Common use of Extraordinary Increases in Component Costs Clause in Contracts

Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b), changes materially greater than normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***]% of the cost for that Component upon which the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug Product increases by [***]% of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee adjustment request pursuant to this Section 4.3, Patheon shall deliver to the Client a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs 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. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. 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 relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by Client.

Appears in 2 contracts

Samples: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)

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Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b), changes materially greater than [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***]% ] of the cost for that Component upon which the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug Product increases by [***]% ] of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee adjustment request pursuant to this Section 4.3, Patheon shall deliver to the Client a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs 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. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. 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 relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by Client.

Appears in 2 contracts

Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)

Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b), changes materially greater than [***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***]% of the cost for that Component upon which the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug Product increases by [***]% of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee adjustment request pursuant to this Section 4.3, Patheon shall deliver to the Client a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs 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. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. 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 relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by Client.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.)

Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees fee for Manufacturing Services in respect of any affected Product to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b), changes materially greater than normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [[ **** ]% of the cost for that Component upon which the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug a Product increases by [[ **** ]% of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component costs Manufacturing Services fees have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee fee adjustment request pursuant to this Section 4.3, Patheon shall deliver to the Client a revised Schedule B or Schedule C A and such budgetary pricing information, adjusted Component costs 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 Patheon and its suppliers. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. From the date Patheon submits a written request fee for a price adjustment as per the terms described above, Patheon shall continue to perform the Manufacturing Services while the parties engage in negotiation respect of revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of the first day of relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by Clienteach affected Product.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Axcan Intermediate Holdings Inc.)

Extraordinary Increases in Component Costs. If If, at any time time, market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall will be entitled entitled, upon written approval from PGx, to request an adjustment to the Fees Price for any affected Product to compensate it Patheon for such demonstrated material the increased in Component costs. For the purposes of this Section 4.3(b), changes Changes materially greater than normal forecasted increases shall be considered to will have occurred if: (i) the cost of a Component increases by [***]% of the cost for that Component upon which the most recent fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug a Product increases by [***]% of the total Component costs for such Drug the Product upon which the most recent fee quote was based. To the extent that If Component costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for set out in (i) and (ii) above shall will operate based on the costs attributed to such Component (or last cost adjustment for the Components) at . Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee adjustment request Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. For a Price adjustment under this Section 4.3, Patheon shall will deliver to the Client PGx a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs or other documentation documents reasonably sufficient to demonstrate that a Fee Price adjustment is justified, provided that in order to support PGx approval. Patheon shall will have no obligation to provide deliver any supporting documents to the extent such documents that are subject to industry standard obligations of confidentiality between Patheon and its suppliers. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree The revised Price will be effective for any Product delivered on a revised Fee. 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 or after the first day of relevant Contract Year unless the Parties otherwise agree or month following PGx’s written approval of the date in which the written request is received by Client.revised Schedule B.

Appears in 1 contract

Samples: Commercial Manufacturing Services Agreement (Clinical Data Inc)

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Extraordinary Increases in Component Costs. If If, at any time time, market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increasesthe cost on which the current fee is based, then Patheon shall will be entitled to request an adjustment to the Fees Price for any affected Product to compensate it for such demonstrated material these increased in Component costs. For ; provided, however, that in no event shall Patheon be permitted to increase the purposes Price by an amount equal to […***…] percent ([…***…]%) or more of the current Price pursuant to this Section 4.3(b), changes 4.3. Changes materially greater than normal forecasted increases shall be considered to the cost on which the current fee is based will have occurred if: (i) the cost of a Component increases by [***]% of the cost for that Component upon which the most recent fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug a Product increases by [***]% of the total Component costs for such Drug the Product upon which the most recent fee quote was based. To the extent that If Component costs have been previously adjusted pursuant to Section 4.2(a) or this Section 4.3(b) to reflect an increase in the cost of one or more Components, the adjustments provided for set out in (i) and (ii) above shall will operate based on the costs attributed to such Component (or last cost adjustment for the Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with For a Fee Price adjustment request pursuant to under this Section 4.3, Patheon shall will deliver to the Client a revised Schedule B or Schedule C and such budgetary pricing information, adjusted Component costs or other documentation documents reasonably sufficient to demonstrate that a Fee Price adjustment is justified, provided that but Patheon shall will have no obligation to provide deliver any supporting documents to the extent such documents that are subject to obligations of confidentiality between Patheon and its suppliers. Upon delivery of such a However, at the Client’s request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. From the date Patheon submits a written request for a price adjustment as per the terms described above, Patheon shall continue allow an independent third party auditor to perform review the Manufacturing Services while information supporting the parties engage increase in negotiation of Component costs and confirm that such information reasonably demonstrates that the Price increase is justified. The revised Fees. Once a price adjustment has been agreed upon such adjustment shall apply retroactively to the later of Price will be effective for any Product delivered on or after the first day of relevant Contract Year unless the Parties otherwise agree or month following Client’s receipt of the date in which the written request is received by Client.revised Schedule B.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Optimer Pharmaceuticals Inc)

Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees fee in respect of any affected Product to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(b9.2(b), changes materially greater than normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***]10% of the cost for that Component upon which the fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug a Product increases by [***]5% of the total Component costs for such Drug Product upon which the fee quote was based. To the extent that Component costs fees have been previously adjusted pursuant to Section 4.2(a9.1(a) or this Section 4.3(b9.2(b) to * Redacted text has been omitted and filed separtely pursuant to a request for confidential treatment. reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee fee adjustment request pursuant to this Section 4.39.2, Patheon shall deliver to the Client a revised Schedule B or Schedule Exhibit C and such budgetary pricing information, adjusted Component costs 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 Patheon and its suppliers. Upon delivery of such a request, each of the Client and Patheon shall forthwith use all reasonable efforts to agree on a revised Feefee in respect of each affected Product. From Notwithstanding anything to the date Patheon submits a written request for a price adjustment as per the terms described abovecontrary in Sections 9.1 and 9.2 hereof, Patheon shall continue not be entitled 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 increase pursuant to Section 9.1(a) to the later extent that such price increase was reflected in a price increase already taken pursuant another provision of the first day of relevant Contract Year unless the Parties otherwise agree Section 9.1 or the date in which the written request is received by Client9.2.

Appears in 1 contract

Samples: Manufacturing and Supply Agreement (First Horizon Pharmaceutical Corp)

Extraordinary Increases in Component Costs. If at any time market conditions result in Patheon’s cost of Components being materially greater than normal forecasted increases, then Patheon shall be entitled to request an adjustment to the Fees Price in respect of any affected Product to compensate it for such demonstrated material increased in Component costs. For the purposes of this Section 4.3(bclause (b), changes materially greater than normal forecasted increases shall be considered to have occurred if: (i) the cost of a Component increases by [***]10% of the cost for that Component upon which the most recent fee quote was based; or (ii) the aggregate cost for all Components required to manufacture the Drug a Product increases by [***]5% of the total Component costs for such Drug Product upon which the most recent fee quote was based. To the extent that Component costs have been previously adjusted pursuant to clause (c) of Section 4.2(a) 4.2 or this Section 4.3(bclause (b) to reflect an increase in the cost of one or more Components, the adjustments provided for in (i) and (ii) above shall operate based on the costs attributed to such Component (or Components) at the time the last of such adjustments were made. In the event Component costs decrease so that they are less than the amount forecasted, such cost reductions shall be passed through to Client. In connection with a Fee Price adjustment request pursuant to this Section 4.3, Patheon shall deliver to the Client Éclat a revised Schedule B or Schedule C to the Product Agreement and such budgetary pricing information, adjusted Component costs 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. Upon delivery of such a requestrequired documents, each of the Client Éclat and Patheon shall forthwith use all reasonable efforts to agree on a revised Fee. From the date Patheon submits a written request Price 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 each affected Product and Schedule B to the later of the first day of relevant Contract Year unless the Parties otherwise agree or the date in which the written request is received by ClientProduct Agreement shall be amended accordingly.

Appears in 1 contract

Samples: Product Agreement (Avadel Pharmaceuticals PLC)

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