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.

5

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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.

9

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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.

10

--------------------------------------------------------------------------------

 

 

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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

34