Specific Diligence Obligations. Without limiting the generality of Sections 8.1 and 8.2, Artelo shall:
(a) Submit to NEOMED, within [***] following the delivery of the Option Exercise Notice, a certification supported by reasonable documentation, that Artelo, its Affiliates and sublicensees (or any combination thereof) control sufficient resources to maintain the performance of the obligations under this Section 8.2;
(b) Use Commercially Reasonable Efforts to initiate, directly or through its Affiliates or sublicensees, a Phase II Clinical Study for a Product within [***] following the delivery of the Option Exercise Notice; and
(c) Use Commercially Reasonable Efforts to initiate, directly or through its Affiliates or sublicensees, a Phase III Clinical Study for a Product within [***] following the delivery of the Option Exercise Notice.
Specific Diligence Obligations. (a) Acorda shall, either through its own efforts and/or those of its Affiliates or sublicensees, use commercially reasonable efforts to develop and commercialize Licensed Products by performing the following actions (each, a “Diligence Milestone”):
(i) within [***] years of the Effective Date, file an IND for a Licensed Product;
(ii) within [***] years of the Effective Date, initiate a Phase I Clinical Trial for a Licensed Product; and
(iii) within [***] years of the Effective Date, file a New Drug Application with the FDA in the U.S. for a Licensed Product. Acorda shall provide written notice to the Institutions within thirty (30) days after it achieves a Diligence Milestone, such notice specifying the Diligence Milestone achieved.
(b) Acorda shall send to the Institutions within thirty (30) days of each calendar anniversary of the Effective Date an updated written development plan covering as a minimum the twelve (12) calendar months preceding the calendar anniversary and the twelve (12) calendar months following it. The report shall be in the form of Schedule 1 Part C and shall show:
(i) the projected and actual dates of first commericial sale;
(ii) milestone progression (dates for projected and achieved milestones); and
(iii) all past, current and projected activities taken or to be taken by Acorda and/or its Affiliates and their sublicensees to bring Licensed Products to market and maximize the sale of Licensed Products in the Licensed Territory. The Institution’s receipt or approval of any such plan shall not be taken to waive or qualify Acorda’s obligations under this Section 5.4
(c) If Acorda does not in a timely manner meet a Diligence Milestone set forth in Section 5.4(a), but Acorda provides to Institutions written evidence that it has used commercially reasonable efforts to meet such Diligence Milestone, then Institutions and Acorda shall negotiate in good faith for sixty (60) days after the applicable Diligence Milestone due date and agree upon a reasonable extension for such Diligence Milestone; provided that the period of such extension shall be between one (1) year and three (3) years. Additional extensions to the same Diligence Milestone (and correlatively, extensions to subsequent Diligence Milestones, as applicable) may be negotiated by the Parties in accordance with this Section 5.4(c), if necessary, based upon the progress that has been made by Acorda to meet the unmet Diligence Milestone.
(d) If Acorda does not in a timely manner meet...
Specific Diligence Obligations. In addition to TMC’s general development diligence requirements set forth above, and in no way limiting them, at all times during the period of time beginning with the Effective Date and ending on the date of the First Sale of the second Product to be Commercialized, TMC will have at least two Products in a combination of Active Early Development and/or Active Clinical Development (it being understood that this obligation will be satisfied if TMC has (i) two or more Products in Active Early Development, (ii) two or more Products in Active Clinical Development, or (iii) one Product in Active Early Development and one Product in Active Clinical Development); provided, however, TMC will not be deemed to be in breach of this specific diligence obligation if TMC encounters an adverse technical, clinical or other condition/event regarding a particular Product (and not a condition/event that applies generally to TMC) which, in TMC’s reasonable judgment, requires the termination or suspension of development work on such particular Product, so long as TMC is engaged in Active Early Development on at least one additional Product within 6 months following the date TMC terminates or suspends such development program.
Specific Diligence Obligations. During the Term, ELAN shall use Commercially Reasonable Efforts (i) to Develop at [***] Clinical Candidate targeted at IL-23 and to Commercialize [***]IL-23 Product for each Diligence Indication in the United States and a Major Market Country, and (ii) to Develop [***]Clinical Candidate targeted at each Program Target other than IL-23 and to Commercialize [***]Collaboration Product for each active Program Target other than IL-23 in the United States and a Major Market Country.
Specific Diligence Obligations. Without limiting the generality of the provision of Section 3.1.2 above, Ophthotech hereby agrees that it will:
(i) file an [***] for a Licensed Product for an [***] within [***] within [***] years of the Effective Date;
(ii) complete a [***] of a Licensed Product for an [***] within [***] within [***] years of the Effective Date; and
(iii) complete a [***] of a Licensed Product for an [***] within [***] within [***] years of the Effective Date.
Specific Diligence Obligations. Without limiting Clause 3.2.2, RPT shall achieve:
(a) The Milestone Event outlined in Milestone Number 1 in any country in the Territory by December 31 2024;
(b) The Milestone Event outlined in Milestone Number 2 by 30 September 2025; and
(c) The Milestone Event outlined in Milestone Number 3 by 30 September 2027. RPT may request in writing that Diaprost consent to revise the date by which each of the milestones described in paragraphs (a), (b) and (c) ought to be attained (Deadline Date) if supported by evidence of technical difficulties or delays in pre-clinical, clinical studies or regulatory processes that are outside of RPT’s reasonable control, including, but not limited to, any delay that would result (a) from emerging safety issues causing the clinical program to be put on hold by a regulatory agency or sponsor and/or mandate before further preclinical works be conducted, (b) from a poor pharmacokinetic or pharmacodynamic profile or efficacy in man that would require further formulation or preclinical development to be conducted, (c) from any administrative issues in preclinical or clinical trial conduct (e.g. contract research or manufacturing organization failing to deliver work in due time, delays in patient recruitments), or (d) from preclinical or clinical findings requiring further investigations to be conducted. Diaprost will discuss any such request in good faith and will not unreasonably deny a request for appropriate extension provided that sufficient objective evidence of the nature set forth above is provided. If RPT fails to achieve the Milestone Events in (a), (b) or (c) above by, or on, the corresponding dates listed above, it may nonetheless elect to make the corresponding Milestone Payment. If RPT does not make such payment, by, or on, the corresponding dates listed above, and Diaprost does not agree to extend the timeframe for the relevant Milestone Event in (a), (b), or (c) above by the dates on which they are due, Diaprost may terminate this Agreement in its entirety in respect of all Parties immediately on written notice to RPT.
Specific Diligence Obligations. Without limiting the generality of the provision of Section 3.1.2 above, Oral DNA hereby agrees that it will: (i) complete the Initial Marketing Activities on or before six (6) months from the Effective Date; (ii) achieve a First Commercial Sale within one hundred twenty (120) days from the Effective Date; (iii) commencing on the sixth Calendar Month following the Effective Date and continuing thereafter, make substantially the same volume of sales calls as made for its primary testing services; and (iv) conduct at least one (1) lecture per Calendar Quarter through one or more members of its management team or scientific advisory board (or such other individual as may be reasonably acceptable to ILI) that discusses the importance of genetic susceptibility in regard to the PST® Genetic Risk Assessment Test and periodontal disease. In the event that Oral DNA fails to use Commercially Reasonable Efforts in complying with its diligence obligations under Sections 3.1.3(a) or (b), then, subject to Section 3.1.3(c), ILI may terminate this Agreement pursuant to Section 7.2.2.
Specific Diligence Obligations. (a) Acorda shall, either through it own efforts and/or those of its Affiliates or sublicensees, use commercially reasonable efforts to develop and commercialize Licensed Products by performing the following actions (each, a “Diligence Milestone”):
i. within [*****] of acceptance by the FDA of an IND for a Licensed Product, initiate a Phase I Clinical Study for a Licensed Product;
ii. within [*****] of the successful completion of the final Phase III Clinical Trial, file a New Drug Application with the FDA in the U.S. for a Licensed Product 5. The term “successful completion”, as defined in the last sentence Article 3.6, shall be amended as follows: As used in this Articles 3.6 and 5.4, “successful completion” of a Clinical Trial shall mean the achievement of statistical significance in respect of the primary endpoint(s) of the Clinical Trial, or achievement of statistical significance in respect of the secondary endpoint(s) of the Clinical Trial following which Acorda continues clinical development with a further Clinical Trial of later phase.
Specific Diligence Obligations. [Note: To be negotiated.]
Specific Diligence Obligations. Without limiting the generality of the provision of Section 3.1.2(a) above, Ribomic hereby agrees that it will achieve the specific milestones set forth in Schedule 2 attached hereto within the timelines set forth on such Schedule 2 (such obligations, the “Specific Diligence Obligations”). In the event that Ribomic fails to meet any of the Specific Diligence Obligations set forth in this Section 3.1.2(b) within the applicable timeline, but is otherwise in compliance with the provisions of Section 3.1.2(a) during the applicable diligence period specified above, then Archemix and Ribomic will negotiate in good faith an extension of the applicable milestone deadline for a period not to exceed [***] days from the applicable deadline date. If the Parties are unable to agree on such an extension within such negotiation period, then on a Licensed Product-by-Licensed Product and country-by-country basis as to such Licensed Product in such country and, with respect to any E5 Country, in all of the E5 Countries, (i) Archemix may, in its sole discretion (A) terminate the licenses granted under Section 2.1.1 of this Agreement for breach under Section 9.2.3 below or (B) convert the licenses granted under Section 2.1.1 of this Agreement from exclusive licenses to non-exclusive licenses, in either case only as such licenses apply to such Licensed Product in such country(ies) and, with respect to any E5 Country, in all of the E5 Countries, and (ii) to the extent Archemix exercises its rights under Section 3.1.2(b)(i)(A) or (B) with respect to a Licensed Product, Archemix’s exclusivity obligations under Section 2.3.1(a) shall terminate with respect to such Licensed Product in such country(ies). Archemix may waive any specific milestone diligence requirement on a case by base basis.
