Common use of Raw Materials Clause in Contracts

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, (2) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment and (3) such delay did not result, in whole or in part, from the negligence or willful misconduct of Catalent. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in the Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied Materials. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment.

Raw Materials. A. Catalent shall be responsible for sourcing and qualifying third-party suppliers of Raw Materials. Catalent shall also be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to to, meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1i) Catalent Catalent, exercising commercially reasonable efforts, is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, for Processing and (2ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’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 Sections 3.4 and (3) such delay did not result, in whole or in part, from the negligence or willful misconduct of Catalent4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in the Specifications, (ii) Client shall be responsible for the timeliness, quantity quantity, and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied Materials. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add notify Client in writing and provide Client with documentary evidence of the difference between Catalent’s same. If Client does not, within 20 business days of its receipt of such notice, designate a lower cost supplier identified in such notice, then Catalent shall [*]. If the documented cost of the Raw Material and from any supplier mandated by Client is less than Catalent’s documented cost for the Supplier’s cost same raw material of the Raw Material to the Unit Pricingequal quality from other suppliers, then Catalent shall [*]. Client [*] will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent[*]. In the case Catalent shall maintain an inventory of Raw Materials in respect of which Client requires a specific Supplier sufficient quantities to be usedable to supply up to [*] per dose strength that is included in the Firm Commitment portion of the most recent Client forecast. Notwithstanding anything to the contrary in this Section 3.2(B), Catalent a sole supplier of any Raw Material shall not be liable for any delay in delivery of Product if Catalent is unable to obtaindeemed a Supplier required by Client, in a timely manner, such particular nor shall the Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for supplied by such Raw Materials promptly following receipt of supplier be deemed Client’s Firm Commitment-supplied Materials.

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, for Processing and (2ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment and (3) such delay did not resulttime frame, the parties will negotiate in whole or in partgood faith an appropriate amendment to this Agreement, from the negligence or willful misconduct of Catalentincluding Section 4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“SupplierVendor”) to be used for a Raw Material. In such an event, (i) such Supplier Vendor will be identified in the Specifications, Specifications and (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier Vendor shall be deemed, deemed Client-supplied Materials for purposes of liability hereunder, Client-supplied Materialsthis Agreement. If the cost of the Raw Material from any such Supplier Vendor is greater than Catalent’s costs for the same raw material of equal quality from other suppliersvendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the SupplierVendor’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who Vendor that has not been previously qualified by Catalent. . C. In the case event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiration of this Agreement, 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 purchased such Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of quantities consistent with Client’s most recent Firm CommitmentCommitment and the vendor’s minimum purchase obligations.

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, Commitment unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1i) Catalent is unable unable, despite using reasonable efforts, to obtain, in a timely manner, a particular Raw Material necessary for Processing of such Product; (ii) due to Process or Package the Productreasons outside of Catalent’s reasonable control, (2) provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment Commitment; and (3iii) such delay did not resultClient-requested label changes result in lead time delay. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame, the parties will negotiate in whole or in parta commercially reasonable manner an appropriate amendment to this Agreement, from the negligence or willful misconduct of Catalentincluding Section 4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“SupplierVendor”) to be used for a Raw Material. In such an event, (i) such Supplier Vendor will be identified in the Specifications, Specifications and (ii) Client shall be responsible if such Vendor has not previously been qualified by Catalent for the timeliness, quantity and quality of supply of the specified Raw Materials from such SupplierMaterial, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier Vendor shall be deemed, deemed Client-supplied Materials for purposes of liability hereunderthis Agreement; provided, Client-supplied Materialshowever, Catalent shall remain responsible for procuring, inspecting and releasing such Raw Material as described in Section 3.2(A), unless otherwise agreed to by the parties in writing. If the cost (as pre-approved in writing by Client) of the Raw Material from any such Supplier Vendor is greater than Catalent’s costs for the same raw material Raw Material of equal quality from other suppliersvendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the SupplierVendor’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs (as pre-approved in writing by Client) associated with qualification of any such Supplier Vendor who has not been previously qualified by Catalent. . C. In the case event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiration of this Agreement, for any reason other than by Client pursuant to Section 16.2(A) or (B), Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent purchased such Raw Materials in respect of which Client requires a specific Supplier to be used, quantities consistent with Client’s most recent Firm Commitment and the vendor’s minimum purchase obligations and Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for delivers such Raw Materials promptly following receipt of to Client or Client’s Firm Commitmentdesignee.

Raw Materials. A. Catalent (a) On a Product-by-Product, Purchase Order-by-Purchase Order and/or SOW-by-SOW basis, HMI shall provide to Supplier certain HMI Raw Materials that are necessary for the Manufacture of Products or the performance of Services. In the event where HMI specifies in a Purchase Order or an SOW that a Product shall be made or that certain Services shall be performed using certain HMI Raw Materials (as applicable), HMI will deliver the amount of HMI Raw Materials that is reasonably expected to be necessary for the initiation of such Purchase Order or SOW at least (a) [***] before the expected production start date for the relevant Product Batch or (b) [***] before the expected start date for the relevant Services, and HMI shall further deliver any remaining amount of the HMI Raw Materials that is necessary for the completion of such Purchase Order (including in connection with any replacement of Products in accordance with the terms hereof) or such SOW. HMI shall be responsible for procuringsourcing and qualifying the suppliers for all HMI Raw Materials, inspecting and releasing adequate HMI will provide Supplier with access to written confirmation of release for each item of the HMI Raw Materials, and upon Supplier’s request in writing, [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item (601)(b)(10). Such excluded information is both (i) not material and (ii) the type that the Registrant treats as private or confidential. Certificates of Analysis if applicable. [***]. Supplier may not use the HMI Raw Materials as necessary for any purpose other than to meet the Firm Commitment, unless otherwise agreed Manufacture Products and to by the parties in writing. Unless a particular Raw Material can be replaced with the same perform Services for HMI. (b) Any raw material from another supplier, Catalent shall not be liable necessary for any delay in delivery the Manufacture of Product or Packaged Product if (1) Catalent the performance of Services that is unable not provided by HMI to obtain, in a timely manner, a particular Supplier as HMI Raw Material is the responsibility of Supplier. Unless otherwise specified herein, all Supplier-sourced materials and consumables shall be [***]. It is acknowledged that pursuant to the Contribution Agreement, HMI shall have contributed certain assets, including certain raw materials necessary to Process or Package for the Manufacture of Product, to Supplier at or prior to the Effective Date. With respect to up to [***] Batches (2i.e., [***]) Catalent placed orders of Drug Substance of Named HMI Product(s) supplied hereunder, if the raw materials contributed by HMI under the Contribution Agreement are of sufficient quantity and suitable for the Manufacture of such Batches of Drug Substance of Named HMI Products, [***]. For purposes of this Section 3.4(b), raw materials are “suitable” if as of the time of initiation of the Manufacture of the applicable Batch of Drug Substance, such raw materials conform in all material respects to the applicable specifications and quality standards for each item of such raw materials set forth in the Quality Agreement (as applicable), and with cGMP. For clarity, for any subsequent Batches of Drug Substance after [***], (i.e., [***]) supplied hereunder, [***] in accordance with Section 5.1 regardless of Supplier’s utilization of any amount of suitable raw materials or other assets contributed to Supplier pursuant to the Contribution Agreement. (c) All HMI Raw Materials promptly following receipt of Client’s Firm Commitment and (3) such delay did not result, in whole or in part, from the negligence or willful misconduct of Catalentwill be provided [***] to Supplier. B. In certain instances(d) For clarity, Client the Drug Substance Batch Price and the Filling Price shall exclude [***]. (e) It is understood and agreed that Supplier-sourced materials may require a specific supplier, manufacturer longer time period to acquire or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier procure the supply thereof and accordingly will be identified purchased by Supplier based on the applicable [***] Forecast; and in the Specifications, (ii) Client shall be responsible for event the timeliness, quantity and quality number of supply Batches of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations any Drug Substance or Drug Product set forth in Section 3.2Aa Binding Forecast is lower than the number of Batches for such Drug Substance or Drug Product set forth in the applicable [***] Forecast that was first submitted by HMI for the applicable period, (iii) Catalent HMI shall not be liable reimburse Supplier for any defects in Raw Materials or in Packaging or Packaged Product as a result the non-cancellable portion of the Supplier-Sourced Material [***] directly attributable to such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such deviation; provided that Supplier shall be deemed, use its commercially reasonable efforts to utilize or store for purposes of liability hereunder, Client-supplied Materials. If later use the cost excessive portion of the Raw Material from any Supplier-sourced materials to mitigate such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm CommitmentHMI.

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material 5 ***Confidential Treatment Requested from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, (2) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment and (3) such delay did not result, in whole or in part, from the negligence or willful misconduct of Catalent. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in the Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied Materials. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment.

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, for Processing and; (2ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment Commitment; and (3iii) with respect to obtaining such delay did not resultRaw Materials necessary for Processing, Catalent’s planning therefore was commercially reasonable and in whole or accordance with industry standards based on Client’s Rolling Forecast and Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment time frame through no fault of either party, Catalent will notify Client in partwriting, from [ * ], the negligence or willful misconduct of Catalentparties will negotiate in good faith an appropriate amendment to this Agreement. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in the Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject Supplier so long as any delay in the delivery of Product to Client does not arise from Catalent’s compliance with failure to performs its obligations set forth in Section 3.2A3.2.A. above, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless such defect is caused by Catalent or Catalent failed to properly perform any testing required by the Specifications, and (iv) [ * ] = Certain information on this document has been redacted and filed separately with the Raw Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied MaterialsSecurities and Exchange Commission. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material Confidential treatment has been requested with respect to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitmentomitted portions.

Raw Materials. A. Catalent shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Product if (1i) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, for Processing and (2ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s 's Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment and (3) such delay did not resulttime frame, the parties will negotiate in whole or in parta commercially reasonable manner an appropriate amendment to this Agreement, from the negligence or willful misconduct of Catalentincluding Section 4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”"Vendor") to be used for a Raw Material. In such an event, (i) such Supplier Vendor will be identified in the Specifications, Specifications and (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier Vendor shall be deemed, deemed Client-supplied Materials for purposes of liability hereunder, Client-supplied Materialsthis Agreement. If the cost of the Raw Material from any such Supplier Vendor is greater than Catalent’s 's costs for the same raw material of equal quality from other suppliersvendors, Catalent shall add the difference between Catalent’s 's cost of the Raw Material and the Supplier’s Vendor's cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier Vendor who has not been previously qualified by Catalent. . C. In the case event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) termination or expiration of this Agreement, Client shall bear the cost of any unused Raw Materials (including packaging), so long as Catalent purchased such Raw Materials in respect of which Client requires quantities consistent with Client's most recent Firm Commitment and the vendor's minimum purchase obligations. D. The parties will work together to implement a specific Supplier safety stock procurement and supply strategy for excipients to be used, Catalent shall not be liable for any delay agreed upon in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitmentseparate written quotation.

Raw Materials. A. Catalent Fleet shall be responsible for procuring, inspecting and releasing adequate ordering [***] Raw Materials other than [***] and the [***] (which shall be provided by Columbia), as necessary required to support Fleet’s obligations under this Agreement. All right, title and interest in and to the Raw Materials provided by Columbia (including but not limited to the [***] and the [***]) shall remain with Columbia at all times. Fleet shall ensure that all Raw Materials are released for use at least [***] prior to their use in manufacturing the Product. Fleet shall maintain sufficient stocks of Raw Materials to meet the Firm Commitmentits manufacturing and supply obligations to, unless otherwise agreed to by the parties and as set out in writing. Unless any Production Schedule by, Columbia; provided however that Fleet shall have a particular Raw Material can be replaced retest date in accordance with the same raw material from another relevant supplier’s written instructions (or where none, Catalent Fleet’s SOPs, which Fleet shall provide to Columbia upon request) for Raw Materials. Raw Materials shall not be liable for any delay in delivery of Product or Packaged Product if (1) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package used beyond their expiration date as provided by the Product, (2) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment and (3) such delay did not result, in whole or in part, from the negligence or willful misconduct of Catalentsupplier. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”) to be used for a Raw Material. In such an event, (i) such Supplier will [***] costs of Raw Materials shall be identified included in the Specifications, (ii) Client Purchase Price. Fleet shall be responsible for the timeliness, quantity and quality of supply [***] of Raw Materials from hereunder which Fleet supplies. For the avoidance of doubt, Columbia shall be responsible for all such Supplier, subject costs only in respect of [***] and [***] provided by Columbia to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent Fleet. Fleet shall not be liable for use any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required purchased directly by the Specifications, and (iv) the Raw Materials from such Supplier shall be deemed, for purposes of liability hereunder, Client-supplied Materials. If the cost of the Raw Material from any such Supplier is greater than Catalent’s costs Columbia except for the same raw material manufacture of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit PricingProduct hereunder. Client Columbia will be responsible for all retesting costs associated with qualification the Raw Materials supplied by Columbia. (ii) Fleet shall notify Columbia of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect that do not meet the specifications of which Client requires a specific Supplier to the Raw Materials, and shall provide Columbia with full details within twenty-four (24) hours of completion of the investigation, but not more than twenty (20) business days from identification of the non-conformity with the specifications. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. 6. A new Section 2.3 (n) shall be used, Catalent shall not be liable for any delay in delivery of Product if Catalent is unable to obtain, in a timely manner, such particular Raw Material necessary to Manufacture or Package inserted into the Product, provided that Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment.Existing Agreement as follows:

Raw Materials. A. Catalent shall on behalf of Client at Client’s expense be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties Parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery of Product or Packaged Client Product if (1i) Catalent is unable to obtain, in a timely manner, using commercially reasonable efforts, a particular Raw Material necessary to Process or Package the Product, for Processing and (2ii) Catalent placed orders for such Raw Materials promptly following receipt of Client’s Firm Commitment. Client acknowledges that Catalent will rely upon the Rolling Forecast to purchase long lead time materials needed for Processing in accordance with the Firm Commitment. In the event that any Raw Material becomes subject to purchase lead time beyond the Firm Commitment and (3) such delay did not resulttime frame, the Parties will negotiate in whole or in partgood faith an appropriate amendment to this Agreement, from the negligence or willful misconduct of Catalentincluding Section 4.2. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“SupplierVendor”) to be used for supply of a Raw Material. In such an event, (i) such Supplier Vendor will be identified in the Specifications, Specifications and (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials from such Supplier, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier Vendor shall be deemed, deemed Client-supplied Materials for purposes of liability hereunder, Client-supplied Materialsthis Agreement. If the cost of the Raw Material from any such Supplier Vendor is greater than Catalent’s costs for the same raw material of equal quality and quantity from other suppliersvendors, Catalent shall add the difference between Catalent’s cost of the Raw Material and the SupplierVendor’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier Vendor who has not been previously qualified by Catalent. . C. In the case event of (i) a Specification change for any reason, or (ii) obsolescence of any Raw Materials, Client shall bear the cost of any unused Raw Materials (including but not limited to packaging and labels), so long as Catalent purchased such Raw Materials in respect of which Client requires a specific Supplier to be usedaccordance with this Agreement, Catalent shall not be liable for any delay and in delivery of Product if Catalent is unable to obtain, in a timely manner, quantities consistent with Client’s Rolling Forecast and most recent Firm Commitment and the vendor’s minimum purchase obligations. All such particular Raw Material necessary to Manufacture or Package the Product, provided that Catalent placed orders for such unused Raw Materials promptly following receipt of paid for by Client shall be delivered to Client’s Firm Commitment.

Raw Materials. A. Catalent shall be responsible for procuring(a) Reasonable quantities of unique components or raw materials, inspecting and releasing adequate Raw Materials as necessary to meet including the Firm CommitmentCompound, unless otherwise agreed to by that are used in the parties in writing. Unless a particular Raw Material can be replaced with the same raw material from another supplier, Catalent shall not be liable for any delay in delivery manufacture of Product or Packaged Product if (1) Catalent is unable to obtain, in a timely manner, a particular Raw Material necessary to Process or Package the Product, shall be purchased or manufactured by Lilly, at its own cost and expense, for use in supplying United Therapeutics’ requirements for the Product under this Agreement based on the Forecast. If United Therapeutics’ change to the quantities of the Product previously forecasted for a calendar month in a Forecast causes any material obsolescence of any quantities of the Product, or any such components or materials purchased by Lilly and allocated for the supply of such Product to United Therapeutics hereunder, and such components or materials cannot reasonably be used by Lilly in the manufacture of other products, United Therapeutics shall bear the reasonable and direct costs and expenses actually incurred by the Parties associated with such change (2including any costs related to returning such components or material to the vendor or otherwise disposing thereof). Lilly shall not make any claim under this Section 7.4(a) Catalent placed orders for such Raw Materials promptly following receipt costs and expenses until such costs and expenses exceed twenty-five thousand Dollars ($25,000) in the aggregate in any Calendar Quarter. Lilly shall keep United Therapeutics reasonably advised as to the quantities of Client’s Firm Commitment and (3) such delay did not result, excess unique components or materials used in whole or in part, from the negligence or willful misconduct manufacture of Catalentthe Product that are purchased by Lilly. B. In certain instances, Client may require a specific supplier, manufacturer or vendor (“Supplier”b) to be used for a Raw Material. In such an event, (i) such Supplier will be identified in If the Specifications, (ii) Client shall be responsible for the timeliness, quantity and quality of available supply of Raw Materials from such Supplierthe Compound or other inputs to the Product, subject to Catalent’s compliance with its obligations set forth in Section 3.2A, (iii) Catalent shall not be liable for any defects in Raw Materials or in Packaging or Packaged Product as a result of such defective Raw Materials from such Supplier, or in Product or Packaged Product as a result of such defective Raw Materials, unless Catalent failed to properly perform any testing required by the Specifications, and (iv) the Raw Materials from such Supplier shall be deemedincluding production time, for purposes of liability hereunder, Client-supplied Materials. If manufacturing the cost of the Raw Material from any Product is in short supply such Supplier is greater than Catalent’s costs for the same raw material of equal quality from other suppliers, Catalent shall add the difference between Catalent’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Unit Pricing. Client will be responsible for all costs associated with qualification of any such Supplier who has not been previously qualified by Catalent. In the case of Raw Materials in respect of which Client requires a specific Supplier to be used, Catalent shall not be liable for any delay in delivery of Product if Catalent that Lilly is unable to obtainfulfill completely United Therapeutics’ outstanding Purchase Orders, Lilly shall allocate such available supply of the Compound and such other inputs to the Product for: the Product in the Field in the Territory for United Therapeutics; and the Product in the Field outside the Territory for Lilly; on a pro rata basis based on aggregate unit sales of the Product in the Territory and outside the Territory in the two most recent Calendar Quarters for which such information is available. Lilly shall inform United Therapeutics of the expected duration of the shortage of the Compound or other inputs to the Product and shall keep United Therapeutics informed on a timely basis of the status of the supply of the Compound or other such inputs to the Product while such shortage is occurring. The Parties shall cooperate to expedite the manufacture of the Product by Lilly when the shortage of the Compound or other inputs to the Product has been alleviated. Lilly agrees to: (i) carry in “safety stock” inventory a minimum three (3) months’ supply of the Compound and a supply of the Product to accommodate United Therapeutics’ orders of the Product for use in the Field in the Territory consistent with the supply of products distributed and sold by Lilly and maintained by Lilly for other products for similar purposes; and (ii) consistent with Section 2.1, in the event of a timely manner, such particular Raw Material necessary shortage of the Compound or other inputs to Manufacture or Package the Product, provided that Catalent placed orders favor the supply of the Product for such Raw Materials promptly following receipt use in the Field in the Territory over the supply of Client’s Firm CommitmentCialis®.