Common use of Responsibility for Costs Clause in Contracts

Responsibility for Costs. For the initial three (3) commercial batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY supplied information, formulations or materials, COMPANY shall bear one hundred percent (100%) of all costs directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY in accordance with all applicable laws and regulations. Upon the completion of all necessary validation batches and in the event a validated Product is rejected due to DPT’s failure to follow cGMP’s and/or comply with applicable written procedures and such failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of all materials (except for the Aptar device) supplied by DPT and cost of destruction. […***…]. In the 11 ***Confidential Treatment Requested event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY supplied information or DPT’s failure to follow written procedures, the COMPANY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be paid by the COMPANY. Destruction of Rejected Product shall be in accordance with all applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.

Responsibility for Costs. For the initial three (3) commercial batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY supplied information, formulations or materials, COMPANY shall bear one hundred percent (100%) of all costs directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY in accordance with all applicable laws and regulations. Upon the completion of all necessary validation batches and in the event a validated Product is rejected due to DPT’s failure to follow cGMP’s and/or comply with applicable written procedures and such failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of all materials (except for the Aptar device) supplied by DPT and cost of destruction. […***…]. In the 11 ***Confidential Treatment Requested event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY supplied information or DPT’s failure to follow written procedures, the COMPANY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be paid by the COMPANY. Destruction of Rejected Product shall be in accordance with all applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.

Responsibility for Costs. For the initial three (3) commercial batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY SERENITY supplied information, formulations or materials, COMPANY SERENITY shall bear one hundred percent (100%) of all costs directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY SERENITY in accordance with all applicable laws and regulationsApplicable Laws (as defined below). Upon the completion of all necessary validation batches and the first three (3) commercial batches, and in the event a validated Product is rejected due to DPT’s 's failure to follow cGMP’s and/or comply with applicable written procedures and such failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of all materials (except for the Aptar device) supplied by DPT and cost costs of destruction. […***…]. In the 11 ***Confidential Treatment Requested event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY SERENITY supplied information or DPT’s 's failure to follow written procedures, the COMPANY SERENITY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be paid by the COMPANYSERENITY. Destruction of Rejected Product shall be in accordance with all applicable laws and regulations Applicable Laws and the party Party conducting the destruction shall indemnify shall, subject to paragraph 11.7, indemnify, defend and hold harmless the other party Party hereto for any and all liability, costs damage, loss, cost, or expenses, expense (including reasonable attorney’s fees and court costs, relating 's fees) resulting from any third party claims made or suits brought against such Party to a the extent arising from the other Party's failure to dispose of such Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.

Responsibility for Costs. For the initial three (3) commercial batches and all validation batches of a Product produced by DPT, or in the event a Rejected Product is due to COMPANY supplied information, formulations or materials, COMPANY shall bear one hundred percent (100%) of all costs directly related to and invoiced for Rejected Product including cost of destruction of the Rejected Product, which shall be conducted by COMPANY in accordance with all applicable laws and regulations. Upon the completion of all necessary validation batches and in the event a validated Product is rejected due to DPT’s failure to follow cGMP’s and/or comply with applicable written procedures and such failure renders the Product unmarketable, DPT shall bear one hundred percent (100%) of the manufacturing fees, costs of all materials (except for the Aptar device) supplied by DPT and cost costs of destruction. […***…]. In the 11 ***Confidential Treatment Requested event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY supplied information or DPT’s failure to follow written procedures, the COMPANY shall bear all Materials Fees with DPT bearing all Manufacturing Fees related to Rejected Product, and with destruction to be paid by the COMPANYshared equally. Destruction of Rejected Product shall be in accordance with all applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.

Responsibility for Costs. For the initial three (3i) commercial batches and all validation batches of a Product produced by DPT, or in In the event a Rejected Product is due to COMPANY supplied information, formulations formulation, API and/or Intermediate Product, or materialsany other materials supplied by Allergan, COMPANY then Allergan shall bear one hundred percent (100%) [***] of all costs directly related to and invoiced for Rejected Product including including, but not limited to cost of API and/or Intermediate Product and cost of destruction of the Rejected Product, which shall be conducted by COMPANY Allergan in accordance with all applicable laws and regulations. Additionally, Allergan shall be responsible for the costs of any rejected un-validated Product where the cause of rejection is not a result of Contractor’s breach of cGMPS. (ii) Upon the completion of all necessary validation batches , and in the event a specific validated Product is rejected due to DPTContractor’s failure to follow cGMP’s and/or comply with applicable written procedures and such failure renders the Product unmarketablespecifications, DPT Contractor shall bear one hundred percent (100%) [***] of the Production Fees, including manufacturing feescosts, costs of all materials (except for directly related to the Aptar device) supplied by DPT Rejected Product and cost costs of destruction. […***…]. , plus any expenses associated with the Product return to include without limitation, reimbursement of custom and freight charges. (iii) In the 11 ***Confidential Treatment Requested event a validated Product does not meet final Specifications and results in a Rejected Product, but such failure is not due to either COMPANY Allergan supplied information API and/or Intermediate Product (or DPTany other materials) or Contractor’s failure to follow comply with written proceduresprocedures or comply with its obligations under this Agreement, the COMPANY Allergan shall bear all Materials Fees cost of materials, including but not limited to API and/or Intermediate Product cost, with DPT Contractor bearing all Manufacturing Fees manufacturing costs related to Rejected Product, and with destruction cost to be paid by the COMPANY. Allergan. (iv) Destruction of Rejected Product shall be in accordance with all applicable laws and regulations and the party conducting the destruction shall indemnify the other party hereto for any liability, costs or expenses, including attorney’s fees and court costs, relating to a failure to dispose of such Product in accordance with such laws and regulations. The party conducting the destruction shall also provide to the other party hereto all manifests and other applicable evidence of proper destruction as may be requested by applicable law.