PRODUCT SAFETY LABS, INC. GENERAL TERMS AND CONDITIONS OF BUSINESS

Jump to Study Cancellation, Termination and Delay Fee

1. Area of Application

1.1 A contract with the Terms and Conditions set out below comes into being when an order is placed with Product Safety Labs, Inc. or any of its subsidiaries or affiliates, hereinafter 'PSL', and when PSL accepts that order. These Terms and Conditions supersede and replace any verbal or written agreement (except for any agreed variation under Clause 14.2), terms on purchase orders, memoranda or clauses in any other documents between the parties.

1.2 Any commitment purported to have been entered into on behalf of PSL by one of its agents, representatives, or similar is only valid accompanied by a written signed confirmation from an authorized signatory of PSL. However, an order placed with PSL is considered as accepted by PSL when PSL proceeds to fulfill that order, without need for any written confirmation by PSL.

1.3 The information provided in a catalogue, website, leaflets, price lists and any other documents prepared by PSL are only indicative and in no way commits PSL and PSL reserves the right to modify such information at any time.

2. Placement of Order

2.1 The customer's order will only be valid if sent by mail, fax or email on customer letterhead or by using approved PSL's sample dispatch sheets or electronic order forms. The customer is responsible for ensuring that orders given by telephone are confirmed by the customer by mail, fax or email immediately after placement by telephone. Orders placed by telephone will be governed by these Terms and Conditions whether or not the customer submits such written confirmation. Also, if the customer sends samples to PSL quoting the customer reference, PSL is entitled to treat this as the customer placing an order and the customer will be bound by these Terms and Conditions on acceptance of such an order by PSL.

2.2 If the customer places any orders with PSL, the commercial aspects of the order not specifically set out in the Terms and Conditions (including, but not limited to price, estimated turnaround times and delivery date) must be agreed at the time of the order and the commercial terms agreed in relation to any initial order will not automatically apply to additional or subsequent orders. Each order is to be treated as a separate contract between PSL and the customer.

3. Prices and Terms of Payment

3.1 If the acknowledgment of the order does not state otherwise, PSL's prices are exclusive of all taxes. Any taxes payable on the quoted prices will be charged to the customer. PSL may revise prices quoted at any time.

3.2 PSL reserves the right to increase the price appropriately if unforeseen costs increases, particularly as a result of increases in the cost of materials, occur after the agreement is signed or if the amount of work exceeds original estimate. On request, PSL will document such increases for the customer.

3.3 If fulfilling any order or performing any services for the customer requires any officers, employees, representatives or agents of PSL to conduct any work on a customer site or any other site outside PSL's usual places of business the customer shall be responsible for the cost of travel, accommodations, subsistence and other disbursements reasonably and properly incurred by PSL in connection with such work (which shall be chargeable in addition to PSL’s prices for such work).

3.4 PSL is entitled to invoice customer at the time the order is placed, for up to a 50% of the total fee quoted for the order.

3.5 Unless otherwise agreed by PSL, in its acceptance of any order, payment of invoices is due within 30 days of the invoice date set forth on each invoice.

3.6 Any invoice which remains outstanding 30 days after the invoice date will incur interest at a rate of 1.5 percent per month or per part of month on the amount outstanding or the maximum permitted by applicable law (whichever is less), calculated from date payment fell due to the date payment is actually received (whether before or after judgment). In addition, customer shall reimburse PSL upon request for all collection costs (including, without limitation, reasonable attorney fees) incurred in connection with any unpaid invoice.

3.7 In the event that the project is cancelled, any funds invoiced and received will be reconciled against work completed.  Invoices are subject to a minimum charge of $100.

4. Duties of Customer In Delivering Samples or Materials

4.1 The customer is solely responsible for the proper delivery of samples sent to PSL for testing. The samples or materials must be in a condition that makes analyses and preparation of reports possible without difficulty. PSL is entitled to reject samples or materials and to terminate the signed agreement for good cause or to interrupt it for an appropriate time period, if the samples, the sampling conditions or the materials do not meet the requirements.

4.2 PSL is entitled to conduct an initial examination of the samples or materials to be able to check their condition before processing the samples, drawing up a report or using them in any testing. The customer shall bear the costs of the initial examination if the samples or materials do not comply with the requirements described in clause 4.1. If the result of the initial examination is that an analysis or testing is impossible or is possible only under more difficult conditions, in particular because the samples or materials have been interspersed with additional foreign materials or are degraded then PSL is entitled to terminate the agreement in conformity with the arrangements set forth in clause 4.1. The customer shall pay costs already incurred by PSL.

4.3 If the customer sends samples or materials or permits samples to be collected by PSL, it is obligated on appropriate request to provide written information concerning the composition of the samples and the condition of the samples or materials, such as pre-treatment and/or additives. If the customer does not comply with this request within an appropriate time to be set by PSL, PSL may terminate the contractual relationship in conformity with the arrangements set forth in clause 4.1 and the customer shall pay costs already incurred by PSL.

4.4 If the samples or the materials contain property or substances which were not reported by the customer and the completion of the order is delayed or rendered impossible as a result, PSL is entitled to charge the customer for the costs thus incurred. In this case the customer has the right to withdraw from the agreement, but the customer must pay all costs incurred until that time. If the performance of the order is impossible due to the aforementioned reasons, the customer is required to pay costs incurred by PSL until that time

5. Property Rights on Sample Material and Sample Storage

5.1 Samples sent by the customer or samples collected by PSL may be retained by PSL to the extent they are needed for the performance of the order. On the other hand, sample material not needed by PSL may be returned to the customer subject to advance notice by the customer or disposed of at customer’s expense. The customer bears the costs incurred in doing so (transport, insurance, disposal. etc.)

6. Delivery Dates. Turnaround Time

6.1 Delivery dates and turnaround times are estimates and are provided to the customer for information only. PSL will use reasonable efforts to meet agreed upon delivery dates and turnaround times.

6.2 Analysis results are often dispatched to the customer by fax or E-Mail. It is the responsibility of the customer to inform PSL in writing before the results are dispatched if this is not acceptable or if he wishes to receive the results only by mail or in any other way.

7. Transfer of Property

7.1 Title in any analysis results, products, equipment, software or similar supplied by PSL to the customer will remain with PSL until all invoices in respect thereof have been paid by the customer in full and until such time the customer has no property rights or rights to use the same and PSL shall be entitled to demand the return of any such items until all such invoices have been paid in full. In addition, despite having accepted any order and beginning to fulfill it, PSL can at any time stop processing any order and doing any work for a customer if that customer is late in paying any amounts due by it to PSL whether for that or any other order.

8. Limited Warranties and Responsibilities

8.1 Orders are handled in the conditions available to PSL in accordance with the current state of technology and methods developed and generally applied by PSL. The customer is aware and acknowledges that the testing methods may not always yield a 100% exact and/or relevant result. Testing methods are subject among other factors to the method’s uncertainty, to the methods suitability to the experimental objective or, in rare cases, to human error or instrumental malfunction that may not always be picked up by the laboratory's quality assurance programs. With respect to the economic importance of the analysis and the potential consequences of faulty result, it is thus the customer’s responsibility to check the plausibility and validity of results. Interpretations as well as all consulting work are based on study results and on information provided by the customer. Interpretations, assessments, consulting work and conclusions are prepared by PSL with a reasonable degree of care but the customer acknowledges that in any event they can only be considered as being the signatory’s opinion. PSL cannot guarantee that these will always be correct or absolute particularly in view of the constant evolution and re-evaluation of scientific knowledge and regulations. In all cases the customer must verify the validity of any interpretation; assessments and conclusions supplied by PSL if the customer wishes to rely on the same in respect of matters of importance and shall do so at its own risk.

8.2 PSL will strive to ensure that appropriate study designs are used to satisfy the regulatory requirements of the customer. However, it is ultimately the Customers responsibility to ensure the proposed study design meets the study objectives. WITHOUT SPECIFIC PRIOR WRITTEN ARRANGEMENTS BETWEEN THE CUSTOMER AND PSL, PSL DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, AND PSL DOES NOT WARRANT THAT THE RESULTS PROVIDED ARE FIT FOR A PARTICULAR PURPOSE.

8.3 PSL will be responsible only for providing the means (laboratories, equipment, knowledge, personnel) for carrying out the testing requested. PSL undertakes to use reasonable care in the analysis, having regard to its level of experience in the test methods required, the price being paid by the customer and the overall circumstances of the testing.

8.4 Each testing report relates exclusively to the sample received by PSL, as specified in the written acceptance by PSL. PSL accepts no responsibility for the way the sample was collected, stored or delivered to PSL unless PSL has specifically agreed in writing to undertake such tasks and responsibility itself.

8.5 If PSL has not expressly been mandated and paid for the design of the sampling plan (including which sample of which raw materials and finished products and at which frequency they should be analyzed) and the definition of the range of analyses to be performed or if the customer has not followed PSL recommendations, PSL shall not bear any responsibility if these points prove to be insufficient or inappropriate.

8.6 IN RELATION TO ANY EQUIPMENT, PRODUCT OR SOFTWARE SUPPLIED BY PSL TO THE CUSTOMER UNLESS AGREED OTHERWISE IN WRITING ALL WARRANTIES CONDITIONS OR OTHER TERMS (WHETHER IMPLIED BY STATUTE, OPERATION OF LAW OR OTHERWISE IN ANY WAY) AS TO SUCH EQUIPMENT, PRODUCTS OR SOFTWARE ARE HEREBY EXPRESSLY EXCLUDED BY PSL TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW PROVIDED THAT (I) PSL CONFIRMS THAT IT PASSES GOOD TITLE IN ANY PSL EQUIPMENT AND PRODUCTS TO THE CUSTOMER AND THAT SUCH PSL EQUIPMENT AND PRODUCTS SHALL CORRESPOND IN ALL MATERIAL RESPECTS WITH THEIR ACCEPTED ORDER SPECIFICATION AT THE TIME OF DELIVERY AND (II) IN THE CASE OF PSL PROPRIETARY SOFTWARE, AS MAY BE SPECIFICALLY COVERED BY THE SPECIFIC SOFTWARE LICENSING TERMS THAT APPLY TO USERS OF SUCH SOFTWARE. THE CUSTOMER MUST SATISFY AS TO THE SUITABILITY OF ANY PRODUCT, EQUIPMENT OR SOFTWARE, WHICH IT ORDERS FROM PSL AND THAT IS POSSESSES THE APPROPRIATE LEGAL AUTHORIZATION AND LICENSES TO MAKE USE OF SUCH.

8.7 Unless otherwise specifically agreed in writing by PSL, PSL accepts no responsibility for any loss or damage, which may occur to any sample in transit. 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 of the laboratories of PSL. PSL will use reasonable care in handling and storing samples. The customer warrants and represents to PSL that all samples sent to PSL for analysis are safe and in a stable condition and undertakes to indemnify PSL for any losses, injures, claims and costs to PSL, its officers, servants, representatives and agents 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 PSL in writing prior to shipment and label the packaging, samples and, or containers appropriately, if the samples are of dangerous nature.

8.8 The contractual relationship shall be solely between the customer and PSL. There shall be no third party beneficiary or collateral warranty (and the parties state their intention to exclude implied by law, statute, or otherwise in any way which confer such rights, to the maximum extent permitted by applicable law)

9. Limit of Liability

9.1 PSL is only liable for proven damages and only in connection with testing and expert reports it produced if these damages are directly due to PSL willful intent and gross negligence. In any case PSL liability is limited to compensation of the direct and immediate damage caused by PSL faulty actions or omissions in connection with the performance of the agreement. PSL’s liability in any way relating to orders placed under this agreement of these Terms and Conditions (whether arising under contract, tort, negligence, through indemnification or otherwise) per claim or series of related claims is limited to the amount actually received from the customer in relation to study in question. The customer is required to indemnify PSL against any compensation claims by third parties in the event of unlimited or limited further use of expert reports, test certificates or reports. Customer's claims due to improper performance of the contract as well as claims for damages must be made within a period of six (6) months from the date of the Customers knowledge of the relevant claim (unless any longer period is prescribed under applicable law and cannot be contractually limited). All exclusions and limitations set out in these Terms and Conditions are intended to have the maximum effect possible under applicable law. Where certain exclusions or limitations are not legally permitted or are regarded as void under applicable law, then PSL does not exclude or limit its liability to such extent. In particular, PSL does not exclude or limit its liability for death or personal injury caused by its gross negligence or for fraudulent misrepresentations where this is not legally permitted or may be regarded as void under applicable law.

9.2 The same limitations of liability, warranty and responsibility and the right to indemnification of PSL by a customer (all as outlined in or resulting from these terms of sales) also applies to the personal liability of office clerks, employees, representatives, managers, officers, directors, agents and consultants of PSL and all PSL trustees, partners and affiliates (all together “the indemnified person[s]").  "Affiliates” means   any   entity that   directly   or   indirectly,   through   one   or   more intermediates, now or hereafter, controls or is controlled by, or is under common control with a party hereto. For the purposes herein, the term "control" (including the terms  "controls",  "controlled   by",  and  "under  common   control  with")   means  the possession,  direct  or  indirect  of  the  power  to  direct  or  cause  the  direction  of  the management and policies of a person or entity, whether through the ownership of voting securities, by contract or otherwise.

9.3 PSL shall not be liable for any indirect, direct or consequential damage (such as loss of business, profits, goodwill, business opportunities, similar) incurred by the customer or by any third party.

9.4 PSL’s contract and obligations are solely with/to its direct customers. There shall thus be no third party or collateral beneficiary of any warranty, claim or indemnity. The customer shall indemnify and hold PSL harmless for any third party claim.

9.5 The warranty period amounts to six months, calculated from the delivery date of the samples, if the acknowledgement of the order does not state otherwise. This period is a period of limitation and also applies to claims for compensation of any harm caused by a defect.

9.6 In any event, for any claims made by the customer against PSL, the customer is required to prove and mitigate any losses howsoever caused.

9.7 The customer acknowledges and agrees that the limitations of liability contained in these Terms and Conditions are:

9.7.1 fair and reasonable,

9.7.2 reflected in the level of charges and of insurance cover carried by PSL, and

9.7.3 just and equitable having full regard to the extent of the responsibility of PSL for any loss or damage likely to be suffered In relation to the PSL equipment, products, software and services supplied.

9.8 Where PSL or any indemnified person is (i) finally found liable by courts or (ii) subject of a claim arising from or in any way connected with its role under or services or products or software provided pursuant to these terms of sales, then the total amount recoverable from PSL or any indemnified person shall be limited to such proportion (the “liability”) as is finally judicially determined to be just and equitable, having regards to the relative responsibility of (A) PSL or any indemnified person and (B) any other person (including both the customer and any director, employee, agent, subsidiary or affiliate of the customer) who may be jointly or severally (an “other party”). For the avoidance of doubt, any limitation or exclusion or restriction on the liability of any other party under any jurisdiction whether arising under statute or contract or resulting from death, bankruptcy, insolvency shall be ignored for the purpose determining the extent of the responsibility of the other party under clause (B) above.

9.9 The customer undertakes to indemnify PSL or any indemnified person for any losses injuries, claims and costs which PSL or any indemnified person 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 these terms of sales, unless the liability rests with PSL according to these terms of sales

10. Repeated Testing

10.1 If the customer raises an objection to a test result reported by PSL then PSL shall review the result. PSL is also entitled to have the review conducted by third parties. If the result objected to is corroborated the customer shall bear the costs of the repeat testing or review. Otherwise, the test result will be corrected free of charge

10.2 A repeat test can only be performed if the conditions of the sample or goods to be sampled make such retesting possible.

10. 3 Objections to the test result are allowed within a period of one month, counting from the time the result is received by the customer.

11. Duty of Confidentiality

11.1 PSL will use reasonable efforts (commensurate with those used in maintaining its own confidential information) to keep analysis results in strict confidence.

11.2 Sponsor shall solely and exclusively own all data, analyses, report or work product generated by PSL under this Agreement.  PSL will promptly disclose to Sponsor any invention, discovery, or commercial idea or plan related to the Compounds, arising from PSL's work under this Agreement.  Sponsor is the sole and exclusive owner of any such invention, discovery and patent rights or any commercial idea or plan, and PSL will execute such documents and take such other action at Sponsor's expense as may be necessary or appropriate to establish, register, record, or otherwise document Sponsor's ownership in the United States and foreign countries.  For clarity and without limiting the foregoing, PSL assigns to Sponsor, free of charge and effective on creation, all knowledge, information, and know-how and any new property and proprietary rights developed in the course of this Agreement.  Sponsor grants to PSL a non-exclusive, perpetual, paid up, royalty free, irrevocable license but not the right to sub-license to use such adaptations and know-how directly related to animal model development in the normal course of its business, provided that PSL remains in full compliance with confidentiality provisions and all of its other obligations under this Agreement.  Even if such written consent is given by PSL the customer 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 hereby agrees to indemnify PSL against any liability which PSL may incur to such third party or to any other party as a result of such divulgence or any such third party reliance. 

12. Force Majeure

12.1 PSL shall not be liable to the customer for any delays in performance or any non-performance of its obligations as a result of causes beyond its control (which for the avoidance of doubt shall include, but not be limited to, acts of God, strike, lock-out, government order, non-availability of equipment or parts, power or other utilities failures, war, riots or public disturbances act of terror, etc.) and also if they affect PSL's suppliers or subcontractors. They entitle PSL to postpone the service or delivery by the duration of the obstacle plus an appropriate start-up period or to withdraw from the agreement entirely or in part with regard to the still not performed portion. If the obstacle lasts longer than three months after the setting of an appropriate additional period of time, the customer is allowed to withdraw from the agreement with regard to the portion still not performed. If the delivery time is extended or PSL is freed from its obligation, the customer may not derive claims for damages there from. PSL may only avail itself of the named circumstances if it informs the customer promptly.

13. Disclaimer and Miscellaneous

13.1 Except as expressly set forth in these General Terms of Sales and Conditions of Contract, all equipment, products, services and software are supplied “as is” and “as available” and PSL expressly disclaims all other representations, warranties, liability, conditions or terms of any kind (whether express, implied, statutory or otherwise), with respect to the analysis, consulting services, equipment, products, software or any other product or service provided or otherwise in any way to the maximum extent permitted by applicable law. Sections 3, 4, 7, 8, 9, 10.3, 11.2, 11.3, 12.1, 13.1, 14 and 15 shall survive any termination or expiration of these General Terms of Sales and Conditions of Contract.

13.2 These Terms and Conditions may be amended by PSL from time to time by sending amended Terms and Conditions to the customer which shall apply to all orders placed after the customer is deemed to have received the amended Terms and Conditions (which for these purposes shall be deemed to be two days after the date on which they are mailed to the customer). No other amendments or variations shall be valid unless signed by an authorized signatory of PSL.

13.3 Should a court waive, limit or hold to be invalid, illegal or unenforceable any part of these Terms and Conditions, all other parts shall remain in full force and effect.

13.4 Failure by either PSL or the customer to exercise the rights under these Terms and Conditions shall not constitute a waiver or forfeiture of such rights

13.5 PSL acknowledges that it will render the Services as an independent contractor and that neither PSL nor any of its employees is an employee of Sponsor.  Accordingly, neither PSL nor its employees will (a) participate in Sponsor employee benefit plans nor receive any other compensation beyond that expressly stated below, (b) have the power or authority to bind Sponsor or to assume or create any obligation or responsibility, express or implied, on Sponsor's part or in Sponsor's name, or (c) represent to any person or entity that PSL or any employee of PSL has such power or authority, nor will PSL or its employees use the name or logo of Sponsor for advertising, promotional, or other purposes without the prior written approval of Sponsor.

13.6 At Sponsor's own expense, Sponsor’s employees whose job responsibilities are reasonably related to a particular Study and/or other representatives of Sponsor who are reasonably acceptable to PSL may visit PSL's facilities  to discuss the progress of the work performed by PSL and to observe the conduct of any Study.  Said visits shall be made upon reasonable advance notice by Sponsor to PSL. Such visits shall not be conducted in such manner, for such durations, or with such frequency as will interfere with PSL’s ability to perform PSL’s duties hereunder or result in an increase in PSL’s cost of providing the Service to be delivered hereunder.

14. Governing Law/ Jurisdiction

14.1 The construction, validity and performance of these Terms and Conditions and any contract formed in accordance with and incorporated in these Terms and Conditions and any dispute in any way relating to these Terms and Conditions shall be governed by the laws of the State of New Jersey, except for the application of conflicts of law principles. Any action or proceeding seeking to enforce any provision of, or based on any right arising out of, this Agreement shall be brought exclusively in the courts of the State of New Jersey, each of the parties consents to the jurisdiction of such courts (and of the appropriate appellate courts) in any such action or proceeding and waives any objection to venue laid therein. Process in any action or proceeding referred to in the preceding sentence may be served on any party anywhere in the world by registered mail or otherwise. Each party hereto irrevocably and unconditionally waives and agrees not to plead or claim in any court that any action, suit or proceeding brought in the courts identified in the first sentence in this Article 14 has been brought in an inconvenient forum.

14.2 Acceptance of payment by check, draft or bill domiciled in another place shall not cause dispensation or substitution of this clause assigning power of jurisdiction.

15. Study Cancellation, Termination and Delay Fee

15.1 Upon acceptance of a proposal from the client confirming contractual authorization for PSL to proceed with a study, PSL will immediately begin preparing for the project and allocating resources for the specified Study. This may include but not be limited to; protocol preparation, assessment of the compound’s physical and chemical characteristics, dedication of technical staff, equipment and facilities for the duration of the project, technical review of previously conducted studies, and placing an order for or receiving test animals. We also strive to offer flexibility to our clients and understand that schedules and research priorities change. In certain circumstances, it will be necessary for a reasonable fee to be charged to the client if they are required to cancel, terminate or delay a study after PSL has incurred expenses.

Study Cancellation Fee – A study is canceled by the client after it is authorized but before it is initiated (protocol signed by Study Director).

A study is terminated by the client after it is initiated (protocol signed by Study Director).

¹ Animal orders can generally be cancelled up to 5 business days prior to shipping.

Study Delay Fee – A study is postponed by the client after being notified by PSL of the proposed initiation date in writing.

² Animals are generally received by the lab 7-10 days prior to the initiation of the in-life phase of the study.