Common use of Program Performance Clause in Contracts

Program Performance. 3.1 Brammer will use Commercially Reasonable Efforts to perform the Services for Customer in accordance with the applicable Work Statement and in accordance with all Applicable Laws. 3.2 [**] 3.3 Brammer will comply with cGMP applicable to the Services, provided that, should cGMP applicable to the Services be changed following the Effective Date, Brammer will use Commercially Reasonable Efforts to comply with such new cGMP requirements without interruption to cGMP status. In the event that compliance with such new cGMP requirements necessitates, in the reasonable determination of the Parties, a change in the Work Statement or the Services, Brammer will submit to Customer a proposed Change Order in accordance with Section 9.2. 3.4 Customer acknowledges that due to the unpredictable nature of biological processes, a Process Performance Qualification (as envisaged to be completed in the second Work Statement) needs to have taken place to establish the commercial process of Manufacturing the Product. 3.5 Brammer undertakes that it shall: (i) use Commercially Reasonable Efforts to ensure that the Facility is ready to perform for the first relevant activity under each Work Statement in accordance with the timeline mutually agreed to by the Parties for such activity; Customer acknowledges that the timelines set forth in any Work Statement are good faith estimates using assumptions based on information available on the date on which the applicable Work Statement is executed. Customer understands that it needs to comply in a timely manner with all of its relevant obligations in order to enable Brammer to achieve such timelines; (ii) give the Customer prompt written notice of any anticipated delay in the completion of the Facility; and (iii) in the event of any delay in the Facility being ready in accordance with (i), use its best efforts (a) to complete the commissioning of the Facility as soon as possible and (b) to perform its obligations under each Work Statement using alternative resources and Facilities, including by giving the Customer priority in the use of available Brammer capacity. 3.6 Brammer will appoint a Brammer representative (the “Program Manager”) to be responsible for overseeing the conduct of the Services and the completion of the Program by Brammer. The Program Manager will coordinate performance of the Services with a representative designated by Customer in writing (the “Customer Representative”), which representative will have responsibility over all matters relating to performance of the Services on behalf of Customer. Unless otherwise agreed in the Work Statement, or mutually agreed to by the Parties, all communications between Brammer and the Customer regarding the conduct of the Services pursuant to the Work Statement will be addressed to or routed through the Program Manager and Customer Representative. The Program Manager and the Customer Representative are named in the Work Statement, and Brammer or Customer may, at its option, substitute, respectively, the Program Manager or the Customer Representative during the course of the Program by providing written notice to the other. 3.7 The Program Manager shall co-ordinate meetings of a joint project team to oversee and co-ordinate the performance of this Agreement on a day-to-day basis. The Program Manager and the Customer Representative shall determine, acting reasonably, which other individuals should be part of the joint project team or otherwise attend joint project team meetings from time to time. The joint project team shall meet in person or by phone every two (2) weeks, or more frequently as may be agreed. The Program Manager shall be responsible for taking minutes of each meeting of the joint project team and circulating such minutes to the Customer Representative for review. 3.8 The Parties shall each nominate two (2) individuals to sit on a joint steering committee to oversee the performance of this Agreement (the “JSC”). The JSC shall meet, whether in person or by telephone, once every 6 months, or ad hoc as may be agreed, to review the progress of all Work Statements and any other matters relating to the Agreement, based on written reports provided to them by the Program Manager and the Customer Representative. Where the JSC is unable, in good faith, to reach agreement on any matter referred to them, either Party may refer the matter for dispute resolution under Section 16. The matters referred to the JSC shall include, without limitation, the agreement of a Specification for a Work Statement; disputes over whether a Product contains a Defect; and such other matters as the Parties may determine from time to time. 3.9 Promptly following the execution of this Agreement, the Parties will enter into a detailed document specifying the quality and regulatory procedures and responsibilities of the Parties with respect to the Manufacture of Product (the “Quality Agreement”, substantially in the form of the draft annexed as Exhibit E; provided, however, that, upon execution, the executed Quality Agreement will replace the draft in Exhibit E). In the event of any conflict between the terms and provisions of this Agreement and the terms and provisions of the Quality Agreement, the terms of this Agreement will control, except with respect to quality related matters. 3.10 The Parties confirm that, subject to successful completion of Work Statement 1, they intend to negotiate in good faith a Commercial Supply Agreement relating to the Product, substantially in the form set out in the non-binding Commercial Supply Term Sheet at Exhibit D.