Documentation and Reports. The Chairman shall be responsible for establishing the agendas for meetings of the Committee. An agenda, together with materials relating to the subject matter of each meeting, shall be sent to members of the Committee prior to each meeting. Any member of the Committee is permitted to add any item to the agenda prior to each meeting. Minutes for all meetings of the Committee shall be prepared to document the Committee’s discharge of its responsibilities. The minutes shall be circulated in draft form to all Committee members to ensure an accurate final record, shall be approved at a subsequent meeting of the Committee. The Committee shall make regular reports to the Board after each meeting of the Committee.
Documentation and Reports. 19.1 The Parties shall comply with the terms of the Information Access Agreement.
19.2 The Supplier shall, or shall procure that any Nominated Supplier or Permitted Subcontractor (as applicable) shall:
(A) maintain complete and maintain the documentation relating to the Manufacture of each batch of the Products in accordance with cGMP (including, without limitation, Batch Records, analysis and data supporting each Certificate of Analysis and Certificate of Compliance) and in accordance with the Quality Agreement and shall retain such documentation for the periods set out in the Quality Agreement;
(B) supply to the Purchaser upon reasonable request copies of the documentation referred to in clause 19.2(A);
(C) keep complete and systematic records of any other documentation generated pursuant to this Agreement; such records to include any operational documentation relating to Manufacture of the Product, any financial records and procedures (including records for compliance with Applicable Laws), distribution and disposition records and all such other documentation relating to the Products and Manufacturing activities under this Agreement;
(D) preserve all records referred to in clause 19.2(C) in accordance with the relevant retention periods specified in the Quality Agreement (where applicable) and shall preserve any records not identified in such Quality Agreement for the greater of: (i) five years and (ii) such other period agreed in writing by the Parties; provided that, in the event a legal matter arises requiring preservation of certain records, the Supplier shall suspend destruction of such records as requested by the Purchaser or any Governmental Entity; and
(E) permit the Purchaser, its Affiliates and their respective representatives access upon reasonable request during Working Hours to all records retained pursuant to this clause 19 (Documentation and Reports).
19.3 For the avoidance of doubt, nothing in clause 19.2(E) shall entitle the Purchaser, its Affiliates or their respective representatives to access financial records, which may be accessed only in accordance with clause 33 (Audit and Inspection Rights).
19.4 In the event of any conflict or inconsistency between the provisions of this clause 19 (Documentation and Reports) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.
Documentation and Reports. 13 ARTICLE 6.
Documentation and Reports. Without limiting any other obligations of LONZA to provide specific documentation hereunder, LONZA shall use all reasonable efforts to provide any documentation to be provided to CLIENT pursuant to a Statement of Work in accordance with the schedule set forth in such Statement of Work and in sufficient detail (and, as appropriate, in good scientific manner) to reflect the work performed and results achieved, including all data in the form required by Applicable Law and/or Regulatory Authorities in Relevant Jurisdictions (“CLIENT Documentation”). In addition, LONZA agrees to provide CLIENT with a report, upon completion or termination of the performance of the applicable Statement of Work, describing the procedures and results obtained in connection with producing, analyzing, developing, testing or otherwise manufacturing the applicable Product(s), including without limitation the applicable Process(es), and all Intellectual Property developed, conceived, invented, first reduced to practice or otherwise made in connection with the performance of the applicable Statement of Work. Each such report will contain sufficient detail so that CLIENT can understand and fully implement and exploit on its own the information described therein, including such information as is required for the CMC section (or equivalent section) of a filing with any Regulatory Authority in a Relevant Jurisdictions (e.g., an IND or NDA, or any corresponding filing in a Relevant Jurisdiction) for such Product and the master batch record. To the extent such information has been previously disclosed in such detail to CLIENT in the CLIENT Documentation, LONZA may reference such CLIENT Documentation to comply with its reporting obligations under this Section 2.5. Upon request by CLIENT from time to time and at CLIENT’s expense, LONZA will provide reasonable assistance to CLIENT to understand and implement the information contained in any such report.
Documentation and Reports. 8.1 Corvis will provide to Customer all Documentation necessary to operate and maintain the Products provided hereunder. Corvis will (a) update the Documentation as such updates are made generally available, and (b) revise data incorporating any changes to the Products which affect form, fit, function or features, in each case at no additional charge to Customer. Such Documentation may be reproduced by Customer for its internal use, provided that any copyright notice of such Documentation is copied as well. Soft copies of such Documentation will be available upon Customer's request. Such Documentation will be used solely for Customer's internal use only on a need-to-know and need- to-use basis. Corvis will provide Customer with other reports as reasonably requested by Customer, including a weekly shipping report, the form of which will be mutually agreed upon between the parties. Such shipping report will include information regarding Purchase Orders placed by Customer, date of placement of Purchase Order and Corvis' ship date of Products.
Documentation and Reports. Corvis will provide to Customer, one electronic copy of the Documentation necessary to operate and maintain the Products provided hereunder for each Specified Site at which such Product is installed. Corvis will provide Customer with (a) updates to the Documentation, as such updates are made generally available, and (b) new and/or revised data incorporating any changes to the Products which affect form, fit, or function, in each case at no additional charge to Customer. Such Documentation may be reproduced by Customer for its internal use, provided that any copyright notice of such Documentation is copied as well. Soft copies of such Documentation will be available upon Customer's request. Such Documentation will be used solely for Customer's internal use only on a need-to-know and need-to-use basis.
Documentation and Reports. 21.1 Flamel shall:
(a) complete the documentation relative to the Manufacture of each batch of the Intermediate Product in accordance with Good Manufacturing Practice and any other reasonable requirements of GSK and shall retain such documentation in accordance with Section 9 of the Technical Agreement;
(b) supply to GSK one (1) completed copy of the Certificate of Analysis relating to the Intermediate Product which is the subject of any Batch Record at the time that such Intermediate Product is delivered;
(c) permit GSK access to all Manufacturing, regulatory and quality control records in respect of the Intermediate Product and the Materials used in their Manufacture;
(d) supply to GSK a report for the validation batches for each batch of Intermediate Product Manufactured summarizing, but not limited to, the analytical results for each batch Manufactured, the stability results, details of any batch failures, process deviations and any out of specification results as provided for in this Agreement; and
(e) complete and lodge with the appropriate authorities where required all documentation relating to the export of intermediate Product where delivery involves export from the country of Manufacture.
Documentation and Reports. A copy of the Cephalon QA Provigil final product disposition will be sent to Circa to effect the shipment of same lot to the designated distributor (CORD). . Cephalon will report all Provigil product quality complaints to Circa within 10 working days of receipt. /s/ Xxxxxx Xxxxx 9/17/97 ---------------------------------------------- --------- Cephalon, Inc. Manufacturing Operations Date /s/ Xxxx Xxxxxx 9/17/97 ---------------------------------------------- --------- Cephalon, Inc. Quality Assurance Date /s/ [SIGNATURE ILLEGIBLE] 9/16/97 ---------------------------------------------- --------- Circa Pharmaceuticals, Inc. Regulatory Affairs Date /s/ [SIGNATURE ILLEGIBLE] 9/16/97 ---------------------------------------------- --------- Circa Pharmaceuticals, Inc Quality Assurance Date SCHEDULE D ---------- PRODUCT VALIDATION AND STABILITY TESTING PROCEDURES --------------------------------------------------- The parties have agreed upon all those applicable specifications for Product validation and stability testing as set forth in the following documents. Any modifications to any such specifications shall be agreed upon by the parties. DCRA # DOCUMENT # TITLE ------ ---------- ----- 874 RD/RA/MODAF Residual Active Assay - Modafinil Cleaning Validation 880 STAB/100MODAF Stability - Modafinil 100 mg Tablets 889 STAB/100MODAFEU Stability - Modafinil 100 mg Tablets (European) 883 STAB/200MODAF Stability - Modafinil 200 mg Tablets 875 STD/MODAF Requalification of Standard - Modafinil PV-001-10047 Process Validation Protocol - Master Blend for Modafinil 100 mg & 200 mg Tablets PV-002-11047 Process Validation Protocol - Compression Process for Modafinil 100 mg Tablets PV-003-11047 Process Validation Protocol - Compression Process for Modafinil 200 mg Tablets PV-004-06057 Process Validation Protocol - Packaging Process for Modafinil 100 mg & 200 mg Tablets CV-003-21047 Cleaning Validation Protocol - Modafinil 200 mg Tablets -23- SCHEDULE E ---------- TOLLING FEES ------------ CEPHALON shall pay CIRCA the following amounts in consideration of the formulation and packaging services rendered hereunder: BATCH PRICING COST/BATCH ------------- ---------- . A single lot per P.O. and delivery Date: Provigil(R) 100 mg packed in 100 counts [*] Provigil(R) 100 mg packed in 12 counts Provigil(R) 200 mg packed in 100 counts Provigil(R) 200 mg packed in 6 counts . 3 or more of the same batch on a single P.O. with the same delivery date: Provigil(R) 100 mg packed in 100 counts [*]...
Documentation and Reports. Buyer shall be responsible for and shall create on behalf of Seller, for submission by Seller, all necessary and required reports for purposes of compliance with the RFS2 Rule and the LCFS Program with respect to any RINs conveyed to Buyer or LCFS Credits generated by Buyer with respect to Ethanol Delivered to Buyer by Seller under this Agreement, including specific transaction reports, periodic compliance and progress reports, and pathway demonstrations (the “Transaction Reports”), all as further provided in the Regulatory Credit Protocol. The Transaction Reports include any periodic reports required to be submitted by Seller or Buyer. Seller shall provide all information about transactions relating to optional RINs and LCFS Credits retained or sold to third parties at least thirty (30) days prior to the deadline for submitting such Transaction Reports. The Transaction Reports shall be provided to Seller by Buyer at least ten (10) days prior to any applicable submission deadline.
Documentation and Reports. The Supplier shall use Commercially Reasonable Efforts to compel [***] to:
(a) complete and maintain (and ensure that any authorized subcontractors complete and maintain) the documentation relating to the Manufacture of each batch of API in accordance with cGMPs and retain such documentation for a minimum period of six (6) years after release of API;
(b) notify the Supplier, who will then notify Purchaser, of any batch failures, process deviations and any out-of-specification results which arise under Manufacture of Product as provided for in this Agreement;
(c) complete and maintain all records and reporting requirements relating to controlled drugs as may be applicable; and
(d) complete and lodge with the appropriate authorities where required all documentation relating to the export of API where Delivery involves export from the country of Manufacture.
