Commercial Quality Agreement definition

Commercial Quality Agreement has the meaning set forth in Section 7.4.

Commercial Quality Agreement. (QAg)” the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services; “Commercially Reasonable Efforts” with respect to CMC, such level of efforts and resources that would be typically and ordinarily expended, in accordance with generally accepted biological manufacturing industry standards, by companies that provide manufacturing and related services in the biopharmaceutical industry, as applicable, of comparable size and resources to CMC, for a similar activity with respect to the scope of Services to be provided under this Agreement, the profit earned under this Agreement and the strategic value of the Agreement to the business of CMC;

Commercial Quality Agreement means the commercial quality agreement, including all Appendices, attached hereto as Annex 4, which Xxxxxx International shall cause Xxxxxx Pharma to enter into with respect to the quality of the Product.

Examples of Commercial Quality Agreement in a sentence

• In the event of any conflict between any provision of the Commercial Quality Agreement and the other provisions of this Agreement, the provisions of the Commercial Quality Agreement shall exclusively govern and control any and all technical, pharmaceutical and/or quality related matters of the Manufacture, whereas the other provisions of this Agreement shall exclusively govern and control any other matters.

• Except for those Deviations of which Ascendis will be notified in writing as set forth in the Commercial Quality Agreement, all Product made available to Ascendis for delivery in accordance with Article 8 under this Agreement shall have been Manufactured in accordance with the Standard; [***].

• Ascendis shall supply and deliver or have delivered to the Warehouse [***] (Incoterms 2010), free of charge and at the risk of Ascendis, including with respect to any applicable transport insurance, such quantity of the Ascendis Materials as required to properly undertake the necessary preparations for the Manufacture of the Product and to timely fulfill Purchase Orders, all in accordance with the Commercial Quality Agreement.

• The Appendices may be amended from time to time separately and independently of the Commercial Quality Agreement.

• Ascendis may conduct routine and for-cause audits according to the provisions in the Commercial Quality Agreement.

• Such delivery shall include quality certificates for the Ascendis Materials as set forth in the Commercial Quality Agreement, upon which certificates Vettex Xxxxrnational and/or its Representatives may fully rely without further investigation.

• Neither Vettex Xxxxrnational nor any of its Representatives shall have any right or obligation to communicate with any such governmental, health and regulatory bodies regarding the Product unless required to do so by law, the Commercial Quality Agreement or as otherwise requested by Ascendis in writing.

• All Vettex Xxxxrials and all Ascendis Materials shall be tested in accordance with the Commercial Quality Agreement.

• Ascendis shall employ Vettex Xxxxrnational and/or its Affiliates in preparing such regulatory filings as set forth in the Commercial Quality Agreement and this Agreement which are relevant to the Manufacture and provide certain supporting documents if reasonably required, all as agreed upon by the Parties in the Agreed Specifications and [***] (“Regulatory Services”).

• Vettex Xxxxrnational shall supply the Product to Ascendis in accordance with the terms of this Agreement, it being understood and agreed that the Manufacture of the Product shall be subcontracted by Vettex Xxxxrnational to Vettex Xxxxma and be performed by Vettex Xxxxma, all as set forth and more fully described in the Commercial Quality Agreement.

More Definitions of Commercial Quality Agreement

Commercial Quality Agreement the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services, as further described in Clause 2.3; “[***]” [***] of an experienced contract manufacturing organization engaged in the cGMP manufacture of biological products that are similar to the Product;

Commercial Quality Agreement. (QAg) the agreement between the Parties defining the quality responsibilities, including cGMP standards, regarding the performance of the Services;

Commercial Quality Agreement is defined in Section 7.1.

Commercial Quality Agreement means the commercial quality agreement, including all Appendices, attached hereto as Annex 4, which Vettex Xxxxrnational shall cause Vettex Xxxxma to enter into with respect to the quality of the Product.

Commercial Quality Agreement means a quality assurance agreement to be agreed between the Parties pursuant to Clause 11.1, which shall include quality responsibilities with respect to, among other things, release testing, stability testing, access to regulatory submissions and record retention requirements, as such agreement may be amended or replaced by agreement between the Parties in writing from time to time;

Commercial Quality Agreement means the written agreement entered into by the Parties on or within [***] after the Effective Date defining pharmaceutical and certain operational responsibilities of the Parties with respect to the quality that is applicable to the Manufacture and Supply of the Licensed Compound Bulk Drug Substance under GMP.