6.4 Future therapeutic indications (for ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor or ivacaftor/tezacaftor/tezacaftor/elexacaftor), which have been marketed by the European Medicines Agency for the United Kingdom or the Medicines and Health Products Regulatory Agency for the duration of the interim access contract, are automatically considered to be an integral part of this agreement and formalized by a complement to the interim agreement. 10.3 The relevant provisions of the agreements covered in point 10.2 should be submitted to the Interim Access Appeal Board for consideration at its first meeting (i.e., no later than two months after the start of this agreement). But the deal comes after years of deadlock. Orkambi obtained its European approval in 2015 and patients and lawmakers urged the parties to reach an agreement on access after several rounds of negotiations. Vertex will work closely with the authorities in Northern Ireland, Wales and Scotland to reach an equivalent agreement in these countries as soon as possible. 2.3.1 Nice`s recommendation was published following an assessment of new evidence gathered during the initial period of the Interim Access Agreement; Or 13.2 This agreement can be executed in a Beké tenais, each of which, when executed and delivered, is an original double, but all the counterparties combined form an agreement. The transmission of the executed signature page of a counter-part of the agreement by fax or (b) e-mail (in PDF, JPEG or any other agreed format) takes effect as a delivery of an executed equivalent of this Agreement. If one of the two types of deliveries is applied without prejudice to the validity of the agreement thus concluded, each party communicates to the other party the original of the other party as soon as possible. No counterparty can be effective until each party has exported and delivered at least one counterpart. Tagged Agreement, England, Kaftrio, NHS England, Refund, Trikafta, Vertex Pharmaceuticals.
2.2 This agreement and its new conditions begin on the date of the publication of this agreement on the NICE website, after the implementation of this agreement by all parties, and replace the previous agreement (of 11 November 2019). The agreement grants access to kaftrio (marketed as Trikafta in the United States) if approved in Europe and expands the prepayment agreement for other approved Vertex drugs, namely Kalydeco (Ivacaftor), Orkambi (Lumacaftor/ivacaftor) and Symkevi (Tezzacafacator/ivacaftor combo). The agreement also includes future indications for these drugs. “I am pleased that NHS England has recognized the value of Kaftrio and that Vertex and NHS England have been able to work quickly, collaboratively and flexibly to extend the existing refund agreement to combination ART prior to marketing authorization,” said Reshma Kewalramani, CEO and President of Vertex. Steve Bates OBE, CEO of the UK BioIndustry Association, commented on the agreement in a statement of 30 June 2020 as s: “It is fantastic to see the NHS and Vertex reach a breakthrough agreement to allow patients with NHS cystic fibrosis to access this important revolutionary therapy.