Agreement, Agreement entitling Yissum to immediate termination under Section 16.3 belowsection 16.2 of this Agreement. 5.56.6. 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 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 YissumPlans, a copy of which shall be incorporated into is attached to this Agreement as Appendix C within 45 (forty-five) days of the Effective Date, as such B. The Development Plan Plans may be amended, modified or replaced from time to time as determined by the Board of Directors of Company as reasonably required in order to achieve the Company (the "Board"), in its sole and absolute discretion, provided however that the Company shall amend any of the milestones commercialization goals set forth in Appendix C under the heading ‘Essential Development Milestone’ Plans; provided, however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans (the Essential Development Milestones”) only if the Company first receives the shall be subject to Yissum’s prior written approval of Yissum for the particular amendmentapproval, not to be unreasonably 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. In Notwithstanding anything to the event that there is no Development Plan (including contrary contained herein, the Essential Company undertakes to use commercially reasonable efforts to meet the 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 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”), which . The Committee shall meet at least twice once 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. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. The Company shall, for the period of the License, shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per every six (6) months 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 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 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 PlanPlans, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sub-Licensee Sublicensee during the six (6) 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) 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 six (6) 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; 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 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. 5.3. 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.[RESERVED] 5.4. [RESERVED] 5.5. If the Company shall not meet one of the Essential milestones set forth in a Development Milestones within the timeframe set out in the Development Plan for the attainment of the said Essential Development MilestonePlan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 18.917.9, 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 one hundred and twenty (120) 120 days to cure such failure of diligencefailure. 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 such failure, to Yissum's reasonable satisfaction, within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 16.3 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. 5.55.6. 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 undertakes6.1 LICENSEE shall, at its own expense, use reasonable commercial efforts (i) to conduct a research and development program to obtain regulatory approval inside and outside the U.S. for use commercially reasonable efforts to carry out of the development, regulatory, manufacturing LICENSED PRODUCTS for at least one NEONATAL INDICATION and marketing work necessary to develop and commercialize Products the ARDS INDICATION generally 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 attached hereto as Appendix C within 45 3 (forty-fivethe "Development Program"); and (ii) days if, in LICENSEE's opinion, the results of the Effective DateDevelopment Program demonstrate acceptable criteria for safety and efficacy, as to file an NDA or PLA in at least the United States for such LICENSED PRODUCTS for a NEONATAL INDICATION and the ARDS INDICATION. LICENSOR and LICENSEE shall review the Development Plan from time to time. With the mutual agreement of LICENSOR and LICENSEE, the 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 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”Article 6.2(a) 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 below may 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 terminationextended. 5.2. The Parties shall establish a steering committee (the “Committee”) 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 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: 6.2 (a) Without limiting the tests and trials conducted and all other actions taken by the Company pursuant to the Development Planforegoing, 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 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 milestones set forth below shall be an objective measure of a Product and the marketing thereof; as well as a description LICENESEE's use of any corporate transaction involving the Products or the Licensed Technology. If progress reasonable commercial efforts set forth 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 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.this Article 6; 5.3. 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. 5.4. If the 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 caused by (i) the requirements filing of an NDA or PLA for approval of a regulatory LICENSED PRODUCT for marketing in the U.S. [***] provided, however, that if LICENSEE abandons a NEONATAL INDICATION based on unsatisfactory safety or other governmental authority; efficacy data for such indication. [***] [***] Confidential treatment requested. 16 (ii) force majeure commencement of marketing such LICENSED PRODUCT in the U.S. within [***] and (iii) no later than [***] commencement by LICENSEE of a program, either by itself or through a SUBLICENSEE, designed and adequately funded to obtain approval to market such LICENSED PRODUCT in the WESTERN EUROPEAN TERRITORY. [***] Confidential treatment requested. The time periods specified in clauses (i) and (ii) above shall be subject to extension with LICENSOR's written consent, which shall not be withheld if LICENSEE reasonably requires additional time due to unforeseen regulatory or technical difficulties provided that LICENSEE is otherwise exercising the efforts recited in the first sentence of paragraph 6.1 above. In such event, LICENSEE shall provide LICENSOR with a description of its reasons for requesting such extension, its modified schedule and its revised Development Plan for achieving such Milestones in accordance with Section 18.9, below; Yissum shall notify the Company in writing of the Company's failure to 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 extended cure period) shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 16.3 belowmodified schedule. 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: Sublicense Agreement (Discovery Laboratories Inc)