Terms & Conditions

1. Interpretation

1.1 In these conditions:

"Account" means an order and supply relationship between the Buyer and Moorfields governed by these terms under which Buyer may Order Products.

"Active" means with respect to a Buyer's Account that the Account has not been suspended by Moorfields nor is the Buyer in arrears under these Conditions to Moorfields.

"Buyer" means the entity or individual having an Account with Moorfields who places Orders.

"Category A" has the meaning set out in Clause 3.1.1.

"Category B" has the meaning set out in Clause 3.1.2.

"Conditions" means these terms and conditions of sale set out in this document including any amendments agreed in writing between Moorfields and the Buyer.

"Contract" means a contract for the sale and purchase of Products pursuant to those Conditions.

"Compendial Standards" means those standards relating to purity, sterility, concentration, product specification and manufacturing processes which are applicable to the Product according to the British Pharmacopeia then in force.

"Delivery" and "Delivered" means ex works (Incoterms 2000) Moorfields' facility once Moorfields notifies the Buyer that the Products are ready for collection.

"GMP" means Good Manufacturing Practices as promulgated in ICH Q7A (Guideline on Good Manufacturing Practice for Active Pharmaceutical Ingredients) applicable to Specials.

"Latent Defect" means a material and unexpected defect in the Product which could not have been identified at the time of Delivery having used reasonable efforts in testing and inspecting the Product.

"Manufacturing Licence" means Moorfields' manufacturing licence number ML/11412/01 and/or ML(S)11412/01 and for Investigational Medicinal Products 11412.

"Moorfields" /means Moorfields Eye Hospital NHS Foundation Trust trading as Moorfields Pharmaceuticals.

"Order" or "Ordered" means each Buyer's order for Products communicated to Moorfields by written instrument, facsimile, email or telephone.

"Price" means the price of the Products notified by Moorfields to Buyer.

"Products" means, as the context requires, those Category A, Category B and?or licensed products, as identified by Moorfields, Ordered by Buyer pursuant to an Account.

"Specials" means unlicensed medicinal products manufactured under an appropriate manufacturing licence issued by the Medicines and Healthcare Products Regulatory Agency.

"Specification" means the specification which the Product must meet as defined by Moorfields.

"Wholesale Dealers Licence" means Moorfields' wholesale dealer's licence number WL/11412/001.

1.2 Any reference in these Conditions to a statute or a provision of a statute shall be construed as a reference to that statute or provision as amended, re-enacted or extended to the relevant time.

1.3 The headings in these Conditions are for convenience only and shall not affect their interpretation.

2. Incorporation and Sale

2.1 An Account may be opened by Moorfields at its sole discretion following receipt of a completed application form and may be suspended or closed at any time without notice.

2.2 These Conditions shall apply to the Contract between Moorfields and the Buyer to the exclusion of all other terms and conditions other than those which may not be excluded as a matter of law by contract and the placing of an Order by Buyer shall constitute an unqualified agreement that the Contract be governed by these Conditions.

2.3 All Orders for Products shall be deemed to be an offer by the Buyer to purchase Products for the Price pursuant to these Conditions. Moorfields shall communicate its acceptance either by oral or written confirmation or by Delivery.

2.4 Any variation to these Conditions (including any special terms and conditions agreed between the parties) shall be inapplicable unless agreed in writing by Moorfields and the Buyer.

3. Product Quality

3.1 The quality and description of the Products supplied hereunder will be designated by Moorfields as either Category A or Category B products and for each Product:

3.1.1 designated as a Category A product it shall be a pharmaceutical preparation manufactured as a Special and according to applicable GMP standards either by Moorfields under its Manufacturing Licence or it shall be supplied by Moorfields under its Wholesale Dealers Licence and the preparation shall based on validated and documented procedures meet, where such standards exist and are applicable, Compendial Standards and Specification; or,

3.1.2 designated as a Category B product it shall be a pharmaceutical preparation manufactured as a Special and according to applicable GMP standards either by Moorfields under its Manufacturing Licence or it shall be supplied by Moorfields under its Wholesale Dealers Licence but the preparation will not have been manufactured to Compendial Standards, the Specification nor have undergone any sterility or analytical testing.

3.2 No application for a product licence or marketing approval has been made for the Products and the Products are only to be administered for human use under the direction of a UK registered doctor or dentist responsible for each patient and may not be exported unless the Buyer has the necessary licences and consents from applicable regulatory authorities.

3.3 The Products shall be marked in accordance with any applicable regulation or requirement in the UK and shall be properly packed using reasonable care and skill to take reasonable steps to minimise any damage during transport.

3.4 The Buyer acknowledges that the Products are Specials and unlicensed and the Buyer will itself, and shall procure that any registered doctor or dentist supplied with such Products by Buyer (or its agent), adequately and effectively warns patients of the status and risks associated with the Products.

3.5 In the event that Moorfields recalls any Products, Moorfields will give instructions, at the time of Product recall on the procedure for returning any Products.

4. Delivery & Inspection

4.1 The Products shall be Delivered within 4 days of the Offer unless Moorfields notifies Buyer before, that the Order has not been accepted by Moorfields or that there will be a delay in Delivery.

4.2 If the Products are Delivered by instalments the Contract will be treated as a single contract and not severable.

4.3 The Buyer shall be entitled to reject any Products which are not delivered in accordance with the Contract subject to the obligations on returns set out in Clause 8 below. The Buyer shall inspect the Products promptly after collection and in any event within 2 working days and shall notify Moorfields in accordance with the procedure for returns set out in Clause 8 below. Other than for Latent Defects in the Products, Buyer will not be entitled to return any Products other than in accordance with the rights under Clause 8.

5. Risk and Property

5.1 Risk of damage to or loss to the Products shall pass to the Buyer upon Delivery. The title to the Products shall pass to the Buyer only once payment is made in full for the Products to Moorfields. Until such time as the title in the Products passes to the Buyer, the Buyer shall hold the Products to Moorfields' order and shall not distribute, use, destroy or dispose of the same.

6. Price

6.1 The Price of the Products shall be notified to Buyer by telephone unless already correctly stated in an Order and unless otherwise stated shall be:

6.1.1 exclusive of taxes, duties, levies and value added tax (which shall be payable by the Buyer subject to receipt of a VAT invoice), and

6.1.2 exclusive of all charges for packaging, packing, shipping, carriage, insurance and transport of the Products to the delivery address and any duties, imposts or levies.

7. Terms of Payment

7.1 Moorfields shall issue the Buyer with an invoice for the Products within a reasonable period after receipt of the order.

7.2 Unless otherwise stated in the Order the Buyer shall pay the Price of all the Products in the Order within thirty (30) days from the issue of invoice.

7.3 Moorfields shall have the right to suspend the Buyer's Account where any invoice remains unpaid for sixty (60) days or more.

7.4 Interest on overdue invoices shall accrue from the date when payment was due from day to day until the date of payment at a rate of 4% above Barclays Bank plc's base rate from time to time in force and shall accrue at such a rate after as well as before any judgement.

8. Returns

8.1 Products will not be accepted for returns except where (i) the Products or packaging at the time of Delivery were faulty, or (ii) the Product has a Latent Defect that has arisen solely due to Moorfields' negligence in or failure to manufacture Product according to the applicable standards for the Product.

8.2 In order to benefit from this returns policy the Products must since Delivery have always been stored and transported in accordance with the applicable transport and storage guidelines and not be used, unsealed, marked, overlabelled, changed or interfered with. Defective Product (excluding Latent Defects)

8.3 Where the Products are returned as a result of faulty Product (other than Latent Defects) and/or packaging the Buyer must:

8.3.1 contact Moorfields' wholesale dealing department within five (5) working days of Delivery to notify Moorfields of the defect, including details of the defect and quantity of Product affected, and request instruction for the return of such Product and/or packaging;

8.3.2 store and transport the Product in accordance with the transport and storage guidelines;

8.3.3 not mark, damage, interfere with or alter the returned Products in any way; and

8.3.4 return the Products together with its packaging with a returns form within two (2) working days of the notification pursuant to Clause 8.5.1.

8.4 The faulty Products and/or packaging will be forwarded to Moorfields' quality assurance department for investigation. Where Moorfields determines that the Product is defective and such defect is due to Moorfields' handling or manufacture of Product then Moorfields will provide the Buyer with replacement Products or credit or refund in accordance with the Buyer's requirements. Latent Defects

8.5 Provided that the Product has been properly stored and transported in accordance with the transport and storage guidelines, where a Latent Defect in a Product becomes apparent to the Buyer before the expiry date of that Product, the Buyer shall notify Moorfields within three (3) working days of discovering the Latent Defect and provide details of the Latent Defect and how and when it was discovered. Buyer shall return such Product having the Latent Defect within two (2) working days of notifying Moorfields.

8.6 The faulty Products and/or packaging will be forwarded to Moorfields' quality assurance department for investigation. Where Moorfields determines that the Latent Defect in the Product is due to Moorfields' handling or manufacture of Product then Moorfields will provide the Buyer with replacement Product or credit or refund in accordance with the Buyer's requirements.

9. Product Recall and Adverse Event Reporting

9.1 In order that Moorfields can comply with its obligations under UK regulations applicable to Specials, Buyer undertakes that it will itself, and shall procure that any registered doctor or dentist supplied with Products by Buyer (or its agent) will:

9.1.1 notify Moorfields:

9.1.1.1 immediately of any serious adverse drug reaction relating to the Product; or

9.1.1.2 promptly, within two (2) working days of the incident, of any suspected adverse drug reaction relating to the Product; together with details of the adverse reaction and such other information as may be necessary to enable Moorfields to file an appropriate report and notification with the relevant regulatory authorities;

9.1.2 upon request by Moorfields, immediately cease all use and prescription of any Product and notify all persons issued or prescribed with the Products to immediately cease all use of such Products and return them to Moorfields where it is known or reasonably suspected that such Products are defective or unsafe;

9.1.3 co-operate with Moorfields at all times in connection with monitoring the safety and performance of the Products and recalling any Products pursuant to this clause 9.

10. Warranties

10.1 Moorfields warrants to the Buyer that:

10.1.1 the Product will be of the standard of quality held out by Moorfields or made known to the Buyer having regard to whether the Product is defined as Category A or Category B product in accordance with clause 3.1 above;

10.1.2 in respect of Product Delivered under each Contract Moorfields will have, as applicable, the relevant Manufacturing Licence and/or Wholesale Dealer's Licence relevant for that Product.

10.2 The Buyer warrants to Moorfields:

10.2.1 that the Buyer is authorised to Order Products from Moorfields being (i) a UK registered doctor or dentist requiring Products for patients under his/her direct control and responsibility or (ii) a pharmacist in a hospital or (iii) a healthcare centre or (iv) a registered pharmacy or (v) a registered veterinary practitioner, or (vi) a licensed wholesale dealer who is permitted to supply to any of (i) to (iv) above;

10.2.2 that the Buyer acknowledges and understands that all Specials supplied under each Contract are unlicensed medicinal products having their own inherent risks and the Buyer will itself and will procure that any registered doctor or dentist supplied with Specials by Buyer (or its agent) will, notify the patient that the Product is a Special and explain the consequences and associated risks of that status;

10.2.3 that it will store and transport the Products in accordance with the notified transport and storage requirements, will immediately destroy any Product as it expires, and will act with due care not to jeopardise the safety of a patient using the Products;

10.2.4 to monitor the safety of the Products and comply with the obligations of Clause 9 and maintain and provide for a period not less than 7 years all documentation relating to the Product for the primary purpose of being able to trace the Product from Delivery through to (and including) use by the patient.

11. Indemnity

11.1 The Buyer shall on demand indemnify and hold harmless Moorfields and each of Moorfields' officers, directors, employees and agents from and against any and all losses, demands, claims, damages, costs, expenses (including consequential losses and loss of profit, reasonable legal costs and expenses and VAT thereon) and liabilities suffered or incurred, directly or indirectly, by Moorfields in consequence of:

11.1.1 any use of the Products in breach of these Conditions or breach of applicable regulations;

11.1.2 any breach of clause 10.2.1.

12. Limitation of Liability

12.1 Nothing in these Conditions shall limit either party's liability to the other for (i) death or personal injury resulting from their negligence, (ii) fraud, or (iii) any breach of a warranty or undertaking which is implied or imposed by law and which cannot be limited or excluded by contract.

12.2 Without prejudice to clause 12.1 the aggregate liability of Moorfields in respect of any loss or damage suffered by the Buyer and arising out of or in connection with this Contract, whether in contract, tort (including negligence) or for breach of statutory duty or in any other way, shall not exceed the amount of Price actually paid by the Buyer to Moorfields pursuant to this Contract.

12.3 Without prejudice to clause 12.1, Moorfields shall not be liable, in contract, tort (including negligence) or for breach of statutory duty or in any other way for;

12.3.1 any loss arising from or in connection with loss of revenue, profits, contracts or business or failure to realise anticipated savings;

12.3.2 any loss of goodwill or reputation; or

12.3.3 any indirect or consequential loss suffered or incurred by the Buyer arising out of or in connection with the use by the Buyer of the Products, or any other matter under this Contract.

13. Termination

13.1 Upon conclusion of each Party's obligations under each Contract for an Order the Contract in respect of that Order shall automatically expire. Either party may terminate a Contract before its expiry upon giving thirty (30) days written notice if the defaulting party fails to pay any sum due hereunder or commits a material breach of its obligations under this Contract and fails to remedy such breach during the period of 30 days provided that the notice generally identifies the breach.

13.2 Termination of a Contract for whatever reason shall not affect the accrued rights of either Moorfields or the Buyer arising under or out of the Contract and all provisions expressed to survive the Contract and the provisions of clauses 10.2 11.1 and 12.3 shall survive termination or expiry and remain in full force and effect.

13.3 An Account may be terminated by Moorfields giving written notice to the last known address of the Buyer such notice to be effective immediately notwithstanding that any amounts outstanding on the Account will continue to be due to Moorfields and will be payable immediately and without further notice.

14. Applicable Law and Jurisdiction

14.1 The validity, construction and performance of the Contract (and any claim, dispute or matter arising under or in connection with it or its enforceability) shall be governed by and construed in accordance with the laws of England and Wales and each party irrevocably submits to the exclusive jurisdiction of the English courts over any claim, dispute or matter arising under or in connection with the Contract or its enforceability and waives any objection to proceedings in such English courts on the grounds of venue or on the grounds that the proceedings have been brought in an inconvenient forum.

15. Miscellaneous

15.1 A person who is not a party to this Contract has no right under the Contracts (Rights of Third Parties) Act 1999 to rely upon or enforce any term of this Contract.

15.2 Moorfields may assign its rights under any Contract to a third party without requiring consent from Buyer provided that notice of such assignment is given to Buyer within 14 working days of the assignment. Buyer may not assign its rights under any Contract without the prior written consent of Moorfields.

15.3 The Conditions contained herein with respect to each Contract constitute the entire agreement and understanding between the parties with regard to the subject matter of that Contract and supersedes and replaces any previous agreement between the parties with regard to its subject matter. No modification, amendment or variation of these Conditions shall be effective unless in writing and signed by both parties and no modification, amendment or variation of these Conditions shall constitute or be construed as a waiver of any provisions of the Contract nor affect any rights or liabilities under the Contract which had accrued up to the date of such modification or variation and the rights and obligations of the parties under the Contract shall remain in full force and effect, except and only to the extent that they are so modified or varied.

15.4 In no event will any delay, failure or omission (in whole or in part) in enforcing, exercising or pursuing any right, power, privilege, claim or remedy be deemed or construed as a waiver of that or any right nor operate as to bar the enforcement of that right.

15.5 If any provision of the Contract shall be found by any court or administrative body of competent jurisdiction to be invalid or unenforceable, such invalidity or unenforceability shall not affect the other provisions of the Contract which shall remain in full force and effect. The obligations of the parties under any invalid or unenforceable provision of the Contract shall be suspended whilst an attempt is made by the parties in good faith to substitute such provisions with valid and enforceable provisions which to the greatest extent possible have the same effect as the invalid and unenforceable provisions would have achieved were they valid.