Common use of Analytical Services Clause in Contracts

Analytical Services. A. PRAECIS desires to have ▇▇▇▇▇▇▇▇ provided a CA for each lot of *** manufactured at ▇▇▇▇▇▇▇▇'▇ facility according to the in-process limits attached hereto as Exhibit B (the "In-Process Limits"). A CA will accompany each lot of *** shipped. ▇. ▇▇▇▇▇▇▇▇ and PRAECIS agree to jointly establish a release procedure for *** manufactured by ▇▇▇▇▇▇▇▇. ▇▇▇▇▇▇▇▇ shall obtain prior written approval from PRAECIS for any exemption in the In-Process Limits. If, at any time, *** produced for PRAECIS fails to meet the In-Process Limits, PRAECIS and ▇▇▇▇▇▇▇▇ agree to work together in good faith to attempt to resolve any such problem through rework of the ***, as appropriate, and ▇▇▇▇▇▇▇▇ will perform a failure investigation and report results to PRAECIS. C. Any changes to the In-Process Limits must be approved and signed by authorized representatives of both parties as may be designated from time to time. ▇. ▇▇▇▇▇▇▇▇ will maintain retention samples no greater than 0.5 gram of each lot of *** produced for a period of (1) year from the date of shipment. Such samples will be returned to PRAECIS or it's designate upon request by PRAECIS. E. Analytical methods will be validated and reports will be provided to PRAECIS. As necessary, cross-validation will be performed with other parties.

Appears in 1 contract

Sources: Supply Agreement (Praecis Pharmaceuticals Inc)

Analytical Services. A. PRAECIS desires to have ▇▇▇▇▇▇▇▇ provided a CA for each lot of *** CMC manufactured at ▇▇▇▇▇▇▇▇'▇ facility according to the in-process limits attached hereto as Exhibit B (the "In-Process Limits"). A CA will accompany each lot of *** CMC shipped. ▇. ▇▇▇▇▇▇▇▇ and PRAECIS agree to jointly establish a release procedure for *** CMC manufactured by ▇▇▇▇▇▇▇▇. ▇▇▇▇▇▇▇▇ shall obtain prior written approval from PRAECIS for any exemption in the In-Process Limits. If, at any time, *** CMC produced for PRAECIS fails to meet the In-Process Limits, PRAECIS and ▇▇▇▇▇▇▇▇ agree to work together in good faith to attempt to resolve any such problem through rework of the ***CMC, as appropriate, and ▇▇▇▇▇▇▇▇ will perform a failure investigation and report results to PRAECIS. C. Any changes to the In-Process Limits must be approved and signed by authorized representatives of both parties as may be designated from time to time. ▇. ▇▇▇▇▇▇▇▇ will maintain retention samples no greater than 0.5 gram of each lot of *** produced CMCproduced for a period of (1) year from the date of shipment. Such samples will be returned to PRAECIS or it's designate upon request by PRAECIS. E. Analytical methods will be validated and reports will be provided to PRAECIS. As necessary, cross-validation will be performed with other parties.

Appears in 1 contract

Sources: Supply Agreement (Praecis Pharmaceuticals Inc)