Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring Raw Materials as necessary to meet the Firm Commitment. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Palatin’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2. B. In certain instances, Palatin may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent. C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other products.
Appears in 3 contracts
Samples: Commercial Supply Agreement (Palatin Technologies Inc), Commercial Supply Agreement (Amag Pharmaceuticals, Inc.), Commercial Supply Agreement (Palatin Technologies Inc)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause Section 4.2.
B. In certain instances, Palatin Client may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an eventevent occurring after the Effective Date, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who specifically required to be used upon written instruction from Client, which Vendor has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by obligations. Such Raw Material shall be the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture property of other productsClient upon payment therefor.
Appears in 1 contract
Samples: Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)
Raw Materials. A. Catalent 7.1 PURCHASE OF RAW MATERIALS. Except for the Bulk API which will be supplied to Manufacturer by Santarus, Manufacturer shall procure purchase all packaging components (including labels, product inserts and other labeling for the Finished Product), raw materials and other ingredients for the manufacture of the Finished Product (collectively, “RAW MATERIALS”). Any obligation that Santarus may have under this Agreement to purchase or reimburse Manufacturer for expired or obsolete Raw Materials only from vendors that are approved shall in writing by Palatin or otherwise qualified no event extend beyond a [***] month supply of such Raw Materials based on the most recent Forecast. Manufacturer shall utilize and manufacture all Raw Materials and Bulk API on a first-in, first-out basis.
7.2 STORAGE OF BULK API AND RAW MATERIALS. Manufacturer shall store the Bulk API and Raw Materials at Manufacturer’s storage facility at the Facility with due care and attention to the requirements set forth in the Specifications and in accordance with GMP and *** Certain information on this page has been omitted and filed separately with the provisions of Commission. Confidential treatment has been requested with respect to the Quality Agreementomitted portions. Catalent shall be responsible for procuring Applicable Laws so as to protect such materials from loss or damage. While the Bulk API and the Raw Materials as necessary are in storage, Manufacturer shall assume the risk of loss or damage to meet such materials from any cause whatsoever. Manufacturer shall ensure that, while such Bulk API is in storage, such materials do not become subject to any lien or other security interest securing any obligation owed or alleged to be owed by Manufacturer to any person or entity.
7.3 SANTARUS’ RESPONSIBILITY FOR COST OF RAW MATERIALS. If Raw Materials become obsolete or otherwise no longer useable in the Firm Commitment. Catalent manufacturing process for the Finished Product because (a) Santarus deviated from the Forecast, or (b) the Specifications have been changed pursuant to Section 3.6, Manufacturer shall not be liable for any delay in delivery use its commercially reasonable efforts to cover the cost of Product if excess Raw Materials by: (i) Catalent returning such Raw Materials to the vendor, (ii) selling such Raw Materials, (iii) utilizing such Raw Materials in manufacturing products for its other customers to the extent possible, and (iv) implementing other measures to mitigate the loss due to such excess Raw Materials. To the extent that Manufacturer is unable to obtainoff-set such loss fully, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders Santarus shall reimburse Manufacturer for such Raw Materials promptly following receipt of Palatin’s Firm Commitment. In but solely to the extent actually incurred by Manufacturer and in no event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate limit of liability set forth in good faith an appropriate amendment to this Agreement, including Clause 4.2Section 7.1.
B. In certain instances, Palatin may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other products.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (Salix Pharmaceuticals LTD)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause Section 4.2.
B. In certain instances, Palatin Client may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an eventevent occurring after the Effective Date, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who specifically required to be used upon written instruction from Client, which Vendor has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by obligations. Such Raw Material shall be the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture property of other products.Client upon payment therefor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. EXECUTION VERSION
Appears in 1 contract
Samples: Softgel Commercial Supply Agreement
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. The Unit Price set forth on Attachment C, incorporates the cost of all Catalent-supplied Raw Materials. Catalent shall not be liable for any delay in delivery of Product if all of the following are true: (i) such delivery delay is caused by Catalent is being unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and or Packaging, (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment, and (iii) Catalent’s inability to obtain such Raw Material in a timely manner was the result of circumstances outside Catalent’s reasonable control. At all times during the first Contract Year, Catalent shall establish and maintain a stock of Raw Materials sufficient to meet *** percent (***%) of the Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time times beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2Section 4.1. Catalent shall use commercially reasonable efforts to promptly notify Client in the event that an impairment to Catalent’s credit or any other financial issue has, or is reasonably likely to have, a material negative impact on Catalent’s ability to purchase the Raw Materials in a timely manner.
B. In certain instancesobtaining Raw Materials hereunder, Palatin may require a Catalent shall only use those specific suppliersuppliers, manufacturer or vendor manufacturers, and/or vendors (“VendorVendors”) that have been approved by Client in advance. The approved Vendors as of the Effective Date are listed in the Specifications, and the parties agree to be used update the Specifications to reflect any additions or amendments to the list of Client-approved Vendors. Catalent shall use commercial reasonable efforts to procure the supply of all Raw Materials for Raw MaterialClient at the lowest prices reasonably available, consistent with and having regard to such matters as security and sources or supply, quality of product, volume requirements, and terms and conditions of supply. In such an event, (i) such Vendor Client will be identified in the Specifications and (ii) the Raw Materials from such responsible for all costs associated with qualification of any Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreementwho has not been previously qualified by Catalent. If Client requests Catalent to change a Vendor and the cost of the Raw Material from any such alternate Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendorsthe existing Vendor, Catalent shall add the difference between Catalent’s cost of the Raw Material and the alternate Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by If Client requests Catalent associated with qualification to change a Vendor and the cost of the Raw Material from any such alternate Vendor who has not been previously qualified by is lower than Catalent’s costs for the same raw material of equal quality from the existing Vendor, Catalent shall subtract the difference between Catalent’s cost of the Raw Material and the alternate Vendor’s cost of the Raw Material from the Unit Pricing.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin shall bear the cost of any unused All Raw Materials (including packaging)hereunder, so long as Catalent and Catalent’s use thereof in the Processing and Packaging, shall comply with: (a) purchased the specifications applicable thereto as reasonably determined by Client and as set forth in the Specifications, current batch records, and/or other appropriate documentation (provided that such Raw Materials in quantities consistent with Palatinspecifications may only be amended upon Client’s then current Firm Commitment and any minimum purchase obligations required by the vendor and prior written approval); (b) used commercially reasonable efforts to mitigate all Applicable Laws, the Quality Agreement, and all applicable Regulatory Approvals; and (c) the use, re-test, or expiration date, as applicable, of such costs by using any such unused Raw Materials Materials, if applicable, in accordance with the manufacture recommendations of other productsthe manufacturers or vendors thereof.
Appears in 1 contract
Samples: Commercial Manufacturing and Packaging Agreement (Vivus Inc)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring Raw Materials as necessary to meet the Firm Commitment. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2.
B. Catalent shall exercise control over its supply chain and shall audit its own suppliers according to Catalent’s supplier qualification processes. In certain instances, Palatin Client may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other productsobligations.
Appears in 1 contract
Samples: Commercial Supply Agreement (Minerva Neurosciences, Inc.)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed by the parties in writing, and, without limiting the foregoing, shall order and hold sufficient capsules and such other Raw Materials as may be agreed by the parties (collectively, the “Safety Stock”). Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause Section 4.2. Client shall bear the risk of loss of such Safety Stock in accordance with Section 3.2(C) as long as Catalent has ordered such Safety Stock in accordance with the Rolling Forecast.
B. In certain instances, Palatin may require If Client requires a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, then (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of the other Sections of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing, unless Client directly pays the Vendor the cost thereof. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who that has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging)) unusable for Processing or Product and unused by Catalent for another customer, so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by the vendor obligations, and (b) used commercially reasonable efforts to mitigate such costs by using any at Client’s election, Catalent shall promptly ship such unused Raw Materials in the manufacture of other productsto Client at Client’s cost.
Appears in 1 contract
Samples: Commercial Supply Agreement (Acadia Pharmaceuticals Inc)
Raw Materials. A. Catalent 7.01 Except for specific raw materials which will be purchased by Ethyl which are listed on Exhibit C attached hereto, all raw materials, chemicals and other materials used to produce MMT (“Raw Materials”) will be provided by Albemarle in such quantities as will enable Albemarle to sustain a production rate of MMT to meet Ethyl’s requirements. All Raw Materials, whether purchased by Ethyl or Albemarle, shall procure meet Ethyls Raw Materials only specifications in effect prior to the Closing Date as modified by mutual agreement. Should Ethyl decide to purchase Raw Materials not included on Exhibit C. Ethyl shall provide Albemarle not less than ninety (90) days prior written notice of its intention to purchase such Raw Materials, and such Raw Materials shall be added to Exhibit C and will thereafter be purchased by Ethyl. Once Ethyl has elected to add a Raw Material to Exhibit C, Ethyl may not thereafter remove a Raw Material from vendors Exhibit C (and require Albemarle to supply the Raw Material) without Albemarle’s prior written consent. If in electing to add a Raw Material to Exhibit C, Albemarle is required to cancel or terminate any contract for the supply of such Raw Materials, Albemarle shall notify Ethyl within said ninety (90) day period and Ethyl shall reimburse Albemarle for such costs directly resulting from such cancellation or termination, provided, however, that are approved unless Ethyl has previously agreed to Albemarle entering into such contract, Ethyl’s liability for cancellation or termination costs will be limited to those cancellation and termination costs which would be applicable if the contract in writing question was no longer than one (1) year in duration and requires the purchase of no more than [ *** ] ([ *** ]%) percent of Ethyl’s annual requirements for such Raw Materials. For purposes of this Agreement, all contracts for Raw Materials in effect on the Closing Date, have been agreed to by Palatin or otherwise qualified in accordance with Ethyl for the provisions term of the Quality Agreementcontracts without renewals or extensions. Catalent All remaining inventory of Raw Materials dedicated to the performance of this Agreement purchased by Albemarle prior to the effective date of Ethyl’s decision to purchase Raw Materials shall be responsible used by Albemarle to make MMT for procuring Ethyl and the cost of these Raw Materials shall be a Reimbursable Cost until such inventory is depleted. Should Albemarle at any time desire to purchase from Ethyl certain of the Raw Materials listed on Exhibit C (as necessary may be amended) for its own use, it will provide Ethyl no less than ninety (90) days written notice of its intent to meet purchase such Raw Materials. Ethyl agrees, subject to the Firm Commitment. Catalent shall not be liable for any delay in delivery terms of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders its supply contracts for such Raw Materials promptly following receipt and product availability in excess of PalatinEthyl’s Firm Commitmentrequirements, to sell such Raw Materials to Albemarle under its standard terms and conditions of sale. In The price for such Raw Materials shall be Ethyl’s cost. Should Albemarle terminate purchasing of such Raw Materials from Ethyl, Ethyl shall have no further obligation to supply such materials during the event that any term of this Agreement. Should Ethyl terminate this Agreement pursuant to Section 3.01, Ethyl’s obligation to supply Raw Material becomes subject Materials to purchase lead time beyond the Firm Commitment time frameAlbemarle shall also terminate. Promptly after notice of Ethyl’s termination is received by Albemarle, the parties will negotiate in enter good faith an appropriate amendment negotiations to this Agreement, including Clause 4.2.
B. In certain instances, Palatin may require evaluate alternatives to provide Albemarle with a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) source of the Raw Materials previously purchased from Ethyl. In administering the above Raw Material purchase provisions, Albemarle and Ethyl shall at all time use their good faith reasonable efforts, consistent with applicable law, to minimize the effect of Raw Materials purchases and changes therein on both Albemarle and Ethyl and to minimize Raw Material purchase cost to both Albemarle and Ethyl.
7.02 Albemarle will maintain proper inventory level records of each Raw Material used to manufacture MMT as well as the production of MMT and update such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. records on a monthly basis and correct the inventories each quarter by actual physical count.
7.03 If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any parties disagree on recorded or reported Raw Material or (iii) termination or expiry of this AgreementMMT inventories, Palatin the parties shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially use their reasonable efforts to mitigate such costs by using resolve promptly any such unused Raw Materials disagreement. Corrections to the accounting records required by such resolution shall be made in the manufacture of other productsfollowing month so as not to delay monthly closings.
Appears in 1 contract
Samples: Supply Agreement (Ethyl Corp)
Raw Materials. A. Catalent 7.01 Except for specific raw materials which will be purchased by Ethyl which are listed on Exhibit C attached hereto, all raw materials, chemicals and other materials used to produce MMT ("Raw Materials") will be provided by Albemarle in such quantities as will enable Albemarle to sustain a production rate of MMT to meet Ethyl's requirements. All Raw Materials, whether purchased by Ethyl or Albemarle, shall procure meet Ethyls Raw Materials only specifications in effect prior to the Closing Date as modified by mutual agreement. Should Ethyl decide to purchase Raw Materials not included on Exhibit C. Ethyl shall provide Albemarle not less than ninety (90) days prior written notice of its intention to purchase such Raw Materials, and such Raw Materials shall be added to Exhibit C and will thereafter be purchased by Ethyl. Once Ethyl has elected to add a Raw Material to Exhibit C, Ethyl may not thereafter remove a Raw Material from vendors Exhibit C (and require Albemarle to supply the Raw Material) without Albemarle's prior written consent. If in electing to add a Raw Material to Exhibit C, Albemarle is required to cancel or terminate any contract for the supply of such Raw Materials, Albemarle shall notify Ethyl within said ninety (90) day period and Ethyl shall reimburse Albemarle for such costs directly resulting from such cancellation or termination, provided, however, that are approved unless Ethyl has previously agreed to Albemarle entering into such contract, Ethyl's liability for cancellation or termination costs will be limited to those cancellation and termination costs which would be applicable if the contract in writing question was no longer than one (1) year in duration and requires the purchase of no more than [REDACTED] ([REDACTED] %) percent of Ethyl's annual requirements for such Raw Materials. For purposes of this Agreement, all contracts for Raw Materials in effect on the Closing Date, have been agreed to by Palatin or otherwise qualified in accordance with Ethyl for the provisions term of the Quality Agreementcontracts without renewals or extensions. Catalent All remaining inventory of Raw Materials dedicated to the performance of this Agreement purchased by Albemarle prior to the effective date of Ethyl's decision to purchase Raw Materials shall be responsible used by Albemarle to make MMT for procuring Ethyl and the cost of these Raw Materials shall be a Reimbursable Cost until such inventory is depleted. Should Albemarle at any time desire to purchase from Ethyl certain of the Raw Materials listed on Exhibit C (as necessary may be amended) for its own use, it will provide Ethyl no less than ninety (90) days written notice of its intent to meet purchase such Raw Materials. Ethyl agrees, subject to the Firm Commitment. Catalent shall not be liable for any delay in delivery terms of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders its supply contracts for such Raw Materials promptly following receipt and product availability in excess of Palatin’s Firm CommitmentEthyl's requirements, to sell such Raw Materials to Albemarle under its standard terms and conditions of sale. In The price for such Raw Materials shall be Ethyl's cost. Should Albemarle terminate purchasing of such Raw Materials from Ethyl, Ethyl shall have no further obligation to supply such materials during the event that any term of this Agreement. Should Ethyl terminate this Agreement pursuant to Section 3.01, Ethyl's obligation to supply Raw Material becomes subject Materials to purchase lead time beyond the Firm Commitment time frameAlbemarle shall also terminate. Promptly after notice of Ethyl's termination is received by Albemarle, the parties will negotiate in enter good faith an appropriate amendment negotiations to this Agreement, including Clause 4.2.
B. In certain instances, Palatin may require evaluate alternatives to provide Albemarle with a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, (i) such Vendor will be identified in the Specifications and (ii) source of the Raw Materials previously purchased from Ethyl. In administering the above Raw Material purchase provisions, Albemarle and Ethyl shall at all time use their good faith reasonable efforts, consistent with applicable law, to minimize the effect of Raw Materials purchases and changes therein on both Albemarle and Ethyl and to minimize Raw Material purchase cost to both Albemarle and Ethyl.
7.02 Albemarle will maintain proper inventory level records of each Raw Material used to manufacture MMT as well as the production of MMT and update such Vendor shall be deemed Palatin-supplied Materials for purposes of this Agreement. records on a monthly basis and correct the inventories each quarter by actual physical count.
7.03 If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any parties disagree on recorded or reported Raw Material or (iii) termination or expiry of this AgreementMMT inventories, Palatin the parties shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Firm Commitment and any minimum purchase obligations required by the vendor and (b) used commercially use their reasonable efforts to mitigate such costs by using resolve promptly any such unused Raw Materials disagreement. Corrections to the accounting records required by such resolution shall be made in the manufacture of other productsfollowing month so as not to delay monthly closings.
Appears in 1 contract
Samples: Supply Agreement (Ethyl Corp)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent X. Xxxxxxxx shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause 4.2.
B. In certain instances, Palatin may require If Client requires a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, then (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of the other Sections of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater or less than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add or reduce the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who that has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging)) unusable for Processing or Product and unused by Catalent for another customer, so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by obligations.
D. Catalent will charge Client for the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused purchase of Raw Materials in the manufacture of other productsat an amount equal to [***]. The parties agree to collaborate to achieve optimal material supply chain costs. In no event will Catalent mark up any Raw Materials more than [***].
Appears in 1 contract
Samples: Manufacturing Preparation and Commercial Supply Agreement (Avadel Pharmaceuticals PLC)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of PalatinClient’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause Section 4.2.
B. In certain instances, Palatin Client may require a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an eventevent occurring after the Effective Date, (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinClient-supplied Materials for purposes of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Client will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who specifically required to be used upon written instruction from Client, which Vendor has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent (a) purchased such Raw Materials in quantities consistent with PalatinClient’s then current most recent Firm Commitment and any the vendor’s minimum purchase obligations required by obligations. Such Raw Material shall be the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture property of other products.Client upon payment therefor. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS ARE DESIGNATED AS [***]. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.EXECUTION VERSION
Appears in 1 contract
Samples: Softgel Commercial Supply Agreement (TherapeuticsMD, Inc.)
Raw Materials. A. Catalent shall procure Raw Materials only from vendors that are approved in writing by Palatin or otherwise qualified in accordance with the provisions of the Quality Agreement. Catalent shall be responsible for procuring procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed by the parties in writing. Catalent shall not be liable for any delay in delivery of Product if (i) Catalent is unable to obtain, [**] = CERTAIN CONFIDENTIAL INFORMATION OMITTED in a timely manner, a particular Raw Material necessary for Processing and (ii) Catalent placed orders for such Raw Materials promptly following receipt of Palatin’s Supernus’ Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in good faith an appropriate amendment to this Agreement, including Clause to Section 4.2.
B. In certain instances, Palatin may require If Supernus requires a specific supplier, manufacturer or vendor (“Vendor”) to be used for Raw Material. In such an event, then (i) such Vendor will be identified in the Specifications and (ii) the Raw Materials from such Vendor shall be deemed PalatinSupernus-supplied Materials for purposes of the other Sections of this Agreement. If the cost of the Raw Material from any such Vendor (other than a Vendor specified in the Specifications as of the Effective Date) is greater than [**] Catalent’s costs for the same raw material of equal quality from other vendors, Catalent shall add the difference [**] between Catalent’s cost of the Raw Material and the Vendor’s cost of the Raw Material to the Unit Pricing. Palatin Supernus will be responsible for all reasonable, out-of-pocket costs incurred by Catalent associated with qualification of any such Vendor who that has not been previously qualified by Catalent.
C. In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiry expiration of this Agreement, Palatin Supernus shall bear the cost of any unused Raw Materials (including packaging)) unusable for Processing or Product and unused by Catalent for another customer, so long as Catalent (a) purchased such Raw Materials in quantities consistent with Palatin’s then current Supernus’ most recent Firm Commitment and any the vendor’s minimum purchase obligations required by the vendor and (b) used commercially reasonable efforts to mitigate such costs by using any such unused Raw Materials in the manufacture of other productsobligations.
Appears in 1 contract
Samples: Commercial Supply Agreement (Supernus Pharmaceuticals, Inc.)