Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 shall include, but not be limited to: (i) 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 ($[…***…] US) extension fee.
Appears in 3 contracts
Samples: Exclusive License Agreement (Bellicum Pharmaceuticals, Inc), Exclusive License Agreement, Exclusive License Agreement (Bellicum Pharmaceuticals, Inc)
Diligence. 5.1 LICENSEE shall itself useagrees to use reasonable efforts and diligence to proceed with the development, manufacture, or sale of Licensed Product(s) and shall cause its sublicensees endeavor to use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce at least one Licensed Product into achieve the commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited tofollowing:
(ia) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales receive financing of Licensed Products;
at least [**] dollars (ii$[**]) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] of following the Agreement Effective Date;
(iiib) Initiation of establish a first pivotal clinical trial and/or Phase III clinical trial of a first facility at which it will practice the Licensed Product 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 Agreement Effective Date;
(e) generate a polyketide library of at least [**] polyketide compounds within [**] of the Effective Date; and
(ivf) The production file an IND for a Licensed Product within [**] from the Effective Date. For purposes 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 determining whether LICENSEE employs for comparable products and services marketed has met its diligence obligations, Sections 5.1 (c)-(f) above may be satisfied by LICENSEELICENSEE or its sublicensees. 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 In the event that LICENSEE can demonstrate to BCM its commercially has not achieved any one or more of the foregoing milestones but has exercised reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) accomplish the same, STANFORD and (iii) above, LICENSEE and BCM will shall 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 […***…] 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 achieve these milestonesa particular Licensed Product if, by paying 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 BCM STANFORD covering the preceding year ending [**], regarding the progress of LICENSEE toward commercialization of Licensed Product(s). Such report shall include, as a one-timeminimum, […***…] dollars ($[…***…] US) extension feeCERTAIN 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
Samples: License Agreement (Kosan Biosciences Inc), License Agreement (Kosan Biosciences Inc), License Agreement (Kosan Biosciences Inc)
Diligence. LICENSEE shall itself use6.1. Licensee, upon execution of this Agreement, will diligently proceed with the development, manufacture, and Sale of Licensed Products, Licensed Services, and Licensed Methods, and will diligently market them in quantities sufficient to meet the market demand.
6.2. In addition to its obligations under Paragraph 6.1, Licensee specifically commits to achieving the following milestones (either itself, or shall cause through its sublicensees to 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 shall include, but not be limited toSublicensees) in its activities under this Agreement:
(ia) Annual report provided to BCM describing LICENSEE’s Milestone #1: Greenhouse Proof of Concept — on or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Productsbefore […*…];
(iib) Initiation Milestone #2: Field Proof of a first Phase II clinical trial of a first Licensed Product within Concept — on or before […***…] of the Agreement Date];
(iiic) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within Milestone #3: Regulatory Submission — on or before […**…];
(d) Milestone #4: Regulatory Approval — on or before […*…] of the Agreement Date]; and
(ive) The production Milestone #5: Commercial Launch of the commercialized a 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) Product — on or (iii), LICENSEE may obtain a before […***…] extension ].
6.3. If The Regents believes that Licensee has failed to meet any milestone set forth in Paragraphs 6.1 and 6.2 by the date set forth therein (if applicable), The Regents will provide written notice to Licensee of time in which the same within a reasonable time. License will have one hundred and twenty (120) days from the date of such written notice (“Cure Period”) to achieve these milestonescomplete the stated milestone or otherwise fulfill the stated diligence obligations. If Licensee is unable to complete the stated milestone or otherwise fulfill the stated diligence obligations within the Cure Period, by paying to BCM Licensee may extend the completion date of such milestone or diligence obligation for a one-time, period of six (6) months from the expiration of the Cure Period upon the payment of […***…] dollars ], due within ten ($10) days of expiration of the Cure Period. Licensee may further extend the completion date of any milestone or diligence obligation for an additional six (6) months upon payment of an additional […***…] US]. Additional extensions may be granted only by mutual written agreement of the Parties. All such payments to extend deadlines are in addition to the annual License Maintenance Fee payment specified in Paragraph 4.2. Should Licensee opt not to pay to extend the completion date or if Licensee should fail to complete the stated milestone or otherwise fulfill the stated diligence obligations by any extended target date, then The Regents may provide written notice to Licensee that the license granted in Paragraph 2.1 has been converted to a non-exclusive license, effective as of the date of expiration of the Cure Period or any extended target date, whichever is later.
(a) extension feeUnless earlier terminated in accordance with other provisions of this Agreement, the non-exclusive license will remain in effect for one (1) year from the date of conversion under this Paragraph 6.
Appears in 3 contracts
Samples: Exclusive License Agreement (Arcadia Biosciences, Inc.), Exclusive License Agreement (Arcadia Biosciences, Inc.), Exclusive License Agreement (Arcadia Biosciences, Inc.)
Diligence. 5.1 LICENSEE shall itself use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, or shall cause its sublicensees through a diligent program for utilizing the PATENT RIGHTS and to usecontinue diligent marketing efforts throughout the life of this Agreement, commercially reasonable efforts, in each case consistent with sound and reasonable prudent business practices and judgment, . LICENSEE has the responsibility to diligently proceed to introduce at least one Licensed Product into the commercial market. Demonstration of such do all that is legally required and 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. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall includeapply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, but not be limited tofor 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 reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:
(i1) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development[XXX]
2) [XXX]
3) [XXX]
4) [XXX] For the purposes of this Agreement, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;
(ii) Initiation initiation of a first Phase II 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 Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency.
5.3 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 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 any MILESTONE deadline, LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall will be deemed to satisfy be in material breach of this Agreement, and fully discharge LICENSEE’s obligations under MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within 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 ninety (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 documentation90) 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) extension feeday period.
Appears in 2 contracts
Samples: Patent License Agreement (Solid Biosciences, LLC), Patent License Agreement (Solid Biosciences, LLC)
Diligence. LICENSEE shall itself use5.1 As an inducement to STANFORD to enter into this Agreement, or shall cause its sublicensees RIGEL agrees to 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 use all reasonable efforts and diligence to proceed with the development, manufacture and sale of Licensed Product(s) and to develop diligently markets for the Licensed Product(s). RIGEL shall include, but not be limited todemonstrate such diligence to STANFORD by achieving proof of principle though written documentation of the following achievements:
(ia) 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 Construction of Licensed Productsa retroviral vector library;
(iib) Initiation Infection of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Datecells with such vector library;
(iiic) Initiation Detection of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] physiological response to such infection in an infected cell;
(d) Isolation and analysis of the Agreement Datepeptide eliciting such physiological response from the cell; and
(ive) Identification of two novel targets for drug design, or demonstration that two previously known targets have a novel activity suitable for drug design.
5.2 If RIGEL is unable to demonstrate items 5.1(a) through (d) within eighteen (18) months after the Effective Date, and item 5.1(e) within thirty six (36) months after the Effective Date, STANFORD may request that RIGEL meet with STANFORD to discuss RIGEL's lack of diligence. The production parties shall meet within thirty (30) days after RIGEL receives any such notice to develop a mutually agreeable plan for remedying any such lack of diligence (the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to terminate this Agreement, which termination shall not have any effect upon the rights granted to RIGEL pursuant to the 1996 License Agreement.
5.3 On or before each anniversary of the commercialized Licensed Products and Effective Date during the marketing and support Exclusivity Term, RIGEL shall make a written annual report to STANFORD covering RIGEL's progress during the preceding year toward commercial use of the commercialized Licensed Products with at least Product(s). Such report shall include as a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement minimum information sufficient to enable STANFORD to satisfy relevant reporting requirements of the foregoing items (i-iv) shall be deemed U.S. Government and to satisfy and fully discharge LICENSEE’s obligations under ascertain RIGEL's progress toward meeting the diligence requirements of 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) extension feeArticle 5.
Appears in 2 contracts
Samples: Collaboration Agreement (Rigel Pharmaceuticals Inc), Collaboration Agreement (Rigel Pharmaceuticals Inc)
Diligence. LICENSEE 8.1 The Regents shall itself usehave the right to terminate this Agreement in its entirety if, by 31 December 2012, the Licensee, including affiliated companies, has not received at least €[**] 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 cause its sublicensees have the right to useimmediately terminate this Agreement.
8.2 The Licensee will complete the following tasks, commercially reasonable effortswithin [**] months of the Effective Date of this Agreement: [**].
8.3 The Licensee, consistent with sound and reasonable business practices and judgmentfrom the date it receives the Interim Report, agrees to use Commercially Reasonable Efforts to proceed, either directly or through a Third Party Licensee, to diligently proceed to introduce develop at least one Licensed Product into the commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited to:
(i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketingIdentified Product, and sales 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 Licensed Products;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 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.
(ii) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] 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 Date;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.
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] 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 Agreement Date; and
(iv) provisions of Sections 8.1 to 8.5, The production Regents will give the Licensee written notice of the commercialized Licensed Products and deficiency in accordance with Section 11.2 (Nonmonetary Default). If, after the marketing and support of Notice Period, or Notice Extension Period, if applicable, the commercialized Licensed Products with deficiency has not been cured, then The Regents may, at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed its option, terminate this Agreement immediately or remove the licensing restriction in Section 2.2 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 providing written notice 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) extension feeLicensee.
Appears in 2 contracts
Samples: Data License Agreement (uniQure B.V.), Data License Agreement (uniQure B.V.)
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 shall include, but not be limited to:
(i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and developmentFollowing the Closing, 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 […***…] until the expiration of the Agreement Date;
(iiiDiligence Period set forth in section 1.5(c)(i)(a)(A) Initiation of a first pivotal clinical trial below, the Buyer shall itself and/or Phase III clinical trial of a first Licensed Product within […***…] with or through other members of the Agreement Date; 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
(iv) The production , if either or both such Regulatory Approvals are obtained, until the expiration of the commercialized Licensed Products and Diligence Period set forth in section 1.5(c)(i)(a)(B) below, the marketing and support Buyer shall itself and/or with or through other members of the commercialized Licensed Products with at least a substantially similar level of effort Buyer Rights Chain Group, as LICENSEE employs for comparable products and services marketed by LICENSEEapplicable, use Commercially Reasonable Efforts to commercialize the FibroCaps Product in the United States and/or the European Union, as applicable. Timely achievement of Notwithstanding the foregoing items (i-iv) shall be deemed to satisfy and fully discharge LICENSEEforegoing, Buyer’s obligations under this Section 1.5(c):
(a) shall expire (A) 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 earlier of (I) First Commercial Sale in the United States or (II) First Commercial Sale in the European Union;
(b) shall not include an obligation to seek any additional Regulatory Approval or label expansion for the Fibrocaps 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
(c) shall not include an obligation to conduct any clinical trial or nonclinical study of 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. BCM recognizes that there are many uncertainties associated If such notice is given, the Buyer shall designate one or more representatives to meet with the development and commercialization Representative (in person at the Buyer’s offices or by telephone) within fifteen (15) Business Days from the date of therapeutic products 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) and the regulatory process required Representative shall be subject to the confidentiality obligations of Section 1.7(d) and regarded as for settlement purposes only, and no statement made in the course of the discussion shall be admissible in any subsequent Legal Proceeding, 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 permitted in the Legal Proceeding. In the event that the Representative and the Buyer’s representatives are unable to resolve the Representative’s claim of the 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 been held by such date, then the Representative may pursue any available remedies in accordance with the terms of this Agreement, subject to Section 1.5(c)(iv), unless the Buyer and the Representative mutually agree to an extension to the foregoing time periods.
(iv) Nothing herein shall constitute a guarantee by the FDA (and foreign regulatory authorities that are equivalent to Buyer of the FDA)achievement of any or all of the Milestone Events. Accordingly, Save in the event of fraud or knowing misrepresentation, the Buyer’s maximum aggregate liability for any and all 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 LICENSEE can demonstrate the Buyer would have become obligated to BCM its commercially pay if the Buyer had exercised the requisite Commercially Reasonable Efforts, together with (A) the Sellers’ reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) legal fees and expenses incurred in enforcing their rights under this Section 1.5 and (iiiB) 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 interest on such revision. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iii), LICENSEE may obtain a amount from the date the applicable Milestone Payment became payable until the date on which payment is made at an annual rate of […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, percent ([…***…] dollars ]%) ($[…***…] US) extension feeaccrued daily and compounded monthly).
Appears in 2 contracts
Samples: Share Purchase Agreement, Share Purchase Agreement (Medicines Co /De)
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 4.1 Licensee will use commercially reasonable efforts shall includeto develop, but not be limited tocommercialize, market, promote, and sell Licensed Products in each of the XLMTM Field and the Pompe Field. Commercially reasonable efforts means efforts equivalent to those utilized by [*] Without limiting the foregoing, Licensee will meet the following:
(ia) 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 Acceptance by the FDA of Licensed Products;
(ii) Initiation of an Investigational New Drug application for a first Phase II clinical trial of a first Licensed Product within in the XLMTM Field by no later than […***…] 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
(ivb) The production Acceptance by the FDA of an Investigational New Drug application for a Licensed Product in the Pompe Field by no later than [*]. 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 relevant deadline date, and, upon the payment to Licensor of [*] within [*] of the commercialized Licensed Products 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 original deadline date; provided that Licensee will only be entitled to [*] for the XLMTM Field and [*] for the marketing 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 support 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 commercialized development, evaluation, testing, and commercialization of each Licensed Products with at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEEProduct. Timely achievement Licensee will also notify Licensor within [*] of the foregoing items first commercial sale by Licensee, its Affiliates, or any Sublicensees of each Licensed Product. Such a report (i-iv) “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 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, 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 strategy;
4.2.5 Projected total development remaining before product launch of each Licensed Product; and
4.2.6 Summary of significant development efforts using the Licensed Patents being performed by Third Parties, including the nature of the relationship between Licensee and such Third Parties.
4.3 The Parties agree that Development Progress Reports shall be deemed to satisfy and fully discharge LICENSEELicensee’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) aboveConfidential Information; provided that BCM Licensor may share a copy of such reports with its direct and indirect licensors.
4.4 Simultaneously with the Development Progress Report, Licensee shall deliver a detailed description of any Licensed Back Improvements, if 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 previously provided pursuant to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feeSection 2.5.2.
Appears in 2 contracts
Samples: License Agreement (Audentes Therapeutics, Inc.), License Agreement (Audentes Therapeutics, Inc.)
Diligence. 5.1 LICENSEE shall itself use, or shall cause its sublicensees to 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 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 reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the "MILESTONES'") by 'he following dates:
1) Completion of Phase I Clinical Trial on or before January 1, 2015.
2) Completion of Phase II Clinical Trial on or before January 1, 2017.
3) Completion of Phase III Clinical Trial on or before January 1, 2019.
4) FIRST COMMERCIAL SALE on or before January 1, 2020.
5.3 LICENSEE must achieve the 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 include, but not be limited to:
effective if LICENSEE: (ia) Annual report provided actually achieves such MILESTONE during such thirty (30) day period or (b) demonstrates that LICENSEE has used commercially reasonable efforts to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and developmentachieve such MILESTONE over the entire course of this AGREEMENT. If, 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 […***…] as of the Agreement Date;
close of such thirty (iii30) Initiation of day period, there is a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] dispute as to whether LICENSEE has met the condition set forth in clause (a) or (b) of the Agreement Date; and
preceding sentence, then such thirty (iv30) The production of day period shall be automatically extended for thirty (30) days, during which time the commercialized Licensed Products and parties shall hold good faith discussions in order to resolve such dispute. If the marketing and support of parties ultimately agree that LICENSEE has met 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 condition set forth in clause (b) above, the foregoing items (i-iv) termination 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 ineffective, 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 panics shall negotiate in good faith a reasonable revision to items revised deadline for achieving such MILESTONE. In addition, regardless of whether LICENSEE can demonstrate that LICENSEE has met the condition set forth in clause (ii) and (iiib) above; , LICENSEE shall have the opportunity to present a revised timeline for achieving the MILESTONE at issue, and the approval to revise the timeline from MICHIGAN shall not be unreasonably withheld, 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 is otherwise in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feecompliance with its other obligations under this AGREEMENT.
Appears in 2 contracts
Samples: Exclusive License Agreement (Heat Biologics, Inc.), Exclusive License Agreement (Heat Biologics, Inc.)
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 5.1 Tengion will use commercially reasonable efforts to bring CHB Licensed Products and WFUHS Licensed Products to market through a thorough and diligent program for exploitation of the CHB Patent Rights, WFUHS Patent Rights and the Know-How. Tengion shall include, but not be limited to: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 foregoing sentence.
5.2 If WFUHS believes Tengion shall have failed to comply with the provisions of this Article 5, WFUHS 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) Annual report provided demonstrate to BCM describing LICENSEEWFUHS’s or its sublicensees’ progress and activities related to research and developmentreasonable satisfaction that it has complied with the provisions of Article 5.1, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;
(ii) Initiation trigger the ADR provisions of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Date;
Article 18 or (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 notify WFUHS that it agrees with at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEEWFUHS. Timely achievement of the foregoing items If Tengion does not satisfy clauses (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 or (ii) and 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, LICENSEE and BCM will 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 such one (1) year period, Tengion has failed to enter into such subfield sublicense, WFUHS may, within the immediately following one (1) year period negotiate in good faith the subfield field of use sublicense directly with a reasonable revision third party. If WFUHS negotiates such sublicense within such time, then Tengion shall enter into a subfield field of use sublicense with such third party, provided that such sublicense (a) is on terms that are substantially similar to items the terms of this Agreement (iiexcept the financial terms), (b) does not obligate Tengion to spend money or dedicate resources, (c) shall exclude any Licensed Product (or related rights to such Licensed Product) that has been or is under active development or is being commercialized by Tengion and (iiid) above; provided is restricted to the 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 (if, for example, it believes that BCM one or more of clauses (a) - (d) above have not been satisfied) within ten (10) days of receiving the negotiated field of use sublicense from WFUHS.
5.2.3 If Tengion fails exercise the sublicense or initiate ADR proceedings within such ten (10) day period, it shall not unreasonably withhold be deemed to have granted WFUHS an irrevocable power of attorney to execute such revisionsublicense on its behalf. If LICENSEE anticipates an arbitrator finds that it 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 within the subfield of the Licensed 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 sublicense as contemplated above within such one (1) year period, then Tengion’s license hereunder will not fulfill a revised item (ii) continue without any change or (iii)consequence, LICENSEE may obtain a […***…] extension subject to the terms and conditions of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feethis Agreement.
Appears in 2 contracts
Samples: License Agreement (Tengion Inc), License Agreement (Tengion Inc)
Diligence. LICENSEE shall itself use3.5.1 In carrying out the Development and in seeking Regulatory Approval, or shall cause its sublicensees OMP agrees to 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 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 includebe the only compound that OMP will at the same time develop or commercialize for identical or similar therapeutic uses. Without limitation to the foregoing, but 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 limited toable 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) Annual report provided If OMP prior to BCM describing LICENSEE[***] OMP has initiated [***] of a Collaboration Compound and such Collaboration Compound fails during such studies, for reasons outside of OMP’s or its sublicensees’ progress and activities related to research and developmentreasonable control, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;then the time periods set forth in Article 3.5.1 above shall be extended for a period [***]
(ii) Initiation of a first Phase II clinical trial of a first Licensed Product within If OMP initiates […***…] of the Agreement Date;
(iii) Initiation of with respect to a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within 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 Agreement Date; andtime 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.
(iv) The production 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 commercialized Licensed Products fact having been resolved under Article 3.5.3 and the marketing and support 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 commercialized Licensed Products with at least a substantially similar level of effort as LICENSEE employs for comparable products two remedies set forth below in Articles 3.6 and services marketed by LICENSEE3.7 to offer ADDEX, provided, however, these remedies shall not be available to ADDEX if [***]. Timely achievement If OMP fails to elect within said [***] days, ADDEX shall have the right to elect which of the foregoing items (i-iv) 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 deemed waived and OMP will have the right to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated proceed with the development and commercialization of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities Collaboration Compound that are equivalent gave rise to the FDA)failure of diligence or replacement thereto subject to the diligence requirements of Article 3.5. Accordingly, in the event that LICENSEE can demonstrate to BCM its commercially reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) The remedies provided by Article 3.6 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 Article 3.7 […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, and such failure […***…] dollars ($]
3.5.5 […***…] US) extension fee.OMP’s diligence obligation shall [***]
Appears in 2 contracts
Samples: Research and Development (Addex Therapeutics Ltd.), Research and Development (Addex Therapeutics Ltd.)
Diligence. LICENSEE shall itself use5.1 As an inducement to STANFORD to enter into this Agreement, or shall cause its sublicensees RIGEL agrees to 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 use all reasonable efforts and diligence to proceed with the development, manufacture and sale of Licensed Product(s) and to develop diligently markets for the Licensed Product(s). RIGEL shall include, but not be limited todemonstrate such diligence to STANFORD by achieving proof of principle though written documentation of the following achievements:
(ia) 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 Construction of Licensed Productsa retroviral vector library;
(iib) Initiation Infection of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Datecells with such vector library;
(iiic) Initiation Detection of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…physiological response to such infection in an infected cell; [ * ] = 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 SECURITIES ACT OF 1933, AS AMENDED.
(d) Isolation and analysis of the Agreement Datepeptide eliciting such physiological response from the cell; and
(ive) Identification of two novel targets for drug design, or demonstration that two previously known targets have a novel activity suitable for drug design.
5.2 If RIGEL is unable to demonstrate items 5.1(a) through (d) within eighteen (18) months after the Effective Date, and item 5.1(e) within thirty six (36) months after the Effective Date, STANFORD may request that RIGEL meet with STANFORD to discuss RIGEL's lack of diligence. The production parties shall meet within thirty (30) days after RIGEL receives any such notice to develop a mutually agreeable plan for remedying any such lack of diligence (the "Proposed Remedy"). If RIGEL fails to perform the Proposed Remedy within one hundred eighty (180) days after the Proposed Remedy is agreed upon, STANFORD may elect to terminate this Agreement, which termination shall not have any effect upon the rights granted to RIGEL pursuant to the 1996 License Agreement.
5.3 On or before each anniversary of the commercialized Licensed Products and Effective Date during the marketing and support Exclusivity Term, RIGEL shall make a written annual report to STANFORD covering RIGEL's progress during the preceding year toward commercial use of the commercialized Licensed Products with at least Product(s). Such report shall include as a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement minimum information sufficient to enable STANFORD to satisfy relevant reporting requirements of the foregoing items (i-iv) shall be deemed U.S. Government and to satisfy and fully discharge LICENSEE’s obligations under ascertain RIGEL's progress toward meeting the diligence requirements of 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) extension feeArticle 5.
Appears in 2 contracts
Samples: Collaboration Agreement (Rigel Pharmaceuticals Inc), Collaboration Agreement (Rigel Pharmaceuticals Inc)
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 4.1 Licensee will use commercially reasonable efforts shall includeto develop, but not be limited tocommercialize, market, promote, and sell Licensed Products in each of the XLMTM Field and the Pompe Field. Commercially reasonable efforts means efforts equivalent to those utilized by ****. Without limiting the foregoing, Licensee will meet the following:
(ia) 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 Acceptance by the FDA of Licensed Products;
(ii) Initiation of an Investigational New Drug application for a first Phase II clinical trial of a first Licensed Product within […in the XLMTM Field by no later than ***…] 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
(ivb) The production Acceptance by the FDA of an Investigational New Drug application for a Licensed Product in the Pompe Field by no later than ****. 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 4.1(a) or (b) by the relevant deadline date, and, upon the payment to Licensor of **** within **** of the commercialized Licensed Products 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 **** for the marketing 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 support 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 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 development, evaluation, testing, and commercialization of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA)each Licensed Product. 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 Licensee 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 […also notify Licensor within ***…] extension * of the first 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 in which covered by such report;
4.2.2 Major activities and accomplishments completed by Licensee, its Affiliates, and any Sublicensees relating directly to achieve these milestones, by paying to BCM a one-time, […the Licensed Product since the last Development Progress Report; ***…] dollars ($[…***…] US) extension feeCERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
Appears in 2 contracts
Samples: License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.)
Diligence. 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 Commercially Reasonable Efforts (a) 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 itself usenot 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 cause be deemed to have satisfied its sublicensees obligations under this Section 2.6 if it files an IND with respect to use, commercially reasonable efforts, consistent one or more Licensed Products by the fifth anniversary of the Effective Date. In the event that Emergent fails to file an IND with sound and reasonable business practices and judgment, respect to diligently proceed to introduce at least one Licensed Product into by such date (the commercial market. Demonstration “Penalty Date”), then it shall pay HPA [**] 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 commercially reasonable efforts 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 includepay HPA a lump sum equal to the difference between [**] Dollars (US $[**]) and the aggregate amount previously paid by Emergent to HPA pursuant to this sentence; and provided, but further, that Emergent shall not be limited to:
(i) Annual report provided required 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, make any payment in the event that LICENSEE can demonstrate Emergent’s failure to BCM file such IND by such date results directly from the failure by HPA to perform any of its commercially reasonable efforts obligations hereunder in a timely manner. Such payment shall be the sole remedy of HPA for any breach of this Section 2.6, and any breach of this Section 2.6 (with reasonable supporting documentationother than a breach of such payment obligation) 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 be deemed a revised item (ii) or (iii), LICENSEE may obtain a […***…] extension material breach of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feethis Agreement for purposes of Section 10.5.
Appears in 2 contracts
Samples: Rbot Vaccine License Agreement (Emergent BioSolutions Inc.), Bt Vaccine License Agreement (Emergent BioSolutions Inc.)
Diligence. LICENSEE (a) Ultragenyx (on its own or acting through any of its Affiliates, sublicensees or subcontractors) shall itself use, or shall cause its sublicensees use Commercially Reasonable Efforts to use, commercially reasonable efforts, consistent with sound develop and reasonable business practices and judgment, to diligently proceed to introduce commercialize at least one Licensed (1) Product into in FAOD and at least (1) Product in [***]. Specifically, Ultragenyx will use Commercially Reasonable Efforts to (a) [***]; (b) [***]; (c) [***]; and (d) within [***] after the commercial market. Demonstration Effective Date, perform at least one of such commercially reasonable efforts shall include, but not be limited to:
the following: (i) 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 […***…] ]; 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) 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 plan for Ultragenyx to continue its development of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within Product. Each agreed upon […***…] extension of the Agreement Date; andtimeline 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.
(ivc) The production For the purposes 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) this Section 3.2(c), all FAOD indications shall be deemed to satisfy one “Indication Cluster” 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). Accordinglyall [***] shall be deemed another “Indication Cluster.” On an Indication Cluster-by-Indication Cluster basis, in the event Ultragenyx fails to satisfy such new timeline or plan that LICENSEE can demonstrate is specific to BCM its commercially reasonable efforts a particular Indication Cluster, then upon written notice by BRI, the license granted to Ultragenyx pursuant to Section 2.1(a) 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 such time. In the event of the conversion of the license to non-exclusive, any sole and/or exclusive rights that Ultragenyx has 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 (with reasonable supporting documentation) to fulfill items i)-(iv), and Ultragenyx’s rights under Sections 5.1(a), 5.3(b), Section 5.4(b), Section 5.5 (iia) and (iii) aboveb), LICENSEE and BCM will negotiate Section 5.6, as well as BRI’s corresponding obligations to Ultragenyx with respect to those Sections, in good faith a reasonable revision each case as such rights and obligations apply to items (ii) any non-exclusive Indication Cluster, shall be suspended for so long as such license remains non-exclusive and (iii) above; provided that BCM shall be automatically reinstated if and when such license becomes exclusive pursuant to the foregoing. Failure to achieve such milestones shall not unreasonably withhold such revisionbe 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 LICENSEE anticipates the license granted to Ultragenyx pursuant to Section 2.1(a) is converted to a non-exclusive license for a particular Indication Cluster pursuant to the terms of this Section 3.2, BRI shall promptly provide Ultragenyx with written notice of any Third Party license that it will not fulfill a revised item (ii) BRI grants under the BRI Technology relating to Compounds or (iii), LICENSEE may obtain a […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feeProducts for such Indication Cluster.
Appears in 2 contracts
Samples: License Agreement (Ultragenyx Pharmaceutical Inc.), License Agreement (Ultragenyx Pharmaceutical Inc.)
Diligence. LICENSEE 4.3.1 Sellas shall itself use, or shall cause its sublicensees use Commercially Reasonable Efforts to use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, Develop the Compound pursuant to diligently proceed to introduce at least one Licensed Product into a development plan (the commercial market. Demonstration “Development Plan”) which will include projected timelines for the achievement of such commercially reasonable efforts shall include, but not be limited to:
the following milestones: (ia) 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 initiation of Licensed Products;
(ii) Initiation of a the first Phase II clinical trial of a first Licensed Product within […***…] in the Territory for a Product; (b) initiation of the first [***] in the Territory for a Product; and (c) the submission of [***] following a [***].
4.3.2 Sellas will deliver the initial Development Plan to GenFleet within [***] of the Agreement Effective Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within . Not later than […***…] 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 Date; andpursuant 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.
(iva) The production If Sellas elects to submit the Impasse to binding arbitration, each Party will first (a) prepare a draft 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) its proposed deadline, which deadline shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with not earlier than [***] after the development and commercialization of therapeutic products and the regulatory process required by the FDA original deadline (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 (iieach a “Draft Deadline”) and (iiib) above, LICENSEE and BCM will negotiate in good faith a reasonable revision submit its Draft Deadline 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 the other Party within […***…] extension following the date of time in which to achieve these milestones, by paying to BCM a one-time, Sellas notice of election of arbitration. Within […***…] dollars 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 revised deadline will be resolved by final and binding arbitration before an independent Third Party arbitrator chosen by the Parties (the “Arbitrator”). The Arbitrator shall have at least ten (10) 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 Arbitrator within […***…] USof failing to agree on a Draft Deadline (or a modified version thereof), then the Parties will request that one be appointed for them by the American Arbitration Association.
(c) extension feeWithin [***] 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 the latter of such Draft Deadlines and to select the Draft Deadline that it determines contains the most fair deadline. The Arbitrator will agree to comply with such [***] before accepting appointment. The authority of the 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 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 the arbitration proceeding, except that the fees of the Arbitrator and other related costs of the arbitration will be shared equally by the 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 all or any portion of such expenses (including reasonable legal fees) so incurred.
Appears in 1 contract
Samples: License Agreement (SELLAS Life Sciences Group, Inc.)
Diligence. LICENSEE Notwithstanding anything herein to the contrary, MMT’s commitment to use Commercially Reasonable Efforts as set forth herein shall itself usenot preclude the suspension or discontinuance of the Promotion of the Product in the Field in a country within the Territory, or shall cause its sublicensees if reasonably appropriate, based on the application of Commercially Reasonable Efforts with respect to use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce at least one Licensed the Promotion of the Product into in such country. If MMT does not document in the commercial market. Demonstration Business Plan [***]the Product in the Field in a country in the Territory (“[***]”) for a period of such commercially reasonable efforts shall include, but not be limited to:
either (i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development[***] calendar months after the Effective Date for Tier 1 Countries, 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 calendar months after the Agreement Date;
Effective Date for Tier 2 Countries or (iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] 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 [***] Business Days after the expiration the applicable Tier Period for such country, SIGA may provide MMT with written notice [***] non-[***] (a “Non-[***] Notice”) in such country, and upon MMT’s receipt 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) such Non-[***] Notice, such country shall be deemed to satisfy be a “Discontinued Country” for purposes of this Agreement. If [***], SIGA shall have the right to designate the applicable country as a Discontinued Country at any time thereafter as long as the relevant Tier Period [***] for the country has been met at the time of the Non-[***] Notice. SIGA hereby acknowledges and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes agrees that there are many uncertainties associated with the development MMT and commercialization of therapeutic products and the regulatory process required by the FDA its Affiliates make (and foreign regulatory authorities that are equivalent to the FDA). Accordinglyhave made) no representation or warranty, either express or implied, at law or in the event that LICENSEE can demonstrate to BCM its commercially reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) and (iii) aboveequity, 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 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 resources that may be expended in the Promotion of the Product. Except as otherwise set forth in Section 2.3 with respect to Competing Products, nothing in this Agreement shall limit or restrict the right of MMT or its Affiliates to develop, make regulatory filings, obtain regulatory approvals with respect to, or to Commercialize any product that is not fulfill the Product or, with respect to MMT only, a revised item (ii) Competing Product or (iii), LICENSEE may obtain a […***…] extension of time to engage in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feeany business or other activity.
Appears in 1 contract
Diligence. 5.1 LICENSEE shall itself useuse 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 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 Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency. The MILESTONES are:
1) submitting an IND to the FDA by August 31, 2013.
2) initiating a Phase I clinical trial by December 31, 2013. [***] MICHIGAN acknowledges and agrees that LICENSEE has fully satisfied its obligations regarding achievement of MILESTONES 1 and 2 above, and that no Delay Option (as defined below) was utilized.
5.3 LICENSEE shall cause have the right to extend by [***] the time it has to achieve the above diligence milestones, such date to be calculated from the dates shown in Paragraph 5.2, as applicable (“Delay Option”). To exercise the Delay Option, LICENSEE must: (i) give MICHIGAN notice in writing at least ten (10) days prior to the MILESTONE deadline that LICENSEE is exercising its sublicensees Delay Option; and (ii) pay MICHIGAN a non-refundable and non-creditable fee of $[***], which shall be due with such notice, and upon such payment, all the above diligence milestone dates shall be extended by [***].
5.4 Subject to useParagraph 5.3, LICENSEE must use commercially reasonable efforts to achieve each MILESTONE on or before the 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, consistent with sound and reasonable business practices and judgment, LICENSEE may request to diligently proceed to introduce at least one Licensed Product into amend or extend the commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited to:
(i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketingMILESTONES, and sales MICHIGAN will not unreasonably withhold consent or approval of Licensed Products;
any such request to amend or extend the MILESTONE if such proposed request is supported by a detailed showing by LICENSEE of: (iia) 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 to achieve such MILESTONE events during the Agreement (with reasonable supporting documentationincluding the amount of monetary investment therein), (b) to fulfill items (ii) due diligence in its performance of research and development of LICENSED PRODUCTS and/or LICENSED PROCESSES, and (iiic) above, LICENSEE plans for future development and BCM will negotiate in good faith a reasonable revision to items (ii) sale of LICENSED PRODUCTS and (iii) above; provided that BCM shall not unreasonably withhold such revisionLICENSED PROCESSES. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iii), LICENSEE may obtain a fails to use commercially reasonable efforts to meet any MILESTONE under this Paragraph by the date of […***…] extension = CONFIDENTIAL TREATMENT REQUESTED the 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 time in which this Agreement, and MICHIGAN may terminate the Agreement effective on thirty (30) days’ notice, unless LICENSEE commences using commercially reasonable efforts to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension fee.the MILESTONE within this thirty day period,
Appears in 1 contract
Samples: License Agreement (OvaScience, Inc.)
Diligence. LICENSEE shall itself use, or shall cause its sublicensees to 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 shall include, but not be limited to:
(i) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and developmentFollowing the Closing, 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 […***…] until the expiration of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial Diligence Period, the Buyer shall itself and/or Phase III clinical trial of a first Licensed Product within […***…] with or through other members of the Agreement Date; and
(iv) The production of Buyer Rights Chain Group, as applicable, use Commercially Reasonable Efforts to achieve the commercialized Licensed Products and Milestone Events. Notwithstanding 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 LICENSEEforegoing, Buyer’s obligations under this Section 32.6(b):
(a) shall expire (A) as to Milestone #1 on the [**] if Regulatory Approval has not been achieved in the United States as of such [**], (B) as to Milestone #2 on the date [**] if Regulatory Approval has not been achieved in the European 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) if the Buyer enters into any agreement for the sale, 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) shall not include an obligation to seek any additional Regulatory Approval or label expansion for the 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) shall not include an obligation to conduct any clinical trial or nonclinical study of the 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.
(ii) If the Buyer terminates or abandons all development and, if commenced as of 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 reasons for such cessation of activities.
(iii) 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. BCM recognizes that there are many uncertainties associated If such notice is given, the Buyer shall designate one or more Buyer Milestone Representatives to meet with the development and commercialization Representative (in person at the Buyer’s offices or by telephone) within fifteen (15) Business Days from the date of therapeutic products such notice to address the Representative’s belief that the Buyer has materially breached its obligations under this Section 2.6. The discussion between the Buyer Milestone Representative(s) and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent Representative shall be subject to the FDA)confidentiality obligations of Section 2.4(f) and regarded as for settlement purposes only, and no statement made in the course of the discussion shall be admissible in any subsequent Legal Proceeding, 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 permitted in the Legal Proceeding. Accordingly, in In the event that LICENSEE can demonstrate the Representative and the Buyer Milestone Representatives are unable to BCM its commercially reasonable efforts resolve the Representative’s claim of the alleged material breach by (with reasonable supporting documentationA) to fulfill items the date that is thirty (ii30) and (iii) aboveBusiness Days after such meeting, 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 (iiiB) 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 been held by such date, then the Representative may pursue any available remedies, subject to Section 2.6(b)(iv), LICENSEE may obtain unless the Buyer and the Representative mutually agree to an extension to the foregoing time periods.
(iv) Nothing herein shall constitute a […***…] extension guarantee by the Buyer of time in which the achievement of any or all of the Milestone Events. The Buyer’s maximum aggregate liability for any and all breaches by the Buyer of its obligations under this Section 2.6(b) shall be limited to achieve these milestonesthe unpaid portion(s), by paying if any, of the Milestone Payment(s) that Buyer would have become obligated to BCM a one-time, […***…] dollars ($[…***…] US) extension feepay if the Buyer had exercised the requisite Commercially Reasonable Efforts.
Appears in 1 contract
Samples: Merger Agreement (Medicines Co /De)
Diligence. LICENSEE (a) Pharmasset shall itself useuse Reasonable Diligence in proceeding with the discovery and development of the Potential Licensed Compounds, or except that Pharmasset’s obligation hereunder shall cause its sublicensees to use, commercially reasonable efforts, consistent with sound expire upon the expiration of the Option Exercise Period.
(b) From 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 shall include, but not be limited to:
after (i) Annual report provided the Effective Date with regard to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development, securing regulatory approvals, manufacturing, sublicensing, marketingthe Primary Compound, and sales of Licensed Products;
(ii) Initiation the effective date of Roche’s exercise of its Option with regard to a first Phase II clinical trial of a first given Potential 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) Compound, Roche shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with use Reasonable Diligence in the development and commercialization of therapeutic products and the regulatory process required by the FDA such Primary Compound (and foreign regulatory authorities Primary Products containing the Primary Compound), or Potential Licensed Compound (and Products containing such Potential Licensed Compound), as the case may be, including [***].
(c) [***] shall [***], as applicable.
(d) If Pharmasset fails to use Reasonable Diligence in the performance of GLP Tox Completion activities for a Potential Licensed Compound (unless the JRC determines that such activities are equivalent 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 no cost to Roche. If Roche fails to use Reasonable Diligence in the FDA). Accordinglyperformance of the Development Plan with respect to a Licensed Compound (including, in the event case of early exercise of an Option, any remaining GLP Tox Completion activities to the extent 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 the JDMC determines that BCM shall not unreasonably withhold such revision. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iiiactivities are necessary for development of such Potential Licensed Compound), LICENSEE may obtain a then Pharmasset shall have the right to reversion of such Licensed Compound in accordance with the provisions of Section 17.4.
(e) With respect to […***…] extension of time in which to achieve these milestones], by paying to BCM a one-time, if […***…] dollars ($], prior to […***…] USin [***], ceases [***] to achieve [***] in such [***] for a period of [***] ([***]) extension fee[***], then [***] shall have the right of a [***] of [***] to [***] in such [***] in accordance with Section [***]. With respect to each [***], if [***], after receiving [***] for a [***] in a [***], ceases [***] in [***] for a period of [***] ([***]) [***], then [***] shall have the right of a [***] of [***] to such [***] in [***] in accordance with Section [***]. For clarity, this Section 3.1(e) does not apply, and [***] shall not have any [***] of [***], if the reason for [***] to [***] or [***] is attributable to a [***] or some other [***] by a [***] that prevents [***] from continuing [***] or [***] activities.
Appears in 1 contract
Diligence. 5.1 LICENSEE shall itself use commercially reasonable efforts to bring one or more LICENSED PRODUCTS to market, and/or one or more LICENSED PROCESSES to commercial use, or shall cause its sublicensees through a diligent program for utilizing the PATENT RIGHTS and to usecontinue diligent marketing efforts throughout the life of this Agreement, commercially reasonable efforts, in each case consistent with sound and reasonable prudent business practices and judgment, . LICENSEE has the responsibility to diligently proceed to introduce at least one Licensed Product into the commercial market. Demonstration of such do all that is legally required and 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. If the commercialization of multiple LICENSED PRODUCTS or LICENSED PROCESSES is commercially reasonable, then the requirement of this paragraph shall includeapply to all such LICENSED PRODUCTS and/or LICENSED PROCESSES. Further, but not be limited tofor 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 reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:
(i1) Annual report provided to BCM describing LICENSEE’s or its sublicensees’ progress and activities related to research and development[**]
2) [**]
3) [**]
4) [**] For the purposes of this Agreement, securing regulatory approvals, manufacturing, sublicensing, marketing, and sales of Licensed Products;
(ii) Initiation initiation of a first Phase II 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 Good Manufacturing Practices (GMP) guidelines provided by the relevant regulatory agency.
5.3 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 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 any MILESTONE deadline, LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall will be deemed to satisfy be in material breach of this Agreement, and fully discharge LICENSEE’s obligations under MICHIGAN may terminate the Agreement effective on ninety (90) days’ written notice, unless LICENSEE achieves the MILESTONE within 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 ninety (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 documentation90) 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) extension feeday period.
Appears in 1 contract
Diligence. LICENSEE shall 5.1 Chondrial will use Commercially Reasonable Efforts to bring the Licensed Products to market through exploitation of the Licensed Patents and commercialization of the Licensed Products.
5.2 Without limiting the generality of the diligence provisions of Section 5.1 above, Chondrial will achieve (either itself use, or shall cause of through its sublicensees to use, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce Affiliates and/or its Sublicensees) the following milestones by the following dates (“Milestones”):
(a) Chondrial will have at least one Licensed Product into two full-time equivalent personnel working on the commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited to:
(i) 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, manufacturing and sales marketing of the Licensed ProductsProducts within the twelve (12) month period from the Effective Date and each subsequent year thereafter;
(iib) Initiation Enrollment of a the first patient in the first Phase II I (or its non-U.S. equivalent) clinical trial of a first Licensed Product within […***…] of thirty (30) months from the Agreement Effective Date;
(iiic) Initiation Enrollment of a the first pivotal clinical trial and/or patient in the first Phase III II (or its non-U.S. equivalent) clinical trial of a first Licensed Product within […***…] sixty (60) months from the Effective Date;
5.2.1 Chondrial will provide to IURTC (at the time of the Agreement Date; and
(iv) The production next due report under Section 8) written notice of the commercialized achievement of each Milestone in this Section 5.2 (and continued confirmation of Chondrial’s sustained achievement of Section 5.2(a)).
5.3 Chondrial will use Commercially Reasonable Efforts to have the Licensed Products and the cleared for marketing and support of the commercialized in those countries in which Chondrial, in its sole discretion, intends to sell Licensed Products by the responsible governmental agencies requiring such clearance. To accomplish such clearances at the earliest possible date, Chondrial will file, according to the usual practice of companies similarly situated to Chondrial, any necessary data with at least a substantially similar level of effort as LICENSEE employs for comparable products and services marketed by LICENSEEsuch governmental agencies. 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 For clarity, the development and commercialization of therapeutic products and the regulatory process required Licensed Products outside of the U.S. is at Chondrial’s sole discretion.
5.4 If IURTC is approached by a bona fide third party about development of an application of the FDA (and foreign regulatory authorities Licensed Patents that are equivalent to is within the FDA). AccordinglyField but is not currently being developed by Chondrial, in IURTC will notify Chondrial of 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) extension feeinquiry.
Appears in 1 contract
Diligence. LICENSEE (a) After the Effective Date, as between the Parties, Newsoara shall itself usebe 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, or shall cause its sublicensees to use, commercially reasonable efforts, consistent with sound and reasonable business practices obtain and judgment, to diligently proceed to introduce at least one maintain Regulatory Approvals for Licensed Product into in the commercial market. Demonstration of such commercially reasonable efforts shall includeField in the Territory.
(b) Without limiting the foregoing, but not be limited to:
Newsoara shall: (i) 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;
[***] within [***] months after [***]; (ii) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Date;
within [***] months after [***]; and (iii) Initiation maintain active clinical Development for the Licensed Products through submission of a the first pivotal Drug Approval Application to NMPA. For the purpose of clause (iii), “active clinical trial and/or Phase III clinical trial of a first Licensed Product within Development” shall require Newsoara to […***…] of the Agreement Date; and
(iv) during any consecutive [***] period [***]. The production of the commercialized Licensed Products deadlines 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 time period set forth in clauses (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) abovemay be extended to the extent that Newsoara’s inability to [***] is caused by delay outside of Newsoara’s reasonable control, LICENSEE including [***]; provided that Newsoara shall immediately notify Genelux of any such delay, and BCM will negotiate 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 good faith a reasonable revision its sole discretion, at any time during the Term of this Agreement, to items 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) If Newsoara conducts clinical Development of 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) [***]; (ii) [***]; and (iii) above; provided that BCM Newsoara 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) extension fee].
Appears in 1 contract
Samples: License Agreement (Genelux Corp)
Diligence. LICENSEE 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 itself usehave the right to 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 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 Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Table of Contents specified above, MSK shall cause its sublicensees have the right to useterminate 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 accrued to be issued).
4.2 Licensee shall use commercially reasonable effortsbest efforts to (i) bring Licensed Products to market through a thorough, consistent with sound vigorous and reasonable business practices diligent program for exploitation of the Licensed Rights, and judgment(ii) continue active, diligent marketing efforts for Licensed Products throughout the Term. Without limiting the foregoing, Licensee shall exercise its best efforts to diligently proceed to introduce at least one Licensed Product into achieve the commercial market. Demonstration of such following milestones: Licensee will use commercially reasonable efforts shall includeto develop and commercialize Licensed Products. Specifically, but not be limited toLicensee will:
(a) Either:
(i) 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;[*]; or
(ii) Initiation [*]; (the achievement of the milestone described in this Section 4.2(a) the “[*] Milestone Achievement”).
(b) [*] in exercise of commercially reasonable efforts in [*].
(c) [*].
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 [*] all clinical trials conducted in the 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. 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 [*] 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 Securities 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.
4.7 If Licensee is the subject of a first Phase II clinical trial of demand, notice, inquiry, or inspection report by a first governmental authority or certification agency in relation to any Licensed Product within […***…] that (i) by its terms directs or contemplates, or may reasonably be expected to require or relate to, suspension or cessation of the Agreement Date;
manufacturing, sale, development, or marketing of Licensed Products efforts, (ii) concerns a recall or potential recall of Licensed Products, (iii) Initiation concerns a loss of a first pivotal clinical trial and/or Phase III clinical trial life or material issue of a first Licensed Product within […***…] of the Agreement Date; and
safety, or (iv) The production may reasonably be expected to prevent Licensee’s compliance with its diligence obligations, then Licensee shall provide a copy to MSK without delay and keep MSK reasonably apprised 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) extension feeresponse.
Appears in 1 contract
Samples: Exclusive License Agreement (Galena Biopharma, Inc.)
Diligence. 5.1 LICENSEE shall itself use, or shall cause its sublicensees to 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 use commercially reasonable efforts shall includeto 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 reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:
1) Initiate communication with all Tier 1 (Largest - see Schedule 2) 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 be limited to:
(ithe very largest - see Schedule 3) 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 […with Category 1 products during ***…] of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] .
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 Agreement Date; and
(iv) The production effective date of the commercialized Licensed Products and the marketing and support of the commercialized Licensed Products with this agreement, LICENSEE will obtain at least a substantially similar level of effort **** new revenue-generating business relationship from among the Companies currently or prospectively identified as LICENSEE employs for comparable products and services marketed by LICENSEETier 1 or 2 Companies. Timely achievement of Additional royalties to MICHIGAN from such additional business under Section 3.1 (b) or (c) herein shall be at least ***** per year. In the foregoing items event that such business relationships do not generate at least ***** per year in additional royalties, the Annual Fee due MICHIGAN (i-ivas defined in Section 3.1 (d)) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with increased by the development and commercialization of therapeutic products difference between ****** and the regulatory process required by royalty amount actually incurred.
5.3 LICENSEE must achieve the FDA MILESTONES on or before the deadline dates indicated. LICENSEE shall notify MICHIGAN within ten (and foreign regulatory authorities that are equivalent 10) days after each deadline as 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 whether such revisionMILESTONE was met. If LICENSEE anticipates that it will not fulfill a revised item fails to meet any MILESTONE under this Article continues for forty-five (ii45) or (iii)days after the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may obtain a […***…] extension of time terminate the Agreement as provided in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feesection 11.3.
Appears in 1 contract
Diligence. 5.1 During the term of this Agreement, LICENSEE shall (itself use, or shall cause through its sublicensees to 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 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 includeapply 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, but not be limited toLICENSEE (itself or through its AFFILIATES or SUBLICENSEES) agrees to reach the following commercialization and research and development milestones for a LICENSED PRODUCT and/or LICENSED PROCESS (together the “MILESTONES”) by the following dates:
(ia) 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[…***…].
(b) […***…].
(c) […***…].
(d) […***…];
(iie) Initiation […***…];
(f) […***…]. For the purposes of a first Phase II clinical trial of a first Licensed Product this Agreement, […***…] shall mean that date upon which […***…] […***…].
5.3 LICENSEE shall notify MICHIGAN 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 days after each MILESTONE deadline date above, as LICENSEE employs for comparable products and services marketed by LICENSEEto whether or not such MILESTONE was met. Timely achievement of the foregoing items (i-iv) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM MICHIGAN 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), and that the parties may wish to amend the MILESTONES under Subparagraphs 5.2(b) through (f). Accordingly, in the event that if 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 believes 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 be unable to timely achieve any MILESTONE in Paragraph 5.2 (iib), (c), (d), (e) or (iii)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 the existence of a safety or efficacy reason not to perform one or more of the steps necessary to allow the achievement of such MILESTONE, then LICENSEE may obtain will promptly consult with MICHIGAN with respect to such determination, and the parties hereto will in good faith 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 such changes to the MILESTONES and related deadlines within […***…] extension ([…***…]) days of time in which the original notification by LICENSEE to achieve these milestonesMICHIGAN. In addition, by paying (i) LICENSEE will have the right to BCM a one-time, elect […***…] dollars extensions to the MILESTONES under Subparagraphs 5.2 ($b) through (f), at […***…] USif such extensions are a result of causes beyond LICENSEE’s direct control or any inaction of the FDA or foreign equivalent and (ii) extension feeLICENSEE will have the right to extend the deadline of any MILESTONE for a period of […***…] after the scheduled deadline for such MILESTONE 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.
5.4 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 During the term of this Agreement, LICENSEE shall (itself use, or shall cause through its sublicensees to 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 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 includeapply 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, but not be limited toLICENSEE (itself or through its AFFILIATES or SUBLICENSEES) agrees to reach the following commercialization and research and development milestones for a LICENSED PRODUCT and/or LICENSED PROCESS (together the “MILESTONES”) by the following dates:
(ia) 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[***].
(b) [***].
(c) [***].
(d) [***];
(iie) Initiation of a first Phase II clinical trial of a first Licensed Product within […***…] of the Agreement Date];
(iiif) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…]. For the purposes of this Agreement, [***] of the Agreement Date; andshall mean that date upon which [***] [***].
(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 5.3 LICENSEE shall notify MICHIGAN within [***] days after each MILESTONE deadline date above, as LICENSEE employs for comparable products and services marketed by LICENSEEto whether or not such MILESTONE was met. Timely achievement of the foregoing items (i-iv) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM MICHIGAN 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), 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) because the event 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 safety or efficacy reason not to perform one or more of the steps necessary to allow the achievement of such MILESTONE, then LICENSEE can demonstrate will promptly consult with MICHIGAN with respect to BCM such determination, and the parties hereto will in good faith determine whether changes to the MILESTONES and related deadlines are appropriate, and if MICHIGAN agrees, at its commercially reasonable efforts sole discretion, that such changes are appropriate, the parties will execute and deliver a written confirmation of such changes to the MILESTONES and related deadlines within [***] (with reasonable supporting documentation[***]) days of the original notification by LICENSEE to fulfill items 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 extensions are a result of causes beyond LICENSEE’s direct control or any inaction of the FDA or foreign equivalent and (ii) and (iii) above, LICENSEE and BCM will negotiate in good faith have the right to extend the deadline of any MILESTONE for 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 period of […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, after the scheduled deadline for such MILESTONE without MICHIGAN’s approval (“MILESTONE EXTENSION”) upon the […***…] dollars ($by LICENSEE to MICHIGAN, within […***…] US([***]) extension feedays 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.
5.4 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 shall itself use, or shall cause its sublicensees to 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 use commercially reasonable efforts shall includeto 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 reach the following commercialization and research and development milestones for the LICENSED PRODUCTS and LICENSED PROCESSES (together the “MILESTONES”) by the following dates:
1) Initiate communication with all Tier 1 (Largest - see Schedule 2) 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 be limited to:
(ithe very largest - see Schedule 3) 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 […with Category 1 products during ***…] of the Agreement Date;
(iii) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within […***…] **.
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 Agreement Date; and
(iv) The production effective date of the commercialized Licensed Products and the marketing and support of the commercialized Licensed Products with this agreement, LICENSEE will obtain at least a substantially similar level of effort **** new revenue-generating business relationship from among the Companies currently or prospectively identified as LICENSEE employs for comparable products and services marketed by LICENSEETier 1 or 2 Companies. Timely achievement of Additional royalties to MICHIGAN from such additional business under Section 3.1 (b) or (c) herein shall be at least ******** per year. In the foregoing items event that such business relationships do not generate at least ***** per year in additional royalties, the Annual Fee due MICHIGAN (i-ivas defined in Section 3.1 (d)) shall be deemed to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with increased by the development and commercialization of therapeutic products difference between ****** and the regulatory process required by royalty amount actually incurred.
5.3 LICENSEE must achieve the FDA MILESTONES on or before the deadline dates indicated. LICENSEE shall notify MICHIGAN within ten (and foreign regulatory authorities that are equivalent 10) days after each deadline as 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 whether such revisionMILESTONE was met. If LICENSEE anticipates that it will not fulfill a revised item fails to meet any MILESTONE under this Article continues for forty-five (ii45) or (iii)days after the date of any MILESTONE deadline, LICENSEE will be deemed to be in material breach of this Agreement, and MICHIGAN may obtain a […***…] extension of time terminate the Agreement as provided in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…***…] US) extension feesection 11.3.
Appears in 1 contract
Diligence. LICENSEE shall itself useAssembly agrees to use diligent efforts to develop, or shall cause 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 detail the progress achieved and any problems encountered in the development, evaluation, testing, manufacture, initial sale, and/or initial marketing of each Licensed Product. Upon reasonable request by IURTC, Assembly will consult with IURTC about tasks, schedules, and progress.
4.2 In partial satisfaction of its sublicensees to useobligations under this Article 4, commercially reasonable efforts, consistent with sound and reasonable business practices and judgment, to diligently proceed to introduce at least one Licensed Product into Assembly will achieve the following commercial market. Demonstration of such commercially reasonable efforts shall include, but not be limited togoals by the dates set forth below:
(i) 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 4.2.1 Preparation of a first Phase II clinical trial of a first Licensed Product preclinical development plan within […***…] three (3) months of the Agreement Effective Date;
(iii) Initiation 4.2.2 Preparation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product development plan within […***…] six (6) months of the Agreement Effective Date;
4.2.3 Negotiation of Series A financing of at least seven million dollars ($7,000,000) within twenty-four (24) months of the Effective Date; and
(iv) The production Assembly will provide IURTC with commercially reasonable evidence of Assembly’s achievement of each of the commercialized Licensed Products above-defined commercial goals within thirty (30) days after the corresponding date. 5 Financial Consideration:
5.1 Assembly will pay to IURTC a royalty on Net Sales by Assembly and the marketing and support of the commercialized Licensed Products with at least a substantially similar level of effort Sublicensees per calendar year as LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall be deemed follows: Net Sales Royalty Less than or equal to satisfy and fully discharge LICENSEE’s obligations under this Section 3. BCM recognizes that there are many uncertainties associated with the development and commercialization of therapeutic products and the regulatory process required by the FDA (and foreign regulatory authorities that are equivalent to the FDA). Accordingly, in the event that LICENSEE can demonstrate to BCM its commercially reasonable efforts (with reasonable supporting documentation) to fulfill items (ii) and (iii) above, LICENSEE and BCM will negotiate in good faith a reasonable revision to items (ii) and (iii) above; provided that BCM shall not unreasonably withhold such revision. If LICENSEE anticipates that it will not fulfill a revised item (ii) or (iii), LICENSEE may obtain a […***…] extension of time in which to achieve these milestones, by paying to BCM a one-time, […***…] dollars ($[…*]) 0.5 % Greater than [*] dollars ($[*…]) and up to [*] USdollars ($[*]) extension [*] % 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 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 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 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 [*]% * [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. If a Sublicense is part of a transaction in which Assembly also conveys rights to Supporting IP, then Assembly will propose in good faith by written notice to IURTC a basis for allocation of 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 reasonable detail the rationale for such allocation. If IURTC in its good faith, reasonable discretion agrees with the proposal, the amount payable to IURTC under this Section 5.3 with respect to Sublicensing Revenue received in connection with such transaction will be determined by the following equation:
Appears in 1 contract
Samples: Exclusive License Agreement (Assembly Biosciences, Inc.)
Diligence. 5.1 LICENSEE shall itself use, or shall cause its sublicensees to use, commercially reasonable efforts, consistent with sound use diligent 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 shall includeto (a) develop a program for exploiting the PATENT RIGHTS, but not be limited to:
(ib) Annual report provided bring LICENSED PRODUCTS to BCM describing LICENSEE’s or its sublicensees’ progress market and activities related (c) to research market throughout the life of this Agreement any and developmentall LICENSED PRODUCTS so developed and brought to market. LICENSEE has the responsibility to use diligent and [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, 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 WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK […***…], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] commercially reasonable efforts to obtain and retain any governmental approvals necessary to manufacture, have manufactured, use, import, distribute and/or sell LICENSED PRODUCTS.
5.2 As part of the Agreement Date;diligence required by Paragraph 5.1, LICENSEE agrees to reach the following commercialization and research and development milestones for the LICENSED PRODUCTS (together the “MILESTONES”) by the following dates:
(iii1) Initiation of a first pivotal clinical trial and/or Phase III clinical trial of a first Licensed Product within By […***…] of LICENSEE will have [***].
2) By [***] LICENSEE will have [***].
3) By [***] LICENSEE will have [***].
5.3 LICENSEE must achieve each MILESTONE on or before the Agreement Date; and
deadline dates indicated and MICHIGAN shall have the sole right to determine that a MILESTONE has been reached, such determination not to be unreasonably withheld, conditioned or delayed. LICENSEE shall notify MICHIGAN within ten (iv10) The production of days after each such deadline as to whether or not such MILESTONE was met. Should LICENSEE fail to achieve the commercialized Licensed Products 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 marketing list and support of the commercialized Licensed Products with at least a substantially similar level of effort as timelines for MILESTONES (“MODIFIED MILESTONES”). If LICENSEE employs for comparable products and services marketed by LICENSEE. Timely achievement of the foregoing items (i-iv) shall cannot meet MODIFIED MILESTONES, LICENSEE will be deemed to satisfy be in material breach of this Agreement, and fully discharge LICENSEE’s obligations under MICHIGAN may terminate the Agreement effective on thirty (30) days notice, unless LICENSEE achieves the MILESTONE within this Section 3thirty-day period. BCM recognizes that there are many uncertainties associated with the development and commercialization of therapeutic products and the regulatory process required Notwithstanding, MICHIGAN may terminate this Agreement immediately if LICENSEE fails to achieve a MILESTONE by the FDA 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 (and foreign regulatory authorities that are equivalent to 9) years after 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) extension feeEffective Date.
Appears in 1 contract
Samples: License Agreement (MDRNA, Inc.)