Exhibit 10.36

 

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

 

MANUFACTURING SERVICES AGREEMENT

 

This Manufacturing Services Agreement (this “Agreement”) is made as of November
23, 2016 (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 Lion Biotechnologies,
Inc., a Nevada corporation having its principal place of business at 112 West
34th Street, 18th Floor, New York, NY 10120 (“LBIO”) (each of Company and LBIO,
a “Party” and, collectively, the “Parties”).

 

RECITALS

 

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

 

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

 

WHEREAS, LBIO 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, LBIO may engage Company to manufacture and perform
services related to the manufacture of LBIO’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; and

 

WHEREAS, the Parties were previously parties to the Cell Therapy Development,
Manufacturing and/or Tissue Processing Terms and Conditions with an effective
date of September 25, 2015 (“Original Agreement”), under which the Parties have
executed several work orders, including WO A-4 executed September 6, 2016 (“WO
A-4”). The Parties desire that this Agreement govern WO A-4.

 

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

 

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 

 

 

1.1           “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 FDA 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 and the EU Commission under 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.

 

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 LBIO.

 

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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 LBIO.

 

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.

 

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

 

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

 

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

 

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

 

1.29         “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 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) 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.

 

1.30         “LBIO” has the meaning set forth in the preamble.

 

1.31         “LBIO Confidential Information” means the Confidential Information
of LBIO.

 

1.32         “LBIO Intellectual Property” means Background Intellectual Property
of LBIO and New LBIO Intellectual Property.

 

1.33         “LBIO Materials” has the meaning set forth in Section 5.1.

 

1.34         “LBIO Parties” has the meaning set forth in Section 17.1.

 

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

 

1.36         “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.

 

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

 

1.38         “New LBIO Intellectual Property” has the meaning set forth in
Section 13.2.1.

 

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

 

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

 

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

 

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

 

1.43         “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.

 

 4 

 

 

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

 

1.45         “Process Specifications” means robust, data-driven specifications
developed by or for LBIO 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.

 

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

 

1.47         “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.

 

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

 

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

 

1.50         “Quality Agreement” means the Quality Agreement entered into by the
Parties simultaneously with the execution hereof relating to the Process and
Product, as may be amended or restated from time to time by the Parties.

 

1.51         “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).

 

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

 

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

 

1.54         “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.

 

1.55         “Security Incident” has the meaning set forth in Section 6.2.6.

 

 5 

 

 

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

 

1.57         “SOP” means a standard operating procedure.

 

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

 

1.59         “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”.

 

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

 

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

 

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

 

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

 

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

 

1.65         “Use” means to perform any operation or set of operations on
Patient Materials, 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.

 

1.66         “WO A-4” has the meaning set forth in the Recitals.

 

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

 

1.68         “Work Orders” has the meaning set forth in the Recitals.

 

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

 

2.            STATEMENTS OF WORK; PERFORMANCE

 

2.1           Statement of Work. From time to time during the Term, 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.

 

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2.2           Modification of Statement of Work. Should LBIO 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, LBIO 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 LBIO 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 LBIO for review
and comment. Additionally, if Company reasonably determines that a change or
addition to the information provided by LBIO 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 LBIO, which
LBIO 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.

 

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
LBIO.

 

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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 LBIO of any delays that arise
during the performance of a Statement of Work.

 

2.3.5           Unless authorized by LBIO in writing, Company shall perform the
Services only at the Facility(ies) designated in the applicable Statement of
Work. Unless authorized by LBIO 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 LBIO in writing, Company
will use Company’s equipment for the performance of the Services. To the extent
that LBIO provides Company with equipment, such equipment shall remain the
property of LBIO. Company shall ensure that all such equipment is properly
maintained in accordance with the below requirements, only used for the Services
and returned to LBIO upon the expiration or termination of this Agreement.

 

2.3.6           All Facilities, equipment, including equipment provided by LBIO,
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 and equipment by Company. Company shall maintain the Facility(ies),
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.

 

2.3.7           Company shall timely procure and store all materials (other than
the Patient Materials and LBIO 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 LBIO 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 LBIO representatives,
and Company’s employees and consultants from any such hazards. Except to the
extent caused by the negligent act or omission of LBIO or any LBIO
representative, LBIO shall not be responsible for any injuries that Company’s
employees or consultants or LBIO’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 LBIO (which such approval may be withheld in LBIO’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 LBIO 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,
LBIO 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. LBIO’s review, audit and inspection, and
attendance rights hereunder shall continue following LBIO’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
LBIO’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 LBIO Confidential Information and assignment of any New LBIO
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 LBIO 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, LBIO 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. LBIO’s review, audit and inspection, and
attendance rights hereunder shall continue following LBIO’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. No later than the fifth day of
each calendar quarter during the Term, LBIO will provide to Company a rolling
twelve (12)-month forecast specifying LBIO’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 LBIO’s good faith
estimate of LBIO’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 LBIO’s anticipated
manufacturing needs. In the event of a Remedial Event the Parties agree that
Company’s obligation to supply and LBIO’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 LBIO of the
Remedial Event and continuing until such time as such Remedial Event is
resolved. LBIO 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, LBIO 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, LBIO shall have no obligation to pay such fees during the
period of suspension. If the Remedial Event lasts longer than three (3) months
then LBIO 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 LBIO 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, LBIO 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 LBIO’s election under the previous sentence, LBIO 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 LBIO’s request (and at
LBIO’s sole discretion), Company and LBIO shall enter into a mutually agreeable
commercial manufacturing agreement whereby Company will provide Product to LBIO
for commercial purposes.

 

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3.           GOVERNANCE

 

3.1           Project Team.

 

3.1.1           Within thirty (30) days of the Effective Date, the Parties shall
establish 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 will be comprised of equal numbers of representatives
from LBIO and Company. A representative from LBIO 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 LBIO 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 LBIO 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 LBIO 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 LBIO under Laws within the timeframes
specified by such Laws, and/or (ii) LBIO is required to report to the applicable
regulatory authorities with sufficient time to allow LBIO 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           Within thirty (30) days of the Effective Date, the Parties shall
establish 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 will be comprised of equal
numbers of representatives from LBIO and Company. A representative from LBIO
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. Following the Effective Date, LBIO shall
provide the Process Specifications to Company and such Background Intellectual
Property of LBIO 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 LBIO’s Background Intellectual
Property shall remain solely vested in LBIO.

 

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. LBIO will
inform Company of any specific requirements LBIO may have relating to the Master
Batch Records, including any information or procedures, including testing
procedures, LBIO wishes to have incorporated therein and Company will reflect
any such instructions provided by LBIO 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 LBIO 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
LBIO.

 

4.2.2           Company will deliver iterative versions of the Master Batch
Record to LBIO on timing set forth in each Statement of Work that calls for the
preparation of a new Master Batch Record. LBIO 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 LBIO will meet promptly to
resolve such objections. The Master Batch Record will be final when approved by
LBIO and shall be deemed LBIO Confidential Information.

 

5.            LBIO MATERIALS

 

5.1           LBIO Materials. LBIO 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 (“LBIO Materials”). All LBIO
Materials supplied to Company shall remain the exclusive property of LBIO. LBIO
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 LBIO Materials be used in humans without the prior written
consent of LBIO.

 

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5.2           Limitation on Liability. Company shall not be liable for (i) the
accuracy or inherent characteristic, or defect of LBIO Materials, LBIO
Confidential Information, Patient Materials, or other information or material
provided by LBIO as such are first provided or made available by or on behalf of
LBIO (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 LBIO 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 LBIO 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 LBIO Materials to any Third Party or use the LBIO 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 LBIO 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 LBIO Materials. Within
thirty (30) days of the expiration or termination of any Statement of Work or
this Agreement, or LBIO’s request, Company shall return to LBIO, or destroy, at
LBIO’s option, all unused supplies of LBIO 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 LBIO in writing, exclusively at the
Facility(ies). All Patient Materials shall remain the sole property of LBIO 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 LBIO 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 LBIO to
incorporate LBIO’s existing clinical coding system into Company’s Patient
Material tracking system, the incorporation of which shall be subject to LBIO’s
prior written approval;

 

6.2.3           Use Patient Materials only in accordance with LBIO’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 LBIO
under this Agreement. Where disclosure is required by Law, Company shall
immediately notify LBIO, work with LBIO to take actions LBIO deems necessary
with regard to the disclosure, use its best efforts to limit the disclosure,
cooperate with LBIO should LBIO 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 LBIO 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           maintain control over Patient Materials received by it hereunder
and not release Patient Materials, without LBIO’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 LBIO 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 LBIO prior to such transfer.
Notwithstanding the foregoing, the restrictions in this Section 6.2.4 shall not
apply to the extent specifically requested by LBIO, in which case, Company shall
take all LBIO requested action;

 

6.2.5           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 LBIO 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;

 

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6.2.6           notify LBIO 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 LBIO’s prior written approval. Company
shall reasonably cooperate with LBIO in its investigation of a Security
Incident, whether discovered by Company, LBIO or a Third Party, which shall
include providing LBIO a detailed description of the Security Incident, the
identity of the Patient Materials affected, and any other information LBIO
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 LBIO 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;

 

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

 

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

 

6.3           Personal Information. LBIO 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 LBIO, and (b) take tangible actions, including
implementing any necessary security and/or protection precautions, as may be
directed by LBIO.

 

6.4           Return or Destruction. Company shall return or destroy all unused
or leftover Patient Materials received from, or on behalf of, LBIO, or otherwise
received by Company on behalf of LBIO upon the earlier of (a) thirty (30) days
after completion or termination of the Services utilizing such Patient Materials
or (b) LBIO’s request, and in accordance with all LBIO 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. LBIO shall provide the requisite LBIO
Materials (including, to the extent applicable, Patient Materials), and
information related to such LBIO 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. Prior to performing Services, the Parties shall
enter into a separate Quality Agreement setting forth the respective quality
assurance and regulatory responsibilities of the Parties. Such Quality Agreement
shall be separately appended to this Agreement.

 

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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 LBIO.
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 LBIO, 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, LBIO will arrange or LBIO will instruct
Company to arrange the transportation of Product or LBIO Materials from
Company’s Facility to the destination indicated by LBIO in accordance with the
applicable Statement of Work and the Quality Agreement, and, if applicable,
LBIO’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 LBIO in accordance with the applicable Statement
of Work.

 

7.5           Inspection. LBIO shall arrange for the examination of the Product
or LBIO 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 LBIO or LBIO’s designee.

 

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

 

7.7           Low Yield. Company shall notify LBIO 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 LBIO upon LBIO’s request therefor.

 

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7.9           Changes and Change of Control. Company shall not make any
amendments, changes or supplements to the Product Specifications without LBIO’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 LBIO’s prior
written approval. All other changes, amendments, and supplements shall be
provided to LBIO 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 LBIO 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 LBIO’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 LBIO. All such submissions and
approvals shall be subject to Section 10.2. The process for Company and LBIO
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 LBIO at the
Facility upon LBIO’s request. Without limitation, LBIO 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 LBIO. Company Operating Documents will remain Company
Confidential Information. Notwithstanding the foregoing, LBIO 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 LBIO 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 LBIO,
obtaining LBIO’s written approval for such disposal or destruction, and allowing
LBIO to take control of such records (excluding Company Operating Documents) at
LBIO’s reasonable cost and expense. All such records shall be protected from
alteration, destruction, and Security Breaches.

 

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           LBIO Regulatory Requirements. Company shall provide LBIO 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 LBIO or,
subject to LBIO’s prior review, directly to the applicable regulatory authority.

 

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, LBIO 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 LBIO. Such records and Reports shall constitute LBIO 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 LBIO 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
LBIO’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.

 

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9.            PRODUCT WARRANTIES; INSPECTION AND RELEASE

 

9.1           Product Warranties. Unless otherwise requested by LBIO 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;

 

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 LBIO 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
LBIO 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, 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; and

 

9.1.6           is being transferred to LBIO 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 LBIO is ready for shipment, Company
will immediately notify LBIO. Product shipment and release procedures, including
terms regarding LBIO 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 LBIO’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 LBIO, and if such Product’s non-conformance is due to
Company’s negligence or willful misconduct, then Company shall produce for LBIO
another Batch of Product to replace the non-conforming Product at no additional
cost to LBIO, or (ii) re-process such Product in accordance with written
instructions provided by LBIO to produce for LBIO another Batch of Product to
replace the non-conforming Product at no additional cost to LBIO; provided,
that, if Company is unable to replace or re-process Product, as applicable,
Company shall refund to LBIO 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 LBIO with respect
to the disposition of any such non-conforming Product, including delivering such
Product to LBIO 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 LBIO
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
LBIO, 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 LBIO’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 LBIO 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; LBIO 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 LBIO 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 LBIO of the scheduling of, or without scheduling when a regulatory
inspection begins, any such inspection and, if possible, will permit LBIO’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 LBIO 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.

 

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10.2.2           Interactions.

 

(a)          To the extent permitted by the relevant regulatory authority and by
Law, LBIO 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.

 

(b)          To the extent that the relevant regulatory authority will not or is
not permitted by Law to directly interact with LBIO, 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
LBIO by Company, in reasonable and sufficient time prior to submission to the
applicable regulatory authority, for LBIO’s prior review and approval. For
clarity, this may include LBIO providing on-site, but indirect, assistance to
Company in connection with a regulatory interaction. Company will incorporate
all of LBIO’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
LBIO, in reasonable and sufficient time prior to submission to the applicable
regulatory authority, for LBIO’s prior comment. Company will consider all of
LBIO’s comments in good faith.

 

(d)          In addition to the requirements of the foregoing subsections (b)
and (c), Company shall furnish LBIO 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.

 

 22 

 

 

(e)          After any of the foregoing interactions, communications, or
reports, Company shall notify LBIO and provide LBIO 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 LBIO’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 LBIO
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 LBIO’s prior written approval to the extent such steps
relate to the Products and/or Services, or which shall be subject to LBIO’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 LBIO’s comments in good faith. In the latter case,
Company will consider all of LBIO’s comments in good faith.

 

10.2.3           All documentation, summaries, minutes and information provided
to LBIO 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 LBIO
on the implementation of such corrective actions. As requested by LBIO, Company
shall confer with LBIO on, and seek LBIO’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 LBIO with all information, records,
documentation, and assistance that LBIO may request and that is reasonably
necessary or useful for LBIO 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 LBIO or, subject to LBIO’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.

 

 23 

 

 

10.4         Inspections by LBIO.

 

10.4.1           At agreed-upon dates and times, which agreement Company shall
not unreasonably withhold, condition or delay, LBIO 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 LBIO’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 LBIO’s audit or inspection of a Facility, LBIO’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 LBIO’s reasonable judgment, LBIO need to conduct
a for-cause audit, LBIO 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 LBIO’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, LBIO 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 LBIO, as necessary or useful, in any such inspection or audit.

 

 24 

 

 

10.4.3           In the event LBIO 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, LBIO 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 LBIO 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 LBIO’s instructions concerning the shipment
of Product and/or the continued provision of Services. LBIO 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 LBIO 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 LBIO with respect to the subject matter herein, except that where
such deficiency causes LBIO to experience a related cost, loss or expense, then
the foregoing limitation does not constitute a waiver of any right otherwise
available to LBIO under this Agreement or at law.

 

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, LBIO 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 LBIO 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 LBIO
Materials), and qualification and management of its subcontractors, supplier(s)
of materials (other than LBIO 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 LBIO 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 LBIO 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 LBIO such rights, then LBIO 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 LBIO. In addition,
for critical raw material suppliers as well as for Third Party manufacturers of
Product, Company shall be required to audit each and LBIO 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, LBIO will abide by standard
policies, operating procedures and the security procedures established by such
Facility with respect to conduct at such Facility provided to LBIO in advance in
writing and with any reasonable instructions or requests by Company while at
such Facility, which could not reasonably be provided to LBIO in advance. During
any such on-site visit of the Facility, LBIO will cooperate with Company in
taking reasonable precautions to avoid exposure of its Representatives to
information regarding activities unrelated to Product manufactured for LBIO.
Notwithstanding the above, Company shall not impose any restrictions or other
procedures that would impede LBIO’s ability to conduct a reasonable and
comprehensive audit.

 

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

 

10.6         Procedures. Representatives of LBIO 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 LBIO in advance in writing and with any reasonable
instructions or requests by Company while at such Facility, which could not
reasonably be provided to LBIO in advance. During any such on-site work, visit,
or access to a Facility, LBIO 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 LBIO working
at the Facility will be and remain employees of LBIO, and LBIO will be solely
responsible for the payment of compensation for such Representatives of LBIO
(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. LBIO 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 LBIO with invoices each
setting forth a detailed account of amounts payable by LBIO. The undisputed
amounts set forth in each such invoice will be due and payable within sixty (60)
days of receipt of such invoice by LBIO. LBIO 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 LBIO to Company, then Company shall credit the deviated amount with the next
invoice to LBIO (or if no more invoices are required Company shall promptly pay
such amount to LBIO), or (b) an underpayment by LBIO to Company, then LBIO 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. LBIO 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 LBIO
in connection with the production of any Product hereunder if LBIO provides to
Company the appropriate valid exemption certificates.

 

 26 

 

 

11.4         Method of Payment. All payments to Company hereunder by LBIO 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         LBIO 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 LBIO against Company.

 

11.6         Late Payment. In the event of a default of payment of any amounts
by LBIO 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 LBIO and/or its
Affiliates (including New LBIO Intellectual Property) are deemed LBIO
Confidential Information, as to which LBIO 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;

 

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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

 

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.

 

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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.

 

12.6         Permitted LBIO Disclosure. Notwithstanding anything else in this
Agreement, LBIO shall further be permitted to disclose information subject to an
obligation of confidentiality under this Agreement to the extent reasonably
necessary for LBIO 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 LBIO 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 or developed independently of this 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, LBIO 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 LBIO. As between the Parties, LBIO shall own all LBIO
Confidential Information and Company shall own all Company Confidential
Information.

 

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13.2         New LBIO Intellectual Property and Assignment.

 

13.2.1           LBIO 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
LBIO 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, LBIO Materials, LBIO Confidential Information
or Background Intellectual Property of LBIO (collectively, “New LBIO
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 LBIO 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 LBIO 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, LBIO agrees that New LBIO 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 LBIO
Intellectual Property, LBIO Materials and/or LBIO 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 LBIO Intellectual Property,
LBIO Materials or LBIO Confidential Information were not a “but for” cause of
such improvement) (“Improvements”).

 

13.2.2           Company hereby assigns and shall assign to LBIO all of its
right, title and interest in and to any New LBIO Intellectual Property. Company
shall promptly disclose to LBIO in writing all New LBIO Intellectual Property.
Company shall execute, and shall require its Representatives, to execute, any
documents reasonably required to confirm LBIO’s ownership of the New LBIO
Intellectual Property, and any documents required to apply for, maintain and
enforce any patent or other right in the New LBIO Intellectual Property. In the
event that LBIO 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 LBIO
Intellectual Property infringe Company Background Intellectual Property or
Improvements, Company hereby irrevocably designates and appoints LBIO 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 LBIO Intellectual Property or Works assigned
to LBIO 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 LBIO 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 LBIO, 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. LBIO will have
the sole right and discretion to file, prosecute, maintain and enforce patent
applications and patents claiming New LBIO Intellectual Property at LBIO’s
expense. Company will cooperate with LBIO in LBIO’s activities to file,
prosecute and maintain patent applications and patents claiming New LBIO
Intellectual Property, and will, upon LBIO’s request, review and provide
comments to LBIO 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
LBIO, 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 LBIO’s Background Intellectual Property conducted by LBIO and any
Third Party for LBIO. 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 LBIO Confidential Information,
LBIO Materials or LBIO Intellectual Property without LBIO’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 LBIO Intellectual Property, or
that it first develops, conceives, invents, reduces to practice or makes while
using LBIO Confidential Information or LBIO Materials, without LBIO’s prior
written consent.

 

14.          REPRESENTATIONS AND WARRANTIES

 

14.1         By LBIO. LBIO 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;

 

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

 

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 LBIO 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
LBIO 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 LBIO 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 LBIO, 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;

 

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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 LBIO;

 

14.2.9           save for security interests expressly given in favor of LBIO,
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
LBIO;

 

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

 

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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.

 

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 WORK ORDER AND/OR 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 [***] WORK ORDER
AND/OR 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 Effective
Date, LBIO 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 will commence on the Effective
Date and expire on the third (3rd) anniversary of the 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 LBIO 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. LBIO 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 FDA requires that the
production of Product must be terminated).

 

16.4         Termination by LBIO or Company. LBIO 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
LBIO under this Section 16.4, LBIO shall, at minimum, remain liable for all fees
owed by LBIO or earned by Company pursuant to any outstanding Statement of Work,
including in the case of termination by LBIO 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 LBIO in
its possession and, at LBIO’s option (and subject to the terms of Article 8),
return or destroy any LBIO Confidential Information and any other LBIO 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           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 LBIO. Company will indemnify LBIO and its
Affiliates and subcontractors, and their respective directors, officers,
employees and agents (the “LBIO 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 (b)
the negligence or willful misconduct of any Company Parties in the performance
of this Agreement. Company’s obligation to indemnify LBIO shall be reduced to
the extent that any Losses are caused by the negligence, willful misconduct,
breach of this Agreement, or fraud of LBIO.

 

17.2         Indemnification of Company. LBIO 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 LBIO of this Agreement, (b)
the research, development, distribution, use, sales or other disposition by or
on behalf of LBIO of the Product, or (c) the negligence or willful misconduct of
any LBIO Parties in the performance of this Agreement. LBIO’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 fraud of
Company.

 

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17.3         Limitation. The obligation of Company under Section 17.1 and LBIO
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.

 

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 LBIO 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.

 

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.

 

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17.5         Insurance. LBIO 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). Upon LBIO’s
request, Company shall furnish to LBIO 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 LBIO’s termination
rights under Article 16.

 

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 LBIO will not have any right to the Condemnation
proceeds. This Section shall be without prejudice to LBIO’s termination rights
under Article 16.

 

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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, 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 LBIO:

 

Lion Biotechnologies, Inc.
Attention: Richard Gaeto
112 West 34th Street, 18th Floor
New York, NY 10120

 

With a copy to:

 

Lion Biotechnologies, Inc.
Attention: Legal Department
112 West 34th Street, 18th Floor
New York, NY 10120

 

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

 

18.5         Entire Agreement, Amendments, Original Agreement.

 

18.5.1           This Agreement, including the Quality Agreement and the
Statements of Work 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 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. 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 acknowledge and agree that this Section 18.5.2
constitutes an amendment to WO A-4 under Section 14 of the Original Agreement.
In furtherance thereof, from and after the Effective Date, 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 that Work Order.

 

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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.

 

18.9         Severability. 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         Pronouns. 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.

 

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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 LBIO, such consent not
to be unreasonably withheld. Notwithstanding the above, LBIO may, without
Company’s prior consent, assign this Agreement, in whole or in part, to LBIO’s
Affiliates or to any entity that may acquire substantially all of the assets of
LBIO 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.

 

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

 

Lion Biotechnologies, Inc.   WUXI Apptec, inc.       /s/ MARIA FARDIS   /s/
SCOTT KRAMER Name Maria Fardis:   Name: Scott Kramer Title: CEO   Title: VP
Finance and Administration November 23, 2016   November 7, 2016

 

 

 

 

Appendix A

 

Statements of Work

 

 

 

 

Appendix B

 

LBIO Materials