The recipient’s attention is drawn in particular to the provisions of clause 11.
1.1 In these Conditions, the following definitions apply:
“Applicable Laws and Regulations”means all applicable laws, statutes, regulations, international conventions and protocols (including the Nagoya Protocol), and industry codes and guidelines from time to time in forcerelating to the handling, storage, distribution, use and disposal of biological materials (including potentially hazardous or infectious biological materials) and, where applicable, the development of vaccines or other medicinal products or medical devices.
“Conditions” means the terms and conditions set out in this document as amended from time to time in accordance with clause 13.1;
“Contract” means the contract between NIBSC and the Recipient for the supply of Materials in accordance with these Conditions.
“Recipient” means the organisation, or its representative, who has requested and is supplied with the Materials by NIBSC;
“Fees” means NIBSC’s handling fees, costs of shipping, insurance and other associated transfer costs of the Materials in GBP as set out in the Sales Acknowledgement or Supply Agreement (as applicable), which fees are subject to change without notice;
“Materials” means the materials (or any part thereof) set out in the Order and supplied to the Recipient by NIBSC pursuant to these Conditions;
“NIBSC” means the Secretary of State for Health acting through the National Institute for Biological Standards and Control as part of the Medicines and Healthcare Products Regulatory Agency;
“Order” means the Recipient’s order form or other written correspondence (including fax or e-mail) from the Recipient setting out the Materials requested or an order submitted through NIBSC’s website ordering system, as the case may be;
“Sales Acknowledgement” means an acknowledgement and acceptance of an Order issued by NIBSC;
“Supply Agreement” means a front sheet headed “Supply Agreement” confirming the Order details and Materials to be supplied pursuant to these Conditions and signed by the Recipient and NIBSC.
1.2 Unless the context otherwise requires, words in the singular shall include the plural and in the plural shall include the singular.
1.3 A reference to any party shall include that party’s representatives.
1.4 A reference to writing or written includes fax and e-mail.
1.5 Any obligation on a party not to do something includes an obligation not to allow that thing to be done.
1.6 Any words following the terms including, include, in particular, for example or any similar expression shall be construed as illustrative and shall not limit the sense of the words, description, definition, phrase or term preceding those terms.
2 Basis of contract
2.1 These Conditions (available on the NIBSC website at http://www.nibsc.org/about_us/terms__conditions.aspx) apply to the Contract to the exclusion of any other terms that the Recipient seeks to impose or incorporate (whether in correspondence or otherwise), or which are implied by trade, custom, practice or course of dealing.
2.2 The Order constitutes an offer by the Recipient to obtain the Materials in accordance with these Conditions. The Recipient shall ensure that the terms of the Order are complete and accurate.
2.3 The Order shall only be deemed to be accepted when a Supply Agreement is executed by both parties, NIBSC issues a Sales Acknowledgement, or Delivery of the Materials (whichever is the earlier) at which point a Contract shall come into existence and constitute the entire agreement between the parties.
2.4 The Recipient shall be deemed to have accepted these Conditions upon a binding agreement coming into existence pursuant to clause 2.3 or, where the Order was placed through NIBSC’s website, by selecting the “Accept Terms and Conditions” box prior to placing the Order.
3 Supply of the Materials, Fees and payment
3.1 The Materials are provided at no cost save that the Recipient shall be responsible for all Fees and shall pay the same to NIBSC in GBP within 30 days after the date of invoice for the Materials in full and in cleared funds to the bank account nominated in writing by NIBSC. NIBSC may invoice the Recipient for the Materials on or at any time after dispatch of the Materials.
3.2 Charges for special or urgent deliveries and carriage charges, including any customs or import charges, may be charged to the Recipient in addition to the Fees.
3.3 All fees and charges are stated exclusive of amounts in respect of value added tax (“VAT”). The Recipient shall, on receipt of a valid VAT invoice from NIBSC, pay to NIBSC such additional amounts in respect of VAT as are chargeable on the supply of the Materials.
3.4 NIBSC reserves the right to:
3.4.1 remove any Materials from its catalogue at any time without notice;
3.4.2 withdraw the Materials in the event of any batch recall and the Recipient shall cooperate with NIBSC in taking all necessary steps to remove the relevant batch from the market;
3.4.3 supply materials and information identical or similar to the Materials to any other commercial or non-commercial entity; and
3.4.4 demand payment in advance of any Delivery.
3.5 The Recipient shall pay all amounts due in full without any deduction or withholding and the Recipient shall not be entitled to assert any credit, set-off or counterclaim against NIBSC in order to justify withholding payment of any such amount in whole or in part. If any deduction or withholding is required by law the Recipient shall pay to NIBSC such sum as will, after the deduction or withholding has been made, leave NIBSC with the same amount as it would have been entitled to receive in the absence of any such requirement to make a deduction or withholding.
3.6 If the Recipient fails to make any payment due to NIBSC under the Contract by the due date for payment (“due date”), then the Recipient shall pay interest on the overdue amount at the rate of 4% per annum above the Bank of England’s base rate from time to time. Such interest shall accrue on a daily basis from the due date until the date of actual payment of the overdue amount, whether such payment is made before or after judgment. The Recipient shall pay the interest together with the overdue amount.
4 Recipient Use of Materials
4.1 The Recipient shall at all times have and maintain appropriate policies in place to ensure the safe and proper handling, storage, use and disposal of the Materials and to safeguard the Materials from theft or misuse.
4.2 The Recipient shall ensure that it has in place all necessary consents, permissions and licences required by its government or other authorities for the import, storage and use of the Materials at all times.
4.3 The Materials are intended for laboratory use only and their use is expressly subject to any pre-existing third party rights and Applicable Laws and Regulations. The Recipient shall not use the Materials for application in human subjects or animals in the human food chain.
4.4 The Recipient shall only use the Materials in accordance with any instructions for use or other documentation provided by NIBSC.
4.5 The Recipient shall not incorporate the Materials or any part thereof, including derivatives (whether modified or not) or progeny of the Materials or any modified or any reverse engineered Materials, into any product for sale except with the express prior written consent of NIBSC (which may be given by NIBSC in the instructions for use or other documentation provided by NIBSC).
4.6 The Recipient shall not use the Materials for in-vitro diagnostics where this has been expressly prohibited in the instructions for use or other documentation provided by NIBSC for the Materials or this is prohibited by the Recipient’s local laws and/or regulations.
4.7 The Recipient acknowledges that any results obtained from the Materials are likely to be dependent on conditions of use and the variability of the Materials beyond the control of NIBSC.
4.8 The Recipient shall not supply the whole or any part of the Materials to any other organisation.
4.9 The Recipient shall ensure that all its employees and all other persons engaged in research using the Materials are aware of and comply with the terms of this Agreement and it shall at all times be liable for the failure of such persons to comply with the terms of this Agreement as though such failure were a breach by the Recipient of the terms of this Agreement.
4.10 The Recipient shall upon request provide NIBSC with such information as may be reasonably required by NIBSC for the purposes of compliance with Applicable Laws and third party rights, to which NIBSC is subject, that apply to the Materials.
5.1 Delivery shall be completed when the Materials arrive at the Recipient’s nominated premises, or from the time of collection of the Materials from NIBSC’s nominated premises by or on behalf of the Recipient, whichever is the earlier (“Delivery”).
5.2 NIBSC will use all reasonable efforts to meet any estimated time or date for delivery given. Time shall not be of the essence in relation to any delivery.
5.3 Unless otherwise expressly agreed, NIBSC may effect delivery of the Materials in one or more instalments. Each instalment shall be treated as a separate agreement governed by these Conditions.
5.4 Upon Delivery the Recipient shall immediately inspect the packages and notify NIBSC within seven (7) days of Delivery of any shortfall, incorrect items or external damage. In the case of non-delivery of the Materials, the Recipient shall notify NIBSC within seven (7) days of receipt of notification from NIBSC that the Materials have been dispatched. Subject to clause 5.5, if any claim is so notified NIBSC’s sole responsibility will be limited to replacing or re-delivering the Materials in question and these Conditions shall apply to any replacement Materials supplied by NIBSC.
5.5 NIBSC shall not be obliged to replace or re-deliver any Materials where non-delivery or damage is caused by the Recipient’s failure to provide NIBSC with adequate delivery instructions, fair wear and tear, abnormal or unsuitable conditions of storage or any use, act, neglect or default of the Recipient or the Recipient’s representatives, agents, employees or nominees.
5.6 Due to the nature of the Materials, Materials correctly supplied may only be returned (at the Recipient’s expense) if they are in satisfactory condition and with the prior written agreement of NIBSC. Any Materials returned pursuant to this clause 5.6 shall be credited to the Recipient’s account.
6 Custodianship and Control of Materials
6.1 NIBSC is the owner or custodian of the Materials and all intellectual property rights subsisting therein shall remain the property of NIBSC or, where applicable, the third party who deposited the Materials with NIBSC (and the supply and transfer of the Materials is made subject to such rights).
6.2 Custodianship of the Material shall pass to the Recipient on Delivery and the Recipient shall assume all risk and responsibility associated with receipt, handling, storage, use, transfer and disposal of the Materials from that time.
6.3 The Recipient acknowledges and agrees that certain Materials have been provided to NIBSC on terms imposed by, and subject to rights of, third parties, relating to access to genetic resources and fair and equitable sharing of benefits and that the Materials are provided to the Recipient, and shall be used by the Recipient, subject to such terms and rights.
7.1 NIBSC warrants that the Materials will conform in all material respects with the specification as set out on the NIBSC website or any instructions for use accompanying the Materials.
7.2 Except as expressly stated above, NIBSC makes no representation and gives no warranty or undertaking in relation to the Materials whatsoever and excludes all implied warranties to the fullest extent permitted by law. In particular NIBSC makes no representation or warranty as to title, quality or fitness for purpose of the Materials or that the supply by NIBSC or the use by the Recipient of the Materials will not infringe the intellectual property rights of any third party.
7.3 The Recipient acknowledges that the Materials may be hazardous, infectious or can harbour infectious agents.
7.4 The Recipient warrants that it has the necessary technical skills to determine the appropriateness of the Materials for the Recipient’s proposed use.
7.5 The Recipient warrants to NIBSC that with respect to the Materials it has complied with, and will at all times in the future comply with, all Applicable Laws and Regulations, and that, to the extent applicable, it has obtained all necessary regulatory and ethical approvals for its proposed activities.
8 Publicity and Publication
8.1 Subject to clause 8.2, in any publication making reference to the Materials, due acknowledgement shall be given of the source of the Materials (quoting the NIBSC’s catalogue reference number).
8.2 The Recipient shall not use the name of NIBSC, the MHRA, or NIBSC’s role and/or reputation as a centre of the MHRA, an OMCL, a National or a European Control Testing Laboratory, or as a World Health Organisation International Laboratory, in any publication (including publicity or promotional materials) in any way which suggests or could be construed as an endorsement of the Recipient’s products, services or research by these entities.
8.3 Nothing in this Agreement shall restrict NIBSC’s right to disclose the existence of a relationship between NIBSC and the Recipient for the purpose of declaring potential conflict of interest to any committee or regulatory body in accordance with NIBSC’s statutory duties.
9 Freedom of Information
9.1 The Recipient acknowledges that NIBSC is subject to the Freedom of Information Act 2000 and the Environmental Information Regulations 2004 (together “FOIA”) and shall assist and co-operate with NIBSC to enable it to comply with the requirements of FOIA.
9.2 Where the Recipient or any of its sub-contractors receive a request for information under FOIA, the Recipient shall:
9.2.1 as soon as reasonably practicable after receipt and in any event within five working days of receipt, forward such request for information to NIBSC;
9.2.2 provide NIBSC with a copy of all Information in its possession or power in the form that NIBSC requires within seven days (or such other period as NIBSC may specify) of NIBSC requesting that Information; and
9.2.3 provide all necessary assistance as reasonably requested by NIBSC to enable it to respond to the request for information within the time for compliance set out in section 10 of FOIA.
9.3 In no event shall the Recipient respond directly to a request for information unless expressly authorised to do so by NIBSC.
10.1 If the Recipient becomes subject to any of the events listed in clause 10.2, or NIBSC reasonably believes that the Recipient is about to become subject to any of them and notifies the Recipient accordingly, then, without limiting any other right or remedy available to NIBSC, NIBSC may cancel or suspend all further deliveries under the Contract or under any other contract between the Recipient and NIBSC and/or terminate the Contract or any other contract immediately without incurring any liability to the Recipient, and all outstanding sums in respect of Materials delivered to the Recipient shall become immediately due.
10.2 For the purposes of clause 10.1, the relevant events are that the Recipient passes a resolution for its winding up or a court of competent jurisdiction makes an order for the Recipient’s winding up or dissolution, or an administration order is made in relation to the Recipient, or an encumbrancer takes possession or sells an asset of the Recipient or a receiver over an asset of the Recipient is appointed, or the Recipient makes an arrangement or composition with creditors generally or makes an application to a court of competent jurisdiction for protection from its creditors generally, or anything analogous to any of the foregoing events occurs under the laws of any applicable jurisdiction, the Recipient’s financial position deteriorates to such an extent that in NIBSC’s opinion the Recipient’s capability to adequately fulfil its obligations under the Contract has been placed in jeopardy or any financial sanctions or trade embargoes are put in place which prohibit NIBSC from fulfilling its obligations under the Contract.
10.3 Termination of the Contract, however arising, shall not affect any of the parties’ rights and remedies that have accrued as at termination. Clauses which expressly or by implication survive termination of the Contract shall continue in full force and effect.
11 Limitation of liability
11.1 Nothing in these Conditions shall limit or exclude NIBSC’s liability for fraud or fraudulent misrepresentation, death or personal injury caused by its negligence, or the negligence of its employees.
11.2 Subject to clause 11.1:
11.2.1 NIBSC shall under no circumstances whatsoever be liable to the Recipient, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, for any loss of data, loss of profit, loss of business or goodwill, or any indirect or consequential loss or damage suffered or incurred by the Recipient arising in relation to the supply of the Materials or the use, keeping, production or disposal of the Materials or any waste products arising from the use thereof by the Recipient or by any other person; and
11.2.2 NIBSC’s total and aggregate liability to the Recipient in respect of all other losses arising under or in connection with the Contract, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, shall in no circumstances exceed 100% of the fees paid to NIBSC for the Materials under the Contract.
11.3 The Recipient shall defend, indemnify and hold NIBSC, its officers, employees and agents harmless against any loss, claim, damage or liability including reasonable legal costs and fees (of whatsoever kind or nature) made against NIBSC which may arise as a result of the wilful act, omission or negligence of the Recipient or its employees, the breach of any of the terms of the Contract, or the use, keeping, production or disposal of the Materials or any waste products arising from the use thereof by the Recipient or on its behalf.
12 Force majeure
12.1 Neither party shall be liable for any failure or delay in performing its obligations under the Contract to the extent that such failure or delay is caused by any event beyond a party’s reasonable control, which by its nature could not have been foreseen, or, if it could have been foreseen, was unavoidable, including strikes, lock-outs or other industrial disputes (whether involving its own workforce or a third party’s), failure of energy sources or transport network, acts of God, war, terrorism, riot, civil commotion, interference by civil or military authorities, national or international calamity, armed conflict, malicious damage, breakdown of plant or machinery, nuclear, chemical or biological contamination, sonic boom, explosions, collapse of building structures, fires, floods, storms, earthquakes, loss at sea, epidemics or similar events, natural disasters or extreme adverse weather conditions, or default of suppliers or subcontractors.
13.1 Except as set out in these Conditions, any variation to the Contract or these Conditions, including the introduction of any additional terms and conditions, shall only be binding when agreed in writing and signed by NIBSC.
13.2 Any notice given to a party under or in connection with the Contract shall be in writing, addressed to that party at its registered office or its principal place of business or such other address as that party may have specified to the other party in writing in accordance with this clause, and shall be delivered personally, sent by pre-paid first class post, recorded delivery, commercial courier or fax. For the purposes of this clause “writing” shall not include e-mail.
13.3 These Conditions, and any Contract between NIBSC and the Recipient, are only in the English language and any instructions for use supplied by NIBSC in relation to the Contract shall also be in the English language (although NIBSC may also provide translations upon request).
13.4 No failure or delay by a party to exercise any right or remedy provided under the Contract or by law shall constitute a waiver of that or any other right or remedy, nor shall it prevent or restrict the further exercise of that or any other right or remedy. No single or partial exercise of such right or remedy shall prevent or restrict the further exercise of that or any other right or remedy.
13.5 If any court or competent authority finds that any provision of the Contract (or part of any provision) is invalid, illegal or unenforceable, that provision or part-provision shall, to the extent required, be deemed to be deleted, and the validity and enforceability of the other provisions of the Contract shall not be affected. If any invalid, unenforceable or illegal provision of the Contract would be valid, enforceable and legal if some part of it were deleted, the provision shall apply with the minimum modification necessary to make it legal, valid and enforceable.
13.6 The Recipient shall not, without the prior written consent of NIBSC, assign, transfer, charge, mortgage, subcontract or deal in any other manner with all or any of its rights or obligations under the Contract.
13.7 NIBSC may, at any time, assign, transfer, charge, mortgage, subcontract or deal in any other manner with all or any of its rights or obligations under the Contract and, in the event of the transfer of all or a substantial part of NIBSC’s activities to one or more government bodies, NIBSC’s rights and obligations shall, notwithstanding any provision to the contrary in the Contract, automatically transfer to such other government body.
13.8 A person who is not a party to the Contract shall not have any rights under or in connection with it.
13.9 The Contract, and any dispute or claim arising out of or in connection with it or its subject matter or formation (including non-contractual disputes or claims), shall be governed by, and construed in accordance with, the law of England and Wales and the parties irrevocably agree that the courts of England and Wales shall have exclusive jurisdiction to settle any dispute or claim that arises out of or in connection with this Contract or its subject matter or formation (including non-contractual disputes or claims).