Annual Product Review. 5.1 Patheon shall perform an annual product review for the Product detailing all drug product lots manufactured, product investigations, stability updates (as required), lots released or rejected, and process or method revisions (including validation reports) for all drug product lots manufactured in the previous Manufacturing Agreement year. All critical release data shall be trended to evaluate the process.
Annual Product Review. Provision of information on manufacture of PRODUCT (includes rejections, deviations, and process changes) — BULK PRODUCT X — PACKED PRODUCT X — Generate report for Eagle X — Approved by X X — filed by X Annual Quality Review of PRODUCT — prepared by X — approved by X X — action and documentation X X REGULATORY AUTHORITY INSPECTION RECORDS FOR PRODUCT MADE AVAILABLE TO THE PARTIES X X AUDITS — supplier of primary packaging components X — API Supplier X — Manufacturing facilities X — audit reports made available to each party X X HEALTH AND SAFETY AND PROTECTION OF ENVIRONMENT — active ingredient X — BULK PRODUCT manufacture X — packing at SUPPLIER X — PRODUCT storage and handling up to delivery to EAGLE X — storage, handling and distribution of PRODUCT after receipt X EUROPEAN UNION PRODUCT TESTING AND RELEASE — Establish Methods in EU Lab X — Assist, as appropriate, in transferring Methods to EU Lab X — Testing of Finished Product in EU X — QP Release in EU X [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. This Amendment No. 1 (“Amendment”) is executed as of August 30, 2013 (“Amendment Effective Date”) by and between: Cipla Limited, a company registered under the Companies Xxx, 0000, having registered office at Xxxxxx Xxxxxxx, Xxxxxx 000000, Xxxxxxxxxxx, Xxxxx (“Cipla”) and Eagle Pharmaceuticals, Inc., a Delaware corporation with principal place of business at 00 Xxxx Xxxxxxxxx, Woodcliff Lake, NJ 07030, USA (“Eagle”). Cipla and Eagle may be referred to, in the singular, as a “Party” and jointly as “Parties”.
Annual Product Review. 5.1 Cardinal shall perform an annual product review for the Product detailing all product lots manufactured, product investigations, lots released or rejected, specification changes (to excipient, in-process controls, or finished product), and process or method revisions (including validation reports) for all Product lots manufactured in the previous calendar year. All critical release data shall be trended to evaluate the process.
Annual Product Review. 19.1 In consultation with OCEANA, BIO HOSPITAL shall provide information upon request for an Annual Product Review. The content of the Annual Product Review shall be agreed to by both OCEANA and BIO HOSPITAL.
Annual Product Review. Xxxxxxxxx-Xxxxx shall provide Auxilium with the required information to perform Annual Product Reviews including information from Third Party Subcontractors. Such information shall contain, but not be limited to, the following: batch production summary, environmental monitoring results, OOS and deviation reports, critical process parameter trending data and change controls summary, document revisions and any FDA audit responses that are specific to the Product.
Annual Product Review. 9.1 Each year the Contractor will conduct an Annual Product Review, which will minimally contain for each Product manufactured:
Annual Product Review. The Client will complete Annual Product Review (“APR”) in accordance with regulatory requirements of the Product marketed authorization, for example 21CFR 314.81(b)(2). Patheon will provide copies of all information and correspondence necessary to support the APR when requested by the Client. Client will provide a copy of the approved Final APR (redacted as applicable) where required. Master Manufacturing Services Agreement
Annual Product Review. 12.1.1 LONZA will perform an Annual Product Review for the PRODUCT and will issue a report to ORPHAN. This report will cover all manufacturing, testing, and storage activities performed by LONZA. It will be a review of any changes at LONZA in the manufacturing, testing, storage or validation of the PRODUCT in the previous calendar year and a summary of lots made, released, and rejected. Also, control charting or trend analysis of key product parameters will be performed. Any abnormalities will be explained in the annual review.
Annual Product Review. The Parties shall meet, in a manner agreed to by the Parties, by February 28 (or such other date as may be agreed by the Parties in writing) of each Calendar Year after the first Calendar Year for an annual Product review (“Product Review”). Within the time period defined by both parties and stated in the Quality Agreement, Manufacturer shall furnish to Purchaser a summary of all modifications made to the Specifications and the Manufacturing Process agreed to by the Parties during the Product Review in accordance with Sections 4.5(a) and (b). Costs and expenses incurred to implement modifications resulting from the Product Review shall be borne by the applicable Party in accordance with the provisions of Sections 4.5(a) and (b).
Annual Product Review. As set forth in the Quality Agreement, or as otherwise agreed to in writing by CBSB and Tercica, CBSB shall provide Tercica with the information required under 21 C.F.R. § 217.180(e)(1) to permit a review of a representative number of Batches of Drug Substance, whether or not approved by CBSB’s quality assurance group.
