Common use of Documentation and Reports Clause in Contracts

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/ ▇▇▇▇▇▇ ▇▇▇▇▇ 9/17/97 ---------------------------------------------- --------- Cephalon, Inc. Manufacturing Operations Date /s/ ▇▇▇▇ ▇▇▇▇▇▇ 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 [*] Provigil(R) 100 mg packed in 12 counts Provigil(R) 200 mg packed in 100 counts Provigil(R) 200 mg packed in 6 counts VOLUME DISCOUNTS: ----------------