Exhibit 10.38
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
COMMERCIAL SUPPLY AGREEMENT
This Commercial Supply Agreement is made as of this 1st day of March, 2023 (the “Effective Date”), by and between ACADIA Pharmaceuticals Inc., a Delaware corporation, with a place of business at 12830 El Camino Real, Suite 400, San Diego, California 92130 (“Client”), and CoreRx Inc, a Florida corporation, having a place of business at 14205 Myerlake Circle, Clearwater, FL 33760 (“CoreRx” or “Supplier” ). Client and CoreRx may individually be referred to as a “party” and collectively as the “parties.”
RECITALS
THEREFORE, in consideration of the circumstances described above and the mutual covenants, terms and conditions set forth below, the parties agree as follows:
ARTICLE 1
DEFINITIONS
The following terms have the following meanings in this Agreement:
ARTICLE 2
VALIDATION, MANUFACTURING, SUPPLY OF PRODUCT, & RELATED SERVICES
ARTICLE 3
MATERIALS
Upon termination or expiration of this Agreement, CoreRx shall, upon Client’s direction and expense, either: (i) deliver all unused Client-supplied Materials provided by Client within th[***] days after termination, or (ii) dispose of the Client-supplied Materials. If Client does not request the return or disposal of Client-supplied Material within [***] days of the Agreement’s termination, then CoreRx will provide written notice to Client of any such unused Client-supplied Materials and shall return the Client-supplied Material to Client, at Client’s cost, without any further liability or obligation to Client.
ARTICLE 4
FORECAST & PURCHASE ORDERS
Client may cancel any Purchase Order. If Client cancels any Purchase Order(s), a cancellation fee shall be assessed as follows:
ARTICLE 5
TESTING; RELEASE
ARTICLE 6
DELIVERY
CoreRx shall deliver Product ExWorks (Incoterms 2020) the Facility promptly following CoreRx’s release of Product and in accordance with Acknowledgments made in accordance with Section 4.2(B). CoreRx shall segregate and store all Product until tender of delivery. To the extent not already held by Client, title to Product shall transfer to Client upon CoreRx’s tender of delivery. If CoreRx provides storage services, title to such items shall pass to Client upon transfer to storage. Client shall be responsible for coordinating the use of a qualified carrier to ship Product. In the event CoreRx arranges shipping or performs similar loading and/or logistics services for Client at Client’s request, such services are performed by CoreRx as a convenience to Client only and do not alter the terms and limitations set forth in this Section 6.1. CoreRx shall not be responsible for Product in transit, including any cost of insurance or transport fee for Product, or any risk associated with transit or customs delays, storage and handling.
Assuming Client pays for the buildout of the cold storage space, storage charges will not begin until [***] years from the Effective Date. If Client does not build out the cold storage space, charges for storage will begin following execution of this Agreement. If Client fails to take delivery of any Product on any scheduled delivery date, CoreRx shall store such Product and have the right to invoice Client monthly following such scheduled delivery for reasonable administration and storage fees.
The foregoing discount amount will be deducted by Client from any amounts invoiced to Client related to the relevant late-delivered Product. The rights and remedies contained in this Section 6.3 are non-exclusive and without prejudice to Client’s right to terminate this Agreement pursuant to Article 16 or any other remedy under this Agreement; provided, however, the above late delivery penalty shall be deducted from any claim of Client for damages arising from late delivery by Supplier of a Product under a Firm Commitment.
ARTICLE 7
PAYMENTS
ARTICLE 8
CHANGES TO SPECIFICATIONS
All Specifications, and any change to the Specifications agreed by the parties from time to time, shall be in writing, dated and signed by the parties. No change in the Specifications shall be implemented by CoreRx, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing) and any Regulatory Approvals required by Applicable Laws have been obtained (a “Change Control”). CoreRx shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use Commercially Reasonable Efforts and good-faith efforts to agree to the terms of such change in a timely manner. As soon as practicable after a request is made for any change in Specifications, CoreRx shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with agreed changes to the Specifications. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. CoreRx reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the Change Control.
ARTICLE 9
RECORDS; REGULATORY MATTERS
ARTICLE 10
CONFIDENTIALITY AND NON-USE
ARTICLE 11
INTELLECTUAL PROPERTY
11.1 As used in this Agreement, “Client IP” means all Intellectual Property and related embodiments owned by or licensed to Client as of the Effective Date or developed by Client other than in connection with this Agreement; “CoreRx IP” means all Intellectual Property and related embodiments owned by or licensed to CoreRx as of the Effective Date or developed by CoreRx other than in connection with this Agreement. “Invention” means any Intellectual Property developed by either party or jointly by the parties in connection with this Agreement. Client IP is the Confidential Information of Client, and CoreRx IP is the Confidential Information of CoreRx.
11.2 All Inventions, ideas, discoveries, developments, methods, data, information, improvements, and biological or chemical materials, (whether or not reduced to practice and whether or not it can be protected under state, federal or foreign patent ,copyright, trade secrecy or similar laws) generated or derived by Client or CoreRx whether alone or together in the course or performing the services pursuant to this Agreement which are related directly to Client’s Product, Client IP, or Client Confidential Information shall be the exclusive property of Client (“Client Arising IP”). Client hereby grants to CoreRx a non-exclusive, non-assignable, paid-up, royalty-free, non-transferable license to use Client Arising IP solely for the performance of the services pursuant to this Agreement. Client Arising IP is the Confidential Information of Client.
11.3 All Inventions, ideas, discoveries, developments, methods, data, information, improvements, and biological or chemical materials, (whether or not reduced to practice and whether or not it can be protected under state, federal or foreign patent, copyright, trade secrecy or similar laws) generated or derived by Client or CoreRx whether alone or together in the course or performing the services pursuant to this Agreement which are not Client Arising IP, that relates directly to CoreRx IP or CoreRx Confidential Information, or relates to developing, formulating, manufacturing, filling, processing, packaging, analyzing or testing drug products other than the Product, shall be the exclusive property of CoreRx (“CoreRx Arising IP”). CoreRx Arising IP is the Confidential Information of CoreRx. CoreRx hereby grants to Client a non-exclusive, non-assignable, paid-up, royalty-free, non- transferable license, with the right to sublicense, to use the CoreRx Arising IP solely to the extent necessary to use for the performance of the services hereunder and as far as necessary for the further development, manufacture, and distribution of the Product.
11.4 Each party shall promptly and fully disclose, in writing, to the other any and all Arising IP respectively. Each party hereby assigns and agrees to assign to the other all applicable right, title and interest in and to any such Arising IP. Each party agrees to cooperate fully in obtaining patent, copyright or other proprietary protection for such Arising IP, all in the name of the applicable party and at such applicable party’s cost and expense, and shall execute and deliver all requested applications, assignments and other documents, and take such other measures as reasonably requested in order to perfect and enforce rights in such Arising IP.
11.5 Each party will cause its employees or contractors who perform activities pursuant to this Agreement to enter into agreements that protect the other party’s Intellectual Property and Confidential Information and enable compliance with this Article 11.
ARTICLE 12
REPRESENTATIONS AND WARRANTIES
ARTICLE 13
INDEMNIFICATION
ARTICLE 14
LIMITATIONS OF LIABILITY
EXCEPT FORCLAIMS ARISING OUT OF CORERX’S GROSS NEGLIGENCE, FRAUD, OR WILLFUL MISCONDUCT, CORERX’S MAXIMUM LIABILITY TO
CLIENT FOR ANY CLAIM FOR CLIENT-SUPPLIED MATERIAL THAT IS LOST, DAMAGED, OR DESTROYED EITHER (I) DUE TO THE FAULT OR NEGLIGENCE OF CORERX WHILE IN CORERX’S CONTROL OR POSSESSION, OR (II) AS A RESULT OF CORERX AND/OR CORERX DEFECTIVE MANUFACTURING DURING THE MANUFACTURING OF ANY GIVEN BATCH OF PRODUCT, CORERX’S LIABILITY FOR ANY SUCH LOST, DAMAGED, OR DESTROYED CLIENT-SUPPLIED MATERIALS SHALL BE BASED UPON:
(A) FOR THE API, THE COST OF [***] FOR THE AMOUNT OF API LOST, DAMAGED, OR DESTROYED, OR
(B) FOR OTHER CLIENT-SUPPLIED MATERIALS, THE [***] FOR THE AMOUNT OF CLIENT-SUPLIED MATERIALS LOST, DAMAGED, OR DESTROYED;
PROVIDED, HOWEVER, THAT CORERX’S LIABILITY FOR SUCH API OR OTHER CLIENT-SUPPLIED MATERIALS SHALL NOT EXCEED THE COST OF THE APPLICABLE BATCH OR BATCHES OF PRODUCT.
ARTICLE 15
INSURANCE
CoreRx shall, at its own cost and expense, obtain and maintain in full force and effect, at all times during the term of this Agreement the following insurance for not less than any limits of liability specified herein or as required by Applicable Law, whichever is greater. All insurance carriers shall have a minimum of “A-” A.M. Best rating. Supplier shall have the right to provide the total limits required by any combination of self-insurance, primary and umbrella/excess coverage during the Term of this Agreement and any and all related agreement(s) and/or Purchase Orders made pursuant to this Agreement and for a period of [***] years thereafter; said insurance to include the following:
(i) Products, Operations, Completed Operations, and Professional Liability Insurance- [***] aggregate per annum
(ii) Commercial General Liability, including Personal Injury and Property Damage covering Supplier’s own operations arising out of or connecting to this Agreement - [***] aggregate.
(iii) Umbrella Liability -[***]aggregate
(iv) Workers’ Compensation as required by any applicable law or regulation and in accordance with the provisions of the laws of the nation, state, territory or province having jurisdiction over CoreRx’s employees.
(v) Employment Practices liability insurance with a limit of not less than [***].
Where allowed by Applicable Law, Client and its Affiliates shall be provided a waiver of subrogation, except for losses due to the sole negligence of Supplier.
All of the above listed insurance shall be issued by duly licensed and financially sound companies that meet industry solvency requirements. If such insurance is written on a claims made basis, CoreRx shall maintain the described insurance coverage for not less than [***] years after destruction of all of the last Batch of Product Manufactured under this Agreement. Such insurance policy shall include Client and their respective affiliates, and their respective directors, officers, employees, agents, and representatives, as additional insureds. The certificate of insurance shall state that all coverages provided by CoreRx shall be primary to any insurance carried by such additional insureds for their own account. Upon written request from the Client, CoreRx shall as
soon as reasonably possible provide a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. CoreRx will further provide Client a minimum of [***] days written notice of a cancellation of, or material change in, the above-referenced insurance. In such case, CoreRx and Client shall engage in good faith negotiations in order to amend this Article to provide adequate insurance and assurances to comply with this Article.
During the Term of this Agreement and for [***] years thereafter, Client shall obtain and maintain at its own cost and expense from a qualified insurance company, comprehensive general liability insurance including, but not limited to product liability coverage, in the amount of at least [***]USD per claim. Client shall provide CoreRx with a certificate of such insurance upon reasonable request.
ARTICLE 16
TERM AND TERMINATION
ARTICLE 17
NOTICE
All notices and other communications under this Agreement shall be in writing and shall be deemed given: (A) when delivered personally or by hand; (B) when delivered by electronic mail (e-mail); (C) when received or refused, if sent by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered, if sent by express courier service; in each case to the parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided, that notices of a change of address shall be effective only upon receipt thereof):
To Client: ACADIA Pharmaceuticals Inc.
Attn:
E-Mail:
Facsimile:
With a copy to: ACADIA Pharmaceuticals Inc.
Attn:
E-Mail:
Facsimile:
To CoreRx: CoreRx, Inc.
Attn:
Facsimile:
Email:
With a copy to: CoreRx, Inc.
Attn:
Facsimile:
Email:
ARTICLE 18
MISCELLANEOUS
[Signature page follows]
IN WITNESS WHEREOF, the parties have caused their respective duly authorized Representatives to execute this Agreement effective as of the Effective Date.
CORERX INC. ACADIA PHARMACEUTICALS INC.
By: /s/ Ajay Damani________________ By: /s/ Benir Ruano_________________
Name: Ajay Damani Name: Benir Ruano
Title: CEO Title: SVP, Tech. Development and Operations
By: /s/ Mark Schneyer_______________
Name: Mark Schneyer
Title: CFO and SVP
ATTACHMENT A
SPECIFICATIONS
[***]
ATTACHMENT B
UNIT PRICING; MILESTONES; APR & CPV
[***]
AMENDMENT NO. 1 TO
COMMERCIAL SUPPLY AGREEMENT
This Amendment No. 1 (“Amendment”) to the Commercial Supply Agreement, effective as of August 1, 2023 (“Amendment Effective Date”) is entered into by and between CoreRx, Inc., having an address at 14205 Myerlake Circle, Clearwater, Florida 33760 (“CoreRx”) and ACADIA Pharmaceuticals Inc., having an address at 12830 El Camino Real, Suite 400, San Diego, California 92130 (“Client” or “Acadia”). Client and CoreRx may individually be referred to as a “party” and collectively as the “parties.”
WHEREAS, CoreRx and Client entered into that certain Commercial Supply Agreement dated effective March 1, 2023 (the “Agreement”). Terms used in this Amendment but not otherwise defined in this Amendment shall have the meanings ascribed to such terms in the Agreement. CoreRx and Client now desire to amend the Agreement upon the terms and conditions noted below;
WHEREAS, the Agreement provides that the parties may mutually agree in writing to amend the Agreement;
WHEREAS, the Parties have agreed to amend the Agreement as set forth herein. Unless otherwise amended as stated below, all terms and conditions of the Agreement shall remain in full force and effect.
In consideration of the mutual covenants and premises contained in this Amendment, the receipt and sufficiency of which are hereby expressly acknowledged, CoreRx and Client hereby agree as follows:
Section 3.2 A. The first sentence shall be amended by revising the first sentence as shown below, deleting the second sentence, and revising the third sentence as shown below. The remainder of Section 3.2 A shall remain such that the amended Section 3.2 A shall be as follows:
Unless otherwise agreed to by the parties in writing, CoreRx shall be responsible for procuring, inspecting, managing, and releasing adequate Raw Materials as necessary to meet the Firm Commitment and shall procure, manage, inspect, test, and store sufficient Raw Materials to manufacture a minimum of [***] Batches in excess of the Firm Commitment (“Safety Stock”). CoreRx will invoice for Safety Stock Raw Materials purchased and any other Raw Materials as requested by Client outside of the Firm Commitment. In the event that Client does not issue Purchase Orders requesting sufficient Product to meet the Firm Commitment during any Firm Commitment Period (on a rolling basis) and any Raw Materials expire or require retesting, such Raw Materials shall be replaced or retested as Client directs at Client's sole cost and expense, including charges for disposal of the expired Raw Materials when applicable, without any liability to CoreRx.
Section 3.2 C. shall be deleted in its entirety and replaced with the following:
CoreRx shall store the Raw Materials, Safety Stock, and packaging materials at controlled room temperature as instructed by Client, unless stated otherwise. During the Term of this Agreement, CoreRx agrees to provide a minimum of [***] pallet spaces for Raw Materials, Safety Stock, and packaging materials needed to support the Product manufacturing campaign. Client agrees to pay CoreRx the amount of [***] per calendar year (to be prorated for 2023 as stated below) to cover the procurement, management and storage of Safety Stock and other Raw Materials (“Safety Stock Fee”). Storage costs of Raw Materials are deemed to be a part of and incorporated into the Safety Stock Fee. The prorated Safety Stock Fee for calendar year 2023 (August through December 2023) is [***], and this prorated fee is due to CoreRx upon full execution of this Amendment. Subsequent Safety Stock Fees are due to CoreRx on January 31st of each calendar year beginning calendar year 2024 (CoreRx may submit invoice sooner). This Amendment to Section 3.2(C) can be cancelled within a [***] notice by the Client and in such event, the Agreement reverts back to the original Agreement 3.2 (C) provision.
4.0 Unused Material Fee: Client agrees to pay CoreRx an amount of up to [***] for costs incurred by CoreRx for materials that were to be used for other CoreRx client projects (“Unused Material Fee”) pursuant to the following terms and conditions:
5.0 Premium Price: Except as provided in this Section 5 and its subparts, Acadia shall pay [***] per bottle premium on the applicable Unit Price (“Premium Price”) on up to [***] Batches that CoreRx Releases to Client on or after [***]. “Release” and/or “Released” shall mean CoreRx issuing a Certificate of Analysis (“COA”) for the relevant batches. Client shall pay the Premium Price on the following Orders pursuant to the terms and conditions set forth in this Section 5 and its subparts:
Table 1.
Order No. | |
1 | [***] |
2 | [***] |
3 | [***] |
4 | [***] |
5.1 CoreRx must Release the specified amount of Batches within [***] business days of the stated release date (“Release Deadline”) for each Order identified above for the Premium Price to be paid and be valid. In the event that CoreRx Releases a lesser amount of Batches than the specified Order amount by the Release Deadline, then Client shall only pay the Premium Price for those Batches that meet the Release Deadline. Accordingly, any Batches that are Released subsequent to the Release Deadline do not qualify for the Premium Price and cannot be rolled over into the next Order’s Release Deadline. For illustration and for example only, if CoreRx Releases [***] out of the [***] Batches specified in Order No. [***] by the Release Deadline, the Premium Price shall be paid on the 4 Batches. The other [***] Batches even if Released before or by Order [***]’s Release Deadline are not eligible for the Premium Price.
5.2 API Delay. In the event that Client does not provide some or all of the API necessary for CoreRx to manufacture the specified amount of Batches in an Order, the parties shall timely engage in good faith discussions to determine a mutually agreed upon different Release date for the applicable Order that shall be set forth in a mutually agreed upon writing. The Premium Price shall apply to any new mutually agreed upon Release date for an Order pursuant to the terms and conditions stated in herein in Section 5 and its subparts.
6.0 Deposit: Client agrees to pay CoreRx a deposit in the amount of [***] (“Deposit”). The Deposit is due to CoreRx upon full execution of this Amendment. CoreRx shall use the Deposit as a credit towards Purchase Orders for Batches shipped on or after November 1, 2023, and will continue to use the Deposit as a credit towards Purchase Orders until the cost of the Batches in the amount of the full Deposit have been shipped by CoreRx (approximately [***] Batches). CoreRx shall account for the Deposit credit on its invoices until the total amount of the Deposit (that is [***]) has been credited.
[Signatures follow on next page]
IN WITNESS WHEREOF, the parties have executed this Amendment as of the Amendment Effective Date by their duly authorized representatives.
Agreed and Accepted: Agreed and Accepted:
CoreRx, Inc.
By /s/ Ajay Damani________________
Name: Ajay Damani
Title: CEO
| ACADIA Pharmaceuticals Inc.
By: /s/ Benir Ruano_______________
Name: Benir Ruano
Title: SVP Tech Dev. and Operations
By: /s/ Doug Williamson___________
Name: Doug Williamson
Title: EVP, Head of Research & Development
|
|
|
|
By /s/ Mark Schneyer______________
Name: Mark Schneyer
Title: EVP & CFO
|