Common use of Development and Commercialization Clause in Contracts

Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plans, a copy of which is attached to this Agreement as Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, 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, not to be unreasonably conditioned, withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones. 5.2. The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the 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) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for 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; 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 Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. 5.3. [RESERVED] 5.4. [RESERVED] 5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 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 up to sixty (60) days. The Company’s failure to cure within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: Research and License Agreement (Scopus BioPharma Inc.)

Development and Commercialization. 5.16.1. The Company undertakes, at its own expense, to use its 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 budgeting), for the development and the commercialization of Products in the Field, prepared by the Company and approved by Yissum (the "Development Plans, 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 B. 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 Plans Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; providedabove, 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 upon Yissum’s prior written approval, such approval not to be unreasonably conditioneddelayed or denied, withheld 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 Plans Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones. 5.26.2. The Parties parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to oversee the exercise of the License. Each Party party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee , which shall meet at least once twice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. The Company shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year every six (6) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s 's request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (ai) the tests and trials conducted and all other actions taken by the Company pursuant to the Development PlansPlan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee Sub-Licensee during the 12 six month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (cii) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for the following 12 (twelve) months; and (diii) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason for that and shall prepare a modified Development Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. 5.36.3. [RESERVED]The Company shall use reasonable commercial efforts to pursue the development and registration of all commercially reasonable indications or uses of the Licensed Technology in the Field. 5.46.4. [RESERVED] 5.5. If Upon completion of the development of any Product, the Company undertakes to use commercially reasonable efforts necessary to maximize Net Sales of such Product on a regular and consistent basis. 6.5. The Development Plan shall not contain certain milestones designated therein as essential milestones (“Essential Milestone/s”). Failure to meet an Essential Milestone by the milestones date set forth out in a the Development PlanPlan for achieving such Essential Milestone (or any modified date pursuant to section 6.1 above or this section 6.5 below), unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure shall entitle Yissum to termination rights in accordance with Section 17.9, section 16 below; or . The Company shall be entitled to extend the period for meeting an Essential Milestone (iii“Milestone Extension”) unless in accordance with the following: a. The Company shall be entitled to a Milestone Extension of six months for each Essential Milestone b. The Company shall be entitled to a Milestone Extension for the period of force majeure and any period for which the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the . The Company’s 's failure to meet its obligations of diligence and shall allow the Company 120 days to cure such failure. If, to Yissum’s reasonable satisfaction, date set for an Essential Milestone together with 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 within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction relevant Milestone Extension shall be a material breach of this Agreement, 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 COMMISSIONsection 16.2 of this Agreement. 5.66.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.76.7. Where legally permissible, the The Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: Research and License Agreement (Pathfinder Cell Therapy, 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 PlansPlan”), a copy of which is attached annexed to this Agreement as Appendix B. C. The Development Plans Plan may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; providedabove, 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 upon Yissum’s prior written approval, which shall not to be unreasonably conditionedwithheld, withheld conditioned or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans Plan and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones. 5.2. 5.2 The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee , who shall meet at least once twice per calendar year. year unless the Parties agree otherwise, The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement, The Company shall consult with Yissum, via Yissum’s Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONIt 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) provide Yissum via Yissum’s Representatives with periodic written reports in the OCS format (“Development Reports”) not less than once per year every twelve (12) months concerning all material activities undertaken in respect of the exercise of the License, (iib) keep Yissum informed via Yissum’s Representatives substantially on a timely basis via the Committee concerning all material activities and changes to a the Development Plan undertaken in respect of the exercise of the License, and (iiic) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related elated work effected by the Company or by any Affiliate or Sublicensee Sub-Licensee during the 12 six (6) 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; as well as sales forecasts, if any have been made in the regular course of the Company’s business; a description of any corporate transaction involving the Products or the Licensed Technology. If progress , and shall detail all proposed changes to the Development Plan, including the reasons therefor. 5.3 Upon completion of the development of any Product as defined in respect of a Product differs from that anticipated in its Development Plan or a preceding Development ReportSection 1.1(aa)(y), the Company shall explain, in its Development Report. The Company shall also make undertakes to perform commercially reasonable efforts actions necessary to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance maximize Net Sales of the Company hereundersuch Product on a regular and consistent basis. 5.3. [RESERVED] 5.4. [RESERVED] 5.5. 5.4 If the Company shall not meet commercialize the milestones set forth in Products, as defined m Section 1 1(aa)(y), within a Development Planreasonable time frame, unless such delay is caused by (ia) the requirements of a regulatory or other governmental authority; (iib) force majeure in accordance with Section 17.9majeure; (c) lack of commercial viability caused by factors external to the Company, belowprovided that the Company shall make commercially reasonable efforts to remove such factors; or (iiid) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 120 ninety (90) 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 up to sixty (60) daysdiligence. The Company’s failure to cure clue within the aforementioned cure such ninety (90) day period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of give Yissum the right to terminate 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 COMMISSIONAgreement as its sole remedy in such event. 5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: License and Sponsored Research Agreement (Environmental Impact Acquisition Corp)

Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development PlansPlan (including the Essential Development Milestones defined below) agreed by Yissum, a copy of which is attached to shall be incorporated into this Agreement as Appendix B. The C within 45 (forty-five) days of the Effective Date, as such Development Plans 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 in Appendix C under the heading ‘Essential Development Plans; provided, however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans Milestone’ (the “”Essential Development Milestones”) shall be subject to Yissum’s prior only if the Company first receives the written approval, not to be unreasonably conditioned, withheld or delayedapproval of Yissum for the particular amendment. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans Plan and subsequent Development Results. Notwithstanding anything 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 contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestonesof such termination. 5.2. The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee , which shall meet at least once twice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum’s Committee Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. 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 shall, for the period of the License, (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year every six (6) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s reasonable request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development PlansPlan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee Sub-Licensee during the 12 six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 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 12 six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall prepare a modified Development Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. 5.3. [RESERVED]Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. 5.4. [RESERVED] 5.5. If the Company shall not meet one of the milestones Essential Development Milestones within the timeframe set forth out in a the Development PlanPlan for the attainment of the said Essential Development Milestone, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.918.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 120 one hundred and twenty (120) days to cure such failurefailure of diligence. If, to Yissum’s reasonable satisfaction, the Company is diligently taking measures to cure such failure, Yissum may, at its sole discretion, notify the Company in writing that it is extending the period given to cure such failure by an additional period of up to sixty (60) days. The Company’s failure to cure such failure, to Yissum’s reasonable satisfaction, within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 16.3 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.65.5. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: Research and License Agreement (Therapix Biosciences Ltd.)

Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development Plans, a copy of which is attached to this Agreement as Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, however, that changes (a) Subject 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, not to be unreasonably conditioned, withheld or delayed. All terms and conditions of the License and this Agreement and upon Medicis’s exercise of its PoC Option in accordance with Section 4.2.1(a) or 12.5.2, Anacor shall apply be hereby deemed to have granted and hereby grants to Medicis the modified exclusive (even as to Anacor) right and license in the Territory, with the right to grant sublicenses (through multiple tiers) in accordance with subsection (b), under the Anacor Exclusively Licensed IP, to make, have made, use, sell, offer for sale, import and otherwise exploit the Medicis Development Plans Compounds and subsequent Development Results. Notwithstanding anything to any Derivatives thereof as and into Products during the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development MilestonesTerm. 5.2. (b) The Parties shall establish a steering committee license granted by Anacor to Medicis in subsection (a) may be sublicensed by Medicis to an Affiliate (without notice to Anacor) or Third Party (with prior written notice to Anacor being required if the “Committee”) sublicense is as to be a forum for the exchange all of information between the Parties Medicis’s rights with respect to the exercise a particular Medicis Development Compound in a particular territory). Medicis shall provide Anacor with a copy of the License. Each Party shall be entitled to designate two (2) representatives each agreement under which it grants a sublicense under its commercialization rights promptly upon execution thereof, to the Committee (extent permitted under the “Committee Representatives”)terms of such agreement; provided that [ * ]. The Committee If Medicis cannot obtain such right, Medicis 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 provide Anacor with a redacted copy of doubtsuch sublicense agreement, 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 provided that all terms related to [ * ] = CERTAIN CONFIDENTIAL INFORMATION REQUEST CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSIONCOMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. The Company Medicis’s rights and obligations under this Agreement, including payment obligations to Anacor, may not be redacted. For each other sublicense agreement, Medicis shall (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect inform Anacor of the exercise identity of the Licensesuch Sublicensee, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for 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; as well as a description the term and scope of any corporate transaction involving the Products or the Licensed Technologysublicense, promptly upon execution of such sublicense agreement. If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explainMedicis shall, in its Development Report. The Company shall also make reasonable efforts each sublicense agreement, require the Sublicensee to provide Yissum with any reasonable additional data that Yissum requires the following to evaluate the performance of the Company hereunder. 5.3. [RESERVED] 5.4. [RESERVED] 5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless Anacor if this Agreement terminates and to Medicis if only such delay is caused by sublicense agreement terminates: (i) the requirements assignment and transfer of ownership and possession of all Regulatory Approvals and other regulatory materials related to a regulatory Medicis Development Compound or other governmental authority; Product held or possessed by such Sublicensee, and (ii) force majeure the assignment of, or a freely sublicensable exclusive license to, all intellectual property Controlled by such Sublicensee that Covers or embodies a Medicis Development Compound or Product and that was created by or on behalf of such Sublicensee during the exercise of its rights or fulfillment of its obligations pursuant to such sublicense agreement. Upon any termination of this Agreement by Anacor that results in accordance a loss of Medicis’s license under Section 4.3.2 hereunder, the rights of each Sublicensee shall survive such termination, but only if the Sublicensee is in compliance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing all terms of the Company’s failure to meet its obligations of diligence sublicense agreement and shall allow the Company 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 up to sixty (60) days. The Company’s failure to cure within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material cures any breach of this AgreementAgreement by Medicis, entitling Yissum [ * ]. Each sublicense agreement shall be subject 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 COMMISSIONthe applicable terms and conditions of this Agreement and any Third Party licenses sublicensed to the Sublicensee. 5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: Research and Development Option and License Agreement (Anacor Pharmaceuticals Inc)

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 the Development PlansJSC representatives of Company collectively having one vote and the JSC representatives of Transferee collectively having one vote. If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action, a copy of which is attached to this Agreement then such matter shall be resolved as Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth provided in the definitive Clinical Development Plans; providedand Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, howeveramong other things, require that changes to for so long as the specified dates Transferee (and/or one or more Permitted Transferees) is Developing a Covered Product(s) for use in the achievement Field in the Territory, the day-to-day Development work shall be conducted under the direction of the Milestones set forth in the Joint Development Plans Committee (the “Joint Development MilestonesCommittee” or “JDC”) comprised of an equal number of representatives from Transferee and Company. All JDC decisions will be made by unanimous vote. If the JDC is unable to decide or resolve any matter properly presented to it for action, then the decision of Company shall be subject to Yissum’s prior written approval, not to final and shall be unreasonably conditioned, withheld or delayed. All in compliance with the terms and conditions of the License and this Agreement shall apply to the modified Development Plans and subsequent Development Results. Notwithstanding anything to the contrary contained hereinAgreement, the Company undertakes to use commercially reasonable efforts to meet the Clinical Development Milestones. 5.2and Collaboration Agreement and Law. The Parties shall establish a steering committee (the “Committee”) JDC will be responsible for coordinating amendments to be a forum any plan for the exchange of information between the Parties with respect to the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the 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) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for 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; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Covered Product differs from for use in the Field in the Territory for review and approval by the JSC, for overseeing such Development work, and for making operational decisions related to such Development work. Unless otherwise agreed in writing by the Transferee and Company, until the First Commercial Sale of a Covered Product in the Territory, the JDC will meet on a regular basis, at such times and in such manner as provided in Clinical Development and Collaboration Agreement. The Clinical Development and Collaboration Agreement shall, among other things, require that anticipated in its Development Plan for so long as the Transferee (or a preceding Development ReportPermitted Transferee) is preparing to Commercialize a Covered Product(s) in the Territory, the Company day-to-day Commercialization preparation work shall explain, in its Development Reportbe conducted under the direction of a Joint Commercialization Committee (“Joint Commercialization Committee” or “JCC”) and supply chain audit procedures. The Company JCC shall also make reasonable efforts 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 provide Yissum decide or resolve any matter properly presented to it for action, then the decision of the Transferee shall be final and in compliance with the terms and conditions of this Agreement and Law. Prior to the First Commercial Sale of a Covered Product (or such longer period as the Parties may agree in writing), the JCC will be responsible for coordinating any reasonable additional data that Yissum requires amendments to evaluate the plan for Commercialization of Covered Product(s) in the Territory, for overseeing performance of the Company Commercialization program, and for making operational decisions related to that program. Periodically, a member of the JCC for each party shall provide to the other party a reasonably detailed summary of the Commercialization activities conducted in the Territory. The JCC will jointly prepare and provide to each Party on at least a Calendar Quarter basis a report, via e-mail, regarding the status of Commercialization activities hereunder. 5.3. [RESERVED] 5.4. [RESERVED] 5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 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 up to sixty (60) days. The Company’s failure to cure within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: 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 the Development Plans, a copy of which is attached to this Agreement as Appendix B. The Development Plans may be modified from time to time by the Company as reasonably required in order to achieve the commercialization goals set forth in the Development Plans; provided, 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, not to be unreasonably conditioned, withheld or delayed. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans and subsequent Development Results. Notwithstanding anything to the contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestones. 5.2. The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee shall meet at least once per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. For the avoidance of doubt, the 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) provide Yissum with periodic written reports (“Development Reports”) not less than once per year concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development Plans, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee during the 12 month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 month period prior to the report; (c) the Company’s plans in respect of the testing, undertaking of trials or commercialization of Products for 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; 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 Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. 5.3. [RESERVED] 5.4. [RESERVED] 5.5. If the Company shall not meet the milestones set forth in a Development Plan, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s failure to meet its obligations of diligence and shall allow the Company 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 up to sixty (60) days. The Company’s failure to cure within the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.6. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: Research and License Agreement (Scopus BioPharma Inc.)

Development and Commercialization. 5.1. The Company undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize Products in accordance with the Development PlansPlan (including the Essential Development Milestones defined below) agreed by Yissum, a copy of which is attached to shall be incorporated into this Agreement as Appendix B. The C within 45 (forty-five) days of the Effective Date, as such Development Plans 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 in Appendix C under the heading ‘Essential Development Plans; provided, however, that changes to the specified dates for the achievement of the Milestones set forth in the Development Plans Milestone’ (the “Essential Development Milestones”) shall be subject to Yissum’s prior only if the Company first receives the written approval, not to be unreasonably conditioned, withheld or delayedapproval of Yissum for the particular amendment. All terms and conditions of the License and this Agreement shall apply to the modified Development Plans Plan and subsequent Development Results. Notwithstanding anything 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 contrary contained herein, the Company undertakes to use commercially reasonable efforts to meet the Development Milestonesof such termination. 5.2. The Parties shall establish a steering committee (the “Committee”) to be a forum for the exchange of information between the Parties with respect to oversee the exercise of the License. Each Party shall be entitled to designate two (2) representatives to the Committee (the “Committee Representatives”). The Committee , which shall meet at least once twice per calendar year. The Committee Representatives shall be bound by the confidentiality arrangements set out in this Agreement. The Company shall consult with Yissum, via Yissum's Committee Representatives, in respect of significant decisions related to the exercise of the License. For the avoidance of doubt, the Committee shall be a forum for the exchange of information between the Parties with respect to the foregoing matters, shall act only in an advisory capacity and shall not have decision-making powers. 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 shall, for the period of the License, (i) provide Yissum with periodic written reports (“Development Reports”) not less than once per year every six (6) months concerning all material activities undertaken in respect of the exercise of the License, (ii) keep Yissum informed on a timely basis via the Committee concerning all material activities and changes to a the Development Plan undertaken in respect of the exercise of the License, and (iii) at Yissum’s 's reasonable request, from time to time, provide Yissum via the Committee with further information relating to the Company’s activities in exercise of the License. The Development Reports shall include detailed descriptions of the progress and results, if any, of: (a) the tests and trials conducted and all other actions taken by the Company pursuant to the Development PlansPlan, and a summary of the Development Results and any other related work effected by the Company or by any Affiliate or Sublicensee Sub-Licensee during the 12 six (6) month period prior to the report, (b) manufacturing, sublicensing, marketing and sales during the 12 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 12 six (6) months; and (d) projections of sales and marketing efforts following the First Commercial Sale. Development Reports shall also set forth a general assessment regarding the achievement of any milestones; the projected – or actual – completion date of the development of a Product and the marketing thereof; as well as a description of any corporate transaction involving the Products or the Licensed Technology. If progress in respect of a Product differs from that anticipated in its Development Plan or a preceding Development Report, the Company shall explain, in its Development Report, the reason therefor and shall prepare a modified Development Plan for Yissum’s review. The Company shall also make reasonable efforts to provide Yissum with any reasonable additional data that Yissum requires to evaluate the performance of the Company hereunder. 5.3. [RESERVED]Upon completion of the development of any Product, the Company undertakes to perform all commercially reasonable actions necessary to maximize Net Sales of such Product on a regular and consistent basis. 5.4. [RESERVED] 5.5. If the Company shall not meet one of the milestones Essential Development Milestones within the timeframe set forth out in a the Development PlanPlan for the attainment of the said Essential Development Milestone, unless such delay is caused by (i) the requirements of a regulatory or other governmental authority; (ii) force majeure in accordance with Section 17.918.9, below; or (iii) unless the Company and Yissum have agreed in writing to amend the Development Plan, Yissum shall notify the Company in writing of the Company’s 's failure to meet its obligations of diligence and shall allow the Company 120 one hundred and twenty (120) days to cure such failurefailure 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 the aforementioned cure period (or extended cure period) to Yissum’s reasonable satisfaction shall be a material breach of this Agreement, entitling Yissum to immediate termination under Section 15.2 16.3 below. PORTIONS OF THIS EXHIBIT HAVE BEEN REDACTED AND ARE SUBJECT TO A CONFIDENTIAL INFORMATION REQUEST FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 5.65.5. The Company shall perform all its activities hereunder in accordance with all applicable laws and regulations, and shall procure the receipt of all approvals and consents necessary for the performance of its obligations hereunder. 5.7. Where legally permissible, the Company agrees to provide Yissum and/or the University (for no consideration) a reasonable number of units of any Product developed and/or manufactured under this Agreement, at the Company’s discretion, for internal academic research purposes only.

Appears in 1 contract

Sources: License Agreement (Therapix Biosciences Ltd.)