Regulatory Cause definition

Regulatory Cause means a delay in the completion of a regulatory stage Development Milestone that is directly caused by the FDA or another Regulatory Authority either (a) putting a clinical hold on a Clinical Study involving a Licensed Product that Erasca or a Sublicensee is developing pursuant to this Agreement, or (b) requiring additional data relating to a Licensed Product that Erasca or a Sublicensee is developing pursuant to this Agreement was outside that agreed upon with the Regulatory Authority in any meeting with such Regulatory Authority in anticipation of such Clinical Study in a material or significant respect and is based on Regulatory Authority guidelines or regulations and such guidelines or regulations were only implemented after Initiation of a human Clinical Study for such Licensed Product, provided, however, that with respect to (a)-(b), (i) such delay came to exist despite Erasca’s (or a Sublicensee’s) use of Commercially Reasonable Efforts to avoid such delay, (ii) such delay is not due in any material respect to Erasca’s (or a Sublicensee’s) actions or inactions that were counter to the guidance provided to Erasca (or a Sublicensee) or otherwise published by the Regulatory Authority, and (iii) such delay is not due in any material respect to Erasca’s (or a Sublicensee’s) failure to provide data to the Regulatory Authority in a form, amount and quality commonly used by companies of comparable resources and capabilities in the biotechnology industry or to undertake preclinical and clinical development in a form and of a quality that would be commonly used in the pharmaceutical industry.
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Regulatory Cause means a delay in the completion of a regulatory stage Development Milestone that is directly caused by the FDA (or other applicable regulatory authority) either (a) putting a clinical hold on a clinical study involving a Licensed Product that Licensee or Sublicensee is developing pursuant to this Agreement, or (b) requiring additional data relating to a Licensed Product that Licensee or a Sublicensee is developing pursuant to this Agreement was outside that agreed upon with the FDA (or other applicable regulatory authority) in any pre-submission meeting in a material or significant respect and is based on FDA (or other applicable regulatory authority) guidelines or regulations and such guidelines or regulations were only implemented after initiation of a human clinical trial for such Licensed Product, provided, however, that with respect to (a)-(b), (i) such delay came to exist despite Licensee’s use of Commercially Reasonable Efforts to avoid such delay, (ii) such delay is not due in any material respect to Licensee’s actions or inactions that were counter to the guidance provided to Licensee or otherwise published by the FDA (or other applicable regulatory authority), and (iii) such delay is not due in any material respect to Licensee’s failure to provide data to the FDA (or other applicable regulatory authority) in a form, amount and quality commonly used in the pharmaceutical industry or to undertake preclinical and clinical development in a form and of a quality that would be commonly used in the pharmaceutical industry.
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Regulatory Cause means the existence of regulatory, safety, technical, scientific, efficacy or other circumstances outside the reasonable control of a Party or its Affiliates, including without limitation difficulties associated with patient enrollment, that inhibit or preclude one or more of the steps necessary to allow the achievement of a particular obligation of such Party under this Agreement.
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Examples of Regulatory Cause in a sentence

  • Licensee shall be granted an additional [***] provided that Licensee provides to University documentation outlining its efforts and supporting the diligence of such efforts to resolve the Regulatory Cause.

  • For clarity, Licensee would continue to engage in good faith efforts to resolve the Regulatory Cause during these extensions.

  • Upon University’s request, Licensee would provide further details so University has a good understanding of the Regulatory Cause.

Related to Regulatory Cause

  • Regulatory Capital Event means the good faith determination by the Company that, as a result of (i) any amendment to, clarification of, or change in, the laws or regulations of the United States or any political subdivision of or in the United States that is enacted or becomes effective after the initial issuance of any share of the Series A Preferred Stock, (ii) any proposed change in those laws or regulations that is announced or becomes effective after the initial issuance of any share of the Series A Preferred Stock, or (iii) any official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws or regulations or policies with respect thereto that is announced after the initial issuance of any share of the Series A Preferred Stock, there is more than an insubstantial risk that the Company will not be entitled to treat the full liquidation preference amount of $25,000 per share of the Series A Preferred Stock then outstanding as “tier 1 capital” (or its equivalent) for purposes of the capital adequacy guidelines of the Federal Reserve (or, as and if applicable, the capital adequacy guidelines or regulations of any successor Appropriate Federal Banking Agency) as then in effect and applicable, for so long as any share of the Series A Preferred Stock is outstanding.

  • Regulatory Capital means the capital requirement specified in Article 11;

  • Regulatory Change means, with respect to any Lender, any change after the date hereof in Federal, state or foreign law or regulations (including, without limitation, Regulation D) or the adoption or making after such date of any interpretation, directive or request applying to a class of banks including such Lender of or under any Federal, state or foreign law or regulations (whether or not having the force of law and whether or not failure to comply therewith would be unlawful) by any court or governmental or monetary authority charged with the interpretation or administration thereof.

  • Regulatory Capital Requirements means any applicable capital resources requirement or applicable overall financial adequacy rule required by the Relevant Regulator, as such requirements or rule are in force from time to time;

  • Regulatory Capital Treatment Event means the Corporation’s reasonable determination that as a result of any (i) amendment to, or change (including any announced prospective change) in, the laws or regulations of the United States or any political subdivision of or in the United States that is enacted or becomes effective after the initial issuance of any shares of Series N Preferred Stock; (ii) proposed change in those laws or regulations that is announced or becomes effective after the initial issuance of any shares of Series N Preferred Stock; or (iii) official administrative decision or judicial decision or administrative action or other official pronouncement interpreting or applying those laws or regulations that is announced after the initial issuance of any shares of Series N Preferred Stock, there is more than an insubstantial risk that the Corporation will not be entitled to treat the full liquidation preference amount of all shares of Series N Preferred Stock then outstanding as Tier 1 capital (or its equivalent) for purposes of the capital adequacy guidelines or regulations of the appropriate federal banking agency, as then in effect and applicable, for as long as any share of Series N Preferred Stock is outstanding.

  • Regulatory Conditions means the conditions set out in paragraphs 3.3 to 3.5 (inclusive) of Part A of Appendix I to the Announcement;

  • regulatory action level RBC means the product of 1.5 and its authorized control level RBC;

  • Change in 1940 Act Law shall have the meaning set forth in the definition of "Investment Company Event."

  • Nuclear Regulatory Commission (NRC) means the U.S. Nuclear Regulatory Commission or its duly authorized representatives.

  • Specific learning disability (SLD) means a heterogeneous group of conditions wherein there is a deficit in processing language, spoken or written, that may manifest itself as a difficulty to comprehend, speak, read, write, spell, or to do mathematical calculations and includes such conditions as perceptual disabilities, dyslexia, dysgraphia, dyscalculia, dyspraxia and developmental aphasia.

  • Regulatory Event means, following the occurrence of a Change in Law (as defined below) with respect to the Issuer and/or Société Générale as Guarantor or in any other capacity (including without limitation as hedging counterparty of the Issuer, market maker of the Certificates or direct or indirect shareholder or sponsor of the Issuer) or any of its affiliates involved in the issuer of the Certificates (hereafter the “Relevant Affiliates” and each of the Issuer, Société Générale and the Relevant Affiliates, a “Relevant Entity”) that, after the Certificates have been issued, (i) any Relevant Entity would incur a materially increased (as compared with circumstances existing prior to such event) amount of tax, duty, liability, penalty, expense, fee, cost or regulatory capital charge however defined or collateral requirements for performing its obligations under the Certificates or hedging the Issuer’s obligations under the Certificates, including, without limitation, due to clearing requirements of, or the absence of, clearing of the transactions entered into in connection with the issue of, or hedging the Issuer’s obligation under, the Certificates, (ii) it is or will become for any Relevant Entity impracticable, impossible (in each case, after using commercially reasonable efforts), unlawful, illegal or otherwise prohibited or contrary, in whole or in part, under any law, regulation, rule, judgement, order or directive of any governmental, administrative or judicial authority, or power, applicable to such Relevant Entity (a) to hold, acquire, issue, reissue, substitute, maintain, settle, or as the case may be, guarantee, the Certificates, (b) to acquire, hold, sponsor or dispose of any asset(s) (or any interest thereof) of any other transaction(s) such Relevant Entity may use in connection with the issue of the Certificates or to hedge the Issuer’s obligations under the Certificates,(c) to perform obligations in connection with, the Certificates or any contractual arrangement entered into between the Issuer and Société Générale or any Relevant Affiliate (including without limitation to hedge the Issuer’s obligations under the Certificates) or (d) to hold, acquire, maintain, increase, substitute or redeem all or a substantial part of its direct or indirect shareholding in the Issuer’s capital or the capital of any Relevant Affiliate or to directly or indirectly sponsor the Issuer or any Relevant Affiliate, or (iii) there is or may be a material adverse effect on a Relevant Entity in connection with the issue of the Certificates.

  • Regulatory Body means those government departments and regulatory, statutory and other entities, committees, ombudsmen and bodies which, whether under statute, rules, regulations, codes of practice or otherwise, are entitled to regulate or investigate the matters dealt with in this Agreement or any other affairs of the Provider or the Department, including, without limitation Ofsted, the European Commission and the European Court of Auditors;

  • Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.

  • Regulatory Problem means any set of facts or circumstance wherein it has been asserted by any governmental regulatory agency (or a Regulated Stockholder reasonably believes that there is a risk of such assertion) that such Regulated Stockholder is not entitled to acquire, own, hold or control, or exercise any significant right (including the right to vote) with respect to, any Equity Securities of the Company or any subsidiary of the Company.

  • DP Regulator means any governmental or regulatory body or authority with responsibility for monitoring or enforcing compliance with the Data Protection Laws;

  • specific learning disabilities means a heterogeneous group of conditions wherein there is a deficit in processing language, spoken or written, that may manifest itself as a difficulty to comprehend, speak, read, write, spell, or to do mathematical calculations and includes such conditions as perceptual disabilities, dyslexia, dysgraphia, dyscalculia, dyspraxia and developmental aphasia;

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Regulator means, with respect to any person, any Government Authority charged with regulating, supervising or examining such person and its Affiliates.

  • Termination for Just Cause means termination because of Executive’s personal dishonesty, incompetence, willful misconduct, breach of fiduciary duty involving personal profit, intentional failure to perform stated duties, willful violation of any law, rule or regulation (other than traffic violations or similar offenses) or final cease-and-desist order, or material breach of any provision of this Agreement.

  • Third Party Terminating Carrier means a Telecommunications Carrier to which traffic is terminated when CLEC originates traffic that is sent through AT&T-TSP’s network, i.e., CLEC is using AT&T-TSP’s Transit Traffic Service.

  • economic activity means putting goods or services on a market. It is not necessary to make a profit to be engaged in economic activity: if others in the market offer the same good or service, it is an economic activity.

  • Regulatory entity means any board, commission, agency,

  • Adverse employment action means an action that affects an em- ployee ’s compensation, promotion, transfer, work assignment, or performance evaluation, or any other employment action that would dissuade a reasonable employee from making or supporting a report of abuse or neglect under Family Code 261.101.

  • Anticipatory Termination means a termination of employment where PNC terminates your employment with PNC (other than for Misconduct or Disability) prior to the date on which a Change of Control occurs, and you reasonably demonstrated that such termination of employment (i) was at the request of a third party that has taken steps reasonably calculated to effect a Change of Control or (ii) otherwise arose in connection with or in anticipation of a Change of Control.

  • Material Change in Content means the occurrence since the Launch Date of a material change in the content, composition or constitution of the Futures Contract or the Commodity.

  • Material Change in Formula means the occurrence since the Launch Date of a material change in the formula for, or the method of, calculating the Reference Price.