Manufacturing Services Agreement between Alimera Sciences, Inc. and Cadence, Inc. dated October 30, 2020 (including related Supplier Quality Agreement)

Manufacturing Services Agreement



THIS MANUFACTURING SERVICES AGREEMENT (“Agreement”) is made and entered into effective as of this 30th day of October,  2020 (“Effective Date”) by and between ALIMERA SCIENCES, INC., a Delaware corporation, and its successors and assigns (hereinafter referred to as “Alimera”), having a principal place of business at 6120 Windward Parkway, Suite 290, Alpharetta, GA 30022, and CADENCE, INC., a Virginia Corporation, and its successors and assigns (hereinafter referred to as “Cadence”), having an address at 9 Technology Drive, Staunton, VA 24401. Alimera and Cadence are referred to herein collectively as the “Parties” and each individually as a “Party.”



RECITALS



WHEREAS, Cadence has expertise in medical device contract manufacturing and offers services in connection therewith;



WHEREAS, Alimera desires to retain Cadence to perform such services (as more particularly defined herein) subject to the terms and conditions set forth herein; and



WHEREAS, it is the intention of the Parties to establish this Agreement to govern the respective rights, duties and obligations of the Parties.



NOW THEREFORE, in consideration of the mutual promises and benefits made and contained herein, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:





1.Definitions.



Cadence and Alimera agree that capitalized terms shall have the meanings set forth within the body of this Agreement and Exhibit 1 attached hereto and incorporated herein by reference.    



2.Services.



2.1Manufacturing Services. Cadence agrees to perform all required manufacturing services for the Product(s) (“Manufacturing Services”). Manufacturing Services shall include Materials procurement and the manufacture, assembly, testing, storage, and shipment of Product in accordance with Alimera’s detailed written Specifications and orders. “Materials” means the components, parts, and subassemblies comprising the Product and appearing on the related bill of materials. “Specifications” for the Product and any revision thereof shall include but are not limited to bill of materials, designs, schematics, assembly drawings, process documentation, test specifications, current revision number, and Approved Vendor List (AVL). The Specifications (and any modifications thereto) are incorporated herein by reference as Exhibit 2. In the event of any conflict between the Specifications and this Agreement, the Specifications shall prevail.



2.2Engineering Changes. Alimera may request that Cadence incorporate engineering changes into the Product by providing a written description of the proposed engineering change sufficient to permit Cadence to evaluate feasibility and cost. Cadence will discuss with Alimera in good faith whether any delivery schedule and/or pricing changes are necessary to incorporate the requested changes. Cadence will proceed with engineering changes when the parties have agreed in writing

upon any changes to the Specifications, delivery schedule, Product pricing, and implementation costs, if any.



2.3Manufacturing Site. The Manufacturing Services shall be performed at Cadence's registered medical device manufacturing facility located at 250 W. Kensinger Dr., Suite 400, Cranberry Township, PA 16066, United States (the “Manufacturing Site”). Cadence will not relocate the Manufacturing Site without providing at least [***] written notice to Alimera to allow Alimera to determine whether such relocation would require regulatory approval. Cadence will not implement any change in the Manufacturing Site until it receives written notification from Alimera authorizing such change. Cadence will cooperate in good faith with Alimera to develop an acceptable transition and relocation plan and shall be responsible for all costs and expenses associated with changes in the Manufacturing Site.  Cadence shall provide Alimera with reasonable access at mutually convenient times (as agreed in good faith) to the areas of the Manufacturing Site in which Products are manufactured, stored, handled or shipped to permit Alimera to verify the performance of the Manufacturing Services in accordance with this Agreement. At all times while on Cadence’s premises, Alimera's representatives shall comply with Cadence policies and procedures related to safety, security and confidentiality.



2.4Tooling; Non-Recurring Expenses (NRE); Software. Alimera will provide, through purchase or otherwise, and will allow Cadence to use solely for Alimera's benefit in accordance with this Agreement any Product-specific tooling, equipment, molds, software and other items that are reasonably necessary for the performance of the Manufacturing Services (collectively, “Alimera Property”). Cadence may purchase or acquire Alimera Property for use under this Agreement on Alimera’s behalf after obtaining Alimera’s prior written consent. Alimera agrees that Alimera shall pay for all reasonably necessary non-recurring expenses associated with the installation as well as removal and shipment of the Alimera Property after termination of this Agreement. Cadence agrees that the provision of Alimera Property to Cadence shall be a bailment and not a sale, and all right, title and interest in Alimera Property, including software that Alimera provides to Cadence or any test software that Alimera engages Cadence to develop, is and shall remain the property of Alimera. Cadence shall handle, store and maintain all Alimera Property under proper conditions to preserve quality and prevent damage or other loss. Cadence shall maintain and service all equipment that Alimera has authorized Cadence to purchase, such equipment to be returned to Alimera in good working order, reasonable wear and tear excepted, following the termination or expiration of this Agreement. Except to the extent caused by Cadence’s negligence or other wrongful conduct, the costs of repairing any equipment or tooling outside of reasonable wear and tear will be the responsibility of Alimera and will be performed only upon Alimera’s written approval. Cadence shall not use all or any part of the Alimera Property for any purpose other than to perform Manufacturing Services under this Agreement. Cadence shall mark all Alimera Property, including equipment, as “Property of Alimera Sciences.” During the term of this Agreement, Cadence shall maintain commercially reasonable insurance to protect against any loss to the Alimera Property while in the possession of Cadence.





3.Forecasts and Purchase Orders



3.1Forecast. Alimera shall provide Cadence, on a monthly basis within the first 5 business days of each calendar month, a rolling twelve (12) month forecast indicating Alimera's monthly Product requirements. The first ninety (90) days of the forecast will be binding and will constitute a firm order for all Manufacturing Services to be completed during such ninety (90) day period (a “Firm Order”). A purchase order for Manufacturing Services to be completed within the first ninety

(90) day period of a forecast will be issued in accordance with Section 3.2 below.



3.2Purchase Orders; Precedence. Alimera may use its standard written purchase order form for any Firm Orders; provided that all Firm Orders must reference this Agreement and the applicable Specifications. All Firm Orders will be deemed to incorporate all of the terms and conditions in this Agreement. The parties agree that the terms and conditions contained in this Agreement shall prevail over any contradictory terms and conditions of any such purchase order, acknowledgment form, or other instrument.



3.3Purchase Order Acceptance.  Purchase orders shall be deemed accepted by Cadence so long as they are consistent with this Agreement. Cadence may reject any purchase order only if (a) the purchase order is an amended order in accordance with Section 7.2 below and the purchase order is outside of the Flexibility Table; (b) the fees reflected in the purchase order are inconsistent with the parties’ agreement with respect to the fees; or (c) the purchase order represents a significant deviation from the forecast for the same period, unless such deviation is within the parameters of the Flexibility Table. Cadence shall notify Alimera of rejection of any purchase order within five (5) business days of receipt of such purchase order. If Cadence does not notify Alimera of rejection of any purchase order during such period, then the purchase order shall be deemed accepted by Cadence.



4.Pricing and Payment.



4.1Fees.  The initial fees shall be as set forth on the Fees List attached hereto and incorporated herein as Exhibit 3 (the “Fees List”). If a Fees List is not attached or completed, then the initial fees shall be as set forth in purchase orders issued by Alimera and accepted by Cadence in accordance with the terms of this Agreement. Changes to the fees will be agreed by the parties in accordance with Section 4.3.



4.2Additional Fees and Costs.  Alimera is responsible for additional fees and costs due to (a) changes to the Specifications; (b) failure of Alimera or an Alimera-Designated Supplier to timely provide sufficient quantities or a reasonable quality level of Materials where applicable to sustain the production schedule; and (c) any expediting charges reasonably necessary because of a change in Alimera's requirements, provided that Alimera shall be responsible for such fees and costs due to reasons specified in (a) or (c) if Cadence received prior written approval from Alimera to incur such fees and costs. “Alimera-Designated Supplier” means a supplier whom Alimera designates in Exhibit 4 as the required source for certain Materials.



4.3Changes in Materials Costs.  Cadence will notify Alimera of changes to the cost of Materials as such changes are identified. On an annual basis, Cadence and Alimera will review any changes to Materials cost and revise the Fees List to reflect any mutually agreed fee changes resulting from changes, if any, to Materials costs and other costs. By way of example only, the fees may be increased or decreased if the market price of fuels, Materials, equipment, labor and other production costs increase or decrease beyond [***] in pricing, as reasonably demonstrated by Cadence or Alimera.



4.4Taxes.  All fees are exclusive of federal, state and local excise, sales, use, VAT, and similar transfer taxes, and any duties, and Alimera shall be responsible for all such tax items. This subsection 4.4 does not apply to taxes on Cadence's net income.



4.5Currency.  The Fees List will be stated in US dollars. Any purchase price for Materials

Inventory made in any currency other than US dollars will be converted into US dollars based on the exchange rate reported on Reuters’ page FIX on the last business day of each month, provided that no adjustment will be made to the converted price set forth in the Fees List unless the reported exchange rate is at least .75% higher or lower than the exchange rate reported in the previous month.



4.6Payment. Alimera agrees to pay all correct invoices in U.S. Dollars, [***] from the invoice delivery date. Cadence shall invoice Alimera only for shipped Product. If Alimera has any reasonable grounds for disputing in good faith any invoiced amounts under this Agreement, Alimera shall pay the undisputed amount in accordance with this Section and shall, within thirty (30) days after its receipt of the applicable invoice, provide Cadence with written notice specifying the amount of the invoice that is disputed, and describing in reasonable detail the basis of the dispute. The parties agree to work to resolve the dispute pursuant to Section 18.7. After resolution of such dispute, Alimera shall pay any amounts owed to Cadence within the longer of (a) the remaining time for payment pursuant to this Agreement or (b) five (5) business days from the date such dispute was resolved. Alimera agrees to pay [***] monthly interest on all late payments, other than amounts disputed in good faith.



4.7Cost Reduction Projects. Cadence agrees to seek ways to reduce the cost of manufacturing Product, including, for example, through reduction or elimination of Materials, improvements to Specifications, and re-design or improvement to assembly or test methods (each, a “Cost Reduction Proposal”). Cadence shall submit each Cost Reduction Proposal in writing to Alimera and include sufficient detail to allow Alimera to determine whether the Cost Reduction Proposal will require prior approval from any governmental or regulatory authority. Cadence will not implement any Cost Reduction Proposal until approved in writing by Alimera. Following approval and implementation, Cadence will receive [***] of the demonstrated cost reduction resulting from the Cost Reduction Proposal, and Alimera will receive the remaining [***]. Alimera will receive [***] of the demonstrated cost reduction resulting from any Cost Reduction Proposal initiated by Alimera.



5.Term and Termination.



5.1Term. The term of this Agreement shall begin on the Effective Date and continue for five years thereafter unless earlier terminated as provided in Section 5.2. After the expiration of the initial term (unless this Agreement is terminated earlier), this Agreement shall automatically renew for separate and successive one-year terms, unless either party provides the other written notice of its intent to not renew this Agreement at least twenty-four (24) months prior to the end of any term.



5.2Termination. Either party may terminate this Agreement (a) for convenience upon twenty-four  (24) months’ prior written notice to the other party; (b) upon the material default of the other party and such default not cured within thirty (30) days after delivery of written notice from the non-defaulting party; or (c) pursuant to Section  18.1. Alimera may also terminate this Agreement immediately upon written notice in the event that Alimera or any regulatory authority withdraws the Product or the ILUVIEN® intravitreal insert or a regulatory authority takes any action or raises any objection that prevents Alimera from marketing, distributing, importing, exporting, or selling Product or ILUVIEN.



5.3Effect of Expiration or Termination. Expiration or termination of this Agreement under any of the foregoing provisions shall not affect the amounts then due under this Agreement by either party or any obligations then outstanding of either party and shall not affect Cadence’s express limited warranty in Section 10.1. In addition, within thirty (30) days of expiration or

termination of this Agreement, Cadence shall promptly deliver to Alimera at Alimera’s designated facility all Alimera Property, Alimera Intellectual Property and Alimera Confidential Information, and Cadence shall provide to Alimera (or its designee) any and all documentation related to the Manufacturing Services that is the property of Alimera, as reasonably requested by Alimera. Upon reasonable request by Alimera, Cadence will provide transition services to Alimera at Cadence’s published labor rates. Upon notice of termination provided by either Party, the Parties shall cooperate to use commercially reasonable efforts to reduce remaining Inventory by seeking to return Materials, cancel pending Materials orders, and otherwise mitigate Inventory levels. Alimera will purchase at cost all usable Inventory remaining upon the date of termination or at the end of any later-ending transitions services period.  Provisions of this Agreement that by their nature would be reasonable expected to survive termination or expiration, including without limitation Sections 1, 4.6,  6,  8,  9, 10,  11, 13,  14,  15,  16, 18 and this Section 5.3 of this Agreement,  along with Sections 4.02 (Records), 4.16 (Complaint Handling), 4.15 (Reporting to Regulatory Authorities), 4.18 (Control of Nonconforming Product), and 4.19 (Rework) of  the Supplier Quality Agreement shall survive any termination or expiration of this Agreement.





6.1Authorization to Procure Materials. Alimera's accepted purchase orders and forecast will constitute authorization for Cadence to procure, without additional approval, Materials Inventory necessary to manufacture the Product covered by such purchase orders.



6.2Preferred Supplier. Alimera shall provide to Cadence and maintain an approved vendor list (the “AVL”) for certain identified Materials (see Exhibit 4). Cadence will purchase the identified Materials only from vendors on a current AVL approved in writing by Alimera.



6.3Materials Warranties. Cadence shall use reasonable efforts to obtain and to pass through to Alimera all relevant vendor warranties with regard to the Materials, including without limitation (i) conformance of the Materials with the vendor's specifications and/or the Specifications; (ii) that the Materials are free from defects in workmanship; (iii) that the Materials comply with applicable Environmental Regulations; and (iv) that the Materials do not infringe the intellectual property rights of third parties.





7.1Shipments. Cadence shall use commercially reasonable efforts to deliver Products in accordance with the delivery times specified in each accepted purchase order. All Products delivered pursuant to the terms of this Agreement shall be suitably packed for shipment in accordance with the Specifications and marked for shipment to Alimera's destination specified in the applicable purchase order. Each time Cadence ships Product, it shall provide Alimera with a certificate of compliance (in English) that confirms that the lot has been manufactured and tested in accordance with the Specifications. Alimera will have sole responsibility for the release of Products to the market. Shipments will be made FCA (Free Carrier, lncoterms 2020) Manufacturing Site, at which time risk of loss and title will pass to Alimera. Cadence will arrange for shipping to Alimera’s designated location using the carrier accounts specified by Alimera. All freight, insurance and other shipping expenses, as well as any special packing expenses not included in the original quotation for the Products, will be included in the Fees List. Cadence shall convey good title to the Product to Alimera, free of all liens of any kind whatsoever.



7.2Quantity Increases and Shipment Schedule Changes.





Maximum Allowable Variance from Accepted Purchase Order Quantities/Shipment Dates





Any decrease in quantity is considered a cancellation only of the decreased quantity, unless the decreased quantity is rescheduled for delivery at a later date in accordance with the Flexibility Table. Quantity cancellations are governed by the terms of Section 7.3 below. Any purchase order quantities increased or rescheduled pursuant to this Section 7.2 (a) may not be subsequently increased or rescheduled without the approval of Cadence, provided that Cadence will use good faith, commercially reasonable efforts to accommodate any subsequent increase or rescheduling. Any reschedules extending shipment dates outside of the Flexibility Table Maximum Reschedule Period require Cadence's prior written approval.







7.3.Cancellation of Orders.



Cancellation of all or any portion of the Product quantity of an accepted purchase order requires Cadence’s prior written approval, which it may or may not grant in its sole discretion.



8.Product Acceptance.  



8.1 Alimera will inspect and accept or reject the Products delivered by Cadence within thirty (30) days of receipt at the “ship to” location on the applicable purchase order. If Products do not comply with the express limited warranty set forth in Section 10.1, Alimera has the right to reject such Products. Products not rejected will be deemed accepted. Alimera may return defective Products, freight collect, after completing a failure report and obtaining a return material authorization number from Cadence to be displayed on the shipping container. Rejected Products will be promptly repaired or replaced at Cadence’s option and at Cadence’s sole cost and returned freight pre-paid. Following delivery of replacement Product, Alimera shall inspect and accept or

reject the Product in accordance with the procedures above. Alimera shall bear all risk and all costs and expenses associated with Products that have been returned to Cadence for which there is no defect found. The parties will attempt to resolve any dispute regarding whether any Products comply with the express limited warranty set forth in Section 10.1, and if the parties cannot resolve such dispute after good faith negotiations, the dispute will be resolved in accordance with Section 18.7.





9.1 In the event that any Product defect or any governmental action attributable to a Product defect requires a Product Recall in Alimera’s reasonable judgment or as directed by a relevant regulatory authority, Alimera shall promptly provide verbal notification to Cadence (followed by a written notification), and the Parties shall cooperate fully in the investigation of the problem. To the extent that the Recall results from a breach by Cadence of its express limited warranty set forth in Section 10.1, then, in addition to Cadence’s obligation to repair or replace any such Products, Cadence shall reimburse Alimera for documented out-of-pocket administrative costs and expenses incurred in conducting such Recall.





10.1Express Limited Warranty. This Section 10.1 sets forth Cadence’s warranty with respect to the Product and Alimera's remedies with respect to a breach by Cadence of such warranty.









10.2Cadence represents and warrants that it is a corporation duly organized, validly existing

and in good standing under the laws of its incorporating jurisdiction and has all requisite power and authority to enter into this Agreement.



10.3Cadence represents and warrants that its execution, delivery and performance of this Agreement, including any product, service or documentation provided by Cadence to Alimera in connection with this Agreement, shall



(a)not conflict with, or result in a material breach of any material agreement, judgment or court decree by which Cadence is bound;



(b)to Cadence's knowledge, not be subject to any actual or threatened third party rights (by way of example, infringe third party patents, be the subject of a copyright assertion, or require a license to or from third parties);



(c)to Cadence’s knowledge, fully comply with all applicable federal, state, and local laws, statutes, acts, ordinances, rules, codes, standards, and regulations and the rights of third parties established by such laws in the United States.



10.4Cadence represents and warrants that it currently has, or prior to the commencement of Manufacturing Services, will obtain, pay for, and maintain any and all licenses, permits, inspections, fees, and qualifications required to perform the Manufacturing Services. In addition, if the Manufacturing Services are to be performed on Alimera's premises, Cadence represents and warrants that Cadence will comply with all applicable safety laws and Alimera's then-current safety and other applicable regulations. Cadence shall not use Alimera's facilities and resources for anyone's benefit other than Alimera.



10.5Cadence represents and warrants to Alimera that there is no action, suit, claim, investigation or proceeding pending or, to the best of its knowledge, threatened against it that, if adversely decided, might adversely affect Cadence's (i) ability to enter into this Agreement; or (ii) the performance of its obligations hereunder.



10.6Cadence represents and warrants that to the extent the performance of the Manufacturing Services hereunder require Cadence's presence during surgery or any other procedure, Cadence will obtain any and all proper authorizations from the medical treatment facility, and that Cadence will not offer any patient care or treatment, or medical or nursing assistance while performing Manufacturing Services under this Agreement.







11.1Relationship of the Parties. Cadence will perform this Agreement as an independent contractor, and this Agreement will not be construed to create between the Parties the relationship of principal and agent, joint-ventures, co-partners, employer and employee, franchiser and franchisee or any other similar relationship, the existence of which is expressly denied by each Party. Cadence will conduct its business under its own name as an independent contractor and is hereby expressly prohibited from holding itself out as an employee, agent, partner or representative of Alimera. Any person employed by Cadence to perform hereunder will not be deemed to be an employee of Alimera, and Cadence and his/her suppliers, subcontractors, agents or representatives will not be, or represent themselves to be, officers, employees, agents or representatives of Alimera and will not bind, or attempt

to bind, Alimera to any agreement, liability or obligation of any nature. No person employed by Cadence or engaged by Cadence as a subcontractor shall have any claim to any benefit offered by Alimera to any of its own employees. During the term of this Agreement and for a period of two (2) years thereafter, neither party shall solicit, hire, employ, or contract with, either directly or indirectly, any employee of the other party without such party’s consent.



11.2Right to Direct Manufacturing Services.  Except as otherwise set forth in this Agreement, Alimera will have no right to control the manner, means, or method by which Cadence performs the Manufacturing Services called for by this Agreement. Rather, Alimera will be entitled only to direct Cadence with respect to the elements of Manufacturing Services to be performed by Cadence and the results to be derived by Alimera and to review and assess the performance of such Manufacturing Services by Cadence for the limited purposes of assuring that such Manufacturing Services have been performed pursuant to the Specifications.









13.1Governmental Communications. Cadence may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting regulatory approval for the Products, regarding the Manufacturing Site generally and non-Product-specific manufacturing operations.



13.2Records and Accounting by Cadence. Cadence shall keep records of the manufacture, testing and shipping of the Products in accordance with the Quality Agreement and cGMP requirements.



13.3Inspection. During the term of this Agreement and for five (5) years thereafter, Alimera may inspect Cadence’s reports and records relating to this Agreement, including without limitation reports and records relating to the invoices issued hereunder, during normal business hours upon reasonable advance notice. A Cadence representative may be present during any such inspection.



13.4Notification of Regulatory Inspections. Cadence’s interactions and correspondences with relevant regulatory authorities, including the U.S. Food and Drug Administration (the “FDA”), in connection with this Agreement shall be handled in accordance with the Quality Agreement.



13.5Reports. Cadence will promptly supply, as requested by Alimera, all Product data in its control, including complaint test results, and all investigations (in manufacturing, testing and storage), that Alimera reasonably requires in order to complete any filing under any applicable regulatory regime.

13.6Regulatory Filings. Alimera shall have the sole responsibility for filing all documents with all regulatory authorities and taking any other actions that may be required for the receipt and maintenance of regulatory authority approval for the commercial manufacture of the Products.





14.1Indemnification by Cadence.  Cadence agrees to defend, indemnify, and hold harmless Alimera, its Affiliates, and its and their respective officers, directors, employees, and agents (the “Alimera Indemnitees”) from and against any and all costs, claims, losses, expenses, or liabilities (including legal costs and reasonable attorney's fees) (“Claims”) to the extent arising out of or resulting from (a) Cadence's performance of Manufacturing Services; (b) Cadence's breach of its obligations under this Agreement; or (c) the negligence of Cadence, its officers, employees, agents, and representatives in the performance of its or their obligations under this Agreement. Cadence’s obligation to indemnify the Alimera Indemnitees under this Section expressly includes any and all third-party Claims to the extent arising out of or related to

(a)Any actual injury or damage to any person or property caused, or alleged to be caused, by a Product sold by Cadence to Alimera under this Agreement, but solely to the extent such injury or damage has been caused by the breach by Cadence of its warranties set forth in this Agreement; or



(b)Any knowing infringement of intellectual property rights of a third party, but solely to the extent such infringement is caused by a process that Cadence uses to manufacture, assemble, or test the Products.



14.2Indemnification by Alimera.  Alimera agrees to defend, indemnify and hold harmless Cadence, its Affiliates, and its and their respective officer, directors, employees, and agents (the “Cadence Indemnitees”), from and against any and all Claims to the extent arising out of or relating to (i) Alimera's breach of its obligations under this Agreement or (b) the negligence of Alimera, its officers, employees, agents and representatives. Alimera’s obligations to indemnify the Cadence Indemnitees under this Section expressly includes any and all third-party Claims to the extent arising out of or related to

(a)Any failure of any Product (and Materials contained therein) sold by Cadence to Alimera to comply with any safety standards or Environmental Regulations to the extent that such failure has not been caused by Cadence’s breach of its warranties set forth in this Agreement;

(b)Any actual or threatened injury or damage to any person or property caused, or alleged to be caused, by a Product, but only to the extent such injury or damage has not been caused by Cadence’s breach of its warranties set forth in this Agreement; or

(c) any infringement of the intellectual property rights of any third party by any Product except to the extent such infringement is the responsibility of Cadence pursuant to Section 14.1(b) above.

14.3Sale of Products Enjoined. Should the use of any Products be enjoined for a cause stated in Section 14.1 (b) or 14.2 (c) above, or in the event the indemnifying party desires to minimize its liabilities under this Section 14, in addition to its indemnification obligations set forth in this Section 14, the indemnifying party's sole responsibility is, subject to Section 2.2, to either substitute a fully equivalent Product or process (as applicable) not subject to such injunction, modify such Product or process (as applicable) without affecting the fit, form, function, or safety of the Product so that the Product or process (as applicable) is no longer subject to such injunction, or obtain the right to continue using the enjoined process or Product (as applicable). In the event that any of the foregoing remedies cannot be effected on commercially reasonable terms, then all accepted purchase orders and the current forecast will be considered cancelled, and Alimera shall purchase all Products and Materials Inventory at the indemnifying party’s cost. Any changes to any Products or process must be made in accordance with Section 2.2. Notwithstanding the foregoing, in the event that a third party makes an infringement claim, but does not obtain an injunction, the indemnifying party shall not be required to substitute a fully equivalent Product or process (as applicable) or modify the Product or process (as applicable) if the indemnifying party obtains an opinion from competent patent counsel reasonably acceptable to the other party that such Product or process is not infringing or that the patents alleged to have been infringed are invalid.







16.1Alimera grants Cadence a non-exclusive, non-sublicensable, non-transferable (except to its Affiliates) license during the term of this Agreement to use Alimera’s patents, trade secrets, know-how, and other intellectual property, in each case solely to the extent necessary to perform Cadence’s obligations under this Agreement and solely to perform such obligations.



16.2Except as expressly set forth in Section 16.1, above, neither Party shall obtain any rights to the existing intellectual property rights of the other Party solely by reason of entering into this Agreement.



16.3Alimera shall have sole and exclusive ownership and all rights relating to any production or design specific to Product(s) manufactured by Cadence under this Agreement and improvements or

modifications to the Product(s) or to the Alimera intellectual property, including patents, trade secrets and know-how, and to all inventions, data, developments, technology, processes, methods, improvements, information, materials, documents, records, data, specifications, plans, schematics, designs, drawings, prototypes, know how, goodwill and other intellectual property which are developed, made, conceived or reduced to practice specifically for Alimera or the Product(s) by Cadence or in connection with the Alimera know-how and Product(s) or which arise solely from the Manufacturing Services provided by Cadence hereunder for Alimera (collectively, the “Cadence Work for Hire”), and any and all improvements, modifications, enhancements to each of the foregoing, and all other information and materials relating thereto and the attendant intellectual property rights of any sort throughout the world, including, without limitation, rights in any patent, copyright, trademark, trade dress and trade name, in any related registrations and applications for registration, and in all trade secrets and know-how and goodwill related in any manner thereto and as a result of Cadence Work for Hire. Cadence shall maintain and make available to Alimera adequate and current written records of all Cadence Work for Hire and any other data that will enable any other person knowledgeable in the art of the subject to fully understand it and carry forward the work on it. Cadence hereby assigns to Alimera (or if assignment is not permitted by applicable law, waives enforcement of and grants to Alimera an exclusive, irrevocable, perpetual, worldwide, fully-paid, royalty-free license, with right to sublicense through multiple tiers of sublicenses) any and all interest of Cadence in the Cadence Work for Hire, including any intellectual property rights thereto.



Notwithstanding the foregoing, the Parties agree that the following does not constitute Cadence Work for Hire: (a) all rights, title and interests in all intellectual property made, generated or derived by Cadence (i) in the course of production or design not specific to a Product, or (ii) that is an improvement to Cadence’s procedure, process, technique or methodology for developing, manufacturing, testing, validating and/or finishing products generally that does not reveal, disclose, embed, embody, incorporate or use any of the Alimera intellectual property; and (b) all rights, title and interests in all intellectual property developed or acquired by Cadence (i) prior to the Effective Date of this Agreement, or (ii) after the Effective Date by or for Cadence independently outside of this Agreement.  



16.4At Alimera’s request and expense, Cadence will cause its employees and agents to cooperate with and assist Alimera in confirming, recording, perfecting, obtaining, maintaining, protecting, defending and enforcing Alimera’s rights in the Cadence Work for Hire and any intellectual property rights thereto, including execution and delivery to Alimera of any necessary or useful documents and the taking of any other actions that Alimera may reasonably request. Alimera will reimburse Cadence for any reasonable out-of-pocket expenses actually incurred by Cadence in fulfilling its obligations under this Section 16.









18.1In the event either Party is prevented from performing or is unable to perform any of its

obligations under this Agreement due to any act of God, acts of government or military bodies, fire, casualty, flood, earthquake, war, strike, lockout, epidemic or pandemic, destruction of production facilities, riot, insurrection, materials unavailability, or any other cause beyond the reasonable control of the Party that is unable to perform (collectively, a “Force Majeure”), and if the Party that is unable to perform has used commercially reasonable efforts to mitigate the effects of the Force Majeure and given prompt written notice to the other Party, then the Party that is unable to perform shall be excused from performance to the extent and for as long as such performance is prevented by the Force Majeure, provided that if such Party is prevented from performance by such Force Majeure for more than ninety (90) days, the other Party may terminate this Agreement on written notice to the Party prevented from performance by the Force Majeure.



18.2Neither Party may assign this Agreement without the prior written consent of the other Party, except that this Agreement and any rights or obligations under or interests in this Agreement by either Party may assigned and transferred automatically to any parent, subsidiary or Affiliate of such assigning Party, or to a third party in the event of the sale, reorganization or other transfer of substantially all of the assigning Party’s relevant business to the third party. A change in control of a Party shall be considered an automatic assignment of this Agreement to the new controlling entity for the purpose of determining the Parties' rights and obligations. All of the terms and provisions of this Agreement will be binding upon, will inure to the benefit of, and be enforceable by successors and assigns of the Parties to this Agreement.



18.3This Agreement will not confer any right or remedy upon any person other than the Parties hereto and their respective permitted successors and assigns.



18.4This Agreement and accepted purchase orders constitute the entire agreement between the Parties with respect to this subject matter, and any modification or amendments to this Agreement must be in writing and signed by both Parties.



18.5The terms "including," "by way of example" or any variation thereof means "including but not limited to" and "by way of example only and without limitation," respectively. This Agreement shall be fairly interpreted in accordance with its terms and without any presumption in favor of or against either Party regardless of the drafter. If any provision of this Agreement is deemed illegal, invalid or unenforceable, the requirements of the provision shall remain to the full extent permissible by law and the offending portions thereof shall be deemed replaced, to the extent possible, with a provision most closely reflecting the purpose of the offending provision.



18.6No right or remedy conferred in this Agreement is intended to be exclusive of any other right or remedy, and each and every right and remedy will be cumulative and in addition to any other right or remedy given now or existing in law or in equity or by statute. IN NO EVENT WILL EITHER PARTY BE LIABLE (WHETHER ARISING IN CONTRACT, TORT, WARRANTY OR OTHERWISE) FOR ANY SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOSS OF ANTICIPATED PROFITS).



18.7The Parties will attempt to resolve all disputes arising out of or in connection with this Agreement through formal negotiation between senior executives of each Party prior to initiating any other dispute-resolution process, including prior to instituting any process before any court or other governmental authority. Within fifteen  (15) days of receipt of notice from a Party seeking to resolve a dispute, the Parties will meet at a mutually agreeable time and location, including through virtual means, to attempt to resolve the noticed dispute. It the Parties are unable to resolve the dispute within

sixty (60) days of notice, either Party may seek alternative means of resolution, including initiating an appropriate process with a court or other governmental authority having jurisdiction. Nothing in this paragraph shall prevent a Party from seeking a preliminary injunction in an appropriate case while the Parties seek to resolve the related dispute. 



18.8Any notice provided under this Agreement will be effective when received and must be given in writing and delivered in person or sent by overnight courier, by reputable express delivery or by registered or certified mail, return receipt requested, as follows:



If to Cadence:Cadence Inc.

9 Technology Drive

Staunton, VA  24401

Attn:  Head of Operations



If to the Alimera:Alimera Sciences, Inc.

6120 Windward Pkwy, Suite 290

Alpharetta, GA 30005

Attn: Head of Operations



Each Party may change its notice address information at any time by notice given in accordance with this Section. 





18.9This Agreement will be governed by and construed in accordance with the laws of the State of Delaware as applicable to contracts made and to be performed in that state, without regard to conflicts of laws principles. The Parties consent to the personal jurisdiction and venue of the state and federal courts covering the State of Delaware.



IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorized corporate officers or representatives as of the date first above written.





ALIMERA SCIENCES, INC.CADENCE, INC.







By: _/s/ Philip John Ashman___________By: __/s/ Jeff Kelly_________________



Name: _Philip John Ashman___________Name: _Jeff Kelly__________________



Title: _Chief Operating Officer_________Title: _Vice President, Sales__________













Exhibit 1:  Definitions





Exhibit 2:  Products











“Product” shall mean Alimera Guideshaft & Handpiece Sub-Assemblies which are later assembled into the finished drug product ILUVIEN® 190 micrograms intravitreal implant in applicator at the drug contract manufacturing site, Alliance Medical Products (d.b.a. Siegfried Irvine).  As provided in Section 7 of the Agreement, Cadence will manufacture and arrange delivery of the following Products:



Product will be manufactured by Cadence per Alimera-approved Design Specifications & Drawings.



Exhibit 3:  Fees List





Pricing originates from Cadence Quote Q001878-4 (Issued 23rd July 2020).  Changes in pricing is subject to Section 4 of this Agreement.





Pricing for Flex Transferred Components (Production-A Builds)

* Total Quantity of [***] is an estimate of the total number of units that are able to be produced using the Excess & Obsolete (E&O) Component Inventory transferring from Flex to Cadence following Assembly Line Decommissioning.  It is understood by both Cadence and Alimera that the Total Order Quantity for Production-A Builds may be lower following final Flex E&O Inventory Counts and following Cadence Qualification Activities. 







Routine Production**

**Pricing for Cadence Qualified Components – [***] (Production-C Builds)





Exhibit 4:  Approved Vendor List





Alimera-Designated Supplier for Qualification & Production-A Builds:





Alimera Approved Vendor List per ILUVIEN Dossier/NDA File:



All other suppliers, components, and materials listed in the Bill of Materials must be approved by Alimera and qualified prior to use by Cadence.

This Supplier Quality Agreement (the “Agreement”) is entered into by and between Alimera Sciences Inc. which includes its subsidiaries and affiliates (collectively Alimera), a company located at 6120 Windward Parkway, Alpharetta, GA 30040 and Cadence Device, a company located at 250 W. Kensinger Dr., Suite 400, Cranberry Township, PA 16066.

INTRODUCTION

Quality Policy & Objectives

Our goal is to improve the quality of life for the patients we serve. Alimera Sciences is committed to providing safe, effective, high-quality, innovative products that meet or exceed our customer’s expectations for use in the treatment of eye disease. We achieve this by maintaining effective quality management and drug safety systems, complying with all regulatory requirements of the regions we operate in, and continuously improving our products and performance.



Alimera Sciences will provide high-quality products with the lowest risk to patients:



We will maintain and continuously improve the effectiveness of the quality management system:





Purpose

The purpose of this “Agreement” is to support our quality policy and quality objectives by defining the terms for which externally provided processes, products, and services (collectively “Product”) will be established, controlled, and maintained for the manufacturing, subcontracting, and distributing of “Product” for Alimera.  Per FDA regulation (21 CFR 820) requirements, Alimera is required to control external providers (collectively “Suppliers”) of “Product” to ensure conformance to Alimera’s defined specifications and all regulatory requirements applicable to the intended use of the “Product” provided.  Since Alimera depends on its suppliers to provide compliant “Product” (including record creation, record maintenance, record transmission, raw materials, components, sub-assemblies, assemblies, storage, handling, labeling,

packaging, transport, etc.), mutual cooperation and agreement in implementing the quality requirements established within this “Agreement” is essential.

Scope

This agreement applies to all externally provided processes, products, and services for Alimera.  The scope of this agreement is intended to ensure initial and on-going production orders are adequately planned and appropriate controls are established based on the risk of the “Product” provided. 

NORMATIVE REFERENCES

Quality Management System Regulations

FDA 21 CFR Part 820 – Quality System Regulation – Medical Devices Current Good Manufacturing Practices

Quality Management System Requirements

ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes



Quality Management System Requirements

Annex 1 Essential Requirements of the Medical Device Directives 93/94/EEC



Risk Management

ISO 14971 – Risk Management System







DEFINITIONS

General

Establish – Define, document, implement, & maintain [FDA 21 CFR Part 820]





Lot or Batch – One or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits [FDA 21 CFR Part 820].



Notified Body – In the European Union, is an entity that has been accredited by a Member State to assess whether a product to be placed on the market meets certain preordained standards.



Process Validation – Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requirements [FDA 21 CFR Part 820].



Regulatory Requirement – all applicable domestic and foreign federal, state, and local laws, statutes, acts, ordinances, rules, codes, standards, guidelines and regulations, applicable to the “Supplier” and the “Product” provided under “Agreement” including but not limited to requirements for labeling, re-labeling, packaging, manufacturing, processing, assembly, record creation, record

retention, record modification, record transmission (including by electronic means), storage, handling, and transport of “Product”. 



Special Process – Any process for production and service provision where the resulting output cannot be verified by subsequent monitoring and measurement.



Specification – Any requirement with which a product, process, service, or other activity must conform [FDA 21 CFR Part 820].



Validation – Establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled [FDA 21 CFR Part 820].



Verification – Confirmation by examination and provision of objective evidence that the specified requirements have been fulfilled [FDA 21 CFR Part 820].



Definition of Responsibilities

Approve – Approval is required prior to implementation of requirement.



Audit – Requirement is assessed through objective evidence and may be subject of a formal audit. 

Evaluate – Requirement is assessed through interactions and may be subject of a formal evaluation.



Responsible – Onus is on the identified party to meet this requirement.



Review – Requirement to be reviewed upon submission of evidence and feedback provided, as appropriate.



Submit – Written notification or submission of evidence to meet requirement shall be provided.

AGREEMENT

See listed requirements and mutual responsibilities in table below.



Exception(s) or Amendment(s)



Supplier Quality Agreement Review and Approval Authorities

[1] If Cadence authorizes this agreement with no exception(s) or amendment(s), no further authorization from Alimera representation is required to enter into this agreement.