Specific Diligence Requirements Sample Clauses
The Specific Diligence Requirements clause sets out particular actions or standards of investigation that a party must undertake before completing a transaction or agreement. This may include conducting background checks, reviewing financial records, or verifying compliance with legal and regulatory obligations. By clearly defining these requirements, the clause ensures that both parties understand their responsibilities and helps prevent disputes arising from inadequate due diligence.
Specific Diligence Requirements. Notwithstanding the generality of Section 4.8(a), the following shall be considered, without limitation, to represent a failure of Equillium to comply with Section 4.8(a):
(i) If, following Stage 2 Study Completion, Equillium fails either (A) within two (2) years to dose the first patient in a PoC Study, and/or (B) to use Commercially Reasonable Efforts to pursue clinical development of Product in at least one Indication for any continuous period greater than three (3) years (subject to extension as described below), Biocon shall have the right to terminate this Agreement in accordance with Section 10.2(b), subject to Section 10.2(c). The two-year and three-year periods in (A) and (B) above shall be extended to the extent of any delays directly attributable to events beyond the reasonable control of Equillium. By way of example and not of limitation, for purposes of this Section 4.8(b)(i), “events beyond the reasonable control of Equillium” include Biocon’s failure to supply Product in accordance with the Clinical Supply Agreement (except to the extent directly attributable to Equillium’s failure to comply with its obligations under the Clinical Supply Agreement), imposition of a clinical hold, Biocon’s failure or delay in performing its obligations under Article 4 that are a prerequisite for Equillium’s clinical development of Product, or delays in receiving required OFAC license(s). However, the foregoing two-year period in (A) and three-year period in (B) above shall not be extended by more than one (1) year in each case by reason of any and all events beyond the reasonable control of Equillium, unless, and only to the extent that, any such delay beyond three (3) years (in the case of (A)) and four (4) years (in the case of (B)) is directly attributable to Biocon’s failure to supply Product in accordance with the Clinical Supply Agreement (except to the extent directly attributable to Equillium’s failure to comply with its obligations thereunder) or Biocon’s failure or delay in performing its obligations under Article 4 that are a prerequisite for Equillium’s clinical development of Product. This Section 4.8(b)(i) and Biocon’s rights hereunder shall automatically terminate and be of no further force or effect upon First US Approval.
(ii) If Equillium has not completed one PoC Study of Product in an Indication that is not an Orphan Indication by the seventh (7th) anniversary of Stage 2 Study Completion (subject to extension as described below), then the ...
Specific Diligence Requirements. If Anthera or its Affiliates or sublicensees do not [***] for a Licensed Product containing one of the Initial Compounds within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate Anthera’s license rights with respect to all Licensed Products containing any Initial Compound in accordance with Section 9.2(b). For example, if Anthera [***] of a Licensed Product containing RSC-3388 within [***] after the Effective Date, Anthera shall be deemed to have satisfied the foregoing diligence obligation and shall retain its license rights with respect to Licensed Products containing any of RSC-3388, S-5920/LY315920 or S-3013/LY333013. In addition, if Anthera fails to [***] for the first Licensed Product within [***] after the Effective Date, Shionogi and Lilly shall have the right to terminate this Agreement in accordance with Section 9.2(b). 4.6
Specific Diligence Requirements. 5.4.1. Overall Development.
(a) ▇▇▇▇▇▇ shall commence Clinical Trials for at least [*] clinical indications in the Field for NEUPREX within [*] years of the Effective Date and shall continue to conduct Clinical Trials of [*] or more Products in at least [*] clinical indications continuously thereafter for a period of at least [*] years following the Effective Date or, if earlier, until [*] or more Products have received Regulatory Approval for a total of [*] different label claims (one of which may be Meningococcemia) from either the FDA or the CEU (e.g., [*] from the FDA and [*] from the CEU).
(b) In the event ▇▇▇▇▇▇ fails to comply with its obligation in Section 5.4.1
(a) as a result of a Clinical Trial being stopped due to safety concerns, lack of efficacy or other unanticipated circumstances, XOMA Ireland may, at its option, notify ▇▇▇▇▇▇ in writing of its intent to terminate the licenses granted to ▇▇▇▇▇▇ under this Agreement. ▇▇▇▇▇▇ shall have (i) [*] to develop and submit to XOMA Ireland in writing a plan (the "Clinical Plan") describing the steps ▇▇▇▇▇▇ intends to take to cure such non-compliance, including a specific time period following submission of the Clinical Plan to XOMA Ireland for commencing one or more additional Clinical Trials and (ii) [*] to commence such Clinical Trial(s) and cure such non-compliance; provided that [*]. In the event such Clinical Trial(s) are not commenced and such compliance is not cured within the time period set forth in the Clinical Plan, the last sentence of Section 5.3 shall apply.
(c) In the event ▇▇▇▇▇▇ fails to comply with its obligation in Section 5.4.1(a) as a result of a Clinical Plan ending (that is, patient follow-up being completed) in the ordinary course of the conduct of such trial, ▇▇▇▇▇▇ shall have a period of (i) [*] to commence the next Clinical Trial of such Product in such indication or file an IND thereby commencing, for purposes hereof, an additional Clinical Trial of a Product in another indication or (ii) [*] to file an IND thereby commencing, for purposes hereof, an additional Clinical Trial of a Product in another indication, before XOMA Ireland shall have the right to terminate the licenses granted hereunder. In the event of any such termination, the last sentence of Section 5.3 shall apply.
Specific Diligence Requirements. NTI shall, either on its own or through its Affiliates or Sublicensees, (a)* * * within * * * after the termination or expiration of the Research Program Term, (b) * * * within * * * after the termination or expiration of the Research Program Term, (c) * * * within * * * after the termination or expiration of the Research Program Term, and (d) * * * within * * * after the termination or expiration of the Research Program Term.
Specific Diligence Requirements. Licensee shall comply with the requirements set forth in Exhibit G and Exhibit H hereto, and in the event of noncompliance thereof, HGEN may, at its option pursuant to Exhibit G, terminate this Agreement pursuant to Section 13.2.
Specific Diligence Requirements. Pursuant to Section 6.4(c) of the Agreement, HGEN may terminate the Agreement pursuant to Section 13.2 if Licensee does not comply with any of the following requirements: