GMP-Grade Product Limited Uses

Limited Uses

Products that are labeled “GMP-grade” or “GMP” or “cGMP” (“GMP Products”) have not been approved, licensed, certified or otherwise cleared by the competent US or foreign governmental authority or other entity under the applicable law for commercial manufacturing of drugs, biologics, medical devices, or in vitro diagnostics. Any GMP Products sold or licensed by CST are provided to Customer as the end-user and are not intended for administration to humans or animals unless and until Customer obtains necessary regulatory authorizations, including from the U.S. Food and Drug Administration, for such use. Customer shall (a) not sell, license, loan, donate or otherwise transfer or make available any GMP Product to any third party, whether alone or in combination with other materials, or use any GMP Product to manufacture any commercial products, (b) not copy, modify, reverse engineer, decompile, disassemble or otherwise attempt to discover the underlying structure or technology of the GMP Products, or use the GMP Products for the purpose of developing any products or services that would compete with CST products or services, (c) not alter or remove from the GMP Products any trademarks, trade names, logos, patent or copyright notices or markings, (d) use the GMP Products solely in accordance with CST GMP Product Terms of Sale and any applicable documentation, and (e) comply with any license, terms of service or similar agreement with respect to any third party products or services used by Customer in connection with the GMP Products.

Please contact [email protected] for information on how to obtain a Drug Master File (DMF) Letter of Authorization from CST.