CLS MedPharma Standard Terms and Conditions

1. Area of Application

1.1 All Orders accepted by Complete Laboratory Solutions; or any of its subsidiaries (“CLS”) will be governed by these General Terms of Service (the “Terms and Conditions”), including orders placed by telephone which have not been confirmed in writing. A contract with these Terms and Conditions comes into being when an order that has been placed with CLS is accepted by CLS and creates a Sales Order (SO) on SAP. An order placed with CLS is considered as accepted by CLS when (a) CLS and proceeds to fulfil that order, without need for any written confirmation from CLS, (b) CLS receives a sample with written confirmation or (c) CLS accepts the order in writing. By ordering any of CLS’ products or services, a customer accepts that the order is bound by these Terms and Conditions.

1.2 Unless otherwise indicated, CLS is hereby authorised to subcontract any or all services or products requested by a customer to any of its approved subcontractors. CLS will contact Customers to inform them of any subcontracting services that may arise. Accordingly, these Terms and Conditions shall apply to any services performed pursuant to such Sales Order. In no event shall CLS be liable for any obligations of a subcontractor under these Terms and Conditions, and customer shall look exclusively to such subcontractor in relation to any rights or remedies it may have under these Terms and Conditions with respect to such sales order or subcontracted services.

1.3 This Terms and Conditions supersedes and replaces all prior verbal or written price quotations and Terms and Conditions between the parties. No officer (other than the CEO of CLS, CCO or designee), employee, agent or subcontractor of CLS has the authority to alter or waive any of this Terms and Conditions or to make any representation which conflicts with or purports to override any of this Terms and Conditions; and no such alteration, waiver or representation shall be binding upon CLS, unless it is in writing and signed by the CEO of CLS, CCO or designee.

2. Services

CLS shall perform the services in connection with, process development and commercial production/release & stability activities of Customer as described in this Terms and Conditions (“Services”) at CLS in compliance with the applicable standard (GMP / ISO9001/ISO17025 andISO15189) at the facility detailed on the accreditation certificates.
 The Customer is responsible for providing the necessary materials identified herein prior to CLS’ initiation of any Services.

3. Placement of Order

3.1 Unless specifically accepted in writing and signed by the CEO, CCO, CFO or Divisional Directors of CLS, any terms proposed or submitted by a customer at any time (including, but not limited to, terms or provisions in the customer’s purchase order, instructions or other document) which differ from these Terms and Conditions are rejected as a material alteration of these Terms and Conditions and shall be of no force or effect. Furthermore, special terms or conditions of prior sales orders which have been agreed by CLS in accordance with these Terms and Conditions, including special pricing, will not automatically apply to subsequent orders. Each sales order accepted by CLS will be treated as a separate contract between CLS and the customer.

3.2 A customer’s order will be valid only if it is sent by email, or other electronic message on letterhead of the customer or by using CLS-approved sample chain of custody forms or electronic order forms and the commercial aspects of the order which are not specifically set out in these Terms and Conditions (including price, estimated turnaround times and delivery date) must be agreed at the time of the sales order. The customer must confirm in writing sales orders given by telephone immediately after they are made and, in any event, will be deemed to have placed a sales order if the customer sends samples to CLS quoting the customer reference given to it by CLS. CLS is not obligated to start any analytical work unless the order is clear and it has been provided all required information.

If your finance department requires Purchase Orders you will need to provide us with a valid purchase order when placing a Sales Order. No work will be undertaken by CLS without a valid sales order / purchase order.

3.3 CLS is entitled to charge management and administrative fees of up to €25.00 in connection with the request for additional services to an existing order. A request for additional services on samples that have entered the laboratory will be treated as a new order and may postpone estimated delivery date accordingly.

3.4 Any logistic / sampling service off-site of the laboratory must be paid in full, unless it has been cancelled or modified by the customer at least forty eight hours (48hrs / 2 working days) in advance for standard collection services, seventy two hours (72hrs / 3 working days) for special / dedicated collections, one hundred and twenty (120hrs / 5 working days) hours in advance for sampling services.

3.5 Where a customer decides to cancel a sampling service job more than 5 days before it is scheduled, and for which we have received either a sales order and or a purchase order, any reasonable costs incurred by CLS personnel and their agents, acting on the customers instruction, will be chargeable to the customer.

3.6 Emergency call out surcharges will apply to collection services required within a forty eight hour (48hour / 2 working days)) period of  placing a sales order and seventy two hours (72hrs/3 working days) in respect of sampling services

3.7 CLS are not responsible where environmental conditions or sample monitoring requirements set by the customer, outside the direct control or influence of CLS, cannot be met. Where monitoring is scheduled, agreed and attempted then the customer will be invoiced for all reasonable expenses.

4. Price and Terms of Payment

4.1 Unless otherwise stated in this Terms and Conditions, CLS’ prices apply “ex works”, excluding special materials, kits, references and compendia standards, which are charged separately. Any additional cost or disbursement (e.g. incurred by CLS in connection with the order) must be paid by the Customer. If these are not supplied by the customer, they will be charged at cost plus 10% handling charge.

4.2. Prices are exclusive of all applicable taxes (including VAT) and are based on tariffs in force at the day of the remittance of the offer to the Customer. Applicable taxes are those in force at the date of invoicing.

4.3 CLS is entitled to charge management and administrative fees of up to fifty Euro (€50.00) in connection with rectification of incomplete paperwork on a per-shipment basis; associated with services under this Terms and Conditions. A request for additional services on samples under this Terms and Conditions that have entered the laboratory will be treated as an amendment to this Terms and Conditions and may postpone estimated delivery date accordingly.

4.4 Any logistic service off-site of the laboratory must be paid in full, unless it has been cancelled or modified by the Customer at least forty-eight hours (48hrs / 2 working days) in advance for collection services or 72hours for any special (dedicated) collection services, one hundred twenty hours (120 hrs / 5 working  Days in advance for sampling services.

4.5 Of-site logistics services must be booked a min of forty-eight hours (48) in advance for collections  and one-hundred and twenty 120hours (120hrs/5 days) in advance of service. Emergency call-out charges will apply to services called off within these time periods. A waiting time of 30mins for access and egress on client sites is factored into the charge for any logistics/sampling service provided. CLS will be entitled to levy a surcharge over and above the 30min maximum waiting time.

4.6 Unless specifically agreed otherwise by CLS in this Terms and Conditions, payment of all invoices is due strictly within thirty (30) days of the invoice date. Any dispute about invoices must be raised within thirty (30) days of the invoice date. The challenge of an analytical result will not entitle a Customer to defer payment. Any invoice which remains outstanding after due date, may be additionally charged with a minimum administrative penalty of Fifty Euro (€50.00) and may carry the interest at the rate of 2 % per annum above Bank of Ireland’s base lending rate from time to time in the Republic of Ireland or the maximum interest rate permitted by applicable law, whichever is lower.

4.7 CLS is entitled to impose a minimum invoice charge of two hundred and fifty Euro (€250.00). CLS has the right to charge an administrative fee of at least Euro (€50.00) to re-issue an invoice.

4.8 The invoice settlement method is bank transfer. Any other method of payment must receive prior Terms and Conditions from CLS. The Customer undertakes to provide bank account details.

4.9 Depending on order size and/or Customer credit score, CLS is entitled to require payment of up to one hundred percent (100%) of the quoted order price as a condition of acceptance.

4.10 All reasonable costs associated with CLS’ compliance with any official requests for information or documents of any purpose relating to Services performed by CLS under this Terms and Conditions, including, but not limited to, meetings outside the Facility, additional documentation not documented in the work order, data re-calculation and report formatting shall be paid by the Customer. The Customer shall be responsible for all such costs including, but not limited to, hourly charge for persons responding to requests, travel, lodging, mileage, legal preparation of any person called to testify and associated fees and all other reasonable expenses associated with any such requests.

5. Duties of Customer in Delivering Samples or Materials

5.1 Unless otherwise agreed in writing by the Parties to the Customer is responsible for the proper delivery of samples to CLS and transportation costs and packaging of samples are fully charged to the Customer. In any case, CLS assumes no responsibility for any loss or damage of samples occurred during transport. The Customer shall be responsible at all times for the safe, appropriate packaging and insurance of samples during transport.

5.2 Unless otherwise agreed in writing by the Parties, samples return costs are fully charged to the customer. In any case, CLS assumes no responsibility for any loss or damage of the samples occurred during transport.

5.3. Samples received by CLS without a regular purchase order (PO) for their analysis will be disposed of by CLS within one month after receiving them and related costs charged to the Customer. Samples will not be processed without an approved sales order backed up by the appropriate PO.

5.4. Unless otherwise agreed in writing by the Parties, the costs related to customs clearance/import into Ireland and/or European Community are the complete responsibility of the Customer. A €120.00 fee as reimbursement for administrative expenses of the management of customs clearance documentation will be applied. Alternatively, the Customer can deal directly with a nominated customs clearance agent, for all transactions (including costs). The sample consignment should have “Delivered Duty Paid (DDP)” clearly stated. The Customer bears all responsibility for correctly labelling samples from a taxation point of view.

5.5 The samples or materials must be in a condition that makes the preparation of reports/analyses or the production of ordered products possible without difficulty. CLS is entitled to conduct an initial examination of the samples or materials to check their condition before processing the samples, drawing up a report or using them in production. The Customer shall bear the costs of this initial examination, if the samples or materials do not comply with the requirements described in this clause. CLS is entitled to impose an additional charge for the preparation of samples that are not supplied according to CLS guidelines. If the result of the initial examination is that an analysis or production is impossible or is possible only under more difficult conditions than originally anticipated – for example, because the samples or materials have been interspersed with foreign materials or substances that were not reported by the Customer or are degraded – CLS shall be entitled to terminate or interrupt the order and the Customer shall bear costs incurred by CLS to that point.

5.6 The Customer must ensure, and hereby warrants, that no sample poses any danger, including on its site, during transportation, in the laboratory or otherwise to CLS premises, instruments, personnel or representatives. It is the Customer’s responsibility to ensure compliance with hazardous waste regulations, including regarding information, transportation and disposal and to inform CLS personnel or representatives about sample health and safety concerns, including any known or suspected toxic or other contaminant that may be present in the sample and its likely level of contamination as well as the risks to CLS premises, instruments, personnel and representatives related to the contamination. The customer will provide CLS with any relevant occupational safety information known to the client, including a Material Safety Data Sheet (MSDS). The Customer shall be responsible for, and indemnifies CLS against, all costs, damages, liabilities and injuries that may be caused to or incurred by CLS or its personnel or representatives including on the sampling site, during the transportation or in the laboratory by the Customer’s sample or by sampling site conditions. The Customer shall bear all extraordinary costs for adequate disposal of hazardous waste resulting from the sample, whether or not described as hazardous waste. At CLS’ request, the Customer must provide CLS with the information required to ensure safe handling, disposal and testing of the sample.

5.7 The Customer must ensure, and hereby warrants, that no sample will be dispatched to CLS, in the absence of (a) completed CLS Chain of Custody form (COC) outlining the testing requested, (b) a signed quotation indicating acceptance of the testing request and (c) a current, valid & signed purchase order covering the testing request. No sample will be logged into CLS testing systems in the absence of all documentation described in this. CLS reserve the right to charge €100 euro for follow up on any sample consignment that does not comply with this requirement.

5.8 The Customer must provide at minimum of 24 hours’ notice in writing to CLS prior to submitting samples for analysis.

6. Property Rights on Sample Material and Sample Storage

6.1 CLS can dispose of or destroy samples 1 month after the analysis has been performed, unless CLS and the Customer have agreed in writing on the terms of CLS’ retention of the sample. CLS also can dispose of or destroy the samples after the agreed upon retention period, without further notice and at Customer’s cost, should an extra cost for CLS arise to comply with any regulation (for example, with respect to disposal of hazardous waste). CLS is entitled to charge the customer a disposal charge for all samples, hazardous and non-hazardous in line with the polluter pays principle enshrined in European Law, transposed into Irish Statute in the European Union (Waste Directive) Regulations 2020.

If the Customer requests the return of unneeded or surplus sample material, CLS will return them to the Customer, at the Customer’s cost and risk.

7. Delivery Dates, Turnaround Time

7.1   Estimated turnaround time (TAT) is 10 working days from receipt of samples. If a shorter TAT is required, an additional surcharge will apply. Due to the uncertainty of the delivery of samples according to the necessary timelines, the availability of critical reagents to conduct the studies and other unforeseeable events, the delivery dates and turnaround times provided by CLS to the Customer are best estimates and do not constitute a commitment by CLS. Nevertheless, CLS shall make commercially reasonable efforts to meet the agreed upon project deadlines. Notwithstanding, specific turnaround time guarantees may be implemented by CLS for specific services.

7.2 Results are issued  through email from CLS in the format of a Certificate of Analysis of Validation Report. The document signed on behalf of CLS by authorised signatory containing and outcomes relating to the Services (s). The document from CLS to the attention of the persons indicated by the Customer in the sales order, promptly after the analysis is completed. Results are available on a  CLS proprietary online portal system for trending purposes.

7.3 Should CLS agree and undertake to provide any bespoke reporting requirements tailored to specific customer needs an additional charge will apply

8. Transfer of Property

8.1 Title in any analysis results, products, equipment, software or similar supplied by CLS to the Customer will remain with CLS until all invoices in respect thereof have been paid by the Customer in full, and until such full payment, the Customer shall have no property rights or other rights to use them. In addition, even if CLS has accepted and begun to fulfil an order, CLS has the right at any time to stop processing that order and to stop doing any work for a Customer if that Customer is late in paying any amount due to CLS, whether for that or any other order.

8.2. CLS will retain copies of all written and recorded information produced from any Services, including but not limited to laboratory notebooks, descriptions, methods and procedures for a period of 10 years following completion of the Services. CLS is entitled to levy additional charges for the archiving and storage of raw data and document storage. After the 10 year time period, CLS may destroy any records pertaining to completed Services, arrange for return to the Client or arrange for external storage of the information for an additional fee. The Client will be responsible for arrangement of any additional insurance cover for such returns/storage.

9. Limited Warranties and Responsibilities

9.1 Orders are handled in the conditions available to CLS in accordance with the current state of technology and methods developed and generally applied by CLS. Analyses, interpretations, assessments, consulting work and conclusions are prepared with a commercially reasonable degree of care but CLS cannot guarantee that these will always be correct or absolute. This limited warranty expires six months after the delivery date of the final report or completion of study, if the acknowledgement of the order does not specifically state otherwise. In all cases, the Customer must independently verify the validity of any results, interpretations, assessments and conclusions supplied by CLS, if it wishes to rely on the same in respect of matters of importance and shall do so at its own risk.

9.2 Each analytical report or Certificate of Analysis (CoA) relates exclusively to the sample analysed by CLS. If CLS has not expressly been mandated and paid for the definition of the sampling plan (including which samples of which raw materials and finished products and at which frequency should be analysed) and the definition of the precise range of analysis to be performed or if the Customer has not followed CLS recommendations, CLS shall not bear any responsibility if the sampling plan and/or the range of analysis to be performed prove to be insufficient or inappropriate.

9.3 The Customer is responsible for the proper delivery of samples sent to CLS for examination/analyses or materials sent for production. Unless otherwise specifically agreed in writing by CLS, CLS accepts no responsibility for any loss or damage, which may occur to any sample in transit or to any facility or site where logistics services are being delivered. The Customer will at all times be liable for the security, packaging and insurance of the sample from its dispatch until it is delivered to the offices or the laboratories of CLS. CLS will use commercially reasonable care in handling and storing samples, but CLS shall not be held responsible for any loss or destruction of samples even after their receipt at its laboratories.

9.4 The Customer warrants and represents to CLS that all samples sent to CLS for analysis are safe and in a stable condition and undertakes to indemnify CLS for any losses, injuries, claims and costs which CLS, or its personnel, may suffer as a result of any sample not being in a safe or stable condition, notwithstanding that the Customer may have given an indication on the sample or any order form of any perceived problem with the sample. The Customer must always inform CLS in writing prior to shipment and label the packaging, samples and/ or containers appropriately, if the samples are dangerous or otherwise of a hazardous nature.

9.5 Unless explicitly agreed in writing by all parties, the contractual relationship shall be exclusively between the Customer and CLS. There shall be no third-party beneficiary or collateral warranty relating to any order and the Customer shall indemnify and hold CLS harmless from and against all third-party claims in any way relating to the Customer or to the order by the Customer.

9.6 CLS does not provide the services of a Qualified Person (QP). It is the responsibility of the Client to ensure that the Service(s) meet the Client’s quality and compliance requirements including any needed for manufacturing or marketing authorisations.

10. Limitation of Liability

10.1. Except to the extent that such limitations are not permitted or void under applicable law: (a) CLS (together with its workers, office administrators, employees, representatives, managers, officers, directors, agents and consultants and all CLS partners and affiliates, the “ CLS Indemnifying Parties”) shall be liable only for the proven direct and immediate damage caused by the CLS Indemnifying Party’s wilful misconduct in connection with the performance of this Terms and Conditions and then, only if CLS has received written notice thereof not later than six (6) months after the date of the Customer’s knowledge of the relevant claim (unless any longer period is prescribed under applicable law and cannot be contractually limited), and (b) in all cases (whether arising under contract, tort, negligence, strict liability, through indemnification or otherwise), the CLS Indemnifying Parties’ liability per claim or series of related claims, and the Customer’s exclusive remedy, with respect to CLS’ services which fall under this Terms and Conditions, shall be limited to the lesser of:

(i) the direct and immediate loss or damage caused by the CLS Indemnifying Party’s wilful misconduct in connection with the

performance of the Services and

(ii) ten times the amount CLS actually received from the customer in relation to the order up to fifty thousand euro (€50,000).

10.2 The CLS Indemnifying Parties shall not be liable for any of the following: (i) loss of business profits; or (ii) depletion of goodwill or other similar losses; or (iii) loss of business opportunities; or (iv) loss of contracts; or (v) loss of revenue; or (vi) loss of anticipated savings; or (vii) loss of or damage to data; or (viii) for any special indirect or consequential losses, costs, charges, expenses or damages incurred by the customer or by any third party. However, the CLS Indemnifying Parties only exclude and limit their liability as permitted by applicable law. The CLS Indemnifying Parties do not exclude or limit their liability for death or personal injury caused by their negligence, for their fraudulent misrepresentation or for breach of implied terms under any applicable statute regarding CLS’ right to always transfer good title (subject to clause). There shall be no third-party beneficiary or collateral warranty relating to any order and the Customer shall indemnify and hold CLS harmless from and against any and all third-party claims in any way relating to the Customer or by the Customer.

10.3 It is a condition of CLS’ acceptance of an order that the Customer indemnifies the CLS Indemnifying Parties for any losses, injuries, claims and costs which the CLS Indemnifying Parties may suffer as a result of arising from or in any way connected with its role under or services or products or software provided pursuant to this Terms and Conditions except to the extent that the CLS Indemnifying Parties are required to bear them according to this Terms and Conditions, and by placing an order the Customer agrees to provide that indemnification.

11. Repeated Analysis

Objections to test results should be made within ten (10) business days after the Customer receives the results. If the test results warrant repeat of the test, then the Customer must formally document such request in writing which must be agreed to by CLS before repeated analysis will be conducted. The cost incurred for the repeated analysis will be documented in a task order or other appropriate contract before the work will be conducted. Furthermore, a repeated analysis will be possible only if CLS has a sufficient amount of the original sample on hand when it receives the Customer’s objection. In the absence of error attributable to services, materials or software provided by CLS, the Customer will be required to pay all costs, including but not limited to consultation, sampling, transportation, analytical and disposal costs for the repeat analysis.

12. Term, Termination and Amendment

No addition to or modification of this Terms and Conditions shall be effective unless made in writing and signed by authorised representatives of both parties. This Terms and Conditions shall commence on the Effective Date and shall continue until the Services have been completed. CLS or the Customer may terminate this Terms and Conditions upon thirty (30) days written notice to the other party for any reason.

13.Force Majeure

CLS cannot be held liable for delays, errors, damages or other problems caused by events or circumstances which are unforeseen or beyond CLS’ reasonable control, or which result from compliance with governmental requests, laws and regulations.

14. Confidentiality, Intellectual Property & Processing of Customer Data

14.1 CLS shall use commercially reasonable efforts to keep data sent by the Customer or on the Customer’s behalf by a third party, confidential in compliance with applicable law.

14.2 CLS shall use commercially reasonable efforts to keep all analysis results and service reports confidential, subject to CLS’ rights set forth in clause 7.2 and the right to use them in order to demonstrate its entitlement to payment for services rendered.

14.3 Analysis results are prepared and supplied for the use of the Customer. The Customer is required to maintain secrecy concerning all services provided by CLS and their results as well as the composition of products and any software delivered by CLS. Analysis results are not to be publicly disclosed or exploited without the prior written consent of CLS. Even if such written consent is given by CLS, the Customer (a) remains responsible for any consequences due to the divulgence of such results to a third party and any reliance of such third party on such results and (b) hereby agrees to indemnify the CLS Indemnified Parties against any liability which the CLS Indemnified Parties may incur as a result of such divulgence or any such third-party reliance.

14.4 CLS will acquire no rights of any kind whatsoever with respect to any information, know-how, materials and/or compounds (“Customer Materials”) provided by the Customer to CLS under the terms of this Terms and Conditions. In consideration of the fees paid to CLS for the Services, the Customer shall own all rights in any results, including any reports, generated by CLS that are derived from the Services. The Customer acknowledges that CLS owns, licenses or controls pre-existing intellectual property such as standard operating procedures, screening protocols, testing materials and laboratory methodologies that are used by CLS to perform the Services and not developed solely for or provided by the Customer (“ CLS Intellectual Property”). CLS may, whether alone or in conjunction with third parties, develop improvements, processes and methods that improve CLS Intellectual Property which can be used by CLS at any time without disclosing the Customer’s confidential information or Customer Materials (“Improvements”). CLS shall own all such Improvements.

15. Disclaimer and Miscellaneous


15.2 Should a court waive, limit or hold to be invalid, illegal or unenforceable any part of this Terms and Conditions, all other parts shall still apply to the greatest extent possible.

15.3 Failure by either CLS or the Customer to exercise the rights under this Terms and Conditions shall not constitute a waiver or forfeiture of such rights.

15.4. CLS certifies that it has not been debarred under sections 306(a) and (b) of the Federal Food, Drug and Cosmetic Act.

15.5 Neither Party shall assign or subcontract its rights or obligations under this Terms and Conditions, in whole or in part, or any interest therein, without prior, written consent of the other Party provided however, that such consent shall not be unreasonably withheld, conditioned or delayed. Subject to the forgoing, this Terms and Conditions shall be binding upon and inure to the benefit of the successors in interest of CLS and the Customer.

16. Governing Law/Jurisdiction

16.1 The construction, validity and performance of this Terms and Conditions shall be governed by governed by l be governed by governed by the laws and the commercial courts of Republic of Ireland, which shall have exclusive jurisdiction