Pricing Basis. The Client acknowledges that the Fees in any Contract Year are quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Product specified in Schedule B or thereafter specified in the forecast provided pursuant to Section 4.2(b) for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume is not met. For greater certainty, if Patheon and the Client agree that the Minimum Run Quantity of the Drug Product shall be reduced whether as a result of a decrease in estimated annual volume or otherwise and, as a result of such reduction, Patheon’s Fees materially increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees by an amount sufficient to absorb such increase. In connection with a Fee adjustment pursuant to Section 4.2(a), Patheon shall deliver to the Client a revised Schedule B and a statement outlining the percentage increase in the PPI upon which such Fee adjustment is based. In connection with all Fee adjustment requests pursuant to this Section 4.2(b) and 4.2(c), Patheon shall deliver to the Client a revised Schedule B and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between Patheon and its suppliers. From the date Patheon submits a written request for a price adjustment as per the terms described above, Patheon shall continue to perform the Manufacturing Services while the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agree.
Appears in 5 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)
Pricing Basis. The Client Customer acknowledges that the Fees Price in respect of a Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug minimum run quantity per Product specified in Schedule B or thereafter specified in the forecast provided pursuant to Section 4.2(b) for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume is not met. B. For greater certainty, if Patheon and the Client Customer agree that the Minimum Run Quantity minimum run quantity in respect of the Drug a Product shall be reduced whether as a result of a decrease in estimated annual volume or otherwise and, as a result of such reductionincreased, Patheon’s Fees materially 's costs to perform the Manufacturing Services and acquire the Materials relating to such Product increase or decrease on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon Price shall be entitled to an increase in the Fees by an amount sufficient to absorb such increaseadjusted respectively. In connection with a Fee Price adjustment pursuant to clause (a) of this Section 4.2(a)4.2, Patheon shall deliver to Customer on or about the Client a revised Schedule B and final quarter of each Year, a statement outlining the percentage increase or decrease in the PPI official index of the industrial producer prices (manufacture of basic pharmaceutical products and pharmaceutical preparation) as determined by the Italian National Statistics Institute (ISTAT) upon which such Fee price adjustment is based. The adjusted prices shall be effective as of January 1st of the following [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. Year in which the adjustment is required. In connection with all Fee adjustment requests Price adjustments pursuant to clause (b) of this Section 4.2(b) and 4.2(c)4.2, Patheon shall deliver to Customer by not later than the Client end of November a revised Schedule B in draft form and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee Price adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between Patheon and its suppliers. From the date Patheon submits a written request for a price Upon delivery of such required Price adjustment as per the terms described abovedocumentation pursuant to clause (b) herein, each of Customer and Patheon shall continue forthwith use all reasonable efforts to perform agree on a revised Price for the Manufacturing Services while Products and Schedule B shall be amended accordingly. Such revised Price shall be effective with respect to any Product delivered after the parties engage in negotiation end of the then current Year. In the event that the Parties fail to reach an agreement on revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively pricing, either Party may terminate this agreement subject to the later provisions of Article 8.2 with [ * ] notice, provided that during such additional period the first day of Price shall remain the relevant Contract Year or same as before the date in which the written request is received by Client unless the Parties otherwise agreerevision process.
Appears in 1 contract
Pricing Basis. The Client acknowledges that the Fees fee for Manufacturing Services in respect of a Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Annual Volume per Product specified in Schedule B or thereafter specified in the forecast provided pursuant to clause (b) of this Section 4.2(b) 4.2 for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume changes or if the Annual Volume is not met. For greater certainty, if Patheon and the Client agree that the Minimum Run Quantity in respect of the Drug a Product shall be reduced whether as a result of a decrease in estimated annual volume Annual Volume or otherwise and, as a result of such reduction, Patheon’s Fees materially 's fees for services relating to such Product increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to to, and shall notify Client in writing of, an increase in the Fees fee for Manufacturing Services in respect of such Product by an amount sufficient to absorb such increase. In connection with a Fee fee adjustment pursuant to clause (a) of this Section 4.2(a)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and a statement outlining the percentage increase in the PPI US Consumer Price Index for All Urban Consumers upon which such Fee fee adjustment is based. In connection with all Fee fee adjustment requests pursuant to clauses (b) and (c) of this Section 4.2(b) and 4.2(c)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee fee adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between by Patheon and to its suppliers. From Upon delivery of such a request, each of the date Patheon submits a written request for a price adjustment as per the terms described above, Client and Patheon shall continue forthwith use all reasonable efforts to perform agree on a revised fee for the Manufacturing Services while in respect of each affected Product and Schedule B shall be amended accordingly. Such revised fee shall be effective with respect to any Product delivered after the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later end of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agreethen current Year.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc)
Pricing Basis. The Client Éclat acknowledges that the Fees Price in respect of a Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Annual Volume per Product specified in Schedule B to a Product Agreement or thereafter specified in the forecast provided pursuant to clause (b) of this Section 4.2(b) 4.2 for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume changes or if the Annual Volume is not met. For greater certainty, if Patheon and the Client Éclat agree that the Minimum Run Quantity in respect of the Drug a Product shall be reduced whether as a result of a decrease in estimated annual volume or otherwise and, as a result of such reduction, Patheon’s Fees materially costs to perform the Manufacturing Services and acquire the Materials relating to such Product increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees Price in respect of such Product by an amount sufficient to absorb such increasethose increases. In connection with a Fee Price adjustment pursuant to clause (a) of this Section 4.2(a)4.2, Patheon shall deliver to Éclat on or about the Client a revised Schedule B and first quarter of each Year, a statement outlining the percentage increase in the PPI Consumer Price Index upon which such Fee price adjustment is based. The adjusted prices shall be effective as of January 1st of the same Year in which the adjustment is required. In connection with all Fee adjustment requests Price adjustments pursuant to clause (b) of this Section 4.2(b) and 4.2(c)4.2, Patheon shall deliver to Éclat by not later than the Client end of October a revised Schedule B to the Product Agreement in draft form and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee Price adjustment is justified. Upon delivery of such required Price adjustment information pursuant to clause (b) herein, provided that each of Éclat and Patheon shall have no obligation forthwith use all reasonable efforts acting in good faith to provide any supporting documents agree on a revised Price for the Products and Schedule B to the extent such documents are subject Product Agreement shall be amended accordingly. Such revised Price shall be effective with respect to obligations any Product delivered after the end of confidentiality between Patheon and its suppliersthe then current Year. From the date Patheon submits In connection with, a written request for a price Price adjustment as per the terms described abovepursuant to clause (c) of this section 4.2, Patheon shall continue deliver to perform Éclat documentation demonstrating the Manufacturing Services while increase in the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agreeComponent Cost.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Avadel Pharmaceuticals PLC)
Pricing Basis. The Client acknowledges that the Fees fee for Manufacturing Services in respect of a Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Annual Volume per Product specified in Schedule B or thereafter specified in the forecast provided pursuant to clause (b) of this Section 4.2(b) 4.2 for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume changes or if the Annual Volume is not met. For greater certainty, if Patheon and the Client -9- <PAGE> agree that the Minimum Run Quantity in respect of the Drug a Product shall be reduced whether as a result of a decrease in estimated annual volume Annual Volume or otherwise and, as a result of such reduction, Patheon’s Fees materially 's fees for services relating to such Product increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees fee for Manufacturing Services in respect of such Product by an amount sufficient to absorb such increase. In connection with a Fee fee adjustment pursuant to clause (a) of this Section 4.2(a)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and a statement outlining the percentage increase in the PPI US Consumer Price Index for All Urban Consumers upon which such Fee fee adjustment is based. In connection with all Fee fee adjustment requests pursuant to clauses (b) and (c) of this Section 4.2(b) and 4.2(c)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee fee adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between by Patheon and to its suppliers. From Upon delivery of such a request, each of the date Patheon submits a written request for a price adjustment as per the terms described above, Client and Patheon shall continue forthwith use all reasonable efforts to perform agree on a revised fee for the Manufacturing Services while in respect of each affected Product and Schedule B shall be amended accordingly. Such revised fee shall be effective with respect to any Product delivered after the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later end of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agreethen current Year.
Appears in 1 contract
Samples: Manufacturing Services Agreement
Pricing Basis. The Client Gilead acknowledges that the Fees fee for the Processing in respect of a Drug Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the minimum order quantity per Drug Product specified in Schedule B or thereafter specified in the forecast provided pursuant to Section 4.2(b) Exhibit C of each Product-Specific Appendix for the Contract Year a given Drug Product and is subject to change as set forth above if the quantity ordered by Gilead in any Firm Order falls below the minimum order quantity for that Drug Product as specified Minimum Run Quantity and estimated annual volume is not metin Exhibit C of the applicable Product-Specific Appendix or, if applicable, any revised minimum order quantity hereinafter agreed to by the Parties in writing; provided that Gilead orders such Drug Product in the time period covered by such Firm Order. For greater certainty, if Patheon and the Client Gilead agree that the Minimum Run Quantity minimum order quantity in respect of the a Drug Product shall be reduced whether as a result of a decrease in estimated annual volume or otherwise and, as a result of such reduction, Patheon’s Fees materially costs relating to such Drug Product increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees fee for the Processing in respect of such Drug Product by an amount sufficient to absorb such increase. In addition, if Gilead will place orders for quantities permitting Patheon to manufacture in larger production runs, the Parties shall review the fee for the Processing of such Drug Product and shall reduce such fee on a per-unit basis by a reasonable amount to reflect savings in Patheon’s costs relating to such Drug Product as a result of such increase if any. In connection with a Fee fee adjustment request pursuant to this Section 4.2(a)4.4, Patheon shall deliver to the Client Gilead a revised Schedule B and a statement outlining the percentage increase in the PPI upon which Exhibit C for such Fee adjustment is based. In connection with all Fee adjustment requests pursuant to this Section 4.2(b) and 4.2(c), Patheon shall deliver to the Client a revised Schedule B Drug Product and such budgetary pricing information information, adjusted Material costs for such Drug Product or other documentation reasonably sufficient to demonstrate that a Fee fee adjustment is justifiedjustified for such Drug Product, provided that no later than [*] prior to the end of the Year. Upon receipt of such a request, each of Gilead and Patheon shall have no obligation forthwith use all reasonable efforts to provide any supporting documents to agree on a revised fee for the extent such documents are subject to obligations Processing in respect of confidentiality between Patheon and its suppliers. From the date Patheon submits a written request for a price adjustment as per the terms described above, Patheon shall continue to perform the Manufacturing Services while the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agreeeach affected Drug Product.
Appears in 1 contract
Samples: Master Clinical and Commercial Supply Agreement (Gilead Sciences Inc)
Pricing Basis. The Client acknowledges that the Fees fee for Manufacturing Services in respect of a Product in any Contract Year are is quoted based upon the Minimum Run Quantity and estimated annual volume for the Drug Annual Volume per Product specified in Schedule B or thereafter specified in the forecast provided pursuant to clause (b) of this Section 4.2(b) 4.2 for the Contract Year and is subject to change if the specified Minimum Run Quantity and estimated annual volume changes or if the Annual Volume is not met. For greater certainty, if Patheon and the Client agree that the Minimum Run Quantity in respect of the Drug a Product shall be reduced whether as a result of a decrease in estimated annual volume Annual Volume or otherwise and, as a result of such reduction, Patheon’s Fees materially 's fees for services relating to such Product increase on a per unit basis, then subject to the limitation set forth in 4.2(a) above Patheon shall be entitled to an increase in the Fees fee for Manufacturing Services in respect of such Product by an amount sufficient to absorb such increase. In connection with a Fee fee adjustment pursuant to clause (a) of this Section 4.2(a)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and a statement outlining the percentage increase in the PPI US Consumer Price Index for All Urban Consumers upon which such Fee fee adjustment is based. In connection with all Fee fee adjustment requests pursuant to clauses (b) and (c) of this Section 4.2(b) and 4.2(c)4.2, Patheon shall deliver to the Client by not later than November 1st of each Year a revised Schedule B in draft form and such budgetary pricing information or other documentation reasonably sufficient to demonstrate that a Fee fee adjustment is justified, provided that Patheon shall have no obligation to provide any supporting documents to the extent such documents are subject to obligations of confidentiality between by Patheon and to its suppliers. From Upon delivery of such a request, each of the date Patheon submits a written request for a price adjustment as per the terms described above, Client and Patheon shall continue forthwith use all reasonable efforts to perform agree on a revised fee for the Manufacturing Services while in respect of each affected Product and Schedule B shall be amended accordingly. Such revised fee shall be effective with respect to any Product delivered after the parties engage in negotiation of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later end of the first day of the relevant Contract Year or the date in which the written request is received by Client unless the Parties otherwise agreethen current Year.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Critical Therapeutics Inc)