Common use of Deviation Reports Clause in Contracts

Deviation Reports. If during the manufacture or other handling of Product by Adolor (a) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (b) there is reasonable evidence that Specifications or cGMPs were not followed in production of the Products, (c) there is reasonable evidence that the Products fail to conform to Specifications, (d) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) which could reasonably be expected to adversely affect the quality of the Products or otherwise are unusual or not expected, or (e) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by a person with appropriate technical knowledge and experience exercising his best professional judgment, then Adolor shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to GSK. Adolor shall include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.

Deviation Reports. If during the manufacture or other handling of a Product by Adolor Draxis (ai) the process or analytical limits vary from typical or established report ranges, release guidelines or release limits, (bii) there is reasonable evidence that Specifications Specifications, cGMPs or cGMPs GSK Group Quality Polices were not followed in production of the Products, (ciii) there is reasonable evidence that the Products fail to conform to Specifications, (div) other events or conditions occur (including, without limitation, events first identified as affecting non-GSK products) which could reasonably be expected to adversely affect the quality of the Products or otherwise are unusual or not expected, or (ev) any physical characteristic or attribute of the Products is recognizable at any time during the manufacturing process to be unusual, atypical or irregular by a person with appropriate technical knowledge and experience exercising his best professional judgment, then Adolor Draxis shall prepare as soon as practicable following the discovery of such deviation a written report detailing such deviation (a “Deviation Report”) and promptly send such Deviation Report, along with all supporting documentation, to GSK. Adolor Draxis shall include in its Deviation Report its analysis and recommendation for Product disposition. The Deviation Report shall be attached to, and shall accompany, copies of all relevant batch records.