Common use of Manufacturing Right Clause in Contracts

Manufacturing Right. Prior to Roche’s exercise of its Option Right for a Collaboration Target, the JRC will determine which Party has responsibility for the manufacture of Collaboration Compounds and Products, subject to the oversight of the JRC, in accordance with the applicable Research Plan and Phase I Plan for such Collaboration Target. If requested by a Party, the other terms under which a Party will manufacture and supply Collaboration Compounds and Products to the other Party will be set forth in one or more manufacturing and supply agreements to be entered into between the Parties (each a “Supply Agreement”). Such Supply Agreements will contain customary terms and conditions, including quality and supply failure remedies, and otherwise be consistent with this Agreement and Roche quality standards. If the Parties cannot agree to the terms of a Supply Agreement within ninety (90) days of initiation of discussions, such matter will be decided by the Expert Committee in accordance with the terms and conditions set forth in Section 12.9.4, mutatis mutandis. After Roche’s exercise of its Option Right for a Collaboration Target, subject to the oversight of the JDC, Roche shall have the right to manufacture all Licensed Products for such Collaboration Target throughout the Territory, subject to this Section 9.1. For Licensed Products in the BPM Territory pursuant to Program 2 and Program 4, (i) Roche, at its option, can elect to transfer the manufacturing process to BPM (or a CRO that is reasonably acceptable to Roche) whereby BPM (or such CRO) would then have responsibility to manufacture its own supply of such Licensed Product at its own costs; or (ii) BPM, at its option, can elect to use a CRO that is acceptable to Roche to perform such manufacturing activities on behalf of BPM in the BPM Territory if such CRO provides a price that is at least […***…] lower than the per unit cost for a Licensed Product than offered by Roche taking into account projected supply volume discounts. The costs of any such manufacturing process transfer pursuant to clause (i) of the preceding sentence shall be shared equally by the Parties, and pursuant to clause (ii) of the preceding sentence shall be borne solely by BPM. For Licensed Products supplied to BPM by Roche in the United States pursuant to Program 2 and Program 4, Roche shall supply such Licensed Products for clinical supply at […***…] and for commercial supply at […***…][…***…]. The other terms under which Roche will manufacture and supply Licensed Products to BPM will be set forth in one or more Supply Agreements. Such Supply Agreements will contain customary terms and conditions, including quality and supply failure remedies, and otherwise be consistent with this Agreement and Roche quality standards. If the Parties cannot agree to the terms of a Supply Agreement within ninety (90) days of initiation of discussions, such matter will be decided by the Expert Committee in accordance with the terms and conditions set forth in Section 12.9.4, mutatis mutandis. At BPM’s request, the Parties will include provisions in such Supply Agreements relating to the manufacture and supply of Companion Diagnostics or Roche Marketed Products for use with Licensed Products for Program 2 and Program 4. Either Party shall have the right to manufacture at risk, or have a CRO approved by Roche manufacture at risk, a Product prior to Roche exercising its Option Right for a Collaboration Target. If Roche exercises its Option Right for a Collaboration Target and Roche accepts the quality of a batch of the applicable Product, then the cost to manufacture such batch shall be a Development Cost. If Roche does not exercise its Option Right for a Collaboration Target, then the cost to manufacture such batch of the applicable Product shall be borne by the Party that manufactured or had manufactured the batch.

Manufacturing Right. Prior to Roche’s exercise of its Option Right for a Collaboration Target, the JRC will determine which Party has responsibility for the manufacture of Collaboration Compounds and Products, subject to the oversight of the JRC, in accordance with the applicable Research Plan and Phase I Plan for such Collaboration Target. If requested by a Party, the other terms under which a Party will manufacture and supply Collaboration Compounds and Products to the other Party will be set forth in one or more manufacturing and supply agreements to be entered into between the Parties (each a “Supply Agreement”). Such Supply Agreements will contain customary terms and conditions, including quality and supply failure remedies, and otherwise be consistent with this Agreement and Roche quality standards. If the Parties cannot agree to the terms of a Supply Agreement within ninety (90) days of initiation of discussions, such matter will be decided by the Expert Committee in accordance with the terms and conditions set forth in Section 12.9.4, mutatis mutandis. ​ After Roche’s exercise of its Option Right for a Collaboration Target, subject to the oversight of the JDC, Roche shall have the right to manufacture all Licensed Products for such Collaboration Target throughout the Territory, subject to this Section 9.1. For Licensed Products in the BPM Territory pursuant to Program 2 and Program 4, (i) Roche, at its option, can elect to transfer the manufacturing process to BPM (or a CRO that is reasonably acceptable to Roche) whereby BPM (or such CRO) would then have responsibility to manufacture its own supply of such Licensed Product at its own costs; or (ii) BPM, at its option, can elect to use a CRO that is acceptable to Roche to perform such manufacturing activities on behalf of BPM in the BPM Territory if such CRO provides a price that is at least […***…] lower than the per unit cost for a Licensed Product than offered by Roche taking into account projected supply volume discounts. The costs of any such manufacturing process transfer pursuant to clause (i) of the preceding sentence shall be shared equally by the Parties, and pursuant to clause (ii) of the preceding sentence shall be borne solely by BPM. For Licensed Products supplied to BPM by Roche in the United States pursuant to Program 2 and Program 4, Roche shall supply such Licensed Products for clinical supply at ​ ​ […***…] and for commercial supply at […***…][…***…]. The other terms under which Roche will manufacture and supply Licensed Products to BPM will be set forth in one or more Supply Agreements. Such Supply Agreements will contain customary terms and conditions, including quality and supply failure remedies, and otherwise be consistent with this Agreement and Roche quality standards. If the Parties cannot agree to the terms of a Supply Agreement within ninety (90) days of initiation of discussions, such matter will be decided by the Expert Committee in accordance with the terms and conditions set forth in Section 12.9.4, mutatis mutandis. At BPM’s request, the Parties will include provisions in such Supply Agreements relating to the manufacture and supply of Companion Diagnostics or Roche Marketed Products for use with Licensed Products for Program 2 and Program 4. Either Party shall have the right to manufacture at risk, or have a CRO approved by Roche manufacture at risk, a Product prior to Roche exercising its Option Right for a Collaboration Target. If Roche exercises its Option Right for a Collaboration Target and Roche accepts the quality of a batch of the applicable Product, then the cost to manufacture such batch shall be a Development Cost. If Roche does not exercise its Option Right for a Collaboration Target, then the cost to manufacture such batch of the applicable Product shall be borne by the Party that manufactured or had manufactured the batch.. ​