Material Variations definition

Material Variations means a material variation, modification or change to the manufacturing-related information or Specifications approved by a Regulatory Authority for the Product, including but not limited to: (i) changing the manufacturer or adding a manufacturing site, (ii) changing the manufacturing process, (iii) changing the formulation of the Product, or (iv) changing the primary packaging.
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Examples of Material Variations in a sentence

  • Upon notification of a proposed Material Variation, the Parties shall in good faith discuss the proposed Material Variations through the JSC, with each Party considering other one’s reasonable input.

  • Notwithstanding the provisions of Clause 10.1 (Material Variations) or this Clause 10.2, on or after the occurrence of a Senior Event of Default, the Senior Agent and/or the Senior Lenders shall be entitled to agree to any amendment, supplement or novation to the Senior Documents without prejudicing the priority created thereby.

  • Material Variations includes but are not limited to the following: changes to the product labeling related to efficacy or safety, changing or adding a manufacturing site, adding a new manufacturing step, changing the formulation of the Product, changing the specification of the Product, changing the primary packaging, changing storage conditions, changing the API manufacturer, or changing of the manufacturing process.

  • LIABILITIES It is hereby understood that any breach of the provisions of Clause 10.1 (Material Variations) shall result in any increased principal amount of the Senior Liabilities being ranked, for all purposes of this Deed and the Security Documents, behind the Mezzanine Liabilities.

  • The costs of Material Variations in the Excluded Territory shall be borne by ArQule and in the Territory shall be borne by Basilea.

Related to Material Variations

  • Material Modifications means and include any modification to an existing RPTs, in aggregate with a related party, having variance of 25% in value of the transaction already approved by the Audit Committee or Board or Shareholders, as the case may be, or such modification as may be decided by the Audit Committee.

  • Material Project Documents means, collectively, the Power Purchase Agreement, the EPC Contract, the Transmission Facilities Construction Agreement, the O&M Agreement, the Coal Supply Agreements, the Coal Transportation Agreement and all other instruments, agreements or other documents arising from or related to the Project, but shall not include any Financing Agreement.

  • Material Permit shall have the meaning ascribed to such term in Section 3.1(n).

  • Material Deviation refers to any contents or characteristics of the proposal that is significantly different from an essential aspect or requirement of the RFP, and : (i) substantially alters the scope and quality of the requirements; (ii) limits the rights of UNDP and/or the obligations of the offeror; and (iii) adversely impacts the fairness and principles of the procurement process, such as those that compromise the competitive position of other offerors.

  • Material Modification means any modification to an Interconnection Request that has a material adverse effect on the cost or timing of Interconnection Studies related to, or any Network Upgrades or Local Upgrades needed to accommodate, any Interconnection Request with a later Queue Position.