[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
|1.4 || |
Compliance with Laws. KBI Biopharma shall perform the Services in all material aspects in compliance with Applicable Laws. Client shall have responsibility for determining regulatory strategy and for all regulatory decisions except for those matters that KBI Biopharma, in its reasonable discretion deems contrary to regulatory requirements or commitments made by KBI Biopharma to Regulatory Authorities, of which matters KBI Biopharma shall promptly notify Client in writing. Should the Applicable Laws change over the course of KBI Biopharmas performance of the Services, KBI Biopharma will use reasonable efforts to satisfy the new requirements. Notwithstanding the foregoing, in the event that compliance with such new Applicable Laws necessitates a change in the scope or nature of the Services to be completed, KBI Biopharma will submit to Client a Change Order in accordance with Article 8.
|1.5 || |
1.5.1 Applicable Laws shall mean all laws, statutes, rules, regulations, directives, decisions, ordinances and other requirements of any Governmental Authority in the United States or the EU applicable to the Services relating to the manufacture, testing, quality, storage and supply of investigational drugs (including biologics); including, without limitation: (a) in the case of cGMP Batches for investigational clinical trials in the U.S., as expressly stated in the relevant Proposal or Quality Agreement, the FD&C Act and cGMPs; and (b) all applicable regulations and guidelines of the FDA, EMA and/or any other relevant Regulatory Authority in the United States and/or the EU applicable to the manufacture, testing, quality, storage and supply of an investigational new drug (including biologics); in each case, together with any and all amendments thereto.
1.5.2 Batch shall mean a specific quantity of Client Product that is intended to be of uniform character and quality and is produced during the same cycle of manufacture.
1.5.3 Cause means, with respect to an audit of a KBI Biopharma facility, that: (a) the audit is prompted by a Regulatory Authority critical finding or recall, or a critical finding in an audit conducted by or on behalf of Client pursuant to Section 5.1, where, in each case, a critical finding is a finding that would result in a regulatory action or has such other meaning as may be provided in the Quality Agreement; or (b) any other for cause basis exists (such as, by way of example and not limitation, notice by any Governmental Authority of KBI Biopharmas noncompliance with Applicable Laws if such noncompliance relates to or may affect the Manufacture of Client Product, or issuance by the FDA of a Form 483 or Warning Letter or a comparable notice issued by any other Governmental Authority).
1.5.4 Certificate of Analysis means a document, signed by an authorized representative of KBI Biopharma, describing the applicable Specifications for, and testing methods applied to, a Batch of Client Product, and the results of such testing, and confirming that such Batch meets the Specifications.
1.5.5 Certificate of Compliance means a document, signed by an authorized representative of KBI Biopharma, attesting that a particular Batch of Client Product was manufactured in accordance with cGMPs.
1.5.6 Client Materials means all Client proprietary materials and information, biological and/or chemical materials, intellectual property and developments, including without limitation, all patents, patent applications, know-how, inventions, designs, concepts, technical information, manuals, or instructions which, as of the Effective Date, are owned, licensed or controlled by Client relating to the development, formulation, manufacture, processing, packaging, analysis or testing of the Client Product and provided to KBI Biopharma by or on behalf of Client.
1.5.7 Client Product shall mean a biologic Manufactured, or to be Manufactured, by KBI Biopharma on behalf of Client pursuant to a Proposal, which biologic may, as specified in such Proposal, either comprise: (a) a KBI Biopharma proprietary cell line (KBI Cell Line), or (b) a biologic which does not use or incorporate a proprietary KBI Biopharma cell line or which Client provides to KBI Biopharma (Non-Proprietary Cell Line), either with or without a Client-specified manufacturing process to be implemented by KBI Biopharma and/or its affiliates in manufacturing such Client Product on Clients behalf; in each case, as more fully described in the applicable Proposal.