Confidential

EXHIBIT 10.39
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS
DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH
ASTERISKS (***), HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
MANUFACTURING AND SUPPLY AGREEMENT

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MANUFACTURING AND SUPPLY AGREEMENT
This MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) dated as of 20
October 2017 (the “Effective Date”) is made by and between Insmed Incorporated,
a Virginia corporation having its principal place of business at 10 Finderne
Avenue, Building 10, Bridgewater, New Jersey 08807, USA (“Client”), and Patheon
UK Limited, a company incorporated in England and Wales having its principal
place of business at Kingfisher Drive, Covingham, Swindon, SN35BZ, United
Kingdom (“Patheon”). Client and Patheon are sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Client has a commercial interest in the manufacture and
commercialization of Amikacin Liposome Inhalation Suspension (ARIKAYCE®), a
sterile, aqueous liposomal suspension designed for oral inhalation via
nebulization which is manufactured using the Client Manufacturing Process (the
“Product”);
WHEREAS, Patheon has expertise and experience in manufacturing and packaging
sterile pharmaceutical products and is interested in providing manufacturing
services to Client in connection with the Product;
WHEREAS, in anticipation of this Agreement and the services that Patheon will
supply hereunder, the Parties are executing an agreement pursuant to which
Patheon would undertake certain technology transfer and construction services in
order to validate Client’s technology package and prepare Patheon’s facilities
for the manufacture of the Product; and
NOW, THEREFORE, in consideration of the foregoing, the mutual promises and
covenants of the Parties contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties hereto, intending to be legally bound, do hereby agree as follows:
ARTICLE I. DEFINITIONS
The following terms shall have the meanings set forth below. Unless the context
indicates otherwise, the singular shall include the plural and the plural shall
include the singular.
“Additional Services” means any services requested and approved by Client that
supplement Patheon’s regular performance of the Manufacturing Services pursuant
to this Agreement or that supplement Patheon’s regular performance of the
Transfer Services pursuant to the Technology Transfer Agreement, as applicable,
as described in Schedule B.
“Affiliate” means, with respect to any Person, any other Person that directly,
or indirectly through one or more intermediaries, controls, is controlled by, or
is under common control with, such Person. For the purposes of this definition
only, a Person will be regarded as in control of another Person if such Person
owns, or directly or indirectly controls, more than 50% of the voting securities
(or comparable equity interests) or other ownership interests

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of the other Person, or if such Person directly or indirectly possesses the
power to direct or cause the direction of the management or policies of the
other Person, whether through the ownership of voting securities, by contract,
or any other means whatsoever.
“Agreed Delivery Date” has the meaning set forth in Section 2.3(f).
“Agreement” has the meaning set forth in the Preamble hereto.
“API” means the active pharmaceutical ingredient amikacin sulfate.
“Applicable Law” means applicable United States and foreign federal, state, and
local laws, orders, rules, regulations, guidelines, standards, customs and
ordinances, including, without limitation, those (to the extent they are
applicable) of the FDA and comparable foreign Regulatory Authorities, including
the FDA Act.
“Base Fee” means the monthly fee paid by Client, as more specifically set forth
in Schedule B. For the avoidance of doubt, Base Fees do not include Technology
Transfer Fees or Capital Expenditures (both as defined in the Technology
Transfer Agreement), Product Fees, Material Costs, Maintenance Costs, Disposal
Costs or charges for Bill Back Items or Additional Services.
“Basic Engineering Design” means the basic engineering design to be conducted by
Patheon as described in the Letter Agreement entered into by the Parties dated
16 June 2017.
“Bill Back Items” means the items and services set forth in Schedule B or other
project-specific items that are used or necessary in connection with the
Manufacture of the Products and that are not included as Materials.
“Certificate of Analysis” means a certificate evidencing the analytical tests
conducted on a specific batch of Product or Material and setting forth, inter
alia, the items tested, specifications, and test results.
“Certificate of Compliance” means a certificate stating that a specific batch of
Product has been Manufactured in compliance with GMP and the Specifications.
“Claim” has the meaning set forth in Section 9.3(a).
“Client” has the meaning set forth in the Preamble hereto.
“Client Indemnified Parties” has the meaning set forth in Section 9.2.
“Client Manufacturing Equipment” means process equipment necessary to
Manufacture the bulk Product that consists of equipment for the bulk
Manufacturing, vial preparation, fill/finish, and in-process control testing of
the Product and its intermediates as more fully set forth in Exhibit F of the
Technology Transfer Agreement.

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“Client Manufacturing Process” means the proprietary process owned or Controlled
by Client for Manufacturing the Product, as disclosed by Client to Patheon, and
each intermediate of the Product, as established as of the Effective Date,
including without limitation, as set forth in the investigational new drug
application filed with the FDA, and, when applicable, as set forth in the NDA as
may be filed with, and approved by, the FDA.
“Client Manufacturing Process Improvements” has the meaning set forth in
Section 5.1(e)(i).
“Client On Site Representative” has the meaning set forth in Section 3.5(a).
“Client Product Improvements” has the meaning set forth in Section 5.1(e)(i).
“Client Specification Improvements” has the meaning set forth in
Section 5.1(e)(i).
“Client-Supplied Materials” has the meaning set forth in Section 2.2(a).
“Commercially Reasonable Efforts” means, with respect to the efforts to be
expended by a Party to achieve any objective, the reasonable, diligent efforts
to accomplish such objective as a similarly situated party (with respect to
size, resources and assets) in the pharmaceutical industry would normally use to
accomplish a similar objective in its own interests under similar circumstances.
“Confidentiality Agreement” has the meaning set forth in Section 7.1.
“Confidential Information” has the meaning set out in the Confidentiality
Agreement.
“Control” or “Controlled” means ownership or the right by a Party to assign or
grant a license or sublicense under Intellectual Property rights to the other
Party of the scope set forth herein, without breaching the terms of any
agreement with a Third Party.
“Deficiency Notice” has the meaning set forth in Section 2.8(b).
“Discretionary Manufacturing Changes” has the meaning set forth in
Section 2.10(b)(ii).
“Disposal Costs” means the cost charged by a Third Party for disposal of waste
from the Manufacture of the Product plus an [***]% handling fee.
“Effective Date” has the meaning set forth in the Preamble hereto
“EMA” means the European Medicines Agency.
“Equipment” means any equipment used in the Manufacture of the Product as more
fully set forth in Exhibit F of the Technology Transfer Agreement.
“Existing Client Intellectual Property” has the meaning set forth in Section
5.1(a).
“Existing Patheon Intellectual Property” has the meaning set forth in
Section 5.1(b).

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“Expected Yield” has the meaning set forth in Section 2.9(a).
“Expert” has the meaning set forth in Section 2.8(d)(vi).
“Exploit” means to make, have made, import, use, sell, offer for sale, receive
or otherwise dispose of a product or process, including the research,
development (including the conduct of clinical trials), registration,
modification, enhancement, improvement, Manufacture, storage, formulation,
optimization, export, transport, distribution, promotion, or marketing of a
product or process.
“Facility” means the facility of Patheon located at Kingfisher Drive, Swindon,
Wiltshire SN3 5BZ, United Kingdom, or such other facility approved in accordance
with Section 3.4(a).
“FDA” means the United States Food and Drug Administration and any successor
organization thereto and all agencies under its direct control.
“FDA Act” means the US Federal Food, Drug, and Cosmetic Act, as amended.
“FDA Approval Date” means the date of receipt by Client of Regulatory Approval
in the United States for Products Manufactured at the Manufacturing Suite.
“Filing Party” has the meaning set forth in Section 3.17(d).
“Final Filing” has the meaning set forth in Section 3.17(g).
“Forecast” has the meaning set forth in Section 2.3(a).
“GMP” means the current good manufacturing practices applicable from time to
time to the Manufacturing of the Product, or any intermediate of the Product,
pursuant to Applicable Law, including those promulgated under the FDA Act at 21
C.F.R. (Parts 210 and 211 and Part 4 as relevant for combination products), and
those promulgated under Directive 2001/83/EC (as amended by Directive
2004/27/EC), Directive 2003/94/EC and EudraLex - Volume 4 of the Rules Governing
Medicinal Products in the European Union entitled “EU Guidelines to Good
Manufacturing Practice Medicinal Products for Human and Veterinary Use”,
together with the latest FDA, EMA and European Commission guidance documents
pertaining to manufacturing and quality control practice, all as updated,
amended and revised from time to time. Guidance in draft status will be
considered as in effect for the purposes of this definition if this guidance has
been adopted by Patheon at the Facility in relation to all its other clients and
included as part of Patheon’s Standard Operating Procedures or if it is agreed
to be adopted by the Commercial Steering Committee.
“Indemnified Party” has the meaning set forth in Section 9.3(a).
“Indemnifying Party” has the meaning set forth in Section 9.3(a).

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“Initial Draft” has the meaning set forth in Section 3.17(e).
“Initial Term” has the meaning set forth in Section 8.1.
“Intellectual Property” includes, without limitation, rights in patents, patent
applications, formulae, trademarks, trademark applications, trade-names,
Inventions, copyrights, designs, trade secrets, databases and rights in know how
(whether or not any of these is registered or capable of registration and
including applications for registration of any such thing) and all other similar
rights or forms of protection of a similar nature or having equivalent or
similar effect to any of these which may subsist anywhere in the world.
“Invention” means information about any innovation, improvement, development,
discovery, computer program, device, trade secret, method, know-how, process,
technique or the like, whether or not written or otherwise fixed in any form or
medium, regardless of the media on which it is contained and whether or not
patentable or copyrightable.
“Loss” means any claims, lawsuits, losses, damages, liabilities, penalties,
costs, and expenses (including reasonable attorneys’ fees and disbursements).
“Maintenance” means the maintenance of Equipment and the Facility in
satisfactory operating condition, including the performance of systematic
inspection and service of Equipment pursuant to the applicable Standard
Operating Procedures of Patheon, as reviewed and agreed to by Client (the
“Equipment Standard Operating Procedures”), or the manufacturer’s terms of
operation and recommended procedures.
“Maintenance Costs” means the cost charged by a Third Party for (a) routine
Maintenance; or (b) revalidation of the Equipment, plus an [***]% handling fee.
“Make Good Costs” has the meaning set forth in Section 8.3(d).
“Manufacture” and “Manufacturing Services” means the manufacture of the
Products, including without limitation the planning, purchasing and receipt of
Patheon-Supplied Materials, planning (based on the Forecast), receipt of
Client-Supplied Materials and the manufacturing, processing, formulating,
filling, bulk packaging, bulk labelling, storage, handling, quality release of
Products (Certificate of Compliance), together with all agreed sample retention,
stability testing, quality control and assurance and waste disposal.
“Manufacturing Services Termination Costs” has the meaning set forth in Section
8.3(e).
“Manufacturing Suite” means the manufacturing suite at the Facility, whose
footprint was determined pursuant to the Technology Transfer Agreement.

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“Marketing Authorization” means an approved New Drug Application as defined in
the FDA Act and the regulations promulgated thereunder, or any corresponding
foreign application, registration, or certification, necessary or reasonably
useful to market any Product in a country or regulatory jurisdiction other than
the United States, including applicable pricing and reimbursement approvals, and
all supplements and amendments thereto.
“Material Costs” has the meaning set forth in Section 2.2(b).
“Materials” means all API, excipients and processing aids, and processing,
filling and packaging components listed in Schedule C, as amended from time to
time by agreement in writing.
“NDA” means the US new drug application for a product, including the Product,
requesting permission to place a drug on the market in accordance with 21 C.F.R.
Part 314, and all supplements (SNDA) filed pursuant to the requirements of the
FDA, including all documents, data, and other information filed concerning such
product that are necessary for FDA approval to market such product in the
Territory.
“Non-Conforming Product” means (a) a batch of Product that fails, or is aborted
during processing; or (b) a Product Manufactured by Patheon that fails to [***].
“Non-Filing Party” has the meaning set forth in Section 3.17(d).
“Party” and “Parties” have the meanings set forth in the Preamble hereto.
“Patheon” has the meaning set forth in the Preamble hereto.
“Patheon Indemnified Parties” has the meaning set forth in Section 9.1.
“Patheon Independent Manufacturing Equipment Improvements” has the meaning set
forth in Section 5.1(f)(i).
“Patheon Manufacturing Equipment” means any equipment, other than the Client
Manufacturing Equipment, necessary to Manufacture the Product including as more
fully set forth in Exhibit F of the Technology Transfer Agreement, waste
handling systems and all building infrastructure and any and all improvements or
additions made thereto, as approved in writing by Client.
“Patheon Nonconformance” has the meaning set forth in Section 2.8(d)(i).
“Patheon-Supplied Materials” has the meaning set forth in Section 2.2(a).

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“Person” means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated association,
joint venture, or other similar entity or organization, including a government
or political subdivision, department, or agency of a government.
“Product” has the meaning set forth in the Recitals hereto in finished,
bulk-packaged form according to the Specifications as described in Schedule A,
as the same may be amended from time to time.
“Product Fee” has the meaning set forth in Section 2.4.
“Project Manager” and “Project Managers” have the meaning set forth in Section
3.5(b).
“Purchase Order” means a written purchase order that sets forth (a) the
quantities of each presentation of Product to be delivered by Patheon to Client,
(b) the requested delivery dates therefor, and (c) the bulk packaging to be used
for such Product.
“Quality Agreement” has the meaning set forth in Section 3.1.
“Regulatory Approval” means any and all approvals (including pricing and
reimbursement approvals), licenses, registrations, or authorizations of any
Regulatory Authority necessary to Exploit the Product in any country in the
Territory, including any approval of a Product, Marketing Authorization and
supplements and amendments thereto.
“Regulatory Authority” means any applicable supra-national, federal, national,
regional, state, provincial, or local regulatory agencies, departments, bureaus,
commissions, councils, or other government entities regulating or otherwise
exercising authority with respect to the Exploitation of a Product in the
Territory.
“Regulatory Filings” has the meaning set forth in Section 3.17.
“Regulatory Obligations” has the meaning set forth in Section 3.17.
“Remediation Period” has the meaning set forth in Section 8.2(a)(vii).
“Reports” has the meaning set forth in Section 3.13.
“Required Manufacturing Changes” has the meaning set forth in Section
2.10(b)(i).
“Shipment Costs” has the meaning set forth in Section 2.8(d)(ii).
“Specifications” means the specifications for each presentation of Product
(i.e., the dosage forms in Schedule A) given by Client to Patheon relating to
the specifications of the Materials; the manufacturing specifications,
directions and processes; the storage requirements; all environmental, health
and safety information for the Product including material safety data sheets and
the finished Product specifications, specifications for bulk

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and primary packaging and shipping requirements for the Product, as amended,
modified, or supplemented from time to time.
“Technology Transfer Agreement” means the agreement executed on the date hereof
between Client and Patheon in order for Patheon to be able to Manufacture the
Products, as described in more detail in the third Recital.
“Term” has the meaning set forth in Section 8.1.
“Territory” means the United States and other territories agreed by the Parties
pursuant to Section 2.2(t) from time to time.
“Third Party” means a Person who is neither a Party nor an Affiliate of a Party.
“Third Party Losses” means Losses incurred as a result of claims brought by
Third Parties.
“Third Party Subcontractors” has the meaning set forth in Section 3.16.
ARTICLE II.     MANUFACTURING SERVICES
2.1    Supply Obligations.
(a)    Subject to the completion of the technology transfer and construction
services under the Technology Transfer Agreement to validate Client’s technology
package and prepare Patheon’s facilities for the manufacture of the Product, and
the terms and conditions hereof, and in consideration for the payments set forth
in Schedule B, Client appoints Patheon as a non-exclusive supplier of the
Products and Patheon shall provide the Manufacturing Services and shall supply
the Product to Client.
(b)    Pursuant to the Technology Transfer Agreement, Client will develop and
Patheon will confirm the Client Manufacturing Process. The Client Manufacturing
Process is the Confidential Information of Client, subject to the terms of the
Confidentiality Agreement, and accordingly Patheon may not allow Third Parties
(other than relevant Regulatory Authorities or Third Party Subcontractors) to
access the Manufacturing Suite or view documentation so describing the
Manufacturing Process without Client’s prior written consent, provided that
third parties may view the filling line from outside the room in which it is
housed.
(c)    Patheon shall Manufacture all Products delivered hereunder:
(i)    at the Manufacturing Suite;
(ii)    in accordance with the Specifications, this Agreement and the Quality
Agreement; and
(iii)    in compliance with GMP and Applicable Laws.

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(d)    Patheon shall ensure that sufficient numbers of adequately educated and
experienced staff are retained at the Facility in order to Manufacture the
volumes of Product set out in the Forecast. Patheon shall perform all activities
necessary to maintain a GMP compliant status of the manufacturing lines and
areas of the Facility applicable to the Manufacture of the Product.
2.2    Materials, Bill Back Items and Additional Services.
(a)    All Materials necessary for the Manufacture of the Product are set forth
in Schedule C. Materials that will be purchased by Client and shipped to Patheon
(“Client-Supplied Materials”) are listed in Part A of Schedule C. Materials that
will be purchased by Patheon (“Patheon-Supplied Materials”) are listed in Part B
of Schedule C.
(b)    Patheon-Supplied Materials will be invoiced to Client [***] at the time
of purchase by Patheon at cost plus an [***]% handling fee, in accordance with
the invoicing procedure set forth in Article IV (“Material Costs”). Patheon
shall obtain the prior written approval of Client on the cost of such
Patheon-Supplied Materials if the cost of any individual item of
Patheon-Supplied Material increases by more than (i) [***]%; or (ii) £[***],
whichever is the lower. Where Client nominates a particular supplier to supply
certain Patheon-Supplied Materials, Patheon shall purchase those Materials from
that supplier subject to Section 2.2(d). All purchases of Patheon-Supplied
Materials by Patheon shall be made on Patheon’s own behalf and not as an agent
for Client.
(c)    Patheon shall store, handle, and protect the Materials with a reasonable
level of care, which shall include taking all reasonable precautions to ensure
that the Materials are not subject to contamination, deterioration, destruction,
or theft. Patheon shall keep adequate records of its usage of the Materials
during the Term.
(d)    Client acknowledges that Patheon is required under GMP to follow certain
verification and approval processes for all vendors used by Patheon in the
procurement of Materials. In the event that Client requests Patheon to procure
Materials from a vendor that is not currently verified by Patheon, Client will
be liable for Patheon’s fees for the performance of any auditing and
verification activities by Patheon under this Section 2.2(d) as an Additional
Service. Client will be responsible for validation of suppliers of
Client-Supplied Materials unless otherwise agreed. Patheon will be responsible
for validation of suppliers of Patheon-Supplied Materials. Any changes to a
supplier of Materials proposed by either Party shall be subject to the change
control procedure set out in Section 2.10(b) and may not be used until, as
applicable, submission has been filed to necessary health authorities and where
appropriate approvals obtained.
(e)    Patheon shall be responsible for ordering and paying for the relevant
quantities of Patheon-Supplied Materials necessary for the Manufacture of
Products on such terms and conditions as Patheon may agree with relevant
suppliers.

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(f)    The Commercial Steering Committee shall discuss and agree the process by
which Patheon shall order from Client the relevant quantities of Client-Supplied
Materials necessary for the Manufacture of Products during the Term. Client will
keep Patheon informed of the standard lead time for and cost of Client-Supplied
Materials and shall supply such Client-Supplied Materials free of charge on a
consignment basis in response to orders placed by Patheon under this Agreement.
(g)    Client will at its sole cost and expense, deliver Client-Supplied
Materials to the Facility DDP (Incoterms 2010) at no cost to Patheon (with any
VAT paid by Client) in the quantities and on the dates agreed with Patheon in
response to orders placed pursuant to the process agreed under Section 2.2(f).
If the Client-Supplied Materials are not received on the agreed date, Patheon
may delay the Manufacture of Product for a period of time proportionate to such
delay.
(h)    All shipments of Client-Supplied Materials, if required, will be
accompanied by Certificate(s) of Analysis from the Material manufacturer or
Client confirming its compliance with the Material’s specifications, together
with all required documentation as specified in the Quality Agreement. Client or
Client’s designee will be the “Importer of Record” for Client-Supplied Materials
imported to the Facility. Client-Supplied Materials will be held by Patheon on
behalf of Client as set forth in this Agreement.
(i)    Title to Client-Supplied Materials will at all times remain the property
of Client. Risk in the Client-Supplied Materials shall remain with Patheon at
all times from the point when the Client-Supplied Materials are delivered to
Patheon until delivery of the Products to Client (or return of the
Client-Supplied Materials to Client), at which time it shall pass to Client (or
its relevant Affiliate). The transfer of risk in the Client-Supplied Materials
to Patheon shall be without prejudice to Section 9.5 (to the extent that the
terms and conditions of Patheon’s policies of insurance do not cover any type of
loss or damage to the Client-Supplied Materials) and shall be subject to any
amounts recoverable by Patheon from its insurer provided that Patheon shall only
insure Client-Supplied Materials up to the values recommended and provided to
Patheon by Client. Patheon shall not be liable for any unrecoverable losses
caused by the under-estimation of such values. The transfer of risk shall
further be subject to any deductible amounts applied by Patheon’s insurer and
the terms and conditions and exclusions of Patheon’s policies of insurance.
(j)    Client-Supplied Materials will only be used by Patheon to perform the
Manufacturing Services or associated activities necessary to perform the
Manufacturing Services.
(k)    Client shall supply the Client-Supplied Materials in accordance with the
requirements of the Quality Agreement, the Specifications, the Marketing
Authorization, and GMP.
(l)    Patheon shall notify Client promptly in writing if, after having carried
out the analysis and testing of Client-Supplied Materials as set out in the
Quality Agreement or the

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Specifications it considers that any delivered Client-Supplied Materials do not
comply with Section 2.2(k), and shall provide samples of such delivery together
with copies of any relevant analysis records. Upon receipt of notification
pursuant to this Section 2.2(l) by Client, the Parties will use Commercially
Reasonable Efforts to agree (each acting in good faith) whether or not the
Client-Supplied Materials in question are compliant with the requirements set
out in Section 2.2(k) and:
(i)    Client shall be entitled at all reasonable times to inspect and/or
analyse the delivery in question;
(ii)    Patheon shall not use any of the Client-Supplied Materials in question
in the Manufacture of Product until the matter has been resolved in accordance
with this Section 2.2(l) and Section 2.2(m) unless agreed otherwise; and
(iii)    at Patheon’s request, Client shall deliver to Patheon replacement
Client-Supplied Materials as soon as practicable, using Commercially Reasonable
Efforts to enable continuity of Patheon’s Manufacture of the relevant Products.
(m)    In the event that the Parties do not agree on whether the Client-Supplied
Materials in question are compliant with the requirements set out in Section
2.2(k), the matter may be referred to an Expert in accordance with the procedure
in Section 2.8(d)(vi).
(n)    If Client-Supplied Materials are not compliant (or are determined to be
non-compliant) with the requirements set out in Section 2.2(k) and Patheon does
not have sufficient quantity of released Client-Supplied Materials that are
compliant, then Patheon will have no liability to Client if this results in
delayed performance of any Manufacturing Services or cancellation or
rescheduling of any manufacturing slots, provided that the non-compliance has
not been caused by a breach of this Agreement by Patheon. Client will pay
Patheon for the Purchase Order in accordance with Section 2.4 which payment will
be credited against the Product Fees that are payable for future Purchase
Orders.
(o)    Where Patheon fails to carry out incoming analysis of Client-Supplied
Materials in accordance with the Specifications and uses the Client-Supplied
Materials in question in the Manufacture of Product and any such Client-Supplied
Materials thereafter are agreed or determined pursuant to Section 2.8(d)(vi) to
not comply with the requirements set out in Section 2.2(k), Patheon shall:
(i)    provide the remedies set out in Section 2.8(d)(ii) for any Non-Conforming
Product that is caused by such a failure (Patheon’s obligation to reimburse
Client-Supplied Materials incorporated into Non-Conforming Product caused by
such a failure will be captured and calculated in the Yield Reimbursement
Payment under Section 2.9 which shall be subject to the limitation of liability
in Section 9.5(a)); and
(ii)    at Client’s option, subject to completion of any quality investigation,
any sample retention requirements and the provisions of the Quality Agreement,
take

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all necessary action (at its own expense), to rework, reprocess (both of which
shall be done promptly) or destroy any Non-Conforming Products caused by such a
failure.
(p)    Client will be responsible for paying for all Non-Conforming Product that
arises from Client-Supplied Materials that do not comply with the requirements
set out in Section 2.2(k) that could not be detected by Patheon carrying out the
incoming analysis of Client-Supplied Materials in accordance with the
Specifications.
(q)    Patheon will provide free of charge sufficient storage capacity to
support storage of the required quantity of Materials for the longer of up to
[***] or the amount of time set forth for the applicable Material on Schedule C.
Patheon will also provide free of charge sufficient storage capacity to support
storage of Product for up to [***] after the release of the relevant Product. 
Any additional storage, or storage of Materials or Product beyond the applicable
period stated herein, will be subject to the mutual agreement of the Parties to
include the fees relating thereto. Patheon’s standard storage fees as of the
Effective Date are [***] per pallet, per [***] for storing the Materials or
finished Product. Storage fees for Materials or Product that contain controlled
substances or require refrigeration are charged at [***] per pallet per [***].
Storage fees are subject to a one pallet minimum charge per [***]. Storage fees
will not apply to (i) any [***] for up to [***] after the Marketing
Authorization for the United States has been granted; and (ii) any stocks of
Products Manufactured during the first [***] after the Effective Date in
anticipation of launch in the US, provided that where Patheon is unable to
accommodate all or some of such launch quantities it may engage a Third Party
Subcontractor to do so in accordance with Section 3.16.
(r)    Bill Back Items will be charged to Client at Patheon’s cost plus a [***]
handling fee. Patheon shall invoice Client [***] for any Bill Back Items used in
connection with the Manufacture of the Products during the preceding [***] in
accordance with ARTICLE IV. Patheon may only invoice Bill Back Items that have
been quoted to and approved in writing by an authorized person of Client in
advance. The cost of any Bill Back Items where use is shared between Client and
Patheon or other clients of Patheon will be apportioned in good faith in
proportion to their use.
(s)    If Client is interested in having Patheon perform Additional Services,
Client will provide Patheon with a written request containing sufficient detail
to enable Patheon to provide Client with a quote and proposal to provide such
Additional Services. Patheon may only invoice for Additional Services that have
been quoted to and approved in writing by an authorized person of Client in
advance. Where a rate for Additional Services has been specified in Schedule B,
such rates are calculated as at the Effective Date. These fees will be adjusted
on 1st January of each year (first review [***]) to reflect any increase in the
UK Consumer Price Index: All Items Index published by the Office for National
Statistics (as published at www .ons.gov.uk) during the previous twelve (12)
months (based on the average of the monthly changes over the 12-month period),
provided that if the increase in the index exceeds [***] it will be implemented
but the Parties shall meet and negotiate in good faith measures to mitigate the
effect of the fee increase. Patheon shall invoice Client monthly for any
Additional Services performed by Patheon during the preceding month in
accordance with Article IV.

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(t)    If Client decides to have Patheon perform Manufacturing Services for the
Product for a territory outside the United States, Japan and/or the European
Union (including the United Kingdom), then Client will inform Patheon of the
additional requirements for each new country and Patheon will prepare a
quotation for consideration by Client of any additional costs for the Product
destined for each new country. The agreed additional requirements and change to
any Product Fees will be set out in a written amendment to this Agreement. The
Product Fees for products supplied to Japan or the European Union (including the
United Kingdom) shall be consistent with those for the United States save to the
extent Additional Services are required in respect of such Products, e.g., extra
visual inspection for Japan, which shall be subject to Section 2.2(s).
(u)    Patheon-Supplied Materials.
(i)    If the Parties agree that Patheon is to source all or any of the
Materials, Client understands and acknowledges that Patheon will rely on
Client’s Purchase Orders and Forecasts in ordering the Patheon-Supplied
Materials required to meet the Purchase Orders. Accordingly, Client authorizes
Patheon to purchase Patheon-Supplied Materials to satisfy the Manufacturing
Services requirements for Products for the first [***] contemplated in the most
recent Forecast or as set out in Schedule C. Patheon may make other purchases of
Patheon-Supplied Materials to meet Manufacturing Services requirements for
longer periods if agreed to in writing by the Parties. Client will give Patheon
written authorization to order Patheon-Supplied Materials for any launch
quantities of Product requested by Client which will be considered a Purchase
Order when accepted by Patheon.
(ii)    Client will reimburse Patheon for any destruction costs of any
Patheon-Supplied Materials ordered by Patheon under Purchase Orders or under
Section 2.2(u)(i) that are not included in finished Products Manufactured for
Client on or before [***] after the forecasted month for which the purchases
have been made (or for a longer period as the Parties may agree). If any
non-expired Patheon-Supplied Materials are used in Products subsequently
manufactured for Client, Client will receive credit for any costs of those
Patheon-Supplied Materials previously paid to Patheon by Client.
(v)    Waste Disposal. Patheon shall dispose of waste arising from the
Manufacture of the Product. Disposal Costs will be invoiced to Client [***] in
accordance with the invoicing procedure set forth in ARTICLE IV. Patheon may
only invoice Disposal Costs that have been quoted to and approved in writing by
an authorized person of Client in advance.
2.3    Forecasting, Order, and Delivery of Products.

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(a)    No later than [***] prior to the anticipated FDA Approval Date and
thereafter at least [***] during the Term, Client shall deliver to Patheon a
written good faith [***] forecast, calculated monthly for the first [***] and
quarterly thereafter, estimating the quantities of each presentation of Product
that Client expects to order from Patheon during such period (each, a
“Forecast”).
(b)    If Patheon is unable to accommodate any portion of the Forecast, it will
notify Client in writing setting out the reasons and the Parties will agree on
any revisions to the Forecast. Without prejudice to Client’s other rights and
remedies under this Agreement, Patheon shall take all such actions as may be
reasonably requested by Client to minimize the damage to Client (if any) caused
by Patheon’s inability to accommodate any portion of the Forecast, [***]. Taking
these actions will not constitute an admission of liability by Patheon or any
acceptance that an inability to accommodate any portion of the Forecast will
cause damage to Client.
(c)    Client shall update the Forecast on or before the first day of each
calendar month on a rolling forward basis. Client shall also update the Forecast
prior to the next monthly deadline if it determines that the volumes estimated
in such Forecast have changed (or will change) by more than [***]. The most
recent Forecast will prevail. Except as set forth in Section 2.3(e) below, each
Forecast shall be non-binding and shall be used by Patheon for planning purposes
only.
(d)    When this Agreement is executed, Client will give Patheon a written [***]
for strategic purposes, of the volume of Product Client then anticipates to
purchase from Patheon for each year during such period (the “Long Term
Forecast”). The Long Term Forecast will thereafter be updated every six months
(as of June 1 and December 1) during the Term. If Patheon is unable to
accommodate any portion of the Long Term Forecast, it will notify Client and the
Parties will agree on any revisions to the Long Term Forecast.
(e)    The first [***] of each Forecast shall be considered binding firm orders.
Client will issue corresponding Purchase Order(s) on a monthly basis to purchase
and, when accepted by Patheon, for Patheon to Manufacture and deliver the agreed
quantity of the Product for each month of such [***] period, provided that the
delivery lead time must be at least [***] from the date of Patheon’s acceptance
(or deemed acceptance) of the Purchase Order pursuant to Section 2.3(f) below.
Expedited Purchase Orders will be subject to additional fees on reasonable terms
that are consistent with those generally offered to Patheon’s other customers.
(f)    Patheon shall accept Purchase Orders by sending an acknowledgement to
Client on or before [***] business days of its receipt of the Purchase Order.
The acknowledgement will include confirmation of the quantity of Product ordered
as set out in the Purchase Order and the delivery date(s) for the Product
ordered as set out in the Purchase Order (“Agreed Delivery Date”). Upon receipt
of such acknowledgement, each Purchase Order will be regarded by the Parties as
a binding irrevocable commitment by Client to purchase from Patheon, and for
Patheon to Manufacture and supply to Client, the relevant quantity of Product
according to the requirements set out in such Purchase Order.

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(g)    Patheon shall only be required to provide a delivery month for any
Purchase Orders or part thereof that do not relate to the first [***] of the
applicable Forecast. The Agreed Delivery Date may be amended by agreement of the
Parties. If Patheon fails to acknowledge receipt of a Purchase Order on or
before the [***] business day period, the Purchase Order will be deemed to have
been accepted by Patheon.
(h)    Patheon shall deliver Product to Client EXW the Facility (as defined in
Incoterms 2010) by the Agreed Delivery Date and in the quantities specified in
the relevant Purchase Order. Client may accept deliveries in advance of the
Agreed Delivery Date at its discretion. All Product shall be packed for shipping
in accordance with the Specifications.
(i)    Title to the Products shall vest in Client from [***]. Risk of loss to
Product shall pass to Client (or a designated Client Affiliate) at the time when
Patheon loads the Product onto the carrier’s vehicle for shipment at the
shipping point at the Facility. Neither payment for the Products by Client, nor
passing of risk in the Products to Client, shall be deemed to constitute
acceptance of such Products by Client.
(j)    Each delivery of Product shall be accompanied by a Certificate of
Analysis and a Certificate of Compliance and such other documents as may be
required pursuant to the Quality Agreement. All Products shall be released for
delivery on or before a quarterly average of [***], and no later than at [***],
after the date that the API is combined with the excipients for the Product in
accordance with the Client Manufacturing Process. If the quarterly average is
greater than [***], the Parties shall engage in good faith discussions to agree
a remediation plan describing the steps to be taken to improve shelf life
performance. Patheon shall use Commercially Reasonable Efforts to implement such
plan. If Product is released later than [***], Client may reject the same if in
its reasonable opinion it will not be able to [***] that has been so released
safely and at commercially reasonable rates. Any such rejected Product shall be
regarded as [***]. The costs of all freight, insurance, handling fees, taxes,
and other costs associated with the shipment of Product, as well as export
licenses, import license, and customs formalities for the import and export of
goods will be borne by Client. Client shall collect shipments from the Facility
on the date specified in the relevant Purchase Order or otherwise following
notification of availability for delivery from Patheon and agreement of a
revised delivery date.
(k)    If Client cancels any Purchase Order after acceptance thereof by Patheon
or deemed acceptance as described in Section 2.3(f) or (g), Client will pay
Patheon [***] of the Product Fee for the Purchase Order which payment will be
credited against the Product Fees that are payable for future Purchase Orders.
(l)    Patheon shall use Commercially Reasonable Efforts to satisfy, any changes
in quantity, delivery phasing or dates requested by Client in respect of
Purchase Orders or any additional orders. Any additional fees to reflect
additional activities required to be conducted by Patheon as a result of these
changes or additional orders shall be agreed by the Parties in advance.
2.4    Product Fees. The purchase price for Products Manufactured hereunder (the
“Product Fee”) shall be calculated according to the model as set forth in
Schedule B. This means that the Product Fee payable per Product varies on an
incremental basis as further described in

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Schedule B. All purchases of Products will be invoiced at the applicable Product
Fee based on the volume of Products expected to be supplied in that calendar
year (or part thereof) based on most recent Forecast at the start of the
calendar year. If the volume of Products ordered by Client during such calendar
year falls into a different volume band then Patheon shall issue a corresponding
invoice or credit note (as the case may be) by 31 March in the following
calendar year. For the avoidance of doubt no Product Fees shall be payable for
the aggregate total of [***] that are included in the Transfer Services as
described in Exhibit C of the Technology Transfer Agreement. [***] are not
included in the Technology Transfer Fees and therefore Product Fees shall be
payable for these batches; any additional [***] shall be charged at the price
specified in the Technology Transfer Agreement. Patheon shall invoice Client for
the relevant Product Fee after the Products have been released by Patheon for
delivery in accordance with Section 2.3(h). All Product Fees will be due and
payable in accordance with the invoicing procedures set forth in ARTICLE IV.
2.5    Base Fees. Patheon will invoice Client [***] in advance for the Base Fees
set forth Schedule B. All Base Fees will be due and payable in accordance with
the invoicing procedures set forth in Article IV.
2.1    Fee Adjustment.
(a)    The Base Fee and Product Fee stated herein are calculated as at the
Effective Date and shall be fixed until [***]. Thereafter, starting on [***] the
Base Fee and Product Fee shall be adjusted annually to reflect any change in the
UK Consumer Price Index: All Items Index published by the Office for National
Statistics (as published at www .ons.gov.uk) during the preceding twelve (12)
months (based on the average of the monthly changes over the 12-month period)
provided that if the increase in the index exceeds [***] it will be implemented
but the Parties shall meet and negotiate in good faith measures to mitigate the
effect of the fee increase.
(b)    Patheon, in collaboration with Client, shall use Commercially Reasonable
Efforts to identify and target potential areas of cost reduction (e.g.,
efficiency savings as a result of increasing volumes, or changes in process,
formulation or components relating to the Products) and process improvements
(e.g., cycle time reductions, inventory reductions, yield improvements or
collaborative procurement) relating to its performance under this Agreement. The
net benefits of cost savings and improved efficiencies achieved as a result of
the same shall be allocated as follows:
(i)    where benefits of cost reductions and improved efficiencies are only
applicable to the Manufacture of the Product(s), the amount of such benefits
shall be [***]; and
(ii)    where benefits of cost reductions and improved efficiencies are
applicable to the general manufacturing and supply chain costs of Patheon, such
that Patheon and/or its customers generally benefit, the allocation of such
benefits shall be [***].
(c)    Exchange Rate Fluctuations

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(i)    Fees. On or before 1 November of each year the Parties will agree a
forward exchange rate to be applied for the following year, effective 1 January,
as defined by the Bloomberg.com one Year Forward Rate. Patheon will adjust the
Base Fee, Product Fees, Technology Transfer Fees, any batch fees under the
Technology Transfer Agreement and any other agreed fees such as fees for
Additional Services to reflect the forward exchange rate (GBP value per contract
at the forward rate) for each calendar year. The first adjustment will be
effective from 1 January 2018. Prior to this date, Patheon will adjust the fees
to reflect the USD/GBP exchange rate for the month in which the invoice is
issued to Client as set out in Section 2.6(c)(ii).
At the end of the calendar year, the Parties will perform a true up based upon,
(i) actual fees using the forward exchange rate and (ii) the theoretical fees
had the Parties applied the monthly average USD/GBP exchange rate as published
on OANDA.com during the calendar year. An example of the calculation is set out
in Schedule G. Where the true up results in a positive or negative balance,
Patheon shall issue a corresponding invoice or credit note in respect of the
balance by 31 March in the following calendar year. Patheon will provide a
report with its true up calculation for the year for Client to review and
comment before any invoice or credit note is triggered. The first true up will
be performed after 31 December 2018.
(ii)    Costs. Patheon will also adjust the Capital Expenditures (as defined in
the Technology Transfer Agreement), Material Costs, Maintenance Costs, Disposal
Costs, charges for Bill Back Items and any other costs that are passed through
to Client to reflect the USD/GBP exchange rate as published on Bloomberg.com for
the month in which the invoice is issued to Client. This adjustment will be made
and communicated to Client prior to being invoiced by Patheon.
2.2    Failure or Inability to Supply Product.
(a)    Patheon shall ensure that Product is Manufactured and delivered to Client
on a timely basis consistent with the terms of this Agreement (including the
Forecast and Purchase Order procedures set forth in Section 2.3). In the event
that Patheon, at any time during the Term, is unable or shall have reason to
believe that it will be unable to supply Client with the full quantity of
Product forecasted to be ordered or actually ordered by Client in a timely
manner and in conformity with the warranty set forth in Section 6.3 (whether by
reason of force majeure or otherwise), Patheon shall notify Client thereof in
writing on or before [***] business days setting out the reasons for such
inability to supply. Promptly thereafter, the Parties shall meet to discuss how
Client shall obtain such full quantity of conforming Product and Patheon will
take all such actions as may be reasonably agreed by the Parties to minimise any
delay. Compliance by Patheon with this Section 2.7(a) shall not relieve Patheon
of any other obligation or liability under this Agreement, including any
obligation or liability under Section 2.7(c) below. If Patheon’s inability to
supply is partial, Patheon shall fulfill Purchase Orders with such quantities of
Product as are available and the Client’s payment obligations relating to the
Product Fee shall be reduced accordingly. In the event Patheon’s inability to
meet Purchase Orders or forecasts is due to a shortage

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of production capacity in the Manufacturing Suite, Patheon shall in addition to
the foregoing requirements, promptly notify Client of such shortage of
production capacity and the estimated date such shortage of production capacity
is to end.
(b)    The Parties acknowledge that following Completion of the Tech Transfer
(as defined in the Technology Transfer Agreement), (i) the engineering approach
and footprint agreed by the Parties for the Manufacturing Suite and utility
requirements is intended to provide capacity for the Manufacture of [***] vials
of Product per [***] and (ii) the provision of personnel supporting the
Manufacturing Suite is intended to support the Manufacture of the volumes of
Product as set out in the relevant Forecast. Patheon undertakes to maintain such
capacity and associated support processes for the Term in order to be able to
ramp up to manufacture of at least [***] vials of Product per year within any
[***] period, subject to Client’s provision of Forecasts for such volumes in
accordance with Section 2.3(a). Patheon shall not without Client’s prior written
consent take any step that might reduce this capacity.
(c)    If Patheon fails to Manufacture the full quantity of Product specified in
a Purchase Order by the Agreed Delivery Date and in conformity with the warranty
set forth in Section 6.3 (and such failure is directly due to the acts or
omissions of Patheon where such acts or omission does not constitute a force
majeure event pursuant to the terms of Section 10.2), and Patheon is unable to
cure such failure on or before [***] days, in full and final settlement of such
failure, Client, at its option, may cancel the unfulfilled portion of such
Purchase Order, in which event Client shall have no liability with respect to
the portion of such Purchase Order so cancelled. The cancelled portion of the
Purchase Order shall count as ordered Product for the purposes of measuring On
Time In Full Delivery Performance in accordance with Schedule D.
(d)    On Time In Full Delivery. The Parties shall measure the delivery
performance of Patheon under this Agreement after each anniversary of the
initial batch of commercial Manufacture of Product, and make any shortfall or
bonus credit based on Patheon’s delivery performance as set out in Schedule D.
2.3    Non-Conforming Product.
(a)    In the event Patheon discovers a potential Non-Conforming Product prior
to delivery of such Product to Client, Patheon shall suspend any planned release
or delivery of such Products in accordance with the Quality Agreement and
provide written notice to Client as soon as practicable describing in detail the
Non-Conforming Product and the potential cause of such Non-Conforming Product.

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(b)    Client will perform a customary inspection of the Products Manufactured
by Patheon on receipt. Such inspection will be limited to a visual inspection of
the shipment-ready packaged Products (and associated shipping documentation) and
Client will not be obliged to perform any testing of the Product. Client shall
(i) on or before [***] days after delivery thereof by Patheon or (ii) on or
before [***] days after Client discovers or is informed of a discovery of
nonconformity that could not reasonably have been detected by the customary
inspection on delivery (but not after the expiration date of the Product), give
Patheon notice of any Non-Conforming Product (including a sample of such
Non-Conforming Product, if applicable) (a “Deficiency Notice”). Should Client
fail to give Patheon the Deficiency Notice on or before the expiry of the
applicable notice period, then the delivery will be deemed to have been accepted
by Client. Patheon will have no liability whether pursuant to this Section 2.8,
Section 3.12 or Section 3.14 or otherwise for any Non-Conforming Product for
which it has not received a Deficiency Notice on or before the expiry of the
applicable notice period.
(c)    Following receipt of a Deficiency Notice Patheon shall conduct a
root-cause analysis to verify whether a Product constitutes a Non-Conforming
Product and, if found, to determine the cause of such Non-Conforming Product
(including by undertaking an appropriate evaluation of a Non-Conforming Product
sample, as applicable). Client shall provide reasonable cooperation to Patheon
in connection with any such root-cause analysis and the payment obligation in
relation to the Product Fee for such Product shall be suspended pending
resolution of the issue. Patheon shall notify Client in writing of its
determination regarding whether the Product constitutes a Non-Conforming Product
on or before [***] days after either discovery of the Non-Conforming Product or
receipt of such Deficiency Notice from Client, as applicable. Such notification
shall include Patheon’s good faith determination of the cause of the
Non-Conforming Product. At Client’s request and following the issue of a
Purchase Order from Client, Patheon will use Commercially Reasonable Efforts to
deliver a replacement delivery of the Product to Client as soon as practicable
after receipt of the Deficiency Notice (subject to Client supplying Patheon with
Client-Supplied Materials, if required) in order to ensure continuity of supply,
and Client shall pay Patheon for such delivery in accordance with the terms of
this Agreement.
(d)    Patheon Nonconformance
(i)    “Patheon Nonconformance” shall mean Patheon’s failure to [***].
(ii)    In the event of a Non-Conforming Product caused by a Patheon
Nonconformance, Patheon shall reimburse Client for:
1.
the Product Fees in respect of Non-Conforming Products; and

2.
any shipment costs incurred by Client in the event that the Non-Conforming
Product was shipped from the Facility at the time of the discovery of the
Patheon Nonconformance (“Shipment Costs”); and

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3.
cost of losses of [***] incorporated into Non-Conforming Product,

in each case, to the extent applicable and/or already paid by Client.
(iii)    Patheon’s obligation to reimburse Client for Client-Supplied Materials
incorporated into Non-Conforming Product caused by a Patheon Nonconformance will
be captured and calculated in the Yield Reimbursement Payment under Section 2.9
which shall be subject to the limitation of liability in Section 9.5(a) herein.
(iv)    [***] shall not apply in relation to (A) the internal expenses incurred
by Patheon to supply conforming Product to Client pursuant to Section 2.8(c) if
this is to replace Non-Conforming Product caused by a Patheon Nonconformance, or
(B) the cost of any [***] or any Shipment Costs or the reimbursement of the
Product Fee pursuant to Section 2.8(d)(ii). Client will not be liable to pay
Product Fees for Non-Conforming Product caused by a Patheon Nonconformance and
Patheon shall have no obligation to reimburse any unpaid Product Fees for
Non-Conforming Product caused by a Patheon Nonconformance.
(v)    If the Non-Conforming Product was caused by any reason other than a
Patheon Nonconformance, as may be determined by an Expert in accordance with
Section 2.8(d)(vi), Client shall be liable for all expected Product Fees for
such Non-Conforming Product (to the extent not already paid), provided that
where the cause of non-conformance is not identifiable but a Patheon
Nonconformance has occurred, then Client shall be liable for [***] of the
Product Fees.
(vi)    If, following the root-cause analysis described in Section 2.8(c),
Patheon notifies Client that it does not believe the Product is a Non-Conforming
Product, or if the Parties disagree as to the cause of a Non-Conforming Product,
the Parties shall first submit such dispute to the Project Managers for prompt
resolution. If the Project Managers cannot resolve the dispute, the Parties
shall submit the dispute to an independent expert or (if mutually agreed to by
the Parties) a testing lab agreed by the Parties (an “Expert”) for evaluation,
provided that both Parties shall be entitled to observe and obtain copies of all
results of such evaluation. The Expert shall determine (i) whether the Product
is a Non-Conforming Product and (ii) the cause (or likely cause) of the
Non-Conforming Product. Both Parties shall cooperate with the Expert’s
reasonable requests for assistance in connection with its evaluation hereunder.
The findings of the Expert shall be binding on the Parties, absent fraud or
manifest error. The Expert shall act as an expert and not as an arbitrator and
(unless the Expert otherwise determines) the fees and expenses of the Expert
shall be borne (1) by Patheon if the testing confirms the Non-Conforming Product
and the cause or likely cause is found to be a Patheon Nonconformance; (2) by
Client if the testing confirms the Non-Conforming Product and the cause or
likely cause is found not to be a Patheon Nonconformance or if the cause or
likely cause of such non-conformance is not identifiable; or (3) by the Party
stating the Product was Non-

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Conforming Product in the event the testing concludes that the Product meets the
warranty set forth in Section 6.3. Costs of dealing with Product complaints and
inquiries will be dealt with in accordance with Section 3.12. Costs of recalls
will be dealt with in accordance with Section 3.14. Patheon shall have no
liability for any Non-Conforming Product unless such Non-Conforming Product is
identified as being due to a Patheon Nonconformance.
2.4    Yield reconciliation
(a)    During its performance of the Manufacturing Services, on an annual basis
Patheon is expected to produce a certain yield of Product using Client-Supplied
Material (the “Expected Yield”). The initial Expected Yield shall be calculated
and mutually agreed by the Parties after the first [***] batches of commercial
Product Manufactured by Patheon. Pending such agreement, the Expected Yield
shall be [***], but shall not be contractually binding and the Parties
acknowledge that this may not be attainable due to the limited experience that
Patheon will have in Manufacturing commercial Product. Accordingly the Yield
Reimbursement Payment and credit set out in Section 2.9(c) shall not apply to
the first [***] batches of commercial Product Manufactured by Patheon.
(b)    On a [***] basis during the Term, Patheon shall provide Client with a
report in respect of the previous [***] and [***] to date showing:
(i)    the number of vials of Products released to be delivered to Client in
accordance with the terms of this Agreement in the applicable periods;
(ii)    Patheon’s inventory of Client-Supplied Materials, quantity of
Client-Supplied Materials that complies with Section 2.2(k) received at the
Facility, Quantity Dispensed, Quantity Converted, and such additional
information as the Parties may agree; and
(iii)    the Achieved Yield in [***] and year to date, where “Achieved Yield”
shall be calculated pursuant to an equation to be agreed by the Steering
Committee taking into account Client-Supplied Materials that have expired as a
result of a Patheon act or omission and any Client-Supplied Materials lost in
the warehouse prior to and during Manufacture, but excluding (i) Client-Supplied
Materials retained by Patheon as samples; (ii) Client-Supplied Materials
contained in Product retained as samples; (iii) Client-Supplied Materials used
in testing (if applicable); (iv) any agreed yield reductions arising from
specific market related requirements such as visual inspection of the Product
that are not part of normal processing and (v) Client-Supplied Materials
received and used by Patheon pursuant to the Technical Transfer Agreement.
(c)    In the event the Achieved Yield in any year after the date of Manufacture
of the [***] of commercial Product is more than [***]% lower than the
then-current Expected Yield for such year, (i) Patheon and Client will engage in
good faith discussions to agree a remediation plan describing the steps to be
taken to achieve the then-current Expected Yield and

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(ii) Patheon will reimburse Client for excess [***] used by Patheon as a result
of Patheon’s failure to meet the Expected Yield in such batches (i.e.,
reimbursement to Client for the actual costs of any [***]) subject to the
limitation of liability in Section 9.5(a) (the “Yield Reimbursement Payment”).
In the event the Achieved Yield in any year is more than [***]% greater than the
then-current Expected Yield for such year, Patheon shall be entitled to reduce
any Yield Reimbursement Payment to be made in the next year by an amount equal
to the value of the excess [***] that would have been used by Patheon if the
Achieved Yield for such calendar year was equal to the then-current Expected
Yield in such batches.
(d)    Patheon shall use Commercially Reasonable Efforts to drive year on year
improvements in the Achieved Yield and the Expected Yield.
2.5    Equipment and Amendment of Product Specifications, Manufacturing Process,
Equipment and Formulation.
(a)    Equipment.
(i)    Title to all Client Manufacturing Equipment will be held by Client or a
Client Affiliate. Title to all Patheon Manufacturing Equipment will be held by
Patheon.
(ii)    Patheon is authorized to use the Client Manufacturing Equipment for the
purposes of performing the Manufacturing Services for Client. Patheon may not
move the Client Manufacturing Equipment from the Facility nor use the Client
Manufacturing Equipment to perform manufacturing services for other clients
without the Client’s prior written consent.
(iii)    Patheon will not sell or offer to sell, assign, pledge, lease or
otherwise transfer or encumber the Client Manufacturing Equipment or any
interest therein, without the prior written consent of Client. Patheon will not
create any adverse lien, security interest or encumbrance in relation to the
Client Manufacturing Equipment.
(iv)    Patheon will use the Client Manufacturing Equipment in accordance with
the Equipment Standard Operating Procedures or the relevant manufacturer’s
instructions and Client’s direction (where agreed by the Parties, if any).
(v)    During the Term, Patheon shall, at its cost, keep the Client
Manufacturing Equipment secure.
(vi)    Client shall be responsible for additions and replacement cost of any
(i) Client Manufacturing Equipment and (ii) Patheon Manufacturing Equipment that
is used only in connection with the Manufacture of the Product or that is used
for Client and other clients of Patheon (the cost of any additions and
replacement for Patheon Manufacturing Equipment that is used for Client and
other clients of Patheon will be apportioned in good faith in proportion to
their use). All replacement parts and repairs to the Client Manufacturing
Equipment will become Client’s property.

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Patheon will not make any material alterations to the Equipment, the
Manufacturing Suite or the Client Manufacturing Process used in the Manufacture
of the Products without Client’s prior written consent.
(vii)    During the Term, Patheon shall provide all Maintenance for the
Equipment and the Facility. Maintenance Costs will be invoiced to Client [***]
in accordance with the invoicing procedure set forth in Article IV, provided
that Patheon may only invoice Maintenance Costs that have been quoted to and
approved in writing by an authorized person of Client in advance. Maintenance
Costs relating to Patheon Manufacturing Equipment that is used for Client and
other clients of Patheon will be apportioned in good faith in proportion to
their use. Notwithstanding the foregoing, with respect to the Client
Manufacturing Equipment and Patheon Manufacturing Equipment, Maintenance Costs
do not include (A) the cost of spare parts (provided that Patheon shall keep
such inventory of original manufacturer spare parts as the Parties agree is
reasonably necessary to maintain the Client Manufacturing Equipment, to include
at a minimum all critical spares recommended by the manufacturer of the Client
Manufacturing Equipment), (B) Equipment breakdowns caused by any reason outside
of Patheon’s reasonable control (other than breakdowns caused by Patheon’s gross
negligence or failure to maintain the Equipment in accordance with the
applicable Equipment Standard Operating Procedures of Patheon or the
manufacturer’s terms of operation and recommended procedures), or
(C) specialized maintenance services not within Patheon’s technical expertise or
that requires specialist equipment where Patheon is required to utilize a Third
Party contractor. Patheon’s costs associated with such spare parts, Equipment
breakdowns and Third Party contractors will be reimbursed by Client as a Bill
Back Item, provided that where such spare parts, Equipment breakdowns and Third
Party contractors relate to Patheon Manufacturing Equipment that is used for
Client and other clients of Patheon, the costs will be apportioned in good faith
in proportion to their use.
(viii)    Patheon shall not be liable for ordinary wear and tear of the Client
Manufacturing Equipment or Patheon Manufacturing Equipment; Patheon shall only
be liable for the repair or replacement of any damage caused to Client
Manufacturing Equipment or Patheon Manufacturing Equipment where such damage
arises due to its gross negligence or willful misconduct or its failure to
maintain Client Manufacturing Equipment or Patheon Manufacturing Equipment
pursuant to the applicable Equipment Standard Operating Procedures of Patheon or
the manufacturer’s terms of operation and recommended procedures. Where this
Section refers to costs relating to any Patheon Manufacturing Equipment, if the
Patheon Manufacturing Equipment is used for Client and other clients of Patheon,
these costs will be apportioned in good faith in proportion to their use.
(ix)    Throughout the Term of this Agreement, Patheon shall maintain property
insurance on all Equipment in the amount equal to at least the replacement value
of such Equipment.

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(x)    Client may examine and inspect the Client Manufacturing Equipment at any
reasonable time (wherever such Client Manufacturing Equipment is located in the
Facility) so that Client can check the Client Manufacturing Equipment’s
existence, condition and proper maintenance.
(xi)    Patheon shall ensure that at all times the Client Manufacturing
Equipment is clearly marked in such a way as to identify that it is owned by
Client. All Client Manufacturing Equipment shall be marked in such a way as to
identify that it is for use only for Client.
(xii)    If any item of the Client Manufacturing Equipment is lost, stolen or
damaged, Patheon will promptly notify Client of such event.
(xiii)    Client shall ensure that on delivery the Client Manufacturing
Equipment complies with all EU mandatory requirements including without
limitation, Supply of Machinery (Safety) Regulations 2008 (UK Regulations,
Secondary UK Legislation), Electrical equipment of machines (General
requirements BS EN 60204-1:2006+A1:2009) (British Product Standards), Machinery
Directive 2006/42/EC (European Union Directive), Low Voltage Directive (LVD)
2006/95/EC (European Union Directive), and Electromagnetic Compatibility (EMC)
Directive  2004/108/EC (European Union Directive).
(b)    Change control
(i)    For changes to the Specifications, Quality Agreement, the Client
Manufacturing Process, the Equipment, the Manufacturing Services to be provided
pursuant hereto, the Transfer Services to be provided pursuant to the Technology
Transfer Agreement or the formulation of the Product that are required by
Applicable Law (collectively, “Required Manufacturing Changes”), Patheon and
Client shall cooperate to promptly make such changes within the required
timeline and assess filing implications (prior approval, changes being effected,
etc.).
(ii)    For changes to the Specifications, Quality Agreement, the Client
Manufacturing Process, the Equipment, the Manufacturing Services to be provided
hereto, the Transfer Services to be provided pursuant to the Technology Transfer
Agreement, or the formulation of the Product that are not Required Manufacturing
Changes (collectively, “Discretionary Manufacturing Changes”), Patheon shall
provide Client with an estimate of the timeframe and cost required to implement
the same. Patheon and Client must each agree to any Discretionary Manufacturing
Changes and shall cooperate in making such changes, and each agrees that it
shall not unreasonably withhold or delay its consent to such Discretionary
Manufacturing Changes. Once Client has approved the estimate in writing, Patheon
shall implement the change within the agreed timeframe. Together Parties will
assess filing implications, as for example, annual reportable status.

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(iii)    Notwithstanding the foregoing, all internal and external costs,
including, without limitation, costs of obsolete Materials, work-in-process and
Product associated with Required Manufacturing Changes shall be allocated
between the Parties as follows: (x) to the extent that the change relates to the
Product, the Specifications, the Client Manufacturing Process, the Equipment,
the Manufacturing Services or the Manufacturing Suite or the Transfer Services
to be provided pursuant to the Technology Transfer Agreement, Client shall pay
the costs and expenses of implementing such change together with the actual cost
of write-off (including waste disposal costs) of any inventory of Products or
Materials rendered obsolete as a result of the change, provided that Client
shall not be liable for the write-off costs of any Materials purchased in excess
of those amounts needed to meet Purchase Orders or as otherwise agreed pursuant
to Section 2.2(u); and (y) to the extent that the change results from a change
in GMP or Applicable Laws that requires changes to the Facility or Manufacturing
process (other than as a direct result of changes to the Product, the
Specifications, the Client Manufacturing Process, the Equipment, the
Manufacturing Services or the Manufacturing Suite or the Transfer Services to be
provided pursuant to the Technology Transfer Agreement), the allocation of such
benefits shall be discussed in good faith and allocated between the Parties as
agreed at the time, having regard to any other Patheon customers who will
benefit from the change.
(iv)    The cost of implementing Discretionary Manufacturing Changes will be
agreed by the Parties.     
(v)    In the event that Client changes the Specifications, Quality Agreement,
the Client Manufacturing Process, the Equipment, the Manufacturing Services to
be provided hereto, the Transfer Services to be provided pursuant to the
Technology Transfer Agreement or the formulation of the Product, or consents to
any change by Patheon, Patheon shall provide to Client at Client’s cost as an
Additional Service any such documentation or other information with respect
thereto as they relate to the Manufacturing Services as Client may reasonably
request in order to obtain or maintain any Regulatory Approval or comply with
GMP or other Applicable Law.
(vi)    Patheon shall not change the Specifications, the Materials or the Client
Manufacturing Process used in the Manufacture of the Products, or make any other
change which may reasonably be expected to have a regulatory impact on the
Product, affect the Marketing Authorization or affect the quality or physical
characteristics of the Product, without first obtaining written consent from
Client.
ARTICLE III.     REGULATORY, ACCESS, AND OTHER MATTERS
3.1    Quality Agreement. Prior to the expiry of the Technology Transfer
Agreement, the Parties shall enter into a mutually agreed upon quality agreement
(“Quality Agreement”). If there is any inconsistency between this Agreement and
the Quality Agreement, the terms of the Quality

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Agreement shall control solely with respect to quality issues, and this
Agreement shall control with respect to all other issues.
3.2    Quality Assurance.
(a)    Patheon shall at all times ensure that agreed quality assurance tests are
adopted and that reference and retention samples are taken, analysed and
retained in accordance with the Quality Agreement. Such samples shall
(notwithstanding any termination of this Agreement) be retained by Patheon for
the periods prescribed in the Quality Agreement at no additional cost.
(b)    Unless otherwise specified in the Quality Agreement, Patheon shall
provide to Client, in a timely manner, sufficient quantities of reference
standards for the Products to enable Client to carry out and/or maintain the
necessary testing capability to comply with its Regulatory Obligations and the
obligations set out in the Quality Agreement throughout the Term.
(c)    Patheon shall institute and maintain process controls during the
Manufacture of the Products in accordance with GMP and shall maintain full
records of such process controls which shall be made available to Client on
request together with retained in-process samples. Such records must align with
documentation set out in the Specifications and samples shall be retained by the
Patheon for such period as may be specified in the Quality Agreement or as
otherwise required by Applicable Law at no additional cost.
3.1    Release. All Product shall be released in accordance with the terms of
the Quality Agreement.
3.2    Maintenance of Facility.
(a)    Patheon shall Manufacture the Product exclusively at the Facility, unless
Client has granted prior written consent to Manufacture the Product at any other
facility, such consent to be granted by Client in its sole discretion.
(b)    Subject to Section 2.10(b), Patheon shall at its own cost ensure that any
and all necessary licenses, registrations, and (subject to any payments required
under Section 3.10(b)) Regulatory Authority approvals have been obtained in
connection with the Facility and Equipment used in connection with the
Manufacture of the Product by Patheon.
(c)    Subject to Section 2.10, Patheon shall maintain the Facility and
Equipment in a state of repair and operating efficiency consistent with the
requirements of the Specifications, the Regulatory Approvals, the Client
Manufacturing Process, GMP, and all other Applicable Law. Prior to each use of
Equipment in Manufacturing the Product, Patheon shall ensure that such Equipment
is cleaned and consistent with any procedures reasonably established by Client
and notified to Patheon, the Specifications, the Regulatory Approvals, the
Client Manufacturing Process, GMP, and all other Applicable Law. Without
limitation of the foregoing, Patheon agrees to implement, in connection with the
Manufacture of the Product, quality assurance and quality

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control procedures, including validation protocols and process change procedures
that are reasonably satisfactory to Client.
(d)    Patheon shall maintain in the Facility an adequate GMP and temperature
controlled area for the Product, all intermediates thereof and Materials used in
Manufacturing the Product in accordance with the Specifications, the Regulatory
Approvals, the Client Manufacturing Process, any risk mitigation plan, the
Quality Agreement, GMP, and all Applicable Law. All Product, intermediates and
Materials (as applicable) shall be held by Patheon in a GMP and temperature
controlled area (on a separate pallet and SAP reference from other products)
until delivery to Client. In order for Patheon and Client to identify any
potential effects on quality, safety or efficacy of the Products, subject to
obligations of confidentiality that Patheon owes to Third Parties, Patheon shall
disclose to Client (on a no-names basis) information relating to the nature of
any other [***]. Client agrees that Patheon may, disclose information (on a
no-names basis and subject to ARTICLE VII) relating to the nature of Client’s
Product to other clients of Patheon at the Facility if requested.
(e)    Patheon shall only use qualified disposal services or sites that have
appropriate environmental and operating permits and are in compliance with the
Quality Agreement and Applicable Law.
(f)    Patheon shall develop and put in place a disaster recovery and business
continuity plan in respect of the Manufacture of Products at the Manufacturing
Suite by 30 June 2018, and provide Client with a copy of the same on request.
Client will provide Patheon with details of its requirements for these plans
within a reasonable period from the Effective Date.
3.3    Client On Site Representatives; Project Managers; Steering Committee
Meetings.
(a)    For so long as Patheon is obliged to Manufacture and supply the Product
for Client, Client shall have the right at all times throughout the Term to have
[***] representatives present (or other number as mutually agreed to by the
Parties) (each, a “Client On Site Representative”) in that portion of Patheon’s
Manufacturing facilities that is being used to Manufacture the Product or store
Materials to observe the procedures and processes used to Manufacture the
Product. Subject to the following sentence, such representatives shall have full
access to the Manufacturing Suite, to any other parts of the Facility that
relate to the Manufacture of the Product, and to all non-financial records that
relate to the Product, the Materials and Bill Back Items. Patheon shall provide
reasonable (semi-permanent) on-site accommodations at the Facility for the
Client On Site Representatives (e.g., office space) provided that Client
complies with the terms set out in Schedule E. For the avoidance of doubt, the
term “non-financial records” as used in this Agreement does not include the
Reports (defined in Section 3.13 below). Client On Site Representatives shall be
appropriately trained by Client (e.g., GMP training) and shall observe at all
times Patheon’s policies and procedures (as amended from time-to-time) as they
pertain to the Facility, including policies relating to health and safety and
compliance with GMP, and comply with all reasonable directions of Patheon in
relation to the same; provided that Client is given notice of such policies and
given a reasonable period of time to review and implement such policies. Patheon
may refuse or limit in its sole discretion at any time admission to the Facility
by any Client On Site Representative who fails to observe such policies or
comply with such reasonable directions.

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Client On Site Representatives shall have (i) no management authority over any
Patheon employee and (ii) no authority to conclude contracts on behalf of
Client.
(b)    Patheon and Client will each appoint a project manager (each, a “Project
Manager” and, together, the “Project Managers”), who will meet as needed to
resolve any issues or problems arising in the performance of this Agreement.
Client’s Project Manager may be one of the Client On Site Representatives.
(c)    Following completion of registration batches the Parties shall establish
a steering committee in respect of commercial supply (the “Commercial Steering
Committee”), which shall meet at least quarterly in order to manage the long
term manufacturing and supply aspects of this Agreement. The responsibilities of
the Commercial Steering Committee shall include without limitation:
(i)     reviewing any ongoing development activities for the Products that may
lead to changes in demand;
(ii)    reviewing and discussing any trends or concerns in relation to delivery
performance, Achieved Yields, usage of Client-Supplied Materials, quality
related issues or plans to improve performance under the Agreement;
(iii)    reviewing any potential restrictions on the availability of additional
space within the Facility, which shall be notified by Patheon sufficiently far
in advance of any proposed agreement with a Third Party in order for Client to
be able assess its likely future requirements and for the Parties to have the
opportunity to negotiate in good faith any reservation of the same; and
(iv)    performing such other responsibilities as the Parties may agree.
Unless otherwise agreed by the Parties the Commercial Steering Committee shall
follow the membership and procedural arrangements agreed for the steering
committee under the Technology Transfer Agreement.
3.4    Notification of Regulatory Inspections. Patheon shall notify Client by
telephone on or before [***], and in writing on or before [***], after learning
of any proposed or unannounced visit or inspection of any part of the Facility
which relates to the Manufacture of the Product by any Regulatory Authority,
including the Occupational Safety and Health Administration or any equivalent
governmental agencies of the country of Manufacture, and provide all relevant
information known to Patheon regarding such investigation. Patheon shall permit
Client or its agents to be present at the Facility to support Patheon during
such visit or inspection if it impacts the Product or affects the Manufacturing
Suite. The responsibility for conducting the inspection rests with Patheon.
Patheon shall provide to Client in so far as it affects the Product or the
Manufacturing Suite either a copy of or a summary of any report and other
written communications received from such Regulatory Authority in connection
with any visit or inspection, including FDA Form 483 observations and responses
(or any equivalent observations and responses from any Regulatory Authority
under Applicable Law). Such copy or summary shall be provided to

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Client on or before [***] business days of Patheon’s receipt thereof (and may be
redacted as Patheon acting reasonably deems necessary to protect the
confidentiality of matters not affecting the Product or the Manufacturing Suite
or which are confidential to Patheon or to other clients of Patheon). Client
shall have the right to review and comment on any communications with such
Regulatory Authority pertaining to such inspection as set forth in Section 3.17.
In the event that Client is subject to an inspection by any Regulatory Authority
that relates to the Products or Patheon’s performance of its obligations under
this Agreement, Patheon shall provide Client and such Regulatory Authority with
access to Patheon’s non-financial records, the Products and those portions of
the Facility used in the Manufacture of the Products or storage, testing,
handling or receiving of the Materials as required by this Agreement or
otherwise by Applicable Law, in each case subject to payment by Client of the
fees set out in Section 3.10(b).
3.5    Manufacturing Records. Patheon shall maintain, or cause to be maintained,
(a) all records necessary to comply with GMP and all other Applicable Law
relating to the Manufacture of Product, (b) all Manufacturing records, standard
operating procedures, equipment log books, batch records, laboratory notebooks,
and all raw data relating to the Manufacturing of the Product, and (c) such
other records as Client may reasonably require in order to ensure compliance by
Patheon with the terms of this Agreement. The template, form and style of all
records referred to herein are the exclusive property of Patheon; Client
Confidential Information and all Product-specific related information contained
in these records shall be deemed Confidential Information of Client and be
retained for such period as may be required by GMP and all other Applicable Law.
3.6    Bulk Packaging. Client shall specify all bulk packaging to be used for
the Product. Patheon agrees to use only such bulk packaging on the Product as
set out in the Specifications.
3.7    Compliance with Applicable Laws. Patheon shall comply and shall cause
each of its Materials and Bill Back Items suppliers to comply with the Quality
Agreement, GMP and Applicable Law in carrying out the Manufacturing of the
Product and its other duties and obligations under this Agreement.
3.8    Compliance Audits.
(a)    With the exception of “for cause” audits (e.g., audits arising in the
event of regulatory issues or material Product conformity issues), Client and
its designated representatives shall have the right to audit [***] all
applicable non-financial records of Patheon for the purpose of determining
Patheon’s compliance with the obligations set forth in this Agreement, including
Sections 2.2(a) and 6.2, and the terms of any Purchase Order. Such audit right
shall include the right to inspect: (a) the Materials used in the Manufacture of
the Product, (b) the holding facilities for such Materials, (c) the
Manufacturing Suite and all Equipment used in the Manufacture of the Product,
(d) all non-financial records relating to the Manufacturing Suite and the
Manufacturing of the Product (subject to any other restrictions set forth in
this Agreement) and (e) all other documentation set forth in the Quality
Agreement, in order to carry out a GMP, quality and/or compliance audit of those
parts of the Facility involved in, or which could affect, the Manufacture of the
Products. Client shall provide Patheon with [***] days prior advance notice of
its intention to conduct such audit and the Parties will determine a mutually
agreeable date for such

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audit. Client shall include no more than [***] of Client’s representatives in
each such audit, with each such audit lasting no more than [***] days, in each
case without Patheon’s prior written consent. Client shall also have the right
to carry out follow up audits subject to payment by Client of the fees set out
in Section 3.10(b) if any observations have been noted during any audit carried
out pursuant to this Section 3.10(a) (excluding any “for cause” audits as
described above or any audits where critical or major observations have been
noted).
(b)    Client may request additional GMP-type audits, additional audit days, or
the participation of additional auditors subject to payment to Patheon of a fee
of [***] for each additional audit day and [***] per audit day for each
additional auditor. Patheon will support the first Product approval, including
its inspection if required, of the FDA or equivalent regulatory launch for other
jurisdictions (where applicable). Additional support (including, without
limitation, subsequent regulatory launches or Product approval
inspections/resulting reports for other jurisdictions) will be subject to
additional fees.
(c)    Patheon shall use Commercially Reasonable Efforts to ensure that any
corrective or preventative actions identified in any audit carried out pursuant
to this Section 3.10 that are agreed by the Parties are carried out in
accordance with any agreed timeline and subject to payment by Client of any
agreed fees.
(d)    Patheon shall be responsible for ensuring the GMP compliance status of
any authorised sub-contractors used in relation to the performance of its
obligations under this Agreement as described in Section 2.2(d). Patheon shall
assess each sub-contractor using Patheon’s standard vendor assurance programme
and shall report its findings to Client within [***] business days of a request
from Client.
3.9    Inventory Reviews. Without limiting the foregoing, Client shall have the
right, with Patheon’s assistance, to conduct an annual inventory count of the
Materials and of the Products. Following an audit or inventory, Client may
discuss its observations and conclusions with Patheon, and Patheon shall
promptly implement such corrective actions after notification thereof by Client.
In the event the Parties are unable to agree upon whether or not corrective
actions are necessary, such dispute shall be resolved pursuant to the terms of
Section 10.10.
3.10    Product Inquiries and Complaints.
(a)    With respect to Products Manufactured by Patheon, Patheon will promptly
submit to Client any Product safety and efficacy inquiries, Product quality
complaints, and adverse drug event reports that it receives, together with all
available evidence and other information relating thereto, in accordance with
procedures to be agreed upon by the Parties. Patheon will promptly advise Client
of any occurrence or information which arises out of the Manufacture of Products
which has or could be reasonably expected to have adverse regulatory compliance
and/or reporting consequences concerning the Products, and provide relevant
information to Client upon request. Except as otherwise required by, or to
comply with, Applicable Law or the terms of this Agreement, Client, as the Party
holding the applicable Marketing Authorization, will be responsible for
investigating and responding to all such inquiries, complaints, and adverse
events regarding the Product, and reporting to the FDA or any other Regulatory
Authority.

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(b)    Pursuant to any reported complaint, adverse drug event or other issue
which may pertain to the Manufacture of the Products Patheon will promptly
conduct all such necessary internal investigations as may be necessary to
determine the validity of such complaint, including performing analytical
testing of corresponding Products or retention samples, and shall provide the
results thereto to Client as soon as reasonably practicable, but no later than
[***] days after Client’s request. Such testing shall be performed using
approved testing procedures as set forth in the applicable Regulatory Approval
or the Quality Agreement. If such investigation or analytical testing concludes
that the reported complaint or adverse drug event was the result of a Patheon
Nonconformance, subject to Client having provided to Patheon a Deficiency Notice
in accordance with the provisions of Section 2.8(b) including as to timing,
Patheon shall [***] associated with such complaint or adverse drug event and
incurred by Client with respect to such Non-Conforming Product, including
reasonable [***]. Costs of recalls will be dealt with in accordance with Section
3.14. If such investigation or analytical testing concludes that the reported
complaint or adverse drug event was not the result of a Patheon Nonconformance,
Client shall compensate Patheon for all costs associated with such complaint or
adverse drug event and incurred by Patheon with respect to such Non-Conforming
Product, including costs of recalls, market withdrawals, returns, and
destruction.
(c)    If the Parties disagree as to which Party is responsible, Patheon and
Client representatives shall attempt to resolve such dispute. If the
representatives cannot resolve such dispute on or before [***] days, the
retention samples shall be submitted by Patheon and Client to an Expert and
Section 2.8(d)(vi) shall apply.
3.11    Reports. Prior to the start of Patheon’s commercial Manufacture of the
Product (or as reasonably requested by Client prior to such date), Patheon and
Client will work together in good faith to develop and agree upon Patheon’s
ordinary course reporting obligations. Such reports (“Reports”) will include
those reports as necessary for Client to (a) manage Product inventory; (b)
measure the Achieved Yield and whether all Products on agreed Purchase Orders
order are delivered on time and in full; (c) manage its financial close and
reporting; (d) monitor on-going Product and process performance for its internal
analysis and reporting; and (e) comply with Applicable Law. Patheon will deliver
such reports via electronic delivery methods, including by utilizing Patheon’s
existing IT systems as practicable.
3.12    Product Recalls.
(a)    In the event (i) any Regulatory Authority issues a request, directive, or
order that Product be recalled, (ii) a court of competent jurisdiction orders
such a recall, or (iii) Client as holder of the applicable Marketing
Authorization shall reasonably determine that Product should be recalled,
withdrawn, or a field correction issued, the Parties shall take all appropriate
corrective actions, and shall cooperate in the investigations surrounding the
recall. In the event that Client or a Regulatory Authority determines that
Product should be recalled, the recall strategy shall be developed by Client in
consultation with Patheon to the extent possible and followed by Patheon. In the
event of any Product recall, withdrawal, or field correction resulting from a
Patheon Nonconformance, Patheon shall [***] associated with such recall,
withdrawal, or field correction, which shall include [***] of the recalled
Product and all other documented [***] incurred

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in connection with such recall, plus reasonable [***] costs incurred by Client
with respect to such Product, up to the maximum liability limits set forth in
Section 9.5. In all other circumstances, all costs associated with any Product
recall, withdrawal, or field correction shall be borne by Client.
(b)    If there is any dispute concerning which Party’s acts or omissions gave
rise to such recall of Product, Patheon and Client representatives shall attempt
to resolve such dispute. If the representatives cannot resolve such dispute on
or before [***] days, the matter shall be submitted by Patheon and Client to an
Expert and Section 2.8(d)(vi) shall apply.
3.13    Payment Audits.
(a)    Upon [***] days’ prior written notice, Client may audit any Third Party
invoices subsequently invoiced to Client pertaining to Patheon’s provision of
Equipment, Materials, Bill Back Items and Additional Services hereunder;
provided, however, that Client will not be entitled to more than one audit
during any [***] month period. Such audits will be conducted during normal
business hours, without undue disruption to Patheon’s business, and may be
conducted by Client, or by an independent public accounting firm designated by
Client who is bound by confidentiality obligations at least as stringent as
those set forth in the Confidentiality Agreement. Client will bear the full cost
of the performance of any such audit.
(b)    If, as a result of any audit of the Third Party invoices, it is shown
that the payments or credits from one Party to the other under this Agreement
with respect to the period of time audited were less than or more than the
amount that should have been paid or credited, then the Parties will reconcile
the amounts owed by each Party to the other.
3.14    Subcontractors. Patheon may arrange for Third Party subcontractors
(“Third Party Subcontractors”) to perform specific Manufacturing Services (such
as testing or analysis) under this Agreement with Client’s written consent or at
Client’s request. Patheon’s liability for Third Party Subcontractors will remain
subject to all limitations on Patheon’s liability as set out in this Agreement.
Patheon will have no liability arising from the performance of Manufacturing
Services by Third Party Subcontractors, (i) to the extent that the Third Party
Subcontractor is following the direct instructions of Client, or (ii) that are
chosen or requested by Client and that provide a service or materials pursuant
to their standard legal terms, provided that Patheon has used Commercially
Reasonable Efforts to enforce such terms or (at Client’s discretion and where
possible to do so) to support Client in enforcing such terms. Patheon shall not
be obliged to use a Third Party Subcontractor requested by Client if it does not
comply with Patheon’s supplier qualification requirements.
3.15    Regulatory Filing Obligations. (a) Except as otherwise set forth in this
Agreement or the Technology Transfer Agreement, each Party will be responsible
for all routine filings and communications with Regulatory Authorities
(“Regulatory Filings”) required with respect to such Party’s Regulatory
Obligations hereunder.
(a)    “Regulatory Obligations” shall mean:

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(i)    with respect to Client, any Regulatory Filings pertaining to Regulatory
Approvals; and
(ii)    with respect to Patheon, any Regulatory Filings pertaining to the
Manufacture of the Products at the Facility, including in connection with a
Facility inspection by a Regulatory Authority (e.g., those described in
Section 3.6).
(b)    Each Party shall have the sole responsibility for Regulatory Filings in
respect of its Regulatory Obligations and shall provide the other with a copy of
any Regulatory Approval relevant to this Agreement on request, to the extent
reasonably required for its Regulatory Filings or in order to satisfy its
obligations under Applicable Laws.
(c)    Cooperation. Each Party (“Non-Filing Party”) will provide reasonable
assistance and cooperation free of charge to the other Party (“Filing Party”) in
connection with the Filing Party’s Regulatory Obligations consistent with the
terms of this Section 3.17 and the Non-Filing Party’s obligations under this
Agreement. The Filing Party shall notify the Non-Filing Party in writing of any
written communications received by the Filing Party from a Regulatory Authority
related to the other Party’s Regulatory Obligations on or before [***] business
days after receipt thereof. The Filing Party shall consult with the Non-Filing
Party concerning the response of the Filing Party to each such communication,
unless such filing is not relevant to the Non-Filing Party’s Regulatory
Obligations.
(d)    Verification of Data. Prior to filing any documents or communications
with a Regulatory Authority that incorporate or uses data generated by the
Non-Filing Party or otherwise relate to the Non-Filing Party’s Regulatory
Obligations, the Filing Party will give the Non-Filing Party a draft of such
document or communication (“Initial Draft”) to give the Non-Filing Party the
opportunity to verify the accuracy and regulatory validity of such Initial
Draft. The Non-Filing Party shall be given a minimum of [***] calendar days to
review the Initial Draft, but the Parties may mutually agree to a different time
for the review as needed under the circumstances. The Initial Draft may be
redacted by the Filing Party as reasonably deems necessary to protect the
confidentiality of matters not affecting the Non-Filing Party or which are
confidential to the Filing Party or to other clients or customers of the
Non-Filing Party. The Parties agree that in reviewing the Initial Draft, the
Non-Filing Party’s role will be limited to verifying the accuracy of the
description of its Regulatory Obligations or accuracy of its data or information
in the Initial Draft.
(e)    Inaccuracies. If the Non-Filing Party determines that any of its data or
information in the Initial Draft is inaccurate or any other errors relating to
the Non-Filing Party’s Regulatory Obligations, the Non-Filing Party will notify
Filing Party in writing of such inaccuracy and provide a recommendation to
remediate the Initial Draft. Such notice shall also include documentation and
data sufficient to substantiate the Non-Filing Party’s claim that the Initial
Draft is inaccurate to the Filing Party’s reasonable satisfaction. The
Non-Filing Party shall provide comments to the Initial Draft no later than [***]
prior to the required filing date with the applicable Regulatory Authority. If
the Non-Filing Party does not provide comments or notify the Filing Party of
inaccuracies on or before such [***] period, the Non-Filing Party will be deemed
to have approved any data or language related to its Regulatory Obligations in
the Initial Draft. The Filing Party shall be required to incorporate the
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to an error in the Non-Filing Party’s data or information or the Non-Filing
Party’s Regulatory Obligations. The Parties will work together in good faith to
resolve any inaccuracies contained in the Initial Draft as soon as practicable
under the circumstances to prevent a delay or postponement of such filing (or
any related inspections by such Regulatory Authority to which the filing
relates).
(f)    Responsibilities. The Filing Party shall deliver a copy of the final
version of the filing (“Final Filing”) to the Non-Filing Party at least [***]
prior to the required filing date. Subject to the foregoing, the Non-Filing
Party will not assume any responsibility for the accuracy of any other materials
submitted by the Filing Party to a Regulatory Authority in connection with this
Agreement. Except as otherwise set forth in this Agreement or the Technology
Transfer Agreement, the Filing Party is solely responsible for the preparation
and filing of any materials required by a Regulatory Authority with respect to
such Party’s Regulatory Obligations hereunder and any relevant costs will be
borne by the Filing Party.
ARTICLE IV.     FEES AND INVOICING
4.1    General. Patheon shall invoice Client for all applicable fees and charges
incurred by Patheon. All invoices shall be sent electronically to [***]. Payment
shall be due [***] days after receipt an undisputed invoice. All fees and costs
in this Agreement are shown in British Pounds (GBP) but which shall be adjusted
as described in Section 2.6(c) so that all invoices from Patheon and payments
from Client to Patheon hereunder shall be in United States Dollars (USD).
4.2    Late Fees. In relation to all invoices issued by Patheon pursuant to this
Agreement, if Client fails to make any payment due to Patheon by the due date
for payment, then, without limiting Patheon’s remedies under Article VIII or at
law, Patheon may charge interest on past due accounts at [***] above the Bank of
England Official Bank Rate per annum.
4.3    Disputed Invoices. If Client disputes any portion of an invoice, (a)
Client shall provide Patheon with written notice of the disputed portion on or
before [***] of receipt by Client of Patheon’s invoice and its reasons therefor
and shall not be obliged to pay such disputed portion unless and until such
disputed portion is determined to be due and owing, and (b) Patheon shall cancel
such invoice and issue a new invoice reflecting the undisputed invoiced amount,
which shall be paid by Client on or before [***] after the date thereof. The
Parties shall use Commercially Reasonable Efforts to resolve the dispute
regarding the disputed amount promptly and in good faith, and if the Parties
agree that a balance is due, Patheon shall issue an invoice for such balance,
and payment shall be due [***] after receipt of such invoice. In the event of
any inconsistency between an invoice and this Agreement, the terms of this
Agreement shall control.
4.4    Taxes.
(a)    VAT.

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(i)    Any payment due to Patheon under this Agreement in consideration for the
provision of Manufacturing Services to Client by Patheon or any payment due to
Patheon under the Technology Transfer Agreement in consideration for the
provision of Transfer Services to Client by Patheon is exclusive of value added
taxes, turnover taxes, sales taxes or similar taxes, including any related
interest and penalties (hereinafter all referred to as “VAT”). If any VAT is
payable on a Manufacturing Service supplied by Patheon to Client under this
Agreement or a Transfer Service supplied by Patheon to Client under the
Technology Transfer Agreement, this VAT will be added to the invoice amount and
will be for the account of (and reimbursable to Patheon by) the Client.
(ii)    If VAT on the supplies by Patheon is payable by Client under a reverse
charge or withholding procedure (i.e., shifting of liability, accounting or
payment requirement to recipient of supplies), Client will ensure that Patheon
will not effectively be held liable for this VAT by the relevant taxing
authorities or other parties.
(iii)    Where applicable, Patheon will use its Commercially Reasonable Efforts
to ensure that its invoices to Client are issued in such a way that these
invoices meet the requirements for deduction of input VAT by Client, if Client
is permitted by law to do so.
(iv)    Each Party will provide the other with reasonable assistance to enable
the recovery, as permitted by Applicable Law, of VAT resulting from payments
made under this Agreement or the Technology Transfer Agreement, such recovery to
be for the benefit of the Party bearing such VAT.
(v)    If Patheon is acting as Client’s buying agent, Patheon will always charge
to the Client VAT in the relevant territory in addition to the amount paid by
Patheon to supplier.
(vi)    Reference to the Manufacturing Services or the Transfer Services in this
Section also includes any element (or the entirety) of the Manufacturing
Services or the Transfer Services characterised as a supply of goods by Patheon,
its Third Party Subcontractors or any tax authority for VAT purposes.
(b)    Duties. Client will bear the cost of all duties, levies, tariffs and
similar charges (and any related interest and penalties) (together “Duties”)
however designated, arising from the performance of the Manufacturing Services
or the Transfer Services by Patheon, including (without limitation) those
imposed as a result of the shipping of Materials or Product to, from or between
Patheon site(s). If these Duties are incurred by Patheon, then Patheon shall be
entitled to invoice Client for these Duties at the time that they are incurred.

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(c)    Withholding Tax.
(i)    Where any sum due to be paid to Patheon under this Agreement or the
Technology Transfer Agreement is subject to any withholding or similar tax,
Client will pay such withholding or similar tax to the appropriate government
authority and deduct the amount paid from the amount then due to Patheon, in a
timely manner and promptly transmit to Patheon an official tax certificate or
other evidence of such withholding sufficient to enable Patheon to claim such
payment of taxes. The Parties agree to cooperate with one another and use
Commercially Reasonable Efforts to reduce or eliminate tax withholding or
similar obligations in respect of royalties, milestone payments, and other
payments made by Client to Patheon under this Agreement or the Technology
Transfer Agreement.
(ii)    Patheon will provide Client any tax forms that may be reasonably
necessary in order for Client not to withhold tax or to withhold tax at a
reduced rate under an applicable bilateral income tax treaty.
(iii)    Each Party will provide the other with reasonable assistance to enable
the recovery, as permitted by Applicable Law, of withholding taxes, or similar
obligations resulting from payments made under this Agreement or the Technology
Transfer Agreement, such recovery to be for the benefit of the Party bearing
such withholding tax.
(d)    No Offset. Any tax or Duty that Client pays, or is required to pay, but
which Client believes should properly be paid by Patheon pursuant to this
Agreement or the Technology Transfer Agreement may not be offset against sums
due by Client to Patheon whether due pursuant to this Agreement or the
Technology Transfer Agreement or otherwise.
ARTICLE V.     INTELLECTUAL PROPERTY
5.1    Ownership.
(a)    Client shall maintain ownership and Control of all of its technology and
Intellectual Property rights existing prior to the Effective Date (“Existing
Client Intellectual Property”).
(b)    Patheon shall maintain ownership and Control of all of its technology and
Intellectual Property rights existing prior to the Effective Date (“Existing
Patheon Intellectual Property”).
(c)    Existing Client Intellectual Property shall include and Client shall own
all right, title, and interest in and to (i) the Product, (ii) the
Specifications, and (iii) the Client Manufacturing Process.
(d)    Existing Patheon Intellectual Property shall include and Patheon shall
own all right, title, and interest in and to the Patheon Manufacturing Equipment
as of the Effective Date.

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(e)    Client shall own all right, title, and interest in and to, all
Intellectual Property with respect to, and any data with respect to:
(i)    (A) any improvement of, modification of, change of, enhancement of, new
indication for, new formula for, new formulation for, new ingredients for, new
dosage for, new dosage strength for, new means of delivery for, or new packaging
for, the Product (“Client Product Improvements”); (B) any improvement of,
modification of, change of, or enhancement of the Specifications (“Client
Specification Improvements”); (C) any improvement of, modification of, change
of, enhancement of, new process for, new procedure for, new step for the Client
Manufacturing Process (the “Client Manufacturing Process Improvements”); and (D)
any improvements of, modification of, change of or enhancement of Client
Manufacturing Equipment (the “Client Manufacturing Equipment Improvements”) in
each of case (A), (B), (C) and (D), (1) that is developed, conceived, or created
after the Effective Date specifically as a result of or in connection with this
Agreement, including Patheon’s Manufacturing of the Product hereunder, (2)
whether or not patentable, (3) whether developed, conceived, or created by
employees of, or consultants to, Client or Patheon, alone or jointly with each
other or with permitted Third Parties (including permitted sublicensees and
subcontractors), and (4) that relates exclusively to the Product,
Specifications, the Client Manufacturing Process or the Client Manufacturing
Equipment as applicable; and
(ii)    any Intellectual Property developed, conceived, or created by Client,
alone or jointly with Third Parties (other than Patheon or its Affiliates, or
their respective employees and consultants), in the course of conducting
activities outside the scope of this Agreement and without any use of any
Existing Patheon Intellectual Property, Patheon Improvements or Patheon
Independent Manufacturing Equipment Improvements (as defined hereunder).
(f)    Patheon shall own all right, title, and interest in and to, all
Intellectual Property with respect to, and any data with respect to:
(i)    any improvement of, modification of, change of, enhancement of any
Patheon Manufacturing Equipment, (1) that is developed, conceived, or created as
a result of or in connection with this Agreement, including Patheon’s
Manufacturing of the Product hereunder, (2) whether or not patentable,
(3) whether developed, conceived, or created by employees of, or consultants to,
Client or Patheon, alone or jointly with each other or with permitted Third
Parties (including permitted sublicensees), and (4) that is of generic
application rather than a specific solution that only has applicability to the
Product, (“Patheon Independent Manufacturing Equipment Improvements”);
(ii)    any improvement of, modification of, change of, enhancement of
manufacturing, processing, formulating, filling or packaging technology or
equipment which is (x) generated or derived by Patheon, alone or jointly, and
(y) of

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generic application rather than specific to the Product (“Patheon Improvement”);
and
(iii)    any Intellectual Property developed, conceived, or created by Patheon,
alone or jointly with Third Parties, in the course of conducting activities
outside the scope of this Agreement and without any use of any Existing Client
Intellectual Property, Client Product Improvements, Client Specification
Improvements, Client Manufacturing Process Improvements or Client Manufacturing
Equipment Improvements.
(g)    Patheon shall, and shall cause its Affiliates to, promptly disclose in
writing and in reasonable detail to Client any Client Product Improvements,
Client Specification Improvements, Client Manufacturing Process Improvements or
Client Manufacturing Equipment Improvements developed, conceived, or created by
employees, consultants, or subcontractors of Patheon or its Affiliates, alone or
jointly with employees, consultants or subcontractors of Client or its
Affiliates. Such written notice will be treated as the Confidential Information
of Client hereunder.
(h)    Client shall, and shall cause its Affiliates to promptly disclose in
writing and in reasonable detail to Patheon any potential Patheon Independent
Manufacturing Equipment Improvements or Patheon Improvement developed,
conceived, or created by employees, consultants, or subcontractors of Client or
its Affiliates, alone or jointly with employees, consultants, or subcontractors
of Patheon or its Affiliates. Such written notice will be treated as the
Confidential Information of Patheon hereunder.
(i)    The Specifications, the Client Manufacturing Process, and any and all
information or material related to the Existing Client Intellectual Property,
Client Product Improvements, Client Specification Improvements, Client
Manufacturing Process Improvements or Client Manufacturing Equipment
Improvements shall constitute Confidential Information of Client, which shall be
deemed the disclosing party with respect to such Confidential Information.
(j)    The Patheon Manufacturing Equipment and any and all information or
material related to the Existing Patheon Intellectual Property, the Patheon
Independent Manufacturing Equipment Improvements or Patheon Improvements shall
constitute Confidential Information of Patheon, which shall be deemed the
Disclosing Party with respect to such Confidential Information.
5.2    Licenses.
(a)    Client hereby grants, for the purposes of this Agreement only, to Patheon
a fully paid-up worldwide, non-exclusive license, under Client’s entire right,
title, and interest in and to the Existing Client Intellectual Property for
Patheon to Manufacture the Products solely pursuant to the terms of this
Agreement.
(b)    Client hereby grants, for the purposes of this Agreement only, to Patheon
a fully paid-up worldwide, non-exclusive license, under Client’s entire right,
title, and interest in and

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to the Client Product Improvements, Client Specification Improvements, Client
Manufacturing Process Improvements and Client Manufacturing Equipment
Improvements, in each case to make Products solely pursuant to the terms of this
Agreement.
(c)    Patheon hereby grants to Client a fully paid-up perpetual worldwide,
non-exclusive license, with the right to sublicense to Affiliates only, under
Patheon’s entire right, title, and interest in and to the Patheon Independent
Manufacturing Equipment Improvements, the Existing Patheon Intellectual Property
(to the extent incorporated in, or used in the Manufacture of, the Product) and
the Patheon Improvements (to the extent incorporated in, or used in the
Manufacture of, the Product) to make, use, offer for sale, sell, import, and
otherwise dispose of the Product only.
5.3    Technology Transfer.
(a)    Upon the request of Client at any time during the [***] period prior to
expiry of this Agreement or in the event of a failure by Patheon to supply
Products in accordance with the terms of this Agreement for a period exceeding
[***] following notice of breach by Client and period of remedy by Patheon
pursuant to Section 8.2(a)(vii), Patheon shall, at Client’s cost (i) have its
representatives meet with representatives of Client or its designee to enable
Client or such designee to Manufacture the Product, and (ii) provide such other
assistance as Client may reasonably request to enable Client or such designee to
Manufacture the Product. Client shall reimburse Patheon for its fees and all
documented out-of-pocket expenses reasonably incurred by Patheon in connection
with such technology transfer, save where the technical transfer arises from a
termination of this Agreement by Client pursuant to Section 8.2(a)(vii)
following a uncured failure by Patheon to supply Products in accordance with the
terms of this Agreement for a period exceeding [***], in which case Patheon will
provide a [***] on its quotation referred to below up to a maximum of [***].
Such [***] shall count towards the Maximum Liability for that year pursuant to
Section 9.5(a). Patheon will provide a quotation for the services which Client
requires pursuant to this Section 5.3 as Additional Services and on acceptance
by Client of the same, Patheon will provide the services stated therein. This
Section is without prejudice to Client’s obligations in Section 2.1(a).
(b)    Following a request for technical transfer services pursuant to
Section 5.3(a), Patheon shall:
(i)    provide to Client copies of all technical documentation, Specifications,
procedures and know-how in their possession or control that are reasonably
required for the Manufacture of the Products in each case as agreed by the
Parties in advance pursuant to Section 5.3;
(ii)    make available to Client the services of such qualified and experienced
scientists, production and quality assurance personnel, engineers, and quality
checking personnel as may be necessary to support the technical transfer process
and the establishment of the Manufacturing process for the Products in each case
as agreed by the Parties in advance pursuant to Section 5.3, and at such
convenient times as the Parties may reasonably agree; and

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(iii)    provide Client or its designee (but not any competitor of Patheon (i.e.
a business that derives greater than [***] of its revenues from performing
contract pharmaceutical development or commercial manufacturing services), with
reasonable access to the Facility to observe the Manufacture of the Products at
such times as the Parties may agree.
ARTICLE VI.     REPRESENTATIONS AND WARRANTIES
6.1    Representations and Warranties of Each Party. Each Party hereby
represents and warrants to the other Party as follows:
(a)    Such Party (i) is duly formed and in good standing under the laws of the
jurisdiction of its formation, (ii) has the power and authority and the legal
right to enter into this Agreement and perform its obligations hereunder, and
(iii) has taken all necessary action on its part required to authorize the
execution and delivery of this Agreement and the performance of its obligations
hereunder. This Agreement has been duly executed and delivered on behalf of such
Party and constitutes a legal, valid, and binding obligation of such Party and
is enforceable against it in accordance with its terms, subject to the effects
of bankruptcy, insolvency, or other similar laws of general application
affecting the enforcement of creditor rights and judicial principles affecting
the availability of specific performance and general principles of equity,
whether enforceability is considered a proceeding at law or equity.
(b)    From FDA Approval Date, all necessary consents, approvals, and
authorizations of all Regulatory Authorities, other governmental authorities,
and other Persons required to be obtained by such Party in connection with the
execution and delivery of this Agreement and the performance of its obligations
hereunder have been obtained.
(c)    The execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder (i) do not and will not conflict with or violate
any requirement of Applicable Law or any provision of the articles of
incorporation, bylaws limited partnership agreement, or other constituent
document of such Party and (ii) do not and will not conflict with, violate, or
breach, or constitute a default or require any consent under, any contractual
obligation or court or administrative order by which such Party is bound.
6.2    Additional Representations, Warranties, and Covenants of Patheon. Patheon
warrants, represents, and covenants that:
(a)    it has facilities, personnel, experience, and expertise sufficient in
quality and quantity to perform its obligations hereunder;
(b)    it shall perform its obligations hereunder in conformity with GMPs where
applicable;
(c)    it will comply with the Quality Agreement and comply with all agreed upon
quality assurance, quality controls, and review procedures in the performance of
its obligations hereunder;

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(d)    it has at the Effective Date and shall, during the Term of this Agreement
and at its cost (subject to Section 2.10(b)), in connection with this Agreement,
observe and comply with all Applicable Laws, including federal, state, and local
laws, orders, regulations, rules, customs, and ordinances now in force or that
may hereafter be in force, pertaining to the Facility and the performance of the
Manufacturing Services and including, without limitation, (i) labor laws,
orders, regulations, rules, customs, and ordinances of the country of
Manufacture and (ii) those of the FDA pertaining to the Manufacturing Services
and the Facility (but not those pertaining to non-Manufacturing matters relating
to the Product, compliance with which shall be the responsibility of Client),
and any laws, orders, regulations, rules, or ordinances issued in addition to,
as a supplement to or as a replacement of Applicable Laws.
(e)    as at the Effective Date, it has received no warning letter from any
Regulatory Authority in relation to the Facility in the [***] period prior to
the Effective Date (including in relation to the compliance of that Facility
with all applicable requirements of GMP);
(f)    as at the Effective Date, there are no outstanding FDA Form 483
observations (or any equivalent observations from any Regulatory Authority under
Applicable Law) in relation to the Facility;
(g)    none of it, its Affiliates, nor any Person under its direction or control
(including Third Party Subcontractors), has ever been, nor will it engage
suppliers which have to its actual knowledge, after due inquiry, been, (i)
debarred or convicted of a crime for which a person can be debarred, under
Section 335(a) or 335(b) of the FDA Act, or any equivalent Applicable Law of the
country of Manufacture, (ii) threatened to be debarred under the FDA Act or any
equivalent Applicable Law of the country of Manufacture or (iii) indicted for a
crime or otherwise (to its actual knowledge after due inquiry) engaged in
conduct for which a person can be debarred by the FDA or any equivalent
Regulatory Authority pursuant to Applicable Law of the country of Manufacture,
and Patheon agrees that it will promptly notify Client in the event it receives
notification of any such debarment, conviction, threat or indictment. Should
Patheon become aware of any suspected non-compliance with the foregoing, Patheon
will notify Client in writing of such issue on or before [***]. For the purpose
of this Section 6.2, suppliers and subcontractors engaged by Patheon to
undertake the Manufacture of the Product shall be deemed to be under Patheon’s
direction or control;
(h)    none of it, its Affiliates, nor any Person under its direction or control
is currently excluded from a federal or state health care program under Sections
1128 or 1156 of the Social Security Act, 42 U.S.C. §§ 1320a-7, 1320c-5 or any
equivalent Applicable Law of the country of Manufacture, as may be amended or
supplemented;
(i)    none of it, its Affiliates, nor any Person under its direction or control
is otherwise currently excluded from contracting with the U.S. federal
government or the government of the country of Manufacture;
(j)    none of it, its Affiliates, nor any Person under its direction or control
is otherwise currently excluded, suspended, or debarred from any U.S. or foreign
governmental program;

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(k)    it shall immediately notify Client if, at any time during the Term,
Patheon, its Affiliates, or any Person under its direction or control is
convicted of an offense that would subject it or Client to exclusion,
suspension, or debarment from any U.S. or foreign governmental program;
(l)    it agrees to keep the Equipment free from all liens and encumbrances; and
(m)    it will not enter into any agreement or arrangement with any other Third
Party that would prevent its ability to perform its obligations hereunder
6.3    Warranty. Patheon warrants that:
(a)    Products will be Manufactured in accordance with Section 2.1(c) of this
Agreement, Quality Agreement, GMP, and all other Applicable Law;
(b)    without prejudice to Section 2.8, at the time of delivery the Products
will conform with the Specifications in accordance with the testing regime set
out therein and will conform with the Certificate of Analysis therefor provided
pursuant to Section 2.3(j);
(c)    at the time of delivery title to such Product will pass to Client as
provided herein free and clear of any security interest, lien, or other
encumbrance;
(d)    at the time of delivery such Product will not be adulterated or
misbranded within the meaning of the FDA Act as a result of a Patheon
Nonconformance; and
(e)    at the time of delivery such Product will not be an article that, under
the provisions of the FDA Act, may not be introduced into interstate commerce as
a result of a Patheon Nonconformance.
6.4    Additional Representations, Warranties, and Covenants of Client. Client
warrants, represents, and covenants that:
(a)    Non-Infringement.
(i)    to its knowledge, as at the Effective Date (1) it or its Affiliates
Control all right, title, and interest in all Intellectual Property in the
Client Manufacturing Process, the Client Manufacturing Equipment, the Product
and the Specifications necessary for performance of the Manufacturing Services;
and (2) it has the right to authorize Patheon to perform the Manufacturing
Services, in each case in accordance with the terms and conditions hereof;
(ii)    to its knowledge, as at the Effective Date, the performance of the
Manufacturing Services hereunder, in accordance with the terms and conditions
hereof and using the Client Manufacturing Process, or the manufacture, use,
supply or other disposition of the Product by Patheon as may be required to
perform its obligations under this Agreement or by Client, does not and will not
result, in the infringement or misappropriation of any Third Party’s
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(iii)    Client or its Affiliates Control and have the right to lawfully
disclose the Specifications to Patheon and to authorize Patheon to use the
Specification to perform the Manufacturing Services;
(iv)    as of the Effective Date, so far as Client is aware there are no actions
or other legal proceedings pending concerning the infringement of Third Party
Intellectual Property rights related to any of the Specifications, the Client
Manufacturing Process or any of the Materials, or the supply, use, or other
disposition of any Product made in accordance with the Specifications.
(b)    Quality and Compliance.
(i)    during the Term, the Product, if Manufactured in accordance with the
Specifications and in compliance with the Quality Agreement, applicable GMP and
Applicable Laws, may be lawfully sold and distributed in every jurisdiction in
which Client markets the Product; and
(ii)    during the Term, on the date of shipment, the Client-Supplied Materials
will conform to the specifications for the Client-Supplied Materials that Client
has given to Patheon and the Client-Supplied Materials will be adequately
contained, packaged, and labelled and will conform to the affirmations of fact
on the container, provided that this shall not negate Patheon’s obligations to
perform any incoming inspections of Client-Supplied Materials as set out in the
Specifications or the Quality Agreement.
(c)    Client agrees that, as a pre-condition to the adding of any country to
the Territory pursuant to Section 2.2(t), Client shall repeat the warranties
above as at the date on which the country is added to the Territory.
6.5    DISCLAIMER. THE FOREGOING EXPRESS WARRANTIES SET FORTH IN THIS ARTICLE VI
ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY
OF MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT,
AND ALL OTHER WARRANTIES ARE HEREBY DISCLAIMED AND EXCLUDED BY EACH PARTY.
ARTICLE VII.     CONFIDENTIALITY
7.1    Confidentiality Obligations. The Parties agree that the terms of the
Confidentiality Agreement dated 28 September 2016 between Client and Patheon
Inc. (an Affiliate of Patheon), shall apply to all Confidential Information
disclosed by a Party or its Affiliates to the other Party and are incorporated
herein by this reference (the “Confidentiality Agreement”), provided that
paragraph 5 of the Confidentiality Agreement shall be replaced with the
following:
“Required Disclosure. The receiving Party may disclose Confidential Information
to the extent that it is required by law or order of any governmental authority
or agency or the rules and regulations of any securities authority or stock
exchange on which securities issued by a Party or

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its Affiliates are traded, including the Securities and Exchange Commission;
provided that the receiving Party, using good faith efforts, shall apply for
confidential treatment of such Confidential Information including Confidential
Information contained in this Agreement or the Technology Transfer Agreement (if
redacted versions of these agreements are required to be disclosed), shall
provide the other Party a copy of the confidential treatment request far enough
in advance and at least [***] business days, if possible, of its filing to give
the other Party a meaningful opportunity to comment thereon and in order to
provide the disclosing Party an opportunity to seek a protective order or the
like with respect to certain Confidential Information, and shall incorporate in
such confidential treatment request any reasonable comments of the other Party,
in each case to the fullest extent permitted under applicable laws, rules or
regulations.”
7.2    Injunctive Relief. Each Party acknowledges that a breach by either Party
of the Confidentiality Agreement or of this Article VII may not reasonably or
adequately be compensated in damages in an action at law and that such a breach
may cause the other Party irreparable injury and damage. By reason thereof, each
Party agrees that the other Party may be entitled, in addition to any other
remedies it may have under this Agreement or otherwise, to apply for preliminary
and permanent injunctive and other equitable relief to prevent or curtail any
breach of the Confidentiality Agreement or this Article VII; provided, however,
that no specification in this Agreement of a specific legal or equitable remedy
will be construed as a waiver or prohibition against the pursuing of other legal
or equitable remedies in the event of such a breach. Each Party agrees that the
existence of any claim, demand, or cause of action of it against the other
Party, whether predicated upon this Agreement, or otherwise, will not constitute
a defense to the enforcement by the other Party, or its successors or assigns,
of the covenants contained in the Confidentiality Agreement and this
Article VII.
ARTICLE VIII.     TERM AND TERMINATION
8.1    Term. This Agreement shall commence as of the Effective Date and, unless
earlier terminated in accordance with the terms hereof, shall expire on the
seventh (7th) anniversary of the FDA Approval Date (the “Initial Term”).
Notwithstanding the foregoing, by mutual agreement, the Parties may commence
discussions three (3) years prior to the end of the Initial Term with a view to
extending the Initial Term for periods of two (2) years each (collectively, the
Initial Term and any extensions thereof, the “Term”).
8.2    Termination. In addition to any other provision of this Agreement
expressly providing for termination of this Agreement, this Agreement may be
terminated as follows:
(a)    Client may terminate this Agreement by notice in writing to Patheon:
(i)    at any time prior to the grant of the Marketing Authorization for the
Product in the United States, by giving Patheon [***] prior written notice if:
(A) Client’s application for Marketing Authorization in the United States is
rejected, or (B) any Regulatory Authority causes the clinical hold or permanent
withdrawal of the Product;

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(ii)    at any time after the grant of the Marketing Authorization for the
Product in the United States, by giving Patheon [***] prior written notice in
the event that the Product is discontinued or withdrawn from (1) the United
States, or (2) any other market in a country or countries of the Territory that
represent [***] or more of Client’s overall Product sales, for safety, quality
or regulatory reasons;
(iii)    if any Regulatory Approval naming Patheon as the Manufacturer of the
Product is withdrawn by the applicable Regulatory Authority in relation to (1)
the United States or (2) any other market in a country or countries of the
Territory that represent [***] or more of Client’s overall Product sales (for
clarity, this does not refer to Patheon’s manufacturer licence issued by the
Medicines and Healthcare products Regulatory Agency in the United Kingdom);
(iv)    if Patheon challenges Client’s ownership of, or right to use, the
Existing Client Intellectual Property by submission to a governmental authority
responsible for Intellectual Property rights or to a court with jurisdiction
over Intellectual Property rights provided that the performance of manufacturing
or development services for other clients shall not be regarded as a challenge
to Client’s ownership of, or right to use, the Existing Client Intellectual
Property;
(v)    for convenience, at any time prior to the FDA Approval Date, with [***]
written notice to Patheon;
(vi)    for convenience, at any time after the FDA Approval Date, by giving
Patheon (1) in the first [***] from the FDA Approval Date, [***] prior written
notice; (2) in the [***] from the FDA Approval Date, [***] prior written notice;
(3) in the [***] from the FDA Approval Date, [***] prior written notice; and (4)
in any extension of this Agreement after the Initial Term, [***] prior written
notice; or
(vii)    at any time upon written notice in the event of any material default by
Patheon in the performance of any of its obligations hereunder, which material
default has not been cured by Patheon on or before [***] after receiving written
notice thereof (“Remediation Period”), provided that (i) the Parties shall use
Commercially Reasonable Efforts to agree a plan to remedy the material default
within [***] days after written notice is given to Patheon and (ii) Patheon
shall continue performing hereunder pursuant to the terms of Section 8.4 below.
Client’s right to terminate this Agreement for a particular breach under this
Section 8.2(a)(vii) may only be exercised for a period of [***] following the
expiry of the Remediation Period (where the breach has not been remedied) and,
if the termination right is not exercised during this period, then Client will
be deemed to have waived its right to terminate this Agreement for such breach.
(b)    Patheon may terminate this Agreement at any time upon written notice in
the event of (i) any material default by Client in the performance of any of its
obligations hereunder (excluding payment), which default has not been cured by
Client on or before [***] after receiving written notice thereof; or (ii)
Client’s default of its payment obligations in accordance with Article

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IV in relation to undisputed invoices which default has not been cured by Client
on or before [***] after receiving written notice thereof; provided, however,
that, if Client fails to cure such payment default, Patheon may not terminate
without first providing a second notice to the attention of Client’s Chief
Executive Officer and an additional [***] cure period.
(c)    This Agreement may be terminated at any time by either Party immediately
upon written notice to the other Party (A) pursuant to Section 10.2, in the
event of a force majeure that remains uncured for the period provided in Section
10.2, or (B) if the other Party shall file in any court or agency, pursuant to
any statute or regulation of any state or country, a petition in bankruptcy or
insolvency or for reorganization or for arrangement or for the appointment of a
receiver or trustee of the other Party or of its assets, or if the other Party
proposes a written agreement of composition of its debts, or if the other Party
shall be served with an involuntary petition against it, filed in any insolvency
proceeding, and such petition is consented to by such Party or is not dismissed
on or before [***] after the filing thereof, or if the other Party shall propose
or be a party to any dissolution or liquidation, or if the other Party shall
make an assignment for the benefit of its creditors.
(d)    This Agreement will automatically terminate should either Client or
Patheon exercise its right to terminate the Technology Transfer Agreement (but
not in the event of an expiration of such agreement as set forth in Section 8.2
thereof) prior to the FDA Approval Date, in which case, any payment to Patheon
will be made in accordance with the Technology Transfer Agreement.
8.3    Effect of Termination.
(a)    The expiration or termination of this Agreement shall be without
prejudice to any rights or obligations of the Parties that may have accrued
prior to such termination, and the provisions of Sections 2.8, 3.7, 3.12, 3.14,
8.3 and 8.4, and ARTICLE I, ARTICLE IV, ARTICLE V, ARTICLE VII, ARTICLE IX and
ARTICLE X shall survive the expiration or termination of this Agreement. Except
as otherwise expressly provided herein, termination of this Agreement in
accordance with the provisions hereof shall not limit remedies that may
otherwise be available in law or equity.
(b)    Upon expiration or termination of this Agreement, subject to the Parties’
obligations under Section 8.4 below, each Party, at the request of the other,
shall return all data, files, records, and other materials in its possession or
control containing or comprising the other Party’s Confidential Information.
(c)    Upon expiration or termination of this Agreement for any reason, subject
to the Parties’ obligations under Section 8.4 below:
(i)    all submitted but unfilled Purchase Orders with respect to which Patheon
has (1) not begun Manufacture of Product shall be cancelled, or (2) begun
Manufacture of the Product shall be completed, unless otherwise agreed;

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(ii)    Patheon will dismantle the Client Manufacturing Equipment and prepare
and make it available for collection from the Facility according to a procedure
agreed by the Parties (acting reasonably), following which Client shall remove
all Client Manufacturing Equipment, Product and Materials from the Facility on
or before the day [***] after the completion of said procedure, failing which
Client will pay a fee equivalent to the aggregate monthly Base Fee for the
Manufacturing Suite for each month or part month the Client Manufacturing
Equipment, Product or Materials remain at the Facility after [***] post
termination;
(iii)    if Patheon has Manufactured any stocks of finished Product in addition
to those ordered pursuant to a Purchase Order, or has ordered any
Patheon-Supplied Materials in addition to those ordered as set out in Section
2.2(u), Client shall at its option place an order with Patheon for any of such
finished Products and/or Patheon-Supplied Materials in accordance with the terms
of this Agreement;
(iv)    Patheon shall submit an invoice for any unpaid Material Costs,
Maintenance Costs, Disposal Costs or any Bill Back Items which were ordered,
purchased, produced or maintained by Patheon in contemplation of the Manufacture
of the Product prior to the date of termination in accordance with Section 2.2,
provided that Client shall not be liable for the costs of any Materials
purchased in excess of those amounts needed to meet Purchase Orders (or such
longer period as the Parties may have otherwise agreed);
(v)    Client shall pay Patheon any earned but unpaid Product Fees, including
those under any outstanding Purchase Order as described in Section 8.3(c)(i);
(vi)    Client shall pay for any earned but undisputed and unpaid Base Fees, or
fees for Additional Services; and
(vii)    Client shall pay all due and outstanding invoices under Article IV.
(d)    Upon expiration or termination of this Agreement for any reason other
than by [***] pursuant to [***], subject to the Parties’ obligations under
Section 8.4 below, Client shall pay to Patheon all and any (i) dismantling
costs, (ii) removal costs and (iii) Make Good Costs associated with the
cessation of the Manufacturing Services or removal of the Client Manufacturing
Equipment from the Facility. “Make Good Costs” means the reasonable costs
required to clean, decontaminate or repair the Facility and return it to a
clean, safe and useable area based on the contamination caused by the
Manufacturing Services or repair of damage caused by the installation or removal
of Client Manufacturing Equipment.

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(e)    Upon expiration or termination of this Agreement for any reason other
than by [***] pursuant to [***], subject to the Parties’ obligations under
Section 8.4 below, Client shall pay to Patheon the following costs
(“Manufacturing Services Termination Costs”): (i) all actual costs incurred by
Patheon to complete activities associated with the completion, expiry or
termination including, without limitation, disposal fees that may be payable for
any Materials and supplies owned by Client to be disposed of by Patheon; and
(ii) all and any direct costs and expenses, or wasted costs and expenses, or
termination or cancellation fees payable by Patheon as a consequence of or
arising from the termination of this Agreement, to include but not limited to,
all and any redundancy costs of employees employed by Patheon to work solely or
mainly in providing the Manufacturing Services and/or Manufacturing the Product,
all and any termination costs in relation to subcontractors and agency staff
working solely or mainly in providing the Manufacturing Services and/or
Manufacturing the Product, any termination or cancellation fees payable to Third
Party suppliers. Patheon will use Commercially Reasonable Efforts to mitigate
the Manufacturing Services Termination Costs. Patheon will further provide
Client with documentation in order to substantiate the Manufacturing Services
Termination Costs.
(f)    Upon termination (in whole) or expiry of this Agreement for any reason:
(i)    the licences granted in Sections 5.2(a) and 5.2(b) shall terminate and
Patheon shall not make any use for any purpose whatsoever of any of Client’s
Intellectual Property or any of Client’s Confidential Information contained in
the Quality Agreement except to the extent necessary to fulfil any Purchase
Order or order placed by Client in accordance with Section 8.3(c)(iii) or to
perform any other obligation under this Agreement;
(ii)    any Yield Reimbursement Payment shall be paid which may be pro rata
basis for any part year as applicable and which may be offset by any undisputed
amounts owing to Patheon under this Agreement.
(g)    Client acknowledges that no Patheon competitor (being a Person that
derives greater than [***] of its revenues from performing contract
pharmaceutical or biopharmaceutical development or commercial manufacturing
services) will be permitted access to the Facility.
(h)    In relation to any representatives of Client that are permitted access to
the Facility pursuant to Section 8.3 or 8.4, Client shall ensure that such
representatives are appropriately trained by Client (e.g., GMP training) and
shall observe at all times Patheon’s policies and procedures (as amended from
time-to-time) as they pertain to the Facility, including policies relating to
health and safety and compliance with GMP, and comply with all reasonable
directions of Patheon in relation to the same; provided that Client is given
notice of such policies and given a reasonable period of time to review and
implement such policies. Patheon may refuse or limit in its sole discretion at
any time admission to the Facility by any of Client’s representatives who fail
to observe such policies or comply with such reasonable directions.

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(i)    The Parties agree that if any fees or charges are duplicated under this
Agreement and the Technology Transfer Agreement, Client shall only be obligated
to make such payment once.
8.4    Transition Assistance. Upon the delivery by either Party of a notice of
termination of this Agreement for any reason other than by Patheon pursuant to
Section 8.2(b) or (c), upon the request of Client, and subject to terms set
forth in this Agreement, Patheon shall provide Client with the reasonable
assistance of its staff and reasonable access to its other internal resources to
provide Client with a reasonable level of technical assistance and consultation
to transfer the Manufacture and the regulatory qualification of the Product to a
supplier of Client’s election, provided that Client will reimburse Patheon for
its fees and all documented costs and out-of-pocket expenses incurred in
connection with such assistance (Patheon would provide a quotation for the
services which Client requires pursuant to this Section 8.4 as Additional
Services and on acceptance by Client of the same, Patheon will provide the
services stated therein).
ARTICLE IX.     INDEMNIFICATION
9.1    Client Indemnification Obligations. Client shall indemnify Patheon, its
Affiliates, and their respective directors, officers, employees, and agents (the
“Patheon Indemnified Parties”), and defend and save each of them harmless, from
and against:
(a)    any and all Third Party Losses incurred by any of them in connection
with, arising from, or occurring as a result of: (i) any gross negligence or
willful misconduct by Client or any of its Affiliates; (ii) any claim made by
any Person that the Manufacture and supply of the Product using the Client
Manufacturing Process or any of Client’s Intellectual Property, in each case in
accordance with the terms hereof, infringes or misappropriates the Intellectual
Property rights of such Person (other than to the extent arising as a result of
any of Patheon’s Intellectual Property used in accordance with the terms of this
Agreement or the use by Patheon of any Third Party Intellectual Property); or
(ii) any product liability claim made by any Person with respect to any Products
which upon delivery conformed to and were Manufactured in accordance with the
terms of Section 2.1(c); or
(b)    any Loss incurred by any of them in connection with: (i) the negligence
or willful misconduct of the Client On Site Representatives at the Facility; or
(ii) any damage to Patheon’s property or any claims of personal injury to any
Patheon employees or Third Party Subcontractors caused as a result of Patheon’s
use of the Client Manufacturing Equipment in the performance of the
Manufacturing Services provided that Patheon and its employees and Third Party
Subcontractors have complied with all applicable Equipment Standard Operating
Procedures or the manufacturer’s terms of operation and recommended procedures
for the Client Manufacturing Equipment, Specifications, and have not otherwise
acted in a negligent manner or committed an act of willful misconduct in
connection with the use and Maintenance of the Client Manufacturing Equipment;
except, in each case for (a) and (b), for those Losses for which Patheon has an
obligation to indemnify the Client Indemnified Parties pursuant to Section 9.2,
as to which Losses each Party shall indemnify the other to the extent of their
respective liability for such Losses; and provided, however, that

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Client will not be required to indemnify the Patheon Indemnified Parties with
respect to any such Loss hereunder to the extent the same is caused by any
breach of contract, negligent act or omission, or intentional misconduct by any
Patheon Indemnified Parties. Client acknowledges that Patheon has not and will
not conduct any freedom to operate searches in relation to the Product or the
Client Manufacturing Process nor reviewed any Third Party patents in relation
thereto and that Patheon’s failure or omission to do so will not be considered
negligence for the purposes of excluding or limiting a claim under this
indemnity.
9.2    Patheon Indemnification Obligations. Patheon shall indemnify Client, its
Affiliates, and their respective directors, officers, employees, and agents (the
“Client Indemnified Parties”), and defend and save each of them harmless, from
and against:
(a)    any Third Party Losses incurred by any of them resulting from, or
relating to, any claim of personal injury or property damage to the extent that
the injury or damage is in connection with, arising from, or occurring as a
result of: (i) any failure by Patheon to Manufacture and supply Products in
accordance with the terms of in this Agreement; (ii) any gross negligence or
willful misconduct by Patheon or any of its Affiliates; or (iii) any product
liability claim made by any Person with respect to any Product Manufactured by
Patheon to the extent any such liability is based on or caused by a Patheon
Nonconformance; or
(b)    any Third Party Losses incurred by any of them in connection with,
arising from, or occurring as a result of a claim that any Existing Patheon
Intellectual Property, Patheon Independent Manufacturing Improvement or Patheon
Improvement used by Patheon in the Manufacture or supply of the Product
infringes or misappropriates the Intellectual Property rights of such Person;
except in each case for (a) and (b) for which Client has an obligation to
indemnify the Patheon Indemnified Parties pursuant to Section 9.1, as to which
Losses each Party shall indemnify the other to the extent of their respective
liability for such Losses; and provided, however, that Patheon will not be
required to indemnify the Client Indemnified Parties with respect to any such
Loss hereunder to the extent the same is caused by any breach of contract,
negligent act or omission, or intentional misconduct by Client Indemnified
Parties.
9.3    Indemnification Procedure.
(a)    Indemnification Procedure. The indemnified Party (the “Indemnified
Party”) shall give the indemnifying Party (the “Indemnifying Party”) prompt
written notice of any Loss, action, or discovery of facts upon which such
Indemnified Party intends to base a request for indemnification under Section
9.1 or 9.2 (a “Claim”), but in no event shall the Indemnifying Party be liable
for any Losses that result from any delay in providing such notice. The
Indemnified Party will: (i) use Commercially Reasonable Efforts to mitigate the
effects of the Claim; (ii) reasonably cooperate with the Indemnifying Party in
the defense of the Claim; and (iii) permit the Indemnifying Party to control the
defense and settlement of the Claim, all at the Indemnifying Party’s cost and
expense.

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(b)    Settlement. With respect to any Losses (i) relating solely to the payment
of money damages in connection with a Claim, (ii) that will not result in the
Indemnified Party becoming subject to injunctive or other relief or otherwise
adversely affect the business or reputation of the Indemnified Party in any
manner, and (iii) as to which the Indemnifying Party has acknowledged in writing
the obligation to indemnify the Indemnified Party hereunder, the Indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter
into any settlement, or otherwise dispose of such Loss, on such terms as the
Indemnifying Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Claims, where the Indemnifying Party has
assumed the defense of the Claim in accordance with Section 9.3(a), the
Indemnifying Party shall have authority to consent to the entry of any judgment,
enter into any settlement, or otherwise dispose of such Loss; provided that it
obtains the prior written consent of the Indemnified Party, which consent shall
not be unreasonably withheld or delayed. The Indemnifying Party shall not,
without the prior written consent of the Indemnified Party, agree to any
settlement or acquiesce to any judgment with respect to a Claim that obligates
the Indemnified Party to pay any amount subject to indemnification by the
Indemnifying Party or causes the Indemnified Party to admit to any civil or
criminal liability.
9.4    Insurance. During the Term and for [***] thereafter, each Party shall
procure and maintain at its own expense from a qualified and licensed insurer
liability insurance or indemnity policies, in an amount not less than [***] in
the aggregate, subject to such deductible or self-retention limits as either
Party in its business discretion may elect. Such policies shall insure against
liability on the part of each Party and any of its Affiliates, as their
interests may appear, due to injury, disability, or death of any person or
persons, or injury to property, arising from the distribution of the Products.
Upon the execution of this Agreement and thereafter on January 1 of each year
during the Term, each Party shall provide to the other a certificate of
insurance (i) summarizing the insurance coverage and (ii) identifying any
exclusions. Each Party shall promptly notify the other of any material adverse
alterations to the terms of this policy or decreases in the amounts for which
insurance is provided.
9.5    Limitation on Damages
(a)    Maximum Liability. Except with respect to (i) [***], or (ii) a breach by
[***] of its obligations under [***], Patheon’s maximum liability to Client
under this Agreement for any reason whatsoever, including, without limitation,
any liability arising under Sections 2.2(o), 2.9, 3.12, 3.14 or 9.2 hereof or
resulting from any and all breaches of its representations, warranties, or any
other obligations under this Agreement in each calendar year will not exceed
[***] of the total [***] received by or payable to Patheon pursuant to this
Agreement in the [***] period prior to the month in which the underlying event
occurred that gave rise to the liability (e.g., the date of the incident or
manufacture). For the first [***] period after the first commercial batch, as
Patheon will not have received [***] for a full [***] period, the amount of the
[***] for the purpose of the limitation of liability shall be calculated based
on the volume of Product set out in the first [***] of the Forecast applicable
on the date of Manufacture of the first commercial batch.
(b)    Section 9.5(a) shall not apply to any reimbursement of the Product Fee,
Shipment Costs or [***] pursuant to Section 2.8(d)(ii).

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(c)    Subject to Section 9.5(d), neither Party will be liable to the other in
contract, tort, negligence, breach of statutory duty, equity, or otherwise for:
(i) any direct or indirect loss of profits, of production, of anticipated
savings, of business, or goodwill; (ii) any reliance damages, including but not
limited to costs or expenditures incurred to evaluate the viability of entering
into this Agreement or to prepare for performance under this Agreement; or (iii)
for any other indirect or consequential loss, liability, damage, costs, penalty
or expense. For the avoidance of doubt this Section 9.5(c) shall not apply to
the costs of a [***] resulting from a Patheon Nonconformance.
(d)    Nothing in this Agreement shall exclude or limit either Party’s liability
for (i) personal injury or death caused by the negligence of that Party, or (ii)
for fraud or fraudulent misrepresentation.
(e)    Sole & Exclusive Remedies. Notwithstanding anything in this Article IX to
the contrary Patheon’s sole liability and Client’s sole and exclusive remedy
whether in contract, tort, equity or otherwise for:
(i)    Non-Conforming Product based on or caused by a Patheon Nonconformance
shall be the rights and remedies set forth in Section 2.2(o), 2.8, 2.9, 3.12,
3.14, 8.2 and 9.2 of this Agreement;
(ii)    late or incomplete deliveries of Product specified in a Purchase Order
by the Agreed Delivery Date as described in Section 2.3(h) (provided that the
late or incomplete delivery is not the result of a breach by Patheon of any
other term of this Agreement) shall be the rights and remedies set forth in
Section 2.7 and Schedule D of this Agreement.  
9.6    Product Liability Claims. As soon as it becomes aware, each Party will
give the other prompt written notice of any defect or alleged defect in a
Product, any injury alleged to have occurred as a result of the use or
application of the Product, and any circumstances that may give rise to
litigation or recall of a Product or regulatory action that may affect the sale
or Manufacture of a Product, specifying, to the extent the Party has such
information, the time, place, and circumstances thereof and the names and
addresses of the persons involved. Each Party will also furnish promptly to the
other copies of all papers received in respect of any claim, action, or suit
arising out of such alleged defect, injury, or regulatory action.
9.7    Allocation of Risk. This Agreement (including, without limitation, this
Article IX) is reasonable and creates a reasonable allocation of risk for the
relative profits the Parties each expect to derive from the Products.

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ARTICLE X.     MISCELLANEOUS
10.1    Notices. Notwithstanding that advance notification of any notices or
other communications may be given by electronic mail transmission, all notices
or other communications that shall or may be given pursuant to this Agreement
shall be in writing (including by confirmed receipt electronic mail) and shall
be deemed to be effective (a) when delivered if sent by registered or certified
mail, return receipt requested, or (b) on the next business day, if sent by
overnight courier, (c) when sent if sent by electronic mail provided that
receipt is confirmed, in each case to the Parties at the following addresses (or
at such other addresses as shall be specified by like notice) with postage or
delivery charges prepaid:
If to Client:
Insmed Incorporated
10 Finderne Avenue, Building 10
Bridgewater, New Jersey 08807, USA
Attn: General Counsel
Email: [***]

If to Patheon:

Patheon UK Limited
Executive Director & General Manager
Kingfisher Drive, Covingham
Swindon, Wiltshire SN3 5BZ
England
Email: [***]

with copy to
Legal Director.
10.2    Force Majeure. Neither Party shall be liable for delay in delivery,
performance or nonperformance, in whole or in part, nor shall the other Party
have the right to terminate this Agreement except as otherwise specifically
provided in this Section 10.2 where such delay in delivery, performance or
nonperformance results from acts beyond the reasonable control and without the
fault or negligence of such Party including, but not limited to, the following
conditions: fires, floods, storms, embargoes, shortages, epidemics, quarantines,
war, acts of war (whether war be declared or not), terrorism, insurrections,
riots, civil commotion, or acts, omissions, or delays in acting by any
governmental authority; provided that the Party affected by such a condition
shall, on or before [***] of its occurrence, give notice to the other Party
stating the nature of the condition, its anticipated duration, and any action
being taken to avoid or minimize its effect. The suspension of performance shall
be of no greater scope and no longer duration than is reasonably required, and
the nonperforming Party shall use its Commercially Reasonable Efforts to remedy
its inability to perform; provided, however, that in the event the suspension of
performance continues for [***] days after the date of the occurrence, and such
failure to perform would constitute a material breach

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of this Agreement in the absence of such force majeure event, the non-affected
Party may terminate this Agreement immediately by written notice to the affected
Party.
10.3    Independent Contractor. The Parties to this Agreement are independent
contractors. Nothing contained in this Agreement shall be construed to place the
Parties in the relationship of employer and employee, partners, principal, and
agent or a joint venture. Neither Party shall have the power to bind or obligate
the other Party nor shall either Party hold itself out as having such authority.
10.4    Waiver. Save where expressly stated to the contrary in this Agreement,
including Sections 2.8, 2.9, 3.12, 3.14, 8.2, 8.4 and 9.5, no waiver by either
Party of any provision or breach of this Agreement shall constitute a waiver by
such Party of any other provision or breach, and no such waiver shall be
effective unless made in writing and signed by an authorized representative of
the Party against whom waiver is sought. No course of conduct or dealing between
the Parties will act as a modification or waiver of any provision of this
Agreement. Either Party’s consent to or approval of any act of the other Party
shall not be deemed to render unnecessary the obtaining of that Party’s consent
to or approval of any subsequent act by the other Party.
10.5    Entire Agreement. This Agreement (together with all Schedules hereto,
which are hereby incorporated by reference), the Quality Agreement, the
Confidentiality Agreement, and the Technology Transfer Agreement constitute the
final, complete, and exclusive agreement between the Parties relating to the
subject matter hereof and supersede all prior conversations, understandings,
promises, and agreements relating to the subject matter hereof. Neither Party
has relied upon any communications, representations, terms or promises, verbal
or written, not set forth herein. No terms, provisions or conditions of any
Purchase Order or other business form or written authorization used by Client or
Patheon will have any effect on the rights, duties, or obligations of the
Parties under or otherwise modify this Agreement, regardless of any failure of
Client or Patheon to object to the terms, provisions, or conditions unless the
document specifically refers to this Agreement and is signed by both Parties.
10.6    Assignment; Change of Control. This Agreement may not be assigned by
Patheon without the prior written consent of Client. Notwithstanding the
foregoing, either Party may assign this Agreement to an Affiliate, or to an
acquirer or successor in interest in connection with a Change of Control of such
Party, without the prior written consent of the other Party, provided that such
Party provides the other Party with written notice of any such assignment. This
Agreement shall be binding upon and inure to the benefit of Client and Patheon
and their respective successors, heirs, executors, administrators, and permitted
assigns. “Change of Control” means the earlier of a public announcement of an
agreement in principle or the closing of (a) a merger, consolidation or similar
transaction providing for the acquisition of the direct or indirect ownership of
more than fifty percent (50%) of a Party’s shares or similar equity interests or
voting power of the outstanding voting securities or that represents the power
to direct the management and policies of a Party or (b) the sale of all or
substantially all of a Party’s assets related to the subject matter of the
Agreement.

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10.7    Amendment; Modification. This Agreement may not be amended, modified,
altered, or supplemented except by a writing signed by both Parties. No
modification of any nature to this Agreement and no representation, agreement,
arrangement, or other communication shall be binding on the Parties unless such
is expressly contained in writing and executed by the Parties as an amendment to
this Agreement. This Agreement may not be amended in any respect by any Purchase
Order, invoice, acknowledgment, or other similar printed document issued by
either Party.
10.8    Governing Law.
(a)    This Agreement and any matter, claim or dispute arising out of or in
connection with it, whether contractual or non-contractual, shall be construed
under and governed by the laws of England without regard to the application of
principles of conflicts of law. Both Parties hereby submit to the exclusive
jurisdiction of the courts of England.
(b)    The Parties expressly exclude the application of the United Nations
Convention on Contracts for the International Sale of Goods, if applicable.
(c)    The Parties agree that nothing in this Agreement shall (i) grant Client
any property ownership rights in the Manufacturing Suite or the Facility or (ii)
constitute a lease to the Manufacturing Suite or the Facility and no
relationship of landlord and tenant is created between Patheon and Client
pursuant to this Agreement. Patheon retains control, possession and management
of the Facility and Manufacturing Suite and Client has no right to exclude
Patheon from the Facility or Manufacturing Suite.
10.9    Compliance with Applicable Laws. Each Party and its Affiliates, and
their respective representatives, shall comply with all Applicable Laws in the
performance of their obligations under this Agreement. Without limiting the
foregoing, each Party and its Affiliates, and their respective representatives,
shall comply with export control laws and regulations of the country of
Manufacture and of the United States. Neither Party nor its Affiliates (or
representatives) shall, directly or indirectly, without prior U.S. government
authorization, export, re-export, or transfer the Product to any country subject
to a U.S. trade embargo, to any resident or national of any country subject to a
U.S. trade embargo, or to any person or entity listed on the “Entity List” or
“Denied Persons List” maintained by the U.S. Department of Commerce or the list
of “Specifically Designated Nationals and Blocked Persons” maintained by the
U.S. Department of Treasury. In so far as the same applies to a Party or its
Affiliates, each Party and its Affiliates and respective representatives shall
comply with the requirements of the Foreign Corrupt Practices Act of 1977 (15
U.S.C. § 78dd-1, et seq.).
10.10    Dispute Resolution.
(a)    The Parties recognize that disputes may arise from time to time during
the Term of this Agreement. It is the objective of the Parties to establish
procedures to facilitate the resolution of such disputes arising under this
Agreement in an expedient manner by mutual cooperation. To accomplish this
objective, the Parties agree to follow the procedures set forth in this
Section 10.10 if and when a dispute arises under this Agreement.

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(b)    Unless otherwise specifically recited in the Agreement, disputes between
the Parties under this Agreement will be first referred to the Project Manager
of each Party as soon as reasonably possible after such dispute has arisen. If
the Project Managers are unable to resolve such a dispute within [***] days of
being requested by a Party to resolve such dispute, each Party shall have the
right, pursuant to written notice, to refer such dispute to the Senior
Management of each Party for attempted resolution by negotiations within [***]
days after such written notice is received. If the Senior Management are unable
to resolve such dispute within [***] days of being requested by a Party to
resolve such dispute, each Party shall have the right to pursue any remedies
available to it at law or in equity.
10.11    Press Releases; Use of Trademarks. The Parties agree not to disclose in
any press release or other public statement any terms or conditions of this
Agreement to any Third Party without the prior consent of the other Party, save
as permitted pursuant to the Confidentiality Agreement. Neither Party shall (a)
issue a press release or make any other public statement that references this
Agreement or (b) use the other Party’s or the other Party’s Affiliates’ names or
trademarks for publicity or advertising purposes, except with the prior written
consent of the other Party, save as permitted pursuant to the Confidentiality
Agreement or Securities and Exchange Commission filings which are required by
Applicable Law, in which instance both Parties shall work together in good faith
to agree the disclosure to be made having due and proper regard to their legal
obligations. Each Party agrees that it shall cooperate fully and in a timely
manner with the other with respect to all disclosures to the Securities and
Exchange Commission or any other governmental or regulatory agencies, including
requests for confidential treatment of Confidential Information of either Party
included in any such disclosure.
10.12    Severability. If any provision of this Agreement is found by a proper
authority to be unenforceable, that provision to the extent it is found to be
unenforceable or invalid shall be severed and the remainder of the provision and
this Agreement will continue in full force and effect. The Parties shall use
their best efforts to agree upon a valid and enforceable provision as a
substitute for any invalid or unenforceable provision, taking in to account the
Parties’ original intent of this Agreement.
10.13    Construction. Unless the context of this Agreement otherwise requires:
(a) words of any gender include each other gender; (b) words using the singular
or plural number also include the plural or singular number, respectively; (c)
the terms “hereof,” “herein,” “hereby,” and derivative or similar words refer to
this entire Agreement; (d) the terms “Article,” “Section,” “Schedule,” refer to
the specified Article, Section or Schedule of this Agreement; (e) “or” is
disjunctive but not necessarily exclusive; and (f) the term “including” or
“includes” means “including without limitation” or “includes without
limitation.” Whenever this Agreement refers to a number of days, such number
shall refer to calendar days unless business days are specified. The captions
and headings of this Agreement are for convenience of reference only and in no
way define, describe, extend, or limit the scope or intent of this Agreement or
the intent of any provision contained in this Agreement. The language of this
Agreement shall be deemed to be the language mutually chosen by the Parties, and
no rule of strict construction shall be applied against either Party hereto.

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10.14    Third Party Beneficiaries. This Agreement is not intended to confer
upon any non-party rights or remedies hereunder, except as may be received or
created as part of a valid assignment.
Without prejudice to the previous sentence, any Affiliate of Client may submit
Purchase Orders under this Agreement if the quantities of Product ordered are
included in the Forecasts given by Client such that Patheon shall receive a
single consolidated Forecast pursuant to Section 2.3(a). Patheon shall submit
invoices to the Affiliate of Client directly for all applicable fees and
charges, which shall be payable by the Affiliate of Client directly in
accordance with ARTICLE IV. The Parties agree that Client may delegate (in part)
the benefits it receives under this Agreement, and its obligations, to any
Affiliate in order that it may benefit from the terms of this Agreement in
connection with Purchase Orders, provided that Client shall remain ultimately
liable for any act or omission under this Agreement of such Affiliate. This
shall not give an Affiliate any right to enforce any term of this Agreement
against Patheon.
10.15    The rights of Patheon and Client to terminate, rescind or agree any
variation, modification, amendment, waiver or settlement under this Agreement
are not subject to the consent of any other person and expressly do not require
the consent of any Affiliate.Further Assurances. Each of the Parties agrees to
duly execute and deliver, or cause to be duly executed and delivered, such
further instruments and do and cause to be done such further acts and things,
including the filing of such additional assignments, agreements, documents, and
instruments, that may be necessary or as the other Party hereto may at any time
and from time to time reasonably request in connection with this Agreement or to
carry out more effectively the provisions and purposes of, or to better assure
and confirm unto such other Party its rights and remedies under, this Agreement.
10.16    Counterparts. This Agreement may be signed in counterparts, each and
every one of which shall be deemed an original. Electronic signatures shall be
treated as original signatures.
[The remainder of this page is left blank intentionally.]

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first written above.
PATHEON UK LIMITED:

INSMED INCORPORATED:
 
 
By:
/s/ Luca Andretta
 
By:
/s/ William H. Lewis
 
 
 
 
 
Name:
Luca Andretta
 
Name:
William H. Lewis
 
 
 
 
 
Title:
 Director

 
Title:
President and CEO
 
Date:
10/20/2018
 
Date:
10/20/2018
 

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[Signature Page of Manufacturing and Supply Agreement]

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Schedule A
Product
Product
Vial Size
Fill Weight
Packaging Configuration
Amikacin Liposome Inhalation Suspension in Vials
[***]
[***]
[***]

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Schedule B
Fees
I.
Base Fee

[***]
Commencement Date
End Date
Fee (per calendar [***])
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

For the avoidance of doubt, the Base Fees will accrue under this Agreement
alone. The fees for the Transfer Services are specified in the Technology
Transfer Agreement.
Consequences for the failure to achieve milestones for the Transfer Services or
effects of early completion of the Transfer Services are specified in Exhibit H
of the Technology Transfer Agreement.

II.
Product Fees

[***]
Tier pricing:
 
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Product Conversion Price
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

Notes:
The tier pricing will apply if [***].
In tier pricing, for any given year the first [***]-[***] vials cost £[***], the
[***] to [***] vials cost £[***], the [***] to [***] vials cost £[***]. etc.
Tier pricing [***]:
The tier pricing below will apply if [***]
 
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Product Conversion Price
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

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Base Fees and Product Fees include:
[***]
Base Fee and Product Fees DO NOT Include:
[***]
Materials:
Cost allocation for the procurement of Materials is set forth in Section 2.2 of
this Agreement. A provisional bill of Materials is listed in Schedule C.

Bill Back Items:
During the Transfer Services, Patheon and Client will work together to develop a
non-exhaustive list of typical Bill Back Items. Terms for the procurement of
Bill Back Items are described in Section 2.2(r).  

Additional Services:
The following non-exhaustive list shall be considered Additional Services and
will be invoiced to Client at the price agreed according to Section 2.2(s).
[***]

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Schedule C
Materials
Part A: Client-Supplied Materials

Material
Specification
 
Cost ($/kg)
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

Part B: Patheon-Supplied Materials

Material
Long lead time
[***]
 

The column for items with a long lead time will be completed in the final
version of the bill of materials to be established during the Transfer Services.
The above list will form the initial basis of the bill of materials for the
Product (“BOM”).The BOM will be further developed during the Transfer Services
to reflect the possibility of local suppliers and any changes to the equipment
/materials needed at the Facility. [***]
This BOM will be updated and agreed by the Parties prior to commercial launch of
the Product.

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Schedule D
On Time In Full Delivery Performance

I. Calculation of OTIF delivery

[***]

II. [***] Delivery Target

[***]

III. Shortfall

[***]

IV. Bonus
[***]

Example calculation:
 
Actual OTIF [***]
Amount of Credit [***]
Bonus Credit due to Patheon
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
Annual Delivery Target (example)
[***]
Shortfall Credit due to Client
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]
[***]

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Schedule E
Client On Site Representatives

The following terms shall apply to any use of on-site office space or other
accommodations that is provided by Patheon for the Client On Site
Representatives:
(a)
Patheon permits only the Client On Site Representatives to use the relevant
office space, which use shall be in common with Patheon and all others
authorised by Patheon;

(b)
the purpose of use of the office space shall be within Use Class B1 of the Town
and Country Planning (Use Classes) Order 1987 and only in connection with the
exercise of the rights of Client under Section 3.5(a);

(c)
the Client On Site Representatives shall use the office space as a licensee and
that no relationship of landlord and tenant shall be created between Patheon and
Client;

(d)
Patheon retains control, possession and management of the office space and
Client has no right to exclude Patheon from the office space;

(e)
the right to use the office space is personal to Client and is not assignable;

(f)
the Client On Site Representatives shall not be entitled to the exclusive use or
occupation of the office space;

(g)
Patheon shall be entitled at any time on giving not less than [***] notice to
require the Client On Site Representatives to transfer to alternative,
comparable space elsewhere within the Facility and the Client On Site
Representatives shall comply with such requirement.

In relation to use of on-site office space or other accommodations that is
provided by Patheon for the Client On Site Representatives, Client agrees:
(a)
not to make any alteration or addition to the office space;

(b)
not to display any advertisement, signboards, nameplate, inscription, flag,
banner, placard, poster, signs or notices in the office space or elsewhere in
the Facility without the prior written consent of Patheon;

(c)
not to do or permit to be done in the office space anything that is illegal or
that may be or become a nuisance, annoyance, inconvenience or disturbance to
Patheon or to occupiers of the Facility or any owner or occupier of a
neighbouring property;

(d)
not to cause or permit to be caused any damage to the office space, any property
of Patheon, the Facility or any neighbouring property; or

(e)
not to obstruct the common parts of the Facility;

(f)
not to apply for any planning permission in respect of the office space or the
Facility;

(g)
not to do anything that will or might constitute a breach of any planning
permissions or similar consents affecting the office space or the Facility or
that will or might invalidate in whole or in part any insurance effected by
Patheon in respect of the office space or the Facility from time to time;

(h)
to comply with all laws and with any recommendations of the relevant suppliers
relating to the supply and removal of electricity, gas, water, sewage,
telecommunications and data and other services and utilities to or from the
office space; and

(i)
to observe any reasonable rules and regulations Patheon makes and notifies to
Client from time to time governing Client’s use of the office space and the
common parts.

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Schedule F
Client [***] Volume Forecast
 
Product
[***] Volume Forecast (Vials)
[***]
[***]
Amikacin Liposome Inhalation Suspension in Vials
[***]
[***]

The Client [***] Volume Forecast for [***] shall be a minimum of [***] unless
agreed otherwise (only for the purpose of determining the Product Fee). Any
commercial Product manufactured for stock building purposes prior to commercial
launch shall count towards the volume of Product purchased.

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Schedule G
Example Exchange Rate Fluctuation Mechanism

 
 
 
 
 
 
 
Option 1 - GBP to USD Contract Pricing
 
 
 
 
 
 
 
 
 
 
 
 
Re-pricing of the following Contract elements:
 
 
 
 
 
 
 
 
 
 
 

[***]

E-3
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the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.