DEVIATION CONTROL Sample Clauses

DEVIATION CONTROL. KBI BioPharma will notify Client of any out of specification (OOS) results or other Critical Deviations within three (3) working days of confirming the OOS or observing the deviation. OOS results will be investigated using the KBI BioPharma Laboratory Investigation Procedure, and if any retesting is conducted, the re-test plan must be approved by KBI BioPharma quality and the Client Quality Contact. Critical Deviations outside of OOS investigations will be investigated for root cause and fully documented by KBI BioPharma, targeting thirty (30) days after the date of discovery for completion. Investigations will include appropriate justification, scientific rationale and supporting data. The Client will review the completed Critical Deviation report and communicate to KBI BioPharma the result of its review, within five (5) business days.
Sample 1
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DEVIATION CONTROL. KBI Biopharma will notify the Client of any out of specification (OOS) results or other Critical/Major Deviation(s) within one (1) business day of confirming an OOS or identifying a Critical/Major deviation. OOS results will be investigated using the KBI Biopharma Laboratory Investigation Procedure, and if any retesting is conducted, the re-test plan must be approved by KBI Biopharma quality and the Client Quality Contact. For assays where there is a limited storage hold time for the Quality Control sample, the Client will provide timely (same business day may be required) approval on the retest plan. Critical and Major Deviations will be investigated for root cause, product/process impact and fully documented by KBI Biopharma, targeting thirty (30) days after the date of discovery for completion. Investigations will include appropriate justification, scientific rationale and supporting data. The Client will review the completed Deviation report and communicate to KBI Biopharma the result of its review, within five (5) business days. Copies of all batch related deviation reports will be provided to the Client as part of the batch disposition documentation.
Sample 1

Related to DEVIATION CONTROL

  • Operational Control THE PARTIES EXPRESSLY AGREE THAT LESSEE SHALL AT ALL TIMES WHILE THE AIRCRAFT IS IN ITS POSSESSION DURING THE TERM MAINTAIN OPERATIONAL CONTROL OF THE AIRCRAFT, AND THAT THE INTENT OF THE PARTIES IS THAT THIS AGREEMENT CONSTITUTE A “DRY” OPERATING LEASE. Lessee shall exercise exclusive authority over initiating, conducting, or terminating any flight conducted pursuant to this Agreement, and the Flight Crew shall be under the exclusive command and control of Lessee in all phases of such flights.

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Compliance Control Services (1) Support reporting to regulatory bodies and support financial statement preparation by making the Fund's accounting records available to the Trust, the Securities and Exchange Commission (the “SEC”), and the independent accountants.

  • Access Control Landlord shall be the sole determinant of the type and amount of any access control or courtesy guard services to be provided to the Project, if any. IN ALL EVENTS, LANDLORD SHALL NOT BE LIABLE TO TENANT, AND TENANT HEREBY WAIVES ANY CLAIM AGAINST LANDLORD, FOR (I) ANY UNAUTHORIZED OR CRIMINAL ENTRY OF THIRD PARTIES INTO THE PREMISES, THE BUILDING OR THE PROJECT, (II) ANY DAMAGE TO PERSONS, OR (III) ANY LOSS OF PROPERTY IN AND ABOUT THE PREMISES, THE BUILDING OR THE PROJECT, BY OR FROM ANY UNAUTHORIZED OR CRIMINAL ACTS OF THIRD PARTIES, REGARDLESS OF ANY ACTION, INACTION, FAILURE, BREAKDOWN, MALFUNCTION AND/OR INSUFFICIENCY OF THE ACCESS CONTROL OR COURTESY GUARD SERVICES PROVIDED BY LANDLORD, IF ANY. Tenant shall provide such supplemental security services and shall install within the Premises such supplemental security equipment, systems and procedures as may reasonably be required for the protection of its employees and invitees, provided that Tenant shall coordinate such services and equipment with any security provided by Landlord. The determination of the extent to which such supplemental security equipment, systems and procedures are reasonably required shall be made in the sole judgment, and shall be the sole responsibility, of Tenant. Tenant acknowledges that it has neither received nor relied upon any representation or warranty made by or on behalf of Landlord with respect to the safety or security of the Premises or the Project or any part thereof or the extent or effectiveness of any security measures or procedures now or hereafter provided by Landlord, and further acknowledges that Tenant has made its own independent determinations with respect to all such matters.

  • Construction Management Landlord or its Affiliate or agent shall supervise the Work, make disbursements required to be made to the contractor, and act as a liaison between the contractor and Tenant and coordinate the relationship between the Work, the Building and the Building’s Systems. In consideration for Landlord’s construction supervision services, Tenant shall pay to Landlord a construction supervision fee equal to three percent (3%) of Tenant’s Costs specified in Section 7.

  • Control Areas Tenant shall be allowed to utilize up to its pro rata share of the Hazardous Materials inventory within any control area or zone (located within the Premises), as designated by the applicable building code, for chemical use or storage. As used in the preceding sentence, Tenant’s pro rata share of any control areas or zones located within the Premises shall be determined based on the rentable square footage that Tenant leases within the applicable control area or zone. For purposes of example only, if a control area or zone contains 10,000 rentable square feet and 2,000 rentable square feet of a tenant’s premises are located within such control area or zone (while such premises as a whole contains 5,000 rentable square feet), the applicable tenant’s pro rata share of such control area would be 20%.

  • Business Continuity The Transfer Agent will maintain a comprehensive business continuity plan and will provide an executive summary of such plan upon reasonable request of the Fund. The Transfer Agent will test the adequacy of its business continuity plan at least annually and upon request, the Fund may participate in such test. Upon request by the Fund, the Transfer Agent will provide the Fund with a letter assessing the most recent business continuity test results. In the event of a business disruption that materially impacts the Transfer Agent’s provision of services under this Agreement, the Transfer Agent will promptly notify the Fund of the disruption and the steps being implemented under the business continuity plan.

  • Pest Control Landlord will be responsible for termite and rodent control. Landlord shall not provide pest control services (which include the removal of ants, cockroaches, spiders and other insects). If the Tenant has a xxxxx infestation after they move in they will be considered the cause of it and charged for the treatments. A pest control company will be sent to the property after the first 6 months of the lease, if an issue is found the tenants will be charged for the treatments.

  • Business Continuity Plan The Warrant Agent shall maintain plans for business continuity, disaster recovery, and backup capabilities and facilities designed to ensure the Warrant Agent’s continued performance of its obligations under this Agreement, including, without limitation, loss of production, loss of systems, loss of equipment, failure of carriers and the failure of the Warrant Agent’s or its supplier’s equipment, computer systems or business systems (“Business Continuity Plan”). Such Business Continuity Plan shall include, but shall not be limited to, testing, accountability and corrective actions designed to be promptly implemented, if necessary. In addition, in the event that the Warrant Agent has knowledge of an incident affecting the integrity or availability of such Business Continuity Plan, then the Warrant Agent shall, as promptly as practicable, but no later than twenty-four (24) hours (or sooner to the extent required by applicable law or regulation) after the Warrant Agent becomes aware of such incident, notify the Company in writing of such incident and provide the Company with updates, as deemed appropriate by the Warrant Agent under the circumstances, with respect to the status of all related remediation efforts in connection with such incident. The Warrant Agent represents that, as of the date of this Agreement, such Business Continuity Plan is active and functioning normally in all material respects.

  • Quality Assurance Licensee agrees that all use of the Licensed Subject Matter shall be only upon the Products manufactured by or for Licensee in accordance with quality standards approved by Licensor prior to the commencement of manufacturing of the Products. Licensee shall submit for Licensor's sole and absolute approval the type of cereal, the name of cereal, the packaging design, advertising material, and all other materials to be used in connection with the Products subject to the sole and absolute approval of Licensor which shall not be unreasonably delayed or withheld.

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