ImmunoGen Responsibilities Sample Clauses

ImmunoGen Responsibilities. Prior to delivery to BI Pharma, ImmunoGen shall test, or cause to be tested, a representative sample of each Drug Product Batch (or components as applicable) to demonstrate that such Drug Product Batch complies with the applicable specifications (manufacturer’s release). For each Drug Product Batch to be delivered to BI Pharma or to a recipient designated by BI Pharma, ImmunoGen shall prepare and submit a representative sample of such Drug Product Batch, and a Certificate of Analysis that identifies the items tested, the applicable specifications and test results. The present format and required content of the Certificate of Analysis is attached hereto as Schedule I. Any changes thereto shall be agreed upon by the Parties. ImmunoGen will also submit a copy of the Manufacturing Documentation. ImmunoGen shall provide raw data upon reasonable request by BI Pharma.