Development Efforts. 4.1. The Company undertakes, at its own expense, to make commercially reasonable efforts to commercialize Licensed Products in the RPE Field and in the Photoreceptor Field, including bio-testing of the Licensed Materials and the Licensed Products, clinical trials and other steps required for obtaining regulatory approvals from the relevant authorities as are consistent with the commercial efforts generally applied to similar products of similar potential throughout the Term. 4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required to meet the development milestones listed in Annex G within the time frames specified therein (the “Development Milestones”). If the Company believes that it will not achieve a Development Milestone, it may notify Hadasit in writing in advance of the relevant deadline. The Company will include with such notice (a) reasonable explanations of the reasons for such failure (“Legitimate Reasons”, and lack of funding shall not constitute a Legitimate Reason) and (b) a reasonable detailed written plan for achieving a reasonable extended and/or amended milestone (the “Plan”). If Hadasit in its reasonable discretion accepts the Plan, then Annex G shall be deemed as having been automatically amended accordingly. Hadasit’s failure to accept or reject the Plan within [*] business days shall be deemed as approval. If there is a dispute between the parties in relation to the Plan, then they shall collaborate to develop a mutually acceptable Plan within [*] days of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by written notice to the Company, to restrict the Field to the RPE Field, and all rights and licenses granted hereunder in the Photoreceptor Field shall revert to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that H▇▇▇▇▇▇ shall not unreasonably exercise such right. 4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope of the License at any time by providing [*] days prior written notice to Hadasit, in which case the provisions of the preceding Section 4.2 shall not longer have any effect.
Appears in 1 contract
Sources: License Agreement (Lineage Cell Therapeutics, Inc.)
Development Efforts. 4.1. The Company undertakes(a) During the applicable Development Term with respect to each Product, at its own expense, to make Alvotech shall (i) use commercially reasonable efforts to commercialize Licensed Products develop such Product for the uses of such Product set forth in the RPE Field Product Data Sheet for such Product in accordance with the Research Plan and (ii) use commercially reasonable efforts (taking into account the commercial potential of such Product in each Alvogen Territory) to obtain, in its own name (or the name of one of its Affiliates) and at its own cost, Regulatory Approvals for such Product in the Photoreceptor Field, including bio-testing Alvogen Territories. Alvotech shall use commercially reasonable efforts to conduct the Research Program in good scientific manner and using cGxP of the Licensed Materials applicable Territory or other applicable jurisdiction where the Research Program is being conducted, to achieve the objectives of the Research Program efficiently and expeditiously, in compliance with all Applicable Laws. Alvotech shall complete all Phase 4 and post-marketing surveillance studies required to be completed by any Regulatory Agency with respect to a Product as a condition to Regulatory Approval of such Product. Notwithstanding anything in this Agreement to the Licensed Productscontrary, clinical trials Alvotech shall be responsible for taking any and all actions required to support all Product dossiers that may be necessary for any Registration or other steps Regulatory Approvals with respect to any Product, regardless of whether such actions are required for obtaining regulatory approvals from to be taken prior to or following receipt of Regulatory Approval with respect to the relevant authorities as are consistent with the commercial efforts generally applied to similar products of similar potential throughout the Termapplicable Product.
4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required to meet the development milestones listed in Annex G within the time frames specified therein (the “Development Milestones”). If the Company believes that it will not achieve a Development Milestone, it may notify Hadasit in writing in advance of the relevant deadline. The Company will include with such notice (a) reasonable explanations of the reasons for such failure (“Legitimate Reasons”, and lack of funding shall not constitute a Legitimate Reason) and (b) Following Successful Completion of a Phase 3 Clinical Trial with respect to each Product, Alvotech shall use commercially reasonable detailed written plan for achieving a reasonable extended and/or amended milestone efforts (taking into account the “Plan”). If Hadasit commercial potential of such Product in each Alvogen Territory) to obtain and maintain, solely in its reasonable discretion accepts own name (or the Planname of one of its Affiliates), then Annex G and at its own cost, all Regulatory Approvals for such Product in the Alvogen Territories, which, for the avoidance of doubt, shall include the Regulatory Approval of the EMA (if applicable); provided, that Alvotech shall be deemed as having been automatically amended accordingly. Hadasitresponsible for obtaining and maintaining all Regulatory Approvals, if any, required to be obtained from each individual country that is included in such Party’s failure to accept or reject Territories and is also covered by the Plan within [*] business days Regulatory Approval of the EMA.
(c) Alvotech shall solely own all Regulatory Approvals that it obtains in accordance with this Section 2.1, and shall be deemed as approval. If there is a dispute between the parties fully responsible for all regulatory activities and requirements and for maintaining such Regulatory Approvals, in relation accordance with Section 5.12.
(d) Alvotech shall, to the Planextent permitted by the applicable Governmental Authority and Applicable Law, then they shall collaborate to develop a mutually acceptable Plan within [*] days (i) promptly inform Alvogen of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by written notice to the Company, to restrict the Field to the RPE Fieldany material oral communication with, and all rights provide copies of written communications with, any Governmental Authority regarding any applications for Regulatory Approval and licenses granted hereunder (ii) exercise commercially reasonable efforts to notify Alvogen prior to participating in any formal meeting with any Governmental Authority in respect of any application for Regulatory Approval and the Photoreceptor Field shall revert opportunity to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that H▇▇▇▇▇▇ shall not unreasonably exercise attend and/or participate in such rightmeeting.
4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope of the License at any time by providing [*] days prior written notice to Hadasit, in which case the provisions of the preceding Section 4.2 shall not longer have any effect.
Appears in 1 contract
Sources: Product Rights Agreement (Alvotech Lux Holdings S.A.S.)
Development Efforts. 4.1. The Company undertakes, at its own expense, to make Licensee shall use commercially reasonable efforts and due diligence, itself and/or through one or more Affiliates or Sublicensees, to commercialize Licensed Products conduct research and development of Products, as promptly as is reasonably and commercially feasible, and, subject to obtaining necessary regulatory approvals, to produce and sell reasonable quantities of Products. Licensee shall keep TSRI generally informed as to Licensee’s progress in the RPE Field such research, development, regulatory approval, production and in the Photoreceptor Fieldsale, including bio-testing its efforts, if any, to sublicense Licensed Technology, and Licensee shall deliver to TSRI [***] written report of such efforts by [***] of each calendar year. Without limiting the foregoing, Licensee shall report to TSRI achievement of the events described on Exhibit C. The parties hereto acknowledge and agree that achievement of the milestones described in Exhibit D attached hereto on or before the dates set forth therein shall be evidence of compliance by Licensee with its development obligations hereunder for the time periods specified in Exhibit D. However, TSRI acknowledges that the drug discovery and development process is inherently uncertain and involves high risks of failure; that, based on results generated through the practice of the Licensed Materials Technology, Licensee may need to alter the course of its Product research and development efforts; and that many factors beyond the Licensed reasonable control of Licensee may delay or prevent Licensee from achieving the milestones by the specified dates. Accordingly, Licensee may amend Exhibit D upon written consent by TSRI, such consent not to be unreasonably withheld, if Licensee reasonably demonstrates to TSRI that Licensee has used commercially reasonable efforts at diligence in its performance of research and development of Products, clinical trials and other steps required for obtaining regulatory approvals from . In the relevant authorities as are consistent with event that Licensee has not achieved the commercial efforts generally applied to similar products of similar potential throughout the Term.
4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required to meet the development milestones listed in Annex G within the time frames specified therein provided in Exhibit D (as may be amended as provided above), TSRI has the “Development Milestones”). If the Company believes that it will not achieve a Development Milestone, it may notify Hadasit in writing in advance of the relevant deadline. The Company will include with such notice right to terminate this Agreement upon ninety (a90) reasonable explanations of the reasons for such failure (“Legitimate Reasons”, and lack of funding shall not constitute a Legitimate Reason) and (b) a reasonable detailed written plan for achieving a reasonable extended and/or amended milestone (the “Plan”). If Hadasit in its reasonable discretion accepts the Plan, then Annex G shall be deemed as having been automatically amended accordingly. Hadasit’s failure to accept or reject the Plan within [*] business days shall be deemed as approval. If there is a dispute between the parties in relation to the Plan, then they shall collaborate to develop a mutually acceptable Plan within [*] days of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by written notice to the Company, to restrict the Field to the RPE Field, and all rights and licenses granted hereunder in the Photoreceptor Field shall revert to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that H▇▇▇▇▇▇ shall not unreasonably exercise such right.
4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope of the License at any time by providing [*] days days’ prior written notice to HadasitLicensee unless, prior to the end of such 90-day period, Licensee reasonably demonstrates to TSRI that Licensee has used commercially reasonable efforts at diligence in which case its performance of research and development of Products and to achieve the provisions of milestones within the time provided in Exhibit D. For clarification, failure to achieve the milestones within the time provided in Exhibit D (as may be amended as provided above) shall [***], but this sentence shall not otherwise affect or limit TSRI’s termination rights in the preceding Section 4.2 shall not longer have any effectsentence.
Appears in 1 contract
Development Efforts. 4.1. The Company undertakes, at its own expense, to make commercially reasonable efforts to commercialize Licensed Products in the RPE Field and in the Photoreceptor Field, including bio-testing of the Licensed Materials and the Licensed Products, clinical trials and other steps required for obtaining regulatory approvals from the relevant authorities as are consistent with the commercial efforts generally applied to similar products of similar potential throughout the Term.
4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required to meet the development milestones listed in Annex G within the time frames specified therein (the “Development Milestones”). If the Company believes that it will not achieve a Development Milestone, it may notify Hadasit in writing in advance of the relevant deadline. The Company will include with such notice (a) reasonable explanations of the reasons for such failure (“Legitimate Reasons”, and lack of funding shall not constitute a Legitimate Reason) and (b) a reasonable detailed written plan for achieving a reasonable extended and/or amended milestone (the “Plan”). If Hadasit in its reasonable discretion accepts the Plan, then Annex G shall be deemed as having been automatically amended accordingly. Hadasit’s failure to accept or reject the Plan within [*[ * ] business days shall be deemed as approval. If there is a dispute between the parties in relation to the Plan, then they shall collaborate to develop a mutually acceptable Plan within [*[ * ] days of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by written notice to the Company, to restrict the Field to the RPE Field, and all rights and licenses granted hereunder in the Photoreceptor Field shall revert to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that H▇▇▇▇▇▇ Hadasit shall not unreasonably exercise such right.
4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope of the License at any time by providing [*[ * ] days prior written notice to Hadasit, in which case the provisions of the preceding Section 4.2 shall not longer have any effect.
Appears in 1 contract
Sources: License Agreement (Biotime Inc)
Development Efforts. 4.1. The Company undertakesVALVOLINE shall perform its obligations and meet its developmental goals set forth on the Development Plan attached hereto as Exhibit C. If VALVOLINE (a) fails to perform such obligations or meet such development goals, at its own expense, to make commercially reasonable efforts to commercialize Licensed Products in the RPE Field and in the Photoreceptor Field, including bio-testing of the Licensed Materials and the Licensed Products, clinical trials and other steps required for obtaining regulatory approvals from the relevant authorities as are consistent with the commercial efforts generally applied to similar products of similar potential throughout the Term.
4.2. Without derogating from the generality of the foregoing, in order to maintain its license in the Photoreceptor Field the Company shall be required or (b) fails to meet the development milestones listed in Annex G within quality or manufacturing cost for the Product, taking into account the specialized premium nature of the Products, as required by FALLBROOK and provided to VALVOLINE from time frames specified therein to time, then FALLBROOK shall have the right upon written notice to suspend the *** Portions of this page have been omitted pursuant to a request for Confidential Treatment filed separately with the Commission. license from FALLBROOK to VALVOLINE under Section 1.1 above for a period of ninety (90) days (the “Development MilestonesSuspension Period”). If During the Company believes that it will Suspension Period, VALVOLINE shall not achieve have the right to use the Trademark on a Product for the specific application under development (“Development MilestoneProduct”), it may notify Hadasit in writing in advance but shall be able to continue to use the Trademark on other non-related Products and as discussed on Exhibit C, FALLBROOK shall have the right to pursue another development partner for such Development Product. FALLBROOK shall provide VALVOLINE with written notice of the relevant deadlinefailure and a list of performance goals. The Company will include with such notice (a) reasonable explanations If, prior to the expiration of the reasons for Suspension Period, VALVOLINE meets or exceeds such failure (“Legitimate Reasons”performance goals, and lack of funding shall not constitute pays to FALLBROOK a Legitimate Reason) and (b) a reasonable detailed written plan reinstatement fee equal to the average quarterly royalty payment for achieving a reasonable extended and/or amended milestone the preceding calendar year or the current calendar year if there is no preceding one (the “PlanReinstatement Fee”), then the suspension on the license from FALLBROOK to VALVOLINE under Section 1.1 for the Development Product shall be removed and VALVOLINE shall once again have the right to use the Trademark in accordance with the terms and conditions of this Agreement on such Development Product and FALLBROOK shall not be able to enter a license agreement with any other development partners for that Development Product. If Hadasit in its reasonable discretion accepts VALVOLINE does not meet or exceed such performance goals or pay to FALLBROOK the PlanReinstatement Fee during the Suspension Period, then Annex G FALLBROOK shall be deemed as having been automatically amended accordingly. Hadasit’s failure to accept or reject have the Plan within [*] business days shall be deemed as approval. If there is a dispute between the parties in relation to the Plan, then they shall collaborate to develop a mutually acceptable Plan within [*] days of Hadasit’s notice. Should the Company not provide a Legitimate Reason and/or a Plan accepted by Hadasit within the respective timeframes mentioned above, then Hadasit shall be entitled, by right upon written notice to the Company, VALVOLINE to restrict the Field terminate this Agreement for such Development Product and can freely enter agreements with additional parties to the RPE Field, and all rights and licenses granted hereunder develop another product in the Photoreceptor Field shall revert to Hadasit. Such restriction shall be the only remedy available to Hadasit for the Company failing to reach a Development Milestone. It is understood and agreed that H▇▇▇▇▇▇ shall not unreasonably exercise such right.
4.3. The Company shall be entitled to remove the Photoreceptor Field from the scope lieu of the License at any time by providing [*] days prior written notice to Hadasit, in which case Development Product and license the provisions of the preceding Section 4.2 shall not longer have any effectTrademark for such product.
Appears in 1 contract
Sources: Trademark License Agreement (Fallbrook Technologies Inc)