Manufacturing Losses definition
Manufacturing Losses means (i) any and all Losses of a Party or both Parties resulting from (A) a Claim or (B) a claim for direct damages or (ii) any other Losses of a Party or both Parties not accounted for in Standard Costs shared by the Parties, in each case in connection with the Manufacturing of Product (including any claim related to or arising out of Product Liability, breach of Product warranty, the inaccuracy of any representation or warranty, failure to comply with Applicable Law or other breach of any provision of this Agreement or a Related Manufacturing Agreement in connection with the Manufacture of Product).
Manufacturing Losses means any and all Losses incurred by one or both Parties, or their Affiliates, resulting from any claim, suit, action, or demand to the extent that such Losses are incurred, relate to, or arise out of the Manufacturing of the Product (including any such claim, suit, action, or demand related to or arising out of Product Liability, breach of Product warranty, the inaccuracy of any representation or warranty, failure to comply with Applicable Law or other breach of any provision of this Agreement, the Collaboration Agreement, or any Related Manufacturing Agreement, in each case, with respect to the Manufacturing of Product), including Losses incurred, related to, or arising under a Related Manufacturing Agreement and Losses resulting, directly or indirectly, from the acts or omissions of any Third Party CMO Manufacturing the Product on the Manufacturing Party’s behalf, except in all cases to the extent such Losses (a) are incurred, relate to, or arise out of the gross negligence, recklessness or willful misconduct of the Manufacturing Party (or its Affiliate) or (b) are caused by or result directly from a material [*] = Certain information contained in this document, marked by brackets, has been omitted because it is both not material and is the type of information that we treat as private or confidential. uncured breach by the Manufacturing Party (or its Affiliate) of any relevant Manufacturing agreement entered into by the Manufacturing Party (or its Affiliate) with any Third Party CMO that Manufactures the Product on the Manufacturing Party’s behalf if such material breach is acknowledged by the Manufacturing Party in writing, results from a failure by the Manufacturing Party to make any undisputed payment when due (after giving effect to any available cure period) or is finally determined by a court or arbitrator of competent jurisdiction; provided, that the foregoing clause (b) shall not apply to any such material breach that is caused by or results directly from an act or omission of a Third Party including any other Third Party CMO that Manufactures the Product on the Manufacturing Party’s behalf.
Manufacturing Losses means any and all Losses incurred by one or both Parties, or their Affiliates, resulting from any claim, suit, action, or demand to the extent that such Losses are incurred, relate to, or arise out of the Manufacturing of the Product (including any such claim, suit, action, or demand related to or arising out of Product Liability, breach of Product warranty, the inaccuracy of any representation or warranty, failure to comply with Applicable Law or other breach of any provision of this Agreement, the Collaboration Agreement, or any Related Manufacturing Agreement, in each case, with respect to the Manufacturing of Product), including Losses incurred, related to, or arising under a Related Manufacturing Agreement and Losses resulting, directly or indirectly, from the acts or omissions of any Third Party CMO Manufacturing the Product on the Manufacturing Party’s behalf, except in all cases to the extent such Losses (a) are incurred, relate to, or arise out of the gross negligence, recklessness or willful misconduct of the Manufacturing Party (or its Affiliate) or (b) are caused by or result directly from a material uncured breach by the Manufacturing Party (or its Affiliate) of any relevant Manufacturing
Examples of Manufacturing Losses in a sentence
Notwithstanding anything to the contrary contained in this Agreement or the Collaboration Agreement, the Parties agree to share equally in that portion of Manufacturing Losses that is included as Allowable Expenses or Development Costs hereunder.
The allocation of financial responsibility for Manufacturing Losses set forth in this ARTICLE 13 shall apply regardless of whether such Manufacturing Losses arise in contract, tort (including negligence and strict product liability), indemnity, contribution, specific performance or otherwise, and irrespective of whether a party has been advised of, or otherwise might have anticipated the possibility of, any such Manufacturing Losses.
With respect to liability for Manufacturing Losses (whether incurred in connection with the Parties’ performance of their respective obligations under this Agreement or a Related Manufacturing Agreement, or otherwise), the provisions of this ARTICLE 13 shall apply to the allocation of financial responsibility between the Parties.