Common use of Review of Batch Documentation; Acceptance Clause in Contracts

Review of Batch Documentation; Acceptance. RADIUS will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. For the avoidance of doubt, RADIUS herewith takes note that certain parts of the Batch Documentation will be written in French as the Facility is in Belgium. RADIUS shall pay all costs incurred with any translation of such Records requested by RADIUS. RADIUS will notify Manufacturer in writing of its acceptance or rejection of such Batch within six (6) weeks of receipt of the complete Batch Documentation relating to such Batch. During this review period, the parties agree to respond promptly, but in any event within ten (10) days, to any reasonable inquiry by the other party with respect to such Batch Documentation. RADIUS has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process.

Appears in 2 contracts

Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)

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Review of Batch Documentation; Acceptance. RADIUS will review the Batch Documentation for each Batch of Product and may test samples of the Batch of Product against the Specifications. For the avoidance of doubt, RADIUS herewith takes note that certain parts of the Batch Documentation will be written in French as the Facility is in Belgium. RADIUS shall pay all costs incurred with any translation of such Records requested by RADIUS. RADIUS will notify Manufacturer in writing of its acceptance or rejection of such Batch within six [*] (6[*]) weeks of receipt of the complete Batch Documentation relating to such Batch. During this review period, the parties agree to respond promptly, but in any event within ten [*] (10[*]) days, to any reasonable inquiry by the other party with respect to such Batch Documentation. RADIUS has no obligation to accept a Batch if such Batch does not comply with the Specifications and/or was not Manufactured in compliance with cGMP (if applicable) and the Manufacturing Process. * Confidential Treatment Requested by the Registrant. Redacted Portion Filed Separately with the Commission.

Appears in 2 contracts

Samples: Development and Manufacturing Services Agreement (Radius Health, Inc.), Development and Manufacturing Services Agreement (Radius Health, Inc.)

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