Common use of Manufacturing Services Clause in Contracts

Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in Schedules B and C to the relevant Product Agreement. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional fees to be paid by Client. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform the Manufacturing Services solely at the Manufacturing Site, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services and supply to Client Product intended for Products to be distributed marketing and sold by Client sale in the Territory for the fees specified in Schedules B and C C. The parties acknowledge that they intend to negotiate an amendment to this Agreement to add ARX-01 in Finished Product Packaging as a Product. If the relevant parties enter into this amendment, Client will still have the right to purchase Product Agreementin Bulk Tablet Packaging from Patheon and have a third party package the Product into Finished Product Packaging for distribution or sale outside of the Territory. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for ProductsProduct; all cost items required for the manufacture of Product that are not included in this list are excluded from the Price and are subject to reasonable additional fees to be paid by the Client. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform the All Manufacturing Services solely will be performed by Patheon at the Manufacturing Site. Patheon may change the Manufacturing Site for the Product only with the prior written consent of Client, unless otherwise agreed in writing by Clientthis consent not to be unreasonably withheld. If During the parties agree that period commencing on the Effective Date up through the Initial Term, Patheon will supply, and Client will purchase, at least a specified minimum percentage supply 100% of the Client’s requirements for a Product under a Product Agreement (offered for sale by Client in the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Territory so long as Patheon fails to remain is in material compliance with its obligations to Client under this Agreement Agreement. But if (a) Patheon fails to meet its supply obligations to Client for three consecutive Firm Orders, (b) in any consecutive six month period, 30% or more of the aggregate quantities of Product to be delivered by Patheon pursuant to Firm Orders during such six month period are not delivered by the due dates specified in the applicable Product AgreementFirm Orders, or (c) Patheon suspends performance under this Agreement or does not fulfill a Firm Order within 90 days after the applicable Delivery Date specified therein then, in each case, Client may obtain up to 20% of its requirements for Product Agreement offered for sale in connection with the Territory from an alternate supplier, regardless of whether any such occurrence is attributable to a Force Majeure Event or where Patheon is or will be prevented from supplying Event. After the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required PeriodInitial Term, Client may, at any time, will only be required to obtain 80% of its requirements for Product offered for sale in the Territory from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the ProductPatheon. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees Price specified in a Product Agreement in Schedules B and C to the relevant Product Agreementmanufacture Products for Client. Schedule B to each a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional fees to be paid by Client, provided, that all such additional fees are subject to Client’s prior written consent. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon will perform may change the Manufacturing Services solely at Site for the Manufacturing SiteProducts only with the prior written consent of Client, unless this consent not to be unreasonably withheld, and subject to any necessary approvals by Regulatory Authorities. Unless otherwise agreed in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (and subject to Section 2.3 below, during the “Required Percentage”)term of any Product Agreement, then Client will purchase from Patheon [***] of its requirements for the applicable Product Agreement will in the Territory set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. In performing the Manufacturing Services, Patheon and Client agree that, unless otherwise set forth in a Product Agreement: (a) Conversion of Active Materials and Components. Patheon will convert Active Materials and Components into Product. (b) Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures; provided that Patheon shall provide Client notice of any material changes to Patheon’s standard operating procedures that are applicable to the batch review and release of a Product in accordance with the terms of the Quality Agreement. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMP. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is Client property. (c) Components. Patheon will purchase and test all Components (with the exception of Client-Supplied Components) [***] and as required by the Specifications.

Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in Schedules B and C to manufacture Products for Client and supply the relevant Product AgreementProducts to Client, in accordance with the Specifications, cGMPs, and all Applicable Laws. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in this list are excluded from the Price and are subject to additional fees to be paid by the Client. Patheon may amend change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld. If Manufacturing Services have not started on or before [*], (i) Patheon shall have the right to request an amendment to the fees set out in Schedules B and C and no such amendment shall be binding unless approved in writing by Client and (ii) Client shall have the right to a Product Agreement as set forth in Article 4terminate this Agreement, effective upon written notice to Patheon. Patheon will perform be the Manufacturing Services solely sole manufacturer of Products offered for sale by Client in the Territory for the Initial Term of this Agreement. Notwithstanding the foregoing, Client shall be entitled, at the Manufacturing Siteits sole cost and expense, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supplyto qualify a single alternative manufacturer (“Backup Manufacturer”) to manufacture Products, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement may take all actions reasonably necessary in connection with a Force Majeure Event the same, including without limitation purchasing small quantities or where Patheon is Products necessary to qualify such Backup Manufacturer. Client shall be permitted to sell any Product that results from the required qualification, validation and maintenance production runs from the Backup Manufacturer(s), provided that the batch sizes of such qualification, validation or will be prevented from supplying maintenance runs do not exceed the maximum batch size validated for the Product by Patheon. Any units from an increase in batch size by the Backup Manufacturer may be used for non-commercial activities. Patheon agrees to cooperate with Client and provide all assistance, at Client’s expense, as may reasonably be requested by Client to qualify a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required PeriodBackup manufacturer, Client provided that Patheon may, at in its sole discretion, refuse to permit access to the Manufacturing Site by any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Productdirect competitor of Patheon. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. (a) Patheon will perform shall provide the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in a Product Agreement in Schedules B and C in order to the relevant Product Agreementproduce Products for Éclat. Schedule B to each a Product Agreement sets forth a list of in detail cost items that are included in the Price for Products; all Products and those cost items that are not included in this list are excluded from the Price and that are subject to additional fees to be paid by Client. Éclat. (b) Subject always to clause 13.6, and unless otherwise stated in a Product Agreement, Patheon may change the Manufacturing Site for the Products only upon providing Éclat with a twelve (12) month written notice and obtaining the prior written consent of Éclat, such consent not to be unreasonably withheld. Éclat may reasonably withhold consent for the change in Manufacturing Site until Patheon provides Éclat with sufficient quantity of Product(s) to ensure an uninterrupted supply to the market. Other than for Neostigmine and Phenylephrine, which are subject to the provisions of the relevant Product Agreement, in the event that Patheon changes the Manufacturing Site of a Product for reasons solely at Patheon’s election, specifically a decision taken by Patheon to close the then current Manufacturing Site for the Product, Patheon shall be solely responsible for all its costs and expenses associated with the change in Manufacturing Site, including all tech transfer costs, and Patheon shall not increase the Price it charges Éclat for the Products solely as a result of the change in Manufacturing Site. (c) If Manufacturing Services under a Product Agreement have not commenced within 12 months of the date of execution of this Agreement Patheon reserves the right to amend the fees set out in Schedules B and C to a Product Agreement as set forth Agreement. (d) Patheon shall manufacture Products only for Éclat and only in Article 4. Patheon will perform the Manufacturing Services solely at the Manufacturing Site, unless otherwise agreed response to and in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, at least a specified minimum percentage of Client’s requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Patheon fails to remain in material compliance with its obligations under this Agreement or purchase orders based on Firm Orders delivered by Éclat to Patheon. (e) Patheon shall be the applicable Product Agreement, or Patheon suspends performance under this Agreement or exclusive manufacturer of Products offered for sale by Éclat in the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation Territory. (if anyf) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. In performing providing the Manufacturing Services, Patheon and Client Éclat agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client in the Territory for the fees specified in Schedules B and C and any additional countries outside the Territory subject to Section 4.5 for the relevant Product Agreementfees specified in applicable amendments entered into by the parties. Schedule B to each Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items . Patheon shall not perform any Manufacturing Services at any location other than at the Manufacturing Site located at 0000 Xxxxxx Xxxxx, Xxxxxxxxxxx, Xxxxxxx, Xxxxxx X0X 0X0 without the express written consent of Client, except that are Patheon may perform certain analytical release and stability testing activities as agreed by the Parties at the Manufacturing Site located at 000 Xxxxxxx Xxxxx, Xxxxxxxxxx, Xxxxxxx, Xxxxxx X0X 0X0. Patheon shall perform the Manufacturing Services in strict compliance with this Agreement, the Specifications, the Quality Agreement, cGMP and Applicable Laws, Patheon may not included in change the Specifications, Manufacturing Site (including facility modification), site of stability testing or any other aspect of the manufacturing process used to perform the Manufacturing Services with respect to the Products without the prior written consent of Client, this list are excluded from the Price and are subject to additional fees consent not to be paid by Clientunreasonably withheld. If Manufacturing Services have not started within 12 months of the date of execution of this Agreement (other than as a result of Patheon’s acts or omissions or a Force Majeure Event), Patheon may amend propose an amendment of the fees set out in Schedules B and C C, which shall be subject to a Product Agreement as set forth Client’s approval. Patheon’s right to manufacture Products offered for sale by Client in Article 4the Territory shall be non-exclusive. Patheon will perform the Manufacturing Services solely at the Manufacturing SiteHowever, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supply, and Client will purchase, shall procure at least a specified minimum percentage […***…] percent ([…***…] %) of Client’s its annual Product requirements for a Product under a Product Agreement (the “Required Percentage”), then the applicable Product Agreement will set forth the Required Percentage and the time period during which the obligation will apply (the “Required Period”). But this obligation (if any) will cease to apply to Client with respect to the Product if Territory from Patheon fails to remain in material compliance with or its obligations under this Agreement or the applicable Product Agreement, or Patheon suspends performance under this Agreement or the applicable Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the ProductAffiliates. In performing the Manufacturing Services, Patheon and Client agree that:

Manufacturing Services. Patheon will perform the Manufacturing Services for Products to be distributed and sold by Client as set out in the Territory relevant Product Agreement for the fees specified Price and in Schedules B accordance with the terms and C conditions of this Agreement, such Product Agreement and the Quality Agreement. Subject to the preceding sentence, Patheon will convert API and Components into Product, and provide supportive Manufacturing Services such as quality assurance (for example quality controls, analytical testing, and stability programs), primary and secondary packaging, and any other related Manufacturing Services as agreed between the parties under the relevant Product Agreement. Schedule B to Patheon (and its applicable Affiliates) will perform all Manufacturing Services in accordance with all Applicable Laws. For each Product Agreement sets forth for which the Parties (or their respective Affiliates) have entered into a list of cost items that are included Product Agreement, and unless otherwise expressly agreed in the Price for Products; all cost items that are not included a Product Agreement, and except as otherwise provided in this list are excluded from Agreement, Patheon will be a non-exclusive manufacturer during the Price and are subject to additional fees to be paid by Client. Patheon may amend term of the fees set out in Schedules B and C to a applicable Product Agreement as set forth in Article 4. Patheon will perform of the Manufacturing Services solely at the Manufacturing SiteProducts offered for sale by Client or its Affiliates, unless otherwise agreed in writing by Client. If the parties agree that Patheon will supplyprovided that, Client agrees to order and purchase from Patheon, and Client will purchasePatheon agrees to manufacture and supply hereunder, at least a specified minimum percentage [***] of Client’s requirements for a Products for commercial sale in the United States (as provided in Client’s rolling forecasts); provided further that, for clarity, the foregoing does not apply to manufacture of any API or Components. Except as otherwise provided in the Product under Agreement covering manufacture of particular Product for Client, for each Product that is covered by a Product Agreement during the term of this Agreement, Patheon shall maintain, commencing on the date that is twelve months after the launch of commercial sales of such Product in the Territory for such Product (the “Required Percentage”or at such later date as agreed in writing, as to a particular Product), then at least two separate and distinct manufacturing sites that are fully qualified and able to perform the applicable Product Agreement will Manufacturing Services set forth the Required Percentage and the time period during which the obligation will apply herein (the “Required PeriodManufacturing Redundancy”). But this obligation (if any) will cease to apply to Client with respect to The details of the Product if allocation of the manufacturing services between such sites, for a Product, shall be as agreed reasonably by the Parties at the time of qualification. In the event Patheon fails to remain maintain, for a consecutive period of [***] in material compliance with its obligations under this Agreement or any twelve month period, the applicable required Manufacturing Redundancy for a Confidential Page 10 of 47 particular Product covered by a Product Agreement, or then Client shall no longer be required to use Patheon suspends performance as the manufacturer of at least [***] of Client’s requirements for such Product under this Agreement or the applicable relevant Product Agreement in connection with a Force Majeure Event or where Patheon is or will be prevented from supplying the Product as a result of the action of a Regulatory Authority. Subject to its obligation (if any) to purchase the Required Percentage of a Product during the Required Period, Client may, at any time, obtain Product from a third party or may, at any time, qualify a third party to perform Manufacturing Services for the Product. In performing the Manufacturing Services, Patheon and Client agree that:Agreement.