Critical Matters definition

Critical Matters means (A) all decisions made by the CRC, JSC and JPTs that, in the reasonable opinion of either Party, are likely to have any of the following impacts: (i) [*] under a Development Plan or Brand Plan; (ii) a change to a Development Plan or Brand Plan that results in the lesser of (a) an increase of [*] or more (provided, that such amount is at least [*]) and (b) [*] or more, in each case, to the then-current budgeted amount of Development Costs and/or General Costs for any specific calendar year under the applicable Development Budget, Operations Budget or Commercialization Budget or the amounts estimated under Sections 7.2.1 (Partner Costs) and 7.2.2 (Amgen Costs); (iii) a change to a Development Plan or Brand Plan that results in a decrease of [*] (provided, that such amount is at least [*]) or more to the then-current budgeted amount of Development Costs and/or General Costs for any specific calendar year under the applicable Development Budget, Operations Budget or Commercialization Budget or the amounts estimated under Sections 7.2.1 (Partner Costs) and 7.2.2 (Amgen Costs); or (iv) a change to a Development Plan (including any plans with respect to a contemplated Regulatory Approval set forth therein) or Brand Plan that would, based upon [*], result in [*] of a Product for any specific calendar year under the applicable Development Plan or Brand Plan; (B) agreement of the initial Commercialization Budget for each Product; (C) agreement of the initial Brand Plan (or material updates thereto reflecting the launch of a new indication), Global Payer Plan and any Access and Pricing Plan for each Product; and (D) deadlocks with respect to the approval of an annual Development Budget, Operations Budget or Commercialization Budget as provided for under Section 7.7 (Budget Deadlocks).
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Critical Matters means, with respect to a decision of the Parties, JSC or JAC, (i) decisions that are likely to [*]; (ii) decisions that are likely to [*]; (iii) decisions with respect to the approval (or amendment) of [*] for each Product; (iv) decisions to approve [*] for each Product, [*] and any changes to [*]; and (v) decisions that are reasonably likely to [*] for any Product [*].
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Critical Matters means: (i) agreement of the initial versions of each of the [***], (ii) any material updates or changes to [***], (iii) decisions that would reasonably be expected to: [***], (iv) a decision to conduct [***] and (v) any material decision with respect to [***].
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Examples of Critical Matters in a sentence

  • Additionally, either Party may request a meeting of the CRC to resolve any Critical Matters requiring resolution.

  • For clarity, resolution of JRC matters pertaining or relating to Critical Matters shall require mutual agreement of the Executive Officers acting in compliance with applicable Law.

  • The CRC will be responsible for (i) providing general oversight of the collaboration; (ii) resolving any matters specifically designated to it under this Agreement; and (iii) resolving any Critical Matters escalated to it from the JSC.

  • Subject to the authority of the JPT with respect to Critical Matters and Joint Decision Matters, Company shall provide Amgen with the opportunity to review and comment on (i) each new version of the DCSI, IB, CDS, and DSUR; (ii) any Dear Investigator letter; and (iii) any response to a material regulatory safety query from a Regulatory Authority, in each case, prior to finalization and/or submission to a Regulatory Authority, and Company shall consider Amgen’s comments in good faith.

  • The following Critical Matters will be referred to Expedited Arbitration in accordance with Section 17.3.8 (Expedited Arbitration): [***].

  • With respect to any Critical Matters not referred to Expedited Arbitration in accordance with Section 9.7.3.1 (Referral to Expedited Arbitration), including all Candidate Category 1 Target Development Critical Matters, no changes will be adopted.

  • If a dispute (originating at either the USCT or the JUSLT) arises on a Critical Matter which cannot be resolved within the JUSLT within [*] Business Days following referral to the JUSLT, the Co-Chair of either Party may cause such dispute to be referred to the Alliance Managers for escalation to the JSC for Critical Matters that are strategic or scientific issues, or to the United States Senior Officers for all other Critical Matters (including budget or resource allocation issues).

  • All matters specifically addressed in Section 2.8.2 (Final Decision‑Making Authority; Non-Critical Matters) or 2.8.3 (Final Decision‑Making Authority; Critical Matters) (collectively “Committee Disputes”), will be treated as specified in Section 2.8.2 (Final Decision‑Making Authority; Non-Critical Matters) or 2.8.3 (Final Decision‑Making Authority; Critical Matters), as applicable, [***].

  • All such Critical Matters so escalated to the Executive Officers [*].

  • From the Initial Regulatory Filing Transfer Date until the CDM Regulatory Filing Transfer Date (if it occurs), as between the parties, subject to the authority of the JPT with respect to Critical Matters and Joint Decision Matters, Company shall permit and reasonably support cross-referencing from Company-owned Regulatory Filings to Regulatory Filings in respect of investigator sponsored studies in respect the Product, to which studies Company has no reasonable objection.


More Definitions of Critical Matters

Critical Matters means any decision of the Parties or any Committee: […***…].
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Related to Critical Matters

  • Legal Matters In the opinion of Xxxxxx Xxxxxxx, General Counsel of Prospect Administration, administrator for Prospect Capital Corporation, a Maryland corporation (the “Company”), the certificates evidencing the Notes (the “Note Certificates”) constitute the valid and binding obligations of the Company, entitled to the benefits of the Indenture and enforceable against the Company in accordance with their terms under the laws of the State of New York subject to applicable bankruptcy, insolvency and similar laws affecting creditors’ rights generally, concepts of reasonableness and equitable principles of general applicability (including, without limitation, concepts of good faith, fair dealing and the lack of bad faith), provided that such counsel expresses no opinion as to the effect of fraudulent conveyance, fraudulent transfer or similar provision of applicable law on the conclusions expressed above. This opinion is given as of the date hereof and is limited to the law of the State of New York as in effect on the date hereof. In addition, this opinion is subject to the same assumptions and qualifications stated in the letter of Skadden, Arps, Slate, Xxxxxxx & Xxxx, LLP dated March 8, 2012, filed as Exhibit (l)(5) to the Company’s registration statement on Form N-2 (File No. 333-176637) and to the further assumptions that (i) the Note Certificates have been duly authorized by all requisite corporate action on the part of the Company and duly executed by the Company under Maryland law, and (ii) they were duly authenticated by the Trustee and issued and delivered by the Company against payment therefor in accordance with the terms of the Amended and Restated Selling Agent Agreement and the Indenture. Capitalized terms used in this paragraph without definition have the meanings ascribed to them in the accompanying prospectus supplement. Prospect Capital Corporation 00 Xxxx 00xx Xxxxxx, 00xx Xxxxx Xxx Xxxx, Xxx Xxxx 00000 In the opinion of Xxxxxxx LLP, as Maryland counsel to the Company, (i) the execution and delivery by the Company of the Indenture, dated as of February 16, 2012, as supplemented through the One Hundred Ninety-Second Supplemental Indenture, between the Company and American Stock Transfer & Trust Company, the One Hundred Ninety-Third Supplemental Indenture, between the Company and American Stock Transfer & Trust Company, the One Hundred Ninety- Fourth Supplemental Indenture, between the Company and American Stock Transfer & Trust Company, the One Hundred Ninety-Fifth Supplemental Indenture, between the Company and American Stock Transfer & Trust Company, the One Hundred Ninety-Sixth Supplemental Indenture, between the Company and American Stock Transfer & Trust Company, and the global notes representing the Notes issued pursuant to each such Supplemental Indenture, and the performance by the Company of its obligations thereunder, have been duly authorized by the Company and (ii) the issuance of the Notes has been duly authorized by the Company. This opinion is given to the Company as of November 12, 2013 and is limited to the laws of the State of Maryland as in effect on November 12, 2013. In addition, this opinion is subject to the same assumptions, qualifications and limitations stated in the opinion letter to the Company of Xxxxxxx LLP, dated March 8, 2012, filed as Exhibit (l)(4) to the Company’s Registration Statement on Form N-2 (File No. 333- 176637). Capitalized terms used in this paragraph without definition have the meanings ascribed to them in the accompanying prospectus supplement. Very truly yours, /s/ Xxxxxxx LLP

  • Environmental Matters means any matter arising out of or relating to health and safety, or pollution or protection of the environment or workplace, including any of the foregoing relating to the presence, use, production, generation, handling, transport, treatment, storage, disposal, distribution, discharge, release, control or cleanup of any Hazardous Substance.

  • Environmental Matter means any past, present or future activity, event or circumstance in respect of the environment, health or safety including the Release of any Hazardous Substance including any substance which is hazardous to Persons, animals, plants, or which has a detrimental effect on the soil, air or water, or the generation, treatment, storage, use, manufacture, holding, collection, processing, treatment, presence, transportation or disposal of any Hazardous Substances.

  • Material Compliance Matter has the same meaning as the term defined in Rule 38a-1, and includes any compliance matter that involves: (1) a violation of the federal securities laws by Distributor (or its officers, directors, employees, or agents); (2) a violation of Distributor's Rule 38a-1 policies and procedures; or (3) a weakness in the design or implementation of Distributor's Rule 38a-1 policies and procedures.

  • Critical professional work means a cornerstone or fundamental decision, requiring the exercise of sound professional judgement of the effects of a decision within a particular professional field.

  • Critical habitat means habitat areas with which endangered, threatened, sensitive or monitored plant, fish, or wildlife species have a primary association (e.g., feeding, breeding, rearing of young, migrating). Such areas are identified herein with reference to lists, categories, and definitions promulgated by the Washington Department of Fish and Wildlife as identified in WAC 232-12-011 or 232-12-014; in the Priority Habitat and Species (PHS) program of the Department of Fish and Wildlife; or by rules and regulations adopted by the U.S. Fish and Wildlife Service, National Marine Fisheries Service, or other agency with jurisdiction for such designations. See also “Habitat of special significance.”

  • Critical Path means those Trade Contractor Work activities identified on the Construction Schedule which, if delayed, will cause a corresponding Delay in the Substantial Completion Date.

  • Excluded Matters shall have the meaning given such term in Section 13.3 hereof.

  • ABS Informational and Computational Material means any written communication as defined in Item 1101(a) of Regulation AB under the 1933 Act and the 1934 Act, as may be amended from time to time.

  • Business Critical means any function identified in any Statement of Work as Business Critical.

  • Critical Illness means an illness, sickness or disease or corrective measure as specified in Section 6 of this policy document.

  • Least developed country construction material means a construction material that—

  • Disclosed Matters means the actions, suits and proceedings and the environmental matters disclosed in Schedule 3.06.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Emergency medical condition means a medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) so that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical attention to result in a condition described in clause (i), (ii), or (iii) of section 1867(e)(1)(A) of the Social Security Act (42 U.S.C. 1395dd(e)(1)(A)). In that provision of the Social Security Act, clause (i) refers to placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; clause (ii) refers to serious impairment to bodily functions; and clause (iii) refers to serious dysfunction of any bodily organ or part.