MASTER SERVICES AGREEMENT between and TG THERAPEUTICS, INC.
Exhibit 10.22
CONFIDENTIAL TREATMENT REQUESTED. Confidential portions of this
document have been redacted and have been separately filed with the
Commission.
between
*
and
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Table of
Contents
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SECTION 1
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DEFINITIONS
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3
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SECTION
2
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RELATED AGREEMENTS AND
EXHIBITS
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10
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SECTION
3
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MANAGEMENT OF
SERVICE
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11
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SECTION
4
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SERVICES
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14
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SECTION
5
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SERVICE
DESCRIPTIONS
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16
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SECTION
6
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CHANGES TO THE
SPECIFICATIONS, ANALYTICAL METHODS, MANUFACTURING PROCESS, FACILITY
OR EQUIPMENT
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24
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SECTION
7
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REGULATORY APPROVALS AND
INSPECTIONS
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25
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SECTION
8
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QUALITY
COMPLIANCE
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26
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SECTION
9
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CONSIDERATION AND PAYMENT
TERMS
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28
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SECTION
10
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CONFIDENTIALITY
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29
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SECTION
11
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OWNERSHIP OF MATERIALS
AND INTELLECTUAL PROPERTY
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31
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SECTION
12
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WARRANTIES
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32
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SECTION
13
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INDEMNIFICATION
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34
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SECTION
14
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DISCLAIMER OF
CONSEQUENTIAL DAMAGES; LIMITATION OF LIABILITY
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35
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SECTION
15
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TERM AND TERMINATION OF
AGREEMENT
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35
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SECTION
16
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ARBITRATION
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39
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SECTION
17
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MISCELLANEOUS
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40
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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 TG Therapeutics, Inc., a
Delaware corporation having its principal place of business at ▇
▇▇▇▇▇▇▇▇▇▇ ▇▇., ▇▇▇ ▇▇▇▇▇, ▇▇▇
▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Client”), and * Client and * are sometimes referred to
herein individually as a “Party” and collectively as
the “Parties”.
WHEREAS, Client and * wish to enter into
a business relationship whereby * 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
*’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.
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.
* Confidential material redacted and filed
separately with the Commission.
3
1.6 “Batch”
shall mean Product Manufactured by * 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 *’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 * 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
*.
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 * in connection with this MSA and applicable
PSA.
1.18 “Clinical
Product” shall mean a Drug Substance or Drug Product which is
Manufactured by * 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.
1.19 “Commercial
Product” shall mean a Drug Substance or Drug Product which is
Manufactured by * which is intended for commercial sale and use by
humans and for importation or exportation into countries or regions
designated in each PSA.
4
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 *, 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.
1.22 “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.
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.
5
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.
* makes no warranty that Engineering
Batches will meet cGMP or the Specifications. If * 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 *.
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.
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 ▇▇▇▇ registrations, service
▇▇▇▇ 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.
6
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
* 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.
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 *’s possession or
under its control, to Client as set forth in greater detail in the
Manufacturing Process Transfer Plan. * shall only be obligated to
use its Commercially Reasonable Efforts in the implementation of
the Manufacturing Transfer Plan, and in no case shall * 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 * refusing to assist in the
transfer of analytical methods to an independent laboratory,
including a visit by * 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 *
manufactured or partially manufactured Products or other indicia
measured at various points during Manufacture, to the extent *
possesses such data, information, or samples. * shall not
be
obligated to deliver the proprietary process information contained
in any drug master file with respect to which * has granted Client a
right of reference. * 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. * 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, *'s assistance shall be time- based,
and * 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.
7
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 * 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 * 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.
1.52 “Process
Validation Batch” shall mean a Batch of Commercial Product
produced from a process validation run conducted by * 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 * 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.
8
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.
1.64 “Reference
Standards” shall mean materials for standards prepared by
Client and/or * 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 “* Assignable Error” means:
negligence, fraud, recklessness, willful misconduct, or material
breach of cGMP (if applicable) on the part of employees,
consultants, contractors, sub-contractors, agents or
representatives of *.
1.68
“Service” or “Services” is defined in
Section 2.1.
9
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 *; (ii) implementation of the
Manufacturing Process at the Facility, including establishing a
small scale Manufacturing Process model at *; (iii) all
Manufacturing Process fit activities, including required small- and
large-scale process development and validation work as allocated
between the Parties to * 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.
1.75
“Warehouse” shall mean *.
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”), * 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 *
will perform such Services for Client, (iii) a description of the
Cell Line; (iv) fees to be
paid to * 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 * and delivered
to Client and the Specifications, (vi) any other deliverables,
(vii) the * 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 provisio of this MSA and the PSA, this MSA shall control,
except as otherwise explicitly specified in the
PSA.
10
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 * 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.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.
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.
3.2.1 Formation 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 * with each of
Client and * having at least three (3) representatives, and with
one (1) representative from each of Client and * having oversight
for quality activities, and with one (1) representative from each
of Client and * 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 representitives at any time. Such Party shall notify,
in writing, of such replacement to the other
Party.
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3.2.2 Responsibilities.
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.
3.3.1 Formation 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
* and Client, with up to four (4)
representatives appointed by each of Client and *. Such
representatives will include the Project Management Team Leaders of
Client and * 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.
3.3.2 Appointment 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.
3.3.3 Responsibilities.
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;
12
(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.
3.4.1 JSC. 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.
3.4.2 Core 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.
3.4.3 Travel
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.
* 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 theMSA 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.
13
3.6 Disputes.
3.6.1 General. 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.
3.6.2 Project 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 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.
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, * shall provide the
Services to Client relating to the Product(s). * 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, * 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, * shall maintain the Facility in accordance with cGMP and in
such condition as will allow * to Manufacture the Products in
accordance with the terms of the MSA and the applicable QAG. *
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. * 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 * 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 *, unless such meeting is for the purpose of
addressing a deficiency in Manufacturing caused by * Assignable
Error or assessing remediation thereof.
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4.4 Subcontract.
* may subcontract any portion of the Services without approval from
Client; provided, however, that * 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, * 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 liability contained within this
MSA or any applicable PSA. Every subcontractor or other third party
agent of * performing pursuant to this Section 4.4 shall be
required by * to agree in writing to comply with relevant portions
of this MSA, together with pertinent PSAs and QAGs. For the
avoidance of doubt, * 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 * 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 * at
the Facility.
4.6 Access to the
Facility.
4.6.1 * 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 * 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 *, request up to two (2) of its personnel to be on-site at the
Facility to observe and consult with * 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. * 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
*.
4.6.2 While at the
Facility, all such Client personnel shall have reasonable access to
all areas as are relevant to *’s performance of the Service
hereunder, provided that * 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 *, shall comply with *
policies and procedures as they apply to * personnel generally
while at the Facility.
15
4.7 Manufacturing
Documentation. * 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. * 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, * 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. * shall
record and maintain such records, data, documentation 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 *. Notwithstanding anything to the contrary, * SOPs not
specific to the Client’s Products may be provided to Client
for on-site review if deemed necessary by both * and Client. Such
SOPs cannot be removed from the * 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, * 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 * shall formally authorize such
reference.
SECTION 5
SERVICE 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 * 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
*, 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 * so that * may disable their
usernames and remove / change passwords in order to secure the *
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 * 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. * 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 * at
*’s expense. For the avoidance of doubt, it shall be the
responsibility of * 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 * to
hold itself out as a qualified manufacturer of biologics for human
use. It shall be the responsibility of * to obtain, maintain and
pay all costs associated with establishment licenses required for
the Facility, the Warehouse and any other facilities used by * in
the performance of its obligations under this MSA and any
applicable PSA.
16
5.3 Raw
Materials.
5.3.1 Management.
* 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 * will make Commercially Reasonable Efforts to
use no more than those amounts, * will not be responsible for Raw
Materials used in excess of the agreed-upon estimate; provided,
however, that * shall be responsible for any such excessive use,
loss, spoilage, or waste of such Raw Materials caused by an *
Assignable Error. In order to become effective, *’s
reasonable strategies regarding Raw Material safety stock and
sourcing from qualified vendors shall be agreed upon by Client. In
the event * 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.
5.3.2 Data
Transfer.
Client and * 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.
17
5.3.3 Testing and
Evaluation. * or vendors qualified
by * 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. *
shall not release any Raw Materials from quarantine that do not
meet their Specifications or are not otherwise suitable for cGMP
use.
5.3.4 Storage.
* shall secure sufficient and suitable cGMP storage facilities
and/or equipment at the Facility that meet the Specifications for
storage of the Raw Materials. * shall preserve and protect the Raw
Materials from loss and damage while in *’s possession,
consistent with reasonable technical and business judgment, the
Specifications and any relevant SOPs or other instructions provided
by Client; provided however, * shall be responsible for loss of Raw
Materials after receipt by * and prior to Manufacture only in cases
of * Assignable Error or breach of this Section 5.3.4. In all other
cases, Client shall be 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 * cannot
reasonably otherwise utilize such Raw
Material.
5.3.5 Service 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.
5.4.1 Management.
Client shall provide to * 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 *. * 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 * will make Commercially Reasonable Efforts
to use no more than those amounts, * will not be responsible for
Client Materials used in excess of the agreed-upon estimate;
provided, however, that * shall be responsible for any such
excessive use, loss, spoilage, or waste of such Client Materials
caused by an * Assignable Error, and further provided that * shall
not be liable for the monetary value of Cell Line loss if it
complied with risk mitigation measures to protect the Cell Line, as
reasonably agreed to by the Parties and set forth in the Quality
Agreement. In order to become effective, *’s reasonable
strategies regarding Client Material safety stock and sourcing from
qualified vendors shall be agreed to by Client. In the event * 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.
18
5.4.2 Data
Transfer. Client shall provide * 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.
5.4.3 Testing and
Evaluation. * 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).
* 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 five (5) Business Days after
*’s receipt of the Client Materials and (b) any
non-conformance of the Client Materials to Specification either:
(i) within sixty (60) calendar days after *’s receipt of the
Client Materials or (ii) if release testing of Client Materials 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, * determines that
such Client Materials are defective or damaged, * 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.
5.4.4 Storage.
* 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. * shall
preserve and protect the Client Materials from loss and damage
while in *’s possession, consistent with reasonable technical
and business judgment, the Specifications and any relevant SOPs or
other instructions provided by Client; provided that * shall only
be liable for loss and damage after receipt/acceptance by * and
prior to Manufacture in cases of * Assignable Error 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.
5.4.5 Service 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 * in the applicable PSA.
5.6 Purchase
Orders. For each Clinical Product or Commercial Product,
Client shall notify * 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”).
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5.8
Batch
Failure during Manufacture.
5.8.1 If, during
Manufacture of a Batch and prior to *’s Batch release, the Core Team
determines that a Batch is Non-Conforming Product (a
“Batch
Failure”), * shall take Commercially Reasonable
Efforts to promptly Manufacture (except to the extent prohibited by
cGMP or applicable QAG) and deliver to Client a replacement Batch
on a date to be mutually agreed by the Parties, which Batch shall
be invoiced and paid for as if it were the failed Batch
(i.e., Client shall only be
invoiced for the Batch conforming to the Specifications and
Manufactured in compliance with cGMP, and actually delivered).
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 Materials and Client Materials actually
used to Manufacture the conforming, cGMP compliant replacement
Batch). Client shall use Commercially Reasonable Efforts to ensure
that * has adequate Client Materials to Manufacture such Batches
and Client’s failure to provide such Client Materials shall
relieve * 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 * fails to provide the remedies contained in this Section
5.8.
5.8.2 The Parties shall
conduct a root cause analysis (including an analysis of whether the
Batch Failure was the fault of *, Client, neither or both) of the
Batch Failure, which shall be done through *’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.
5.8.3 The 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 * Service Fee to Manufacture the failed Batch; (2)
*’s costs to procure the Raw Materials used in the failed
Batch plus applicable * handling fees associated with such Raw
Materials; (3) * 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.
5.8.4 In 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
20
which
such re-Manufactured Batch is actually delivered by * unless the root cause analysis
determined the Batch Failure resulted from * Assignable Error, in
which case, the Service Fee in effect at the time of the Purchase
Order for the failed Batch shall apply.
5.9 Storage, Packaging
and Delivery.
5.9.1 Service
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.
5.9.2 Products.
(a) Release by * and Acceptance by Client.
(i) * 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 * shall deliver to Client a copy of the
Manufacturing Documentation in support of the *’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 * of the result within the latter of
thirty (30) Business Days of *’s release of Product or
Client’s receipt of the Batch Related Documents. Upon
Client’s acceptance, * 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 *’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 thirty
(30) Business Day period, the Product will be deemed to have been
accepted by Client and * 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 *’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 *’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 * as
Non-Conforming Product, at the option of Client, * 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
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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
* 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 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 *. In such case, if Client proves the Latent
Defect is solely due to * 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 * within one (1) month
from Client’s 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
*’s release of the Product and prior to each pick-up by
Client or Client’s designated carrier, * 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. * shall schedule
Delivery with the carrier selected and paid for by Client;
Client shall
compensate * for storage costs
for the Manufactured Product stored with * for more than sixty (60)
calendar days following release, as set forth in the applicable
PSA;
(ii)
* 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 * prior to * release. Upon
*’s release of Product, * shall store the Manufactured
Product as described in Section 5.9.2(c) and Client shall
compensate * for storage costs for the Manufactured Product stored
with * for more than sixty (60) calendar days following release, as
set forth in the applicable PSA;
22
(iii) * 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, * 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, * shall store the
Products Manufactured hereunder.
(ii) * 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 * to prepare Manufactured Product to be picked up
by Client or Client’s designated carrier with a pick-up date
within sixty calendar (60) days of Client’s receipt of the
Batch Related Documents, * shall store the Product at the Warehouse
and Client shall pay storage fees to * as set forth in Section 9.1
for the period of storage at the Warehouse in excess of sixty (60)
calendar days from release until the actual delivery date, in
accordance with the applicable PSA.
(iv) * shall store
and handle all Manufactured Product in accordance with applicable
storage and handling Specifications, including all times when * and
Client agree that * 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 *’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.
23
6.1 Approval for
Change. * 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, * shall accommodate such
requirements or requests, subject to the following:
(a) Client shall
promptly notify * in writing of the required and/or requested
Change(s), and provide information necessary for * to evaluate the
effect of such Change(s); provided, however, in the event * first
learns of a required Change it shall notify Client thereof in
writing, and * 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
*’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), *, 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 * 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), * shall
commence implementation of such Change(s);
(c) During any such
implementation, * shall provide Client with regular updates on the
progress of implementation. Subject to any timeframe imposed by
Applicable Law, * shall exercise Commercially Reasonable Efforts to
implement the Change according to the Implementation Plan and
Budget’s target completion date. * shall provide
written notice to Client if * 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
24
(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 * 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 * as set forth in Section 7.2, shall be
borne by *, 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
7 REGULATORY
APPROVALS AND INSPECTIONS.
7.1 Regulatory
Approvals. * 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. * 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. * shall facilitate on-site inspections of
the Facility conducted by Regulatory Authorities. * 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 * at the Facility, as further defined in the applicable
QAG. Any direct expenses or costs incurred by * for 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 * at the
Facility. Further, Client shall be entitled to attend, as an
observer, any
wrap-up meeting between * and a Regulatory
Authority related to such an inspection related to the Services or
the Manufacture of Product by * at the Facility. * 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 * thereto. Client’s comments in such regard
shall be considered in good faith and be given due regard by * in
formulating any proposed response to a Regulatory
Authority.
25
7.4 Regulatory
Support. During the
Term, * 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, *
shall review and correct such documents as they relate to *
activities at no charge to Client (updates will be made with
respect to regulatory filings for which Client has engaged * and
paid the associated flat rate fees for support). In addition, *
will maintain at *’s expense, the relevant Drug Master File,
including any updates thereto, and shall provide a letter
authorizing Client to reference *’s Drug Master Files on file
with the FDA and other Regulatory Authorities in connection with
the pursuit of Regulatory Approval for the Products.
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 * 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 * 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 *’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 * Assignable Error, * 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 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 * is unable to replace the Recalled or
returned Products (except where this inability results from a
failure to receive the Client Materials), then * shall credit to
Client the price that Client paid to * for Manufacturing and
Services for the affected Products. 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.
26
For the
purpose of this Section, Recall expenses shall not include the
value of the Product that is the subject of such Recall or any loss
of reputation or good will, or lost profits or any other costs or
expenses not associated with the Product that is the subject of the
Recall. If * 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 *, 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.
8.3.1 Audit by
Client. Upon Client’s request, but no more than once
per year, * 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 * with the terms of this MSA or
any applicable PSA; provided, however that in the event Client uses
a designee, * must provide prior written consent, which shall not
be unreasonably withheld, conditioned or delayed. * 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. * 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.
8.3.2 Audit
Notice. Client shall provide * with a written notice at
least three (3) months 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 * Assignable Error, the foregoing
sentence shall not apply and Client may conduct such audit or visit
by providing * with a prior notice by email. Access to *’s
facilities shall be coordinated with * so as to minimize disruption
to *’s ability to perform services for its other clients.
Client representatives must comply with all of *’s generally
applicable cGMP, confidentiality and security procedures and
protocols during such observations, consultations,
and
inspections.
* shall at all times cooperate and provide all the
necessary documents reasonably required by Client during such
audit; provided that, to the extent necessary, * 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 *’s security, safety or
confidentiality procedures.
27
9.1
Consideration.
In consideration for *’s performing the Service and other
obligations undertaken by * pursuant to a PSA, Client shall pay *
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 *
(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.
9.2.1 Service Fee of the Project Stages and
Batches. According to the invoicing plan set forth in
the applicable Project Plan or applicable PSA, or upon *’s
release of a Batch of Product, as applicable, * shall invoice
Client for the Service Fee set forth in the applicable
PSA.
9.2.2 Raw
Materials. With respect to the Raw Materials, * 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. * 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 *’s completion
of such project stage or upon *’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 * with Raw Materials for Product.
9.2.3 Client
Materials. With respect to the Client Materials, which
shall be supplied by Client to * at no cost during *’s
performance the Service, * shall submit an invoice to Client in an
amount as set forth in Section 9.1 upon *’s completion of
such project stage of the Service *’s release of a Batch of
Product, as applicable.
9.3
Payment.
9.3.1
Mode of Payment;
Foreign Exchange. All payments to * due under
the MSA or any applicable PSA shall be made within thirty (30)
Business Days from the receipt of the *’s invoice in USD $ by
means of telegraphic transfer to the account with the bank
designated by * 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 “▇▇▇▇://▇▇▇.▇▇▇▇▇▇▇▇▇.▇▇▇/▇▇▇▇▇▇▇/▇▇▇▇▇▇▇▇▇▇”
(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.
28
9.3.2 Taxes.
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 * and any withholding tax lawfully levied
on any payment to be made by Client to *, each of which shall be
solely borne by *. Client shall pay or reimburse * 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 *. * 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 *.
9.3.3 Price
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
*’s invoice.
9.3.4 Default
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 * 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
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
29
or results
disclosed by * 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 * 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 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.
30
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.
11.1
Reference Standard,
Client Technology, Client Materials, Cell Line, and Product.
* 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 * pursuant to Section 5.1, shall be
deemed to be included in the Background IP of Client. Client hereby
grants * a royalty-free, non-transferable, revocable and
non-sublicensable and fully-paid-up right and license to use such
Intellectual 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”.
11.3.1 Client
Invention. Any Invention that is conceived and first reduced
to practice solely by one or more employees or officers of * (or
its third party consultant or subcontractor) and does not
constitute an * Invention shall be a “Client
Invention”. * shall notify Client of such Client Invention(s)
to Client immediately after *, the Project Management Team
Leader,
31
respective project
personnel, * employees or officers or other
applicable third parties working for * 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 * shall provide reasonable cooperation to Client at
the expense of Client (as to all reasonable out-of-pocket expenses
incurred by * that are supported by adequate documentation). In the
event that * wishes to use the Client Invention for purposes
outside the scope of the MSA, Client hereby grants * a worldwide,
irrevocable, royalty-free and fully-paid- up license 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.
11.3.2
* Invention. Any Invention that is conceived and first
reduced to practice solely by one or more employees or officers of
* (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 * (“*
Invention”), and shall not be deemed to be Client
Invention or Joint Invention for the purposes of the MSA. No
Background IP of * and the * 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 * Invention shall be agreed upon prior to such
incorporation.
11.3.3 Client-* Joint
Invention. Any Invention that is conceived and first
reduced to practice jointly by one or more employees, or officers
of * (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 * (a
“Joint
Invention”), and shall not be a Client Invention or *
Invention for the purposes of the MSA. Subject to the terms and
conditions of the MSA, any such Joint Invention may be exploited by
* 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 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
32
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
* 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 * informed of any information known to
Client which would affect *’s provision of the Service
hereunder and (c) to the best of its knowledge, *’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 *’s
Warranties.
* represents, warrants and covenants that:
12.3.1 As of the
Effective Date and during the Term, (i) * is the lawful owner,
lessee, operator, or licensee of the Facility, equipment,
machinery, as well as permissions required, to enable * to perform
its obligations under this MSA, and (ii) to the best of *’s
knowledge none of the * Inventions or * Background IP infringes any
third party Intellectual Property Right.
12.3.2 All 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) * is not nor
has it ever been, and (ii) * has not used, and will not use, the
services of any person excluded, debarred, suspended (or subject to
exclusion, debarment or suspension) under 21 U.S.C. §335(a) or
(b) or otherwise disqualified by Applicable Law, including, the FDA
Debarment List (▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/▇▇▇/▇▇▇▇▇▇▇▇▇▇_▇▇▇/▇▇▇▇▇/▇▇▇▇▇▇▇.▇▇▇),
as amended or replaced from time to time, in connection with any of
the Services or Manufacturing performed under this MSA or any PSA.
* agrees to notify Client promptly in the event of any violation of
*’s obligations under this Section. This certification
applies to * and its respective officers, agents, and employees as
well as subcontractors performing on behalf of * 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.
33
13.1
Indemnification by
*. *
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 * or its officers, directors, employees or
agents, including any subcontractor or vendor used in the
Manufacture of Product, or (iv) any claim that
*’s use of * 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 *, 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 * 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 *’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 * 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 * 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 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.
34
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.
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.
15.2 Termination.
This MSA or a PSA may be earlier terminated as set forth in this
Section 15.2.
15.2.1 Material
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 twenty (20) Business Days after receipt of such
written notice, then the non-breaching Party may terminate this
Agreement on twenty (20) Business Days’ written notice after
expiration of such twenty (20) Business Day period. This MSA shall
terminate if all effective PSAs are terminated.
15.2.2 Insolvency.
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.
35
15.2.3 Force 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.
15.2.4 Import
Failure. Client shall be entitled to terminate a PSA upon
twenty (20) Business Days’ notice to *, if, despite the efforts of * 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.
15.2.5 Other Specified
Events. The Parties may additionally terminate a PSA as set
forth in the applicable PSA.
15.3 Effect of
Expiration or Termination.
15.3.1 Payment 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 * shall not be deemed earned and shall be returned to
Client.
15.3.2 Decommissioning.
Upon expiration or termination of a PSA for any reason, * shall
cease and refrain from the Services described in any applicable PSA
(including the Manufacturing 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, * 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 Service Fees 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, * shall bear the costs and expenses for such
destruction, except in the case of Section 15.2.4
or Section 15.2.5 for which destruction Client shall pay the
cost.
36
(ii) If
* terminates a PSA pursuant to Section
15.2.1, 15.2.2, 15.2.3, or 15.2.5, upon *’s election, * 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 * elected (i) above, Client
shall pay the Service Fee 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 * elected (ii)
above, Client shall bear the costs and expenses for such
destruction and the costs incurred by * for the Service; 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, * 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 Service Fee 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, * shall bear the costs and
expenses for such activities except in the case of Section 15.2.4
or Section 15.2.5 for which destruction Client shall pay the
cost.
(ii) If *
terminates a PSA pursuant to Section 15.2.1, 15.2.2, 15.2.3, or
15.2.5, upon *’s election, * may (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) destroy such Product in process. If *
elected (i) above, Client shall pay the Service Fee 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 * elected (ii) above, Client
shall bear the costs and expenses for such activities.
(iii) If a
PSA is naturally expired pursuant to Section 15.1, the provisions
of (ii) above shall apply.
37
(c) Client Materials, Cell Line, and Reference
Standards. Upon expiration or termination of a PSA, upon
Client’s election, * 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, *
shall deliver or dispose at no additional cost to Client and *
shall bear such costs and expenses for such
activities;
(ii)
If * 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 15.2.4or 15.2.5,
Client shall bear such costsand expenses for such
activities;
(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, * shall deliver the remaining Raw Materials to
Client for Client’s payment of *’s cost to procure such
Raw Materials, or dispose of them at Client’s election. *
shall bear the costs and expenses for the delivery of the
RawMaterials.
(ii)
If * 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, * may
deliver the remaining Raw Materials to Client or dispose of them at
*’s election. If so delivered, Client shall pay *’s
cost to procure such Raw Materials to * and bear the costs and
expenses for the deliveryof such Raw Materials by *.
(iii)
If a PSA is
naturally expired pursuant to Section 15.1, the provisions of (ii)
above shall apply.
(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.
38
(ii) If
* 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.
15.3.3 Outbound
Transfer. Upon any
termination of a PSA or in connection with its expiration, Client
shall be entitled to give notice to * 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 *
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 *’s
reasonable costs of assistance related to effectuation of the
Manufacturing Process Transfer Plan.
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 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.
16.2
Arbitration.
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
39
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.
16.3 Costs 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.
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:
TG
Therapeutics, ▇▇▇.▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇., ▇▇▇
▇▇▇▇▇
▇▇▇
▇▇▇▇, ▇▇ ▇▇▇▇▇
Attention: Senior
Vice President Operations
Facsimile:
If to
*:
*
With copy to:
* Legal
& Compliance Department
40
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 one hundred
eighty (180) consecutive days, or it is reasonably foreseeable that
such Force Majeure Event will persist for more than one hundred
eighty (180) days consecutive days, 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 sixty (60) days the Parties have failed to
reach agreement, the Non-Affected Party shall have the right to
terminate this MSA upon thirty (30) days’ written
failure.
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, * may, without such consent,
assign the MSA to (i) its Affiliate or (ii) any purchaser of
substantially all of the assets of *, 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.
41
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, 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.
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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.
Signature:
_______________________________________
Name:
▇▇▇▇▇▇▇
▇. ▇▇▇▇▇
Title:
Chief Executive
Officer
Date:
*
Signature:
Name: *
Date:
43