Exhibit 10.3

 

MASTER SERVICES AGREEMENT

 

THIS MASTER SERVICES AGREEMENT (the “Agreement”) is made and entered into as of
May 6, 2013 (the “Effective Date”) by and between PPD DEVELOPMENT, LLC, a
Delaware limited liability company, with its principal executive offices located
at 929 North Front Street, Wilmington, North Carolina 28401 (“PPD”) and Celldex
Therapeutics Inc., a corporation with its principal executive offices located at
119 Fourth Avenue, Needham, MA 02494 (“Sponsor”).

 

WHEREAS, Sponsor is engaged in the development, manufacture, distribution and
sale of pharmaceutical products; and

 

WHEREAS, PPD is a clinical research organization engaged in the business of
managing clinical research programs and providing clinical development and other
related services; and

 

WHEREAS, Sponsor may wish to retain the services of PPD from time to time to
perform clinical development services in connection with certain clinical
research programs Sponsor is conducting (individually, a “Project”), in which
case the terms and conditions for each such Project shall be set forth in a
project addendum to be attached to this Agreement and incorporated herein by
reference (individually, a “Project Addendum” and collectively, the “Project
Addenda”); and

 

WHEREAS, PPD is willing to provide such services to Sponsor in accordance with
the terms and conditions of this Agreement and the attached Project Addenda.

 

NOW, THEREFORE, for good and valuable consideration contained herein, the
exchange, receipt and sufficiency of which are acknowledged, the parties agree
as follows:

 

1.             SERVICES.

 

1.1          Services to be Provided by PPD.  PPD hereby agrees to provide to
Sponsor the services identified and described in the Services section of each
Project Addendum attached to this Agreement (the “Services”).  PPD and its
Agents (and Affiliates if applicable pursuant to Section 13.11) shall perform
the Services for each Project set forth in the applicable Project Addendum in
compliance with (i) the protocol for the Project (“Protocol”), which may be
attached to and as amended or updated from time to time by written agreement of
the parties,  and made a part of the applicable Project Addendum, (ii) the terms
and conditions of this Agreement, (iii) the terms and conditions of the
applicable Project Addendum, (iv) PPD’s standard operating procedures (“SOPs”),
which have been approved by Sponsor, and (v) all applicable laws, rules and
regulations including in strict accordance with: all applicable federal,
national, regional and local  statutes, rules, guidelines, and regulations
(“Applicable Law”), including without limitation;

(i)            the United States Food, Drug and Cosmetic Act, as amended, and
any and all rules and regulations promulgated there under (the “Act”), Title 21
Code of Federal Regulations (“CFR”) Parts 50, 56 and 312, and any other
applicable FDA regulations or guidance documents;

(ii)           European Commission Directive 2001/20 EC; and

(iii)          ICH guidelines and Good Clinical Practices;

Sponsor agrees that PPD is responsible only for those Services set forth on a
properly executed Project Addendum which is signed by authorized representatives
of both parties to this Agreement.

 

1.2          Project Addendum.  In the event that the parties hereto shall reach
agreement with respect to the provision of Services for a Project, PPD and
Sponsor shall execute a Project Addendum evidencing such Services.  Each Project
Addendum shall be in writing and signed by authorized representatives of both
parties and attached to this Agreement and incorporated into and made a part of
this Agreement by reference, and each such Project Addendum and this Agreement
shall constitute the entire agreement for the applicable Project.  To the extent
any terms set forth in a Project Addendum conflict with the terms set forth in
this Agreement, the terms of this Agreement shall control unless otherwise
specifically set forth in the Project Addendum. PPD shall report in accordance
with any specific reporting obligations set forth in

 

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a Project Addendum to Sponsor regarding progress under each Project Addendum
including provision of all data, work products, incidents and results relating
to the Services.

 

1.3          Sponsor and PPD Cooperation.

 

Sponsor will reasonably cooperate with PPD in providing information to PPD,
taking action and executing documents, as appropriate, to achieve the objectives
of this Agreement.  Sponsor acknowledges and agrees that PPD’s performance under
this Agreement is dependent on Sponsor’s timely and effective reasonable
cooperation with PPD.  Accordingly, Sponsor acknowledges that any delay by
Sponsor may result in PPD being released from an obligation or schedule deadline
or in Sponsor having to pay extra fees in order for PPD to meet a specific
obligation or deadline despite the delay. PPD agrees to reasonably cooperate
with Sponsor and provide Sponsor a reasonable time to respond to PPD’s requests
to achieve the objectives of this Agreement. Sponsor shall comply with all
Applicable Laws governing the performance of its obligations hereunder and the
subject matter of this Agreement, including without limitation, Sponsor’s
Property (as defined below).

 

1.4          Serious Adverse Event and Medical Management Plan.  Notwithstanding
anything to the contrary herein, in the event PPD and Sponsor agree in writing
upon a serious adverse event and medical management plan relating to a specific
Project (“SMMP”), the parties shall comply with the terms and conditions of any
such SMMP.  In the event of any conflict between the terms and conditions of the
SMMP and the relevant Project Addendum, the terms and conditions of the SMMP
shall control.  Sponsor shall be responsible for any additional costs associated
with compliance with the SMMP. Costs associated with compliance with the SMMP
shall be agreed to in a Project Addendum or amendment thereto.

 

1.5          Patient Enrollment.  Enrollment numbers are good faith estimates
and PPD shall exercise reasonable diligence and efforts to meet such enrollment
estimates in accordance with any mutually agreed upon estimated time-lines.

 

1.6          Final Protocol.  The parties agree that Sponsor shall be solely
responsible for the final review, approval and adoption of the Protocol and PPD
shall not be liable for such Protocol.

 

2.             COMPENSATION AND PAYMENT.

 

2.1          Charges for Services.  Sponsor shall pay PPD for all Services
performed under this Agreement and any Project Addendum (“Direct Fees”) in
accordance with the rates for such Services set forth in such Project Addendum
which shall be inclusive of any and all applicable taxes unless expressly stated
otherwise; with the exception of taxes required to be added to invoicing issued
by PPD as required by local regulations, such as VAT or GST in Australia. 
Sponsor shall also reimburse PPD for all out-of-pocket expenses incurred in
connection with the performance of the Services with respect to a Project,
including, without limitation, investigator grants and fees, reasonable travel
expenses, shipping and postage costs, copying and printing fees, copyright fees,
third party drug storage and distribution fees, required Institutional Review
Board or similar board or committee fees, and other “pass through” expenses
reasonably expected to be incurred in connection with performing the Services
(collectively, the “Pass Through Costs”) and agreed in advance in writing with
Sponsor through inclusion in the relevant Project Addendum and subject to
production of reasonable documentary proof of such expenditure if requested by
Sponsor.  All Pass Through Costs invoiced to Sponsor will be at actual cost with
no mark-up for administration or overhead. Except as otherwise expressly
provided in a Project Addendum, PPD shall submit to Sponsor for each Project a
monthly invoice describing the Services performed on such Project, the Direct
Fees due for such Services, and all Pass Through Costs paid by PPD and
identifying the relevant Project and Project Addendum.  Sponsor shall pay each
undisputed invoice within thirty (30) days of receipt of said invoice.  If
payment is not received by PPD within such thirty-day period, PPD shall provide
notice to Sponsor in writing of such unpaid invoice.   In the event that Sponsor
disputes one or

 

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more items in an invoice, Sponsor will notify PPD  in writing within ten
(10) working days of receipt of the invoice and such notice shall contain a
reasonably specific description of the item(s) being disputed and the basis
therefor.  PPD will respond to Sponsor in writing within ten (10) working days
of receipt of the notification.   The parties shall use good faith efforts to
resolve the dispute within sixty (60) days of receipt of the invoice. If PPD and
Sponsor resolve said dispute Sponsor shall pay the disputed amount within thirty
(30) days of resolution of said dispute.  PPD shall have no obligation to pay
subcontractor costs or investigator grant payments to any subcontractor or
investigator site (the “Site”) for conduct of services related to a Project
until PPD has received payment of such Pass Through Costs from Sponsor. 
Notwithstanding anything to the contrary contained herein, Sponsor acknowledges
and agrees that certain vendor and subcontractor contracts, including without
limitation, contracts for investigator meetings and patient recruitment
services, must be advanced and paid up front by Sponsor.  PPD shall be under no
obligation to incur any such vendor or subcontractor fees until such fees are
received from Sponsor.  In addition, in certain circumstances, PPD may require
investigator grants to be advanced by Sponsor at the timeframes mutually agreed
upon by the parties.

 

2.2          Payment after Termination.  Upon termination of any Project
Addendum or this Agreement pursuant to Section 3 below, Sponsor shall pay PPD
all Direct Fees and Pass Through Costs for all Services, and any portion of
Services, performed through the termination date within thirty (30) days of the
termination date where feasible for PPD to calculate the final costs associated
with Services performed within such a timescale, but in no case longer than
sixty (60) days.  In addition, Sponsor shall reimburse PPD for all future
non-cancelable obligations to third parties (where such obligations were created
and agreed as a result of a Project being authorized by the Sponsor).  Any funds
held by PPD which shall be determined to be unearned shall be returned to
Sponsor within ninety (90) days following conclusion of the Project. 
Notwithstanding the foregoing, certain Services of PPD require greater
utilization of resources at the outset such that compensation for such Services
based on a percentage of milestones completed prior to PPD fully completing the
milestones would work to the detriment of PPD.  Accordingly, the parties agree
that in the event of early termination, at PPD’s sole but reasonable discretion,
PPD shall be entitled to compensation for all completed and partially completed
Services on a time and materials basis for work actually conducted by PPD up to
the date of termination.

 

2.3          Pre-Execution Services.  In the event Sponsor requests PPD to begin
providing the Services for a Project prior to the execution by Sponsor of a
Project Addendum or other mutually agreed upon writing, Sponsor agrees that PPD
shall be compensated for Services performed at Sponsor’s request in accordance
with the PPD Proposal for Services.

 

2.4          Payments.  Unless otherwise set forth in a Project Addendum, all
payments to PPD under this Agreement or any Project Addendum shall be made as
follows:

 

If made by check, payment mailed to:

PPD Development, LLC

 

26361 Network Place

 

Chicago, IL 60673-1263

 

Tax ID# 74-2325267

 

 

 

Overnight Address:

 

JPMorgan Chase

 

131 S. Dearborn, 6th Floor

 

Chicago, IL 60603

 

Attn: PPD Development, LLC/Box 26361

 

 

If made by wire transfer, payment wired to:

JPMorgan Chase

 

Acct: 500002360

 

R/T Number: 021000021 (ACH & Wire)

 

SWIFT/BIC: CHASUS33

 

Beneficiary: PPD Development, LLC

 

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Any changes to the payee information set forth above require a writing signed by
PPD’s treasurer or chief financial officer.

 

3.             TERM AND TERMINATION.

 

3.1          Term.  The term of this Agreement shall commence on the Effective
Date and shall continue for a period of three (3) years unless extended by
mutual written agreement by the parties.  Each Project Addendum shall be
effective upon the date signed by the last signatory thereto and shall terminate
upon (i) the completion of the Services to be provided thereunder, and
(ii) PPD’s receipt of all Direct Fees, Pass Through Costs, and any other
payments due to PPD related to the Services provided thereunder, unless earlier
terminated in accordance with this Section 3.

 

3.2          Early Termination.  Subject to Section 3.4, any Project Addendum
may be terminated individually, or this Agreement may be terminated in its
entirety, with or without cause by Sponsor upon thirty (30) days prior written
notice.  PPD may terminate any Project Addendum upon Sponsor’s breach of this
Agreement upon thirty (30) days prior written notice provided that such breach
was not remedied by Sponsor within the afore-mentioned thirty (30) day prior
notice period.

 

3.3          Insolvency.  Either party hereto may terminate this Agreement
immediately upon the occurrence of an “Insolvency Event” with respect to the
other party.  For purposes of this Agreement, “Insolvency Event” shall mean
(1) a party or any of its Affiliates shall commence a voluntary proceeding
seeking liquidation, reorganization or other relief with respect to itself or
its debts under any bankruptcy, insolvency or other similar law or seeking the
appointment of a trustee, receiver, liquidator, custodian or other similar
official of it or any substantial part of its property, or shall consent to any
such relief or to the appointment of or taking possession by any such official
in an involuntary case or other proceeding commenced against it, or shall make a
general assignment for the benefit of creditors, or shall fail generally to pay
its debts as they become due, or shall take any action to authorize any of the
foregoing; (2) an involuntary case or other proceeding shall be commenced
against a party or any of its  Affiliates seeking liquidation, reorganization or
other relief with respect to it or its debts under bankruptcy, insolvency or
other similar law or seeking the appointment of a trustee, receiver, liquidator,
custodian or other similar official of it or any substantial part of its
property, and such involuntary case or other proceeding shall remain undismissed
and unstayed for a period of sixty (60) days; or (3) an order for relief shall
be entered against a party or any of its subsidiaries under the federal
bankruptcy laws now or hereafter in effect.

 

3.4          Effect of Termination.  The termination of this Agreement in its
entirety by either party shall automatically terminate all Project Addenda,
unless otherwise agreed in writing. In the event that a Project Addendum extends
past the termination of this Agreement, the terms and conditions of the
Agreement shall extend only for such period of time as is necessary for
completion of the Services and any related obligations under such Project
Addendum.

 

3.5          Wind Down.  Upon the termination of this Agreement or a Project
Addendum, PPD shall cooperate with Sponsor to provide for an orderly wind-down
of the Services provided by PPD hereunder. PPD shall cooperate with Sponsor, at
Sponsor’s reasonable request, to develop and begin implementing a wind-down plan
for the Services including, where appropriate, the transition to new service
provider(s) designated by Sponsor. Sponsor shall reimburse PPD for all
reasonable costs associated with the transition to a new services provider(s).
In connection with any termination or expiration of this Agreement, PPD shall
return to Sponsor all copies of all materials, data, work product, specimens,
reports and all other property of Sponsor under this Agreement, in accordance
with Section 5.6 and 10.2 of the Agreement.

 

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3.6          Provisions Surviving Termination.  The obligations of the parties
contained in Sections 2, 3.4, 3.5, 3.6, 5, 6, 7, 8, 9, 10.2, 13.2, 13.3, 13.6,
13.7, 13.8, 13.11, and 13.12 hereof and herein shall survive termination of this
Agreement.

 

4.             PERSONNEL.

 

4.1          Project Management.  The Services with respect to each Project
shall be performed by PPD under the direction of the person identified as the
Project Manager in the applicable Project Addendum or such other person
acceptable to Sponsor and mutually agreed to in writing (email is sufficient) as
PPD may from time to time designate as the Project Manager, such Sponsor
acceptance of the designated Project Manager not to be unreasonably withheld or
delayed in all instances. PPD shall provide Sponsor with a list of functional
area leads and copies of their curriculum vitaes (e-mail is acceptable) for
prior approval by Sponsor (such approval by Sponsor shall not be unreasonably
withheld or delayed) before commencing the Services under any Project Addendum. 
In the event that any of the functional area leads will be replaced or become
unavailable during the term of a Project Addendum, PPD shall provide Sponsor the
name of the substitute and a copy of the substitute’s curriculum vitae for
approval (such approval by Sponsor shall not be unreasonably withheld or
delayed) prior to commencing services under a Project Addendum (e-mail
notification is acceptable).

 

4.2          Covenant Not to Interfere.  Neither party will solicit for
employment any employee of the other party during the active term of this
Agreement.  As used in this section “solicit” means the initiation by a party or
its agent of a contact with any of the other party’s then current employees who
are performing services under this Agreement for the purpose of offering
employment to such employees, but shall not include the circumstance where any
such employee initiates a contact with the other party for the purpose of
obtaining employment whether in response to a general advertisement of
employment or where such contact is initiated by a third party who was not
instructed to contact such employee by the hiring party.

 

4.3          Personnel Retention.  In the event of delays in the performance of
the Project, i.e., after PPD is authorized to commence work, which are beyond
the control of PPD, and where Sponsor desires in writing for PPD to keep PPD
Project personnel assigned to the Project, in addition to any other sums payable
to PPD hereunder, Sponsor agrees that Sponsor shall pay a personnel fee
calculated on an FTE-day basis. Said personnel fees shall be invoiced by PPD on
a monthly basis, and shall be due and payable by Sponsor within 30 days of
receipt of an undisputed invoice in accordance with Section 2.1.

 

5.             CONFIDENTIALITY.

 

5.1          Sponsor Confidential Information.  PPD and its Affiliates shall
treat all information obtained from Sponsor (including, without limitation,
information regarding Sponsor’s business, services, methodologies, marketing
strategies, business plans and proposals, employees and personnel, standard
operating procedures, prices and rates, technology, tools, programs and software
programs; scientific or technical information including any experimental
results, trade secret, invention, idea, procedure, formulation, process, formula
or data; any information relating to Sponsor drug products and proposed drug
products; current or proposed studies on Sponsor products; prior research and
results of studies on Sponsor’s drug products; and reports and decisions
resulting from clinical trials on Sponsor’s drug products) and all Sponsor
Property (as defined in Section 7.2) (“Sponsor Confidential Information”) as the
confidential and exclusive property of Sponsor.

 

5.2          PPD Confidential Information.  Sponsor shall treat all information
obtained from PPD or any of PPD’s Affiliates including, without limitation, any
PPD bids or proposals, standard operating procedures, personnel information, all
PPD Property (as defined below) and any revisions, improvements or enhancements
thereto (“PPD Confidential Information”) as the confidential and exclusive
property of PPD.  For avoidance of doubt PPD Confidential Information excludes
Sponsor Property, In addition, any affiliate of Sponsor receiving information
from PPD or any PPD Affiliate shall be bound by these confidentiality
obligations.  Further, any information disclosed, obtained, or observed by
Sponsor or any

 

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affiliate of Sponsor during an audit of PPD or an Affiliate of PPD, or the
facilities of either, with the exception of Sponsor Confidential Information,
shall be treated as confidential by Sponsor in accordance with the terms
contained herein.

 

5.3          Use of Sponsor Confidential Information and PPD Confidential
Information.  Each party shall use the other’s Confidential Information solely
for the purposes contemplated by this Agreement and for no other purpose without
the prior written consent of the other party.  Neither party shall publish,
disseminate or otherwise disclose Confidential Information of the other to any
third party without first obtaining the written consent of such other party. 
Each party shall restrict the dissemination of the other’s Confidential
Information with its organization to only those persons who have a need to know,
and shall ensure that all of its directors, officers, employees, agents,
representatives and advisors (collectively, “Agents”) are aware of this
Agreement and bound by the terms of confidentiality stated herein.

 

5.4          Exceptions to Confidential Information.  The above provisions of
confidentiality shall not apply to that part of disclosing party’s Confidential
Information which the receiving party is able to demonstrate by documentary
evidence: (i) was in the receiving party’s possession prior to receipt from the
disclosing party other than as a result of the receiving party’s breach of any
legal obligation or is independently developed by the receiving party; (ii) was
in the public domain at the time of receipt from disclosing party;
(iii) subsequently becomes a part of the public domain through no fault of the
receiving party or its Agents; or (iv) is lawfully received by the receiving
party from a third party having a right of further disclosure.

 

5.5          Disclosure Required by Law.  The non-disclosure obligations
pursuant to this Agreement shall not apply to Confidential Information that a
receiving party is required to disclose pursuant to any judicial action, order
of the court or other governmental agency; provided, however, that the receiving
party shall make all reasonable efforts to notify the disclosing party prior to
the disclosure of Confidential Information and allow the disclosing party the
opportunity to contest and avoid such disclosure, and further provided that the
receiving party shall disclose only that portion of such Confidential
Information (and solely for such purpose) that it is legally required to
disclose.

 

5.6          Return of Information.  Upon termination or expiration of this
Agreement or at the disclosing party’s earlier written request, the receiving
party shall return, and shall cause its Agents and Affiliates to return, all
documentary, electronic or other tangible forms of Confidential Information
provided by the disclosing party including, without limitation, any and all
copies thereof, or, at the disclosing party’s request, destroy all or such parts
of the disclosing party’s Confidential Information as the disclosing party shall
direct.  Notwithstanding the foregoing, the receiving party may retain copies of
such of the disclosing party’s Confidential Information as is reasonably
necessary for regulatory and business archival purposes, subject to the ongoing
obligation to maintain the confidentiality of such information.

 

5.7          Remedy.  Each party agrees that its obligations hereunder are
necessary and reasonable in order to protect the other party and the other
party’s business, and expressly agrees that monetary damages would be inadequate
to compensate the other party for any breach of the terms of this Agreement. 
Accordingly, each party agrees and acknowledges that any such violation or
threatened violation will cause irreparable injury to the other party, and that,
in addition to any other remedies that may be available, in law, in equity or
otherwise, the other party shall be entitled to seek injunctive relief against
the threatened breach of this Agreement or a Project Addendum or the
continuation of any such breach.

 

6.             DATA PRIVACY.

 

6.1          Definitions. For the purpose of this Section 6, ‘Personal Data’,
‘Process/Processing’, ‘Data Controller’, ‘Data Processor’ and ‘Data Subject’
shall have the same meaning as in Directive 95/46/EC of the European Parliament
and of the Council of 24 October 1995 on the protection of individuals with
regard to the processing of personal data and on the free movement of such data
(“Directive 95/46/EC”) as implemented in the law of any EU Member State which is
applicable to the provision of the Services or as defined in the law of any
other country which is applicable to the provision

 

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of the Services (including, as applicable, the Health Insurance Portability and
Accountability Act of 1996  (HIPAA) Privacy and Security Rules, 45 C.F.R. Parts
160-164, and the Health Information Technology for Economic and Clinical Health
Act (HITECH), P.L. No. 111-005, Part I, Title XIII, Subpart D, 13401-13409, and
state privacy laws) (collectively referred to as the “Applicable Data Privacy
Laws”).

 

6.2          Compliance. Each party warrants to the other that it will Process
the Personal Data in compliance with all Applicable Data Privacy Laws.

 

6.3          Data Processing. The Sponsor and PPD acknowledge that the Sponsor
is the Data Controller and PPD is the Data Processor with respect to the
Processing of Personal Data relating to the Services provided under this
Agreement. In the event that the Services are performed by any PPD Affiliate
then such PPD Affiliate shall be a sub-Processor.  PPD shall Process the
Personal Data only in accordance with written instructions from the Sponsor or
as may be required or permitted by Applicable Law including the Applicable Data
Privacy Laws.  (The instructions may be specific instructions or instructions of
a general nature as set out in this Agreement, a Project Addendum, Protocol, SOP
or SMMP or as otherwise notified by the Sponsor to PPD during the Term).

 

6.4          Representative. If Sponsor needs to appoint a representative to
comply with Applicable Data Privacy Law in any EU Member State pursuant to
Article 4 of Directive 95/46/EC and PPD is willing to provide such services to
Sponsor, Sponsor and PPD shall enter into a mutually acceptable agreement for
such representative purposes. Unless and until such an agreement is entered
into, PPD shall not be deemed to be a representative under any Applicable Data
Privacy Law.

 

6.5          Security. PPD and its Affiliates and Agents as applicable shall
implement appropriate technical and organisational measures to protect the
Personal Data as required by ICH-GCP and Applicable Data Privacy Laws.

 

6.6          Data Privacy Requests. PPD shall promptly notify the Sponsor in
writing if it or  its Affiliates and Agents as applicable receives any
communication with regard to data privacy relating to the Services from a Data
Subject, a privacy authority or other regulatory authority, and provide the
Sponsor with cooperation and assistance in relation to any such communication.
PPD shall be entitled to charge the Sponsor for such assistance, at its usual
hourly rate, unless the communication relates to a breach or violation by PPD or
a PPD Affiliate or Agent of its obligations under this Section 6.  However, PPD
and Sponsor recognize that any fees charged to the requesting party must comply
with Applicable Data Privacy Laws.

 

6.7          Security Breaches. If PPD becomes aware of any breach of an
Applicable Data Privacy Law relating to the Services, then it shall promptly
notify the Sponsor and, if requested, assist the Sponsor in meeting any
obligations under Applicable Data Privacy Law to notify Data Subjects,
regulatory authorities or other required parties.  PPD shall not respond
directly to any Data Subjects, privacy authority or regulatory authority without
obtaining the express written consent of Sponsor, unless otherwise required by
Applicable Law. PPD shall be entitled to charge the Sponsor for such assistance,
at its usual hourly rate, unless PPD or a PPD Affiliate was responsible for such
breach.

 

6.8          Data transfers. PPD shall only Process or otherwise transfer
Personal Data outside the European Economic Area (member states of the European
Union plus, Norway, Iceland & Liechtenstein) as set out in this Agreement, any
Project Addendum, Protocol, SOP or SMMP or with the prior consent of the
Sponsor.

 

7.             INTELLECTUAL PROPERTY.

 

7.1          No License.  The delivery of any information to a party hereto,
shall not be deemed to grant the receiving party any right or license under any
patent or patent application or to any know-how, technology or invention of the
disclosing party except as expressly stated herein. PPD hereby grants and will
grant to Sponsor a non-exclusive, fully-paid up, compensation-free, irrevocable
(except in the event of material breach), perpetual world-wide license to use
any PPD Property which is incorporated into a

 

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deliverable under the Project Addendum to the extent reasonably necessary for
Sponsor to utilize the deliverables as contemplated by the Project Addendum and
for commercialization of the relevant Project. Unless prior approved in writing
by PPD, Sponsor shall not sublicense or transfer this license hereby granted (or
to be granted) to any other party except that Sponsor may sublicense or transfer
this license to a bona fide development or commercialization partner in respect
of the relevant Project upon due notice to PPD provided that in no event shall
any such transferee or sub licensee of Sponsor be PPD’s direct competitor.

 

7.2          Sponsor Property.   Subject to Section 7.3 below, PPD hereby
assigns to Sponsor all rights PPD or its Agents or Affiliates may have or may
acquire in any  information, data,  results, any invention, technology,
know-how, discovery, improvement, works, products or other intellectual
property  relating to a Project drug or Protocol and which is (i) a direct and
sole result of PPD’s or its Agents’ or Affiliates’ provision of the Services or
(ii) specifically set forth as a deliverable under a Project Addendum
(collectively, “Sponsor Property”). The parties hereby agree, for the avoidance
of any doubt, that all Sponsor Property, is the exclusive property of Sponsor.
Sponsor shall be free to use Sponsor Property without restriction, subject to
Applicable Law and PPD shall assist Sponsor, at Sponsor’s sole cost and expense,
in obtaining or extending protection therefor.  PPD warrants that it has and
will continue to have valid agreements with all of its Affiliates and Agents to
effect the terms of this Section 7.2. PPD shall promptly disclose in writing to
Sponsor full details of any and all such Sponsor Property.  PPD agrees to (as is
reasonably necessary) execute and have executed assignments of all Sponsor
Property (and any and all rights therein) to Sponsor. PPD further agrees, at
Sponsor’s sole cost and expense, to execute other documents that may be
reasonably necessary or helpful to Sponsor, or at PPD’s sole but reasonable
discretion, which may relate to any litigation or interference and/or
controversy in connection therewith.  PPD acknowledges that Sponsor has the
exclusive right to file patent applications and own patents in connection with
the Sponsor Property.

 

7.3          PPD Property.  PPD possesses certain inventions, processes,
technology, know-how, trade secrets, improvements, other intellectual property
and assets, including, without limitation, those related to business or product
plans or proposals, marketing strategies, standard operating procedures, data,
composition of matter, research, experimental results, personnel data, financial
information and conditions, pricing information, customer information,
supplier/vendor information, raw materials, data collection and data management
processes, laboratory analyses, analytical, biotechnology and clinical methods,
procedures and techniques, computer technical expertise and software (including
code) which have been independently developed without the benefit of any
information provided by Sponsor (collectively, “PPD Property”).  Sponsor and PPD
agree that any PPD Property or revisions, improvements or enhancements thereto
which are developed without the benefit of any Sponsor Property or Sponsor
Confidential Information  shall be the sole and exclusive property of PPD, and
Sponsor shall have no rights, title and interest to such PPD Property.

 

7.4          Work for Hire.  The parties expressly agree that any and all
Sponsor Property which represents original works of authorship, reports, data,
technical information, communications, materials, and/or concepts and plans
made, conceived or written by PPD or its Affiliates or Agents as a result of
Services performed for Sponsor pursuant to this Agreement is and shall be a work
for hire as defined under 17 USC §101 or equivalent provisions and shall belong
exclusively to Sponsor, including, without limitation, exclusive rights to
Sponsor to use and obtain copyrights therein.

 

8.             INDEMNIFICATION.

 

8.1          Sponsor Indemnity.  Sponsor shall indemnify, defend, and hold
harmless PPD, PPD Affiliates (as that term is defined in Section 13.11), and
their Agents (“PPD Indemnitees”) from and against any and all damages,
liabilities, losses, fines, penalties, settlement amounts, costs and expenses of
any kind or nature whatsoever, including, without limitation, reasonable
attorneys’ fees, expert witness fees, court costs, , incurred in connection with
any claim, demand, action, proceeding, investigation or hearing (collectively, a
“Claim”) directly or indirectly relating to or arising from this Agreement or
any Services provided by PPD Indemnitees hereunder, including but not limited
to, Project related services

 

8

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provided by PPD at the request of Sponsor yet prior to finalization of the
relevant Project Addendum; provided however, that Sponsor shall have no
obligation of indemnity hereunder with respect to any Claim which arose from 
the negligence, intentional misconduct or material breach of this Agreement or
any Project Addendum on the part of PPD or its Agents or Affiliates.

 

8.2          PPD Indemnity.  PPD shall indemnify, defend and hold harmless
Sponsor and its Agents from and against any and all damages, liabilities,
losses, fines, penalties, settlement amounts, cost and expenses of any kind or
nature whatsoever, including, without limitation, reasonable attorney’s fees,
expert witnesses and court costs, incurred in connection with any Claim arising
from the negligence, intentional misconduct, or material breach of this
Agreement of PPD or its Agents or Affiliates; provided however, that PPD shall
have no obligation of indemnity hereunder with respect to any Claim which arose
from the negligence, intentional misconduct or material breach of this Agreement
on the part of Sponsor or its Agents or Affiliates.

 

8.3          Indemnification Procedure.  Each indemnified party shall give the
indemnifying party prompt notice of any Claim for which indemnification is
sought hereunder.  The indemnifying party shall have the right to control the
defense and settlement of a Claim, provided the indemnifying party shall act
reasonably and in good faith with respect to all matters relating to the
settlement or disposition of the Claim, and the indemnified party shall
reasonably cooperate in the investigation, defense and settlement of such
Claim.  Any indemnified party shall have the right to participate in, but not
control, the defense and settlement of a Claim and to employ separate legal
counsel of its own choice; provided, however, that such employment shall be at
the indemnified party’s own expense, unless (i) the employment thereof has been
specifically authorized by the indemnifying party, or (ii) the indemnifying
party has failed to assume the defense and employ counsel (in which case the
indemnified party shall control the defense and settlement of such Claim);
provided however that the defense or settlement under this Section 8.3
(ii) shall not act as a waiver of rights to indemnification and shall not excuse
the indemnifying party from its obligations hereunder and, all reasonable costs
and expenses incurred by the Party claiming indemnification shall be subject to
indemnity by the indemnifying Party..  The costs and expenses, including
reasonable fees and disbursements of counsel, incurred by any indemnified party
in connection with any Claim shall be reimbursed on a monthly basis by the
indemnifying party subject to refund in the event the indemnifying party is
ultimately held not to be obligated to indemnify the indemnified party. Neither
party will enter into any settlement agreement that attributes fault or
negligence to the other party, requires any payment by the other party, or
restricts the future actions or activities of the other party, without the other
party’s prior written consent, which shall not be unreasonably withheld.

 

9.             LIMITATION OF LIABILITY.

 

NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL OR
INDIRECT DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT (OR THE
TERMINATION HEREOF) OR ANY PROJECT ADDENDUM, INCLUDING, WITHOUT LIMITATION, LOSS
OF PROFITS OR ANTICIPATED SALES.

 

TO THE FULLEST EXTENT PERMITTED BY LAW, AND NOTWITHSTANDING ANY OTHER PROVISION
OF THIS AGREEMENT OR ANY PROJECT ADDENDUM, THE TOTAL LIABILITY, IN THE
AGGREGATE, OF PPD AND ITS AGENTS, AND ANY OF THEM, TO SPONSOR AND ANYONE
CLAIMING BY OR THROUGH SPONSOR, FOR ANY AND ALL CLAIMS, LOSSES, COSTS OR
DAMAGES, INCLUDING WITHOUT LIMITATION, 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 THIS AGREEMENT OR ANY PROJECT ADDENDUM
FROM ANY CAUSE OR CAUSES SHALL NOT EXCEED TWO TIMES THE TOTAL DIRECT FEES
RECEIVED BY PPD UNDER THE APPLICABLE PROJECT ADDENDUM, WHICH IS THE SUBJECT OF
THE CLAIM, UNLESS AND TO THE EXTENT SUCH CLAIMS, LOSSES, COSTS OR DAMAGES ARE
CAUSED BY THE GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT OF PPD OR ITS
AFFILIATES OR AGENTS.

 

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10.          RECORD STORAGE.

 

10.1        Record Maintenance during Project.  During the term of this
Agreement, PPD shall maintain all materials, documents and all other data
obtained or generated by PPD in the course of providing the Services hereunder,
including all computerized records and files in accordance with Applicable Law
and Sponsor’s instructions.  PPD shall cooperate with any reasonable internal
review or audit by Sponsor and make available to Sponsor for examination and
duplication, during normal business hours and at mutually agreeable times, all
documentation, data and information relating to a Project.

 

10.2        Record Maintenance after Expiration or Termination.  Upon the
expiration or termination of the Services other than for Sponsor’s breach of
required payment hereunder, all materials and all other data and information
obtained or generated by PPD in the course of providing the Services hereunder
(collectively, the “Records”) shall, at Sponsor’s option, be (i) delivered to
Sponsor at its expense and risk, to its offices identified herein in such form
as is then currently in the possession of PPD, (ii) securely retained by PPD for
Sponsor for a period of three (3) years after the expiration or termination of
the Services, or (iii) disposed of at Sponsor’s expense, as directed by written
request of Sponsor, unless the Records are otherwise required to be stored or
maintained by PPD under Applicable Law.  If PPD is required or requested to
maintain and/or store the Records for a period beyond three (3) years after the
termination or expiration of the Services, Sponsor shall reimburse PPD for its
maintenance and storage costs. In no event shall PPD dispose of Records without
first giving Sponsor sixty (60) days prior written notice of its intent to
dispose of the Records and allowing Sponsor the opportunity to take control of
such Records.  PPD shall be entitled at its expense to retain copies of the
Records reasonably necessary for regulatory purposes or to demonstrate the
satisfaction of its obligations hereunder, all subject to the confidentiality
obligations set forth in Section 5 above.

 

11.          REGULATORY.

 

11.1        PPD hereby certifies 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. PPD further certifies that it has never been debarred
and, none of its employees, Affiliates, has ever been 1) debarred 2) threatened
to be debarred or 3) to its knowledge, indicted for a crime or otherwise engaged
in conduct for which a person can be debarred, under the Food, Drug and Cosmetic
Act or any other Applicable Law.  PPD agrees that it will promptly notify
Sponsor in the event of any such debarment, conviction, threat or indictment
related to the performance of Services hereunder.   If PPD or any of its Agents
or Affiliates or subcontractors (as defined in Section 13.1) who perform
Services for a Project is debarred or receives notice of an action or threat of
action of debarment, PPD shall immediately notify Sponsor of same.  The
debarment of PPD or any of its Agents or subcontractors (as defined in section
13.1) (which are providing services to Sponsor on a Project under this
Agreement) or Affiliates  that remains in place for a period of at least thirty
(30) days shall be deemed to be a material breach of this Agreement, unless,
with respect to the debarment of an Agent or subcontractor (as defined in
Section 13.1) which is providing services to Sponsor hereunder, PPD is able to
replace the Agent or subcontractor  (as defined in Section 13.1) within such
30-day period, in which case the debarment of the replaced Agent or
subcontractor (as defined in section 13.1) shall not be a material breach of
this Agreement. PPD hereby further certifies that it shall include a similar
debarment provision to that set out in Section 11.1  above in contracts with
subcontractors (as defined in Section 13.11) and shall not knowingly utilize any
debarred subcontractors (as defined in section 13.1) when providing Services
pursuant to this Agreement and any Project Addendum.

 

11.2        In the event any Applicable Law governing any Services is amended,
revised or revoked during the term of this Agreement, the parties will discuss
the effect (if any) of such change on the Agreement and/or on Services being
provided under this Agreement together with any financial implications and will
document any required changes to any Project Addendum by written Amendment
executed by both parties.

 

11.3        During the term of this Agreement and for a period of one year
thereafter, Sponsor or its designee (provided that such designee is not
considered by PPD to be a competitor of PPD) may, upon

 

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reasonable advance notice that is mutually agreeable by the parties, during
regular business hours and at Sponsor’s sole cost and expense, audit PPD’s or
Affiliates’ records, facilities or procedures related to PPD’s or Affiliates’
provision of the Services.  Such designee shall, in advance of such audit,
execute a mutually agreeable confidentiality and non-disclosure agreement with
PPD. Sponsor agrees to hold such records and procedures in confidence, in
accordance with Section 5 of this Agreement.  Audits shall be conducted by
Sponsor on site at PPD or its Affiliate, in a manner designed to cause the least
interruption to PPD’s or its Affiliate’s business operations.  Sponsor may
perform quality assurance audits of the work performed hereunder, documentation
and record-keeping procedures and storage facilities to determine that the
Services are being conducted in accordance with this Agreement and the relevant
Project Addendum.  The parties will discuss any audit findings as soon as
reasonably practicable following the audit.

 

11.4        PPD  shall promptly notify Sponsor of any impending inspection or
audit by the FDA or other federal, state, or foreign government authority 
(“Regulatory Authority”) which directly relates to the Services.   In the event
that PPD receives from a Regulatory Authority a notice of inspection
(hereinafter “Notice”) which directly relates to any Services under this
Agreement, PPD shall (i) promptly notify Sponsor of the Notice; (ii) keep
Sponsor informed of the progress of the inspection; and (iii) provide a copy to
Sponsor of any project documents directly related to the Services produced to
such Regulatory Authority.  Notwithstanding the foregoing, in the event any
Regulatory Authority issues any findings or commences an enforcement action
(e.g. FDA 483) to PPD directly related to the Services provided hereunder or if
any of PPD’s practices/procedures which are directly impactful upon the Services
provided hereunder are found to be objectionable by a regulatory authority, PPD
shall promptly notify Sponsor of any such findings or enforcement action.

 

12.          CURRENCY MANAGEMENT.

 

12.1        Direct Fees.  All Direct Fees owed to PPD for Services performed
under this Agreement or any Project Addendum shall generally be invoiced to and
paid by Sponsor in the “Contract Currency”, which shall be defined as the
currency, or currencies, designated in any budget or payment schedule set forth
in a Project Addendum.  However, any Services performed outside the United
States shall be invoiced to and paid by Sponsor in the local currency where such
Services are performed with any Services performed in Europe being invoiced to
and paid by Sponsor in British pounds or Euros.

 

In special circumstances, PPD may invoice Sponsor in United States dollars
(“USD”) for Services performed outside the United States.  In such cases, PPD
shall specify in the proposal and the contract the estimated exchange rate or
rates (“Exchange Rate”) used to prepare the budget or payment schedule for such
Project Addendum. This Exchange Rate will be the one used for the preparation of
each invoice for Services and payment by the Sponsor.  The “Spot Rate” for
purposes of reconciliation, shall mean the actual spot rate in the Wall Street
Journal at the close of the day before the date on which the invoice is raised. 
At the conclusion of each calendar year, a reconciliation shall be undertaken. 
PPD shall compare the USD total of the invoices billed to Sponsor that year at
the Exchange Rate with the USD total of those same invoices when converted using
the Spot Rates.  In the event the comparison demonstrates that the difference in
such amounts is five percent (5%) or more and is greater than USD $50,000 such
difference shall be invoiced or credited, as the case may be, to Sponsor.  The
reconciliation invoice or credit note will be issued by PPD in USD.  The process
of reconciliation is not cumulative but shall be conducted on a calendar year
basis and completed by the end of March in the subsequent year.

 

12.2        Pass Through Costs.  Where PPD incurs Pass Through Costs in a
currency other than the Contract Currency, PPD shall, for Sponsor invoicing and
payment purposes, convert such costs to the Contract Currency based on an
average reasonable market exchange rate between the local currency and the
Contract Currency for the month in which such costs were incurred.

 

12.3        Investigator Fees.  PPD shall pay investigator fees in the currency
specified in the investigator agreements.  For Sponsor invoicing and payment
purposes, PPD shall convert all investigator fees that are to be paid in a
currency other than the Contract Currency to the Contract

 

11

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Currency.  The conversion to the Contract Currency shall be based on an average
reasonable market exchange rate between the currency specified in an
investigator agreement and the Contract Currency for the month prior to the
month the Sponsor invoice is raised.  All amounts invoiced to Sponsor will be
based upon an accrual of costs owed to investigators.  At the end of the project
a reconciliation will be completed between the estimated exchange rate used for
the purposes of billing on the basis of the accrued costs versus the exchange
rate when the actual payment is made to the sites, and any variation will be
billed or credited to the Sponsor as applicable.

 

13.          MISCELLANEOUS.

 

13.1        Independent Contractor Relationship.  The parties hereto are
independent contractors, and nothing contained in this Agreement is intended,
and shall not be construed, to place the parties in the relationship of
partners, principal and agent, employer/employee or joint venturer.  Neither
party shall have any right, power or authority to bind or obligate the other,
nor shall either hold itself out as having such right, power or authority.

 

13.2        Publicity.  Neither party shall mention or otherwise use the name,
insignia, symbol, trademark, trade name or logotype of the other party (or any
abbreviation or adaptation thereof) in any publication, press release,
promotional material or other form of publicity without the prior written
approval of the other party in each instance.  The restrictions imposed by this
Section shall not prohibit a party from making any disclosure identifying the
other party that is required by any Applicable Law.

 

13.3        Publication.  PPD and Affiliates may not publish any articles or
make any presentations relating to the Services provided to Sponsor hereunder
with respect to a Project or referring to data, information or materials
generated as part of the Services without the prior written consent of Sponsor.
Neither party will issue any press release or statement regarding this Agreement
or the Services, written or oral, to the communications media or any third party
without the prior written consent of the other.

 

13.4        Insurance.  Sponsor and PPD will each undertake to purchase and
maintain insurance of such types and amounts reasonably adequate to cover any
liabilities arising out of its obligations hereunder (including but not limited
to that required by Applicable Law).   Sponsor further undertakes to purchase
and maintain insurance of such types and amounts reasonably adequate (including
but not limited to that required by law) to cover any liabilities arising
in relation to all clinical trials contracted to PPD pursuant to this Agreement.

 

Sponsor and PPD will each undertake, upon request, to provide the other party
a certificate (or certificates) of insurance setting forth the liability limits,
exclusions and deductibles of the insurance such party is required to carry
pursuant to this Agreement.

 

13.5        Force Majeure.  If either party shall be delayed, hindered, or
prevented from the performance of any act required hereunder by reason of
strike, lockouts, labor troubles, restrictive governmental or judicial orders or
decrees, riots, insurrection, war, acts of God, inclement weather, or other
cause beyond such party’s reasonable control (each, a “Disability”), then
performance of such act shall be excused for the length of time necessary to
cure such Disability and resume performance.  A party shall not be liable for
any delays resulting from a Disability, and any affected timelines shall be
extended for a period at least equal to that of the Disability.  The party
incurring the Disability shall provide notice to the other of the commencement
and termination of the Disability.

 

13.6        Notices. Any notice required or permitted to be given hereunder by
either party hereto shall be in writing and shall be deemed given on the date
delivered if delivered (i) personally, (ii) on the first business day after the
date sent if sent by recognized overnight courier, (iii) on the date transmitted
if sent via facsimile (with confirmation of receipt generated by the
transmitting machine), or (iv) on the second business day after the date
deposited if mailed by certified mail, return receipt requested, postage
prepaid. All notices to each party shall be sent to the address for said party
set forth in the applicable Project Addendum.  If no address is provided in the
Project Addendum, then notices shall be sent to the following address:

 

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If to PPD:

 

PPD Development, LLC

 

 

929 North Front Street

 

 

Wilmington, North Carolina 28401

 

 

Attention: CEO

 

 

Tel: (910) 251-0081

 

 

Fax: (910) 558-5820

 

 

 

If to Sponsor:

 

Celldex Therapeutics, Inc.

 

 

119 Fourth Avenue

 

 

Needham, MA 02494

 

 

Tel: (781) 433-0771

 

 

Fax: (781) 433-0262

 

 

Attention: CEO, CFO and CCO

 

Either party may change its notice address by notice to the other party hereto
in the form and manner provided in this Section 13.6.

 

13.7        Governing Law.  This Agreement and the rights and obligations of the
parties hereunder shall be governed by and construed in accordance with the laws
of the State of New Jersey without reference to its conflicts of laws
provisions. The parties hereby consent to the jurisdiction of the state and
federal courts sitting in the State of New Jersey, and any Courts of Appeal
there from, in connection with any dispute arising in connection with this
Agreement or the provision of Services hereunder.

 

13.8        Severability.  If any provision of this Agreement or any Project
Addendum is held to be illegal, invalid or unenforceable under any present or
future law, and if the rights or obligations of any party hereto under this
Agreement or such Project Addendum will not be materially or adversely affected
thereby, (a) such provision will be fully severable, (b) this Agreement or such
Project Addendum will be construed and enforced as if such illegal, invalid or
unenforceable provision had never compromised a part hereof, (c) the remaining
provisions of this Agreement or such Project Addendum will remain in full force
and effect and will not be affected by the illegal, invalid or unenforceable
provision or by its severance here from, and (d) in lieu of such illegal,
invalid or unenforceable provision, there will be added automatically as a party
of this Agreement or such Project Addendum, a legal, valid and enforceable
provision as similar in terms as to such illegal, invalid or unenforceable
provision as may be possible and reasonably acceptable to the parties herein.

 

13.9        Waiver.  Any term or condition of this Agreement or a Project
Addendum may be waived at any time by the party that is entitled to the benefit
thereof, but no such waiver shall be effective unless set forth in a written
instrument duly executed by or on behalf of the party waiving such term or
condition.  No waiver by any party hereto of any term or condition of this
Agreement or a Project Addendum, in any one or more instances, shall be deemed
to be or construed as a waiver of the same or any other term or condition of
this Agreement or such Project Addendum on any future occasion.

 

13.10      Amendments.  No amendment, change or modification to this Agreement
or any Project Addendum shall be effective unless in writing and executed by the
parties hereto.

 

13.11      Assignment and Subcontracting.  This Agreement and any Project
Addendum may not be assigned by either party without the prior written consent
of the other party; provided, however, that (i) a party hereto may assign this
Agreement or a Project Addendum hereunder with prompt notice but without the
requirement for consent to a successor-in-interest to the party’s business to
which this Agreement relates and (ii) PPD may assign this Agreement or a Project
Addendum or subcontract all or part of the Services to be performed hereunder to
PPD Affiliates, provided that such Affiliates are bound by all applicable terms
of this Agreement and the relevant Project Addendum or Addenda.  “PPD
Affiliates” shall mean entities which can provide the Services and which
controls, is controlled by or is under common

 

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control with PPD or PPD’s parent company Pharmaceutical Product Development,
LLC.  In the event the Services shall be performed by a PPD Affiliate, such PPD
Affiliate may be the contracting party to any Project Addendum for the Services.
PPD shall notify Sponsor of the intention to subcontract or delegate its
obligation to perform any portion of the Services under a Project Addendum to a
subcontractor.  PPD shall be responsible and retain primary liability for the
performance of all obligations of PPD under this Agreement and any breach
thereof by PPD or subcontractors selected and managed by PPD. When used in this
Agreement, the term “subcontractor” shall mean and refer to any third party to
whom PPD has subcontracted or delegated PPD’s obligation to perform any portion
of the Services hereunder (but shall exclude Affiliates of PPD and any third
party vendor whose expenses are considered a Pass Through Cost).

 

13.12      Construction.  Except where the context otherwise requires, wherever
used the singular shall include the plural, the plural the singular, the use of
any gender shall be applicable to all genders and the word “or” is used in the
inclusive sense.  The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement.  The language of this Agreement shall be deemed to be the language
mutually chosen by the parties and no rule of strict construction shall be
applied against either party hereto.

 

13.13      MedDRA and WHODrug Dictionary License.  The parties acknowledge that
MedDRA and Uppsala Monitoring Centre product licenses are required by all
parties who wish to distribute or receive MedDRA or WHODrug dictionary
terminology.  Each party represents and warrants that it possesses a current
MedDRA and/or Uppsala Monitoring Centre product license as required.  In the
event Sponsor requests that PPD perform services which require PPD to distribute
MedDRA terminology or WHODrug dictionary to third parties, Sponsor shall be
responsible for ensuring that all such third parties possess the necessary
MedDRA and/or Uppsala Monitoring Centre product licenses.

 

13.14      Counterparts and Electronic Signatures.  This Agreement or any
Project Addendum hereunder may be executed in counterparts, each of which shall
be deemed an original and all of which together shall constitute one and the
same instrument.  Each party may execute this Agreement or any Project Addendum
by facsimile transmission or in Portable Document Format sent by electronic
means.  Signatures of authorized signatories of the parties transmitted by
facsimile or sent by electronic means in Portable Document Format shall be
deemed to be original signatures, shall be valid and binding, and, upon
delivery, shall constitute due execution of this Agreement or any Project
Addendum hereunder.

 

13.15      Representative.  With regard to any Project conducted under this
Agreement, Sponsor represents and warrants that it shall not name any PPD
employee, contractor, or other PPD representative on Line 15 of Form FDA 1571.
Sponsor acknowledges and understands that if Sponsor desires that any PPD
employee, contractor, or other PPD representative be named as the Senior Medical
Officer in Canada on Line 87 of Form HC/SC 3011 or in any similar capacity for
clinical trials conducted in other countries, Sponsor must first submit such a
request to PPD in writing for the performance of services pursuant to such
naming, including, without limitation, responsibility for review and evaluation
of information relevant to the safety of the Study Drug.  If PPD agrees to
perform such services, the parties shall enter into good faith negotiations and
enter into either a separate agreement or written amendment to the applicable
Project Addendum prior to PPD initiating the services.

 

13.16      Entire Agreement. This Agreement constitutes the entire agreement
between the parties and supersedes all prior negotiations, representations or
agreements, either written or oral, with respect to the subject matter hereof.

 

14.          WARRANTIES

 

14.1        Each party warrants the following:

 

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(a) that it is authorized to enter into this Agreement and that the terms of
this Agreement are not (and shall not become) inconsistent with or constitute a
violation of any contracted or other legal obligation to which it is subject;
and

 

(b) that in performing under this Agreement it shall (i) conduct business in
compliance with all Applicable Laws,; and (ii) shall not achieve business
results by illegal act or unethical conduct.

 

(c)  that it and its Affiliates as applicable have all necessary or appropriate
qualifications, authorizations, licenses and permits to perform the Services
under this Agreement.

 

14.2        PPD warrants that (a) it is not currently involved in any material
litigation, and is unaware of any pending litigation proceedings, relating to
its or its  Affiliates’ Services provided in a clinical trial for any third
party; and (b) it has not within the past ten (10) years received any warnings
from the FDA or other Regulatory Authority relating to services it has provided
to third parties during the conduct of a clinical trial.

 

IN WITNESS WHEREOF, this Agreement has been executed and delivered by the
parties hereto by their duly authorized officers as of the date first above
written.

 

PPD DEVELOPMENT, LLC

 

CELLDEX THERAPEUTICS, INC.

 

 

 

 

 

 

 

 

 

 

By:

/s/ William J. Sharbaugh

 

By:

/s/ Anthony S. Marucci

 

 

 

 

 

Name:

William J. Sharbaugh

 

Name:

Anthony S. Marucci

 

 

 

 

 

Title:

Chief Operating Officer

 

Title:

President & CEO

 

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