Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following: (a) receive financing of at least [**] dollars ($[**]) within [**] following the Effective Date; (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date; (c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date; (d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; (e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and (f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones. 5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval. 5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 3 contracts
Sources: License Agreement (Kosan Biosciences Inc), License Agreement (Kosan Biosciences Inc), License Agreement (Kosan Biosciences Inc)
Diligence. 5.1 LICENSEE agrees shall itself use, or shall cause its sublicensees to use use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce at least one Licensed Product into the commercial market. Demonstration of such commercially reasonable efforts and diligence to proceed with the developmentshall include, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the followingbut not be limited to:
(ai) receive financing Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;
(ii) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] of the Agreement Date; and
(iv) The production of the commercialized Licensed Products and the marketing and support of the commercialized Licensed Products with at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with the development and commercialization of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA). Accordingly, in the event that LICENSEE can demonstrate to BCM its commercially reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) and (iii) above, LICENSEE and BCM will negotiate in good faith a reasonable revision to items (ii) and (iii) above; provided that BCM shall not unreasonably withhold such revision. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iii), LICENSEE may obtain a […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…**]*…] US) within [**] following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestonesfee.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 3 contracts
Sources: Exclusive License Agreement (Bellicum Pharmaceuticals, Inc), Exclusive License Agreement, Exclusive License Agreement (Bellicum Pharmaceuticals, Inc)
Diligence. 5.1 LICENSEE agrees to Tengion will use commercially reasonable efforts to bring CHB Licensed Products and diligence WFUHS Licensed Products to proceed market through a thorough and diligent program for exploitation of the CHB Patent Rights, WFUHS Patent Rights and the Know-How. Tengion shall not be required to be researching and developing Licensed Products in all or multiple subfields within the Licensed Field simultaneously in order to be deemed in compliance with the developmentforegoing sentence.
5.2 If WFUHS believes Tengion shall have failed to comply with the provisions of this Article 5, manufactureWFUHS shall notify Tengion of the same.
5.2.1 Upon receipt of such notice, Tengion shall have a period of sixty (60) days to (i) demonstrate to WFUHS’s reasonable satisfaction that it has complied with the provisions of Article 5.1, (ii) trigger the ADR provisions of Article 18 or sale (iii) notify WFUHS that it agrees with WFUHS. If Tengion does not satisfy clauses (i) or (ii) above or Tengion is found in the ADR proceedings to have not complied with Article 5.1 or if Tengion provides the notice contemplated in clause (iii) above, then Tengion shall, within the immediately following one (1) year period, exercise commercially reasonable efforts to grant a sublicense to a third party with respect to a subfield within the Field.
5.2.2 If at the end of Licensed Product(ssuch one (1) and year period, Tengion has failed to enter into such subfield sublicense, WFUHS may, within the immediately following one (1) year period negotiate the subfield field of use sublicense directly with a third party. If WFUHS negotiates such sublicense within such time, then Tengion shall endeavor to achieve the following:
enter into a subfield field of use sublicense with such third party, provided that such sublicense (a) receive financing is on terms that are substantially similar to the terms of at least [**] dollars this Agreement ($[**]) within [**] following except the Effective Date;
financial terms), (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
does not obligate Tengion to spend money or dedicate resources, (c) sequence at least [**] base pairs of DNA from one shall exclude any Licensed Product (or more [**] within [**] from the Effective Date;
related rights to such Licensed Product) that has been or is under active development or is being commercialized by Tengion and (d) generate a polyketide library of at least [**] polyketide compounds within [**] of is restricted to the Effective Date;subfield as to which Tengion has attempted, but failed, to comply with Article 5.
2.1. Tengion must execute such sublicense or initiate ADR proceedings (e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND if, for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligationsexample, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event it believes that LICENSEE has not achieved any one or more of clauses (a) - (d) above have not been satisfied) within ten (10) days of receiving the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension negotiated field of time in which LICENSEE may accomplish such milestone and all subsequent milestonesuse sublicense from WFUHS.
5.2 STANFORD may terminate LICENSEE's rights 5.2.3 If Tengion fails exercise the sublicense or initiate ADR proceedings within such ten (10) day period, it shall be deemed to have granted WFUHS an irrevocable power of attorney to execute such sublicense on its behalf. If an arbitrator finds that Tengion has initiated ADR proceedings without reasonable factual or legal basis or solely in order to delay further development, he or she shall have to power to order the termination of this license under this Agreement with respect to a particular Licensed Product if, after final FDA approval within the subfield of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for Field as to which Tengion has failed to comply with Article 5.1. * Confidential Treatment Requested 14
5.2.4 If WFUHS is unable to negotiate a continuous period of [**] after sublicense as contemplated above within such final approval.
5.3 On one (1) year period, then Tengion’s license hereunder will continue without any change or before [**] of each year during consequence, subject to the term terms and conditions of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5Agreement.
Appears in 2 contracts
Sources: License Agreement (Tengion Inc), License Agreement (Tengion Inc)
Diligence. 5.1 LICENSEE agrees 8.1 The Regents shall have the right to use reasonable efforts and diligence to proceed with terminate this Agreement in its entirety if, by 31 December 2012, the developmentLicensee, manufactureincluding affiliated companies, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of has not received at least €[**] dollars Euros) during the course of the calendar year of 2012 by way of equity and/or debt financings and/or payments by third party pharma/life sciences companies provided, however, that ($a) the Parties shall meet within the [**] day period after receipt of a Notice of Default (as defined below in Section 11.1) to agree in good faith whether the Licensee has nevertheless raised sufficient funds to be able to comply with its obligations under this Agreement and the Collaboration Agreement and (b) the termination shall not become effective at the end of the [**] day Notice Period (defined below in Section 11.2) if either (i) the parties agree that the Licensee has raised sufficient funds to be able to comply with its obligations under this Agreement and the Collaboration Agreement; or (ii) the Licensee receives additional funds during such [**] day Notice Period sufficient to reach the €[**] Euros) threshold for the [**]-period starting from 1 January 2012, as shown by written tangible evidence; or (iii) if the Licensee provides The Regents, within [**] days of receipt of The Regents’ Notice of Default, with a plan for raising such funds (“Funding Plan”) within a specified time period, and The Regents accepts such Funding Plan, and Licensee thereafter diligently continues such implementation until such funds are received within the specified time period. The Regents will notify Licensee of either The Regents’ acceptance or rejection, in its sole discretion, of Licensee’s Funding Plan. Any decision by The Regents to reject a Funding Plan pursuant to this Section 8.1 will be deemed final and The Regents shall have the right to immediately terminate this Agreement.
8.2 The Licensee will complete the following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents tasks, within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] months of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term Date of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending Agreement: [**].
8.3 The Licensee, regarding from the progress date it receives the Interim Report, agrees to use Commercially Reasonable Efforts to proceed, either directly or through a Third Party Licensee, to develop at least one Identified Product, and seek to obtain regulatory approval for such Identified Product in the U.S. and the European Union, and to use Commercially Reasonable Efforts to market the same in quantities sufficient to meet the market demands therefor in the U.S. and in France, Germany, Italy, Spain and the UK.
8.4 The Parties acknowledge that developing and seeking regulatory approvals for an Identified Product may include sequential implementation of LICENSEE toward commercialization clinical trials and intervals between clinical trials for data interpretation and clinical program planning and approval. The Regents acknowledge that in determining whether Licensee has met its requirement to use Commercially Reasonably Efforts in accordance with Section 8.3, reference will be made to the totality of Licensed Licensee’s activities with respect to all Identified Product(s) (if, in Licensee’s sole discretion, it decides to develop more than one Identified Product) in all countries, not on a country-by-country basis.
8.5 The Licensee will use Commercially Reasonable Efforts to obtain all necessary regulatory approvals in each country where Identified Products are manufactured, used, Sold, offered for Sale or imported.
8.6 Subject to Section 8.7, if the Licensee materially fails to comply with any of the provisions of Sections 8.1 to 8.5, then The Regents has the right and option to either terminate this Agreement or remove the licensing restriction in Section 2.2. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant) and The Regents shall be free to license the rights granted in Section 2.1 to other for-profit entities.
8.7 To exercise either the right to terminate this Agreement or to remove the licensing restriction in Section 2.2 for the Licensee’s material failure to comply with any of the provisions of Sections 8.1 to 8.5, The Regents will give the Licensee written notice of the deficiency in accordance with Section 11.2 (Nonmonetary Default). Such report shall includeIf, as a minimumafter the Notice Period, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient or Notice Extension Period, if applicable, the deficiency has not been cured, then The Regents may, at its option, terminate this Agreement immediately or remove the licensing restriction in Section 2.2 by providing written notice to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5Licensee.
Appears in 2 contracts
Sources: Data License Agreement (uniQure B.V.), Data License Agreement (uniQure B.V.)
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use through a thorough, vigorous and diligent program for exploiting the same and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE has the responsibility to use commercially reasonable efforts to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES.
5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for the developmentLICENSED PRODUCTS and LICENSED PROCESSES (together the "MILESTONES'") by 'he following dates:
1) Completion of Phase I Clinical Trial on or before January 1, manufacture2015.
2) Completion of Phase II Clinical Trial on or before January 1, 2017.
3) Completion of Phase III Clinical Trial on or sale of Licensed Product(sbefore January 1, 2019.
4) and shall endeavor to FIRST COMMERCIAL SALE on or before January 1, 2020.
5.3 LICENSEE must achieve the following:
MILESTONES on or before the deadline dates indicated. If LICENSEE fails to meet any MILESTONE under Paragraph 5.2 MICHIGAN may terminate this AGREEMENT effective on thirty (30) days prior written notice to LICENSEE, subject, however, to the rights of any SUBLICENSEE granted pursuant to Paragraph: provided, however , that any such termination shall not be effective if LICENSEE: (a) receive financing of at least [**] dollars actually achieves such MILESTONE during such thirty ($[**]30) within [**] following the Effective Date;
day period or (b) establish a facility at which it will practice demonstrates that LICENSEE has used commercially reasonable efforts to achieve such MILESTONE over the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs entire course of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] this AGREEMENT. If, as of the Effective Date;
close of such thirty (e30) generate day period, there is a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining dispute as to whether LICENSEE has met its diligence obligationsthe condition set forth in clause (a) or (b) of the preceding sentence, Sections 5.1 then such thirty (c)-(f30) above may day period shall be satisfied by LICENSEE or its sublicenseesautomatically extended for thirty (30) days, during which time the parties shall hold good faith discussions in order to resolve such dispute. In If the event parties ultimately agree that LICENSEE has not achieved any one or more of met the foregoing milestones but has exercised reasonable efforts to accomplish condition set forth in clause (b) above, the sametermination shall be deemed ineffective, STANFORD and LICENSEE the panics shall negotiate in good faith an extension a revised deadline for achieving such MILESTONE. In addition, regardless of time in which whether LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, can demonstrate that LICENSEE has not sold met the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Productcondition set forth in clause (b) above, LICENSEE shall make have the opportunity to present a written annual report revised timeline for achieving the MILESTONE at issue, and the approval to STANFORD covering revise the preceding year ending [**]timeline from MICHIGAN shall not be unreasonably withheld, regarding the progress of provided that LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of is otherwise in compliance with its other obligations under this Article 5AGREEMENT.
Appears in 2 contracts
Sources: Exclusive License Agreement (Heat Biologics, Inc.), Exclusive License Agreement (Heat Biologics, Inc.)
Diligence. 5.1 LICENSEE agrees (i) Following the Closing, until the expiration of the Diligence Period set forth in section 1.5(c)(i)(a)(A) below, the Buyer shall itself and/or with or through other members of the Buyer Rights Chain Group, as applicable, use Commercially Reasonable Efforts to obtain Regulatory Approval for the FibroCaps Product in the United States and the European Union and, if either or both such Regulatory Approvals are obtained, until the expiration of the Diligence Period set forth in section 1.5(c)(i)(a)(B) below, the Buyer shall itself and/or with or through other members of the Buyer Rights Chain Group, as applicable, use reasonable efforts and diligence Commercially Reasonable Efforts to proceed with commercialize the developmentFibroCaps Product in the United States and/or the European Union, manufactureas applicable. Notwithstanding the foregoing, or sale of Licensed Product(s) and shall endeavor to achieve the following:Buyer’s obligations under this Section 1.5(c):
(a) receive financing of at least [**] dollars shall expire ($[**]A) within [**] as to Milestones #1 and #2, on January 1, 2016 (save as provided in the chart set forth in Section 1.5(b) above) and (B) as to Milestone #3, 4 and 5, on the date 24 months following the Effective Dateearlier of (I) First Commercial Sale in the United States or (II) First Commercial Sale in the European Union;
(b) establish a facility at which it will practice shall not include an obligation to seek any additional Regulatory Approval or label expansion for the Licensed Patents within [**] Fibrocaps Product (A) in the United States following the Effective Date;initial Regulatory Approval in the United States or (B) in the European Union following the initial Regulatory Approval in the European Union; and
(c) sequence at least [**] base pairs shall not include an obligation to conduct any clinical trial or nonclinical study of DNA from the FibroCaps Product, whether or not such studies would be necessary for any Regulatory Approval other than a post-regulatory approval pediatric indication study.
(ii) If the Buyer permanently terminates or abandons all efforts to obtain the Regulatory Approvals and, if commenced as of such time, commercialization activities with respect to the FibroCaps Product, the Buyer shall send written notice thereof to the Representative together with an explanation of the reasons for such cessation of activities.
(iii) If the Representative in good faith believes that the Buyer has breached its obligations under this Section 1.5, then the Representative may provide the Buyer with written notice thereof, which notice shall specify the alleged breach. If such notice is given, the Buyer shall designate one or more [**] representatives to meet with the Representative (in person at the Buyer’s offices or by telephone) within [**] fifteen (15) Business Days from the Effective Date;
(ddate of such notice to discuss the Representative’s belief that the Buyer has breached its obligations under this Section 1.5. The discussion between the Buyer’s representative(s) generate a polyketide library and the Representative shall be subject to the confidentiality obligations of at least [**] polyketide compounds within [**] Section 1.7(d) and regarded as for settlement purposes only, and no statement made in the course of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] discussion shall be admissible in any subsequent Legal Proceeding, although the fact that something is stated in the course of the Effective Date; and
(f) file discussion will not preclude a party to a Legal Proceeding from adducing other evidence of an IND for a Licensed Product within [**] from identical or similar nature that otherwise would be permitted in the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicenseesLegal Proceeding. In the event that LICENSEE has not achieved any one or more the Representative and the Buyer’s representatives are unable to resolve the Representative’s claim of the foregoing milestones but alleged breach by (A) the date that is thirty (30) Business Days after such meeting, or (B) the date that is sixty (60) Business Days after the written notice from the Representative to the Buyer of the alleged breach if no meeting (whether in person or by telephone) has exercised reasonable efforts been held by such date, then the Representative may pursue any available remedies in accordance with the terms of this Agreement, subject to accomplish Section 1.5(c)(iv), unless the same, STANFORD Buyer and LICENSEE shall negotiate in good faith the Representative mutually agree to an extension to the foregoing time periods.
(iv) Nothing herein shall constitute a guarantee by the Buyer of time the achievement of any or all of the Milestone Events. Save in which LICENSEE may accomplish such milestone the event of fraud or knowing misrepresentation, the Buyer’s maximum aggregate liability for any and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's breaches by the Buyer of its obligations under this Section 1.5(c) shall be limited to the unpaid portion(s), if any, of the Milestone Payment(s) that the Buyer would have become obligated to pay if the Buyer had exercised the requisite Commercially Reasonable Efforts, together with (A) the Sellers’ reasonable legal fees and expenses incurred in enforcing their rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for Section 1.5 and (B) interest on such Licensed Product, LICENSEE has not sold amount from the Licensed Product for a continuous period date the applicable Milestone Payment became payable until the date on which payment is made at an annual rate of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending percent ([**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s%) (accrued daily and compounded monthly). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 2 contracts
Sources: Share Purchase Agreement, Share Purchase Agreement (Medicines Co /De)
Diligence. 5.1 LICENSEE agrees to 4.1 Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and diligence sell Licensed Products in each of the XLMTM Field and the Pompe Field. Commercially reasonable efforts means efforts equivalent to proceed with those utilized by [*] Without limiting the developmentforegoing, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve Licensee will meet the following:
(a) receive financing Acceptance by the FDA of at least an Investigational New Drug application for a Licensed Product in the XLMTM Field by no later than [**] dollars ($[**]) within [**] following the Effective Date;; and
(b) establish Acceptance by the FDA of an Investigational New Drug application for a facility at which it will practice Licensed Product in the Licensed Patents within Pompe Field by no later than [**] following ]. Licensee will notify Licensor in writing as soon as Licensee believes in good faith that Licensee will not be able to achieve either milestone set forth in Section 4.l (a) or (b) by the Effective Date;
(c) sequence at least relevant deadline date, and, upon the payment to Licensor of [**] base pairs of DNA from one or more [**] within [*] of the original deadline date, the deadline date for such milestone set forth in Section 4.l (a) or (b), as applicable, will be extended for [*] from the Effective Date;
(d) generate a polyketide library of at least original deadline date; provided that Licensee will only be entitled to [*] for the XLMTM Field and [*] polyketide compounds for the Pompe Field, each of which extensions will require a payment of [*] as provided in this Section 4.1.
4.2 Within [*] after the Effective Date and within [*] of each December 1 thereafter, Licensee shall provide Licensor with written progress reports, setting forth in such detail as Licensor may reasonably request, the progress of the development, evaluation, testing, and commercialization of each Licensed Product. Licensee will also notify Licensor within [*] of the Effective Datefirst commercial sale by Licensee, its Affiliates, or any Sublicensees of each Licensed Product. Such a report (“Development Progress Report”), setting forth the current stage of development of Licensed Products, shall include:
4.2.1 Date of Development Progress Report and time covered by such report;
(e) generate a polyketide library 4.2.2 Major activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to the Licensed Product since the last Development Progress Report;
4.2.3 Significant research and development projects relating directly to the Licensed Product currently being performed by Licensee, its Affiliates, and any Sublicensees and projected dates of completion;
4.2.4 A development plan covering the next two years at least [**] polyketide compounds within [**] least, which will include future development activities to be undertaken by Licensee, its Affiliates, or any Sublicensees during the next reporting period relating directly to the Licensed Product, Licensee’s strategy to bring the Licensed Product to commercialization, and projected timeline for completing the necessary tasks to accomplish the goals of the Effective Datestrategy;
4.2.5 Projected total development remaining before product launch of each Licensed Product; and
(f) file an IND for a 4.2.6 Summary of significant development efforts using the Licensed Product within [**] from Patents being performed by Third Parties, including the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more nature of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD relationship between Licensee and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestonesThird Parties.
5.2 STANFORD 4.3 The Parties agree that Development Progress Reports shall be deemed Licensee’s Confidential Information; provided that Licensor may terminate LICENSEE's rights under this Agreement share a copy of such reports with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approvalits direct and indirect licensors.
5.3 On or before [**] 4.4 Simultaneously with the Development Progress Report, Licensee shall deliver a detailed description of each year during the term of this Agreement until LICENSEE markets a any Licensed ProductBack Improvements, LICENSEE shall make a written annual report if not previously provided pursuant to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5Section 2.5.2.
Appears in 2 contracts
Sources: License Agreement (Audentes Therapeutics, Inc.), License Agreement (Audentes Therapeutics, Inc.)
Diligence. 5.1 LICENSEE agrees to 4.1 Licensee will use commercially reasonable efforts to develop, commercialize, market, promote, and diligence sell Licensed Products in each of the XLMTM Field and the Pompe Field. Commercially reasonable efforts means efforts equivalent to proceed with those utilized by ****. Without limiting the developmentforegoing, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve Licensee will meet the following:
(a) receive financing Acceptance by the FDA of at least [an Investigational New Drug application for a Licensed Product in the XLMTM Field by no later than **] dollars ($[**]) within [**] following the Effective Date;; and
(b) establish a facility at which it will practice Acceptance by the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs FDA of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND Investigational New Drug application for a Licensed Product within [in the Pompe Field by no later than **] from the Effective Date**. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate Licensee will notify Licensor in writing as soon as Licensee believes in good faith an extension that Licensee will not be able to achieve either milestone set forth in Section 4.1(a) or (b) by the relevant deadline date, and, upon the payment to Licensor of time in which LICENSEE may accomplish **** within **** of the original deadline date, the deadline date for such milestone set forth in Section 4.1(a) or (b), as applicable, will be extended for **** from the original deadline date; provided that Licensee will only be entitled to **** for the XLMTM Field and all subsequent milestones**** for the Pompe Field, each of which extensions will require a payment of **** as provided in this Section 4.1.
5.2 STANFORD 4.2 Within **** after the Effective Date and within **** of each December 1 thereafter, Licensee shall provide Licensor with written progress reports, setting forth in such detail as Licensor may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product ifreasonably request, after final FDA approval the progress of a NDA for such the development, evaluation, testing, and commercialization of each Licensed Product. Licensee will also notify Licensor within **** of the first commercial sale by Licensee, LICENSEE has not sold its Affiliates, or any Sublicensees of each Licensed Product. Such a report (“Development Progress Report”), setting forth the current stage of development of Licensed Products, shall include:
4.2.1 Date of Development Progress Report and time covered by such report;
4.2.2 Major activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to the Licensed Product for a continuous period of [since the last Development Progress Report; **] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 2 contracts
Sources: License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.)
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available.
5.2 Without limiting Paragraph 5.1, LICENSEE agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for the development, manufacture, or sale of Licensed Product(sLICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
(a1) receive financing of at least [**XXX]
2) [XXX]
3) [XXX]
4) [XXX] dollars ($[**]) within [**] following For the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligationsthis Agreement, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval initiation of a NDA for such Licensed Product, LICENSEE clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has not sold been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the Licensed Product for a continuous period of [**] after such final approvalrelevant regulatory agency.
5.3 On LICENSEE must achieve each MILESTONE on or before [**] the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of each year during the term any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement until effective on ninety (90) days’ written notice, unless LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering achieves the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of MILESTONE within this Article 5ninety (90) day period.
Appears in 2 contracts
Sources: Patent License Agreement (Solid Biosciences, LLC), Patent License Agreement (Solid Biosciences, LLC)
Diligence. 5.1 LICENSEE The Parties acknowledge and agree that Emergent’s development of the Licensed Products is subject to, and dependent upon, the availability of government funding for such product and clinical development activities; that the availability of such funding in general, and for Emergent specifically, is uncertain as of the Effective Date; that the timing and continuity of any such funding is also uncertain; and that any and all of these factors could result in significant delays in Emergent’s Exploitation of the Licensed Products. Emergent agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
Commercially Reasonable Efforts (a) receive financing to respond to any solicitations and procurement proposals of government agencies in each Major Market (including, in the case of the United States, federal, state and local agencies), of which HPA gives notice to Emergent or of which Emergent is otherwise aware, that are directly applicable to one or more Licensed Products, and (b) to enter into procurement contracts and development contracts with such government agencies with respect to the Licensed Products; provided, however, that Emergent shall not be required to do so with respect to any Licensed Product if a Third Party has instituted, or in the good faith judgment of Emergent is reasonably likely to institute, an Infringement Suit with respect to the Exploitation of such Licensed Product in such Major Market. Emergent shall be deemed to have satisfied its obligations under this Section 2.6 if it files an IND with respect to one or more Licensed Products by the fifth anniversary of the Effective Date. In the event that Emergent fails to file an IND with respect to at least one Licensed Product by such date (the “Penalty Date”), then it shall pay HPA [**] dollars Dollars (US $[**]) within ten days after the Penalty Date, and an equal sum thereafter on an annual basis, within ten days after each anniversary of the Penalty Date, until such time as Emergent has filed an IND with respect to at least one Licensed Product; provided, however, that if Emergent files such an IND after the Penalty Date and prior to the fifth anniversary of the Penalty Date, then within ten days after such filing Emergent shall pay HPA a lump sum equal to the difference between [**] following the Effective Date;
Dollars (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending US $[**]) and the aggregate amount previously paid by Emergent to HPA pursuant to this sentence; and provided, regarding further, that Emergent shall not be required to make any payment in the progress event that Emergent’s failure to file such IND by such date results directly from the failure by HPA to perform any of LICENSEE toward commercialization of Licensed Product(s)its obligations hereunder in a timely manner. Such report payment shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements be the sole remedy of the U.S. Government and HPA for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements any breach of this Article 5Section 2.6, and any breach of this Section 2.6 (other than a breach of such payment obligation) shall not be deemed a material breach of this Agreement for purposes of Section 10.5.
Appears in 2 contracts
Sources: Rbot Vaccine License Agreement (Emergent BioSolutions Inc.), Bt Vaccine License Agreement (Emergent BioSolutions Inc.)
Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing Ultragenyx (on its own or acting through any of its Affiliates, sublicensees or subcontractors) shall use Commercially Reasonable Efforts to develop and commercialize at least one (1) Product in FAOD and at least (1) Product in [**] dollars *]. Specifically, Ultragenyx will use Commercially Reasonable Efforts to ($a) [***]; (b) [***]; (c) [***]; and (d) within [***] following after the Effective Date;, perform at least one of the following: (i) [***]; or (ii) [***]; in each case of (a)-(d) above, provided that each such timeline shall be extended to account for any delay resulting from factors beyond Ultragenyx’s reasonable control, including regulatory, medical, safety or efficacy delays.
(b) establish If Ultragenyx shall fail to achieve such milestones within such applicable time frame(s) (as such time frame(s) may be extended pursuant to 3.2(a) above), BRI may provide written notice to Ultragenyx and upon receipt of any such notice, the Parties shall discuss in good faith Ultragenyx’s progress for the development of such Product in the applicable jurisdiction and the Parties may agree on an amended timeline or a facility at which it will practice plan for Ultragenyx to continue its development of the Licensed Patents within Product. Each agreed upon [***] following extension of the Effective Date;timeline shall be subject to the payment by Ultragenyx of an extension fee of [***]. For clarity, if a delay in timeline is due to new regulatory, development, or safety requirements or other similar actions by regulatory authorities or other government agencies, such timeline is not subject to the payment by Ultragenyx of an extension fee.
(c) sequence at least For the purposes of this Section 3.2(c), all FAOD indications shall be deemed one “Indication Cluster” and all [**] base pairs of DNA from one or more [**] within [**] from shall be deemed another “Indication Cluster.” On an Indication Cluster-by-Indication Cluster basis, in the Effective Date;
(devent Ultragenyx fails to satisfy such new timeline or plan that is specific to a particular Indication Cluster, then upon written notice by BRI, the license granted to Ultragenyx pursuant to Section 2.1(a) generate a polyketide library shall become non-exclusive solely for such Indication Cluster, provided that all obligations for payment of royalties or milestones remain the same for such Indication Cluster and provided, that, if Ultragenyx subsequently obtains Regulatory Approval for the Product for such Indication Cluster, the license under Section 2.1(a) shall thereupon automatically convert back to an exclusive license for such Indication Cluster so long as BRI still maintains the right to grant an exclusive license to Ultragenyx at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicenseessuch time. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but conversion of the license to non-exclusive, any sole and/or exclusive rights that Ultragenyx has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to such non-exclusive Indication Cluster, including without limitation such rights under Section 3.1, this Section 3.2, and Section 3.3 shall also automatically become non-exclusive. Further, on an Indication Cluster-by-Indication Cluster basis, Ultragenyx’s rights regarding BRI Independent Studies under Sections 3.3 (i)-(iv), and Ultragenyx’s rights under Sections 5.1(a), 5.3(b), Section 5.4(b), Section 5.5 (a) and (b), and Section 5.6, as well as BRI’s corresponding obligations to Ultragenyx with respect to those Sections, in each case as such rights and obligations apply to any non-exclusive Indication Cluster, shall be suspended for so long as such license remains non-exclusive and shall be automatically reinstated if and when such license becomes exclusive pursuant to the foregoing. Failure to achieve such milestones shall not be a material breach of this Agreement. The remedy provided for pursuant to this Section 3.2 shall be BRI’s sole and exclusive remedy for or relating to Ultragenyx’s failure to achieve any milestone. If the license granted to Ultragenyx pursuant to Section 2.1(a) is converted to a non-exclusive license for a particular Licensed Product ifIndication Cluster pursuant to the terms of this Section 3.2, after final FDA approval BRI shall promptly provide Ultragenyx with written notice of a NDA any Third Party license that BRI grants under the BRI Technology relating to Compounds or Products for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approvalIndication Cluster.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 2 contracts
Sources: License Agreement (Ultragenyx Pharmaceutical Inc.), License Agreement (Ultragenyx Pharmaceutical Inc.)
Diligence. 5.1 LICENSEE 3.5.1 In carrying out the Development and in seeking Regulatory Approval, OMP agrees to use such commercially reasonable and diligent efforts as are commensurate with the level of time, effort and funding expended by OMP on other projects at a similar stage of development, with a target market of a similar size, patient population and importance, and as otherwise consistent with its overall business strategy. OMP does not in any way represent or warrant that a Collaboration Compound hereunder shall be the only compound that OMP will at the same time develop or commercialize for identical or similar therapeutic uses. Without limitation to the foregoing, non-achievement of the following development milestones within the Time to Complete set forth below shall be an objective measure of OMP’s non-performance for the time periods specified: [***] [***] OMP shall promptly notify ADDEX upon the accomplishment of each of the foregoing Milestones.
3.5.2 If, notwithstanding OMP’s exercise of the efforts recited in Article 3.5.1 above, OMP is unable to meet or anticipates that it may not be able to make a Selection or to meet any of the Milestones within the Time to Complete set forth above, OMP shall have the right to request an extension for such Milestone(s), which shall not be unreasonably refused. Without limitation, the following shall be examples of instances in which OMP shall be entitled to such extension: [***], to the extent that [***]. In addition, Parties recognize that OMP may, after discussion with the JDC, need to discontinue the Development of a Collaboration Compound for reasons outside its reasonable control, in which case the following shall apply, depending on the stage of Development:
(i) If OMP prior to [***] OMP has initiated [***] of a Collaboration Compound and such Collaboration Compound fails during such studies, for reasons outside of OMP’s reasonable control, then the time periods set forth in Article 3.5.1 above shall be extended for a period [***]
(ii) If OMP initiates [***] with respect to a Collaboration Compound and such Collaboration Compound fails [***], for reasons outside of OMP’s reasonable control, the time periods specified in Article 3.5.1 above shall be extended for a period [***];
3.5.3 If the Parties disagree as to whether OMP is entitled to an extension of the time to make a Selection under Article 2.8 or to the Time to Complete as set forth in 3.5.2 above for any Milestone specified in 3.5.1 above, or whether or not OMP is complying with its obligations under 3.5.1 above, then, upon the written request by either Party, such matter shall be resolved in accordance with Article 18. However, notwithstanding any other provision of Article 18 and Appendix C, the mediation procedure of Section 1.1 of Appendix C shall not apply. Moreover the arbitration shall be concluded within [***] calendar days after the Panel of Arbitrators has been appointed in accordance with Section 1.2 of Appendix C, and the time periods recited in Appendix C shall be reset accordingly to achieve the [***] day completion date. Subsection (c) of Section 1.2 of Appendix C shall not apply. As circumstances may warrant the Parties will seek arbitrators with appropriate commercial and technical backgrounds to resolve disputes under this Article.
3.5.4 In the event that OMP or its Affiliate or Sublicensee in charge of Early Stage Development of a Collaboration Compound fails to make a Selection or achieve the Milestones set forth in Article 3.5.1 within the Times to Complete with respect to [***] with any applicable extensions under Article 3.5.2 and any disputes of the fact having been resolved under Article 3.5.3 and determine that OMP or its Affiliate or Sublicensee did not comply with its obligations under Article 3.5.1, then OMP shall have [***] calendar days to provide a written election which at its sole discretion of the two remedies set forth below in Articles 3.6 and 3.7 to offer ADDEX, provided, however, these remedies shall not be available to ADDEX if [***]. If OMP fails to elect within said [***] days, ADDEX shall have the right to elect which of the two remedies set forth below in Articles 3.6 and 3.7 that ADDEX wishes to pursue. If neither Party elects to elect a remedy, then OMP’s failure of diligence under Article 3.5.1 shall be waived and OMP will have the right to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of at least [**] dollars ($[**]) within [**] following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] development of the Effective Date;
(e) generate a polyketide library Collaboration Compound that gave rise to the failure of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts replacement thereto subject to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.3.5. The remedies provided by Article 3.6 and Article 3.7 [***] and such failure [***]
3.5.5 [***] OMP’s diligence obligation shall [***]
Appears in 2 contracts
Sources: Research and Development (Addex Therapeutics Ltd.), Research and Development (Addex Therapeutics Ltd.)
Diligence. 5.1 LICENSEE agrees 4.3.1 Sellas shall use Commercially Reasonable Efforts to use reasonable efforts and diligence Develop the Compound pursuant to proceed with a development plan (the development, manufacture, or sale “Development Plan”) which will include projected timelines for the achievement of Licensed Product(s) and shall endeavor to achieve the following:
following milestones: (a) receive financing initiation of at least the first [***] dollars in the Territory for a Product; ($b) initiation of the first [**]*] in the Territory for a Product; and (c) within the submission of [***] following a [***].
4.3.2 Sellas will deliver the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents initial Development Plan to GenFleet within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least . Not later than [***] polyketide compounds after December 31 of each Calendar Year during the Term, when Development of a Product in the Field in the Territory is ongoing, Sellas shall provide to GenFleet an updated Development Plan for the pending Calendar Year. Such update shall take into account completion, commencement, changes in or cessation of Development activities not contemplated by the then-current Development Plan to reflect the continued diligence of Sellas and its Sublicensees.
4.3.3 Sellas shall itself or through its Sublicensees use Commercially Reasonable Efforts to (a) Develop and seek Regulatory Approval for a Product in the United States, and (b) Commercialize Products following Regulatory Approval in the Territory.
4.3.4 The Parties further agree that the Development Plan shall be consistent with the diligence milestone events set forth in this Section 4.3.4 (each a “Diligence Milestone Event”) and Sellas shall complete each Diligence Milestone Event (either itself or through a Sublicensee) prior to or upon each respective deadline subject to any extension provided for in this Section 4.3.4 (each, as extended, a “Milestone Deadline”): First [***] for a Product in the Territory (“Diligence Milestone Event 1”) [***] following [***] for such Product [***] If Sellas fails to meet the deadline for a Diligence Milestone Event (whether the original deadline, or as extended pursuant to the process set forth above, or as determined in accordance with Section 4.3.5, as applicable), then GenFleet may treat such failure as a material breach which has not been cured in accordance with Section 13.2.1 and GenFleet is entitled to terminate this Agreement pursuant to Section 13.2.1.
4.3.5 If the Parties cannot reach agreement on the Impasse before [***] prior to the original deadline, then Sellas may, in its sole discretion, submit the matter to binding arbitration for resolution before the original deadline as set forth below.
(a) If Sellas elects to submit the Impasse to binding arbitration, each Party will first (a) prepare a draft of its proposed deadline, which deadline shall be not earlier than [***] after the original deadline (each a “Draft Deadline”) and (b) submit its Draft Deadline to the other Party within [***] following the date of Sellas notice of election of arbitration. Within [***] following the last Party’s submission of its Draft Deadline to the other Party, the Parties will meet and determine whether they agree to enter into either Party’s Draft Deadline, or a modified version thereof, as the revised deadline.
(b) If the Parties are unable to agree on the selection of a Draft Deadline (or a modified version thereof), the determination of the Effective Date; and
revised deadline will be resolved by final and binding arbitration before an independent Third Party arbitrator chosen by the Parties (fthe “Arbitrator”). The Arbitrator shall have at least ten (10) file years of subject matter expertise with respect to regulatory matters in the U.S. pharmaceutical industry. If the Parties are unable to agree on an IND for a Licensed Product Arbitrator within [***] from of failing to agree on a Draft Deadline (or a modified version thereof), then the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may Parties will request that one be satisfied appointed for them by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestonesAmerican Arbitration Association.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of (c) Within [***] after such final approval.
5.3 On or before following the appointment of the Arbitrator, each Party will submit its Draft Deadline to the Arbitrator, as well as any supporting materials. For clarity, the Draft Deadline submitted to the Arbitrator by each Party must be identical to the Draft Deadline previously submitted to the other Party above. The Arbitrator will be instructed to select one of the Parties’ Draft Deadlines within [***] following the receipt of each year during the term latter of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report such Draft Deadlines and to STANFORD covering select the preceding year ending Draft Deadline that it determines contains the most fair deadline. The Arbitrator will agree to comply with such [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONbefore accepting appointment. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements The authority of the U.S. Government Arbitrator will be limited to selecting only one or the other of the Draft Deadlines submitted by the Parties. The selection by the Arbitrator of one Party’s Draft Deadline will be binding and for STANFORD conclusive upon both Parties and their Affiliates, and such Draft Deadline will be the applicable deadline.
4.3.6 Each Party will bear its own costs and expenses (including legal fees and expenses) relating to ascertain progress the arbitration proceeding, except that the fees of the Arbitrator and other related costs of the arbitration will be shared equally by LICENSEE toward meeting the diligence requirements Parties, unless the Arbitrator determines that a Party has incurred unreasonable expenses due to vexatious or bad faith positions taken by the other Party, in which event the Arbitrator may make an award of this Article 5all or any portion of such expenses (including reasonable legal fees) so incurred.
Appears in 1 contract
Sources: License Agreement (SELLAS Life Sciences Group, Inc.)
Diligence. 5.1 LICENSEE agrees Notwithstanding anything herein to the contrary, MMT’s commitment to use reasonable efforts and diligence Commercially Reasonable Efforts as set forth herein shall not preclude the suspension or discontinuance of the Promotion of the Product in the Field in a country within the Territory, if reasonably appropriate, based on the application of Commercially Reasonable Efforts with respect to proceed with the development, manufacture, or sale Promotion of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of at least Product in such country. If MMT does not document in the Business Plan [**] dollars *]the Product in the Field in a country in the Territory ($“[***]”) within for a period of either (i) [***] following calendar months after the Effective Date;
Date for Tier 1 Countries, (bii) establish a facility at which it will practice the Licensed Patents within [***] following calendar months after the Effective Date;
Date for Tier 2 Countries or (ciii) sequence at least [***] base pairs of DNA from one or more calendar months after the Effective Date for Tier 3 Countries (each such time period set forth in (i)-(iii) being a “Tier Period”), then no later than [***] within Business Days after the expiration the applicable Tier Period for such country, SIGA may provide MMT with written notice [***] from the Effective Date;
(d) generate a polyketide library of at least non-[***] polyketide compounds within (a “Non-[***] Notice”) in such country, and upon MMT’s receipt of the Effective Date;
(e) generate a polyketide library of at least such Non-[***] polyketide compounds within Notice, such country shall be deemed to be a “Discontinued Country” for purposes of this Agreement. If [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding SIGA shall have the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, right to designate the applicable country as a minimum, Discontinued Country at any time thereafter as long as the relevant Tier Period [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements for the country has been met at the time of the U.S. Government Non-[***] Notice. SIGA hereby acknowledges and agrees that MMT and its Affiliates make (and have made) no representation or warranty, either express or implied, at law or in equity, that it will be able to successfully achieve any amount of Net Product Sales Amount, and SIGA specifically disclaims that it is relying upon or has relied upon any such representations or warranties that may have been made by any individual or entity. SIGA acknowledges and agrees that MMT and its Affiliates have, and will continue to have, other programs that may compete for STANFORD resources that may be expended in the Promotion of the Product. Except as otherwise set forth in Section 2.3 with respect to ascertain progress by LICENSEE toward meeting Competing Products, nothing in this Agreement shall limit or restrict the diligence requirements right of this Article 5MMT or its Affiliates to develop, make regulatory filings, obtain regulatory approvals with respect to, or to Commercialize any product that is not the Product or, with respect to MMT only, a Competing Product or to engage in any business or other activity.
Appears in 1 contract
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE, AFFILIATES and SUBLICENSEES.
5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for the development, manufacture, or sale of Licensed Product(sLICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
1) Initiate communication with all Tier 1 (aLargest - see Schedule 2) receive financing Cosmetic or Chemical Companies with Category 1 Products (defined at those which explicitly use ******** within their product or marketing literature during ********.
2) Initiate communication with all Tier 2 Companies (Significant size, but not the very largest - see Schedule 3) with Category 1 products during ********.
3) Complete product research on all Category 2 (defined as those products which are suspected by LICENSEE of using ******** by virtue of claimed activity or description of active ingredients) within ********.
4) Initiate communication with all Tier 1 Companies with Category 2 products (to be determined based on research completed in Milestone #3) within ********.
5) Within ******** of the effective date of this agreement, LICENSEE will obtain at least [**] dollars ($[**]) within [**] following * new revenue-generating business relationship from among the Effective Date;
Companies currently or prospectively identified as Tier 1 or 2 Companies. Additional royalties to MICHIGAN from such additional business under Section 3.1 (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
or (c) sequence herein shall be at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees* per year. In the event that LICENSEE has such business relationships do not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [generate at least **] after such final approval*** per year in additional royalties, the Annual Fee due MICHIGAN (as defined in Section 3.1 (d)) shall be increased by the difference between ****** and the royalty amount actually incurred.
5.3 On LICENSEE must achieve the MILESTONES on or before [**] the deadline dates indicated. LICENSEE shall notify MICHIGAN within ten (10) days after each deadline as to whether such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article continues for forty-five (45) days after the date of each year during the term any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5provided in section 11.3.
Appears in 1 contract
Diligence. 5.1 LICENSEE agrees (a) Subject to Section 10.3, ONCOMED shall use commercially reasonable efforts to diligently develop, test, obtain regulatory approval of, market and sell [***] with respect to each Commercial Therapeutic License, as a prudent business person would undertake. At a minimum, ONCOMED shall use commercially reasonable efforts and diligence to proceed with the developmentdiligence, manufacturefor each Commercial Therapeutic License, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of at least to: [**] dollars ($*]. MORPHOSYS agrees that in the event ONCOMED or its Sublicensee is not able to meet the foregoing milestones, then MORPHOSYS and ONCOMED will convene a discussion to review and approve changes to the time schedules for the diligence milestones based on [***] and taking into account that [***] directed to the [***]. Should the Parties fail to agree to changes to the time schedules for the diligence milestones then Section 12.13 shall govern. For each Commercial Therapeutic License for which the fee under Section 6.1(c) has been paid, ONCOMED shall provide to MORPHOSYS, annually, a reasonably detailed development report covering the preceding twelve (12) months and a summary of estimated development for the forthcoming twelve (12) months, which report shall first be due within [**] following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approvalpayment under Section 6.1(c).
5.3 On or before [**] (b) MORPHOSYS shall use commercially reasonable efforts (i) to provide the MORPHOSYS Customer Support in accordance with Section 2.3(b), and (ii) should ONCOMED elect MORPHOSYS to carry out the objective of each year during applying its MORPHOSYS Antibody Affinity Optimization Technology to a HuCAL Antibody selected by ONCOMED, to apply the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report MORPHOSYS Antibody Affinity Optimization Technology to STANFORD covering optimize the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall includeHuCAL Antibody selected by ONCOMED, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of specified in the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5Collaboration Plan.
Appears in 1 contract
Sources: Subscription and License Agreement (OncoMed Pharmaceuticals Inc)
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring at least one LICENSED PRODUCT to market or one LICENSED PROCESS to commercial use through a commercially reasonable diligent program for exploiting the PATENT RIGHTS and to continue active, diligent marketing efforts using commercially reasonable efforts for any LICENSED PRODUCT that [***] = CONFIDENTIAL TREATMENT REQUESTED achieves regulatory approval throughout the life of this Agreement. LICENSEE has the responsibility to use commercially reasonable efforts to obtain and retain any necessary governmental approvals that are required to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES .
5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use commercially reasonable efforts to reach the following commercialization and diligence research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the dates specified below. For the purposes of this Agreement, initiation of a clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has been manufactured according to proceed with Good Manufacturing Practices (GMP) guidelines provided by the developmentrelevant regulatory agency. The MILESTONES are:
1) submitting an IND to the FDA by August 31, manufacture2013.
2) initiating a Phase I clinical trial by December 31, or sale 2013. [***] MICHIGAN acknowledges and agrees that LICENSEE has fully satisfied its obligations regarding achievement of Licensed Product(sMILESTONES 1 and 2 above, and that no Delay Option (as defined below) and was utilized.
5.3 LICENSEE shall endeavor have the right to extend by [***] the time it has to achieve the following:
above diligence milestones, such date to be calculated from the dates shown in Paragraph 5.2, as applicable (a“Delay Option”). To exercise the Delay Option, LICENSEE must: (i) receive financing of give MICHIGAN notice in writing at least [**] dollars ten (10) days prior to the MILESTONE deadline that LICENSEE is exercising its Delay Option; and (ii) pay MICHIGAN a non-refundable and non-creditable fee of $[***]) within , which shall be due with such notice, and upon such payment, all the above diligence milestone dates shall be extended by [**] following *].
5.4 Subject to Paragraph 5.3, LICENSEE must use commercially reasonable efforts to achieve each MILESTONE on or before the Effective Date;
deadline dates indicated. LICENSEE shall notify MICHIGAN within ten (10) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE believes that it is or will be unable to achieve any MILESTONE by such deadline (as the deadline may have been extended pursuant to Paragraph 5.3) despite its using commercially reasonable efforts, LICENSEE may request to amend or extend the MILESTONES, and MICHIGAN will not unreasonably withhold consent or approval of any such request to amend or extend the MILESTONE if such proposed request is supported by a detailed showing by LICENSEE of: (a) its commercially reasonable efforts to achieve such MILESTONE events during the Agreement (including the amount of monetary investment therein), (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
due diligence in its performance of research and development of LICENSED PRODUCTS and/or LICENSED PROCESSES, and (c) sequence at least [**] base pairs plans for future development and sale of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective DateLICENSED PRODUCTS and LICENSED PROCESSES. For purposes of determining whether If LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised fails to use commercially reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights meet any MILESTONE under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold Paragraph by the Licensed Product for a continuous period date of [**] after such final approval.
5.3 On or before [**] of each year during = CONFIDENTIAL TREATMENT REQUESTED the term applicable MILESTONE deadline (as extended), and MICHIGAN justifiably withholds consent to LICENSEE’S request to amend or extend as described in the previous sentence, then LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement until effective on thirty (30) days’ notice, unless LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report commences using commercially reasonable efforts to STANFORD covering achieve the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of MILESTONE within this Article 5.thirty day period,
Appears in 1 contract
Sources: License Agreement (OvaScience, Inc.)
Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing Pharmasset shall use Reasonable Diligence in proceeding with the discovery and development of at least [**] dollars ($[**]) within [**] following the Effective Date;Potential Licensed Compounds, except that Pharmasset’s obligation hereunder shall expire upon the expiration of the Option Exercise Period.
(b) establish From and after (i) the Effective Date with regard to the Primary Compound, and (ii) the effective date of Roche’s exercise of its Option with regard to a facility at which it will practice given Potential Licensed Compound, Roche shall use Reasonable Diligence in the development and commercialization of such Primary Compound (and Primary Products containing the Primary Compound), or Potential Licensed Patents within Compound (and Products containing such Potential Licensed Compound), as the case may be, including [**] following the Effective Date;*].
(c) sequence at least [***] base pairs of DNA from one or more shall [**] within [**] from the Effective Date;], as applicable.
(d) generate If Pharmasset fails to use Reasonable Diligence in the performance of GLP Tox Completion activities for a polyketide library Potential Licensed Compound (unless the JRC determines that such activities are not necessary for development of such Potential Licensed Compound), then Roche shall have the right to exercise its Option for such Potential Licensed Compound at least [**] polyketide compounds within [**] no cost to Roche. If Roche fails to use Reasonable Diligence in the performance of the Effective Date;Development Plan with respect to a Licensed Compound (including, in the case of early exercise of an Option, any remaining GLP Tox Completion activities to the extent that the JDMC determines that such activities are necessary for development of such Potential Licensed Compound), then Pharmasset shall have the right to reversion of such Licensed Compound in accordance with the provisions of Section 17.4.
(e) generate a polyketide library of at least With respect to [**] polyketide compounds within *], if [**] of the Effective Date; and
(f) file an IND for a Licensed Product within *], prior to [***] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligationsin [***], Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts ceases [***] to accomplish the same, STANFORD and LICENSEE shall negotiate achieve [***] in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product [***] for a continuous period of [***] after such final approval.
5.3 On or before ([***]) [***], then [***] shall have the right of a [***] of [***] to [***] in such [***] in accordance with Section [***]. With respect to each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [***], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, if [***], after receiving [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONfor a [***] in a [***], ceases [***] in [***] for a period of [***] ([***]) [***], then [***] shall have the right of a [***] of [***] to such [***] in [***] in accordance with Section [***]. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient For clarity, this Section 3.1(e) does not apply, and [***] shall not have any [***] of [***], if the reason for [***] to enable STANFORD [***] or [***] is attributable to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress a [***] or some other [***] by LICENSEE toward meeting the diligence requirements of this Article 5a [***] that prevents [***] from continuing [***] or [***] activities.
Appears in 1 contract
Diligence. 5.1 During the term of this Agreement, LICENSEE shall (itself or through its AFFILIATES or SUBLICENSEES) use commercially reasonable efforts to […***…] one or more LICENSED PRODUCTS and/or LICENSED PROCESSES, as applicable. LICENSEE and/or SUBLICENSEE has the responsibility to do all that is legally required and commercially reasonable to […***…] LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement so of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES.
5.2 As part of the diligence required by Paragraph 5.1 and subject to the provisions of Paragraph 5.3 and 5.4, LICENSEE (itself or through its AFFILIATES or SUBLICENSEES) agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for a LICENSED PRODUCT and/or LICENSED PROCESS (together the development, manufacture, or sale of Licensed Product(s“MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
(a) receive financing of at least […**] dollars ($[**…]) within [**] following the Effective Date;.
(b) establish a facility at which it will practice the Licensed Patents within […**] following the Effective Date;*…].
(c) sequence at least […**] base pairs of DNA from one or more [**] within [**] from the Effective Date;…].
(d) generate a polyketide library of at least […**] polyketide compounds within [**] of the Effective Date…];
(e) generate a polyketide library of at least […**] polyketide compounds within [**] of the Effective Date; and…];
(f) file an IND for a Licensed Product […***…]. For the purposes of this Agreement, […***…] shall mean that date upon which […***…] […***…].
5.3 LICENSEE shall notify MICHIGAN within […***…] from days after each MILESTONE deadline date above, as to whether or not such MILESTONE was met. MICHIGAN recognizes that there are uncertainties associated with the Effective Datedevelopment of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA), and that the parties may wish to amend the MILESTONES under Subparagraphs 5.2(b) through (f). For purposes Accordingly, if LICENSEE believes in good faith that it will be unable to timely achieve any MILESTONE in Paragraph 5.2 (b), (c), (d), (e) or (f) because the LICENSEE believes in good faith, after consultation with its clinical advisors, regulatory advisors and/or with regulatory agencies, that there is the possibility of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE the existence of a safety or its sublicensees. In the event that LICENSEE has efficacy reason not achieved any to perform one or more of the foregoing milestones but has exercised reasonable efforts steps necessary to accomplish allow the sameachievement of such MILESTONE, STANFORD then LICENSEE will promptly consult with MICHIGAN with respect to such determination, and LICENSEE shall negotiate the parties hereto will in good faith an extension determine whether changes to the MILESTONES and related deadlines are appropriate, and if MICHIGAN agrees, at its sole discretion, that such changes are appropriate, the parties will execute and deliver a written confirmation of time in which such changes to the MILESTONES and related deadlines within […***…] ([…***…]) days of the original notification by LICENSEE may accomplish to MICHIGAN. In addition, (i) LICENSEE will have the right to elect […***…] extensions to the MILESTONES under Subparagraphs 5.2 (b) through (f), at […***…] if such milestone extensions are a result of causes beyond LICENSEE’s direct control or any inaction of the FDA or foreign equivalent and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect (ii) LICENSEE will have the right to a particular Licensed Product if, after final FDA approval extend the deadline of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product any MILESTONE for a continuous period of […***…] after the scheduled deadline for such final approvalMILESTONE without MICHIGAN’s approval (“MILESTONE EXTENSION”) upon the […***…] by LICENSEE to MICHIGAN, within […***…] ([…***…]) days after the date of the scheduled deadline for such MILESTONE […***…], accompanied by written notice from LICENSEE to MICHIGAN specifying the MILESTONE for which LICENSEE is […***…], and setting forth in such notice the […***…] extended due date for such MILESTONE. Upon the timely delivery to MICHIGAN from LICENSEE of the […***…] notice, the due date for the MILESTONE as specified in such notice from LICENSEE and […***…] by LICENSEE to MICHIGAN as provided herein, will be extended to a date which is […***…] after the relevant original due date therefor. LICENSEE shall not be entitled to more than […***…] MILESTONE EXTENSIONS under Subparagraph 5.3(ii) and no more than […***…] extensions if […***…]. For clarity, any election to extend a MILESTONE under this Paragraph 5.3 will extend all remaining milestones in subparagraphs 5.2(b) through (f) by the applicable time period. The […***…] by LICENSEE to MICHIGAN in this Agreement.
5.3 On 5.4 If LICENSEE (itself or before through its AFFILIATES or SUBLICENSEES) […**] of each year during *…], MICHIGAN may terminate the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report solely as to STANFORD the PATENT RIGHTS covering the preceding year ending LICENSED PRODUCT for which […***…], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, effective on […***…] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by days’ notice, unless LICENSEE toward meeting the diligence requirements of […***…] within this Article 5[…***…] day period.
Appears in 1 contract
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use. LICENSEE has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE, AFFILIATES and SUBLICENSEES.
5.2 As part of the diligence required by Paragraph 5.1, LICENSEE agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for the development, manufacture, or sale of Licensed Product(sLICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
1) Initiate communication with all Tier 1 (aLargest - see Schedule 2) receive financing Cosmetic or Chemical Companies with Category 1 Products (defined at those which explicitly use ********* within their product or marketing literature during ***** .
2) Initiate communication with all Tier 2 Companies (Significant size, but not the very largest - see Schedule 3) with Category 1 products during ******.
3) Complete product research on all Category 2 (defined as those products which are suspected by LICENSEE of using ******* by virtue of claimed activity or description of active ingredients) within ******.
4) Initiate communication with all Tier 1 Companies with Category 2 products (to be determined based on research completed in Milestone #3) within *****.
5) Within ***** of the effective date of this agreement, LICENSEE will obtain at least [**] dollars ($[**]) within [**] following * new revenue-generating business relationship from among the Effective Date;
Companies currently or prospectively identified as Tier 1 or 2 Companies. Additional royalties to MICHIGAN from such additional business under Section 3.1 (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
or (c) sequence herein shall be at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees* per year. In the event that LICENSEE has such business relationships do not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [generate at least **] after such final approval*** per year in additional royalties, the Annual Fee due MICHIGAN (as defined in Section 3.1 (d)) shall be increased by the difference between ****** and the royalty amount actually incurred.
5.3 On LICENSEE must achieve the MILESTONES on or before [**] the deadline dates indicated. LICENSEE shall notify MICHIGAN within ten (10) days after each deadline as to whether such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article continues for forty-five (45) days after the date of each year during the term any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5provided in section 11.3.
Appears in 1 contract
Diligence. 5.1 LICENSEE 3.5.1 In carrying out the Development and in seeking Regulatory Approval, OMP agrees to use such commercially reasonable and diligent efforts and diligence to proceed as are commensurate with the level of time, effort and funding expended by OMP on other projects at a similar stage of development, manufacturewith a target market of a similar size, patient population and importance, and as otherwise consistent with its overall business strategy. OMP does not in any way represent or sale warrant that a Collaboration Compound hereunder shall be the only compound that OMP will at the same time develop or commercialize for identical or similar therapeutic uses. Without limitation to the foregoing, non-achievement of Licensed Product(s) and the following development milestones within the Time to Complete set forth below shall endeavor be an objective measure of OMP’s non-performance for the time periods specified: [***] [***] [***] [***] [***] [***] [***] [***] OMP shall promptly notify ADDEX upon the accomplishment of each of the foregoing Milestones.
3.5.2 If, notwithstanding OMP’s exercise of the efforts recited in Article 3.5.1 above, OMP is unable to achieve meet or anticipates that it may not be able to make a Selection or to meet any of the followingMilestones within the Time to Complete set forth above, OMP shall have the right to request an extension for such Milestone(s), which shall not be unreasonably refused. Without limitation, the following shall be examples of instances in which OMP shall be entitled to such extension: [***], to the extent that [***]. In addition, Parties recognize that OMP may, after discussion with the JDC, need to discontinue the Development of a Collaboration Compound for reasons outside its reasonable control, in which case the following shall apply, depending on the stage of Development:
(ai) receive financing of at least If OMP prior to [***] dollars ($OMP has initiated [***] of a Collaboration Compound and such Collaboration Compound fails during such studies, for reasons outside of OMP’s reasonable control, then the time periods set forth in Article 3.5.1 above shall be extended for a period [***]
(ii) If OMP initiates [***] with respect to a Collaboration Compound and such Collaboration Compound fails [***], for reasons outside of OMP’s reasonable control, the time periods specified in Article 3.5.1 above shall be extended for a period [***];
3.5.3 If the Parties disagree as to whether OMP is entitled to an extension of the time to make a Selection under Article 2.8 or to the Time to Complete as set forth in 3.5.2 above for any Milestone specified in 3.5.1 above, or whether or not OMP is complying with its obligations under 3.5.1 above, then, upon the written request by either Party, such matter shall be resolved in accordance with Article 18. However, notwithstanding any other provision of Article 18 and Appendix C, the mediation procedure of Section 1.1 of Appendix C shall not apply. Moreover the arbitration shall be concluded within [***] following calendar days after the Effective Date;
(b) establish a facility at which it will practice Panel of Arbitrators has been appointed in accordance with Section 1.2 of Appendix C, and the Licensed Patents within time periods recited in Appendix C shall be reset accordingly to achieve the [***] following the Effective Date;
day completion date. Subsection (c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from Section 1.2 of Appendix C shall not apply. As circumstances may warrant the Effective Date;Parties will seek arbitrators with appropriate commercial and technical backgrounds to resolve disputes under this Article.
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. 3.5.4 In the event that LICENSEE has not achieved any one OMP or more its Affiliate or Sublicensee in charge of Early Stage Development of a Collaboration Compound fails to make a Selection or achieve the foregoing milestones but has exercised reasonable efforts Milestones set forth in Article 3.5.1 within the Times to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement Complete with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.with any applicable extensions under
Appears in 1 contract
Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of at least [**] dollars ($[**]) within [**] following After the Effective Date;, as between the Parties, Newsoara shall be solely responsible for all aspects of the Development of the Licensed Viruses and the Licensed Products in the Field in the Territory at Newsoara’s own cost and expense. Newsoara shall use Commercially Reasonable Efforts to Develop, and obtain and maintain Regulatory Approvals for Licensed Product in the Field in the Territory.
(b) establish a facility at which it will practice Without limiting the Licensed Patents within foregoing, Newsoara shall: (i) [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [***] from months after [***]; (ii) [***] within [***] months after [***]; and (iii) maintain active clinical Development for the Effective Date;Licensed Products through submission of the first Drug Approval Application to NMPA. For the purpose of clause (iii), “active clinical Development” shall require Newsoara to [***] during any consecutive [***] period [***]. The deadlines and time period set forth in clauses (i), (ii) and (iii) may be extended to the extent that Newsoara’s inability to [***] is caused by delay outside of Newsoara’s reasonable control, including [***]; provided that Newsoara shall immediately notify Genelux of any such delay, and shall promptly undertake and continue all Commercially Reasonable Efforts necessary to [***] as soon as reasonably practicable. Failure to meet the deadlines set forth above due to delay outside Newsoara’s reasonable control shall not be considered a breach of this Agreement by itself.
(c) Subject to the terms and conditions of this Agreement, Newsoara may elect, in its sole discretion, at any time during the Term of this Agreement, to Develop any Derived Molecule and Derived Product in the Field in the Territory at Newsoara’s own cost and expense. Newsoara shall have no diligence obligations with respect to any Derived Molecules or Derived Product, but any decision or efforts by Newsoara to Develop or Exploit any Derived Molecules and Derived Products must not reduce the efforts, resources, and other commitments devoted by Newsoara to the Development and Commercialization of Olvi-Vec in the Field in the Territory, and Newsoara may not prioritize the Development or Commercialization of any Derived Molecule or Derived Product over the Development and Commercialization of Olvi-Vec.
(d) generate a polyketide library If Newsoara conducts clinical Development of at least other Oncolytic Virus product, in order to ensure that Newsoara prioritizes the Development of Olvi-Vec over other Oncolytic Virus products, Newsoara shall ensure that (i) [**] polyketide compounds within *]; (ii) [**] of the Effective Date;
*]; and (eiii) generate a polyketide library of at least Newsoara shall [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 1 contract
Sources: License Agreement (Genelux Corp)
Diligence. 5.1 LICENSEE agrees 4.1 Licensee will secure at least [*] in funding (“Initial Funding”), as evidenced by bank statements or electronic account statements by [*]. If Licensee has not secured this amount of minimum funding by the date specified above, MSK shall have the right to use reasonable efforts terminate the Agreement upon [*] business days’ advance written notice, subject to Licensee’s right to cure any shortfall during said notice period. Licensee will secure financing (either debt or equity) with gross proceeds totaling [*] by [*] (the “First Raise”) and diligence to proceed additional gross proceeds totaling Twenty-Five Million U.S. Dollars ($25,000,000) by December 31, 2018 (the “Second Raise”). If Licensee has not secured either of the First Raise or Second Raise by the applicable dates [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the developmentSecurities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, manufactureas amended. Table of Contents specified above, MSK shall have the right to terminate the License with [*] business days’ written notice, subject to Licensee’s right to cure any shortfall during said notice period; provided, however, that if MSK terminates the License as provided herein, Section 5.1(a)(iv) shall become null and void (and no additional Shares as contemplated therein shall be due and owing unless previously issued or sale accrued to be issued).
4.2 Licensee shall use commercially reasonable best efforts to (i) bring Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Licensed Product(sRights, and (ii) and continue active, diligent marketing efforts for Licensed Products throughout the Term. Without limiting the foregoing, Licensee shall endeavor exercise its best efforts to achieve the followingfollowing milestones: Licensee will use commercially reasonable efforts to develop and commercialize Licensed Products. Specifically, Licensee will:
(a) receive financing of at least Either:
(i) [*]; or
(ii) [*]; (the achievement of the milestone described in this Section 4.2(a) the “[*] dollars ($[**]) within [**] following the Effective Date;Milestone Achievement”).
(b) establish a facility at which it will practice the Licensed Patents within [*] in exercise of commercially reasonable efforts in [*] following the Effective Date;].
(c) sequence at least [**] base pairs of DNA from one or more [**] ].
4.3 Licensee shall give MSK written notice and evidence within [*] days of the achievement of each of the above specific diligence obligations.
4.4 [*] from all clinical trials conducted in the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] United States and sponsored by Licensee during the Term. Licensee shall have access to, and the right to utilize, all data generated in clinical trials conducted by MSK relating to the Licensed Rights, including without limitation those trials that are ongoing as of the Effective Date;
(e) generate a polyketide library of at least . Further, Licensee shall [*] to the extent that [*].
4.5 Licensee’s current projections of its business plan for the development of the Licensed Rights, including, for example, estimates of [*] polyketide compounds within planned for each phase of development of the Licensed Rights for a [*] period, to the extent formed by Licensee, is annexed hereto and made part of this Agreement. Licensee shall provide similar reports to MSK [*] to relay update and status information on Licensee’s business, research and development progress, including projections of activity anticipated for the next [*].
4.6 Licensee shall be solely responsible, at its sole cost and expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale of [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Effective Date; andSecurities Act of 1933, as amended. Table of Contents Licensed Products (“Regulatory Approval”). Licensee shall advise MSK, through information contained in annual reports described in Section 4.5 above, of its program of development for obtaining said approvals.
(f) file an IND for 4.7 If Licensee is the subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product within [**] from the Effective Date. For purposes that (i) by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of determining whether LICENSEE has met manufacturing, sale, development, or marketing of Licensed Products efforts, (ii) concerns a recall or potential recall of Licensed Products, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to prevent Licensee’s compliance with its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or then Licensee shall provide a copy to MSK without delay and keep MSK reasonably apprised of its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestonesresponse.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 1 contract
Sources: Exclusive License Agreement (Galena Biopharma, Inc.)
Diligence. 5.1 LICENSEE agrees to (i) Following the Closing, until the expiration of the Diligence Period, the Buyer shall itself and/or with or through other members of the Buyer Rights Chain Group, as applicable, use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor Commercially Reasonable Efforts to achieve the following:Milestone Events. Notwithstanding the foregoing, Buyer’s obligations under this Section 2.6(b):
(a) receive financing of at least shall expire (A) as to Milestone #1 on the [**] dollars ($if Regulatory Approval has not been achieved in the United States as of such [**], (B) within as to Milestone #2 on the date [**] following if Regulatory Approval has not been achieved in the Effective DateEuropean Union as of the end of such [**] period and (C) as to Milestone A, [**] months after the Closing Date if a Japan Agreement has not been entered into as of such date;
(b) establish a facility at which it will practice if the Licensed Patents within [**] following Buyer enters into any agreement for the Effective Datesale, transfer, assignment or exclusive license of the Product for any territories other than Japan, the Buyer shall not be obligated to include the territory of Japan in such Agreement;
(c) sequence at least [**] base pairs of DNA from one shall not include an obligation to seek any additional Regulatory Approval or more [**] within [**] from label expansion for the Effective Date;Product (A) in the United States following the initial Regulatory Approval in the United States or (B) in the European Union following the initial Regulatory Approval in the European Union; and
(d) generate a polyketide library of at least [**] polyketide compounds within [**] shall not include an obligation to conduct any clinical trial or nonclinical study of the Effective Date;Product other than the completion of those studies set forth on Schedule 2.6(b)(iii), whether or not such studies result in any Regulatory Approval.
(eii) generate a polyketide library If the Buyer terminates or abandons all development and, if commenced as of at least [**] polyketide compounds within [**] such time, commercialization activities with respect to the Product, the Buyer shall send written notice thereof to the Representative together with an explanation of the Effective Date; andreasons for such cessation of activities.
(fiii) file an IND for a Licensed Product If the Representative in good faith believes that the Buyer has materially breached its obligations under this Section 2.6, then the Representative may provide the Buyer with written notice thereof, which notice shall specify the alleged material breach. If such notice is given, the Buyer shall designate one or more Buyer Milestone Representatives to meet with the Representative (in person at the Buyer’s offices or by telephone) within [**] fifteen (15) Business Days from the Effective Datedate of such notice to address the Representative’s belief that the Buyer has materially breached its obligations under this Section 2.6. For The discussion between the Buyer Milestone Representative(s) and the Representative shall be subject to the confidentiality obligations of Section 2.4(f) and regarded as for settlement purposes only, and no statement made in the course of determining whether LICENSEE has met its diligence obligationsthe discussion shall be admissible in any subsequent Legal Proceeding, Sections 5.1 (c)-(f) above may although the fact that something is stated in the course of the discussion will not preclude a party to a Legal Proceeding from adducing other evidence of an identical or similar nature that otherwise would be satisfied by LICENSEE or its sublicenseespermitted in the Legal Proceeding. In the event that LICENSEE has not achieved any one or more the Representative and the Buyer Milestone Representatives are unable to resolve the Representative’s claim of the foregoing milestones but alleged material breach by (A) the date that is thirty (30) Business Days after such meeting, or (B) the date that is sixty (60) Business Days after the written notice from the Representative to the Buyer of the alleged material breach if no meeting (whether in person or by telephone) has exercised reasonable efforts been held by such date, then the Representative may pursue any available remedies, subject to accomplish Section 2.6(b)(iv), unless the same, STANFORD Buyer and LICENSEE shall negotiate in good faith the Representative mutually agree to an extension to the foregoing time periods.
(iv) Nothing herein shall constitute a guarantee by the Buyer of time in which LICENSEE may accomplish such milestone the achievement of any or all of the Milestone Events. The Buyer’s maximum aggregate liability for any and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights breaches by the Buyer of its obligations under this Agreement with respect Section 2.6(b) shall be limited to a particular Licensed Product ifthe unpaid portion(s), after final FDA approval of a NDA for such Licensed Productif any, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD Milestone Payment(s) that Buyer would have become obligated to ascertain progress by LICENSEE toward meeting pay if the diligence requirements of this Article 5Buyer had exercised the requisite Commercially Reasonable Efforts.
Appears in 1 contract
Sources: Merger Agreement (Medicines Co /De)
Diligence. 5.1 During the term of this Agreement, LICENSEE shall (itself or through its AFFILIATES or SUBLICENSEES) use commercially reasonable efforts to [***] one or more LICENSED PRODUCTS and/or LICENSED PROCESSES, as applicable. LICENSEE and/or SUBLICENSEE has the responsibility to do all that is legally required and commercially reasonable to [***] LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement so of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES.
5.2 As part of the diligence required by Paragraph 5.1 and subject to the provisions of Paragraph 5.3 and 5.4, LICENSEE (itself or through its AFFILIATES or SUBLICENSEES) agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for a LICENSED PRODUCT and/or LICENSED PROCESS (together the development, manufacture, or sale of Licensed Product(s“MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
(a) receive financing of at least [**] dollars ($[**]) within [**] following the Effective Date;.
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;*].
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;].
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date];
(e) generate a polyketide library of at least [***];
(f) [***]. For the purposes of this Agreement, [***] polyketide compounds shall mean that date upon which [***] [***].
5.3 LICENSEE shall notify MICHIGAN within [***] days after each MILESTONE deadline date above, as to whether or not such MILESTONE was met. MICHIGAN recognizes that there are uncertainties associated with the development of therapeutic products and the Effective Date; and
regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA), and that the parties may wish to amend the MILESTONES under Subparagraphs 5.2(b) through (f). Accordingly, if LICENSEE believes in good faith that it will be unable to timely achieve any MILESTONE in Paragraph 5.2 (b), (c), (d), (e) or (f) file an IND for because the LICENSEE believes in good faith, after consultation with its clinical advisors, regulatory advisors and/or with regulatory agencies, that there is the possibility of the existence of a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE safety or its sublicensees. In the event that LICENSEE has efficacy reason not achieved any to perform one or more of the foregoing milestones but has exercised reasonable efforts steps necessary to accomplish allow the sameachievement of such MILESTONE, STANFORD then LICENSEE will promptly consult with MICHIGAN with respect to such determination, and LICENSEE shall negotiate the parties hereto will in good faith an extension determine whether changes to the MILESTONES and related deadlines are appropriate, and if MICHIGAN agrees, at its sole discretion, that such changes are appropriate, the parties will execute and deliver a written confirmation of time in which such changes to the MILESTONES and related deadlines within [***] ([***]) days of the original notification by LICENSEE may accomplish to MICHIGAN. In addition, (i) LICENSEE will have the right to elect [***] extensions to the MILESTONES under Subparagraphs 5.2 (b) through (f), at [***] if such milestone extensions are a result of causes beyond LICENSEE’s direct control or any inaction of the FDA or foreign equivalent and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect (ii) LICENSEE will have the right to a particular Licensed Product if, after final FDA approval extend the deadline of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product any MILESTONE for a continuous period of [***] after the scheduled deadline for such final approval.
5.3 On or before MILESTONE without MICHIGAN’s approval (“MILESTONE EXTENSION”) upon the [***] by LICENSEE to MICHIGAN, within [***] ([***]) days after the date of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending scheduled deadline for such MILESTONE [***], regarding accompanied by written notice from LICENSEE to MICHIGAN specifying the progress of MILESTONE for which LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, is [***], and setting forth in such notice the [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSIONextended due date for such MILESTONE. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient Upon the timely delivery to enable STANFORD to satisfy reporting requirements MICHIGAN from LICENSEE of the U.S. Government [***] notice, the due date for the MILESTONE as specified in such notice from LICENSEE and for STANFORD to ascertain progress [***] by LICENSEE toward meeting to MICHIGAN as provided herein, will be extended to a date which is [***] after the diligence requirements of relevant original due date therefor. LICENSEE shall not be entitled to more than [***] MILESTONE EXTENSIONS under Subparagraph 5.3(ii) and no more than [***] extensions if [***]. For clarity, any election to extend a MILESTONE under this Article 5Paragraph 5.3 will extend all remaining milestones in subparagraphs 5.2(b) through (f) by the applicable time period. The [***] by LICENSEE to MICHIGAN in this Agreement.
5.4 If LICENSEE (itself or through its AFFILIATES or SUBLICENSEES) [***], MICHIGAN may terminate the Agreement solely as to the PATENT RIGHTS covering the LICENSED PRODUCT for which [***], effective on [***] days’ notice, unless LICENSEE [***] within this [***] day period.
Appears in 1 contract
Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and AlgoRx shall endeavor to achieve the following:
(a) receive financing of at least [**] dollars ($[**]) within [**] following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised exercise commercially reasonable efforts to accomplish develop, or to license to a Third Party to develop, each of the sameAlgoRx Named Products in order to retain such product as an AlgoRx Named Product, STANFORD and LICENSEE shall negotiate expend (or its licensee shall expend) at least ******* per **** in good faith research and development to support such efforts per AlgoRx Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one AlgoRx Named Product in a closely-related class of AlgoRx Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(a). PRL shall exercise commercially reasonable efforts to develop, or to license to a Third Party to develop, each of the PowderJect Named Products in order to retain such product as an extension PowderJect Named Product, and shall expend (or its licensee shall expend) at least ******* per **** in research and development to support such efforts per PowderJect Named Product until Regulatory Approval is achieved; provided that the foregoing shall apply to only one PowderJect Named Product in a closely-related class of time in which LICENSEE may accomplish PowderJect Named Products that are established by agreement of the Parties as provided at the end of Section 2.3(b). Twelve (12) months after designation of an Selectable Product as either an AlgoRx Named Product or a PowderJect Named Product (and once every subsequent twelve-month period), the designating Party shall provide to the other Party an annual summary of its diligence with respect to such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement product. If, with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Named Product, LICENSEE the designating Party (or its Affiliate or sublicensee) has, during the applicable twelve-month period, expended the required amount of development funds, then the designating Party shall be deemed to have satisfied its diligence obligations under this Section 2.4(c) with respect to such Named Product. If the designating Party (or its Affiliate or sublicensee) has not sold expended the Licensed required amount of development funding on, or is not otherwise continuing to use commercially reasonable efforts to develop, a particular Named Product, then such Named Product for a continuous period of [**] after shall cease to be the designating Party's Named Product, and the non-designating Party shall have the co-exclusive rights to pursue such final approval.
5.3 On or before [**] of each year during product and shall also be free to designate such product as its own Named Product under the term above terms of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5Section 2.3.
Appears in 1 contract
Diligence. 5.1 LICENSEE shall use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, through a diligent program for utilizing the PATENT RIGHTS and to continue diligent marketing efforts throughout the life of this Agreement, in each case consistent with prudent business practices and judgment. LICENSEE has the responsibility to do all that is legally required and commercially reasonable to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall apply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, for the sake of clarity, LICENSEE must make commercially reasonable amounts or levels of LICENSED PRODUCTS and/or LICENSED PROCESSES available.
5.2 Without limiting Paragraph 5.1, LICENSEE agrees to use reasonable efforts reach the following commercialization and diligence to proceed with research and development milestones for the development, manufacture, or sale of Licensed Product(sLICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) and shall endeavor to achieve by the followingfollowing dates:
(a1) receive financing of at least [**]
2) [**]
3) [**]
4) [**] dollars ($[**]) within [**] following For the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligationsthis Agreement, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval initiation of a NDA for such Licensed Product, LICENSEE clinical trial shall mean that date upon which the first patient or subject is treated with a LICENSED PRODUCT under a protocol approved by an appropriate drug regulatory agency with a therapeutic agent or process that has not sold been manufactured according to Good Manufacturing Practices (GMP) guidelines provided by the Licensed Product for a continuous period of [**] after such final approvalrelevant regulatory agency.
5.3 On LICENSEE must achieve each MILESTONE on or before [**] the deadline dates indicated above. LICENSEE shall notify MICHIGAN within thirty (30) days after each such deadline as to whether or not such MILESTONE was met. If LICENSEE fails to meet any MILESTONE under this Article by the date of each year during the term any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may terminate the Agreement until effective on ninety (90) days’ written notice, unless LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering achieves the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of MILESTONE within this Article 5ninety (90) day period.
Appears in 1 contract
Diligence. 5.1 LICENSEE agrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
4.1 (a) receive financing LICENSEE (itself and/or through its Affiliates and Sublicensees) shall use commercially reasonable efforts to (i) bring Licensed Products to the commercial market through a diligent program for exploitation of at least the Licensed Rights, and (ii) continue active, diligent marketing efforts for Licensed Products following Regulatory Approval (as defined below) throughout the License Term. Without limiting the foregoing, LICENSEE shall meet the following milestones with respect to each Patent Family: • From the Restatement Effective Date through the [**] dollars ($[**]) within [**] following the Effective Date;
(b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Restatement Effective Date;
: LICENSEE, its Affiliates or Sublicensees, alone or together, will actively conduct, for a Licensed Product, (ei) generate technology development and research, (ii) preclinical in vivo testing, or (iii) a polyketide library of at least Phase 1 clinical trial. • From the [**] polyketide compounds within [**] of the Restatement Effective Date through the [***] of the Restatement Effective Date; and
(f) file an IND : during each calendar year, LICENSEE, its Affiliates or Sublicensees, alone or together, will actively conduct, for a Licensed Product within Product, (i) a Phase 1 clinical trial; (ii) a Phase 2 clinical trial, or (iii) a Phase 3 clinical trial; or will have filed for or obtained regulatory approval for a Licensed Product; or will have launched for sale or sold a Licensed Product. • From the [***] from of the Restatement Effective Date through the [***]: during each calendar year, LICENSEE, its Affiliates or Sublicensees, alone or together, will actively conduct, for a Licensed Product, (i) a Phase 2 clinical trial, or (ii) a Phase 3 clinical trial; or will have filed for or received regulatory approval for a Licensed Product; or will have launched for sale or sold a Licensed Product. AND • From the Restatement Effective Date through the [***] of the Restatement Effective Date: during each calendar year, LICENSEE, its Affiliates or Sublicensees, alone or together, will expend, for development of a Licensed Product, at least $[***]. * Confidential Information, indicated by [***], has been omitted from this filing and filed separately with the Securities and Exchange Commission. • From the [***] of the Restatement Effective Date through the [***] of the Restatement Effective Date: during each calendar year, LICENSEE, its Affiliates or Sublicensees, alone or together, will expend, for development of a Licensed Product, at least $[***]. • From the [***] of the Restatement Effective Date through the termination of the Agreement: during each calendar year, LICENSEE, its Affiliates or Sublicensees, alone or together, will expend, for development or commercialization of a Licensed Product, at least $[***]. For purposes clarity, and notwithstanding anything to the contrary herein, (i) the diligence requirements for each Patent Family will be deemed satisfied by achievement for each Patent Family of determining whether LICENSEE has met its the diligence obligationsmilestone of a single Licensed Product covered by such Patent Family, Sections 5.1 and (c)-(fii) above the Parties acknowledge that a particular Licensed Product may be satisfied covered by LICENSEE multiple, or its sublicensees. In all, Patent Families, such that the event that LICENSEE has not achieved any one or more achievement of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such a particular milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA shall be deemed to satisfy the same milestone for all Patent Families covering such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 1 contract
Sources: Exclusive License Agreement (Fate Therapeutics Inc)
Diligence. 5.1 LICENSEE agrees to shall use diligent and commercially reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall endeavor to achieve the following:
(a) receive financing of at least [**] dollars ($[**]) within [**] following develop a program for exploiting the Effective Date;
PATENT RIGHTS, (b) establish a facility at which it will practice the Licensed Patents within [**] following the Effective Date;
bring LICENSED PRODUCTS to market and (c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from to market throughout the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term life of this Agreement until any and all LICENSED PRODUCTS so developed and brought to market. LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report has the responsibility to STANFORD covering the preceding year ending use diligent and [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH RESPECT TO AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE OMITTED PORTIONS. information sufficient SECURITIES AND EXCHANGE COMMISSION.] commercially reasonable efforts to enable STANFORD obtain and retain any governmental approvals necessary to satisfy reporting requirements manufacture, have manufactured, use, import, distribute and/or sell LICENSED PRODUCTS.
5.2 As part of the U.S. Government diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for STANFORD the LICENSED PRODUCTS (together the “MILESTONES”) by the following dates:
1) By [***] LICENSEE will have [***].
2) By [***] LICENSEE will have [***].
3) By [***] LICENSEE will have [***].
5.3 LICENSEE must achieve each MILESTONE on or before the deadline dates indicated and MICHIGAN shall have the sole right to ascertain progress determine that a MILESTONE has been reached, such determination not to be unreasonably withheld, conditioned or delayed. LICENSEE shall notify MICHIGAN within ten (10) days after each such deadline as to whether or not such MILESTONE was met. Should LICENSEE fail to achieve the above MILESTONES, LICENSEE will have the option to extend the MILESTONE timelines by supplementing the Annual Fees by an additional 50% and by meeting with MICHIGAN to revise the list and timelines for MILESTONES (“MODIFIED MILESTONES”). If LICENSEE toward meeting the diligence requirements cannot meet MODIFIED MILESTONES, LICENSEE will be deemed to be in material breach of this Article 5Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days notice, unless LICENSEE achieves the MILESTONE within this thirty-day period. Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the indicated date and does not provide the notice to MICHIGAN referred to above.
5.4 MICHIGAN may terminate this license upon written notice if the FIRST COMMERCIAL SALE does not occur on or before the date nine (9) years after the Effective Date.
Appears in 1 contract
Sources: License Agreement (MDRNA, Inc.)
Diligence. 5.1 LICENSEE Assembly agrees to use diligent efforts to develop, manufacture, promote and sell Licensed Products.
4.1 Within ninety (90) days of the Effective Date, Assembly will provide IURTC with a Development Plan. Assembly will update the Development Plan to reflect the next year’s plan and report progress for the past year against the Development Plan in writing to IURTC no later than January 31 of each subsequent year during the Term. The updates and reports will summarize in reasonable efforts detail the progress achieved and diligence to proceed with any problems encountered in the development, evaluation, testing, manufacture, or sale initial sale, and/or initial marketing of each Licensed Product(s) Product. Upon reasonable request by IURTC, Assembly will consult with IURTC about tasks, schedules, and shall endeavor to progress.
4.2 In partial satisfaction of its obligations under this Article 4, Assembly will achieve the followingfollowing commercial goals by the dates set forth below:
4.2.1 Preparation of a preclinical development plan within three (a3) receive months of the Effective Date;
4.2.2 Preparation of a clinical development plan within six (6) months of the Effective Date;
4.2.3 Negotiation of Series A financing of at least seven million dollars ($7,000,000) within twenty-four (24) months of the Effective Date; Assembly will provide IURTC with commercially reasonable evidence of Assembly’s achievement of each of the above-defined commercial goals within thirty (30) days after the corresponding date. 5 Financial Consideration:
5.1 Assembly will pay to IURTC a royalty on Net Sales by Assembly and Sublicensees per calendar year as follows: Net Sales Royalty Less than or equal to [**] dollars ($[*]) 0.5 % Greater than [*] dollars ($[*]) within and up to [*] dollars ($[*]) [*] % Greater than [*] dollars ($[*]) and up to [*] dollars ($[*]) [*] % Greater than [*] dollars ($[*]) 1.75 % The royalty will apply to all Licensed Products made during the Term, though such products may be Sold after the Term. No multiple royalties will be payable because the Licensed Product, or the manufacture or use thereof, are or will be covered by more than one of the patent applications or patents in the Patent Rights. Royalties will be paid to IURTC within thirty (30) days of the end of each fiscal quarter in which the Net Sales occurred.
5.2 Beginning with the 2014 calendar year, Assembly will pay to IURTC an annual diligence maintenance fee according to the table below: 2014 $ 25,000 2015 $ 50,000 2016 through the year in which First Commercial Sale occurs $ 75,000 the year following First Commercial Sale and all subsequent years $ 100,000 The diligence maintenance fee will be paid by Assembly to IURTC within thirty (30) days after the Effective Date;
(b) establish a facility at end of the calendar year for which it is due. For each calendar year, payments received by IURTC under paragraphs 5.1, 5.3, and 5.4 in such calendar year will practice be fully creditable against that year’s diligence maintenance fee.
5.3 Assembly will pay to IURTC a percentage of Sublicensing Revenue according to the Licensed Patents within table below: effective date of Sublicense percentage of Sublicensing Revenue Prior to beginning phase 1 clinical trials [*]% On or after beginning phase 1 clinical trials, but before beginning phase 2 clinical trials [*]% On or after beginning phase 2 clinical trials [*]% * [*] following Confidential treatment requested; certain information omitted and filed separately with the Effective Date;
(c) sequence at least [**] base pairs SEC. If a Sublicense is part of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(f) file an IND for a Licensed Product within [**] from the Effective Date. For purposes of determining whether LICENSEE has met its diligence obligationstransaction in which Assembly also conveys rights to Supporting IP, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate then Assembly will propose in good faith an extension by written notice to IURTC a basis for allocation of time the consideration received by Assembly for such transaction between the Patent Rights and the Supporting IP based on the relative value to be attributed to the Sublicense as part of the overall transaction. Such notice will describe in which LICENSEE may accomplish reasonable detail the rationale for such milestone and all subsequent milestones.
5.2 STANFORD may terminate LICENSEE's rights allocation. If IURTC in its good faith, reasonable discretion agrees with the proposal, the amount payable to IURTC under this Agreement Section 5.3 with respect to a particular Licensed Product if, after final FDA approval of a NDA for Sublicensing Revenue received in connection with such Licensed Product, LICENSEE has not sold transaction will be determined by the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.following equation:
Appears in 1 contract
Sources: Exclusive License Agreement (Assembly Biosciences, Inc.)
Diligence. 5.1 LICENSEE agrees (a) Licensee shall use its Commercially Reasonable Efforts to use reasonable efforts (i) [***], and diligence to proceed with (ii) thereafter [***], provided that, [***]. Without limiting the developmentforegoing, manufacture, or sale of Licensed Product(s) and Licensee shall endeavor to achieve meet the followingfollowing milestone activities:
(ai) receive financing of at least use Commercially Reasonable Efforts to [**] dollars *]; provided that ($x) if [***]) within , then the [**] following *], using such Commercially Reasonable Efforts, [***], and (y) if [***], then this milestone will be deemed to have been achieved;
(ii) use Commercially Reasonable Efforts [***]; provided that [***], then the Effective Date[***], using such Commercially Reasonable Efforts, [***], but not for more [***];
(iii) if [***], then Licensee will use Commercially Reasonable Efforts to [***]; provided that [***], then the [***], using such Commercially Reasonable Efforts, [***], but not for more than [***].
(b) establish a facility at which it will practice the Licensed Patents Licensee shall give MSK written notice and evidence within [**] following the Effective Date;
(c) sequence at least [**] base pairs of DNA from one or more [**] within [**] from the Effective Date;
(d) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date;achievement of each of the above specific diligence milestones.
(ec) generate a polyketide library of at least Licensee shall provide to MSK, within [**] polyketide compounds within [**] of the Original Effective Date; and
, a reasonable summary business plan (fthe “Summary Plan”) file an IND for a the development of the Licensed Product within Rights, including, for example, [***]. Thereafter, Licensee shall provide update reports to MSK [***] from to relay update and status information on Licensee's business, research and development progress with respect to development of Licensed Product(s), including projections of activity anticipated [***], generally in accordance with the Effective Datetopic listed in the template provided in Exhibit B of this Agreement.
(d) Licensee shall be solely responsible, at its sole cost and expense, for securing any necessary governmental or regulatory approvals for development, manufacture, and sale of Licensed Products, and shall use Commercially Reasonable Efforts to obtain such approvals. For purposes Licensee shall advise MSK, [***], of determining whether LICENSEE has met its program of development for obtaining said approvals.
4.2 If Licensee is the subject of a demand, notice, inquiry, or inspection report by a governmental authority or certification agency in relation to any Licensed Product that (i) by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of manufacturing, sale, development, or marketing of Licensed Products efforts, (ii) concerns a recall or potential recall of Licensed Products, (iii) concerns a loss of life or material issue of safety, or (iv) may reasonably be expected to prevent Licensee's compliance with its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEE or then Licensee shall provide a copy to MSK without delay and keep MSK reasonably apprised of its sublicensees. In the event that LICENSEE has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts to accomplish the same, STANFORD and LICENSEE shall negotiate in good faith an extension of time in which LICENSEE may accomplish such milestone and all subsequent milestonesresponse.
5.2 STANFORD may terminate LICENSEE's rights under this Agreement with respect to a particular Licensed Product if, after final FDA approval of a NDA for such Licensed Product, LICENSEE has not sold the Licensed Product for a continuous period of [**] after such final approval.
5.3 On or before [**] of each year during the term of this Agreement until LICENSEE markets a Licensed Product, LICENSEE shall make a written annual report to STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a minimum, [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. information sufficient to enable STANFORD to satisfy reporting requirements of the U.S. Government and for STANFORD to ascertain progress by LICENSEE toward meeting the diligence requirements of this Article 5.
Appears in 1 contract
Sources: Exclusive License Agreement (Atara Biotherapeutics, Inc.)