Apic Quality Agreement Template

21 I. Introduction / Purpose / Scope I.1 Contracting Parties Note: Although the APIC model is intended for quality agreements between API manufacturers/intermediaries (but not distributors or distributors) and their customers, the model uses the more general term SUPPLIER instead of MANUFACTURER. The reason for this is that even if you purchase an API or intermediary from the original manufacturer, you may be billed by another legal entity or the supply contract is concluded with another legal entity of the same company, especially if the production site is part of a larger company (see also the next note). This quality contract exists after and between > to < full address of the supplier, hereinafter referred to as the SUPPLIER, and > to < full address of the customer, hereinafter referred to as the CUSTOMER. While the SUPPLIER manufactures and supplies the CUSTOMER with active pharmaceutical ingredients (APIs) suitable for pharmaceutical use (alternatively: API intermediates suitable for API production). The CUSTOMER and the SUPPLIER may be referred to herein individually as a party and collectively as the parties. Note: If the party providing the APIs or intermediates is another legal entity within the same company, or if the production facilities involved in the production of the API or intermediaries are different legal entities of the same company, the following additional paragraph would be appropriate: THE SUPPLIER sells and markets products manufactured by itself or its affiliates, among other things, located at

that the affiliates have the ability and desire to manufacture as subcontractors and that the SUPPLIER has the desire to supply the products. The SUPPLIER is responsible for the trade and packaging of samples of approved products. Any reference to the SUPPLIER must therefore be understood in the following as a reference to the SUPPLIER and/or the manufacturing company. Note: If necessary, the following definition of the term “Affiliate” can be included in the previous paragraph or listed in the Definitions section (I.4). For the purposes of this Quality Agreement, the term affiliate means any company that controls, is controlled by or is under common control with the relevant party. The term control refers to the direct or indirect ownership of more than 50% of the respective shares or the power to determine the management or policy of that company or party. The aforementioned parties wish to define in more detail the individual responsibilities with regard to the qualitative aspects of the manufacture, control and acceptance of the products manufactured by the SUPPLIER and delivered to the CUSTOMER in order to ensure compliance with the applicable Good Manufacturing Practices (GMP), the CUSTOMER`s marketing authorizations with regard to finished pharmaceutical products, including the SUPPLIER`s APIs, applicable regulatory requirements and all other requirements contained therein.

Agreement to ensure compliance with the requirements laid down in the Agreement. To achieve this goal, this quality agreement contains a detailed list of activities related to manufacturing, inspection, GMP compliance and product acceptance Version 02 July 2017 Page 21/42 Supplier qualification A summary of the examination: This is a GMP requirement to certify the seller to provide high quality and safe medicines and prevent recalls, deaths, adverse events and serious illnesses due to 23 of the quality agreement. Either party may terminate this Quality Agreement with 6 months` written notice to the other party. Note: The definition of the validity period up to 2 years after the last delivery of the PRODUCT by the SUPPLIER to the CUSTOMER is very common and is therefore recommended by the APIC. This may be different depending on each company`s preference. II.3 Assignment Neither party shall have the right to assign all or any part of its rights or obligations under this Quality Agreement without the prior written consent of the other party, whose consent may not be unreasonably withheld. Notwithstanding the foregoing, prior written consent is not required (i) in the event of an assignment of rights or obligations to an affiliate of the assignor (optional extension: provided that the assignor ensures that such affiliate returns those rights to the assignor immediately prior to its departure as an affiliate of the assignor) or (ii) in connection with a merger; Consolidation or sale of all or substantially all of the party`s assets to a third party, unless such a merger, consolidation or sale takes place with a competitor of the other party. II.4 Related agreements If there is a supply contract between THE SUPPLIER and THE CUSTOMER and there are contradictions between the supply contract and the quality contract, the supply contract prevails over the quality contract for all non-quality related matters, unless otherwise specified in the delivery contract. The quality agreement prevails in all quality-related matters. II.5 Changes to this Quality Agreement must be made in writing and signed by the appropriate representatives of both parties. The parties agree to amend the terms of this Quality Agreement, which must be amended to ensure that the PRODUCT continues to comply with the regulatory requirements of the applicable jurisdictions and the requirements of the CUSTOMER. If a modification of this Quality Agreement is proposed, the proposing party will forward the proposed modification to the appropriate contact person of the SUPPLIER and the CUSTOMER for review and approval.

The relevant contacts are listed in section V. Note: The annexes may be amended in the same manner as the Agreement without the need to revise, revise or approve the Agreement in its entirety. II.6 Privacy (optional) Version 02 July 2017 Page 23/42 Product quality ratings Document valid from: 07.11.2017 Document number: I-SMI. TI.14 Version No. 05 Classification: Document publicly replaced: I-SMI. TI.14_04 from: 14.08.2014 QMI documents root: – Referenced 10 APIC Quality Agreement Guideline 5. Format and structure of a quality agreement 5.1 General aspects The Annex to this APIC Directive is a ready-to-use quality agreement (see the typical structure of such an agreement in point 5.2). The Introduction and General Provisions sections deal with the scope and terms of the Agreement. The quality responsibilities section, also in some cases referred to as the division (or delimitation) of responsibilities, includes the main quality and regulatory issues and the corresponding responsibilities usually found in a quality agreement. However, the model does not mention all points of the pharmaceutical quality system, as the quality requirements sufficiently covered by reference to the applicable quality standard/GMP (as indicated in section 1 of the model) do not need to be repeated in the agreement. Quality tasks can be assigned to one or both parties as needed. In order to provide a convenient and quick overview, a tabular format has been chosen for this section.

The format of the template should be flexible, with the template providing all the individual elements required for most quality agreements. There are several ways in which both parties can benefit from using a standardized template: The template can completely replace its own agreement The template can be used as the basis for a (slightly) modified and custom draft contract Some sections of the template can be used when drafting your own agreement The template wording can be used to resolve disputes, if it is mutually understood as good industry practice. .