Reprocessing and Reworking Sample Clauses

Reprocessing and Reworking. 5.3.1 Prior to any Product batch being reprocessed or reworked, SurModics must obtain approval of the GNE Quality Unit in advance. Reprocessing and reworking are considered Significant Deviations and shall be handled in accordance to Section 7.2. [*] 5.3.2 [*]
AutoNDA by SimpleDocs
Reprocessing and Reworking. If either Ophthotech or Agilent determines that reprocessing or reworking of the GMP API is necessary due to OOS, manufacturing deviation, unmet Specifications, or otherwise, the procedure will be documented and approved by Agilent Chemical Development, Agilent Manufacturing, Agilent QA and Ophthotech QA, provided that Agilent shall not reprocess or rework the GMP API without the prior written consent of Ophthotech.
Reprocessing and Reworking. A. CELGENE will work with SIEGFRIED to support any reprocessing and reworking procedures as allowed by cGMP, and to support any required filing(s), if required. Product will not be reworked without prior notification to CELGENE.
Reprocessing and Reworking. Reprocessing or reworking of the API or any other intermediates in the GMP stages of the manufacturing process is not allowed under this Quality Agreement.
Reprocessing and Reworking. If requested by , a reprocessing procedure is permitted according to ICH Guidelines , Chapter 14.2 and any other applicable local regulation. Reworking must be performed, if at all, according to the SUBSTANCE (s) registration documents, if it is part of the dossier, or according to ICH Q7, chapter 14.3 and any other applicable local regulation. CMS should be informed of such batches/lots.

Related to Reprocessing and Reworking

  • Subprocessing The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the subprocessor which imposes the same obligations on the subprocessor as are imposed on the data importer under the Clauses. Where the subprocessor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the subprocessor's obligations under such agreement.

  • Processing operations The personal data transferred will be subject to the following basic processing activities (please specify):

  • Skidding and Yarding Methods of skid- ding or yarding specified for particular areas, if any, are indicated on Sale Area Map. Outside Clearcutting Units and construction clearings, insofar as ground conditions permit, products shall not be skidded against reserve trees or groups of reproduction and tractors shall be equipped with a winch to facilitate skidding. B6.421 Rigging. Insofar as practicable, needed rigging shall be slung on stumps or trees desig- nated for cutting.

  • Transportation Management Tenant shall fully comply with all present or future programs intended to manage parking, transportation or traffic in and around the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities.

  • Filing and Processing A. Filing

  • Sub-processing 11.1 The data importer shall not subcontract any of its processing operations performed on behalf of the data exporter under the Clauses without the prior written consent of the data exporter. Where the data importer subcontracts its obligations under the Clauses, with the consent of the data exporter, it shall do so only by way of a written agreement with the sub-processor which imposes the same obligations on the sub- processor as are imposed on the data importer under the Clauses. Where the sub-processor fails to fulfil its data protection obligations under such written agreement the data importer shall remain fully liable to the data exporter for the performance of the sub-processor’s obligations under such agreement. 11.2 The prior written contract between the data importer and the sub-processor shall also provide for a third-party beneficiary clause as laid down in Clause 3 for cases where the data subject is not able to bring the claim for compensation referred to in paragraph 1 of Clause 6 against the data exporter or the data importer because they have factually disappeared or have ceased to exist in law or have become insolvent and no successor entity has assumed the entire legal obligations of the data exporter or data importer by contract or by operation of law. Such third-party liability of the sub-processor shall be limited to its own processing operations under the Clauses. 11.3 The provisions relating to data protection aspects for sub-processing of the contract referred to in paragraph 1 shall be governed by the law of the Member State in which the data exporter is established, namely ........................................ 11.4 The data exporter shall keep a list of sub-processing agreements concluded under the Clauses and notified by the data importer pursuant to Clause 5(j), which shall be updated at least once a year. The list shall be available to the data exporter’s data protection supervisory authority.

  • Claims Processing BCBSM will process Provider's Clean Claims submitted in accordance with this Agreement in a timely fashion.

  • Data Processing Agreement The Data Processing Agreement, including the Approved Data Transfer Mechanisms (as defined in the Data Processing Agreement) that apply to your use of the Services and transfer of Personal Data, is incorporated into this Agreement by this reference. Each party will comply with the terms of the Data Processing Agreement and will train its employees on DP Law.

  • Dewatering (a) Where the whole of a site is so affected by surface water following a period of rain that all productive work is suspended by agreement of the Parties, then dewatering shall proceed as above with Employees so engaged being paid at penalty rates as is the case for safety rectification work. This work is typically performed by Employees engaged within CW1, CW2 or CW3 classifications. When other Employees are undertaking productive work in an area or areas not so affected then dewatering will only attract single time rates. (b) Where a part of a site is affected by surface water following a period of rain, thus rendering some areas unsafe for productive work, consistent with the Employer’s obligations under the OH&S Act, appropriate Employees shall assist in the tidying up of their own work site or area if it is so affected. Where required, appropriate Employees will be provided with the appropriate PPE. Such work to be paid at single time rates. Productive work will continue in areas not so affected. (c) To avoid any confusion any ‘dewatering’ time which prevents an Employee from being engaged in their normal productive work is not included in any calculation for the purposes of determining whether an Employee is entitled to go home due to wet weather (refer clauses 32.4 and 32.5)

  • Felling and Bucking Felling shall be done to minimize breakage of Included Timber and dam- age to residual timber. Unless agreed otherwise, felling shall be done by saws or shears. Bucking shall be done to permit removal of all minimum pieces set forth in A2. B6.411 Felling in Clearings. Insofar as ground conditions, tree lean, and shape of clearings per- mit, trees shall be felled so that their tops do not extend outside Clearcutting Units, construction clearings, and ar- eas of regeneration cutting. B6.000 Xxxxx Xxxxxxx. Stumps shall not exceed, on the side adjacent to the highest ground, the maximum heights set forth in A6, except that occasional stumps of greater heights are acceptable when Purchaser determines that they are necessary for safe and efficient conduct of logging. Unless otherwise agreed, Purchaser shall re-cut high stumps so they will not exceed heights specified in A6 and shall dispose of severed portions in the same manner as other logging debris. The xxxxx heights shown in A6 were selected with the objective of maximum reasonable utilization of the timber, unless Sale Area Map shows special areas where xxxxx heights are lower for aesthetic, land treatment, or silvicultural rea- sons.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!