Terms and Conditions

Pharmaron Lab Services and/or its Affiliates (“Pharmaron”), agree to perform the services specified in the accompanying Work Order (“Services”). “Affiliate” shall mean, with respect to a party, any other entity that directly or indirectly controls, is controlled by, or is under common control with, such party. “Control” means the ownership and voting control of more than fifty percent (50%) of the outstanding voting securities or interest in capital or profits of an entity, or the right to direct or control the management or affairs of such entity by contract or similar arrangement. Services are provided subject to the terms and conditions (“Terms and Conditions”) hereof. These Terms and Conditions along with the attached proposal and Work Order hereinafter collectively constitute the “Proposal”. The Proposal constitutes the whole agreement and understanding between the parties and supersedes all prior discussions and agreements (whether oral or written) between Pharmaron and the Customer and/or their agents or advisers.

General

Pharmaron shall perform the Services as set forth in the Proposal and pursuant to good scientific practices. Good Laboratory Practice (“GLP”) Services, as applicable, will be performed in accordance with 21 CFR Part 58 and OECD principles.
The timeframe quoted for completion of Services is a good faith estimate and is not guaranteed.
Pharmaron shall notify the Customer as soon as possible, and subsequently in written form, of any changes that occur at any time during the Services which Pharmaron considers significant.
If agreed upon by the parties in the Proposal, Pharmaron shall prepare a report based on data generated during the Services (a “Report”). Reports will be archived in a validated scientific data management system and signed electronically in compliance with 21 CFR Part 11.
If specified in the Proposal, Pharmaron will provide a draft Report for Customer’s review. Customer’s comments must be returned to Pharmaron within four (4) weeks of receipt of the draft. If the Report is delayed through no fault of Pharmaron, Pharmaron may at its discretion finalize any open Reports and issue any remaining invoices due in accordance with the payment terms agreed upon by the parties in the Proposal. If at Customer’s request additional revisions are required after a Report is finalized, Pharmaron may prepare a Report amendment at Customer’s additional expense.
All procedures and animal handling/husbandry techniques required for the completion of in-vivo Services, as applicable, are subject to review by Pharmaron’s Institutional Animal Care and Use Committee (“IACUC”), a formal body constituted under governmental regulation. In the event that the IACUC does not approve a procedure, Pharmaron will propose alternative methodologies whereby study objectives may be met.

Materials

The Customer shall supply to Pharmaron any compound, sample, biological material, small molecule test article, large molecule test article, medical device, or other material (“Materials”) in amounts sufficient for performance of Services. The Customer shall comply with all applicable laws and regulations relating to the transmittal of Materials to Pharmaron’s laboratories, and shall provide Pharmaron with notice of any requirements, known hazards, safety concerns, and potential risks of any Material either prior to or with its shipment, including but not limited to all stability and storage specifications, shipping requirements, and handling procedures that have been established by the Customer to ensure against degradation and/or damage to the Materials.
If tissue procurement is required, Pharmaron will not be held responsible for tissue specimens that fail experimental QC criteria due to the intrinsic variability of tissue specimens. If additional tissues are necessary, the Customer will be informed, and the cost of replacement tissue will be billed to the Customer.
Upon completion of Services, Pharmaron will retain for a period of six (6) months any remaining Materials, ancillary samples, residual samples, or other such materials resulting from the Services or not consumed during the Services (“Residual Materials”), after which time the Residual Materials will be safely disposed of with written approval from Customer. At Customer’s written request and expense, Pharmaron will return to Customer or Customer’s designee any such Residual Materials. In such event, Pharmaron will not be responsible for (a) damages of any nature which may arise from returning Residual Materials, (b) the quality or fate of any Residual Material after it has left the control of Pharmaron, or (c) any Residual Material left with Pharmaron after the six (6) month retention period. Alternatively, Customer may elect to store the Materials for an extended period of time subject to a storage fee.
For animal studies:
(a) if there are problems with the Materials, Customer’s formulation, or Customer’s recipe to be used by Pharmaron to prepare a formulation for dosing, Customer may be charged for additional expenses incurred by rescheduling the dosing or testing of the animals;
(b) if any adverse reactions are observed when the animals are dosed or tested with the Materials, Customer will be responsible for reimbursing the cost of post-study recovery time, veterinary checks, euthanasia of animals (if necessary), and replacement cost of the animals to Pharmaron.

Billing/Payment Terms

In consideration for the Services performed by Pharmaron pursuant to the Work Order, Customer shall pay to Pharmaron in US Dollars the sum specified in the Proposal upon receipt of invoice(s) from Pharmaron in accordance with the billing schedule set forth in the Proposal. Invoices will be paid within thirty (30) days of receipt or as otherwise agreed by the parties in the Proposal.
Pricing for this Proposal is based on the attached Work Order. Any modifications to the Work Order will result in an amended Work Order (a “Change Order”) and a possible adjustment in price to reflect the change. A Change Order shall not be implemented unless in writing and signed by a duly authorized representative of each party.
The Customer is responsible for all bank charges assessed by the originating bank associated with payment of invoices by wire transfer or other electronic means.
Any undisputed invoice for which payment is not received by Pharmaron within thirty (30) days of the issue date of invoice (or within the payment period agreed upon by the parties in the Proposal) is subject to interest at one and one-half percent (1.5%) per month until paid, and the Customer shall be responsible for payment or reimbursement to Pharmaron for any legal fees and costs incurred in efforts to collect such delinquent account.
Pharmaron is not responsible for any taxes or assessments, including value-added tax (“VAT”) assessed by any tax authority outside the United States of America.
The cost of any additional materials purchased by Pharmaron for the study will be invoiced to the Customer along with a fifteen percent (15%) premium to cover sourcing and administrative costs. Shipping and handling will also be charged at a premium of fifteen percent (15%).
Pharmaron will make commercially reasonable efforts to accommodate schedule changes requested by Customer; however, if Customer requests to delay Services or cancel a Work Order, current cancellation/postponement fees will apply in proportion to the number of days’ notice given. Customer will also be responsible for payment of any non-recoverable expenses incurred by Pharmaron in preparation for performance of Services.
A project management fee will be assessed for any study subcontracted out in its entirety.

Confidentiality

Pharmaron undertakes to keep secret and treat as confidential all information relating to the Materials and Services or any other information supplied to Pharmaron by the Customer pursuant to the terms of the Proposal.
The Customer undertakes to keep secret and treat as confidential Pharmaron’s proprietary expertise and know‐how.
The obligations under this Section shall not extend to any information, procedures, systems, documentation or advice which Pharmaron or the Customer can demonstrate:
(a) is at the time of disclosure or later becomes generally known in the public domain or ceases to be secret (other than as a result of a breach of this Section);
(b) is at the time of disclosure already in the receiving party’s possession free from any obligation of confidentiality
(c) is received after disclosure hereunder from a third party without any known breach of an obligation of confidentiality;
(d) is independently developed by or on behalf of the receiving party; or
(e) is disclosed with written permission from the disclosing party.
Confidential information of the other party may be disclosed pursuant to an order of a court of competent jurisdiction or pursuant to any statute or regulation. Such information shall remain confidential for all other purposes.

Intellectual Property

All relevant Pharmaron Standard Operating Procedures (“SOPs”) and laboratory protocols used during performance of Services shall be considered Pharmaron Confidential Information and shall at all times remain the proprietary property of Pharmaron. Customer shall not use those procedures or convey them to any third party without Pharmaron’s prior express written consent.
All Materials and information transmitted, exchanged, and generated between Customer and Pharmaron pursuant to this Proposal are the sole property of Customer. Subject to Pharmaron’s receipt of payment, all deliverables and Reports (collectively “Deliverables”) prepared by Pharmaron for Customer hereunder, including any components thereof, are “works made for hire” and may be used by Customer without additional compensation to Pharmaron. In the event any Deliverables prepared by Pharmaron and paid for by Customer do not qualify as works made for hire under copyright laws, Pharmaron agrees to assign all rights and interests to such Deliverables, including copyrights, to Customer.
Where the Customer discloses data or information produced by Pharmaron pursuant to the outcome of the Services to a third party the Customer undertakes to give a true and fair representation of these data. In addition, conclusions or claims made from these data by the Customer will not be inferred, implied or stated as Pharmaron conclusions or claims.

Inspection

Customer’s authorized representatives may observe the performance of Services on Pharmaron’s premises at any time during normal business hours with reasonable advance notice; however, Pharmaron may refuse Customer access to such facilities at any time when (i) Pharmaron or its employees or agents are performing surgery, or (ii) such inspection would compromise health and safety guidance or confidentiality of another customer.
Pharmaron shall as soon as reasonably practicable notify the Customer if it receives notification from any government or other authority of an inspection which specifically involves Services under a Work Order. In the event that a government or other authority inspects Pharmaron as a direct result of the Services, Customer shall reimburse Pharmaron for the time Pharmaron spends cooperating with any such inspector, together with any other reasonable costs Pharmaron may have incurred. This condition specifically excludes any general inspection of Pharmaron’s facilities, and any inspection brought about as a result of any act or default of Pharmaron, its employees or agents.
The Customer shall notify Pharmaron in a timely manner if it becomes aware of any inspection by a government or other authority which involves or might involve Pharmaron.

Ethical Considerations in the Use of Laboratory Animals (as applicable)

The Customer recognizes its responsibilities with regard to the ethical use of laboratory animals and therefore warrants that:
(a) the intent of the Services is to extend the pharmacological, metabolic and/or biochemical knowledge base of the Materials;
(b) to the best of the Customer’s current knowledge of the Materials, the Services will not unnecessarily duplicate previous studies;
(c) the Materials are not expected to cause pain or discomfort as a result of known physiochemical properties;
(d) the Work Order submitted to Pharmaron has been (i) peer-reviewed for its scientific merit and (ii) evaluated to determine any possibilities for replacement, reduction, or refinement of animal use.

Disclaimer of Warranty; Limitation of Liability

Customer understands and agrees that unexpected or unanticipated results of Services shall not in themselves constitute non-conformance. For the avoidance of doubt, Customer remains liable for payment of Services performed by Pharmaron under this Proposal that yield unanticipated results where such non-conformity is due to causes beyond the control of Pharmaron or not attributable to any negligence, willful misconduct, or material breach of this Proposal by Pharmaron. In no event shall Customer withhold payment for such Services or apply any payment for such Services toward any other payment owed by Customer, hereunder or otherwise. Pharmaron makes no express or implied warranties of merchantability or fitness for a particular purpose of any work performed or information or products supplied by it. In no event shall Pharmaron be liable to the Customer for any indirect, special, incidental, consequential, or punitive damages of any type or kind (including, without limitation, lost profits) regardless of whether any such losses or damages are characterized as arising from breach of contract, breach of warranty, tort, strict liability, or otherwise, even if a party is advised of the possibility of such losses or damages, or if such losses or damages are foreseeable. In no event shall Pharmaron’s liability, if any, for damages relating to or arising out of this Proposal exceed the fees paid to Pharmaron under this Proposal.

Indemnification

Indemnification by Pharmaron. Pharmaron agrees to defend, indemnify and hold harmless Customer against any third party claims (“Claim(s)”), and agrees to bear all costs and expenses incurred in connection with the defense or settlement of any such Claim arising out of (a) Pharmaron’s failure to comply with applicable laws and/or regulations governing or applicable to the Services or (b) Pharmaron’s material breach of this Proposal. This indemnity expressly excludes Claims to the extent arising out of or resulting from Customer’s negligence or willful misconduct. As a condition of indemnification, Customer must promptly notify Pharmaron of a covered claim, must tender to Pharmaron (and/or its insurer) full authority to defend or settle the claim, and must reasonably cooperate with the defense..
Indemnification by Customer. Customer agrees to defend, indemnify and hold harmless Pharmaron against any Claims, and agrees to bear all costs and expenses incurred in connection with the defense or settlement of any such Claim arising out of (a) Customer’s use of the Deliverables, (b) the use of the results or other data or information from the Services, (c) the development, manufacture, use or commercialization of any product or service based on any data or information developed through the Services or discovered using any data or information developed through the Services, (d) Customer’s negligence or willful misconduct in connection with this Agreement, (e) Customer’s material breach of this Agreement, or (f) any actual or alleged infringement of a third party’s intellectual property rights arising out of Pharmaron’s use of any Material provided by Customer. This indemnity expressly excludes Claims to the extent arising out of or resulting from Pharmaron’s negligence or willful misconduct. As a condition of this indemnification obligation, Pharmaron must promptly notify Customer of a covered claim, must tender to Customer (and/or its insurer) full authority to defend or settle the claim, and must reasonably cooperate with the defense.

Term and Termination

This Proposal shall expire upon completion of all Services set forth under the Work Order.
Either party may terminate this Proposal upon written notice to the other party with immediate effect if:
(a) the other party breaches its obligations hereunder and such breach cannot be remedied;
(b) the other party fails to remedy such breach within 60 days of receipt of a notice specifying the breach and requiring it to be remedied;
(c) the other party ceases to carry on its business, becomes insolvent, files for bankruptcy, shall be adjudicated bankrupt, shall file a petition under insolvency laws, shall be dissolved, or shall have a receiver appointed over the whole or any part of its assets, or undergoes any similar or equivalent process in any jurisdiction.
In the event of termination or expiration of this Proposal:
(a) Pharmaron shall retain any payments received by it and Customer shall pay, within 30 days of its receipt, a final invoice issued by Pharmaron for service fees and costs incurred or irrevocably committed by Pharmaron up to the effective date of termination for which no payment has been received;
(b) Any termination of this Proposal shall be without prejudice to either party’s obligations or to any rights accrued in respect of any breach committed by the other prior to the date of such termination.

Governing Law

This Proposal shall be governed by and construed in accordance with the laws of the State of Delaware, USA, without giving effect to conflict of laws provisions.

Force Majeure

In the event a party is prevented or hindered from carrying out its obligations under this Proposal by circumstances beyond its reasonable control (“Force Majeure Events”), the performance of any such obligations shall be suspended for the duration of the Force Majeure Event and the affected party shall not be liable for any delay in the performance of its obligations caused thereby, provided that if any such Force Majeure Event lasts for more than 6 months, the other party may terminate this Proposal upon 30 days’ written notice.

Notices

Any notice required hereunder shall be personally delivered, sent by certified or registered mail with postage paid and return receipt requested, or sent by nationally recognized overnight courier to the address of the relevant party provided in the Proposal or such other address as may be provided by either party from time to time by written notice to the other, and shall be deemed given upon confirmation of receipt by the receiving party.

Waiver

Failure by either party to exercise or enforce any right conferred upon it under this Proposal shall not be deemed to be a waiver of such right or operate so as to bar the exercise or enforcement thereof at any subsequent time or times.

Lab Services Terms and Conditions