Exhibit 10.33

 

 

MASTER SERVICES AGREEMENT FOR

CLINICAL RESEARCH AND RELATED SERVICES

 

INC RESEARCH, LLC 1CELLECTAR BIOSCIENCES, INC.MSA

 

 

Table of Contents

 

1. DEFINITIONS 3       2. SERVICES 6       3. TRANSFER OF SPONSOR
OBLIGATIONS/RESPONSIBILITIES 9       4. INVOICING, COMPENSATION AND PAYMENT 9  
    5. TERM AND TERMINATION 12       6. INDEMNIFICATION, LIABILITY AND INSURANCE
14       7. CONFIDENTIALITY 16       8. PROPRIETARY RIGHTS/LICENSURE 17       9.
RIGHT TO AUDIT 18       10. DISCLAIMER 19       11. NOTICES 19       12. FORCE
MAJEURE 20       13. GENERAL PROVISIONS 20

 

INC RESEARCH, LLC 2CELLECTAR BIOSCIENCES, INC.MSA

 

 

This MASTER SERVICES AGREEMENT (“Agreement”), effectively dated as of the last
date of authorized signature herein (“Effective Date”), is made by and between
Cellectar Biosciences, Inc. (“Sponsor”), with principal offices located at 3301
Agriculture Drive, Madison, Wisconsin 53716 and INC Research, LLC, together with
its Affiliates (“INC Research”), a Delaware limited liability company, with
principal offices located in the United States at 3201 Beechleaf Court, Suite
600, Raleigh, North Carolina 27604-1547.

 

WITNESSETH:

 

WHEREAS, Sponsor is engaged in the business of developing, manufacturing,
distributing, and/or selling pharmaceutical products, biotechnological products,
and/or medical devices;

 

WHEREAS, INC Research is engaged in the business of providing clinical research
services, data management, and related services in the pharmaceutical,
biotechnology, and medical device industries;

 

WHEREAS, Sponsor and INC Research desire to agree on terms which will be applied
to govern INC Research’s provision of services for Sponsor (excluding INC
Research Phase I Services as defined in Section 1) in connection with support of
clinical investigation, management and/or research of a particular Study or
Studies; and

 

WHEREAS, both Parties desire to comply with the terms and conditions hereinafter
provided in connection with Study research.

 

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
* * * * * * * * * * * *

NOW, THEREFORE, in consideration of the foregoing and for other good and
valuable consideration, the receipt and adequacy of which hereby are mutually
acknowledged, the Parties intending to be legally bound do hereby agree as
follows:

 

1.DEFINITIONS.

 

Terms contained in this Agreement shall have the meanings set forth in this
section and as they may be defined throughout this Agreement.

 

1.1“Affiliates” shall mean any corporation or organization that directly or
indirectly controls, is controlled by or is under common control with such
Party. “Control”, “controls”, or “controlled” shall mean the possession, direct
or indirect, of the power to direct, or the power to cause the direction of the
management and policies of an entity, whether through ownership of fifty percent
(50%) of voting securities, by contract or otherwise. Any reference to “INC
Research” in this Agreement shall be deemed to include its Affiliates unless
otherwise so stated as being applicable to INC Research, LLC, or an individual
Affiliate exclusively.

 

1.2“Applicable Laws and Regulations” shall mean any and all international,
national, federal, state, and local laws and regulations, including, without
limitation, the regulations and guidelines of the FDA, the Food, Drug, and
Cosmetic Act and, as applicable, accepted standards of Good Clinical Practice
(“GCP”) and International Conference on Harmonization (“ICH”) guidelines that
may be applicable to a Study or the Services.

 

INC RESEARCH, LLC 3CELLECTAR BIOSCIENCES, INC.MSA

 

 

1.3“Change Order” shall mean an amendment to a Work Order that captures a change
in the scope of Services or other Study specific parameters, which may include
an increase or decrease in the Direct Costs and expenses and/or any timeline
adjustments required due to the change in assumptions. Each Change Order shall
be agreed in writing between the Parties and expressly approved by an authorized
individual on behalf of each Party.

 

1.4“Clinical Trial Agreement” shall mean the signed contractual agreement
between Sponsor (or INC Research) and the Investigator and/or Site that manages
the relationship, financial support and/or proprietary information during the
performance of the Study by such Investigator and/or Site.

 

1.5“Commercially Reasonable Efforts” shall mean the efforts and resources which
would be used (including without limitation the promptness in which such efforts
and resources would be applied) by a Party, consistent with generally accepted
industry standards, with regard to the activity to be undertaken by such Party.

 

1.6“Confidential Information” shall mean all non-public, protected and/or
proprietary information in the broadest sense communicated, observed, or heard,
by either Sponsor or INC Research, including either Party's employees,
consultants, agents, Affiliates, and/or the Study-related Investigators and/or
Sites, and Third Party Vendors that relates to past, present or future research,
development, processes, protocol(s), financial statements, personnel
information, pricing and/or business activities of the Party disclosing the
Confidential Information (hereinafter “the Disclosing Party”) and its respective
systems, procedures, algorithms, and data of which the Party receiving the
Confidential Information (the “Receiving Party”) may construct, acquire, access,
or possess by reason of this Agreement. Confidential Information will include
any “Confidential Information” disclosed previously by a Disclosing Party to a
Receiving Party in connection with the discussions among the Parties with
respect to the subject matter of this Agreement. The Parties further agree that
Confidential Information shall include that information discovered during an
audit of either Party’s or its respective Affiliates’ facilities.

 

1.7“Direct Costs” shall mean the applicable price charged for labor in the
performance of Services to be performed under this Agreement, as set forth in
the applicable Work Order.

 

1.8“FDA” shall mean the United States Food and Drug Administration.

 

INC RESEARCH, LLC 4CELLECTAR BIOSCIENCES, INC.MSA

 

 

1.9“Force Majeure” shall mean an event or occurrence beyond a Party’s control
such as, but not limited to, the following: acts of God, war, threat of war,
government retaliation against foreign enemies, government regulation or
advisory, disasters, floods, fire, earthquakes, pandemics, accidents or other
casualty, strikes or threats of strikes (exception: neither Party may terminate
or suspend this Agreement for strikes, labor disputes, or work stoppages
involving its respective employees or agents), civil disorder, terrorist acts
and/or threats of terrorism, acts of foreign enemies, or curtailment of
transportation services making it illegal, impossible, or commercially
impracticable to perform its obligations under this Agreement.

 

1.10“Licensed Software” shall mean software created by INC Research on SAS®
platform and which is configured to process, analyze, summarize, and report
clinical trial data.

 

1.11“INC Research Phase I Services” shall mean Phase I services performed at an
INC Research facility, where INC Research would serve as a Study
Investigator/Site.

 

1.12“INC Research Property” means work product templates, inventions, processes,
know-how, improvements, trade-secrets, other intellectual property and assets,
including, but not limited to INC Research Licensed Software, methods,
procedures and techniques, manuals, personnel information, internal audit
training and policies, financial data, technical expertise and software, which
have been or may be independently developed by INC Research and relate to INC
Research’s business or operations.

 

1.13“Indemnity Claim” means any matter upon which an indemnified party intends
to base a claim for indemnification.

 

1.14“Investigator” means a qualified clinical investigator as defined in ICH E6
4.1.1 engaged to conduct a clinical investigation of a particular Study and/or
Study Product.

 

1.15“Party” means either INC Research or Sponsor; and both collectively as
“Parties”.

 

1.16“Pass Through Costs” shall mean any costs that are not Direct Costs incurred
by INC Research in the performance of Services, including without limitation,
such costs as Service-related travel and Third Party Vendor fees for items such
as printing, laboratory fees, shipping and facsimile costs, language
translation, telephone charges, advertising, investigator meeting expenses,
and/or other expenses associated with the conduct of the Study. Travel costs
include, but are not limited to, those associated with reasonable
transportation, lodging, internet connection, and meals.

 

1.17“Protocol” means the particular written protocol including the clinical
testing procedures, conditions, and instructions for conducting a particular
Study.

 

1.18“Regulatory Authority” shall mean the FDA or any other state or governing
national or multinational regulatory authority or government agency that is
equivalent to or has any similar regulatory functions and responsibilities as
the FDA.

 

INC RESEARCH, LLC 5CELLECTAR BIOSCIENCES, INC.MSA

 

 

1.19“Services” shall mean the particular clinical research services and other
tasks to be performed by INC Research for a given Study pursuant to this
Agreement, as more fully set forth in the Work Order applicable to such Study.

 

1.20“Site” shall mean a hospital, clinic, institution, academic institution, or
office of a practicing physician participating in the conduct of the Study.

 

1.21“Sponsor Losses” shall mean third party claims, actions, damages,
liabilities, costs and expenses (including reasonable legal counsel fees and
expenses) incurred by Sponsor.

 

1.22“Study” or “Studies” shall mean the clinical investigation, management
and/or research activities related to a particular human clinical trial, or
similar Sponsor project conducted pursuant to the applicable Protocol or Sponsor
instructions, including any management and oversight thereof.

 

1.23“Study Product” means, for a given Study, the therapeutic compound of
Sponsor that is the subject of such Study, as well as any applicable placebo,
potential product, or device administered as a result of the Protocol.

 

1.24“Study Records” refers to all information regardless of purpose, format,
location, system or origination that is a result of the conduct of a Study
and/or performance of Services by INC Research and/or any INC Research
sub-contracted service providers.

 

1.25“Third Party Vendor” shall mean any person or party other than INC Research
or Sponsor involved with the provision of services or goods under a Work Order
(including but not limited to hospitals, IRBs, laboratories, pharmacists,
Investigators, and/or Sites).

 

1.26“Work Order” means an individual project agreement executed between Sponsor
and INC Research for a given Study that: (a) expressly references this
Agreement; (b) is made with respect to such specific Study; (c) is signed by
both Parties; and (d) specifies the parameters of and sets forth the details of
the clinical research services to be performed by INC Research in conducting the
Study.

 

2.SERVICES.

 

2.1Work Order. Each Work Order will specify the basic parameters of a Study,
including, without limitation, the scope of work, Study-specific assumptions,
estimated time period for completing Services, estimated budget, payment and
currency schedules, resource allocation and/or, as applicable, other specific
Services to be performed by INC Research. Each Work Order is hereby incorporated
herein by reference, subject to mutually agreeable Change Orders.

 

INC RESEARCH, LLC 6CELLECTAR BIOSCIENCES, INC.MSA

 

 

An Affiliate of a Party can enter into, or perform Services in association with,
Work Orders under this Agreement with the other Party or an Affiliate of the
other Party, with such Affiliates being bound by the terms and conditions
contained herein, and provided that each of INC Research, LLC or Cellectar
Biosciences, Inc., as applicable, shall remain responsible for the actions and
omissions of its Affiliates.

 

Each Work Order shall constitute a unique agreement and shall stand alone with
respect to any other Work Order entered under this Agreement. The performance of
obligations under any one Work Order shall not affect, and shall at all times be
unrelated to, the performance of any other Work Order entered into under this
Agreement. To the extent that terms and/or provisions of a Work Order conflict
with the terms and/or provisions of this Agreement, the terms and/or provisions
of this Agreement shall control unless the Work Order expressly and specifically
states otherwise.

 

2.2Change Orders. In the event Sponsor requests a change in the scope of
Services as originally defined in the Work Order or if there are changes to the
assumptions upon which the Work Order is based (including, but not limited to,
changes in an agreed upon starting date for a Study or suspension of the Study
by Sponsor), the Parties will agree to such change in writing prior to engaging
in out of scope activities (“Contract Modification”).

 

Once the need for a potential Contract Modification is identified, INC Research
may provide written description of the Contract Modification, including any
resulting impact to the Study budget, through use of a Change Notification Form
(CNF). The CNF will be submitted to Sponsor for verification of the
modifications to the scope of Services, and any resulting Study budget
implications. Sponsor’s execution of the CNF shall serve as Sponsor approval and
instruction for INC Research to proceed with the modification of Services (and
resulting budget revisions) as set forth in the CNF. The Parties acknowledge
that upon signature of the CNF by Sponsor, the services set forth in the CNF
shall be considered Services to be performed by INC Research under the Work
Order, and shall therefore be governed by and subject to the terms and
conditions of this Agreement and corresponding Work Order.

 

A Change Order shall be completed upon the cumulative CNF(s) Direct Cost and
Pass Through Costs equaling to or exceeding the threshold amount as set forth in
the requisite Work Oder.

 

Notwithstanding the above, an exception will apply if a modification reasonably
involves the safety of a human subject or the integrity of the Study data, in
which case INC Research shall quickly act on the requested change, and when
practicable, give notice promptly to Sponsor by telephone or electronic
communication that such scope change occurred and a Contract Modification may be
required.

 

INC RESEARCH, LLC 7CELLECTAR BIOSCIENCES, INC.MSA

 

 

CNFs and Change Orders may be approved and forwarded via hand-delivery,
facsimile, electronic mail, portable document format (PDF), or overnight
courier. Absent compelling reasons, Change Order requests will be considered and
a response will be affirmatively given to INC Research within fifteen (15)
calendar days of Sponsor's receipt of same. The Parties agree to work together
in good faith and use Commercially Reasonable Efforts to ensure that the Study
timelines are not adversely affected, it being understood, however, that INC
Research is under no obligation to perform any out of scope work until a CNF
and/or Change Order is agreed to by both Parties.

 

2.3Professional Standards. Each Party shall use Commercially Reasonable Efforts
to progress the Study in a timely manner applying professional standards
consistent with GCP and in adherence to Applicable Laws and Regulations.

 

The major Study milestones and target dates will be described in the applicable
Work Order. Subject to mutually agreed Change Order(s), both Parties agree that
the Work Order shall set forth a reasonable schedule for the Services to be
performed, and each Party will use Commercially Reasonable Efforts to comply
with the timelines stated therein.

 

2.4Interruption or Delay. In the event that any Study is placed on hold for a
period of thirty (30) days or more, Sponsor will compensate INC Research for
Study obligations incurred per the Work Order and the Parties will negotiate a
commercially reasonable fee to compensate INC Research for retention and
training of INC Research-assigned resources for the Study. Such compensation
shall be set forth in a Change Order as described in Section 2.2 herein.

 

In the event that a milestone-based Study is interrupted or delayed for any
other reasons beyond INC Research’s reasonable control, to the extent that such
milestone(s) are affected, INC Research shall be entitled to receive payment for
Services properly performed under the applicable Work Order.

 

Sponsor acknowledges and agrees that INC Research will require documents, data
records, and cooperative efforts by Sponsor and/or other designees in order to
properly perform the Services outlined in each Work Order, and that INC Research
is not responsible for errors, delays, or other consequences arising from the
failure of Sponsor or such designees to provide such data, records, or
cooperative efforts. In the event of a delay caused by actions neither directed
by nor attributable to INC Research, which affect INC Research’s ability to meet
any timelines, the Parties shall re-negotiate in good faith to amend the
targeted dates accordingly.

 

For the sake of clarity, INC Research shall not be responsible for errors,
omissions and/or delays during the conduct of any Study, to the extent such
delays are caused by or result from (i) Sponsor’s actions or omissions, (ii) any
Third Party Vendor’s actions or omissions, (iii) a Force Majeure event or (iv)
any other causes outside the direct control of INC Research. The financial
burden of any additional costs associated with such delays is the responsibility
of Sponsor.

 

INC RESEARCH, LLC 8CELLECTAR BIOSCIENCES, INC.MSA

 

 

3.TRANSFER OF SPONSOR OBLIGATIONS/RESPONSIBILITIES.

 

The transfer of obligations and/or responsibilities from Sponsor to INC Research
pursuant to Applicable Laws and Regulations will be mutually agreed and set
forth in each individual Work Order. Any such regulatory responsibilities not
specifically transferred to INC Research shall remain the regulatory
responsibility of Sponsor. Under no circumstance shall INC Research be required
to accept responsibilities and conduct itself contrary to Applicable Laws and
Regulations.

 

4.INVOICING, COMPENSATIONAND PAYMENT.

 

4.1Direct Cost Compensation. In exchange for valuable consideration with regard
to INC Research’s performance of the Services hereunder, Sponsor shall pay INC
Research for Direct Costs in accordance with a detailed budget as described in
each applicable Work Order. Unless otherwise agreed to in the requisite Work
Order, INC Research may submit, at its discretion, at a minimum, monthly
invoices or other substantiating internal documentation to Sponsor for timely
payment in accordance with this Section 4.

 

4.2Pass Through Cost Compensation. Sponsor shall advance INC Research for Pass
Through Costs incurred by INC Research from Sponsor-approved Third Party Vendors
in connection with INC Research’s performance of Services. Unless otherwise
agreed to in the Work Order, INC Research shall submit at least monthly invoices
or other substantiating internal documentation to Sponsor for payment in
accordance with this Section 4.

 

As set forth in a Work Order, INC Research may negotiate the Investigator
grants, and/or Site Clinical Trial Agreement terms and/or other Study-related
agreements on behalf of Sponsor and at Sponsor’s direction. Sponsor shall be
obligated to provide timely feedback in connection with any such negotiations,
and INC Research shall not be responsible for any undue delays attributable to
Sponsor’s failure to provide approvals and timely responses. Investigator grant
fees and other approved Site fees, including payments for screening failures and
non-complete subjects, will be billed to Sponsor at mutually agreed upon amounts
for the applicable Study. Said fees shall be paid in advance of INC Research’s
expectation to pay the Investigator and/or Site, and Sponsor shall be
responsible for any adverse action taken by an Investigator or Site as a result
of failure to pay grant amounts and other costs due and payable in a timely
manner. INC Research shall have no liability for any failure to make payments if
required funding is not provided to INC Research in advance by Sponsor. Each
Clinical Trial Agreement with Investigators shall contain a statement to that
effect. INC Research shall have no duty to pursue collection of allegedly
unearned fees paid to Investigators and/or Sites.

 

INC RESEARCH, LLC 9CELLECTAR BIOSCIENCES, INC.MSA

 

 

In addition, Sponsor shall reimburse INC Research for all costs and expenses
incurred by INC Research or others engaged by INC Research on behalf of Sponsor
to ensure patient safety, continuity of treatment and compliance with Applicable
Laws and Regulations, to the extent that such costs are actual, reasonable and
verifiable. Such costs may include, but are not limited to, reasonable and
customary costs incurred associated with the diagnosis of an adverse reaction,
adverse event or personal injury involving the Study Product or associated with
the applicable Protocol. In the event that an Investigator reasonably assesses
that a diagnostic procedure(s) is/are medically necessary and connected to the
Study, yet the suspected adverse event is later deemed not to be Study-related,
then Sponsor shall be required to pay for reasonable costs of said diagnostic
procedure(s).

 

4.3Invoicing. Sponsor shall render all payments due and payable to INC Research
within forty-five (45) days of the receipt of an invoice. Sponsor further agrees
to reasonably consider payments schedules within each Work Order to allow INC
Research to maintain cash neutrality by invoicing in advance as stipulated in
the Work Order. Sponsor shall pay INC Research interest in an amount equal to
one and one-half percent (1 ½%) (or such maximum lesser amount allowed by
Applicable Laws and Regulations) per month with regard to all undisputed amounts
past due and payable. Sponsor shall also reimburse INC Research for all costs
incurred in collecting any late payments, including, without limitation,
attorneys’ fees.

 

All invoices shall be deemed received: (i) five (5) business days after the date
postmarked if sent by mail; (ii) on the date of delivery and/or read receipt if
they are sent electronically; or (iii) upon signature if delivered by overnight
delivery service. In the event that any non-disputed amounts remain unpaid for
ten (10) days after the invoice due date, INC Research may stop work on the
Services until it receives such past due payment. However, prior to any such
work stoppage, INC Research shall give five (5) business days’ notice of its
intent to cease Services to allow escalation of the issue within Sponsor’s
organization and the Parties shall discuss resolution of the nonpayment of
non-disputed amounts in good faith. Other than as may be required under
Applicable Laws and Regulations, INC Research shall have no liability to Sponsor
for any costs or damages as a result of such suspension caused by Sponsor’s
failure to pay non-disputed amounts in accordance with the payment terms
contained herein.

 

If any portion of an invoice is disputed, then Sponsor shall pay the undisputed
amounts according to the payment terms herein. If Sponsor, in good faith
identifies items in an invoice which are disputed, Sponsor will notify INC
Research in writing, noting its objection to the disputed item(s) with
specificity, within twenty (20) business days of receipt of the invoice.
Invoices for which no written objection is received by INC Research by Sponsor
within such twenty (20) business day period shall be deemed accepted by Sponsor
as true and correct. INC Research will respond to such written notification
within ten (10) business days of receipt of the disputed notification. This
communication exchange will continue until documentation justifying the charge
has been provided to Sponsor or until INC Research reduces or deletes the
disputed amount to Sponsor’s reasonable satisfaction. Any dispute over invoiced
amounts due that cannot be resolved by direct good faith negotiation between the
parties shall be resolved in accordance with Section 13.9 (Dispute Resolution)
of this Agreement. Should INC Research be required to utilize a third party
invoicing service/system as mandated by Sponsor, any costs associated with such
utilization shall be invoiced to Sponsor as incurred, without mark-up.

 

INC RESEARCH, LLC 10CELLECTAR BIOSCIENCES, INC.MSA

 

 

Sponsor shall not withhold payment of any amounts due and payable under this
Agreement by reason of any setoff any claim or dispute with INC Research,
whether relating to INC Research’s breach, bankruptcy or otherwise.

 

4.4Study Close and Financial Records. Within the latter of (i) ninety (90) days
after the conclusion of the Services; or (ii) sixty (60) days after the receipt
of a final invoice from a Third Party Vendor for each Work Order, INC Research
will submit to Sponsor a final invoice with an accounting of all amounts
invoiced by INC Research, and all payments made by Sponsor. Any overpayment by
Sponsor shall be credited or refunded to Sponsor by INC Research within thirty
(30) days of the final invoice. Any underpayment by Sponsor shall be paid to INC
Research within thirty (30) days after receipt by Sponsor of such final invoice.

 

INC Research shall keep and maintain complete and accurate books and records in
sufficient detail to determine amounts owed to INC Research hereunder. Such
books and records shall be maintained for at least one (1) year following
completion or termination of a Work Order and shall be made available for
inspection, copying and audit by Sponsor in accordance with Section 9 and for
the purpose of determining the accuracy of amounts invoiced.

 

4.5Taxes. INC Research shall invoice Sponsor, and Sponsor shall promptly pay or
reimburse INC Research for taxes or duties actually incurred by INC Research
which are imposed upon INC Research by any governmental agency, including, but
not limited to Value Added Tax, Stamp Tax and/or General Sales Tax, as a result
of this Agreement with the exception of taxes based on INC Research’s income. If
requested by INC Research, Sponsor shall deliver to INC Research official
documentation for such taxes paid.

 

If any payments made by the Parties under this Agreement become subject to
withholding taxes under Applicable Laws and Regulations, each Party shall be
authorized to withhold such taxes as are required under Applicable Laws and
Regulations, pay such taxes to the appropriate government authority, and remit
the balance due to the other Party net of such taxes. The Parties agree to
cooperate in good faith to qualify the transactions for any exemptions or
reductions in the amount of otherwise applicable withholding tax provided under
Applicable Laws and Regulations (including the provisions of any relevant income
tax treaty) and to complete such forms as necessary for such purpose.

 

INC RESEARCH, LLC 11CELLECTAR BIOSCIENCES, INC.MSA

 

 

4.6Currency. Unless otherwise agreed in the applicable Work Order, Sponsor shall
make all payments to INC Research in United States dollars (“US Currency”), and
accordingly INC Research shall invoice Sponsor for all Direct Costs and Pass
Through Costs in US Currency. If Direct Costs are incurred in a currency other
than US Currency, then INC Research and Sponsor will define the mechanism for
currency exchange adjustment in the Work Order. If Pass Through Costs are
incurred in a currency differing from US Currency, then INC Research shall
invoice Sponsor using the exchange rate published in oanda.com at the average
bid rate on the day the expense invoice is generated by INC Research.

 

5.TERM AND TERMINATION.

 

5.1General Term. This Agreement shall commence as of the Effective Date and
shall continue for a period of five (5) years, or until earlier terminated as
provided below. Any Work Orders in existence as of the date of expiration or
termination of this Agreement shall continue to be governed by the terms and
conditions of this Agreement unless such Work Order is specifically terminated
in accordance with the terms herein, or as otherwise mutually agreed in writing
by the Parties.

 

5.2Termination. Either Party may terminate this Agreement or any and all
associated Work Order(s) upon sixty (60) days written notice to the other Party.
Upon receipt of notice of termination, INC Research shall use reasonable efforts
to avoid incurring additional costs and expenses on the project during the
closeout or winding down period.

 

Either Party may terminate this Agreement or any individual Work Order as
follows:

a)On written notice effective immediately if the other Party commits a material
breach of this Agreement or a Work Order which cannot be cured, or for a
material breach of this Agreement or a Work Order which is capable of cure but
is not cured within thirty (30) days of receipt of written notice from the other
Party (“material breach” being defined herein as failure to substantially comply
with any material provision of this Agreement or any Work Order, including
without limitation failure by Sponsor to pay any undisputed portion of an
invoice within thirty (30) days of receipt of notice of an overdue invoice);

 

b)On written notice effective immediately if the other Party becomes insolvent,
is dissolved or liquidated, makes a general assignment for the benefit of its
creditors, files or has filed against it, a petition in bankruptcy, or has a
receiver appointed for a substantial part of its assets;

 

c)On written notice effective immediately if the other Party ceases, or
threatens to cease, to carry on business or maintain itself as a going concern;
or

 

d)On written notice effective immediately as a result of reasonably compelling
scientific evidence that patient safety is at risk should the Study continue,
Study data integrity compromise, and/or reasonable belief that Applicable Laws
and Regulations will be materially violated should this Agreement continue in
effect.

 

INC RESEARCH, LLC 12CELLECTAR BIOSCIENCES, INC.MSA

 

 

5.3Termination Obligations. Upon receipt of a termination notice, the Parties
will promptly meet and agree upon any winding down activities and associated
costs for any Study prior to the performance of any additional tasks not
otherwise addressed in a Work Order. Costs associated with any winding down
period will be invoiced to Sponsor on fee for service basis using the rates in
effect as of the termination date unless otherwise agreed upon by the Parties.

 

5.4Payment Obligations Upon Termination. In the event of termination of any Work
Order, Sponsor will pay to INC Research any Direct Costs and Pass Through Costs
incurred and/or actual costs resulting from commitments (including the
fulfillment of any regulatory requirements), which cannot reasonably be
cancelled and which were entered into by INC Research with respect to the
Services at the time of notice of termination and five percent (5%) of the
remainder of the Direct Costs set forth in the Work Order; provided that INC
Research has used Commercially Reasonable Efforts to minimize such costs.

 

In the event of excess payment to INC Research by Sponsor, INC Research shall
either apply such excess payment as a credit against other amounts due and
payable or promptly refund such excess if there are no outstanding payments owed
INC Research. Sponsor shall pay INC Research any additional amounts owed, but
not yet paid, for Services performed or expenses incurred up to the effective
date of termination.

 

Any payment(s) due and payable under this Section 5.4 shall be made in
accordance with Section 4.3 of this Agreement.

 

5.5Study Records Retention. At Sponsor’s request and expense, and following
satisfaction of Sponsor’s obligations, if the provision of INC Research’s
Services, and/or Services provided by any INC Research sub-contracted service
providers, under this Agreement are terminated by either Party for any reason,
INC Research shall transfer all regulatory responsibility for the Study Records
to Sponsor and provide Sponsor with all applicable Study Records. The transfer
of Study Records will occur within ninety (90) days following the effective date
of termination unless otherwise mutually agreed upon in writing by the Parties.
INC Research may elect to retain copies of some or all such Study Records
according to INC Research’s standard practices for preserving is business
records and in accordance with Applicable Laws and Regulations. INC Research
shall maintain any such copies of Study Records as Confidential Information of
Sponsor.

 

INC RESEARCH, LLC 13CELLECTAR BIOSCIENCES, INC.MSA

 

 

INC Research will not retain any regulatory responsibility for the Study Records
and will not store Sponsor’s Study Records on its premises on Sponsor’s behalf
after the termination or expiration of the Work Order. The Parties may mutually
agree to extend Services related to the Study Records in a Change Order, or in a
separate agreement, that details the terms for the extended retention period and
compensation for such retention. In the event that Sponsor is unable or refuses
to accept the return of the Study Records for any reason, INC Research may elect
to dispose of any Study Records according to its policies and in a confidential
manner unless otherwise prohibited by Applicable Laws and Regulations. INC
Research will demonstrate due diligence in contacting Sponsor to provide
notification of the intention to dispose of Study Records at least ninety (90)
days prior to disposition

 

6.INDEMNIFICATION, LIABILITY AND INSURANCE.

 

6.1Indemnification by Sponsor. Sponsor shall defend, indemnify, and hold
harmless INC Research, its Affiliates and its and their respective directors,
officers, employees, agents and Third Party Vendors from and against any and all
third party losses, claims, actions, damages, liabilities, awards, costs and
expenses (including reasonable legal counsel fees and expenses), whether joint
or several, relating to or arising from or in connection with this Agreement or
the Services contemplated herein, including without limitation, any Study,
Protocol, specifications, or Study Product, performed or administered as a
result of this Agreement and or its associated Work Order(s), or any litigation,
investigation or other proceeding relating to any of the foregoing except to the
extent that such third party claims arise from (i) the negligence or reckless or
willful act or omission of INC Research, its Affiliates or its and their
respective directors, officers, employees, or agents; or (ii) any breach of this
Agreement by INC Research, its Affiliates, or its and their respective
directors, officers, employees, or agents.

 

6.2Indemnification by INC Research. INC Research shall defend, indemnify, and
hold harmless Sponsor, its Affiliates and its and their respective directors,
officers, employees, and agents from and against any and all Sponsor Losses, but
only to the extent such Sponsor Losses are related to or arise from or in
connection with INC Research’s negligence or intentional misconduct, except to
the extent that such Sponsor Losses arise from (i) the negligence or reckless or
willful act or omission of Sponsor, its Affiliates or its and their respective
directors, officers, employees, or agents; or (ii) any breach of this Agreement
by Sponsor, its Affiliates, or its and their respective directors, officers,
employees, or agents.

 

6.3Indemnification Procedures. The Party seeking indemnity will give the
indemnifying Party prompt written notice of an Indemnity Claim under this
Section 6. The indemnified Party shall have the right to participate jointly
with the indemnifying Party, at its own expense, in the defense, settlement or
other disposition of any Indemnity Claim. With respect to any Indemnity Claim
relating solely to the payment of money damages and which could not result in
the indemnified Party becoming subject to injunctive or other equitable relief
or otherwise adversely affect the business of the indemnified Party in any
manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the indemnified Party hereunder, the
indemnifying Party shall have the sole right to defend, settle or otherwise
dispose of such Indemnity Claim, on such terms as the indemnifying Party, in its
sole discretion, shall deem appropriate, provided that the indemnifying Party
shall offer evidence of its ability to pay any damages claimed and with respect
to any such settlement shall have obtained the written release of the
indemnified Party from the Indemnity Claim. The indemnifying Party shall obtain
the written consent of the indemnified Party, which shall not be unduly
withheld, conditioned or delayed, prior to ceasing to defend, settle or
otherwise dispose of any Indemnity Claim if, as a result thereof, the
indemnified Party would become subject to injunctive or other equitable relief
or the business of the indemnified Party would be adversely affected in any
manner.

 

INC RESEARCH, LLC 14CELLECTAR BIOSCIENCES, INC.MSA

 

 

6.4Third Party Vendor Indemnification. Upon reasonable request by
Sponsor-approved Third Party Vendors utilized in connection with this Agreement,
Sponsor shall execute and provide a separate letter of indemnification with such
Third Party Vendors, in a form mutually acceptable to the parties. If requested
by Sponsor, and at Sponsor’s expense, INC Research will assist administratively
with the tasks related to this Section 6.4. Notwithstanding the above, INC
Research shall not be required to indemnify any Third Party Vendors required by
Sponsor or mutually selected between the Parties to be obtained in accordance
with a Study, and INC Research shall not be responsible for any delays resulting
from negotiations involving Sponsor and Third Party Vendors which are related to
the indemnification rights of any such Third Party Vendor.

 

6.5Limitation of Liability. In no event will either Party be liable for any
indirect, special, incidental or consequential damages in connection with or
related to this Agreement (including loss of profits, use, data, or other
economic advantage), howsoever arising, either out of breach of this Agreement,
including breach of warranty, or in tort, even if the other Party has been
previously advised of the possibility of such damage. INC Research’s total
liability for damages shall be limited to the value of the Services completed
under the applicable Work Order (excluding Pass Through Costs).

 

6.6Insurance. Upon written request, each Party shall provide the other with a
copy of its effective Certificate of Insurance or such other documented evidence
offering that it has adequate coverage consistent with human clinical trial
industry standards. Sponsor shall maintain coverage at such amounts that are the
greater of a) the levels detailed in the requisite Work Order or b) compulsory
amounts indicated by local statutory requirements in the country in which the
Services are being performed. Each such INC Research and Sponsor policy shall be
in effect during the term of the applicable Work Order and for at least three
(3) years after the termination or expiration of such Work Order, in either a
primary policy or an extended reporting period endorsement. Sponsor’s liability
shall not be limited to that which is recoverable by insurance.

 

If requested by Sponsor to contract with any Third Party Vendors, Sponsor hereby
authorizes INC Research to provide such Third Party Vendors with a copy of
Sponsor’s Certificate of Insurance. Sponsor represents and warrants that its
insurance (i) does not have an exclusion for the Study Product, (ii) covers the
Study which is the subject of this Agreement or any Work Order and (iii) has no
exclusions that would impede a patient from making a claim against the policy
and will provide a Certificate of Insurance showing evidence of such
declaration.

 

INC RESEARCH, LLC 15CELLECTAR BIOSCIENCES, INC.MSA

 

 

7.CONFIDENTIALITY.

 

7.1Obligations. Either Sponsor or INC Research may become the recipient of
Confidential Information of the other during the term of this Agreement. The
Receiving Party shall treat the Disclosing Party’s Confidential Information as
confidential and proprietary and shall protect it with the same level of
prudence and care as it would protect its own proprietary or confidential
information, but in no event less than reasonable care. The Receiving Party
shall not disclose the Confidential Information to any third party except to the
extent that they reasonably need to know the disclosed information to carry out
the purposes of this Agreement. Additionally, INC Research is authorized to
disseminate limited, blinded, and automatized Protocol or Study information
necessary to perform core business functions as well as for the purpose of
soliciting and evaluating Third Party Vendor bids and project costing.

 

7.2Exceptions. Confidential Information shall not include, and these
confidentiality obligations shall not operate as a restriction on each Party’s
right to use, disclose, or otherwise deal with information which:

 

a)was in the Receiving Party’s possession prior to the time it was acquired from
the Disclosing Party and which was not directly or indirectly acquired from the
Disclosing Party;

 

b)is or lawfully becomes generally available to the public through no fault of
Receiving Party;

 

c)is lawfully and independently made available to the Receiving Party by a third
party;

 

d)is released from its confidential status by the Disclosing Party; or

 

e)is independently developed by or for the Receiving Party without the use of
the Disclosing Party’s Confidential Information as evidenced by the Receiving
Party’s written records.

 

Nothing in this Agreement shall be construed to restrict the Parties from
disclosing Confidential Information as required by law or court order or other
governmental order or request, provided in each case the Party requested to make
such disclosure shall, to the extent permitted by law, timely inform the other
Party and use all Commercially Reasonable Efforts to limit the disclosure and
maintain the confidentiality of such Confidential Information to the extent
possible. In addition, the Party required to make such disclosure shall permit
the other Party to attempt to limit such disclosure by appropriate legal means.

 

INC RESEARCH, LLC 16CELLECTAR BIOSCIENCES, INC.MSA

 

 

7.3Term of Confidentiality. These obligations of confidentiality shall remain in
effect for a period of seven (7) years after the expiration or termination of
this Agreement.

 

8.PROPRIETARY RIGHTS/LICENSURE.

 

8.1Ownership. All materials, documents, information, programs and suggestions
initially provided to INC Research by Sponsor or on behalf of Sponsor in
connection with any Study shall be the exclusive property of Sponsor. Any
copyrightable work created by INC Research in direct connection with the
performance of INC Research’s Services as outlined in this Agreement and
contained in the Study data shall be considered work made for hire, whether
published or unpublished, and all rights therein shall be the property of
Sponsor as author and owner of copyright in such particular work.
Notwithstanding the above, Sponsor acknowledges that any INC Research Property
that is improved, modified or developed by INC Research under or during the term
of this Agreement shall be the sole and exclusive property of INC Research.

 

8.2Publication. Sponsor shall be free to publish or utilize Study data for
promotion or other purposes. At Sponsor’s own expense, Sponsor may request
collaboration from INC Research or its Study-related Third Party Vendors to
assist with preparation of the manuscript. If INC Research is required to
negotiate and/or execute Clinical Trial Agreements, Sponsor will consider
publication requests initiated by such Study-related Institution(s) and/or
Site(s). INC Research shall have no liability whatsoever for any delay resulting
from such Sponsor consideration and response.

 

8.3Licensure. Sponsor certifies that all relevant required licenses, including
but not limited to those connected with drug dictionaries, and in particular the
Uppsala Monitoring Centre and the Medical Dictionary for Regulatory Activities
(MedDRA), shall at all times during the course of this Agreement be in full
force and effect. In accordance with the requisite licensing agreement and
validation requirements, Sponsor agrees to provide evidence of such licensure to
INC Research and/or permits INC Research to seek validation from the licensor.

 

8.4Software Rights. INC Research may facilitate the distribution of software and
associated software documentation in accordance with this Agreement. INC
Research may accordingly grant Sponsor a non-exclusive right to use, store,
disseminate such software and associated program documentation for the sole
purpose of conducting a clinical trial for which INC Research is providing
relevant Services. Notwithstanding the above, the distribution of INC Research
Licensed Software shall be governed solely by the terms of Appendix A of this
Agreement.

 

INC RESEARCH, LLC 17CELLECTAR BIOSCIENCES, INC.MSA

 

 

9.RIGHT TO AUDIT.

 

9.1INC Research will permit Sponsor-designated representatives (unless such
representatives are competitors of INC Research) to examine, at a reasonable
time and during normal business hours, raw Study data, financials and other
relevant information, which Sponsor may reasonably require in order to confirm
that the Study is being conducted in conformance with the Protocol and in
compliance with Applicable Laws and Regulations. Such audits shall be limited to
one audit per twelve-month period at no-cost to Sponsor. Additional audits shall
be at Sponsor’s expense. Sponsor will provide INC Research with a minimum of
thirty (30) days advance notice of its intention to conduct such audit in order
for INC Research to facilitate the availability of appropriate staff. INC
Research will notify Sponsor as soon as practical if any Regulatory Authority
requests an inspection or commences an unscheduled inspection that includes any
aspect of Sponsor’s project(s) in the inspection scope.

 

9.2Both Parties shall promptly notify the other Party of any Regulatory
Authority inspections, investigation or inquiry concerning any Study or project
of Sponsor for which INC Research is performing Services (“Inspection”). Where
appropriate and permitted by the Regulatory Authority, Sponsor will have the
right to be present at any such Inspections if they occur on INC Research
premises. INC Research will have primary responsibility for preparing any
responses for Inspections occurring on INC Research premises and Sponsor shall
be responsible for providing information to INC Research required for providing
adequate responses to Inspection findings as required. Sponsor, its agents and
consultants shall strictly observe all obligations of confidentiality concerning
any documents, information, data or materials in accordance with Section 7.1
herein. Commercially reasonable costs associated with hosting and responding to
any Inspection (including any preparation, participation, follow-up and
resolution of findings), shall be reimbursed by Sponsor on a time and materials
basis.

 

9.3If, during the course of conducting the Services, INC Research becomes aware
of information which indicates possible fraud/misconduct by an Investigator
and/or at a Site, and after a reasonable investigation determines that the
possibility of fraud/misconduct is substantiated, INC Research will promptly
inform Sponsor of its findings and present an action plan for Sponsor's
approval. It will be Sponsor’s responsibility to conduct a full investigation
outside of the action plan unless delegated to INC Research by Sponsor, in which
case Sponsor shall pay for all reasonable costs incurred by INC Research to
perform such investigation. If fraud or misconduct (hereafter together referred
to as “fraud” for purposes of this section 9.3) is confirmed, then it will be
the responsibility of Sponsor to notify the FDA or any other appropriate
Regulatory Authority. After completion of its investigation, Sponsor will
provide evidence satisfactory to INC Research either (i) that fraud was not
committed or, (ii) if fraud was committed, that confirms the proper reporting of
the fraud to the appropriate Regulatory Authority. If Sponsor does not
investigate the possible fraud within a reasonable time, or if fraud is
confirmed by investigation and Sponsor does not fulfill its obligations to
report the fraud within a reasonable time, then INC Research may report its
suspicions of possible fraud to the appropriate Regulatory Authority and notify
Sponsor of this action in writing.

 

INC RESEARCH, LLC 18CELLECTAR BIOSCIENCES, INC.MSA

 

 

10.DISCLAIMER

 

10.1Sponsor acknowledges that the results of the Services to be provided as
outlined herein are inherently uncertain and that, accordingly, there can be no
assurance, representation or warranty by INC Research that the Study Product
will be successfully marketed by Sponsor.

 

10.2Sponsor acknowledges that INC Research shall not be responsible for the
authenticity of the Study Product.

 

10.3Sponsor acknowledges that the terms of this Agreement exclude all implied
warranties including, but not limited to, the implied warranties of
merchantability and fitness for a particular purpose.

 

10.4Sponsor acknowledges that the Services to be provided by INC Research as
outlined herein are based upon information supplied by INC Research and Sponsor,
as well as others, and that INC Research does not guarantee or warrant the
results of such Services to any functions or other standards. In connection with
deliverables associated with this Agreement and/or its associated Work Order(s),
the sole remedy of Sponsor for any breach or default of INC Research which is
not cured by INC Research within a reasonable cure period shall be termination
of this Agreement and/or its associated Work Order.

 

10.5Independent Contractor. INC Research is performing the Services as an
independent contractor and not as an employee, agent, franchise, partner of, or
joint venturer with Sponsor. Any Third Party Vendors are understood to be
exercising independent judgment, and shall not be deemed to be employees,
subcontractors, and/or agents of INC Research; and under no circumstance shall
INC Research be responsible for the conduct of, or the independent or medical
judgment, of any such third party.

 

11.NOTICES

 

This Agreement, including any exhibits, may be amended or modified only by an
instrument of equal formality signed by duly authorized representatives of the
respective Parties. All formal or legal notices, requests, demands or other
communications hereunder, other than communications reasonably deemed to be
day-to-day within the duties of project management shall be in writing and shall
be deemed given if personally delivered or disseminated by nationally recognized
courier or certified mail with return receipt within five (5) days after prior
mailing to the address set forth below:

 

INC RESEARCH, LLC 19CELLECTAR BIOSCIENCES, INC.MSA

 

 

If to: Cellectar Biosciences, Inc.   3301 Agriculture Drive   Madison, WI 53716
  Phone: 608-441-8120   Facsimile: 608-441-8121     If to: INC RESEARCH, LLC  
Attention: Global Sponsor Solutions   INC Research, LLC   3201 Beechleaf Court  
Suite 600   Raleigh, NC 27604-1547   Phone: 919-876-9300   Facsimile:
919-882-0425

 

12.FORCE MAJEURE

 

The performance of this Agreement by either Party, in part or in full, may be
impacted by a Force Majeure event. In such a case, either Party may terminate,
suspend, or partially perform its obligations under this Agreement, without
liability or further obligation, by written notice to the other Party if such
obligations are delayed, prevented, or frustrated by any of the above events, or
similar events or occurrences, to the extent such events or occurrences are
beyond the reasonable control of the Party whose reasonable performance is
prevented, made impracticable, or partially curtailed; provided, however, that
Sponsor must perform its obligations to pay for all INC Research non-cancellable
expenses incurred as a result of the above events or similar intervening causes.
Sponsor also agrees to pay all reasonable expenses incurred in connection with
Sponsor-directed meetings whereby any of the above actions or threats of actions
prevent the attendees from attending or delay the departure of attendees from a
designated meeting facility. Unless otherwise agreed by the Parties in writing,
any deadline or time for performance which falls due during or subsequent to
such Force Majeure event shall be automatically extended for a minimum period of
time equal to the period of disability.

 

13.GENERAL PROVISIONS

 

13.1Compliance with Government Regulations. To the extent applicable, both
Sponsor and INC Research shall comply with any applicable validated methodology,
generally accepted professional standards of care, and all Applicable Laws and
Regulations of each country where the Services will be conducted, including
without limitation ICH Guidelines for GCP. The Parties will also comply to the
extent applicable with the United States Federal anti-kickback statute (42
U.S.C. 1320a-7b), and the related safe harbor regulations. Should any such
government regulatory requirements be changed, each Party will use Commercially
Reasonable Efforts to satisfy the new requirements. In the event that compliance
with such new regulatory requirements necessitates a change in the Services, the
Parties will evaluate a Contract Modification to be mutually agreed for the
changes in the Services.

 

INC RESEARCH, LLC 20CELLECTAR BIOSCIENCES, INC.MSA

 

 

Both Sponsor and INC Research warrant that they are, and will remain, in
compliance with the Foreign Corrupt Practices Act (“FCPA”) and/or all other,
applicable anti-bribery laws or regulations. A breach of this warranty, will
allow the non-breaching Party to immediately terminate this Agreement and/or any
associated Work Order.

 

Nothing contained in this Agreement shall be construed in any manner as an
obligation or inducement for either Party to recommend that any person or entity
purchase the other Party’s products or services, or those of any organization
affiliated with the other Party.

 

13.2Qualifications. Each Party hereby represents that it has not been debarred
and has not been convicted of a crime which could lead to debarment under the
Generic Drug Enforcement Act of 1992. Each Party hereby represents that to the
best of its knowledge it has not utilized, and will use its reasonable efforts
not to utilize, the services of any individual or legal entity in the
performance of Services or obligations under this Agreement that has been
convicted of a crime which could lead to debarment. In the event that INC
Research becomes aware that any of its officers, directors or employees has
become debarred, then INC Research shall notify Sponsor promptly.

 

13.3Survival of Terms. The rights, duties and obligations under Sections 4, 6,
7, 8, 9, 10, 13 and Appendix A shall survive the termination or expiration of
this Agreement.

 

13.4Binding Agreement. This Agreement shall be binding upon the Parties hereto
and shall inure to the benefits of the Parties hereto. No modification of this
Agreement shall be deemed effective unless engaged in writing and executed as
described herein, and any waiver granted shall not be deemed effective unless in
writing, executed by the Party against whom enforcement of the waiver is sought.

 

13.5Data Protection. If any of the Services under this Agreement will involve
the collection or processing of personal data (as defined by applicable data
protection legislation) within the European Economic Area (“EEA”), then Sponsor
shall serve as the Data Controller of such Personal Data, as defined by the
European Union Data Protection Directive 95/46/EC, (the “Directive”), and INC
Research shall act only as the Data Processor under the written instructions of
Sponsor regarding the handling of personal data in connection with this
Agreement. Where INC Research’s processing of such personal data takes place in
countries that have not received an "adequacy" finding pursuant to Articles 25
and 26 of the Directive, INC Research shall make transfers of such personal data
to INC Research Affiliates and contractors in such countries in compliance with
the applicable requirements of Articles 25 and 26 of the Directive concerning
international and onward data transfers. In addition to its adherence to the
Directive, INC Research, LLC subscribes to the "Safe Harbor Principles" issued
by the U.S. Commerce Department on July 21, 2000 and as a result, currently
appears on the Department's Safe Harbor list (available at
http://www.export.gov/safeharbor) as a member of both the European Union –
United States and Switzerland – United States Safe Harbor Programs. In the event
of a lapse of INC Research, LLC’s Safe Harbor status, INC Research will promptly
remedy such a lapse or work with Sponsor to find an alternative means of meeting
the adequacy requirements of the Directive. If the Safe Harbor framework is
amended, INC Research, LLC shall update its processes and certifications as
needed to continue compliance with the Safe Harbor Programs. If requested by INC
Research, in order to enable INC Research to comply with the Directive, Sponsor
will execute any documents necessary for such compliance which may include the
INC Research standard Data Processing Agreement and/or an EU model clause
contract deemed by the European Commission to offer sufficient data protection
safeguards in relation to any transfer of personal data out of the EEA, unless
the parties deem that there is another exemption that it believes satisfies the
Directive’s requirements and that adherence encompasses the personal data that
is the subject of the transfer. Each Party represents that procedures compatible
with the relevant directives, data protection laws and regulations will be
employed so that processing and transfer of relative personal data and
identifiers, relating to all data subjects or protected information will not be
impeded.

 

INC RESEARCH, LLC 21CELLECTAR BIOSCIENCES, INC.MSA

 

 

13.6Entire Agreement. The making, execution, and delivery of this Agreement by
INC Research and Sponsor have been induced by no representations, statements,
warranties, or agreements other than those herein expressed. This Agreement, in
conjunction with its attachments, embodies the entire and integrated
understanding between the Parties hereto and supersedes all prior agreements or
understandings, negotiations, or representations either written or oral,
regarding its subject matter.

 

13.7No Effect to Printed Standard Terms. Regardless of anything to contrary, no
printed standard terms appearing on any proposal, purchase order, invoice,
quotation, or other documentation relating to the Services will be effective in
adding to or changing the terms of this Agreement or any Work Order.

 

13.8Governing Law. This Agreement shall be governed by and construed and
enforced in accordance with the laws of the State of Delaware, excluding that
body of law known as choice of law, and shall be binding upon the Parties hereto
in the United States and worldwide.

 

13.9Dispute Resolution. In the event a dispute arises between the Parties over
the interpretation and application of this Agreement, the Parties shall attempt
to settle such a dispute first by good faith negotiation and consultation
between themselves with senior representatives with authority to resolve the
dispute.

 

If such efforts do not result in a resolution, and at least thirty (30) days
have elapsed since notification of the dispute, then the Parties may next seek
to mediate their dispute using a professional mediator from the American
Arbitration Association (AAA). The Parties agree to convene with the mediator,
with senior representatives of the Parties present (having authority to resolve
the dispute), for at least one session.

 

INC RESEARCH, LLC 22CELLECTAR BIOSCIENCES, INC.MSA

 

 

If mediation does not result in the resolution of a dispute or sixty (60) days
have elapsed since the notification of the dispute, the Parties agree to resolve
the dispute through arbitration before a single arbitrator in accordance with
the Commercial Arbitration Rules of the AAA, then pertaining (available at
www.adr.org), except where those rules conflict with this provision, in which
case this provision controls. Any court with jurisdiction shall enforce this
clause and enter judgment on any award. The arbitrator shall be selected within
ten (10) business days of commencement of the arbitration from the AAA’s
National Roster of Arbitrators pursuant to agreement or through selection
procedures administered by the AAA. Within forty-five (45) days of initiation of
arbitration, the Parties shall reach agreement upon and thereafter follow
procedures assuring that the arbitration will be concluded and the award
rendered within no more than eight (8) months from selection of the arbitrator
or, failing agreement, procedures meeting such time limits designated by the
AAA. The arbitration shall be held in a mutually agreed neutral setting and
shall apply the substantive law of Delaware, except that the interpretation and
enforcement of this arbitration provision shall be governed by the Federal
Arbitration Act. The arbitrator shall be bound by the expressed terms of this
Agreement. Each Party shall bear their own costs in connection with any of the
remedial actions set forth above.

 

By agreeing to arbitration, the Parties do not intend to deprive any competent
court of such court’s jurisdiction to issue a pre-arbitral injunction,
pre-arbitral attachment or other order in aid of the arbitration proceedings and
the enforcement of any award or judgment. Without prejudice to such provisional
remedies in aid of arbitration as may be available under the jurisdiction of a
national court, the court of arbitration shall have full authority to grant
provisional remedies and to award damages for failure of any party to respect
the court of arbitration’s order to that effect.

 

13.10Waiver. Waiver or forbearance by either Party or the failure by either
Party to claim a breach of any provision of this Agreement or to exercise any
right or remedy provided by hereunder, or under Applicable Laws and Regulations,
shall not constitute a waiver with respect to any subsequent breach of this
Agreement.

 

13.11Severability. If any part, term, provision or provisions of this Agreement
shall be held to be invalid, illegal, unenforceable or in conflict with the law
of jurisdiction, the validity, legality and enforceability of the remaining
provisions shall not in any way be affected or impaired thereby.

 

13.12Headings Not Controlling. Headings used in this Agreement are for reference
purposes only and shall not be used to modify the meaning of the terms and
conditions of this Agreement.

 

INC RESEARCH, LLC 23CELLECTAR BIOSCIENCES, INC.MSA

 

 

13.13Counterparts. This Agreement along with any requisite Work Order may be
executed in several counterparts by duly authorized individuals on behalf the
Parties, each document of which shall be deemed an original but all of which
shall constitute one and the same instrument.

 

IN WITNESS WHEREOF, the undersigned have caused this Agreement to be executed by
a duly authorized individual on behalf of each requisite Party effective as of
the Effective Date. In the event that the Parties execute this Agreement by
exchange of portable document format, other electronically signed copies or
facsimile signed copies, the Parties agree that, upon being signed by both
Parties, this Agreement shall become effective and binding and that such copies
will constitute evidence of the existence of this Agreement. Thereafter, the
Parties agree that in connection with request for information that either Party
may need from the other related to the Services provided hereunder, both Parties
expressly permit communication via facsimile or electronic means to the extent
allowed by Applicable Laws and Regulations to be disseminated in that manner.

 

INC RESEARCH, LLC   CELLECTAR BIOSCIENCES, INC.       By: /s/ Andrew I. Shaw  
By: /s/ Jarrod Longcor Name: Andrew I. Shaw   Name: Jarrod Longcor Title:
 Assistant General Counsel   Title: SVP Corp. Dev & Operations Date: Sep 27,
2016   Date: Oct. 6, 2016

 

INC RESEARCH, LLC       By: /s/ Jason Meggs   Name: Jason Meggs   Title: SVP
Global Business Finance   Date: Sep 27, 2016  

 

INC RESEARCH, LLC 24CELLECTAR BIOSCIENCES, INC.MSA

 

 

APPENDIX A

Software License Terms

 

Sponsor acknowledges that INC Research is the sole owner of Licensed Software
and that should Sponsor desire a non-exclusive license to utilize the Licensed
Software, Sponsor shall be subject to the terms as delineated in this Appendix A
(“Appendix”). Accordingly, INC Research is willing to grant Sponsor such a
non-exclusive license, subject to the terms and conditions set forth in the
Agreement, and more specifically in this Appendix. Should any of the terms of
the Agreement conflict, in any way, with the terms of this Appendix, the terms
of this Appendix shall govern, solely over matters as they relate to the
Software License Terms.

 

1.LICENSE.

 

1.1.License Grant.

 

1.1.1.       Subject to the terms and conditions set forth in this Appendix A,
INC Research hereby grants to Sponsor and Sponsor accepts from INC Research, a
non-exclusive right and license (the “License”) to utilize, reproduce, and
distribute the Licensed Software only for: (i) internal, non-commercial purposes
in connection with the clinical trial data with which the Licensed Software was
provided by INC Research (the “Data Set”); and (ii) submission to government
agencies in connection with Sponsor’s applications for approval of the Data Set
from such government agencies.

 

1.1.2.       This License is not a sale of the original or any copy of the
Licensed Software.

 

1.2.       Updates and Support. Unless otherwise agreed in writing between the
parties pursuant to a separate agreement, Sponsor will not be entitled to
receive any enhancements, updates or new versions of the Licensed Software, and
INC Research shall not be obligated to maintain or support the Licensed Software
in any way.

 

1.3.       Ownership. Sponsor acknowledges that the Licensed Software is the
valuable, confidential, and proprietary property of INC Research as described in
the Agreement, the development of which required the investment of substantial
time, effort and financial resources by INC Research, and further acknowledges
that INC Research shall retain exclusive title to this property both during the
term and after the termination of the Agreement. Sponsor agrees that, both
during the term of the Agreement and after its termination, it will not contest,
directly or indirectly, INC Research’s ownership, title, right or interest in
the Licensed Software. Without limitation, Sponsor acknowledges the validity of
any copyrights, patents, or trade secrets (collectively “Intellectual Property”)
that may arise out of the Licensed Software, agrees that any rights in and to
the Intellectual Property in the Licensed Software shall remain the exclusive
property of INC Research at all times (INC Research Property), and agrees that
it will take no action inconsistent with such rights. EXCEPT AS OTHERWISE
PROVIDED IN THE AGREEMENT, SPONSOR SHALL NOT, IN WHOLE OR IN PART, AT ANY TIME
DURING THE TERM OF OR AFTER THE TERMINATION OF THE AGREEMENT: (i) SELL,
TRANSFER, ASSIGN, LEASE, RENT, OR SUBLICENSE THE LICENSED SOFTWARE TO ANY THIRD
PARTY; (ii) DISCLOSE, COPY OR REPRODUCE IN ANY MANNER, DISPLAY, OR DISTRIBUTE
THE LICENSED SOFTWARE TO ANY THIRD PARTY; (iii) MODIFY, DISASSEMBLE, DECOMPILE,
REVERSE ENGINEER OR TRANSLATE THE LICENSED SOFTWARE; OR (iv) ALLOW ANY PERSON OR
ENTITY TO COMMIT ANY OF THE ACTIONS DESCRIBED IN (i) THROUGH (iii) ABOVE.
Sponsor shall take appropriate action, by instruction, agreement, or otherwise,
with respect to its employees and contractors permitted under the Agreement to
have access to the Licensed Software, to ensure that all of Sponsor's
obligations under this Section shall be satisfied.

 

INC RESEARCH, LLC 25CELLECTAR BIOSCIENCES, INC.MSA

 

 

2.REPRESENTATIONS.

 

2.1.    Mutual Representations. Each of the parties hereto represents and
warrants to the other that:

 

2.1.1.       Each is a legal entity duly organized and validly existing under
the laws of the state of its formation and has full power and authority to
execute, deliver and perform the terms of this Appendix.

 

2.1.2.       This Appendix is not in conflict with any other agreements to which
it is a party.

 

2.1.3.       The execution, delivery and performance by such party of this
Appendix have been duly authorized by all necessary action of such party, do not
require any approval which has not been obtained, do not contravene the
organizational documents of such party or any law, regulation, rule, or order
binding on such party, and do not contravene the provisions of or constitute a
default under any indentures, mortgage, contract, or other agreement or
instrument to which it is a party.

 

2.2.       Sponsor’s Representations. Sponsor represents and warrants to INC
Research that:

 

2.2.1.       Sponsor shall be solely responsible for the use of the Licensed
Software pursuant to the terms of this Appendix.

 

2.2.2.       Sponsor shall comply with all applicable laws and regulations and
obtain all appropriate government approvals pertaining to the use of the
Licensed Software.

 

3.       INDEMNIFICATION. Sponsor agrees to defend, indemnify, and hold INC
Research, and its officers, directors, shareholders, agents and employees,
harmless against all costs, expenses, and losses (including reasonable attorney
fees and costs) incurred as a result: of (i) claims of a third party against INC
Research based on Sponsor’s use of the Licensed Software pursuant to this
Appendix; and/or (ii) a breach by Sponsor of any of the representations set
forth in Section 2 of this Appendix.

 

INC RESEARCH, LLC 26CELLECTAR BIOSCIENCES, INC.MSA

 

 

4.TERMINATION.

 

4.1.       Term. The terms of this Appendix, shall commence on the Effective
Date of the Agreement and shall continue in perpetuity.

 

4.2.       Early Termination. The terms of this Appendix shall be terminable at
the option of either party upon written notice to the other party if:

 

4.2.1.       the other party is in material breach or default with respect to
any material term or provision of this Appendix and fails to cure the same
within fourteen (14) days after written notice thereof, which notice shall
specify the breach or default in reasonable detail;

 

4.2.2.       the other party has made a material representation or warranty in
this Appendix that is materially false or misleading;

 

4.2.3.       either party is adjudged bankrupt, files or has filed against it
any petition under bankruptcy, insolvency, or similar laws, has a receiver
appointed for its business property, or makes a general assignment for the
benefit of creditors, and such condition is not remedied or removed within
thirty (30) days; or

 

4.2.4.       a court of final jurisdiction determines that either party’s
exercise of its rights hereunder or the use of the Licensed Software infringes
or contravenes any valid and outstanding right or license of a third party based
upon a patent or copyright or any similar proprietary rights.

 

4.3.        Effect of Termination. Within ten (10) days after the date of
termination of the terms of this Appendix for any reason, Sponsor shall return
all original copies of the Licensed Software and give INC Research written
notice certifying that the original copies of the Licensed Software and any
other material received from INC Research in connection with this Appendix have
been returned to INC Research, and that the Licensed Software has been erased
from all computer memories and storage devices within Sponsor’s control and that
Sponsor has not retained any copies of the Licensed Software. In addition to all
other remedies available to INC Research under the Agreement and the terms of
this Appendix, INC Research shall be entitled to specific performance of
Sponsor’s obligations to return and erase the Licensed Software pursuant to this
Section.

 

4.4.       Survival of Certain Terms. The following shall survive any
termination of this Appendix for any reason: Sections 1.3, 2, 3, 4.4, 5, and 6.

 

INC RESEARCH, LLC 27CELLECTAR BIOSCIENCES, INC.MSA

 

 

5.WARRANTY EXCLUSION.

 

THE LICENSED SOFTWARE IS PROVIDED BY INC RESEARCH “AS-IS” AND “AS AVAILABLE” AND
INC RESEARCH MAKES NO WARRANTIES WHATSOEVER WITH RESPECT TO THE LICENSED
SOFTWARE, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND
NON-INFRINGEMENT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, INC RESEARCH
MAKES NO WARRANTY WITH RESPECT TO, AND SPONSOR ACCEPTS SOLE RESPONSIBILITY FOR,
THE INSTALLATION AND USE OF THE LICENSED SOFTWARE, ANY RESULTS OBTAINED FROM
SUCH USE, AND THE SELECTION, USE OF AND RESULTS OBTAINED FROM ANY OTHER PROGRAM,
PROGRAMMING EQUIPMENT OR SERVICES OPERATED OR APPLIED IN CONNECTION WITH THE
LICENSED SOFTWARE. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, INC
RESEARCH ALSO MAKES NO WARRANTY THAT THE LICENSED SOFTWARE WILL MEET SPONSOR’S
TECHNICAL OR OTHER REQUIREMENTS. INC RESEARCH DOES NOT REPRESENT OR WARRANT THAT
THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR THAT THE LICENSED SOFTWARE IS
ERROR-FREE, PROBLEM-FREE, OR WITHOUT OTHER LIMITATIONS. NO REPRESENTATIONS,
WARRANTIES OR GUARANTEES WHATSOEVER ARE MADE AS TO THE ACCURACY, ADEQUACY,
AVAILABILITY, RELIABILITY, TIMELINESS, COMPLETENESS, SUITABILITY OR
APPLICABILITY OF THE LICENSED SOFTWARE. IF APPLICABLE LAW REQUIRES ANY
WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE, ALL SUCH WARRANTIES ARE
LIMITED IN DURATION TO THE SHORTEST PERIOD OF TIME REQUIRED BY LAW. NO ORAL OR
WRITTEN INFORMATION OR ADVICE GIVEN BY INC RESEARCH, ITS DEALERS, DISTRIBUTORS,
AGENTS OR EMPLOYEES SHALL CREATE A WARRANTY OR IN ANY WAY INCREASE THE SCOPE OF
ANY WARRANTY PROVIDED HEREIN.

 

6.MISCELLANEOUS.

 

6.1.       No Implied Rights. Except as expressly provided for in this Appendix,
nothing contained herein shall be construed as conferring any license or other
rights, by implication, estoppel, or otherwise, under any patents or patent
applications, trade secrets, proprietary information, copyrights, trademarks,
trade names, or trade dress of either party.

 

6.2.       Injunctive Relief. Sponsor acknowledges that any breach of Sponsor’s
obligations under this Appendix may result in irreparable injury for which INC
Research shall not have an adequate remedy at law. Accordingly, if Sponsor
breaches or threatens to breach any of Sponsor’s obligations under this
Appendix, INC Research shall be entitled, without showing or proving any actual
damage sustained, to a temporary restraining order, preliminary injunction,
permanent injunction, and/or order compelling specific performance, to prevent
the breach of Sponsor’s obligations under this Appendix. Nothing in this
Appendix shall be interpreted as prohibiting INC Research from pursuing or
obtaining any other remedies otherwise available to it for such actual or
threatened breach, including recovery of damages.

 

INC RESEARCH, LLC 28CELLECTAR BIOSCIENCES, INC.MSA

 

 

6.3.       Assignment. The terms of this Appendix shall bind and inure to the
benefit of the parties and their respective permitted successors and assigns.
INC Research shall have the right to assign or otherwise transfer its rights or
obligations under this Appendix whether by contract or operation of law without
Sponsor’s consent. Sponsor shall not have the right to assign, by contract,
operation of law or otherwise, the terms of this Appendix or any of the rights,
interests, or obligations hereunder without the prior written consent of INC
Research. A successor in interest by merger, operation of law or purchase of the
assets or entire business of Sponsor or otherwise shall not acquire all or any
portion of Sponsor’s interests hereunder without the prior written consent of
INC Research.

 

6.4.       Informed Review. Each party acknowledges that it has received and
reviewed this Appendix and that normal rules of construction, to the effect that
ambiguities are to be resolved against the drafting party, shall not apply to
this Appendix or to any amendments, modification, schedules, or attachments to
this Appendix.

 

INC RESEARCH, LLC 29CELLECTAR BIOSCIENCES, INC.MSA