Second Amendment, dated September 17, 2024, to Manufacturing Agreement, dated September 9, 2020 and first amended July 25, 2023, by and between ARS Pharmaceuticals, Inc. and Renaissance Lakewood, LLC
Exhibit 10.1
CERTAIN INFORMATION CONTAINED IN THIS EXHIBIT, MARKED BY [***], HAS BEEN EXCLUDED BECAUSE THE REGISTRANT HAS DETERMINED THE INFORMATION IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
SECOND AMENDMENT TO MANUFACTURING AGREEMENT
This Second Amendment to Manufacturing Agreement (this “Amendment”), effective as of September 17, 2024 (the “Second Amendment Effective Date”), is made by and between ARS Pharmaceuticals Operations, Inc. formerly known as ARS Pharmaceuticals, Inc., a corporation organized under the laws of the State of California with an office at 11682 El Camino Real, Suite 120 San Diego CA 92130 (“COMPANY”) and Renaissance Lakewood, LLC, a limited liability company organized under the laws of the State of Delaware with an office at 1200 Paco Way, Lakewood, New Jersey 08701 (“RENAISSANCE”).
RECITALS
A. Reference is made to that certain Manufacturing Agreement, dated as of September 9, 2020, by and between COMPANY and RENAISSANCE, as amended July 25, 2023 (the “Agreement”). Capitalized terms used but not otherwise defined herein shall have the respective meanings given in the Agreement.
B. COMPANY and RENAISSANCE desire to enter into this Amendment for purposes of modifying the Agreement as set forth herein.
Now, therefore, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
Any such material which is subsequently rendered in excess of that required to support up to [***] of COMPANY’s Forecasted Needs may be subject to [***] and [***] which will be invoiced by RENAISSANCE in accordance with Section 2.9, and, in addition, should COMPANY subsequently reduce its Forecasted Needs such that the inventory of RENAISSANCE Material is in excess of an amount required to support [***] COMPANY’s then current Forecasted Needs, then RENAISSANCE may invoice COMPANY for [***], also in accordance with Section 2.9.
Each initial Manufacturing Fee to be paid by COMPANY to RENAISSANCE is listed in Schedule B.
(For example: [***])
Further, the Manufacturing Fee for any new Product that is not yet included in Schedule B will be negotiated by the parties in good faith using their commercially reasonable efforts, and if the parties are able to agree on the Manufacturing Fee, the Agreement will be amended to reflect that pricing prior to the time of first production of such new Product.
Payment for all deliveries of Product shall be made in U.S. Dollars (USD), net [***] after the date of RENAISSANCE’s invoice therefor. Invoices for Product shall be generated upon [***] of Product from RENAISSANCE. Total invoice price shall be equal to [***], plus any other additional amounts listed in Schedule B, less any pre-payments made for excess RENAISSANCE Materials in accordance with Section 2.6(b). Payment for the purchase of any materials or services purchased under a Project Protocol shall be made in U.S. Dollars (USD), net thirty (30) days after the date of RENAISSANCE’s invoice therefor. Payment shall be made by check, wire transfer, electronic fund transfer or through other instrument accepted by RENAISSANCE. Payment by wire or electronic fund transfer should be made to the following:
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The initial term of this Agreement shall commence on the Effective Date and will terminate (a) for Product designated for commercial sale in the U.S. on December 31st immediately following the five (5) year anniversary of the U.S. Launch Date (the “U.S. Initial Term”), and (b) for Product designated for commercial sale in the E.U., on December 31st immediately following the five (5) year anniversary of the E.U. Launch Date (the “E.U. Initial Term” and with the U.S. Initial Term, each an “Initial Term”); in each case, unless sooner terminated pursuant to Section 4.2.Thereafter, each of the U.S. Initial Term and the E.U. Initial Term shall automatically renew for periods of twenty-four (24) months (each a “U.S. Renewal Term” and an “E.U. Renewal Term ” respectively and each a “Renewal Term” and collectively with each Initial Term, the “U.S. Term” and “E.U. Term” and collectively, the “Term”), unless either party shall give notice to the other to the contrary not later than twenty-four (24) months prior to the expiration of the Initial Term or the then-current Renewal Term. For clarity, each of the U.S. Term and the E.U. Term may be independently or collectively renewed pursuant to this Section 4.1.
Any inventory procured or developed by RENAISSANCE specifically for the Manufacture of Product, [***]. At such time and as instructed by COMPANY, RENAISSANCE will either destroy such obsolete inventory or raw materials or ship such obsolete inventory or raw materials to COMPANY. [***] shall bear [***] of all shipping and destruction costs related to such obsolete inventory or raw materials. Any such destruction shall be in accordance with Applicable Law, and each party shall also provide the other party with all manifests and other applicable evidence of proper destruction as may be requested by the other party or required by Applicable Law. If RENAISSANCE does not receive disposition instructions from COMPANY within [***] from date of notification, obsolete inventory [***] shall be subject to [***] or destruction at RENAISSANCE’s discretion and [***] for such costs under a Project Protocol.
2.14 Expansion Generally
RENAISSANCE agrees to use Commercially Reasonable Efforts to increase its capacity to Manufacture and supply Product under this Agreement in order to accommodate the growth of the market for Product as set forth in the forecasts provided by COMPANY.
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Each of the parties has caused this Amendment to be duly executed on its behalf as of the Second Amendment Effective Date.
ARS PHARMACEUTICALS OPERATIONS, INC.
By: /s/ Richard Lowenthal
Name: Richard Lowenthal
Title: CEO and President
Renaissance Lakewood, LLC
By: /s/ Serge Maltais
Name: /s/ Serge Maltais
Title: President and CEO
Schedule B – Product Description; Manufacturing Fee; Materials Fee
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Schedule F – Drawings
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Schedule G
Estimated Materials Fee for E.U. Printed Material
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