Nonconformity. (a) Nonconformity. If either Party becomes aware that any batch or shipment of Supplied Compound or Clinical Supply has a Nonconformity, at any time regardless of the status of Cempra’s testing and quality assurance activities, such Party shall notify the other Party within [*] Business Days of becoming aware of a Nonconformity. “Nonconformity” means a product characteristic that (i) is attributable to failure to [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. manufacture, test, package, store, label, release or deliver any Supplied Compound or Clinical Supply in accordance with the Specifications or cGMP prior to such Supplied Compound or Clinical Supply being made available at the Delivery Point (such a Nonconformity, a “Cempra Nonconformity”) or (ii) is not a Cempra Nonconformity and causes any Supplied Compound or Clinical Supply to fail to conform to the applicable Specifications or cGMP. In the event of a Nonconformity, the Parties shall mutually agree as to the procedure by which the Nonconformity will be investigated.
Appears in 1 contract
Sources: Supply Agreement
Nonconformity. (a) Nonconformity. If either Party becomes aware that any batch or shipment of Supplied Compound or Clinical Supply has a Nonconformity, at any time regardless of the status of Cempra’s testing and quality assurance activities, such Party shall notify the other Party within [*] Business Days of becoming aware of a Nonconformity. “Nonconformity” means a product characteristic that (i) is attributable to failure to [*] Confidential treatment requested; certain information omitted and filed separately with the SEC. manufacture, test, package, store, label, release or deliver any Supplied Compound or Clinical Supply in accordance with the Specifications or cGMP prior to such Supplied Compound or Clinical Supply being made available at the Delivery Point (such a Nonconformity, a “Cempra Nonconformity”) or (ii) is not a Cempra Nonconformity and causes any Supplied Compound or Clinical Supply to fail to conform to the applicable Specifications or cGMP. In the event of a Nonconformity, the Parties shall mutually agree as to the procedure by which the Nonconformity will be investigated.
Appears in 1 contract
Sources: Supply Agreement (Cempra, Inc.)