Document:

alny-ex104_214.htm

EXHIBIT 10.4

 

MANUFACTURING SERVICES AGREEMENT FOR PATISIRAN (ALN-TTR02) 

COMMERCIAL DRUG SUBSTANCE SUPPLY 

THIS MANUFACTURING SERVICES AGREEMENT is made as of March 28, 2018 (the “Effective Date”) by and between ALNYLAM PHARMACEUTICALS, INC., a Delaware corporation with an office at 300 Third Street, Cambridge, MA 02142 (together with its Affiliates, collectively, “Alnylam”) and Agilent Technologies, Inc., a Delaware corporation with an office at 5555 Airport Blvd, Suite 100, Boulder, CO 80301 (“Manufacturer”).  

RECITALS: 

WHEREAS, Alnylam desires to engage Manufacturer to perform certain Manufacturing Services (as such term is defined below), on the terms and conditions set forth below, and Manufacturer desires to perform such Services for Alnylam. 

AGREEMENT: 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants of the 

parties set forth in this Agreement, the parties hereto agree as follows: 

	
1.
	
Definitions. 

Unless this Agreement expressly provides to the contrary, the following terms, whether used in the singular or plural, have the respective meanings set forth below.  

	
 
	
1.1
	
“Affiliate” means, with respect to either Alnylam or Manufacturer, any corporation, company, partnership, joint venture and/or firm which controls, is controlled by or is under common control with Alnylam or Manufacturer, as the case may be. As used in the definition of Affiliate, “control” means (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction), and (b) in the case of non-corporate entities, the direct or indirect power to manage, direct or cause the direction of the management and policies of the non-corporate entity or the power to elect more than fifty percent (50%) of the members of the governing body of such non-corporate entity. 

	
 
	
1.2
	
“Agreement” means this Manufacturing Services Agreement, together with all Appendices attached hereto, as amended from time to time by the parties in accordance with Section 15.7, and all fully accepted Purchase Orders entered into by the parties. 

	
 
	
1.3
	
“Alnylam Equipment” means the Equipment, if any, identified on a Purchase Order to be either provided by Alnylam or purchased or otherwise acquired by Manufacturer at Alnylam’s expense, at Alnylam’s discretion, dedicated for exclusive use for the Manufacture of Product under this Agreement.  

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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1.4
	
“Alnylam Indemnitees” has the meaning set forth in Section 12.1. 

	
 
	
1.5
	
“Alnylam Technology” means (a) Product and any intermediates, components, or derivatives of Product; (b) Specifications; and (c) the Technology of Alnylam developed or obtained by or on behalf of Alnylam independent of this Agreement and without reliance upon the Confidential Information of Manufacturer.  

CONFIDENTIAL 

	
 
	
1.6
	
“API/Drug Substance” means the active pharmaceutical ingredient or drug substance identified on the applicable Purchase Order. 

	
 
	
1.7
	
“Applicable Law” means all applicable ordinances, rules, regulations, laws, guidelines, guidances, requirements and court orders of any kind whatsoever of any Authority, as amended from time to time including cGMP (if applicable). 

	
 
	
1.8
	
“Authority” means any government regulatory authority responsible for granting approvals for the performance of Services under this Agreement or for issuing regulations pertaining to the Manufacture and/or use of Product in the intended country of use, including, but not limited to, the FDA and the EMA. 

	
 
	
1.9
	
“Batch” means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch record. 

	
 
	
1.10
	
“Batch Documentation” has the meaning set forth in Section 6.2. 

	
 
	
1.11
	
[***] 

	
 
	
1.12
	
“Certificate of Analysis” means a document signed by an authorized representative of Manufacturer, describing Specifications for, and testing methods applied to, Product, and the results of testing. 

	
 
	
1.13
	
“Certificate of Compliance” means a document signed by an authorized representative of Manufacturer, certifying that a particular Batch was Manufactured in accordance with cGMP (if applicable), all other Applicable Law, the Manufacturing Process, and the Specifications. 

	
 
	
1.14
	
“cGMP” means current good manufacturing practices and regulations applicable to the Manufacture of Product that are promulgated by any Authority. 

	
 
	
1.15
	
“Change Order” has the meaning set forth in Section 5.3(a). 

	
 
	
1.16
	
“Collaboration Partner” means a third-party that Alnylam has entered into a written and executed agreement establishing a material, bona fide development, manufacturing, 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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commercialization and/or marketing collaboration for one or more of Alnylam’s RNAi drug product(s) that is the subject of a Purchase Order under this Agreement. [***] 

	
 
	
1.17
	
“Confidential Information” has the meaning set forth in Section 10.1. 

“EMA” means the European Medicines Agency, and any successor agency having substantially the same functions. 

“Equipment” means any equipment or machinery, including Alnylam Equipment, used by Manufacturer in the Manufacturing of Product, or the holding, processing, testing or release of Product. 

“Facility” means the facility(ies) of Manufacturer identified in the applicable Purchase Order. 

“FDA” means the United States Food and Drug Administration, and any successor agency having substantially the same functions. 

“Forecast” has the meaning set forth in Section 2.2 and, as the case may be, shall include the Product Launch Forecast and/or the Life Cycle Management Forecast. 

“Force majeure” has the meaning set forth in Section 15.2. 

“Improvements” means all Technology and discoveries, inventions, developments, modifications, innovations, updates, enhancements, improvements, writings or rights (whether or not protectable under patent, trademark, copyright or similar laws) that are conceived, discovered, invented, developed, created, made or reduced to practice in the performance of Services under this Agreement. For clarity, Improvements do not include any improvements to any and all Manufacturer Technology, including but not limited to any generic manufacturing processes or methods, in each case to the extent not specific to any Product being Manufactured hereunder.  

“Key Process Indicators” shall be the key measurement criteria applicable to certain Manufacturing activities undertaken by Manufacturer under this Agreement. The Key Process Indicators shall be jointly defined by Alnylam and Manufacturer as part of routine business review meetings. 

“Life Cycle Management Forecast” has the meaning set forth in Section 2.4. 

“Life Cycle Management Period” shall mean the period of time commencing immediately upon the expiration of the Product Launch Period and ending upon the effective date of any expiration or termination of this Agreement. 

“Manufacture” and “Manufacturing” means any steps, processes and activities necessary to produce Product including the manufacturing, processing, packaging, labeling, quality control testing, stability testing, release, storage or supply of Product. For the avoidance of 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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doubt, the Manufacture of Product under this Agreement shall include all Product testing and release activities. 

“Manufacturer Indemnitees” has the meaning set forth in Section 12.2. 

“Manufacturer Technology” means the Technology of Manufacturer (a) existing prior to the Effective Date; or (b) developed or obtained by or on behalf of Manufacturer independent of this Agreement and without reliance upon the Confidential Information of Alnylam.  

“Manufacturing Process” means any and all processes and activities (or any step in any process or activity) used or planned to be used by Manufacturer to Manufacture Product, as evidenced in the Batch Documentation or master Batch Documentation. 

[***]

“Product” means any product as specified in the applicable Purchase Order, including, if applicable, bulk packaging and/or labeling as provided in such Purchase Order. 

“Product Launch Forecast” has the meaning set forth in Section 2.3. 

“Product Launch Period” means the period of time commencing on the date on which Alnylam receives authorization to market the Product for commercial sale from the FDA and ending on the first annual anniversary of such date.  

“Purchase Order” means a written work order referencing this Agreement, substantially in the form attached hereto as Appendix A, for the performance of Services by Manufacturer under this Agreement. 

“Quality Technical Agreement” has the meaning set forth in Section 2.7.  

“Records” has the meaning set forth in Section 5.6(a). 

“Representative” has the meaning set forth in Section 3.1. 

“Required Consent” means any rights, licenses, consents or approvals required to permit Alnylam the right to access, use and transfer the sequences, structure information or other Specifications to Manufacturer and/or have the Product made by Manufacturer, to the extent using processes and/or procedures specified by Alnylam, without infringing the ownership or license rights (including patent and copyright) of any third party.  

“Services” means the Manufacturing and/or other services described in a Purchase Order entered into by the parties.  

“Specifications” means the list of tests, references to any analytical procedures and appropriate acceptance criteria which are numerical limits, ranges or other criteria for tests described in order to establish a set of criteria to which Product at any stage of Manufacture 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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should conform to be considered acceptable for its intended use that are provided by or approved by Alnylam, as such Specifications are amended or supplemented from time to time by Alnylam in writing to Manufacturer. Manufacturer will review such proposed specifications and assess the business impact to scope of work, fees, schedule and yield, and such amended or supplemented Specification will be effective once it has been signed by authorized representatives of both parties. 

“Technology” means all methods, techniques, trade secrets, copyrights, know-how, data, documentation, regulatory submissions, specifications and other intellectual property of any kind (whether or not protectable under patent, trademark, copyright or similar laws).  

	
2.
	
Engagement of Manufacturer. 

	
 
	
2.1
	
Engagement of Manufacturer. Alnylam hereby engages Manufacturer to perform the obligations set forth herein and in each Purchase Order in accordance with the terms and conditions of this Agreement and the Quality Technical Agreement, and Manufacturer hereby accepts such engagement. 

	
 
	
2.2
	
Forecast. In alignment with the schedule for mutually agreed business review meetings, Alnylam will provide to Manufacturer a written, quarterly estimate of demand and delivery dates for the Product for the subsequent [***] months during the Term (the “Forecast”). The Forecast will be updated [***]), and promptly following a material increase to the Forecast (but within the reserve capacity requirements of Section 2.5). As set forth in more detail in Sections 2.3 and 2.4 below, the Forecast will include binding and non-binding portions as it relates to the overall [***] month rolling forecast. Without limiting either party’s obligations under this Agreement, Alnylam and Manufacturer shall review and agree upon the Forecast at least once per calendar quarter to ensure that Manufacturer maintains sufficient capacity to meet its obligations under this Agreement; provided however, Manufacturer shall at all times maintain sufficient capacity to Manufacture at lease [***] Batches per calendar year under this Agreement. 

	
 
	
2.3
	
Product Launch Forecast. During the Product Launch Period, Alnylam will provide Manufacturer with Forecasts of its demand for the Product (each, a “Product Launch Forecast”). [***]  

	
 
	
2.4
	
Life Cycle Management Forecast. Alnylam will provide Manufacturer with Forecasts of its demand for the Product during the Life Cycle Management Period (each, a “Life Cycle Management Forecast”). The first [***] months of each Life Cycle Management Forecast shall be binding; the balance of each Life Cycle Management Forecast shall be non-binding and is provided to Manufacturer for planning purposes only.  

	
 
	
2.5
	
Reservation of Capacity. Manufacturer shall reserve sufficient manufacturing capacity, and purchase such raw materials and other resources (including Labor) needed to meet [***]% of Alnylam’s demand for Product set forth in the binding portion of each Forecast. For the purpose of clarity, Alnylam will submit a purchase order for the binding portion of the respective Forecasts below along with each Forecast: 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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(a)
	
Product Launch. [***]

	
 
	
(b)
	
Life Cycle Management. Manufacturer shall reserve sufficient manufacturing capacity, raw materials, and other resources including, but not limited to, human resources, needed to meet up to [***]% of the quantity of Product set forth in each Life Cycle Management Forecast. [***] 

	
 
	
(c)
	
The percentages set forth in this Section 2.3 shall be increased to an amount equal to the quantity of Product that make up a complete Batch.  

	
 
	
2.6
	
Services and Purchase Orders. All Services shall be ordered by Alnylam pursuant to a Purchase Order and shall be consistent with the then-current Forecast. Each Purchase Order will be appended to this Agreement, will include the material terms for the order, and may include the scope of work, specified Services, Specifications, deliverables, timelines (including Manufacturer’s committed Batch disposition month), committed Product quantity in grams, and such other details and special arrangements as are agreed to by the parties with respect to the activities to be performed under such Purchase Order. Each Purchase Order submitted to Manufacturer by Alnylam that conforms to the requirements of this Agreement and the applicable Forecast shall be deemed accepted by Manufacturer when received from Alnylam unless Manufacturer provides Alnylam with written notice of rejection, including specific reasons for such rejection, within [***] days of receipt of any Purchase Order based on Alnylam’s financial condition or timely payment history. For the avoidance of doubt, a Purchase Order may be accepted by manual signature, electronic signature or via other electronic means mutually acceptable to both Manufacturer and Alnylam. Documents relating to the relevant project, including Specifications, proposals, quotations and any other relevant documentation, will only be effective if attached to the applicable Purchase Order and incorporated in the Purchase Order by reference. Each accepted Purchase Order will be subject to the terms of this Agreement and will be incorporated herein and form part of this Agreement. Manufacturer will perform the Services specified in each Purchase Order, as amended by any applicable Change Order(s), in accordance with the terms and conditions of such Purchase Order and this Agreement.  

	
 
	
2.7
	
Quality Technical Agreement. As required by Applicable Law, the parties will also agree upon a Quality Technical Agreement containing quality assurance provisions for the Manufacture of Product (“Quality Technical Agreement”).  

	
 
	
2.8
	
Conflict Between Documents. If there is any conflict, discrepancy, or inconsistency between the terms of this Agreement and any Purchase Order, Quality Technical Agreement or other document or form used by the parties, the terms of this Agreement will control; provided, however, that the Quality Technical Agreement shall control with regard to matters of Quality. 

	
 
	
2.9
	
[***]

	
 
	
(a)
	
Alnylam has reviewed Manufacturer’s [***], an outline of which is set forth at Appendix B. Manufacturer shall (i) maintain [***] for the duration of the Term, 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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(ii) meet with Alnylam annually to inform Alnylam of any changes and updates made [***], and  (iii) shall [***]. Manufacturer’s agreement to [***] Manufacturer and Alnylam shall review the [***] at such other intervals as the Parties may agree, but no more than once per year. 

	
 
	
(b)
	
[***] 

	
 
	
(c)
	
Without limiting the generality of the foregoing, Manufacturer shall at all times commit sufficient resources necessary to meet its obligations under this Agreement. Except where failure to provide adequate notice is due to circumstances that are beyond the reasonable control of Manufacturer, Manufacturer shall provide Alnylam with at least [***] months advance written notice of any changes to the facility, process, or site infrastructure to the extent such changes [***]. 

	
 
	
(d)
	
Manufacturer will also provide at least [***] month notification if Manufacturer decides to cease manufacturing services for nucleic acid therapeutics. 

	
3.
	
Manufacturing Management. 

	
 
	
3.1
	
Representatives. Each party will appoint a representative having primary responsibility for day-to-day interactions with the other party for the Services (each, a “Representative”), who will be identified in the applicable Purchase Order. Each party may change its Representative by providing written notice to the other party in accordance with Section 15.4; provided, that Manufacturer will use reasonable efforts to provide Alnylam with at least fifteen (15) days prior written notice of any change in its Representative for the Services. Except for notices or communications required or permitted under this Agreement, which will be subject to Section 15.4, or unless otherwise mutually agreed by the parties in writing, all communications between Manufacturer and Alnylam regarding the conduct of the Services pursuant to such Purchase Order will be addressed to or routed directly through the parties’ respective Representatives. 

	
 
	
3.2
	
Communications. The parties will hold project team meetings via teleconference or in person, on a periodic basis as agreed upon by the Representatives. Manufacturer will make written reports to Alnylam as specified in the applicable Purchase Order. 

	
 
	
3.3
	
Subcontracting. Manufacturer may not subcontract with any third party including any Affiliate of Manufacturer, to perform any of its obligations under this Agreement without the prior written consent of Alnylam, which consent Alnylam may withhold in its reasonable discretion. Manufacturer will be solely responsible for the performance of any permitted subcontractor, and for costs, expenses, damages, or losses of any nature arising out of such performance as if such performance had been provided by Manufacturer itself under this Agreement. Manufacturer will cause any such permitted subcontractor to be bound by, and to comply with, the terms of this Agreement, as applicable, including all confidentiality, quality assurance, regulatory and other obligations and requirements of Manufacturer set forth in this Agreement. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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3.4
	
Failure to Supply.  

	
 
	
(a)
	
Force Majeure. If Alnylam or Manufacturer determines, in its sole but reasonable discretion, that Manufacturer will fail to deliver the full quantity of Product within [***] weeks after the delivery date as set forth in the applicable Purchase Order due to a Force Majeure event, then the parties will discuss in good faith a recovery plan. Such plan may include decisions of whether or not to proceed with the Manufacture of the delayed Product. If the parties agree that Product will not be delivered within [***] weeks after the delivery date, the decision of whether or not to proceed with the Manufacture of the delayed Product [***].  

	
 
	
(b)
	
Manufacturer-Caused Delays. If Alnylam determines, in its sole but reasonable discretion, that Manufacturer will fail to deliver the full quantity of Product within [***] weeks [***] as set forth in the applicable Purchase Order due to a Manufacturer-Caused Event, [***] then Manufacturer will incur a [***]. If the parties agree that Product will not be delivered within [***] weeks [***], the decision of whether or not to proceed with the Manufacture of the delayed Product [***]. 

	
 
	
(c)
	
Nonconformance.  Section 5 - Nonconformances (Deviations) and Laboratory Investigations of the Quality Technical Agreement applies to nonconformances in the manufacturing process of a Batch.  If in accordance with Section 5 of the Quality Technical Agreement, Alnylam rejects a Batch due to nonconformance rather than proceed with a remediation of such Batch, [***]. 

	
 
	
3.5
	
Notice of Impending Issues. Without limiting the applicability of the foregoing, if Manufacturer has reason to believe that it will be unable to comply with any of its obligations set forth in this Agreement for any reason, including as a consequence of Manufacturer’s or any Affiliate’s financial condition, Manufacturer will promptly notify Alnylam thereof and provide a plan for solving the problem. 

	
4.
	
Materials and Equipment. 

	
 
	
4.1
	
Supply of Materials. Unless the parties otherwise agree in a Purchase Order, Manufacturer will supply, in accordance with the relevant approved raw material specifications, all materials to be used by Manufacturer in the performance of Services under a Purchase Order. 

	
 
	
4.2
	
Ownership of Materials. Manufacturer shall own and have title to and have risk of damage, risk of loss for, all raw materials (including, but not limited to, Safety Stock), any intermediates and components of Product (including, but not limited to any Safety Stock converted into the Product), and any work in process at each and every stage of the Manufacturing Process.  [***]. Manufacturer will ensure that the Product, any intermediates and components of any Product (including, but not limited to any Safety Stock converted into the Product), and any work in process, are free and clear of any liens or encumbrances. Manufacturer will at all times take such measures as are required to 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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protect the Product, any intermediates and components of any Product (including, but not limited to any Safety Stock converted into the Product), and any work in process from loss, damage and theft at all stages of the Manufacturing Process. Manufacturer will immediately notify Alnylam within [***] days if at any time it believes any the Safety Stock, Product, or any intermediates and components of any Product, or any work in process have been damaged, lost or stolen.  

	
 
	
4.3
	
Supply of Equipment.  

	
 
	
(a)
	
Except as set forth in Section 4.3(b) and unless otherwise agreed in a Purchase Order, Manufacturer will supply and maintain all Equipment necessary to perform the Services. 

	
 
	
(b)
	
Alnylam will provide the Alnylam Equipment listed in any applicable Purchase Order. Except as set forth in writing to the contrary, Alnylam shall at all times retain all right, title and interest in and to the Alnylam Equipment. Manufacturer shall ensure that the Alnylam Equipment is properly labeled as Alnylam property and remains free and clear of any liens or encumbrances. Manufacturer will not use the Alnylam Equipment except in performance of Services under the applicable Purchase Order. At Alnylam’s written request and expense, the Alnylam Equipment will be returned to Alnylam, or to Alnylam’s designee. Manufacturer will be responsible at Alnylam’s cost, for maintenance of the Alnylam Equipment on-site at Manufacturer’s facility. Invoices for maintenance services of Alnylam Equipment will be provided to Alnylam at least once per year or upon request. To the extent Alnylam provides spare parts for the Alnylam Equipment, such spare parts will remain the property of Alnylam and will be used by Manufacturer only for maintenance of the Alnylam Equipment. Manufacturer will notify Alnylam within [***] hours if at any time it believes any Alnylam Equipment has been damaged, lost or stolen. 

	
 
	
4.4
	
Safety Stock. 

	
 
	
(a)
	
At all times during the term of this Agreement, Manufacturer shall maintain a mutually agreed upon inventory level of critical raw materials (“Safety Stock”) required for Manufacturer to Manufacture and supply at least [***] of the Product for Alnylam or [***] of critical raw materials inventory based on the applicable Forecast, whichever is greater (the “Safety Stock Level”). Upon request, Manufacturer shall provide verification to Alnylam (including by electronic means) that such Safety Stock is maintained in such quantities as required by this Agreement. Safety stock inventory will be used in a first-expiry, first-out (FEFO) basis to ensure adequate shelf-life prior to production use. In addition, Manufacturer will store the Safety Stock according to Manufacturer’s site inventory management procedures.  [***]  

	
 
	
(b)
	
Manufacturer shall invoice Alnylam, and Alnylam shall pay Manufacturer by means of a Purchase Order in an amount [***] incurred by Manufacturer to acquire 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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such raw materials that comprise the Safety Stock. In the event an increase in Safety Stock levels is required or if the Safety Stock levels need to be replenished following the use of a portion of such Safety Stock to Manufacture Product under this Agreement, Manufacturer will invoice Alnylam an additional amount to increase Alnylam’s purchase commitment so that it is at all times [***]. In the event the parties mutually agree to decrease the Safety Stock levels or upon Manufacturer’s use of a portion of the Safety Stock to Manufacturer Product pursuant to this Agreement, once such portion of Safety Stock has been consumed in the Manufacture of Product, Manufacturer will credit Alnylam’s account in an amount [***] and such credit shall be applied against the next invoice sent by Manufacturer to Alnylam. All financial adjustments to the Safety Stock with Manufacturer will be done once per calendar quarter and shall be memorialized in writing by Manufacturer with supporting documentation to be provided to Alnylam upon request.  

	
 
	
(c)
	
Manufacturer will use commercially reasonable efforts (which shall include, but shall not be limited to, working in good faith with Alnylam) to manage and use the Safety Stock in a manner that minimizes the risk that any amount of the Safety Stock expires before it can be used to Manufacture Product hereunder, including, but not limited to, using the Safety Stock on a first-expiry, first-out basis. In the event that any raw materials that comprise Safety Stock do expire without any fault on the part of Manufacturer, or if the Safety Stock is not required for consumption to satisfy the demand for Products under the binding portion of the Forecast and cannot otherwise be used by Manufacturer in the operation of its business in the ordinary course, an amount [***] will be added to the next invoice sent by Manufacturer to Alnylam and the expired material will be shipped to a destination of Alnylam’s choosing or disposed of by Manufacturer upon Alnylam’s direction.  

	
 
	
(d)
	
Except as set forth in Section 7, Manufacturer shall at all times retain title to the Safety Stock and assumes the risk of loss of any or all of such Safety Stock. In the event any or all of the Safety Stock is damaged or destroyed, [***].  

	
 
	
4.5
	
Purchase Commitment. To the extent that Alnylam retains the ability to control the sourcing of Product manufacturing without violating conflicting contractual obligations owed by Alnylam to third parties, Alnylam shall purchase from Manufacturer at least [***] (the “Minimum Purchase Obligation”); provided, however, in addition to the other remedies available to Alnylam under this Agreement, Alnylam’s foregoing Minimum Purchase Obligation shall be adjusted appropriately to account for any periods of time during which [***]. 

	
5.
	
Manufacture of Product. 

	
 
	
5.1
	
Applicable Law; Specifications. Manufacturer will comply with all Applicable Law in performing Services. Product will be Manufactured according to the Specifications. For the avoidance of doubt, Manufacturer shall be responsible and liable for any breach of Applicable Law by its permitted subcontractors. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

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5.2
	
Resources; Facility. 

	
 
	
(a)
	
Performance of Services. Manufacturer will perform all Services at the Facility, provide all staff necessary to perform the Services in accordance with the terms of the applicable Purchase Order and this Agreement, and hold at such Facility all Equipment, Alnylam Equipment, Safety Stock and other items used in the Services. Manufacturer will not change the location of such Facility or use any additional facility for the performance of Services under this Agreement without at least [***] months’ prior written notice to, and prior written consent from, Alnylam, which consent will not be unreasonably withheld or delayed (it being understood and agreed that Alnylam may withhold consent pending satisfactory completion of a quality assurance audit and/or regulatory impact assessment of the new location or additional facility, as the case may be). Manufacturer will maintain, at its own expense, the Facility and all Equipment required for the Manufacture of Product in a state of repair and operating efficiency consistent with the requirements of cGMP (if applicable) and all Applicable Law. 

	
 
	
(b)
	
Validation. Manufacturer, at Manufacturer’s sole cost and expense, will be responsible for performing all validation of the Facility, Equipment and cleaning and maintenance processes employed in the Manufacturing Process in accordance with cGMP (if applicable), Manufacturer’s SOPs, the applicable Quality Technical Agreement (if any), and Applicable Law. Notwithstanding the foregoing, validation of Alnylam Equipment shall be at Alnylam’s sole cost and expense. Manufacturer will also be responsible for ensuring that all manufacturing processes are validated and are carried out in accordance with requirements of cGMP and the mutually agreed Quality Technical Agreement.  

	
 
	
(c)
	
Licenses and Permits. Manufacturer will be responsible for obtaining, at its expense, any Facility or other licenses (excluding any licenses related to Required Consents) or permits, and any regulatory and government approvals necessary for the performance of Services by Manufacturer under this Agreement. At Alnylam’s request, Manufacturer will provide Alnylam with copies of all such approvals and submissions to Authorities, and Alnylam will have the right to use any and all information contained in such approvals or submissions in connection with regulatory approval and/or commercial development of Product. 

	
 
	
(d)
	
Access to Facility; [***]. Alnylam’s access to Manufacturer’s Facility shall be governed by the Quality Technical Agreement. [***]  

	
 
	
5.3
	
Changes to Purchase Orders; Cancellation. 

	
 
	
(a)
	
Changes to Purchase Orders. If the scope of work of a Purchase Order changes, then the applicable Purchase Order may be amended as provided in this Section 5.3(a). If a required modification to a Purchase Order is identified by Alnylam or by Manufacturer, the identifying party will notify the other party in writing as soon as reasonably possible. Manufacturer will provide Alnylam with a change order 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

11

 

	
 
		
containing a description of the required modifications and their effect on the scope, fees and timelines specified in the Purchase Order (“Change Order”). No Change Order will be effective unless and until it has been signed by authorized representatives of both parties. If Alnylam does not approve such Change Order, and has not terminated the Purchase Order, but requests the Purchase Order to be amended to take into account the modification, then the parties will use reasonable efforts to agree on a Change Order that is mutually acceptable. If practicable, Manufacturer will continue to work under the existing Purchase Order during any such negotiations; provided, such efforts would facilitate the completion of the work envisioned in the proposed Change Order, but will not commence work in accordance with the Change Order until it is authorized in writing by Alnylam. 

	
 
	
(b)
	
Changes to Purchase Orders. If Alnylam needs to cancel or delay the delivery date set forth in a Purchase Order, Alnylam shall promptly so advise Manufacturer, unless cancellation is the result of a termination of this Agreement, in which case Alnylam will follow the notice provisions of Sections 14 and 15.4. If Alnylam delays the delivery date set forth in a Purchase Order, Manufacturer shall, within [***] business days of being so notified, advise Alnylam of the impact such delay may have on Manufacturer’s schedule for the Manufacture of Product, and Manufacturer agrees to use all commercially reasonable efforts to agree upon a new delivery date for the Product under such Purchase Order. [***]  

   

	
 
	
(i)
	
[***]

		
	
[***]
	
[***]

	
[***] 
	
[***]

	
 
	
(ii)
	
[***]

		
	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

[***]  

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

12

 

 

	
 
	
5.4
	
Changes to Specifications. Any and all changes to the Specification shall be managed under the applicable terms of the Quality Technical Agreement.  

	
 
	
5.5
	
[***]

	
 
	
5.6
	
Records; Sample Retention. 

	
 
	
(a)
	
Records. Manufacturer will keep complete and accurate records (including reports, accounts, notes, raw data, and records of all information and results obtained from performance of Services) of all work done by it under this Agreement, in form and substance as specified in the applicable Purchase Order, the applicable Quality Technical Agreement, and this Agreement (collectively, the “Records”). All such Records will be accessible to Alnylam. Unless required by Applicable Law, Manufacturer will not transfer, deliver or otherwise provide any such Records to any party other than Alnylam, without the prior written approval of Alnylam. Records will be available at reasonable times for inspection, examination and copying (excluding non-Product specific SOPs and analytical methods), by or on behalf of Alnylam, at Alnylam’s cost and expense. All original Records of the Manufacture of Product under this Agreement will be retained and archived by Manufacturer in accordance with cGMP (if applicable) and Applicable Law, but in no case for less than a period of [***] years following completion of the applicable Purchase Order. Upon Alnylam’s request, Manufacturer will promptly provide Alnylam with copies of such Records (excluding non-Product specific SOPs and analytical methods). [***] years after completion of a Purchase Order, all of the aforementioned records will be sent to Alnylam or Alnylam’s designee; provided, however, that, upon Agilent’s consent, Alnylam may elect to have such records retained in Manufacturer’s archives for an additional period of time at a reasonable charge to Alnylam. 

	
 
	
(b)
	
Sample Retention. Manufacturer will take and retain, for such period and in such quantities as may be required by cGMP (if applicable) and the applicable Quality Technical Agreement, samples of Product from the Manufacturing Process produced under this Agreement. Further, upon Alnylam’s written request, Manufacturer will submit such samples to Alnylam, at Alnylam’s cost and expense.  

	
 
	
5.7
	
Regulatory Matters.  The provisions of Section 4 of the Quality Technical Agreement will apply with respect to regulatory matters, except as set forth below, which provisions shall supplement Section 4.11 of the Quality Technical Agreement. 

	
 
	
(a)
	
Regulatory Inspections. Manufacturer will permit Alnylam or its agents to be present in any visit or inspection by any Authority of the Facility to the extent it relates specifically to the Product and/or the Manufacturing Process. Manufacturer will provide Alnylam with a copy of any report or other written communication 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

13

 

	
 
		
received from such Authority in connection with such visit or inspection, and any written communication received from any Authority relating to any Product, the Facility (if it relates to or affects the Manufacture of Product) or the Manufacturing Process (if it relates to or affects the Manufacture of Product), within [***] days after receipt, and will consult in good faith with  Alnylam before responding to each such communication that relates specifically to the Manufacture of a Product. Manufacturer will provide Alnylam with a copy of its final responses within [***] days after submission. 

 

	
 
	
5.8
	
Waste Disposal. The generation, collection, storage, handling, transportation, movement and release of hazardous materials and waste generated in connection with the Services will be the responsibility of Manufacturer at Manufacturer’s sole cost and expense. Without limiting other applicable requirements, Manufacturer will prepare, execute and maintain, as the generator of waste, all licenses, registrations, approvals, authorizations, notices, shipping documents and waste manifests required under Applicable Law. 

	
 
	
5.9
	
Safety Procedures. Manufacturer will be solely responsible for implementing and maintaining health and safety procedures for the performance of Services and for the handling of any materials or hazardous waste used in or generated by the Services. [***].  

	
 
	
5.10
	
Inventory Updates. Manufacturer will provide Alnylam with reports specifying the quantities and Batch numbers of Safety Stock, work-in-progress and Product in Manufacturer’s possession and the location thereof, and such other information reasonably requested by Alnylam to allow Alnylam to accurately report Alnylam inventory, and manage demand for Product. Such reports will be received by Alnylam no later than the [***], and will be in (a) electronic format or (b) hardcopy as mutually agreed by the parties. [***] 

	
6.
	
Testing and Acceptance Process. 

	
 
	
6.1
	
Testing by Manufacturer. The Product Manufactured under this Agreement will be Manufactured in accordance with the Manufacturing Process approved by Alnylam, the Specifications and with cGMP (unless otherwise expressly stated in the applicable Purchase Order). Each Batch of Product will be sampled and tested by Manufacturer against the Specifications, and the quality assurance department of Manufacturer will review the documentation relating to the Manufacture of the Batch and will assess if the Manufacture has taken place in compliance with cGMP (if applicable), the Specifications and the Manufacturing Process.  

	
 
	
6.2
	
Provision of Records. If, based upon such tests and documentation review, a Batch of Product conforms to the Specifications and was Manufactured according to cGMP (if applicable), the Specifications and the Manufacturing Process, then a Certificate of Compliance will be completed and approved by the quality assurance department of Manufacturer. This Certificate of Compliance, a Certificate of Analysis, all quality control data Supporting the Certificate of Analysis, the Specifications, and a complete and accurate copy of the Batch records (collectively, the “Batch Documentation”) for each Batch of 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

14

 

	
 
		
Product will be delivered electronically to Alnylam. Upon request, Manufacturer will also deliver to Alnylam all Records in the possession or under the control of Manufacturer relating to the Manufacture of each Batch of Product (or any intermediate or component of Product). If Alnylam requires additional copies of such Batch Documentation, these will be provided by Manufacturer to Alnylam at cost.  

	
 
	
6.3
	
Review of Batch Documentation; Acceptance. Manufacturer will provide all Batch Documentation to Alnylam prior to the shipment of any such Products to Alnylam. Following the receipt of a complete and accurate copy of the executed Batch Documentation, Alnylam will use commercially reasonable efforts to review such Batch Documentation and advise Manufacturer of any deficiencies or corrections needed within [***] days (“Target Review Period”) of receiving such Batch Documentation. Following Manufacturer’s resolution (to Alnylam’s satisfaction) of any issues raised by Alnylam’s review of the relevant Batch Documentation, Manufacturer shall ship the Batch of Product without delay. If Alnylam is to exceed the Target Review Period, Alnylam will notify Manufacturer of the exception to the Target Review Period at least [***] days prior to the expiration of the Target Review Period and advise Manufacturer of a third party GMP storage facility of Alnylam’s choosing to ship the Product. [***] Alnylam’s acceptance of the Product will occur at the time of delivery of the Product to the carrier pursuant to Section 7. Alnylam’s acceptance of the Product shall not affect the Product warranties provided by Manufacturer pursuant to this Agreement. Notwithstanding Alnylam’s prior acceptance, should any Batch of Product fail to conform to the warranty set forth in Section 11.1(e), Alnylam shall have the remedies set forth in Section 6.5, provided that such nonconformity is not the direct result of [***] 

	
 
	
6.4
	
Disputes. In case of any disagreement between the parties as to whether Product conforms to the applicable Specifications or cGMP (if applicable) or was Manufactured in accordance with the Manufacturing Process, the quality assurance representatives of the parties will attempt in good faith to resolve any such disagreement and Alnylam and Manufacturer will follow their respective SOPs to determine the conformity of the Product to the Specifications and cGMP (if applicable) and Manufacture in compliance with the Manufacturing Process. If the foregoing discussions do not resolve the disagreement in a reasonable time (which will not exceed [***] days), a representative sample of such Product and/or relevant documentation will be submitted to an independent testing laboratory (in the case of an alleged failure to meet Specifications) and/or independent cGMP consultant (in the case of an alleged failure to comply with cGMP or the Manufacturing Process), as appropriate, that are mutually agreed upon by the parties for tests and final determination of whether such Product conforms with such Specifications and/or cGMP (if applicable). The laboratory must meet cGMP and cGLP (if applicable). The laboratory and consultant, as applicable, must be of recognized standing in the industry, and consent to the appointment of such laboratory and consultant will not be unreasonably withheld or delayed by either party. Such laboratory will use the test methods contained in the applicable Specifications. The determination of conformance by such laboratory and/or cGMP consultant, as applicable, with respect to all or part of such 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

15

 

Product will be final and binding on the parties absent manifest error. The fees and expenses of the laboratory and/or consultant, as applicable, incurred in making such determination will be paid by the party against whom the determination is made. 

	
 
	
6.5
	
Product Non-Compliance and Remedies. If a Batch of Product fails to conform to the warranty in Section 11.1(e), then Manufacturer will, at Alnylam’s sole option: 

(a) [***]  

[***]

Moreover, the parties will meet to discuss, evaluate and analyze the reasons for and implications of the failure to comply with cGMP (if applicable) and/or the Manufacturing Process and will decide whether to proceed with or to amend the applicable Purchase Order via a Change Order, or to terminate the manufacture of the affected Batch. [***] 

	
 
	
6.6
	
Recalls. In the event that Alnylam is required or voluntarily decides to recall any Product Manufactured by Manufacturer pursuant to this Agreement, then Manufacturer will promptly provide Alnylam with all reasonably requested information related thereto to assist Alnylam in implementing such recall. If such recall is initiated [***], Manufacturer will promptly reimburse Alnylam for [***]. Otherwise, Alnylam will be solely responsible for all costs and expenses related to such recall. 

	
7.
	
Shipping and Delivery. 

Except as provided in Section 6.3, Manufacturer agrees not to ship Product to Alnylam or its designee until it has received a written approval from Alnylam or Alnylam’s designee to release and ship, provided, however, that any resulting delay in delivery shall not exceed the time periods set forth in Section 6.3. Manufacturer will ensure that each Batch will be delivered to Alnylam or Alnylam’s designee in accordance with the instructions for shipping and packaging specified by Alnylam in the applicable Purchase Order or as otherwise agreed to by the parties in writing. Delivery terms will be [***]. A bill of landing will be furnished to Alnylam with respect to each shipment.  

	
8.
	
Fees and Payments. 

	
 
	
8.1
	
Price. The price of Product and/or the fees and expenses for the performance of Services (the “Fees”) will be set forth in the applicable Purchase Order. The Fees shall be paid according to the following schedule: 

 

			
	
[***]
	
[***]
	
[***]

	
[***]
	
 
	
[***]

	
[***]
	
[***]
	
[***]

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

16

 

			
	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]

	
[***]
	
[***]
	
[***]

All dollar ($) amounts specified in this Agreement are United States dollar amounts and all payments to be made under this Agreement will be made in United States dollars to a bank account located in the United States.  

	
 
	
8.2
	
Invoice. Manufacturer will invoice Alnylam according to[***] referencing in each such invoice the Purchase Order(s) to which such invoice relates. Payment of undisputed invoices will be due [***] days after receipt of the invoice and reasonable supporting documentation by Alnylam. [***] accordance with the schedule set forth in Section 8.1 above.  

	
 
	
8.3
	
Payments. Alnylam will make all undisputed payments pursuant to this Agreement by check or wire transfer to a bank account designated in writing by Manufacturer and reasonably communicated to Alnylam. [***]  

	
 
	
8.4
	
Financial Records. For time and material and/or professional services, Manufacturer will keep accurate records of all work performed and invoice calculations, and, upon the request of Alnylam, will permit Alnylam or its duly authorized agents to examine such records during normal business hours for the purpose of verifying the correctness of all such calculations. 

	
 
	
8.5
	
Taxes. [***] 

	
9.
	
Intellectual Property Rights. 

	
 
	
9.1
	
Alnylam Technology. All rights to and interests in Alnylam Technology will remain solely in Alnylam and no right or interest therein is transferred or granted to Manufacturer under this Agreement. Manufacturer acknowledges and agrees that it does not acquire a license or any other right to Alnylam Technology except for the limited purpose of carrying out its duties and obligations under this Agreement and that such limited, non-exclusive, license 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

17

 

	
 
		
will expire upon the completion of such duties and obligations or the termination or expiration of this Agreement, whichever is the first to occur. 

	
 
	
9.2
	
Manufacturer Technology. All rights to and interests in Manufacturer Technology will remain solely in Manufacturer and no right or interest therein is transferred or granted to Alnylam under this Agreement.  

	
 
	
9.3
	
Improvements. Manufacturer agrees [***]. 

	
 
	
9.4
	
Patent Filings. [***]  

	
 
	
9.5
	
Required Consents. Without limiting any other provisions of this Agreement, Alnylam’s use of the Product may necessitate the procurement of separate licenses from third parties. Alnylam shall have full responsibility for the determination of whether and from which third party it requires any such license and for the procurement of such license as well as the procurement of any Required Consents. 

	
10.
	
Confidentiality. 

	
 
	
10.1
	
Definition. “Confidential Information” means any and all non-public scientific, technical, financial regulatory or business information, or data or trade secrets in whatever form (written, oral or visual) that is (a) furnished or made available by one party (the “Discloser”) to the other (the “Recipient”) or developed by either Party under this Agreement; and (i) if in tangible form, is labeled in writing as proprietary or confidential; or (ii) if in oral or visual form, is identified as proprietary or confidential at the time of disclosure or within [***] days after such disclosure. Confidential Information of Alnylam includes (x) Alnylam Technology and Improvements; (y) development and marketing plans, regulatory and business strategies, financial information, and forecasts of Alnylam; and (z) all information of third parties that Alnylam has an obligation to keep confidential. Manufacturer Technology and Manufacturer pricing for products and Services shall be considered Manufacturer Confidential Information, whether or not labeled confidential.  

	
 
	
10.2
	
Confidentiality Obligations. Recipient agrees to (a) hold in confidence all Discloser’s Confidential Information, and not disclose Discloser’s Confidential Information except as expressly provided in Section 10.3, without the prior written consent of Discloser; (b) use Discloser’s Confidential Information solely to carry out Recipient’s obligations under this Agreement or in the reasonable exercise of Recipient’s rights under this Agreement; (c) treat Discloser’s Confidential Information with the same degree of care Recipient uses to protect Recipient’s own confidential information but in no event with less than a reasonable degree of care; and (d) reproduce Discloser’s Confidential Information solely to the extent necessary to carry out Recipient’s rights or obligations under this Agreement, with all such reproductions being considered Discloser’s Confidential Information.  

	
 
	
10.3
	
Permitted Disclosure. Recipient may provide Discloser’s Confidential Information to its Affiliates, and to its and their directors, employees, consultants, contractors and agents; provided, however, that (a) any such Affiliates, directors, employees, consultants, and 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

18

 

	
 
		
agents are bound by written obligations of confidentiality with respect to the disclosing party’s Confidential Information that are at least as restrictive as those set forth in this Agreement; (b) Recipient remains liable for the compliance of such Affiliates, employees, consultants, and agents with such obligations; and (c) in the case of Manufacturer, such disclosure is only to the extent necessary for Manufacturer to carry out its obligations under this Agreement. Recipient may also disclose Discloser’s Confidential Information to (i) any Authority; or (ii) any third parties only to the extent such disclosure is required to comply with Applicable Law, the rules of any stock exchange or listing entity, or to defend or prosecute litigation; provided, that Recipient provides prior written notice of such disclosure to Discloser, takes all reasonable and lawful actions to avoid or minimize the degree of such disclosure, and cooperates reasonably with Discloser in any efforts to seek a protective order. Furthermore, Alnylam may disclose Confidential Information of Manufacturer relating to the Development and/or Manufacture of Product to entities with whom Alnylam has (or may have) a marketing and/or development collaboration (including, but not limited to, Collaboration Partners) or to bona fide actual or prospective underwriters, investors, lenders or other financing sources or to potential acquirers of the business to which this Agreement relates, and who in each case have a specific need to know such Confidential Information and who are bound by a like obligation of confidentiality and restrictions no less restrictive than those set forth in this Article 10; [***]. 

	
 
	
10.4
	
Exceptions. Recipient’s obligations of non-disclosure and non-use under this Agreement will not apply to any portion of Discloser’s Confidential Information that Recipient can demonstrate, by competent proof: 

	
 
	
(a)
	
is generally known to the public at the time of disclosure or becomes generally known through no wrongful act on the part of Recipient or its Affiliates; 

	
 
	
(b)
	
is in Recipient’s or its Affiliates’ possession at the time of disclosure other than as a result of Recipient’s or its Affiliate’s breach of any legal obligation; 

	
 
	
(c)
	
becomes known to Recipient or its Affiliates on a non-confidential basis through disclosure by sources other than the Discloser having the legal right to disclose such Confidential Information; or 

	
 
	
(d)
	
is independently developed by Recipient or its Affiliates without reference to or reliance upon Discloser’s Confidential Information. 

If Recipient is required by law, a governmental authority, by order of a court of competent jurisdiction or the rules of any stock exchange to which Recipient is subject to disclose any Confidential Information, Recipient will give Discloser prompt written notice of such requirement or order and Recipient will take all reasonable and lawful actions to avoid or minimize the degree of such disclosure. Recipient will cooperate reasonably with Discloser in any efforts to seek a protective order. 

	
11.
	
Representations and Warranties. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

19

 

	
 
	
11.1
	
Manufacturer Representations and Warranties. Manufacturer represents and warrants to Alnylam that: 

	
 
	
(a)
	
it has the full power and right to enter into this Agreement and that, with the exception of Required Consents, if any, there are no outstanding agreements, assignments, licenses, encumbrances or rights of any kind held by other parties, private or public, that are inconsistent with the provisions of this Agreement; 

	
 
	
(b)
	
the execution and delivery of this Agreement by Manufacturer has been authorized by all requisite corporate or company action and this Agreement is and will remain a valid and binding obligation of Manufacturer, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors; 

	
 
	
(c)
	
the Services will be performed with requisite care, skill and diligence, by individuals who are appropriately trained and qualified; and in accordance with Applicable Law and industry standards, and all applicable provisions of Alnylam’s policies and procedures that Alnylam has provided to Manufacturer in writing;  

	
 
	
(d)
	
to the best of its knowledge, the use of Manufacturer Technology as contemplated in the Services will not violate any patent, trade secret or other proprietary or intellectual property rights of any third party and it will promptly notify Alnylam in writing should it become aware of any claims asserting such violation;  

	
 
	
(e)
	
at the time of delivery to Alnylam, the Product Manufactured under this Agreement (i) will have been Manufactured in accordance with cGMP (if applicable) and all other Applicable Law, the Manufacturing Process, the applicable Quality Technical Agreement, and Specifications; (ii) will not be adulterated or misbranded under the FDCA or other Applicable Law; and (iii) will not have been produced in violation of any applicable provisions of the United States Fair Labor Standards Act, as amended; however, the foregoing warranty excludes defects caused by Alnylam’s (i) failure to provide a suitable storage, use or operating environment for the Product, (ii) use of reagents or biochemical with the Product (iii) modification to the Product, or (iv) abuse, misuse or neglect of the Product,; and  

	
 
	
(f)
	
it has not been debarred, nor is it subject to a pending debarment, and that it will not use in any capacity in connection with the Services any person who has been debarred pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is the subject of a conviction described in such section. Manufacturer will notify Alnylam immediately if Manufacturer, its Affiliates, or approved subcontractors, or any person used to perform Services under this Agreement, or any of their respective officers or directors, as applicable, is subject to the foregoing, or if any action, suit, claim, investigation, or proceeding relating to the foregoing is pending, or to the best of Manufacturer’s knowledge, is threatened. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

20

 

	
 
	
11.2
	
Alnylam Representations and Warranties. Alnylam represents and warrants to Manufacturer that: 

	
 
	
(a)
	
it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights held by other parties, private or public, that are inconsistent with the provisions of this Agreement;  

	
 
	
(b)
	
the execution and delivery of this Agreement by Alnylam has been authorized by all requisite corporate action and this Agreement is and will remain a valid and binding obligation of Alnylam, enforceable in accordance with its terms, subject to laws of general application relating to bankruptcy, insolvency and the relief of debtors; 

	
 
	
(c)
	
it is responsible for obtaining and it will have obtained as of the Effective Date, all Required Consents necessary for Alnylam to provide the sequences and other Specifications as contemplated hereunder to Manufacturer to permit the synthesis by Manufacturer of the Products. Manufacturer will be relieved of the performance of any obligations hereunder that may be affected by Alnylam’s failure to promptly obtain any Required Consents for Manufacturer; and 

	
 
	
(d)
	
to the best of its knowledge, the use of any Alnylam Technology as contemplated in the Services will not violate any patent, trade secret or other proprietary or intellectual property rights of any third party and it will promptly notify Manufacturer in writing should it become aware of any claims asserting such violation. 

	
 
	
11.3
	
Disclaimer of Other Representations and Warranties. EXCEPT AS EXPRESSLY SET 

FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY 

REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. 

	
12.
	
Indemnification. 

	
 
	
12.1
	
Indemnification by Manufacturer. Manufacturer will indemnify, defend and hold harmless Alnylam, its Affiliates and its and their respective officers, directors, employees, subcontractors, and agents (collectively, the “Alnylam Indemnitees”) against any and all losses, damages, liabilities or expenses (including reasonable attorneys’ fees and other costs of defense) (collectively, “Losses”) in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Alnylam Indemnitee by any third party to the extent they arise out of or relate to any (a) breach of its representations and warranties under this Agreement by Manufacturer; or (b) Manufacturer Indemnitee’s gross negligence or willful misconduct in performing obligations under this Agreement; except in all cases to the extent such Losses are within the scope of the indemnification obligation of Alnylam under Section 12.2 below.  

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

21

 

	
 
	
12.2
	
Indemnification by Alnylam. Alnylam will indemnify, defend and hold harmless Manufacturer, its Affiliates and its and their respective officers, directors, employees, approved subcontractors, and agents (collectively, the “Manufacturer Indemnitees”) against any and all Losses in connection with any and all actions, suits, claims or demands that may be brought or instituted against any Manufacturer Indemnitee by any third party to the extent they arise out of or relate to (a) (i) the use, by Alnylam Indemnitees of the Product or any result or data generated from such use or the provision of any Service; (ii) Alnylam’s use, handling, storage and disposal of the Product including, without limitation, any use which results in death or injury to any person; and (iii) any actual or alleged act of infringement by Alnylam or its Collaboration Partners of any third party’s intellectual property rights as a result of Alnylam’s use of the Product, or the use or sale of any data, results or Product resulting from such use or the Services provided hereunder; (b) any breach of its representations and warranties under this Agreement by Alnylam; or (c) any Alnylam Indemnitee’s gross negligence or willful misconduct in performing obligations under this Agreement; except in all cases to the extent such Losses are within the scope of the indemnification obligation of Manufacturer under Section 12.1 above. 

	
 
	
12.3
	
Indemnification Procedures. Each party must notify the other party within thirty (30) days of receipt of any claims made for which the other party might be liable under Section 12.1 or 12.2, as the case may be. Subject to Section 12.4, the indemnifying party will have the sole right to defend, negotiate, and settle such claims. The indemnified party will be entitled to participate in the defense of such matter and to employ counsel at its expense to assist in such defense; provided, however, that the indemnifying party will have final decisionmaking authority regarding all aspects of the defense of any claim. The party seeking indemnification will provide the indemnifying party with such information and assistance as the indemnifying party may reasonably request, at the expense of the indemnifying party. The parties understand that no insurance deductible will be credited against losses for which a party is responsible under this Section 12. 

	
 
	
12.4
	
Settlement. Neither party will be responsible nor bound by any settlement of any claim or suit made without its prior written consent; provided, however, that the indemnified party will not unreasonably withhold or delay such consent. If a settlement contains an absolute waiver of liability for the indemnified party, and each party has acted in compliance with the requirements of Section 12.3, then the indemnified party’s consent will be deemed given. Notwithstanding the foregoing, Manufacturer will not agree to settle any claim on such terms or conditions as would impair Alnylam’s ability or right to Manufacture, market, sell or otherwise use Product, or as would impair Manufacturer’s ability, right or obligation to perform its obligations under this Agreement. 

	
 
	
12.5
	
Limitation of Liability. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING 

OUT OF THIS AGREEMENT (INCLUDING LOST PROFITS), HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION WILL NOT APPLY 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

22

 

TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 10 OR ITS INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION 12. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, TO THE FULLEST EXTENT PERMITTED BY LAW, IN NO EVENT WILL MANUFACTURER’S LIABILITY ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, EXCEED [***]. 

	
13.
	
Insurance. 

	
 
	
13.1
	
Manufacturer Insurance. Manufacturer will secure and maintain in full force and effect throughout the term of this Agreement (and for at least [***] years thereafter for claims made coverage), the following minimum insurance coverage: 

(a) Commercial General Liability, [***]. 

	
 
	
13.2
	
Additional Insured; Evidence of Insurance. Manufacturer shall list Alnylam as an additional insured for the liabilities covered under this Agreement on each of the policies listed in Section 13.1. Manufacturer will, provide Alnylam with a Certificate of Insurance evidencing coverage and all endorsements required under this Section 13.  

	
 
	
13.3
	
Insurance Information. [***] 

	
14.
	
Term and Termination. 

	
 
	
14.1
	
Term. This Agreement will take effect as of the Effective Date and, unless earlier terminated pursuant to this Section 14, will expire on the later of (a) five (5) years from the Effective Date; or (b) the completion of Services under all Purchase Orders executed by the parties prior to the fifth anniversary of the Effective Date, (the “Initial Term”). The term of this Agreement may be extended continuously for additional two (2) year periods (a “Renewal Term”). unless: (i) Alnylam gives written notice of termination to Manufacturer at least [***] months prior to the expiration of the Initial Term, (ii) Manufacturer gives written notice of termination to Alnylam at least [***] months prior to the expiration of the Initial Term. During a Renewal Term, either party may terminate the Agreement: (i) Alnylam by giving [***] months’ prior written notice to Manufacturer; and (ii) Manufacturer by giving [***] months’ prior written notice to Alnylam. 

	
 
	
14.2
	
Termination by Alnylam. Alnylam will have the right, in its sole discretion, to terminate this Agreement or any Purchase Order, subject to Section 5.3(b), (a) upon sixty (60) days’ prior written notice to Manufacturer if (i) Manufacturer is or will be unable to perform the Services in accordance with the agreed upon timeframe and/or fees and expenses set forth in the applicable Purchase Order; (ii) Manufacturer fails to obtain or maintain any material governmental licenses or approvals required in connection with the Services, or (iii) if Manufacturer materially breaches the terms of the [***]; provided, however, that Manufacturer will have an opportunity to (y) cure the any of the foregoing [***], or (z) provide Alnylam with a plan to remedy the foregoing within the [***], and if so cured, no 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

23

 

	
 
		
termination will be deemed to have occurred as long as Manufacturer diligently pursues the plan to remedy the breach and completes such plan in accordance with the time frame mutually agreed to by the Parties; or (b) upon thirty (30) days’ prior written notice to Manufacturer if Alnylam determines, in its reasonable judgment and supported by written documentation provided to Manufacturer, that the Product is not commercially viable. 

	
 
	
14.3
	
Termination by Either Party. Either party will have the right to terminate this Agreement or any signed Purchase Orders that are pending by written notice to the other party, upon the occurrence of any of the following: 

	
 
	
(a)
	
the other party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes subject to involuntary proceedings under any bankruptcy or insolvency law (which proceedings remain undismissed for [***] days);  

	
 
	
(b)
	
the other party fails to start and diligently pursue the cure of a material breach of this Agreement (other than a breach under the [***] which is covered by Section 14.2) within [***] days after receiving written notice from the other party of such breach; or 

	
 
	
(c)
	
a force majeure event that will, or continues to, prevent performance (in whole or substantial part) of this Agreement or any pending Purchase Order for a period of at least [***] days. In the case of a force majeure event relating solely to a pending Purchase Order, the right to terminate will be limited to such Purchase Order. 

	
 
	
14.4
	
Effect of Termination. Manufacturer will, upon the effective date of termination set forth in the termination notice from Alnylam, promptly cease performance of the applicable Services and will take all reasonable steps to mitigate the out-of-pocket expenses incurred in connection therewith. In particular, Manufacturer will use its commercially reasonable efforts to: 

	
 
	
(a)
	
immediately cancel, to the greatest extent possible, any third-party obligations;  

	
 
	
(b)
	
promptly inform Alnylam of any irrevocable commitments made in connection with any pending Purchase Order(s) prior to termination; 

	
 
	
(c)
	
promptly return to the vendor for a refund all unused, unopened materials in Manufacturer’s possession that are related to any pending Purchase Order; provided, that Alnylam will have the option, but not the obligation, to take possession of any such materials upon payment to Manufacturer for such materials; 

	
 
	
(d)
	
promptly inform Alnylam of the cost of any remaining unused, unreturnable materials ordered pursuant to any pending Purchase Order(s), and invoice Alnylam for such amount, and either deliver such materials to Alnylam (or its designee) or 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

24

 

	
 
		
properly dispose of them, at Alnylam’s cost and expense, as instructed by Alnylam; and  

	
 
	
(e)
	
perform only those services and activities mutually agreed upon by Alnylam and Manufacturer as being necessary or advisable in connection with the close-out of any pending Purchase Order(s). 

Expiration or termination of this Agreement will not affect (a) the amounts due under this Agreement that exist as of the date of expiration or termination, and (b) as of such date, the cancellation fees accrued under Section 5.3(b). In addition, Alnylam will purchase from Manufacturer all Safety Stock in existence as of the effective date of expiration or termination of this Agreement pursuant to the terms of Section 4.4. 

	
 
	
14.5
	
Return of Materials/Confidential Information. Upon the expiration or termination of this Agreement for any reason, Recipient agrees, except as otherwise provided in this Agreement, to return to Discloser all documentation or other tangible evidence or embodiment of Discloser’s Confidential Information and not to use such Confidential Information, unless otherwise agreed. Notwithstanding the foregoing, Recipient may retain one archival copy of Discloser’s Confidential Information in order to monitor Recipient’s ongoing obligations of confidentiality and non-use under this Agreement; provided, that such archival copy must be kept confidential in accordance with Section 10 and segregated from Recipient’s regular files. Manufacturer will also promptly return all Alnylam Equipment, retained samples, data, reports and other property, information and know-how in recorded form that was provided by Alnylam, or developed in the performance of the Services, that are owned by or licensed to Alnylam.  

	
 
	
14.6
	
Inventories. Upon expiration or termination of this Agreement or a pending Purchase Order, Alnylam [***]

	
 
	
14.7
	
Payment Reconciliation. Following completion of the activities under a particular Purchase Order for services performed on a time and material basis, Manufacturer will provide Alnylam with an itemized statement of all work performed by it in connection with the terminated Purchase Order, an itemized breakdown of the costs associated with that work, and a final invoice for that Purchase Order. For the sake of clarity, the foregoing obligation does not apply to Manufacturing services. [***]. 

	
 
	
14.8
	
Survival. Expiration or termination of this Agreement for any reason will not relieve either party of any obligation accruing prior to such expiration or termination. Further, the provisions of Sections 1, 2.7, 2.8, 3.3, 5.4 through 5.7, 6, 8, 9, 10 12, 13, 14.4 through 14.8 and 15, and the provisions of the applicable Quality Technical Agreement will survive any termination or expiration of this Agreement.  

	
15.
	
Miscellaneous. 

	
 
	
15.1
	
Independent Contractor. All Services will be rendered by Manufacturer as an independent contractor for federal, state and local income tax purposes and for all other purposes. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

25

 

	
 
		
Manufacturer will not in any way represent itself to be a partner or joint venturer of or with Alnylam. This Agreement does not create an employer-employee relationship between Alnylam on the one hand and Manufacturer or any employee, subcontractors, Affiliate of Manufacturer, or any Manufacturer personnel on the other. Manufacturer is acting under this Agreement as an independent contractor with full power and authority to determine the means, manner and method of performance of Manufacturer’s duties. Manufacturer will be responsible for and will withhold and/or pay any and all applicable federal, state or local taxes, payroll taxes, workers’ compensation contributions, unemployment insurance contributions, or other payroll deductions from the compensation of Manufacturer’s employees and other Manufacturer personnel. Manufacturer understands and agrees that it is solely responsible for such matters and that it will indemnify Alnylam and hold Alnylam harmless from all claims and demands in connection with such matters.  

	
 
	
15.2
	
Force Majeure. Except as otherwise expressly set forth in this Agreement, neither party will have breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected party, including fire, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), insurrections, riots, civil commotion, strikes, acts of God or acts, omissions, or delays in acting, by any governmental authority (“force majeure”). The party affected by any event of force majeure will promptly notify the other party, explaining the nature, details and expected duration of the force majeure event. Such party will also notify the other party from time to time as to when the affected party reasonably expects to resume performance in whole or in part of its obligations under this Agreement, and to notify the other party of the cessation of any such event. A party affected by an event of force majeure will use its reasonable efforts to remedy, remove, or mitigate such event and the effects of it with all reasonable dispatch. If a party anticipates that an event of force majeure may occur, such party will notify the other party of the nature, details and expected duration of the force majeure event. Upon termination of the event of force majeure, the performance of any suspended obligation or duty will promptly recommence.  

	
 
	
15.3
	
Public Statements. Except to the extent required by applicable law or regulation or the rules of any stock exchange or listing agency, neither party will make any public statement or release concerning this Agreement or the transactions contemplated by this Agreement, or use the other party’s name or the name of any Affiliate of the other party in any form of advertising, promotion or publicity, without obtaining the prior written consent of the other party.  

	
 
	
15.4
	
Notices. All notices must be in writing and sent to the address for the recipient set forth in this Agreement below or at such other address as the recipient may specify in writing under this procedure. All notices must be given by (a) personal delivery, with receipt acknowledged; or (b) prepaid certified or registered mail, return receipt requested; or (c) prepaid recognized next business day or express delivery service. Notices will be effective upon receipt or at a later date stated in the notice. 

If to Manufacturer, to: Agilent Technologies, Inc. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

26

 

5555 Airport Blvd., Suite 100 

Boulder, CO 80301 

Attn: General Manager 

With a copy to: Agilent Technologies, Inc. 

5301 Stevens Creek Blvd. 

Santa Clara, CA 95051 

Attn: General Counsel 

If to Alnylam, to:  Alnylam Pharmaceuticals, Inc. 

300 Third Street, 3rd Floor 

Cambridge, MA 02142 

Attention: Office of General Counsel 

With a copy to: Faber Daeufer & Itrato PC 

890 Winter Street, Suite 315 

Waltham, MA 02451 Attention: Sumy Daeufer, Esq. 

	
 
	
15.5
	
Assignment. This Agreement may not be assigned or otherwise transferred by either party without the prior written consent of the other party; provided, however, that the other party may, without such consent, but with notice to the other party, assign this Agreement, in whole or in part, (a) in connection with the transfer or sale of all or substantially all of its assets or the line of business or Product to which this Agreement relates; (b) to a successor entity or acquirer in the event of a merger, consolidation or change of control; or (c) to any Affiliate [***]. Any purported assignment in violation of the preceding sentence will be void. Any permitted assignee will assume the rights and obligations of its assignor under this Agreement. 

	
 
	
15.6
	
Entire Agreement. This Agreement, together with the attached Appendices and any fullysigned Purchase Orders, each of which are incorporated into this Agreement, constitute the entire agreement between the parties with respect to the specific subject matter of this Agreement and all prior agreements with respect such subject matter are superseded [***].  

	
 
	
15.7
	
No Modification. This Agreement and and/or any Purchase Order or Quality Technical Agreement may be changed only by a writing signed by authorized representatives of each party. 

	
 
	
15.8
	
Severability; Reformation. Each provision in this Agreement is independent and severable from the others, and no provision will be rendered unenforceable because any other provision is found by a proper authority to be invalid or unenforceable in whole or in part. If any provision of this Agreement is found by such an authority to be invalid or unenforceable in whole or in part, such provision will be changed and interpreted so as to best accomplish the objectives of such unenforceable or invalid provision and the intent of the parties, within the limits of applicable law. 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

27

 

	
 
	
15.9
	
Governing Law. This Agreement and any disputes arising out of or relating to this Agreement will be governed by, construed and interpreted in accordance with the internal laws of [***], without regard to any choice of law principle that would require the application of the law of another jurisdiction. The parties expressly reject any application to this Agreement of (a) the United Nations Convention on Contracts for the International Sale of Goods; and (b) the 1974 Convention on the Limitation Period in the International Sale of Goods, as amended by that certain Protocol, done at Vienna on April 11, 1980. 

	
 
	
15.10
	
Jurisdiction; Venue. Any legal action or proceeding concerning the validity, interpretation and enforcement of this Agreement, matters arising out of or related to this Agreement or its making, performance or breach, or related matters will be brought exclusively in the state courts of [***]. All parties consent to the exclusive jurisdiction of those courts and waive any objection to the propriety or convenience of such venues. 

	
 
	
15.11
	
Waiver. Any delay in enforcing a party’s rights under this Agreement, or any waiver as to a particular default or other matter, will not constitute a waiver of such party’s rights to the future enforcement of its rights under this Agreement, except with respect to an express written waiver relating to a particular matter for a particular period of time signed by an authorized representative of the waiving party, as applicable. 

	
 
	
15.12
	
No Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole benefit of the parties hereto and their successors and permitted assigns, and they will not be construed as conferring any rights on any other persons 

	
 
	
15.13
	
No Strict Construction; Headings. This Agreement has been prepared jointly and will not be strictly construed against either party. The section headings are included solely for convenience of reference and will not control or affect the meaning or interpretation of any of the provisions of this Agreement. The words “include,” “includes” and “including” when used in this Agreement are deemed to be followed by the phrase “but not limited to”. 

	
 
	
15.14
	
Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which together will constitute one and the same instrument. Electronic signatures shall have the same force and effect as originals. 

	
 
	
15.15
	
Dispute Resolution. The parties recognize that bona fide disputes may arise which relate to the parties’ rights and obligations under this Agreement. The parties shall first try to settle such dispute amicably among themselves by referring such dispute, controversy or claim (a “Dispute”) to the parties’ respective chief executive officers, or any other executive officer designated by such chief executive officer (the “Executive Officers”). A dispute shall be referred to such Executive Officers upon one party providing the other party with written notice of referral of such Dispute to the Executive Officers. The parties agree to attempt to resolve such Dispute through good faith discussions. If the Executive Officers fail to come to consensus on such Dispute within [***] days of receipt of such written notice then either party may seek all available remedies, including legal remedies. Nothing herein will prohibit either party from initiating litigation or other judicial or administrative 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

28

 

	
 
		
proceedings if such party would be irreparably harmed by a failure to act while the parties are attempting to resolve the dispute through negotiation. 

[Remainder of page left blank intentionally] 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

29

 

  

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

		
	
ALNYLAM PHARMACEUTICALS, INC.

By:  /s/ Alfred Boyle________________________

Print Name:  Alfred Boyle___________________

Title:   SVP Technical Operations______________

 
	
Agilent Technologies, Inc.

By:  /s/ Brian Carothers______________________

Print Name:  Brian Carothers_________________

Title:   VP NASD__________________________

 

   

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

30

 

  

APPENDIX A 

SAMPLE PURCHASE ORDER 

THIS PURCHASE ORDER is by and between ALNYLAM PHARMACEUTICALS, INC. (“Alnylam”) and Agilent Technologies, Inc. (“Manufacturer”), will be effective as of the last date of signature below, and upon execution will be incorporated into the Manufacturing Services Agreement between Alnylam and Manufacturer dated March 28, 2018 (the “Agreement”). Capitalized terms in this Purchase Order will have the same meanings as set forth in the Agreement. 

Alnylam hereby engages Manufacturer to provide Services, as follows: 

[***]

All terms and conditions of the Agreement will apply to this Purchase Order. In the event of any conflict between this Purchase Order and the terms of the Agreement, the terms of the Agreement will control. 

[Remainder of page left blank intentionally] 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

31

 

 

  

PURCHASE ORDER AGREED TO AND ACCEPTED BY: 

ALNYLAM PHARMACEUTICALS, INC. AGILENT TECHNOLOGIES, INC. 

By:  By:  

Print Name: 

 
 
Print Name: 

 
 
Title:  Title:  Date:  Date:  

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

32

 

  

EXHIBIT A  PATISIRAN SPECIFICATIONS 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 4 pages were omitted.

 

[***]

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

33

 

APPENDIX B 

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 1 page was omitted.

 

[***]

 

 

 

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934.

34EX-10.1

 Exhibit 10.1 

INDEMNIFICATION AGREEMENT 

THIS INDEMNIFICATION AGREEMENT (“Agreement”) is made and entered into as of the
         day of                     , 20         , by and between
Spirit MTA REIT, a Maryland trust (the “Company”), and                             
(“Indemnitee”). 
 WHEREAS, at the request of the Company, Indemnitee currently serves as a director of the Company and
may, therefore, be subjected to claims, suits or proceedings arising as a result of his service; and 
 WHEREAS, as an inducement to
Indemnitee to continue to serve as such director, the Company has agreed to indemnify and to advance expenses and costs incurred by Indemnitee in connection with any such claims, suits or proceedings, to the maximum extent permitted by law; and 

WHEREAS, the parties by this Agreement desire to set forth their agreement regarding indemnification and advance of expenses; 

NOW, THEREFORE, in consideration of the premises and the covenants contained herein, the Company and Indemnitee do hereby covenant and agree
as follows: 
 Section 1. Definitions. For purposes of this Agreement: 

(a) “Adjudged” shall mean adjudged finally by a court or arbitral or other authority of competent jurisdiction and not subject
to appeal. 
 (b) “Change of Control” means a change of control of the Company occurring after the Effective Date of a
nature that would be required to be reported in response to Item 6(e) of Schedule 14A of Regulation 14A (or in response to any similar item on any similar schedule or form) promulgated under the Securities Exchange Act of 1934, as amended (the
“Exchange Act”), whether or not the Company is then subject to such reporting requirement; provided, however, that, without limitation, such a Change of Control shall be deemed to have occurred if, after the Effective Date:
(i) any “person” (as such term is used in Sections 13(d) and 14(d) of the Exchange Act) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly
or indirectly, of securities of the Company representing 50% or more of the combined voting power of all of the Company’s then-outstanding securities entitled to vote generally in the election of directors without the prior approval of at least
two-thirds of the members of the Board of Directors of the Company (the “Board of Directors”) in office immediately prior to such person’s attaining such percentage interest;
(ii) the Company is a party to a merger, consolidation, sale of assets, plan of liquidation or other reorganization not 

  
 -1- 

 
approved by at least two-thirds of the members of the Board of Directors then in office, as a consequence of which members of the Board of Directors in
office immediately prior to such transaction or event constitute less than a majority of the Board of Directors thereafter; or (iii) at any time, a majority of the members of the Board of Directors are not comprised of (A) individuals who
were directors as of the Effective Date and/or (B) individuals whose election by the Board of Directors or nomination for election by the Company’s stockholders was approved by the affirmative vote of at least two-thirds of the directors then in office who were directors as of the Effective Date or whose election for nomination for election was previously so approved. 

(c) “Corporate Status” means the status of a person as a present or former director, officer, employee or agent of the Company
or as a director, trustee, officer, partner, member, manager or trustee. 
 (d) “Disinterested Director” means a director of
the Company who is not and was not a party to the Proceeding in respect of which indemnification and/or advance of Expenses is sought by Indemnitee. 

(e) “Effective Date” means the date set forth in the first paragraph of this Agreement. 

(f) “Enterprise” means any foreign or domestic corporation, real estate investment trust, partnership, limited liability
company, joint venture, trust, employee benefit plan or other enterprise in which Indemnitee is or was serving as a director, trustee, officer, partner, manager, managing member, fiduciary, employee or agent at the request of the Company. As a
clarification and without limiting the circumstances in which Indemnitee may be serving at the request of the Company, service by Indemnitee shall be deemed to be at the request of the Company if Indemnitee serves or served as a director, trustee,
officer, partner, manager, managing member, fiduciary, employee or agent of any corporation, real estate investment trust, partnership, limited liability company, joint venture, trust, employee benefit plan or other enterprise (i) of which a
majority of the voting power or equity interest is owned directly or indirectly by the Company or (ii) the management of which is controlled directly or indirectly by the Company. 

(g) “Expenses” means any and all disbursements or expenses incurred by Indemnitee in connection with prosecuting, defending,
preparing to prosecute or defend, investigating, being or preparing to be a witness in or otherwise participating in a Proceeding, including, without limitation, reasonable attorneys’ fees and costs, retainers, court costs, transcript costs,
fees of experts, witness fees, travel expenses, duplicating costs, printing and binding costs, telephone charges, postage, delivery service fees, federal, state, local or foreign taxes imposed on Indemnitee as a result of the actual or deemed
receipt of any payments under this Agreement, and any 

  
 -2- 

 
Employee Retirement Income Security Act of 1974, as amended (“ERISA”), excise taxes and penalties. Expenses shall also include (i) expenses incurred in connection with any
appeal resulting from any Proceeding including, without limitation, the premium, security for and other costs relating to any cost bond, supersedeas bond or other appeal bond or its equivalent, (ii) expenses incurred in connection with recovery
under any directors’ and officers’ liability insurance policies maintained by the Company, regardless of whether the Indemnitee is ultimately determined to be entitled to such indemnification, advancement or expenses or insurance recovery,
as the case may be, and (iii) expenses incurred by Indemnitee in establishing or enforcing his right to indemnification or reimbursement under this Agreement. Expenses, however, shall not include amounts paid in settlement by Indemnitee or the
amount of judgments, fines or penalties against Indemnitee (other than ERISA excise tax penalties). 
 (h) “Independent
Counsel” means a law firm, or a member of a law firm, that is of outstanding reputation, experienced in matters of corporation law and neither is, nor in the past five years preceding the date of selection has been, retained to represent:
(i) the Company or Indemnitee in any matter material to either such party (other than with respect to matters concerning Indemnitee under this Agreement or of other indemnitees under similar indemnification agreements); or (ii) any other
party to or participant or witness in the Proceeding giving rise to a claim for indemnification or advance of Expenses hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the
applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or Indemnitee in an action to determine Indemnitee’s rights under this Agreement. The Company agrees to pay the
reasonable fees and expenses of the Independent Counsel. 
 (i) “Proceeding” means any threatened, pending or completed
action, suit, arbitration, mediation, alternate dispute resolution procedure, investigation, inquiry, administrative hearing or any other proceeding, whether brought by or in the right of the Company or otherwise and whether of a civil (including
intentional or unintentional tort claims), criminal, administrative or investigative (formal or informal) nature, including any appeal therefrom, in which Indemnitee was, is, will or might be involved as a party or otherwise, by reason of any action
taken by or omission by Indemnitee, or of any action or omission on Indemnitee’s part, in each case in or in connection with Indemnitee’s Corporate Status and whether or not acting or serving in such capacity at the time any liability or
Expense is incurred for which indemnification, reimbursement or advancement of Expenses can be provided under this Agreement, except one pending or completed on or before the Effective Date, unless otherwise specifically agreed in writing by the
Company and Indemnitee. If Indemnitee reasonably believes that a given situation may lead to or culminate in the institution of a Proceeding, such situation shall also be considered a 

  
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Proceeding. The term “Proceeding” shall be broadly construed and shall include, without limitation, the investigation, preparation, prosecution, defense, settlement, arbitration or
appeal of, and the giving of testimony in or related to, any threatened, pending or completed claim, action, suit or other proceeding, whether of a civil, criminal, administrative or investigative nature. 

Section 2. Services by Indemnitee. The Company expressly confirms and agrees that it has entered into this Agreement
and assumed the obligations imposed on it hereby in order to induce the Indemnitee to serve or continue to serve as a director of the Company, and the Company acknowledges that Indemnitee is relying upon this Agreement in serving or
continuing to serve as a director. However, this Agreement shall not impose any independent obligation on Indemnitee or the Company to continue Indemnitee’s service to the Company. Indemnitee shall be entitled to resign or otherwise terminate
such service with immediate effect at any time, and neither such resignation or termination nor the length of such service shall affect Indemnitee’s rights under this Agreement. This Agreement shall not be deemed an employment contract between
the Company (or any other entity) and Indemnitee. 
 Section 3. General. The Company shall indemnify and advance
Expenses to, Indemnitee (a) as provided in this Agreement and (b) otherwise to the maximum extent not prohibited by Maryland law in effect on the Effective Date and as amended from time to time; provided, however, that no change in
Maryland law shall have the effect of reducing the benefits available to Indemnitee hereunder based on Maryland law as in effect on the Effective Date. The rights of Indemnitee provided in this Section 3 shall include,
without limitation, the rights set forth in the other sections of this Agreement, including any additional indemnification permitted by Section 2-418(g) of the Maryland General Corporation Law (the
“MGCL”). 
 Section 4. Indemnification. If Indemnitee is, or is threatened to be, made a party to
any Proceeding, the Company shall indemnify Indemnitee against all judgments, penalties, fines and amounts paid in settlement and all Expenses actually and reasonably incurred by him or on his behalf in connection with any such Proceeding unless
(and only to the extent) it is established by clear and convincing evidence that (a) the act or omission of Indemnitee was material to the matter giving rise to the Proceeding and (i) was committed in bad faith or (ii) was the result
of active and deliberate dishonesty, Indemnitee actually received an improper personal benefit in money, property or services or in the case of any criminal Proceeding, Indemnitee had reasonable cause to believe that the act or omission was
unlawful. 
 Section 5. Certain Limits on Indemnification. Notwithstanding any other provision of this Agreement
(other than Section 6), Indemnitee shall not be entitled to: 
 (a) indemnification hereunder if the Proceeding was
one by or in the right of the Company and Indemnitee is Adjudged to be liable to the Company; 

  
 -4- 

 (b) indemnification hereunder if Indemnitee is Adjudged to be liable on the basis that personal
benefit was improperly received in any Proceeding charging improper personal benefit to Indemnitee; or 
 (c) indemnification or advance of
Expenses hereunder if the Proceeding was brought by Indemnitee unless: (i) the Proceeding was brought to establish or enforce indemnification rights under this Agreement, and then only to the extent in accordance with and as authorized by
Section 12 of this Agreement; or (ii) the Company’s charter or Bylaws, a resolution of the stockholders entitled to vote generally in the election of directors or of the Board of Directors or an agreement approved by
the Board of Directors to which the Company is a party expressly provide otherwise. 
 Section 6. Court-Ordered
Indemnification. Notwithstanding any other provision of this Agreement, a court of appropriate jurisdiction, upon application of Indemnitee and such notice as the court shall require, may order indemnification in the following circumstances:

 (a) if it determines Indemnitee is entitled to reimbursement under Section 2-418(d)(I) of the
MGCL, the court shall order indemnification, in which case Indemnitee shall be entitled to recover the Expenses of securing such reimbursement; or 

(b) if it determines that Indemnitee is fairly and reasonably entitled to indemnification in view of all the relevant circumstances, whether or
not Indemnitee (i) has met the standards of conduct set forth in Section 2-418(b) of the MGCL or (ii) has been Adjudged liable for receipt of an improper personal benefit under Section 2-418(c) of the MGCL, the court may order such indemnification as the court shall deem proper. However, indemnification with respect to any Proceeding by or in the right of the Company or in which
liability shall have been Adjudged in the circumstances described in Section 2-418(c) of the MGCL shall be limited to Expenses. 

Section 7. Indemnification for Expenses of a Party Who is Wholly or Partly Successful. Notwithstanding any
other provision of this Agreement, and without limiting any such provision, to the extent that Indemnitee was or is made a party to (or otherwise becomes a participant in) any Proceeding and is successful, on the merits or otherwise, in the defense
of such Proceeding, Indemnitee shall be indemnified for all Expenses actually and reasonably incurred by him or on his behalf in connection therewith. If Indemnitee is not wholly successful in such Proceeding but is successful, on the merits or
otherwise, as to one or more but less than all claims, issues or matters in such Proceeding, the Company shall indemnify 

  
 -5- 

 
Indemnitee under this Section 7 for all Expenses actually and reasonably incurred by him or on his behalf in connection with each such claim, issue or matter, allocated
on a reasonable and proportionate basis. For purposes of this Section 7 and, without limitation, the termination of any claim, issue or matter in such a Proceeding by dismissal, with or without prejudice, shall be deemed to
be a successful result as to such claim, issue or matter. 
 Section 8. Advance of Expenses for a Party. lf
Indemnitee was, is, or is threatened to be, made a party to any Proceeding, the Company shall, without requiring a preliminary determination of Indemnitee’s ultimate entitlement to indemnification hereunder, advance all Expenses incurred by or
on behalf of Indemnitee in connection with such Proceeding within ten days after the receipt by the Company of a statement or statements requesting such advance or advances from time to time, whether prior to or after final disposition of such
Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred by Indemnitee and shall include or be preceded or accompanied by a written affirmation by Indemnitee of Indemnitee’s good faith belief that the standard of
conduct necessary for indemnification by the Company as authorized by law and by this Agreement has been met and a written undertaking by or on behalf of Indemnitee, in substantially the form attached hereto as Exhibit A or in such form as
may be required under applicable law as in effect at the time of the execution thereof, to reimburse the Company for any Expenses advanced to Indemnitee relating to claims, issues or matters in the Proceeding as to which it shall ultimately be
established that the standard of conduct set forth in Exhibit A has not been met by Indemnitee and which have not been successfully resolved as described in Section 7 of this Agreement. Advances shall be
interest-free and unsecured. The undertaking required by this Section 8 shall be an unlimited general obligation by or on behalf of Indemnitee and shall be accepted without reference to Indemnitee’s financial ability
to repay such advanced Expenses and without any requirement to post security therefor. 
 Section 9. Indemnification
and Advance of Expenses of a Witness. Notwithstanding any other provision of this Agreement, to the extent that Indemnitee was, is or may be made a witness or otherwise asked to participate in any Proceeding, whether instituted by the Company or
any other party, and to which Indemnitee is not a party, he shall be advanced all reasonable Expenses and indemnified against all Expenses actually and reasonably incurred by him or on his behalf in connection therewith within ten days after the
receipt by the Company of a statement or statements requesting such advance or advances from time to time, whether prior to or after final disposition of such Proceeding. Such statement or statements shall reasonably evidence the Expenses incurred
by Indemnitee. Advances shall be interest-free and unsecured. 
 Section 10. Procedure for Determination of
Entitlement to Indemnification. 

  
 -6- 

 (a) To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a
written request, including therein or therewith such documentation and information as is reasonably available to Indemnitee and is reasonably necessary to determine whether and to what extent Indemnitee is entitled to indemnification; provided that
any failure or delay in giving such notice shall not relieve the Company of its obligations under this Agreement unless and to the extent that (i) none of the Company or its subsidiaries are party to or aware of such Proceeding and (ii) the Company
is materially prejudiced by such failure or delay. Indemnitee may submit one or more such requests from time to time and at such time(s) as Indemnitee deems appropriate in his sole discretion. The officer of the Company receiving any such request
from Indemnitee shall, promptly upon receipt of such a request for indemnification, advise the Board of Directors in writing that Indemnitee has requested indemnification. 

(b) Upon written request by Indemnitee for indemnification pursuant to Section 10(a) above, a determination, if
required by applicable law, with respect to Indemnitee’s entitlement thereto shall promptly be made in the specific case: (i) if a Change of Control has occurred, by Independent Counsel, in a written opinion to the Board of Directors, a
copy of which shall be delivered to Indemnitee, which Independent Counsel shall be selected by the Indemnitee and approved by the Board of Directors in accordance with Section 2-4 I 8(e)(2)(ii) of the
MGCL, which approval will not be unreasonably withheld or delayed; or (ii) if a Change of Control has not occurred, (A) by the Board of Directors by a majority vote of a quorum consisting entirely of Disinterested Directors or, if such a
quorum cannot be obtained, then by a majority vote of a duly authorized committee of the Board of Directors consisting solely of one or more Disinterested Directors, (B) if Independent Counsel has been selected by the Board of Directors in
accordance with Section 2-418(e)(2)(ii) of the MGCL and approved by the Indemnitee, which approval shall not be unreasonably withheld or delayed, by Independent Counsel, in a written opinion to the Board
of Directors, a copy of which shall be delivered to Indemnitee or (C) if so directed by a majority of the members of the Board of Directors, by the stockholders of the Company. If it is so determined that Indemnitee is entitled to
indemnification, payment to Indemnitee shall be made within ten days after such determination. Indemnitee shall cooperate with the person, persons or entity making such determination with respect to Indemnitee’s entitlement to indemnification,
including providing to such person, persons or entity upon reasonable advance request any documentation or information which is not privileged or otherwise protected from disclosure and which is reasonably available to Indemnitee and reasonably
necessary to such determination in the discretion of the Board of Directors or Independent Counsel if retained pursuant to clause (ii)(B) of this Section 10(b). Any Expenses incurred by Indemnitee in so cooperating with the
person, persons or entity making such determination shall be borne by the Company (irrespective of the determination as to Indemnitee’s entitlement to indemnification) and the Company shall indemnify and hold Indemnitee harmless therefrom. 

  
 -7- 

 (c) The Company shall pay the reasonable fees and expenses of Independent Counsel, if one is
appointed. 
 Section 11. Presumptions and Effect of Certain Proceedings. 

(a) In making any determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such
determination shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee has submitted a request for indemnification in accordance with Section 10(a) of this Agreement, and the Company
shall have the burden of proof and the burden of persuasion by clear and convincing evidence to overcome that presumption in connection with the making of any determination contrary to that presumption. 

(b) The termination of any Proceeding or of any claim, issue or matter therein, by judgment, order, settlement or conviction, upon a plea of
nolo contendere or its equivalent, or entry of an order of probation prior to judgment, does not create a presumption that Indemnitee did not meet the requisite standard of conduct described herein for indemnification. 

(c) The knowledge and/or actions, or failure to act, of any other director, officer, employee or agent of the Company or any other director,
trustee, officer, partner, manager, managing member, fiduciary, employee or agent of any Enterprise shall not be imputed to Indemnitee for purposes of determining any other right to indemnification under this Agreement. 

(d) For purposes of this Agreement, Indemnitee shall be considered to have been wholly successful with respect to any Proceeding if such
Proceeding is disposed of, on the merits or otherwise (including a disposition without prejudice), without (i) the disposition being adverse to Indemnitee, (ii) it being Adjudged that Indemnitee was liable to the Company, (iii) a plea
of guilty by Indemnitee, (iv) it being Adjudged that an act or omission of Indemnitee was material to the matter giving rise to the Proceeding and was (A) committed in bad faith or (B) the result of Indemnitee’s active and
deliberate dishonesty, (v) it being Adjudged that Indemnitee actually received an improper personal benefit in money, property or services or (vi) with respect to any criminal proceeding, it being Adjudged that Indemnitee had reasonable
cause to believe the act or omission was unlawful. 

  
 -8- 

 Section 12. Remedies of Indemnitee. 

(a) If (i) a determination is made pursuant to Section 10(b) of this Agreement that Indemnitee is not entitled
to indemnification under this Agreement, (ii) advance of Expenses is not timely made pursuant to Section 8 or Section 9 of this Agreement, (iii) no determination of entitlement to
indemnification shall have been made pursuant to Section l0(b) of this Agreement within 60 days after receipt by the Company of the request for indemnification, (iv) payment of indemnification is not made pursuant to
Section 7 of this Agreement within ten days after receipt by the Company of a written request therefor, or (v) payment of indemnification pursuant to any other section of this Agreement or the charter or Bylaws of the
Company is not made within ten days after a determination has been made that Indemnitee is entitled to indemnification, Indemnitee shall be entitled to an adjudication in an appropriate court located in the State of Maryland, or in any other court
of competent jurisdiction, of his entitlement to such indemnification or advance of Expenses. Alternatively, Indemnitee, at his option, may seek an award in arbitration to be conducted by a single arbitrator pursuant to the Commercial Arbitration
Rules of the American Arbitration Association. Indemnitee shall commence a proceeding seeking an adjudication or an award in arbitration within 180 days following the date on which Indemnitee first has the right to commence such proceeding pursuant
to this Section 12(a); provided, however, that the foregoing clause shall not apply to a proceeding brought by Indemnitee to enforce his rights under Section 7 of this Agreement. Except as set
forth herein, the provisions of Maryland law (without regard to its conflicts of laws rules) shall apply to any such arbitration. The Company shall not oppose Indemnitee’s right to seek any such adjudication or award in arbitration. 

(b) In any judicial proceeding or arbitration commenced pursuant to this Section 12, Indemnitee shall be presumed to
be entitled to indemnification or advance of Expenses, as the case may be, under this Agreement and the Company shall have the burden of proving that Indemnitee is not entitled to indemnification or advance of Expenses, as the case may be. If
Indemnitee commences a judicial proceeding or arbitration pursuant to this Section 12, Indemnitee shall not be required to reimburse the Company for any advances pursuant to Section of this Agreement until a final
determination is made with respect to Indemnitee’s entitlement to indemnification (as to which all rights of appeal have been exhausted or lapsed). The Company shall, to the fullest extent not prohibited by law, be precluded from asserting in
any judicial proceeding or arbitration commenced pursuant to this Section 12 that the procedures and presumptions of this Agreement are not valid, binding and enforceable and shall stipulate in any such court or before any
such arbitrator that the Company is bound by all of the provisions of this Agreement. 
 (c) If a determination shall have been made pursuant
to Section l0(b) of this Agreement that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in any judicial proceeding or arbitration commenced pursuant to this Section 12,
absent a misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make Indemnitee’s statement not materially misleading, in connection with the request for indemnification that was not introduced in evidence
in connection with the determination. 

  
 -9- 

 (d) In the event that Indemnitee, pursuant to this Section 12, seeks a
judicial adjudication of or an award in arbitration to enforce his rights under, or to recover damages for breach of, this Agreement, Indemnitee shall be entitled to advancement from the Company for any and all Expenses actually and reasonably
incurred by him in such judicial adjudication or arbitration in accordance with this Agreement; provided, however, that if Indemnitee’s claim pursuant to this Section 12 is unsuccessful, then all such Expenses advanced
to Indemnitee by the Company shall be repaid by Indemnitee to the Company. 
 (e) Interest shall be paid by the Company to Indemnitee at the
maximum rate allowed to be charged for judgments under the Courts and Judicial Proceedings Article of the Annotated Code of Maryland for amounts which the Company pays or is obligated to pay for the period commencing with the date that is the tenth
day following the date on which the Indemnitee requests indemnification or advancement of Expenses in accordance with this Agreement and ending on the date such payment is made to Indemnitee by the Company. 

Section 13. Defense of the Underlying Proceeding. 

(a) Indemnitee shall notify the Company promptly in writing upon being served with any summons, citation, subpoena, complaint, indictment,
request or other document relating to any Proceeding which may result in the right to indemnification or the advance of Expenses hereunder and shall include with such notice a description of the nature of the Proceeding and a summary of the facts
underlying the Proceeding. The failure to give any such notice shall not disqualify Indemnitee from the right, or otherwise affect in any manner any right of Indemnitee, to indemnification or the advance of Expenses under this Agreement unless the
Company’s ability to defend in such Proceeding or to obtain proceeds under any insurance policy is materially and adversely prejudiced thereby, and then only to the extent the Company is thereby actually so prejudiced. 

(b) Subject to the provisions of the last sentence of this Section 13(b) and of Section l3(c) below, the
Company shall have the right to defend Indemnitee in any Proceeding which may give rise to indemnification hereunder using a law firm of the Company’s choice, subject to the prior written approval of the Indemnitee, which shall not be
unreasonably withheld or delayed; provided, however, that the Company shall notify Indemnitee in writing of any such decision to defend within 15 calendar days following receipt of notice of any such Proceeding under Section l 3(a) above.
Indemnitee shall have the right to retain a separate law firm in any such Proceeding at 

  
 -10- 

 
Indemnitee’s sole expense. The Company shall not, without the prior written consent of Indemnitee, which shall not be unreasonably withheld or delayed, consent to the entry of any judgment
against Indemnitee or enter into any settlement or compromise which (i) includes an admission of fault of Indemnitee, (ii) does not include, as an unconditional term thereof, the full release of Indemnitee from all liability in respect of
such Proceeding, which release shall be in form and substance reasonably satisfactory to Indemnitee or (iii) would impose any Expense, judgment, fine, penalty or limitation on Indemnitee. This Section l3(b) shall not apply to a
Proceeding brought by Indemnitee under Section 12 of this Agreement, a Proceeding by or in the right of the Company or in the case of clause (ii) of Section 13(c). 

(c) Notwithstanding the provisions of Section 13(b) above, if in a Proceeding to which Indemnitee is a party
(i) Indemnitee reasonably concludes, based upon an opinion of counsel approved by the Company, which approval shall not be unreasonably withheld or delayed, that he may have separate defenses or counterclaims to assert with respect to any issue
which may not be consistent with other defendants in such Proceeding, (ii) Indemnitee reasonably concludes that an actual or apparent conflict of interest or potential conflict of interest exists between Indemnitee and the Company, or
(iii) if the Company fails to assume the defense of such Proceeding in a timely manner, Indemnitee shall be entitled to be represented by separate legal counsel of Indemnitee’s choice, subject, except in the case of (ii) or (iii)
above, to the prior approval of the Company, which shall not be unreasonably withheld or delayed, at the expense of the Company. In addition, if the Company fails to comply with any of its obligations under this Agreement or in the event that the
Company or any other person takes any action to declare this Agreement void or unenforceable, or institutes any Proceeding to deny or to recover from Indemnitee the benefits intended to be provided to Indemnitee hereunder, Indemnitee shall have the
right to retain counsel of Indemnitee’s choice, at the expense of the Company (subject to Section 12(d) of this Agreement), to represent Indemnitee in connection with any such matter. 

Section 14. Jointly Indemnifiable Claims. 

(a) Given that certain Jointly Indemnifiable Claims may arise, the Company acknowledges and agrees that the Company shall, and to the extent
applicable shall cause any Enterprise to (i) be fully and primarily responsible for, and be the indemnitor of first resort with respect to, payment to or payment on behalf of the Indemnitee in respect of indemnification or advancement of
Expenses in connection with any such Jointly Indemnifiable Claim, irrespective of any right of recovery the Indemnitee may have from the Third-Party Indemnitors, and (ii) be required to advance the full amount of Expenses incurred by the
Indemnitee and shall be liable for the full amount of all Expenses, judgments, fines, penalties and amounts paid in settlement to the extent not prohibited by (and not merely to the extent affirmatively permitted by) applicable law and as required
by the terms of this Agreement, without regard to any rights the Indemnitee may have against the Third-Party Indemnitors. Under no circumstance shall the Company or any 

  
 -11- 

 Enterprise be entitled to, and the Company hereby irrevocably waives, relinquishes and releases, any claims
against the Third-Party Indemnitors for subrogation, contribution or recovery of any kind and no right of advancement or recovery the Indemnitee may have from the Third-Party Indemnitors shall reduce or otherwise alter the rights of the Indemnitee
or the obligations of the Company or any Enterprise. The Company further agrees that no advancement or payment by any Third-Party Indemnitor on behalf of Indemnitee with respect to any Proceeding for which Indemnitee has sought indemnification
rights from the Company shall affect the foregoing and the Third-Party Indemnitor(s) shall have a right to receive from the Company, contribution and/or be subrogated, to the extent of such advancement or payment to all of the rights of recovery of
Indemnitee against the Company. The Company and the Indemnitee agree that each of the Third-Party Indemnitors shall be third-party beneficiaries with respect to this Agreement entitled to enforce this Section 14 as though
each such Third-Party Indemnitor were a party to this Agreement. 
 (b) For purposes of this Agreement “Third-Party Indemnitor”
means any person or entity that has or may in the future provide to the Indemnitee any indemnification or Expense advancement rights and/or insurance benefits other than (i) the Company, (ii) any Enterprise and (iii) any entity or entities
through which the Company maintains liability insurance applicable to the Indemnitee. 
 (c) For purposes of this Agreement, “Jointly
Indemnifiable Claims” shall mean any Proceeding for which the Indemnitee shall be entitled to indemnification, advancement of Expenses or insurance from (i) the Company and/or any Enterprise pursuant to this Agreement, the charter or
Bylaws or other governing documents of the Company or any Enterprise, any agreement or a resolution of the stockholders of the Company entitled to vote generally in the election of directors or of the Board of Directors, or otherwise, on the one
hand, and (ii) any Third-Party Indemnitor pursuant to any agreement between any Third-Party Indemnitor and the Indemnitee pursuant to which the Indemnitee is indemnified, the laws of the jurisdiction of incorporation or organization of any
Third-Party Indemnitor and/or the certificate of incorporation, certificate of organization, bylaws, partnership agreement, operating agreement, certificate of formation, certificate of limited partnership or other organizational or governing
documents of any Third-Party Indemnitor, on the other hand. 

  
 -12- 

 Section 15. Non-Exclusivity;
Survival of Rights; Subrogation. 
 (a) The rights of indemnification and advance of Expenses as provided by this Agreement shall not be
deemed exclusive of any other rights to which Indemnitee may at any time be entitled under applicable law, the charter or Bylaws or other governing documents of the Company or any Enterprise, any agreement or a resolution of the stockholders
entitled to vote generally in the election of directors or of the Board of Directors, or otherwise. Unless consented to in writing by Indemnitee, no amendment, alteration or repeal of this Agreement or of any provision hereof shall limit or restrict
any right of Indemnitee under this Agreement in respect of any action taken or omitted by such Indemnitee in or by reason of his Corporate Status prior to such amendment, alteration or repeal, regardless of whether a claim with respect to such
action or inaction is raised prior or subsequent to such amendment, alteration or repeal. No right or remedy herein conferred is intended to be exclusive of any other right or remedy, and every other right or remedy shall be cumulative and in
addition to every other right or remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion of any right or remedy hereunder, or otherwise, shall not prohibit the concurrent assertion or employment of any
other right or remedy. 
 (b) Except as set forth in Section 14, in the event of any payment under this Agreement,
the Company shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers required and take all action necessary to secure such rights, including execution of such documents as are
necessary to enable the Company to bring suit to enforce such rights. 
 Section 16. Insurance. The Company will
use its reasonable best efforts to acquire directors and officers liability insurance, on terms and conditions deemed appropriate by the Board of Directors, with the advice of counsel, covering Indemnitee or any claim made against Indemnitee by
reason of his Corporate Status or by reason of alleged actions or omissions by Indemnitee in such capacity and covering the Company for any indemnification or advance of Expenses made by the Company to Indemnitee for any claims made against
Indemnitee by reason of his Corporate Status or by reason of alleged actions or omissions by Indemnitee in such capacity. Without in any way limiting any other obligation under this Agreement, the Company shall indemnify Indemnitee for any payment
by Indemnitee arising out of the amount of any deductible or retention and the amount of any excess of the aggregate of all judgments, penalties, fines, settlements and Expenses incurred by Indemnitee in connection with a Proceeding over the
coverage of any insurance referred to in the previous sentence. The purchase, establishment and maintenance of any such insurance shall not in any way limit or affect the rights or obligations of the Company or Indemnitee under this Agreement except
as expressly provided herein, and the 

  
 -13- 

 
execution and delivery of this Agreement by the Company and the Indemnitee shall not in any way limit or affect the rights or obligations of the Company under any such insurance policies. If, at
the time the Company receives notice from any source of a Proceeding to which Indemnitee is a party or a participant (as a witness or otherwise) the Company has director and officer liability insurance in effect, the Company shall give prompt notice
of such Proceeding to the insurers in accordance with the procedures set forth in the respective policies. 

Section 17. Coordination of Payments. Except as set forth in Section 14, the Company shall
not be liable under this Agreement to make any payment of amounts otherwise indemnifiable or payable or reimbursable as Expenses hereunder if and to the extent that Indemnitee has otherwise actually received such payment under any insurance policy,
contract, agreement or otherwise. 
 Section 18. Contribution. If the indemnification provided in this Agreement is unavailable in
whole or in part and may not be paid to Indemnitee for any reason, other than for failure to satisfy the standard of conduct set forth in Section 4 or due to the provisions of Section 5, then, with respect to any Proceeding in which the Company is
jointly liable with Indemnitee (or would be if joined in such Proceeding), to the fullest extent permissible under applicable law, the Company, in lieu of indemnifying and holding harmless Indemnitee, shall pay, in the first instance, the entire
amount incurred by Indemnitee, whether for Expenses, judgments, penalties, and/or amounts paid or to be paid in settlement, in connection with any Proceeding without requiring Indemnitee to contribute to such payment, and the Company hereby waives
and relinquishes any right of contribution it may have at any time against Indemnitee. 
 Section 19. Reports to
Stockholders. To the extent required by the MGCL, the Company shall report in writing to its stockholders the payment of any amounts for indemnification of, or advance of Expenses to, Indemnitee under this Agreement arising out of a Proceeding
by or in the right of the Company with the notice of the meeting of stockholders of the Company next following the date of the payment of any such indemnification or advance of Expenses or prior to such meeting. 

Section 20. Duration of Agreement; Binding Effect. 

(a) This Agreement shall be effective as of the Effective Date and may apply to acts or omissions of Indemnitee taken in or in connection with
Indemnitee’s Corporate Status which occurred prior to such date if Indemnitee was an officer, director, employee or agent of the Company or was a director, trustee, officer, partner, manager, managing member, fiduciary, employee or agent of any
Enterprise at the time such act or omission occurred. 
 (b) This Agreement shall continue until and terminate on the later of (i) the
date that Indemnitee shall have ceased to serve as a director, officer, employee or agent of the Company or as a director, trustee, officer, partner, manager, managing member, fiduciary, employee or agent of any Enterprise and (ii) the date
that Indemnitee is no longer subject to any actual or possible Proceeding (including any rights of appeal thereto and any Proceeding commenced by Indemnitee pursuant to Section 12 of this Agreement). 

(c) The indemnification and advance of Expenses provided by, or granted pursuant to, this Agreement shall be binding upon and be enforceable by
the parties hereto and their respective successors and assigns (including any direct or indirect successor by purchase, merger, consolidation or otherwise to all or 

  
 -14- 

 
substantially all of the business or assets of the Company), shall continue as to an Indemnitee who has ceased to be a director, officer, employee or agent of the Company or a director, trustee,
officer, partner, manager, managing member, fiduciary, employee or agent of any Enterprise, and shall inure to the benefit of Indemnitee and his spouse, assigns, heirs, devisees, executors and administrators and other legal representatives. 

(d) The Company shall require and cause any successor (whether direct or indirect by purchase, merger, consolidation or otherwise) to all,
substantially all or a substantial part, of the business and/or assets of the Company, by written agreement in form and substance satisfactory to Indemnitee, expressly to assume and agree to perform this Agreement in the same manner and to the same
extent that the Company would be required to perform if no such succession had taken place. 
 (e) The Company and Indemnitee agree herein
that a monetary remedy for breach of this Agreement, at some later date, may be inadequate, impracticable and difficult of proof, and further agree that such breach may cause Indemnitee irreparable harm. Accordingly, the parties hereto agree that
Indemnitee may enforce this Agreement by seeking injunctive relief and/or specific performance hereof, without any necessity of showing actual damage or irreparable harm and that by seeking injunctive relief and/or specific performance, Indemnitee
shall not be precluded from seeking or obtaining any other relief to which he may be entitled. Indemnitee shall further be entitled to such specific performance and injunctive relief, including temporary restraining orders, preliminary injunctions
and permanent injunctions, without the necessity of posting bonds or other undertakings in connection therewith. The Company acknowledges that, in the absence of a waiver, a bond or undertaking may be required of Indemnitee by a court, and the
Company hereby waives any such requirement of such a bond or undertaking. 
 Section 21.
Section 409A. It is intended that any indemnification payment or advancement of Expenses made hereunder shall be exempt from Section 409A of the Internal Revenue Code of 1986, as amended, and the guidance issued
thereunder (“Section 409A”) pursuant to Treasury Regulation Section l .409A-l (b)(10). Notwithstanding the foregoing, if any indemnification payment or advancement of Expenses made hereunder
shall be determined to be “nonqualified deferred compensation” within the meaning of Section 409A, then (i) the amount of the indemnification payment or advancement of Expenses during one taxable year shall not affect the amount
of the indemnification payments or advancement of Expenses during any other taxable year, (ii) the indemnification 

  
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payments or advancement of Expenses must be made on or before the last day of the Indemnitee’s taxable year following the year in which the expense was incurred, and (iii) the right to
indemnification payments or advancement of Expenses hereunder is not subject to liquidation or exchange for another benefit. 

Section 22. Severability. If any provision or provisions of this Agreement shall be held to be invalid, illegal or
unenforceable for any reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of this Agreement (including, without limitation, each portion of any Section, paragraph or sentence of this Agreement containing
any such provision held to be invalid, illegal or unenforceable that is not itself invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby and shall remain enforceable to the fullest extent permitted by law;
(b) such provision or provisions shall be deemed reformed to the extent necessary to conform to applicable law and to give the maximum effect to the intent of the parties hereto; and (c) to the fullest extent possible, the provisions of
this Agreement (including, without limitation, each portion of any Section, paragraph or sentence of this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is not itself invalid, illegal or unenforceable)
shall be construed so as to give effect to the intent manifested thereby. 
 Section 23. Identical Counterparts.
This Agreement may be executed in one or more counterparts, each of which shall for all purposes be deemed to be an original but all of which together shall constitute one and the same Agreement. One such counterpart signed by the party against whom
enforceability is sought shall be sufficient to evidence the existence of this Agreement. 
 Section 24. Headings.
The headings of the paragraphs of this Agreement are inserted for convenience only and shall not be deemed to constitute part of this Agreement or to affect the construction thereof. 

Section 25. Modification and Waiver. No supplement, modification or amendment of this Agreement shall be
binding unless executed in writing by both of the parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof (whether or not similar) nor, unless otherwise
expressly stated, shall such waiver constitute a continuing waiver. 
 Section 26. Notices. All notices,
requests, demands and other communications hereunder shall be in writing and shall be deemed to have been duly given if (i) delivered by hand and receipted for by the party to whom said notice or other communication shall have been directed or
(ii) mailed by certified or registered mail with postage prepaid, on the third business day after the date on which it is so mailed: 

  
 -16- 

 (a) If to Indemnitee, to the address set forth on the signature page hereto. 

(b) If to the Company, to: 

Spirit MTA REIT 
 2727 N.
Harwood Street, Suite 300 
 Dallas, TX 75201 

Attn: Jay Young, General Counsel 
 or to such
other address as may have been furnished in writing to Indemnitee by the Company or to the Company by Indemnitee, as the case may be. 

Section 27. Governing Law. The parties agree that this Agreement shall be governed by, and construed and enforced in
accordance with, the laws of the State of Maryland, without regard to its conflicts of laws rules. 
 Section 28.
Miscellaneous. Use of the masculine pronoun shall be deemed to include usage of the feminine pronoun where appropriate. 
 [SIGNATURE
PAGE FOLLOWS] 

  
 -17- 

 EXHIBIT A 

FORM OF UNDERTAKING TO REPAY EXPENSES ADVANCED 

The Board of Directors of Spirit MTA REIT (SMTA) 
 Re:
Undertaking to Repay Expenses Advanced 
 Ladies and Gentleman, 

This undertaking is being provided pursuant to that certain Indemnification Agreement dated
                    by and between SMTA and the undersigned Indemnitee (“Indemnification Agreement”) pursuant to which I am entitled
to advance Expenses in connection with [DESCRIPTION OF PROCEEDINGS] (the “Proceeding”). 
 Terms used herein and not
otherwise defined shall have the meanings specified in the Indemnification Agreement. 
 I am subject to the Proceeding by reason of my
Corporate Status or by reason of alleged actions or omissions by me in such capacity. I hereby affirm my good belief that at all times, insofar as I was involved as [a director] [an officer] of the Company, in any of the facts or
events giving rise to the Proceeding, I (1) did not act with bad faith or active or deliberate dishonesty, (2) did not receive any improper personal benefit in money, property or services and (3) in the case of any criminal proceeding, had
no reasonable cause to believe that any act or omission by me was unlawful. 
 In consideration of the advance of Expenses by the Company
for reasonable attorneys’ fees and related Expenses incurred by me in connection with the Proceeding (the “Advanced Expenses”), I hereby agree that if, in connection with the Proceeding, it is established that (1) an act
or omission by me was material to the matter giving rise to the Proceeding and (a) was committed in bad faith or (b) was the result of active and deliberate dishonesty or (2) I actually received an improper personal benefit in money,
property or services or (3) in the case of any criminal proceeding, I had reasonable cause to believe that the act or omission was unlawful, then I shall promptly reimburse the portion of the Advanced Expenses relating to the claims, issues or
matters in the Proceeding as to which the foregoing findings have been established. 

 IN WITNESS WHEREOF, I have executed this Affirmation and Undertaking on this
        day of                 20  

 

	
	
	   

	
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