Documentation and Reports. The Committee 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. 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 and shall be distributed periodically to the full Board. The Committee shall make regular reports to the Board.
Documentation and Reports. 19.1 The Parties shall comply with the terms of the Information Access Agreement.
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. 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. 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. 21.1 Flamel shall:
Documentation and Reports. The Supplier shall use Commercially Reasonable Efforts to compel [***] to:
