Significant Deviation definition

Significant Deviation shall have the meaning set forth in Section 4.3(c) hereof.

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Significant Deviation means any deviation: (i) resulting in an immediate or probable wide-ranging impact on GMP products, processes or systems in any facility where activities are conducted pursuant to this Agreement, (ii) which could result in significant Product safety or efficacy risks (e.g., sterility failure or data integrity issues), (iii) which would require notification to a regulatory authority, or (iv) which would otherwise be considered by reasonable quality assurance professionals to be significant.

Significant Deviation means an omission, alteration or relocation of an erosion or

Examples of Significant Deviation in a sentence

• Any Expense which shall exceed its prescribed Budget shall solely be the responsibility of the party incurring it unless such expense is required to implement an approved Significant Deviation from the Annual Business Plan or is necessary to support sales orders above budgeted sales pursuant to sales programs contemplated by the Annual Business Plan.

• AstraZeneca hereby agrees and acknowledges that, upon any delivery of osimertinib by or on behalf of AstraZeneca or its Affiliate to ▇▇▇▇▇▇▇▇▇ or its Affiliate, such osimertinib will not have a Significant Deviation (as defined in the Supply Agreement) or fail to meet Specification (as defined in the Supply Agreement).

• In the event of a dispute regarding whether any Product meets the Specifications or otherwise has a Significant Deviation, Perrigo shall submit a sample of such Product to a mutually acceptable independent laboratory for testing and the test results obtained by such laboratory shall be final and controlling.

• Supplier will notify Perrigo within two (2) business days of learning and/or receiving notice, whether before or after delivery of the affected Product to Perrigo, that any Product contains a Significant Deviation, foreign material, contaminant, defect or latent defect, Supplier will thoroughly investigate and document all such events.

• In the event the test results indicate that Product in question does meet the Specifications and does not have a Significant Deviation, Perrigo shall pay all additional shipping and transportation costs for such Product.

More Definitions of Significant Deviation

Significant Deviation has the meaning set forth in Attachment B of this QUALITY AGREEMENT.

Significant Deviation means a material variance from the Project Proposal, in so far as the contribution of the Subgrantee is concerned, which might affect the objectives of the Project or the adequate use of the Subgrant, regardless of the cause, e.g. changes in outcome and/or output level, changes to the respective indicators or to crucial activities.

Significant Deviation means any material non-conformity from established requirements as provided in the applicable product registration, applicable validation and/or qualification documents as well as applicable Batch production records and associated procedures, methods and Specifications.

Significant Deviation means: (i) any specification that either falls outside the Approved Package or that cannot be defined because the Approved Package lacks the required information, and whose extrapolation cannot be made, in a straightforward fashion, by means of Foreground or Background. Significant Deviation consists, among others, in : • [***] • Changes in Propanol specification • Changes in safety philosophy Significant Deviation does not include minor changes that are linked to (a) overall performance optimization as a result of the integration of the PFT in existing facilities, (b) lay-out or (c) plot plan considerations. (ii) any and all deviation from HSE matters covered by the Approved Package; (iii) any and all freedom to operate matters not identified pursuant to Paragraphs 9.1 and 9.2.

Significant Deviation has the meaning set forth in the Contract Manufacturing Agreement.

Significant Deviation means: (i) any specification that either falls outside the Approved Package or that cannot be defined because the Approved Package lacks the required information, and whose extrapolation cannot be made, in a straightforward fashion, by means of Foreground or Background. Significant Deviation consists, among others, in : • Changes in microorganism • Changes in nutrient agent(s) that changes the microorganism performance by at least [***]% • Change in reactor concept and/or technology • Change in volumetric productivity of the reactor by at least [***]% • Changes in distillation technology (packing vs trays, operating conditions that require other levels of utilities, etc) • Changes in Propanol specification • Changes in safety philosophy Significant Deviation does not include minor changes that are linked to (a) overall performance optimization as a result of the integration of the PFT in existing facilities, (b) lay-out or (c) plot plan considerations. (ii) any and all deviation from HSE matters covered by the Approved Package; [***] Indicates that text has been omitted which is the subject of a confidential treatment request. The text has been separately filed with the Securities and Exchange Commission. (iii) any and all freedom to operate matters not identified pursuant to Paragraphs 9.1 and 9.2.

Significant Deviation and "material impact" shall mean a material variance from the Bank's strategic plan submitted pursuant to this Agreement, as the term "significant deviation" is further described in PPM 5400-9, Appendix B.