Exhibit 10.8

 

[***] Certain information in this document has been excluded pursuant to
Regulation S-K, Item 601(b)(10). Such excluded information is not material and
would likely cause competitive harm to the registrant if publicly disclosed.

 

CONFIDENTIAL

 

 

COMMERCIAL PACKAGING AGREEMENT

This Commercial Packaging Agreement (“Agreement”) is made as of this 11th day of
November, 2019 (“Effective Date”), by and among Aimmune Therapeutics, Inc., a
Delaware corporation, with a place of business at 8000 Marina Blvd., Suite 300,
Brisbane, CA  94005 and/or any Affiliate as may become a party to this Agreement
or subsequent assignee (“Client”), and AndersonBrecon Inc., an Illinois
corporation, doing business as PCI of Illinois, with a place of business at 4545
Assembly Drive, Rockford, IL 61109 (“PCI-US”), and Millmount Healthcare Limited,
with an address at Block 7, City North Business Campus, Stamullen Hall,
Stamullen, Co. Meath, Ireland (“PCI-Ireland” and, together with PCI-US, “PCI”).

RECITALS

A.

Client is a pharmaceutical company that develops, markets and sells
pharmaceutical products, including Client’s proprietary pharmaceutical product
AR101 for the treatment of peanut allergy (“Palforzia”);

B.

PCI specializes in packaging for the pharmaceutical industry and has certain
technical and commercial information and know-how relating to, among other
things, performing packaging and labeling of pharmaceutical and other products,
into various sized primary and secondary containers; and

C.

Client desires to engage PCI to provide certain commercial packaging and
labeling services to Client, and PCI desires to provide such services, all
pursuant to the terms and conditions set forth in this Agreement.

THEREFORE, in consideration of the mutual covenants, terms and conditions set
forth below, the parties agree as follows:

Article 1
DEFINITIONS

The following terms have the following meanings in this Agreement:

1.1“Affiliate(s)” means, with respect to PCI, Client or any third party, any
corporation, firm, partnership or other entity that controls, is controlled by
or is under common control with such entity.  For the purposes of this
definition, “control” shall mean the ownership of at least 50% of the voting
share capital of an entity or any other comparable equity or ownership interest.

 

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1.2“Applicable Laws” means (i) all laws, ordinances, rules and regulations, as
amended from time to time, of all countries in the Territory, applicable to the
Packaging or any aspect thereof and the obligations of PCI or Client, as the
context requires, under this Agreement, including but not limited to cGMP and
the FD&C Act, and (ii) any applicable laws, rules and regulations of any other
foreign jurisdiction in the Territory, including but not limited to any cGMP and
FD&C Act equivalents.

1.3“Authorization(s) to Package” means a document, signed by a Client
representative or designee and provided to PCI prior to the commencement of
Packaging of Bulk Product, indicating such Bulk Product has been authorized to
be Packaged.

1.4“Authorization to Transfer” means a document, signed by a Client
representative or designee and provided to PCI, authorizing PCI to transfer the
Packaged Product from a Facility.

1.5“Batch” means a defined quantity of Bulk Product that has been or is being
Packaged in accordance with the Specifications.

1.6“Bulk Product” means Palforzia in bulk and work in process form that is
specified in the Quality Agreement, or such other product included by amendment
in the Quality Agreement.

1.7“Business Day” means any day other than a Saturday, Sunday or a national
holiday in the United States.

1.8“Certificate(s) of Analysis” means a certificate indicating the Bulk
Product’s conformance to the applicable Specifications, signed by a Client
representative or designee and provided to PCI prior to the commencement of
Packaging of such Bulk Product.

1.9“Certificate(s) of Conformance” means, with respect to a Client-supplied
Material other than Bulk Product, a certificate indicating such Client-supplied
Material’s conformance with all required testing and other applicable
Specifications, signed by a representative of the supplier of such material and
provided to PCI prior to the commencement of Packaging using such material.

1.10“Certificate(s) of Release” means a certificate indicating that the
Packaging conforms with the Specifications, signed by a PCI representative and
provided to Client following the completion of Packaging in accordance with the
Quality Agreement.

1.11“cGMP” means all applicable laws, regulations and standards of the countries
within the Territory relating to the Packaging including but not limited to, the
FDA current Good Manufacturing Practices, as set forth in the Title 21 of the
United States Code of Federal Regulations, and any current Good Manufacturing
Practices of the Health Products Regulatory Authority of Ireland (HPRA) as such
regulations and guidelines may be revised from time to time and equivalent
non-U.S. regulations solely to the extent such other non-U.S. jurisdictions are
otherwise included in the definition of “Applicable Laws.”

1.12“Client” has the meaning set forth in the introductory paragraph, or any
successor or permitted assign.

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1.13“Client Indemnitees” has the meaning set forth in Section 14.1.

1.14“Client Intellectual Property” means all Intellectual Property and
embodiments thereof owned by or licensed to Client as of the Effective Date or
after by Client.

1.15“Client Inventions” has the meaning set forth in Section 12.3

1.16“Client Material Loss” has the meaning set forth in Section 3.1(h).

1.17“Client-supplied Materials” means any materials to be supplied by or on
behalf of Client to PCI for Packaging, as provided in the Quality Agreement,
including Bulk Product, artwork and labeling.

1.18 “Confidential Information” has the meaning set forth in Section 11.2.

1.19“Contract Year means, except for the period ending December 31, 2019, each
twelve (12) month period during the Term of this Agreement, commencing on
January 1st and ending on the following December 31st.  The initial Contract
Year shall mean that period beginning on the Effective Date and ending on
December 31, 2019.

1.20 “Defective Packaging” has the meaning set forth in Section 6.1(a).

1.21“Delivery Date(s)” has the meaning set forth in Section 5.3(b).

1.22“Effective Date” has the meaning set forth in the introductory paragraph.

1.23“Equipment” shall mean the machines, tooling and other equipment owned by
Client and located at a Facility as agreed to from time to time by the Parties
in writing; for clarification to the extent not agreed in writing any [***].

1.24“Exception Notice” has the meaning set forth in Section 6.1(a).

1.25“Excess Loss” has the meaning set forth in Section 3.1(i).

1.26“Facility” means PCI’s facilities located in [***] and such other facility
as agreed in writing by the parties.  

1.27“FDA” means the United States Food and Drug Administration or any successor
Regulatory Authority having substantially the same function.

1.28“FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as
amended or supplemented from time to time.

1.29“Firm Commitment” has the meaning set forth in Section 5.2(a).

1.30“Initial Term” has the meaning set forth in Section 17.1.

1.31“Intellectual Property” means all intellectual property (whether or not
patented or registered), including without limitation, brands, patents, patent
applications, formulae, know-how, trade secrets, copyrights, trademarks,
trademark applications, trade names, trade dress,

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trade secrets, industrial designs, equipment and tooling designs, other designs,
concepts, technical information, manuals, standard operating procedures,
instructions, specifications, inventions, processes, data, improvements and
developments.

1.32“Ireland Quality Agreement” has the meaning set forth in Section 10.8.

1.33“Inventions” has the meaning set forth in Section 12.3.

1.34“Latent Defect” has the meaning set forth in Section 6.1(a).

1.35“Loss Allowance” has the meaning set forth in Section 3.1(g).

1.36“Losses” has the meaning set forth in Section 14.1.

1.37 “Minimum Requirement” has the meaning set forth in Section 5.1.

1.38“Other Related Services” has the meaning set forth in Section 2.2.

1.39“Package” or “Packaging” or “Packaged” means the packaging of Bulk Product
and labeling the packages which contain the Bulk Product in accordance with the
Specifications.

1.40“Packaged Product” means the finished product resulting from the Packaging
performed by PCI under this Agreement.

1.41“PCI” has the meaning set forth in the introductory paragraph, or any
successor or permitted assign.

1.42 “PCI Indemnitees” has the meaning set forth in Section 14.2.

1.43“PCI Intellectual Property” means all Intellectual Property and embodiments
thereof owned by or licensed to PCI as of the Effective Date or after by PCI.

1.44“Permitted Subcontractor” has the meaning set forth in Section 2.3.

1.45“Pricing” has the meaning set forth in Section 8.1(a).

1.46“Purchase Order” has the meaning set forth in Section 5.3(a).

1.47“Qualified Person” has the meaning set forth in Section 10.9(a).

1.48“Qualified Person Services” has the meaning set forth in Section 10.9.

1.49“Quality Agreement” has the meaning set forth in Section 10.8.

1.50“Raw Materials” means all raw materials, supplies, components and packaging
necessary to Package and ship Packaged Product in accordance with the
Specifications, as provided in the Quality Agreement, but not including
Client-supplied Materials.

1.51“Recall” has the meaning set forth in Section 10.6.

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1.52“Records” has the meaning set forth in Section 10.2.

1.53“Regulatory Approval” means all approvals, permits, product and/or
establishment licenses, registrations or authorizations, from the applicable
Regulatory Authority that are necessary or advisable in connection with the
development, manufacture, testing, use, storage, exportation, importation,
transport, promotion, marketing, distribution or sale of Packaged Product, along
with satisfaction of any related applicable regulatory requirements.

1.54“Regulatory Authority” means any federal, state or local governmental or
regulatory bodies, agencies, departments, bureaus, courts or other entities in
the United States (including the FDA), Ireland and in any other country of the
Territory that is responsible for (A) the regulation (including pricing) of any
aspect of pharmaceutical or medicinal products intended for human use or (B)
health, safety or environmental matters generally.

1.55 “Representatives” has the meaning set forth in Section 11.1.

1.56“Review Period” has the meaning set forth in Section 6.1(a).

1.57“Rolling Forecast” has the meaning set forth in Section 5.2(a).

1.58“Specifications” means the procedures, requirements, standards, quality
control testing and other data and the scope of services as set forth in in the
Quality Agreement along with any valid amendments or modifications thereto, in
accordance with Article 9.  

1.59“Supplier” has the meaning set forth in Section 3.3(a).

1.60“Term” has the meaning set forth in Section 17.1.

1.61“Territory” means the countries or territories listed on Attachment A, which
the parties may update by mutual written consent from time to time.

1.62“US Quality Agreement” has the meaning set forth in Section 10.8.

Article 2
PROCESSING & RELATED SERVICES

2.1Supply and Purchase of Packaging.  PCI shall Package Bulk Product in
accordance with the Specifications, Applicable Laws and the terms and conditions
of this Agreement for the consideration provided herein.  Client shall be
responsible for the manufacturing and testing of Bulk Products, testing of
Packaged Products (except to the extent PCI expressly provides testing pursuant
to this Agreement), and sale and distribution of the Packaged Product.

2.2Other Related Services.  PCI shall provide such related services (including
tooling purchases and non-routine repair; analytical work; stability; auditing
of Suppliers (as contemplated by Section 3.3(c)); and retain storage) other than
Packaging, as agreed to in writing by the parties from time to time (“Other
Related Services”).  Such writing shall include the scope and fees for any such
services and be appended to this Agreement.  The terms and

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conditions of this Agreement shall govern and apply to such services, including
repair and other services provided under Article 4.

2.3Subcontracting. PCI may subcontract its obligations under this Agreement in
whole or in part to third parties, only upon prior written consent of Client
(each such approved subcontractor, a “Permitted Subcontractor”), such approval
not to be unreasonably withheld or delayed. Each Permitted Subcontractor shall
be listed in Attachment C and the work to be performed by such Permitted
Subcontractor shall be specifically and explicitly set forth in such Attachment
C.  PCI shall at all times remain liable for such Permitted Subcontractor’s
performance of Packaging under this Agreement. PCI hereby expressly waives any
requirement that Client exhaust any right, power or remedy, or proceed against a
Permitted Subcontractor, for any obligation or performance hereunder prior to
proceeding directly against PCI.  A subcontractor shall not include any provider
of components for the Packaging.  

Article 3
MATERIALS

3.1Client-Supplied Materials.

(a)Supply.  Client or a supplier on Client’s behalf shall supply to PCI for
Packaging, [***] Client-supplied Materials, including Bulk Product, in
quantities sufficient to meet Client’s requirements for Packaging, as set forth
in Article 5.  Client shall deliver or cause to be delivered such items,
together with associated Certificates of Analysis, Certificates of Conformance,
lot numbers, expiration dates and Authorizations to Package to a Facility no
later than [***] ([***]) [***] before, but not earlier than [***] ([***]) [***]
before, the Delivery Date for the Packaged Product in which such items will be
used by PCI.  If PCI fails to receive the foregoing on a timely basis, PCI shall
have the right to (i) [***]; or (ii) [***]; or (iii) [***].  The preceding
supply schedule for Client-supplied Materials may be adjusted upon mutual
agreement of the parties if Client is launching a new product.  PCI shall use
such items solely and exclusively for Packaging hereunder.  Prior to first
delivery of any such items, Client shall provide to PCI a copy of all associated
material safety data sheets, safe handling instructions and health and
environmental information, and shall promptly provide any updates, or revisions
thereto.

(b)Conformity.  Within [***] ([***]) [***] of receipt of Client-supplied
Materials by PCI, PCI shall confirm that the labels on such items conform to
their accompanying packing slip, including [***]. Unless otherwise expressly
required by the Specifications, PCI shall have no obligation to test such items
to confirm that they meet the associated Specifications, Certificate of Analysis
or Certificate of Conformance or otherwise; but in the event that PCI detects a
nonconformity with Specifications, PCI shall give Client prompt notice of such
nonconformity.  PCI shall not be liable for any defects in Client-supplied
Materials, or in Packaging or Packaged Product as a result of defective
Client-supplied Materials, unless PCI failed to properly perform the foregoing
obligations.  PCI shall follow Client’s reasonable written instructions in
respect of return or disposal of defective Client-supplied Materials, [***].

(c)Customs. Unless otherwise agreed in writing between the parties, Client shall
be solely responsible for the proper release and clearance of Client-supplied
Materials to be provided by Client or a Supplier for [***] and foreign customs
purposes, including any return

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thereof required by any Regulatory Authority following improper or unauthorized
release, and Client acknowledges that it is the owner of such items for customs
purposes.  If PCI and Client agree in writing that PCI will act as the importer
of record for Client-supplied Materials in a particular jurisdiction [***], PCI
shall charge administrative fees for such services as set out in an attachment
to this Agreement or a quotation signed by both Client and PCI, and pass through
to Client any and all [***] relating to the importation of the Client-supplied
Materials. [***]. PCI shall have no responsibility, liability or further
obligation if Client-supplied Materials are not approved or released from
customs except to the extent such action is proximately caused by PCI’s
[***].  PCI shall have no obligation to take any pre- or post-customs release
action, including obtaining binding rulings, advising of liquidation or filing
petitions or protests. If PCI is not acting as the importer of record for
Client-supplied Materials, Client shall reimburse PCI for [***] incurred by PCI
relating to the importation of the Client-supplied Materials.  Notwithstanding
anything to the contrary herein, if any delay in customs clearance or release of
any Client-supplied Materials occurs such that PCI cannot supply the quantity of
Packaged Product to Client by the Delivery Dates specified in accepted Purchase
Orders, then PCI shall not be obligated to supply Packaged Product to Client
hereunder until full and proper customs clearance or release is obtained by
Client.

(d)Title and Risk of Loss for Client-supplied Materials.  Title and risk of loss
to Client-supplied Materials shall remain with [***] while such items are [***]
and for the duration of the [***].  PCI’s liability for any loss to such
Client-supplied Materials shall be [***] as set forth in Section 3.1(h).  Client
shall obtain and maintain insurance for Client-supplied Materials in accordance
with Section 16.1.

(e)Artwork and Packaging.  Client shall provide or approve, prior to the
procurement of applicable components, all artwork, advertising and packaging
information necessary for Packaging.  Such artwork, advertising and packaging
information is and shall remain the exclusive property of Client, and Client
shall be solely responsible for the content thereof.  Such artwork, advertising
and packaging information or any reproduction thereof may not be used by PCI in
any manner other than performing its obligations hereunder.  PCI requires no
less than [***] ([***]) [***] notice of changes in artwork, advertising and
packaging information; provided, however, that PCI will work with Client in good
faith to expedite copy changes on a quicker basis.  If Client provides PCI with
less notice of changes in artwork, advertising and packaging information, PCI
shall not be responsible for any delay in the delivery of Packaged Products to
which such changes apply.

(f)Expired Client-Supplied Materials.  Client will be required to dispose of any
Client-supplied Materials that have expired within [***] ([***]) [***] of such
expiration.  PCI will manage destruction of such expired Client-supplied
Materials if requested by Client and will invoice Client for the costs
thereof.  Notwithstanding anything to the contrary herein, PCI reserves the
right to [***].

(g)Loss Allowance.  For each type of Packaged Product, the parties will mutually
determine an annual allowance for Bulk Product and other Client-supplied
Materials that are not converted to Packaged Product (“Loss Allowance”).  With
respect to each type of Packaged Product, the initial Loss Allowance for each
product shall be established by good faith negotiation between Client and PCI
after the first [***] packaging lots following the validation campaign,
instructed by data from such packaging Batches.  The Loss Allowance shall be

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adjusted in the event of any changes to the Specifications, including without
limitation any changes to the Bulk Product.  If the parties do not agree, PCI
will determine a commercially reasonable Loss Allowance.

(h)Liability for Loss.  PCI’s liability for loss or damage to Client-supplied
Materials is limited to: (i) [***] (ii) [***] or (iii) [***] (collectively,
“Client Material Loss”).  When calculating the amount of Client Material Loss,
the following shall not be counted as issued to the line for Packaging: (i)
[***] (ii) [***] and (iii) [***]. For clarification, the expectation of the
parties is that Pricing is based upon [***]; PCI is obligated to deliver such
amounts of Packaged Products to meet Client’s Purchase Orders and the related
tier notwithstanding Client Material Loss that may be incurred.

(i)Annual Reconciliation of Excess Loss; Reimbursement.  Within [***] ([***])
[***] following the end of each Contract Year, PCI will perform a reconciliation
for each type of Packaged Product for the prior Contract Year and will calculate
for applicable Client-supplied Materials (i) the Client Material Loss and (ii)
the amount, if any, by which the Client Material Loss exceeds the Loss Allowance
(such excess referred to as the “Excess Loss”).  PCI will reimburse Client for
Excess Loss, if any, at the lesser of (i) [***] or (ii) [***], in either case
subject to the limitation set forth in Section 15.1.  For purposes of this
Section 3.1(i), “cost” shall mean (i) [***] and (ii) [***].

(j)Inventory Management. In accordance with its standard operating procedures,
PCI shall provide, upon reasonable request by the Client, physical copies of
inventory management details to the Client regarding Raw Materials, artwork and
Client-supplied Materials.  

3.2Raw Materials.

(a)Procurement.  PCI shall be responsible for procuring, inspecting and
releasing adequate Raw Materials as necessary to meet the Firm Commitment,
unless otherwise agreed to by the parties in writing.  PCI shall rely on the
Firm Commitment for purchasing Raw Materials for use in the Packaged Products
forecasted. To the extent practicable, PCI will procure Raw Materials on a [***]
basis based on projected [***] requirements in an effort to reduce costs of such
components and materials.  Notwithstanding anything to the contrary herein, if
the lead time necessary to acquire Raw Materials is greater than [***] ([***])
[***], PCI shall submit orders for such Raw Materials based on the Rolling
Forecast in a timely manner, and [***].  In the event that the quantity of
Packaged Products in any Rolling Forecast provided by Client pursuant to Article
5 decreases or increases by [***] percent ([***]%) from one Rolling Forecast to
the next, PCI reserves the right (i) [***] and (ii) in accordance with Section
8.2, [***].

(b)Title and Risk of Loss for Raw Materials.  Title and risk of loss with
respect to the Raw Materials used for the Packaged Products will remain with PCI
until PCI delivers Packaged Products to a common carrier for shipment to Client.

(c)Reimbursement for Raw Materials.  In the event of (i) a Specification change
for any reason, (ii) obsolescence of any Raw Material or (iii) further to
Article 17, termination or expiration of this Agreement, Client shall bear the
cost of any unused Raw

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Materials plus [***]% so long as PCI purchased such Raw Materials in quantities
consistent with [***].  Payment will be due within [***] ([***]) [***] of
Client’s receipt of PCI’s invoice.

(d)Storage.  After [***] ([***]) [***], Raw Materials (solely to the extent
purchased consistent with Section 3.2(a) based upon the Firm Commitment and
Rolling Forecast and provided that there are no outstanding Purchase Orders to
use such Raw Materials within [***] ([***]) [***]) or Client-supplied Materials,
including Bulk Product, held in inventory will be subject to storage and
carrying cost as [***].

3.3Mandated Supplier.

(a)Use of Supplier.  In certain instances, Client may require a specific
supplier, manufacturer or vendor (“Supplier”) to be used for Raw Materials or to
furnish Client-supplied Materials.  In such an event, (i) such Supplier will be
identified in the Specifications or otherwise in writing, (ii) Client shall be
responsible for the timeliness, quantity and quality of supply of Raw Materials
or Client-supplied Materials from such Supplier, (iii) PCI shall not be liable
for any defects in Raw Materials or Client-supplied Materials from such
Supplier, or in Packaging or Packaged Product as a result of such defective Raw
Materials or Client-supplied Materials, unless PCI failed to properly perform
any testing required by the Specifications, and (iv) Raw Materials from such
Supplier shall be deemed, for all purposes hereunder including required supply
schedule and liability, Client-supplied Materials.  If a Supplier fails to
deliver the appropriate quantity and quality of Raw Materials or Client-supplied
Materials on the required supply schedule and PCI is unable to resolve the issue
with Supplier, PCI shall so notify Client of such supply issue and Client shall,
to the extent practicable, have a discussion with the Supplier in an effort to
resolve such failure.  Client shall have no obligation to continue such
discussion with the Supplier following the initial discussion or after such
offer of an initial discussion, if the Supplier refuses such discussion.  If a
Supplier refuses such discussion or fails to supply PCI with Raw Materials or
Client-supplied Materials such that PCI cannot supply Packaged Product to
Client, then, to the extent of such failure, PCI shall not be obligated to
supply Packaged Product to Client hereunder until such failure to supply is
remedied, either with the Supplier or with an alternate supplier.

(b)Costs. If the cost of the Raw Material from any such Supplier is greater than
PCI’s costs for the same raw material of equal quality from other suppliers,
[***].  Client will be responsible for [***] associated with qualification of
any such Supplier that has not been previously qualified (as described in
Section 3.3(c)) by PCI.

(c)Qualification. Client acknowledges and agrees that any Supplier mandated by
Client (i) [***] and (ii) prior to the delivery of any Raw Materials or
Client-supplied Materials by such Supplier to a Facility, must pass either (A)
the quality audit conducted by PCI or, (B) if Client acknowledges in writing to
PCI no later than [***] ([***]) [***] after selection of the Supplier that
Client shall be solely responsible for conducting all quality audits of such
Supplier, the quality audit conducted by Client.   Notwithstanding anything to
the contrary herein, Client further acknowledges and agrees that PCI shall not
be required to utilize or contract with any Supplier that fails to meet the
foregoing [***] audit requirements.

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Article 4
EQUIPMENT

4.1PCI shall procure on behalf of Client the Equipment.  The Equipment will be
dedicated solely to Client’s Products.  The Equipment will be owned and risk of
loss maintained by [***] and located in the applicable PCI Facility agreed to by
the parties from time to time in writing.  PCI shall be responsible to maintain
and operate Equipment in accordance with commercially reasonable business
practice, including routine repair and maintenance.  In the case of Equipment
[***], both Client and PCI will assess associated costs and agree on the final
cost that will be paid by [***].  

4.2PCI shall use the Equipment only for performing packaging and storage
processes for Client.  PCI may not use the Equipment for any other purpose.  PCI
shall negotiate cost and obtain prior written approval from Client in writing
before using the Equipment for any other purposes.

4.3  PCI shall use [***] to maintain all Equipment in good working order. Any
alterations, additions or improvements to the Equipment are considered part of
the Equipment.  Client shall own the Equipment and PCI shall maintain all
Equipment free of any liens or other encumbrances and return any Equipment to
Client promptly upon request by Client; provided, however, that if return of
Equipment is requested during the Term, the parties will negotiate in good faith
the timing of the return so as to not delay Packaging by PCI.

Article 5
MINIMUM COMMITMENT, PURCHASE ORDERS & FORECASTS

5.1 Minimum Requirement.  During each Contract Year, Client shall purchase
Packaging from PCI Ireland of at least the quantities of Bulk Product in the
form of a minimum requirement (“Minimum Requirement”) as set forth in Section
II(10) of Attachment B (Additional Payment) and from PCI-US in accordance with
the “Capacity Utilization Fee Schedule” as set forth in Section I(2) of
Attachment B and PCI shall supply such Packaging in the amounts ordered in
accordance with such Minimum Requirements and amounts ordered in accordance with
Attachment B for Client. For clarification, subject to Section 11.7, this
Agreement is non-exclusive and nothing contained herein shall prevent Client to
purchase Packaging from other suppliers, provided it meets its ordering
obligations set forth above.

5.2Forecast.  

(a)On or before the [***] ([***]) day of each [***], beginning at least [***]
([***]) [***] prior to the earliest Delivery Date, unless otherwise agreed to by
Client and PCI, Client shall furnish to PCI a written [***] rolling forecast of
the quantities of Bulk Product that Client intends to have PCI Package during
such period (“Rolling Forecast”).  The Rolling Forecast shall be submitted on a
[***] basis and in Excel spreadsheet format and shall include [***] quantity
requirements by Client Packaged Product and the proposed Delivery Date(s) (as
defined in Section 5.3(b) below). The first [***] ([***]) [***] of such Rolling
Forecast shall constitute a binding order for the quantities of Packaged Product
specified therein (“Firm Commitment”) and the following [***] ([***]) [***] of
the Rolling Forecast shall be non-binding, good faith
estimates.  Notwithstanding anything to the contrary herein, if the lead time

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necessary to schedule production is greater than [***] ([***]) [***], PCI shall
schedule production based on the Rolling Forecast in a timely manner.  In the
event PCI believes it may not be able to meet the requirements of any Rolling
Forecast, it shall notify Client within [***] ([***]) [***] of receipt of such
Rolling Forecast, and the parties shall agree in good faith appropriate
modifications to the Rolling Forecast.

(b)In recognition of higher uncertainty during the Packaged Product launch
period (first [***] ([***]) [***] after approval in each market within the
Territory) both parties agree to meet and discuss frequently ([***]) the Rolling
Forecast in good faith and review forecast variability and flexibility to react
to unplanned upsides or downsides even in the binding period to ensure
supply.  PCI hereby agrees to make available sufficient qualified personnel to
react to an increase of up to an additional [***] percent ([***]%) of the
forecasted quantities during the first [***] ([***]) [***] after each market
approval subject to component availability.

5.3Purchase Orders.

(a)From time to time as provided in this Section 5.3(a), Client shall submit to
PCI a written binding, non-cancelable purchase order for Packaging specifying
the number of Batches, in whole Batch increments, to be Packaged, the Batch size
(to the extent the Specifications permit Batches of different sizes), and the
proposed Delivery Date(s) for each Batch, (each, a “Purchase
Order”).  Concurrently with the submission of each Rolling Forecast, Client
shall submit a Purchase Order for the portion of the Firm Commitment which is
not already subject to a Purchase Order.  Purchase Orders for Packaging
quantities of Bulk Product in excess of the Firm Commitment shall be submitted
by Client at least [***] ([***]) [***] in advance of the delivery date(s)
requested in the Purchase Order.

(b)Provided that a Purchase Order is consistent with the Firm Commitment and
other terms and conditions of this Agreement, within [***] ([***]) [***]
following receipt of a Purchase Order, PCI shall issue a written acknowledgement
to Client that it accepts such Purchase Order with the proposed delivery date(s)
or reasonable alternative delivery date(s), in which event the parties shall
[***] reach mutual agreement on acceptable Delivery Date(s).  The term “Delivery
Date(s)” refers to the firm date(s), as agreed upon by the parties pursuant to
this Section 5.3(b), upon which PCI must deliver to Client or authorized agent
of Client the Packaged Products.

(c)Subject to Section 5.3(d), PCI may reject Purchase Orders in excess of the
Firm Commitment or otherwise not given in material compliance with this
Agreement.

(d)PCI shall [***] to Package Bulk Product in quantities which are up to [***]%
in excess of the quantities specified in the Firm Commitment, subject to PCI’s
other supply commitments and packaging and equipment capacity; [***].  Within
[***] ([***]) [***] of receipt of a Purchase Order for quantities of Packaged
Product in excess of the applicable Rolling Forecast, PCI will notify Client of
PCI’s capacity to supply such excess quantity.

(e)If Client fails to place Purchase Orders sufficient to satisfy the Firm
Commitment, [***].    

5.4[***]

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5.5Client’s Modification or Cancellation of Purchase Orders.  Client may modify
the Delivery Date or quantity of Bulk Product to be packaged in a Purchase Order
only by submitting a written change order to PCI at least [***] ([***]) [***] in
advance of the original Delivery Date covered by such change order.  Such change
order shall be effective and binding against PCI [***], and notwithstanding the
foregoing, Client shall remain responsible for the Firm Commitment.  In no event
shall PCI be required to incur [***] in connection with such change order or its
efforts to accommodate such a change.  Any [***] incurred by PCI shall be paid
for by Client.

5.6Unplanned Delay of Packaging.  PCI shall [***] meet the delivery obligations
of each Purchase Order, subject to the terms and conditions of this
Agreement.  PCI shall provide Client with as much advance written notice (which
may be by e-mail) as possible (and will [***] provide at least [***] ([***])
[***] advance written notice where possible) if PCI determines that any
Packaging will be delayed for any reason [***].

5.7Observation of Packaging.  In addition to Client’s audit right pursuant to
Section 10.5, Client may send a reasonable number of representatives to a
Facility to observe Packaging, upon reasonable advance written request to
PCI.  Such representatives shall abide by all PCI safety rules and other
applicable employee policies and procedures, and Client shall be responsible for
such compliance and must have the appropriate insurance in place to cover such
responsibilities.  Client shall indemnify and hold harmless PCI for any Losses
resulting from an action, omission or other activity of such representatives
while on PCI’s premises.  PCI reserves the right to require such representatives
to enter into separate confidentiality agreements directly with PCI in such
persons’ individual capacities on terms substantially similar to those set forth
in Article 11.

Article 6
TESTING; SAMPLES; RELEASE

6.1Releasing; Rejection; Inspection.    

(a)Releasing; Rejection. PCI shall provide Client or its designee with a
Certificate of Release for each Batch consistent with the requirements in the
Quality Agreement. Client shall be responsible for final release of Packaged
Product to the market.  Unless within [***] ([***]) [***] after Client’s receipt
of a Batch (“Review Period”), Client or its designee notifies PCI in writing (an
“Exception Notice”) that the Packaging of such Batch does not meet the warranty
set forth in Section 13.1(a) (“Defective Packaging”), and provides a sample of
the alleged Defective Packaging, the Packaging shall be deemed accepted by
Client and Client shall have no right to reject such Batch.  Upon timely receipt
of an Exception Notice from Client, PCI shall conduct an appropriate
investigation in its discretion to determine whether or not it agrees with
Client that the Packaging is Defective Packaging and to determine the cause of
any nonconformity.  If PCI agrees that Packaging is Defective Packaging, then
Section 6.3 shall apply.  For avoidance of doubt, where the cause of
nonconformity cannot be determined or assigned as above, Section 6.3 shall not
apply.  For the purposes of this Agreement, hidden flaws, weaknesses, or
imperfections of the Packaged Product that causes such Packaged Product to not
meet the PCI warranties set forth in Section 13.1(a) and which cannot be readily
ascertained from review of Batch documentation provided by PCI, or mere
observation or customary incoming inspection of Packaged Product at Client’s
shipping destination, shall be

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considered latent defects and be deemed Defective Packaging (each, a “Latent
Defect”).  Upon discovery of such a Latent Defect within the shelf-life of a
Packaged Product, Client shall have [***] ([***]) [***] to notify PCI and
provide an Exception Notice describing such Latent Defect and Defective
Packaging.  Latent Defects shall otherwise be subject to all other provisions,
processes and remedies as contained within Article 6.

(b)Inbound Inspection. Client shall notify PCI of any cGMP claim found during
inbound inspection of Client-supplied Materials at the distribution center
designated from time to time by Client or any discrepancy found during the
distribution process related to labeling/packaging of the Packaged Product.  PCI
shall work with Client to resolve cGMP claims or discrepancies in good faith.

6.2Discrepant Results.  In the event of a disagreement between the parties
regarding whether Packaging is Defective Packaging, which disagreement cannot be
resolved by the parties within [***] of the date of the completion of PCI’s
investigation, the parties shall cause a mutually agreeable independent third
party to review records, test data and to perform comparative tests and/or
analyses on samples of the alleged Defective Packaging and its components,
including Client-supplied Materials.  The independent party’s determination as
to whether or not Packaging is Defective Packaging and the cause of any
nonconformity shall be final and binding.  Unless otherwise agreed to by the
parties in writing, the costs associated with such testing and review shall be
borne by [***].

6.3Defective Packaging.  PCI will[***], either re-Package at its cost any Batch
of Defective Packaging (and Client shall be liable to pay for either the
rejected Batch(es) or the replacement Batch(es), but not both), or credit any
payments made by Client for such Batch.  THE FOREGOING OBLIGATION OF PCI TO
RE-PACKAGE OR CREDIT PAYMENTS MADE BY CLIENT AND REIMBURSE FOR CLIENT-SUPPLIED
MATERIALS IN THE EVENT OF EXCESS LOSS UNDER SECTION 3.1(i) SHALL BE CLIENT’S
SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PACKAGING AND IS IN
LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.    

6.4Supply of Material for Defective Packaging.  In the event PCI re-Packages
Batches of Defective Packaging pursuant to Section 6.3, Client shall supply,
[***], PCI with sufficient quantities of Client-supplied Materials in order for
PCI to complete such re-Packaging.

Article 7
DELIVERY

7.1Delivery.  PCI shall tender Packaged Product for delivery [***] (Incoterms
2010) the Facility promptly following PCI’s receipt of the Authorization to
Transfer, which shall be provided by Client no more than [***] ([***]) [***]
after PCI’s issuance of a Certificate of Release, provided, that Client’s
failure to provide the Authorization to Transfer in such timeframe shall be
deemed as authorizing PCI to tender the Packaged Product for
delivery.  Notwithstanding the prior sentence, the parties agree that
[***].  Client shall qualify at least [***] ([***]) carrier to deliver Packaged
Product; provided, that if Client does not provide such carrier, PCI may select
one.  If the Packaged Product is to be exported out of the [***], Client shall
be solely responsible for obtaining all required export or import licenses
available to the Packaged Product prior to such export or import and shall
reimburse PCI for [***] for delivery

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and transportation of Packaged Product from the applicable Facility.  PCI should
not be listed as the exporter (U.S. Principle Party in Interest) on any
documentation relating to the export out of the United States.

7.2Failure to Take Delivery; Storage.  Upon written agreement of the parties, or
if Client fails to take delivery of any Packaged Product on any scheduled
Delivery Date, PCI shall store such Packaged Product under conditions in
accordance with the Specifications as Client’s agent.  If Client or its
authorized agent fails to take delivery within [***] ([***]) [***] of the
Delivery Date, Client shall be billed $[***] per pallet of unshipped Packaged
Product at such time and thereafter on the [***] until Client or its authorized
agent releases and takes delivery of such Packaged Product.  For each such Batch
of stored Packaged Product, Client agrees that: (A) [***], (B) [***], (C) [***],
and (D) [***].  Within [***] ([***]) [***] following a written request from PCI,
Client shall provide PCI with a letter confirming items (A) through (D) of this
Section 7.2 for each Batch of stored Packaged Product.

7.3[***]. If [***] of [***] is [***] than [***] after the [***], and provided
that (i) [***] and (ii) [***] shall [***] the following [***]:

(a)[***] within [***] the [***];

(b)[***] within [***] the [***];

(c)[***] than [***] the [***].

Article 8
PAYMENTS

8.1Fees.  In consideration for PCI performing services hereunder:

(a)Client shall pay PCI the pricing for Packaging set forth on Attachment B
(“Pricing”).  All undisputed fees shall be paid within [***] ([***]) [***]
following date of invoice, which invoice shall be submitted to Client by PCI
[***].

(b)Other Fees.  Client shall pay PCI for all other fees and expenses of PCI
owing in accordance with the terms of this Agreement, including pursuant to
Sections 2.2, 5.1, 7.2 and 17.3.  All undisputed fees and expenses shall be paid
within [***] ([***]) [***] following date of invoice, which invoice shall be
submitted to Client by PCI as and when appropriate.

8.2Pricing Adjustment. The Pricing shall be adjusted following advance written
notice from PCI to Client and shall be effective on January 1st of each calendar
year of the Term as follows:  (i) labor costs shall be subject to annual
increase [***] to reflect any increase in the Producer Price Index, commodity
code [***], issued by the Bureau of Labor Statistics, United States Department
of Labor over the prior calendar year (based on the publication by the United
States Department of Labor of the PPI on or about October 15th of the prior
calendar year); (ii) cost in Raw Materials shall be subject to [***]; and (iii)
production costs shall be subject to [***].  Upon request, PCI will provide
Client with supporting evidence of the increase in PCI’s costs for Raw
Materials.  In addition, the parties acknowledge and agree that the Pricing is
based on PCI performing order runs of consistent size and frequency and that the
Pricing shall be

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subject to review and adjustment promptly following the occurrence of any
unanticipated fluctuation in order run sizes or frequency or fluctuations in
forecasted quantities as described in Sections 5.2 and 5.3.  For example, such
adjustment may include an increase in the Pricing due to reduced order run
sizes.  In addition, the parties shall negotiate in good faith changes to the
Pricing resulting from changes to Applicable Laws that are reasonably likely to
materially increase the cost of providing the Packaging.

8.3Payment Terms.  Client shall make payment in U.S. Dollars, and otherwise as
directed in the applicable invoice.  In the event payment is not received by PCI
on or before the due date, then PCI may, in addition to any other remedies
available at equity or in law, at its option, elect to do any one or more of the
following: (A) charge interest on the outstanding undisputed sum from the due
date (both before and after any judgment) at [***] percent ([***]%) per month
[***] or [***], whichever is less; (B) suspend any further performance hereunder
until such undisputed invoice is paid in full; and/or (C) terminate this
Agreement pursuant to Section 17.2(b) in the event of an unpaid undisputed
invoice.

8.4Taxes.  PCI shall bear and pay all federal, state and local taxes based upon
or measured by its net income, and all franchise taxes based upon its
corporation existence, or its general corporate right to transact business.  Any
other tax, however denominated and measured, imposed upon the Packaged Products
or Packaging or upon their storage, inventory, sales, transportation, delivery,
use or consumption shall be paid directly by Client, or if prepaid by PCI, shall
be invoiced to Client, at cost, as a separate item and paid by Client to PCI.

Article 9
CHANGES TO SPECIFICATIONS

All Specifications and any changes thereto agreed to by the parties from time to
time shall be in writing, dated and signed by the parties and, if applicable,
any such changes shall require a written amendment of the applicable Quality
Agreement to document any such changes.  Any change to the Packaging process
shall be deemed a Specification change.  No change in the Specifications shall
be implemented by PCI, whether requested by Client, requested by PCI or
requested or required by any Regulatory Authority, until the parties have agreed
in writing to such change, the implementation date of such change, and any
increase or decrease in costs, expenses or fees associated with such change
(including any change to Pricing).  PCI shall respond promptly to any request
made by Client for a change in the Specifications, and both parties shall use
commercially reasonable, good faith efforts to agree to the terms of such change
in a timely manner.  As soon as possible after a request is made for any change
in Specifications, PCI shall notify Client of the costs associated with such
change and shall provide such supporting documentation as Client may reasonably
require.  Client shall pay all costs associated with such agreed upon changes.
If there is a conflict between the terms of this Agreement and the terms of the
Specifications, this Agreement shall control. PCI reserves the right to postpone
effecting changes to the Specifications, or in the case of changes requested or
required by any Regulatory Authority postpone Packaging under this Agreement,
until such time as the parties agree to and execute the required written
amendment.

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Article 10
RECORDS; REGULATORY MATTERS

10.1Batch Records and Data.  Within [***] ([***]) [***] following the completion
of Packaging of each Batch, PCI shall provide Client with properly completed
copies of Batch records prepared in accordance with the Specifications;
provided, that if an unplanned deviation in the Packaging process occurs, PCI
shall provide such Batch records within [***] ([***]) [***] following resolution
of the unplanned deviation.

10.2Recordkeeping and Audit of Financial Records.  PCI shall maintain [***]
complete and accurate books, records, reports, financial records, accounts and
all other information relating to Packaging, including all information required
to be maintained by Applicable Laws, in accordance with PCI standard operating
procedures, and accurate records of expenses incurred sufficient to document any
expenses invoiced to Client (“Records”). All Records shall be deemed
Confidential Information. Such information shall be maintained for a period of
at least [***] ([***]) [***] from the relevant Packaged Product expiration date
or longer if required under Applicable Laws.

10.3Regulatory Compliance.  Client shall be solely responsible for and will
obtain all Regulatory Approvals associated specifically with the Packaged
Products, including any applications and amendments in connection
therewith.  Client shall use [***] to expedite and obtain all Regulatory
Approvals necessary for PCI to commence Packaging at each Facility.  PCI will be
responsible to maintain all permits and licenses required by any Regulatory
Authority with respect to each Facility generally.

10.4Governmental Inspections and Requests.  PCI shall promptly advise Client if
an authorized agent of any Regulatory Authority visits a Facility concerning the
Packaging.  PCI shall furnish to Client a copy of the relevant portions of any
report by such Regulatory Authority within [***] ([***]) [***] of PCI’s receipt
of such report.  Further, upon receipt of a Regulatory Authority request to
inspect a Facility or audit PCI’s books and records with respect to Packaging,
PCI shall notify Client, cooperate with Client, and shall provide Client with a
copy of the relevant portions of any written document received from such
Regulatory Authority, all in accordance with the Quality Agreement.  [***].

10.5Client Inspections and Audits.

(a)During the Term, up to [***] ([***]) duly-authorized employees, agents or
representatives of Client shall be granted access for a maximum of up to [***]
([***]) [***] (unless otherwise agreed to by PCI in writing) upon reasonable
prior written notice and at reasonable times during regular business hours to
(i) the portion of a Facility where PCI performs Packaging, (ii) relevant
personnel involved in Packaging and (iii) Records described in Section 10.2, in
each case solely for the purpose of [***].

(b)Client will arrange audit visits with PCI Quality Management at least [***]
([***]) [***] in advance of such visit.  Inspections shall be designed to
minimize disruption of operations at such Facility.  Client may not conduct an
inspection under this Section 10.5 more than [***] during any [***] ([***])-
[***] period; provided, that additional

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inspections may be conducted upon reasonable advance written notice in the event
there is a specific quality problem concerning Packaging.

(c)The costs incurred by Client for any [***] audit, examination or inspection
under this Section 10 will be borne by Client, except in the case of a “for
cause” audit, in which case [***].  In all instances, PCI shall be solely
responsible for its own costs, including without limitation any out-of-pocket
costs that PCI may incur in connection with any audit, examination or inspection
under this Section 10.

(d)Employees, agents and representatives of Client performing an audit or
inspection shall abide by all PCI safety rules and other applicable employee
policies and procedures, and Client shall be responsible for such compliance and
must have the appropriate insurance in place to cover such
responsibilities.  [***]  PCI reserves the right to require such representatives
to enter into separate confidentiality agreements directly with PCI in such
persons’ individual capacities on terms substantially similar to those set forth
in Article 11.

10.6Recall.  If a Regulatory Authority orders or requires the recall of any
Packaged Product supplied hereunder or if Client or PCI believes a recall, field
alert, Packaged Product withdrawal or field correction (“Recall”) may be
necessary with respect to any Packaged Product supplied under this Agreement,
the party receiving the notice from the Regulatory Authority or that holds such
belief shall promptly notify the other party in writing.  With respect to any
Recall, PCI shall provide all necessary cooperation and assistance to
Client.  Client shall provide PCI with an advance copy of any proposed
submission to a Regulatory Authority in respect of any Recall, and shall
consider in good faith any comments from PCI.  The cost of any Recall shall be
borne by Client, and Client shall reimburse PCI for expenses incurred in
connection with any Recall, in each case unless such Recall is caused solely by
[***] in which case PCI’s liability for such Recall costs and expenses is
limited to a maximum of the lesser of (i) $[***] or (ii) [***].  In addition to
the payment contemplated by the immediately preceding sentence, any
Client-supplied Materials in the Recalled Packaged Product that are destroyed or
that cannot be re-packaged shall be included in the Excess Loss calculations
under Section 3.1(i). For purposes of clarification, Recall costs and expenses
shall include, without limitation, [***].  In the event that a Packaged Product
is Recalled or Client is required to disseminate information relating to
Packaged Product covered by this Agreement, Client shall so notify PCI within
[***] so as to enable PCI to provide Client with such assistance in connection
with such Recall as may reasonably be requested by Client.  PCI will comply with
all such reasonable requests from Client.  Client shall handle exclusively the
organization and implementation of all Recalls of Packaged Products. Any such
Recall shall be implemented and administered in a manner which is appropriate
and reasonable under the circumstances and in conformity with any requests or
orders of the applicable Regulatory Authority[***].

10.7Duty to Inform.  Client shall inform PCI [***] of any important information
relating to the activity, side effects, toxicity and/or safety of the Packaged
Products that becomes known to Client during the term of this Agreement and that
is relevant to the performance of the Packaging by PCI.

10.8Quality Agreement.  Prior to the first Packaging at a relevant Facility
hereunder, the parties shall negotiate in good faith and enter into a quality
agreement. For the US such quality agreement shall be entered into
contemporaneously with this Agreement (“US Quality

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Agreement”). For Ireland the quality agreement shall be entered into prior to
any relevant orders from Ireland (the “Ireland Quality Agreement,” together with
the US Quality Agreement, the “Quality Agreement”).  References to the “Quality
Agreement” throughout this Agreement shall be deemed to refer to the Quality
Agreement relevant to the activity in question. The Quality Agreement shall in
no way determine liability or financial responsibility of the parties for the
responsibilities set forth therein.  In the event of a conflict between any of
the provisions of this Agreement and the Quality Agreement with respect to
quality-related activities, including compliance with cGMP, the provisions of
the Quality Agreement shall govern.  In the event of a conflict between any of
the provisions of this Agreement and the Quality Agreement with respect to any
commercial matters, including allocation of risk, liability and financial
responsibility, the provisions of this Agreement shall govern.

10.9Qualified Person Services. The following terms shall apply to the services
to be provided by the QP (as defined below) (“Qualified Person Services”):

(a)Designated QP.  PCI-Ireland shall provide and perform all Qualified Person
Services, through a Qualified Person designated by PCI-Ireland, who is
registered by the applicable authority in Ireland or other EU Member State
(“Qualified Person” or “QP”).  “Qualified Person” has the meaning ascribed to it
under Article 48 and 49 of Directive 2001/83/EC on the Community Code relating
to medical products for human use.

(b)Obligations of Client. Client shall at all times: (i) [***] cooperate with
PCI-Ireland and allow the designated QP [***] access to [***] personnel,
information, documentation, premises, and procedures requested by the QP which
are relevant to the performance of the Qualified Person Services; (ii) provide
[***] information to the QP necessary for PCI-Ireland to provide the Qualified
Person Services; and (iii) promptly notify PCI-Ireland of any changes to the
site of drug product manufacture and release testing and any material
non-compliance by Client or its contract manufacturers with Applicable Laws
(including without limitation cGMP) that affects or has the potential to affect
Batch certification.

(c)Obligations of PCI-Ireland.  PCI-Ireland will assure that its QP will
reasonably cooperate with Client and its licensee and any other qualified
persons designated by Client with respect to declarations for starting and
intermediate materials as well as Packaged Product release.  In addition, upon
Client’s request, PCI-Ireland and the designated QP shall provide [***].

(d)QP’s Discretion.  Client acknowledges that the designated QP is not obligated
to issue a declaration, including without limitation a declaration of cGMP
status of active substance manufacturers (“Declaration”) or release or
certification (collectively a “Release”) unless and until the QP is satisfied
that all requirements for such Declaration or Release have been met.  In no
event shall either the QP or PCI-Ireland be obligated to issue a Declaration or
Release, or rely on a Declaration or Release of another qualified person, if the
QP reasonably believes that doing so would be contrary to or violate any
Applicable Laws governing the performance of the Qualified Person Services.

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Article 11
CONFIDENTIALITY AND NON-USE

11.1Mutual Obligation.  PCI and Client each agrees that it will not use the
other party’s Confidential Information except in connection with the performance
of its obligations hereunder and will not disclose the other party’s
Confidential Information to any third party without the prior written consent of
the other party, except to the extent (i) required by Applicable Laws and (ii)
is necessary for the receiving party to conduct financings, to file or prosecute
patent applications, to prosecute or defend litigation, to comply with
Applicable Laws (including without limitation securities laws, cGMP regulations,
the FD&C Act or regulations promulgated thereunder), to prepare or submit any
filings with any Regulatory Authority relating to the Packaged Product or its
Packaging (including any BLA or MAA), to prepare for or undergo any inspections
(including a PLI or PAI) by any Regulatory Authorities for the Packaged Product,
to make any filing with the Securities and Exchange Commission or the securities
regulators of any state or other jurisdiction or otherwise to establish rights
or enforce obligations under this Agreement, but only to the extent that any
such disclosure is reasonably necessary; provided, that prior to making any such
legally required or necessary disclosure, the party making such disclosure shall
give the other party as much prior notice of the requirement for and contents of
such disclosure as is practicable under the circumstances.  Notwithstanding the
foregoing, each party may disclose the other party’s Confidential Information to
any of its Affiliates, officers, directors, employees, advisors and service
providers (“Representatives”) that (A) need to know such Confidential
Information for the purpose of performing under this Agreement, (B) are advised
of the contents of this Article 11 and (C) agree to be bound by the terms of
this Article 11.  Without prejudice to the rights and remedies otherwise
available to a party at law or in equity, the parties agree that a non-breaching
party shall be entitled to seek equitable relief by way of specific performance
and injunction or otherwise if the other party breaches or threatens to breach
any of the provisions of this Article 11.

11.2Definition.  As used in this Agreement, the term “Confidential Information”
includes all such information furnished by PCI or Client, or any of their
respective Representatives or Affiliates, to the other party or its
Representatives or Affiliates, whether furnished before, on or after the
Effective Date and furnished in any form, including written, verbal, visual,
electronic or in any other media or manner.  Confidential Information includes
all proprietary technologies, know-how, trade secrets, discoveries, inventions
and any other Intellectual Property (whether or not patented or registered),
materials and information regarding composition of matter, manufacture, handling
and storage, analyses, compilations, business or technical information and other
materials prepared by either party, or any of their respective Representatives
or Affiliates, containing or based in whole or in part on any such information
furnished by the other party or its Representatives or Affiliates.  Confidential
Information also includes the existence of this Agreement and its terms.

11.3Exclusions.  Notwithstanding Section 11.2, Confidential Information does not
include information that (A) is or becomes generally available to the public or
within the industry to which such information relates other than as a result of
a breach of this Agreement, (B) is already known by the receiving party at the
time of disclosure as evidenced by the receiving party’s written records, (C)
becomes available to the receiving party on a non-confidential basis from a
source that the receiving party reasonably believes is entitled to disclose it
on a non-confidential basis or (D) was or is independently developed by or for
the

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receiving party without reference to, use of or access to the Confidential
Information of the other party as evidenced by the receiving party’s written
records.

11.4No Implied License.  Except as expressly set forth in Section 12.1, the
receiving party will obtain no right of any kind or license under any
Confidential Information of the disclosing party, including any patent
application or patent, by reason of this Agreement.  All Confidential
Information will remain the sole property of the party disclosing such
information or data, subject to Article 12.

11.5Return of Confidential Information.  Upon expiration or termination of this
Agreement, the party receiving Confidential Information will cease its use and,
upon request, within [***] ([***]) [***] either return or destroy (and certify
as to such destruction) all Confidential Information of the other party,
including any copies thereof, except for a single copy thereof which may be
retained for the sole purpose of determining the scope of the obligations
incurred under this Agreement.  Notwithstanding the generality of the foregoing,
nothing contained herein shall be construed as requiring the destruction of
system wide back-up materials which may incidentally contain or have reference
to Confidential Information.

11.6Survival.  The obligations of this Article will terminate [***] ([***])
[***] from the expiration or termination of this Agreement, except with respect
to trade secrets, for which the obligations of this Article will continue for so
long as such information remains a trade secret under Applicable Laws.

11.7Exclusivity. During the term of this Agreement, and for a period of one (1)
year following the expiration or termination of this Agreement, PCI agrees that,
other than pursuant to this Agreement, it will not package for commercial
distribution any oral immunotherapy product for the treatment of peanut allergy.

Article 12
INTELLECTUAL PROPERTY

12.1Ownership of Client Intellectual Property; License.  All Intellectual
Property owned or controlled by Client prior to the Effective Date or developed
independently of this Agreement without use of PCI Intellectual Property or PCI
Confidential Information, including but not limited to any improvements to
Intellectual Property owned or controlled by Client, shall be the sole and
exclusive property of Client.  Client grants to PCI a non-exclusive,
non-transferable, royalty-free license to use Client Intellectual Property
solely to the extent necessary for PCI to perform its obligations under this
Agreement.  No other license to Client Intellectual Property is hereby granted.
PCI hereby agrees that it shall not assign, mortgage, pledge, grant a security
interest in, or encumber any of Client’s Equipment or Intellectual Property.

12.2Ownership of PCI Intellectual Property. All Intellectual Property owned or
controlled by PCI prior to the Effective Date or developed independently of this
Agreement [***], including but not limited to any improvements to PCI’s
proprietary packaging processes shall be the sole and exclusive property of
PCI.  PCI hereby grants to Client and its Affiliates an irrevocable, worldwide,
royalty-free, non-exclusive license under PCI Intellectual Property to use PCI
Intellectual Property solely to the extent necessary for Client to perform its
obligations under this Agreement and to distribute and sell the Packaged Product
in accordance with this

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Agreement. The foregoing license shall be sublicensable through multiple tiers
to Client’s commercial vendors to distribute and sell the Packaged Product on
behalf of Client. Except as otherwise set forth in this Agreement, no license or
other right to PCI Intellectual Property is granted to Client.

12.3Ownership of Inventions. In performing the Packaging, PCI or its employees,
independent contractors, consultants, agents or other authorized representatives
may discover or develop Intellectual Property, whether or not patentable
(collectively, the “Inventions”).  PCI and Client agree that all Inventions,
[***] that relate to Client’s proprietary products or to its Intellectual
Property shall be owned solely by Client, whether made in whole or in part by
PCI (“Client Inventions”).  All Inventions that are made by PCI that are not
Client Inventions shall be owned solely by PCI. PCI hereby assigns, and will
cause its employees, independent contractors, consultants, agents or other
authorized representatives to assign, all of its right, title and interest in
and to all Client Inventions and related Intellectual Property rights (including
enforcement rights), and shall take all necessary actions to effect such
assignment.  PCI hereby designates Client as its agent for, and grants to Client
a power of attorney, which power of attorney shall be deemed coupled with an
interest, solely for the purpose of effecting the foregoing assignment from PCI
to Client.

12.4Ownership of Deliverables.  Except as set forth in Section 12.2, all data
and information resulting from the conduct of the Packaging for Client and
required to be delivered to Client hereunder shall be the sole property of
Client and shall be subject to Client’s exclusive use, commercial or otherwise.

12.5Change in Processes.  The parties agree that the Quality Agreement shall
provide that Client shall have the right to review and approve any [***] changes
in Packaging processes utilized by PCI under this Agreement, including processes
that incorporate technologies owned by third parties.

12.6Technology Transfer.  Commencing promptly upon the effective date of
expiration or termination of this Agreement, or upon Client’s written request,
PCI shall transfer to Client and/or its designated alternative packager(s) of
Bulk Product any equipment or tooling designs and any other designs that are
unique to the Packaging of the Bulk Product (regardless of whether such designs
were made prior to or after the Effective Date) then at PCI, and shall make
PCI’s personnel reasonably available as necessary to effect an orderly transfer
to Client or such alternative supplier(s).  In the event that such designs
referenced in this paragraph include any PCI Intellectual Property, PCI hereby
grants to Client under PCI’s Intellectual Property a non-exclusive, worldwide,
irrevocable, fully paid up, royalty-free, perpetual license solely to use such
designs for the Packaging of Bulk Product and to make, have made, sell, offer to
sell or import Packaged Product. The foregoing license shall be sublicensable
through multiple tiers to Client’s commercial vendors for the Packaging of Bulk
Product and to make, have made, sell, offer to sell or import Packaged Product
on behalf of Client.

Article 13
REPRESENTATIONS AND WARRANTIES

13.1PCI.  PCI represents, warrants and undertakes to Client that:

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(a)Packaging shall be performed in accordance with Applicable Laws and in
conformance with the Specifications, this Agreement and the Quality Agreement;
provided, that PCI shall not be liable for defects attributable to
Client-supplied Materials (including artwork and labeling);

(b)it has and will maintain all rights, licenses and permits for the Facilities
necessary to perform the Packaging hereunder;

(c)the terms of this Agreement do not violate and will not cause a breach of or
a default under the terms of any other agreement to which PCI is a party or by
which it is subject or bound;

(d)neither PCI nor its representatives, employees or agents involved with the
Packaging or Other Related Services provided hereunder have been debarred
pursuant to the FD&C Act.  PCI further warrants, represents and covenants that
it shall not use in any capacity the services of any person debarred under the
FD&C Act. PCI will immediately notify Client of any allegations or
investigations of any PCI personnel regarding actual or threatened claims of
professional or research misconduct or any violation of Applicable Laws relating
to or potentially affecting Client, the Quality Agreement, this Agreement, or
the performance of the Packaging or Other Related Services hereunder or under
the Quality Agreement; and

(e)any PCI technology used by PCI for the performance of the Packaging or Other
Related Services by PCI under this Agreement, whether owned by PCI or owned by a
third party, will, to its knowledge, not violate or infringe upon any
Intellectual Property or other right (including contractual right) held by any
third person or entity.

13.2Client.  Client represents, warrants and undertakes to PCI that:

(a)the Client-supplied Materials (including artwork and labeling) shall have
been produced in accordance with and not violate Applicable Laws and shall
comply with all applicable specifications;

(b)no Client-supplied Materials shall, at the time of delivery, be (i)
adulterated or misbranded within the meaning of the FD&C Act, or any similar law
of any other jurisdiction, or (ii) an article which may not, under the
provisions of the FD&C Act, or any similar law of any other jurisdiction, be
introduced into interstate commerce;

(c)no specific safe handling instructions, health and environmental information
or material safety data sheets are applicable to any other Client-supplied
Materials, except as provided to PCI in writing by Client [***];

(d)all Packaged Product delivered to Client by PCI will be held, used and
disposed of by or on behalf of the Client in accordance with all Applicable
Laws, and Client will otherwise comply with all laws, rules, regulations and
guidelines applicable to Client’s performance under this Agreement and its use
of Packaged Product provided by PCI under this Agreement;

(e)Client will not release any Batch of Packaged Product if Client knows [***]
that Packaging does not comply with the Specifications;

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(f)Client has all necessary authority to use and to permit PCI to use pursuant
to this Agreement all Intellectual Property related to Client-supplied Materials
(including artwork and labeling), and the Packaging, including any copyrights,
trademarks, trade dress, trade secrets, patents, inventions and developments;
and

(g)the work to be performed by PCI under this Agreement, to the extent based on
Client’s Intellectual Property, products or components of Client, including
Client-supplied Materials, and information provided by Client or otherwise
caused by Client, will to its knowledge not violate or infringe upon any
trademark, trade name, copyright, patent, trade secret, trade dress or other
Intellectual Property or other right held by any person or entity.

13.3LIMITATIONS.  THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS Article
13 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY
TO THE OTHER PARTY, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS,
WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED
WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR
PURPOSE.

Article 14
INDEMNIFICATION

14.1Indemnification by PCI.  PCI shall indemnify, defend and hold harmless
Client, its Affiliates, and their respective directors, officers, employees,
representatives, and agents (“Client Indemnitees”) from and against any and all
suits, claims, losses, demands, liabilities, damages, costs and expenses
(including reasonable attorneys’ fees and reasonable investigative costs) in
connection with any suit, demand or action by any third party (“Losses”) arising
out of or resulting from (A) any breach of its representations, warranties or
obligations set forth in this Agreement; (B) any negligence or willful
misconduct by PCI; or (C) any actual or alleged infringement or violation of any
third party Intellectual Property by PCI’s packaging technology or processes; in
each case except to the extent that any of the foregoing arises out of or
results from any Client Indemnitee’s negligence, willful misconduct or breach of
this Agreement.

14.2Indemnification by Client.  Client shall indemnify, defend and hold harmless
PCI, its Affiliates, and their respective directors, officers, employees,
representatives, and agents (“PCI Indemnitees”) from and against any and all
Losses arising out of or resulting from (A) any breach of its representations,
warranties or obligations set forth in this Agreement, (B) any manufacture,
labeling, packaging, sale, promotion, distribution or use of or exposure to
Client-supplied Materials or Packaged Product, including product liability, (C)
Client’s exercise of control over the Packaging, to the extent that Client’s
instructions or directions violate Applicable Laws, (D) any actual or alleged
infringement or violation of any third party Intellectual Property by Client’s
Intellectual Property, products or components of Client, including
Client-supplied Materials, information provided by Client or otherwise caused by
Client, or (E) any negligence or willful misconduct by Client; in each case
except to the extent that any of the foregoing arises out of or results from any
PCI Indemnitee’s negligence, willful misconduct or breach of this Agreement.

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14.3Indemnification Procedures.  All indemnification obligations in this
Agreement are conditioned upon the party seeking indemnification promptly
notifying the indemnifying party of any claim or liability of which the party
seeking indemnification becomes aware (including a copy of any related
complaint, summons, notice or other instrument); provided, that failure to
provide such notice within a reasonable period of time shall not relieve the
indemnifying party of any of its obligations hereunder except to the extent the
indemnifying party is [***] prejudiced by such failure.  The indemnifying party
will assume and conduct the legal defense of the indemnified party in any suit
that could result in claims under this Article 14.  The indemnifying party will
not [***]. The indemnified party shall cooperate with the indemnifying party in
the defense of any such claim or liability and any related settlement
negotiations at the indemnifying party’s expense.

Article 15
LIMITATIONS OF LIABILITY

15.1PCI’S LIABILITY UNDER THIS AGREEMENT FOR ANY PACKAGING BATCHES GIVING RISE
TO A PARTICULAR CLAIM SHALL IN NO EVENT EXCEED [***].

15.2IN NO EVENT SHALL PCI’S TOTAL LIABILITY UNDER THIS AGREEMENT WITH RESPECT TO
ANY [***] PERIOD EXCEED [***] PAID DURING SUCH [***]-[***] PERIOD BY CLIENT TO
PCI UNDER THIS AGREEMENT.  IN NO [***] PERIOD SHALL PCI’S LIABILITY UNDER THIS
AGREEMENT EXCEED [***].

15.3NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL,
SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES, PROFITS OR DATA
ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT,
EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

15.4WITH RESPECT TO SECTIONS 15.1 AND 15.2, THE LIMITATIONS AND EXCLUSIONS OF
LIABILITY DO NOT APPLY TO ANY DAMAGES ATTRIBUTABLE TO (i) [***] OR (ii) [***].
WITH RESPECT TO SECTIONS 15.1, 15.2 AND 15.3, THE LIMITATIONS AND EXCLUSIONS OF
LIABILITY DO NOT APPLY TO ANY OF THE FOLLOWING: (i) [***]; (ii) [***]; OR (iii)
[***].

Article 16
INSURANCE

16.1By Client.  Client shall maintain (i) property insurance against the perils
of physical loss, including those generally associated with “all risk” property
insurance and theft, in amounts sufficient to protect all Client-supplied
Materials at PCI’s facility or while in transit, (ii) a commercial general
liability insurance policy covering personal injury damages with limits of
$[***] ([***] dollars) per occurrence, (iii) an umbrella liability insurance
policy with limits of $[***] ([***] dollars) per occurrence and (iv) a product
liability insurance policy with limits of $[***] ([***] dollars) per
occurrence.  Client agrees to designate PCI as an “additional insured” under
such general liability insurance policy. Client shall also carry and maintain in
force at all times relevant hereto all other insurance required by law or
statute.

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16.2By PCI.  PCI shall maintain (i) employer’s liability insurance with a limit
of not less than [***] dollars ($[***]), (ii) commercial general liability
insurance with limits of [***] dollars ($[***]) per occurrence and a general
aggregate limit of [***] dollars ($[***]), (iii) umbrella liability insurance,
in excess of the above coverage [***] with a limit per occurrence of [***]
dollars ($[***]) and an aggregate limit of [***] dollars ($[***]), and (iv)
products liability insurance exclusive of the above coverage for general
liability [***] with a per claim limit of [***] dollars ($[***]) and an
aggregate limit of [***] dollars ($[***]).

16.3General. The policies required in this Article 16 shall remain in effect
throughout the term of this Agreement and shall not be canceled or subject to
reduction or any other material modification without written notice to the other
party.  Each party may self-insure all or any portion of the required insurance
as long as, together with its Affiliates, its US GAAP net worth is greater than
$[***] or its annual EBITDA (earnings before interest, taxes, depreciation and
amortization) is greater than $[***].  Each required insurance policy, other
than self-insurance, shall be obtained from an insurance carrier with an A.M.
Best rating of at least A- VII.  If any of the required policies of insurance
are written on a claims made basis, such policies shall be maintained throughout
the Term and for a period of at least [***] thereafter.  Upon the other party’s
written request from time to time, each party shall promptly furnish to the
other party a certificate of insurance or other evidence of the required
insurance.

Article 17
TERM AND TERMINATION

17.1Term.  This Agreement shall commence on the Effective Date and shall
continue until the end of the fourth (4th) Contract Year, unless earlier
terminated in accordance with Section 17.2 (the “Initial Term”).  At the end of
the Initial Term, this Agreement shall automatically extend for successive one
(1)-year periods (such additional one (1)-year periods, together with the
Initial Term, the “Term”) unless and until one party gives the other party at
least three (3) years prior written notice of its desire to terminate as of the
end of the then-current Term.

17.2Termination.  This Agreement may be terminated immediately without further
action:

(a)by either party if 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, administrative receiver, trustee or administrator, or
makes an assignment for the benefit of creditors, or suffers or permits the
entry of any order adjudicating it to be bankrupt or insolvent and such order is
not discharged within thirty (30) calendar days, or takes any equivalent or
similar action in consequence of debt in any jurisdiction;

(b)by either party if the other party materially breaches any of the provisions
of this Agreement and such breach is not cured within thirty (30) days after the
giving of written notice requiring the breach to be remedied; provided, that in
the case of a failure of Client to make payments in accordance with the terms of
this Agreement, PCI may terminate this Agreement if such payment breach is not
cured within 30 calendar days of receipt of notice of non-payment from PCI; or

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(c)by Client for any reason or no reason upon twenty four (24) calendar months’
prior written notice to PCI; or  

(d)by either party if any required license, permit or certificate required of
the other party to perform its obligations under this Agreement is not approved
and/or issued, or is revoked, by any applicable Regulatory Authority; or

(e) by Client if Client decides to discontinue the marketing or sale of the
Packaged Product in the United States.

17.3Effect of Termination.  Expiration or termination of this Agreement shall be
without prejudice to any rights or obligations that accrued to the benefit of
either party prior to such expiration or termination.  In the event of a
termination of this Agreement:

(a)PCI shall promptly return to Client, at Client’s expense and at Client’s
direction, any remaining inventory of Client-supplied Materials and Client
Confidential Information; provided, that PCI shall have no obligation to so
return such items until all undisputed outstanding invoices sent by PCI to
Client have been paid in full.

(b)In accordance with the provisions regarding payment under this Agreement,
Client shall pay PCI all invoiced amounts outstanding hereunder, plus, upon
receipt of invoice therefore, for any (i) [***], (ii) [***], (iii) [***] and
(iv) [***] made, in connection with PCI’s performance of this Agreement, so long
as such [***] were made by PCI consistent with Client’s most recent Firm
Commitment and Client’s minimum purchase obligations.

(c)Removal of Equipment.  Upon expiration or any termination of this Agreement,
the Parties shall within [***] ([***]) [***] agree on a procedure which allows
Client to gain reasonable access to the Facilities, as Client reasonably
requires, to remove any Equipment that is owned by Client from such Facilities
(with Client [***] to access and remove such Equipment) or offer PCI to purchase
such Equipment from Client by paying Client [***]).

17.4Survival.  The rights and obligations of the parties shall continue under
Article 12 (Intellectual Property), Article 14 (Indemnification), Article 15
(Limitations of Liability), Article 18 (Notice), Article 19 (Miscellaneous);
under Article 11 (Confidentiality and Non-Use) and Article 16 (Insurance), in
each case to the extent expressly stated therein; and under Sections 3.1(h)
(Liability for Loss), 3.1(i) (Annual Reconciliation of Excess Loss;
Reimbursement), 6.2 (Discrepant Results), 6.3 (Defective Packaging), 8.3
(Payment Terms), 8.4 (Taxes), 10.2 (Recordkeeping), 10.6 (Recall), 13.3
(Limitations on Warranties), 17.3 (Effect of Termination) and 17.4 (Survival),
in each case in accordance with their respective terms if applicable,
notwithstanding expiration or termination of this Agreement.

Article 18
NOTICE

All notices and other communications hereunder shall be in writing and shall be
deemed given: (A) when delivered personally; (B) when delivered by facsimile
transmission (receipt verified); (C) when received or refused, if mailed by
registered or certified mail (return receipt requested), postage prepaid; or (D)
when delivered if sent by express courier service, to the parties at the
following addresses (or at such other address for a party as shall be specified
by

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like notice; provided, that notices of a change of address shall be effective
only upon receipt thereof):

To Client:

Aimmune Therapeutics, Inc.

8000 Marina Blvd., Suite 300

Brisbane, CA  94005
Attn:  [***]

[***]
With a copy to: [***]

 

To PCI:

3001 Red Lion Road
Philadelphia, PA 19114
Attn:  [***]
Facsimile:  [***]

 

Article 19
MISCELLANEOUS

19.1Entire Agreement; Amendments.  This Agreement, together with all Attachments
and the Quality Agreement, constitutes the entire understanding between the
parties, and supersedes any contracts, agreements or understandings (oral or
written) of the parties (except for confidentiality agreements), with respect to
the subject matter hereof, including for avoidance of doubt, any quotation
letters referenced in Attachment B.  No modification or amendment to this
Agreement shall be effected by or result from the receipt, acceptance, signing
or acknowledgment of any Party’s purchase orders, order acknowledgements,
quotations, invoices, shipping documents or other business forms containing
terms or conditions in addition to or different from the terms and conditions
set forth in this Agreement, and the terms of this Agreement shall supersede any
provision in any purchase order or other document that is in addition to or
inconsistent with the terms of this Agreement.  No term of this Agreement may be
amended except upon written agreement of the parties, unless otherwise expressly
provided in this Agreement.

19.2Captions; Certain Conventions.  The captions in this Agreement are for
convenience only and are not to be interpreted or construed as a substantive
part of this Agreement.  Unless otherwise expressly provided herein or the
context of this Agreement otherwise requires, (A) words of any gender include
each other gender, (B) words such as “herein,” “hereof,” and “hereunder” refer
to this Agreement as a whole and not merely to the particular provision in which
such words appear, (C) words using the singular shall include the plural, and
vice versa, (D) the words “include(s)” and “including” shall be deemed to be
followed by the phrase “but not limited to,” “without limitation” or words of
similar import, (E) the word “or” shall be deemed to include the word “and”
(e.g., “and/or”) and (F) references to “Article,” “Section,” “subsection,”
“clause” or other subdivision, or to an Attachment or other appendix, without
reference to a document are to the specified provision or Attachment of this
Agreement.  This Agreement shall be construed as if it were drafted jointly by
the parties.

19.3Further Assurances.  The parties agree to execute, acknowledge and deliver
such further instruments and to take all such other incidental acts as may be
reasonably necessary or appropriate to carry out the purpose and intent of this
Agreement.

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19.4No Waiver.  Failure by either party to insist upon strict compliance with
any term of this Agreement in any one or more instances will not be deemed to be
a waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure.

19.5Severability.  If any term of this Agreement is declared invalid or
unenforceable by a court or other body of competent jurisdiction, the remaining
terms of this Agreement will continue in full force and effect.

19.6Non-Solicitation.  PCI shall not solicit (either directly or indirectly) for
employment or employ any of Client’s employees during the Term of this
Agreement.  In the event PCI desires to solicit for employment or employ one of
such Client’s employees, then PCI must obtain Client’s prior written approval
for such solicitation or employment, which may be withheld in its sole
discretion.  Client shall not solicit (either directly or indirectly) for
employment or employ any of PCI’s or its Affiliates’ employees.  In the event
Client desires to solicit for employment or employ one of such PCI’s or its
Affiliates’ employees, then Client must obtain PCI’s prior written approval for
such solicitation or employment, which may be withheld in its sole
discretion.  For the purposes of this Section, “solicit” does not include
contact resulting from means such as public advertisement, placement firm
searches or similar means not directed specifically to an individual and to
which the individual responds on his or her own initiative.

19.7Independent Contractors.  The relationship of PCI and Client is that of
independent contractors, and neither will incur any debts or make any
commitments for the other except to the extent expressly provided in this
Agreement.  Nothing in this Agreement is intended to create or will be construed
as creating between the parties the relationship of joint ventures, co-partners,
employer/employee or principal and agent.  Neither PCI nor Client shall have any
responsibility for the hiring, termination or compensation of the other’s
employees or contractors or for any employee benefits of any such employee or
contractor.

19.8Successors and Assigns.  This Agreement will be binding upon and inure to
the benefit of the parties, their successors and permitted assigns.  Neither
party may assign this Agreement, in whole or in part, without the prior written
consent of the other party, except that either party may, without the other
party’s consent, assign this Agreement in its entirety to an Affiliate or to a
successor to substantially all of the business or assets of the assigning party
or the assigning party’s business unit responsible for performance under this
Agreement.

19.9No Third Party Beneficiaries.  Except as provided under Article 14, this
Agreement shall not confer any rights or remedies upon any person or entity
other than the parties named herein and their respective successors and
permitted assigns.

19.10Governing Law.  This Agreement shall be governed by and construed under the
laws of the State of Delaware, excluding its conflicts of law provisions.  The
United Nations Convention on Contracts for the International Sale of Goods shall
not apply to this Agreement.

19.11Alternative Dispute Resolution.  Any dispute, controversy or claim that
arises between the parties out of or in connection with this Agreement, or the
breach thereof, shall be exclusively and finally resolved by binding
arbitration. A party that wishes to initiate the dispute resolution process
shall send written notice to the other party with a summary of the controversy

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and a request to initiate these dispute resolution procedures.  A representative
of each party shall meet in person or by electronic means (videoconference etc.)
to attempt in good faith to negotiate a resolution of the dispute prior to
pursuing other available remedies.  If the project managers cannot promptly
resolve the issue, they will refer the dispute to the chief executive officers
of the parties, or their designees, for resolution.  If within [***] ([***])
[***] after such meeting the parties have not succeeded in negotiating a
resolution of the dispute, either party may elect to submit such matter for
resolution by arbitration in New York administered by the Judicial Arbitration
and Mediation Services, Inc. (“JAMS”), under its Comprehensive Arbitration Rules
and Procedures then in effect.  The parties will mutually select [***] ([***])
arbitrator.  If the parties are unable to select the arbitrator within [***]
([***]) [***] of the submission of the dispute to arbitration, the parties
consent to the selection of the arbitrator by the JAMS administrator. The
arbitrator shall have significant experience in resolving business contract
disputes in the biotechnology packaging industry. Judgment on the award rendered
by the arbitrator(s) may be entered in any court having jurisdiction
thereof.  The language to be used in the arbitral proceedings shall be
English.  Disputes regarding the validity, scope or enforceability of
intellectual property rights shall not be subject to arbitration pursuant to
this Section 19.11 but instead shall be submitted to a court of competent
jurisdiction.  Notwithstanding the foregoing, each party may institute a formal
court action at any time in order to avoid the expiration of any applicable
limitations period, preserve a superior position with respect to other
creditors, protect the validity, scope or enforceability of its intellectual
property rights, or seek injunctive or other equitable relief. All aspects of
the arbitration shall be treated as confidential. Neither the parties nor the
arbitrators may disclose the existence, content or results of the arbitration,
except as necessary to comply with legal or regulatory requirements.  Before
making any such disclosure, a party shall give written notice to the other party
and shall afford such party a reasonable opportunity to protect its interests.

19.12Prevailing Party.  In any dispute resolution proceeding between the parties
in connection with this Agreement, the prevailing party will be entitled to
recover its reasonable attorney’s fees and costs in such proceeding from the
other party.

19.13Publicity.  Neither party will make any press release or other public
disclosure regarding this Agreement or the transactions contemplated hereby
without the other party’s express prior written consent, except as required
under Applicable Laws, by any governmental agency or by the rules of any stock
exchange on which the securities of the disclosing party are listed, in which
case the party required to make the press release or public disclosure shall use
commercially reasonable efforts to obtain the approval of the other party as to
the form, nature and extent of the press release or public disclosure prior to
issuing the press release or making the public disclosure.

19.14Setoff.  Without limiting PCI’s rights under law or in equity, PCI and its
Affiliates, parent or related entities, collectively or individually, may
exercise a right of set-off against any and all amounts due to PCI from
Client.  For purposes of this Section, PCI, its Affiliates, parent or related
entities shall be deemed to be a single creditor.

19.15Force Majeure.  Except as to payments required under this Agreement, a
party shall not be liable in damages for, nor shall this Agreement be terminable
or cancelable by reason of, any delay or default in such party’s performance
hereunder if such default or delay is caused by events beyond such party’s
reasonable control, including acts of God, law or

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regulation or other action or failure to act of any government or agency
thereof, strikes, lockouts, slowdowns, delay of subcontractors or vendors, war
(declared or undeclared) or insurrection, civil commotion, terrorism,
destruction of production facilities or materials by earthquake, fire, flood or
weather, labor disturbances, epidemic or failure of suppliers, public utilities
or common carriers; provided, that the party seeking relief under this Section
shall immediately notify the other party of such cause(s) beyond such party’s
reasonable control and provide an estimate of the anticipated duration.  The
party that may invoke this Section 19.15 shall use commercially reasonable
efforts to reinstate its ongoing obligations to the other party as soon as
practicable. If such Force Majeure event is expected to delay Packaging for more
than [***] ([***]) [***] the parties shall consult with each other to consider
how to address such delay.  If the cause(s) shall continue unabated for [***]
([***]) [***], then both parties shall meet to discuss and negotiate in good
faith what modifications to this Agreement should result from such cause(s) and
the party not claiming a force majeure event shall have the right to terminate
this Agreement upon the expiration of such [***] ([***])-[***] period.

19.16Counterparts.  This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which together will
constitute one and the same instrument.  Any photocopy, facsimile or electronic
reproduction of the executed Agreement shall constitute an original.

[Signature page follows]

 

30

 

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CONFIDENTIAL

 

IN WITNESS WHEREOF, the parties have caused their respective duly authorized
representatives to execute this Agreement effective as of the Effective Date.

 

ANDERSONBRECON INC.

 

 

By: /s/ Phil DiGiacomo

 

Name: Phil Digiacomo

 

Its: SVP of Sales

AIMMUNE THERAPEUTICS, INC.

 

 

By: /s/ Michael S. Holfinger

 

Name: Michael Holfinger

 

Its: SVP, Technical Operations

 

MILLMOUNT HEALTHCARE LIMITED

 

 

By: /s/ Phil DiGiacomo

 

Name: Phil DiGiacomo

 

Its: SVP of Sales

 

 

 

 

 

 

 

 

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CONFIDENTIAL

 

ATTACHMENT A

TERRITORY

 

[***]

 

 

 

 

 

 

 

 

 

 

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CONFIDENTIAL

 

ATTACHMENT B

UNIT PRICING, FEES AND MINIMUM REQUIREMENT

[***]

 

 

 

 

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CONFIDENTIAL

 

 

ATTACHMENT C

PERMITTED SUBCONTRACTORS

[***]

 

 

 

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