Common use of Non-Conforming Clause in Contracts

Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client or SBL as Non-Conforming Product, at the option of Client, SBL shall take Commercially Reasonable Efforts to promptly Manufacture replacement Product (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client the quantity of the Product equivalent to the quantity of Non-Conforming Product on a date to be mutually agreed by the Parties and such replacement Batch shall be invoiced and paid for as if it were the original Non-Conforming Product. If SBL does not confirm the non-conformity, the Parties shall refer to an independent and mutually agreed-on laboratory or firm with international repute to test the disputed Product. The costs of the independent laboratory will be borne by the Party responsible for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. Section 5.9.2(a) (i) and (ii) shall apply to such replaced Product mutatis mutandis. Responsibility for the costs of such Non-Conforming Product shall be as if such Non-Conforming Product is a Batch Failure and Section 5.8.2 – 5.8.4 shall apply to such Non-Conforming Product mutatis mutandis. The remedies contained in this Section 5.9.2 shall be the sole and exclusive remedy of client for Non-Conforming Product.

Appears in 1 contract

Samples: Master Services Agreement (Tg Therapeutics, Inc.)

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Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client or SBL as Non-Conforming Product, at the option of Client, SBL shall take Commercially Reasonable Efforts to promptly Manufacture replacement Product (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client the quantity of the Product equivalent to the quantity of Non-Conforming Product on a date to be mutually agreed by the Parties and such replacement Batch shall be invoiced and paid for as if it were the original Non-Conforming Product. If SBL does not confirm the non-conformity, the Parties shall refer to an independent and mutually agreed-on laboratory or firm with international repute to test the disputed Product. The costs of the independent ​ ​ ​ laboratory will be borne by the Party responsible for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. Section 5.9.2(a) (i) and (ii) shall apply to such replaced Product mutatis mutandis. Responsibility for the costs of such Non-Conforming Product shall be as if such Non-Conforming Product is a Batch Failure and Section 5.8.2 – 5.8.4 shall apply to such Non-Conforming Product mutatis mutandis. The remedies contained in this Section 5.9.2 shall be the sole and exclusive remedy of client for Non-Non- Conforming Product.. ​

Appears in 1 contract

Samples: Master Services Agreement (Checkpoint Therapeutics, Inc.)

Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client or SBL as to be Non-Conforming Product, at the option of Client, SBL shall take use Commercially Reasonable Efforts to promptly re-Manufacture replacement Product (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client the quantity of the Product equivalent to the quantity of Non-Conforming Product as soon as possible and on a date to be mutually agreed by the Parties Parties, but no later [***] (as defined in the applicable PSA) for such Product, and such replacement Batch shall be invoiced and paid for as if it were the original Non-Conforming Product. If SBL does not confirm the nonthat such Product is Non-conformityConforming Product, the Parties shall refer to an independent and mutually agreed-on laboratory or firm with international repute to test the disputed Product. The costs of the independent laboratory will be borne shared by the Parties equally; provided, however, that to the extent either Party is determined to be incorrect as to whether a Product is a Non-Conforming Product, such Party will be responsible of the reasonable costs incurred for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, ’s test and the Party at fault shall must reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the reasonable costs incurred with respect to the independent laboratory’s test. The decision of the independent laboratory must be in writing and will be binding on the Parties. Section 5.9.2(a) (i) and (ii) shall apply to such replaced Product mutatis mutandis. Responsibility for the costs of such Non-Conforming Product shall be allocated between the Parties as if such Non-Conforming Product is a Batch Failure and Section 5.8.2 – 5.8.4 shall apply to such Non-Conforming Product mutatis mutandis. The remedies contained in this Section 5.9.2 shall be the sole and exclusive remedy of client for Client in the event of Non-Conforming Product.

Appears in 1 contract

Samples: Master Services Agreement (Immunomedics Inc)

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Non-Conforming. If, during the Acceptance Procedure, any Product is determined by Client or SBL * as Non-Conforming Product, at the option of Client, SBL * shall take Commercially Reasonable Efforts to promptly Manufacture replacement Product (except to the extent prohibited by cGMP or applicable QAG) and deliver to Client the quantity of the Product equivalent to the quantity of Non-Conforming Product on a date to be * Confidential material redacted and filed separately with the Commission. mutually agreed by the Parties and such replacement Batch shall be invoiced and paid for as if it were the original Non-Conforming Product. If SBL * does not confirm the non-conformity, the Parties shall refer to an independent and mutually agreed-on laboratory or firm with international repute to test the disputed Product. The costs of the independent laboratory will be borne by the Party responsible for the Batch Failure, as determined by the independent laboratory, whose written decision shall be binding on the Parties. If the independent laboratory is paid in advance of a final written determination, the Parties shall share equally such expense, and the Party at fault shall reimburse the other Party for its share of any such expenses paid after there has been a final written determination made by the independent laboratory. Section 5.9.2(a) (i) and (ii) shall apply to such replaced Product mutatis mutandis. Responsibility for the costs of such Non-Conforming Product shall be as if such Non-Conforming Product is a Batch Failure and Section 5.8.2 – 5.8.4 shall apply to such Non-Conforming Product mutatis mutandis. The remedies contained in this Section 5.9.2 shall be the sole and exclusive remedy of client for Non-Conforming Product.

Appears in 1 contract

Samples: Master Services Agreement (Tg Therapeutics, Inc.)

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