Exhibit 10.2

Execution Version

CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT
BOTH (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY
DISCLOSED. SUCH EXCLUDED INFORMATION HAS BEEN MARKED WITH “[*].”

MASTER SERVICES AGREEMENT

between

SAMSUNG BIOLOGICS CO., LTD.

and

CHECKPOINT THERAPEUTICS, INC.

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Table of Contents

SECTION 1

DEFINITIONS

3

SECTION 2

RELATED AGREEMENTS AND EXHIBITS

11

SECTION 3

MANAGEMENT OF SERVICE

12

SECTION 4

SERVICES

15

SECTION 5

SERVICE DESCRIPTIONS

17

SECTION 6

CHANGES TO THE SPECIFICATIONS, ANALYTICAL METHODS, MANUFACTURING PROCESS,
FACILITY OR EQUIPMENT

25

SECTION 7

REGULATORY APPROVALS AND INSPECTIONS.

26

SECTION 8

QUALITY COMPLIANCE

27

SECTION 9

CONSIDERATION AND PAYMENT TERMS

29

SECTION 10

CONFIDENTIALITY

30

SECTION 11

OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY

32

SECTION 12

WARRANTIES

34

SECTION 13

INDEMNIFICATION

35

SECTION 14

DISCLAIMER OF CONSEQUENTIAL DAMAGES; LIMITATION OF LIABILITY

36

SECTION 15

TERM AND TERMINATION OF AGREEMENT

36

SECTION 16

ARBITRATION

40

SECTION 17

MISCELLANEOUS

41

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MASTER SERVICES AGREEMENT

THIS MASTER SERVICES AGREEMENT (this “MSA”) is made and entered into as of the
date of last signature below (the “Effective Date”) by and between Checkpoint
Therapeutics, Inc., a Delaware corporation having its principal place of
business at 2 Gansevoort St., 9th Floor, New York, NY 10014 (“Client”), and
Samsung BioLogics Co., Ltd., a company with offices at 300, Songdo bio-daero,
Yeonsu-gu, Incheon, 21987, Republic of Korea (“SBL”). Client and SBL are
sometimes referred to herein individually as a “Party” and collectively as the
“Parties”.

WHEREAS, Client and SBL wish to enter into a business relationship whereby SBL
will provide Client with certain biologics manufacturing services;

NOW, THEREFORE, in consideration of the mutual promises, covenants and
agreements hereinafter set forth and for other valuable consideration, the
Parties agree as follows:

SECTION 1    DEFINITIONS

1.1

“Acceptance Procedure” shall mean the review of the Batch Related Documents and
test(s) of the Product, if necessary, to verify that the Product delivered meets
the Specifications and complies with Regulatory Authority requirements,
conducted by Client after SBL’s release of the Product, to determine whether to
accept the same, in accordance with the applicable QAG as modified from time to
time by written agreement between the Parties.

1.2

“Affected Party” is defined in Section 17.3.

1.3

“Affiliate” shall mean any corporation, company, partnership or other entity
which directly or indirectly, controls, is controlled by or is under common
control with either Party hereto. A corporation or other entity shall be
regarded as controlling another corporation or other entity if it owns or
directly or indirectly controls more than fifty percent (50 %) of the voting
stock or other ownership interest of the corporation or other entity, or if
possesses, directly or indirectly, the power to direct or cause the direction of
the management and policies of the corporation or other entity or the power to
elect or appoint more than fifty percent (50 %) of the members of the governing
body of the corporation or other entity.

1.4

“Applicable Laws” shall mean any and all applicable laws of any jurisdiction
which are applicable to any of the Parties in carrying out activities described
in this MSA or any PSAs that may be in effect from time to time, and shall
include all statutes, enactments, acts of legislature, laws, ordinances, rules,
regulations, notifications, guidelines, directions, directives and orders of any
Regulatory Authority, statutory authority, stock exchange, securities regulatory
agency, tribunal, board, or court or any central or state government or local
authority or other governmental entity in such jurisdictions.

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1.5

“Background IP” shall mean Intellectual Property which has been owned and/or
controlled by a Party prior to the Effective Date or outside, or not relating
to, the performance of the MSA and any pertinent PSA.

1.6

“Batch” shall mean Product Manufactured by SBL from a single run of the
applicable Manufacturing Process.

1.7

“Batch Record” is defined in the applicable QAG.

1.8

“Batch Related Documents” means Manufacturing Documentation in support of the
SBL’s release of a Product.

1.9

“Binding Year” shall be defined in the applicable PSA.

1.10

“Business Day” shall mean a day on which commercial banks are open for business
in both the Republic of Korea and New York, New York.

1.11

“Cell Line” shall mean the aliquot of cells supplied to SBL by Client to perform
the Services and their progeny.

1.12

“Certificate of Analysis” is defined in the applicable QAG.

1.13

“Certificate of Compliance” is defined in the applicable QAG.

1.14

“Change” is defined in Section 6.1.

1.15

“Client” is defined in the preamble.

1.16

“Client Materials” shall mean Client reagents and other materials supplied by
Client or its third party supplier to be used in the Service hereunder, as each
is further defined in the PSA and/or applicable QAG. In the case of a Drug
Product PSA, Client Materials shall also include Drug Substance and/or other
active pharmaceutical ingredients, which may or may not be Manufactured by SBL.

1.17

“Client Technology” shall mean know-how, technology, research and other
information of Client including and relating to the Manufacturing Process,
analytical methods, quality control analysis, specifications, transportation and
storage requirements provided by Client to SBL in connection with this MSA and
applicable PSA.

1.18

“Clinical Product” shall mean a Drug Substance or Drug Product which is
Manufactured by SBL pursuant to a PSA and which is to be used by Client in a
research study or studies that investigate the safety of human use or
prospectively assign human participants or groups of humans to one or more
health-related interventions to evaluate the effects on health outcomes.

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1.19

“Commercial Product” shall mean a Drug Substance or Drug Product which is
Manufactured by SBL which is intended for commercial sale and use by humans and
for importation or exportation into countries or regions designated in each PSA.

1.20

“Commercially Reasonable Efforts” shall mean with respect to an activity to be
carried out by a Party, the carrying out of such activity in a diligent manner,
which, in the case of SBL, requires using the efforts of sufficient numbers of
personnel appropriately qualified by experience and training, in the application
of such resources as would be reasonably applied by a qualified manufacturer of
biologics for human use adhering to recognized standards in the manufacture and
testing of such products, or, in the case of Client, using such efforts as would
be typically be used in the biopharmaceutical industry by companies of
comparable resources and expertise. “Commercially Reasonable Efforts” requires
prompt assignment of responsibility for such task or activity to specific
qualified employee(s) and allocation of resources designed to advance progress
with respect to such task or activity but does not require the taking of actions
which would require either Party to violate Applicable Laws or break any
existing contractual commitments with third parties which were entered into
prior to the Effective Date, the performance of which at such time was not
reasonably foreseeable to be in conflict, or otherwise inconsistent, with such
Party’s obligations under the MSA or any PSA.

1.21

“Common Raw Materials” is defined in Section 5.3.1.

1.22

“Confidential Information” is defined in Section 10.1.

1.23

“Control” (including, with correlative meanings, “Controlled”) means possession,
directly or indirectly, of power to direct or cause the direction of management
or policies (whether through ownership of securities or other ownership
interest, by contract or otherwise) of that person or entity and/or the
ownership of more than 50% of the voting shares of that person or entity.

1.24

“Core Team” is defined in Section 3.3.

1.25

“current Good Manufacturing Practices” or “cGMP” shall mean current good
manufacturing practices and regulations applicable to the Manufacture of Product
that are promulgated by any Regulatory Authority, including as promulgated under
and in accordance with (i) the U.S. Federal Food, Drug and Cosmetic Act, Title
21 of the U.S. Code of Federal Regulations, Parts 210, 211, 600, 601 and 610,
(ii) relevant EU legislation, including European Directive 2003/94/EC or
national implementations of that Directive, (iii) relevant guidelines, including
the EU Guidelines for Good Manufacturing Practices for Medicinal Products
(Eudralex Vol. 4 and Annexes thereto), (iv) International Conference on
Harmonisation Good Manufacturing Practice Guide for Active Pharmaceuticals
Ingredients and (v) and any analogous set of regulations, guidelines or
standards as defined, from time to time, by any relevant Regulatory Authority
having jurisdiction over the development, manufacture or commercialization of
the Product, as applicable, in each case as in effect as of the date such
manufacturing for the Product are or were conducted.

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1.26

“Damages” means any damages, costs, expenses, fines, penalties (including
reasonable attorneys’ fees and costs), losses and liabilities.

1.27

“Disclosing Party” is defined in Section 10.1.

1.28

“Drug Product” means a finished or intermediate dosage form that contains a Drug
Substance, generally, but not necessarily, in association with one or more other
ingredients.

1.29

“Drug Substance” means an active ingredient that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease or to affect the structure or
any function of the human body, but does not include intermediates used in the
synthesis of such ingredient.

1.30

“Effective Date” is defined in the preamble.

1.31

“EMA” shall mean the European Medicines Agency, or any successor agency.

1.32

“Engineering Batch” shall mean a Batch that is intended to demonstrate the
transfer of the Manufacturing Process to the Facility. After Manufacture, Client
shall have the right to make whatever further use of non-cGMP Engineering
Batches as it shall determine, provided that Client pays for such Batches
according to this MSA, such use is not for human use and does not violate any
Applicable Laws. SBL makes no warranty that Engineering Batches will meet cGMP
or the Specifications. If SBL determines that an Engineering Batch does meet
cGMP and the Specifications, it will release such Engineering Batch as a cGMP
Batch, and thereafter Client shall be entitled to use such Engineering Batch for
human use.

1.33

“Facility” shall mean one or more of the manufacturing facilities of SBL where
the Services shall be performed, located at 300, Songdo bio-daero, Yeonsu-gu,
Incheon, 21987, Republic of Korea.

1.34

“FDA” shall mean the United States Food and Drug Administration or any successor
agency thereto.

1.35

“Firm Period” shall be defined in the applicable PSA.

1.36

“Force Majeure Event” is defined in Section 17.3.

1.37

“Implementation Plan and Budget” is defined in Section 6.2(b).

1.38

“Indemnified Party” is defined in Section 13.3.

1.39

“Indemnifying Party” is defined in Section 13.3.

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1.40

“Intellectual Property” is shall mean (a) patents, patent rights, provisional
patent applications, patent applications, designs, registered designs,
registered design applications, industrial designs, industrial design
applications and industrial design registrations, including any and all
divisions, continuations, continuations-in-part, extensions, restorations,
substitutions, renewals, registrations, revalidations, reexaminations, reissues
or additions, including supplementary certificates of protection, of or to any
of the foregoing items; (b) copyrights, copyright registrations, copyright
applications, original works of authorship fixed in any tangible medium of
expression, including literary works (including all forms and types of computer
software, including all source code, object code, firmware, development tools,
files, records and data, and all documentation related to any of the foregoing),
pictorial and graphic works; (c) trade secrets, technology, developments,
discoveries and improvements, know-how, proprietary rights, formulae,
confidential and proprietary information, technical information, techniques,
inventions, designs, drawings, procedures, processes, models, formulations,
manuals and systems, whether or not patentable or copyrightable, including all
biological, chemical, biochemical, toxicological, pharmacological and metabolic
material and information and data relating thereto and formulation, clinical,
analytical and stability information and data which have actual or potential
commercial value and are not available in the public domain; (d) trademarks,
trademark registrations, trademark applications, service marks, service mark
registrations, service mark applications, business marks, brand names, trade
names, trade dress, names, logos and slogans, Internet domain names, and all
goodwill associated therewith; and (e) all other intellectual property or
proprietary rights, in each case whether or not subject to statutory
registration or protection.

1.41

“Joint Steering Committee” or “JSC” is defined in Section 3.2.1.

1.42

“Manufacturing” or to “Manufacture” shall mean the manufacturing of the Product,
and any services relating to such manufacturing, including, but not limited to,
testing, quality control, documentations, archiving, handling, storage and
packaging, release and delivery of the Product, to be performed by SBL at the
Facility under the MSA and any applicable PSA.

1.43

“Manufacturing Documentation” shall mean data acquired and generated, documents
and records describing or otherwise related to the Manufacturing Process
including, without limitation: documents and records consisting of or containing
process descriptions, requirements and specifications; Client Materials and
Specifications; analytical methods, process trend and variability data;
validations protocols and reports; process development reports; Batch Records;
Batch Related Documents, and SOPs, including, without limitation, SOP’s for the
Raw Materials handling, the Manufacturing operations, equipment operation,
in-process, final Product and stability quality control testing, quality
assurance, validation, storage and shipping.

1.44

“Manufacturing Process” shall mean the mutually agreed production process and
analytical methods for the Manufacturing of the Product pursuant to the
applicable PSA, as summarily described in the applicable QAG and as described in
the Manufacturing Documentation, as such process may be changed from time to
time in accordance with the MSA.

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1.45

“Manufacturing Process Transfer” means the Commercially Reasonable Efforts of
the parties undertaken pursuant to the Manufacturing Process Transfer Plan to
transfer the Manufacturing Process (together with copies of relevant books and
records) in SBL’s possession or under its control, to Client as set forth in
greater detail in the Manufacturing Process Transfer Plan. SBL shall only be
obligated to use its Commercially Reasonable Efforts in the implementation of
the Manufacturing Transfer Plan, and in no case shall SBL personnel be required
to visit the site of Client or any third party manufacturer. For the avoidance
of doubt, the foregoing prohibition shall not be construed as a basis for SBL
refusing to assist in the transfer of analytical methods to an independent
laboratory, including a visit by SBL personnel to such site to assist in method
transfer, if, and only as, reasonably necessary, and at Client’s cost and
expense. For the avoidance of doubt, Manufacturing Process Transfer shall
include, without limitation, the transfer of data, information, or samples of
validated or SBL manufactured or partially manufactured Products or other
indicia measured at various points during Manufacture, to the extent SBL
possesses such data, information, or samples. SBL shall not be obligated to
deliver the proprietary process information contained in any drug master file
with respect to which SBL has granted Client a right of reference. SBL shall
provide Manufacturing Process Transfer services with a capacity of one (1) full
time employee equivalent (“FTE”) month for each of upstream, downstream and
analytics, for a total maximum of three (3) FTE months. SBL will have no
obligation to provide Manufacturing Process Transfer services more than twelve
(12) months after termination of the MSA or applicable PSA. For clarity, SBL's
assistance shall be time-based, and SBL shall in no way guarantee or ensure that
after Manufacturing Process Transfer services is complete, Client or its
third-party manufacturer will be able to manufacture the Product.

1.46

“Manufacturing Process Transfer Plan” means that plan addressing orderly
Manufacturing Process Transfer, to be prepared in writing and reasonably agreed
to by the parties within the forty (40) Business Day period following notice
from Client to SBL of its intention to commence Manufacturing Process Transfer.

1.47

“Non-Affected Party” is defined in Section 17.3.

1.48

“Non-Conforming Product” shall mean an entire Batch of Product, any portion of
which fails to conform to the Specifications, cGMP (if applicable), and any
other mutually agreed upon written express requirements for SBL to follow under
the applicable PSA and the applicable QAG.

1.49

“Party” and “Parties” is defined in the preamble.

1.50

“Pilot Batch” means a Batch of Product designated as a pilot Batch which shall
not comply with cGMP and is not required to meet the Specifications.

1.51

“Pre-Approval Inspection” means an on-site inspection of the Facility by the
Regulatory Authority prior to granting the Regulatory Approval for a Commercial
Product as required by various Regulatory Authorities to ensure that the
Manufacturing Process and the Facility meet the appropriate requirements and
comply with cGMP.

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1.52

“Process Validation Batch” shall mean a Batch of Commercial Product produced
from a process validation run conducted by SBL hereunder to (i) demonstrate and
document the consistency and reproducibility of the Manufacturing Process at the
Facility, and (ii) support the Regulatory Approval of both the Product
Manufactured and the Manufacturing Process at the Facility each as defined in
the Project Plan.

1.53

“Product” shall mean Clinical Product or Commercial Product to be Manufactured
by SBL pursuant to this MSA and any applicable PSA.

1.54

“Product Purchase Commitment” is defined in Section 5.7.

1.55

“Product specific agreement” or “PSA” is defined in Section 2.1.

1.56

“Project Management Team Leader” is defined in Section 3.3.2.

1.57

“Project Plan” shall mean a formal, approved document used to guide both project
execution and project control. The primary uses of the Project Plan are to
document planning assumptions and decisions, facilitate communication among
project stakeholders, and document approved scope, cost, and schedule baselines.
The Project Plan will contain the description and overall objectives of the
Services for Manufacturing a Product and shall include, among other things: (a)
JSC and Core Team membership rosters, (b) change request procedures, (c)
details, intentions, and deliverables for Technology Transfer, (d) project
schedule, (e) detailed procurement plan, as needed, and (f) project budgets and
invoicing plans.

1.58

“PSA Effective Date” shall mean the effective date of any PSA governed by this
MSA.

1.59

“Purchase Order” is defined in Section 5.6.

1.60

“Quality Agreement” or “QAG” shall mean that certain quality agreement between
the Parties that governs their respective responsibilities related to quality
systems and quality requirements for the Product(s) Manufactured hereunder,
including quality control, testing and release of such Product(s) at the
Facility. Clinical Products and Commercial Products shall have separate forms of
QAGs.

1.61

“Quarter” means each period of three (3) consecutive calendar months beginning
on January 1, April 1, July 1, or October 1.

1.62

“Raw Materials” shall mean those materials that are used in the Manufacturing
Process, including, but not limited to, chemicals, reagents, filters,
excipients, disposable consumables, and secondary packaging materials. Raw
Materials exclude the Client Materials.

1.63

“Receiving Party” is defined in Section 10.1.

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1.64

“Reference Standards” shall mean materials for standards prepared by Client
and/or SBL in accordance with the applicable QAG.

1.65

“Regulatory Approval” shall mean all approvals, licenses, registrations or
authorizations thereof of any national, regional, state or local regulatory
agency, department, bureau or other governmental entity in any jurisdiction
where the Product is marketed or intended to be marketed, necessary for the
manufacture and sale of the Product, which manufacturing includes the
Manufacturing of the Products at the Facility.

1.66

“Regulatory Authority” shall mean any national (e.g., the FDA), supra-national
(e.g., the EMA), regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, in any jurisdiction
responsible for granting the Regulatory Approval.

1.67

“SBL Assignable Error” means: [*].

1.68

“Service” or “Services” is defined in Section 2.1.

1.69

“Service Fee” is defined in Section 9.1.

1.70

“Specialized Raw Materials” is defined in Section 5.3.1.

1.71

“Specification(s)” shall mean the observable and measurable characteristics of
the Products, Client Materials, or Raw Materials, as the case maybe, and the
criteria for their storage, handling, packaging and shipping, which details are
provided in documentation as reviewed and approved in writing by the Parties.

1.72

“Standard Operating Procedure(s)” or “SOP(s)” shall mean the standard operating
procedures established by and mutually agreed upon by both Parties regarding the
Manufacturing Process.

1.73

“Technology Transfer” shall mean the activities by the Parties necessary to
Manufacture the Product for Client at the Facility or otherwise conduct the
Services, as further described in the applicable PSA and/or Project Plan which
may include: (i) transfer of the Client Technology and Client Material from
Client to SBL; (ii) implementation of the Manufacturing Process at the Facility,
including establishing a small scale Manufacturing Process model at SBL; (iii)
all Manufacturing Process fit activities, including required small- and
large-scale process development and validation work as allocated between the
Parties to SBL and process engineering required to modify / equip, qualify and
validate the Facility for the Manufacturing of the Commercial Product; (iv)
stability testing, if applicable, for the Product required for licensure; (v)
comparability testing to the appropriate reference product, and (vi) regulatory
support for all Regulatory Approvals, each as further described in the Project
Plan.

1.74

“Term” is defined in Section 15.1.

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1.75

“Warehouse” shall mean SBL’s warehouse for storage of the Product located at
300, Songdo bio-daero, Yeonsu-gu, Incheon, 21987, Republic of Korea.

SECTION 2RELATED AGREEMENTS AND EXHIBITS

2.1

Product specific agreements. Pursuant to one or more product specific agreements
entered into and mutually agreed from time to time by duly authorized
representatives of the Parties (“Product specific agreements” or “PSAs”), SBL
will perform manufacturing services for Client as specified in such PSAs and
applicable Project Plan and in accordance with the terms and conditions of this
MSA (“Services”). Each PSA shall refer to this MSA and contain as applicable (i)
a high level scope of work of the Services to be performed under such PSA which
describes key activities, (ii) the Product for which Samsung will perform such
Services for Client, (iii) a description of the Cell Line; (iv) fees to be paid
to SBL by Client for the Services with a general timing plan for invoicing and a
more detailed plan to be in the Project Plan, (v) if the Services pertain to the
manufacture of the Product, the number of batches of Product to be manufactured
by SBL and delivered to Client and the Specifications, (vi) any other
deliverables, (vii) the Samsung facility where the Services are to be performed,
and (viii) the Regulatory Approvals to be obtained by the Parties. Services
shall be governed by the terms and conditions of this MSA, the applicable PSA,
and any applicable Quality Agreement. In the event of a conflict between a
Quality Agreement and either any provision of this MSA or any PSA, the MSA or
PSA shall control except with respect to Product quality terms, in which case,
the Quality Agreement will control. In the event of a conflict between any
provision of this MSA and the PSA, this MSA shall control, except as otherwise
explicitly specified in the PSA.

2.2

Project Plan. Concurrently with the execution of a PSA or within a reasonable
time after the PSA effective date, the Parties shall agree upon a Project Plan
which will specify in detail scope and schedule of the Services, including
Technology Transfer and Manufacture. The Project Plan shall also set forth the
JSC members (if applicable), Core Team members, and Project Management Team
Leader for the Services as well as the frequency and duration of meetings. The
Project Plan may be updated as needed by the mutual agreement of the Client and
SBL and is governed by and incorporated into the applicable PSA by reference. If
there is a conflict between the Project Plan and the applicable PSA, the PSA
shall control. If any of the assumptions shared in writing by the Parties and on
which the Parties have relied in defining the scope of the activities required
to effect the Technology Transfer and/or other Services including but not
limited to Manufacture, and the associated timeframes, fees, expenditures and
costs proves to be invalid, or if for any reason other than a Party’s negligence
in planning, it becomes apparent that additional activities are required as part
of or in connection with the Technology Transfer and/or other Services including
but not limited to Manufacture, the Parties shall (acting reasonably and in good
faith) discuss and seek to agree appropriate revisions to the Technology
Transfer activities, and associated timelines and pricing.

2.3

Quality Agreement (QAG). The Parties shall agree upon and finalize a Quality
Agreement in good faith within a reasonable period time after each PSA Effective
Date which shall cover such PSA. No Manufacturing of Products for human use
shall be conducted without an agreed upon, applicable QAG.

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Clinical Products and Commercial Products shall have separate QAGs. The Quality
Agreement may be amended from time to time, subject to the JSC’s approval
followed by the Parties’ written agreement pursuant to Section 17.9 (if
applicable), which is incorporated herein by reference.

SECTION 3MANAGEMENT OF SERVICE

3.1

General. Each Party will be responsible for its internal decision making process
and for reasonably informing the other Party of decisions affecting the Service
in a regular and timely manner. Without limiting the foregoing, the Parties
shall establish the joint committees or teams set forth herein to advise the
Parties on certain matters including, without limitation, Facility modification,
Technology Transfer, and optimization of the Manufacturing operation relating to
the Product.

3.2

Joint Steering Committee.

3.2.1Formation and Composition. The applicable Project Plan will set forth a
Joint Steering Committee for that Product (the “Joint Steering Committee” or
“JSC”) if the Parties mutually agree that such JSC is necessary. The JSC will be
a cross-functional committee composed of an equal number of representatives
appointed by each of Client and SBL with each of Client and SBL having at least
three (3) representatives, and with one (1) representative from each of Client
and SBL having oversight for quality activities, and with one (1) representative
from each of Client and SBL having oversight for manufacturing and supply chain
activities, including the transfer and implementation of the Manufacturing
Process at the Facility. Either Party may replace any or all of its
representatives at any time. Such Party shall notify, in writing, of such
replacement to the other Party.

3.2.2Responsibilities. The JSC shall (i) establish and oversee the governance
structure for the Service including the formation of any subcommittee hereunder;
(ii) monitor any Facility modification and the Technology Transfer and
Manufacturing strategy of the Product at the Facility, including strategies for
the Regulatory Approval of the Facility to Manufacture the Product; (iii)
provide strategic guidance to the Core Team as required by the Project Plan;
(iv) conduct high level project stage reviews with the Core Team as required by
the Project Plan at appropriate milestones or completion of key deliverables or
a sequence of event to review and approve key deliverables, evaluate the Core
Team’s progress and performance, all in order to ensure that the Manufacturing
Process is being implemented appropriately; (v) advise on and/or resolve
business, manufacturing, supply chain, quality, regulatory or other issues
unresolved at the Core Team level; (vi) review and recommend for approval by the
Parties any changes to the MSA or the applicable PSA; (vii) review and approve
changes to the Specifications, analytical methods, the Manufacturing Process,
the Facility or equipment as escalated to the JSC by the Core Team or by a Party
pursuant to Section 3.6 below; (viii) review completion of the Service; (ix)
settle disputes or disagreements unresolved by a subcommittee; and (x) perform
such other functions as appropriate to further the purposes of the MSA as
determined by the Parties. For the avoidance of doubt, the JSC shall be a
reviewing and consultative body, without authority to make decisions not
otherwise concurred in by the Parties.

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3.3

Core Team.

3.3.1Formation and Composition. The applicable Project Plan will set forth a
Core Team for that Product (the “Core Team”). The Core Team shall be composed of
an equal number of representatives from each of SBL and Client, with up to four
(4) representatives appointed by each of Client and SBL. Such representatives
will include the Project Management Team Leaders of Client and SBL as well as
such of their representatives from manufacturing, technical operations, supply
chain, quality assurance, quality control, regulatory affairs or other
individuals with expertise and responsibilities for those functions required
from time-to-time to execute the Facility modification, the Technology Transfer
and Manufacturing. Either Party may replace any or all of its representatives at
any time. Such Party shall notify, in writing, of such replacement to the other
Party.

3.3.2Appointment of Project Management Team Leader. Each Party shall appoint a
Project Management Team Leader (each, a “Project Management Team Leader”) to act
as the primary contact for such Party in connection with matters related to the
Service. Each Project Management Team Leader, unless otherwise mutually agreed,
shall serve as the leaders of the Core Team. A Party may replace its Project
Management Team Leader at any time and from time to time for any reason. Such
Party shall notify, in writing, of such replacement to the other Party.

3.3.3Responsibilities. The Core Team shall (i) develop and maintain the Project
Plan and monitor, review and manage the Service according to the MSA and
applicable PSA; (ii) conduct project stage reviews with the JSC as required by
the Project Plan at appropriate milestones or completion of key deliverables or
a sequence of event to review key deliverables, review its progress and
performance against plans; (iii) develop a change management process to
identify, review and recommend any significant changes in the project scope,
time, fee or risk to the JSC; (iv) investigate and resolve business,
manufacturing, supply chain, quality, regulatory or other issues arising during
the Service; (v) review and escalate to the JSC, as needed, changes to the
Project Plan or applicable QAG; (vi) review and recommend to the JSC changes to
the Specifications, analytical methods, the Manufacturing Process, the Facility
or equipment; (vii) coordinate the activities of the Parties relating to the
Manufacturing hereunder, including but not limited to: managing the technical
operations and quality aspects of routine manufacturing, conducting Product
testing technical operations and quality aspects of routine manufacturing,
conducting Product testing and release, and managing supply chain activities
including shipping and delivery logistics; (viii) report periodically on
operation and quality progress and performance; and (ix) perform such other
tasks and undertake such other responsibilities as may be specifically delegate
to the Core Team by mutual agreement of the Parties. For the avoidance of doubt,
the Core Team shall be without authority to make decisions not otherwise
concurred in by the Parties.

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3.4

Meetings

3.4.1JSC. The JSC shall meet by audio or video teleconference or in-person as
agreed by the JSC or as necessary to make determinations as required of it. Any
member of the JSC may designate a substitute to attend and perform the functions
of that member at any meeting of the JSC and each Party may, in its reasonable
discretion, invite non-member representatives of such Party to attend such
meeting with advance notice to the other Party; provided, however, such
non-member representatives are subject to enforceable obligations of
confidentiality to the inviting Party.

3.4.2Core Team. The Core Team shall meet by audio or video teleconference or
in-person as agreed by the Core Team. Any member of the Core Team may designate
a substitute to attend and perform the functions of that member at any meeting
of the Core Team and each Party may, in its reasonable discretion, invite
non-member representatives of such Party to attend such meetings with advance
notice to the other Party; provided, however, such non-member representatives
are subject to enforceable obligations of confidentiality to the inviting Party.

3.4.3Travel Expenses. Each Party shall be responsible for all of its own
expenses of traveling to and participating in any joint committee or team
meeting, including the JSC and Core Team.

3.5

Decisions. All decisions of JSC, the Core Team and any other joint committee or
team formed under the MSA or any applicable PSA, except as expressly set forth
herein, shall be made by the unanimous agreement of its members or their
designated representatives, with a Party’s members of designated representatives
having, in the aggregate, one (1) vote (with the casting of fractional votes
being impermissible), and shall be reflected in written meeting minutes which
summarily address topics discussed, delegation of work, schedules and decision
of such committee or team. SBL shall prepare written minutes of the JSC and Core
Team within fifteen (15) Business Days of the meeting to which they relate,
which shall be subject to approval by the authorized representatives of the
Parties; provided, however, no joint committee or team herein may amend or waive
any provision of the MSA or applicable PSA, including without limitation, the
financial terms set forth in Section 9. The MSA or any PSA may be amended, and
provision of the MSA or any PSA may be waived, pursuant to Section 17.9 only.

3.6

Disputes.

3.6.1General. In the event that the Core Team and any other joint committee or
team formed under the MSA or any applicable PSA, is unable, despite the good
faith efforts of all members, to resolve a disputed issue that is within the
purview of such joint committee or team within ten (10) Business Days of meeting
request by either Party, the disputed issue shall be referred immediately by
such joint committee or team to the JSC. If the disputes still cannot be
resolved within an additional twenty (20) Business Days of meeting request by
the JSC, the matter may be handled in accordance with Section 16.

3.6.2Project Management Team Leaders. Subject to Section 3.6.1, the Project
Management Team Leaders (or their respective designees) will in good faith
attempt to mutually resolve in a

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timely fashion any disagreement with respect to the Service hereunder, which
could reasonably affect the quality of the Manufacturing of the Product,
including without limitation, the related management processes and operations,
control of production planning and scheduling, prioritization decisions,
allocation of resources, timing of in-process and release testing, oversight of
auxiliary facilities (e.g., in-process tests that need to be conducted at
laboratories other than those at the Facility), Facility modification, the
Technology Transfer, registration and troubleshooting decisions, and any other
matters relating to implementation of the Manufacturing Process and the
Manufacturing of the Product hereunder.

SECTION 4SERVICES

4.1

Services. During the Term, in accordance with and subject to the terms and
conditions set forth in this MSA, applicable PSA, and the applicable QAG, SBL
shall provide the Services to Client relating to the Product(s). SBL shall at
all times make Commercially Reasonable Efforts to complete the Services in
accordance with the timelines set forth in the applicable PSA. Except as
otherwise expressly set forth in the MSA, applicable PSA, or the applicable QAG
or as otherwise mutually agreed in writing by the Parties, SBL shall be
responsible at its own cost and discretion for operating and maintaining the
Facility.

4.2

Compliance with Applicable Law. Subject to the provisions of Section 6 below,
SBL shall maintain the Facility in accordance with cGMP and in such condition as
will allow SBL to Manufacture the Products in accordance with the terms of the
MSA and the applicable QAG. SBL shall perform the Services under the MSA in
conformance with cGMP, if applicable, any requirements of the Regulatory
Authorities that shall be mutually agreed upon by the Parties, and all
Applicable Laws.

4.3

Project Personnel. SBL shall adequately staff the Facility with personnel
necessary (including consultants and contractors), who have sufficient technical
expertise by virtue of training and experience to perform its obligations under
the MSA and any applicable PSA. Notwithstanding anything to the contrary and in
addition to the JSC and Core Team meetings described in Section 3 above, Client
and SBL may arrange for core project personnel to have regular meetings, which
shall be by audio or video teleconference. The Project Plan shall specify the
frequency and duration of such meetings; provided that the associated costs for
meetings requested solely by Client in excess of the number set forth in the
Project Plan shall be passed through to Client by SBL, unless such meeting is
for the purpose of addressing a deficiency in Manufacturing caused by SBL
Assignable Error or assessing remediation thereof.

4.4

Subcontract. SBL may subcontract any portion of the Services without approval
from Client; provided, however, that SBL will not subcontract or otherwise
engage subcontractors or other third party agents to manufacture, conduct
quality control testing, or perform Services directly related to manufacturing
or quality control testing without the prior written approval of Client, which
shall not be unreasonably withheld, conditioned, or delayed. Notwithstanding any
subcontracting, SBL shall be primarily obligated to Client for any subcontracted
services as if it were providing the Services itself, and shall be jointly and
severally liable to Client for the performance of any such Service. The
preceding sentence is not meant to nor shall it be construed as altering or
eliminating any mutually agreed upon limitations of

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liability contained within this MSA or any applicable PSA. Every subcontractor
or other third party agent of SBL performing pursuant to this Section 4.4 shall
be required by SBL to agree in writing to comply with relevant portions of this
MSA, together with pertinent PSAs and QAGs. For the avoidance of doubt, SBL
shall not directly or indirectly use on its own behalf or through any
subcontractor, other vendor or any third party in the performance of this MSA or
any PSA, any invention, technology, data or information that would require
Client to obtain a license from SBL not otherwise granted pursuant to this MSA
or an applicable PSA, or obtain a license from any such subcontractor, vendor or
third party a license in order to make, have, made, use, offer for sell, sell,
import or otherwise exploit any Product, unless Client has agreed in advance in
writing.

4.5

Development and Manufacturing Site. Except as is provided in Section 4.4 or
otherwise agreed by Client, all Services shall be performed by SBL at the
Facility.

4.6

Access to the Facility.

4.6.1SBL shall accommodate visits by Client personnel in the Facility during
operational hours during the Term, upon Client’s request, to coordinate,
expedite and guide the Service. Client will provide SBL with written notice at
least one (1) month prior to any visit, and the Parties shall decide on a
mutually agreeable date, duration, visitor list, and agenda prior to the visit.
Additionally, Client may, at no cost to SBL, request up to two (2) of its
personnel to be on-site at the Facility to observe and consult with SBL during
the performance of Services under this MSA and such additional personnel in such
numbers as deemed necessary by Client shall be accommodated upon mutual
agreement. SBL shall make reasonable efforts to provide such Client personnel
working space and access to guest wireless connections. All applicable
out-of-pocket expenses associated with such on-site Client personnel shall be
passed through to Client by SBL.

4.6.2While at the Facility, all such Client personnel shall have reasonable
access to all areas as are relevant to SBL’s performance of the Service
hereunder, provided that SBL may reasonably restrict Client personnel’s access
to those portions of the Facility as it deems reasonably necessary for safety,
confidentiality and cGMP, and visitors admitted pursuant to this Section, upon
request of SBL, shall comply with SBL policies and procedures as they apply to
SBL personnel generally while at the Facility.

4.7

Manufacturing Documentation. SBL shall maintain in the English language,
complete, true and accurate Manufacturing Documentation, and shall keep them in
strict confidence and shall not use them for purposes other than providing or
performing the Service or other obligations hereunder. SBL shall maintain all
such Manufacturing Documentation for at least that period specified in the
applicable QAG or such longer period as may be required by Applicable Law. Upon
written request of Client and at mutually agreeable times, Client shall have the
right to review Manufacturing Documentation, including the Batch Records, at the
Facility as further defined in the applicable QAG; provided, however, SBL shall
not delay any such request of Client for more than fifteen (15) Business Days.
Client may also request scanned or printed copies of such Manufacturing
Documentation, but shall be responsible for reasonable costs associated
therewith. SBL shall record and maintain such records, data, documentation

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and other information in the language as so required in the applicable QAG or as
so required by a Regulatory Authority and in compliance with Applicable Law, or
as otherwise may be set forth in an applicable PSA. The form and style of Batch
documents, including, but not limited to, Batch production records, lot
packaging records, equipment set up control, operating parameters, and data
printouts, raw material data, and laboratory notebooks are the exclusive
property of SBL. Notwithstanding anything to the contrary, SBL SOPs not specific
to the Client’s Products may be provided to Client for on-site review if deemed
necessary by both SBL and Client. Such SOPs cannot be removed from the SBL
premises, copied, photographed or otherwise replicated, but to the extent
required for filing in connection with any Regulatory Approval related to a
Product including, but not limited to, an IND, BLA or MAA, SBL will file,
maintain and update such SOPs with appropriate Regulatory Authorities by means
of a Drug Master File, Common Technical Document or other means by which such
SOPs may remain confidential, but available by reference to Client to effect
Regulatory Approvals, and SBL shall formally authorize such reference.

SECTION 5SERVICE DESCRIPTIONS

5.1

Technology Transfer Requirements. The Parties shall make their personnel
available at the Facility to enable the transfer and implementation in
accordance with the Project Plan. Client shall transfer to and grant SBL the
limited license set forth below in Section 11.2 in respect of the Reference
Standards, Client Technology, Client Materials, and Cell Line In the event that
Client agrees to utilize SBL’s [*] portal for Technology Transfer, Client agrees
that (a) in the event of any relevant change that affects a Client user’s
authorization to use such portal, Client shall promptly notify SBL so that SBL
may disable their usernames and remove / change passwords in order to secure the
SBL Portal and (b) Client shall ensure that all of Client’s users have
up-to-date antivirus software installed on the computer devices used to access
such portal.

5.2

Facility Modification and Equipment. Except as otherwise specifically provided
herein to the contrary, and upon mutual agreement of the Parties, Client and SBL
will agree on what equipment in the Facility is necessary to perform the
Services, and if it is necessary or Client deems it necessary to procure
additional equipment beyond that which is in the Facility as of the applicable
PSA Effective Date, the Core Team shall determine equitable allocation of costs
including, as applicable, procurement, validation, installation, maintenance,
commissioning, and decommissioning/validation (which determination shall be
escalated to the JSC if in dispute). Thereafter, if any additional equipment is
necessary at the request of Client, such costs shall be dealt with by the Change
provisions of this MSA. SBL shall modify the Facility and engineer, procure,
install, commission, test, qualify, troubleshoot and validate necessary
equipment and instruments in order to accommodate Manufacture of the Product at
the Facility, as further described in the Project Plan and applicable QAG.
Except as provided in this Section 5.2 or any applicable PSA, the Facility,
Warehouse and all the equipment shall be maintained, tested, validated,
calibrated and qualified for their intended uses by SBL at SBL’s expense. For
the avoidance of doubt, it shall be the responsibility of SBL to effect such
changes at the Facility including, but not limited to changes in equipment, as
are required by changes in laws, rules or regulations related to the
manufacture, handling, storage, packaging and disposal of biologics generally,
compliance therewith being necessary in order for SBL to hold itself out as a
qualified manufacturer of biologics for

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human use. It shall be the responsibility of SBL to obtain, maintain and pay all
costs associated with establishment licenses required for the Facility, the
Warehouse and any other facilities used by SBL in the performance of its
obligations under this MSA and any applicable PSA.

5.3

Raw Materials.

5.3.1Management. SBL shall procure and maintain a reasonable quantity of the Raw
Materials, required for the Services in accordance with the MSA and any
applicable PSA, as further described in the applicable QAG. On a per-Product
basis, the Core Team shall finalize the categorization of the Raw Materials into
Raw Materials which shall be used for that specific Product only (“Specialized
Raw Materials”), Raw Materials which can be used across multiple products and/or
customers (“Common Raw Materials”), and Raw Materials which will not be charged
on a cost- plus basis to the Client, and shall attach such list to the
applicable PSA. Such list of Common Raw Materials and Specialized Raw Materials
may be amended from time to time, subject to the Parties’ approval. Prior to the
commencement of Manufacture, the Core Team shall agree on estimates for
quantities of Raw Materials anticipated to be consumed in the Manufacture of
each Batch. Although SBL will make Commercially Reasonable Efforts to use no
more than those amounts, SBL will not be responsible for Raw Materials used in
excess of the agreed-upon estimate; provided, however, that SBL shall be
responsible for any such excessive use, loss, spoilage, or waste of such Raw
Materials caused by an SBL Assignable Error. In order to become effective, SBL’s
reasonable strategies regarding Raw Material safety stock and sourcing from
qualified vendors shall be agreed upon by Client. In the event SBL is not able
to utilize any capacity reserved to Manufacture Product according to an
agreed-upon forecast or manufacturing plan due to Client’s failure to agree to
such reasonable strategies, then Client shall be responsible for the costs of
such reserved capacity regardless of whether it is utilized or not.

5.3.2Data Transfer. Client and SBL shall agree on the Specifications for the Raw
Materials, including without limitation analytical methods, supplier information
including supplier site information, and other information concerning the
stability, storage, and safety thereof that are available and required for the
Manufacturing hereunder, as further described in the applicable QAG.

5.3.3Testing and Evaluation. SBL or vendors qualified by SBL shall perform all
testing and evaluation of the Raw Materials as required by the Specifications
for the Raw Materials and the cGMPs, as further described in the applicable QAG,
if applicable. SBL shall not release any Raw Materials from quarantine that do
not meet their Specifications or are not otherwise suitable for cGMP use.

5.3.4Storage. SBL shall secure sufficient and suitable cGMP storage facilities
and/or equipment at the Facility that meet the Specifications for storage of the
Raw Materials. SBL shall preserve and protect the Raw Materials from loss and
damage while in SBL’s possession, consistent with reasonable technical and
business judgment, the Specifications and any relevant SOPs or other
instructions provided by Client; provided however, SBL shall be responsible [*]
and [*] only in cases of SBL Assignable Error or breach of this Section 5.3.4.
In all other cases, Client shall be

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responsible for the risk of loss of the Raw Materials. Upon obsolescence, or
upon expiration or earlier termination of a PSA, Client shall be responsible for
the loss of Raw Material purchased in reliance on a Purchase Order, Firm Period,
or Binding Year which Client fails to honor and SBL cannot reasonably otherwise
utilize such Raw Material.

5.3.5Service Fee Related to Raw Material. Common Raw Materials and Specialized
Raw Materials will be charged on a cost-plus basis to Client in accordance with
Sections 9.1(ii) and 9.2.2, subject to any changes in the scope of work.

5.4

Client Materials.

5.4.1Management. Client shall provide to SBL free of charge, either by itself or
through its third party supplier, Client Materials in amounts reasonably
necessary to carry out the Services as agreed by the Parties. The applicable PSA
shall set forth the exact timing of such provision of Client Materials to SBL.
SBL shall make Commercially Reasonable Efforts to import the Client Materials to
the Republic of Korea in a timely manner, provided that Client provides
reasonable assistance. The title to such Client Materials shall remain at all
times with the Client. Prior to the commencement of Manufacture, the Core Team
shall agree on estimates of quantities for Client Material anticipated to be
consumed in the Manufacture of each Batch. Although SBL will make Commercially
Reasonable Efforts to use no more than those amounts, SBL will not be
responsible for Client Materials used in excess of the agreed-upon estimate;
provided, however, that SBL shall be responsible for [*] caused by an SBL
Assignable Error, and further provided that SBL shall not be liable for the
monetary value of [*], as reasonably agreed to by the Parties and set forth in
the Quality Agreement. In order to become effective, SBL’s reasonable strategies
regarding Client Material safety stock and sourcing from qualified vendors shall
be agreed to by Client. In the event SBL is not able to utilize any capacity
reserved to Manufacture Product according to an agreed- upon forecast or
manufacturing plan due to Client’s failure to agree to such reasonable
strategies, then Client shall be responsible for the costs of such reserved
capacity regardless of whether it is utilized or not.

5.4.2Data Transfer. Client shall provide SBL with the Specifications of the
Client Materials, including without limitation analytical methods, supplier
information, and other information concerning the stability, storage, and safety
thereof that are available and required for the Manufacturing hereunder, as
further described in the applicable QAG.

5.4.3Testing and Evaluation. SBL shall perform testing of the Client Materials
in accordance with the applicable QAG and/or Client’s instruction prior to the
performance of the Manufacturing hereunder, in order to determine whether such
Client Materials meet the Specification described in the applicable QAG (if
applicable). SBL shall inform Client of (a) any damage to the Client Materials
received that is visually obvious (e.g., damaged or punctured containers and
temperature monitoring results outside of predetermined Specifications) within
[*] Business Days after SBL’s receipt of the Client Materials and (b) any
non-conformance of the Client Materials to Specification either: (i) [*] after
SBL’s receipt of the Client Materials or (ii) if release testing of Client
Materials

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is not to be performed until it is needed for Manufacture, within sixty (60)
calendar days after such release testing is performed; or (iii) as is otherwise
agreed between the Parties. If, prior to performing any Service on the Client
Materials, SBL determines that such Client Materials are defective or damaged,
SBL shall not perform the Service on such Client Materials and shall follow
Client’s written instructions regarding disposal or return of such Client
materials to Client, such disposal or return to be at Client’s discretion and
cost.

5.4.4Storage. SBL shall secure sufficient and suitable cGMP storage facilities
and/or equipment at the Facility that meet the Specifications for storage of
reasonable quantities of Client Materials in light of quantities of Product
anticipated to be Manufactured. SBL shall preserve and protect the Client
Materials from loss and damage while in SBL’s possession, consistent with
reasonable technical and business judgment, the Specifications and any relevant
SOPs or other instructions provided by Client; provided that SBL shall only be
liable for loss and damage after [*] and [*]  or breach of this Section 5.4.4.
In all other cases, Client shall be responsible for the risk of loss of the
Client Materials.

5.4.5Service Fee Related to Client Material. Handling fees relating to the
Client Material will be charged to Client in accordance with Sections 9.1(iii)
and 9.2.3.

5.5

Forecasts. For each Commercial Product, the Parties shall determine a mutually
agreeable mechanism for forecasting of each Product, which shall be detailed in
writing and attached to each relevant PSA. For Clinical Product, the Parties
shall agree upon the number and schedule of Batches to be Manufactured by SBL in
the applicable PSA.

5.6

Purchase Orders. For each Clinical Product or Commercial Product, Client shall
notify SBL in a binding form and procedure to be agreed upon in the applicable
PSA requesting a specific amount of Product to be Manufactured (a “Purchase
Order”).

5.7

Product Purchase Commitment. As further set forth in a PSA, during the Term the
Parties may agree that Client will purchase a minimum quantity of batches of a
certain Product in a given year (a “Product Purchase Commitment”).

5.8

Batch Failure during Manufacture

5.8.1If, during Manufacture of a Batch and prior to SBL’s Batch release, the
Core Team determines that a Batch is Non-Conforming Product (a “Batch Failure”),
[*]. Client shall be responsible for the costs and fees of the Raw Materials and
Client Materials for the replacement Batch as if it were the failed Batch (i.e.,
Client shall only be invoiced the applicable cost of the Raw

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Materials and Client Materials actually used to Manufacture the conforming, cGMP
compliant replacement Batch). Client shall use Commercially Reasonable Efforts
to ensure that SBL has adequate Client Materials to Manufacture such Batches and
Client’s failure to provide such Client Materials shall relieve SBL of its
obligations to provide a remedy pursuant to this Section 5.8. The remedies
contained in Section 5.8 of this MSA shall be the sole and exclusive remedies of
Client regarding a Batch Failure and a Batch Failure shall not constitute a
material breach of this MSA or a PSA unless SBL fails to provide the remedies
contained in this Section 5.8.

5.8.2The Parties shall conduct a root cause analysis (including an analysis of
whether the Batch Failure was the fault of SBL, Client, neither or both) of the
Batch Failure, which shall be done through SBL’s deviation process and which
result will be reviewed and confirmed by the JSC. If either the Core Team does
not agree on the Batch Failure root cause, and the JSC does not agree on the
results of the Core Team’s Batch Failure root cause analysis, the Parties shall
refer review of such root cause analysis to an independent mutually agreed-on
laboratory or firm with international repute, acting as a neutral arbiter, to
conduct a root cause analysis of the Batch Failure. The costs of the independent
laboratory will be borne by the Party responsible for the Batch Failure, as
determined by the independent laboratory, whose written decision shall be
binding on the Parties. If the independent laboratory is paid in advance of a
final written determination, the Parties shall share equally such expense, and
the Party at fault shall reimburse the other Party for its share of any such
expenses paid after there has been a final written determination made by the
independent laboratory.

5.8.3The PSA applicable to such Product Batch Failure shall set forth
responsibility among the Parties for the following costs in the event of a Batch
Failure: (1) the SBL Service Fee to Manufacture the failed Batch; (2) SBL’s
costs to procure the Raw Materials used in the failed Batch plus applicable SBL
handling fees associated with such Raw Materials; (3) SBL handling fees
associated with the applicable Client Materials used in the failed Batch; and
(4) Client’s cost to procure the Client Materials (which shall not include Cell
Line) used in the failed Batch which amount is to be calculated based on the
actual replacement value (as opposed to the market value) of such materials as
supported by reasonable documentary evidence by Client.

5.8.4In the event that any of the foregoing procedures results in a Batch being
delivered in a different year than the year in which the original Batch was
ordered for delivery by Client, the Service Fee for such re-Manufactured Batch
shall be the Service Fee in effect in the Year in which such re-Manufactured
Batch is actually delivered by SBL unless the root cause analysis determined the
Batch Failure resulted from SBL Assignable Error, in which case, the Service Fee
in effect at the time of the Purchase Order for the failed Batch shall apply.

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5.9

Storage, Packaging and Delivery.

5.9.1Service Deliverables other than Products. Storage, packaging  and  delivery
 of  the Service deliverables other than Products Manufactured hereunder shall
be made in accordance with the terms of this MSA, applicable PSA, Project Plan,
applicable QAG and the Applicable Laws.

5.9.2Products.

(a)

Release by SBL and Acceptance by Client.

(i)

SBL shall perform all testing in accordance with the Specifications of the
Product and release the Product in accordance with the terms of the applicable
QAG. Upon such release SBL shall deliver to Client a copy of the Manufacturing
Documentation in support of the SBL’s release of the Product for each Batch
(“Batch Related Documents”), including a Certificate of Analysis and Certificate
of Compliance, in accordance with the applicable QAG;

(ii)

Acceptance of Product. Client will complete the Acceptance Procedure and
determine the acceptability of such Product in accordance with the applicable
QAG and notify SBL of the result within the latter of [*] of SBL’s release of
Product or Client’s receipt of the Batch Related Documents. Upon Client’s
acceptance, SBL will have no liability for such Product once entrusted to the
carrier (the Parties shall use good-faith efforts to minimize the time-period
between Client’s acceptance and SBL’s delivery to the carrier), except as set
forth in Section 5.9.2(a)(iv) regarding Latent Defects. If Client does not
reject such Product within the [*] period, the Product will be deemed to have
been accepted by Client and SBL will have no liability for such Product once
entrusted to the carrier (the Parties shall use good-faith efforts to minimize
the time-period between Client’s acceptance and SBL’s delivery to the carrier),
except (A) as set forth in Section 5.9.2(a)(iv) regarding Latent Defects or (B)
due to a breach of SBL’s obligations with regard to (I) handling or storage or
(II) the Specifications insofar as they relate to packaging and shipping.

(iii)

Non-Conforming. If, during the Acceptance Procedure, any Product is determined
by Client or SBL as Non-Conforming Product, at the option of Client, SBL shall
take Commercially Reasonable Efforts to promptly Manufacture replacement Product
(except to the extent prohibited by cGMP or applicable QAG) and deliver to
Client the quantity of the Product equivalent to the quantity of Non-Conforming
Product on a date to be mutually agreed by the Parties and such replacement
Batch shall be invoiced and paid for as if it were the original Non-Conforming
Product. If SBL does not confirm the non-conformity, the Parties shall refer to
an independent and mutually agreed-on laboratory or firm with international
repute to test the disputed Product. The costs of the independent

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laboratory will be borne by the Party responsible for the Batch Failure, as
determined by the independent laboratory, whose written decision shall be
binding on the Parties. If the independent laboratory is paid in advance of a
final written determination, the Parties shall share equally such expense, and
the Party at fault shall reimburse the other Party for its share of any such
expenses paid after there has been a final written determination made by the
independent laboratory. Section 5.9.2(a) (i) and (ii) shall apply to such
replaced Product mutatis mutandis. Responsibility for the costs of such
Non-Conforming Product shall be as if such Non-Conforming Product is a Batch
Failure and Section 5.8.2 – 5.8.4 shall apply to such Non-Conforming Product
mutatis mutandis. The remedies contained in this Section 5.9.2 shall be the sole
and exclusive remedy of client for Non- Conforming Product.

(iv)

Latent Defect. At any time after completion of review of the Batch Related
Documents, if Client finds any hidden defects of the Product which could not
have been reasonably discovered through the review of the Batch Related
Documents (“Latent Defect”), Client shall promptly give notice of such claim in
writing to SBL. In such case, if Client proves the Latent Defect is solely due
to SBL Assignable Error, the above Section 5.9.2(a)(iii) and Section 13.1 shall
apply. If no written claim for Latent Defect of the Product is received by SBL
within [*] discovery of the Latent Defect, the Product shall be deemed as
irrevocably accepted. Notwithstanding anything to the contrary; such claim for
Latent Defect must be made within a time period to be set forth in the
applicable PSA, but in no event after the expiration date of the Product. For
the avoidance of doubt, a Latent Defect is a defect in existence at the time of
completion of the Acceptance Procedure.

(b)

Delivery. Shipping conditions, title transfer to Client and risk of loss for the
Product Manufactured hereunder shall be [*]. The Parties further agree as
follows:

(i)

At the time of SBL’s release of the Product and prior to each pick-up by Client
or Client’s designated carrier, SBL shall propose to Client a delivery schedule
of the Product, in order for the Parties to agree on it in advance for each
pick-up. SBL shall schedule Delivery with the carrier selected and paid for by
Client;

(ii)

SBL shall not deliver the Product until it has been instructed to by Client in
accordance with the applicable QAG. Client shall confirm specific delivery
instructions with SBL prior to SBL release. Upon SBL’s release of Product, SBL
shall store the Manufactured Product as described in Section 5.9.2(c) and Client
shall compensate SBL for storage costs for the Manufactured Product stored with
SBL for more than sixty (60) calendar days following release, as set forth in
the applicable PSA;

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(iii)

SBL shall provide Client with invoice, packing lists, supporting export
documents as specified by Client by separate delivery and shipment documentation
instructions, together with each shipment of the Product (or such other
deliverables); and

(iv)

In cooperation with Client and subject to the delivery schedule agreed by the
Parties, SBL shall adhere to the first-expire-first-out (FEFO) principle in
shipping all released Product.

(c)

Storage, Packaging and Shipping Container.

(i)

Pursuant to the terms of this MSA and any applicable PSA, SBL shall store the
Products Manufactured hereunder.

(ii)

SBL shall store, package, label and prepare shipment according to the
Specifications for the Product Manufactured hereunder, the applicable QAG and
the SOPs, and using storage and/or shipping containers determined in the
applicable PSA.

(iii)

If Client does not direct SBL to prepare Manufactured Product to be picked up by
Client or Client’s designated carrier with a pick-up date within [*] of Client’s
receipt of the Batch Related Documents, SBL shall store the Product at the
Warehouse and Client shall pay storage fees to SBL as set forth in Section 9.1
for the period of storage at the Warehouse in excess of [*] from release until
the actual delivery date, in accordance with the applicable PSA.

(iv)

SBL shall store and handle all Manufactured Product in accordance with
applicable storage and handling Specifications, including all times when SBL and
Client agree that SBL shall store Manufactured Product per Section
5.9.2(c)(iii), but shall have no obligation regarding risk of loss and damage of
Manufactured Product in its possession unless such loss or damage resulted from
SBL’s negligence or willful misconduct.

5.10

Supply Interruptions. On a PSA by PSA basis, the Parties will discuss
appropriate steps to alleviate any expected or actual shortfall in Manufactured
Product. The Parties may agree on a PSA by PSA basis, in what events, if any,
such a supply failure could constitute a material breach of this MSA or a PSA.

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SECTION 6CHANGES TO THE SPECIFICATIONS, ANALYTICAL METHODS, MANUFACTURING
PROCESS, FACILITY OR EQUIPMENT

6.1

Approval for Change.  SBL shall not make any change to the Manufacturing
Process, the Services,  or the Specifications (a “Change”), without the prior
written consent of Client in accordance with the applicable QAG.

6.2

Changes Required by cGMP, Regulatory Authorities or Requested by Client. Except
as otherwise expressly set forth to the contrary in the applicable QAG, in the
event that cGMP, a Regulatory Authority, Applicable Law, or any other regulatory
or legal authority requires, or Client requests, a Change, SBL shall accommodate
such requirements or requests, subject to the following:

(a)

Client shall promptly notify SBL in writing of the required and/or requested
Change(s), and provide information necessary for SBL to evaluate the effect of
such Change(s); provided, however, in the event SBL first learns of a required
Change it shall notify Client thereof in writing, and SBL shall promptly advise
Client as to any (i) additional equipment required, modifications to the
Facility or equipment, and/or additional equipment and the Facility
qualification and validation requirements; (ii) Manufacturing Process
development, transfer, scale-up, testing, qualification, or validation
requirements; (iii) regulatory requirements pursuant to such Changes; (iv)
changes to the Manufacturing scheduling and/or Product delivery schedule; and
(v) other impacts on the Facility or SBL’s ability to manufacture products
(including the Products) in the Facility, if any, which may result from such
Change(s). The notification and formal approval procedure of such Changes shall
be in accordance with the applicable QAG (i.e., change control procedures) (if
applicable). The Parties shall meet in a timely manner to identify and discuss
such Changes as appropriate;

(b)

Prior to implementation of any such Change(s), SBL, subject to Section 5.2,
shall provide Client with an estimated plan and budget of the reasonable and
necessary costs that would be incurred by SBL as a result of the implementation
of any such Change(s), including, but not limited to for (i) process and
analytical development; (ii) equipment and/or the Facility modifications,
qualification, validation, maintenance, and decommissioning/disposal; (iii)
process and analytical validation; (iv) document revisions or changes, the
Facility, equipment, and system modifications or changes; (v) additional
stability testing; and (vi) preparing submissions to Regulatory Authorities
(collectively, the “Implementation Plan and Budget”). Following review and
approval by Client of such Implementation Plan and Budget, subject to the Core
Team’s approval and agreement followed by the Parties’ written agreement
pursuant to Section

17.9 (if applicable), SBL shall commence implementation of such Change(s);

(c)

During any such implementation, SBL shall provide Client with regular updates on
the progress of implementation. Subject to any timeframe imposed by Applicable
Law, SBL shall exercise Commercially Reasonable Efforts to implement the Change
according to

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the Implementation Plan and Budget’s target completion date. SBL shall provide
written notice to Client if SBL becomes aware of any cause which may create
delay with the implementation of Changes. Following any such notice, both
Parties shall discuss an amendment of Implementation Plan and Budget; and

(d)

Upon the approval of the Implementation Plan and Budget for Change(s), both
Parties shall negotiate in good faith to determine the allocation of the costs
incurred by SBL for the implementation of any such Change(s) between the
Parties, in accordance with the following principles:

(i)the costs for the general Facility Changes required by cGMP, any Regulatory
Authority, or any Applicable Laws related to the maintaining the Manufacturing
Facility by SBL as set forth in Section 7.2, shall be borne by SBL, provided
that where the Change relates exclusively or partially to the Manufacture of
Product in which case the costs shall be borne by Client fully or
proportionally, respectively;

(ii)the costs for the Changes other than (i) above, and requested by Client and
required uniquely to the Manufacture of the Product and beneficial solely to
Client shall be borne by Client; and

(iii)the costs for the Changes other than (i) and (ii) above shall be discussed
in good faith by the Parties to achieve equitable allocation of costs.

SECTION 7REGULATORY APPROVALS AND INSPECTIONS.

7.1

Regulatory Approvals. SBL shall provide reasonable assistance and cooperation in
order for Client to obtain and maintain the Regulatory Approvals. The direct
costs and fees associated with such assistance and cooperation, to the extent
not detailed in the MSA or PSA shall be borne by Client, or as otherwise
mutually agreed between the Parties. As specified in the applicable PSA, the
Parties shall agree on which Regulatory Approvals are to be obtained.

7.2

Regulatory Approvals for the Facility. SBL shall obtain and continuously
maintain all approvals, licenses, registrations or authorizations of any
federal, state or local regulatory agency, department, bureau or other
governmental entity (other than the Regulatory Approvals, which will be obtained
or maintained by Client) that are required to Manufacture and ship the Product
at the Facility and perform the Services including, but not limited to, cGMP
Manufacture.

7.3

Regulatory Inspections. SBL shall facilitate on-site inspections of the Facility
conducted by Regulatory Authorities. SBL shall notify Client according to the
applicable QAG provisions of any contacts or inquiries by the Regulatory
Authorities, including inspections, Pre-Approval Inspections, sample requests,
and written correspondence and its result, related to the Manufacture of Product
by SBL at the Facility, as further defined in the applicable QAG. Any direct
expenses or costs incurred by SBL for

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such inspections including Pre-Approval Inspections at the Facility shall be
borne by Client. Unless prohibited by the pertinent Regulatory Authority, Client
shall be entitled to witness any inspection or audit by a Regulatory Authority
of the Facility or Warehouse related to the Manufacture of Product by SBL at the
Facility. Further, Client shall be entitled to attend, as an observer, any
wrap-up meeting between SBL and a Regulatory Authority related to such an
inspection related to the Services or the Manufacture of Product by SBL at the
Facility. SBL shall timely provide Client with a copy of any Form 483,
inspection report or regulatory letter issued by a Regulatory Authority, and
shall provide Client a meaningful opportunity to review and comment upon any
response of SBL thereto. Client’s comments in such regard shall be considered in
good faith and be given due regard by SBL in formulating any proposed response
to a Regulatory Authority.

7.4

Regulatory Support. During the Term, SBL will assist Client with all regulatory
matters relating to Services and Manufacture and review the Common Technical
Document pertaining to the Products, as it relates to Chemistry, Manufacturing
and Controls, and make such corrections as are necessary to accurately reflect
the Products, in each case at Client’s request and reasonable expense; provided,
however, SBL shall review and correct such documents as they relate to SBL
activities at no charge to Client (updates will be made with respect to
regulatory filings for which Client has engaged SBL and paid the associated flat
rate fees for support). In addition, SBL will maintain at SBL’s expense, the
relevant Drug Master File, including any updates thereto, and shall provide a
letter authorizing Client to reference SBL’s Drug Master Files on file with the
FDA and other Regulatory Authorities in connection with the pursuit of
Regulatory Approval for the Products.

SECTION 8QUALITY COMPLIANCE

8.1

Quality Agreement. Both Parties shall adhere to the provisions of the applicable
 QAG and the  Parties agree that all elements of quality assurance, quality
control and the like shall be governed by the terms and conditions of the
applicable QAG. In the event of a conflict between the MSA and the applicable
QAG, the MSA shall prevail over those of the applicable QAG with the exception
of Product quality-related matters, cGMP and related regulatory requirements in
which case, the terms of the applicable QAG shall prevail.

8.2

Responsibility for Recalled Product. For a Commercial Product, either Party
shall notify the other Party as soon as practicably possible if any Commercial
Product is the subject of a threatened or actual recall by a Regulatory
Authority, (a “Recall”) which may be attributable to any Service or Manufacture
by or on behalf of SBL hereunder. Client shall be responsible for conducting all
Recalls and shall make all decisions regarding, and in all events shall have
sole authority for, conducting any recalls, market withdrawals or corrections
with respect to the Product and SBL shall at all times exercise Commercially
Reasonable Efforts to provide its assistance and cooperation to Client in
conducting such Recalls to the extent the Recall arises out of SBL’s Manufacture
of Product. Details regarding the roles and responsibilities of the Parties in
regard to Recalls are set forth in the applicable QAG. If such Recall results
solely from SBL Assignable Error, SBL shall be responsible for direct and
documented out-of- pocket costs associated with such Recall subject to the
limitation of liability sections of the PSA applicable to such Recalled Product
and, subject to written instructions of Client to the contrary, will use

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its Commercially Reasonable Efforts to replace the Recalled Products with new
Products, contingent upon the receipt from Client free-of-charge of all Client
Materials required for the Manufacture of the replacement Product. If SBL is
unable to replace the Recalled or returned Products (except where this inability
results from a failure to receive the Client Materials), then SBL [*]. In all
other circumstances, Recalls will be made at Client’s cost and expense. The
provisions of this Section 8.2 shall not apply to any Clinical Product and shall
be Client’s sole and exclusive remedy with respect to a Recall due to the
delivery of Non-Conforming Product.

For the purpose of this Section, Recall expenses shall not include the [*] or
[*] that is the subject of the Recall. If SBL and Client cannot agree which
Party is at fault or whether a Recall was reasonably beyond the control of the
Parties, then an independent third-party technical expert of international
repute, acceptable to both Parties, shall be designated to make such
determination. The designated technical expert shall not be an employee,
consultant, officer, director or shareholder of, or otherwise associated with,
or have been retained during the prior five (5) years by, or be retained during
the ensuing five (5) years, by SBL, Client or their respective Affiliates. The
technical expert’s determination will be, in the absence of fraud or manifest
error, binding and conclusive upon the Parties. The cost of designating such
technical expert shall be borne by the Party determined at fault, and if neither
Party is determined to be at fault, then the cost of such technical expert shall
be borne by both Parties in equal proportion.

8.3

Records & Audit.

8.3.1Audit by Client. Upon Client’s request, but no more than [*], SBL shall
accept an audit of the Facility and, if necessary in the judgment of Client, the
Warehouse, by Client and allow Client to inspect and audit the Facility and, if
necessary in the judgment of Client, the Warehouse, and Manufacture of the
Product solely to ascertain compliance by SBL with the terms of this MSA or any
applicable PSA; provided, however that in the event Client uses a designee, SBL
must provide prior written consent, which shall not be unreasonably withheld,
conditioned or delayed. SBL shall be reimbursed for its reasonable costs for
audits beyond the audit described in the first sentence of this Section 8.3.1,
except for audits conducted to measure corrective action or remediation
following a finding of deficiency either by Client in a previous audit or by a
Regulatory Authority or as is contemplated by Section 8.3.2(ii). Client shall
not be limited in the number of its audits conducted to measure corrective
action or remediation, and such audits shall not count against the limit
expressed in the first sentence of this Section 8.3.1. SBL will make
Commercially Reasonable Efforts to require vendors or subcontractors to accept
an audit or visit to their facilities by Client upon similar notice as described
in Section 8.3.2 below.

8.3.2Audit Notice. Client shall provide SBL with a written notice at least [*]
prior to the initiation of the audit of the Facility and, if necessary in the
judgment of Client, the Warehouse, set forth in Section 8.3.1, which shall be
conducted on a mutually agreeable date and time, and with a mutually agreed
duration, agenda, and number of attendees, which in the case of Client shall not
be limited to less than three (3) without the consent of Client. Notwithstanding
the foregoing, if the audit is required for cause (i) due to safety reasons or
other reasons that necessitates immediate audit of or visit to the Facility or
(ii) due to the SBL Assignable Error, the foregoing sentence shall not apply

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and Client may conduct such audit or visit by providing SBL with a prior notice
by email. Access to SBL’s facilities shall be coordinated with SBL so as to
minimize disruption to SBL’s ability to perform services for its other clients.
Client representatives must comply with all of SBL’s generally applicable cGMP,
confidentiality and security procedures and protocols during such observations,
consultations, and inspections. SBL shall at all times cooperate and provide all
the necessary documents reasonably required by Client during such audit;
provided that, to the extent necessary, SBL may redact or withhold documents to
protect the confidential information of its other clients. Client shall be
solely responsible for any costs and liability caused by Client’s or its
representatives’ failure to comply with SBL’s security, safety or
confidentiality procedures.

SECTION 9CONSIDERATION AND PAYMENT TERMS

9.1

Consideration. In consideration for SBL’s performing the Service and other
obligations undertaken  by SBL pursuant to a PSA, Client shall pay SBL amounts
as set forth in the applicable PSA (the “Service Fee”); (ii) a handling
surcharge of a certain percentage or certain amount to be set forth in the
applicable PSA of the costs of Raw Materials paid by SBL (including but not
limited to taxes and customs duties/fees); (iii) a handling surcharge of a
certain percentage or certain amount to be set forth in the applicable PSA
related to the Client Materials (which shall be based on the actual costs of
such materials as supported by reasonable documentary evidence as opposed to the
market value thereof); and (iv) storage fees as set forth in the relevant PSA.

9.2

Invoices.

9.2.1Service Fee of the Project Stages and Batches. According to the invoicing
plan set forth in the applicable Project Plan or applicable PSA, or upon SBL’s
release of a Batch of Product, as applicable, SBL shall invoice Client for the
Service Fee set forth in the applicable PSA.

9.2.2Raw Materials.   With respect to the Raw Materials, SBL shall submit
invoices to Client for the applicable Raw Materials cost (including any agreed
upon safety stock) as set forth according to Section 9.1 as follows. SBL shall
submit an invoice to Client (i) for the cost of Specialized Raw Materials
procured upon receipt of the invoice from vendors/suppliers; and (ii) for the
cost of Common Raw Materials used by SBL’s completion of such project stage or
upon SBL’s release of a Batch of Product as applicable. Notwithstanding the
foregoing, the Parties shall collaborate in the selection of the vendors of the
Raw Materials. All such vendors shall be approved by Client before supplying SBL
with Raw Materials for Product.

9.2.3Client Materials.    With respect to the Client Materials, which shall be
supplied by Client to SBL at no cost during SBL’s performance the Service, SBL
shall submit an invoice to Client in an amount as set forth in Section 9.1 upon
SBL’s completion of such project stage of the Service SBL’s release of a Batch
of Product, as applicable.

9.3

Payment.

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9.3.1Mode of Payment; Foreign Exchange.   All payments to SBL due under the MSA
or any applicable PSA shall be made within [*] from the receipt of the SBL’s
invoice in USD $ by means of telegraphic transfer to the account with the bank
designated by SBL in the foregoing invoice. For the purpose of computing payment
amounts incurred in a currency other than USD$, such currency shall be converted
into USD$ using the basic exchange rate published by Bloomberg (or its successor
institution) on its website “http://www.bloomberg.com/markets/currencies” (or
any other website that may be used by Bloomberg or its successor institution for
publication of currency exchange rates) at the opening of business on such
invoice date.

9.3.2Taxes. All prices and charges are exclusive of any applicable taxes,
levies, imposts, duties and fees of whatever nature imposed by any law or
regulations in any country in respect of the Services, importation or
exportation of Raw Materials, Client Materials, Batches, and Product, which
shall be paid by Client. For the avoidance of doubt, the foregoing shall not
include any taxes imposed on the income or profit of SBL and any withholding tax
lawfully levied on any payment to be made by Client to SBL, each of which shall
be solely borne by SBL. Client shall pay or reimburse SBL for all customs duties
and taxes in connection with the purchase, sale, importation or exportation of
any Raw Materials, Client Materials, Batches, or Product or the provision of
Services, except to the extent such duties and taxes are recoverable by or
refundable to SBL. SBL agrees to assist Client in claiming exemption under
double taxation or similar agreement or treaty from time to time in force to
obtain a refund of any customs duties, value added taxes, and other taxes
payable by SBL.

9.3.3Price Adjustments. The Service Fees as set forth in the applicable PSA,
shall be adjusted annually, on the last day of January, effective January 1 of
each year during the Term, by the percentage change in the consumer price index
as published by the Bank of Korea for the immediately preceding twelve (12)
months. The relevant date for price adjustment under this Section shall be the
issue date of SBL’s invoice.

9.3.4Default Interest.Any amount that is not paid by a Party to the other when
due under the MSA or any PSA shall bear default interest at the rate of ten
percent (10%) per annum, or such lesser maximum rate allowed by Applicable Law,
from the day following the due date until paid in full. In the event there is an
amount which is invoiced by SBL but not paid by Client for more than six (6)
months after the due date, such event shall be considered a material breach of
the relevant PSA.

SECTION 10     CONFIDENTIALITY

10.1

Confidential Information.   “Confidential Information” shall mean any data,
know-how and other information, whether technical or non-technical disclosed by
one Party (hereinafter the “Disclosing Party”) or otherwise became known to the
other Party (hereinafter the “Receiving Party”) hereunder relating to the
subject matter of the MSA, regardless of form or manner of disclosure, i.e.,
whether disclosed in writing, in electronic file or format or in other tangible
manner, or orally, visually or in other intangible manner. If a Party intends to
disclose such information in writing, in electronic file or format or in other
tangible manner, such Party will make reasonable efforts to indicate it is
confidential; and if

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to disclose orally, visually or in other intangible manner, such Party will make
reasonable efforts to reduce it in summary form in writing or in electronic file
or format, identified as confidential and delivered to the other Party within
thirty (30) days after such oral or visual disclosure; provided, however, in
each case, a failure to do so shall not constitute a breach of this term nor
shall deny, negate or destroy the confidential nature thereof, and no such
failure shall serve as conclusive evidence that the disclosed information shall
not be considered Confidential Information by and between the Parties.
Furthermore, the existence and terms of the MSA shall be deemed to be the
Confidential Information of both Parties and any information, data or results
disclosed by SBL to Client relating to the Product, the Services or Manufacture
under this MSA or any PSA, as well as the Manufacturing Process, the Project
Plan and the Specifications shall be the Confidential Information of Client,
unless otherwise specifically identified as SBL Confidential Information by the
terms of this Agreement. The Parties acknowledge and agree that the
Manufacturing Process and the Project Plan may contain a mixture of both Party’s
Background IP, ownership of which shall not be affected by this MSA.

Notwithstanding the foregoing, Confidential Information shall not include the
information, which as evidenced by written records:

(a)

was at the time of disclosure by the Disclosing Party hereunder publicly known
or available;

(b)

after disclosure by the Disclosing Party hereunder, became publicly known or
available by publication or otherwise, other than by an authorized act or
omission by the Receiving Party;

(c)

was in the possession of the Receiving Party without confidentiality restriction
at the time of the disclosure by the Disclosing Party hereunder;

(d)

was lawfully received from any third party having the lawful right to make such
disclosure, without obligation of confidentiality; or

(e)

was independently developed by the Receiving Party’s directors, officers or
employees without reference to the Confidential Information, as demonstrated by
records created contemporaneously with such development.

10.2

Confidentiality. The Receiving Party recognizes the proprietary and confidential
nature of the Disclosing Party’s Confidential Information and agrees that no
right, title, ownership, license, or interest of any character in the Disclosing
Party’s Confidential Information other than as specifically granted herein, is
conveyed or transferred to the Receiving Party. Both Parties further agree to
maintain the Disclosing Party’s Confidential Information in confidence and not
to disclose or divulge the Disclosing Party’s Confidential Information, in whole
or in part, to any third party, and not use the Disclosing Party’s Confidential
Information for any purpose other than pursuing the MSA. Each Party shall guard
such Confidential Information using the same degree of care as it normally uses
to guard its own confidential or proprietary information of like importance, but
in any event no less than reasonable care. The Receiving Party shall limit
disclosure of the Disclosing Party’s Confidential Information to its and those
of its Affiliates’ directors, officers, employees, consultants and agents
(“Representatives”) who have a need to know the Disclosing Party’s Confidential
Information for performance of the Service and implementation of the MSA,
provided that, the Receiving Party shall undertake procedures to ensure that
each of its Representatives to whom the Disclosing Party’s Confidential
Information is disclosed

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understands (i) the confidential nature of the Disclosing Party’s Confidential
Information and (ii) that he or she is under an obligation similar to those
contained herein to hold the Disclosing Party’s Confidential Information
disclosed strictly confidential.

10.3

Authorized Disclosures. Disclosure is permitted in the event that (a) the
Disclosing Party’s Confidential Information is reasonably required to obtain or
maintain any Regulatory Approvals for the Products in any or all jurisdictions
or (b) the Disclosing Party needs to disclose such Confidential Information to
comply with Applicable Law; provided that such Receiving Party shall exercise
its Commercially Reasonable Efforts to limit disclosure of the Disclosing
Party’s Confidential Information to that which is necessary for compliance and
to otherwise maintain the confidentiality of the Confidential Information.

10.4

Survival of confidential obligations. The confidential obligations of the
Receiving Party shall survive for a period of five (5) years from the expiration
or termination of this MSA.

10.5

Return of the Confidential Information. All written, printed or other tangible
Confidential Information of the Disclosing Party disclosed under the MSA, and
all copies thereof shall be returned to the Disclosing Party (or destroyed at
the Disclosing Party’s request) by the Receiving Party within thirty (30)
business days from the written request by the Disclosing Party. All Confidential
Information disclosed electronically shall be completely deleted and destroyed
by the Receiving Party within thirty (30) business days from the written request
by the Disclosing Party. Notwithstanding the foregoing, (i) digital backup files
automatically generated by the Receiving Party’s customary electronic data
processing system may be retained and properly stored as confidential files for
the sole purpose of backup and will be deleted in accordance with the Receiving
Party’s retention policy, and (ii) a single copy of the Confidential Information
may be retained in the secured files of the Receiving Party for the sole purpose
of determining the scope of obligations incurred by it under the MSA provided
that the Receiving Party shall keep such Confidential Information in confidence
and will use the Confidential Information solely to comply with the terms of the
MSA as well as the applicable law, rule and regulation.

SECTION 11    OWNERSHIP OF MATERIALS AND INTELLECTUAL PROPERTY

11.1

Reference Standard, Client Technology, Client Materials, Cell Line, and Product.
SBL hereby understands and agrees that all rights to, titles of and interests in
the Reference Standards, Client Technology, Client Materials, Cell Line,
Product, the Manufacturing Process and any work in process or semi processed
goods thereof belong to Client, unless otherwise provided herein.

11.2

Background Intellectual Property.  It is acknowledged that each Party possesses
Background IP. Any Intellectual Property relating to the Reference Standards,
Client Technology, Client Materials and Cell Line owned and/or controlled by
Client as of the date of provision of such Reference Standards, Client
Technology, Client Materials and Cell Line by Client to SBL pursuant to Section
5.1, shall be deemed to be included in the Background IP of Client. Client
hereby grants SBL a royalty-free, non- transferable, revocable and
non-sublicensable and fully-paid-up right and license to use such Intellectual

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Property relating to such Reference Standards, Client Technology, Client
Materials, Cell Line, during the Term for the sole purposes of Manufacturing of
the Product or Services in accordance with the MSA.

11.3

Inventions. Any Intellectual Property arising out of or resulting from the
Service under the MSA, including but not limited to those contained in the
Manufacturing Documentation, shall be hereinafter collectively called an
“Invention”.

11.3.1Client Invention. Any Invention that is [*] by one or more employees or
officers of SBL (or its third party consultant or subcontractor) and does not
constitute an SBL Invention shall be a “Client Invention”. SBL shall notify
Client of such Client Invention(s) to Client immediately after SBL, the Project
Management Team Leader, respective project personnel, SBL employees or officers
or other applicable third parties working for SBL hereunder makes, conceives or
reduces to practice such Client Invention, and shall take all necessary measures
so that Client would have the sole and exclusive ownership of any and all Client
Invention. Client may use any Client Invention for any purpose, including filing
patent application and SBL shall provide reasonable cooperation to Client at the
expense of Client (as to all reasonable out-of-pocket expenses incurred by SBL
that are supported by adequate documentation). In the event that SBL wishes to
use the Client Invention for purposes outside the scope of the MSA, Client
hereby grants SBL a [*] to use such Client Invention. This Section 11.3 shall
survive the expiration or earlier termination and continue in effect as long as
the intellectual property right to such Client Invention is legally valid.

11.3.2SBL Invention. Any Invention that is [*] by one or more employees or
officers of SBL (or its third party consultant or subcontractor) and which is
not derived from, or arises out of Client Background IP or Client’s Confidential
Information or any other proprietary right of Client or its third party vendors,
contractors, or other partners or clients under or in connection with the MSA,
shall be the property of SBL (“SBL Invention”), and shall not be deemed to be
Client Invention or Joint Invention for the purposes of the MSA. No Background
IP of SBL and the SBL Invention shall be incorporated into the Product or
Manufacturing Process without the joint review and approval of both Parties and
the terms of a license to use such Background IP or SBL Invention shall be
agreed upon prior to such incorporation.

11.3.3Client-SBL Joint Invention. Any Invention that is [*] by one or more
employees, or officers of SBL (or its third party consultant or subcontractor)
or their respective Affiliates, on the one hand and one or more employees,
officers, agents or contractors of Client (or its Affiliates) on the other hand
and which is not derived from, or arises out of either Party’s Background IP or
Confidential Information or any other proprietary right of a Party or its third
party vendors, contractors, or other partners or clients under or in connection
with the MSA, shall be jointly owned by Client and SBL (a “Joint Invention”),
and shall not be a Client Invention or SBL Invention for the purposes of the
MSA. Subject to the terms and conditions of the MSA, any such Joint Invention
may be exploited by SBL or Client without compensation and liability of other
obligation (including accounting obligations) to the other Party, and each Party
has a non-exclusive, royalty-free, worldwide license, with the right to
sublicense, under its interest in such Joint Inventions and any Intellectual
Property rights (including

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patents) covering the same, for any purpose; provided that in the event of
sublicense, each Party shall make written notice to the other Party of the fact.
This license shall continue for the life of the applicable right.

SECTION 12    WARRANTIES.

12.1

The Parties General Warranties.   Each Party warrants and represents that: (i)
it has the corporate power and authority to enter into this MSA and has taken
all necessary action on its part required to authorize the execution, delivery
and performance of this Agreement; (ii) it is aware of no legal, contractual or
other restriction, limitation or condition that might adversely affect its
ability to enter into this MSA and perform its obligations hereunder; (iii) it
is duly organized, validly existing and in good standing under the laws of the
jurisdiction in which it is incorporated; (iv) this MSA (a) has been duly
executed and delivered by a duly authorized representative of it, and (b) is the
legal, valid and binding obligation of it, enforceable against it in accordance
with its terms, except as enforceability may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other similar laws now or
hereafter in effect relating to or affecting creditors’ rights generally; and
(v) the execution, delivery and performance of this Agreement by it does not and
will not (a) violate any Applicable Laws applicable to it, or (b) violate or
conflict with any provision of its Articles of Incorporation or By-laws or other
organizational documents.

12.2

Client’s Warranties. Client represents, warrants and covenants to SBL that as of
the Effective Date of the MSA and during the Term: (a) Client will comply with
all Applicable Laws, and that it will keep SBL informed of any information known
to Client which would affect SBL’s provision of the Service hereunder and (c) to
the best of its knowledge, SBL’s use of the Client Materials, Manufacturing
Process, and Client Technology for the purpose of the Service and to the extent
as set forth in the MSA will not infringe any third party’s Intellectual
Property rights.

12.3

SBL’s Warranties. SBL represents, warrants and covenants that:

12.3.1As of the Effective Date and during the Term, (i) SBL is the lawful owner,
lessee, operator, or licensee of the Facility, equipment, machinery, as well as
permissions required, to enable SBL to perform its obligations under this MSA,
and (ii) to the best of SBL’s knowledge none of the SBL Inventions or SBL
Background IP infringes any third party Intellectual Property Right

12.3.2All Product Batches, at the time of delivery to Client’s designated
carrier, shall (a) conform to the Specifications (except for Pilot Batches and
Engineering Batches unless otherwise agreed) ; (b) be Manufactured, packaged,
handled and stored in compliance with the requirements of cGMPs (except for
Pilot Batches and Engineering Batches unless otherwise agreed) and all
Applicable Laws; (c) comply with the Standard Operating Procedures; (d) be
Manufactured in compliance with the Quality Agreement; and (e) be transferred
free and clear of any liens, claims or encumbrances of any kind.

12.3.3(i) SBL is not nor has it ever been, and (ii) SBL has not used, and will
not use, the services of any person excluded, debarred, suspended (or subject to
exclusion, debarment or suspension) under

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21 U.S.C. §335(a) or (b) or otherwise disqualified by Applicable Law, including,
the FDA Debarment List
(http://www.fda.gov/ora/compliance_ref/debar/default.htm), as amended or
replaced from time to time, in connection with any of the Services or
Manufacturing performed under this MSA or any PSA. SBL agrees to notify Client
promptly in the event of any violation of SBL’s obligations under this Section.
This certification applies to SBL and its respective officers, agents, and
employees as well as subcontractors performing on behalf of SBL under this
Agreement

12.4

No Other Warranties. THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS
SECTION ARE EXPRESSLY IN LIEU OF AND EXCLUDE, AND THE PARTIES HEREBY EXPRESSLY
DISCLAIM AND NEGATE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAWS, ALL
OTHER REPRESENTATIONS AND WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED (ARISING BY
OPERATION OF LAW OR OTHERWISE), INCLUDING IMPLIED WARRANTIES OF MERCHANTABILITY
AND FITNESS FOR A PARTICULAR PURPOSE, EVEN IF THAT PURPOSE IS KNOWN.

SECTION 13    INDEMNIFICATION

13.1

Indemnification by SBL. SBL shall indemnify and hold harmless Client, its
Affiliates, and their respective officers, directors, employees or agents from
and against any Damages arising or resulting from any third party (which shall
exclude Client Affiliates) claims to the extent such Damages are relating to,
arising out of, in connection with, or resulting from claims, demands, or
actions based upon

(i)gross negligence or willful misconduct; (ii) breach of the MSA or any PSA;
(iii) violation of Applicable Law, in the case of clauses (i) through (iii) of
or by SBL or its officers, directors, employees or agents, including any
subcontractor or vendor used in the Manufacture of Product, or (iv) any claim
that SBL’s use of SBL Background IP infringes any third party’s Intellectual
Property rights, except to the extent that such Damages are caused by the causes
as set forth in Section 13.2 for which Client is obliged to indemnify.

13.2

Indemnification by Client. Client shall indemnify and hold harmless SBL, its
Affiliates, and their respective officers, directors, employees or agents from
and against any Damages arising or resulting from any third party (which shall
exclude SBL Affiliates) claims to the extent such Damages are relating to,
arising out of, in connection with, or resulting from claims, demands or actions
based upon (i) gross negligence or willful misconduct, (ii) any claim that SBL’s
use of the Client Materials, Manufacturing Process, and Client Technology for
the purpose of the Services and solely to the extent as set forth in the MSA
infringes any third party’s Intellectual Property rights, (iii) breach of the
MSA or any PSA, or (iv) violation of Applicable Law, in each case except to the
extent that such Damages are caused by the causes as set forth in Section 13.1
for which SBL is obliged to indemnify and in the case of clauses (i), (iii), and
(iv) of or by Client or its officers, directors, employees, or agents.

13.3

Indemnification Procedure.    The foregoing indemnification by SBL or Client
shall be conditioned, if and to the extent Damages are based on or related to a
third party claim, upon a Party who intends to claim indemnification under
Sections 13.1 and 13.2 (the “Indemnified Party”) (i) providing written notice to
the other Party (“Indemnifying Party”) within twenty (20) calendar days after
the Indemnified

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Party have been given written notice of such third party claim, provided that
absence or delay of such prior written notice will not relieve the Indemnifying
Party of its obligation to indemnify except to the extent such absence or delay
materially prejudices the Indemnifying Party’s ability to defend the third party
claim; (ii) permitting the Indemnifying Party, upon timely notice by the
Indemnified Party, the opportunity to assume full responsibility (at the
Indemnifying Party’s cost and expense) for the investigation and defense of any
such claim with counsel reasonably satisfactory to the Indemnified Party,
provided, however, the Indemnifying Party shall keep the Indemnified Party
informed as to the progress of the defense of any claim and that the Indemnified
Party shall cooperate in such defense and shall make available all records,
materials and witness reasonably requested by the Indemnifying Party in
connection therewith; and (iii) not settling or compromising any such claim
without the Indemnifying Party’s prior written consent, with such consent not to
be unreasonably denied, withheld or conditioned. Furthermore, the Indemnifying
Party shall not settle or compromise any such claim without the Indemnified
Party’s prior written consent; provided, however, no such consent shall be
required if such settlement or compromise involves only the payment of money,
does not require a finding or admission of fault or guild on the party of the
Indemnified Party, and provides for a general release of the Indemnified Party.

SECTION 14     DISCLAIMER OF CONSEQUENTIAL DAMAGES; LIMITATION OF LIABILITY

14.1

Disclaimer of Consequential Damages. EXCEPT FOR DAMAGES BASED ON OR RELATED TO A
THIRD PARTY CLAIM ARISING UNDER SECTIONS 13.1 AND 13.2, OR BASED ON GROSS
NEGLIGENCE OR WILLFUL MISCONDUCT, NEITHER PARTY WILL BE LIABLE UNDER THIS
AGREEMENT FOR ANY SPECIAL, PUNITIVE, CONSEQUENTIAL, INCIDENTAL OR OTHER INDIRECT
DAMAGES OF ANY TYPE OR NATURE, WHETHER BASED IN CONTRACT, TORT, STRICT
LIABILITY, NEGLIGENCE OR OTHERWISE, INCLUDING LOSS OF PROFITS OR REVENUES.

14.2

Limitation of Liability. Specific caps on Damages shall be set forth in the
applicable PSA.

SECTION 15    TERM AND TERMINATION OF AGREEMENT

15.1

Term. This MSA will become effective as of the Effective Date and will be in
effect for as long as a PSA is in effect (the “Term”). Each PSA will have its
own initial term as stated therein. Each PSA for clinical supply shall
automatically renew for successive terms of one (1) year each or upon execution
of a PSA for commercial supply, whichever is earlier, and each PSA for
commercial supply, including supply of stocking inventories in advance of
Regulatory Approval, shall automatically renew for successive terms of three (3)
years each, unless a Party gives written notice to the other Party of its
intention to not renew a PSA for clinical supply ninety (90) days prior to the
end of the then current PSA term, or a Party gives written notice to the other
Party of its intention to not renew a PSA for commercial supply thirty-six (36)
months prior to the end of the then current PSA term.

15.2Termination.This MSA or a PSA may be earlier terminated as set forth in this
Section 15.2.

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15.2.1Material Breach.   A Party may terminate any PSA for a material breach by
the other   Party; provided, however, that the non-breaching Party shall give
the breaching Party written notice of such breach and if the breaching Party
fails to commence Commercially Reasonable Efforts to cure that breach within [*]
after receipt of such written notice, then the non-breaching Party may terminate
this Agreement on [*] written notice after expiration of such twenty [*]. This
MSA shall terminate if all effective PSAs are terminated.

15.2.2Insolvency. This MSA may be terminated by either Party upon written notice
at any time during the MSA if the other Party: (a) files in any court pursuant
to any statute a petition in bankruptcy or insolvency or for reorganization or
for an arrangement or for the appointment of a receiver or trustee of such
Party, or of its assets; (b) proposes a written agreement of composition for
extension of its debts; (c) is served with an involuntary petition against it,
filed in any insolvency proceeding which is admitted in the court; or (d) makes
an assignment for the benefit of its creditors. The Party affected shall
immediately notify the other Party in writing of the occurrence of any of the
foregoing events.

15.2.3Force Majeure.   Either Party may terminate a PSA in accordance with
Section 17.3 in the event a Party is unable to perform its obligations pursuant
to a PSA due to a Force Majeure Event.

15.2.4Import Failure.   Client shall be entitled to terminate a PSA upon twenty
(20) Business Days’ notice to SBL, if, despite the efforts of SBL pursuant to
Section 5.4.1, Client Material destined for use in connection with the Services
have been prohibited from entry into the Republic of South Korea by the Korean
Custom Service. Such termination right shall only exist if such Client Materials
have been denied entry and shall not be implicated by mere delays in the
importation process. If such termination relates to efforts to import into the
Republic of Korea Client Materials for the initial Batch of a Product under a
PSA, the applicable PSA shall be deemed to be void ab initio without further
cost or expense to either Party; provided, however, the Party’s thereafter shall
reasonably cooperate with regard to disposition of such Client Materials at the
cost of Client.

15.2.5Other Specified Events. The Parties may additionally terminate a PSA as
set forth in the applicable PSA.

15.3

Effect of Expiration or Termination.

15.3.1Payment of Amounts Due. Expiration or termination of the MSA or PSA for
any reason shall not exempt any Party from paying to any other Party any amounts
owing to such Party at the time of such expiration or termination; provided,
however, with respect to a termination deemed to be ab initio, and up-front fee
paid to SBL shall not be deemed earned and shall be returned to Client.

15.3.2Decommissioning.  Upon expiration or termination of a PSA for any reason,
SBL shall  cease and refrain from the Services described in any applicable PSA
(including the Manufacturing

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and supplying the Product) for Client unless otherwise provided in the following
Sections 15.3.2(a) to 15.3.2(d), and both Parties shall pursue decommissioning
activities as set forth hereunder.

(a)

Fully Manufactured Product.

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, 15.2.4 or
15.2.5, upon Client’s election, SBL shall (i) deliver already fully Manufactured
Product to Client in accordance with the terms and conditions of the MSA and
applicable PSA or (ii) destroy such Product. If Client elected (i) above, Client
shall pay the [*] and any related costs or fees for the Service relating to such
Product in accordance with the terms and conditions of the MSA and applicable
PSA, and if Client elected (ii) above, SBL shall [*], except in the case of
Section 15.2.4 or Section 15.2.5 for which destruction Client shall pay the
cost.

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5,
upon SBL’s election, SBL may (i) deliver the fully Manufactured Product to
Client in accordance with the terms and conditions of the MSA and applicable PSA
(including the current Firm Period period or Binding Year in the PSA) or (ii)
destroy such Product. If SBL elected (i) above, Client shall pay the [*] and any
related costs or fees for the Service relating to such Product in accordance
with the terms and conditions of the MSA and applicable PSA, and if SBL elected
(ii) above, Client shall bear the costs and expenses for [*]; provided, however,
such costs and expenses to be borne by Client shall in no event exceed the
Service Fee for the Service relating to such Product.

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii)
above shall apply

(b)

Client Materials being used for the Service (Product in Process).

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, 15.2.4,
or 15.2.5, upon Client’s election, SBL shall (i) continue to use the Client
Materials being used for the Manufacturing hereunder (the Product in process)
and deliver the fully Manufactured Product to Client in accordance with the
terms and conditions of the MSA and applicable PSA, or (ii) deliver to Client or
destroy such Product in process. If Client elected (i) above, Client shall pay
the [*] and any related costs or fees for the Service relating to the fully
Manufactured Product in accordance with the terms and conditions of the MSA and
applicable PSA, and if Client elected (ii) above, SBL shall [*].

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5,
upon SBL’s election, SBL may (i) continue to use the Client Materials being used

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for the Manufacturing hereunder (the Product in process) and deliver the fully
Manufactured Product to Client in accordance with the terms and conditions of
the MSA and applicable PSA, or (ii) destroy such Product in process. If SBL
elected (i) above, Client shall pay the [*] and any related costs or fees for
the Service relating to the fully Manufactured Product in accordance with the
terms and conditions of the MSA, and if SBL elected (ii) above, Client shall
[*].

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii)
above shall apply.

(c)

Client Materials, Cell Line, and Reference Standards. Upon expiration or
termination of a PSA, upon Client’s election, SBL shall deliver to Client and/or
destroy all remaining Client Materials (subject to Sections 15.3.2(a) and
15.3.2(b)), all remaining Cell Line vials, Reference Standards and other
materials required for Manufacturing.

The costs and expenses for such activities shall be borne by the Parties as
follows:

(i)

If Client terminates the PSA pursuant to Section 15.2.1, 15.2.2 or 15.2.3, SBL
shall [*];

(ii)

If SBL terminates the PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or 15.2.5,
or Client terminates the PSA pursuant to Section 15.2.4 or 15.2.5, [*];

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii)
above shall reply.

(d)

Raw Materials.

(i)

If Client terminates a PSA pursuant to Section 15.2.1, 15.2.2 or 15.2.3 and if
Client so elects, SBL shall deliver the remaining Raw Materials to Client for
Client’s payment of SBL’s cost to procure such Raw Materials, or dispose of them
at Client’s election. SBL shall [*].

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3 or 15.2.5, or
Client terminates a PSA pursuant to Section 15.2.4 or 15.4.5, SBL may deliver
the remaining Raw Materials to Client or dispose of them at SBL’s election. If
so delivered, Client shall pay [*] to SBL and bear the costs and expenses for
the [*] by SBL.

(iii)

If a PSA is naturally expired pursuant to Section 15.1, the provisions of (ii)
above shall apply.

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(e)

Outstanding Obligations Regarding Purchase of Product.

(i)

If Client terminates a PSA pursuant to Section 15.2.1 or 15.2.2 Client shall be
released from any outstanding binding obligations to purchase Product as of the
date of notice of termination including but not limited to pursuant to a Firm
Period, binding forecast, purchase order, minimum purchase commitment, or
otherwise; provided, however, that Client shall purchase Product Manufactured
prior to such date of notice, pursuant to the terms of this MSA and PSA.

(ii)

If SBL terminates a PSA pursuant to Section 15.2.1 or 15.2.2, outstanding
binding obligations to purchase Product as of the date of notice of termination
shall survive termination of such PSA, including but not limited to pursuant to
a Firm Period, binding forecast, purchase order, minimum purchase commitment, or
otherwise.

(iii)

For all other cases of termination of a PSA, subsection (ii) shall apply.

(f)

Survival. Any termination or expiration of this MSA shall not affect any
outstanding obligations due hereunder prior to such termination or expiration,
nor shall it prejudice any other remedies that the parties may have under this
MSA. For greater certainty, except as otherwise expressly provided, termination
or expiration of this MSA, irrespective of the cause, shall not affect any
rights or obligations which, from the context thereof, are intended to survive
termination or expiration of this MSA, including but not limited to Sections 1,
8, 9, 10, 11, 12, 13, 14, 15, 16 and 17.2.

15.3.3Outbound Transfer. Upon any termination of a PSA or in connection with its
expiration, Client shall be entitled to give notice to SBL of a Manufacturing
Process Transfer, which shall commence the preparation and effectuation of a
Manufacturing Process Transfer Plan for the Product identified therein. In
addition, Client shall be entitled to give notice to SBL of a Manufacturing
Process Transfer and commence the preparation and effectuation of a
Manufacturing Process Transfer Plan in the absence of a termination or
expiration of a PSA in order to establish second source Manufacturing. Client
shall pay SBL’s reasonable costs of assistance related to effectuation of the
Manufacturing Process Transfer Plan.

SECTION 16    ARBITRATION

16.1

Informal Discussions. Except as otherwise provided herein, in the event of any
controversy or claim arising out of or relating to this MSA, or the rights or
obligations of the Parties hereunder, the Parties shall first try to settle
their differences amicably between themselves through the Core Team and then the
JSC. Thereafter, either Party may initiate informal dispute resolution on the
executive level by sending written notice of the dispute to the other Party, and
within thirty (30) days after such notice appropriate executives of the Parties
shall meet for attempted resolution by good faith negotiations. If such
representatives are unable to resolve such disputed matter within such thirty
(30) day period, either Party may refer the matter by written notice to the
Chief Executive Officer of the other Party, or his/her

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designee, and the Chief Executive Officer of such Party, for discussion and
resolution. If such individuals or their designees are unable to resolve such
dispute within thirty (30) days of such written notice, and such dispute relates
to a claimed breach of this MSA, a PSA or a QAG, either Party may initiate
binding arbitration proceedings in accordance with the provisions of this
Article 16. For the avoidance of doubt, no claim other than a claim of a breach
of this Agreement shall be subject to arbitration.

16.2Arbitration. If the Parties do not fully settle a claimed breach of this
MSA, a PSA or a QAG pursuant to Section 16.1, and a Party wishes to pursue the
matter, each such claim shall be finally resolved by binding arbitration in
accordance with the Commercial Arbitration Rules of the International Chamber of
Commerce (“ICC”), and judgment on the arbitration award may be entered in any
court having jurisdiction thereof to enforce the arbitration award. The
arbitration shall be conducted by a panel of three neutral persons experienced
in the pharmaceutical business, and within thirty (30) days after initiation of
arbitration, each Party shall select one person to act as arbitrator and the two
Party-selected arbitrators shall select a third arbitrator within thirty (30)
days of their appointment. If the arbitrators selected by the Parties are unable
or fail to agree upon the third arbitrator, the third arbitrator shall be
appointed by the ICC. The place of arbitration shall be New York, New York,
United States and all proceedings and communications shall be in English. Either
Party may apply to the arbitrators for interim injunctive relief until the
arbitration award is rendered or the controversy is otherwise resolved. Either
Party also may, without waiving any remedy under this Agreement, seek from any
court having jurisdiction any injunctive or provisional relief necessary to
protect the rights or property of that Party pending the arbitration award. The
arbitrators shall have no authority to award punitive or any other type of
damages not measured by a Party’s direct compensatory damages, and in all cases,
any decision or determination by the arbitrators shall comply with Article 14,
as applicable. The Parties agree that, in the event of a good faith dispute over
the nature or quality of performance under this Agreement, neither Party may
terminate this Agreement until final resolution of the dispute through
arbitration or other judicial determination. The Parties further agree that any
payments made pursuant to this Agreement pending resolution of the dispute shall
be refunded if an arbitrator or court determines that such payments are not due.

16.3Costs and Fees. Each Party shall bear its own attorneys’ fees, costs, and
disbursements arising out of the arbitration, and shall pay an equal share of
the fees and costs of the arbitrators. Absent the filing of an application to
correct or vacate the arbitration award as permitted by Applicable Law, each
Party shall fully perform and satisfy the arbitration award within fifteen (15)
days after the service of the award on such Party.

SECTION 17    MISCELLANEOUS

17.1

Notices. Any notice required or permitted under the MSA shall be in writing with
duly authorized signature and made to the following addresses or facsimile
numbers:

If to Client:

Checkpoint Therapeutics, Inc.

2 Gansevoort St., 9th Floor

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New York, NY 10014

Attention: Senior Vice President Operations Facsimile:

If to SBL:

Samsung BioLogics Co., Ltd.

300, Songdo bio-daero, Yeonsu-gu Incheon 21987, South Korea

Attention: Head of Corporate Business Operations Facsimile: +82-32-455-3242

With copy to: SBL Legal & Compliance Department

Either Party may change its designated address and facsimile number by notice to
the other Party in the manner provided in this Section 17.1.

Any notice shall be deemed to have been delivered on the date of delivery of
delivered personally, or on the next day of sending if sent by facsimile, or on
the fifth day of posting if sent by registered or certified mail with return
receipt requested and postage prepaid.

17.2

Governing Law. This MSA shall be construed and interpreted in accordance with
the laws of State of New York, United States and all rights and remedies shall
be governed by such laws without regard to principles of conflicts of law. The
United Nations Convention on Contracts for the International Sale of Goods shall
not apply to the transactions contemplated by the MSA.

17.3

Effect of Force Majeure Event. Neither Party (the “Affected Party”) shall be
liable to the other Party (the “Non-Affected Party”) for failure or delay to
perform its obligation under the MSA or any applicable PSA when such failure or
delay is due to riots, storms, fires, explosions, floods, earthquakes, war,
embargoes, blockades, insurrections, terrorism, an act of God or any other cause
similar thereto which is beyond the control of the Affected Party including
those affected upstream suppliers (“Force Majeure Event”).

Each Party agrees to give the other Party prompt written notice of the
occurrence of any Force Majeure Event, the nature thereof, and the extent to
which the affected Party will be unable fully to perform its obligations under
the MSA. If a condition constituting Force Majeure Event as defined herein
exists for more than [*], or it is reasonably foreseeable that such Force
Majeure Event will persist for more than [*], the Parties shall endeavor in good
faith to negotiate a mutually satisfactory solution to the problem, if
practicable, including use of a third party to fulfill the obligations hereunder
of the party invoking Force Majeure Event, at the expense of the party invoking
Force Majeure Event. If after good faith efforts to negotiate a mutually
satisfactory solution for at least [*] the Parties have failed to reach
agreement, the Non-Affected Party shall have the right to terminate this MSA
upon [*] written failure.

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17.4

Assignment. Neither Party shall assign, in whole or in part, the MSA without the
prior written consent of the other Party, such approval not to be unreasonably
withheld, conditioned or delayed. Notwithstanding the above, Client may, without
such consent, assign the MSA to (i) its Affiliate or (ii) any purchaser of
Client’s rights relating to the Product or all or substantially all of the
assets of Client, or of all of its capital stock, or to any successor
corporation or entity resulting from any merger or consolidation of such Party
with or into such corporation or entity. Notwithstanding the above, SBL may,
without such consent, assign the MSA to (i) its Affiliate or (ii) any purchaser
of substantially all of the assets of SBL, or of all of its capital stock, or to
any successor corporation or entity resulting from any merger or consolidation
of such Party with or into such corporation or entity.

17.5

No Grant of License. Nothing in the MSA shall affect, or grant any right to,
patents, know-how or other intellectual property owned by either Party prior to
the commencement of the MSA unless otherwise expressly provided in the MSA.

17.6

No Right to Use Names. Except as expressly provided herein, no right, expressed
or implied, is granted by the MSA to use in any manner the name of either of the
Parties or any other trade name, symbol, logo or trademark of the other Party in
connection with the performance of the MSA, without the prior written consent of
the other Party.

17.7

Independent Contractors. The Parties hereto are independent contractors and
nothing contained in the MSA shall be deemed or construed to create a
partnership, joint venture, employment, franchise, agency or fiduciary
relationship between the Parties.

17.8

Integration. This MSA constitutes the entire agreement between the Parties
relating to the subject matter of the MSA and supersedes all previous oral and
written communications between the Parties with respect to the subject matter of
the MSA.

17.9

Amendment; Waiver. Except as otherwise expressly provided herein, no alteration
of or modification to the MSA shall be effective unless made in writing and
executed by an authorized representative of both Parties. No course of dealing
or failing of either Party to strictly enforce any term, right or condition of
the MSA in any instance shall be construed as a general waiver or relinquishment
of such term, right or condition. The observance of any provision of the MSA may
be waived (either generally or any given instance and either retroactively or
prospectively) only with the written consent of the Party granting such waiver.

17.10

Severability. The Parties do not intend to violate any Applicable Law. However,
if any sentence, paragraph, clause or combination of the MSA is in violation of
any law or is found to be otherwise unenforceable, such sentence, paragraph,
clause or combination of the same shall be deleted and the remainder of the MSA
shall remain binding, provided that such deletion does not alter the basic
purpose and structure of the MSA.

17.11

Construction. The Parties mutually acknowledge that they have participated in
the negotiation and preparation of the MSA. Ambiguities, if any, in the MSA
shall not be construed against any Party,

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irrespective of which Party may be deemed to have drafted the MSA or authorized
the ambiguous provision.

17.12

Interpretation. The captions and headings to the MSA are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of the MSA. Unless context otherwise clearly requires, whenever used
in the MSA: (a) the words “include” or “including” shall be construed as
incorporating, also, “but not limited to” or “without limitation”; (b) the words
“hereof,” “herein,” “hereby” and derivative or similar words refer to the MSA;
(c) the word “law” or “laws” shall mean any applicable, legally binding statute,
ordinance, resolution, regulation, code, guideline, rule, order, decree,
judgment, injunction, mandate or other legally binding requirement of a
governmental authority (including a court, tribunal, agency, legislative body or
other instrumentality of any (i) government or country or territory, (ii) any
state, province, county, city or other political subdivision thereof, or (iii)
any supranational body); and (d) all references to the word “will” are
interchangeable with the word “shall” and shall be understood to be imperative
or mandatory in nature. All references to days, months, quarters or years are
references to calendar days, calendar months, calendar quarters, or calendar
years. Whenever any matter hereunder requires consent or approval, such consent
or approval shall not be unreasonably withheld or delayed.

17.13

Counterparts. This MSA may be executed in two or more counterparts, each of
which will be deemed an original, but all of which together will constitute one
and the same instrument.

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IN WITNESS WHEREOF, the Parties have executed the MSA as of the date first above
written.

CHECKPOINT THERAPEUTICS, INC.

Signature:

/s/ James F. Oliviero

Name:

James F. Oliviero

Title:

Chief Executive Officer

Date:

SAMSUNG BIOLOGICS CO., LTD.

Signature:

/s/ Dr. Tae Han Kim

Name:

Dr. Tae Han Kim

Title:

President & CEO

Date:

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