ACCEPTABLE USE RESTRICTIONS You must: • not use the App or any Service in any unlawful manner, for any unlawful purpose, or in any manner inconsistent with these terms, or act fraudulently or maliciously, for example, by hacking into or inserting malicious code, such as viruses, or harmful data, into the App, any Service or any operating system; • not infringe our intellectual property rights or those of any third party in relation to your use of the App or any Service, including by the submission of any material (to the extent that such use is not licensed by these terms); • not transmit any material that is defamatory, offensive or otherwise objectionable in relation to your use of the App or any Service; • not use the App or any Service in a way that could damage, disable, overburden, impair or compromise our systems or security or interfere with other users; and • not collect or harvest any information or data from any Service or our systems or attempt to decipher any transmissions to or from the servers running any Service.
Compliance; Permits; Restrictions (a) The Company and each of its Subsidiaries are, and since January 1, 2019 have been, in compliance in all material respects with all applicable Laws, including the Federal Food, Drug, and Cosmetic Act (“FDCA”), the U.S. Food and Drug Administration (“FDA”) regulations adopted thereunder, the Public Health Service Act and any other similar Law administered or promulgated by the FDA or other comparable Governmental Body responsible for regulation of the development, clinical testing, manufacturing, sale, marketing, distribution and importation or exportation of drug and biopharmaceutical products (each, a “Drug Regulatory Agency”), except for any noncompliance, either individually or in the aggregate, which would not be material to the Company. No investigation, claim, suit, proceeding, audit or other action by any Governmental Body is pending or, to the Company’s Knowledge, threatened against the Company or any of its Subsidiaries. There is no agreement, judgment, injunction, order or decree binding upon the Company or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any business practice of the Company or any of its Subsidiaries, any acquisition of material property by the Company or any of its Subsidiaries or the conduct of business by the Company or any of its Subsidiaries as currently conducted, (ii) is reasonably likely to have an adverse effect on the Company’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, delaying, making illegal or otherwise interfering with the Contemplated Transactions. Notwithstanding the foregoing, for all purposes of this Agreement, the Company does not make any representation or warranty (pursuant to this Section 2.15 or elsewhere) regarding the effect of any applicable Antitrust Laws on the Company’s ability to execute, deliver or perform its obligations under this Agreement or to consummate the Contemplated Transactions as a result of any enactment, promulgation, application or threatened or actual judicial or administrative investigation or litigation under, or enforcement of, any Antitrust Laws with respect to the consummation of the Contemplated Transactions. (b) The Company and its Subsidiaries hold all required Governmental Authorizations which are material to the operation of the business of the Company and its Subsidiaries as currently conducted (the “Company Permits”). Section 2.15(b) of the Company Disclosure Schedule identifies each Company Permit. The Company and its Subsidiaries hold all right, title and interest in and to all Company Permits free and clear of any Encumbrance. The Company and each of its Subsidiaries is in material compliance with the terms of the Company Permits. No Legal Proceeding is pending or, to the Company’s Knowledge, threatened, which seeks to revoke, limit, suspend, or materially modify any Company Permit. The rights and benefits of each Company Permit will be available to the Surviving Corporation or its Subsidiaries, as applicable, immediately after the Effective Time on terms substantially identical to those enjoyed by the Company and its Subsidiaries as of the date of this Agreement and immediately prior to the Effective Time. (c) There are no proceedings pending or, to the Company’s Knowledge, threatened with respect to an alleged material violation by the Company or any of its Subsidiaries of the FDCA, FDA regulations adopted thereunder, the Public Health Service Act or any other similar Law administered or promulgated by any Drug Regulatory Agency. The Company is not currently conducting or addressing, and to the Company’s Knowledge there is no basis to expect that it will be required to conduct or address, any corrective actions, including, without limitation, product recalls or clinical holds. (d) To the Company’s Knowledge, all clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, the Company or its Subsidiaries, or in which the Company or its Subsidiaries or their respective current products or product candidates have participated, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and in compliance in all material respects with the applicable regulations of any applicable Drug Regulatory Agency and other applicable Law, including 21 C.F.R. Parts 50, 54, 56, 58 and 312. Since January 1, 2019, neither the Company nor any of its Subsidiaries has received any notices, correspondence, or other communications from any Drug Regulatory Agency requiring, or, to the Company’s Knowledge, threatening to initiate, the termination or suspension of any clinical studies conducted by or on behalf of, or sponsored by, the Company or any of its Subsidiaries or in which the Company or any of its Subsidiaries or their respective current products or product candidates have participated. (e) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the Company’s Knowledge, threatened investigation in respect of its business or products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. To the Company’s Knowledge, neither the Company nor any of its Subsidiaries has committed any acts, made any statement, or failed to make any statement, in each case in respect of its business or products that would violate the FDA’s “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy, and any amendments thereto. None of the Company, any of its Subsidiaries or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) any similar applicable Law. No debarment or exclusionary claims, actions, proceedings or investigations in respect of their business or products are pending or, to the Company’s Knowledge, threatened against the Company, any of its Subsidiaries or any of their respective officers, employees or agents.
Restricted Uses Without limiting the unsupported or prohibited use cases identified in the Stripe Identity Permitted Businesses list, you must not, and must not enable or allow any other party to: (a) modify the Stripe Identity Services in any way, including by changing
Permitted and Prohibited Uses 1.1. The Data may only be used for linguistic education and research, including but not limited to information retrieval, document understanding, machine translation or speech recognition. 1.2. User shall not publish, retransmit, display, redistribute, reproduce or commercially exploit the Data in any form, except that User may include limited excerpts from the Data in articles, reports and other documents describing the results of User’s linguistic education and research.
Restricted Use Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Adalimumab (Humira® / Biosimilar) NHSE Children with Severe Refractory Uveitis with onset in childhood (age 2 or more up to 18 or less) - as per NHS England policy Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Adalimumab (biosimilar) (Imraldi® / Amjevita®) ICB Peripheral spondyloarthritis - following use of 3 DMARDs, as per local pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Adalimumab (biosimilar) various ICB weekly use for dose escalations in NICE-approved rheumatology indications Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Adefovir Hepsera ® NHSE Hepatitis B Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care CG165 - Oct 17 Double Red ADHD drugs - various (Various) ICB First-line use in children and adolescents with ADHD - as per NICE CG 72 - Do Not Do (Not a licensed indication). Not recommended for routine use - Specialist initiation only CG72 - Feb 16 Double Red ADHD drugs - various (Various) ICB Use in pre-school children - as per NICE CG 72 - Do Not Do (Not a licensed indication). Not recommended for routine use - Specialist initiation only CG72 - Feb 16 BLACK Afamelanotide Scenesse® NHSE erythropoietic protoporphyria Not commissioned. No NHS prescribing in primary or secondary care HST27 – July 2023 Hospital Afatinib ▼ (Giotrif® ▼) NHSE Treatment of epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small-cell lung cancer - as per NICE TA 310 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA310 - April 2014 BLACK Afatinib ▼ (Giotrif® ▼) NHSE Advanced squamous non-small-cell lung cancer after platinum-based chemotherapy - as per NICE TA 444 (terminated appraisal) Not commissioned. No NHS prescribing in primary or secondary care TA444 - May 17 Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance Hospital Aflibercept (Eylea®) ICB Treatment of Wet Age-related Macular Degeneration Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA294 - Jul 13 Hospital Aflibercept (Eylea®) ICB Wet Age-related Macular Degeneration (AMD) Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA294 - Jul 13 Hospital Aflibercept (Eylea®) ICB Wet Age-related Macular Degeneration (AMD) in new patients Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA294 - Jul 13 Hospital Aflibercept (Eylea®) ICB Visual impairment caused by macular oedema secondary to central retinal vein occlusion (CRVO) - as per NICE TA 305 and local treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA305 - Feb 14 BLACK Aflibercept (Zaltrap®) NHSE Treatment of metastatic colorectal cancer that has progressed following prior oxaliplatin-based chemotherapy (along with irinotecan and fluorouracil- based therapy) - as per NICE TA 307 - NICE Do Not Do Not commissioned. No NHS prescribing in primary or secondary care TA307 - Mar 14 Hospital Aflibercept (Eylea®) ICB Treatment of visual impairment caused by diabetic macular oedema (DMO) Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA346 - Jul 15 Hospital Aflibercept (Eylea®) ICB Visual impairment caused by macular oedema after branch retinal vein occlusion - as per NICE TA 409 and local treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA409 - Sep 16 Hospital Aflibercept (Eylea®) ICB Treatment of visual impairment due to myopic choroidal neovascularisation in adults - as per NICE TA 486 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA486 - Nov 17 Hospital Aflibercept (Eylea®) ICB Treatment of Diabetic Macular Oedema (DMO) as part of a treat and extend regimen in line with the locally commissioned treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance Hospital Aflibercept (Eylea®) ICB Treatment of Wet Age-related Macular Degeneration (AMD) as part of a treat and extend regimen in line with the locally commissioned treatment pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Aflibercept (switched to Ranibizumab (Lucentis®) (Eylea®) ICB Switching between products in the treatment of Wet Age-related Macular Degeneration (AMD) in previously treated patients who have not responded adequately to, or who have intolerance to aflibercept (Eylea®) - as per locally commissioned pathway Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NG82 - Jan 18 Hospital Agalsidase alfa and beta (Replagal® (alpha) / Fabrazyme® (beta)) NHSE Fabry disease (α-galactosidase A deficiency) Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. BLACK Agomelatine (Valdoxan®) ICB 4th line use in depression where other treatments have failed or not been tolerated (terminated appraisal) Not commissioned. No NHS prescribing in primary or secondary care TA231 - Sep 11 Hospital Albumin bound paclitaxel Abraxane ® NHSE with gemcitabine for untreated metastatic pancreatic cancer Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA476 - Sep 17 Hospital Albutrenpenonacog alfa (Idelvion) NHSE Haemophilia B - as per NHS England policy SSC1652 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. DM Albutropin NHSE Adult onset growth hormone deficiency . Discontinued Medicines NICE has not issued any guidance. Hospital Aldesleukin (Proleukin) NHSE Cancer - metastatic renal cancer Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Alectinib (Alecensa®) NHSE Untreated ALK-positive advanced non- small-cell lung cancer - as per NICE TA 536 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA536 - Aug 18 Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance BLACK Alectinib ▼ (Alecensa® ▼) NHSE Previously treated anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer - as per NICE TA 438 (terminated appraisal) Not commissioned. No NHS prescribing in primary or secondary care TA438 - Mar 17 Hospital Alemtuzumab (Lemtrada®) NHSE Chronic lymphocytic leukaemia (CLL) as per NHS England policy 2013 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Alemtuzumab (Lemtrada®) NHSE Pre-transplant immunosuppression Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Alemtuzumab (MabCampath®) NHSE Behcet's syndrome Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Alemtuzumab ▼ (Lemtrada® ▼) NHSE Treatment of adults with relapsing- remitting multiple sclerosis (RRMS) - as per NICE TA 312 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA312 - May 14 Double Red Alendronate / Vitamin D3 combination (Fosavance®) ICB Treatment of post menopausal osteoporosis in women at risk of vitamin D deficiency Not recommended for routine use NICE has not issued any guidance. GREEN Alendronic acid (sodium alendronate) (Generics available) ICB Secondary prevention of osteoporotic fragility fractures in postmenopausal women - as per NICE criteria Formulary - Drugs that can be initiated by Prescriber in Primary Care TA161 - Oct 08 GREEN Alendronic acid (sodium alendronate) (Generic available) ICB Primary prevention of osteoporotic fragility fractures in postmenopausal women as per NICE criteria Formulary - Drugs that can be initiated by Prescriber in Primary Care TA464 - Aug 17 ADVICE Alfacalcidol (AlfaD®, One- Alpha®) ICB Preparation for hyperparathyroidectomy Formulary - Specialist advice required from primary or secondary care clinician with relevant expertise prior to primary care initiation NICE has not issued any guidance. Hospital Alglucosidase alfa (Myozyme®) NHSE Pompe disease (a lysosomal storage disorder caused by deficiency of acid alpha-glucosidase) - as per NHS England Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance BLACK Alimemazine (Trimeprazine) (Generics) ICB Sedative in children / general antihistamine Not commissioned. No NHS prescribing in primary or secondary care NICE has not issued any guidance. Hospital Alipogene tiparvovec (Glybera®) NHSE (Gene therapy treatment for ) Lipoprotein lipase deficiency - as per NHSE policy Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Alirocumab ▼ (Praluent® ▼) ICB Treating primary hypercholesterolaemia and mixed dyslipidaemia - as per NICE TA 393 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA393 - Jun 16 BLACK Aliskiren ▼ (Rasilez® ▼) ICB Treatment of essential hypertension - as per NICE CG 127 Not commissioned. No NHS prescribing in primary or secondary care CG127 - Sep 11 Double Red Alisporivir ((aka Debio 025 / DEB025 / UNIL- 025)) NHSE Viral Hepatitis C - as per NHSE policy Not recommended for routine use NICE has not issued any guidance. Hospital Alitretinoin (Toctino®) ICB Treatment of severe chronic hand eczema - as per NICE TA 177 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA177 - Aug 09 BLACK Alpelisib Piqray® NHSE with fulvestrant for treating hormone- receptor positive, HER2-negative, PIK3CA-positive advanced breast cancer (terminated appraisal) Not commissioned. No NHS prescribing in primary or secondary care TA652 – October 2020 Hospital Alpelisib Piqray® NHSE with fulvestrant for treating hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA816 – August 2022 Double Red Alpha blockers - various (Various) ICB Treatment of cor pulmonale - as per NICE CG 101 . Not recommended for routine use CG101 - Jul 10 Hospital Alpha-mannosidase - recombinant human (Lamazym®) NHSE Alpha Mannosidase deficiency - as per NHSE policy Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. GREEN Alprostadil cream (Vitaros®) ICB Erectile dysfunction (as per SLS conditions only) Formulary - Drugs that can be initiated by Prescriber in Primary Care NICE has not issued any guidance. Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance Hospital Alteplase (Actilyse®) ICB Treatment of acute ischaemic stroke - as per NICE TA 264 Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA264 - Sep 12 Double Red Amantadine Hydrochloride (Lysovir®) ICB Treatment and prophylaxis of influenza Not recommended for routine use TA168 - Feb 09 Hospital Ambrisentan (Volibris® ▼) NHSE Pulmonary Arterial Hypertension - specialist centre only Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Amifampridine (phosphate) ▼ (Firdapse® ▼) NHSE Treatment of myasthenias - ▇▇▇▇▇▇▇- ▇▇▇▇▇ syndrome - as per NHS England policy Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Amikacin - liposomal for inhalation (Arikace®) NHSE Gram-negative bacterial infection in Cystic Fibrosis . Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Double Red Amikacin (for inhalation) (Amikin®) NHSE Gram-negative bacterial infection in Cystic Fibrosis Not recommended for routine use NICE has not issued any guidance. BLACK Aminobenzoic acid (capsules and powder) (Potaba®) ICB Peyronie's disease, Scleroderma Not commissioned. No NHS prescribing in primary or secondary care NICE has not issued any guidance. AMB 2 Amiodarone (Cordarone X®) ICB Supraventricular and ventricular arrhythmias Shared Care Agreement Level 2 - Prescribe the drug and perform a more intense level of monitoring, e.g. quarterly CG180 - Jun 14 BLACK Amivantamab n/a NHSE EGFR exon 20 insertion mutation- positive advanced non-small-cell lung cancer after platinum-based chemotherapy Not commissioned. No NHS prescribing in primary or secondary care TA850 – December 2022 BLACK Amorolfine (Loceryl and other equivalent preparations) ICB Fungal nail infections Not commissioned. No NHS prescribing in primary or secondary care NICE has not issued any guidance. Hospital Amphotericin B, itraconazole & voriconazole (Various) NHSE Chronic Pulmonary Aspergillosis (CPA) - specialist centre only Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Traffic Light Classification Drug Name Brand Name Commissione r Indication (assume licenced unless stated) Instructions for Prescriber NICE Guidance Hospital Anabasum NHSE Scleroderma Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. AMB Anagrelide ▼ (Xagrid® ▼ / Agrelin® / Agrylin®) ICB Thrombocythaemia Prescribe the drug and perform a basic level of monitoring, e.g. a standard annual review NICE has not issued any guidance. Hospital Anakinra Kineret® NHSE Still’s disease Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care TA685 – March 2021 Hospital Anakinra (Kineret®) NHSE Cryopyrin-associated periodic syndrome (CAPS) Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Anakinra (Kineret®) NHSE Adult onset Still's disease Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NICE has not issued any guidance. Hospital Anakinra (Kineret®) NHSE Rheumatoid arthritis Restricted use – Prescribing to remain with the hospital or specialist service. No prescribing in primary care NG100 - Oct 2020 Hospital Anakinra (Kineret®) NHSE Juvenile Idiopathic Arthritis (JIA) Res