Abbott. 2.2.1 Abbott will carry out process development of the selected formulation of Bulk Product on its [**] in accordance with the Development Protocol agreed between the parties and attached hereto as Appendix A. 2.2.2 Abbott will provide Barrier, or its nominee, with samples (approximately [**] kg) of Bulk Product resulting from this process development programme ("mock NDA lot") for Barrier, or its nominee, to carry out further milling and tabletting experiments. 2.2.3 Abbott will then manufacture six (6) batches of Bulk Product using the [**], each batch being [**] kg, and will supply these six (6) batches to Barrier, or its nominee, for milling and tabletting into Finished product. 2.2.4 Abbott will carry out in process controls and analytical characterization appropriate for NDA batches. Abbott will take forensic samples for the FDA and will provide such samples to Barrier or its nominee. ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request. 2.2.5 Abbott will provide Barrier with copies of executed batch records, including all associated documentation such as test results and any deviation reports. 2.2.6 Abbott will provide Barrier with a final development report as soon as reasonably possible after completing the development programme.
Appears in 1 contract
Sources: Development and Supply Agreement (Barrier Therapeutics Inc)
Abbott. 2.2.1 Abbott will carry out process development of the selected formulation of selec▇▇▇ ▇▇rmulatio▇ ▇▇ Bulk Product on its [**] in accordance with the Development Protocol agreed between the parties and attached hereto as Appendix A.
2.2.2 Abbott will provide Barrier, or its nominee, with samples (approximately approxima▇▇▇▇ [**] kg) of Bulk Product resulting from this process development programme ("mock NDA lot") for Barrier, or its nominee, to carry out further milling and tabletting experiments.
2.2.3 Abbott will then manufacture six (6) batches of Bulk Product using the t▇▇ [**], each batch being [**] kg, and will supply these six (6) batches to Barrier, or its nominee, for milling and tabletting into Finished product.
2.2.4 Abbott will carry out in process controls and analytical characterization characteriz▇▇▇▇▇ appropriate for NDA batches. Abbott will take forensic samples for the FDA and will provide such ▇▇▇▇ samples to Barrier or its nominee. ** Certain information in this exhibit has been omitted and will be filed separately with the Securities and Exchange Commission pursuant to a confidential treatment request.
2.2.5 Abbott will provide Barrier with copies of executed batch records, including ▇ncluding all associated documentation such as test results and any deviation reports.
2.2.6 Abbott will provide Barrier with a final development report as soon as ▇▇ reasonably possible after completing the development programme.
Appears in 1 contract
Sources: Development and Supply Agreement (Barrier Therapeutics Inc)