Terms and Conditions
Terms and Conditions of Sale
1. DEFINITIONS AND INTERPRETATION
1.1. Capitalized words and phrases in these Terms have the following meanings: Confidential Information means any information in any form or medium that one party (the Disclosing Party) discloses to the other party (the Receiving Party) at any time concerning the business affairs, technology, plans, strategy, products or services (or future products or services) of the Disclosing Party or any of its affiliates, or any information otherwise confidential to the Disclosing Party or its affiliates.
Contract means the contract between Owen Mumford and the Customer for the sale of Products and/or the provision of Services that incorporates the Proposal and these Terms.
Customer means the person purchasing the Products and/or Services from Owen Mumford. GMP means Good Manufacturing Practice principles relevant to medical device manufacturing as set out in EC Directive 93/42/EEC or Title 21 part 280 of the Code of Federal Regulations. Owen Mumford means Owen Mumford Limited, a company registered in the United Kingdom under company no. 1257871 with the registered office at Primsdown Industrial Estate, Worcester Road, Chipping Norton, Oxfordshire, OX7 5XP, United Kingdom.
Products means the products agreed in the Contract to be supplied by Owen Mumford.
Proposal means any quotation, proposal, standard price list, or contractual document (such as a reseller or distribution agreement) issued by Owen Mumford referencing these Terms. Services means the services agreed in the Contract to be provided by Owen Mumford. Terms means these terms and conditions.
1.2. Phrases beginning with the words including, in particular, for example and similar words are examples and do not limit what is described.
1.3. References to a person include an individual, company, partnership, or other corporate body.
1.4. References to a statute, regulation, statutory or regulatory provision, or code include references to it as amended, re-enacted, or both from time to time, as well as any related subordinate legislation or re-enactments.
2. APPLICATION OF TERMS
2.1. The Contract is governed by these Terms to the exclusion of all other terms and conditions (including those that the Customer attempts to apply through a purchase order or other document), except for any contained in a Proposal or other document that the parties expressly agree will take priority over these terms and conditions. Any terms and conditions that might otherwise be implied by law, custom, or otherwise are excluded from the Contract to the extent allowed by law.
2.2. Each order placed by the Customer is considered an offer by the Customer to purchase Products and/or Services under these Terms. No order is considered accepted by Owen Mumford, and no Contract is formed, until Owen Mumford issues written acceptance of the order or until Owen Mumford starts work to supply the Products and/or Services.
2.3. Any quotation given by Owen Mumford does not constitute an offer and is only valid for thirty (30) days from its date. Owen Mumford may withdraw any quotation at any time at its sole discretion.
2.4. Nothing in these Terms overrides any Quality and Technical Agreement or similar agreement between the parties relating to the quality of Products provided by Owen Mumford.
3. GENERAL OBLIGATIONS OF THE CUSTOMER
3.1. The Customer will cooperate with Owen Mumford in all matters related to the manufacture and supply of Products, or performance of Services, and will respond promptly to all reasonable requests for information from Owen Mumford.
3.2. The Customer will supply, or arrange for the supply to Owen Mumford of, any information or materials (including, as relevant, samples of any drug specified in the Contract) reasonably required by Owen Mumford for performance, along with material safety data sheets and any other information necessary to ensure safe storage and handling of those materials by Owen Mumford. The Customer will ensure that all information provided is accurate and complete. Owen Mumford will use such materials only to perform the Contract and will return them to the Customer upon termination of the Contract or completion of performance.
3.3. If the Contract specifies a minimum order quantity for the Products, the Customer will ensure that its orders meet or exceed that minimum order quantity.
3.4. If Owen Mumford is prevented from or delayed in performing its obligations under the Contract due to any breach by the Customer of this clause 3, or any other action or inaction by the Customer, Owen Mumford will not be responsible for such non-performance or delay and will be entitled to payment as though it had performed.
4. DEVELOPMENT WORK AND OTHER SERVICES
4.1. Owen Mumford will make reasonable efforts to provide the Services to the Customer in accordance with applicable law (including GMP) and (except as set out in clause 5.2) in all material respects according to any agreed specification between Owen Mumford and the Customer.
4.2. While Owen Mumford will perform the Services according to the Contract in all material respects, it is the Customer’s responsibility to ensure the Services and any deliverables described in the Contract are suitable for their intended purpose.
4.3. Owen Mumford will do its best to meet any performance dates agreed with the Customer for the Services, but any such dates are estimates only. Owen Mumford will keep the Customer reasonably informed about the progress of the Services. If Owen Mumford becomes aware of anything that will or is likely to delay or affect its performance of the Services, it will inform the Customer and provide details of any corrective actions planned.
4.4. If any assumptions or dependencies are identified in the Proposal, Owen Mumford will not be responsible for any delay or non-performance caused by those assumptions or dependencies not being met. Owen Mumford may, acting reasonably and with written notice to the Customer, adjust the price or estimated timelines to reflect any unmet assumption or dependency or any Customer act or omission.
5. AMENDMENTS TO SPECIFICATIONS
5.1. The Customer may request an amendment to the specifications for the Products and/or Services at any time. If an amendment is reasonably practical, Owen Mumford will, at its option, provide the Customer with a proposed adjustment to the charges and any timeline changes necessary to accommodate the amendment. Owen Mumford may also suggest amendments at any time, and will provide proposed adjustments to charges and timelines at the same time. In either case, the Customer may choose to proceed with the amendment by accepting Owen Mumford’s adjustment to charges and timings and notifying Owen Mumford within fourteen (14) days of receiving the proposal.
5.2. Owen Mumford may change the specifications of any Products and/or Services if needed to comply with law or regulatory requirements, avoid third-party intellectual property violations, or if the amendment does not materially affect the nature or quality of the Products and/or Services.
6. REGULATIONS
6.1. Owen Mumford will, at its own cost, prepare and maintain all approvals and registrations for manufacturing facilities and quality assurance systems needed for manufacturing Products under the Contract.
6.2. The Customer is responsible for obtaining and maintaining all regulatory approvals and registrations for the use of the Products in each country where it intends to use or sell them. Product registrations should be secured in Owen Mumford’s name whenever possible (or otherwise in the Customer’s name) and the Customer must provide Owen Mumford with a full copy of all filed documents and relevant correspondence. The Customer will transfer any such registration and all related documents to Owen Mumford, or Owen Mumford’s nominee, upon request and provide reasonable assistance for the transfer. If a transfer is requested, Owen Mumford will reimburse the Customer for any applicable regulatory authority fees paid by the Customer, proportionate to the remaining term of the registration.
6.3. Owen Mumford will maintain records relating to the manufacture of the Products as required by GMP and provide copies to the Customer upon request.
6.4. If requested by the Customer, Owen Mumford may provide additional documents or assistance as agreed to support regulatory submissions for the Product. Owen Mumford may charge its standard hourly rates for this work.
6.5. The Customer must comply with all regulatory requirements related to the Products, including those regarding licenses, complaints, distribution and storage. The Customer will maintain accurate and current records to enable the immediate recall of any Product batch from subsequent purchasers. These records must include delivery details for each purchaser, including batch numbers, delivery dates, and names and contact details.
7. PRODUCTS – ORDERING AND DELIVERY
7.1. The Products are described in Owen Mumford’s catalogs, brochures, or website (as applicable), or in the Proposal, and will be provided according to their specifications.
7.2. If a minimum order quantity and/or batch size has been agreed in the Contract, the Customer must order according to those requirements.
7.3. If the Customer agrees to purchase a certain quantity of Products and arrange delivery over a period, the Customer must give Owen Mumford reasonable notice of delivery requirements during that period.
7.4. The Customer must provide any materials (such as drug quantities) required for each order to Owen Mumford prior to or as soon as possible after placing the order. Owen Mumford may refuse to accept an order until the necessary materials are received.
7.5. Without limiting clause 7.4, where relevant:
a) all primary container systems (syringes and cartridges), system components (bungs, needle shields, etc.) and drug product samples (water for injection, drug) needed for commercial batch release testing and other tests must be provided free of charge by the Customer to Owen Mumford (in an amount to be mutually agreed as early as possible before the order is submitted);
b) the specification will define acceptable syringes, including break loose and glide force requirements for use with the Product. Owen Mumford will release Product batches tested with Customer-supplied syringes on the basis that they are compatible with the specification; and
c) the Customer is responsible for the costs of any failed batches and of any investigation work due to syringe incompatibility issues.
7.6. Owen Mumford will use reasonable efforts to deliver the Products within the agreed lead time (excluding any shipping requested by the Customer). Any delivery dates specified by Owen Mumford are estimates only.
7.7. Unless otherwise agreed in writing, delivery will take place at Owen Mumford’s place of business when the Customer is notified that Products are ready for pick-up. The Customer must collect or arrange collection within five (5) business days. If Owen Mumford agrees to arrange shipping to another address, it is at the Customer’s expense and risk, and the Customer is responsible for unloading.
7.8. Owen Mumford may deliver Products in installments. Any delay in, or defect with, one installment does not entitle the Customer to cancel other installments.
7.9. If the Customer refuses delivery, fails to arrange collection under clause 7.7, or Owen Mumford cannot deliver on time due to the Customer not providing proper instructions, paperwork, licenses, or authorizations, Products are deemed delivered on Owen Mumford’s intended delivery date and Owen Mumford may charge for all storage costs (including insurance) until collection.
7.10. If Owen Mumford delivers more or less than the ordered quantity:
a) In case of a shortfall, the Customer cannot object to or reject the Products actually delivered solely because of the shortfall; and
b) In case of a surplus, the Customer shall return the surplus to Owen Mumford at Owen Mumford’s risk and cost or, with Owen Mumford’s consent, pay for the surplus.
8. PRODUCTS – WARRANTY AND INSPECTION
8.1. Owen Mumford warrants that Products will be manufactured under GMP and comply in all material respects with their specifications on delivery or for any warranty period agreed in the Proposal.
8.2. Where applicable, before delivery of any Products, Owen Mumford will perform tests (including as required by any quality agreement) to verify compliance with specifications and will supply a certificate of conformity with each batch.
8.3. The Customer must acknowledge receipt of each shipment promptly upon arrival. The Customer must inspect each batch within fourteen (14) days after receipt and may, by written notice to Owen Mumford within that period, reject any batch that does not comply with the warranty in clause 8.1. Owen Mumford will, at its option and as soon as is reasonably practicable, either replace the batch at its own cost (not including the cost of any Customer-supplied materials in the Products) or refund amounts paid for that batch. If requested, the Customer must return the rejected batch at Owen Mumford’s expense. Provided Owen Mumford complies with this clause, it has no further liability to the Customer for any failure of the Products to meet the warranty in clause 8.1.
8.4. If the parties cannot agree whether a batch meets the warranty, they will refer the matter to an independent expert laboratory agreed between them. The decision of the expert is binding (except for fraud or manifest error), and costs are borne by the party the expert disagrees with.
8.5. Owen Mumford is not liable for any non-conformity with clause 8.1 caused by: (a) damage during transport; (b) the Customer not following Owen Mumford’s instructions (oral or written) regarding storage, commissioning, installation, use, maintenance, or, if not provided, good trade practice; (c) following a drawing, design or specification supplied by the Customer; or (d) fair wear and tear, willful damage, negligence, or abnormal storage or working conditions.
8.6 These conditions apply to any repaired or replaced Products supplied by Owen Mumford.
9. RISK/TITLE IN PRODUCTS
9.1. Risk passes to the Customer upon delivery (or deemed delivery under clause 7.9).
9.2. Title does not pass until Owen Mumford receives full payment for the Products, except that if the Customer resells as permitted under clause 9.4, ownership passes on resale.
9.3. Until title passes to the Customer, the Customer must:
a) hold the Products on trust as Owen Mumford’s bailee;
b) store the Products separately from other goods so they are clearly identifiable as Owen Mumford’s property;
c) not destroy, deface or conceal identifying marks or packaging on the Products;
d) maintain the Products in satisfactory condition, insure them for their full price against all reasonable risks and hold insurance proceeds on trust for Owen Mumford;
e) immediately notify Owen Mumford if it becomes affected by any of the events listed in Error! Bookmark not defined.
9.4. The Customer may resell the Products before title passes only:
a) in the ordinary course of business at full market value; and
b) as a sale of Owen Mumford’s property on the Customer’s own behalf as principal.
9.5. If before title passes, the Customer is affected by any of the events in clause 15.3.c) or places a charge or encumbrance over any of the Products:
a) the right to resell ceases immediately;
b) the right to use the Products in the ordinary course of business ceases immediately; and
c) Owen Mumford may require immediate delivery of all Products in the Customer’s possession not resold or irreversibly incorporated, and, if needed, may enter any Customer or third-party premises to recover them.
9.6. The Customer grants Owen Mumford, its agents, and employees an irrevocable license to enter any premises where the Products are stored at any time with reasonable notice to inspect or recover them if the right to possession ends.
10. PRICE AND PAYMENT
10.1. The price for Products and/or Services is as set out in Owen Mumford’s Proposal or acceptance of order, exclusive of VAT, which, if applicable, will be payable by the Customer at the prevailing rate upon receipt of a proper VAT invoice.
10.2. Unless stated otherwise, Owen Mumford may invoice the Customer:
a) for Products at any time on or after actual or deemed delivery;
b) for fixed-fee Services, at each invoicing milestone set out in the Contract, or, if no milestones are agreed, at the start of the Services;
c) for time-and-materials Services, monthly in arrears.
10.3. The Customer must pay all invoices in full in cash or cleared funds to Owen Mumford’s nominated bank account within thirty (30) days of the invoice date. Time for payment is of the essence.
10.4. Owen Mumford may vary the Customer’s payment terms by written notice at any time, especially if it decides the Customer presents a credit risk. Changes may include requiring prepayment with order or requiring immediate payment of invoices.
10.5. All payments must be made in full without set-off or deductions.
10.6. In case of late payment, Owen Mumford may claim, and the Customer must pay, interest and recovery costs as permitted by the Late Payment of Commercial Debts (Interest) Act 1998.
11. CONFIDENTIALITY
11.1. The Receiving Party must:
a) keep all Confidential Information strictly confidential and take all reasonable precautions against unauthorized disclosure, at least as stringent as for its own confidential information;
b) not disclose Confidential Information to any third party without prior written consent from the Disclosing Party, except as allowed by the Contract;
c) not use Confidential Information except for Contract performance (or legal or professional advice from its representatives) without prior written consent from the Disclosing Party;
d) not reference Confidential Information in a patent application or use it to challenge, oppose, or invalidate a patent or application owned or controlled by the Disclosing Party; and
e) promptly inform the Disclosing Party if it becomes aware of unauthorized possession, use, or knowledge of any Confidential Information.
11.2. The Receiving Party may disclose Confidential Information to its directors, officers, employees, agents, and legal or professional advisors (and, if needed, to affiliates’ personnel) who need access for Contract performance or advice. Before disclosing, the Receiving Party must ensure all such people know it’s confidential and are under materially similar written confidentiality obligations. The Receiving Party is responsible for any misuse or disclosure by its recipients.
11.3. These duties of confidence and non-use do not apply to Confidential Information where the Receiving Party can show (with records):
a) it was already public at disclosure or has since become public (not via the Receiving Party);
b) it was already known to the Receiving Party before disclosure;
c) it was disclosed to the Receiving Party by a third party with no reason to suspect a confidentiality breach; or
d) it was independently developed without relying on the Disclosing Party’s Confidential Information.
11.4. Disclosure obligations in clauses 11.1.a) and 11.1.b) do not prevent a Receiving Party from disclosing Confidential Information if required by law or a court or authority, provided the Receiving Party gives notice to the Disclosing Party in advance where allowed by law, and discloses only what is required to comply.
11.5. On termination of the Contract, the Receiving Party will immediately stop using Confidential Information and will quickly destroy or return all Confidential Information in its possession. As an exception, one copy may be kept for record-keeping or legal compliance, and Confidential Information need not be deleted from back-ups if it is not accessed after termination.
11.6. Neither party may use the other’s name or logo in any press release, advertisement, or for any promotional purpose without the other’s prior written consent.
12. INTELLECTUAL PROPERTY RIGHTS
12.1. Nothing in the Contract affects the ownership of either party’s intellectual property rights or gives any license to the other except as expressly stated.
12.2. The Customer grants Owen Mumford a non-exclusive, royalty-free license under any intellectual property rights in materials provided by the Customer, only as needed to perform Services and provide Products. The Customer warrants it may provide such materials and grant the license, and that use by Owen Mumford will not infringe third-party rights.
12.3. All intellectual property rights in or arising from the Services will be owned by Owen Mumford. The Customer may not file for or register any patent for the combination of the Product with any drug.
12.4. Owen Mumford makes no representation or warranty that the Customer’s (or anyone’s) use of the Products will not infringe third-party rights, and is not liable for any such claims.
12.5. If the Products are to be manufactured to a modified specification agreed with the Customer, the Customer will indemnify Owen Mumford for all losses, liabilities, damages, and expenses (including legal fees and costs) arising from claims relating to Owen Mumford’s use of the modified specification.
13. LIMITATION OF LIABILITY – THE CUSTOMER’S ATTENTION IS EXPRESSLY DRAWN TO THIS CLAUSE
13.1. Nothing in the Contract limits or excludes either party’s liability for death or personal injury caused by negligence, for fraud, for liability that cannot be limited or excluded as a matter of law or, in the case of the Customer, for payment obligations.
13.2. Owen Mumford will indemnify the Customer against all losses, liabilities, damages and expenses (including legal fees and costs) for claims brought by third parties for death or personal injury arising directly from a breach of warranty (clause 8.1) or negligence by Owen Mumford, except where these result from the Customer’s negligence, contract breach, willful misconduct, or use of any drug or specifications from the Customer.
13.3. The Customer will indemnify Owen Mumford for all losses, liabilities, damages and expenses (including legal fees and costs) for claims brought by third parties for death or personal injury arising directly from the development, manufacture, sale or use of any Product (or drug in the Product) developed under the Contract, except where these are due to Owen Mumford’s negligence or breach of warranty in clause 8.1.
13.4. The indemnities in clauses 13.2 and 13.3 only apply if the indemnified party:
a) promptly notifies the indemnifying party in writing of the claim;
b) makes no admission about the claim;
c) allows the indemnifying party to manage the defense or settlement of the claim; and
d) provides all reasonable assistance (at the indemnifying party’s expense) in dealing with the claim.
13.5. Subject to clause 13.1, and except under the indemnity in 13.2, Owen Mumford’s liability for contract breach, negligence, or any cause related to the Contract:
a) does not cover any indirect or consequential lost profits, lost contracts, lost management time, lost goodwill, or lost business (whether direct or indirect);
b) will not exceed the total price of the Products and/or Services supplied or to be supplied under the Contract.
13.6. During the Contract and for two (2) years after, each party will maintain (with a reputable insurer) third-party liability insurance including product liability for at least $5 million per claim, and provide proof if requested.
14. RECALLS
14.1. Owen Mumford is responsible for investigating any complaints (including any adverse events) about the Product unless they are related to Customer-provided or designed materials (like drugs, components, or modifications made at the Customer’s request). The Customer is responsible for investigating any other complaints. Both parties agree to cooperate as reasonably required, including providing information for regulators.
14.2. If the Customer believes a Product should be recalled or withdrawn, it must promptly notify Owen Mumford in writing with reasons. The Customer will follow Owen Mumford’s reasonable instructions regarding any recall or withdrawal. If the recall or withdrawal is required solely due to Owen Mumford’s negligence or breach of clause 8.1, Owen Mumford will reimburse the direct and reasonable recall expenses.
15. SUSPENSION, CANCELLATION AND TERMINATION
15.1. Owen Mumford may suspend deliveries and/or Services if the Customer fails to pay under this or any other Owen Mumford contract by the due date, or if the Customer commits/is about to commit (or Owen Mumford reasonably suspects they will commit) any event listed in 15.3 that would allow Owen Mumford to terminate (and, in that case, Owen Mumford is entitled to remedies in 15.5 b).
15.2. Orders may only be canceled at Owen Mumford’s discretion. Any consent to cancel may involve additional terms or payments.
15.3. Either party may terminate the Contract by written notice if the other:
a) materially breaches a term of the Contract that cannot be remedied;
b) materially breaches a term of the Contract and does not correct it within thirty (30) days of written notice specifying the breach;
c) has a receiver, administrator or other similar officer appointed over it or its assets, resolves or is ordered to wind up (other than for a legitimate merger or restructure), arranges with creditors, ceases business, is legally deemed unable to pay debts, or is subject to similar proceedings.
15.4. Owen Mumford may terminate the Contract by written notice and, at its option, cancel all orders for affected Products or Services, if Owen Mumford’s Products are recalled or if safety or third-party rights concerns are identified. Owen Mumford will return any prepaid amounts for Products or Services not supplied under canceled orders but will not be otherwise liable to the Customer.
15.5. On any termination, the Customer will, without limiting Owen Mumford’s other rights:
a) immediately pay all outstanding invoices and any interest due to Owen Mumford;
b) pay Owen Mumford at the contract rate for all work performed to the termination date (or, if no rate agreed, a reasonable pro-rated sum), reimburse costs or disbursements set out in the Proposal, and also reimburse any other costs or commitments incurred prior to termination if requested by Owen Mumford. Owen Mumford will invoice for all such amounts promptly after termination.
15.6. Clauses 1, 11-14 (inclusive), 15.5 and 16-18 (inclusive) survive any termination of the Contract.
16. GENERAL
16.1. Neither party is liable for delays or failures to perform under the Contract (other than payment) caused by events beyond their reasonable control. Affected parties must notify the other, stating the nature and likely duration of the event. If delayed for three (3) months or more, either party may terminate by immediate written notice.
16.2. Owen Mumford may use subcontractors but remains responsible for all obligations under the Contract.
16.3. Owen Mumford is a data controller for any personal data provided in connection with the Contract. It will comply with legal obligations and use personal data according to its privacy policy at https://www.owenmumford.com/privacy-policy/. The Customer must ensure that any personal data they provide is provided lawfully.
16.4. The Contract sets out the complete agreement between the parties on its subject matter. Each party confirms it has not relied on any statement or warranty that is not set out in the Contract.
16.5. No waiver of any right or remedy under the Contract is valid unless in writing. Exercising any right or remedy does not limit other rights or remedies.
16.6. If any part of the Contract is found illegal, unenforceable, or void, that part is severed and the remainder continues in force.
16.7. The Customer may not assign or transfer rights or obligations under the Contract without Owen Mumford’s prior written consent.
16.8. Owen Mumford will comply with all relevant anti-bribery and anti-corruption laws, including the Bribery Act 2010. Owen Mumford is not required to comply with the Customer’s anti-bribery, ethics or anti-corruption protocols, even if provided. The Customer must report any offer or request for improper advantage by Owen Mumford employees or agents.
16.9. The Contract can only be amended by the parties’ written agreement.
16.10. A person or entity that is not a party to the Contract has no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any Contract term.
17. NOTICES
Notices under the Contract must be in writing and delivered by hand or post to the recipient’s registered office or agreed address, or sent by email to an agreed address (and notices to Owen Mumford may be sent to info@owenmumford.com). A notice is deemed received: i) when delivered by hand or post; or ii) when sent by email (if receipt is confirmed). This clause does not apply to serving legal proceedings or documents.
18. GOVERNING LAW AND JURISDICTION
The Contract and any disputes or claims (including non-contractual matters) relating to it or its subject matter are governed by the law of England and Wales, and subject to the exclusive jurisdiction of the courts of England and Wales.
Owen Mumford – Terms and Conditions for the Sale of Goods and Supply of Services – version 21 April 2025