Replacement of Product and Dispute Procedure. If ARIAD SWISSCO rejects, in accordance with Section 11.2.1 any proposed delivery or shipment (or portion thereof) of the Product as Non-Conforming and ARIAD US disagrees that the alleged Non-Conformance exists, ARIAD US shall so notify ARIAD SWISSCO in writing (an “Objection Notice”) within [**] of receipt of ARIAD SWISSCO’s notice of rejection and the following procedures shall apply: in the case of a Latent Defect ARIAD US shall inspect the returned representative sample of Product or other evidence of Non-Conformance and attempt to reach agreement with ARIAD SWISSCO as to whether or not the Product is Non-Conforming. If ARIAD SWISSCO and ARIAD US fail within [**] after delivery of the Objection Notice to agree as to whether the Product is Non-Conforming, in the case of a Latent Defect representative samples of the batch of the Product in question and their reference samples shall be submitted to a mutually-acceptable, independent, qualified Third Party laboratory or consultant for analysis or review to determine whether there is a Non-Conformance. For clarity, this may include a decision whether or not contamination is present. The results of such evaluation shall be binding upon the Parties. The Parties initially shall [**] the cost of such evaluation, except that the Party that is determined to have been incorrect in its determination of whether the Product was or was not Non-Conforming shall assume the responsibility for, and pay, the costs of any such evaluation and reimburse the other Party for any amounts previously paid to the independent laboratory or consultant in connection with that determination.
Replacement of Product and Dispute Procedure. If MannKind notifies Sanofi in writing, within thirty (30) days of MannKind’s receipt of notice that Sanofi is rejecting Product, that MannKind disagrees with Sanofi’s claim that the Product is defective (an “Objection Notice”), the following procedures shall apply. Sanofi and MannKind will review available documentation and perform re-testing of the Product as appropriate to attempt to reach agreement as to whether or not Product fails to conform to any warranty set forth in Section 8.2 of this Agreement. If Sanofi and MannKind fail within ten (10) days after delivery of the Objection Notice to agree as to whether Product is defective, representative samples of the batch of Product in question shall be submitted to a mutually-acceptable independent laboratory or consultant for analysis or review. The results of such evaluation shall be binding upon the Parties. The Parties shall share equally the cost of such evaluation except that the Party that is determined to have been incorrect in its determination of whether Product should be rejected shall assume the responsibility for, and pay, the costs of any such evaluation and reimburse the other for any amounts previously paid to the independent laboratory or consultant in connection with that determination.
Replacement of Product and Dispute Procedure. If Alfacell believes that Product was wrongly rejected, it shall notify Par in writing, within twenty (20) days of receipt by Alfacell of Par’s written notice of rejection, that Alfacell disagrees with such basis for rejection (an “Objection Notice”). If Par and Alfacell cannot agree, within twenty (20) days after receipt by Par of the Objection Notice, whether Product rejected by Par is defective, representative samples of the batch of Product in question shall be submitted to a mutually-acceptable independent laboratory or consultant for analysis and/or review. The results of such evaluation shall be binding upon the Parties. The Party that is determined to have been incorrect in its determination of whether the Product should be rejected shall pay the costs of any such evaluation and reimburse the other Party for any amounts previously paid by the other Party to the independent laboratory or consultant in connection with such evaluation. If such evaluation is inconclusive as to whether the Product rejected is defective, or if it is conclusive as to the fact that the Product rejected is defective but it cannot be determined which Party is responsible for such defect, then the Parties shall each be responsible for one-half of the costs related to such evaluation and Par may, in its discretion, purchase replacement Product when available for delivery. The Parties may also mutually agree in their discretion to further testing.
