4. Term and Termination
(a) This Agreement shall become effective and binding on the Parties upon the Effective Date and shall remain in effect until fully performed unless earlier terminated as permitted below (the “Term“).
(b) Either party may terminate this Agreement upon [REDACTED] in the following circumstances:
(i) the other party commits a material breach of this Agreement and has not remedied such breach within [REDACTED] from receipt of written notice of such breach;
(ii) if following the Expected Approval Date and consultation within the Working Committee, either (A) an adverse safety signal exists in any population in which the Product is being or has been tested which would be reasonably and objectively likely to cause the Product not to have a safety profile suitable for the grant or issuance of a Marketing Approval; or (B) there is reasonable and objective evidence, or opinion from the MHRA, that the Product will not secure a Marketing Approval.
(c) UK may terminate this Agreement upon written notice to Roche in the following circumstances:
(i) an Excusable Delay (defined below) has continued for [REDACTED];
(ii) if Delivery of the whole of the Firm Quantity has [REDACTED] after the date on which the final tranche of the Firm Quantity is required under the Delivery Schedule and the reasons for the delays have been discussed by the Working Committee (or such later date agreed by the parties) (the “Longstop Date“);
(iii) if the Marketing Approval is subsequently after grant or issuance withdrawn, suspended or conditioned in such a manner to cause material delay in [REDACTED];
(iv) if Roche purports to assign, sub-contract, novate, create a trust in or otherwise transfer or dispose of this Agreement in breach of its terms, including those at Section 15;
(v) the Agreement has been substantially amended to the extent that the Public Contracts Regulations 2015 require a new procurement procedure in circumstances where UK has given notice to Roche of such consequences of the amendment;
(vi) UK has become aware that Roche should have been excluded under Regulation 57(1) or (2) of the Public Contracts Regulations 2015 from the procurement procedure leading to the award of this Agreement;
(vii) there has been a failure by Roche and/or any other person involved in the development, manufacture, packaging, storage, transport or supply of the Product to comply with legal obligations in the fields of environmental, social or labour Law, where such failure to comply materially adversely affects the performance by Roche of its obligations under this Agreement. Where such failure to comply with legal obligations in the fields of environmental, social or labour Law is a failure by a party other than Roche, UK may request the replacement of such party and Roche shall use Commercially Reasonable Efforts to comply with such request as an alternative to UK terminating this Agreement under this section 4(c)(vii);
(viii) if a breach of the representations and warranties in Section 10 occurs on or after the Effective Date; or
(ix) Roche becomes insolvent or bankrupt or makes an assignment in favor of its creditors or a proposal under applicable bankruptcy legislation, or if the business or property of Roche shall be placed in the hands of a receiver or trustee in bankruptcy, by voluntary act or otherwise.