UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 16, 2023
ALIMERA SCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-34703 |
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20-0028718 |
(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
6310 Town Square, Suite 400 Alpharetta, Georgia |
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30005 |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (678) 990-5740
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Not Applicable |
(Former name or former address, if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, $0.01 par value per share |
ALIM |
The Nasdaq Stock Market LLC (Nasdaq Global Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 1.01. Entry into a Material Definitive Agreement.
Product Rights Agreement
On May 17, 2023 (the “Closing Date”), Alimera Sciences, Inc. (“Alimera” or the “Company”) entered into a product rights agreement (the “Product Rights Agreement”) with EyePoint Pharmaceuticals, Inc. (“EyePoint”) whereby Alimera was granted an exclusive and sublicensable (in accordance with the terms of the Product Rights Agreement) right and license (the “License”) under EyePoint’s and its affiliates’ interest in certain of EyePoint’s and its affiliates’ intellectual property to develop, manufacture, sell, commercialize and otherwise exploit certain products, including YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg, for the treatment and prevention of uveitis in the entire world, except Europe, the Middle East and Africa (the “Licensed Territory”). The Licensed Territory excludes such territories because Alimera had previously licensed from EyePoint rights to certain products, which included YUTIQ (known as ILUVIEN® in Europe, the Middle East and Africa) for the treatment and prevention of uveitis in Europe, the Middle East and Africa pursuant to that certain Second Amended and Restated Collaboration Agreement, dated as of July 10, 2017, by and between pSivida, US, Inc. (f/k/a Control Delivery Systems, Inc.) (n/k/a EyePoint Pharmaceuticals U.S., Inc., an affiliate of EyePoint) and Alimera. The License also excludes any rights to YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye in China and certain other countries and regions in Asia, which rights are subject to a pre-existing exclusive license between EyePoint and Ocumension Therapeutics.
Additionally, pursuant to the Product Rights Agreement, EyePoint will transfer and assign to Alimera certain assets (the “Transferred Assets”) and certain contracts with third parties related to YUTIQ (collectively, the “Asset Transfer” and together with the License, the “Transaction”), including the new drug application #210331 for YUTIQ (the “YUTIQ NDA”). The Transaction closed on the Closing Date.
Pursuant to the Product Rights Agreement, Alimera has paid to EyePoint an upfront payment of $75 million (the “Upfront Payment”). Alimera will also make four quarterly guaranteed payments to EyePoint totaling $7.5 million during 2024 (“Guaranteed Payments”). Alimera will also pay royalties to EyePoint from 2025 to 2028 at a percentage of mid-to-low double digits of Alimera’s annual U.S. net sales of certain products (including YUTIQ and ILUVIEN) in excess of certain thresholds, beginning at $70 million in 2025, increasing annually thereafter (“Royalties”). Upon Alimera’s payment of the Upfront Payment and the Guaranteed Payments, the licenses and rights granted to Alimera will automatically become perpetual and irrevocable.
Unless terminated earlier, the Product Rights Agreement has a term that continues until the latest of (a) the expiration of the YUTIQ NDA, (b) the receipt by EyePoint of the Upfront Payment, all Guaranteed Payments and all Royalties (assuming that all such amounts have become payable in accordance with the terms of the Product Rights Agreement), and (c) such time when Alimera and its affiliates and sublicensees permanently cease commercializing and otherwise exploiting certain products (including YUTIQ) in the Licensed Territory.
During the term of the Product Rights Agreement and subject to certain exceptions set forth in the Product Rights Agreement, EyePoint and its affiliates will not directly or indirectly develop or commercialize or otherwise exploit certain products meeting the criteria specified in the Product Rights Agreement (including YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg and ILUVIEN (fluocinolone acetonide intravitreal implant) 0.19 mg) (the “Competing Products”) for the treatment and prevention of eye diseases in humans in the Licensed Territory. Subject to the licenses and rights granted to Alimera and the restrictive covenants described in the foregoing sentence, nothing in the Product Rights Agreement restricts or limits EyePoint’s right to exploit any product other than the Competing Products, including EYP-1901 and any intravitreal implant (whether bioerodible or non-erodible) utilizing any technology (including EyePoint’s Durasert® technology).
The Product Rights Agreement may be terminated by EyePoint (a) immediately upon written notice to Alimera if Alimera has failed to cure in full certain breaches of its other obligations to pay under the Product Rights Agreement within the specified notice period following written notice by EyePoint to Alimera of such breach, or (b) upon any repudiation or rejection by Alimera of its obligations under the Product Rights Agreement or any other transaction documents contemplated therewith in the event of any insolvency event of Alimera. Upon termination of the Product Rights Agreement by EyePoint prior to expiration, among other things, all licenses and rights granted to Alimera will terminate; the other related transaction agreements will terminate; and if the Product Rights Agreement is terminated
by EyePoint for failure by Alimera to make certain payments, Alimera will assign back to EyePoint at no cost to EyePoint then-existing Transferred Assets and grant to EyePoint a non-exclusive, worldwide and fully paid-up license under Alimera’s intellectual property rights to exploit certain products for the treatment and prevention of uveitis in the Licensed Territory.
The Product Rights Agreement further provides that EyePoint and Alimera will indemnify each other for losses arising from certain breaches of the Product Rights Agreement, including breaches of certain representations and warranties, and for certain other matters and subject to certain limitations as more fully described in the Product Rights Agreement.
Alimera also entered into a transition services agreement with EyePoint under which EyePoint has agreed to provide certain transition services to Alimera on a cost-plus pricing arrangement for a limited period of time following the Closing Date.
Commercial Supply Agreement
In connection with the Transaction, Alimera entered into a commercial supply agreement (the “Supply Agreement”) with EyePoint pursuant to which, during the term of the Product Rights Agreement, EyePoint will be responsible for manufacturing and exclusively supplying (subject to certain exceptions set forth in the Supply Agreement) to Alimera agreed-upon quantities of YUTIQ necessary for Alimera to commercialize YUTIQ in the United States at certain cost plus amounts, subject to adjustments set forth in the Supply Agreement.
EyePoint’s manufacture and supply to Alimera of YUTIQ under the Supply Agreement will be exclusive (subject to certain exceptions set forth in the Supply Agreement) until Alimera has the right and ability to manufacture and supply YUTIQ for commercialization in the United States. During the period of exclusivity, Alimera is prohibited from manufacturing, having manufactured or obtaining a commercial supply of YUTIQ for sale in the United States other than from EyePoint without EyePoint’s prior written consent or as otherwise agreed pursuant to the Supply Agreement. The exclusive obligations will automatically terminate if, among other things, EyePoint fails to meet certain deadlines and other requirements set forth in the Supply Agreement.
Alimera may elect to manufacture YUTIQ after an initial 18-month term following the Closing Date upon the satisfaction of certain conditions including completion of a technology transfer, at which time EyePoint and Alimera would comply with certain provisions set forth in the Supply Agreement to accomplish such transfer of responsibilities.
The term of the Supply Agreement is for a period of two (2) years, and shall thereafter automatically renew for successive one (1) year terms unless either party provides notice of non-renewal to the other party within a specified period of time prior to the beginning of the next automatic renewal term; provided, that the term of the Supply Agreement automatically terminates upon the successful completion of the transfer of manufacturing for YUTIQ to Alimera or its designee in accordance with the Supply Agreement. The Supply Agreement also automatically terminates upon termination of the Product Rights Agreement.
The Product Rights Agreement and the Supply Agreement contain customary representations and warranties. The assertions embodied in the representations and warrants were made solely for purposes of the Transaction and may be subject to important qualifications and limitations. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to stockholders or may have been used for purpose of allocating risk between Alimera and EyePoint rather than establishing matters as facts. For the foregoing reasons, no person should rely on such representations and warranties as statements of factual information at the time they were made or otherwise.
The description of the Product Rights Agreement and the Supply Agreement in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the full text of the Product Rights Agreement and the Supply Agreement, copies of which are filed as Exhibits 2.1 and 10.1 hereto, respectively, and incorporated herein by reference.
Joinder and Amendment to Securities Purchase Agreement
On May 17, 2023, Alimera entered into a joinder and amendment (the “Purchase Agreement Amendment”) to its Securities Purchase Agreement dated March 24, 2023, among Alimera and the purchasers party thereto (such purchasers, the “Original Investors” and such agreement as amended by the Purchase Agreement Amendment, the “Purchase Agreement”). The Purchase Agreement Amendment added certain investors (the “New Investors” and together with the Original Investors, the “Investors”) as parties to the Purchase Agreement with respect to the Tranche 2 Closing (as defined below) and amended certain provisions of the Purchase Agreement. Pursuant to the Purchase Agreement, on May 17, 2023, Alimera issued 66,617 shares of its Series B Convertible Preferred Stock, par value $0.01 per share (the “Series B Preferred”) and 1,401,901 shares of its common stock, par value $0.01 per share (the “Common Stock”), for an aggregate purchase price of $69.0 million (the “Tranche 2 Closing”). Further, pursuant to the terms of the Purchase Agreement Amendment, Alimera and the Original Investors agreed to reduce the number of shares of Common Stock issuable upon exercise of warrants originally issued and sold to the Original Investors from 5,714,286 to 1,600,000 (the “Warrants”). The proceeds from the Tranche 2 Closing were utilized by Alimera to fund a portion of the upfront cash payment due upon closing of the Transaction.
The Purchase Agreement Amendment amended the director designation rights held by Caligan Partners LP and its affiliates (collectively, “Caligan”) and (ii) Velan Capital Master Fund LP and an affiliate (collectively, “Velan”). Velan received the right to designate one additional director for election to Alimera’s board of directors (the “Board”) upon the Tranche 2 Closing. Caligan received the right to have an additional Board observer seat upon the Tranche 2 Closing, which will convert into a right to designate one additional director for election to the Board upon Stockholder Approval (as defined below). Additionally, the Purchase Agreement Amendment clarified that for so long as (i) Caligan or (ii) Velan beneficially holds 50% or more of the shares of Common Stock that such investor and its affiliates acquired pursuant to the Purchase Agreement (calculated on as-converted basis based on the applicable conversion price), such investor and its affiliates shall have the right to designate a director for election to the Board, provided that if any such investor’s ownership position in Alimera is materially reduced, whether through sales by such investor or additional issuances by Alimera, such right shall be concomitantly reduced in any year if required by applicable listing rules of The Nasdaq Stock Market.
Further, the Purchase Agreement Amendment granted the New Investors participation rights in future equity financings consummated by Alimera consistent with the participation rights of the Original Investors. Accordingly, so long as an Investor owns a number of shares of Common Stock equal to at least 25% of the shares of Common Stock purchased pursuant to the Purchase Agreement (on an as-converted basis), such Investor is entitled to certain participation rights if Alimera elects to offer or sell new securities (a “Subsequent Financing”) in either a private or public offering. Alimera is obligated to notify such Investor of any Subsequent Financing and its terms, and such Investor will have the right, subject to certain exceptions, to purchase or otherwise acquire in a separate private placement, at the price and on the terms specified in the notice provided by Alimera, up to such number of new securities which equals the proportion that the number of shares of Common Stock then held by such Investor bears to the total number of shares of Common Stock then outstanding, assuming the sale of new securities in the Subsequent Financing and the full conversion and/or exercise, as applicable, of all derivative securities of Alimera then outstanding.
The Purchase Agreement Amendment is filed as Exhibit 10.2 to this Current Report on Form 8-K. The foregoing description of the Purchase Agreement Amendment and the Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to such documents.
Certificate of Amendment to Certificate of Designation of Series B Convertible Preferred Stock
The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series B Preferred are set forth in the Certificate of Designation of Series B Convertible Preferred Stock (the “Certificate of Designation”), as amended by the Certificate of Amendment to the Certificate of Designation of Series B Convertible Preferred Stock (the “Certificate of Amendment”), which Alimera filed with the Secretary of State of the State of Delaware on May 16, 2023. Alimera intends to hold a meeting of its stockholders to approve the issuance of Common Stock upon conversion of the Series B Preferred and exercise of the Warrants in excess of the conversion limitations set forth in the Certificate of Designation, as amended (“Stockholder Approval”). The Certificate of Amendment amended and restated various terms of the Certificate of Designation, including, but not limited, to:
Authorized Shares. The authorized number of shares of Series B Preferred Stock increased to 78,617.
Conversion Price. The initial conversion price of the shares of Series B Preferred issued at the Tranche 2 Closing was set at $1.70, subject to certain customary adjustments, including a weighted average anti-dilution adjustment.
Conversion Limitations. In addition to the existing conversion limitations contemplated in the Certificate of Designation, the aggregate number of shares of Common Stock that may be issued at the Tranche 2 Closing pursuant to the Purchase Agreement, as amended, and the transactions contemplated thereby may not exceed 1,401,901 (19.99% of the voting power or number of shares of Common Stock, issued and outstanding immediately prior to the execution of the Purchase Agreement) (the “Acquisition Cap”).
Series B Directors. Effective as of the Tranche 2 Closing and subject to the provisions of the Purchase Agreement, as amended, Velan received the right to designate one additional director for election to the Board.
Voting Rights. The amount of indebtedness Alimera is permitted to incur under its credit facility with SLR Investment Corp. (“SLR”) without consent of the holders of a majority of the outstanding shares of capital stock issued pursuant to the Purchase Agreement (the “Preferred Majority”) increased to $67,500,000. Additionally, pursuant to the Certificate of Amendment, consent of the Preferred Majority is required for Alimera to permit the acquisition of Alimera by means of merger, consolidation, stock sale or other corporate reorganization, or to sell all or virtually all of Alimera’s assets.
The Certificate of Amendment is filed as Exhibit 3.1 to this Current Report on Form 8-K. The foregoing description of the Certificate of Amendment and the Series B Preferred does not purport to be complete and is qualified in its entirety by reference to such exhibit and to the Certificate of Designation.
Sixth Amendment to Loan and Security Agreement and Amendment to Exit Fee Agreements
On May 17, 2023, Alimera entered into the Sixth Amendment (the “Amendment”) to its Loan and Security Agreement dated December 31, 2019, with SLR as collateral agent, and the lenders party thereto, including SLR in its capacity as a lender (each a “Lender” and collectively, the “Lenders”) (as amended by the First Amendment dated as of May 1, 2020, the Second Amendment dated as of March 30, 2021, the Third Amendment dated as of February 22, 2022, the Fourth Amendment dated December 7, 2022, and the Fifth Amended dated March 24, 2023, the “Loan Agreement,” and as further amended by the Amendment, the “Amended Loan Agreement”).
Pursuant to the Amendment, the Lenders agreed to, among other things, increase the amount available for an additional term loan under the facility from $15,000,000 to $20,000,000, and fund the full amount under such term loan on May 17, 2023. The draw was used to pay a portion of the upfront cash payment due upon the closing of the Transaction. The Amendment also specifies the minimum revenue amount, calculated on a trailing six-month basis and tested at the end of each calendar quarter in 2023 and 2024, that Alimera must achieve for each such period.
The maturity date of the Amended Loan Agreement remains April 30, 2028, and the interest-only period remains in effect through April 30, 2025. As previously disclosed, the interest-only period may be extended an additional 12 months if Alimera meets certain financial targets by March 31, 2025. Upon execution of the Amendment, Alimera paid the Lenders a non-refundable amendment fee of $211,000.
Alimera is also obligated to pay additional fees under its existing fee agreements, as amended by the Omnibus Amendment to Exit Fee Agreements (the “Exit Fee Amendment”) dated as of May 17, 2023, by and among Alimera, SLR as collateral agent, and the Lenders. The Exit Fee Amendment amended Alimera’s existing exit fee agreements to include references to YUTIQ in the calculation of aggregate revenues used to determine sales milestone events. The fees payable pursuant to Alimera’s existing exit fee agreements, as amended, will not exceed $3,387,500 in total.
The foregoing descriptions of the terms and conditions of the Amendment and the Exit Fee Amendment do not purport to be complete and are qualified in their entirety by the full text of the Amendment and the Exit Fee Amendment, which Alimera intends to file as exhibits to its Quarterly Report on Form 10-Q for the quarter ending June 30, 2023.
Item 2.01 Completion of Acquisition or Disposition of Assets.
The information set forth in Item 1.01 is incorporated herein by reference.
Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
The information disclosed in Item 1.01 is incorporated herein by reference.
Item 3.02. Unregistered Sales of Equity Securities
The information set forth in Item 1.01 is incorporated herein by reference.
Item 3.03 Material Modification to Rights of Security Holders
The information disclosed in Item 1.01 and Item 5.03 is incorporated herein by reference.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(b)
In connection with the appointment of one additional director by Velan pursuant to the Purchase Agreement Amendment, and as described under Item 1.01, Garheng Kong, M.D., Ph.D. resigned from the Board effective as of the Tranche 2 Closing on May 17, 2023. This resignation was not the result of any dispute or disagreement with Alimera or the Board on any matter relating to Alimera’s operations, policies, or practices. Alimera greatly appreciates Dr. Kong’s dedicated service as a director and wishes him the best in his future endeavors.
(d)
As described under Item 1.01, upon the Tranche 2 Closing, Velan had the right to designate one additional director for election to the Board. Accordingly, and based in part upon the recommendation of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”), the Board appointed Jason Werner to the Board on May 17, 2023, as a Class II director and as a designee of Velan. In addition, the Board appointed Mr. Werner to the Nominating Committee.
In connection with his election to the Board and pursuant to Alimera’s non-employee director compensation program (the “Director Compensation Program”), the Compensation Committee of the Board granted Mr. Werner options to purchase 921 shares of Common Stock at an exercise price of the closing price per share of the Common Stock on May 18, 2023, the first trading date after his appointment to the Board. The options will vest and become exercisable in monthly installments of 460 shares and 461 shares on June 12, 2023 and July 12, 2023, respectively, with the final installment to be adjusted as necessary to avoid any fractional shares in any installment, provided Mr. Werner provides continuous service to Alimera through the applicable vesting date. In the event of a change of control of Alimera or if Mr. Werner’s service terminates due to death or disability, the options will accelerate and immediately become exercisable. Also pursuant to the Director Compensation Program, Mr. Werner will receive a $40,000 annual retainer for his service on the Board and a $4,000 annual retainer for his service on the Nominating Committee, with such retainers initially to be prorated to Alimera’s 2023 annual meeting of stockholders. In addition, under the Director Compensation Program, Mr. Werner will be eligible to receive, upon the conclusion of each annual meeting of stockholders beginning in 2023, options to purchase an additional 6,000 shares of Common Stock, provided he is then continuing to serve on the Board.
Mr. Werner and Alimera have also entered into an indemnification agreement requiring Alimera to indemnify him to the fullest extent permitted under Delaware law with respect to his service as a director. The indemnification agreement is in the form Alimera has entered into with its other directors and executive officers.
Alimera had previously entered into a consulting agreement dated April 4, 2023 (the “Consulting Agreement”), with an entity controlled by Mr. Werner, pursuant to which Mr. Werner was entitled to up $240,000 annually for services performed under such agreement, not to exceed $20,000 per month. In connection with Mr. Werner’s election to the Board, Alimera terminated the Consulting Agreement. Prior to the termination of the Consulting Agreement, less than $10,000 was paid or payable to Mr. Werner for his services thereunder.
Item 5.03. Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
In connection with the Tranche 2 Closing, on May 16, 2023, Alimera filed the Certificate of Amendment with the Secretary of State of the State of Delaware authorizing the additional shares of Series B Preferred Stock and the changes to such series described in Item 1.01. The Certificate of Amendment is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 8.01. Other Events.
On May 18, 2023, Alimera issued a press release announcing the Transaction, the Tranche 2 Closing and the Amendment. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
Financial Statements of Business Acquired.
(a)The registrant hereby undertakes to file the financial statements if required by this Item 9.01(a) not later than 71 days after the date this Form 8-K was due for filing.
Pro Forma Financial Statements.
(b)The registrant hereby undertakes to file the pro forma financial information if required by this Item 9.01(b) not later than 71 days after the date this Form 8-K was due for filing.
(d) Exhibits
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Exhibit No. |
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Description |
2.1* |
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3.1 |
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Certificate of Amendment to Certificate of Designation of Series B Convertible Preferred Stock |
10.1* |
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10.2 |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the inline XBRL document) |
* Certain confidential information contained in this agreement has been omitted because it is (i) not material and (ii) something the company actually treats as confidential.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ALIMERA SCIENCES, INC. |
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Dated: May 18, 2023 |
By: |
/s/ Russell L. Skibsted |
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Name: |
Russell L. Skibsted |
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Title: |
Chief Financial Officer and Senior Vice President |
Exhibit 2.1
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.
PRODUCT RIGHTS AGREEMENT
between
EyePoint Pharmaceuticals, Inc.
and
Alimera Sciences, Inc.
May 17, 2023
TABLE OF CONTENTS
Page
ARTICLE 1 DEFINITIONS.................................................................................................................1
ARTICLE 2 LICENSES AND OTHER RIGHTS.....................................................................................17
2.1...................................................................................License Grants to Alimera17
2.2.............................................................................................................Retained Rights18
2.3.....................................................................................................Right to Sublicense18
2.4.................................................................................................Right to Subcontract18
2.5.....................................................................................................................Deliverables19
2.6.................................................................................License Grants to EyePoint20
2.7.................................................................................................No Implied Licenses20
2.8.........................................................................................................................Exclusivity20
2.9.....................................................................Right to Use EyePoint Materials21
ARTICLE 3 Asset Transfer and Assumption of Liabilities.............................................................................21
3.1...........................................................................................................................Generally21
3.2.............................................................................................Transferred Contracts21
3.3.....................................................................................Closing of Asset Transfer21
3.4.................................................................Assignment of Transferred Assets22
3.5...............Assumption of Assumed Liabilities; Excluded Liabilities22
3.6.......................................................Transfer Documentation; Cooperation22
3.7.......................................................................................Maintenance of Business23
ARTICLE 4 REGULATORY MATTERS...............................................................................................24
4.1Maintenance of YUTIQ NDA; Interactions with Regulatory Authorities and Regulatory Filings24
4.2.............................................................................................Reporting Obligations27
4.3.....................................................................................Adverse Event Reporting27
4.4.................................................................................................No Harmful Actions27
4.5...............................................................................Notice of Regulatory Action28
4.6.....................................................................................................................................Recalls28
4.7...............................................................................................Current Clinical Trials29
ARTICLE 5 COVENANTS...............................................................................................................29
5.1.......................................................................................................Supply Obligation29
5.2.............................Development and Commercialization Obligations29
5.3.....................Commercialization Reports and Information Sharing30
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5.4...............................................................................................EyePoint Trademarks30
5.5.........................................................................................Use of EyePoint Names31
5.6...........................................................................................................................Diversion31
5.7.........................................................................Transition Services Agreement32
5.8...........................................................................................Covenants of EyePoint32
5.9.............................................................................................Compliance with Law32
5.10.............................................................................................Employee Covenants32
5.11...........................................................UKRF Licenses and B&L Agreement33
5.12.......................Subcontractors and Third Party Service Providers33
5.13.....................................................................................................................YUTIQ 5033
5.14.......................................................................................................................................[***]Error! Bookmark not defined.
ARTICLE 6 PAYMENTS.................................................................................................................34
6.1.........................................................................................................Upfront Payment34
6.2.............................................................................................Guaranteed Payments34
6.3.................................................................................................................................Royalties34
6.4...........................................................................................................Royalty Reports34
6.5.........................................................................................................Payment Method35
6.6.....................................................................................................................................Interest35
6.7.........................................................................................................................................Taxes35
6.8.............................................................................Allocation of Purchase Price36
6.9.............................................................................................................Financial Audits36
ARTICLE 7 CONFIDENTIALITY; PUBLICATION...............................................................................37
7.1.........................................................................................Confidential Information37
7.2.........................................................................................................................Disclosure37
7.3.......................................................................................Disclosure of Agreement38
ARTICLE 8 REPRESENTATIONS AND WARRANTIES.........................................................................39
8.1...................................Representations and Warranties of Each Party39
8.2.........................................Representations and Warranties of EyePoint40
8.3...........................................Representations and Warranties of Alimera41
8.4.....................................................Debarment; Exclusion; Disqualification42
8.5.........................................................................NO OTHER WARRANTIES42
ARTICLE 9 INDEMNIFICATION.....................................................................................................43
9.1...................................................................................................................................Survival43
9.2...........................................................................................................................Indemnity43
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9.3Losses Net of Insurance Proceeds and Other Third-Party Recoveries43
9.4...........................Indemnification Procedure for Third Party Claims44
9.5...............Indemnification Procedure for Non-Third Party Claims45
9.6.................................................................................................Mitigation of Losses45
9.7...............................................................................................Limitation of Liability45
9.8...........................................................................................................................Insurance46
ARTICLE 10 INTELLECTUAL PROPERTY.........................................................................................46
10.1.....................................................................................................................Ownership46
10.2.Patent Prosecution, Maintenance, Enforcement and Defense46
10.3.............................................................................................EyePoint Trademarks50
10.4...........................................................................Common Interest Agreement51
10.5.............................................Maintenance of EyePoint Domain Names52
ARTICLE 11 TERM AND TERMINATION...........................................................................................52
11.1.......................................................................................................................................Term52
11.2.....................................................................................................................Termination52
11.3...............................................................................................Effect of Termination52
11.4.................................................................................................Rights in Insolvency53
11.5...........................................................................................................Accrued Rights54
11.6.................................................................................................................................Survival54
ARTICLE 12 MISCELLANEOUS.....................................................................................................54
12.1...........................................................................................................Force Majeure54
12.2.....................................................................................................................Assignment54
12.3.....................................................................................................................Severability54
12.4.................................................................................................................................Notices55
12.5...........................................................................................................Governing Law56
12.6...................................................................................................Internal Resolution56
12.7...................................................................................................Binding Arbitration56
12.8.............................................................................................................................Headings57
12.9...................................................................................Independent Contractors57
12.10.................................................................................................................................Waiver57
12.11...................................................................Waiver of Rule of Construction57
12.12.................................Cumulative Remedies; Recovery of Damages57
12.13...........................................................................Business Day Requirements57
12.14.........................................................................................................Further Actions57
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12.15...............................................................................................................Construction57
12.16...................................................................Entire Agreement; Amendments58
12.17...............................................................................................................Counterparts58
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In Witness Whereof, the Parties intending to be bound have caused this Product Rights 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 the Product Rights Agreement]
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.
List of Schedules and Exhibits
Schedule 1.56:Excluded Patent Rights
Schedule 1.67:EyePoint Domain Names
Schedule 1.68:EyePoint Existing Patent Rights
Schedule 1.73:EyePoint Names
Schedule 1.105:Non-Exclusive Trademarks
Schedule 1.148:Transferred Assets
Schedule 1.150Transferred Contracts
Schedule 1.155:UKRF Licenses
Schedule 1.167:YUTIQ-Specific Trademarks
Schedule 4.7:Current Clinical Trials
Schedule 8.2(k):Disclosure
Exhibit A:Bill of Sale
Exhibit B:Commercial Supply Agreement
Exhibit C:Transition Services Agreement
Exhibit D:Alimera FDA Transfer Letters
Exhibit E:EyePoint FDA Transfer Letters Schedule 1.56 Excluded Patent Rights
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.
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Schedule - 1
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.
Schedule 1.67 EyePoint Domain Names Schedule 1.68 EyePoint Existing Patent Rights
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Schedule - 1
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.
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Schedule - 1
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.
Schedule 1.73
EyePoint Names
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Schedule - 1
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.
Schedule 1.105
Non-Exclusive Trademarks
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Schedule - 1
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.
Schedule 1.148
Transferred Assets
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Schedule - 1
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.
Schedule 1.150
Transferred Contracts
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Schedule - 1
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.
Schedule 1.155
UKRF Licenses
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Schedule - 1
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.
Schedule 1.167
YUTIQ-Specific Trademarks
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Schedule - 1
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.
Schedule 4.7
Current Clinical Trials
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Schedule - 1
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.
Schedule - 2
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.
Schedule 8.2(k)
Disclosure
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Schedule - 1
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.
Exhibit A Bill of Sale Exhibit B Commercial Supply Agreement
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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.
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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.
Exhibit C Transition Services Agreement Exhibit D Alimera FDA Transfer Letters
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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.
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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.
Exhibit E
EyePoint FDA Transfer Letters
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Exhibit 3.1
ALIMERA SCIENCES, INC.
CERTIFICATE OF AMENDMENT
TO THE
CERTIFICATE OF DESIGNATION
OF
SERIES B CONVERTIBLE PREFERRED STOCK
(Pursuant to Section 242 of the General Corporation Law of the State of Delaware)
Pursuant to Section 242 of the General Corporation Law of the State of Delaware (the “DGCL”), Alimera Sciences, Inc. (the “Corporation”), a corporation organized and existing under the DGCL, does hereby certify that:
FIRST: Pursuant to the authority vested in the Board of Directors of the Corporation (the “Board of Directors”) by the Certificate of Incorporation of the Corporation, as amended (the “Certificate of Incorporation”), the Board of Directors, on May 13, 2023, in accordance with Section 242 of the DGCL, duly adopted resolutions setting forth proposed amendments to the Certificate of Designation of Series B Convertible Preferred Stock (the “Certificate of Designation”), with the effect of amending the Certificate of Designation as follows:
RESOLVED, that Section 1(a) of the Certificate of Designation is amended and restated in its entirety as follows:
“There shall be created from the 10,000,000 shares of Preferred Stock authorized to be issued by the Certificate of Incorporation, a series of Preferred Stock designated as “Series B Convertible Preferred Stock” (the “Series B Preferred Stock”), and the authorized number of shares of Preferred Stock constituting the Series B Preferred Stock shall be 78,617.”
RESOLVED, that Section 3(c) of the Certificate of Designation is amended and restated in its entirety as follows:
“(c)Unless waived by the Preferred Majority (as defined in the Purchase Agreement), the following shall be deemed to constitute a Liquidation Transaction: (i) any acquisition of the Corporation by means of merger, consolidation, stock sale, tender offer, exchange offer or other form of corporate reorganization in which outstanding shares of the Corporation are exchanged or sold, in one transaction or a series of related transactions, for cash, securities, property or other consideration issued, or caused to be issued, by the acquiring entity or its subsidiary, or any other person or group or affiliated persons and in which the holders of capital stock of the Corporation hold less than a majority of the voting power of the surviving entity and (ii) any sale, transfer, exclusive license or lease of all or substantially all of the properties or assets of the Corporation and its subsidiaries (each of such transactions in clause (i) and (ii), together with an actual liquidation, dissolution or winding up of the Corporation, a “Liquidation Transaction”), provided that none of the following shall be deemed to constitute a Liquidation Transaction: (w) the conversion of all or a portion of the Series B Preferred Stock into Common Stock; (x) a transaction for which the sole purpose is to change the state of the Corporation’s incorporation, (y) a transaction for which the sole purpose is to create a holding company that will hold no assets other than shares of the Corporation and that will have securities with rights preferences, privileges and restrictions substantially similar to those of the Corporation and that are owned in substantially the same proportions by the persons who held such securities of the Corporation, in each case immediately prior to such transaction or (z) a license transaction entered into by the Corporation for the purpose of developing and/or commercializing one or more of the Corporation’s products, so long as such license transaction would not be reasonably considered to be a sale or license of all or substantially all of the assets of the Corporation.”
RESOLVED, that Section 5(b) of the Certificate of Designation is amended and restated in its entirety as follows:
“(b)For so long as an Original Purchaser (as defined in the Purchase Agreement) of the Series B Preferred Stock beneficially holds 50% or more of the shares of Common Stock (calculated on as-converted basis based on the Applicable Conversion Price (as adjusted for stock splits, combinations, stock dividends, recapitalizations and the like)) such Original Purchaser acquired pursuant to the Purchase Agreement, such Original Purchaser shall have the right to designate up to one director for election to the Board of Directors; provided, however, that for any Original Purchaser that is affiliated with another Original Purchaser, such designation right shall apply collectively to such affiliated purchasers. Effective as of the Tranche 2 Closing Date, one Original Purchaser shall have the right to designate one additional individual director for election to the Board of Directors, and effective upon Stockholder Approval, the other Original Purchaser shall have the right to designate one additional individual director for election to the Board of Directors; provided, however, that the provisions of this Section 5(b) are subject to the limitations set forth in the Purchase Agreement, including, without limitation, the step-down requirements under applicable Nasdaq Stock Market (“Nasdaq”) rules.”
RESOLVED, that Section 6(a) of the Certificate of Designation is amended and restated in its entirety as follows:
“(a) Right to Convert; Optional Conversion. Prior to the conclusion of the Initial Meeting, the Series B Preferred Stock is not convertible into Common Stock or any other security of the Corporation. If Stockholder Approval is not obtained at the Initial Meeting, following conclusion of such meeting, each share of Series B Preferred Stock shall be convertible, at the option of the holder thereof, at any time, at the office of the Corporation or any transfer agent for such stock, into such number of fully paid and nonassessable shares of Common Stock as is determined by dividing (i) the Series B Original Issue Price plus any accrued but unpaid dividends to which such share of Series B Preferred Stock is then entitled by (ii) the then-effective Applicable Conversion Price, determined as hereinafter provided, in effect on the date the certificate is surrendered for conversion or notice is provided for non-certificated shares; provided, however, prior to Stockholder Approval, (y) no conversion of shares of Series B Preferred Stock into Common Stock shall exceed the Change of Control Cap, the Exchange Cap and the Ownership Limitation; and (z) no conversion of shares of Series B Preferred Stock issued at the Tranche 2 Closing Date (as defined in the Purchase Agreement) into Common Stock shall exceed the Acquisition Cap.”
RESOLVED, that Section 6(c)(ii) of the Certificate of Designation is amended and restated in its entirety as follows:
“With respect to the shares of Series B Preferred Stock issued at the Tranche 2 Closing Date, the initial Applicable Conversion Price shall be $1.70 (as adjusted for stock splits, combinations, stock dividends, recapitalizations and the like) per share (the “Tranche 2 Conversion Price”).”
RESOLVED, that Section 6(d) of the Certificate of Designation is amended and restated in its entirety as follows:
“Ownership Limitation. Unless and until the Stockholder Approval is obtained, no shares of Common Stock will be issued or delivered upon conversion of any Series B Preferred Stock, and no Series B Preferred Stock will be convertible, in each case to the extent, and only to the extent, that such issuance, delivery, conversion or convertibility would result in such holder of the Series B Preferred Stock (together with the holder’s affiliates and any other person whose beneficial ownership of Common Stock would be aggregated with the holder’s for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and applicable regulations, including any “group” (within the meaning of the Exchange Act) of which such Holder is a member beneficially owning in excess of either 4.99% or 9.99% (as designated by the applicable holder on the signature page of such Holder to the Purchase Agreement) of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon such conversion (the restrictions set forth in this sentence, the “Ownership Limitation”). Prior to obtaining Stockholder Approval, a holder of the Series B Preferred Stock, upon notice to the Corporation, may increase or decrease the Ownership Limitation provisions of this Section 6(d), provided that the Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon such conversion, the Exchange Cap or the Change of Control Cap immediately after giving effect to the issuance of shares of Common Stock upon conversion of the Series B Preferred Stock held by the holder. Any increase in the Ownership Limitation will not be effective until the 61st day after such written notice is delivered to the Corporation.”
RESOLVED, that Section 6(e) of the Certificate of Designation is amended and restated in its entirety as follows:
“Exchange Cap. Unless and until the Stockholder Approval is obtained, no shares of Common Stock will be issued or delivered upon conversion of any Series B Preferred Stock, and no Series B Preferred Stock will be convertible, in each case to the extent, and only to the extent, that such issuance, delivery, conversion or convertibility would cause the aggregate number of shares of Common Stock that would be issued pursuant to the Purchase Agreement and the transactions contemplated thereby to exceed 1,401,901 (19.99% of the voting power or number of shares of Common Stock, issued and outstanding immediately prior to the execution of the original Purchase Agreement), which number of shares shall be reduced, on a share-for-share basis, by the number of shares of Common Stock issued or issuable pursuant to any transaction or series of transactions that may be aggregated with the transactions contemplated by the Purchase Agreement under applicable Nasdaq rules (such maximum number of shares, the “Exchange Cap”).
RESOLVED, that a new Section 6(p) is added to the Certificate of Designation as follows:
“Acquisition Cap. Unless and until the Stockholder Approval is obtained, no shares of Common Stock will be issued or delivered upon conversion of any Series B Preferred Stock issued at the Tranche 2 Closing Date, and no Series B Preferred Stock issued at the Tranche 2 Closing Date will be convertible, in each case to the extent, and only to the extent, that such issuance, delivery, conversion or convertibility would cause the aggregate number of shares of Common Stock that would be issued pursuant to the conversion of the Series B Preferred Stock issued at the Tranche 2 Closing Date to exceed 1,401,901 (19.99% of the voting power or number of shares of Common Stock, issued and outstanding immediately prior to the execution of the original Purchase Agreement), which number of shares shall be reduced, on a share-for-share basis, by the number of shares of Common Stock issued or issuable pursuant to any transaction or series of transactions that may be aggregated with the transactions contemplated by the Purchase Agreement under applicable Nasdaq rules (such maximum number of shares, the “Acquisition Cap”).”
RESOLVED, that Section 7(a)(iii) of the Certificate of Designation is amended and restated in its entirety as follows:
“authorize, create, issue or obligate itself to issue (by reclassification, merger or otherwise) any security (or any class or series thereof) or any indebtedness, in each case that has any rights, preferences or privileges senior to, or on a parity with, the Series B Preferred Stock, or any security convertible into or exercisable for any such security or indebtedness (other than (1) the issuance of up to an aggregate of $67,500,000 of indebtedness pursuant to the Corporation’s credit facility with SLR Investment Corp., as the same may be amended, refinanced or resyndicated from time to time or (2) the issuance of up to an aggregate of $500,000 of indebtedness pursuant to operating, capital or equipment leases entered into in the ordinary course of business);”
RESOLVED, that a new Section 7(a)(vii) is hereby added to the Certificate of Designation as follows:
(vii) consummate a Liquidation Transaction.
SECOND: The foregoing amendments were duly adopted in accordance with the provisions of Section 103 and 242 of the DGCL.
IN WITNESS WHEREOF, the Corporation has caused this Certificate of Amendment to be signed by its President and Chief Executive Officer on May 16, 2023.
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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: President and Chief Executive Officer |
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:
ARTICLE 1.
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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, [***]. |
1.4 “Certificate of Analysis” as to any batch of the Product, means a certificate attesting to the results of testing of such batch of Product against the criteria specified in the Product Specifications, and including test methods, specification parameters and the pass/fail criteria, used to show that a particular batch of such Product meets the Product Specifications. |
1.5 “Certificate of Compliance” as to any batch of the Product, means a certificate attesting that such batch of a Product was Manufactured, stored and packaged for shipment in accordance with Applicable Laws, including cGMP. |
1.6 “cGMP” means current good manufacturing practices promulgated by the FDA, as specified in the U.S. Code of Federal Regulations (21 CFR Parts 210, 211 and 820) and interpreted by FDA’s guidance documents, as such practices govern the Manufacture of the Product intended for use in the United States. |
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. |
1.8 “Facility” means any facility owned by EyePoint or its Affiliate or any Third Party that is used in the conduct of the Manufacturing Services. As of the Effective Date, EyePoint Manufactures the Product at its facility located at 480 Pleasant St., Suite B300, Watertown, MA 02472. |
1.9 “Manufacturing Services” means the Manufacture by EyePoint or its Affiliates (directly or through Third Party contract manufacturers) of batches of the Product in final packaged and serialized form ordered by Alimera under this Agreement. |
1.10 “Nonconforming Product” means any Product supplied to Alimera by EyePoint under this Agreement that does not conform with the Product Requirements at the time that such Product is delivered to Alimera, regardless of the time of the discovery of such nonconformity. Each Nonconforming Product shall be regarded as having a “Nonconformity” which shall include any “Latent Defect” as set forth in Section 4.3. For clarity, [***]. |
1.11 “Product” as referred to in this Agreement means YUTIQ. |
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
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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 [***]. |
1.13 “3PL Facility” means the facility of EyePoint’s designated Third Party logistics solutions provider that is responsible for warehousing inventory of the Product following final release but prior to purchase by Alimera. As of the Effective Date, [***] provides such services for the Product at its facility located at [***]. |
ARTICLE 2.
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2.1 Manufacture and Sale of Product. During the Term, Alimera will purchase from EyePoint, and EyePoint shall Manufacture (directly or through an Affiliate or Third Party) and supply to Alimera, the Product for Commercialization in the United States in accordance with the terms of this Agreement. The Manufacture and supply to Alimera of the Product under this Agreement shall be exclusive until Alimera has the right and the ability, following completion of a technology transfer, to Manufacture and supply the Product for Commercialization in the United States. The exceptions to the exclusivity are set forth in Section 2.2 below. During the exclusive supply period, Alimera shall not Manufacture, have Manufactured, or obtain a commercial supply of the Product for sale in the United States other than from EyePoint without EyePoint’s prior written consent or as otherwise agreed pursuant to Section 2.2 below. The Product shall conform to the written release specifications for the Product attached hereto as Exhibit A (as amended from time to time by mutual agreement of the Parties, the “Product Specifications”) and be Manufactured, stored and shipped in accordance with the then current Product Requirements. To the extent EyePoint uses any Affiliate or Third Party to Manufacture or supply the Product, EyePoint shall cause such Affiliate or Third Party to comply with, and EyePoint shall itself remain at all times responsible for, all obligations applicable to such Manufacture or supply under this Agreement. |
2.2 Alimera Right to Assume Manufacturing. |
(a) Alimera may elect to Manufacture the Product from and after the Initial Term (as defined below), to support the Development and Commercialization of the Product by Alimera in the Field in the Licensed Territory (“Manufacturing Transfer Election”). If Alimera elects to use a Third Party contract manufacturer to Manufacture the Product on Alimera’s behalf, then any such Third Party contract manufacturer must meet the following conditions: such Third Party (i) is [***], or otherwise meets the internal quality criteria of each of Alimera and EyePoint for its Third Party contract manufacturers as consistently applied across its products and confirmed by each Party (it being understood and agreed that EyePoint may not unreasonably withhold or delay such confirmation); (ii) will Manufacture the Product at a manufacturing facility located in the United States, the United Kingdom, other country in Europe or [***]; (iii) has [***] entered into a confidentiality and non-use agreement with EyePoint protecting EyePoint’s proprietary Manufacturing technology that is [***]; and (iv) may not Manufacture the Product for commercial sale in the United States during the Initial Term unless EyePoint provides its written consent, subject to the exception set forth in the last sentence of Section 2.2(b) below. Alimera may exercise the Manufacturing Transfer Election by providing written notice thereof to EyePoint, including the name of any Third Party contract manufacturer proposed by Alimera to Manufacture
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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. |
(b) Following EyePoint’s receipt of the Manufacturing Transfer Notice, the Parties shall [***] agree on a written transfer plan to transfer Manufacturing of the Product for use in the Licensed Territory to Alimera no later than [***], provided such date is on or after the expiration of the Initial Term or earlier if permitted under the last sentence of this Section 2.2(b) or in Section 2.2(d) (the “Manufacturing Transfer Plan”). The Manufacturing Transfer Plan shall include [***]the following terms: (i[***] before Manufacturing of the Product for the Licensed Territory is fully transitioned from EyePoint to Alimera, and agreement by the Parties on updated forecasts and other terms under this Agreement to enable such transition; (ii) agreement on [***] terms to wind down and terminate this Agreement, including [***]; and (iii) a technology transfer plan[***]. Once agreed, the Manufacturing Transfer Plan shall be incorporated herein by reference, and the Parties will execute on the Manufacturing Transfer Plan. For the avoidance of doubt, Alimera or its selected Third Party contract manufacturer may Manufacture the Product for Alimera’s internal evaluation, including for sampling or other testing purposes, without violating the exclusive Manufacturing requirements set forth in Section 2.1 above. |
(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. |
(d) The exclusive obligation in Section 2.1 above shall automatically terminate, and Alimera may Manufacture or have Manufactured by a Third Party contract manufacturer (subject in all cases to the requirements on any Third Party contract manufacturer set forth in Section 2.2(a)), all or any part of the Rolling Forecast in the event that EyePoint is more than [***] late in delivering [***] percent ([***]%) or more of the quantities of the Product set forth in the Firm Order and such late delivery is due to the actions or omissions of EyePoint. |
(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
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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. |
ARTICLE 3.
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3.1 Forecasts. |
(a) Prior to the execution of this Agreement, EyePoint shared with Alimera its 2023 demand forecast for the Product for the U.S. market. At least [***] prior to the commencement of each Agreement Year during the Term after the first Agreement Year, EyePoint and Alimera shall discuss [***] a non-binding plan of Product supply quantities and timelines for the upcoming Agreement Year based on [***] (the “Agreement Year Plan”). |
(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
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EyePoint’s counterproposal in its written notice will automatically be deemed accepted by Alimera. The [***]of each Rolling Forecast [***] shall be binding upon the Parties and referred to herein as the “Firm Order”. EyePoint may decline to approve and adjust any portion of the [***] of each Rolling Forecast by providing written notice to Alimera within [***] of receipt thereof; provided, that (i) EyePoint shall approve the [***]s of each Rolling Forecast that is within [***] percent ([***]%) of the quantity requirements for the same period in the immediately preceding Rolling Forecast to the extent previously approved by EyePoint, and (ii) not otherwise act unreasonably in declining to approve and adjusting any such Rolling Forecast. Once approved, the Firm Order may only be changed by [***]. If EyePoint fails to provide its written notice to adjust during such [***] period, then such portion of such Rolling Forecast will automatically be deemed accepted by EyePoint. Attached hereto as Exhibit B is the initial Rolling Forecast, the Firm Order of which is based on [***] demand forecast for the Product for the U.S. market. |
3.2 Purchase Orders. |
(a) All purchases shall be pursuant to purchase orders (each, a “Purchase Order”) submitted by Alimera to EyePoint. Alimera shall submit [***] Purchase Order for each Calendar Quarter[***], and shall specify in such Purchase Order (i) the quantity of the Product ordered, and (ii) the requested delivery date, which Purchase Order shall be [***] for such Calendar Quarter set forth in the Firm Order. All Purchase Orders shall be [***]. EyePoint will be deemed to have accepted any Purchase Orders for the Firm Order period that (w) do not exceed [***]the quantity of Product set forth in the Firm Order for the applicable period, and (x) are otherwise consistent with the delivery dates for the applicable period set forth in the Firm Order. EyePoint shall consider [***] all or any portion of a Purchase Order that (y) exceeds [***] the quantity of Product set forth in the Firm Order for the applicable period, or (z) is otherwise inconsistent with the delivery dates set forth in the Firm Order for the applicable period. EyePoint may decline to accept all or any portion of a Purchase Order by providing written notice to Alimera within [***] following receipt of a Purchase Order. For clarity, if EyePoint does not provide written notice to Alimera that it is declining to accept all or any portion of a Purchase Order in writing within [***] following receipt thereof, then that Purchase Order shall be deemed to have been accepted by EyePoint. Once accepted, a Purchase Order becomes part of this Agreement, and no changes may be made without [***]. |
(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. |
(a) The Product Manufactured by EyePoint pursuant to this Agreement and ordered by Alimera pursuant to a Purchase Order accepted by EyePoint will, after final release by EyePoint (which, for the sake of clarity will occur after serialization), be delivered [***] within [***] of (before or after) the delivery date set forth in the applicable Purchase Order. Upon Alimera’s request and EyePoint’s prior written consent, the Product may be stored [***] at a facility
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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. |
3.4 Packaging. All Product released for final delivery to Alimera (or its designee) under this Agreement will be in finished form, and will include primary and secondary packaging, labeling and serialization. |
ARTICLE 4.
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4.1 Quality Control. EyePoint will apply its quality control procedures and in-plant quality control checks to the Manufacture of the Product for Alimera, in accordance with Applicable Laws and other industry standards. In addition, EyePoint will test and release Product in accordance with the Product Requirements. |
4.2 Quality Agreement. Within [***] following the Effective Date, the Parties shall enter into an agreement outlining the responsibilities of the Parties for quality and compliance-related issues in the Manufacturing of the Product, including Recalls, complaints, returns, regulatory audits and compliance with the Product Requirements (the “Quality Agreement”). In the event of a conflict between the terms of this Agreement and the Quality Agreement, the Quality Agreement shall govern for quality-related matters and this Agreement shall govern for all other matters. |
4.3 Inspection and Acceptance. |
(a) All Product shall be received subject to Alimera’s right of inspection and rejection. Alimera or Alimera’s designee will have [***] following EyePoint’s delivery of the Product in accordance with Section 3.3(a) (the “Inspection Period”) to inspect delivered Product and to reject the portion of any shipment that contains (i) [***], or (ii) [***]. Any portion of a shipment of the Product that is not rejected within the Inspection Period shall be deemed accepted by Alimera. Alimera may reject all or any portion of a shipment by providing written notice thereof specifying the shortfall or the nature and type of the alleged Nonconformity, as applicable (a “Deficiency Notice”). Such Deficiency Notice shall be considered timely given as long as postmarked, hand-delivered or received by facsimile or email no later than the expiration of the Inspection Period, subject to subsection (b) below. |
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(b) Notwithstanding acceptance by Alimera of the Product in accordance with subsection (a) above, with respect to latent Nonconformities and Nonconformities [***] (each, a “Latent Defect”), Alimera shall deliver a Deficiency Notice to EyePoint within [***] following detection of any such Latent Defect. |
(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) [***]. |
(d) Upon receipt of a Deficiency Notice, EyePoint shall have [***] to advise Alimera in writing as to whether it agrees that the shipment includes Nonconforming Product. If EyePoint does not respond to the Deficiency Notice within such [***] period, the Deficiency Notice will be deemed accepted by EyePoint. If EyePoint notifies Alimera that it disagrees with Alimera’s conclusion in the Deficiency Notice that the shipment includes Nonconforming Product, then the Parties will [***] select an independent laboratory that meets the requirements of cGMP, if Product analysis is required, or an independent Third Party expert with manufacturing expertise, as appropriate, if any other evaluation is required, in either case, of recognized standing in the industry (each such laboratory or expert to be referred to as, an “Independent Expert”), to evaluate a representative sample of the Product in question, using the testing methods described in the Product Specifications, to determine if the Product has a Nonconformity. This evaluation will be binding upon the Parties. If the evaluation certifies that the Product has a Nonconformity, then such Product shall be deemed rejected by Alimera and EyePoint will be responsible for the cost of the evaluation by the Independent Expert. If the evaluation certifies that no Nonconformity exists, then Alimera will be deemed to have accepted delivery of the Product and Alimera will be responsible for the cost of the evaluation by the Independent Expert. |
4.4 Rejection. |
(a) If Alimera rejects a shipment due to a shortfall in accordance with Section 4.3(a), EyePoint will [***] deliver any missing quantity of Product within [***] of receipt of the applicable Deficiency Notice, or if such delivery is not possible, EyePoint shall [***] either (i) refund Alimera for the invoice price of any amounts paid in respect of the missing quantity of Product within [***], or (ii) credit Alimera for the invoice price of any amounts paid in respect of the shortfall against subsequent Purchase Orders or if no subsequent Purchase Orders, refund such amount to Alimera. |
(b) Subject to Sections 4.3, 4.4(c) and 4.4(d), Alimera has the right to reject and return, at the expense of EyePoint, any portion of any shipment of the Product that is the subject of a validly delivered Deficiency Notice (i) if EyePoint has not sent a response to such Deficiency Notice within [***] following receipt thereof, (ii) if an Independent Expert engaged under Section 4.3 has determined that such portion is Nonconforming Product, or (iii) if the Parties agree that such portion is Nonconforming Product, without invalidating any remainder of such shipment (the date of each of the foregoing (i)‑(iii), the “Rejection Date”). For clarity, the Deficiency Notice will apply only to those portions of the shipment identified in the Deficiency Notice and the remedies set forth in this Section 4.4 will not apply to any other portions of such shipment. |
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(c) If Alimera rejects a portion of a shipment for Nonconformity in accordance with Section 4.4(b), EyePoint will [***] replace the Nonconforming Product with Product that meets the Product Requirements as soon as possible and within [***] of the Rejection Date, at EyePoint’s cost, or if such replacement is not possible, then EyePoint shall [***], either (i) refund Alimera for the invoice price of any amounts paid in respect of the Nonconforming Product within [***], or (ii) credit Alimera for the invoice price of any amounts paid in respect of the Nonconforming Product against subsequent Purchase Orders or if no subsequent Purchase Orders, refund such amount to Alimera. Additionally, EyePoint shall bear the cost of disposition for rejected Product for which it bears responsibility under this Section 4.4. Furthermore, in such event, EyePoint shall [***] prevent future Nonconformities. |
(d) The remedies set forth in this Section 4.4 are Alimera’s [***] under this Agreement with respect to any Nonconforming Product. Notwithstanding the foregoing, nothing in this Section shall be deemed a limitation on EyePoint’s obligations, or Alimera’s rights, under Section 4.5 or ARTICLE 10. |
4.5 Recalls. |
(a) EyePoint and Alimera will each maintain records necessary to permit a Recall of the Product delivered to Alimera or customers of Alimera. Each Party will [***] notify the other Party of any information that it becomes aware of in relation to the Manufacture of Product which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receipt of such information, each Party will stop making any further shipments of the Product in its possession or control until a decision has been made by the owner of the YUTIQ NDA as to whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, with respect to the Product in the U.S. market will be made by the owner of the YUTIQ NDA and implemented in accordance with Section 4.6 of the Product Rights Agreement. |
(b) If (i) any Regulatory Authority issues a directive, order or written request that the Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Alimera determines that the Product should be Recalled or that a “Dear Doctor” letter is required for the Product, each Party shall provide all assistance reasonably requested by the other Party with respect thereto. |
(c) If a Recall of the Product for the U.S. market results from, or arises out of, a failure by EyePoint to Manufacture the Product in accordance with the Product Requirements, then EyePoint shall be responsible for Alimera’s reasonable and documented expenses of the Recall and EyePoint shall [***] either (i) [***] [***] replace the Nonconforming Product with Product that meets the Product Requirements as soon as possible, at EyePoint’s cost, or (ii) refund Alimera for the invoice price of any amounts paid in respect of the Nonconforming Product within [***] of the Recall date. EyePoint shall [***] prevent future Nonconformities. Additionally, EyePoint shall bear the cost of disposition for any Recalled Product for which it bears responsibility under this Section 4.5(c). Alimera will give EyePoint prompt written notice of any Recalls for which Alimera believes EyePoint has responsibility under this Section 4.5(c). In all other circumstances where the Recall for the Product does not result from, or arise out of, a failure by EyePoint to Manufacture the Product in accordance with the Product Requirements, recalls or other corrective
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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. |
ARTICLE 5.
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5.1 Supply Price. Alimera will purchase the Product Manufactured under this Agreement from EyePoint at the following price (the “Supply Price”): (a) during the eighteen- (18-) month period following the Effective Date (the “Initial Supply Period”), the applicable Unit Price plus [***] percent ([***]%); and (b) following the Initial Supply Period, the applicable Unit Price plus [***] percent ([***]%). |
5.2 Unit Price. On an Agreement Year-by-Agreement Year basis, the price per unit of Product to be charged by EyePoint for performing the Manufacturing Services, including the cost of Components, will be based on (a) [***] (the “Unit Price”), subject to adjustment in accordance with Section 5.3. The Unit Price for the first Agreement Year ending on December 31, 2023 shall be $[***]. The Parties acknowledge and agree that EyePoint has provided to Alimera information relating to its methodology and calculation of the Unit Price for the first Agreement Year, which methodology and calculation is based in part on the demand forecast for the Product for the U.S. market for the first Agreement Year. For each subsequent Agreement Year, EyePoint will reset the Unit Price using the same methodology used to calculate the Unit Price for the first Agreement Year; provided, that (i) any changes in Component costs will be passed through to Alimera, and (ii) in no event shall the portion of the Unit Price attributable to direct labor or overhead costs increase by more than [***] percent ([***]%) as compared to such portion of the Unit Price for the prior Agreement Year. Prior to resetting the Unit Price for an Agreement Year, EyePoint shall consult with Alimera as to its updated calculations, which shall take into account [***]. EyePoint shall notify Alimera of the updated Unit Price for each Agreement Year after the first Agreement Year at least [***] prior to the commencement of such Agreement Year. Consistent with GAAP, (x) [***], and (y) [***]. |
5.3 Mid-Agreement Year Adjustments to Unit Price. During any Agreement Year, the Unit Price may be adjusted on a mid-Agreement Year basis as follows [***] (it being understood and agreed that any adjustment made under this Section 5.3 does not supersede or replace the annual process to reset the Unit Price under Section 5.2): |
(a) If, at any time during an Agreement Year, (i) extraordinary circumstances beyond the reasonable control of EyePoint occur, or (ii) a change in volume of Product ordered during such Agreement Year as compared to the volume projections in the Agreement Year Plan for such Agreement Year agreed by the Parties, result in an increase of at least [***] percent ([***]%) of EyePoint’s standard cost of goods sold per unit of the Product on a fully loaded basis as determined in accordance with GAAP, then the Parties will [***] agree on an adjustment to the Unit Price to compensate EyePoint only for such increased costs. For a Unit Price adjustment under this Section 5.3(a), EyePoint will deliver to Alimera information reasonably sufficient to demonstrate that a Unit Price adjustment is justified. The revised Unit Price will be effective for any Product delivered on or after [***] following the Parties’ agreement on the adjusted Unit Price. |
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(b) Amendments to the Product Specifications as agreed by the Parties as of the Effective Date that are requested by Alimera following the Effective Date, or amendments to the Quality Agreement requested by Alimera following execution of the Quality Agreement, will be implemented only following a technical and cost review that EyePoint will perform at Alimera’s cost and are subject to Alimera and EyePoint reaching agreement on Unit Price changes required because of the amendments. If Alimera accepts a proposed Unit Price change, the proposed change in the Product Specifications or the Quality Agreement and the associated scope of work will be implemented at Alimera’s cost, and the Unit Price change will become effective only for those orders of Product that are manufactured under the revised Product Specifications or Quality Agreement. In addition, Alimera agrees to purchase all inventory of the Product (including Components and work-in-process) held under the previous Product Specifications or Quality Agreement and purchased or maintained by EyePoint in order to fill Firm Orders or under Section 2.4, if such inventory (i) complies with the previous Product Specifications and Quality Agreement and meets the Shelf Life Requirements set forth in Section 6.1, and (ii) can no longer be used under the revised Product Specifications or Quality Agreement. Open purchase orders for Components no longer required under any revised Product Specifications that were placed by EyePoint with suppliers in order to fill Firm Orders or under Section 2.4 will be cancelled where possible, but if the orders may not be cancelled without penalty, they will be assigned to and paid for by Alimera. Additional payments or price increases may also be required to compensate EyePoint for fees and other expenses incurred by EyePoint to comply with Regulatory Authority requirements relating to any change in Product Specifications or the Quality Agreement. |
5.4 Invoices. EyePoint will invoice Alimera (a) at the time that the Product is delivered to Alimera or its designee in accordance with Section 3.3(a), for all amounts due for such Product delivered under each Purchase Order, or (b) [***] for any other amounts due under this Agreement. Invoices will be addressed to Alimera and sent electronically to [***] or such other email address provided by Alimera in accordance with ARTICLE 11. Payment on undisputed invoices will be due as follows: (i) [***] percent ([***]%) shall be paid within [***] after the date of the applicable invoice, and (ii) the remaining [***] percent ([***]%) shall be paid within [***] after the date of the applicable invoice; provided, that Alimera may reasonably dispute any invoice or portion thereof to the extent that it reasonably believes that the charges reflected therein are inaccurate. Once such reasonable dispute is resolved, Alimera shall pay any remaining undisputed charges within [***] of the date that such resolution occurs. All payments due under this Agreement will be paid in Dollars by wire transfer of immediately available funds to a bank account specified by EyePoint in writing. |
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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ARTICLE 6.
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6.1 Compliance with Product Requirements. EyePoint hereby represents, warrants and covenants to Alimera that the Product supplied to Alimera under this Agreement shall (a) conform to the Product Specifications at the time of release for delivery to Alimera, (b) be Manufactured, stored, tested, documented, released and packaged for shipment in accordance with Applicable Laws, including cGMP, (c) be prepared for shipment in accordance with the shipping instructions provided by Alimera, (d) conform with all packaging requirements set forth in Section 3.4, (e) for any Product ordered by Alimera with a delivery date occurring during the Initial Term, such Product shall have at least [***] of shelf life remaining from the delivery date, and for any Product ordered by Alimera with a delivery date occurring following the Initial Term, such Product shall have at least [***] of shelf life remaining from the delivery date (the “Shelf Life Requirements”), (f) conform to the applicable Purchase Order, (g) be conveyed with good title to the Product, free of all liens of any kind whatsoever, and (h) not be adulterated or misbranded within the meaning of the United States Federal Food, Drug and Cosmetic Act, as may be amended from time to time (items (a) through (h), collectively, the “Product Requirements”). |
6.2 Additional Representations and Warranties by EyePoint. |
(a) EyePoint, either directly or through its Affiliates or subcontractors, has obtained and shall maintain and/or renew, where applicable, all Approvals required by all Applicable Laws for the performance of the Manufacturing Services under this Agreement; provided, that the foregoing excludes responsibilities relating to the YUTIQ NDA, which responsibilities are addressed in the Product Rights Agreement. |
(b) At the time of release for delivery, the Product Manufactured and supplied pursuant to this Agreement shall be merchantable, fit and sufficient for its intended use and purpose, meet the Shelf Life Requirements and be free from material defects in material and workmanship. |
(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. |
6.4 Environmental Compliance. The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated by or on behalf of EyePoint in connection with the Manufacture of the Product will be the responsibility of EyePoint, at the cost and expense of EyePoint. Without limiting other legally applicable requirements, EyePoint will prepare, execute, and maintain as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Laws. |
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6.5 Audit by Alimera. Upon at least [***]’ prior written notice and no more than [***] per Calendar Year per Facility (except as provided below), EyePoint will permit [***] Alimera representatives (which may include representatives of Alimera’s Affiliates and any of their respective consultants) who are subject to confidentiality obligations no less stringent than the confidentiality obligations set forth in this Agreement, to conduct during normal business hours quality assurance audits and inspections of EyePoint’s Records (as defined below) and the portion of the Facility where the Product is Manufactured for Alimera to the extent reasonably necessary to verify compliance with this Agreement. Notwithstanding the foregoing, (a) Alimera’s audit and inspection rights with respect to the Facilities that are owned and operated by unaffiliated Third Parties shall be subject at all times to the terms, conditions, restrictions and limitations set forth in any applicable agreement between EyePoint and such Third Parties, and (b) subject to (a), Alimera may conduct additional audits in the event any audit conducted by Alimera or an audit by a Regulatory Authority reveals a material compliance deficiency with respect to the Manufacture of the Product under this Agreement. All information disclosed or ascertained by Alimera in connection with any audit or inspection will be deemed to constitute Confidential Information of EyePoint, subject to the terms of ARTICLE 7. |
6.6 Regulatory Authority Inspections. EyePoint will be responsible for, and shall participate in, inspections of its Facility by any Regulatory Authorities. EyePoint will notify Alimera of any inspections of its Facility that are related in any material respect to the Manufacture of the Product under this Agreement. |
6.7 Cure of Deficiencies and Other Issues. |
(a) EyePoint will be responsible for correcting any material deficiencies identified in any inspection of the Facility conducted by any Regulatory Authority in the United States, at the cost of EyePoint. In addition, following any audit provided for in Section 6.5, Alimera will discuss its observations and conclusions with EyePoint, and any corrective actions will be discussed by the Parties. If EyePoint agrees that an item identified by Alimera is a material deficiency (such agreement not to be unreasonably withheld, conditioned or delayed) for which EyePoint is responsible, EyePoint will [***] correct such deficiency at its sole cost. |
(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. |
6.8 Interactions with Regulatory Authorities. EyePoint will be solely responsible for all contacts and communications with any Regulatory Authorities with respect to matters relating to the Manufacturing Services; provided, that in the event of any conflict between the terms of this Agreement and the Product Rights Agreement with respect to regulatory matters relating to the Product, the terms of this Agreement shall control solely with respect to regulatory matters for the Product that are specific to the Manufacturing Services, and the Product Rights Agreement shall apply with respect to all other regulatory matters relating to the Product. Alimera shall provide [***] assistance requested by EyePoint in the investigation of all complaints received relating to the Product in the United States to the extent that such complaints may have arisen from the Manufacturing Services provided by EyePoint hereunder. EyePoint will [***] notify Alimera
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within [***] after EyePoint receives any contact or communication from any Regulatory Authority relating to the Manufacture of the Product under this Agreement and will [***]provide Alimera with, to the extent permissible under Applicable Laws, copies of any such communication that is made in writing. EyePoint will consult with Alimera regarding the response to any inquiry or observation from any Regulatory Authority relating to the Manufacture of the Product under this Agreement and will allow Alimera to participate in any further contacts or communications relating to the Manufacture of the Product under this Agreement to the extent permitted by Applicable Law and reasonably practicable. |
6.9 Information. EyePoint and Alimera shall [***] with respect to the preparation of the Annual Product Quality Review. Subject to receipt of necessary information from Alimera, EyePoint shall [***], within [***] of the close of the applicable regulatory approval reporting period, provide a written summary to Alimera, in the form of an Annual Product Quality Review, all data in its control relating to the Manufacture of the Product under this Agreement, including release test results, complaint test results, and all investigations (in manufacturing, testing and storage) as required by Applicable Laws or that is otherwise reasonably required in order to obtain or maintain Approvals for the Product in the United States. Alimera shall [***] review and comment on EyePoint’s draft of the Annual Product Quality Review and shall collaborate with EyePoint to revise the draft Annual Product Quality Review. Any additional data or report requested by Alimera beyond the scope of cGMP, what is required to be provided under the Quality Agreement, annual post-marketing NDA report, and customary Regulatory Authority requirements in the United States will be subject to an additional fee to be agreed upon between EyePoint and Alimera. |
6.10 Records and Retained Samples. EyePoint will maintain all materials, data and documentation obtained or generated by EyePoint in the course of performing the Manufacturing Services under this Agreement, including all reference standards, retained samples of the Product and key intermediates, and computerized records and files (the “Records”) in a secure area reasonably protected from fire, theft and destruction for the longer of (a) five (5) years after completion of the applicable Purchase Order under which such Records were generated, or (b) two (2) years past the last expiration date of the Product supplied under this Agreement, or, in each case, such longer period as is required by Applicable Law (the “Retention Period”). At the end of the Retention Period, all Records will, at Alimera’s option, either be (i) delivered to Alimera or to its designee in such form as is then currently in the possession of EyePoint, (ii) retained by EyePoint, at Alimera’s cost, until further disposition instructions are received, or (iii) disposed of, at the direction and written request of Alimera. Notwithstanding anything in this Section 6.10 to the contrary, EyePoint may retain copies of any Records as necessary to comply with Applicable Laws or its obligations under this Agreement. |
6.11 Product Complaints. Alimera will have the sole responsibility for responding to questions and complaints regarding the Product from its customers. Questions or complaints regarding the Product received by EyePoint from Alimera’s customers, healthcare providers or patients in the U.S. will be [***] referred to Alimera. As further set forth in the Quality Agreement, EyePoint shall provide all assistance reasonably requested by Alimera to allow Alimera to determine the cause of and resolve any questions and complaints regarding the Product in the U.S. market. |
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ARTICLE 7.
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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 8.
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8.1 No Licenses or Other Rights. No licenses or other rights relating to Patent Rights, Know-How or other intellectual property are granted under this Agreement. In the event of any conflict between the terms of this Agreement and the terms of the Product Rights Agreement with respect to intellectual property rights, the terms of the Product Rights Agreement shall control. |
ARTICLE 9.
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9.1 Term. This Agreement will become effective as of the Effective Date, shall continue for a period of two (2) years, and shall, thereafter, automatically renew for successive one (1) year terms unless either Party provides notice of non-renewal to the other Party at [***] prior to the beginning of the next automatic renewal term (the “Term”); provided, that the Term shall automatically terminate upon the successful completion of the transfer of Manufacturing for the Product to Alimera or its designee in accordance with the Manufacturing Transfer Plan. The Parties shall [***] wind down activities under this Agreement following such transfer of Manufacturing of the Product to Alimera or its designee. |
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. |
9.4 Survival Provisions. Expiration or termination of this Agreement through any means and for any reason will not relieve the Parties of any obligation accruing prior thereto, including, but not limited to, the obligation to pay money, and will be without prejudice to the rights and remedies of either Party with respect to the antecedent breach of any of the provisions of this Agreement. Further, the following provisions will survive expiration or termination of this Agreement: ARTICLE 1 (to the extent applicable to the other surviving provisions), Section 4.3, Section 4.4, Section 4.5, ARTICLE 5 (to the extent applicable to payment obligations accruing prior to the effective date of termination), Section 6.1, Section 6.2(b), Section 6.6, Sections 6.8 through 6.11 (inclusive), ARTICLE 7, ARTICLE 8, the last sentence of Section 9.1, this Section 9.4, ARTICLE 10 and ARTICLE 11. |
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ARTICLE 10.
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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. |
10.2 Limitation of Liability. DURING THE [***] OF THE TERM, THE TOTAL LIABILITY OF EYEPOINT UNDER THIS AGREEMENT SHALL BE LIMITED TO $[***]. AFTER THE [***] OF THE TERM, THE TOTAL LIABILITY OF EYEPOINT UNDER THIS AGREEMENT SHALL BE LIMITED TO [***]. NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS OR THE PERFORMANCE OF ITS OBLIGATIONS HEREUNDER, INCLUDING ANY LOST PROFITS ARISING OUT OF THISAGREEMENT, IN EACH CASE, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY WHETHER INCONTRACT, TORT, NEGLIGENCE, BREACH OF STATUTORY DUTY OR OTHERWISE, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 10.2 OR THE PRODUCT RIGHTS AGREEMENT IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY UNDER THE PRODUCT RIGHTS AGREEMENT (OR THIS AGREEMENT), DAMAGES AVAILABLE FOR A PARTY’S BREACH OF ITS OBLIGATIONS UNDER ARTICLE 7, FRAUD, RECKLESSNESS OR WILLFUL MISCONDUCT. |
10.3 NO OTHER WARRANTIES. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, (A) NO REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF EYEPOINT OR ALIMERA, AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE EXPRESSLY DISCLAIMED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OR MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY WITH RESPECT TO THE PRODUCT. |
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. |
ARTICLE 11. MISCELLANEOUS |
11.1 Incorporation by Reference. Article 12 of the Product Rights Agreement (except Section 12.16 thereof) shall apply to this Agreement, mutatis mutandis, as between the Parties hereto as if set forth herein. |
11.2 Entire Agreement; Amendment. This Agreement (including accepted Purchase Orders and the Exhibits hereto), the Quality Agreement and the Product Rights Agreement contain the entire understanding of the Parties with respect to the subject matter hereof. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or
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written, in respect to such subject matter are superseded by the terms of this Agreement. The Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified or waived, only by a written instrument duly executed by authorized representative(s) of both Parties. |
{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
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EXHIBIT B
INITIAL ROLLING FORECAST
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Exhibit B-1
Exhibit 10.2
Execution Version
JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT
This Joinder and Amendment to Securities Purchase Agreement (this “Amendment”) dated as of May 17, 2023 (the “Amendment Effective Date”), between Alimera Sciences, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto, amends that certain Securities Purchase Agreement (the “Purchase Agreement”) dated as of March 24, 2023, between the Company and the purchasers party thereto (the “Original Purchasers”).
WHEREAS, the Company and the Original Purchasers desire to amend the Purchase Agreement subject to and in accordance with the terms and conditions set forth in this Amendment, including to add the purchasers listed on Exhibit A hereto (each, including its successors and assigns, a “New Purchaser”, and collectively, the “New Purchasers”, and together with the Original Purchasers and their respective successors and assigns, each a “Purchaser” and collectively, the “Purchasers”) as parties to the Purchase Agreement, as amended as of the Amendment Effective Date.
NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Amendment, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser agree as follows:
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Definitions; Effectiveness. The Purchase Agreement shall be amended effective as of the Amendment Effective Date. Terms used but not defined herein shall have the meanings ascribed to them in the Purchase Agreement. The term “Agreement” as used in the Purchase Agreement shall at all times refer to the Purchase Agreement as modified by this Amendment. |
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Amendments to Purchase Agreement. |
2.1 The New Purchasers shall be added as parties to the Purchase Agreement with respect to the Tranche 2 Closing, effective as of the Amendment Effective Date, and all references to “Purchasers” in the Purchase Agreement shall include references to the New Purchasers, except where the terms and provisions of the Purchase Agreement specifically reference the Original Purchasers or expressly dictate otherwise. |
2.2 The following definitions contained in Section 1.1 of the Purchase Agreement are hereby amended and restated in their entirety as follows: |
“Caligan” means Caligan Partners Master Fund LP, Caligan Partners CV VI LP and certain accounts managed by Caligan Partners LP.
“Certificate of Designation” means the certificate of designation setting forth the powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series B Convertible Preferred Stock, as amended and/or restated from time to time.
“Stockholder Approval” means such approval as may be required by the applicable rules and regulations of the Nasdaq Stock Market (or any successor entity) from the stockholders of the Company with respect to the transactions contemplated by the Transaction Documents, including the issuance of all of the Conversion Shares and Warrant Shares in excess of the Exchange Cap, the Change of Control Cap, and the Acquisition Cap (each as defined in the Certificate of Designation).
“Tranche 2 Subscription Amount” means, as to each Purchaser, the aggregate amount to be paid for the Securities purchased hereunder at the Tranche 2 Closing, in United States dollars and in immediately available funds, as specified below such Purchaser’s name on the signature page of the Joinder and Amendment to this Agreement and next to the heading “Tranche 2 Subscription Amount”.
“Tranche 2 Conversion Price” means $1.70.
“Tranche 2 Closing Date” means May 17, 2023.
“Transaction Documents” means this Agreement, the Certificate of Designation, the Warrants, and the Registration Rights Agreement, each as may be amended and/or restated from time to time.
“Velan” means Velan Capital Master Fund LP and Velan Capital SPV I LLC.
2.3 The following definitions are hereby added to Section 1.1 of the Purchase Agreement: |
“AIGH Affiliates” means AIGH Investment Partners, LP, WVP Emerging Manager Onshore Fund, LLC – AIGH Series, and WVP Emerging Manager Onshore Fund, LLC – Optimized Equity Series.
“Altium” means Altium Growth Fund, LP.
“Clearline” means Clearline Capital Partners LP and Clearline Capital Partners Master Fund LP.
“EyePoint Transaction” means the acquisition or license by the Company of assets of EyePoint Pharmaceuticals, Inc. and its affiliates to enable the Company to commercialize its product globally.
“Lytton Affiliates” means Alice Winzer Lytton Family LLC and Lytton-Kambara Foundation.
“Stonepine” means Stonepine Capital, LP and its Affiliates.
2.4 Section 2.1(b) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“On the Tranche 2 Closing Date, upon the terms and subject to the conditions set forth herein, the Company shall issue and sell to each Purchaser, and each Purchaser shall, severally and not jointly, purchase from the Company, such aggregate number of shares of Common Stock and/or Preferred Stock set forth opposite such Purchaser’s name on Schedule B hereto at the price per share of Common Stock of $1.70 and the price per share of Preferred Stock at the Per Share Purchase Price (which aggregate amount for all Purchasers shall be 66,617 shares of Preferred Stock and 1,401,901 shares of Common Stock). The aggregate purchase price for the Shares to be purchased by each Purchaser at the Tranche 2 Closing shall be the amount set forth opposite such Purchaser’s name on Schedule B hereto. On the Tranche 2 Closing Date, each Purchaser shall deliver to the Company, via wire transfer, immediately available funds equal to such Purchaser’s Tranche 2 Subscription Amount, and the Company shall deliver to such Purchaser its respective Shares as determined pursuant to Section 2.2(b), and the Company and such Purchaser shall deliver the other items set forth in Section 2.2 (the “Tranche 2 Closing”).
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Further, notwithstanding anything to the contrary contained herein or in the Warrants, at the Tranche 2 Closing, the number of shares of Common Stock issuable upon exercise of the Warrants held by the Original Purchasers shall be reduced to the aggregate number of shares of Common Stock set forth opposite such Original Purchaser’s name under the column entitled “Warrants” on Schedule B hereto. The Tranche 2 Closing shall occur remotely via the electronic exchange of documents and signatures. For the avoidance of doubt, all of the Shares issued at the Tranche 2 Closing shall be deemed to be “Registrable Securities” for purposes of the Registration Rights Agreement.”
2.5 Section 2.2(b)(iv) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“(iv)executed copy of the indemnification agreement with the director of the Company designated by Velan and its Affiliates, executed by the Company.”
2.6 A new Section 2.2(b)(v) is hereby added to the Purchase Agreement as follows: |
“(v)Warrants registered in the name of the Original Purchasers, to purchase up to such number of shares of Common Stock as set forth opposite each Original Purchaser’s name on Schedule B hereto (reflecting a reduction in the number of shares issuable upon exercise of the Warrants originally issued and sold to each Original Purchaser), duly executed by the Company.”
2.7 Section 2.2(d)(iii) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“(iii) executed copy of the indemnification agreement with the director of the Company designated by Velan and its Affiliates, executed by such director.”
2.8 Section 2.3(c) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“(c)Board of Directors. Pursuant to and in accordance with the rights set forth in Section 4.13, the Board of Directors shall have elected, effective as of the Tranche 1 Closing, Mike Kaseta and Adam Morgan (or such other individuals designated by the applicable Purchasers, which other individuals are acceptable to the Company, such acceptance not to be unreasonably withheld) to the Board of Directors of the Company, to serve as a Class I Director and a Class III Director, respectively. The Board of Directors shall have elected, effective as of the Tranche 2 Closing, Jason Werner (or such other individual designated by Velan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld) to the Board of Directors of the Company, to serve as a Class II Director.”
2.9 Section 2.3(d) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
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“(d) Pursuant to and in accordance with the rights set forth in Section 4.13, David Johnson shall have been appointed as an initial observer to the Board of Directors. Additionally, effective as of the Tranche 2 Closing, Ross DeMont (or such other individual designated by Caligan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld) shall have been appointed as an observer to the Board of Directors, with the rights and subject to the limitations of Section 4.14(b), and the Board of Directors shall elect Ross DeMont (or such other individual designated by Caligan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld) to the Board of Directors of the Company effective upon Stockholder Approval. For the avoidance of doubt, following Stockholder Approval, no Purchaser shall have the right to appoint any observers to the Board of Directors, and all such rights under Section 4.14(b) shall terminate.”
2.10 The first paragraph of Section 4.3 of the Purchase Agreement is hereby amended and restated as follows: |
“4.3Participation Rights. At any time after the date hereof, for so long as (i) Velan and its Affiliates, (ii) Caligan and its Affiliates, (iii) Clearline and its Affiliates, (iv) Stonepine and its Affiliates, (v) the AIGH Affiliates, (vi) Altium and its Affiliates or (vii) the Lytton Affiliates (each of (i) - (vii) a “Purchaser” for purposes of this Section 4.3) owns a number of shares of Common Stock equal to at least 25% of the shares of Common Stock purchased hereunder (an as-converted basis) by such Purchaser, if the Company proposes to offer or sell any New Securities (a “Subsequent Financing”), the Company shall offer such New Securities to such Purchaser as follows:”
2.11 The last sentence of Section 4.5 of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“The Company shall use the net proceeds of the Tranche 2 Closing to fund a portion of the upfront consideration payable to EyePoint Pharmaceuticals, Inc. in connection with the EyePoint Transaction.”
2.12 Section 4.12(a) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“The Company shall use its reasonable best efforts to call, hold and convene a meeting of its stockholders to vote on the approval of transactions contemplated by this Agreement, including the issuance of all of the Conversion Shares and Warrant Shares in excess of the Exchange Cap, the Change of Control Cap, and the Acquisition Cap as required under the rules of the Trading Market (such approval, the “Stockholder Approval” and such meeting, the “Company Stockholders Meeting”). The Board of Directors shall recommend to the Company stockholders that the Company stockholders vote in favor thereof, as required under applicable Nasdaq rules (the “Recommendation”) and shall include such Recommendation in the Proxy Statement. In connection with the Company Stockholders Meeting, the Company shall prepare and file with the Commission the Proxy Statement in preliminary form, and the Company shall use its reasonable best efforts to respond as promptly as practicable to any comments of the Commission with respect thereto.
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The Company shall use its reasonable best efforts to prepare and file with the Commission the definitive Proxy Statement and to cause the definitive Proxy Statement to be mailed to the Company’s stockholders as promptly as practicable after the filing of the definitive Proxy Statement with the Commission. The Company shall take any action required to be taken under any applicable state securities laws in connection with this Agreement. The Company shall notify the Purchasers promptly of the receipt of any written comments from the Commission or its staff and of any request by the Commission or its staff for amendments or supplements to the Proxy Statement or for additional information and shall supply the Purchasers with copies of all correspondence between the Company or any of its representatives, on the one hand, and the Commission or its staff, on the other hand, with respect to the Proxy Statement. Prior to filing or mailing the preliminary or definitive Proxy Statement (or any amendment or supplement thereto) or responding to the comments of the Commission with respect thereto, the Company (i) shall provide the Purchasers a reasonable opportunity to review such document or response and (ii) shall consider in good faith comments proposed by the Purchasers on such document or response. If, despite the Company’s reasonable best efforts the Stockholder Approval is not obtained at the Company Stockholders Meeting, the Company shall cause an additional Stockholder Meeting to be held within 90 days later. If, despite the Company’s reasonable best efforts the Stockholder Approval is not obtained after such subsequent stockholder meeting, the Company shall cause an additional Stockholder Meeting to be held semi-annually thereafter until such Stockholder Approval is obtained. Notwithstanding the foregoing, the Company shall not be required to hold a Stockholder Meeting or seek Stockholder Approval any time following the time when, if upon full exercise of the Warrants and conversion of the Preferred Stock, the issuance of the Conversion Shares and the Warrant Shares would not exceed the Change in Control Cap, the Exchange Cap, or the Acquisition Cap.”
2.13 Section 4.14(a) of the Purchase Agreement is hereby amended and restated in its entirety as follows: |
“(a)(i) The Board of Directors shall elect, (A) effective as of the Tranche 1 Closing, one designee of each of (x) Caligan and its Affiliates and (y) Velan and its Affiliates (each of (x) and (y), a “Purchaser” for purposes of this Section 4.14), which Caligan designee shall initially be Mike Kaseta and which Velan designee shall initially be Adam Morgan (or such other individuals designated by the applicable Purchasers (including in the event any of its designees is unable to serve, or no longer serves, as a director for any reason), which other individuals are acceptable to the Company, such acceptance not to be unreasonably withheld) to the Board of Directors of the Company, to serve as a Class I Director and a Class III Director, respectively (as such term is defined in the Company’s Restated Certificate of Incorporation as filed with the Secretary of State of Delaware) with such designee’s initial terms expiring at the Company’s 2023 and 2025 annual meetings of stockholders, respectively, and (B) effective as of the Tranche 2 Closing, Jason Werner (or such other individual designated by Velan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld; provided, however, that such designee must be an “independent director” as defined in applicable Nasdaq and Commission rules and regulations) to the Board of Directors of the Company, to serve as a Class II Director with an initial term expiring at the Company’s 2024 annual meeting of stockholders, and (ii) effective as of the Tranche 2 Closing, Ross DeMont (or such other individual designated by Caligan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld) shall have been appointed as an observer to the Board of Directors, with the rights and subject to the limitations of Section 4.14(b), and the Board of Directors shall elect Ross DeMont (or such other individual designated by Caligan and its Affiliates, which other individual is acceptable to the Company, such acceptance not to be unreasonably withheld provided, however, that such designee must be an “independent director” as defined in applicable Nasdaq and Commission rules and regulations) to the Board of Directors of the Company to be effective upon Stockholder Approval (collectively, the “Board Representation Right”).
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Each Purchaser shall retain its Board Representation Right for so long as such Purchaser owns 50% of the shares of Common Stock (calculated on an as-converted basis) such Purchaser acquired pursuant to this Agreement and the transactions contemplated hereby; provided that, notwithstanding any Purchaser’s retention of such shares, if any Purchaser’s ownership position in the Company is materially reduced, whether through sales by such Purchaser or additional issuances by the Company, such Board Representation Right shall be concomitantly reduced in any year if required by applicable Nasdaq rules. The Board of Directors shall also accept the resignations of (i) two incumbent directors effective as of the Tranche 1 Closing, (ii) one incumbent director effective as of the Tranche 2 Closing and (iii) one incumbent director effective upon Stockholder Approval, such that the size of the Board of Directors shall not be increased in connection with the director appointments pursuant to the Board Representation Right. Further, the Board of Directors shall reduce to no more than seven directors, including the Purchaser-designated directors, no later than the Company’s 2024 annual meeting of stockholders (the “2024 Annual Meeting”), whereat the Company shall submit to its stockholders a proposal to declassify the structure of the Board of Directors on a phased-in basis, such that, if approved by the Company’s stockholders, directors elected at and subsequent to the 2024 Annual Meeting shall be elected to one-year terms and the entire Board of Directors shall be annually elected beginning with the Company’s 2026 annual meeting of stockholders (the “Declassification Proposal”). The Board of Directors shall recommend in favor of, and use its reasonable best efforts to solicit stockholder approval of the Declassification Proposal at the 2024 Annual Meeting and to have all directors and executive officers of the Company vote all shares of Common Stock beneficially owned by them and over which they have voting control in favor of the Declassification Proposal. Immediately following the appointment of each Purchaser designee to the Board of Directors, the Company shall (a) add such designee as a covered party under the Company’s current director and officer insurance policy, and (b) deliver to such designee an indemnification agreement, duly executed by the Company and in the same form entered into by the Company with each of the Company’s other directors.”
2.14 The last sentence of Section 4.14(b) of the Purchase Agreement is hereby amended and restated as follows: |
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“Notwithstanding the foregoing, no Purchaser shall have any rights under this Section 4.14(b) following Stockholder Approval, subject to the provisions of Section 2.3(c).”
2.15 Schedule B hereto hereby amends and restates in its entirety Schedule B attached to the Purchase Agreement. |
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Joinder. The New Purchasers hereby agree to be subject to and bound by the terms and conditions of the Purchase Agreement and shall each be deemed to be a party thereto as of the Amendment Effective Date. |
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Representations. Each party represents to the other parties that all representations contained in the Purchase Agreement are true and accurate as of the date of this Amendment (with the exception of the outstanding shares of capital stock and equity awards described in Section 3.1(t) of the Purchase Agreement), and that such representations are deemed to be given or repeated by each party, as the case may be, on the date of this Amendment. |
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Deliverables; Conditions to Closing. |
5.1 The Tranche 2 Company Deliverables and the Tranche 2 Purchasers’ Deliverables, as set forth in Section 2.2(b) and 2.2(d) of the Purchase Agreement, respectively, as amended by Section 2.5 and 2.6 hereof, shall be the only deliverables required of the parties to effect the Tranche 2 Closing under such Sections. |
5.2 Section 2.3(b) of the Purchase Agreement is hereby amended by adding the following provisions to the end of such section: |
“(xi) prior to or contemporaneously with the Tranche 2 Closing, the amendment by the Company of its credit facility with SLR Investment Corp., on terms previously agreed upon by the Company and the Preferred Majority;
(xii) prior to or contemporaneously with the Tranche 2 Closing, the execution by the Company and EyePoint Pharmaceuticals, Inc. of a Product Rights Agreement, a Commercial Supply Agreement and a Transition Services Agreement (collectively, the “EyePoint Transaction Documents”);
“(xiii) prior to or contemporaneously with the Tranche 2 Closing, the execution by the Company and the Purchasers of that certain Joinder and Amendment to Registration Rights Agreement; and
(xiv) prior to the Tranche 2 Closing, the filing by the Company of a Certificate of Amendment to the Certificate of Designations with the Secretary of State of the State of Delaware in substantially the form attached as Exhibit B to this Amendment.”
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Miscellaneous. |
6.1 Termination. This Amendment shall automatically terminate and be of no effect if the Tranche 2 Closing has not been consummated on or before June 15, 2023; provided, however, that no such termination will affect the right of any party to sue for any breach by any other party (or parties). Notwithstanding the foregoing, the Company and each Purchaser, with respect to such Purchaser only and
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without any effect whatsoever on the obligations between the Company and any other Purchaser, may, by mutual written agreement, extend the term of this Amendment. |
6.2 Continued Validity of Purchase Agreement. Except as amended hereby, the Purchase Agreement shall continue in full force and effect as originally constituted and is ratified and affirmed by the parties hereto. |
6.3 Headings. The headings herein are for convenience only, do not constitute a part of this Amendment and shall not be deemed to limit or affect any of the provisions hereof. |
6.4 Successors and Assigns. This Amendment shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns. |
6.5 No Third-Party Beneficiaries. This Amendment is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person, except as otherwise set forth in Section 4.6 of the Purchase Agreement. |
6.6 Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Amendment shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without regard to the principles of conflicts of law thereof. Each party agrees that all legal proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Amendment (whether brought against a party hereto or its respective Affiliates) shall be commenced exclusively in the state and federal courts sitting in the State of Delaware. Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the State of Delaware for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is improper or is an inconvenient venue for such proceeding. Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Amendment and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law. |
6.7 Execution. This Amendment may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof. |
6.8 Severability. If any term, provision, covenant or restriction of this Amendment is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth in this Amendment or the Purchase Agreement shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is
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hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable. |
6.9 Independent Nature of Purchasers’ Obligations and Rights. The obligations of each Purchaser are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance or non-performance of the obligations of any other Purchaser. Nothing contained herein or in any other Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents. Each Purchaser shall be entitled to independently protect and enforce its rights including, without limitation, the rights arising out of this Amendment, and it shall not be necessary for any other Purchaser to be joined as an additional party in any proceeding for such purpose. Each Purchaser has been represented by its own separate legal counsel in its review and negotiation of this Amendment. It is expressly understood and agreed that each provision contained in this Amendment is between the Company and a Purchaser, solely, and not between the Company and the Purchasers collectively and not between and among the Purchasers. |
6.10 Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to revise this Amendment and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of this Amendment. In addition, each and every reference to share prices and shares of Preferred Stock or Common Stock in this Amendment shall be subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the Preferred Stock or Common Stock that occur after the date of this Amendment. |
6.11 WAIVER OF JURY TRIAL. IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY. |
(Signature Pages Follow)
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IN WITNESS WHEREOF, the parties hereto have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
ALIMERA SCIENCES, INC. |
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Address for Notice: |
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By: |
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/s/ Rick Eiswirth |
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6310 Town Square, Suite 400 |
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Name: Rick Eiswirth |
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Alpharetta, GA 30005 |
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Title: Chief Executive Officer |
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Facsimile: |
With a copy to (which shall not constitute notice): |
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Email: |
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Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP One Marina Park Drive, Suite 900 Boston, MA 02210 Attention: Keith Scherer
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[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK
SIGNATURE PAGES FOR PURCHASERS FOLLOWS]
[ISSUER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AMENDMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Account managed by Caligan Partners LP |
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By: Caligan Partners LP, its investment manager |
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Signature of Authorized Signatory of Purchaser: |
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/s/ David Johnson |
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Name of Authorized Signatory: |
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David Johnson |
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Managing Member |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Account managed by Caligan Partners LP |
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By: Caligan Partners LP, its investment manager |
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Signature of Authorized Signatory of Purchaser: |
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/s/ David Johnson |
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Name of Authorized Signatory: |
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David Johnson |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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CALIGAN PARTNERS MASTER FUND LP |
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By: Caligan Partners LP, its investment manager |
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Signature of Authorized Signatory of Purchaser: |
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/s/ David Johnson |
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Name of Authorized Signatory: |
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David Johnson |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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CALIGAN PARTNERS CV VI LP |
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Signature of Authorized Signatory of Purchaser: |
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/s/ David Johnson |
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Name of Authorized Signatory: |
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David Johnson |
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Title of Authorized Signatory: |
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Managing Member of General Partner |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Account managed by Caligan Partners LP |
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By: Caligan Partners LP, its investment manager |
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Signature of Authorized Signatory of Purchaser: |
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/s/ David Johnson |
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Name of Authorized Signatory: |
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David Johnson |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Velan Capital Master Fund LP |
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By: Velan Capital Holdings LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Adam Morgan |
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Name of Authorized Signatory: |
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Adam Morgan |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Velan Capital SPV I LLC |
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By: Velan Capital Holdings LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Adam Morgan |
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Name of Authorized Signatory: |
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Adam Morgan |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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AIGH Investment Partners, L.P. |
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By: AIGH Capital Management, LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Orin Hirschman |
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Name of Authorized Signatory: |
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Orin Hirschman |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
WVP Emerging Manager Onshore Fund, LLC – AIGH Series |
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|
By: AIGH Capital Management, LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Orin Hirschman |
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Name of Authorized Signatory: |
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Orin Hirschman |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
WVP Emerging Manager Onshore Fund, LLC – Optimized Equity Series |
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|
By: AIGH Capital Management, LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Orin Hirschman |
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Name of Authorized Signatory: |
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Orin Hirschman |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Altium Growth Fund, LP |
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By: Altium Capital Management, LLC |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Mark Gottlieb |
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Name of Authorized Signatory: |
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Mark Gottlieb |
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Title of Authorized Signatory: |
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COO |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
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Clearline Capital Partners LP |
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By: Marc Majzner |
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Signature of Authorized Signatory of Purchaser: |
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/s/ Marc Majzner |
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Name of Authorized Signatory: |
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Marc Majzner |
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
Clearline Capital Partners Master Fund LP |
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By: Marc Majzner |
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Signature of Authorized Signatory of Purchaser: |
|
/s/ Marc Majzner |
||||||||
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||||||||||
Name of Authorized Signatory: |
|
Marc Majzner |
||||||||
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Title of Authorized Signatory: |
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Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
Stonepine Capital LP |
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|
By: Stonepine Capital Management, LLC |
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Signature of Authorized Signatory of Purchaser: |
|
/s/ Timothy P. Lynch |
||||||||
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Name of Authorized Signatory: |
|
Timothy P. Lynch |
||||||||
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||||||||||
Title of Authorized Signatory: |
|
Managing Member |
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
Alice Winzer Lytton Family LLC |
||||||||
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||||||||||
|
By: Laurence Lytton |
|||||||||
Signature of Authorized Signatory of Purchaser: |
|
/s/ Laurence Lytton |
||||||||
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||||||||||
Name of Authorized Signatory: |
|
Laurence Lytton |
||||||||
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||||||||||
Title of Authorized Signatory: |
|
Managing Partner |
||||||||
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Email Address of Authorized Signatory: |
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Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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||||||
Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
IN WITNESS WHEREOF, the undersigned have caused this Joinder and Amendment to Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
Name of Purchaser: |
|
Lytton-Kambara Foundation |
||||||||
|
||||||||||
|
By: Laurence Lytton |
|||||||||
Signature of Authorized Signatory of Purchaser: |
|
/s/ Laurence Lytton |
||||||||
|
||||||||||
Name of Authorized Signatory: |
|
Laurence Lytton |
||||||||
|
||||||||||
Title of Authorized Signatory: |
|
President |
||||||||
|
||||||||||
Email Address of Authorized Signatory: |
|
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||||||||
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||||||||||
Facsimile Number of Authorized Signatory: |
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Address for Notice to Purchaser: |
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With a copy to: |
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Tranche 2 Subscription Amount: $ |
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||||||
Beneficial ownership limitation: |
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[PURCHASER SIGNATURE PAGE TO JOINDER AND AMENDMENT TO SECURITIES PURCHASE AGREEMENT]
Exhibit A
New Purchasers (Tranche 2)
Velan Capital SPV I LLC |
Caligan Partners CV VI LP |
Account managed by Caligan Partners LP |
AIGH Investment Partners, LP |
WVP Emerging Manager Onshore Fund, LLC – AIGH Series |
WVP Emerging Manager Onshore Fund, LLC – Optimized Equity Series |
Altium Growth Fund, LP |
Clearline Capital Partners LP |
Clearline Capital Partners Master Fund LP |
Stonepine Capital, LP |
Alice Winzer Lytton Family LLC |
Lytton-Kambara Foundation |
Exhibit B
Certificate of Amendment to Certificate of Designation of Series B Convertible Preferred Stock
SCHEDULE B
Tranche 2 Closing
Purchaser Entities |
Shares of Series B Convertible Preferred Stock |
Shares of Common Stock |
Warrants |
Aggregate Purchase Price |
Velan Capital Master Fund LP |
8,117 |
1,401,901 |
800,000 |
$10,500,000 |
Velan Capital SPV I LLC |
7,000 |
- |
- |
$7,000,000 |
Account managed by Caligan Partners LP |
2,625 |
- |
280,000 |
$2,625,000 |
Account managed by Caligan Partners LP |
1,750 |
- |
186,667 |
$1,750,000 |
Caligan Partners Master Fund LP |
1,550 |
- |
333,333 |
$1,550,000 |
Caligan Partners CV VI LP |
13,575 |
- |
- |
$13,575,000 |
Account managed by Caligan Partners LP |
3,000 |
- |
- |
$3,000,000 |
AIGH Investment Partners, LP |
3,000 |
- |
- |
$3,000,000 |
WVP Emerging Manager Onshore Fund, LLC – AIGH Series |
786 |
- |
- |
$786,000 |
WVP Emerging Manager Onshore Fund, LLC – Optimized Equity Series |
214 |
- |
- |
$214,000 |
Altium Growth Fund, LP |
5,000 |
- |
- |
$5,000,000 |
Clearline Capital Partners LP |
3,922 |
- |
- |
$3,922,130 |
Clearline Capital Partners Master Fund LP |
1,078 |
- |
- |
$1,077,870 |
Stonepine Capital, LP |
10,000 |
- |
- |
$10,000,000 |
Alice Winzer Lytton Family LLC |
1,400 |
- |
- |
$1,400,000 |
Lytton-Kambara Foundation |
3,600 |
- |
- |
$3,600,000 |
Total |
66,617 |
1,401,901 |
1,600,000 |
$69,000,000 |
Exhibit 99.1
FOR IMMEDIATE RELEASE
|
|
Alimera Acquires U.S. Commercial Rights to YUTIQ®
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Expected to be immediately accretive to revenue and Adjusted EBITDA in 2023 |
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Alimera projects at least $100 million of consolidated net revenue and over $20 million of Adjusted EBITDA* in 2024 |
· |
Leverages Alimera’s existing U.S. commercial infrastructure |
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Industry veteran Jason Werner added to Alimera Board of Directors |
ATLANTA (May 18, 2023) – Alimera Sciences, Inc. (Nasdaq: ALIM) (Alimera), a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer, today announced its acquisition of additional commercialization rights for YUTIQ (fluocinolone acetonide intravitreal insert) 0.18mg for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye from EyePoint Pharmaceuticals, Inc. (EyePoint). A live conference call will be hosted today at 8:30 a.m. ET to provide a corporate update. Please refer to the information in the paragraphs below for conference call dial-in information and webcast registration.
“This is a landmark transaction for Alimera, bringing critical mass to our revenue base and leveraging the commercial infrastructure we have built in the U.S. We know this product very well, having marketed ILUVIEN for the uveitis indication in Europe and the Middle East for several years now. We believe there are immediate synergies in adding YUTIQ to our portfolio that will be accretive to revenue, Adjusted EBITDA and cash flow in the second half of 2023,” said Rick Eiswirth, Alimera’s President and Chief Executive Officer. “EyePoint has done a wonderful job growing YUTIQ to almost $30 million in revenue in 2022. We believe that deploying a larger commercial team focused on both ILUVIEN and YUTIQ will increase utilization of both products moving forward and expect Alimera to generate in excess of $100 million in net revenue and $20 million in Adjusted EBITDA* in 2024.”
YUTIQ net product revenue increased 60% to $7.4 million in Q1 2023 compared with $4.6 million in Q1 2022. For the full year of 2022, YUTIQ net product revenue increased 67% to $28.3 million compared to $16.9 million in 2021.** Alimera now has exclusive global rights to YUTIQ excluding China, Hong Kong, Taiwan, Macau, South Korea and Southeast Asia, where EyePoint has a pre-existing license with Ocumension Therapeutics.
Under the terms of the agreement with EyePoint:
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Alimera made an upfront cash payment of $75 million at closing; an additional $7.5 million will be paid in equal quarterly installments in 2024. |
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EyePoint will also receive potential royalties from 2025 to 2028 based on combined net revenues in the U.S. from ILUVIEN and YUTIQ in excess of certain thresholds, beginning at $70 million in 2025 and increasing annually thereafter. |
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Alimera will immediately assume control of all commercial activities related to YUTIQ in the U.S. |
Alimera funded the upfront payment and obtained additional working capital with:
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A $69 million private placement of Series B preferred stock and common stock to a syndicate of investors led by Velan Capital and Caligan Partners. |
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Borrowing of an additional $20 million through an amendment to its existing term loan agreement with SLR Capital Partners, LLC. |
“We deeply appreciate the support of SLR Capital and our new shareholders with this transformative transaction for Alimera,” continued Mr. Eiswirth.
Board of Directors Changes
In conjunction with these transactions, Alimera has added Jason Werner to its Board of Directors, as a designee of Velan Capital. Prior to this appointment, long-term board member, Garheng Kong, resigned as director.
“On behalf of the entire board and management, I would like to express our sincerest gratitude to Garheng for his dedication to Alimera for almost twenty years. His committed leadership has played a crucial role in our growth and development as an organization,” said Mr. Eiswirth. “We are fortunate to have Jason joining our Board of Directors, and excited about the ophthalmic and operational experience he brings as we integrate YUTIQ into our portfolio and continue to grow Alimera.”
Mr. Werner currently serves as the Chief Executive Officer of SightStream Biotherapeutics Inc., a biotechnology company focused on developing regenerative medicines in ophthalmics. Mr. Werner also currently serves on the board of directors of InflammX Therapeutics Inc, a privately-held developer of novel treatments of the Inflammasome (NLRP3) Pathway based in San Diego, California. Mr. Werner previously co-founded and served as Chief Operating Officer of Eyevance Pharmaceuticals through its sale to Santen Pharmaceuticals Ltd. He has held a variety of Commercial Development roles and Corporate Strategy positions at companies such as Sun Pharma, Nicox SA and Inspire Pharmaceuticals, all within the field of ophthalmics.
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* See “Non-GAAP Financial Measures” below.
** According to EyePoint’s SEC reports.
Mr. Werner received his B.S. in business administration from the University of New Hampshire.
Securities Purchase Agreement
Alimera issued 1,401,901 shares of its common stock and 66,617 shares of its Series B Preferred Stock in exchange for an aggregate of $69 million in gross proceeds. Upon approval by Alimera’s stockholders, the Series B Preferred Stock issued in this second tranche will be mandatorily convertible into 39,186,471 shares of Alimera common stock, subject to adjustment. The purchase price of the common stock and the initial conversion price of this second tranche of Series B Preferred Stock is $1.70 per share. In connection with the funding of this second tranche, the purchasers of the first tranche of Series B Preferred Stock forfeited 4,114,286 of the common stock warrants obtained in connection with the first tranche funding for no consideration.
Amendment to the Loan and Security Agreement
The term loan amendment increased the available amount under the facility from $15 million to $20 million, all of which was funded in connection with the transactions. The maturity date on the facility remains April 30, 2028, with monthly interest-only continuing to May 1, 2025, when principal amortization begins. The interest-only period may be extended an additional 12 months if Alimera achieves $7.5 million in Adjusted EBITDA, as defined in the amended agreement, for any trailing 12-month period ending on or before March 31, 2025. Interest on outstanding borrowing under the term loan is payable at the greater of one-month SOFR or 4.60% plus 5.15% per annum.
The securities sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. Alimera has agreed to file one or more registration statements with the SEC registering the resale of the shares of common stock issued and issuable upon conversion of the Series B Preferred Stock issued in the private placement.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.
ALIM Call Details – Alimera Corporate Update
Conference Call to Be Held May 18, 2023
A live conference call will be hosted on May 18, 2023, at 8:30 a.m. ET by Rick Eiswirth, President and Chief Executive Officer, and Russell Skibsted, Chief Financial Officer, to discuss Alimera’s financial results and provide an update on corporate developments.
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* See “Non-GAAP Financial Measures” below.
** According to EyePoint’s SEC reports.
Please refer to the information below for conference call dial-in information and webcast registration.
Conference date: Thursday, May 18, 2023, 8:30 a.m. ET
Conference dial-in: 844-839-2190
International dial-in: 412-717-9583
Conference Call Name: Alimera Sciences (Nasdaq: ALIM) Corporate Update Call
Conference Call Pre-registration: Participants are asked to pre-register for the call by navigating to: https://dpregister.com/sreg/10179426/f98ecd113e
Please note that registered participants will receive their dial-in number upon registration and will dial directly into the call without delay. All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the Alimera Sciences call.
The conference call will also be available through a live webcast which is also available through the company’s website, www.alimerasciences.com in the Events section under Investor Relations.
Live Webcast URL: https://event.choruscall.com/mediaframe/webcast.html?webcastid=IOhr4gKA
A replay will be available on Alimera’s website, www.alimerasciences.com, under “Investor Relations” one hour following the live call.
Conference Call replay: US Toll Free: 1-877-344-7529
International Toll: 1-412-317-0088
Canada Toll Free: 855-669-9658
Replay Access Code: 8053807
End Date: June 1, 2023
Webcast Replay End Date: August 18, 2023
About Alimera Sciences, Inc.
Alimera Sciences is a global pharmaceutical company whose mission is to be invaluable to patients, physicians and partners concerned with retinal health and maintaining better vision longer. For more information, please visit www.alimerasciences.com.
Non-GAAP Financial Measures
This press release includes forecasted Adjusted EBITDA, which is a non-GAAP financial measure. Alimera uses this measure to supplement the financial information presented on a GAAP basis. Alimera believes that excluding certain items from its GAAP financial results allows management to better understand its ongoing operations and analyze its financial performance from period to period and provides meaningful supplemental information to its investors.
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* See “Non-GAAP Financial Measures” below.
** According to EyePoint’s SEC reports.
Alimera defines “Adjusted EBITDA” as earnings before interest, taxes, depreciation, amortization, stock-based compensation expenses, net unrealized gains and losses from foreign currency exchange transactions, gains on extinguishment of debt, severance expenses and change in fair value of warrant asset.
Alimera believes that Adjusted EBITDA, when taken together with GAAP net income or loss, its most directly comparable GAAP financial measure, provides meaningful supplemental information to investors regarding Alimera’s performance by excluding certain items that may not be indicative of its business, results of operations, or outlook.
This non-GAAP financial measure may not be comparable to similarly titled measures reported by other companies, including companies in Alimera’s industry, because not all companies calculate Adjusted EBITDA in an identical manner or may use other financial measures to evaluate their performance. Therefore, this non-GAAP financial measure may be limited in its usefulness for comparison between companies. The presentation of this non-GAAP financial measure is not intended to be considered in isolation from or as a substitute for other financial performance measures prepared in accordance with GAAP and should be read only in conjunction with financial information presented on a GAAP basis. The principal limitation of this non-GAAP financial measure is that it excludes significant elements required by GAAP to be recorded in Alimera’s financial statements. In addition, non-GAAP financial measures are subject to inherent limitations because they reflect the exercise of judgments by management. Investors are encouraged not to rely on any single financial measure to evaluate Alimera’s business.
Alimera’s anticipated consolidated net revenue and Adjusted EBITDA is based on information available as of May 18, 2023 and expected cost savings and synergies, In addition, such forecasts assume foreign exchange rates prevailing as of March 31, 2023.
Alimera has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K and has not provided a quantitative reconciliation of forecasted Adjusted EBITDA to forecasted GAAP net income or loss, its most directly comparable GAAP financial measure, within this press release because Alimera is unable, without making unreasonable efforts, to calculate certain reconciling items with confidence. These items include, but are not limited to, income taxes which are directly impacted by unpredictable fluctuations in the market price of Alimera's stock. These statements are forward-looking and actual results may differ materially. Refer to “Forward Looking Statements” below for information on the factors that could cause Alimera's actual results to differ materially from these forward-looking statements.
Forward Looking Statements
This press release contains “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, regarding, among other things, Alimera’s expectations with respect to its future operating and financial results and the expected cost savings and synergies resulting from the YUTIQ acquisition and foreign exchange rates.
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* See “Non-GAAP Financial Measures” below.
** According to EyePoint’s SEC reports.
Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties (some of which are beyond Alimera’s control), including factors that could delay, divert or change any of them, and could cause actual results to differ materially from those projected in these forward-looking statements. Other factors are discussed in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Alimera’s most recently filed Quarterly Report on Form 10-Q, most recently filed Annual Report on Form 10-K, and any of Alimera’s subsequent filings with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov.
All forward-looking statements contained in this press release are expressly qualified by the cautionary statements contained or referred to herein. Alimera cautions investors not to rely on the forward-looking statements Alimera makes or that are made on its behalf as predictions of future events. These forward-looking statements speak only as of the date of this press release. Alimera undertakes no obligation, and specifically declines any obligation, to publicly update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
For press inquiries: Jules Abraham for Alimera Sciences 917-885-7378 julesa@coreir.com |
For investor inquiries: Scott Gordon
for Alimera Sciences |
# # #
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* See “Non-GAAP Financial Measures” below.
** According to EyePoint’s SEC reports.