Provision Language
9. Governance and Oversight
(a) The Parties shall establish a working committee (the “Working Committee”) to oversee the implementation of the Agreement. The Working Committee shall consist of the Party representatives set out in Annex E. Each Party may replace its representatives upon written notice to the other Party. From time to time, the Working Committee may invite additional, non–voting representatives to its meetings as dictated by the respective meeting agenda. [REDACTED]
(b) The Parties shall co–operate fully, candidly and transparently through the Working Committee in connection with the matters requiring consultation in Annex E, and other matters relating to the Agreement. The Working Committee shall in particular:
(i) agree a plan for supply of Product and [REDACTED]
(ii) report on, discuss, consult on and raise any concerns regarding the Parties’ performance under the Agreement including Roche’s progress towards and achievement of those matters identified in Part C of Annex E;
(iii) agree a plan for Distribution of the Product including in relation to the procedures in place or to be put in place with NHS hospitals and bona fide distribution hubs relating to supply chain management and a plan for how Non Standard Distribution and associated costs for Non Standard Distribution shall be managed;
(iv) report on, discuss, consult on and raise any concerns regarding disclosure of Roche Confidential Information as contemplated by Section 7;
(v) review, measure performance against and discuss possibilities to update the Delivery Schedule; and
(vi) discuss and devise any alternative mechanism for supply of the Product in accordance with Section 2(b)(i).
(c) The Parties acknowledge and agree that the Working Committee is a forum for discussion to facilitate the operation of this Agreement. For the avoidance of doubt, the Working Committee shall not have the authority to amend any of the terms and conditions of this Agreement or waive any rights of a Party under this Agreement.
(d) The first meeting of the Working Committee shall occur [REDACTED] Thereafter, the Working Committee shall [REDACTED] or such other intervals and at such additional times as the Parties agree or as required to fulfil functions allocated to the Working Committee pursuant to this Agreement. The Parties shall hold Working Committee meetings by video or telephone conference or as otherwise agreed between the Parties and may agree from time to time to take decisions in writing.
(e) The Parties acknowledge that the Working Committee will operate by consensus. Each Party shall bear all expenses of their respective Working Committee representatives related to their participation in the Working Committee.
(f) Roche shall keep UK regularly informed through the Working Committee of the status and its progress in securing all regulatory approvals (including the Marketing Approval) required for Product in the Territory as well as the maintenance and renewal of the same, and the progress towards achieving Delivery of the Units volume of Product in compliance with the Delivery Schedule.
(g) UK and Roche shall cooperate and share relevant information through the Working Committee to facilitate the Delivery of Product in accordance with the Delivery Schedule and to facilitate and fulfil the objectives of this Agreement.
(h) If a Regulatory License applicable to the Product to be supplied hereunder, or any regulatory approval (including the Marketing Approval) for the Product is suspended, withdrawn or discontinued in, or withdrawn from, any market (including in the Territory) for safety, quality or regulatory reasons, then Roche shall promptly give UK notice of such discontinuation, suspension or withdrawal through the Working Committee. If a UK License is suspended, withdrawn or discontinued then UK shall promptly give Roche notice of such discontinuation, suspension or withdrawal through the Working Committee.
(i) Notwithstanding its reporting obligations through the Working Committee, Roche shall keep UK [REDACTED], informed of all material events relating to the development, manufacture and supply of the Product including with respect to those items in Annex E.