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

  • Honduras: Latest Political Reforms Leave Critical Matters Still Unresolved,” Latin American Regional Report: Caribbean & Central America, February 2019.

  • Data regarding representative exchange rates, the consumer price index, and their rates of change are set out below: Rate of change 2012201120102012 Accounting Policies on Critical Matters and Critical Accounting EstimatesWorldReginfo - f5fe760c-cdf6-43cc-95f4-ba6e66f9c662The financial statements of the Bank are prepared in accordance with accounting principles and rules, the main points of which are described in Note 1 to the Financial Statements.

  • 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.

  • 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.

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

  • Critical Matters to be Audited The Bank is of the view that the following matters are important to the proper maintenance and reporting of its financial accounts.

  • 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, [***].

  • These objectives will remain mere pipe dreams as long as the North continues to use the WTO and allied institutions as instruments of trade and financial imperialism against the South.B. Critical Matters to be AddressedThe present writer believes that the WTO might be able to realize parts of its visions if it changes its methodology for delivery and if, more especially, it allows developing countries, which form two-thirds of its current membership, to have a sense of ownership in the free trade agenda.

  • This is, in a way, a study of Flann’s characterisation, although it goes beyond his conventional appearances as a character within literary texts to include his role as texts’ author-209 Erich Poppe, On Cycles and Other Critical Matters: Some Issues in Medieval Irish Literary History and Criticism, Quiggin Memorial Lectures 9 (Cambridge: ASNaC 2008).figure and his appearances in attributional or prefatial apparatus.

  • Government Gazette No.41613 published on 7 May 2018.6.5.5 Repositioning the Relationship between Parliament and the In- dependent Communications Authority of South Africa: Implica- tions and Critical Matters for the Sixth ParliamentIn terms of section 15(1) of the ICASA Act, the Authority is financed from funds received from National Treasury.


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.

  • transitional matter means a matter that needs to be dealt with for the purpose of effecting the transition from the provisions of the Acts amended by this Act as in force before this Act comes into operation to the provisions of those Acts as in force after this Act comes into operation.

  • staff matters means the remuneration, conditions of service, promotion, conduct, suspension, dismissal or retirement of staff;

  • 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.

  • Academic and professional matters means the following policy development and implementation matters:

  • Critical control point means a point, step, or procedure in a food proc- ess at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels.

  • 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.”

  • Serious Medical Condition means all of the following medical conditions:

  • 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.

  • Critical group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.

  • 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.

  • Clinical experience means providing direct services to individuals with mental illness or the provision of direct geriatric services or special education services. Experience may include supervised internships, practicums, and field experience.

  • Debilitating medical condition means one or more of the following:

  • Qualifying medical condition means seizure disorder,

  • Complex or chronic medical condition means a physical,

  • 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.

  • Pre-existing Medical Condition means any condition which:

  • 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 recent onset and sufficient severity (including severe pain), such that a prudent layperson, who possesses an average knowledge of health and medicine, could reasonably expect the absence of immediate medical care could result in: