Remedies for Non-Conforming Product. 7.4.1 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or a portion thereof materially fails to conform to the Product Warranties due to the failure of: (a) CBSW personnel properly to execute the Master Production Record, (b) CBSW personnel to comply with cGMP, (c) CBSW or its personnel otherwise, or (d) the Facility utilities, then CBSW will produce for Client sufficient quantities of Product to replace the non-conforming Batch of Product or portion thereof (the "Production Rerun"), in accordance with the provisions of this Agreement without charging Client monthly fees or portion thereof for the time needed for such Production Rerun, (ii) for Hourly Fees (as set forth on Schedule 11.1), (iii) for Materials needed for the Production Rerun and (iv) other expenses incurred in The Production Rerun (collectively the "Production Rerun Expenses"). In addition, [***] . 7.4.2 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or portion thereof materially fails to conform to the Product Warranties for any reason other than as set forth in Section 7.4.1, then CBSW will perform a Production Rerun at Client's expense and Client will bear the expenses of any resulting required Product recall. 7.4.3 Client acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties is as set forth in this Section 7.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims. 7.4.4 Nothing in this Section 7.4 or elsewhere in this Agreement shall preclude Client from making a claim against CBSW [***] .
Appears in 3 contracts
Samples: Cell Therapy Manufacturing Agreement (Ortec International Inc), Cell Therapy Manufacturing Agreement (Ortec International Inc), Cell Therapy Manufacturing Agreement (Ortec International Inc)
Remedies for Non-Conforming Product. 7.4.1 5.4.1 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.35.3, that a Batch of Product or a portion thereof materially fails to conform to the Product Warranties due to the failure of: (a) CBSW LWI personnel properly to execute the Master Production Record, (b) CBSW LWI personnel to comply with cGMP, or (c) CBSW or its personnel otherwise, or (d) the Facility utilities, then CBSW then, at CLIENT’s request, LWI will produce for Client CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product or portion thereof (the "“Production Rerun"”), in accordance with the provisions of this Agreement without charging Client monthly fees or portion thereof and at no additional cost to CLIENT. LWI shall complete any Production Rerun as soon as possible following CLIENT’s request therefore and in any event within 60 days of such request. If more than 25% of the Batches of a Product ordered by CLIENT for delivery during any 12 month period in which CLIENT orders more than 20 Batches, fails to conform to the time needed for such Production Rerun, Product Warranties due to the failure of (ii) for Hourly Fees (as set forth on Schedule 11.1a), (iiib) for Materials needed for or (c) and LWI cannot cure the Production Rerun cause(s) of such failures within sixty (60) days of notice thereof, then the Minimum Purchase Obligation relating to such Product shall be of no further force and (iv) other expenses incurred in The Production Rerun (collectively the "Production Rerun Expenses"). In addition, [***] effect.
7.4.2 5.4.2 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.35.3, that a Batch of Product or portion thereof materially fails to conform to the Product Warranties for any reason other than as set forth in Section 7.4.15.4.1, then CBSW will perform LWI shall have no liability to CLIENT with respect to such Batch and LWI will, at CLIENT’s request, produce for CLIENT a Production Rerun at Client's expense and Client will bear the expenses of any resulting required Product recallCLIENT’s expense.
7.4.3 Client 5.4.3 CLIENT acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties is as set forth in this Section 7.45.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims.
7.4.4 Nothing in this Section 7.4 or elsewhere in this Agreement shall preclude Client from making a claim against CBSW [***] .
Appears in 2 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Heat Biologics, Inc.)
Remedies for Non-Conforming Product. 7.4.1 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or a portion thereof materially fails to conform to the Product Warranties due to the failure of: (a) CBSW personnel properly to execute the Master Production Record, (b) CBSW personnel to comply with cGMP, (c) CBSW or its personnel otherwise, or (d) the Facility utilities, then CBSW will produce for Client sufficient quantities of Product to replace the non-conforming Batch of Product or portion thereof (the "Production Rerun"), in accordance with the provisions of this Agreement without charging Client monthly fees or portion thereof for the time needed for such Production Rerun, (ii) for Hourly Fees (as set forth on Schedule 11.1), (iii) for Materials needed for the Production Rerun and (iv) other expenses incurred in The Production Rerun [***] [***] (collectively the "Production Rerun Expenses"). In addition, [***] .
7.4.2 In the event that the Parties agree, or an independent testing laboratory or an arbitrator determines, pursuant to Section 7.3, that a Batch of Product or portion thereof materially fails to conform to the Product Warranties for any reason other than as set forth in Section 7.4.1, then CBSW will perform a Production Rerun at Client's expense and Client will bear the expenses of any resulting required Product recall.
7.4.3 Client acknowledges and agrees that its sole remedy with respect to the failure of Product to conform with any of the Product Warranties is as set forth in this Section 7.4, and in furtherance thereof, Client hereby waives all other remedies at law or in equity regarding the foregoing claims.
7.4.4 Nothing in this Section 7.4 or elsewhere in this Agreement shall preclude Client from making a claim against CBSW [***] .
Appears in 1 contract
Samples: Cell Therapy Manufacturing Agreement (Ortec International Inc)