Product & Regulatory Disclaimer

Effective Date: Jan 01, 2026

This Product and Regulatory Disclaimer applies to product information, product pages, brochures, data sheets, technical communications, quotations, drawings, samples, and other materials provided by BioExcel Pharma.

1. Product Use

BioExcel Pharma products are supplied for laboratory, research, quality control, pharmaceutical, bioprocessing, industrial, or related commercial use as applicable. Products are not intended for use in humans, animals, clinical treatment, diagnostic procedures, or any application not expressly approved in writing by BioExcel Pharma and supported by applicable product documentation.

2. Customer Responsibility

Customers are responsible for confirming product suitability, specifications, configuration, materials, quality requirements, documentation requirements, validation requirements, regulatory requirements, storage, handling, compatibility, and final application before purchase or use.

3. Product Information

Product information, images, specifications, drawings, technical documents, and descriptions are provided for general informational purposes and may vary based on product configuration, supplier, lot, availability, customer requirements, or approved drawing/specification. BioExcel Pharma may update product information, specifications, packaging, documentation, or availability without prior notice unless otherwise agreed in writing.

4. Quality and Regulatory Documentation

Certificates, compliance documents, lot records, quality documents, product data sheets, and related documentation may vary based on product type, configuration, supplier, lot, regulatory status, and order requirements. Customers should request required documentation before placing an order. Special documentation, testing, validation support, or compliance requests may require additional cost and lead time.

5. Regulatory Limitation

BioExcel Pharma does not guarantee regulatory approval of a customer's final product, process, submission, facility, validation program, or application unless expressly agreed in writing by an authorized representative of BioExcel Pharma. Customers are responsible for complying with all applicable laws, regulations, internal quality procedures, validation requirements, and documentation requirements related to the use of BioExcel Pharma products.

6. Samples and Evaluation Materials

Samples, trial units, or evaluation materials are provided for customer assessment only unless otherwise agreed in writing. Customers are responsible for testing, validating, and confirming suitability before production, regulated, or commercial use.

7. Sterile, Custom, and Single-Use Products

Sterile, custom, and single-use products should be used only according to applicable product labels, specifications, storage requirements, expiration dates, and documentation. Customers are responsible for confirming compatibility with their process and intended use before implementation.

8. No Modification Without Approval

Product modifications, relabeling, repackaging, reprocessing, reuse of single-use products, or use outside stated specifications may affect product performance, safety, documentation, regulatory status, and warranty coverage.

9. Relationship to Commercial Terms

This Product and Regulatory Disclaimer supplements BioExcel Pharma's commercial Terms and Conditions, quotations, sales orders, invoices, delivery documents, and product-specific documentation. In the event of a conflict, the written quotation, approved specification, applicable product documentation, or signed agreement may control for the specific transaction.

10. Governing Law

This Product and Regulatory Disclaimer is governed by the laws of the State of New Jersey, without regard to conflict of law rules.

11. Contact Information

BioExcel Pharma LLC, Operating Address: 6 Corporate Dr, Space A, Cranbury, New Jersey 08512. Questions may be submitted through the BioExcel Pharma website contact form or by written notice to the operating address listed above.