Exhibit 10.1
EXECUTION COPY
Confidential
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS (I) NOT MATERIAL AND (II) OF THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
COMMERCIAL SUPPLY AGREEMENT
This COMMERCIAL SUPPLY AGREEMENT (this “Agreement”) is made as of May 17, 2023 (the “Effective Date”), by and between EyePoint Pharmaceuticals, Inc., a Delaware corporation with its principal place of business at 480 Pleasant Street, Suite C-400, Watertown, MA 02472 (“EyePoint”), and Alimera Sciences, Inc., a Delaware corporation with its principal place of business at 6310 Town Square, Suite 400, Alpharetta, GA 30005 (“Alimera”) (collectively, the “Parties” and each, a “Party”). Capitalized terms used, but not otherwise defined, in this Agreement have the meanings assigned to them in the Product Rights Agreement (as defined below).
RECITALS
Whereas, EyePoint owns the rights to, and has commercialized in the United States, YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg (“YUTIQ”), which was approved by the U.S. Food and Drug Administration for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye;
Whereas, contemporaneously with the execution and delivery of this Agreement, EyePoint and Alimera are entering into that certain Product Rights Agreement (the “Product Rights Agreement”), pursuant to which EyePoint grants to Alimera certain licenses and rights, and assigns to Alimera certain rights, with respect to Products (as defined therein), including YUTIQ, subject to terms and conditions set forth therein; and
Whereas, pursuant to the Product Rights Agreement, EyePoint has agreed to manufacture and exclusively supply to Alimera all quantities of YUTIQ necessary for Alimera to Commercialize YUTIQ in the United States, subject to the terms and conditions set forth in this Agreement.
Now, Therefore, in consideration of the foregoing and the mutual covenants, conditions, and provisions contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.1 “Agreement Year” means (a) the initial period following the Effective Date and ending on December 31, 2023, and (b) each consecutive twelve (12) month period thereafter occurring during the Term, provided that the last Agreement Year during the Term shall terminate upon the expiration or termination of this Agreement. |
1.2 “Annual Product Quality Review” means review of written records, including the Product Specifications, maintained and required by Part 211 of Title 21 of the U.S. Code of Federal Regulations and other requirements under Applicable Laws and/or by applicable Regulatory Authorities in the United States to evaluate the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. |
1.3 “Applicable Laws” has the meaning set forth in the Product Rights Agreement; provided, that notwithstanding anything to the contrary in this Agreement, [***]. |
1.7 “Components” means, collectively, all packaging components, raw materials, ingredients, including active pharmaceutical ingredients, and other materials (including injectors, labels, product inserts and other labelling for the Product) required to manufacture the Product in accordance with the Product Specifications. |
1.12 “Recall” means any action (a) by a Party to recover title to or possession of quantities of the Product sold or shipped to Third Parties (including, without limitation, the 2
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voluntary withdrawal of the Product from the market), or (b) by any Regulatory Authorities to seize or destroy the Product. A Recall shall also include [***]. |
ARTICLE 2. |
the Product on Alimera’s behalf and receive the technology transfer (the “Manufacturing Transfer Notice”). For the sake of clarity, Alimera may submit the Manufacturing Transfer Notice to EyePoint effective during the Initial Term. |
(c) Following the transfer contemplated by the Manufacturing Transfer Plan, Alimera shall ensure that the supply of the Product Manufactured by or on behalf of Alimera and its Affiliates that is introduced into the market for sale in the Field in the Licensed Territory meets all quality standards required by Applicable Law, including cGMP. If Alimera exercises the Manufacturing Transfer Election, then [***], it will [***] support, or find a Third Party to support, the Manufacturing of the Product for the Commercialization of YUTIQ by Ocumension (or any successor Third Party Licensee) in the Ocumension Field in the Ocumension Territory; provided, that Alimera acknowledges and agrees that Ocumension’s prior written consent is required in connection with any change to the Manufacturing and supply arrangements for YUTIQ for use in the Ocumension Field in the Ocumension Territory. |
(e) Notwithstanding anything to the contrary set forth in this Agreement or the Product Rights Agreement, EyePoint shall have no obligation to conduct [***] technology transfer of the Manufacturing process for the Product to Alimera or its designee. |
2.3 Components and Equipment. EyePoint will purchase or lease, at its own cost, all Components and equipment used in the Manufacturing Services, which cost shall be factored into the Unit Price in accordance with Section 5.2. |
2.4 Capacity; Inventory. Alimera acknowledges that (a) during the initial two (2) year period following the Effective Date (the “Initial Term”), EyePoint plans to build its inventory 4
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of finished Product in order to meet demand, and (b) EyePoint anticipates meeting its supply obligations under this Agreement from existing inventory of the Product and does not anticipate Manufacturing Product to order (it being understood and agreed by Alimera that the foregoing statement is not intended to be a binding obligation of EyePoint under this Agreement). EyePoint shall [***] maintain, at its election, capacity and/or inventory of finished Product (or Components sufficient to Manufacture finished Product) adequate to fulfill the Firm Order of each Rolling Forecast. EyePoint shall provide written notice to Alimera as soon as practicable of any event or issue that would reasonably be expected to adversely affect EyePoint’s capacity to supply the Product to Alimera hereunder in any material respect, including a supply shortage, and shall [***] resolve, [***], any such event or issue. If EyePoint experiences a supply shortage resulting from circumstances outside of EyePoint’s reasonable control that renders EyePoint unable to supply the ordered quantity of Product to both Alimera and Ocumension, then EyePoint shall be entitled to deliver [***], until such supply shortage is resolved, and such reduced delivery shall not be deemed to be a breach of this Agreement; provided, that in determining such allocation of Product, EyePoint may [***]. |
2.5 Improvements to Manufacturing Process. [***] the Parties shall discuss [***] potential improvements to the Manufacturing process for the Product at the Facility. Neither Party has any obligation to agree to implement or bear financial or other responsibility for any improvements to the Manufacturing process for the Product at the Facility. Any agreement by the Parties to implement any such improvements will be documented in writing and mutually agreed upon by the Parties. |
(b) At least [***][***] prior to the beginning of each Calendar Quarter occurring during the Term, Alimera shall deliver to EyePoint a proposed [***] rolling forecast of the quantities of the Product that Alimera expects to order [***] (the “Rolling Forecast”). The Parties shall [***][***] review each Rolling Forecast proposed by Alimera and discuss any limitations on the quantities of Product requested by Alimera for [***] of the Rolling Forecast based on capacity and other relevant factors. The Parties shall [***] agree on the Rolling Forecast for [***] within [***] after EyePoint’s receipt thereof. EyePoint will automatically be deemed to have accepted such portion of the Rolling Forecast if it has not sent written notice to Alimera of its rejection of such portion within [***] after EyePoint receives the Rolling Forecast. Such written notice must include [***] its reason for rejecting such portion of the Rolling Forecast and the amounts that it can accept for such period. If EyePoint provides such written notice to Alimera, then the Parties shall [***] agree on [***] of the Rolling Forecast within [***] after Alimera’s receipt thereof, and if the Parties are not able to agree on such portion of the Rolling Forecast during such period, then 5
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3.2 Purchase Orders. |
(b) This Agreement, together with the Product Rights Agreement, sets forth the exclusive contract terms between the Parties with respect to, and shall apply to, all orders for the Product. Any terms in a Purchase Order, sales order, invoice or other notice submitted by either Party to the other Party that are different from or additional to the provisions hereof shall be null and void notwithstanding EyePoint’s delivery of, and Alimera’s acceptance of, the Product under such Purchase Order, sales order, invoice or other notice containing such terms. |
3.3 Delivery and Storage. |
designated by EyePoint. EyePoint shall, if possible, provide Alimera notice of the anticipated delivery date at least [***] prior to delivery, and under all circumstances shall provide notice of the anticipated delivered date at least [***] prior to delivery, and if such delivery date changes, EyePoint shall [***] provide Alimera notice of such change. The Product will be shipped via a carrier designated in writing by Alimera to the location specified by Alimera in the applicable Purchase Order. EyePoint shall include a Certificate of Analysis and a Certificate of Compliance with each shipment of the Product. |
(b) If EyePoint stores the Product on Alimera’s behalf at the 3PL Facility, title and risk of loss will pass to Alimera upon [***]. |
(c) Prior to delivery, the Product at the Facility and the 3PL Facility will be stored in a clean, secured and segregated area and otherwise in accordance with Applicable Laws and the storage specifications for the Product as agreed upon between the Parties in writing and in accordance with the Quality Agreement, cGMP and the Product label. |
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(c) Alimera shall retain in accordance with the Product Specifications any portion of a shipment of Product that is Nonconforming Product and subject to a Deficiency Notice. [***] Alimera shall [***] provide to EyePoint (i) [***], and (ii) [***]. |
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actions for the Product in the U.S. market will be made at Alimera’s cost and expense, including any costs incurred by EyePoint to provide assistance reasonably requested by Alimera in connection therewith. |
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5.5 Interest. Section 6.6 of the Product Rights Agreement and the defined terms used therein shall apply, mutatis mutandis, as between the Parties hereto as if set forth herein. |
5.6 Taxes. All fees are exclusive of, and Alimera shall be solely responsible for, any sales or import related taxes, including value-added tax or importation duties, related to the Product supplied under this Agreement. EyePoint shall be solely responsible for taxes in respect of its income. |
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(c) Neither EyePoint, nor any of its officers, directors or employees are suspended, debarred, or proposed for debarment under Section 21 U.S.C. 335a. EyePoint agrees to [***] notify Alimera if such debarment occurs or comes to its attention, and shall, with respect to any person so debarred [***] remove such person from performing any Manufacturing Services. |
6.3 Product Specifications. Subject to Section 5.3(b), any changes to the Product Specifications shall require the mutual written agreement of the Parties. |
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6.7 Cure of Deficiencies and Other Issues. |
(b) If EyePoint is late in delivering Product to Alimera or its designee, or delivers a shipment of Product that includes a shortfall, EyePoint shall [***] prevent future late deliveries and shortfalls. Upon the request of Alimera, EyePoint shall discuss with Alimera the reason for any late delivery or shortfall and EyePoint’s plan to prevent future late deliveries and shortfalls. |
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7.1 Incorporation of Confidentiality Provisions in Product Rights Agreement. Article 7 of the Product Rights Agreement and the defined terms used therein shall apply, mutatis mutandis, as between the Parties hereto as if set forth herein. |
ARTICLE 9. |
9.2 Material Breach of Payment Obligations. EyePoint shall have the right to suspend its obligations under this Agreement if Alimera fails to make payment of any undisputed amount under this Agreement within [***] following written notice from EyePoint that such amount is past due. |
9.3 Automatic Termination. This Agreement shall automatically terminate upon termination of the Product Rights Agreement. |
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10.1 Claims for Indemnification. Claims for indemnification relating to this Agreement may only be made in accordance with Article 9 of the Product Rights Agreement, subject to Section 10.2 below. |
10.4 Insurance. Section 9.8 of the Product Rights Agreement shall apply to this Agreement, mutatis mutandis, as between the Parties hereto as if set forth herein. |
{Signature Page Follows}
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In Witness Whereof, the Parties intending to be bound have caused this Commercial Supply Agreement to be executed by their duly authorized representatives as of the Effective Date.
EYEPOINT PHARMACEUTICALS, INC. |
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By: | /s/ Nancy Lurker |
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Name: | Nancy Lurker |
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Title: | Chief Executive Officer |
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ALIMERA SCIENCES, INC. |
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By: | /s/ Richard S. Eiswirth, Jr. |
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Name: | Richard S. Eiswirth, Jr. |
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Title: | Chief Executive Officer |
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[Signature Page to Commercial Supply Agreement]
EXHIBIT A
PRODUCT SPECIFICATIONS
EXHIBIT B
INITIAL ROLLING FORECAST
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] | [***] |
Exhibit B-1