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 0000 Xxxxxx Xxxxxx Xxxx., Xxxxxxxxxxxx, XX 00000 (“Company”),
and Lion Biotechnologies, Inc., a Nevada corporation having its principal place of business at 000 Xxxx 00xx Xxxxxx,
00xx Xxxxx, Xxx Xxxx, XX 00000 (“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 “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.
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.
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.
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.
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 X-0, X-0, X-0, 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.
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.
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.
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.
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.
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.
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.
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.
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;
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;
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.
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.
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.
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.
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.
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.
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.
(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.
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.
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.
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.
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;
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.
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.
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.
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, xxx 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;
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;
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
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.
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.
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.
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.
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.
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: Xxxx Xxxxx
0000 Xxxxxx Xxxxxx Xxxx.
Xxxxxxxxxxxx, XX 00000
With a copy to “Vice President, Manufacturing”
at the above address.
If to LBIO:
Lion Biotechnologies, Inc.
Attention: Xxxxxxx Xxxxx
000 Xxxx 00xx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
With a copy to:
Lion Biotechnologies, Inc.
Attention: Legal Department
000 Xxxx 00xx Xxxxxx, 00xx Xxxxx
Xxx Xxxx, XX 00000
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.
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.
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.
18.15.4 Nothing
in this Agreement will prevent either Party from exercising any right under this Agreement, including the right of termination,
or require either Party to forego or delay any proceeding to seek equitable or injunctive relief to stop or prevent any breach
of this Agreement if that Party reasonably believes that it would be irreparably harmed by any delay in seeking such relief.
18.16 No
Presumption against Drafter. For purposes of this Agreement, each Party hereby waives any rule of construction that requires
that ambiguities in this Agreement (including any Appendix hereto) be construed against the drafter.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
IN WITNESS WHEREOF, the Parties have executed this Agreement
as of the Effective Date.
| Lion Biotechnologies, Inc. |
|
WUXI Apptec, inc. |
| |
|
|
| /s/ XXXXX XXXXXX |
|
/s/ XXXXX XXXXXX |
| Name Xxxxx Xxxxxx: |
|
Name: Xxxxx Xxxxxx |
| Title: CEO |
|
Title: VP Finance and Administration |
| November 23, 2016 |
|
November 7, 2016 |
Appendix
A
Statements of Work
Appendix
B
LBIO Materials
