Terms and Conditions

Project Deposits

Projects with a total estimated value exceeding USD $10,000 require a non-refundable deposit equal to 50% of the quoted amount prior to project commencement. Work will not be scheduled or initiated until the deposit is received and cleared. The remaining 50% is invoiced upon project completion, net 30 days

Disclaimer

DISCLAIMER: While we aim to deliver high-quality & reliable services and results, inherent risks like scientific and reviewer-specific uncertainties and external factors may affect them. Ultimately, responsibility for testing decisions, decisions related to the safety and market-readiness of evaluated and/or tested products, and reliance on our services lies with you, the sponsor.

This document sets forth the terms and conditions for the services described in the accompanying estimate / quotation (this “Agreement”). By issuing a purchase order, or providing written authorization (including by email) to start work, the Sponsor agrees to these terms. Capitalized terms have the meanings set out in Section 9.0 (Definitions).

1.0 General

1.1 Acceptance and Commencement of Work. A formal purchase order or written authorization (including email authorization) is required to commence work. By issuing a purchase order or written authorization, the Sponsor acknowledges acceptance of the quotation, any accompanying scope/statement of work, and these terms and conditions (collectively, the “Order”).

1.2 Estimates and Additional Charges. Unless expressly stated as a fixed fee, the financial figures provided in any quotation are estimates only. Additional charges may apply if the scope of Services changes (e.g., additional tests are required, expanded consultation is requested, vendors update their prices, or regulatory feedback requires modifications). Any advisory services beyond the standard scope of the purchased Service will be billed at $250.00 per hour unless otherwise agreed in writing.

1.3 Assessments and Drafts. The quoted price for assessments (including, but not limited to, biological safety evaluations, clinical evaluations, and toxicological risk assessments) includes up to three (3) draft updates. Any drafts exceeding three will incur additional charges. Invoicing for these assessments will occur upon issuance of the first draft, with payment due according to the terms specified on the invoice.

1.4 Invoicing; Payment Terms; Disputes. Unless otherwise specified by a separate written agreement, all undisputed amounts are due within thirty (30) days of the invoice date. If the Sponsor disputes any portion of an invoice, it must notify Groenakker in writing within ten (10) business days of receipt, describe the disputed amount and basis in reasonable detail, and pay all undisputed portions when due. For any undisputed invoice amount not paid when due: (a) interest will accrue at 1.5% per month (or the maximum rate allowed by law, whichever is lower) from the original due date until paid; (b) Groenakker may cease or suspend work and/or withhold Deliverables, reports, or other materials until all undisputed amounts have been paid; and (c) the Sponsor will reimburse Groenakker for reasonable collection costs (including attorneys’ fees) incurred to collect past-due undisputed amounts. The Sponsor may not set off or withhold amounts owed under this Agreement against amounts it asserts are owed by Groenakker.

1.5 Taxes. Prices are exclusive of all applicable sales, use, value-added, goods and services, withholding or similar taxes, duties, and governmental charges (collectively, “Taxes”). The Sponsor is responsible for all Taxes arising from the Order, except taxes based on Groenakker’s net income. If the Sponsor claims a tax exemption, it shall provide a valid exemption certificate.

1.6 Change Orders. Any change to the scope, schedule, Deliverables, or assumptions must be agreed in a written change order executed by the parties (“Change Order”). Groenakker may pause performance impacted by the proposed change until a Change Order is executed. Change Orders may affect pricing and turnaround times.

1.7 Deliverable Acceptance. The Sponsor shall review Deliverables promptly. If the Sponsor in good faith believes a Deliverable materially fails to conform to the applicable scope, it must notify Groenakker in writing within ten (10) business days of delivery, describing the nonconformity in reasonable detail. Groenakker will use commercially reasonable efforts to correct validated nonconformities. A Deliverable will be deemed accepted upon the earlier of correction or the Sponsor’s failure to provide timely notice.

1.8 Scheduling and Turnaround Times. All turnaround times are estimates and subject to change based on factors including Sponsor responsiveness, material availability, vendor capacity, regulatory input, and events beyond Groenakker’s reasonable control. Time is not of the essence unless expressly stated in the Order with applicable STAT fees paid.

1.9 Compliance with Laws. Each party will comply with applicable laws and regulations in connection with this Agreement.

1.10 Non-Exclusivity. The Agreement is non-exclusive. Groenakker may provide similar services to other customers, provided it honors its confidentiality obligations.

2.0 Subcontracted Work

2.1 Subcontracting Rights. Groenakker may, in its discretion, subcontract any portion of the work to vendors qualified in accordance with Groenakker’s ISO 13485 quality management system.

2.2 Vendors. (a) Laboratory Testing: All laboratory testing is performed by ISO/IEC 17025-accredited vendors. Groenakker does not operate in-house testing facilities. (b) Vendors may be domestic (USA) or international. Sponsor-directed selection of specific vendors, methods, or geographic locations may affect estimated costs and turnaround times and the Sponsor assumes the associated risks of such direction.

2.3 Vendor Payment Terms. (a) Pre-Payment or Deposits: If a testing facility requires pre-payment or a deposit due to turnaround time, project value, or other factors, this requirement will be noted in the estimate; testing will begin only once such payment is received. (b) Standard Terms: For studies where pre-payment is not required, invoices will be issued at study commencement, with payment due within thirty (30) days from the invoice date.

2.4 Protocols and Reports. Draft reports, updates to issued reports, or customized protocols/reports requested by the Sponsor may incur additional fees. Groenakker will provide a separate quotation for such additional services upon request.

2.5 Study Commencement. Groenakker will schedule subcontracted work to begin once: (a) the Sponsor has provided a valid purchase order of sufficient value; (b) the Sponsor has provided all information required to complete laboratory test request forms; (c) the Sponsor has delivered sufficient Test Materials to perform the required tests; (d) the Sponsor has signed and approved testing protocols (if required for a particular test or GLP study); and (e) the Sponsor has submitted any required pre-payments or deposits.

2.6 Audits and Visits. Upon at least ten (10) business days’ prior written notice and during normal business hours, the Sponsor may conduct a reasonable (up to four (4) hours) quality audit of Groenakker’s relevant documentation limited to the Services. Sponsor audits of third-party vendors must be arranged directly with the vendor and may be subject to the vendor’s policies and fees.

2.7 Test Materials; Chain of Custody; Risk of Loss. The Sponsor is responsible for packaging, labeling, and shipping Test Materials to Groenakker and for providing accurate documentation (including current safety data sheets). Title and risk of loss for Test Materials remain with the Sponsor at all times; the Sponsor is responsible for adequate insurance coverage for shipments. Groenakker is not responsible for loss of samples at any point in the testing process.

2.8 Sample Retention and Disposal. Unless otherwise required by law, protocol, or the Order, non-GLP samples and residual Test Materials will be retained for ninety (90) days after final report issuance and may thereafter be discarded or returned at the Sponsor’s expense. Extended retention or special handling (including hazardous-waste disposal) may incur additional fees.

2.9 Hazardous and Controlled Materials. The Sponsor represents that Test Materials are fit for the intended testing and do not require permits, licenses, or special handling beyond what the Sponsor discloses in writing. Radioactive materials, select agents, BSL-3/4 materials, narcotics/controlled substances, human tissues/biological specimens, or other regulated materials will not be accepted without Groenakker’s prior written consent and may be subject to additional requirements and fees.

2.10 Records Retention. Groenakker will retain its records relating to the Services for at least five (5) years after final report issuance, unless a longer period is required by law or expressly agreed in the Order.

3.0 Limitations of Liability, Indemnities, and Disclaimers

3.1 Liability Cap. Groenakker’s total liability to the Sponsor for any claims arising out of or relating to this Agreement-whether in contract, tort (including negligence), or otherwise-shall not exceed the amount paid by the Sponsor for the affected Services in the twelve (12) months preceding the claim (excluding Pass-Through Costs). The foregoing cap does not apply to the extent liability cannot be limited under applicable law or to the extent a claim is finally determined to have resulted from Groenakker’s gross negligence or willful misconduct.

3.2 Liability Not Excluded by Law. Nothing in this Agreement excludes or limits liability where such exclusion or limitation is not permitted by applicable law.

3.3 Exclusion of Certain Damages. GROENAKKER SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, CONSEQUENTIAL, PUNITIVE, EXEMPLARY, OR INCIDENTAL DAMAGES OF ANY KIND (INCLUDING LOST PROFITS, LOSS OF GOODWILL, OR DIMINUTION OF MARKET VALUE), REGARDLESS OF WHETHER THOSE DAMAGES ARISE FROM CONTRACT, WARRANTY, TORT, STRICT LIABILITY, OR OTHERWISE-EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES OR SUCH LOSSES WERE REASONABLY FORESEEABLE.

3.4 Failure or Delay in Performance. GROENAKKER SHALL NOT BE LIABLE FOR ANY FAILURE, ERROR, OR DELAY IN PERFORMING SERVICES, BY THE ACTS OR OMISSIONS OF THE SPONSOR OR ITS AGENTS, OR BY THIRD-PARTY VENDORS.

3.5 Sponsor Indemnification. The Sponsor agrees to defend, indemnify, and hold harmless Groenakker and its affiliates (including their officers, directors, and employees) against any third-party Claim to the extent it arises from or relates to: (a) Groenakker’s execution or performance of its obligations under this Agreement ; (b) any harmful or unsafe effect of the Test Materials; (c) the Sponsor’s use of the Results or Deliverables, or any use, consumption, sale, distribution, or marketing of a substance tested by Groenakker; (d) the negligence or intentional misconduct of the Sponsor; or (e) infringement or misappropriation of any intellectual property right through performance of the Services using the Sponsor’s information. This indemnity does not apply to the extent a Claim is caused by Groenakker’s gross negligence or willful misconduct.

3.6 Exclusion of Implied Warranties. Except as expressly stated in this Agreement, all warranties, conditions, and terms (express or implied, statutory or otherwise) are disclaimed, including any implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement.

3.7 Disclaimer of Warranties; No Guarantees. THE SERVICES (INCLUDING ADVISORY SERVICES, TESTING, ANALYSIS, AND RELATED CONSULTATIONS) ARE PROVIDED “AS IS” AND “AS AVAILABLE.” GROENAKKER MAKES NO REPRESENTATIONS, WARRANTIES, OR GUARANTEES OF ANY KIND, EXPRESS OR IMPLIED, REGARDING THE ACCURACY, RELIABILITY, COMPLETENESS, OR SUITABILITY OF THE SERVICES OR ANY RESULTS DERIVED THEREFROM. GROENAKKER DOES NOT GUARANTEE THAT ANY RESULTS WILL MEET SPONSOR EXPECTATIONS, ACHIEVE ANY PARTICULAR OUTCOME, OR BE ACCEPTED BY ANY REGULATORY AUTHORITY OR THIRD PARTY.

3.8 Inherent Risks. THE SPONSOR ACKNOWLEDGES THAT THE SERVICES INVOLVE INHERENT RISKS, INCLUDING SCIENTIFIC UNCERTAINTIES, METHODOLOGICAL LIMITATIONS, EXTERNAL FACTORS BEYOND GROENAKKER’S CONTROL (SUCH AS CHANGES IN REGULATORY STANDARDS, MARKET CONDITIONS, OR TECHNOLOGICAL ADVANCEMENTS), AND POTENTIAL ERRORS IN INTERPRETATION OR APPLICATION OF DATA. THESE RISKS MAY RESULT IN UNEXPECTED OUTCOMES, DELAYS, INACCURACIES, OR NON-ACCEPTANCE OF RESULTS.

3.9 No Liability for Outcomes or Regulatory Acceptance. TO THE FULLEST EXTENT PERMITTED BY LAW, GROENAKKER SHALL NOT BE LIABLE FOR ANY OUTCOMES RESULTING FROM THE SPONSOR’S USE OR RELIANCE ON THE SERVICES OR FOR DECISIONS BY REGULATORY AUTHORITIES OR THIRD PARTIES REGARDING ACCEPTANCE, REJECTION, OR INTERPRETATION OF TESTING DATA OR RESULTS. THE SPONSOR’S SOLE AND EXCLUSIVE REMEDY FOR DISSATISFACTION WITH THE SERVICES IS TO DISCONTINUE THEIR USE.

3.10 Insurance. Groenakker maintains commercially reasonable levels of insurance (e.g., general liability and professional liability) customary for companies offering similar services. Evidence of coverage will be provided upon reasonable request.

3.11 Limitations Period. Any claim arising out of or relating to this Agreement must be brought within one (1) year after the cause of action accrues, unless a longer period is required by applicable law.

4.0 Force Majeure

4.1 No Breach; Notice. Neither party shall be liable for delay or failure to perform any obligation under this Agreement to the extent such delay or failure results from events beyond its reasonable control (“Force Majeure Event”), including but not limited to acts of God, war, terrorism, riots, embargoes, acts of civil or military authorities, fire, floods, accidents, pandemics, epidemics, strikes, or shortages of transportation facilities, fuel, energy, labor, or materials. The affected party will provide prompt notice and will use commercially reasonable efforts to mitigate the effects.

5.0 Delay or Cancellation of Services

5.1 Postponement or Termination by Sponsor. If the Sponsor postpones, delays, or terminates the Services for any reason, Groenakker may: (a) reallocate resources reserved for those Services without liability; and (b) charge delay or cancellation fees in accordance with Groenakker’s then-current policy, including any vendor pass-through cancellation or rescheduling fees.

5.2 Termination by Groenakker. Groenakker may terminate this Agreement or suspend Services immediately upon written notice if the Sponsor breaches any material term (including failure to make timely payments), or if continued performance would violate applicable laws or regulations.

5.3 Resumption. If Services are suspended for more than thirty (30) days, resumption may be subject to a restart fee and revised schedule.

6.0 Independent Contractor

6.1 Independent Relationship. Nothing in this Agreement creates a partnership, joint venture, or other relationship except that of independent contractor. Neither party shall hold itself out as an agent or representative of the other.

7.0 Governing Law and Dispute Resolution

7.1 Governing Law. This Agreement is governed by the laws of the State of Pennsylvania, without regard to conflict-of-law principles. The U.N. Convention on Contracts for the International Sale of Goods does not apply.

7.2 Dispute Resolution; Arbitration. Any dispute arising out of or relating to this Agreement shall be resolved through good-faith negotiations. If unresolved within thirty (30) days, the parties agree to binding arbitration in Delaware under the Commercial Arbitration Rules of the American Arbitration Association. Either party may seek temporary or preliminary injunctive relief in a court of competent jurisdiction to protect its Confidential Information or intellectual property. The prevailing party is entitled to recover reasonable attorneys’ fees and costs.

8.0 Miscellaneous

8.1 Entire Agreement; Order of Precedence. This Agreement (together with the applicable quotation/SOW) constitutes the entire understanding between the parties and supersedes all prior or contemporaneous agreements regarding its subject matter. In the event of a conflict, the following order of precedence applies: (1) a mutually executed Change Order (most recent first); (2) the quotation/SOW (including any exhibit expressly incorporated); (3) these terms and conditions; and (4) any purchase order terms (which are expressly rejected to the extent they conflict).

8.2 Severability. If any provision is held invalid or unenforceable, the remaining provisions remain in full force and effect.

8.3 Assignment. Neither party may assign this Agreement without the other party’s prior written consent, except to an affiliate or in connection with a merger, acquisition, or sale of all or substantially all of its assets, provided the assignee assumes all obligations herein.

8.4 Notices. All notices must be in writing and delivered via email, certified mail, or overnight courier to the addresses specified in the quotation or purchase order (or as updated by notice). Notices by email are effective when sent, provided no bounce-back is received.

8.5 Waiver. No waiver of any breach constitutes a waiver of any subsequent breach.

8.6 Survival. Sections 3.0, 7.0, 8.0, 9.0, 10.0, and 11.0 survive termination or expiration of this Agreement.

8.7 No Third-Party Beneficiaries. There are no third-party beneficiaries to this Agreement.

8.8 Export Controls and Sanctions. Each party will comply with applicable export controls, sanctions, and anti-boycott laws. The Sponsor shall not submit Test Materials or request Services requiring Groenakker or its vendors to violate such laws.

8.9 Anti-Bribery. Each party will comply with applicable anti-corruption and anti-bribery laws (including the U.S. FCPA and U.K. Bribery Act).

8.10 Data Protection; No PHI. Each party will comply with applicable data-protection laws. The Sponsor shall not provide protected health information (PHI) or other sensitive personal data unless the parties first execute the appropriate data-processing or business associate agreement.

8.11 Publicity. Neither party will use the other’s name, logo, or trademarks in publicity, advertising, or press releases without prior written consent.

8.12 Non-Solicitation. During the term of the Agreement and for twelve (12) months thereafter, neither party will, without the other party’s prior written consent, solicit for employment any employee directly involved in the Services; general solicitations not directed at specific individuals are permitted.

8.13 Currency. Unless stated otherwise in the quotation, all amounts are in U.S. Dollars (USD).

8.14 Electronic Signatures; Counterparts. The parties agree that electronic signatures and counterparts are valid and enforceable.

9.0 Definitions

9.1 Affiliate. Any entity that directly or indirectly controls, is controlled by, or is under common control with a party; “control” means ownership or control, directly or indirectly, of more than fifty percent (50%) of the voting interests or the right to appoint a majority of directors (or equivalent).

9.2 Agreement. This document and the terms and conditions set forth herein, together with the applicable quotation/SOW.

9.3 Business Day. Any day other than a Saturday, Sunday, or a day on which banks in Delaware are authorized or required by law to close.

9.4 Change Order. A written, mutually executed amendment to the scope, schedule, assumptions, or pricing of the Services.

9.5 Claim. Any third-party claim, demand, action, suit, proceeding, settlement, or investigation.

9.6 Deliverables. Any results, final reports, or other end products identified in the Order as part of the Services.

9.7 Pass-Through Costs. Third-party charges incurred in connection with the Services, including vendor fees, animal costs, shipping/courier charges, customs and brokerage, materials, and similar costs.

9.8 Results. All materials, data, documents, or information produced or developed by Groenakker specifically from performing the Services relating to the Test Materials and/or Sponsor information.

9.9 Services. The tasks or services described in the Order to be provided by Groenakker to the Sponsor.

9.10 Sponsor. The entity named in the quotation or purchase order that is entering into this Agreement with Groenakker. If Sponsor’s client provides certain approvals (e.g., protocol approvals), the Agreement remains between Groenakker and the Sponsor.

9.11 Subcontractor. Any third party engaged by a party to perform services customarily provided by that party in the ordinary course of business.

9.12 Test Materials. Any compounds, materials, or substances described in the relevant protocol(s) to be tested or used in the performance of the Services, and provided to Groenakker by the Sponsor or its designee, together with applicable safety data sheets and handling instructions.