Exhibit 10.1

[Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of
this exhibit have been omitted by means of marking such portions with asterisks
as the identified confidential portions (i) are not material and (ii) would be
competitively harmful if publicly disclosed.]

Master Services Agreement

Manufacture of ITI-007

CONFIDENTIAL

Manufacturing Services Agreement

(the “Agreement”)

by and between

Lonza Ltd

Münchensteinerstrasse 38

CH-4002 Basel

Switzerland

- hereinafter “Lonza” -

and

ITI Limited

2 Church Street, Hamilton HM 11, Bermuda

- hereinafter “Customer” -

Effective as of January 10, 2017 (the “Effective Date”)

 

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

CONFIDENTIAL

 

Table of Contents

 

          Page   1    Definitions and Interpretation      1   2    Performance
of Services      5   3    Project Management / Steering Committee      6   4   
Quality      7   5    Insurance      7   6    Forecasting, Ordering and
Cancellation      7   7    Delivery and Acceptance      9   8    Price and
Payment      10   9    Capital Equipment      11   10    Intellectual Property
     11   11    Warranties      12   12    Indemnification and Liability      13
  13    Confidentiality      14   14    Term and Termination      15   15   
Force Majeure      16   16    Miscellaneous      16  

Appendix A

Appendix B

 

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

CONFIDENTIAL

 

Recitals

WHEREAS, Customer is engaged in the development and research of certain products
and requires assistance in the development and manufacture of product;

WHEREAS, Lonza and its Affiliates have expertise in the evaluation, development
and manufacture of products;

WHEREAS, Customer wishes to engage Lonza for Services relating to the
development and manufacture of the Product as described in this Agreement; and

WHEREAS, Lonza, or its Affiliate, is prepared to perform such Services for
Customer on the terms and subject to the conditions set out herein.

NOW, THEREFORE, in consideration of the mutual promises contained herein, and
for other good and valuable consideration, the parties intending to be legally
bound, agree as follows:

 

1

Definitions and Interpretation

 

“Affiliate”   

means any company, partnership or other entity which directly or indirectly
Controls, is Controlled by or is under common Control with the relevant Party.
“Control” means the ownership of more than fifty percent (50%) of the issued
share capital or the legal power to direct or cause the direction of the general
management and policies of the relevant Party.

“Agreement”   

means this agreement incorporating all Appendices, as amended from time to time
by written agreement of the Parties.

“Applicable Laws”   

means all relevant U.S. and European Union federal, state and local laws,
statutes, rules, and regulations which are applicable to a Party’s activities
hereunder, including, without limitation, the applicable regulations and
guidelines of any Governmental Authority and all applicable cGMP together with
amendments thereto.

“Approval”   

means the first marketing approval by the FDA or EMA of Product from the
Facility for commercial supply.

“Background Intellectual Property”   

means any Intellectual Property either (i) owned or controlled by a Party prior
to the Effective Date or (ii) developed or acquired by a Party independently
from the performance of the Services hereunder during the Term of this
Agreement.

“Batch”   

means the Product derived from a single run of the Manufacturing Process.

“Batch Price”   

means the Price of each Batch.

“Campaign”   

means a series of no less than three (3) cGMP Batches manufactured
consecutively.

“Cancellation Fee”   

has the meaning given in Clause 6.6.

 

1

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

CONFIDENTIAL

 

“Capital Equipment”   

means those certain pieces of equipment described in the Project Plan used to
produce the Product that are purchased by Customer or for which Customer
reimburses Lonza, including, without limitation, the related documentation
regarding the design, validation, operation, calibration and maintenance of such
equipment.

“Certificate of Analysis”   

means a document prepared by Lonza for each Batch that lists each of the tests
performed by Lonza or approved External Laboratories, the Specifications for
each test and the test results.

“Certificate of Compliance”   

means a document prepared by Lonza: (i) listing the manufacturing date, unique
Batch number, and concentration of Product in such Batch, (ii) certifying that
such Batch was manufactured in accordance with the Master Batch Record and cGMP,
if applicable.

“cGMP”   

means those laws and regulations applicable in the U.S. and Europe, relating to
the manufacture of medicinal products for human use, including, without
limitation, current good manufacturing practices as specified in the ICH
guidelines, including without limitation, ICH Q7A “ICH Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients”, US Federal Food Drug and
Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610) and the Guide to Good
Manufacturing Practices for Medicinal Products as promulgated under European
Directive 91/356/EEC. For the avoidance of doubt, Lonza’s operational quality
standards are defined in internal cGMP policy documents.

“cGMP Batches”   

means any Batches which are required under the Project Plan to be manufactured
in accordance with cGMP.

“Change”   

means any change to the Services, pricing or Scope of Work incorporated into a
written amendment to the Agreement in accordance with clause 16.2 or effected in
accordance with the Quality Agreement.

“Commencement Date”   

means the date of commencement of manufacturing activities for a Batch
hereunder.

“Competitor”   

means an entity that derived greater than twenty-five (25) percent of its
revenues from providing contract manufacturing services to third parties in the
last completed fiscal year prior to the date of the proposed assignment.

“Confidential Information”   

means Customer Information and Lonza Information, as the context requires.

“Customer Information”   

means all technical and other information not known to Lonza or in the public
domain relating to the Manufacturing Process and the Product, from time to time
supplied by the Customer to Lonza, including any materials supplied by Customer
to Lonza in accordance with the Project Plan.

 

2

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

CONFIDENTIAL

 

“Customer Materials”   

means any Raw Materials, components of Product, or other materials of any nature
provided by Customer.

“EMA”   

means the European Medicines Agency, or any successor agency thereto.

“Engineering Batches”   

means a Batch that is intended to demonstrate the transfer of the Manufacturing
Process to the Facility.

“External Laboratories”   

means any Third Party instructed by Lonza, with Customer’s prior consent, to
conduct any of the activities required to complete the Services.

“Facility”   

means Lonza’s manufacturing facilities in [***] or such other Lonza facility as
may be agreed upon by the Parties.

“FDA”   

means the United States Food and Drug Administration, or any successor agency
thereto.

“Governmental Authority”   

means any Regulatory Authority and any national, multi-national, regional, state
or local regulatory agency, department, bureau, or other governmental entity in
the U.S. or European Union.

“Intellectual Property”   

means (i) inventions (whether or not patentable), patents, trade secrets,
copyrights, trademarks, trade names and domain names, rights in designs, rights
in computer software, database rights, rights in confidential information
(including know-how) and any other intellectual property rights, in each case
whether registered or unregistered, (ii) all applications (or rights to apply)
for, and renewals or extensions of, any of the rights described in the foregoing
clause (i) and (iii) and all rights and applications that are similar or
equivalent to the rights and application described in the foregoing clauses
(i) and (ii), which exist now, or which come to exist in the future, in any part
of the world.

“Lonza Information”   

means all information that is proprietary to Lonza or any Affiliate of Lonza and
that is maintained in confidence by Lonza or any Affiliate of Lonza and that is
disclosed by Lonza or any Affiliate of Lonza to Customer under or in connection
with this Agreement, including without limitation, any and all Lonza know-how
and trade secrets.

“Manufacturing Process”   

means the production process provided by Customer for the manufacture of
Product, as such process may be improved or modified from time to time by
agreement of the Parties in writing.

“Master Batch Record”   

means the document, proposed by Lonza and approved by Customer, which defines
the manufacturing methods, test methods and other procedures, directions and
controls associated with the manufacture and testing of Product, and which may
be amended from time to time by agreement of the Parties in writing.

“New Customer Intellectual Property”   

has the meaning given in Clause 10.2.

 

3

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

CONFIDENTIAL

 

“New General Application Intellectual Property”   

has the meaning given in Clause 10.3.

“Party”   

means each of Lonza and Customer and, together, the “Parties”.

“Price”   

means the price for the Services and Products as set out in Appendix A.

“Process Validation Batch”   

means a Batch that is produced with the intent to show reproducibility of the
Manufacturing Process and is required to complete process validation studies.

“Product”   

means the proprietary molecule identified by Customer as ITI-007, to be
manufactured by Lonza for Customer using the Manufacturing Process as specified
in the Project Plan.

“Project Plan”   

means the plan(s) describing the Services to be performed by Lonza under this
Agreement, including any update and amendment of the Project Plan to which the
Parties may agree from time to time in writing. The initial Project Plan is
attached hereto as Appendix A.

“Quality Agreement”   

means the written quality agreement, to be entered into by the Parties in
accordance with Section 4.1 of this Agreement, setting out the responsibilities
of each of the Parties in relation to Product quality as required for compliance
with cGMP, and which shall be consistent with this Agreement and Applicable Laws
(including meeting the requirements of the FDA’s then-current Guidance for
Industry regarding “Contract Manufacturing Arrangements for Drugs: Quality
Agreements” and the ICH guidance regarding “Q10 Pharmaceutical Quality
Systems”).

“Raw Materials”   

means all ingredients, solvents and other components of the Product required to
perform the Manufacturing Process or Services set forth in the bill of materials
detailing the same (but excluding any consumables). “Regulatory Authority” means
the FDA, EMA and any other similar regulatory authorities as may be agreed upon
in writing by the Parties.

“Regulatory Approval”   

means any approval (including any supplements, amendments, pre- and
post-marketing approvals, and pricing and reimbursement approvals, and including
the Approval), licenses, registrations or any other authorizations required by a
Regulatory Authority necessary for the manufacture, distribution, sale or use of
the Product.

“Release”   

has the meaning given in Clause 7.1.

“Services”   

means all or any part of the services to be performed by Lonza under this
Agreement (including, without limitation, process and analytical method
transfer; process development; process optimization; validation; clinical and
commercial manufacturing; and quality control and quality assurance activities),
particulars of which are set out in a Project Plan.

 

4

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

CONFIDENTIAL

 

“Specifications”   

means the mutually agreed upon specifications, including test procedures and
acceptance criteria, of the Product as specified in Appendix B, which may be
amended from time to time in accordance with this Agreement.

“Term”   

has the meaning given in Clause 14.1.

“Third Party”   

means any party other than Customer, Lonza and their respective Affiliates.

In this Agreement references to the Parties are to the Parties to this
Agreement, headings are used for convenience only and do not affect its
interpretation, references to a statutory provision include references to the
statutory provision as modified or re-enacted or both from time to time and to
any subordinate legislation made under the statutory provision, references to
the singular include the plural and vice versa, and references to the word
“including” are to be construed without limitation.

 

2

Performance of Services

 

2.1

Performance of Services. Subject to Clause 2.3, Lonza shall itself and through
its Affiliates, diligently carry out the Services as provided in the Project
Plan and in accordance with this Agreement and use commercially reasonable
efforts to perform the Services without any material defect and according to the
estimated timelines as set forth in the Project Plan. Lonza shall retain
appropriately qualified and trained personnel with the requisite knowledge and
experience to perform the Services in accordance with this Agreement. Lonza may
not subcontract or delegate any of its rights or obligations under this
Agreement to perform the Services without Customer’s prior written consent not
to be unreasonably withheld or delayed; provided, that any approved
subcontractors and approved External Laboratories shall be subject to the same
obligations and other provisions contained in this Agreement or any applicable
Project Plan, including the obligation to maintain Customer Information in
confidence under terms no less stringent than as set forth herein. Except as
otherwise agreed to by the Parties or as otherwise agreed to under the Quality
Agreement, Lonza shall be liable and responsible for the compliance by such
subcontractors and External Laboratories with the applicable provisions of this
Agreement.

 

2.2

Technology Transfer. The Parties expressly agree that they shall work together
to transfer the Manufacturing Process to the Facility, including implementing
the technology transfer plan set forth in Project Plan. Customer shall fully
support such technology transfer as reasonably requested by Lonza.

 

2.3

Engineering Batches. Lonza shall manufacture Engineering Batches in accordance
with the Project Plan. Customer shall have the right to make whatever further
use of the non-cGMP Engineering Batches as it shall determine, provided that
Customer pays for such Batches, such use is not for human use and does not
violate any Applicable Laws. Lonza makes no warranty that Engineering Batches
will meet cGMP or the Specifications. If Lonza determines that an Engineering
Batch does meet cGMP and the Specifications, it will release such Engineering
Batch as a cGMP Batch. Regardless of whether any Engineering Batch meets cGMP or
the Specifications, Customer shall pay to Lonza the Price for such Engineering
Batch in accordance with the terms of this Agreement.

 

2.4

cGMP Batches. Lonza will, in accordance with the terms of this Agreement and the
Quality Agreement, manufacture at the Facility and Release to Customer, cGMP
Batches that comply with the Manufacturing Process, cGMP and the Specifications
and this Agreement, and each released Batch will be accompanied by a Certificate
of Analysis; provided, however, that cGMP manufacture shall not commence until
at least one (1) successful Engineering Batch has been manufactured in
compliance with cGMP and Specifications. Prior to commencement of cGMP
manufacturing, Lonza shall review the process assumptions. In the event that
there is a material difference in the process assumptions as compared with the
process results demonstrated during the manufacture

 

5

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

CONFIDENTIAL

 

 

of Engineering Batches, the Parties shall meet to discuss in good faith a
revision to the Batch Price to reflect such difference.

 

2.5

Process Validation Batches. Lonza shall manufacture and deliver Process
Validation Batches as mutually agreed by Parties sufficient to document the
operability and reproducibility of the Manufacturing Process and permit the
Parties to complete and file the necessary regulatory documents.

 

  2.5.1

Prior to commencement of Process Validation Batches, Lonza and Customer shall
agree a process validation plan identifying the validation requirements of the
Manufacturing Process. All process validation activities are excluded from the
Price of Process Validation Batches shall be approved by the Customer in advance
and shall be paid for by the Customer at the Price set out in the applicable
Project Plan.

 

  2.5.2

Any regulatory support activities (including pre-Approval inspection) required
and agreed to by Customer to support the Approval of the Product from the
Facility shall be performed and supported by Lonza as reasonably requested by
Customer. All such regulatory support activities are excluded from the Price of
Process Validation Batches, shall be approved by the Customer in advance, and
shall be paid for by the Customer at the Price set out in the applicable Project
Plan.

 

2.6

Supply of Customer Information and Customer Materials. Customer shall supply to
Lonza all Customer Information and Customer Materials and other information or
materials that may be reasonably required by Lonza to perform the Services.
Lonza shall not be responsible for any delays arising out of Customer’s failure
to provide to Lonza such Customer Information, Customer Materials, or other
information or materials reasonably required to perform the Services. Customer
shall be responsible for all additional costs and expenses arising out of such
delay, including, if applicable, any idle Facility capacity costs.

 

2.7

Raw Materials. Lonza shall procure all required Raw Materials as well as
consumables other than those Raw Materials that are Customer Materials. Customer
shall be responsible for payment for all consumables and Raw Materials ordered
or irrevocably committed to be procured by Lonza hereunder where the Parties
agree that such Raw Materials are included in the Price as identified in the
Project Plan. Upon cancellation of any Batch or termination of the Agreement,
all unused Raw Materials shall be paid for by Customer within thirty (30) days
of invoice and at Customer’s option will either be (a) held by Lonza for future
use for the production of Product, (b) delivered to Customer, or (c) disposed of
by Lonza. Lonza may not use any Raw Materials or Customer Materials for any
purpose other than to perform Services in accordance with this Agreement.

 

3

Project Management / Steering Committee

 

3.1

Project Plans. With respect to a new project to be governed by this Agreement, a
new Project Plan shall be added by agreement in a writing signed by the Parties
and appended to Appendix A. Each Project Plan shall include a description of the
Services to be provided, the Product to be manufactured, Specifications, a
schedule for completion of the Project Plan, pricing details, and such other
information as is necessary for relevant Services. In the event of a conflict
between the terms of a Project Plan and this Agreement, the terms of this
Agreement will govern, except to the extent that the applicable Project Plan
expressly and specifically states an intent to supersede this Agreement on a
specific matter.

 

3.2

Project Management. With respect to each Project Plan, each Party will appoint a
project manager who will be the person responsible for overseeing the Project
Plan on behalf of the respective Party.

 

3.3

Steering Committee. Each Party shall name a mutually agreed upon equal number of
representatives for the Steering Committee, which shall meet twice per calendar
year, or as

 

6

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

CONFIDENTIAL

 

 

otherwise mutually agreed by the Parties. In the event that a Steering Committee
dispute cannot be resolved, such dispute shall be escalated to a senior
executive of each of Customer and Lonza.

The primary function of the Steering Committee is to ensure the ongoing
communication between the Parties and to discuss and resolve any issues arising
under this Agreement. In addition to the primary function described above, the
Steering Committee shall take on the following responsibilities:

 

  3.3.1

discuss and seek resolution of issues around management of the Services;

 

  3.3.2

agree and monitor deadlines and milestones for the Services; and

 

  3.3.3

discuss and recommend any changes to the Services (although such changes will
not take effect until they have been incorporated into a written amendment to
the Project Plan which has been signed by the Parties).

The Steering Committee may not waive or modify the terms of this Agreement, or
take any action that would bind a Party without its prior written consent.

 

3.4

Person in Plant. Customer shall be permitted to have, at no additional cost, one
(1) employee at the Facility as reasonably requested by Customer, at any time
during the Manufacturing Process for the purpose of observing, reporting on, and
consulting as to the performance of the Services. Such employee shall be subject
to and agree to abide by confidentiality obligations to Third Parties and
Lonza’s customary practices and operating procedures regarding persons in plant,
and such employee agrees to comply with all instructions of Lonza’s employees at
the Facility.

 

4

Quality

 

4.1

Responsibility for quality assurance and quality control of Product shall be
allocated between Customer and Lonza as set forth in the Quality Agreement and
in Lonza standard operating procedures. If there is a conflict between the terms
and conditions of this Agreement and the Quality Agreement, the terms and
conditions of this Agreement shall prevail. If the Quality Agreement is not in
place at the Effective Date, Lonza and Customer commit to enter into the Quality
Agreement in a timely manner, but in no event later than the commencement of
cGMP manufacturing. Provisions regarding inspections by Regulatory Authorities
and audits shall be set out in the Quality Agreement.

 

5

Insurance

 

5.1

Each Party shall, during the Term and [***] after delivery of the last Product
manufactured or Services provided under this Agreement, obtain and maintain at
its own cost and expense from a qualified insurance company, comprehensive
general liability insurance including, but not limited to product liability
coverage in the amount of at least [***] per claim in the case of a Lonza
insurance policy and [***] in the case of a Customer insurance policy. Each
Party shall provide the respective other Party with a certificate of such
insurance upon reasonable request.

 

6

Forecasting, Ordering and Cancellation

 

6.1

Forecasting and Ordering. No later than [***], Customer shall supply Lonza with
a written forecast showing Customer’s good faith estimated quarterly
requirements for Batches for the following [***] (the “Forecast”). No later than
[***] following Lonza’s receipt of a Forecast, Lonza shall provide written
notice to Customer with an estimated production schedule showing the estimated
Commencement Date and delivery date of each Batch; provided that if the Forecast
for any [***] exceeds the capacity reserved for such [***] in Section 6.4 of
this Agreement or agreed between the Parties in accordance with Section 6.9 of
this Agreement (the “Reserved Capacity”), Lonza

 

7

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

CONFIDENTIAL

 

 

shall notify Customer within [***] of receipt of the Forecast of its ability (as
of the date of receipt of the Forecast) to manufacture the number of Batches
forecasted in excess of the Reserved Capacity. The [***] of any Forecast shall
be binding (“Binding Forecast”). Except as otherwise provided in Section 6.4
below, binding purchase orders (“Purchase Orders”) for the [***] shall be
submitted by Customer on the basis of the Binding Forecast within [***] of
submission of the Forecast. No Forecast shall amend any previous Binding
Forecast, and all Purchase Orders shall be for an amount not less than [***].

 

6.2

Order Confirmation. Lonza shall confirm the delivery date(s) and quantity of
Product to be delivered as set out in each Purchase Order within [***] days of
receipt from Customer of the relevant Purchase Order. Upon confirmation, each
Purchase Order will be regarded by the Parties as a binding commitment by Lonza
to manufacture and to deliver to Customer the relevant quantity of Product
according to the requirements set out in such Purchase Order. Lonza shall
confirm and accept each Purchase Order that is consistent with the corresponding
Forecast. Any delivery date set forth in Lonza’s written confirmation of a
purchase order shall be an estimated delivery date only. All ordered Batches
shall be scheduled in a single Campaign in each calendar year unless otherwise
agreed by Lonza. Any additional or inconsistent terms or conditions of any
Customer purchase order, acknowledgement, invoice, or similar standardized form
given or received pursuant to this Agreement shall have no effect and such terms
and conditions are hereby rejected.

 

6.3

Rescheduling. Lonza shall have the right to reschedule a Commencement Date of
any Batch or Campaign upon reasonable prior written notice to Customer, provided
that the rescheduled Commencement Date is no earlier or no later than [***] from
the Commencement Date originally estimated at the time of Lonza’s acceptance of
the binding purchase order. If the Customer requests to change the Commencement
Date, Lonza will make all reasonable attempts to accommodate the request;
provided, however, in the event that this change would impact other projects
scheduled for occupancy in the designated suite or suites, manufacture of the
Customer’s Batch or Campaign may be delayed until an adequate time period is
available in the Facility schedule, and any such change requested by Customer
may result in a rescheduling fee, all of which shall be confirmed by their
Parties in writing. Any delay requested by Customer of more than [***] shall be
considered a cancellation pursuant to Section 6.6.

 

6.4

Dedicated Supply: Lonza will reserve capacity for Customer, sufficient for the
manufacture of approximately (i) [***] for [***], until [***], at which time the
commitment for [***] capacity becomes binding; (ii) [***] for [***]; and (iii)
[***] for [***]. Customer may cancel this reservation in writing by [***], only
if Approval is not received, on or before end [***] without penalty. For [***],
the Reserved Capacity becomes binding [***] prior to the estimated Commencement
Date of the campaign.

 

6.5

Product Quantities. Quantities of Product arising from a Campaign up to a
maximum of [***] above or below the Purchase Order will be invoiced according to
the [***] price as outlined in the Project Plan. In case of additional surplus
quantities or quantities below [***] of the target quantity the Parties will
negotiate in good faith a reasonable price. The Purchase Order shall be
fulfilled if at least [***] of the target quantity is delivered.

 

6.6

Cancellation of a Binding Purchase Order. Customer may cancel a binding purchase
order upon written notice to Lonza, subject to the payment of a cancellation fee
as calculated below (the “Cancellation Fee”):

 

  6.6.1

In the event that Customer provides written notice of cancellation to Lonza
[***] prior to the Commencement Date of one or more Batches, then [***] of the
Batch Price of each such Batch cancelled is payable; or

 

  6.6.2

In the event Customer provides written notice of cancellation more than [***]
prior to the Commencement Date of a Batch, then [***] Cancellation Fee is
payable.

 

8

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

CONFIDENTIAL

 

6.7

Payment of Cancellation Fee. Any Cancellation Fee shall be payable within [***]
following the written notice of cancellation associated with the cancelled
Batch. Any Cancellation Fee shall include all costs associated with the
cancelled Batch, including any Raw Materials.

 

6.8

Replacement Project. Notwithstanding the foregoing, Lonza will use commercially
reasonable efforts to secure a new project (but excluding any project then under
contract with Lonza) for the cGMP manufacturing space, and for the same dates
and duration that would have been occupied by Customer, and then, in such case,
the Cancellation Fee for each Batch cancelled that is replaced by a Batch of the
new project shall be reduced by an amount equal to [***] of the production fees
associated with such replacement Batch.

 

6.9

Commercial Supply Negotiations: Prior to [***], Customer and Lonza will enter
good faith negotiations to develop and finalize an operating model that can
support projected commercial supply of Product starting in [***].

 

7

Delivery and Acceptance

 

7.1

Delivery. All Product shall be delivered FCA (as defined by Incoterms® 2010) the
Facility. Lonza shall deliver to Customer the Certificate of Analysis, the
Certificate of Compliance and such other documentation as is reasonably required
to meet all applicable regulatory requirements of the Governmental Authorities
not later than the date of delivery of Batches to the common carrier chosen by
Customer (the “Release”). With respect to any Customer Materials, title and risk
of loss shall remain with the Customer and shall not transfer to Lonza. With
respect to Product, title and risk of loss shall transfer to Customer upon
Release in accordance with this provision.

 

7.2

Storage. Customer shall arrange for shipment and take delivery of such Batch
from the Facility, at Customer’s expense, within [***] after Release or pay
applicable storage costs. Lonza shall provide storage on a bill and hold basis
for such Batch(es) at no charge for up to [***]; provided that any additional
storage beyond [***] will be subject to availability and, if available, will be
charged to Customer and will be subject to a separate agreement. In addition to
Section 8.2, Customer shall be responsible for all value added tax (VAT) and any
other applicable taxes, levies, import, duties and fees of whatever nature
imposed as a result of any storage. Notwithstanding anything to the contrary
contained in this Agreement, in no event shall Lonza be required to store any
Batch for more than [***] after Release. Within [***] following a written
request from Lonza, Customer shall provide Lonza with a letter in form
satisfactory to Lonza confirming the bill and hold status of each stored Batch.

 

7.3

Acceptance/Rejection of Product.

 

  7.3.1

Promptly following Release of Batches, Customer shall inspect such Batches and
shall have the right to test such Batches to determine compliance with the
Specifications. Customer shall notify Lonza in writing of any rejection of a
Batch based on any claim that it fails to meet Specifications within [***] of
Release, after which time all unrejected Batches shall be deemed accepted.
Customer shall inform Lonza in writing in case of concealed or latent defects
(i.e. not discovered by routine quality control means), promptly upon discovery
of such defects but no later than [***] after delivery of the Product.

 

  7.3.2

In the event that Lonza believes that a Batch has been incorrectly rejected,
Lonza may require that Customer provide to it Batch samples for testing. Lonza
may retain and test the samples of such Batch. In the event of a discrepancy
between Customer’s and Lonza’s test results such that Lonza’s test results fall
within relevant Specifications, or there exists a dispute between the Parties
over the extent to which such failure is attributable to a given Party, the
Parties shall cause an independent laboratory promptly to review records, test
data and perform comparative tests and analyses on samples of the Product that
allegedly fails to conform to Specifications. Such independent laboratory shall
be mutually agreed upon by the Parties. The independent laboratory’s results
shall be in writing and shall be

 

9

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

 

final and binding save for manifest error. Unless otherwise agreed to by the
Parties in writing, the costs associated with such testing and review shall be
borne by the Party against whom the independent laboratory rules.

 

  7.3.3

For Engineering Batches, Lonza shall, at its own expense, reprocess any
Engineering Batch or, if reprocessing is not possible, replace any Engineering
Batch that failed to conform with the Specifications (a “Failed Engineering
Batch”). Following completion of Engineering Batches, before proceeding to
Process Validation Batches, the Parties shall agree, in writing, that the
Process is validation ready. Following such agreement to proceed with Process
Validation Batches, Lonza shall, at its own expense, reprocess any Batch or, if
reprocessing is not possible, replace any Batch that failed to conform with the
Specifications (a “Failed Batch”). Such reprocessing or replacement shall be
made as promptly as practicable, in light of available manufacturing capacity.
Where possible, any replacement Batch shall be manufactured with the next
scheduled cGMP Batch or Campaign. Customer acknowledges and agrees that its sole
remedy with respect to a Failed Engineering Batch or a Failed Batch is as set
forth in this Clause 7.3.3, and in furtherance thereof, Customer hereby waives
all other remedies at law or in equity regarding the foregoing claims. Lonza
shall be responsible for the cost of Raw Materials or Customer Materials
consumed in any Failed Batch. Customer shall be responsible for the cost of Raw
Materials or Customer Materials consumed in any Failed Engineering Batch;
provided, however that in the event that it is determined (by the Parties or an
independent laboratory) that a Failed Engineering Batch was solely due to
Lonza’s material breach of its obligations hereunder, gross negligence or
operator error, then Lonza shall be responsible for the cost of Raw Materials or
Customer Materials consumed in such Failed Engineering Batch. Lonza shall
promptly destroy each Failed Engineering Batch or Failed Batch at its cost and
expense, if reprocessing is not possible.

 

8

Price and Payment

 

8.1

Pricing for the Services provided by Lonza are set out in, and based on the
assumptions and information set out in, the applicable Project Plan. In the
event of changes to the Services based on Customer’s request, the Parties shall
discuss and agree upon any additional costs.

 

8.2

Unless otherwise indicated in writing by Lonza, all Prices and charges are
exclusive of value added tax (VAT) and of any other applicable taxes, levies,
import, duties and fees of whatever nature imposed by or under the authority of
any government or public authority and all such charges applicable to the
Services shall be paid by Customer (other than taxes based on Lonza’s income).

 

8.3

Lonza shall issue invoices to Customer for [***] of the Price for Products or
Services upon the confirmation of a Purchase Order for the applicable Batch or
Campaign, [***] of the Price for Products or Services upon commencement of the
manufacturing of Products or Services, and [***] upon Release of applicable
Batches or completion of applicable Services, unless otherwise stated in the
Project Plan. To the extent not included in the Price, charges for Raw Materials
for each Batch shall be invoiced upon the Release of each Batch, provided, that
any Raw Materials required to be ordered more than [***] in advance shall be
invoiced [***] at the time of order by Lonza and [***] upon Release of the
Batch. All undisputed invoices are payable within [***] of date of invoice.
Payment shall be made without deduction, deferment, set-off, lien or
counterclaim.

 

8.4

If in default of payment of any undisputed invoice on the due date, interest
shall accrue on any amount overdue at the lesser of (i) rate of [***] per month
above the London Interbank Offered Rate (LIBOR) or (ii) [***]; and Lonza shall,
at its sole discretion, and without prejudice to any other of its accrued
rights, be entitled upon [***] notice to suspend the provision of the Services
and or delivery of Product until all overdue amounts have been paid in full
including interest for late payments.

 

10

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

CONFIDENTIAL

 

8.5

Price adjustments.

 

  8.5.1

Not more than once per calendar year, Lonza may adjust the Price in accordance
with the European Union Manufacturing Producer Prices Index (or any successor
index) increase for the previous calendar year. The new Price reflecting such
Batch Price adjustment shall be effective for any Batch for which the
Commencement Date is on or after the date of Lonza’s notice to Customer of the
Price adjustment.

 

  8.5.2

In addition to the above, the Price may be changed by Lonza, upon reasonable
prior written notice to Customer (providing reasonable detail and documentation
in support thereof), to reflect (i) an increase in variable costs (such as
energy or Raw Materials) by more than [***] (based on the initial Price or any
previously amended Price), or for a process adjustment or assumption changes,
and (ii) any material change in an environmental, safety or regulatory standard
that substantially impacts Lonza’s cost and ability to perform the Services.

 

  8.5.3

The Prices outlined in the Project Plan are based on the currency exchange rate
of the [***] to the United States Dollars (USD) at the Effective Date. Lonza
shall bear the risk of any increase or decrease of the [***]/USD exchange rate
up to [***] from the base currency exchange rate. If the [***]/USD exchange rate
is more than [***] the base currency exchange rate at the date on which the
Prices become due for payment, then the Prices will be adjusted to compensate
all exchange rate differences higher than [***]. The currency adjustments to be
made, if any, shall be based on the market rate of exchange as published by
Bloomberg.

 

9

Capital Equipment

 

9.1

Any Capital Equipment required for the performance of the Services shall be
acquired on terms to be agreed by the Parties prior to commencement of the
relevant Services.

 

10

Intellectual Property

 

10.1

Except as expressly otherwise provided herein, neither Party will, as a result
of this Agreement, acquire any right, title, or interest in any Background
Intellectual Property of the other Party, including any improvements made
thereto during the Services under this Agreement.

 

10.2

Subject to Clause 10.3, Customer shall own all right, title, and interest in and
to any and all Intellectual Property that Lonza and its Affiliates, the External
Laboratories or other contractors or agents of Lonza develops, conceives,
invents, first reduces to practice or makes, solely or jointly with Customer or
others, that is a direct derivative of or improvement to Customer Information or
Customer Background Intellectual Property, or that cannot be practiced without
use of Customer Information or Customer Background Intellectual Property
(collectively, the “New Customer Intellectual Property”). For avoidance of
doubt, “New Customer Intellectual Property” shall include any material,
processes or other items that embody, or that are claimed or covered by, any of
the foregoing Intellectual Property, but excluding any New General Application
Intellectual Property.

 

10.3

Notwithstanding Clause 10.2, and subject to the license granted in Clause 10.5,
Lonza shall own all right, title and interest in Intellectual Property that
Lonza and its Affiliates, the External Laboratories or other contractors or
agents of Lonza, solely or with each other (and without Customer), develops,
conceives, invents, or first reduces to practice or makes in the course of
performance of the Services that is generally applicable to the development or
manufacture of chemical or biological products or product components (“New
General Application Intellectual Property”). For avoidance of doubt, “New
General Application Intellectual Property” shall include any material, processes
or other items that embody, or that are claimed or covered by, any of the
foregoing Intellectual Property.

 

11

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

CONFIDENTIAL

 

10.4

Lonza hereby assigns to Customer all of its right, title and interest in any New
Customer Intellectual Property. Lonza shall execute, and shall require its
personnel as well as its Affiliates, External Laboratories or other contractors
or agents and their personnel involved in the performance of the Services to
execute, any documents reasonably required to confirm Customer’s ownership of
the New Customer Intellectual Property, and any documents required to apply for,
maintain and enforce any patent or other right in the New Customer Intellectual
Property.

 

10.5

Subject to the terms and conditions set forth herein (including the payment of
the Price as required above), Lonza hereby grants to Customer a non-exclusive,
world-wide, fully paid-up, irrevocable, transferable license, including the
right to grant sublicenses, under the New General Application Intellectual
Property, to use, sell and import the Product manufactured under this Agreement.

 

10.6

Customer hereby grants Lonza the non-exclusive right to use the Customer
Information, Customer Background Intellectual Property and New Customer
Intellectual Property during the Term solely for the purpose of fulfilling its
obligations under this Agreement and in accordance with the terms of this
Agreement.

 

10.7

Customer will have the right to transfer the Manufacturing Process to itself and
any Third Party for the manufacture of that Product (but no other product);
provided, however, to the extent such technology transfer includes Lonza
Confidential Information, Lonza Background Intellectual Property or New General
Application Intellectual Property, such technology transfer shall be subject to
(i) approval by Lonza in writing; (ii) a reasonable royalty and licensing fee;
and (iii) terms to be agreed upon by the Parties. Lonza shall provide reasonably
necessary documents to complete such technology transfer and Customer shall
reimburse Lonza for any costs (based on a full-time employee rate for such
support) and expenses.

 

11

Warranties

 

11.1

Lonza warrants, represents and covenants to Customer that:

 

  11.1.1

the Services shall be performed in accordance with all Applicable Laws;

 

  11.1.2

except with respect to any development services and Engineering Batches, the
manufacture of Product shall be performed in accordance with cGMP and will meet
the Specifications at the date of delivery;

 

  11.1.3

To its knowledge, any Intellectual Property provided and used by Lonza and its
Affiliates in performance of Services which relate to developing, formulation,
manufacturing, filling, processing, packaging, analyzing or testing the Product
shall not infringe, violate or misappropriate any third party Intellectual
Property rights, and this warranty shall not apply to the extent such
infringement, violation or misappropriation of any third Party Intellectual
Property is based upon, in part or whole, Client’s written instructions,
Specifications or use of Client Materials.

 

  11.1.4

Lonza is not debarred, and has not been convicted of a crime which could lead to
debarment, under 21 U.S.C. §335(a) or (b) (“the Debarment Act”), and Lonza will
not in the performance of its obligations under this Agreement use the services
of any person debarred or suspended under the Debarment Act. If Lonza becomes
debarred or receives notice of action with respect to its debarment, Lonza shall
promptly notify Customer;

 

  11.1.5

no transactions or dealings under this Agreement shall be conducted with or for
an individual or entity that is designated as the target of any sanctions,
restrictions or embargoes administered by the United Nations, European Union,
United Kingdom or the United States of America;

 

12

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

CONFIDENTIAL

 

  11.1.6

it or its Affiliate holds all necessary permits, registrations, approvals,
consents and licenses to enable it to perform the Services at the Facility; and

 

  11.1.7

it has the necessary corporate authorizations to enter into and perform this
Agreement.

 

11.2

Customer warrants that:

 

11.3

To its knowledge, Customer has all the rights to Customer Information and
Customer Background Intellectual Property necessary to permit Lonza to perform
the Services without infringing the Intellectual Property rights of any Third
Party and the use of Customer Information and Customer Background Intellectual
Property in the performance of the Services shall not infringe any Third Party
Intellectual Property rights;

 

11.4

Customer will promptly notify Lonza in writing if it receives or is notified of
a formal written claim from a Third Party that Customer Information and Customer
Intellectual Property or that the use by Lonza thereof for the provision of the
Services infringes any Intellectual Property or other rights of any Third Party;
and

 

11.5

Customer has the necessary corporate authorizations to enter into this
Agreement.

 

11.6

DISCLAIMER: THE WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE IN LIEU OF
ALL OTHER WARRANTIES, AND ALL OTHER WARRANTIES, BOTH EXPRESS AND IMPLIED, ARE
EXPRESSLY DISCLAIMED, INCLUDING WITHOUT LIMITATION ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

12

Indemnification and Liability

 

12.1

Indemnification by Lonza. Lonza shall indemnify the Customer, its Affiliates,
and their respective officers, employees and agents (“Customer Indemnitees”) for
any loss, damage, costs and expenses (including reasonable attorney fees) that
Customer Indemnitees may suffer as a result of any Third Party claim arising
directly out of (i) any material breach of the warranties given by Lonza in
Clause 11.1 above or (ii) any claims alleging that the Services (excluding use
by Lonza of Customer Information and Customer Background Intellectual Property)
infringe any Intellectual Property rights of a Third Party except, in each case,
to the extent that such claims resulted from the negligence, intentional
misconduct or breach of this Agreement by any Customer Indemnitees.

 

12.2

Indemnification by Customer. Customer shall indemnify Lonza, its Affiliates, and
their respective officers, employees and agents (“Lonza Indemnitees”) from and
against any loss, damage, costs and expenses (including reasonable attorney
fees) that Lonza Indemnitees may suffer as a result of any Third Party claim
arising directly out of (i) any material breach of the warranties given by
Customer in Clause 11.2 above; or (ii) any claims alleging that Lonza’s use of
Customer Information or Customer Background Intellectual Property in accordance
with this Agreement infringes any Intellectual Property rights of third parties;
or (iii) the use, sale, or distribution of any Product, including any claims of
product liability but excluding claims covered by Lonza’s indemnification
obligation in Section 12.2(ii); except, in each case, to the extent that such
claims resulted from the negligence, intentional misconduct or breach of this
Agreement by any Lonza Indemnitees.

 

12.3

Indemnification Procedure. If the Party to be indemnified intends to claim
indemnification under this Clause 12, it shall promptly notify the indemnifying
Party in writing of such claim. The indemnitor shall have the right to control
the defense and settlement thereof; provided, however, that any indemnitee shall
have the right to retain its own counsel at its own expense. The indemnitee, its
employees and agents, shall reasonably cooperate with the indemnitor in the
investigation of any liability covered by this Clause 12, and shall not consent
to any settlement or judgment of such claim, nor make any admission, without the
indemnifying Party’s prior written consent. The failure to deliver prompt
written notice to the indemnitor of any claim, to the extent prejudicial to its
ability to defend such claim, shall relieve the indemnitor of any obligation to
the indemnitee under this Clause 12.

 

13

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

CONFIDENTIAL

 

12.4

DISCLAIMER OF CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO
THE OTHER PARTY FOR INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR CONSEQUENTIAL
DAMAGES, LOST PROFITS OR LOST REVENUES ARISING FROM OR RELATED TO THIS
AGREEMENT, EXCEPT TO THE EXTENT RESULTING FROM FRAUD, GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT.

 

12.5

[***]

 

13

Confidentiality

 

13.1

A Party receiving Confidential Information (the “Receiving Party”) agrees to
strictly keep secret any and all Confidential Information received during the
Term from or on behalf of the other Party (the “Disclosing Party”) using at
least the same level of measures as it uses to protect its own Confidential
Information, but in any case at least commercially reasonable and customary
efforts. Confidential Information shall include information disclosed in any
form including but not limited to in writing, orally, graphically or in
electronic or other form to the Receiving Party, observed by the Receiving Party
or its employees, agents, consultants, or representatives, or otherwise learned
by the Receiving Party under this Agreement, which the Receiving Party knows or
reasonably should know is confidential or proprietary.

 

13.2

Notwithstanding the foregoing, Receiving Party may disclose to any courts and/or
other authorities Confidential Information of the Disclosing Party which is or
will be required pursuant to applicable governmental or administrative or public
law, rule, regulation or order. In such case the Party that received the
Confidential Information will, to the extent legally permitted, inform the other
Party promptly in writing and cooperate with the Disclosing Party in seeking to
minimize the extent of Confidential Information which is required to be
disclosed to the courts and/or authorities.

 

13.3

The obligation to maintain confidentiality under this Agreement does not apply
to Confidential Information, which:

 

  13.3.1

at the time of disclosure was publicly available; or

 

  13.3.2

is or becomes publicly available other than as a result of a breach of this
Agreement by the Receiving Party; or

 

  13.3.3

as the Receiving Party can establish by competent proof, was rightfully in its
possession at the time of disclosure by the Disclosing Party and had not been
received from or on behalf of Disclosing Party; or

 

  13.3.4

is supplied to a Party by a Third Party which was not in breach of an obligation
of confidentiality to Disclosing Party or any other party; or

 

  13.3.5

is developed by the Receiving Party independently from and without use of the
Disclosing Party’s Confidential Information, as evidenced by the Receiving
Party’s contemporaneous written records.

 

13.4

The Receiving Party will use the Disclosing Party’s Confidential Information
only for the purposes of this Agreement and will not make any use of the
Confidential Information for its own separate benefit or the benefit of any
Third Party including, without limitation, with respect to research or product
development or any reverse engineering or similar testing. The Receiving Party
agrees to return or destroy promptly (and certify such destruction) on
Disclosing Party’s request all written or tangible Confidential Information of
the Disclosing Party, except that one copy of such Confidential Information may
be kept by the Receiving Party in its confidential files for record keeping
purposes only.

 

14

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

CONFIDENTIAL

 

13.5

Each Party will restrict the disclosure of Confidential Information to such
officers, employees, consultants and representatives of itself and its
Affiliates who have been informed of the confidential nature of the Confidential
Information and who have a need to know such Confidential Information for the
purpose of this Agreement. Prior to disclosure to such persons, the Receiving
Party shall bind its and its Affiliates’ officers, employees, consultants and
representatives to confidentiality and non-use obligations no less stringent
than those set forth herein. The Receiving Party shall notify the Disclosing
Party as promptly as practicable of any unauthorized use or disclosure of its
Confidential Information.

 

13.6

The Receiving Party shall at any time be fully liable for any and all breaches
of the confidentiality obligations in this Clause 13 by any of its Affiliates or
the employees, consultants and representatives of itself or its Affiliates.

 

13.7

Each Party hereto expressly agrees that any breach or threatened breach of the
undertakings of confidentiality provided under this Clause 13 by a Party may
cause irreparable harm to the other Party and that money damages may not provide
a sufficient remedy to the non-breaching Party for any breach or threatened
breach. In the event of any breach and/or threatened breach, then, in addition
to all other remedies available at law or in equity, the non-breaching Party
shall be entitled to seek injunctive relief and any other relief deemed
appropriate by the non-breaching Party, without posting a bond.

 

14

Term and Termination

 

14.1

Term. This Agreement shall commence on the Effective Date and shall end on the
seventh (7th) anniversary of the Effective Date, or the fifth (5th) anniversary
of Approval, whichever is longer, unless terminated earlier as provided herein
or extended by mutual written consent of the Parties (the “Term”).
Notwithstanding the foregoing, each Project Plan may have separate term and
termination provisions so long as the term of any Project Plan does not extend
beyond the Term.

 

14.2

Termination. This Agreement may be terminated as follows:

 

  14.2.1

by either Party for any reason upon twenty-four (24) months prior written notice
to the other Party;

 

  14.2.2

by either Party if the other Party breaches a material provision of this
Agreement or a Project Plan and fails to cure such breach to the reasonable
satisfaction of the non-breaching Party within [***] for non-payment) following
written notification of such breach from the non-breaching party to the
breaching party; provided, however, that such [***] period shall be extended as
agreed by the Parties if the identified breach is incapable of cure within [***]
and if the breaching Party provides a plan and timeline to cure the breach,
promptly commences efforts to cure the breach and diligently prosecutes such
cure (it being understood that this extended period shall be unavailable for any
breach regarding non-payment), in which case such Party shall have an additional
[***] to cure the breach;

 

  14.2.3

Termination for NDA Rejection. Customer may terminate this Agreement if Customer
receives notice that the New Drug Application for Product has been rejected,
suspended indefinitely or terminated by the FDA. Customer must provide [***]
written notice of termination in advance of the date of termination. For the
avoidance of doubt, in the event of termination by Customer, Customer shall
remain liable for all fees actually incurred by Lonza, including, but not
limited to, work conducted prior to the effective date of termination (including
all un-cancellable labor commitments, non-cancellable Third Party fees, and all
work in process including all professional services rendered through the
effective date of

 

15

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

 

termination), for any charges for materials that have already been purchased for
the project and for any wind- down costs agreed by the Parties to be performed
by Lonza.

 

  14.2.4

by either Party, immediately, if the other Party becomes insolvent, is dissolved
or liquidated, makes a general assignment for the benefit of its creditors, or
files or has filed against it, a petition in bankruptcy that is not dismissed
within 90 days or has a receiver appointed for a substantial part of its assets;
or

 

  14.2.5

by either Party pursuant to Clause 15.

 

14.3

Consequences of Termination. In the event of termination hereunder, Lonza shall
be compensated for (i) Services rendered up to the date of termination,
including in respect of any Product in-process; (ii) all costs incurred through
the date of termination, including Raw Materials costs for Raw Materials used or
purchased for use in accordance with the Project Plan; (iii) all unreimbursed
Capital Equipment and related decommissioning charges incurred pursuant to
Clause 9; (iv) all amounts due under Clause 6.4, without proration of the final
calendar year and (v) any applicable Cancellation Fees. In the case of
termination by Lonza for Customer’s material breach, Cancellation Fees shall be
calculated as of the effective date of termination.

 

14.4

Survival. The rights and obligations of each Party which by their nature survive
the termination or expiration of this Agreement shall survive the termination or
expiration of this Agreement, including Clauses 1, 10-13 and 16 (to the extent
relevant).

 

15

Force Majeure

 

15.1

If Lonza or its Affiliate or permitted contractor, as applicable, is prevented
or delayed in the performance of any of its obligations under the Agreement by
Force Majeure and gives written notice thereof to Customer specifying the
matters constituting Force Majeure together with such evidence as Lonza
reasonably can give and specifying the period for which it is estimated that
such prevention or delay will continue, Lonza shall be excused from the
performance or the punctual performance of such obligations as the case may be
from the date of such notice for so long as such cause of prevention or delay
shall continue. Provided that, if such Force Majeure persists for a period of
[***] or more, Customer may terminate this Agreement by delivering written
notice to Lonza.

 

15.2

“Force Majeure” means any reason or cause beyond Lonza’s reasonable control and
that is not foreseeable nor due to Lonza’s negligence and affecting the
performance by Lonza of its obligations under the Agreement, which may include,
but is not limited to, any cause arising from or attributable to acts of God,
strike, lockouts, labor troubles, restrictive governmental orders or decrees,
riots, insurrection, war, terrorists acts, or the inability of Lonza to obtain
any required raw material, energy source, equipment, labour or transportation.

 

16

Miscellaneous

 

16.1

Severability. If any provision hereof is or becomes at any time illegal, invalid
or unenforceable in any respect, neither the legality, validity nor
enforceability of the remaining provisions hereof shall in any way be affected
or impaired thereby. The Parties hereto undertake to substitute any illegal,
invalid or unenforceable provision by a provision which is as far as possible
commercially equivalent considering the legal interests and the Purpose.

 

16.2

Amendments/Assignment. Modifications and/or amendments of this Agreement must be
in writing and signed by the Parties. Lonza shall be entitled to instruct one or
more of its Affiliates to perform any of Lonza’s obligations contained in this
Agreement, but Lonza shall remain fully responsible in respect of those
obligations, and its Affiliates’ actions and omissions shall be deemed made by
Lonza. Subject thereto, neither Party may assign its interest under this
Agreement without the prior

 

16

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

CONFIDENTIAL

 

 

written consent of the other Party, such consent not to be unreasonably
withheld, conditioned or delayed, provided, however that (a) Lonza may assign
this Agreement to any Affiliate of Lonza or (b) either Party may assign this
Agreement to any third party in connection with the sale or transfer (by
whatever method) of all or substantially all of the assets of the business
related to this Agreement; provided, however, that Customer shall not assign
this Agreement to a Competitor of Lonza, and (c) Lonza shall be entitled to
sell, assign and/or transfer its payment receivables resulting from this
Agreement without the consent of the Customer. For purposes of this Clause 16.2,
the terms “assign” and “assignment” shall include, without limitation (i) the
sale of fifty percent (50%) or more of the outstanding stock of such Party to an
Affiliate of such Party or an unrelated entity or natural person, (ii) the sale
or transfer or other assignment of all or substantially all of the assets of the
Party or the line of business or Product to which this Agreement relates, and
(iii) a merger, consolidation, acquisition or other form of business
combination. Any purported assignment without a required consent shall be void.
No assignment shall relieve any Party of responsibility for the performance of
any obligation that accrued prior to the effective date of such assignment. This
Agreement shall be binding upon the Parties’ successors and permitted assigns.

 

16.3

Notice. All notices must be written and sent to the address of the Party first
set forth above. All notices must be given (a) by personal delivery, with
receipt acknowledged, (b) by facsimile followed by hard copy delivered by the
methods under (c) or (d), (c) by prepaid certified or registered mail, return
receipt requested, or (d) by prepaid recognized next business day delivery
service. Notices will be effective upon receipt or at a later date stated in the
notice.

 

16.4

Governing Law/Jurisdiction. This Agreement is governed in all respects by the
laws of New York, USA, without regard to its conflicts of laws principles. The
Parties agree to submit to the jurisdiction of the courts of New York, USA.

 

16.5

Entire Agreement. This Agreement and the Project Plan and Quality Agreement,
together with the Appendices referenced and incorporated herein, constitute the
entire agreement between the Parties as to the subject matter hereof and
supersedes all prior and contemporaneous agreements with respect to the subject
matter hereof. This Agreement may be executed in any number of counterparts,
each of which shall be deemed to be an original, and all of which together shall
constitute one and the same document. Each Party acknowledges that an original
signature or a copy thereof transmitted by facsimile or by .pdf shall constitute
an original signature for purposes of this Agreement.

 

16.6

Waiver. Failure by a Party to insist upon strict compliance with any term of
this Agreement in any one or more instances will not be deemed to be a waiver of
its rights to insist upon such strict compliance with respect to any subsequent
failure.

 

16.7

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

 

16.8

No Third Party Beneficiaries. This Agreement shall not confer any rights or
remedies upon any person or entity other than the Parties and their respective
successors and permitted assigns.

 

16.9

Publicity. Neither Party will make any press release or other public disclosure
regarding this Agreement or the transactions contemplated hereby without the
other Party’s express prior written consent, except as required under Applicable
Laws, by any governmental agency or by the rules of any stock exchange on which
the securities of the disclosing party are listed, in which case the party
required to make the press release or public disclosure shall use commercially
reasonable efforts to obtain the approval of the other party as to the form,
nature and extent of the press release or public disclosure prior to issuing the
press release or making the public disclosure. In addition, neither Party shall
use the other Party’s name in a manner that could be construed as an endorsement
of the other Party’s product or service, including any scientific conclusion as
to safety or efficacy.

 

17

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

CONFIDENTIAL

 

IN WITNESS WHEREOF, each of the Parties hereto has caused this Manufacturing
Services Agreement to be executed by its duly authorized representative
effective as of the Effective Date.

 

LONZA LTD By:   /s/ Cordula Altekrüger  

Name: Cordula Altekrüger

Title: Senior Legal Counsel

 

By:   /s/ Bart A.M. van Aarnhem  

Name: Bart A.M. van Aarnhem

Title: Senior Legal Counsel

 

ITI Limited By:   /s/ Michael Halstead  

Name: Michael Halstead

Title: SVP, General Counsel

 

By:   /s/ Sharon Mates  

Name: Sharon Mates

Title: CEO

 

18

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

CONFIDENTIAL

 

APPENDIX A

Project Plan A -1

[***]

 

1