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Research Use and Confidentiality Agreement 2024

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This Research Use and Confidentiality Agreement (the “Agreement”) is entered into by and between Lonestar Research, a division of Lonestar Services, LLC, a Delaware Limited Liability Company with a mailing address at 2028 E Ben White Blvd #240-1778, Austin, TX 78741 (hereinafter referred to as “Lonestar Research”), and the research laboratory or individual acting on behalf of a research laboratory (hereinafter referred to as “Lab” or “Lab’s”). This Agreement outlines the terms and conditions under which Lonestar Research agrees to supply its products, designated for Research Use Only (“RUO”), and the obligations of the Lab to ensure compliance with applicable laws, maintain confidentiality, and prevent misuse of Products.

Introduction

1.1 This Agreement serves to establish a binding legal relationship between Lonestar Research and the Lab, fostering compliance with all legal and regulatory requirements governing RUO products and explicitly safeguarding against improper use, including but not limited to human or animal consumption, diagnostics, or therapeutic applications.

1.2 The Lab agrees to utilize the Products exclusively for in vitro research purposes, as defined in this Agreement, while upholding the confidentiality of the terms herein and affirming responsibility for any misuse.

1.3 Both parties recognize the mutual benefits of adhering to the terms of this Agreement. For the Lab, these benefits include:

(a) Regulatory Protection: By entering into this Agreement, the Lab demonstrates its commitment to adhering to all applicable laws and regulations governing RUO products, significantly reducing its risk of legal scrutiny or enforcement actions by regulatory agencies.

(b) Enhanced Credibility: Labs that comply with RUO standards and confidentiality obligations reinforce their reputation as trustworthy, professional research entities capable of handling sensitive and proprietary materials responsibly.

(c) Access to High-Quality Products: Lonestar Research’s Products are rigorously designed for research purposes, ensuring reliable performance and alignment with scientific standards. This Agreement assures continued access to these products.

(d) Clear Accountability and Guidance: The detailed terms of this Agreement provide clarity on permissible uses and responsibilities, empowering the Lab to align its practices with industry best practices and avoid inadvertent violations.

This Agreement is intended to provide Lonestar Research with maximum legal protection while establishing the Lab’s full accountability for any actions that contravene its terms.

Definitions

2.1 “Lonestar Research”: Refers to Lonestar Services, LLC, its representatives, affiliates, and service providers.

2.2 “Lab” or “Lab’s”: Refers to the entity or individual authorized to purchase and legally permitted to use Products exclusively for research purposes, and which assumes full responsibility for adherence to all terms of this Agreement. Lonestar Research reserves the right to refuse sales to any entity without documented scientific research credentials.

2.3 “Products”: Refers to any goods or materials supplied by Lonestar Research, designated for Research Use Only.

2.4 “Research Use Only" or "RUO”: Defined as use limited to in vitro research, explicitly excluding human or animal consumption, diagnostics, therapeutic, or veterinary use. RUO materials are defined under 21 C.F.R. § 809.10(c) and Texas Health & Safety Code § 431.001 et seq. RUO materials are not FDA-approved for human or veterinary applications, diagnostics, therapeutics, or clinical use.

2.5 “Improper Use”: Includes any use of Products in a manner inconsistent with RUO designations, such as human or animal consumption, diagnostics, therapeutics, or veterinary applications, as well as any attempt to repackage, resell, or use the materials in any manner inconsistent with RUO designation.

2.6 “Confidential Information”: Refers to the existence, terms, and details of this Agreement, along with any proprietary communications or data shared between the parties.

2.7 “Compliance Obligations”: Refers to all applicable laws, regulations, and industry standards governing the use, handling, and storage of RUO Products.

2.8 “Force Majeure”: Includes events beyond the reasonable control of a party, such as natural disasters, government actions, or acts of terrorism, which render performance under this Agreement impossible. Force Majeure does not excuse monetary obligations, such as payments owed under this Agreement.

2.9 “Proprietary Information”: Refers to any non-public, proprietary, or confidential information, including but not limited to technical data, research methods, and trade secrets, disclosed by either party in connection with this Agreement.

2.10 “Termination Obligations”: Refers to the responsibilities outlined in Section 11.3 that the Lab must fulfill upon termination of this Agreement.

2.11 “Compliance Obligations”: Refers to all applicable laws:

Texas Dangerous Drug Act (§ 483.001 et seq.)
Texas Food, Drug, and Cosmetic Act (§ 431.001 et seq.)
Texas Deceptive Trade Practices Act (§ 17.41 et seq.)
Texas Controlled Substances Act (§ 481.001 et seq.)
Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.)
FDA RUO Labeling & Distribution (21 C.F.R. § 809.10(c))
Prohibited Acts & Misbranding (21 U.S.C. § 331 & 352)

Scope of Agreement

3.1 Products Covered: This Agreement applies to all Products designated by Lonestar Research for RUO purposes.

3.2 Permissible Uses: Products shall only be used for in vitro research purposes as defined in Section 2.4.

3.3 Prohibited Uses: Products may not be used for any purpose that constitutes Improper Use, as defined in Section 2.5, and Lab must ensure safeguards are in place to prevent such misuse.

3.4 Acknowledgment of RUO Restrictions: The Lab acknowledges its obligation to comply with all RUO restrictions and applicable jurisdictional requirements, further warranting that Products will not be used in any manner inconsistent with their intended purpose. The Lab certifies that all personnel handling the Products have received appropriate RUO training, and maintains records of use for a minimum of five (5) years in case of regulatory audits.

3.5 No Warranty of Fitness for Non-RUO Purposes: Lonestar Research makes no representation or warranty that Products are fit for purposes other than RUO.

Confidentiality

4.1 Confidentiality Obligations: The Lab agrees to maintain the confidentiality of this Agreement’s existence and terms, as well as any associated communications or proprietary data.

4.2 Prohibition on Disclosure: The Lab shall not disclose Confidential Information to unauthorized parties without the prior written consent of Lonestar Research.

4.3 Penalties for Breach: Breaches of confidentiality shall incur a penalty of $250,000 per occurrence or the maximum enforceable penalty under applicable law. The penalty shall be enforceable as liquidated damages, subject to applicable law, and does not preclude Lonestar Research from seeking injunctive relief or additional remedies.

4.4 Mutual Obligations: Lonestar Research agrees to maintain the confidentiality of any proprietary information shared by the Lab under this Agreement, with equivalent penalties for breaches.

Obligations and Representations by Lab

5.1 Legitimate Research Entity: The Lab attests to being a legitimate research entity or an individual acting on behalf of such an entity.

5.2 Compliance with Jurisdictional Requirements: The Lab affirms compliance with all applicable jurisdictional and accreditation requirements and assumes responsibility for ongoing compliance with laws and industry standards.

5.3 Legal and Operational Responsibility: The Lab assumes full responsibility for ensuring the legal compliance of its operations, including safeguarding against Improper Use of the Products, and agrees to implement sufficient internal controls and training to prevent misuse.

5.4 Indemnification: The Lab agrees to indemnify and hold Lonestar Research harmless for any liabilities, damages, or claims arising from Improper Use.

5.5 Notification of Misuse: The Lab agrees to immediately notify Lonestar Research upon discovering any potential or actual misuse of the Products, including but not limited to violations of RUO restrictions. Lonestar Research may report violations to the Texas Department of State Health Services (DSHS), the FDA, or other regulatory agencies if required by law.

5.6 Right to Refuse Sales and Terminate Agreements: Lonestar Research reserves the right to refuse sales or terminate agreements if it has reason to believe that the Lab is engaging in Improper Use or violating RUO restrictions.

Product Limitations and Disclaimers

6.1 Exclusive RUO Designation: Products are designated exclusively for RUO as defined in Section 2.4. Specifically, the Lab certifies under penalty of perjury that it:
(a) Understands the limitations of RUO Products;
(b) Has internal controls in place to prevent misuse;
(c) Will provide appropriate training to all personnel handling the Products; and
(d) Will maintain compliance records as outlined in Section 7.

6.2 Prohibited Uses: Lab affirms that Products will not be:
(a) Used for human or animal consumption;
(b) Used in clinical, diagnostic, therapeutic, or veterinary applications;
(c) Resold, repackaged, or distributed without Lonestar Research's written consent; or
(d) Combined or modified to create compounds for use outside the RUO scope.

6.3 FDA Status and Limitations: The Lab acknowledges that the Products have not been evaluated by the FDA for diagnostic, therapeutic, or other uses and are not intended for such purposes.

6.4 Liability Disclaimer: Lonestar Research disclaims all liability for claims, damages, or misuse of the Products, including any arising from Improper Use.

6.5 Responsibility for Diversion Prevention: The Lab understands that it is solely responsible for ensuring the Products are not diverted or repurposed for human or animal use.

6.6 No Guarantee of Research Outcomes: Lonestar Research provides no guarantee that the Products will meet any specific research outcomes or scientific objectives.

Compliance Obligations and Restrictions on Use

7.1 The Lab shall implement robust internal controls to prevent misuse of Products, including but not limited to:
(a) Written policies and procedures for handling and storage;
(b) Training programs for personnel involved in the use of Products;
(c) Record-keeping systems to document the purpose and use of all Products; and
(d) Regular internal audits to ensure compliance.

7.2 Records must be retained for a minimum of five (5) years or as required by applicable law, whichever is longer.

7.3 Prohibited Actions: The Lab shall not modify, resell, or use Products beyond RUO purposes. Any Improper Use is strictly prohibited.

7.4 Termination of Services: Lonestar Research reserves the right to terminate services to the Lab for any violations of this Agreement, including Improper Use.

7.5 Reporting and Non-Enforcement: Lonestar Research does not act as an enforcement entity and does not monitor the use of its Products for compliance. While Lonestar Research reserves the right to report Improper Use if explicitly required by law, it fully relies on the Lab's internal controls, processes, and safeguards to ensure compliance with RUO restrictions. Lonestar Research assumes no responsibility or liability for monitoring or verifying the Lab's adherence to these terms, placing the entire obligation for compliance and liability on the Lab. This provision is intended to provide transparency and assurance, ensuring that labs can operate with peace of mind while taking full responsibility for their compliance measures.

7.6 Regulatory Cooperation: The Lab acknowledges that Lonestar Research will comply with lawful requests from regulatory bodies, including the FDA and Texas DSHS, to provide documentation or information related to the Lab’s purchase and use of the Products. Lonestar Research does not monitor the use of its Products but reserves the right to cooperate fully with regulatory authorities if misuse is discovered. Lonestar Research may provide purchase records to regulatory agencies if required by law.

Indemnification and Assumption of Liability

The Lab assumes full liability for any misuse of Products, including legal actions, fines, or penalties imposed by regulatory authorities.

8.1 Indemnification by Lab: The Lab agrees to indemnify, defend, and hold harmless Lonestar Research, its affiliates, officers, directors, employees, agents, successors, service providers, web hosting providers and payment processors, and assigns (collectively, the "Indemnified Parties") from and against any and all claims, demands, suits, actions, liabilities, damages, losses, costs, and expenses, including reasonable attorneys’ fees and court costs, arising out of or relating to:
(a) The Lab’s breach of this Agreement, including any violation of the restrictions on use as outlined in Section 7;
(b) The Lab’s negligence, misconduct, or improper use of the Products;
(c) Any violation of applicable laws, regulations, or industry standards by the Lab;
(d) Any third-party claims arising from the Lab’s handling, storage, or use of the Products; and
(e) Any other acts or omissions by the Lab or its representatives in connection with this Agreement or the Products.

8.2 Assumption of Liability: The Lab acknowledges and agrees that it assumes full and exclusive responsibility for:
(a) Ensuring compliance with all applicable laws, regulations, and industry standards governing the use, handling, and storage of the Products;
(b) Implementing and maintaining sufficient internal controls and processes to prevent any Improper Use of the Products;
(c) Ensuring that all individuals within its organization who access or handle the Products are adequately trained and informed of the restrictions and obligations under this Agreement; and
(d) Any and all damages, losses, or liabilities resulting from the Lab’s use or misuse of the Products, including any harm caused to third parties or property.

8.3 Waiver of Liability by Lonestar Research: To the maximum extent permitted by law, the Lab expressly waives and releases any and all claims against the Indemnified Parties, including but not limited to web hosting providers and payment processors, for:
(a) Any direct, indirect, incidental, consequential, punitive, or special damages arising out of or relating to the Lab’s use or misuse of the Products;
(b) Any loss of profits, revenue, data, or goodwill resulting from the use or inability to use the Products; and
(c) Any damages or penalties imposed by regulatory authorities due to the Lab’s failure to comply with applicable laws or this Agreement.

8.4 Defense and Cooperation: The Lab agrees to promptly notify Lonestar Research in writing of any claim, demand, or action covered by this indemnification provision. The Lab further agrees to cooperate fully, at its own expense, with the Indemnified Parties in the defense of any such claim, demand, or action, and to assume control of the defense and settlement of any such claim, provided that the Indemnified Parties may participate in the defense and settlement of any such claim at their own expense.

8.5 Survival: The obligations under this Section 8 shall survive the termination or expiration of this Agreement.

Amendments, Updates, and Notice

9.1 Right to Amend: Lonestar Research reserves the sole right to amend, modify, or update the terms of this Agreement at any time, in whole or in part, to reflect changes in applicable laws, regulations, business practices, or operational requirements. Any such amendments shall be effective immediately upon posting to Lonestar Research's designated website or upon other written notice to the Lab, unless otherwise specified. Amendments will not apply retroactively to actions or obligations arising before the effective date of the amendments. Material changes will not impose unreasonable new obligations on the Lab retroactively.

9.2 Lab’s Obligation to Review Updates: The Lab agrees to periodically review the terms of this Agreement as posted at https://lonestarlab.org/terms.html to ensure continued compliance. The Lab acknowledges and agrees that continued use of the Products after the effective date of any updates constitutes acceptance of the revised terms.

9.3 Notification of Material Changes: Lonestar Research will make reasonable efforts to notify the Lab of material changes to this Agreement via email to the address provided in Section 13. However, failure to receive such notice shall not relieve the Lab of its obligation to comply with the updated terms. If the Lab objects to any changes, it may terminate this Agreement within thirty (30) days of receiving notice of the update without penalty.

9.4 Non-Waiver of Terms: The Lab acknowledges that Lonestar Research's failure to enforce any provision of this Agreement or to notify the Lab of an update does not constitute a waiver of Lonestar Research's rights under the updated Agreement.

9.5 Entire Agreement Supersedes Prior Terms: This Agreement, as updated from time to time, constitutes the entire agreement between the parties regarding its subject matter and supersedes any prior agreements, understandings, or communications, whether written or oral.

9.6 Survival of Provisions: All provisions of this Agreement that, by their nature, should survive termination or expiration of this Agreement, including but not limited to Sections 4 (Confidentiality), 6 (Product Limitations and Disclaimers), 7 (Restrictions on Use), and 8 (Indemnification and Assumption of Liability), shall survive and remain in full force and effect.

Dispute Resolution and Arbitration

10.1 Binding Arbitration: All disputes shall be resolved through binding arbitration in Austin, TX, in accordance with the rules of the American Arbitration Association. The arbitration shall be conducted by a single arbitrator under the rules of the American Arbitration Association. Each party shall bear its own costs, except as awarded by the arbitrator.

10.2 Governing Law: This Agreement shall be governed by the laws of the State of Texas.

10.3 Disclaimer of Regulatory Responsibility: Lonestar Research disclaims responsibility for any intellectual property infringement by the Lab or for any penalties imposed by regulatory authorities due to the Lab’s Improper Use of Products.

Termination

11.1 Termination by Either Party: This Agreement may be terminated by either party upon providing thirty (30) days' prior written notice to the other party. Termination may also occur immediately if there is a material breach of this Agreement by the other party, subject to Section 11.3 below.

11.2 Termination by Lonestar Research: Lonestar Research reserves the right to terminate this Agreement immediately and without prior notice if the Lab violates any provisions related to Improper Use (as defined in Section 2.5) or Confidentiality (as defined in Section 4).

11.3 Obligations Upon Termination: Upon termination of this Agreement for any reason, the Lab shall:
(a) Cease all use of the Products supplied by Lonestar Research.
(b) Return or destroy all Confidential Information belonging to Lonestar Research, as instructed by Lonestar Research.
(c) Return or destroy all Products and RUO materials supplied by Lonestar Research.
(d) Provide written certification of compliance with these obligations within ten (10) business days of termination.

11.4 Surviving Obligations: Notwithstanding termination of this Agreement, the following provisions shall survive and remain in full force and effect:
(a) Section 4 (Confidentiality)
(b) Section 6 (Product Limitations and Disclaimers)
(c) Section 7 (Restrictions on Use)
(d) Section 8 (Indemnification and Assumption of Liability)
(e) Section 10 (Dispute Resolution and Arbitration)
(f) Any other provision of this Agreement that by its nature is intended to survive termination.

11.5 No Waiver of Rights: Termination of this Agreement shall not be construed as a waiver of any rights, remedies, or claims that either party may have under this Agreement or applicable law, nor shall it relieve either party of liability for any breaches of this Agreement occurring prior to the date of termination.

11.6 Not Liable for Loss: Lonestar Research is not liable for the Lab’s losses resulting from termination of the agreement.

FDA AND TEXAS REGULATORY DISCLAIMER

THE PRODUCTS PROVIDED BY LONESTAR RESEARCH ARE DESIGNATED SOLELY FOR RESEARCH USE ONLY (RUO) AND ARE NOT INTENDED FOR USE IN HUMANS OR ANIMALS, INCLUDING BUT NOT LIMITED TO DIAGNOSTIC, THERAPEUTIC, OR VETERINARY APPLICATIONS. THE PRODUCTS HAVE NOT BEEN EVALUATED, APPROVED, OR CLEARED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) OR ANY OTHER REGULATORY AUTHORITY FOR ANY MEDICAL, PHARMACEUTICAL, OR CLINICAL PURPOSES. ANY USE OF THE PRODUCTS OUTSIDE THE RUO DESIGNATION MAY VIOLATE APPLICABLE FEDERAL OR STATE LAWS AND REGULATIONS.

THE PRODUCTS ARE NOT SUBJECT TO FDA DRUG APPROVAL PROCESSES UNDER 21 U.S.C. § 301 ET SEQ., NOR ARE THEY REGULATED AS PHARMACEUTICALS, MEDICAL DEVICES, OR THERAPEUTIC SUBSTANCES UNDER 21 U.S.C. § 321(g)(1). THE LAB HEREBY CERTIFIES THAT IT UNDERSTANDS THESE LIMITATIONS AND ACCEPTS FULL RESPONSIBILITY FOR ENSURING COMPLIANCE WITH ALL APPLICABLE REGULATORY REQUIREMENTS.

UNDER TEXAS LAW, RUO PRODUCTS DO NOT FALL UNDER THE DEFINITION OF A DANGEROUS DRUG (TEXAS HEALTH & SAFETY CODE § 483.001 ET SEQ.), NOR ARE THEY CONTROLLED SUBSTANCES UNDER TEXAS HEALTH & SAFETY CODE § 481.001 ET SEQ. HOWEVER, THE LAB ACKNOWLEDGES THAT MISBRANDING UNDER TEXAS HEALTH & SAFETY CODE § 431.112 REMAINS A REGULATORY RISK IF PRODUCTS ARE REPRESENTED OR USED IN A MANNER INCONSISTENT WITH RUO DESIGNATION.

THE LAB CERTIFIES THAT IT WILL NOT MISREPRESENT, RELABEL, REPACKAGE, OR MODIFY THE PRODUCTS IN A WAY THAT COULD CREATE IMPLIED MEDICAL, DIAGNOSTIC, OR THERAPEUTIC USE CLAIMS IN VIOLATION OF TEXAS BUSINESS & COMMERCE CODE § 17.46(B)(24) OR FEDERAL MISBRANDING PROVISIONS UNDER 21 U.S.C. § 331 & 352.

ALL PRODUCTS SOLD BY LONESTAR RESEARCH ARE LABELED IN COMPLIANCE WITH 21 C.F.R. § 809.10(C), WHICH GOVERNS THE MARKETING AND SALE OF RESEARCH USE ONLY MATERIALS. THE LAB AGREES THAT ANY USE OF THE PRODUCTS OUTSIDE THE RUO DESIGNATION COULD TRIGGER REGULATORY ENFORCEMENT ACTIONS, AND IT ACCEPTS FULL LIABILITY FOR ENSURING COMPLIANCE WITH THESE RESTRICTIONS.

LONESTAR RESEARCH EXPRESSLY DISCLAIMS ANY LIABILITY FOR THE MISUSE OF PRODUCTS IN A MANNER INCONSISTENT WITH THEIR RUO DESIGNATION, INCLUDING ANY CLAIMS ARISING FROM HUMAN OR ANIMAL USE OR VIOLATIONS OF STATE OR FEDERAL LAW. BY ENTERING INTO THIS AGREEMENT, THE LAB ACKNOWLEDGES AND AGREES TO ADHERE STRICTLY TO THESE LIMITATIONS.

13.Initialed Statements Section

To further affirm the Lab’s understanding of and compliance with the terms of this Agreement, the Lab must acknowledge each of the following statements by checking each box in the space provided. These acknowledgments confirm that the Lab will use all products exclusively for in vitro research applications in compliance with 21 U.S.C. § 301 et seq., 21 C.F.R. § 809.10(c), and Texas Health & Safety Code §§ 431.001, 431.112, and 483.001, and that any deviation, misrepresentation, or misuse may result in termination of service, legal liability, and potential notification to Texas DSHS, the FDA, or other regulatory authorities, if required by law. The Lab assumes full responsibility for regulatory compliance, product handling, and adherence to RUO restrictions, indemnifying Lonestar Research against any violations:

[esigninja formid="4" field_id="47" display="value" ] ☑ I confirm that the products will be used exclusively for in vitro research applications.

[esigninja formid="4" field_id="52" display="value" ] ☑ I understand that Lonestar Research does not provide products intended to diagnose, treat, cure, or prevent any disease.

[esigninja formid="4" field_id="53" display="value" ] ☑ I acknowledge that the products are not drugs, medications, or pharmaceutical preparations as defined under U.S. & Texas law.

[esigninja formid="4" field_id="54" display="value" ] ☑ I understand that Lonestar Research is not a compounding pharmacy or chemical compounding facility as defined under U.S. & Texas law.

[esigninja formid="4" field_id="55" display="value" ] ☑ I understand that statements made by Lonestar Research or its representatives have not been evaluated by the FDA or Texas DSHS.

[esigninja formid="4" field_id="59" display="value" ] ☑ I confirm that I have read and understand the entirety of this Agreement, including all definitions and referenced sections.

Agreement Execution and Acknowledgment

By completing and signing this section, the Lab affirms its agreement to all terms and conditions set forth in this Research Use and Confidentiality Agreement. This includes, but is not limited to, adherence to restrictions on the use of Products, compliance with applicable laws and regulations, and acceptance of all liability as specified in this Agreement. The Lab further acknowledges that this signed section constitutes a binding contract between the Lab and Lonestar Research.

Lab Name:	[esigninja formid="4" field_id="36" display="value" ]
Authorized Rep Name:	[esigninja formid="4" field_id="38" display="value" ] [esigninja formid="4" field_id="39" display="value" ]
Contact Email:	[esigninja formid="4" field_id="41" display="value" ]
Contact Phone:	[esigninja formid="4" field_id="40" display="value" ]
Shipping Address:	[esigninja formid="4" field_id="42" display="value" ] [esigninja formid="4" field_id="43" display="value" ], [esigninja formid="4" field_id="44" display="value" ] [esigninja formid="4" field_id="45" display="value" ]

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Acknowledgment and Agreement
By signing below, the undersigned affirms that they are an authorized representative of the Lab, have read and understood the entirety of this Agreement, and agree to all its terms and conditions.

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Signed by Lloyd Armbrust
Signed On: August 13, 2025

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March 5, 2025 10:01 am CDT

Research Use and Confidentiality Agreement 2024 Uploaded by Lloyd Armbrust - lab@lonestar.io IP 136.62.177.195