Cell and Gene Therapy – Terms of Purchase
1 DEFINITIONS AND INTERPRETATION
1.1 In this Contract, unless the context otherwise requires, the following expressions have the following meanings:
“Affiliate” any entity that directly or indirectly ”controls”, or is ”controlled” by, or is under common ”control” with either Party, ”control” meaning the beneficial ownership of more than fifty per cent of the issued share capital of a company or other legal entity or the legal power to direct or cause the direction of the general management of the company or other legal entity, and ”controlled” shall be construed accordingly;
”Artwork and Packaging Materials” has the meaning given to it in Clause 3.18;
“Business Day” any day other than: (i) a Saturday; (ii) a Sunday; (iii) a day which is a bank holiday in England or (iv) a day when Central Pharma is not open for business;
“Central Pharma” Central Pharma Cell and Gene Therapy Limited, a company incorporated and registered in England under company number 12769240, whose principal place of business and registered office are at Caxton Road, Elm Farm Industrial Estate, Bedford, Bedfordshire, MK41 0HT, England;
”Certificate of Analysis” a certificate authenticating the pharmaceutical analysis of a batch of the Goods;
“cGMP” any and all current good manufacturing practices as defined by: (i) EU Directive 2001/83/EC; (ii) EU Directive 2003/94/EC; and (iii) the European Commission’s Guidance, ”EudraLex – Volume 4 Good Manufacturing Practice (GMP) Guidelines”, each as amended from time to time, and such other practices relating to the manufacture and packaging of pharmaceutical products imposed from time to time by any applicable laws or codes issued by any relevant Regulatory Authority in any country where the relevant Goods are manufactured or sold to end-users from time to time;
“Confidential Information” the terms of this Contract, and any information in any form or medium concerning the other Party or one of its Affiliates or the other Party’s business or the business of one of its Affiliates in relation to this Contract which is expressly marked as confidential or which a reasonable person would reasonably consider to be confidential whether disclosed or obtained before, on or after the effective date of this Contract together with any reproductions of such information or any part of this information (which in the case of Central Pharma’s Confidential Information includes the Data, and any Materials which are specifically created, made, designed, devised, adapted, discovered or invented by the Supplier for Central Pharma);
this “Contract” these Terms and Conditions and any relevant terms of any applicable Long Term Agreement (if any), together with the relevant Order and any document referred to in these Terms and Conditions, the Order or the Long Term Agreement;
“CP Brand” the trade marks, service marks, domain names, trade names, logos, style, devices (whether registered or not) used by Central Pharma Cell and Gene Therapy Ltd (or its customers or clients) in relation to any part of its business, or any Goods or any Services from time to time;
“CP Site” the site where Central Pharma Cell and Gene Therapy is based, or such other site as Central Pharma stipulates for the delivery of the Goods or the receipt of the Services in any Order (or as may be stipulated in any Long Term Agreement);
“Data” any data used in relation to Central Pharma Cell and Gene Therapy or its customers, clients, employees or other suppliers including data provided or made available by Central Pharma Cell and Gene Therapy to the Supplier, or otherwise received or discovered by the Supplier, in relation to this Contract;
“Event of Force Majeure” any event beyond the reasonable control of either Party including any act of God, actions or omissions of any third party which is not an Affiliate of the Party seeking to rely on Clause 12 (including hackers, suppliers, couriers, governments, quasi-governmental, supra-national or local authorities), insurrection, riot, protests, rallies, civil war, civil commotion, war, hostilities, threat of war, warlike operations, armed conflict, imposition of sanctions, embargo, seizure or forfeiture, breaking off of diplomatic relations or similar actions, national emergencies, national event (including death of a member of the Royal Family), terrorism, nuclear, chemical or biological contamination or sonic boom, piracy, arrests, restraints or detainments of any competent authority, blockade, strikes or combinations or lock-out of workers (other than of the Party seeking to rely on Clause 12), unusual traffic volumes, closure or disruption to roads or transport or particular areas, epidemic or pandemic (including COVID-19), compulsory or recommended measures to avoid epidemic or pandemic, fire, explosion, storm, flood, drought, adverse weather conditions (including cold, heat, wind, rain, snow, ice or fog), loss at sea, earthquake, volcano, ash cloud, natural disaster, accident, collapse of building structures, failure of machinery (other than used by the relevant Party) or third party computers or third party hardware or vehicles, failure or problems with public utility supplies (including general: electrical, telecoms, water, gas, postal, courier, communications or Internet disruption or failure), shortage of or delay in or inability to obtain supplies, stocks, storage, materials, equipment or transportation;
“Fees” the fees payable by Central Pharma Cell and Gene Therapy to the Supplier for the supply by the Supplier of the Goods or the Services as stipulated in the relevant Order (or any Long Term Agreement);
“Goods” any goods provided or to be provided by the Supplier to Central Pharma pursuant to this Contract, as may be more particularly described in the Order (or any Long Term Agreement);
“Intellectual Property Rights” copyright and related rights, trade marks and service marks, trade names and domain names, rights under licences, rights in get-up, rights to goodwill or to sue for passing off or unfair competition, patents, rights to inventions, rights in designs, rights in computer software, database rights, rights in confidential information (including know-how and trade secrets) and any other intellectual property rights, in each case whether registered or unregistered and including all applications (or rights to apply) for, and renewals or extensions of, such rights and all similar or equivalent rights or forms of protection which subsist or will subsist now or in the future in any part of the world;
“Liability” liability in or for breach of contract (including liability under any indemnity), tort (whether deliberate or not), negligence, breach of statutory duty, misrepresentation, restitution or any other cause of action whatsoever relating to or arising under or in connection with this Contract, including liability expressly provided for under this Contract or arising by reason of the invalidity or unenforceability of any term of this Contract (and for the purposes of this definition, all references to “this Contract” shall be deemed to include any collateral contract, but each Order shall constitute a separate ”Contract”);
“Long Term Agreement” any written agreement between the Parties, governing the long-term relationship concerning the supply of Goods or Services by the Supplier to Central Pharma;
“Materials” all materials of any nature, including works of authorship, inventions, creations, diagrams, models, drawings, designs, processes, systems, methodologies, charts, flowcharts, catalogues, descriptions, products, documents, brochures, notes, records, results, reports, ideas, concepts, discoveries, know-how, information, data, databases, research, lists, logos, images, plans, specifications, manuals, deliverables, software (whether in object code or source code), routines, algorithms and tools;
“Normal Working Hours” 9:00 to 17:00 on a Business Day, or as may be reasonably stipulated by Central Pharma to the Supplier from time to time;
“Order” any written document (which may be stated to be a ”purchase order”) provided by Central Pharma to the Supplier containing the specific information relating to the particular Goods or Services supplied or to be supplied by the Supplier to Central Pharma, and which document is either: (i) expressly agreed in writing by both Parties; or (ii) supplied by Central Pharma to the Supplier;
“Party” either Central Pharma or the Supplier;
“Regulatory Authority” a regulatory authority or agency with competence to issue any permission, approval or consent for the manufacture and supply of the Goods or the distribution, marketing and sale of the Goods in the territory of manufacture or end-sale, or any other issuing regulatory authority relevant to the Supplier, Central Pharma or both in respect of the Goods, the Services or both;
“Services” any services provided or to be provided by the Supplier to Central Pharma pursuant to this Contract, as may be more particularly described in the Order (but which in any event may include services relating to the manufacture, supply or delivery of the Goods);
“Specifications” any specifications for the Goods or Services as stipulated in the relevant Order (or any Long Term Agreement), including as may be more particularly set out in any marketing authorisation issued or granted by the relevant Regulatory Authority specific to certain Goods;
the “Supplier” the supplier of the Goods or the Services to Central Pharma whose details may be set out in Central Pharma’s relevant Order (or any Long Term Agreement between that supplier and Central Pharma); and “Supplier Site” the site where the Supplier is based, or such other site as agreed between the Parties in writing for the manufacture of the Goods or the provision of the Services (or as may be stipulated in any Long Term Agreement).
1.2 In this Contract:
1.2.1 references to Clauses are to clauses of these Terms and Conditions;
1.2.2 headings are inserted for convenience only and shall not affect the interpretation or construction of this Contract;
1.2.3 words imparting the singular shall include the plural and vice versa;
1.2.4 words imparting a gender shall include the other gender and the neutral and references to ”persons” shall include an individual, company, corporation, firm or partnership;
1.2.5 where the words “include(s)”, “including” or “in particular” are used in this Contract, they are deemed to have the words “without limitation” following them;
1.2.6 any obligation in this Contract on a person not to do something includes an obligation not to agree, allow, permit or acquiesce to that thing being done;
1.2.7 references to any statute or statutory provision shall include any subordinate legislation made under it, any provision which it has modified or re-enacted (whether with or without modification) and any provision which subsequently supersedes it or re-enacts it (whether with or without modification); and
1.2.8 references to “written” or in “writing” (except in respect of sending a notice in accordance with Clause 13) includes in electronic form.
2 CONTRACT
2.1 The terms of this Contract apply to the exclusion of any terms and conditions submitted, proposed or stipulated by the Supplier in whatever form and at whatever time. These Terms and Conditions apply to all Goods and Services.
2.2 This Contract (together with any documents referred to in it) constitutes the whole agreement and understanding of the Parties as to its subject matter and there are no provisions, terms, conditions or obligations, whether oral or written, express or implied, other than those contained or referred to in this Contract.
2.3 Save as expressly provided in this Contract, it (together with any documents referred to in it) shall operate to the entire exclusion of any other agreement, understanding or arrangement of any kind between the Parties preceding the date of this Contract and in any way relating to the subject matter of this Contract. No representation, undertaking or promise shall be taken to have been given or be implied from anything said or written in negotiations between the Parties prior to this Contract except as expressly stated in this Contract. Neither Party shall have any remedy in respect of any untrue statement made by the other Party upon which that Party relied in entering into this Contract (unless such untrue statement was made fraudulently or as to a fundamental matter) and that Party’s only remedies shall be for breach of contract as provided in this Contract.
2.4 This Contract shall be legally formed and the Parties shall be legally bound when the Supplier communicates to Central Pharma the Supplier’s agreement to supply the relevant Goods and Services in accordance with the terms of the Order (as may be varied, before the Supplier’s agreement, by Central Pharma in writing). The submission of an Order by Central Pharma to the Supplier shall be deemed to be an offer by Central Pharma to purchase or obtain Goods or Services subject to these Terms and Conditions. The Supplier may accept the Order by written acceptance or by acting in accordance with the terms of the Order. In any event, the acceptance by the Supplier of any delivery instruction by delivering the Goods or commencing supply of the Services shall constitute unqualified acceptance by the Supplier of these Terms and Conditions.
2.5 No change to this Contract shall be binding unless it is agreed in writing by both Parties or their authorised representatives.
2.6 In the event of any conflict between this Contract or any Long Term Agreement, then the Long Term Agreement will prevail except to the extent otherwise expressly agreed by both Parties in writing.
2.7 If the Supplier provides Central Pharma with a quotation, order confirmation or any other document, such document shall be purely for the Supplier’s administrative purposes only and shall not form part of this Contract.
2.8 Once accepted by the Supplier, each Order constitutes a separate contract. There may be more than one contract between the Parties in force at the same time as this Contract.
3 GOODS
3.1 The Supplier shall ensure that, in addition to conforming in all respects with the relevant provisions of the Sale of Goods Act 1979 and the Supply of Goods and Services Act 1982 and with all other statutory and legal requirements:
3.1.1 the Goods shall be without fault;
3.1.2 the Goods shall not be “defective” within the meaning of the Consumer Protection Act 1987 and shall be safe to use;
3.1.3 when used with other products which are reasonably foreseeable that Central Pharma may make available to its staff and third parties, the Goods shall not cause those other products to be “defective” within the meaning of the Consumer Protection Act 1987 or unsafe to use;
3.1.4 the Goods shall conform in all respects with the Order and any Long Term Agreement (including the Specifications) and all samples provided by Central Pharma or the Supplier, and all written descriptions published by or on behalf of the Supplier (whether specifically to Central Pharma or generally) in respect of the Goods;
3.1.5 the Goods shall be capable of any standard as may be specified in this Contract or otherwise agreed in writing between the Parties;
3.1.6 the Goods shall be of excellent quality, material and workmanship;
3.1.7 the Goods shall, unless otherwise agreed in writing by the Parties, be manufactured and assembled at, and supplied from, the Supplier Site, and any proposed change of the Supplier Site shall be subject to Central Pharma’s prior written agreement;
3.1.8 it shall allow Central Pharma and its representatives, during Normal Working Hours, access to inspect the manufacturing and storage facilities of the Supplier relevant to the Goods or the Services;
3.1.9 where appropriate, each batch of Goods delivered by the Supplier to Central Pharma shall be accompanied by a Certificate of Analysis and any other documentation reasonably required by Central Pharma from time to time; and
3.1.10 the Goods and any output from the provision of any Services, and the intended use of them by Central Pharma and its staff and any anticipated user or customer of Central Pharma shall:
3.1.10.1 conform in all respects with all applicable laws, rules, regulations, bye-laws and codes of practice (including cGMP) applicable in the territory of manufacture, the territory of destination in which Central Pharma or the CP Site is based and the territory of anticipated use;
3.1.10.2 not infringe the privacy rights or the Intellectual Property Rights of any third party; and
3.1.10.3 not contain any material detrimental to Central Pharma or its staff or any anticipated user.
3.2 The Supplier shall:
3.2.1 before delivery of the Goods, use adequate facilities for performing its activities under this Contract, including the manufacture, storage and transportation of the Goods;
3.2.2 manufacture and supply the Goods in a professional manner and with the care, skill and diligence required in accordance with best practice and standards prevailing in the pharmaceutical industry for similar pharmaceutical products, including cGMP;
3.2.3 observe all applicable laws, regulations, byelaws and codes of practice in respect of the manufacture, sale, supply, storage, packaging and transportation of the Goods from the Supplier to Central Pharma’s nominated delivery address;
3.2.4 obtain and pay for and at all times maintain and comply with and conform to, all necessary or desirable licences, authorisations (including manufacturing authorisations), approvals, consents, permissions and certificates of origin required for the manufacture, storage, sale, transportation and supply of the Goods as are applicable at the Supplier Site, or otherwise required by law or Central Pharma;
3.2.5 on or before delivery of the Goods to Central Pharma, check the Goods in accordance with its regulatory requirements and give adequate advice and information to Central Pharma as to the handling and storage of the Goods;
3.2.6 make its representatives available, at all reasonable times and upon reasonable notice, to Central Pharma for the purposes of consultation and advice relating to this Contract and the Goods, and attend meetings and telephone calls with representatives of Central Pharma as may be necessary for the performance of its duties under this Contract;
3.2.7 provide any information and support that may reasonably be requested by Central Pharma to enable Central Pharma to discharge its duties or exercise its rights under this Contract promptly and efficiently; and
3.2.8 at all times conduct its business in a manner that will reflect favourably on the Goods and on the good name and reputation of Central Pharma and not participate in any illegal, deceptive, misleading or unethical practices including disparagement of the Goods or Central Pharma.
3.3 The Supplier shall deliver the Goods carriage paid to Central Pharma at the CP Site (inclusive of all charges for packaging, packing, shipping, insurance, carriage and delivery). Where the Parties are in different countries, unless stipulated otherwise in this Contract, delivery shall be DDP (Incoterms 2020); but to the extent that there is any conflict between Incoterms 2020 and any other provision of this Contract, the relevant provision of this Contract shall prevail.
3.4 The Supplier shall deliver the Goods to Central Pharma at the time required by this Contract (and not earlier or later than the specified delivery time or period). Time for delivery shall be of the essence.
3.5 Unless otherwise stipulated by Central Pharma in writing, deliveries will only be accepted by Central Pharma, or a third party nominated to take delivery on its behalf, during Normal Working Hours. The Supplier shall off-load the Goods at the place and in the manner directed by Central Pharma or Central Pharma’s agent.
3.6 All Goods shall be subject to Central Pharma’s testing and inspection. Without prejudice to any rights that Central Pharma may have in relation to the delivered Goods, Central Pharma shall not be deemed to have accepted any Goods until after such testing and inspection have been completed to Central Pharma’s satisfaction. The payment of any Fees by Central Pharma (in whole or in part) shall not constitute deemed acceptance.
3.7 The Supplier shall package, store and deliver the Goods in accordance with the Specifications and any other instructions provided by Central Pharma to the Supplier from time to time, including in relation to temperature control, quantity limitations and storage requirements. In addition to any express instructions of Central Pharma, the Supplier shall ensure that such packaging and storage protect the Goods against infestation, damage or other contamination until the Goods reach their final intended destination.
3.8 The Supplier shall show the following details on the outside of every package (where applicable for the type of Goods):
3.8.1 a description of the Goods;
3.8.2 the quantity in the package;
3.8.3 any special directions for storage and opening;
3.8.4 the expiry date of any contents;
3.8.5 the Supplier’s mark or batch number; and
3.8.6 the name and address of the Supplier.
3.9 The Supplier shall ensure that a delivery note accompanies each delivery of the Goods, confirming the date, quantity and type of Goods delivered, and such other information as requested by Central Pharma from time to time.
3.10 The Supplier shall provide Central Pharma with the following documentation in respect of each delivery of the Goods: (i) a packing list, (ii) a Certificate of Analysis or a copy of the declaration of conformity (where applicable), (iii) all documentation required to export the Goods from the country of supply where the Goods are delivered outside the United Kingdom and (v) all other documentation required by Central Pharma from time to time.
3.11 The Supplier shall not allow any unauthorised people to have access to any Goods or part-made Goods which are being provided to Central Pharma.
3.12 The Supplier shall ensure that at all times before delivery the Goods being made or which have been made are:
3.12.1 adequately segregated from material deemed to be rejected material;
3.12.2 adequately segregated from other goods; and
3.12.3 protected (including with all sufficient packaging) from infestation, damage or other contamination.
3.13 Unless Central Pharma otherwise agrees in writing, the Supplier shall not deliver the Goods covered by any Order by instalments. Where Central Pharma agrees to accept delivery by instalments, failure by the Supplier to deliver any instalment in accordance with this Contract shall entitle Central Pharma to treat the whole Contract as repudiated.
3.14 If the Goods are delivered to Central Pharma in excess of the quantities ordered, Central Pharma shall not be obliged to pay for the excess.
3.15 The risk in the Goods shall pass to Central Pharma on completion of delivery (including off-loading and stacking) in accordance with this Contract.
3.16 Without prejudice to any right of rejection which Central Pharma may be entitled to exercise, equitable and legal title in the Goods shall pass to Central Pharma upon whichever is the earlier of payment in part or full or delivery. The title and risk in any Goods which are not accepted by Central Pharma or which are rejected by Central Pharma shall immediately revert to the Supplier upon Central Pharma’s non-acceptance or rejection.
3.17 The Supplier shall immediately advise Central Pharma in writing with as much notice as possible if it becomes aware of any circumstances which may cause delay, disruption or failure to deliver the Goods and the Supplier shall use all reasonable endeavours to mitigate against such problems.
3.18 Central Pharma may from time to time provide the Supplier with artwork, trade marks and other material for the packaging, trade dress, labels, leaflets or other product inserts and printed materials to be affixed to or packaged with the Goods or used on the Goods’ packaging (the ”Artwork and Packaging Materials”).
3.19 The Supplier shall not, save as required by any applicable law or regulation, affix to the Goods or their packaging any trade marks, business names, labels or signs other than previously approved in writing by Central Pharma.
3.20 The Supplier shall not make any change to the packaging, layout, content or appearance of any trade dress, labels, leaflets or other product inserts and printed materials to be affixed to or packaged with the Goods or used on the Goods’ packaging, including the Artwork and Packing Materials, without the prior written consent of Central Pharma.
3.21 The Supplier shall not unreasonably refuse any request of Central Pharma to inspect and test the Goods prior to their despatch and, upon request, shall provide Central Pharma with reasonable facilities for such inspection and testing.
3.22 Central Pharma shall not be required to return to the Supplier any packaging or packaging materials for the Goods.
4 SERVICES
4.1 The Supplier shall provide the Services in accordance with the Order and any Long Term Agreement including any Specifications, timeframe and location for providing the Services. Time for performance of the Services shall be of the essence.
4.2 The Supplier warrants and undertakes that:
4.2.1 it shall provide the Services in a professional manner and with the care, skill and diligence required in accordance with best practice and standards prevailing in the industry for similar services;
4.2.2 it shall provide the Services in a safe manner and comply with all health and safety laws, regulations and codes of practice, including those applicable in the Supplier’s territory and Central Pharma’s territory;
4.2.3 anyone providing the Services on behalf of the Supplier has the necessary skill and expertise to provide the Services;
4.2.4 except as otherwise agreed by Central Pharma in writing, it shall provide the Services at the CP Site during Normal Working Hours;
4.2.5 if it uses any of Central Pharma’s Materials or accesses any part of the CP Site, it shall take good care of them, not damage them and restore them, and shall leave them clean and tidy;
4.2.6 it shall dispose of any waste or hazardous materials in an appropriate manner, and in accordance with any industry good practice and Central Pharma’s policies;
4.2.7 it shall comply with all applicable laws, regulations, guidance (including cGMP), byelaws and licences in relation to the supply of the Services;
4.2.8 it shall work and co-operate with all of Central Pharma’s staff, representatives, customers and regulators, and make its representatives available at all reasonable times for discussion and meetings with Central Pharma and Central Pharma’s staff, representatives, customers and regulators regarding this Contract and the Services, including any relevant Regulatory Authority;
4.2.9 it shall ensure that while any of its staff or representatives are at the CP Site they conform to all rules, regulations, procedures and codes of practice applicable to the CP Site for staff, security, health and safety and dress practice and any other reasonable requirements of Central Pharma;
4.2.10 it shall use its best endeavours to cause minimum disruption to Central Pharma and Central Pharma’s representatives, including while at the CP Site minimising any noise and distraction or interference with machinery or equipment, not obstructing any right of way and only accessing such parts of the CP Site as is necessary;
4.2.11 it shall take all reasonable precautions to maintain the security of the CP Site and protect it from unauthorised access at all times;
4.2.12 it shall not remove from the CP Site anything that does not belong to the Supplier;
4.2.13 it shall immediately advise Central Pharma with as much notice as possible if it becomes aware of any circumstances which may cause delay, disruption or failure to perform the Services or this Contract and the Supplier shall use all reasonable endeavours to mitigate against such problems;
4.2.14 it has all necessary rights to enter into and perform this Contract, and all individuals involved with providing the Services have all relevant licences and authorisations at all times;
4.2.15 if in the course of the provision of the Services, the Supplier discovers that further Goods or Materials are needed in order to complete the provision of the Services to the standard expected by Central Pharma, it shall inform Central Pharma of those further Goods or Materials in advance with as much warning as possible, obtain Central Pharma’s prior consent in writing to providing those further Goods or Materials before continuing with the provision of the Services and minimise the cost of those further Goods or Materials (including, if they are chargeable, supplying them to Central Pharma at cost price). Except to the extent agreed in writing by Central Pharma, the Supplier shall only be permitted to charge for those Goods and Materials if they were not reasonably foreseeable at the time that this Contract was entered into. Central Pharma may refuse those Goods or Materials without being in breach of this Contract;
4.2.16 it shall provide independent and unbiased advice to Central Pharma in accordance with best industry practice;
4.2.17 it shall not do anything which may leave Central Pharma or Central Pharma’s staff or clients with any exposure under any anti-bribery or anti-corruption laws;
4.2.18 it shall not, without the prior written consent of Central Pharma, accept any commission, gift, financial benefit or inducement from any third party to recommend such third party’s goods or services to Central Pharma and shall ensure that its staff and representatives will not accept any such commission, gift, financial benefit or inducement which may be offered;
4.2.19 it shall without charge and upon request provide such instructions and information as Central Pharma reasonably requires to make full and safe use of the Services;
4.2.20 it shall ensure that all personnel involved in the sale, supply, importation, manufacture, assembly, storage and delivery of the Goods and with the provision of the Services are fully trained and supervised and qualified to undertake their work, including in accordance with cGMP;
4.2.21 it shall allow Central Pharma’s representatives, during Normal Working Hours, access to inspect the facilities of the Supplier, including the Supplier Site, relevant to the Services; and
4.2.22 it shall comply with all reasonable directions, requests, instructions and requirements of Central Pharma, as well as the requirements of any relevant Regulatory Authority and Central Pharma’s customers in relation to the supply of the Goods and the provision of the Services, including providing any information, data, documents, access and right to inspect, in whatever form reasonably required by Central Pharma, its customers or such Regulatory Authority.
5 CENTRAL PHARMA’S ADDITIONAL OBLIGATIONS
5.1 Central Pharma shall use its reasonable endeavours to:
5.1.1 provide the Supplier in a timely manner with all information reasonably required by the Supplier for it to perform its obligations under this Contract;
5.1.2 prepare the CP Site, if applicable, for receipt and provision of the Goods and the Services;
5.1.3 inform the Supplier of any rules and regulations relevant to the Supplier’s provision of Goods and the Services at the CP Site and any timings for the provision of the Goods and Services;
5.1.4 where relevant, ensure that the relevant staff and representatives of Central Pharma or its customers are available at the CP Site at any time agreed by Central Pharma to enable the Supplier to perform its obligations under this Contract; and
5.1.5 provide the Supplier with reasonable co-operation, and be available at all reasonable times for discussion and meetings with the Supplier, to enable the Supplier to promptly perform its obligations under this Contract.
6 QUALITY ISSUES AND INDEMNITY
6.1 Without prejudice to any other right or remedy which Central Pharma may have whether under this Contract, at law or otherwise, if Central Pharma reasonably believes that any of the Goods or the Services which have been or should have been supplied are not or were not supplied in accordance with, or that the Supplier has failed to comply in any way with, any of the terms of this Contract or any contract between the Parties (including as to timing or quality), Central Pharma shall be entitled to exercise any one or more of the following remedies at its discretion, whether or not any part of the Goods or the Services have been accepted or already received by Central Pharma:
6.1.1 to reject the Goods or Services or a whole batch or instalment of the Goods or Services (in whole or in part, irrespective of whether some of the rejected Goods or Services comply with this Contract) on the basis that a full refund for the rejected Goods or Services shall be paid promptly by the Supplier. The Supplier shall at its own expense within seven days from the date of receipt of notice of rejection remove the rejected Goods. If the rejected Goods have not been removed within that period, Central Pharma may return to the Supplier or destroy the rejected Goods at the Supplier’s risk and expense;
6.1.2 to rescind this Contract (in whole or in part);
6.1.3 to give the Supplier the opportunity within a reasonable period stipulated by Central Pharma at the Supplier’s expense either to remedy any defect in the Goods or the Services or to supply or provide replacement Goods or Services and carry out any other necessary work to ensure that the terms of this Contract are fulfilled;
6.1.4 to refuse to accept any further deliveries or provision of the Goods or Services (under this Contract or any contract) but without any Liability of Central Pharma to the Supplier;
6.1.5 to carry out at the Supplier’s expense any work necessary to make the Goods or the Services comply with this Contract;
6.1.6 to recover from the Supplier any expenditure reasonably incurred by Central Pharma in obtaining the Goods or the Services or related goods or services other than from the Supplier; and
6.1.7 to claim such losses and damages as may have been sustained by Central Pharma or its Affiliates in consequence of the Supplier’s breaches of this Contract (including liabilities to Central Pharma’s customers, Central Pharma’s internal costs, downtime, cost of removal or destruction, and any storage costs and additional expenditure or liability incurred by Central Pharma in obtaining replacement goods or services or in delaying manufacture or in supplying or delays in supplying or not supplying its customers).
6.2 The Supplier shall indemnify Central Pharma and its Affiliates from and against all liabilities, losses, damages, costs, expenses, claims, demands, proceedings and judgments incurred by them in connection with:
6.2.1 any late or defective or unsafe Goods or Services, workmanship, quality or materials;
6.2.2 any infringement or alleged infringement of any Intellectual Property Rights of any third party anywhere in the world in any way relating to the use, manufacture or supply of the Goods or the Services; or
6.2.3 any breach or negligent performance or failure or delay in performance of this Contract by the Supplier or its staff or its representatives.
7 INSURANCE AND PRODUCT RECALLS
7.1 During the term of this Contract and for a minimum of seven years after its termination or expiry, the Supplier shall take out and maintain in full force and effect at its own expense and cost (and not do anything to adversely affect the effectiveness of) insurance operating on a worldwide basis with a well- established insurance company of repute to cover the Supplier’s professional indemnity, product liability and public liability liabilities under or in connection with this Contract with a limit of indemnity of not less than £5,000,000 (five- million pounds sterling) for each and every claim.
7.2 The Supplier shall provide Central Pharma with documentary evidence that such insurance is being maintained. The Supplier shall promptly lodge with Central Pharma a copy of its current insurance policy together with all renewals and receipts for the premiums. The Supplier shall promptly inform Central Pharma if it becomes aware of any circumstance under which the insurance referred to in this Clause 7 may cease to be valid.
7.3 If any Regulatory Authority requires the recall of any Goods or if either Party reasonably deems it necessary to initiate a voluntary recall of any Goods, the Party so contacted by the Regulatory Authority or initiating the recall shall immediately inform the other Party in writing of the same and shall consult with the other Party regarding the timely compliance with all relevant laws and regulations in respect of the recall.
7.4 Each Party shall provide the other Party with all assistance reasonably required to effect any recall of any of the Goods in compliance with all relevant laws and regulations.
7.5 All costs reasonably incurred by either Party which result directly from any recall of any Goods shall be borne by Central Pharma unless the reason for such recall or withdrawal is the Supplier’s breach of this Contract, in which event, all such costs shall be borne by the Supplier.
8 CONFIDENTIALITY
8.1 Each Party shall keep and procure to be kept secret and confidential the Confidential Information of the other Party and shall not use nor disclose the same save:
8.1.1 for the purposes of the proper performance of this Contract;
8.1.2 as otherwise permitted by this Contract or any Long Term Agreement;
8.1.3 as required under any applicable law, or by order of a court or governmental body or authority of competent jurisdiction (including any tax authority); or
8.1.4 with the prior written consent of the other Party.
8.2 Each Party shall protect the other Party’s Confidential Information with at least the same degree of care (which shall not be less than a reasonable standard of care) that it uses in connection with the protection of its own confidential information.
8.3 Where one Party discloses Confidential Information of the other Party to its representative, employee, consultant, subcontractor, supplier, customer, agent, professional adviser, auditor or insurer, it shall do so on a need-to-know basis and subject to obligations equivalent to those set out in this Clause 8. Each Party shall be responsible for the compliance with said obligations by its own representative, employee, consultant, subcontractor, supplier, customer, agent, professional adviser, auditor or insurer.
8.4 The obligations of confidentiality in this Clause 8 shall not extend to any information which either Party can show:
8.4.1 is in, or has become part of, the public domain other than as a result of a breach of the confidentiality obligations of this Contract;
8.4.2 was already in its written records prior to receipt;
8.4.3 was independently developed by it; or
8.4.4 was independently disclosed to it by a third party entitled to disclose it.
8.5 If either Party is required to disclose any Confidential Information of the other Party under any applicable law, or by order of a court or governmental body or authority of competent jurisdiction (including any tax authority), then the Party so required may disclose the Confidential Information to the extent required but shall, prior to any disclosure where practicable, give the other Party as much warning as practicable and consult with the other Party in writing and, at the other Party’s request and cost, fully co-operate with and assist that other Party in opposing any such disclosure.
8.6 If either Party becomes aware of any unauthorised use or disclosure of the Confidential Information of the other Party, that Party shall promptly inform the other Party in writing of such use or disclosure. Each Party shall if requested assist the other Party (at the other Party’s cost) in taking any reasonable steps to help the other Party regain possession of its Confidential Information and prevent its further unauthorised use or disclosure as the other Party may determine.
8.7 Except to the extent necessary for the other Party to continue exercising its rights and performing its obligations under this Contract or at law (or for its own normal retention of records which any reasonable business would wish to retain, including to show performance of its obligations under this Contract or any agreement or for dealing with customers’ issues or for regulatory reasons), upon expiry or termination of this Contract and at such other times as the Party owning the Confidential Information may reasonably request, the owner of Confidential Information may at its option require the other Party to delete promptly all Confidential Information belonging to the Party requiring the action from any computer disks, tapes or other material in its possession or under its control or promptly deliver up or destroy materials and tangible items in its possession or under its control which contain any such Confidential Information.
8.8 Neither Party shall make any announcement of any kind in respect of the subject matter of this Contract except with the prior written consent of the other Party (such consent not to be unreasonably conditioned, withheld or delayed) or as is required by applicable law.
8.9 The obligations in respect of the other Party’s Confidential Information in this Clause 8 shall continue after expiry or termination of this Agreement for whatever reason.
9 INTELLECTUAL PROPERTY RIGHTS
9.1 Unless otherwise agreed by Central Pharma in writing, as between the Parties, the Supplier acknowledges that Central Pharma shall own all Intellectual Property Rights in any Goods, Services, Materials (including the Artwork and Packaging Materials) and CP Brand, in whatever form and on whatever media, to the extent that they are specifically created, made, designed, devised, adapted, discovered or invented by the Supplier for Central Pharma or provided by Central Pharma to the Supplier. The Supplier hereby assigns to Central Pharma, by way of present and future assignment, absolutely with full title guarantee all such Intellectual Property Rights owned by the Supplier, for the full term of such rights and all renewals and extensions, together with all accrued rights of action. The Supplier shall deliver up to Central Pharma all such Goods, Services and Materials in whatever form and on whatever media reasonably required by Central Pharma.
9.2 The Supplier shall have a limited non-exclusive licence to use such Goods, Services, Materials and CP Brands described in Clause 9.1 to the extent necessary for performing its obligations pursuant to this Contract; such licence shall be non-transferable and non-sublicensable unless Central Pharma gives its prior written consent.
9.3 To the extent that the Supplier’s supply of any Goods, Services, Materials or CP Brand involves any part of the Goods, Services, Materials, names or domain names not specifically created, made, designed, devised, adapted, discovered or invented by the Supplier for Central Pharma or provided by Central Pharma to the Supplier, the Supplier hereby grants to Central Pharma for use by Central Pharma, its assignees and licensees, and their respective agents, sub- contractors, staff, representatives and customers and clients, an irrevocable, worldwide, royalty-free, perpetual, transferable, sub-licensable licence to use such part of the Goods, Services, Materials, names or domain names for any purpose.
9.4 The Supplier acknowledges that, as between the Parties, Central Pharma owns all Intellectual Property Rights in the Data and each CP Brand.
9.5 The Supplier acknowledges that all tooling, moulding, gauges, dies, jigs, fixtures, plates, cylinders, rollers, equipment and patterns which the Supplier makes, purchases or acquires specifically for the manufacture of the Goods for Central Pharma shall be used solely for the manufacture of the Goods for Central Pharma and not for any other purpose or any other customer. The Supplier shall keep all such tooling, moulding, gauges, dies, jigs, fixtures, plates, cylinders, rollers, equipment and patterns in good repair and condition, and if Central Pharma requires to buy any of them the Supplier shall promptly sell them to Central Pharma at their market price.
9.6 In performing this Contract, each Party shall comply with all applicable data protection legislation.
10 THE FEES
10.1 In consideration of the Supplier providing Central Pharma with the relevant Goods and Services in accordance with the terms and conditions of this Contract, Central Pharma shall pay the relevant Fees to the Supplier.
10.2 The Fees payable by Central Pharma to the Supplier shall be as set out in the Order or any Long Term Agreement.
10.3 Unless the Order or any Long Term Agreement provides to the contrary:
10.3.1 for Goods, the Supplier shall provide Central Pharma with an invoice for the Fees showing VAT separately after the Supplier has supplied all of the Goods in full compliance with this Contract; and
10.3.2 for Services, the Supplier shall provide Central Pharma with an invoice for the Fees showing VAT separately after the Supplier has provided all of the Services in full compliance with this Contract and Central Pharma has received the Services in full to its reasonable satisfaction.
10.4 Central Pharma shall pay the Supplier for all undisputed Fees within 60 days following receipt by Central Pharma of the Supplier’s relevant invoice with any relevant accompanying documentation reasonably requested by Central Pharma.
10.5 Central Pharma is entitled to refuse to make payment in respect of any invoice of the Supplier which does not identify the relevant Order or the particular Goods or Services in respect of which payment is claimed.
10.6 Central Pharma is entitled to set off against the Fees any sums owed by the Supplier to Central Pharma in respect of this Contract or otherwise.
10.7 Unless otherwise agreed by the Parties in writing or stipulated in the relevant Order, Central Pharma shall make all payments to the Supplier in Pound Sterling or such other currency which is in force in England from time to time to a bank account designated by the Supplier on its relevant invoice or by such other payment method reasonably required by the Supplier from time to time.
10.8 Unless otherwise set out in the Order, all sums due as set out in each Order are inclusive of VAT and of any sales, import and export taxes, customs and duties.
10.9 Where this Contract provides for payment of any Services to be on a time basis, the Supplier shall maintain full and accurate records of the time spent in providing the Services and shall produce such records to Central Pharma for inspection at all reasonable times on request.
10.10 Unless otherwise agreed specifically in this Contract or otherwise by the Parties in writing, the Fees shall include all relevant costs and expenses of the Supplier, and no further costs or expenses shall be payable by Central Pharma in addition to the Fees.
10.11 Without prejudice to any other right or remedy available to the Supplier, whether under this Contract, at law or otherwise, if Central Pharma is late in paying any sums due under this Contract, the Supplier may, subject to the Supplier giving Central Pharma not less than fourteen days’ notice, charge interest on the amount due but unpaid at an annual rate of interest of three per cent above the base rate of the National Westminster Bank from time to time, such interest to run from day to day and to be compounded monthly.
11 TERM AND TERMINATION
11.1 This Contract shall commence on the date on which this Contract is entered into and, unless terminated earlier in accordance with the termination provisions of this Contract, shall continue in full force and effect until the latest of:
11.1.1 the conclusion of the provision of the Goods or the Services in accordance with the Order;
11.1.2 the conclusion of the payment of all sums due under this Contract in cleared funds; or
11.1.3 where the nature of this Contract is for the supply of Goods or Services for an indefinite period either Party giving to the other Party no less than three months’ notice of termination.
11.2 Notwithstanding anything else contained in this Contract, it may be terminated by either Party notifying the other Party with immediate effect if:
11.2.1 the other Party is in material breach of any of its obligations under this Contract which is incapable of remedy;
11.2.2 the other Party fails to remedy, where capable of remedy, any material breach of any of its obligations under this Contract after having been required in writing to remedy such breach within a period of no less than 30 days;
11.2.3 the other Party is in persistent material breach of any of its obligations under this Contract;
11.2.4 the other Party suspends, or threatens to suspend, payment of its debts or is unable to pay its debts as they fall due or admits inability to pay its debts or is deemed unable to pay its debts within the meaning of section 123 of the Insolvency Act 1986 as if the words “it is proved to the satisfaction of the court that” did not appear in sections 123(1)(e) or 123(2);
11.2.5 the other Party begins negotiations with all or any class of its creditors with a view to rescheduling any of its debts, or makes a proposal for or enters into any compromise or arrangement with any of its creditors, other than for the sole purpose of a scheme for a solvent amalgamation of that other Party with one or more other companies or the solvent reconstruction of that other Party;
11.2.6 the other Party applies to court for, or obtains, a moratorium under Part A1 of the Insolvency Act 1986;
11.2.7 a petition is filed, a notice is given, a resolution is passed, or an order is made, for or in connection with the winding up of the other Party (being a company, limited liability partnership or partnership), other than for the sole purpose of a scheme for a solvent amalgamation of that other Party with one or more other companies or the solvent reconstruction of that other Party;
11.2.8 an application is made to court, or an order is made, for the appointment of an administrator or a notice of intention to appoint an administrator is given or an administrator is appointed over the other Party;
11.2.9 the holder of a qualifying floating charge over the assets of that other Party has become entitled to appoint or has appointed an administrative receiver;
11.2.10 a person becomes entitled to appoint a receiver over all or any of the assets of the other Party or a receiver is appointed over all or any of the assets of the other Party;
11.2.11 a creditor or encumbrancer of the other Party attaches or takes possession of, or a distress, execution, sequestration or other such process is levied or enforced on or sued against, the whole or any part of its assets and such attachment or process is not discharged within fourteen days;
11.2.12 any event occurs, or proceeding is taken, with respect to the other Party in any jurisdiction to which it is subject that has an effect equivalent or similar to any of the events mentioned in Clauses 11.2.4 to 11.2.11;
11.2.13 the other Party ceases, or threatens to cease, to carry on all or substantially the whole of its business; or
11.2.14 the other Party’s financial position deteriorates so far as to reasonably justify the opinion that its ability to give effect to the terms of this Contract is in jeopardy.
11.3 The expiry or termination of this Contract will be without prejudice to any other rights or remedies which either Party may be entitled to under this Contract or at law and will not affect any accrued rights or liabilities of either Party.
11.4 The expiry or termination of this Contract will not affect the coming into force or continuance in force of any provision which is expressly or by implication intended to come into or continue into force on or after such termination.
11.5 Upon the expiry or termination of this Contract for any reason, the Supplier shall:
11.5.1 promptly return to Central Pharma any artwork, packaging, promotional material or other documentation or items supplied by Central Pharma to the Supplier, including all Artwork and Packaging Materials (other than any documentation or item which the Supplier is required to retain to comply with the requirements of any Regulatory Authority or which the Supplier is permitted to retain under the Long Term Agreement);
11.5.2 immediately cease to use or exploit whether directly or indirectly the Intellectual Property Rights of Central Pharma (other than as may be necessary for the manufacture (including assembly) and supply of any Goods or the provision of such Services subject to a legally binding but incomplete Order as at the date of termination of this Contract or to be delivered to Central Pharma in accordance with Clause 11.5.3; and
11.5.3 deliver any Goods or perform any Services which are the subject of a legally binding but incomplete Order to Central Pharma at the price and in accordance with the delivery instructions (where applicable), stipulated in each relevant Order.
11.6 Upon the expiry or termination of this Contract for any reason, Central Pharma shall take delivery of and pay the Supplier within 60 days of receipt of an invoice for all binding Orders provided to, and accepted by, the Supplier prior to the expiry or termination of this Contract provided that such invoice shall not be raised until delivery of the Goods or the performance of the Services which are the subject of such Orders has been completed in accordance with this Contract and Central Pharma shall pay to the Supplier any outstanding invoices or other undisputed sums within the same 60-day period.
12 FORCE MAJEURE
12.1 Neither Party shall have any Liability for any breach, hindrance or delay in performance of its obligations under this Contract which is caused by an Event of Force Majeure, regardless of whether the circumstances in question could have been foreseen.
12.2 Each Party shall inform the other Party in writing upon becoming aware of an Event of Force Majeure, such communication to contain details of the circumstances giving rise to the Event of Force Majeure.
12.3 The performance of each Party’s obligations shall be suspended during the period that the circumstances persist and such Party shall be granted an extension of time for performance equal to the period of the delay.
12.4 If there is an Event of Force Majeure which continues without a break for more than three months, either Party may terminate this Contract by notifying the other Party with immediate effect, in which event neither Party shall have any Liability by reason of such termination save as otherwise described in this Contract.
12.5 Each Party shall use its reasonable endeavours to assist and co-operate with the other Party to mitigate the effects of an Event of Force Majeure, but neither Party shall be required to take steps that it would be unreasonable to expect it to take.
13 NOTICES
13.1 Any notice required or authorised to be given under this Contract shall be in writing and shall be served by personal delivery or by letter sent by a generally recognised commercial express courier addressed to the relevant Party at its principal place of business as stated in this Contract or at such other address as the relevant Party informs the other Party in writing for this purpose from time to time or at the address of the relevant Party last known to the other Party.
13.2 Any notice served by letter by express courier shall be deemed to have been served two Business Days after the same shall have been despatched, and in proving such service it shall be sufficient to prove that the letter was properly addressed, despatched and delivered, and any notice served by personal delivery shall be deemed served on the date of such delivery.
13.3 This Clause 13 does not apply to the service of any proceedings or any documents in any legal action concerning this Contract.
14 ASSIGNMENT
14.1 The Supplier shall not (and shall not purport to) assign, sub-license, subcontract, transfer, novate, charge or otherwise encumber, create any trust over or deal in any manner with this Contract or any of its rights, liabilities or obligations under this Contract without the prior written consent of Central Pharma.
14.2 If the Supplier subcontracts any of its obligations under this Contract to a subcontractor in accordance with Clause 14.1, the Supplier shall be and remain fully liable for the performance of any subcontractor so appointed and Central Pharma shall have no contractual relationship with any such sub-contractor.
15 WAIVER
15.1 Unless a Party expressly states in writing that it is waiving a particular power, right or remedy in a particular stated instance, no failure or delay or omission by either Party in exercising any power, right or remedy under this Contract or at law shall operate as a waiver of such power, right or remedy; and no waiver in any particular instance shall extend to or affect any other or subsequent event or impair any powers, rights or remedies in respect of it or in any way modify or diminish that Party’s other powers, rights or remedies under this Contract or at law.
16 SEVERABILITY
16.1 If any provision of this Contract (or part of any provision) is found by any court or other authority of competent jurisdiction to be invalid, illegal or unenforceable, that provision or part-provision shall, to the extent required, be deemed not to form part of this Contract, and the validity and enforceability of the other provisions of this Contract shall not be affected.
16.2 If a provision of this Contract (or part of any provision) is found illegal, invalid or unenforceable, the Parties shall negotiate in good faith to amend such provision such that, as amended, it is legal, valid and enforceable, and, to the greatest extent possible, achieves the Parties’ original commercial intention.
17 RELATIONSHIP OF THE PARTIES
17.1 The relationship of the Parties is that of independent contractors dealing at arm’s length. Except as otherwise stated in this Contract, nothing in this Contract shall constitute the Parties as partners, joint venturers or co-owners, or constitute either Party as the agent, employee or representative of the other Party, or empower either Party to act for, bind or otherwise create or assume any obligation on behalf of the other Party, and neither Party shall hold itself out as having authority to do the same.
18 THIRD PARTY RIGHTS
18.1 Subject to Clause 6.2, a person who is not a party to this Contract has no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Contract.
18.2 The rights of the Parties to terminate, rescind or agree any variation, waiver or settlement under this Contract are not subject to the consent of any other person.
19 GOVERNING LAW AND JURISDICTION
19.1 This Contract, and any dispute or claim arising out of or in connection with it or its subject matter or its formation, shall be governed by, and construed in accordance with, the laws of England and Wales.
19.2 If each Party is domiciled in either the United Kingdom or the European Union, the Parties irrevocably agree that the courts of England shall have exclusive jurisdiction to settle any claim, dispute or matter of difference which may arise out of or in connection with this Contract or its subject matter or its formation (including non-contractual disputes or claims).
19.3 If either Party is or both of the Parties are domiciled outside of the United Kingdom and the European Union, any claim, dispute or matter of difference which may arise out of or in connection with this Contract or its subject matter or its formation (including non-contractual disputes or claims) shall be exclusively referred to and finally resolved by arbitration under the London Court of International Arbitration Rules (the LCIA Arbitration Rules). The LCIA Arbitration Rules are deemed to be incorporated by reference into this Clause 19.3. The number of arbitrators shall be one. The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English.
19.4 All dealings, correspondence and contacts between the Parties shall be made or conducted in the English language.