Critical Matters Clause Samples
Critical Matters. If the JSC is unable to reach consensus on any Critical Matter, the members of the JSC appointed by either Party will have the right to require that such issue be escalated to the Designated Officers for determination; provided that if, in the good faith determination of either Party, resolution of such Critical Matter requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on a Product or a Party or patients, (i) the members of the JSC appointed by BeiGene will have the right to make an interim decision pending Designated Officer determination if such matter is primarily related to Commercialization (including pricing that is above the Applicable Retail Baseline Price, promotion, marketing, market access and reimbursement) (subject to (ii) below and except as otherwise provided for under Section 5.6 (Promotional Materials)) or Distribution (except as otherwise provided for under Section 4.4 (Distribution) and Section 6.6 (Use of Affiliates and Third Party Contractors)) of the Products in the Collaboration Territory, (ii) the members of the JSC appointed by Amgen will have the right to make an interim decision pending Designated Officer determination if such matter is related to Manufacturing (including product quality), safety or compliance matters (including Quality and Compliance Standards and Applicable Law and compliance with any of the foregoing), (iii) the members of the JSC appointed by Amgen will have the right to make an interim decision pending Designated Officer determination if such matter is related to Development with respect to the Products in the Collaboration Territory and (iv) the members of the JSC appointed by BeiGene will have the right to make an interim decision pending Designated Officer determination if such matter is related to regulatory matters with respect to the Products in the Collaboration Territory, in each case so long as such decision is consistent with the applicable Commercialization Plan, Access and Pricing Plan, Commercialization Budget, Global Brand Plan, Global Development Plan and Global Development Budget.
Critical Matters. If the JSC is unable to reach consensus on any Critical Matter, the members of the JSC appointed by either Party will have the right to require that such issue be escalated to the Designated Officers for determination; provided that if, in the good faith determination of either Party, resolution of such Critical Matter requires exigent action pursuant to Applicable Law or to prevent a material adverse effect on the Development or Commercialization of the Product or patients, (a) Amgen will have the right to make an interim decision for an exigent action within the Amgen Territory and (b) KKC will have the right to make an interim decision for an exigent action within the KKC Territory, in each case pending such determination by the Designated Officers; provided further, that prior to making any such exigent actions, each Party shall use reasonable efforts, if possible in a reasonable time-frame determined by the Party with the right to make such interim decision, to: (a) notify the other Party of the need for such exigent action; (b) solicit the other Party’s feedback (and the other Party shall reasonably cooperate to provide such feedback within the time -frame required by the Party with the right to make such interim decision on an accelerated basis) and (c) subject to the other Party providing feedback within the required time -frame, consider such feedback in good faith when taking such exigent action.
Critical Matters. 13.1. Neither the Board of Directors nor the Partners may pass any resolution or take any action relating to a Critical Matter unless such Critical Matter has been approved by unanimous Resolution.
13.2. For the purposes of this Agreement, a "Critical Matter" shall be any of the following:
(a) the allotment of unissued shares in the Agent, the alteration or variation of rights attaching to any issued or unissued shares of the Agent or the creation or issue of options over or securities convertible into shares in the Agent;
(b) any increase or reduction of the authorised share capital of the Agent;
(c) the merger of the Business with that of any other entity, the acquisition of any interest in any company or business, the establishment of any new business, or any material alteration in the nature and or direction of the Project conducted by the Partnership;
(d) other than for full value and in the ordinary course of business, the transfer, sale or surrender of any asset of the Business having a book or market value, whichever is the greater, in excess of $10,000;
(e) other than in the ordinary course of business, the grant of any mortgage, charge or other security interest over any assets of or undertaking of the Partnership;
(f) the adoption by the Board of Directors of any distribution policy that differs from that policy described in clause 8 (as amended from time to time by agreement between the parties) and any distribution or decision not too make a distribution which, in either case, is different from the agreed distribution policy;
(g) the borrowing of any amounts;
(h) any expenditure by the Agent or agreement to expend amounts or any agreement to incur any liability, contingent or otherwise, aggregating in excess of $10,000 in any one financial year of the Partnership and not provided for in the budget for that financial year;
(i) any proposal to cease to carry on the business or a substantial part of the business of the Partnership or to wind up or dissolve the Partnership or to take advantage of any law providing for the relief of debtors in adverse financial circumstances;
(j) the delegation of any powers of the Board of Directors to any person;
(k) the entering into of any agreement or arrangement between the Board of Directors or the Agent and any of the parties to this agreement or their associates or any third party not at arm's length with any of them or any agreement or arrangement made other than in the normal course of the business of th...