Provision Language
3. Use; Regulatory
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(b) As between the Parties, (a) Roche shall be responsible at its sole cost and risk for filing and prosecuting to grant or issuance all approvals, licenses, permits, certifications, registrations or authorizations necessary for the manufacture, packaging, import, storage, and transport of the Product for, after grant of a Marketing Approval, commercial use in the Territory [United Kingdom] (“Regulatory Licenses“) and (b) UK shall and shall procure that its Authorised Agents shall be responsible at its or their sole cost and risk for filing and prosecuting to grant or issuance all approvals, licenses, permits, certifications, registrations or authorisations necessary for, after grant of a Marketing Approval, storage of the Product but not for Distribution undertaken by or on behalf of Roche (“UK Licenses“).
(c) Roche shall use CRE to seek an emergency use authorization, accelerated approval, conditional approval, temporary approval under Regulation 174 of the Human Medicines Regulations 2012 (subject to SoS [Secretary of State] Approval), conditional or full marketing approval or any other similar approval required under Law in the Territory for the commercial supply of the Product in the Territory for an indication covering the treatment of SARS–CoV–2 (the “Therapeutic Indication“) but excluding any pricing or reimbursement approvals from the UK Medicines and Healthcare products Regulatory Agency (“MHRA“) (the “Marketing Approval“). [REDACTED]
(d) [REDACTED]
(e) [REDACTED] Subject to any obligations on Roche in relation to the label for the Product under the Further Marketing Approval all Units Delivered on or after the date of the Further Marketing Approval shall be licensed under the Further Marketing Approval. Roche shall keep UK informed as to progress towards the Further Marketing Approval through the Working Committee. In conjunction with seeking the Further Marketing Approval, Roche shall use CRE to seek guidance from the MHRA that any Product Delivered under the original Marketing Approval prior to the granting or issuance of the Further Marketing Approval may from the date of the Further Marketing Approval be used under the Further Marketing Approval. [The definition of Further Marketing Approval appears to have been redacted from the agreement.]
(f) Roche shall use CRE to maintain the grant or issuance of a Marketing Approval (and, if applicable, a Further Marketing Approval), including fulfilling any conditions attached to such approval(s) by the MHRA. Furthermore, if the initial Marketing Approval granted is by way of Regulation 174 of the Human Medicines Regulations 2012 subject to SoS Approval, then Roche shall use CRE to continue to pursue a Marketing Approval on a conditional or full basis for the Product. This obligation shall continue to apply after the expiry or termination of this Agreement until such time as the shelf life of all Product supplied hereunder has expired.
5. Limited Warranty; Indemnity; Limitation of Liability
(a) Roche warrants, represents and undertakes to UK that:
(i) at the time of Delivery, Product shall have been manufactured, labelled, handled, stored, transported, sold and packaged in accordance with (A) the relevant Marketing Approval; (B) all applicable Laws including Good Manufacturing Practice (GMP) (including record and sample keeping, deviation reporting, testing and quality requirements), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP); (C) all other Regulatory Licenses applicable to the Product; and (D) the specifications set forth in the approved Product monograph and Annex A;
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(vi) following grant of a Marketing Approval, all Product prior to Delivery shall be finally quality released for supply by an entity established in the Territory;
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(viii) it has and shall maintain a properly documented system of quality controls and processes (including quality management systems) that, at a minimum, meet requirements under applicable Laws and which cover all aspects of its obligations under this Agreement (including those it may subcontract to others) and shall at all times comply with such quality controls, systems and processes; […]
9. Governance and Oversight
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(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.
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(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.