Exhibit 10.26

 

Text Marked By [* * *] Has Been Omitted Pursuant To A Request For Confidential
Treatment And Was Filed Separately With The Securities And Exchange Commission.

 

AMENDED AND RESTATED MANUFACTURING SERVICES AGREEMENT

 

This Amended and Restated Manufacturing Services Agreement (this “Agreement”) is
made as of December 18, 2017 (the “Effective Date”) by and between WuXi AppTec,
Inc., a corporation organized under the laws of Delaware having a place of
business at 4751 League Island Blvd., Philadelphia, PA 19112 (“Company”), and
Iovance Biotherapeutics, Inc. (f.d.b.a. Lion Biotechnologies, Inc.), a Delaware
corporation having its principal place of business at 999 Skyway Road, Suite
150, San Carlos, CA 94070 (“Iovance”) (each of Company and Iovance, a “Party”
and, collectively, the “Parties”).

 

RECITALS

 

WHEREAS, Company has experience in the development, manufacture and supply of
biopharmaceutical products;

 

WHEREAS, Iovance is developing various novel cancer immunotherapies, including
autologous cell therapy products based on its tumor infiltrating lymphocytes
(“TILs”) technology;

 

WHEREAS, Iovance has developed a proprietary process that utilizes a patient’s
own TILs, whereby a patient’s TILs are expanded in vitro and then infused back
into the patient;

 

WHEREAS, from time to time, Iovance may engage Company to manufacture and
perform services related to the manufacture of Iovance’s autologous cell therapy
products for use in clinical trials, all on the terms set out in this Agreement
and the applicable Statements of Work between the Parties;

 

WHEREAS, the Parties previously executed that certain Manufacturing Services
Agreement (the “Original Agreement”), with an effective date of November 23,
2016 (the “Original Effective Date”); and

 

WHEREAS, the Parties desire to amend and restate the Original Agreement in its
entirety on the terms and subject to the conditions set forth in this Agreement
to modify the terms applicable to equipment provided by Iovance and augment the
scope of the relationship to permit the manufacturing of Product for patients
based in the European Union and certain other countries as described herein and
the Parties acknowledge and agree that this Agreement satisfies the requirement
of Section 18.5.1 of the Original Agreement that any amendment of the Original
Agreement be in writing.

 

NOW, THEREFORE, in consideration of the foregoing and the mutual promises and
covenants hereinafter set forth, Company and Iovance, intending to be legally
bound, hereby agree as follows:

 

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AGREEMENT

 

1.DEFINITIONS

 

When used in this Agreement, capitalized terms will have the meanings as defined
below and throughout this Agreement. Unless the context indicates otherwise, the
singular will include the plural and the plural will include the singular.

 

1.1       “AAA” has the meaning set forth in Section 18.15.3.

 

1.2       “Affiliate” means, with respect to either Party, any other corporation
or business entity that directly, or indirectly through one (1) or more
intermediaries, controls, is controlled by or is under common control with such
Party. For purposes of this definition, the term “control” and, with correlative
meanings, the terms “controlled by” and “under common control with” means direct
or indirect ownership of more than fifty percent (50%) of the securities or
other ownership interests representing the equity voting stock or general
partnership or membership interest of such entity or the power to direct or
cause the direction of the management or policies of such entity, whether
through the ownership of voting securities, by contract, or otherwise.

 

1.3       “Agreement” has the meaning set forth in the preamble, and, for
clarity, includes the Appendices, the Statements of Work and the Quality
Agreement, all of which are incorporated herein by this reference, as amended
from time to time in accordance with this Agreement or otherwise by written
agreement of the Parties.

 

1.4       “Background Intellectual Property” has the meaning set forth in
Section 13.1.

 

1.5       “Batch” means a specific quantity of Product that is intended to have
uniform character and quality, within specified limits, and is produced from one
manufacturing run using the Process.

 

1.6       “Batch Record” means the production record pertaining to a Batch.

 

1.7       “cGMP” means the then current good manufacturing practices, standards,
guidelines and regulations promulgated and published by the FDA, European
Commission and/or the European Medicines Agency relating to the testing,
manufacturing, processing, packaging, labelling, holding or distribution of
biologics, drug substances, human cells, tissues, and cellular or tissue-based
products, and/or finished drugs, to the extent applicable to the Services,
including any standards, guidelines and regulations as promulgated by: (i) the
FDA under and in accordance with the U.S. Federal Food, Drug and Cosmetic Act,
Title 21, Parts 210, 211, 600, 610, and 1271 of the U.S. Code of Federal
Regulations and the Public Health Service Act, to the extent applicable; and/or
(ii) the European Medicines Agency, EU Commission and EU member state
governmental authorities under and in accordance with European Directive
2003/94/EC, including, in each case of (i) and (ii), the ICH Harmonised
Tripartite Good Manufacturing Practice Guide to the extent it, or components
thereof, are adopted by the FDA and/or the European Medicines Agency.

 

1.8       “Change Order” has the meaning set forth in Section 2.2.

 

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1.9       “COA” means a certificate of analysis, which, with respect to a Batch
of Product or Product components, including packaging and labelling, shall
include, at a minimum: (i) name, address, and contact phone number of each of
the facilities where such Product or component was manufactured; (ii) Product or
component name and details; (iii) Product or component batch number and other
identification; (iv) date of manufacture; (v) date of expiry, to the extent
applicable; (vi) a list of each test performed, the location of the test
facility, the acceptance limits as indicated in the Product Specifications or
material specifications, and the results obtained (and the COA should document
actual values, where Product Specifications or component specifications are
quantitative, and maintain the significant figures and rounding of numbers
defined in the Product Specifications or component specifications); and (vii)
such other information or statements as may reasonably be requested by Iovance.

 

1.10     “Company” has the meaning set forth in the preamble.

 

1.11     “Company Confidential Information” means the Confidential Information
of Company.

 

1.12     “Company Operating Documents” means the standard operating procedures,
standard manufacturing procedures, standard testing procedures, control
specifications, raw material specifications, protocols, validation
documentation, and supporting documentation used by Company in the performance
of Services and for operation and maintenance of a Facility and Company
equipment used in the performance of Services, excluding any of the foregoing
that are unique to the Product or Services or provided by Iovance.

 

1.13     “Company Parties” has the meaning set forth in Section 17.2.

 

1.14     “Condemnation” has the meaning set forth in Section 18.3.

 

1.15     “Confidential Information” has the meaning set forth in Section 12.1.

 

1.16     “CPA” has the meaning set forth in Section 11.2.

 

1.17     “Effective Date” has the meaning set forth in the preamble.

 

1.18     “Facility(ies)” means the facility(ies) designated within the
applicable Statement of Work where all development work, processing and
manufacturing and other Services shall be conducted. Such term includes all of
the equipment, machinery and facilities of Company at such location that are
used in the performance of the Services.

 

1.19     “FDA” means the U.S. Food and Drug Administration, and any successor
agency thereof.

 

1.20     “Force Majeure Event” has the meaning set forth in Section 18.2.

 

1.21     “Forecast” has the meaning set forth in Section 2.7.

 

1.22     “Improvements” has the meaning set forth in Section 13.2.1.

 

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1.23     “Indemnitee” has the meaning set forth in Section 17.4.1.

 

1.24     “Indemnitor” has the meaning set forth in Section 17.4.1.

 

1.25     “Initial Agreement” has the meaning set forth in Section 18.5.2.

 

1.26     “Institutional Review Board” means an institutional review board,
independent ethics committee or equivalent entity that approves, monitors and
reviews medical research.

 

1.27     “Insurance Policy” has the meaning set forth in Section 17.5.

 

1.28     “Intellectual Property” has the meaning set forth in Section 13.1.

 

1.29     “Iovance” has the meaning set forth in the preamble.

 

1.30     “Iovance Confidential Information” means the Confidential Information
of Iovance.

 

1.31     “Iovance Intellectual Property” means Background Intellectual Property
of Iovance and New Iovance Intellectual Property.

 

1.32     “Iovance Materials” has the meaning set forth in Section 5.1.

 

1.33     “Iovance Parties” has the meaning set forth in Section 17.1.

 

1.34     “Joint Steering Committee” or “JSC” has the meaning set forth in
Section 3.3.

 

1.35     “Law” or “Laws” means (a) all applicable constitutional provisions,
laws, statutes, codes, rules, regulations, guidances, orders, treaties,
judgments, decrees, directives, injunctions and/or ordinances of any United
States or European Union (as it exists on the Effective Date) governmental
entity or authority, which are applicable to the Parties, their respective
obligations under this Agreement, or otherwise to the Patient Materials, Process
and/or Product (any component thereof and/or the manufacture or processing
thereof), including Directive 2001/83/EC, Directive 2004/23/EC and Directive
95/374/EC and the General Data Protection Regulation 2016 (when in force), and
(b) cGMPs. Any reference to a particular law or regulation will be interpreted
to include any revision of or successor to such statute, law, rule or regulation
regardless of how it is numbered or classified.

 

1.36     “Losses” has the meaning set forth in Section 17.1.

 

1.37     “Master Batch Record” or “MBR” means the documentation that contains a
detailed description of the Process and any other instructions to be followed by
Company in the production of Product.

 

1.38     “Materials” has the meaning set forth in Section 5.2.

 

1.39     “New Iovance Intellectual Property” has the meaning set forth in
Section 13.2.1.

 

1.40     “Original Agreement” has the meaning set forth in the Recitals.

 

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1.41     “Original Effective Date” has the meaning set forth in the Recitals.

 

1.42     “Party” or “Parties” has the meaning set forth in the preamble.

 

1.43     “Patient Material” means (a) the Patient Tumor, and (b) all biological
materials derived therefrom.

 

1.44     “Patient Tumor” means the patient’s primary or metastatic tumor
provided by or on behalf of Iovance to Company hereunder for Company to apply
the Process to and from which the TILs will be isolated and expanded to produce
a Product.

 

1.45     “Personal Information” means any data about an identified or
identifiable individual, including data that identifies an individual or that
could be reasonably used to identify, locate, track, or contact an individual,
in any media or format, including computerized or electronic records and
paper-based files. Personal Information includes both (i) directly identifiable
information, such as a name, identification number or unique job title, Social
Security number or other government-issued identifier, or credit card
information, and (ii) indirectly identifiable information, such as date of
birth, unique mobile or wearable device identifier, telephone number and
Internet Protocol address, as well as key-coded data.

 

1.46     “Process” means Iovance’s proprietary process for expanding TILs from a
Patient Tumor in vitro to produce a Product and provided by Iovance to Company
pursuant to this Agreement, as such process may be further developed under this
Agreement.

 

1.47     “Process Specifications” means robust, data-driven specifications
developed by or for Iovance with respect to the implementation of the Process as
set forth in the Quality Agreement, as such specifications may be amended from
time to time in accordance with the Quality Agreement.

 

1.48     “Product” means the finalized TIL cell therapy product that is produced
from Patient Material by the application of the Process.

 

1.49     “Product Specifications” means the testing methods and associated
robust, data-driven acceptance criteria used to assess the Product manufactured
under this Agreement, as such methods and/or acceptance criteria may be amended
from time to time in accordance with the Quality Agreement.

 

1.50     “Product Warranties” means those warranties as specifically stated in
Section 9.1.

 

1.51     “Project Team” has the meaning set forth in Section 3.1.

 

1.52     “Purchased Equipment” has the meaning set forth in Section 2.3.5.

 

1.53     “Quality Agreement” means the Quality Agreement entered into by the
Parties on November 3, 2016, as may be amended or restated from time to time by
the Parties.

 

1.54     “Regulatory Approval” means the approvals, licenses, registrations or
authorizations (including marketing authorizations) of any regulatory authority
that may be necessary for the development, marketing, sale and commercialization
of the Product (including such approvals as are necessary to distribute
investigational product).

 

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1.55     “Remedial Event” means an event whereby Product is subject to a recall,
field corrective action, or other regulatory action, including a clinical hold.

 

1.56     “Report” has the meaning set forth in Section 3.2.

 

1.57     “Representatives” means, with respect to a Party, (a) its employees,
contractors, subcontractors, consultants, agents, Affiliates or persons
otherwise associated with such Party as a result of the performance of this
Agreement or a Statement of Work and (b) the employees, contractors,
subcontractors, consultants, agents of such Party’s Affiliates or persons
otherwise associated with such Party’s Affiliates as a result of the performance
of this Agreement or a Statement of Work.

 

1.58     “Security Incident” has the meaning set forth in Section 6.2.7.

 

1.59     “Services” means the activities performed by Company under a Statement
of Work.

 

1.60     “SOP” means a standard operating procedure.

 

1.61     “Specifications” means the Product Specifications and the Process
Specifications.

 

1.62     “Statement of Work” means a statement of work that is signed by the
Parties and attached hereto as Appendix A or later becomes attached through an
amendment by the Parties as further detailed in Article 2. As each subsequent
Statement of Work is agreed to and signed by the Parties, each shall state that
it is to be incorporated and made a part of this Agreement and shall be
consecutively numbered (for example as A-1, A-2, A-3, etc.). For clarity, the
plural of “Statement of Work” is “Statements of Work”.

 

1.63     “Suite” means one (1) Company cGMP compliant unit space suitable for
the performance of Services under a Statement of Work.

 

1.64     “Taxes” has the meaning set forth in Section 11.3.

 

1.65     “Term” has the meaning set forth in Section 16.1.

 

1.66     “Third Party” means any party other than Company, Iovance or their
respective Affiliates.

 

1.67     “TILs” has the meaning set forth in the recitals.

 

1.68     “Use” means to perform any operation or set of operations on Patient
Materials or Personal Information, whether or not by automatic means, including
collecting, recording, organization, storage, access, adaptation, alteration,
retrieval, consultation, use, evaluation, analysis, reporting, sharing,
disclosure, dissemination, transmission, making available, alignment,
combination, blocking, deleting, erasure or destruction.

 

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1.69     “WO A-4” has the meaning set forth in Section 18.5.2.

 

1.70     “Work” has the meaning set forth in Section 13.2.1.

 

2.STATEMENTS OF WORK; PERFORMANCE

 

2.1       Statement of Work. From time to time, the Parties will enter into
individual Statements of Work, which shall describe the Services to be performed
by Company thereunder and other details related thereto. Statements of Work
shall be in a form to be agreed by the Parties and may include the following as
applicable to the Services: Process transfer, Process development,
Specifications, nature (e.g., expected tumor types) of applicable Patient
Tumors, number of Product lots required to be produced per month and in the
aggregate during the term of the Statement of Work, timelines for receipt,
delivery and dispatch of applicable Patient Tumors and Products, required Suite
availability, required delivery terms for Product, financial consideration, and
such other terms as the Parties mutually determine. Once agreed to by the
Parties, each such Statement of Work shall be executed by each of the Parties
and appended hereto as part of Appendix A. In the event of a conflict between
the terms and conditions of this Agreement and any Statement of Work, the terms
and conditions of this Agreement shall control unless the Parties expressly
agree in a Statement of Work that a particular clause in such Statement of Work
will control.

 

2.2        Modification of Statement of Work. Should Iovance want to modify a
Statement of Work, including a change or revision to the method or manner of
performance of Company’s obligations under such Statement of Work, or the
facilities, equipment, or materials to be used in performing the Services
subject to such Statement of Work, Iovance may propose to Company an amendment
to the Statement of Work with the desired modifications (“Change Order”). Upon
receipt of such Change Order, Company will evaluate the Change Order and discuss
with Iovance those Change Order elements that Company may reasonably
accommodate. Based on such discussions, Company will prepare a modified version
of the Statement of Work reflecting the elements of such Change Order (including
any changes to the estimated timing, estimated charges or scope of Services) and
will submit such modified version of the Statement of Work to Iovance for review
and comment. Additionally, if Company reasonably determines that a change or
addition to the information provided by Iovance hereunder, or gained under an
applicable Statement of Work necessitates a change to (i) the method or manner
of performance of Company’s obligations hereunder including an acceleration of
such obligations, (ii) production or assay batch records, or (iii) the
facilities, equipment, materials, Services or site, which may cause an activity
start date to be rescheduled, Company may propose a Change Order to Iovance,
which Iovance will consider in good faith, but which will otherwise be subject
to this Section 2.2. If the Parties agree on terms, they will execute such
modified Statement of Work and such modified Statement of Work shall be appended
and become part of the original (or prior) Statement of Work and this Agreement.
Thereafter such modified version of the Statement of Work will be deemed to have
replaced the prior version of the Statement of Work and to be binding on the
Parties. Notwithstanding the foregoing, if a modified version of the Statement
of Work is not agreed to and executed by both Parties, the then-current
Statement of Work shall remain in effect.

 

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2.3       Performance by Company.

 

2.3.1       Company will perform the Services in a professional and workmanlike
manner and in accordance with generally accepted industry practices and the
standards and the terms of this Agreement, the applicable Statement of Work, the
Quality Agreement, and all Laws, and will ensure the same of any Affiliates and
Third Parties performing Services on behalf of Company.

 

2.3.2       Company shall not amend, modify, change or supplement a Statement of
Work, or any part thereof, without the prior written consent of Iovance.

 

2.3.3       Company shall assign such qualified scientific, technical, and other
personnel and allocate such Suite capacity to perform the Services as set forth
in the applicable Statement of Work. To the extent such Statement of Work does
not specify scientific, technical or other personnel or Suite capacity, Company
shall assign such scientific, technical and other personnel, and shall allocate
such Suite capacity, as is reasonably and customarily necessary for performing
the Services as set forth in the applicable Statement of Work, and consistent
with all Laws, this Agreement and the Quality Agreement. Company shall ensure
that Company personnel, and any Affiliates or Third Parties, assigned to perform
activities under this Agreement shall be capable of professionally and
competently performing the applicable Services. All persons and entities
providing Services shall be appropriately trained and qualified to perform their
assigned responsibilities.

 

2.3.4       Company will promptly notify Iovance of any delays that arise during
the performance of a Statement of Work.

 

2.3.5       Unless authorized by Iovance in writing, Company shall perform the
Services only at the Facility(ies) designated in the applicable Statement of
Work. Unless authorized by Iovance in writing, Company may not utilize any
facility, other than the Facility(ies), in connection with the Services and/or
Products. Unless otherwise provided by or authorized by Iovance in writing,
Company will use Company’s equipment for the performance of the Services.
Without limiting the foregoing, Iovance will purchase and lease to Company, for
no additional consideration other than Company’s performance under this
Agreement and the Statements of Work, such equipment as is identified in the
applicable Statement of Work to be provided by Iovance to Company (the
“Purchased Equipment”). All Purchased Equipment will be delivered to Company
free and clear of all liens and encumbrances other than those securing
obligations being serviced by Iovance, and Company will not permit or cause to
be suffered any liens or encumbrance on any Purchased Equipment. Company will be
responsible for the maintenance of the Purchased Equipment for so long as the
Purchased Equipment is used in performance of the Services, including furnishing
all necessary and appropriate utilities for its operation and maintenance.

 

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2.3.6       Company shall ensure that all Purchased Equipment is properly
maintained in accordance with cGMP, is protected from deterioration other than
normal wear and tear, is only used for the Services, and is returned to Iovance
upon the expiration or termination of this Agreement at Iovance’s reasonable and
pre-approved cost and expense. Except for the use of accessories required for
the operation of the Purchased Equipment, Company shall not make any
alterations, modifications, or additions to the Purchased Equipment and shall
not remove anything from the Purchased Equipment, without the prior written
consent of Iovance. Company shall provide Iovance and its Representatives with
full and free access to the Purchased Equipment during normal business hours.
All Purchased Equipment is and shall remain the property of Iovance and shall be
and remain tagged accordingly. In no event shall Company have any interest in
the Purchased Equipment other than Company’s leasehold interest consisting of
Company’s right to possess and use the Purchased Equipment as provided in this
Agreement. Company will not claim or identify the Purchased Equipment as being
owned by Company. The Purchased Equipment will be located solely at the
Facilities until so notified by Iovance. Iovance may file at Iovance’s expense
any document or other information necessary to demonstrate and secure its
ownership in the Purchased Equipment, including a Uniform Commercial Code
financing statement providing the name of Iovance as lessor and of Company as
lessee and indicating the collateral as the Purchased Equipment. Iovance may
also notify any person who has filed a Uniform Commercial Code financing
statement against Company covering equipment, or who otherwise might claim an
interest in Company’s equipment, as to Iovance’s interest in the Purchased
Equipment. Company shall cooperate with Iovance in completing and filing, and
shall execute or join with Iovance in executing, any such documents, information
or notifications. Iovance shall not be liable or otherwise responsible for any
loss, damage or other consequence suffered by Company, its Affiliates or any
Third Party as a direct or indirect result of the Purchased Equipment or the use
of the Purchased Equipment by Company, its Representatives or any unauthorized
person while the Purchased Equipment is in the possession or under the control
of Company, except to the extent such loss, damage or consequence is the direct
or indirect result of the actions or omissions of Iovance’s or any of its
Representatives’ (for clarity, excluding Company) use of or physical contact
with the Purchased Equipment.

 

2.3.7       All Facilities, equipment, including Purchased Equipment, and
processes shall be appropriately qualified, monitored, verified, and validated,
as applicable, commensurate with the Services to be performed as may be required
under Law, prior to the commencement of the Services utilizing such Facilities,
equipment and processes, including Purchased Equipment, by Company. Company
shall maintain the Facility(ies), equipment, including Purchased Equipment and
contract rights in use at the Facility(ies) in conditions adequate to perform
the Services in accordance with all Laws, this Agreement, the Quality Agreement,
and the applicable Statement of Work.

 

2.3.8       Company shall timely procure and store all materials (other than the
Patient Materials and Iovance Materials) that are required for the performance
of the Services as such Services are described in applicable Statements of Work.

 

2.4       Compliance with Safety, Health and Environmental Laws. Company shall
be responsible for compliance with all Laws related to health, safety and the
environment where Services are performed, including providing its employees and
consultants engaged in the performance of Services or Iovance representatives
engaged in the review of Services with all required information and training
concerning any potential hazards involved in the performance or review of the
Services and any precautionary measures to protect such Iovance representatives,
and Company’s employees and consultants from any such hazards. Except to the
extent caused by the negligent act or omission of Iovance or any Iovance
representative, Iovance shall not be responsible for any injuries that Company’s
employees or consultants or Iovance’s representatives may suffer in the
performance or review of Services.

 

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2.5       Outsourcing to Third Parties. Company shall, only after receiving
prior written approval by Iovance (which such approval may be withheld in
Iovance’s sole discretion), be entitled to outsource discrete portions of the
Services to Third Parties, which such approval shall be received in the form of
an executed Statement of Work that specifically identifies such Third Parties,
the Services to be so outsourced, and the location(s) at which such outsourced
Services will be performed; provided that (i) the terms of any such arrangement
between such Third Party and Company are substantially identical in their effect
to those set forth in this Agreement, especially in terms of confidentiality,
Intellectual Property rights, and compliance with Laws, (ii) Company shall be
responsible for the initial and ongoing Third Party qualification (including any
appropriate validation or verification of the Services to be performed by such
Third Party, including, to the extent applicable, equipment to be used by any
such Third Party), to the extent required by Law, and for Company’s obligations
for Services provided by any Third Party under this Agreement or any Statement
of Work, and (iii) Company shall remain liable for Company’s obligations under
this Agreement or any applicable Statement of Work regardless of the failure of
any such Third Party to perform the subcontracted Services in accordance with
this Agreement. Company hereby expressly waives any requirement that Iovance
exhaust any right, power or remedy, or proceed against any such Third Party, for
a breach of any of Company’s obligation or performance hereunder due to such
Third Party’s failure prior to proceeding directly against Company. Subject to
Section 10.4.2, Iovance shall have the right to review Company’s qualification
of all Third Parties and Third Party activities under this Agreement or any
Statement of Work and shall have the right to inspect or audit, itself or
through a Representative, or attend any Company inspection or audit of such
Third Party before providing written approval of such Third Party. Iovance’s
review, audit and inspection, and attendance rights hereunder shall continue
following Iovance’s written approval of the Third Party and shall further extend
to any Third Party re-qualification (including any appropriate re-validation or
re-verification of Services, including, to the extent applicable, equipment to
be used by any such Third Party), to the extent such re-qualification is
required by Law, and re-qualification of Third Party activities under this
Agreement or any Statement of Work conducted by Company of any such Third Party.

 

2.6       Use of Affiliates. Company may exercise its rights and perform its
obligations under this Agreement through one (1) or more of its Affiliates with
Iovance’s prior written consent; provided, that, Company (i) shall be
responsible for ensuring that all of its Affiliates comply with the terms and
conditions of this Agreement (including all obligations with respect to the
confidential treatment of Iovance Confidential Information and assignment of any
New Iovance Intellectual Property), each Statement of Work, the Quality
Agreement and all Laws, (ii) shall be responsible for the initial and ongoing
Affiliate qualification, to the extent required by Law, and for its obligations
with respect to the Services that are provided by any Affiliates on behalf of
Company under this Agreement or any Statement of Work, (iii) shall remain
directly responsible for the performance of its Affiliates under this Agreement
(including performance under any applicable Statement of Work), and (iv) hereby
expressly waives any requirement that Iovance exhaust any right, power or
remedy, or proceed against any such Affiliate for any obligation or performance
hereunder (including performance under any applicable Statement of Work), prior
to preceding directly against Company. Subject to Section 10.4.2, Iovance shall
have the right to review Company’s Affiliate qualification and qualification of
such Affiliate’s activities under this Agreement or any Statement of Work and
shall have the right to inspect or audit, itself or through a Representative, or
attend any Company inspection or audit of such Affiliate before providing
written approval of such Affiliate. Iovance’s review, audit and inspection, and
attendance rights hereunder shall continue following Iovance’s written approval
of any such Affiliate of Company and shall further extend to any Affiliate
re-qualification, to the extent such re-qualification is required by Law, and
re-qualification of such Affiliate’s activities under this Agreement or any
Statement of Work conducted by Company.

 

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2.7       Forecast and Suspended Services. From time-to-time during the Term,
Iovance will provide to Company a rolling twelve (12)-month forecast specifying
Iovance’s anticipated requirements for the number of Batches to be Processed by
calendar quarter for the succeeding four (4) calendar quarters, including
anticipated tumor type (the “Forecast”). The number of Batches set forth in the
Forecast shall constitute Iovance’s good faith estimate of Iovance’s
requirements for Company’s manufacturing capacity for such periods.
Additionally, the Parties shall meet once per month, either in person or via
teleconference or videoconference, to discuss Iovance’s anticipated
manufacturing needs. In the event of a Remedial Event the Parties agree that
Company’s obligation to supply and Iovance’s obligation to purchase any Batches
included in the Forecast that would be affected by such Remedial Event, shall be
suspended commencing upon receipt by Company of written notice from Iovance of
the Remedial Event and continuing until such time as such Remedial Event is
resolved. Iovance shall promptly notify Company when any such Remedial Event is
resolved and the Parties obligations which were suspended shall resume.
Regardless of any such suspension, Iovance shall remain obligated to pay for the
manufacturing suite fees as specified in an applicable Statement of Work;
provided, that, if an investigation conducted under the Quality Agreement
determines that such Remedial Event was caused by the negligence or willful
misconduct of Company, Iovance shall have no obligation to pay such fees during
the period of suspension. If the Remedial Event lasts longer than three (3)
months then Iovance may (i) elect to resume the affected manufacturing
activities in accordance with the Forecast, or (ii) pay Company for the agreed
suite fees plus other fixed costs for the Batches contained in the Forecast for
the duration of the Remedial Event, or (iii) allow Company to use the suite(s)
and manufacturing capacity for Third Party projects for the duration of the
Remedial Event plus six (6) months, in which case during such time Iovance shall
have no obligation to pay to Company any amounts for such manufacturing suite
fees or Batches included in the Forecast; provided, that, if an investigation
conducted under the Quality Agreement determines that such Remedial Event is
caused by the negligence or willful misconduct of Company, Iovance shall have no
obligation to pay suite fees or other fixed costs during the period of
suspension and may elect to maintain the suspension of manufacturing activities
until the resolution of the Remedial Event. With regard to Iovance’s election
under the previous sentence, Iovance shall give Company at least thirty (30)
days’ notice of its intent.

 

2.8       Timing of Services. Each Party understands that once the timing for
manufacturing Batches is established that it is of the utmost importance that
the execution of each Party’s obligations is consistent with meeting the timing
required for Batch production. Accordingly, both Parties shall perform their
respective obligations in order to meet the timing guidelines for Batch
production provided in the applicable Statement of Work.

 

2.9       Commercial Manufacturing Agreement. Upon Iovance’s request (and at
Iovance’s sole discretion), Company and Iovance shall enter into a mutually
agreeable commercial manufacturing agreement whereby Company will provide
Product to Iovance for commercial purposes.

 

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3.GOVERNANCE

 

3.1       Project Team.

 

3.1.1       In accordance with the Original Agreement, the Parties have
established a project team (“Project Team”), which consists of personnel from
each Party who are appropriately skilled and knowledgeable in relation to the
Services. The Project Team is comprised of equal numbers of representatives from
Iovance and Company. A representative from Iovance shall chair the Project Team.

 

3.1.2       The Project Team shall be responsible for the following:

 

(a)coordinating transfer of technology and knowledge related to the Services;

 

(b)amending and updating Statements of Work;

 

(c)implementation of the Services through each Statement of Work;

 

(d)monitoring of the Services under each Statement of Work;

 

(e)reporting to the JSC on the progress of the Services; and

 

(f)establishing Project Team subgroups as reasonably necessary.

 

3.1.3       Decisions of the Project Team shall be made by unanimous agreement
of the Parties, with each Party’s representatives having one (1) vote in the
aggregate. For purposes of clarity, decisions by the Project Team may be made by
as few as one (1) representative from each Party and in any forum (face-to-face,
videoconference, teleconference, etc.). In the event that unanimity is not
achieved within the Project Team, either Party may, within thirty (30) days,
refer such matter to the JSC and the JSC shall promptly discuss the matter and
attempt in good faith to resolve the matter.

 

3.1.4       Unless otherwise agreed to by the Parties in writing;

 

(a)the Project Team shall meet at least bi-weekly, in person, or by
teleconference or videoconference;

 

(b)the Project Team members from Company shall keep the Project Team members
from Iovance fully and regularly informed as to its progress with its
obligations under each Statement of Work, including written Project reports, and
progress with respect to general obligations under this Agreement as Iovance may
reasonably request; and

 

(c)Project Team subgroups shall communicate and meet as necessary in order for
the activities allocated to them to be conducted in accordance with the
timelines mandated by the Project Team.

 

 

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3.2        Reports. Company shall (a) be available for conference calls
discussing progress, problems and plans associated with the Services and (b)
upon the request of Iovance provide written reports to the Project Team setting
forth the results of the Services (each a “Report”). Company shall also provide
other reports, data, and information to the Project Team as agreed to by the
Project Team, or as set forth in an applicable Statement of Work, from
time-to-time. Company shall further provide other reports, data, and information
that (i) Company is required to provide to Iovance under Laws within the
timeframes specified by such Laws, and/or (ii) Iovance is required to report to
the applicable regulatory authorities with sufficient time to allow Iovance to
evaluate the relevant reports, data, and/or information and provide its report
to the applicable regulatory authorities within the timeframes required by Law.

 

3.3       Joint Steering Committee.

 

3.3.1       In accordance with the Original Agreement, the Parties have
established a joint steering committee (the “Joint Steering Committee” or
“JSC”), which consists of personnel from each Party who are appropriately
skilled and knowledgeable in relation to the Services. The JSC is comprised of
equal numbers of representatives from Iovance and Company. A representative from
Iovance shall chair the JSC.

 

3.3.2       The JSC shall be responsible for the following:

 

(a)managing the overall relationship between the Parties;

 

(b)providing strategic guidance and management regarding clinical and commercial
development, key contractual responsibilities and alignment across all
functional activities;

 

(c)establishing and monitoring the goals and prioritization of the Services, and
overseeing the Services generally;

 

(d)providing resources and budget guidance for the Services;

 

(e)establishing performance metrics focusing on adherence to milestones, budgets
and the objectives of the Services;

 

(f)resolving disputes referred to the JSC by the Project Team; and

 

(g)discussing reports provided by the Project Team.

 

3.3.3       Decisions of the JSC shall be made by unanimous agreement of the
Parties, with each Party’s representatives having one (1) vote in the aggregate.
For purposes of clarity, decisions by the JSC may be made by as few as one (1)
representative from each Party and in any forum (face-to-face, videoconference,
teleconference, etc.). In the event that unanimity is not achieved within the
JSC, either Party may, within thirty (30) days, refer such matter for resolution
pursuant to Section 18.15.1.

 

3.3.4       Unless otherwise agreed to by the Parties in writing, the JSC shall
meet once per calendar quarter, in person, or by teleconference or
videoconference.

 

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3.4       Committee Minutes. The Party hosting a given Project Team or JSC
meeting will be responsible for preparing reasonably detailed written minutes
that reflect, without limitation, material decisions made, action items
identified and unresolved matters discussed at such meetings. The initial draft
of the meeting minutes for a given meeting, reflecting key decisions, action
items and unresolved matter, among other details, shall be completed by the end
of such meeting and circulated to the other Party for subsequent review and
approval.

 

4.TECHNOLOGY TRANSFER

 

4.1      Process Specifications. From time to time, Iovance shall provide the
Process Specifications to Company and such Background Intellectual Property of
Iovance as may be reasonably required by Company to perform the Services
hereunder pursuant to a Statement of Work. For clarity, all right and title to
and in such Process Specifications and Iovance’s Background Intellectual
Property shall remain solely vested in Iovance.

 

4.2       Master Batch Record.

 

4.2.1       Company will prepare Master Batch Records as required to execute the
Process in accordance with the Process Specifications, this Agreement, any
applicable Statement of Work, all Laws, and the Quality Agreement. Iovance will
inform Company of any specific requirements Iovance may have relating to the
Master Batch Records, including any information or procedures, including testing
procedures, Iovance wishes to have incorporated therein and Company will reflect
any such instructions provided by Iovance in the Master Batch Record. If Company
intends to include in the Master Batch Record the use of any assay, medium, or
other technology that either is not commercially available or is subject to a
separate licensing or royalty payment, Company will inform Iovance of such
intention in advance and the Parties will meet to discuss and attempt to agree
in good faith on the terms of use of such non-commercially available materials
or technology in the Process. Company will not incorporate any of Company’s
Background Intellectual Property, or that of any Affiliate or Third Party, into
the Process or the Master Batch Records without the prior written consent of
Iovance.

 

4.2.2       Company will deliver iterative versions of the Master Batch Record
to Iovance on timing set forth in each Statement of Work that calls for the
preparation of a new Master Batch Record. Iovance will notify Company in writing
of any objections or comments it has to the draft Master Batch Record, and upon
such notification, representatives of Company and Iovance will meet promptly to
resolve such objections. The Master Batch Record will be final when approved by
Iovance and shall be deemed Iovance Confidential Information.

 

5.Iovance MATERIALS

 

5.1       Iovance Materials. Iovance will provide Company with the materials,
and rights with respect to associated intellectual property, set forth in
Appendix B or as expressly stated in a Statement of Work (“Iovance Materials”).
All Iovance Materials supplied to Company shall remain the exclusive property of
Iovance. Iovance Materials shall only be used as described in the applicable
Statement of Work, this Agreement, the Quality Agreement and in compliance with
all Laws. Under no circumstances shall Iovance Materials be used in humans
without the prior written consent of Iovance.

 

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5.2       Limitation on Liability. Company shall not be liable for (i) the
accuracy or inherent characteristic, or defect of Iovance Materials, Iovance
Confidential Information, Patient Materials, or other information or material
provided by Iovance as such are first provided or made available by or on behalf
of Iovance (collectively, “Materials”) or for any error or defect in the
Services to the extent directly arising out of or related to any such
inaccuracies, inherent characteristic or defect in such Materials at the time
first provided or made available nor for (ii) any consequences of such
inaccuracies, inherent characteristics or defects that could not reasonably be
avoided by Company, including any delay in Company’s performance of the Services
in accordance with any Statement of Work to the extent directly resulting from
such inaccuracies, inherent characteristic or defects in Materials at the time
first provided or made available.

 

5.3       Disclaimer. ANY MATERIALS PROVIDED BY Iovance HEREUNDER (INCLUDING
“MATERIALS”) ARE PROVIDED WITHOUT REPRESENTATION OR WARRANTY OF ANY SORT,
WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, INCLUDING ANY REPRESENTATION OR
WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, AND Iovance MAKES NO REPRESENTATION THAT THE USE OF SUCH MATERIALS WILL
NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT OF ANY THIRD PARTY.

 

5.4       Transfer, Records and Return. Company shall not transfer any portion
of the Iovance Materials to any Third Party or use the Iovance Materials for any
purpose other than the purposes of performing its obligations under, and in
accordance with, this Agreement, the Quality Agreement, the applicable Statement
of Work, and all Laws. Company shall hold, store and transport all supplies of
the Iovance Materials in compliance with all Laws, this Agreement, the Quality
Agreement, and the applicable Statement of Work. Company shall maintain complete
and accurate records relating to the disposition of all Iovance Materials.
Within thirty (30) days of the expiration or termination of any Statement of
Work or this Agreement, or Iovance’s request, Company shall return to Iovance,
or destroy, at Iovance’s option, all unused supplies of Iovance Materials.

 

6.PATIENT MATERIALS

 

6.1       Handling, Storage and Use of Patient Materials. As Patient Materials
will include biological materials received from individual patients, as well as
intermediates and Product manufactured from Patient Tumors, Company shall
handle, use and store Patient Materials strictly in accordance with this
Agreement, the applicable Statement of Work, the Quality Agreement, and all
Laws, and, unless otherwise requested by Iovance in writing, exclusively at the
Facility(ies). All Patient Materials shall remain the sole property of Iovance
and shall not be used for any other purpose other than for the performance of
obligations under the applicable Statement of Work.

 

6.2       Privacy and Data Protection. Throughout the Term, Company shall:

 

6.2.1       promptly inform Iovance of all subcontractors and other Third
Parties involved in and the geographic location of all Patient Material data and
any such data flows across country borders that are undertaken by or on behalf
of Company in performing the Services;

 

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6.2.2       use its material tracking system to ensure that Patient Materials
can be traced and identified through the production stream and ultimately
matched with the correct subject. Company shall work with Iovance to incorporate
Iovance’s existing clinical coding system into Company’s Patient Material
tracking system, the incorporation of which shall be subject to Iovance’s prior
written approval;

 

6.2.3       Use Patient Materials only in accordance with Iovance’s
instructions, this Agreement, the Quality Agreement, each Statement of Work, and
all Laws, and in good faith performance of its obligations on behalf of Iovance
under this Agreement. Where disclosure is required by Law, Company shall
immediately notify Iovance, work with Iovance to take actions Iovance deems
necessary with regard to the disclosure, use its best efforts to limit the
disclosure, cooperate with Iovance should Iovance wish to pursue an order
limiting the disclosure, and only disclose the minimum amount of Patient
Materials needed to comply with such Law. For the avoidance of doubt, Company
shall not Use any Patient Materials that it may access or otherwise receive
under this Agreement for its own marketing, analytics or other purposes, Company
shall not license, sell or otherwise provide Patient Materials to any Third
Party that has not been approved in writing by Iovance and that has not entered
into a written agreement obligating it to protect Patient Materials in
accordance with the standards set forth in this Article 6;

 

6.2.4       without limiting Section 6.1, Use all Personal Information and
Patient Materials only in accordance with

 

(a)all applicable privacy, security and data protection Laws (including the
United States Health Insurance Portability and Accountability Act of 1996, as
amended by the HITECH Act, including the Standards for Privacy of Individually
Identifiable Health Information, and the EU Data Protection Directive 95/46/EC
and the General Data Protection Regulation 2016 (when in force)), rules,
regulations, codes of conduct, certifications, bilateral and multilateral
privacy and data protection frameworks and enforceable forms of self-regulation,
including those restricting cross border transfer of data,

 

(b)all Laws governing biosamples and their use (such as EU Directive 2005/28/EC
of 8 April 2005 laying down principles and detailed guidelines for good clinical
practice as regards investigational medicinal products for human use, as well as
the requirements for authorization of the manufacturing or importation of such
products) and its various implementation laws in the EU Member States,

 

(c)all similar laws in Switzerland as are referenced in the foregoing
subsections (a) and (b), such as the Swiss Human Research Act (as amended in
2014) and the Swiss Federal Data Protection Act, and

 

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(d)all Laws governing outbound telephone calls, transmission of electronic mail,
transmission of facsimile messages and any other communications-related privacy
or data protection laws and regulations (including the EU ePrivacy Regulation
once it has entered into force);

 

6.2.5       maintain control over Patient Materials received by it hereunder and
not release Patient Materials, without Iovance’s written consent, to any person
or entity other than the Representatives of Company who (a) are under Company’s
direct supervision and control and (b) have a need to access Patient Materials
in connection with this Agreement. Any Representative of Company that is a Third
Party shall first be approved by Iovance prior to receipt of or access to
Patient Materials. Company shall further not allow anyone to take or send
Patient Materials to any location other than the Facility(ies), unless written
permission is obtained by Company from Iovance prior to such transfer.
Notwithstanding the foregoing, the restrictions in this Section 6.2.4 shall not
apply to the extent specifically requested by Iovance, in which case, Company
shall take all Iovance requested action;

 

6.2.6       implement reasonable physical, technical and administrative
safeguards, which shall be in accordance with all Laws, as appropriate for the
sensitivity of the information and Patient Materials, to protect Patient
Materials and Iovance Confidential Information received by Company pursuant to
this Agreement from loss, misuse, and unauthorized access, disclosure,
alteration or destruction, including implementation and enforcement of
administrative, technical and physical security policies and procedures, and
training of all staff responsible for handling Patient Materials in accordance
with the requirements set forth in this Article 6;

 

6.2.7       notify Iovance within a reasonable period, in no event to exceed
seventy-two (72) hours after discovery, or shorter if required by Law of any
unauthorized uses or disclosures of Patient Materials or any Security Incident
involving Patient Materials, including any incident that Company reasonably
believes to involve unauthorized access to or disclosure of Patient Materials,
of which it becomes aware; provided, further, that if Company (or any of its
Representatives, or their personnel) is responsible for the Security Incident,
Company shall promptly take all necessary and appropriate corrective action. All
corrective actions shall be subject to Iovance’s prior written approval. Company
shall reasonably cooperate with Iovance in its investigation of a Security
Incident, whether discovered by Company, Iovance or a Third Party, which shall
include providing Iovance a detailed description of the Security Incident, the
identity of the Patient Materials affected, and any other information Iovance
reasonably may request concerning such Security Incident, as soon as such
information can be collected or otherwise becomes available. Company shall pay
for or reimburse Iovance for all costs, losses and expenses relating to any
Security Incident arising from Company’s gross negligence or willful misconduct,
including costs of forensic assessments and breach notifications, as applicable,
and all other remedies required by Law. “Security Incident” shall mean any
actual or suspected event in which Patient Materials is or may have been lost,
stolen, improperly altered or destroyed, improperly accessed, or used for a
purpose not permitted under this Agreement;

 

6.2.8       cooperate with Iovance to respond to any inquiries regarding
practices related to the Use of Patient Materials in connection with this
Agreement; and

 

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6.2.9       obligate its Representatives, or any personnel thereof, to adhere to
the standards as described in this Article 6.

 

6.3       Personal Information. Iovance shall use commercially reasonable
efforts to not provide, and Company shall not receive, any patient identifying
information, including Personal Information. In the event that Company receives
any patient identifying information, including Personal Information, Company
shall (a) immediately notify Iovance, and (b) take tangible actions, including
implementing any necessary security and/or protection precautions, as may be
directed by Iovance.

 

6.4       Return or Destruction. Company shall return or destroy all unused or
leftover Patient Materials received from, or on behalf of, Iovance, or otherwise
received by Company on behalf of Iovance upon the earlier of (a) thirty (30)
days after completion or termination of the Services utilizing such Patient
Materials or (b) Iovance’s request, and in accordance with all Iovance written
instructions, including confirmation of destruction. Company shall not retain
such Patient Materials, except as set forth in the Quality Agreement.

 

6.5       Breach. Company shall be responsible for any and all breaches of this
Article 6 by its Representatives.

 

7.MANUFACTURE OF PRODUCT; ORDER PROCESS; DELIVERIES

 

7.1       Manufacture by Company. Iovance shall provide the requisite Iovance
Materials (including, to the extent applicable, Patient Materials), and
information related to such Iovance Materials, as is required for Processing by
Company into Product in accordance with the timing set forth in the applicable
Statement of Work. Company will perform such Services as set forth in this
Agreement, the Quality Agreement and the applicable Statement of Work. Company
shall handle and store all quantities of Product, Patient Materials and any
other materials used in the Services in accordance with the terms and conditions
of this Agreement (including the applicable Specifications), the Quality
Agreement, the applicable Statement of Work, and all Laws.

 

7.2       Quality Agreement. The Parties have entered into the Quality
Agreement, which sets forth the respective quality assurance and regulatory
responsibilities of the Parties.

 

7.3       Delivery. Product shall be delivered FCA (Incoterms 2010) Company
Facility. Transportation of Product or Materials, whether or not under any
arrangements made by Company, will be at the sole risk and expense of Iovance.
Product shall be made available for shipment in accordance with the Quality
Agreement.

 

7.4       Shipment. Company will package and label Product for shipment in
accordance with the Master Batch Record, Specifications, any written
instructions provided by Iovance, the applicable Statement of Work, this
Agreement, the Quality Agreement, and all Laws. Such packaging and labelling
shall further comply with Company’s SOPs to the extent they do not conflict with
the foregoing. At its sole discretion, Iovance will arrange or Iovance will
instruct Company to arrange the transportation of Product or Iovance Materials
from Company’s Facility to the destination indicated by Iovance in accordance
with the applicable Statement of Work and the Quality Agreement, and, if
applicable, Iovance’s written requests, instructions, and directions. All
reasonable, pre-approved costs and expenses incurred by Company in complying
with this Section 7.4 will be charged to Iovance in accordance with the
applicable Statement of Work.

 

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7.5       Inspection. Iovance shall arrange for the examination of the Product
or Iovance Materials by recipient as soon as practicable after receipt. Notice
of all claims arising out of: (1) visible damage to or total or partial loss of
Product in transit or (2) non-delivery shall be given in writing to Company and
the carrier as soon as possible by Iovance or Iovance’s designee.

 

7.6       Damaged Product or Iovance Materials. To the extent possible, Iovance
or Iovance’s designee shall make damaged Product or Iovance Materials and
associated packaging materials available for inspection and shall reasonably
comply with the requirements of any insurance policy covering the Product or
Iovance Materials. Company shall provide reasonable assistance to Iovance in
pursuing any claims arising out of the transportation of Product or Materials.

 

7.7       Low Yield. Company shall notify Iovance in writing as soon as Company
becomes aware of an anticipated low yield of Product (e.g., a Batch is not
expected to yield the number of cells anticipated for the particular Patient
Material type as set forth in the Statement of Work or Specifications or any
other circumstances that may lead to a low yield or inadequate Product volume)
and such notification shall include the relevant circumstances, including the
underlying reasons (if known at the time of notification) for such low yield
(e.g., available quantities of materials, equipment problem, manufacturing
capacity or other resources needed in the manufacture of Product), proposed
remedial measures, and the date such shortage is expected to end. To the extent
that a low yield of Product meets the definition of a deviation under the
Quality Agreement, the low yield shall further be subject to the deviation
procedures in the Quality Agreement.

 

7.8       Storage, Waste. Company shall, in accordance with all Laws, this
Agreement (including the Specifications), the applicable Statement of Work, and
Quality Agreement, maintain adequate storage accommodations for all of the
materials, Patient Materials and Product. In connection with the Services,
Company shall be solely responsible for maintaining safety procedures in
connection with the production and manufacture of Product and for the
generation, treatment, storage, transportation and/or disposal of waste relating
thereto, all of which shall comply with all Laws, including all applicable
environmental and occupational safety and health requirements in the
jurisdiction of the applicable Facility, this Agreement, the applicable
Statement of Work, and the Quality Agreement. Company shall supply certificates
of destruction to Iovance upon Iovance’s request therefor.

 

7.9       Changes and Change of Control. Company shall not make any amendments,
changes or supplements to the Product Specifications without Iovance’s prior
written consent. Company shall further not make any amendments, changes or
supplements to the Products or Services, including to the raw materials used in
the Process (including the specifications therefor or the source thereof),
equipment and machinery, the test methods used in connection with the Services
and/or Products, the Process and/or Process Specifications, approved, qualified,
validated, and/or verified methods (including the method of qualification,
validation and/or verification), or the cleaning process or procedures, to the
extent that any amendment, change or supplement could reasonably have a direct
impact on the quality, safety, purity, potency, or performance of Product or
require submissions to or approvals from any regulatory authority or other
review authority, such as Institutional Review Boards, without Iovance’s prior
written approval. All other changes, amendments, and supplements shall be
provided to Iovance in the Product Documentation, as defined in the Quality
Agreement. All permitted amendments, changes, or supplements shall, in each
instance, comply with all Laws and shall be made in accordance with this
Agreement, each Statement of Work, and the Quality Agreement. In the event that
any amendment, change or supplement is required in order to comply with Law or
is required by a regulatory authority or other review authority, including
Institutional Review Boards, Company shall immediately notify Iovance in
writing. All such amendments, changes, and supplements required in order to
comply with Law or that are required by a regulatory or other review authority
shall be subject to Iovance’s written approval and notification requirements of
this Section. Notwithstanding the foregoing, if any amendment, change or
supplement requires submissions to or approvals from any regulatory authority or
other review authority, including Institutional Review Boards, Company shall not
implement such amendment, change or supplement until such submission to or
approval has been made and/or obtained by Iovance. All such submissions and
approvals shall be subject to Section 10.2. The process for Company and Iovance
requested amendments, changes and supplements, as well as implementation of all
such amendments, changes and supplements shall be further specified in the
Quality Agreement.

 

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8.RECORDS; REPORTS

 

8.1       Records.

 

8.1.1       Company will maintain accurate and complete records of documents,
accounts, invoices, records and/or other information relating to the Services,
including as required by this Agreement, the applicable Statement of Work, the
Quality Agreement, all Laws and generally accepted industry practices and
standards, and all procedures, records, reports and findings in connection with
Company’s (or its subcontractor’s, as applicable) audit of the suppliers of
materials. Company will retain possession of all Batch Records (which Batch
Records shall be made accessible through a secured electronic portal) and
Company Operating Documents, and will make such records and documents available
for review and, solely with respect to Batch Records, copy by Iovance at the
Facility upon Iovance’s request. Without limitation, Iovance may inspect data
and records related to Services, including deviations, discrepancies,
out-of-Specifications, failures, investigations, and Batch-specific
environmental monitoring data, water and testing data, and Process data as
reasonably requested by Iovance. Company Operating Documents will remain Company
Confidential Information. Notwithstanding the foregoing, Iovance will have the
right to use and reference through a Drug Master File, or other such means as
agreed to by the Parties, those portions of Company Operating Documents if
required by Law for Iovance to fulfill its responsibilities under such Law, or
as required for any filings, submissions, interactions, or communications with
any applicable regulatory authority, review authority, including Institutional
Review Boards, or clinical trial investigators, sites, and/or subjects. Company
shall maintain all records in connection with this Agreement for the longer of
(a) ten (10) years after the completion of the Services giving rise to such
records; or (b) the period that Company is required by Laws to retain such
records for recordkeeping, testing and regulatory purposes. Company shall not
dispose of or otherwise destroy any such records without notifying Iovance,
obtaining Iovance’s written approval for such disposal or destruction, and
allowing Iovance to take control of such records (excluding Company Operating
Documents) at Iovance’s reasonable cost and expense. All such records shall be
protected from alteration, destruction, and Security Breaches.

 

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8.1.2       Without limiting the foregoing Section 8.1.1, each Party shall
maintain, in accordance with and for the period required under this Agreement,
the Quality Agreement, each Statement of Work, and all Laws, complete and
adequate records pertaining to the Services, including validation data,
stability testing data, as applicable, Batch Records, and the methods and
Facilities used for the Services.

 

8.2       Iovance Regulatory Requirements. Company shall provide Iovance with
all requested records, Reports, and documentation related to the Services as
required under Law or for any filings, submissions, interactions, or
communications with any applicable regulatory authority review authority,
including Institutional Review Boards, or clinical trial investigators, sites,
and/or subjects; provided, that, to the extent the requested documentation is a
Company Operating Document, Company shall provide such documentation to Iovance
or, subject to Iovance’s prior review, directly to the applicable regulatory
authority. The Company will also promptly cooperate with Iovance and respond to
all inquiries, audits or information requests etc. from data protection agencies
or data subjects, at the Company’s own expense, that Iovance or the Company may
receive and that pertain to Personal Information or to any Laws mentioned under
Section 6.2.4.

 

8.3       Language. All records and Reports shall be written in or translated
into English and in the form as required under the applicable Statement of Work.

 

8.4       Ownership. Except to the extent required by Law, Iovance shall be the
sole owner of the records generated through or in connection with the
performance of the Services (excluding Company Operating Documents) and Reports
and all rights, title and interest in and to such records and Reports shall vest
solely with Iovance. Such records and Reports shall constitute Iovance
Confidential Information and are subject to the provisions of Article 12 hereof.
Company further agrees to execute any documents or undertake any further actions
if requested by Iovance to evidence transfer of title to such records and
Reports. Company shall not use such records or Reports for any use, commercial
or noncommercial, other than for performing its obligations hereunder, without
Iovance’s prior written consent. Notwithstanding anything to the contrary in
this Agreement, all such records and Reports and the possession/retention
thereof will be subject to the terms of this Section 8.

 

9.PRODUCT WARRANTIES; INSPECTION AND RELEASE

 

9.1       Product Warranties. Unless otherwise requested by Iovance in writing,
as further specified in Section 12 and 13 of the Quality Agreement, Company
represents, warrants and guarantees that any Product at the time of delivery
pursuant to Section 7.3:

 

9.1.1       conforms to the Specifications;

 

9.1.2       was subject to Services performed in accordance with the Master
Batch Record and Process Specifications;

 

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9.1.3       was subject to Services performed in accordance with this Agreement,
the applicable Statement of Work, the Quality Agreement, and all Laws;

 

9.1.4       was manufactured in Facilities that are in compliance with all Laws
at the time of such manufacture;

 

9.1.5       unless otherwise requested by Iovance in writing, as further
specified in Section 12 and 13 of the Quality Agreement, the article comprising
each shipment or other delivery hereafter made by Company to, or on the order of
Iovance is hereby guaranteed as of the date of such shipment or delivery, to be,
on such date, not adulterated by Company within the meaning of the Federal Food,
Drug and Cosmetic Act, or similarly designated under other Laws of equivalent
intent or effect, and not an article which may not, under the provisions of
section 404, 505, or 512 of the Federal Food, Drug, and Cosmetic Act, be
introduced into interstate commerce, or similarly designated under other Laws of
equivalent intent or effect; and

 

9.1.6       is being transferred to Iovance free and clear of any pledge, lien,
restriction, claim, charge, security interest and/or other encumbrance, except
as such existed prior to transfer to Company hereunder.

 

The foregoing representations and warranties set forth in Sections 9.1.1 through
9.1.6, inclusive, shall be deemed the “Product Warranties”.

 

9.2       Product Inspection, Shipment and Release.

 

9.2.1        When the Product ordered by Iovance is ready for shipment, Company
will immediately notify Iovance. Product shipment and release procedures,
including terms regarding Iovance requests for shipment, shall be specified in
the Quality Agreement.

 

9.2.2       In the event that Product does not meet the Product Warranties,
then, at Iovance’s option, which such option shall be articulated in writing,
Company shall: (i) destroy such Product, in compliance with Law and all written
instructions provided by Iovance, and if such Product’s non-conformance is due
to Company’s negligence or willful misconduct, then Company shall produce for
Iovance another Batch of Product to replace the non-conforming Product at no
additional cost to Iovance, or (ii) re-process such Product in accordance with
written instructions provided by Iovance to produce for Iovance another Batch of
Product to replace the non-conforming Product at no additional cost to Iovance;
provided, that, if Company is unable to replace or re-process Product, as
applicable, Company shall refund to Iovance the price of the manufacturing run,
raw materials (excluding Patient Materials) and associated testing for that
non-conforming Product. Company shall adhere to any instructions provided by
Iovance with respect to the disposition of any such non-conforming Product,
including delivering such Product to Iovance for further testing. The Parties
shall reasonably cooperate to investigate the cause of any such non-conformance.
The rights and remedies set forth in this Section 9.2.2 constitute the exclusive
rights and remedies of Iovance in respect of the matters identified under this
Section 9.2.2 and 9.2.3.

 

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9.2.3       Should either Party discover any Product non-conformance,
deficiency, or deviation following the release, issuance of a COA by Company or
Iovance, shipment, administration, and/or infusion of Product, immediate notice
shall be provided to the other Party. In such circumstances, the Parties shall
follow the applicable procedures specified in the Quality Agreement. In the
event that an investigation concludes that such Product non-conformance,
deficiency, or deviation had an adverse impact on Product quality so as to
render the Product to be unusable and such non-conformance, deficiency, or
deviation is due to Company’s negligence or willful misconduct, then at
Iovance’s discretion, such non-conforming Product may be treated in accordance
with Section 9.2.2. Further terms regarding Product non-conformance and
deviations shall be specified in the Quality Agreement. The rights and remedies
set forth in this Section 9.2.3 constitute the exclusive rights and remedies of
Iovance in respect of the matters identified under this Section 9.2.3, except
that where such unusable Product led to a clinical adverse event that gave rise
to an indemnifiable Loss, then the rights and remedies under Section 17 also
apply.

 

10.REGULATORY MATTERS; INSPECTIONS; Iovance ACCESS

 

10.1     Permits and Approvals. During the Term, Company will maintain all
licenses, permits, registrations, identifications and approvals necessary for
the performance of the Services in the Facility(ies). Company will promptly
notify Iovance if Company receives notice that any such license, permit, or
approval is or may be revoked or suspended, or otherwise limited, or should
Company receive notification of any investigation, threat, pending, current, or
future proceeding, or notice of the foregoing.

 

10.2     Inspections by and Interactions with Regulatory Agencies.

 

10.2.1       Inspections and Regulatory Authority Interactions. Company will
allow representatives of any regulatory agency to inspect the relevant parts of
the Facility(ies) where the Services are carried out and to inspect any relevant
documentation and records, including the Master Batch Record and Batch Records,
as such regulatory agency is authorized to inspect by Law, to verify compliance
with all Laws and other practices or regulations. Company will immediately
notify Iovance of the scheduling of, or without scheduling when a regulatory
inspection begins, any such inspection and, if possible, will permit Iovance’s
attendance at and participation in any such inspection to the extent such
inspection is related to the Products and/or Services or would reasonably be
expected to affect Company’s ability to perform its obligations under this
Agreement. Company will promptly send to Iovance a copy of (or in the case of
oral interactions, summaries or minutes of) any communications, reports,
citations, inspectional findings, establishment inspection reports, FDA Form
483s, warning letters, untitled letters, or other assertions of noncompliance
received by Company from a regulatory authority that is related to or would
reasonably be expected to otherwise impact the Products and/or Services.

 

10.2.2       Interactions.

 

(a)To the extent permitted by the relevant regulatory authority and by Law,
Iovance shall be solely and exclusively responsible for all interactions and
communications with and reports to the applicable regulatory authorities related
to the Products and/or Services.

 

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(b)To the extent that the relevant regulatory authority will not or is not
permitted by Law to directly interact with Iovance, copies of (or summaries in
the case of oral communications, interactions, and reports) all interactions and
communications with, and reports to, the applicable regulatory authority related
to the Products and/or Services (whether written or oral) shall be submitted to
Iovance by Company, in reasonable and sufficient time prior to submission to the
applicable regulatory authority, for Iovance’s prior review and approval. For
clarity, this may include Iovance providing on-site, but indirect, assistance to
Company in connection with a regulatory interaction. Company will incorporate
all of Iovance’s comments in good faith that are factually accurate and not
contrary to Company’s responsibility under Law.

 

(c)Company shall be responsible for all interactions and communications with and
reports to the applicable regulatory authorities that are not related to the
Products and/or Services, but that could reasonably be expected to impact the
Products and/or Services. Company, however, shall provide copies of all
communications, interactions, and reports proposed for submission (or summaries
in the case of oral communications, interactions, and reports) that could
reasonably be expected to impact the Product and/or Services, to Iovance, in
reasonable and sufficient time prior to submission to the applicable regulatory
authority, for Iovance’s prior comment. Company will consider all of Iovance’s
comments in good faith.

 

(d)In addition to the requirements of the foregoing subsections (b) and (c),
Company shall furnish Iovance with final copies (or summaries or minutes in the
case of oral communications, interactions, and reports) of all communications
and interactions with, and reports to any applicable regulatory authority that
relate to or could reasonably be expected to otherwise impact the Products
and/or Services.

 

(e)After any of the foregoing interactions, communications, or reports, Company
shall notify Iovance and provide Iovance with copies (or summaries or minutes in
the case of oral communications, reports, and interactions) of any further
communications with or received from, or reports to such regulatory agency
relating to the subject matter of the response to the extent such response
relates to the Products and/or Services or could reasonably be expected to
impact the Products and/or Services. Any further interactions and communications
with, or reports to the applicable regulatory authority to the extent related to
the Products and/or Services or could reasonably be expected to impact the
Products and/or Services shall be governed by the terms of this Section 10.2.2
(including with respect to Iovance’s right to comment on and/or approve the
interaction, communication, or report prior to any submission to a regulatory
authority), applied mutatis mutandis. Company shall further keep Iovance
promptly and fully informed of the steps taken by Company to resolve any
outstanding issues with such regulatory agency and the anticipated timetable of
resolution of such issues to the extent that they do not involve interactions
and communications with, or reports to an applicable regulatory authority, which
shall be subject to Iovance’s prior written approval to the extent such steps
relate to the Products and/or Services, or which shall be subject to Iovance’s
comment prior to implementation to the extent such steps could reasonably be
expected to impact the Products and/or Services. In the former case, Company
shall incorporate all of Iovance’s comments in good faith. In the latter case,
Company will consider all of Iovance’s comments in good faith.

 

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10.2.3       All documentation, summaries, minutes and information provided to
Iovance by Company under this Section may be redacted for any Third Party
confidential or proprietary information.

 

10.2.4       Company shall take all necessary, requested, or required corrective
actions as a result of any communications, reports, citations, inspectional
findings, establishment inspection reports, FDA Form 483s, warning letters,
untitled letters, or other assertions of noncompliance received by Company from
a regulatory authority that are related to or may otherwise impact the Products
and/or Services and shall, as agreed to by the Parties, update Iovance on the
implementation of such corrective actions. As requested by Iovance, Company
shall confer with Iovance on, and seek Iovance’s prior written consent before
implementing, such corrective actions to the extent they impact the Products
and/or Services or affect Company’s ability to perform its obligations under
this Agreement.

 

10.2.5       Company shall provide Iovance with all information, records,
documentation, and assistance that Iovance may request and that is reasonably
necessary or useful for Iovance to address any interaction or communication
with, or report to a regulatory authority; provided, that, to the extent the
requested documentation is a Company Operating Document, Company shall provide
such documentation to Iovance or, subject to Iovance’s prior review, directly to
the applicable regulatory authority.

 

10.3     Other Interactions. Interactions and communications with any clinical
trial site, investigator, subject, and/or Institutional Review Boards, as well
as with any other manufacturing establishments and/or consignees pursuant to 21
C.F.R. § 1271.160 shall be governed by the Quality Agreement.

 

10.4     Inspections by Iovance.

 

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10.4.1       At agreed-upon dates and times, which agreement Company shall not
unreasonably withhold, condition or delay, Iovance and/or its Representatives
may visit, inspect, or audit any Facility and/or Services, be present in any
Facility during the performance of the Services, and review documents,
operations, procedures, and records as they pertain to the performance of the
Services, including to: (a) determine Company’s compliance with, to the extent
applicable, the requirements of this Agreement and the Quality Agreement; (b)
inspect for compliance with Law (including, to the extent applicable, cGMPs, and
environmental, health and safety Laws); (c) perform risk and loss control
assessments to support Iovance’s insurance and self-insurance programs; (d)
inspect storage facilities and quality systems for Product; (e) review Company’s
practices, controls, technologies, and procedures with regard to the electronic
storage, access, and transmission of records, reports, data, and information
relating to the Services to conduct and (f) review, copy (excluding Company
Operating Documents), and audit records of Company with respect Company’s
performance of its obligations with respect to the Services or Products. As part
of Iovance’s audit or inspection of a Facility, Iovance’s audit or inspection
may include the auditing or inspection of any documentation of Company’s
suppliers (including suppliers of materials) and Third Party service providers
who perform Services, to the extent it relates to the Products and Services,
including documentation relating to the Company’s Third Party service providers
who perform Services and/or supplier qualification procedures; the initial and
ongoing qualification (including any appropriate validation or verification of
Services, including, to the extent applicable, equipment to be used by any such
Third Party) of any Third Party service provider who performs Services,
including risk assessments, audit reports or questionnaires, and associated
corrective actions. Should, in Iovance’s reasonable judgment, Iovance need to
conduct a for-cause audit, Iovance shall provide Company with two (2) days’
prior written notice where practicable and where such notice would not frustrate
the purpose of the audit in Iovance’s reasonable determination.

 

10.4.2       In accordance with the terms of the applicable agreement with
Company and Third Party manufacturers, suppliers, or other persons or entities
providing Services, Iovance may participate in or independently conduct, itself
or through a Representative, an audit or inspection of Company’s Third Party
manufacturers, suppliers, or other persons or entities providing Services in
furtherance of this Agreement. Company’s quality assurance department shall
cooperate with Iovance, as necessary or useful, in any such inspection or audit.

 

10.4.3       In the event Iovance identifies any deficiency with respect to the
performance of the Services or compliance with this Agreement, the Quality
Agreement or any applicable Statement of Work during any inspection, audit, or
review pursuant to Section 10.4.1 or 10.4.2, or otherwise, Iovance shall notify
Company of such deficiency. Company shall investigate and respond to any such
deficiency, including the timely implementation of a corrective action plan (if,
and as applicable), the process for which shall be further set forth in the
Quality Agreement. Company shall fully implement any such corrective action plan
prior to producing any further Product; provided, however, that Iovance may (but
shall not be obligated to), in its sole discretion, accept Product and/or
request the production of Product from Company prior to completion of the
corrective action. During the pendency of such deviation(s) and/or corrective
action(s), Company shall comply with Iovance’s instructions concerning the
shipment of Product and/or the continued provision of Services. Iovance shall
have the right to review all relevant documentation in connection with such
deficiency and corrective action. If the corrective actions taken do not
reasonably address a deficiency that would reasonably impact Product quality,
then Iovance shall have the right to terminate this Agreement effective
immediately pursuant to Section 16.2 and without any further cure period under
Section 16.2. The rights and remedies set forth in this Section 10.4.3
constitute the exclusive rights and remedies of Iovance with respect to the
subject matter herein, except that where such deficiency causes Iovance to
experience a related cost, loss or expense, then the foregoing limitation does
not constitute a waiver of any right otherwise available to Iovance under this
Agreement or at law.

 

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10.4.4       In the event an audit or inspection of a Third Party service
provider who performs Services or raw material supplier reveals a material
quality compliance issue related to the Services, Iovance shall have the right
to direct Company promptly identify and qualify a new Third Party, or raw
material supplier, as applicable, acceptable to and approved by Iovance in
writing and to provide the Services or raw materials impacted by such material
quality compliance issue, as applicable. Notwithstanding the foregoing, Company
shall be fully responsible for sourcing and testing of materials (other than
Iovance Materials), and qualification and management of its subcontractors,
supplier(s) of materials (other than Iovance Materials), and Third Parties
providing Services under an applicable Statement of Work.

 

10.4.5       Company shall ensure that Third Parties involved in the performance
of the Services (or any component thereof including materials suppliers) permit
and afford Iovance the same rights as set forth in Section 10.4.1; provided that
if Company expects that it will not be able to include all such terms and
conditions in its agreement with a particular Third Party or supplier, Company
shall notify Iovance of same and the Parties will discuss and mutually agree
upon an appropriate course of action; provided further that if the Parties do
not agree on an appropriate course of action and any such Third Party or
supplier does not afford Iovance such rights, then Iovance shall have the right
to terminate this Agreement effective immediately.

 

10.4.6       For clarity, any such inspection or audit (or failure to inspect or
audit) shall not relieve Company of its obligation to comply with all Laws, each
Statement of Work, this Agreement and the Quality Agreement and does not
constitute a waiver of any right otherwise available to Iovance. In addition,
for critical raw material suppliers as well as for Third Party manufacturers of
Product, Company shall be required to audit each and Iovance shall have the
right to review the audit reports and findings and Company’s procedures for
auditing such suppliers.

 

10.4.7       While on-site at a Facility, Iovance will abide by standard
policies, operating procedures and the security procedures established by such
Facility with respect to conduct at such Facility provided to Iovance in advance
in writing and with any reasonable instructions or requests by Company while at
such Facility, which could not reasonably be provided to Iovance in advance.
During any such on-site visit of the Facility, Iovance will cooperate with
Company in taking reasonable precautions to avoid exposure of its
Representatives to information regarding activities unrelated to Product
manufactured for Iovance. Notwithstanding the above, Company shall not impose
any restrictions or other procedures that would impede Iovance’s ability to
conduct a reasonable and comprehensive audit.

 

10.5     Iovance Access. Without limiting Iovance’s obligations under Section
10.4.7, Representatives of Iovance may act as a person-in-plant and observe the
Services. For the avoidance of doubt, Iovance Personnel may not physically
participate in the production or manufacture of any Product that may be used in
or on humans.

 

 27 

 

 

10.6     Procedures. Representatives of Iovance working at, visiting, or
otherwise having access to a Facility will abide by applicable Company Operating
Documents, standard policies and security procedures with respect to conduct at
such Facility provided to Iovance in advance in writing and with any reasonable
instructions or requests by Company while at such Facility, which could not
reasonably be provided to Iovance in advance. During any such on-site work,
visit, or access to a Facility, Iovance will cooperate with Company in taking
reasonable precautions to avoid exposure of its Representatives to information
regarding activities unrelated to Product or the Services. Representatives of
Iovance working at the Facility will be and remain employees of Iovance, and
Iovance will be solely responsible for the payment of compensation for such
Representatives of Iovance (including applicable federal, state and local
withholding, FICA and other payroll taxes, workers’ compensation insurance,
health insurance, and other similar statutory and fringe benefits).

 

11.FINANCIAL TERMS

 

11.1     Payments. Iovance will make payments to Company in the amounts and as
set forth in the applicable Statement of Work.

 

11.2     Invoices. In accordance with payment schedule set forth in the
applicable Statement of Work, Company will provide Iovance with invoices each
setting forth a detailed account of amounts payable by Iovance. The undisputed
amounts set forth in each such invoice will be due and payable within sixty (60)
days of receipt of such invoice by Iovance. Iovance will have the right to audit
any necessary documents associated with such invoices either by itself or by a
certified public accountant (“CPA”) reasonably acceptable to Company. In case
the audit of the CPA reveals a discrepancy that resulted in (a) an overpayment
by Iovance to Company, then Company shall credit the deviated amount with the
next invoice to Iovance (or if no more invoices are required Company shall
promptly pay such amount to Iovance), or (b) an underpayment by Iovance to
Company, then Iovance shall promptly pay such amount to Company. In the event an
invoice is disputed, the Parties shall work together in good faith to resolve
such dispute as expeditiously as possible and payment on any such disputed
amount shall be due thirty (30) days after the dispute is resolved.

 

11.3     Taxes. Iovance agrees that it is responsible for and will pay any
sales, use or other taxes (the “Taxes”) resulting from Company’s production of
Product under this Agreement (except for income or personal property taxes
payable by Company). Company will list the Taxes as separate line item(s) in the
applicable invoices. Company will not collect any sales and use taxes from
Iovance in connection with the production of any Product hereunder if Iovance
provides to Company the appropriate valid exemption certificates.

 

11.4     Method of Payment. All payments to Company hereunder by Iovance will be
in United States currency and will be by check, wire transfer, money order, or
other method of payment approved by the Parties.

 

11.5     Iovance shall not have the right to set off any of its payment
obligations owed to Company against any damages, credits, claims or charges
assessed by Iovance against Company.

 

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11.6     Late Payment. In the event of a default of payment of any amounts by
Iovance on the due date, then (a) interest shall accrue on any amount overdue at
the annual rate of one per cent (1%) above the prime rate of interest published
from time to time in the Wall Street Journal (or similar successor rate),
interest to accrue on a day to day basis both before and after judgment; and (b)
Company shall, without prejudice to any other of its accrued rights, be entitled
to suspend or immediately terminate those Services and/or Statement(s) of Work
to which such late payment relates.

 

12.CONFIDENTIAL INFORMATION

 

12.1     Definition. “Confidential Information” means all confidential,
proprietary and/or trade secret information or materials owned or controlled by
a Party, including technical, scientific and other know-how and information,
trade secrets, knowledge, technology, means, methods, processes, practices,
formulas, instructions, skills, techniques, procedures, controls,
specifications, data, results and other material, pre-clinical and clinical
trial results, manufacturing procedures, test procedures and purification and
isolation techniques, other procedures related to the Services, and any tangible
embodiments of any of the foregoing, and any scientific, manufacturing,
marketing and business plans, any financial and personnel matters relating to a
Party or its present or future products, sales, suppliers, customers, employees,
investors or business, that has been disclosed by or on behalf of such Party to
the other Party either in connection with the discussions and negotiations
pertaining to this Agreement or in the course of performing this Agreement, or
that has been developed under this Agreement. Without limiting the foregoing,
(a) the terms of this Agreement are deemed the “Confidential Information” of
both Parties and will be subject to the terms and conditions set forth in this
Article 12, and (b) the Product, the Process, the Master Batch Record,
Specifications, and all other Intellectual Property of Iovance and/or its
Affiliates (including New Iovance Intellectual Property) are deemed Iovance
Confidential Information, as to which Iovance will be deemed the disclosing
Party and Company will be deemed the receiving Party in all circumstances, and
are subject to the terms and conditions of this Article 12.

 

12.2     Exclusions. Notwithstanding the foregoing Section 12.1, any information
disclosed by a Party to the other Party will not be deemed “Confidential
Information” to the extent that such information:

 

12.2.1       At the time of disclosure is in the public domain, other than as a
result of a breach of an obligation of confidentiality or non-use or other
misappropriation;

 

12.2.2       Becomes part of the public domain, by publication or otherwise,
other than as a result of a breach of an obligation of confidentiality or
non-use or other misappropriation;

 

12.2.3       At the time of disclosure is already in possession of the Party who
received such information, without restriction as to confidentiality or use, as
established by contemporaneous written records;

 

12.2.4       Is lawfully provided to a Party, without restriction as to
confidentiality or use, by a Third Party lawfully entitled to possess and make
unrestricted disclosures of such information; or

 

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12.2.5       Is independently developed by a Party without use of or reference
to the other Party’s Confidential Information, as established by contemporaneous
written records.

 

12.3     Disclosure and Use Restriction. Each receiving Party agrees to keep
confidential all Confidential Information it receives and not to disclose,
transfer or use it for any purpose other than as expressly permitted under this
Agreement. The receiving Party will not use the Confidential Information of the
other Party for any purpose other than the performance of its obligations and
exercise of its rights under this Agreement. Subject to the terms of Article 8,
the receiving Party (a) agrees to return or destroy promptly (and certify such
destruction) at the owning Party’s request all Confidential Information of the
owning Party, and (b) if not earlier requested, upon termination of this
Agreement, shall promptly return to the disclosing Party such Confidential
Information, and shall destroy all copies thereof, together with all notes,
drawings, abstracts and other information relating to the disclosing Party’s
Confidential Information prepared by the receiving Party or any of its
representatives, regardless of the medium in which such information is stored;
provided, however, that the receiving Party may maintain one (1) archival copy
of the disclosing Party’s Confidential Information, which such archival copy
shall remain subject to the obligations of confidentiality and non-use set forth
herein. The return or destruction of the Confidential Information as provided
above shall not relieve the receiving Party of its other obligations under this
Article 12.

 

12.4     Security and Use. Each receiving Party agrees to (i) institute and
maintain reasonable and customary security procedures to identify, protect and
account for all copies of Confidential Information of the disclosing Party, and
(ii) limit disclosure of the disclosing Party’s Confidential Information to its
Representatives having a need to know such Confidential Information for purposes
of the receiving Party exercising its rights and performing its obligations
under this Agreement; provided that such Representatives are informed of the
confidential nature of the information, and are subject to obligations of
confidentiality, non-disclosure, non-use and inventions similar to and at least
as restrictive as those set forth in this Agreement. The receiving Party shall
notify the owning Party as promptly as practicable of any unauthorized use or
disclosure of the Confidential Information, but in any event no later than
seventy-two (72) hours thereafter; provided, that, for clarity, such
notification shall not excuse the receiving Party from any liability in
connection with such unauthorized use or disclosure.

 

12.5     Government-Required Disclosure. If a duly constituted government
authority, court or regulatory agency orders that a Party hereto disclose
information with respect to which it is subject to an obligation of
confidentiality under this Agreement, such Party shall comply with the order,
but shall (a) give prompt written notice to the disclosing Party of the proposed
disclosure, and allow the disclosing Party at least thirty (30) days to object
to all or any portion of the disclosure before it is disclosed; (b) if advance
notice is not possible, provide written notice of disclosure immediately
thereafter; (c) to the extent possible, minimize the extent of such disclosure;
and (d) use reasonable efforts to secure confidential treatment of such
information prior to its disclosure (whether through protective orders or
otherwise), it being understood that any information so disclosed shall
otherwise remain subject to the limitations on use and disclosure hereunder. The
Party permitted to disclose any Confidential Information under this Section
shall take into consideration all comments and objections raised by the other
Party. The Party permitted to disclose any Confidential Information under this
Section shall further cooperate with and provide the other Party with the
opportunity to seek any protective order reasonably deemed necessary by such
Party.

 

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12.6     Permitted Iovance Disclosure. Notwithstanding anything else in this
Agreement, Iovance shall further be permitted to disclose information subject to
an obligation of confidentiality under this Agreement to the extent reasonably
necessary for Iovance to comply with any Laws, make any filings, submissions or
reports to an applicable regulatory authority, and to preserve the safety of any
subjects in a Iovance clinical trial.

 

12.7     Publicity. Neither Party will refer to, display or use the other’s
name, trademarks or trade names confusingly similar thereto, alone or in
conjunction with any other words or names, in any manner or connection
whatsoever, including any publication, article, or any form of advertising or
publicity, except with the prior written consent of the other Party. Neither
Party shall disclose to any Third Party nor to the public generally (a) the
terms of this Agreement, or (b) the specific relationship between the Parties
established hereunder, except where such disclosure is necessary for Regulatory
Approval of Product. Notwithstanding the foregoing, the Parties shall have the
right to disclose the material commercial terms of this Agreement to any
potential acquirer, merger or commercial partner or significant investor;
provided, however, that prior to any such disclosure, such Party (1) shall
require the intended recipient to sign an undertaking agreeing to accord
confidential treatment to such information at least as restrictive as the terms
set forth herein and not use such information except to evaluate the proposed
acquisition, merger, commercial arrangement or investment, and (2) shall take
such other steps reasonably necessary to secure confidential treatment of such
information.

 

13.INTELLECTUAL PROPERTY

 

13.1     Generally. For purposes of this Agreement, “Intellectual Property”
means collectively all legal rights in works or ideas, including any patents,
copyrights, trade secrets, know-how, inventions (whether or not patentable),
discoveries, improvements, and all other intellectual property rights, including
all applications and registrations with respect thereto, and all data,
information (including Confidential Information), reports and any and all
related documentation. Neither Party will, as a result of this Agreement,
acquire any right, title or interest in to any Intellectual Property owned or
controlled by the other Party or the other Party’s Affiliates prior to the
Effective Date (including Intellectual Property owned or controlled by the other
Party or the other Party’s Affiliates prior to the Original Effective Date) or
developed independently of this Agreement and the Original Agreement
(“Background Intellectual Property”), or, except for the limited licenses
expressly granted under this Agreement, any license or right to use any
Intellectual Property owned or controlled by the other Party or the other
Party’s Affiliates. For the avoidance of doubt, Iovance is not granted any
rights, licenses, or sublicenses to any cell lines, plasmids, or other products
or processes that are licensed by Company that may be used in Services;
provided, that, Company shall not use any such cell lines, plasmids, or other
products or processes that are licensed by Company in the performance of the
Services without first obtaining the prior written consent of Iovance. As
between the Parties, Iovance shall own all Iovance Confidential Information and
Company shall own all Company Confidential Information.

 

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13.2     New Iovance Intellectual Property and Assignment.

 

13.2.1       Iovance shall own all right, title, and interest in and to any and
all Intellectual Property that Company or its Representatives develops,
conceives, invents, first reduces to practice or makes, solely or jointly with
Iovance or others, that is a development, improvement, modification, addition,
adaptation, enhancement, derivative, variant or progeny resulting from the use
of or access to Product, Process, Iovance Materials, Iovance Confidential
Information or Background Intellectual Property of Iovance (collectively, “New
Iovance Intellectual Property”), including any and all moral rights and
Intellectual Property rights inherent therein and appurtenant thereto, including
all patent rights, copyrights, trademarks, know-how and trade secrets and the
rights to apply for the same. Company further acknowledges and agrees that all
original works of authorship that are made by Company (solely or jointly with
others) in the performance of a Statement of Work (a “Work”) and that are
protectable by copyright are “works made for hire,” as that term is defined in
the United States Copyright Act. However, to the extent that any Work may not,
by operation of any Laws, be a work made for hire, Company hereby assigns,
transfers and conveys to Iovance all of Company’s worldwide right, title and
interest in and to such Work, including all Intellectual Property rights
relating thereto. For avoidance of doubt, “New Iovance Intellectual Property”
shall include any material (including biological material), processes or other
items that embody, or that are claimed or covered by, any of the foregoing
Intellectual Property. Notwithstanding the foregoing, Iovance agrees that New
Iovance Intellectual Property does not include Company Background Intellectual
Property or improvements thereto that are developed by Company through the
performance of the Services, provided, that such improvements (i) are made
without the benefit of Iovance Intellectual Property, Iovance Materials and/or
Iovance Confidential Information, and (ii) could have been developed without
performance of the Services (i.e., in the event that unique aspects of the
Services and/or Iovance Intellectual Property, Iovance Materials or Iovance
Confidential Information were not a “but for” cause of such improvement)
(“Improvements”).

 

13.2.2       Company hereby assigns and shall assign to Iovance all of its
right, title and interest in and to any New Iovance Intellectual Property.
Company shall promptly disclose to Iovance in writing all New Iovance
Intellectual Property. Company shall execute, and shall require its
Representatives, to execute, any documents reasonably required to confirm
Iovance’s ownership of the New Iovance Intellectual Property, and any documents
required to apply for, maintain and enforce any patent or other right in the New
Iovance Intellectual Property. In the event that Iovance requires an appointment
as an agent or attorney in fact, and cannot reasonably obtain such appointment
from Company for any reason other than Company’s reasonable dispute regarding
the claims associated with such New Iovance Intellectual Property infringe
Company Background Intellectual Property or Improvements, Company hereby
irrevocably designates and appoints Iovance and its duly authorized officers and
agents as Company’s agent and attorney in fact, to act for and in Company’s
behalf and stead to execute and file and prosecute any such applications for
United States or foreign patents, trademarks, copyrights or other registration
covering New Iovance Intellectual Property or Works assigned to Iovance
hereunder, and to do all other lawfully permitted acts to further the
prosecution, issuance, enforcement and defense of patents, trademarks,
copyrights or other registrations thereon with the same legal force and effect
as if executed by Company.

 

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13.2.3       Each Party confirms and shall ensure that its Representatives are
subject to and bound by the same assignment obligations of the Parties under
this Section 13.2.

 

13.3     License. Company hereby grants to Iovance a non-exclusive, world-wide,
fully paid-up, irrevocable, transferable license, including the right to grant
sublicenses under, in and to Company Background Intellectual Property and
Improvements to the extent such Background Intellectual Property or Improvements
are embedded in any deliverable provided hereunder or used in the manufacturing
of Product for which there is no reasonable substitute available to Iovance, to
develop, conduct clinical trials for, formulate, manufacture, test, label,
package, seek Regulatory Approval for, market, commercialize, make, have made,
use, sell and import Product.

 

13.4     Prosecution, Maintenance and Enforcement of Patents. Iovance will have
the sole right and discretion to file, prosecute, maintain and enforce patent
applications and patents claiming New Iovance Intellectual Property at Iovance’s
expense. Company will cooperate with Iovance in Iovance’s activities to file,
prosecute and maintain patent applications and patents claiming New Iovance
Intellectual Property, and will, upon Iovance’s request, review and provide
comments to Iovance relating to such patent applications and patents.

 

13.5     Nonassertion. Except to the extent required to protect Company
Background Intellectual Property or Improvements rights, and without limiting
Section 13.3, Company and its Affiliates hereby covenant and agree not to, alone
or in cooperation with any Third Party, sue or bring any cause of action against
Iovance, its Representatives, suppliers, distributors, salespersons, customers,
licensees or end-users for any patent infringement based on any development,
manufacturing or commercialization activities relating to the Product, the
Process or Iovance’s Background Intellectual Property conducted by Iovance and
any Third Party for Iovance. This covenant will run with and attach to any and
all patent rights owned or controlled, in whole or in part, by Company and shall
be binding upon any assignee or sublicensee of any Intellectual Property from
Company.

 

13.6     Other Covenants. Company agrees that (a) it will not publish or
publicly present the results of any data or other information generated from the
activities hereunder that includes or consists of Iovance Confidential
Information, Iovance Materials or Iovance Intellectual Property without
Iovance’s prior written consent, and (b) it will at no time file or have filed
any patent application or initiate any procedure purporting to obtain any legal
rights covering any discovery or inventions that would infringe New Iovance
Intellectual Property, or that it first develops, conceives, invents, reduces to
practice or makes while using Iovance Confidential Information or Iovance
Materials, without Iovance’s prior written consent.

 

14.REPRESENTATIONS AND WARRANTIES

 

14.1     By Iovance. Iovance hereby represents, warrants and covenants to
Company that:

 

14.1.1       it is a corporation duly organized and validly existing under the
laws of its jurisdiction of incorporation or organization;

 

14.1.2       the execution, delivery, and performance of this Agreement by
Iovance has been duly authorized by all requisite corporate action and does not
require any shareholder action or approval;

 

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14.1.3       it has the power and authority to execute and deliver this
Agreement and all Statements of Work and to perform its obligations hereunder
and thereunder; and

 

14.1.4       the execution, delivery, and performance by Iovance of this
Agreement, its compliance with the provisions of this Agreement does not and
shall not conflict with or result in a breach of any of the terms and provisions
of or constitute a default under (a) any other agreement to which it is a party;
(b) its certificate of incorporation or bylaws; or (c) any order, writ,
injunction, or decree of any governmental authority entered against it or by
which any of its property is bound.

 

14.2     By Company. Company hereby represents, warrants and covenants to
Iovance that:

 

14.2.1       it is a corporation or entity duly organized and validly existing
under the laws of its jurisdiction of incorporation or organization;

 

14.2.2       the execution, delivery, and performance of this Agreement by
Company have been duly authorized by all requisite corporate action and do not
require any shareholder action or approval;

 

14.2.3       it has the power and authority to execute and deliver this
Agreement and to perform its obligations hereunder;

 

14.2.4       the execution, delivery, and performance by Company of this
Agreement and its compliance with the provisions of this Agreement does not and
shall not conflict with or result in a breach of any of the terms and provisions
of or constitute a default under (a) any other agreement to which it is a party;
(b) the provisions of its charter or organizational documents or bylaws; or (c)
any order, writ, injunction, or decree of any governmental authority entered
against it or by which any of its property is bound;

 

14.2.5       the Product released to Iovance conforms to the Specifications, has
been and shall be the subject of Services performed in accordance with this
Agreement, the applicable Statement of Work, the Quality Agreement, unless
otherwise waived in writing by Iovance, and all Laws; and is and will be free
and clear of all liens and encumbrances;

 

14.2.6       the operation of the Facility(ies) are and will continue to be in
compliance with all Laws (including the receipt and possession of all applicable
licenses, permits, registrations and authorizations);

 

14.2.7       it has maintained and will continue to maintain, in accordance with
and for the period required under this Agreement, the applicable Statement of
Work, the Quality Agreement, and all Laws, complete and adequate records
pertaining to the Services, Products, methods and the Facility(ies) used in the
performance of this Agreement;

 

14.2.8       it, and its Representatives providing Services under this
Agreement, are not, have not, and will not be, at the time of performance of any
of the Services hereunder, charged, named in an action, found liable, or
convicted for conduct relating to the development or approval of, or otherwise
relating to the regulation of, any health care product under any Law. In the
event that the foregoing should occur or should Company receive notification of
any investigation, threat, pending, current, or future proceeding, or notice of
the foregoing, Company shall immediately notify Iovance;

 

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14.2.9       save for security interests expressly given in favor of Iovance, it
will have good and marketable title, free and clear of any pledge, lien,
restriction, claim, charge, security interest and/or other encumbrance, to all
Product to be delivered hereunder;

 

14.2.10       it, and its Representatives, is and are not and will not be, at
the time of performance of any Services hereunder, disqualified, excluded or
debarred by any regulatory agency or other governmental authority for any
purpose pursuant to Law. Debarment, disqualification, and exclusion shall
include, but shall not be limited to, FDA debarment, temporary denial, and
suspension pursuant to 21 C.F.R. § 335a, FDA investigator disqualification or
restriction pursuant to 21 U.S.C. §§ 312.70, 511.1(c), or 812.119, exclusion
from participation in federal or state healthcare programs, and debarment,
suspension, or ineligibility to participate in federal procurement and
non-procurement programs. Prior to employing or otherwise engaging any
individual or entity in connection to the Services, Company agrees to review all
applicable public lists to ensure that such individuals or entities are not
disqualified, excluded, or debarred and agrees not to employ or otherwise engage
any individual or entity who is presently or has ever been disqualified,
excluded or debarred. In the event that the foregoing should occur or should
Company receive notification of any investigation, threat, pending, current, or
future proceeding, or notice of the foregoing, Company shall immediately notify
Iovance;

 

14.2.11       it will conduct the Services in compliance with all Laws,
including those dealing with occupational safety and health, those dealing with
public safety and health, those dealing with patient privacy, those dealing with
protecting the environment, and those dealing with disposal of wastes;

 

14.2.12       any processes or materials used by Company in the Services or
otherwise used in the manufacturing of Product (other than the Process) do not
infringe any Intellectual Property rights of any Third Party;

 

14.2.13       it will not enter into any agreement or arrangement with any party
which will hinder it or prevent it from performing its obligations under this
Agreement;

 

14.2.14       each of its Representatives is subject to a written agreement that
assigns to Company all Intellectual Property made by such individual in the
course of his or her employment with Company or the performance of activities
hereunder, and Company will not use any of its Representatives in the
performance of its obligations hereunder, including the performance of any
Services or Statement of Work, that are not each subject to such written
obligations; and

 

14.2.15       it shall comply with all rules and obligations vis-à-vis employees
and self-employed consultants (if any), and, as set out by all Laws, collective
and individual agreements, including (a) payment of salaries, social security
charges, insurances and withholding taxes on the income received by the workers
involved in the performance of this Agreement, as well as (b) any other
obligations deriving from the employment agreement and/or self-employment
agreement, including provisions protection of the personnel, safety and physical
integrity, in full compliance with all Laws and the individual and collective
agreements. Company expressly undertakes to perform this Agreement using only
personnel duly employed or otherwise engaged in accordance with all Laws.

 

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15.DISCLAIMER; LIMITATION OF LIABILITY

 

15.1     Disclaimer. EXCEPT AS EXPRESSLY SET FORTH WITHIN THIS AGREEMENT, A
STATEMENT OF WORK OR THE QUALITY AGREEMENT AND TO THE EXTENT PERMITTED BY LAW,
NEITHER PARTY MAKES ANY EXPRESS OR IMPLIED WARRANTIES RELATING TO THE SERVICES
OR OTHER ACTIVITIES HEREUNDER, INCLUDING WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

 

15.2     Limitation of Liability. Under no circumstances shall EITHER Party be
liable to the other PARTY for indirect, MULTIPLE, special, consequential,
LIQUIDATED, OR PUNITIVE DAMAGES, INCLUDING lost profits, OR lost revenue AND THE
TOTAL LIABILITY OF EITHER PARTY AND ITS REPRESENTATIVES TO THE OTHER PARTY AND
ANYONE CLAIMING BY OR THROUGH THE OTHER PARTY, FOR ANY AND ALL CLAIMS, LOSSES,
COSTS OR DAMAGES, INCLUDING ATTORNEYS’ FEES AND COSTS AND EXPERT-WITNESS FEES
AND COSTS OF ANY NATURE WHATSOEVER OR CLAIMS EXPENSES RESULTING FROM OR IN ANY
WAY RELATED TO AN APPLICABLE STATEMENT OF WORK FROM ANY CAUSE OR CAUSES SHALL
NOT EXCEED, ON A CLAIM-BY-CLAIM BASIS, THE FEES PAID OR OWED FOR THE [***] OF
THE SERVICES GIVING RISE TO SUCH LIABILITY UNDER [***] STATEMENT OF WORK (WITH
[***] UNDERSTOOD TO MEAN A GIVEN [***] AS OPPOSED TO A [***] OF A [***] (E.G.,
IN THE CONTEXT OF A [***], A [***] WOULD BE [***], RATHER THAN A [***] IN THE
[***] RELATED TO SUCH [***])). the foregoing limitations of liability shall not
apply to a Party’s (a) breach of its obligations pursuant to Article 12
(CONFIDENTIALITY) or Article 13 (INTELLECTUAL PROPERTY), (b) GROSS NEGLIGENCE or
willful misconduct hereunder, (c) obligations pursuant to Section 17.1 or
Section 17.2 (INDEMNIFICATION), or (D) FRAUD.

 

15.3     Further Limitation. Whereas there are inherent risks of microorganism
contamination of Product resulting from the open process steps associated with
Patient Tumor acquisition and the Process as of the Original Effective Date,
Iovance agrees that notwithstanding anything to the contrary in this Agreement,
for so long as the Process has such open process steps, Company shall not be
liable for any damages of any kind whatsoever, including Losses where such
damages or Losses arise or result from the contamination of Product by
microorganisms, including viruses. This limitation shall not apply if the
contamination was caused by the negligence, willful misconduct or breach of this
Agreement by Company.

 

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16.TERM AND TERMINATION

 

16.1     Term. The term of this Agreement shall be deemed to have commenced on
the Original Effective Date and shall expire on the third (3rd) anniversary of
the Original Effective Date, unless earlier terminated in accordance with this
Agreement (the “Term”); provided, that the Term may be extended upon the mutual
written consent of the Parties.

 

16.2     Termination for Material Breach. Either Party may terminate this
Agreement, by written notice to the other Party, for any material breach of this
Agreement by the other Party, if such breach is not cured within thirty (30)
days after the breaching Party receives written notice of such breach from the
non-breaching Party; provided, however, that if such breach (other than a breach
for non-payment) is not capable of being cured within such thirty (30) -day
period and the breaching Party has commenced and diligently continued actions to
cure such breach within such thirty (30)-day period, the cure period may be
extended, with the written consent of the non-breaching Party, to ninety (90)
days, so long as the breaching Party is making diligent efforts to cure such
breach. Such termination shall be effective upon expiration of such cure period.
In the event of termination by Iovance under this Section 16.2, any termination
fees in the applicable Statements of Work will not apply.

 

16.3     Termination of Clinical Trials; Frustration of Purpose. Iovance may
immediately terminate a Statement of Work or the manufacturing of a lot under a
given Statement of Work upon written notice to Company if (a) any clinical trial
for which Product is being produced hereunder has been or will be terminated, or
(b) the purpose of such Statement of Work or manufacturing such lot becomes
fundamentally frustrated (e.g., TILs cannot be harvested from the applicable
patient, the patient can no longer use the Product, or TILs are not being
produced in sufficient quantities for use in a patient or the FDA requires that
the production of Product must be terminated).

 

16.4     Termination by Iovance or Company. Iovance may terminate this Agreement
or any Statement of Work by providing written notice of termination not less
than thirty (30) days in advance of the date of termination. Company may
terminate this Agreement by providing written notice of termination not less
than one hundred eighty (180) days in advance of the date of termination;
provided, that, this Agreement shall remain in full force and effect with
respect to any Statements of Work outstanding at the time that such termination
becomes effective. For the avoidance of doubt, in the event of termination by
Iovance under this Section 16.4, Iovance shall, at minimum, remain liable for
all fees owed by Iovance or earned by Company pursuant to any outstanding
Statement of Work, including in the case of termination by Iovance under
Sections 16.3, or 16.4 or termination by Company under Section 16.5 any
termination fees agreed to by the parties in such Statement of Work.

 

16.5     Termination or Insolvency. Either Party may terminate this Agreement
upon notice to the other Party, upon (a) the dissolution, termination of
existence, liquidation or business failure of the other Party; (b) the
appointment of a custodian or receiver for the other Party who has not been
terminated or dismissed within thirty (30) days of such appointment; or (c) the
institution by the other Party of any proceeding under national, federal or
state bankruptcy, reorganization, receivership or other similar laws affecting
the rights of creditors generally or the making by such Party of a composition
or any assignment for the benefit of creditors under any national, federal or
state bankruptcy, reorganization, receivership or other similar law affecting
the rights of creditors generally, which proceeding is not dismissed within
thirty (30) days of filing. All rights and licenses granted pursuant to this
Agreement are, and shall otherwise be deemed to be, for purposes of
Section 365(n) of Title 11 of the United States Code, licenses of rights of
“intellectual property” as defined therein.

 

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16.6     Effects of Termination.

 

16.6.1       Accrued Rights. Termination or expiration of this Agreement or any
Statement of Work for any reason will be without prejudice to any rights that
will have accrued to the benefit of a Party prior to such termination or
expiration. Such termination or expiration will not relieve a Party of
obligations that are expressly indicated to or which by their nature should
survive the termination or expiration of this Agreement.

 

16.6.2       Disposition of Remaining Confidential Information. Upon termination
or expiration of a Statement of Work or this Agreement, Company will cease use
of and store any property (including Intellectual Property) of Iovance in its
possession and, at Iovance’s option (and subject to the terms of Article 8),
return or destroy any Iovance Confidential Information and, except as provided
in Section 16.6.3, any other Iovance property in its possession or control.
Notwithstanding the foregoing provisions, each Party may retain in its secure
archival files a single copy of the other Party’s Confidential Information for
documentation purposes only and which shall remain subject to the obligations of
nonuse and confidentiality set forth in this Agreement.

 

16.6.3       Purchased Equipment. Upon termination or expiration of a Statement
of Work or this Agreement, Company will, if so requested by Iovance, pack and
ship at Company’s expense any Purchased Equipment related to the Statement of
Work, or, in the case of termination or expiration of this Agreement, any
Purchased Equipment generally, to a destination or destinations designated by
Iovance. Company shall insure that any Purchased Equipment so returned to
Iovance is in its original condition but for reasonable wear and tear of the
Purchased Equipment contemplated by this Agreement.

 

16.6.4       Survival. The provisions of this Agreement that by their nature
should survive the termination or expiration of this Agreement, including
Articles 8, 12, 13, 15, 17 and 18, and Sections 5.4, 6.4 and 16.6 of this
Agreement, together with any appendices referenced therein.

 

17.INDEMNIFICATION

 

17.1     Indemnification of Iovance. Company will indemnify Iovance and its
Affiliates and subcontractors, and their respective directors, officers,
employees and agents (the “Iovance Parties”), and defend and hold each of them
harmless, from and against all claims, lawsuits or other action or threat by a
Third Party, including any and all losses, damages, liabilities, costs and
expenses (including reasonable attorneys’ fees and expenses) incurred in the
defense or settlement thereof or in damages awarded therein (collectively,
“Losses”) to the extent such Losses arise out of or result from: (a) any
material breach by Company (or any Company Parties) of this Agreement or the
Original Agreement, or (b) the negligence or willful misconduct of any Company
Parties in the performance of this Agreement or the Original Agreement.
Company’s obligation to indemnify Iovance shall be reduced to the extent that
any Losses are caused by the negligence, willful misconduct, breach of this
Agreement or the Original Agreement, or fraud of Iovance.

 

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17.2     Indemnification of Company. Iovance will indemnify Company and its
Affiliates and subcontractors, and their respective directors, officers,
employees and agents (the “Company Parties”), and defend and hold each of them
harmless, from and against any and all Losses to the extent such Losses arise
out of or result from: (a) any material breach by Iovance of this Agreement or
the Original Agreement, (b) the research, development, distribution, use, sales
or other disposition by or on behalf of Iovance of the Product, or (c) the
negligence or willful misconduct of any Iovance Parties in the performance of
this Agreement or the Original Agreement. Iovance’s obligation to indemnify
Company shall be reduced to the extent that any Losses are caused by the
negligence, willful misconduct, breach of this Agreement or the Original
Agreement, or fraud of Company.

 

17.3     Limitation. The obligation of Company under Section 17.1 and Iovance
under Section 17.2 is limited to [***] dollars ($[***]) per indemnifiable claim,
except that this limitation will not apply with respect to any such claim
arising out of or relating to fraud, gross negligence or willful misconduct by
the Indemnitor. For the avoidance of doubt, this limitation will not apply with
respect to any Loss relating to personal injury or death arising out of or
relating to fraud, gross negligence, willful misconduct or breach of this
Agreement or the Original Agreement.

 

17.4     Indemnification Procedure.

 

17.4.1       An “Indemnitor” means the indemnifying Party. An “Indemnitee” means
the indemnified Party, its Affiliates and subcontractors, and their respective
directors, officers, employees and agents, who shall be represented through the
Party to this Agreement with whom they are associated.

 

17.4.2       An Indemnitee which intends to claim indemnification under
Section 17.1 or Section 17.2 hereof shall promptly notify the Indemnitor in
writing of any claim, lawsuit or other action in respect of which the
Indemnitee, its Affiliates, or any of their respective directors, officers,
employees and agents intend to claim such indemnification. The Indemnitee shall
permit, and shall cause its Affiliates and subcontractors and their respective
directors, officers, employees and agents to permit, the Indemnitor, at its
discretion, to settle any such claim, lawsuit or other action and agrees to the
complete control of such defense or settlement by the Indemnitor; provided,
however, that in order for the Indemnitor to exercise such rights, such
settlement shall not adversely affect the Indemnitee’s rights under this
Agreement or impose any obligations on the Indemnitee in addition to those set
forth in this Agreement. No such claim, lawsuit or other action shall be settled
without the prior written consent of the Indemnitor and the Indemnitor shall not
be responsible for any legal fees or other costs incurred other than as provided
herein. The Indemnitee, its Affiliates and subcontractors and their respective
directors, officers, employees and agents shall cooperate fully with the
Indemnitor and its legal representatives in the investigation and defense of any
claim, lawsuit or other action covered by this indemnification, all at the
reasonable expense of the Indemnitor. The Indemnitee shall have the right, but
not the obligation, to be represented by counsel of its own selection and
expense. It is understood that only Company or Iovance may claim indemnity under
this Article 17 (on its own behalf or on behalf of its indemnitees), and other
Indemnitees may not directly claim indemnity hereunder.

 

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17.4.3       Exclusivity. The rights and remedies set forth in this Section 17
constitute the exclusive rights and remedies of the Parties in respect of the
matters indemnified under Section 17.1 and 17.2.

 

17.5     Insurance. Iovance will maintain, at all times during the Term and for
five (5) years thereafter, a products liability insurance policy (the “Insurance
Policy”), with a per occurrence limit of at least two million dollars
($2,000,000) and an aggregate limit of at least five million dollars
($5,000,000). Likewise, Company will maintain, at all times during the Term and
for at least five (5) years thereafter, commercial general liability insurance
including contractual liability coverage and product liability coverage, with a
per occurrence limit of at least two million dollars ($2,000,000) and an
aggregate limit of at least five million dollars ($5,000,000). In addition,
Company will, and has a contractual responsibility to, maintain, at all times
during the Term insurance of a type and in an amount necessary to fully cover
the loss of all Purchased Equipment on Company premises or under Company’s
control and will arrange for Iovance to be named as loss payee on all such
insurance. Upon Iovance’s request, Company shall furnish to Iovance certificates
that all insurance required under this Agreement. Any failure by Company to
provide such certifications shall be deemed a material breach of this Agreement.
Company shall provide thirty (30) days’ prior written notice of all
cancellation, non-renewal or material changes in such policy(ies); provided,
that, for clarity, at all times Company must comply with the insurance minimums
set forth above.

 

18.MISCELLANEOUS

 

18.1     Independent Contractors. Each of the Parties is an independent
contractor and nothing herein contained shall be deemed to constitute the
relationship of partners, joint venturers, nor of principal and agent between
the Parties. Neither Party shall at any time enter into, incur, or hold itself
out to Third Parties as having authority to enter into or incur, on behalf of
the other Party, any commitment, expense, or liability whatsoever.

 

18.2     Force Majeure. Neither Party shall be in breach of this Agreement if
and to the extent there is any failure of performance under this Agreement
occasioned by an act of God, fire, flood, act of government or state, war, civil
commotion, insurrection, acts of terrorism, embargo, sabotage, prevention from
or hindrance in obtaining energy or other utilities, or any other similar reason
beyond the control and without the fault or negligence of the Party affected
thereby (a “Force Majeure Event”). Such excuse shall continue as long as the
Force Majeure Event continues to affect performance. Upon cessation of such
Force Majeure Event, the affected Party shall promptly resume performance under
this Agreement as soon as it is commercially reasonable for the Party to do so.
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 to fully perform its obligations under
this Agreement. Each Party further agrees to use commercially reasonable efforts
to correct the Force Majeure Event as quickly as practicable (provided that in
no event shall a Party be required to settle any labor dispute) and to give the
other Party prompt written notice when it is again fully able to perform such
obligations. This Section shall be without prejudice to Iovance’s termination
rights under Article 16.

 

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18.3     Condemnation. If the Facility(ies) are, or any individual Facility is,
condemned or taken as a result of the exercise of the power of eminent domain or
will be conveyed to a governmental agency having power of eminent domain under
the threat of the exercise of such power (any of the foregoing, a
“Condemnation”), then this Agreement will terminate as of the date on which
title to the Facility(ies) vests in the authority so exercising or threatening
to exercise such power and Iovance will not have any right to the Condemnation
proceeds. This Section shall be without prejudice to Iovance’s termination
rights under Article 16.

 

18.4     Notices. Any notice required or permitted to be given under this
Agreement by any Party shall be in writing and shall be (a) delivered
personally, (b) sent by registered mail, return receipt requested, postage
prepaid, (c) sent by a nationally-recognized courier service guaranteeing
next-day or second day delivery, charges prepaid, or (d) delivered by facsimile
(with documented evidence of transmission), to the addresses or facsimile
numbers of the other Party set forth below, with an electronic copy of the
notice sent to the email address provided, or at such other addresses as may
from time to time be furnished by similar notice by any Party. The effective
date of any notice under this Agreement shall be the date of receipt by the
receiving Party.

 

If to Company:

 

WuXi AppTec, Inc.
Attention: Alan Moore

4751 League Island Blvd.
Philadelphia, PA 19112

 

With a copy to “Vice President, Manufacturing” at the above address.

 

If to Iovance:

 

Iovance Biotherapeutics, Inc.
Attention: Richard Gaeto
999 Skyway Road, Suite 150
San Carlos, CA 94070

 

With a copy to:

 

Iovance Biotherapeutics, Inc.
Attention: Legal Department
999 Skyway Road, Suite 150
San Carlos, CA 94070

With an electronic copy to:

legal@iovance.com

 

Either Party may change its address for notice by giving notice thereof in the
manner set forth in this Section 18.4.

 

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18.5     Entire Agreement, Amendments, Initial Agreement.

 

18.5.1       This Agreement, including the Quality Agreement and the Statements
of Work and Change Orders entered into by the Parties from time to time and the
Appendices attached hereto or thereto and referenced herein or therein,
constitutes the full understanding of the Parties, a complete and fully
integrated agreement and a complete and exclusive statement of the terms of
their agreement with respect to the specific subject matter hereof and
supersedes all prior agreements and understandings, oral and written, among the
Parties with respect to the subject matter hereof (including the Original
Agreement). No terms, conditions, understandings or agreements purporting to
amend, modify or vary the terms of this Agreement (including any Appendix
hereto) shall be binding unless hereafter made in a written instrument
referencing this Agreement and signed by each of the Parties.

 

18.5.2       The Parties were previously parties to that certain Cell Therapy
Development, Manufacturing and/or Tissue Processing Terms and Conditions with an
effective date of September 25, 2015 (the “Initial Agreement”), which predates
this Agreement and the Original Agreement, and under such Initial Agreement the
Parties have executed several work orders, including WO A-4, executed September
6, 2016 (“WO A-4”). The Parties desire that the Original Agreement, as amended
and restated by this Agreement, govern WO A-4. The Parties acknowledge and agree
that this Section 18.5.2 constitutes an amendment to WO A-4 under Section 14 of
the Initial Agreement. In furtherance thereof, from and after the Original
Effective Date, the Original Agreement, as amended and restated by this
Agreement, shall solely govern the performance of WO A-4. Accordingly,
references to Statements of Work herein shall also be deemed to refer to WO A-4.

 

18.6     Governing Law. This Agreement and any disputes hereunder will be
governed by and construed in accordance with the laws of the State of New York,
without giving effect to its conflicts of laws provisions. The United Nations
Convention on Contracts for the International Sale of Goods will not apply to
this Agreement. This provision shall operate without prejudice to either Party’s
ability to seek injunctive or other interlocutory relief in any court accepting
jurisdiction in order to protect and enforce its Intellectual Property rights.

 

18.7     Equitable Relief. The Parties agree that the obligations contained in
Articles 12 and 13 are necessary and reasonable in order to protect the Parties’
respective businesses. The Parties further agree that monetary damages may be
inadequate to compensate a Party for any breach by the other Party of its
covenants and agreements with respect to Articles 12 and 13, and that each Party
shall be entitled to seek injunctive or other equitable relief against the
threatened or continued breach of those provisions, and agree that no bond or
other security shall be required in obtaining such equitable relief.
Furthermore, except as expressly set forth in this Agreement, none of the
remedies set forth in this Agreement are intended to be exclusive, and each
Party shall have available to it all remedies available under law or in equity.

 

18.8     Counterparts. This Agreement and any amendment hereto may be executed
in any number of counterparts, each of which shall for all purposes be deemed an
original and all of which shall constitute the same instrument. This Agreement
shall be effective upon full execution by facsimile, PDF or original, and a
facsimile or scanned signature shall be deemed to be and shall be as effective
as an original signature. Signature pages may be exchanged via email.

 

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18.9     Severability. As a fully integrated agreement, each right or obligation
of each Party to this Agreement is fully dependent on the Party retaining all of
its other rights and performing all of its other obligations under this
Agreement. Nevertheless, if any part of this Agreement shall be found to be
invalid or unenforceable under Law in any jurisdiction, such part shall be
ineffective only to the extent of such invalidity or unenforceability in such
jurisdiction, without in any way affecting the remaining parts of this Agreement
in that jurisdiction or the validity or enforceability of this Agreement as a
whole in any other jurisdiction. In addition, the part that is ineffective shall
be reformed in a mutually agreeable manner so as to as nearly approximate the
intent of the Parties as possible.

 

18.10   Titles and Subtitles. All headings, titles and subtitles used in this
Agreement (including any Appendix hereto) are for convenience only and are not
to be considered when construing or interpreting any term or provision of this
Agreement (or any Appendix hereto).

 

18.11   Recitals, Definitions and Appendices. All “RECITALS”, “DEFINITIONS” and
Appendices referred to herein form an integral part of this Agreement and are
incorporated into this Agreement by such reference.

 

18.12   Interpretation and Construction.

 

18.12.1       Where the context requires, (i) all pronouns used herein will be
deemed to refer to the masculine, feminine or neuter gender as the context
requires and (ii) the singular context will include the plural and vice versa.

 

18.12.2       The words “include”, “includes” and “including” (and words of
similar meaning) shall be deemed to be followed by the phrase “without
limitation”.

 

18.12.3       For purposes of interpretation of this Agreement, the following
shall apply:

 

(a)“Personal Information” shall be understood to include personal data.

 

(b)With respect to the Use of Personal Information, “Use” shall be understood to
include the processing of Personal Information.

 

(c)“patients” shall be understood to be synonymous with study subjects.

 

(d)“regulatory agency” shall be understood to be synonymous with regulatory
authority.

 

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18.13   Assignment, Third Party Beneficiaries. This Agreement shall be binding
upon the successors and assigns of the Parties and the name of a Party appearing
herein shall be deemed to include the names of its successors and assigns.
Company may not assign its interest under this Agreement (including the Quality
Agreement) without the prior written consent of Iovance, such consent not to be
unreasonably withheld. Notwithstanding the above, Iovance may, without Company’s
prior consent, assign this Agreement, in whole or in part, to Iovance’s
Affiliates or to any entity that may acquire substantially all of the assets of
Iovance to which this Agreement relates. This Agreement shall be binding upon,
and inure to the benefits of, the Parties hereto and their respective successors
and assigns. Any permitted assignment of this Agreement by either Party will be
conditioned upon that Party’s permitted assignee agreeing in writing to comply
with all the terms and conditions contained in this Agreement, the Statements of
Work, the Quality Agreement and all Laws. No assignment shall relieve any Party
of responsibility for the performance of any obligation that accrued prior to
the effective date of such assignment. None of the provisions of this Agreement
shall be for the benefit of or enforceable by any Third Party, including any
creditor of either Party hereto. No such Third Party shall obtain any right
under any provision of this Agreement or shall by reasons of any such provision
make any claim in respect of any debt, liability or obligation (or otherwise)
against either Party hereto.

 

18.14    Waiver. The failure of any Party at any time or times to require
performance of any provision of this Agreement (including any Appendix hereto)
will in no manner affect its rights at a later time to enforce the same. No
waiver by any Party of any term, provision or condition contained in this
Agreement (including any Appendix hereto), whether by conduct or otherwise, in
any one or more instances, shall be deemed to be or construed as a further or
continuing waiver of any such term, provision or condition or of any other term,
provision or condition of this Agreement (including any Appendix hereto).

 

18.15   Dispute Resolution, Arbitration.

 

18.15.1       If the JSC is unable to resolve a dispute pursuant to Section
3.3.3, despite each Party’s good faith efforts, either Party may refer the
dispute to the President of each Party’s respective business unit (or other
designee), who will attempt to resolve such dispute by negotiation and
consultation for a thirty (30) day period following receipt of such written
notice.

 

18.15.2       In the event that no agreement is reached by the Presidents (or
other designees) with respect to such dispute within thirty (30) days after its
referral to them, either Party may refer the matter to binding arbitration
pursuant to Section 18.15.3.

 

18.15.3       In the event Presidents (or other designees) have not resolved a
dispute referred to them pursuant to Section 18.15.2 within thirty (30) days of
receipt of the written notice referring such dispute to the Presidents (or other
designees), either Party may at any time after such thirty (30) day period
submit such dispute to be finally settled by arbitration administered in
accordance with the procedural rules of the American Arbitration Association
(the “AAA”) in effect at the time of submission, as modified by this Section
18.15.3. The arbitration will be governed by the Laws of the State of New York.
The arbitration will be heard and determined by three arbitrators who are
retired judges or attorneys with at least twenty (20) years of relevant
experience in the pharmaceutical and biotechnology industry, each of whom will
be impartial and independent and will not have worked for or on behalf of either
Party for at least five (5) years. Each Party will appoint one (1) arbitrator
and the third arbitrator will be selected by the two (2) Party-appointed
arbitrators, or, failing agreement within thirty (30) days following appointment
of the second arbitrator, by the AAA. Such arbitration will take place in New
York, New York. The arbitration award so given will, absent manifest error, be a
final and binding determination of the applicable dispute, will be fully
enforceable in any court of competent jurisdiction, and will not include any
damages expressly prohibited by Section 15.2. Each Party will pay the fees,
costs and expenses for the arbitrator it chooses, and the Parties will share
payment for the third arbitrator. Except in a proceeding to enforce the results
of the arbitration or as otherwise required by Law or securities exchange,
neither Party nor any arbitrator may disclose the existence, content or results
of any arbitration hereunder without the prior written consent of both Parties.

 

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18.15.4       Nothing in this Agreement will prevent either Party from
exercising any right under this Agreement, including the right of termination,
or require either Party to forego or delay any proceeding to seek equitable or
injunctive relief to stop or prevent any breach of this Agreement if that Party
reasonably believes that it would be irreparably harmed by any delay in seeking
such relief.

 

18.16   No Presumption against Drafter. For purposes of this Agreement, each
Party hereby waives any rule of construction that requires that ambiguities in
this Agreement (including any Appendix hereto) be construed against the drafter.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.

 

IOVANCE BIOTHERAPEUTICS, Inc.   WUXI Apptec, inc.             Name:   Name:    
  Title:   Title:

 

 

 

 

Appendix A

 

Statements of Work

 

 

 

 

Appendix B

 

Iovance Materials