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 a written plan and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon 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 steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 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 the 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 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 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 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 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 Company 90 days to cure its failure of diligence. The Company’s failure to cure within such 90 day period to BNS’ reasonable satisfaction shall be a material breach of this Agreement. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4. 5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Research and License Agreement (Immune Pharmaceuticals 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 a written plan and timetable for the development and Development Plan (including the commercialization of Products Essential Development Milestones defined below) agreed by Yissum, a copy of which is attached to shall be incorporated into this Agreement as Appendix C. The C within 45 (forty-five) days of the Effective Date, as such Development Plan may be amended, modified or replaced from time to time as determined by the Board of Directors of the Company as reasonably required (the “Board”), in order to achieve its sole and absolute discretion, provided however that the commercialization goals Company shall amend any of the milestones set forth above, upon BNSin Appendix C under the heading ‘Essential Development Milestone’ approval, which shall not be unreasonably denied, conditioned or delayed(”Essential Development Milestones”) only if the Company first receives the written approval of Yissum for the particular amendment. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. In the event that there is no Development Plan (including the Essential Development Milestones) prepared by the Company that meets Yissum’s approval and is incorporated into this Agreement within 45 (forty-five) days of the Effective Date, then Yissum shall be entitled, at its sole discretion, to terminate without cause, with immediate effect, this Agreement and all rights of the Company hereunder, upon written notice to the Company of such termination.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least once every 6 monthstwice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNSYissum, via BNS’ 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 shall, for the period of the License, (i) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum 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’ Yissum’s reasonable request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the 6 six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall detail all proposed changes to the prepare a modified Development Plan, including the reasons therefore.
5.3Plan for Yissum’s review. The Company shall pursue 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 commercial also make reasonable efforts to sublicense provide Yissum with any reasonable additional data that Yissum requires to evaluate the particular indication or use performance of the Product provided the sublicense has no negative economic or regulatory impact on the overall development and commercialization of the ProductCompany hereunder.
5.45.3. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in Section 6, below, shall not release the Company from its obligation as stated in this Section.
5.4. If the Company shall not commercialize meet one of the Products Essential Development Milestones within a reasonable the timeframe set out in major markets (US, EU)the Development Plan for the attainment of the said Essential Development Milestone, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 18.9, below; (iii) unfavorable economic conditions or (iv) unless the Company and BNS have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 one hundred and twenty (120) days to cure its such failure of diligence. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of up to sixty (60) days. The Company’s failure to cure such failure, to Yissum’s reasonable satisfaction, within such 90 day the aforementioned cure period to BNS’ reasonable satisfaction (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 be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 Sublicenseregulations, and shall copy BNS on procure the receipt of all correspondence with regard to such breachapprovals and consents necessary for the performance of its obligations hereunder.
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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: 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 its 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 a written plan and timetable for the development JSC representatives of Company collectively having one vote and the commercialization JSC representatives of Products 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 copy Covered Product(s) for use in the Field in the Territory, the day-to-day Development work shall be conducted under the direction of which is attached to this Agreement as Appendix C. The the Joint Development Plan may be modified Committee (“Joint Development Committee” or “JDC”) comprised of an equal number of representatives 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 delayedTransferee 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 License Clinical Development and this Collaboration Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.2Law. The Parties shall establish JDC will be responsible for coordinating amendments to any plan for Development in respect of a steering committee (Covered Product for use in the “Committee”) to oversee Field in 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 Territory for review and approval by the confidentiality arrangements set out JSC, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise agreed in this 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 Company 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 consult 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 BNSthe 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), via BNS’ Representativesthe JCC will be responsible for coordinating any amendments to the plan for Commercialization of Covered Product(s) in the Territory, in respect for overseeing performance of significant the Commercialization program, and for making operational decisions related to the exercise that program. Periodically, a member of the License. For the avoidance of doubt, the Committee JCC for each party shall be a forum for the exchange of information between the Parties with respect provide to the foregoing matters, shall act only other party a reasonably detailed summary of the Commercialization activities conducted in an advisory capacity and shall not have decision-making powersthe Territory. The Company shall (i) JCC will jointly prepare and provide to BNS each Party on at least a Calendar Quarter basis a report, 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 the exercise of the Licensee-mail, (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 status of any milestones; the projected — or actual — completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; a description of any corporate transaction involving the Products or the Licensed Technology; and shall detail all proposed changes to the Development Plan, including the reasons thereforeCommercialization activities hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use 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 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 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 Company 90 days to cure its failure of diligence. The Company’s failure to cure within such 90 day period to BNS’ reasonable satisfaction shall be a material breach of this Agreement. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Technology Transfer Agreement
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 a written plan and timetable for the development and Development Plan (including the commercialization of Products Essential Development Milestones defined below) agreed by Yissum, a copy of which is attached to shall be incorporated into this Agreement as Appendix C. The C within 45 (forty-five) days of the Effective Date, as such Development Plan may be amended, modified or replaced from time to time as determined by the Board of Directors of the Company as reasonably required (the "Board"), in order to achieve its sole and absolute discretion, provided however that the commercialization goals Company shall amend any of the milestones set forth above, upon BNSin Appendix C under the heading ‘Essential Development Milestone’ approval, which shall not be unreasonably denied, conditioned or delayed(“Essential Development Milestones”) only if the Company first receives the written approval of Yissum for the particular amendment. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. In the event that there is no Development Plan (including the Essential Development Milestones) prepared by the Company that meets Yissum’s approval and is incorporated into this Agreement within 45 (forty-five) days of the Effective Date, then Yissum shall be entitled, at its sole discretion, to terminate without cause, with immediate effect, this Agreement and all rights of the Company hereunder, upon written notice to the Company of such termination.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least once every 6 monthstwice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNSYissum, via BNS’ 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 shall, for the period of the License, (i) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum 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’ Yissum's reasonable request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the 6 six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall detail all proposed changes to the prepare a modified Development Plan, including the reasons therefore.
5.3Plan for Yissum’s review. The Company shall pursue 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 commercial also make reasonable efforts to sublicense provide Yissum with any reasonable additional data that Yissum requires to evaluate the particular indication or use performance of the Product provided the sublicense has no negative economic or regulatory impact on the overall development and commercialization of the ProductCompany hereunder.
5.45.3. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in Section 6, below, shall not release the Company from its obligation as stated in this Section.
5.4. If the Company shall not commercialize meet one of the Products Essential Development Milestones within a reasonable the timeframe set out in major markets (US, EU)the Development Plan for the attainment of the said Essential Development Milestone, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 18.9, below; (iii) unfavorable economic conditions or (iv) unless the Company and BNS have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s 's failure to meet its obligations of diligence and shall allow the Company 90 one hundred and twenty (120) days to cure its such failure of diligence. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of up to sixty (60) days. The Company’s 's failure to cure such failure, to Yissum's reasonable satisfaction, within such 90 day the aforementioned cure period to BNS’ reasonable satisfaction (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 be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 Sublicenseregulations, and shall copy BNS on procure the receipt of all correspondence with regard to such breachapprovals and consents necessary for the performance of its obligations hereunder.
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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
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 a written plan and timetable for the development and the commercialization of Products Development Plan approved by Yissum, a copy of which is shall be attached to this Agreement as Appendix C. C within sixty (60) days of the Effective Date. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon BNS’ Yissum’s prior written approval, which shall not be unreasonably denied, conditioned or delayedbut without derogating from the dates of the achievement of the Milestones set forth in this Section 5. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet all of the following milestones identified in Section 7.3 below for at least one Product (the “Development Milestones”).
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the Research, Research program and the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”), which shall meet at least once every 6 monthstwice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNSYissum, via BNS’ 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) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum 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 Yissum’s request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the 6 six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the six (6) month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall detail all proposed changes prepare a modified Development Plan for Yissum’s review and approval. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum reasonably requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the of, at least one Product in the Field. In US for the event that indications set forth in the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use 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 ProductDevelopment Plan.
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in Section 6, 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 timeframe in major markets (US, EU)time frame, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unfavorable economic conditions or (iv) unless the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 one hundred eighty (180) days to cure its such failure of diligence. The Company’s failure to cure within such 90 one hundred eighty (180) day period to BNS’ Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Companyregulations, and shall procure the receipt of all approvals and consents necessary for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission performance of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 productobligations hereunder.
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 agrees to provide Yissum or the Sublicensee to observe the terms University (for no consideration) a defined number 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 units 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 Product developed or omission of the Sublicensee which is not promptly remedied by the Company or the Sublicensee and which would have constituted a breach of manufactured under this Agreement by the Company had it been an act or omission of the Companyat cost, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall constitute a breach of this Agreement by the Companyfor academic research purposes only.
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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Research and License Agreement (Virpax Pharmaceuticals, Inc.)
Development and Commercialization. 5.1. The Company undertakes(a) Subject to Subsection 2.2(b), BioChem shall, at its own expense, to use its commercially reasonable commercial efforts to carry out develop Compound Leads and to commercialize Commercialized Products in such countries in the developmentTerritory where in BioChem's opinion it is commercially viable to do so.
(b) BioChem shall have the right to decide, regulatoryin its sole discretion, manufacturing which Compound Leads to develop and marketing work necessary which Commercialized Products to commercialize. In the event BioChem decides, in its sole discretion, not to develop and commercialize Products in accordance with a written plan Compound Lead or a Commercialized Product or discontinues commercialization and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon 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 steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 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 the 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 Compound Lead or a Commercialized Product (collectively, "Discontinued Compounds"), ATI shall have the right 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 license from BioChem hereunder to the Development Plan, including the reasons therefore.
5.3. The Company shall pursue the development and registration commercialization of commercially reasonable indications such Discontinued Compound either alone or uses of the Product in through licenses with one or more third Persons both within and outside the Field. In the event that the Company shall decide not The license 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 develop 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 commercialize 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 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 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 Company 90 days to cure its failure of diligence. The Company’s failure to cure within such 90 day period to BNS’ reasonable satisfaction Discontinued Compounds shall be a material breach royalty-bearing license, payable by ATI to BioChem at the same rate and upon the same terms and conditions (including milestone payments) as those contained in Article III of this Agreement, mutatis mutandis. The Company shall be entitled Notwithstanding anything to grant the contrary herein contained, for so long as BioChem continues the development and/or commercialization of one (1) Compound Lead in a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicensetherapeutic class, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor other Compound Leads in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor that therapeutic class shall not be considered a Sublicense Discontinued Compounds. The Joint Steering Committee shall determine whether Compound Leads are in the same therapeutic class; bearing in mind that it is the expressed intention of the Parties that, while BioChem shall have the right to develop more than one Compound Lead for purposes of this Section 5.4.
5.5. Upon submission of its request the same clinical indication at the same time, should BioChem decide not to obtain develop more than one Compound Lead at the written consent of BNS to a Sublicensesame time, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of the Company regarding terms and conditions of the Sublicense; and shall notify BNS in writing, whether Compound Lead not developed by BioChem would not be considered 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 executionDiscontinued Compound.
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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: License Agreement (Immunogen Inc)
Development and Commercialization. 5.1. The Company undertakes4.1 A joint governance committee (“Governance Committee”) shall oversee and manage the relationship between the Parties and any Sublicensee under this Agreement, at its own expenseincluding without limitation, to use its commercially reasonable efforts to carry out the developmentcoordination of the transfer of information between the Parties, regulatory, manufacturing and marketing work necessary to develop and commercialize Products the facilitation of the development of the Licensed Product in the Territory in accordance with the Development Plan, and proposed clinical trial design and protocols (if any). The Governance Committee shall include up to three (3) members of each Party and one (1) member of any Sublicensee. Notwithstanding the foregoing, nothing in this Section 4.1 or the operations of the Governance Committee shall supersede Licensor’s rights to approve a written plan and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. The Development Plan or any pre-clinical or clinical trial pursuant to Sections 2.1 and 2.2 respectively. The Governance Committee shall be co-chaired by a representative of Licensee and a representative of Licensor. The co-chairpersons shall be responsible for calling meetings, setting the agenda, circulating the agenda at least ten (10) days prior to each meeting and distributing minutes of the meetings within ten (10) days following such meetings (provided that each co-chairperson may be modified elect to delegate the performance of its responsibilities to other members of the Governance Committee from time to time time), but shall not otherwise have any greater power or authority than any other member of the Governance Committee. Each Party shall disclose to the co-chairpersons any proposed agenda items, along with appropriate information at least twenty (20) days in advance of each meeting of the Governance Committee. Each member of the Governance Committee selected by each Party shall have substantial experience in biopharmaceutical product development, manufacturing and/or commercialization and other such expertise as appropriate to the activities of the Governance Committee. Each Party may replace its members of the Governance Committee upon written notice to the other Party and shall replace its members as the expertise required by the Company Governance Committee changes over time. The Governance Committee shall hold meetings at such times 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 determined by a majority of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise entire membership of the License including committee, but in no event, shall such meetings be held less frequently than once every month. Meetings of the Company’s development effortsGovernance Committee shall be held by videoconference. Meetings of the Governance Committee shall be effective if at least two (2) members of the Governance Committee, representing each Party, are in attendance or participating in the meeting. Each Party shall be entitled to designate two representatives to responsible for the Committee (the “Representatives”)expenses incurred in connection with its employees, 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 consultants and its members of the License. For the avoidance of doubt, the Governance Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only attending or otherwise participating 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 the 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 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 thereforeGovernance Committee meetings.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. 4.2 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 objective(s) set forth in Section 6, below, shall the Development Plan are not release achieved in accordance with 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 such delay is caused by (i) the requirements terms of a regulatory authority; (ii) force majeure; (iii) unfavorable economic conditions or (iv) unless the Company and BNS have agreed in writing to amend the Development Plan, BNS Licensor shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 days to cure its failure of diligence. The Company’s failure to cure within such 90 day period to BNS’ reasonable satisfaction shall be a material breach of this Agreement. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of the Company regarding terms and conditions of the Sublicense; and shall notify BNS Licensee thereof in writing, whether and Licensee shall have thirty (30) days following such notification to establish, to the reasonable satisfaction of Licensor, that any failures have been remedied as contemplated above. In the event Licensee fails to establish the same to Licensor’s reasonable satisfaction, Licensor shall have the right, in its sole discretion, to terminate the licenses granted to Licensee under this Agreement, either in whole or on a proposed Sublicensee is an Affiliate country-by-country basis, effective immediately.
4.3 Licensee or is otherwise its Sublicensees, at its or their own expense, will be responsible for all sales and marketing activities related to the CompanyLicensed Product in the Territory.
4.4 Upon the receipt of Governmental Approval, Licensee agrees to use Commercially Reasonable Efforts to promote the sale, marketing, and distribution of, and otherwise commercialize and sell, the Licensed Product in the Territory in the Field. Licensee shall provide Licensor with quarterly written reports of Licensee’s commercialization efforts and activities for such quarter and a description of its plans for future commercialization efforts and activities. In addition, the Company Licensee shall provide BNS with an executed copy such other information, financial or otherwise, Licensor may reasonably request relating to the marketing, sale or distribution of the Sublicense (or Sublicense amendment, as the case may be) within 10 days of its executionLicensed Product.
5.6. If 4.5 Beginning on 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 date of first commercial sale of the product.
5.7Licensed Product in the Territory, Licensee shall use Commercially Reasonable Efforts to deploy its sales representatives to sell the Licensed Product in the Territory. Any Sublicense In the event Licensee materially fails to meet any commercialization objective set forth on Schedule 1 attached hereto (the “Commercialization Objectives”), Licensor shall be dependent on notify Licensee thereof in writing, and Licensee shall have thirty (30) days following such notification to establish, to the validity reasonable satisfaction of the License and shall terminate upon termination of the License.
5.8. The Company shall ensure Licensor, that any Sublicense failures have been remedied as contemplated above. In the event Licensee fails to establish the same to Licensor’s reasonable satisfaction, Licensor shall include material terms that bind have the Sublicensee right, in its sole discretion, to observe terminate the terms of license granted to Licensee under this Agreement, includingeither in whole or on a country-by-country basis, 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 breacheffective immediately.
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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Development and Supply Agreement (Evofem Biosciences, Inc.)
Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan and timetable for the development and the commercialization of Products a copy of which is attached to this Agreement as Appendix C. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon BNS’ Yissum’s approval, which shall not be unreasonably denied, conditioned or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 6 six (6) months. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNSYissum, via BNS’ Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to BNS Yissum via BNS’ Yissum's Representatives with periodic written reports (“Development Reports”) not less than once per every 6 six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum informed via BNS’ 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 BNS’ Yissum's reasonable request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include a summary of the Development Results and any other related work performed by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the 6 six month period prior to the report. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s '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 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 6section 7, below, shall not release the Company from its obligation as stated in this Sectionsection. If the Company shall not commercialize the Products within a reasonable timeframe in major markets (US, EU)time frame, unless such delay is caused by (i) the requirements of a regulatory authority; (ii) force majeure; or (iii) unfavorable economic conditions or (iv) unless the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s 's failure to meet its obligations of diligence and shall allow the Company 90 ninety (90) days to cure its failure of diligence. The Company’s 's failure to cure within such 90 ninety (90) day period to BNS’ Yissum's reasonable satisfaction shall be a material breach of this Agreement. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Research and License Agreement (Immune Pharmaceuticals 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 a written plan and timetable for the development and the commercialization of Products Development Plans, a copy of which is attached to this Agreement as Appendix C. B. The Development Plan Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth abovein the Development Plans; provided, upon BNS’ however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans (the “Development Milestones”) shall be subject to Yissum’s prior written approval, which shall not to be unreasonably deniedconditioned, conditioned withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 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 mattersexercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 months from the Effective Date year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum informed via BNS’ Representatives on a timely basis via the Committee concerning all material activities and changes to the a Development Plan undertaken in respect of the exercise of the License, and (iii) at BNS’ reasonable Yissum’s request, from time to time, provide BNS Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the 6 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; and . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall detail all proposed changes explain, in its Development Report. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use 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.[RESERVED]
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in Section 6, below, shall not release the Company from its obligation as stated in this Section[RESERVED]
5.5. If the Company shall not commercialize meet the Products within milestones set forth in a reasonable timeframe in major markets (US, EU)Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unfavorable economic conditions or (iv) unless the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of diligenceup to sixty (60) days. The Company’s failure to cure within such 90 day the aforementioned cure period (or extended cure period) to BNS’ Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below.
5.6. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Companyregulations, and shall procure the receipt of all approvals and consents necessary for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission performance of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 productobligations hereunder.
5.7. Any Sublicense shall be dependent on Where legally permissible, the validity Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of the License and shall terminate upon termination units 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 Product developed and/or manufactured under 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 by the Company had it been an act or omission of the Company’s discretion, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall constitute a breach of this Agreement by the Companyfor internal academic research purposes only.
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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.16.1. The Company undertakes, at its own expense, to use its commercially reasonable best efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with a written plan (with milestones, timetable and timetable budgeting), for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the "Development Plan") a copy of which is which, that meets Yissum’s reasonable approval, shall be finalized by the Company and attached to this Agreement as Appendix C. D within 120 (one hundred twenty) days from the end of the Research Program that is described in Appendix C of this Agreement and contemplated to be completed within 4 (four) months. The parties agree that the Development Plan will not cover REPEL-CV Products given the funding, development and commercialization by the Company of REPEL-CV Products. The Development Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth above, upon BNS’ Yissum’s prior written approval, which shall such approval not to be unreasonably delayed or denied, conditioned or delayedbut without derogating from the dates of the achievement of the significant milestones set forth in the Development Plan. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan and subsequent Development Results.
5.26.2. The Parties parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 6 monthstwice per calendar year. The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with BNSYissum, via BNS’ Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. The Company shall (i) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 six (6) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum 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 Yissum's request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (i) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plan, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the 6 six month period prior to the report, (ii) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 (twelve) months; and (iii) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — or actual — completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason for that and shall detail all proposed changes to the prepare a modified Development Plan, including the reasons therefore.
5.3Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder.
6.3. The Company shall use reasonable commercial efforts to pursue the development and registration of all commercially reasonable indications or uses of the Product Licensed Technology in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use 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.
5.46.4. Upon completion of the development of any Product, the Company undertakes to perform all use commercially reasonable actions efforts necessary to maximize Net Sales of such Product on a regular and consistent basis.
6.5. Payments of The Development Plan shall contain certain milestones designated therein as essential milestones (“Essential Milestone/s”). Failure to meet an Essential Milestone by the License Maintenance Fee as date set forth out in Section 6, the Development Plan for achieving such Essential Milestone (or any modified date pursuant to section 6.1 above or this section 6.5 below), shall not release the Company from its obligation as stated entitle Yissum to termination rights in this Sectionaccordance with section 16 below. If the The Company shall not commercialize be entitled to extend the Products within period for meeting an Essential Milestone (“Milestone Extension”) in accordance with the following:
a. The Company shall be entitled to a reasonable timeframe in major markets (US, EU), unless such delay is caused by (i) Milestone Extension of six months for each Essential Milestone
b. The Company shall be entitled to a Milestone Extension for the requirements period of a regulatory authority; (ii) force majeure; (iii) unfavorable economic conditions or (iv) unless majeure and any period for which the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS shall notify the Company in writing of the . The Company’s 's failure to meet its obligations of diligence and shall allow the Company 90 days to cure its failure of diligence. The Company’s failure to cure within such 90 day period to BNS’ reasonable satisfaction date set for an Essential Milestone together with the relevant Milestone Extension shall be a material breach of this Agreement entitling Yissum to immediate termination under section 16.2 of this Agreement.
6.6. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Companyregulations, and shall procure the receipt of all approvals and consents necessary for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes performance of this Section 5.4its obligations hereunder.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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.
5.86.7. The Company shall ensure that agrees to provide Yissum and/or the University (for no consideration) a reasonable number units of any Sublicense shall include material terms that bind the Sublicensee to observe the terms of Product developed and/or manufactured under 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 breachfor academic research purposes only.
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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall 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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: 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 a written plan and timetable for the development and the commercialization of Products Development Plans, a copy of which is attached to this Agreement as Appendix C. B. The Development Plan Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth abovein the Development Plans; provided, upon BNS’ however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans (the “Development Milestones”) shall be subject to Yissum’s prior written approval, which shall not to be unreasonably deniedconditioned, conditioned withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plan Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones.
5.2. The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development efforts. Each Party shall be entitled to designate two representatives to the Committee (the “Representatives”), which shall meet at least once every 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 mattersexercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the Committee shall act only in an advisory capacity and shall not have decision-making powers. 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 (i) prepare and provide to BNS via BNS’ Representatives Yissum with periodic written reports (“Development Reports”) not less than once per every 6 months from the Effective Date year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep BNS Yissum informed via BNS’ Representatives on a timely basis via the Committee concerning all material activities and changes to the a Development Plan undertaken in respect of the exercise of the License, and (iii) at BNS’ reasonable Yissum’s request, from time to time, provide BNS Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee during the 6 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected — – or actual — – completion date of the development of a Product and the marketing thereof; sales forecasts, if any have been made in the regular course of the Company’s business; as well as a description of any corporate transaction involving the Products or the Licensed Technology; and . If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall detail all proposed changes explain, in its Development Report. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the Development Plan, including performance of the reasons thereforeCompany hereunder.
5.3. The Company shall pursue the development and registration of commercially reasonable indications or uses of the Product in the Field. In the event that the Company shall decide not to pursue the development of a particular indication or use of the Product, the Company shall use 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.[RESERVED]
5.4. Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. Payments of the License Maintenance Fee as set forth in Section 6, below, shall not release the Company from its obligation as stated in this Section[RESERVED]
5.5. If the Company shall not commercialize meet the Products within milestones set forth in a reasonable timeframe in major markets (US, EU)Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeuremajeure in accordance with Section 17.9, below; or (iii) unfavorable economic conditions or (iv) unless the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of diligenceup to sixty (60) days. The Company’s failure to cure within such 90 day the aforementioned cure period (or extended cure period) to BNS’ Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to 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 be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee perform all its activities hereunder in accordance with all applicable laws and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor the right to make use of the Licensed Technology on behalf of the Companyregulations, and shall procure the receipt of all approvals and consents necessary for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission performance of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 productobligations hereunder.
5.7. Any Sublicense shall be dependent on Where legally permissible, the validity Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of the License and shall terminate upon termination units 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 Product developed and/or manufactured under 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 by the Company had it been an act or omission of the Company’s discretion, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall constitute a breach of this Agreement by the Companyfor internal academic research purposes only.
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 Sublicense or any part thereof to any third party.
Appears in 1 contract
Samples: Research and License Agreement (Scopus BioPharma Inc.)
Development and Commercialization. 5.1. 5.1 The Company undertakes, at its own expense, to use its commercially reasonable 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”), a copy of which is attached annexed 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’ Yissum’s approval, which shall not be unreasonably deniedwithheld, 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. 5.2 The Parties shall establish a steering committee (the “Committee”) to oversee the exercise of the License including the Company’s development effortsLicense. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Representatives”), which who shall meet at least once every 6 months. twice per calendar year unless the Parties agree otherwise, The Representatives shall be bound by the confidentiality arrangements set out in this Agreement. , The Company shall consult with BNSYissum, via BNS’ 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. 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 shall be entitled to convene Committee meetings by telephone or video conference. Notwithstanding anything to the contrary, including any reports regarding the Research, the Company shall (ia) prepare and provide to BNS Yissum via BNS’ Yissum’s Representatives with periodic written reports in the OCS format (“Development Reports”) not less than once per every 6 twelve (12) months from the Effective Date concerning all material activities undertaken in respect of the exercise of the License, (iib) keep BNS Yissum informed via BNS’ 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 BNS’ reasonable Yissum’s request, from time to time, provide BNS Yissum with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include a summary of the Development Results and any other related elated work performed effected by or on behalf of the Company or by or on behalf of any Affiliate or Sublicensee Sub-Licensee during the 6 six (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 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 thereforetherefor.
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 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. 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. 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. .
5.4 If the Company shall not commercialize the Products Products, as defined m Section 1 1(aa)(y), within a reasonable timeframe in major markets (US, EU)time frame, unless such delay is caused by (ia) the requirements of a regulatory authority; (iib) force majeure; (iiic) unfavorable economic conditions 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 (ivd) unless the Company and BNS Yissum have agreed in writing to amend the Development Plan, BNS Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 90 ninety (90) days to cure its failure of diligence. The Company’s failure to cure clue within such 90 ninety (90) day period to BNS’ Yissum’s reasonable satisfaction shall be a material breach of this Agreement. The Company shall be entitled to grant a Sublicense only after obtaining BNS’ written approval regarding the identity of the Sublicensee and all material terms and conditions of the Sublicense, which approval shall not be unreasonably withheld, conditioned or delayed. For the avoidance of doubt, an agreement with a subcontractor in which the Company must grant the subcontractor give Yissum the right to make use of the Licensed Technology on behalf of the Company, and for which use the Company is required to pay or otherwise compensate the subcontractor shall not be considered a Sublicense for purposes of this Section 5.4.
5.5. Upon submission of its request to obtain the written consent of BNS to a Sublicense, the Company shall fully disclose and submit to BNS all documentation relating to the Sublicense, adequately disclose to BNS any other business connection which it now has or is in the process of forming with the Sublicensee which may reasonably effect the decision of 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 by the Company had it been an act or omission of the Company, and which the Company has not used commercially reasonable efforts to promptly cure, including termination of the Sublicense, shall constitute a breach of this Agreement by the Companyas its sole remedy in such event.
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 Sublicense or any part thereof to any third party.
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Samples: License and Sponsored Research Agreement (Environmental Impact Acquisition Corp)