Exhibit 10.1

 

MASTER SERVICES AGREEMENT

 

This Master Services Agreement (this “Agreement”) is entered into as of the 10th
day of September, 2014 (the “Effective Date”) by and between Vaccinogen, Inc.
having its registered address at 5300 Westview Drive, Suite 406, Frederick, MD
21703 (“Vaccinogen” or “Company”), and RxTrials, Inc. d/b/a OnPoint CRO, having
its registered address at 2838 Leaf Shade Drive, Suite B, Ellicott City, MD
21042 USA (“RxTrials”). The above parties are hereinafter referred to each as a
“Party” and jointly as the “Parties.”

 

RECITALS

 

WHEREAS, Vaccinogen wishes to conduct a multi-center clinical trial entitled “A
Randomized Multicenter Study of Active Specific Immunotherapy with OncoVAX® in
Patients with State II Colon Cancer” (herein “OncoVAX Study”) Protocol No.
Vaccinogen, Inc. ASI 2005-03 in accordance with the protocol attached hereto as
Exhibit D and incorporated herein by reference (“Protocol”); and

 

WHEREAS, RxTrials specializes in providing protocol development, site selection,
site enrollment diagnostics, enrollment management, site and investigator
education, clinical trial awareness services, clinical operations, and project
management on behalf of clinical trial sponsors; and

 

WHEREAS, Vaccinogen wishes to retain RxTrials to provide services of site
selection, clinical operations, project management (including management of
third party vendors contracted to Vaccinogen to provide services including but
not limited to data management, biostatistics, medical monitoring, and safety
reporting), and trial enrolment for the OncoVAX Study in colon cancer; and

 

WHEREAS, RxTrials and Vaccinogen desire to enter into a Master Services
Agreement to set forth the terms and conditions under which Vaccinogen would
engage RxTrials to perform such services in connection with the OncoVAX Study;

 

NOW, THEREFORE, in consideration of the foregoing and of the covenants,
agreements and conditions contained herein, and other good and valuable
consideration, the adequacy and receipt of which are hereby acknowledged, the
Parties hereto agree as follows:

 

DEFINITIONS

 

In this Master Services Agreement, the following initially capitalized terms
shall have the following meanings:

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 1

 

  

“Affiliates” with respect to a person or entity shall mean any other person or
entity that directly, or indirectly through one of more intermediaries,
controls, is controlled by or is under common control with such person or
entity; for the purposes of this definition only, “control” and, with
correlative meanings, the terms “controlled by” and “under common control with”,
shall mean (a) the possession, directly or indirectly, of the power to direct
the management or policies of a person or entity, whether through the ownership
of voting securities, by contract or otherwise, or (b) the ownership, directly
or indirectly, of at least fifty percent (50%) of the voting securities or other
ownership interest of a person or entity.

 

“Applicable Laws” shall mean all applicable provisions of all statutes, laws,
rules, regulations, administrative codes, ordinances, decrees, orders,
decisions, injunctions, awards judgments, permits and licenses of or from
governmental authorities, including, without limitation, those relating to or
governing the use or regulation of the investigational product.

 

“Business Day” means any day that is not a Saturday, a Sunday or a national
holiday in the United States. For avoidance of doubt, any reference to “day”
herein shall mean calendar days.

 

“Change Order” shall mean a specific form of amendment to a Task Order, to be
used when the Parties mutually agree to modify the scope of the Services or the
assumptions on which a Task Order is based. A Change Order form is attached to
this Agreement as Exhibit B.

 

“Confidential Information” shall mean all information (including, without
limitation, Study Protocols, case report forms, clinical data, other data,
reports, specifications, computer programs or models and related documentation,
business information, know-how, trade secrets, including, without limitation,
any products, technologies and know-how, and any product developments and
modifications) pertaining to the Study. This Master Service Agreement and the
terms and conditions herein shall be considered to be Vaccinogen Confidential
Information. RxTrials’ processes, know-how, and business information shall be
considered RxTrials Confidential Information. Confidential Information does not
include information which the receiving Party can establish by reliable written
evidence that (i) at the date of its disclosure is publicly known or at any time
after that date becomes publicly known (other than by breach of this Agreement),
or (ii) was in its possession at the time of disclosure and was not obtained,
directly or indirectly, by or as a result of breach of a confidentiality
obligation under this Agreement.

 

“GxP” shall mean collectively Good Manufacturing Practices (GMP), Good
Laboratory Practices (GLP), Good Clinical Practices (GCP) and Good Clinical
Laboratory Practices (GCLP).

 

“Representatives” shall mean a Party's directors, officers, employees, agents
and representatives.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

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“Services” mean the services to be performed by RxTrials and obligations
undertaken by RxTrials as outlined in this Agreement and in Exhibits A and B,
attached hereto and made a part hereof. For avoidance of doubt, Services
includes services performed by any subcontractor of RxTrials.

 

“Study” shall mean a clinical trial relating to Vaccinogen’s cancer
immunotherapies conducted by, or on behalf, of Vaccinogen or its Affiliates, or
such a study or trial sponsored by a Third Party that receives support from
Vaccinogen or Vaccinogen Affiliates within the framework of which the Parties
agree that RxTrials or its Affiliates shall perform the Services.

 

1            Task Orders and Services

 

1.1           .RxTrials hereby agrees to perform services for Vaccinogen from
time to time under the terms set forth in this Agreement.

 

1.2           Services to be performed by RxTrials shall be mutually agreed upon
by the Parties and set forth in Task Orders. Each Task Order shall define the
scope and timelines of RxTrials’ Services and otherwise set out the additional
terms and conditions applicable to RxTrials’ Services with respect to the Study.
Each Task Order will incorporate by reference the terms of this Agreement. Any
Services shall be carried out by RxTrials upon the terms and conditions set
forth in this Agreement and under specific terms and conditions set forth in
each Task Order (hereinafter collectively referred to as the “Terms and
Conditions”). In the event of any conflict between this Agreement and any
provision of a Task Order, the terms of this Agreement shall control, except to
the extent the Task Order expressly states that the provision in the Task Order
takes precedence with respect to the Services provided under such Task Order. A
sample Task Order form is attached as Exhibit A to this Agreement.

 

1.3           Any necessary modifications to a Task Order, whether following a
Study Protocol amendment, procedure modification or not, shall only be effective
when made by a written Change Order executed by both Parties. A Change Order
form is attached as Exhibit B to this Agreement. Each Party shall respond
promptly to a request for a Change Order made by the other Party. As part of a
Change Order request or response, RxTrials will propose, in writing, any
necessary modifications to the milestone dates, target dates and other
timelines, fees or costs described in the Task Order. No change to the Scope of
Work and/or Budget in respect of the Services to be provided under any Task
Order shall be effective unless it is set forth in a Change Order executed by
both Parties.

 

1.4           RxTrials shall not subcontract any Services to another entity
without Vaccinogen’s prior written approval, and such approval shall not be
unreasonably withheld by Vaccinogen. RxTrials agrees that any approved
subcontractor will be required to execute a written agreement which extends all
relevant obligations of RxTrials under this Master Agreement and the applicable
Task Order to the subcontractor. RxTrials shall be solely liable for ensuring
the satisfactory performance of all subcontracted Services by subcontractors
selected by RxTrials and approved by Vaccinogen. Any subcontract shall be in
writing and shall include a provision that grants Vaccinogen rights to monitor
the subcontractor, conduct inspections and audits of the subcontractor’s
facilities (if applicable), and to receive notice of regulatory actions and
communications, and in each case such benefits shall be on terms no less
favorable than those provided to Vaccinogen under this Agreement.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 3

 

  

2            Compensation for Services Rendered

 

2.1           In consideration for RxTrials’ performance of the Services under a
Task Order, Vaccinogen shall pay RxTrials’ fees in accordance with the terms of
the relevant executed Task Order and as set forth in Schedule B attached to the
relevant Task Order, which references the negotiated fee schedule attached as
Exhibit C to this Agreement. All fees shall be paid in United States currency;
if at any time any service or pass-through in any Task Order or Amendment
requires RxTrials to incur costs in non-United States currency, such costs will
be budgeted and paid by Vaccinogen in the equivalent U.S. currency based on the
exchange rate obtained from www.oanda.com for the first Business Day of the
calendar month of the date of the relevant invoice to Vaccinogen. Vaccinogen
shall have no obligation for any pass-through cost that is not invoiced to it
within ninety (90) days of the date that such pass-through cost is incurred by
RxTrials.

 

2.2           RxTrials shall provide to Vaccinogen separate invoices for each
Task Order within fifteen (15) days of the end of each calendar month.
Pass-through expenses must be invoiced no later than forty-five (45) days after
the end of a calendar month. RxTrials shall provide Vaccinogen with estimates of
unbilled amounts incurred no later fifteen (15) days after the end of a calendar
month. Unless otherwise stated in a Task Order, all amounts due under any
undisputed invoice shall be paid within forty-five (45) days of receipt by
Vaccinogen of the applicable invoice, other than the initial payment due which
shall be paid by Vaccinogen within three (3) business days of signing this
Agreement. All payments will be made to RxTrials via electronic funds transfer
using bank information to be provided separately and in writing by RxTrials.

 

2.3           With respect to each Task Order, Vaccinogen or its designee shall
have the right, at any time during the term of the applicable Task Order and for
a period of two (2) years thereafter, with reasonable advance written notice, to
audit RxTrials financial and other records relating to RxTrials performance
under such Task Order (including institution and investigator records and
RxTrials records regarding investigator fees paid pursuant to the Study)
(collectively the “First Audit”). In the event that any such audit reveals any
excess amounts paid by Vaccinogen (“Overpayment”), RxTrials shall promptly pay
to Vaccinogen any such amounts with interest of ten percent (10%) per annum
which will be calculated on the basis of the number of days such amounts
remained overpaid and, in the event that such excess amounts represent more than
five percent (5%) of what was actually owed, RxTrials shall promptly reimburse
Vaccinogen for the cost of such audit, and then RxTrials or its designee shall
have the right to conduct a second audit (“Second Audit”) within thirty (30)
days. If the findings of the Second Audit do not show an Overpayment, Vaccinogen
shall pay RxTrials (i) the amount paid by RxTrials to Vaccinogen as a result of
the First Audit and (ii) the cost of the Second Audit. The rights provided in
this Section shall be cumulative and in addition to any other rights or remedies
that may be available to Vaccinogen. Any auditor designated by either Party
under this Section 2.3 shall not be compensated on a contingency basis.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 4

 

  

2.4           Any significant change to the scope of the Services in a Task
Order shall result in an adjustment to the related Budget by amendment and shall
be subject to a Change Order.

 

2.5           No changes to the scope of the Services recited in a Task Order
can be implemented by RxTrials without prior written approval via a Task Order
from the Vaccinogen Representative. It will be RxTrials’ responsibility to
proactively identify additional services outside the original scope of Services
that need to be performed in furtherance of the implementation of such change.
RxTrials shall submit to the Vaccinogen Representative the costs associated with
the performance of such additional services for initiating a Change Order to the
relevant Task Order.

 

2.6           Additional services not specifically recited in the Master Service
Agreement may be contracted separately upon mutual written agreement of the
Parties.

 

2.7           RxTrials will assess, and Vaccinogen agrees to pay, a late payment
penalty fee which is interest of ten percent (10%) per annum on the amount
overdue, and which will be assessed monthly against any unpaid overdue balance,
except against amounts reasonably withheld by Vaccinogen due to RxTrials’s (i)
failure to provide Services or (ii) other breach of this Agreement pending
resolution of dispute as described in Section 18 of this Agreement. Such late
payment fees will continue to be applied and paid, if applicable, in the event
of termination, suspension, or expiration of this Agreement.

 

3            Regulatory Compliance

 

3.1           During the term of this Agreement and while performing Services
under any Task Order and any renewals thereof, RxTrials shall comply with the
Protocol, all applicable foreign, federal, state and local laws, rules and
regulations and guidance documents, and those of any relevant regulatory
authority outside the United States such as the European Medicines Agency (EMA),
including but not limited to, rules governing United States federal and state
healthcare programs, and rules and regulations promulgated by FDA, rules and
regulations with respect to the Services performed by RxTrials hereunder,
including GxP and the requirements of 21 C.F.R. Part 312, Good Clinical
Practices, including but not limited to the Drug and Cosmetic Act, 1940 and the
regulations promulgated pursuant thereto, with the standard of care customary in
the contract research organization industry and consistent with ethical
principles acceptable to the worldwide community for the conduct of clinical
trials. In the event of any actual or alleged noncompliance with GxP, the
Protocol, or with applicable foreign, federal, state, or local laws, rules, or
regulations (anywhere in the world) that may affect the integrity of Study data,
RxTrials shall notify Vaccinogen in writing immediately.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 5

 

  

3.2           Vaccinogen shall comply with all applicable laws, regulations and
guidance documents, including but not limited to, rules governing United States
federal and state healthcare programs, while conducting Study or Clinical Trial
under any Task Order.

 

3.3           While on Vaccinogen’s premises or while on the premises of
Vaccinogen’s study sites, RxTrials and its Representatives shall comply with
Vaccinogen’s policies, provided that Vaccinogen has delivered to RxTrials a
written copy of any such applicable policies.

 

3.4           Parties expressly agree to comply with federal regulations for the
protection of human subjects. Each Party shall immediately notify the other
Party with regard to any safety or regulatory issues resulting from or arising
out of any Study or Clinical Trial.

 

4            Use and Disclosure of Confidential Information

 

4.1           Any current Task Order or potential Task Order which is the
subject of consideration, evaluation and discussion between the Parties and the
existence and contents of this Agreement shall be considered Confidential
Information.

 

4.2           The Parties agree that the Confidential Information may be used
solely for the purpose of performing each Party’s obligations under this
Agreement and not for any other purpose. Except as provided in Section 4.5
below, the Confidential Information will be held in complete and strict
confidence and may only be disclosed to Representatives of the Parties on a
strict need-to-know basis for the performance of such Party’s obligations under
the Agreement.

 

4.3           The Parties undertake to ensure that each of its Representatives
who receive Confidential Information is made aware of and observes the
obligations under this Agreement. For the avoidance of any doubt, any disclosure
or unauthorized use of any Confidential Information under this Agreement by any
of the Representatives of a Party shall constitute a breach by the relevant
Party of this Agreement.

 

4.4           Upon written request by either Party, each Party agrees that it
will, as soon as reasonably practicable, return or destroy (at the disclosing
Party’s discretion) all copies of any document in such Party’s or such Party’s
Representative’s possession containing or reflecting Confidential Information,
provided however that the Parties may retain copies of such Confidential
Information for purposes of performing their obligations under this Agreement
and as applicable regulations may require.

 

4.5           Section 4.2 above does not, however, apply to the extent that any
Party is required to make a disclosure of Confidential Information by law or
pursuant to any order of court or other competent authority or tribunal or by
any applicable stock exchange regulations or the regulations of any other
recognized market place. In the event that any Party would be required to make
any such disclosure, each Party undertakes to give the other Party prompt and
reasonable notice prior to any such disclosure in order to make it possible for
the other Party to seek an appropriate protective order or other remedy. Each
Party also agrees and undertakes to use its best efforts to ensure that any
Confidential Information disclosed under this Section 4.5, to the extent
possible, will be treated confidentially by any Party receiving such
Confidential Information.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 6

 

  

4.6           Neither Party, nor any of its Representatives, makes any
representation or warranty, express or implied, as to the accuracy, reliability
or completeness of any of the Confidential Information, and neither Party, nor
any of its Representatives, will have any liability whatsoever to the other
Party resulting from any unauthorized use of the Confidential Information.

 

4.7           RxTrials acknowledges all Confidential Information, including the
discussions between the Parties hereto, are considered inside information under
applicable law and that neither RxTrials nor any of its Representatives may deal
in price-affected securities in relation to the inside information, encourage
another person to deal in price-affected securities or disclose the inside
information except as permitted by law.

 

5            Non-solicitation

 

5.1           Neither Party shall, during the term of this Agreement and for a
period of one year following its termination, either directly or indirectly
recruit, solicit, induce or attempt to induce any current director, officer or
employee of the other Party (including any director, officer or employee of any
company within the same group as the other Party) to terminate his or her
employment with such Party or otherwise be employed by it or any other person,
firm or company and shall not approach any such employee for such purpose or
authorize or approve the taking of such action by any other person without the
prior written consent of the other Party.

 

5.2           Neither Party shall, during the term of this Agreement and for a
period of one years following its termination, other than in the ordinary course
of business, either directly or indirectly approach, recruit, solicit, induce or
attempt to induce any person or entity that is a customer, supplier, agent,
representative or adviser of the other Party, or that the Parties otherwise know
has some form of business relationship of any kind with the other Party, to
cease, restrict or vary in any way its relationship with the other Party without
the prior written consent of the other Party, but in any event not in connection
with a current or potential Task Order.

 

6            Contacts

 

6.1           All communications made by Vaccinogen to RxTrials in connection
with the provision of Services under this Agreement or in connection with any
current or potential Task Order shall be directed to Adam R. Chasse, MHA, Chief
Operating Officer, adam.chasse@rxtrialsinc.com, 410-465-2455 x113.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 7

 

 

6.2           All communications made by RxTrials to Vaccinogen in connection
with the provision of Services under this Agreement or in connection with any
current or potential Task Order shall be directed to Andrew Tussing, Chief
Executive Officer, atussing@vaccinogeninc.com, 301 668 8400 or his designee
which shall be provided in writing.

 

7            Term and Termination; Effect of Termination

 

7.1           This Master Services Agreement shall take effect on the Effective
Date and is contingent upon an accepted budget by Vaccinogen. The Agreement
shall continue until the earlier of (i) seven (7) years after the Effective Date
(the “Term”), (ii) the date that all Services under all Task Orders executed
prior to the expiration of the Term are completed or (iii) when otherwise
terminated by the Parties in accordance with this Section 7.

 

7.2           Either Party may terminate this Agreement immediately upon written
notice to the other Party upon the occurrence of any of the following: (1) the
other Party 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 the other Party
or any of its subsidiaries 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; (3) failure of the other Party to maintain proper
levels of security and protection from disclosure of any unauthorized third
party patient information or a Party’s Confidential Information; or (4) an order
for relief shall be entered against the other Party or any of its subsidiaries
under the federal bankruptcy laws now or hereafter in effect.

 

7.3           Vaccinogen may terminate this Agreement, without cause, upon
providing ninety (90) days written notice to RxTrials. RxTrials may terminate
this Agreement, without cause, upon providing ninety (90) days prior written
notice to Vaccinogen.

 

7.4           Vaccinogen may terminate this Agreement and any Task Order
immediately upon written notice to RxTrials for safety concerns or as otherwise
required by any applicable law or regulation.

 

7.5           Vaccinogen may terminate this Agreement or any Task Order
immediately upon written notice to RxTrials if RxTrials fails to remedy a
material breach of the Agreement or provide a corrective action plan which is
reasonably acceptable to Vaccinogen within thirty (30) days after written notice
by Vaccinogen to RxTrials of the breach.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 8

 

  

7.6           RxTrials may terminate this Agreement or any Task Order
immediately upon written notice to Vaccinogen if Vaccinogen fails to remedy a
material breach of the Agreement or provide a corrective action plan which is
reasonably acceptable to RxTrials within thirty (30) days after written notice
by RxTrials to Vaccinogen of the breach.

 

7.7           RxTrials may suspend performance of this Agreement or any Task
Order in the event Vaccinogen fails to make timely payments, provided that
RxTrials shall give Vaccinogen fifteen (15) days written notice of such
non-payment before suspension of performance.

 

7.8           Termination or expiration of this Agreement shall not affect any
rights or obligations which have accrued prior thereto or in connection
therewith, or any obligations hereunder which by their terms survive termination
or expiration.

 

7.9           Upon notice of Termination of a Task Order by or to RxTrials,
RxTrials (1) shall use commercially reasonable efforts to conclude or transfer
any uncompleted Services, as directed by Vaccinogen, as expeditiously as
possible, and (2) shall not undertake future work, incur additional expenses, or
enter into further commitments with regard to any Services, except as mutually
agreed upon in writing by the Parties.

 

7.10         Within thirty (30) days or as soon as practicably possible
thereafter, or such other period of time mutually agreed to in writing by the
Parties, after the effective date of termination of this Agreement or a Task
Order, RxTrials shall deliver to Vaccinogen all materials, data and information
either to the Study or to the Services which are Vaccinogen’s property as
defined under Section 9 of this Agreement or the relevant Task Order.

 

8            Failure to Perform; Remedies

 

8.1           Vaccinogen may terminate the Agreement immediately upon notice to
RxTrials if (i) RxTrials does not provide Services conforming to the Services
set forth in each Task Order in all material respects, (ii) such failure is due
to a reason other than a Force Majeure Event (as described below in Section 8.2)
or Vaccinogen’s negligence or failure to act as reasonably required under this
Agreement, (iii) Vaccinogen has provided timely notice to RxTrials in writing of
such material non-compliance, and (iv) Vaccinogen has allowed RxTrials thirty
(30) days from the date of such notice to correct such material non-compliance
or provide a corrective action plan reasonably acceptable to Vaccinogen.

 

8.2           Neither Party shall be liable or deemed to be in default under
this Agreement for any delay due to causes beyond the control of the Party,
including but not limited to, war, civil disorders, acts of terrorism, acts of
God, explosions, fires, electrical or other utility failures, government action
(“Force Majeure Event”), provided that the affected Party promptly notifies the
other Party of the causes and its effects on the affected Party's performance
hereunder. For avoidance of doubt, performance shall be excused only to the
extent of and during the reasonable continuance of such Force Majeure Event.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

 

Page 9

 

  

9           Deliverables, Work Product & Intellectual Property

 

9.1           All methodologies, innovations, discoveries, modifications, and
practices conceived, reduced to practice, made or developed by RxTrials for
protocol development, site selection, site enrolment diagnostics, patient
treatment, immunotherapy, enrollment management, site and investigator
education, and clinical trial awareness services in connection with RxTrials’
performance of the Services related to, and solely applicable to, the Study
shall be the sole and exclusive property of Vaccinogen, and RxTrials hereby
assigns all of its rights to all of the foregoing to Vaccinogen. All
methodologies, innovations, discoveries and practices conceived, reduced to
practice, made or developed by RxTrials not exclusively related to the Services
shall be the sole property of RxTrials. All other reports, communications,
materials, information, innovations and discoveries (whether or not patentable
or copyrightable) conceived, reduced to practice, made or developed by RxTrials
solely or jointly with others in connection with RxTrials’ performance of the
Services shall be promptly disclosed to and be the sole property of Vaccinogen,
and RxTrials hereby assigns all of its rights to all of the foregoing to
Vaccinogen.

 

9.2           Notwithstanding the foregoing, Vaccinogen shall not acquire
ownership of any materials, information, products, costs, operational
techniques, financial and tax information, projections, research and development
plans, inventions, trade secrets and know-how and/or other intellectual property
owned by RxTrials prior to RxTrials’ performance of Services under this
Agreement or that is licensed by RxTrials from any third party.

 

10          Presentations, Publications and Publicity

 

10.1         Other than describing performance metrics in its marketing efforts
in a manner that does not name Vaccinogen nor disclose study details, and that
only references a Study in broad therapeutic terms (e.g., “surgical oncology
study”), RxTrials shall not present or publish, nor submit for publication, any
work resulting from the Services without Vaccinogen’s prior written approval.

 

10.2         No Party hereto shall use any other Party’s or its Affiliates names
or trademarks for publicity or advertising purposes, except with the prior
written consent of such other Party.

 

11          Representation and Warranties

 

11.1         Each Party represents and warrants that the total payment for the
Services represents fair market value for the Services and has not been
determined in any manner that takes into account the volume or value of any
referrals or business between RxTrials and Vaccinogen.

 

11.2         Each Party hereby represents and warrants that it has not and will
not use in any capacity the services of any individual, corporation, partnership
or association which has been debarred, and has not been convicted of a crime
which could lead to debarment, under the Generic Drug Enforcement Act of 1992,
21 U.S.C. § 335a(a) and (b). In the event that during the term of this
Agreement, either Party or any of its employees or agents who perform Services
hereunder is debarred or receives notice of an action or threat of action of
debarment, that Party shall immediately notify the other Party of same.

 

  Initials by RxTrials:  _________       Initials by Vaccinogen:  _________

 

Page 10

 

  

12         Independent Contractor

 

12.1         RxTrials' status under this Agreement is that of an independent
contractor. Vaccinogen shall not be responsible for withholding, and shall not
withhold, FICA or taxes of any kind from any payments it owes to RxTrials.

 

12.2         RxTrials shall not be deemed an agent, partner, employee or joint
venture partner of Vaccinogen for any purpose whatsoever. RxTrials does not have
the authority to take action on Vaccinogen’s behalf or to bind Vaccinogen, and
RxTrials shall not enter into any contract or agreement with a third party that
purports to obligate or bind Vaccinogen.

 

12.3         This Agreement shall not entitle RxTrials to participate in any
benefit plan or program of Vaccinogen.

 

12.4         RxTrials is not entitled to worker’s compensation coverage by
Vaccinogen, and RxTrials hereby waives any and all rights RxTrials may have to
be covered under Vaccinogen’s worker’s compensation policies.

 

13         Indemnification

 

13.1          Vaccinogen hereby agrees to indemnify RxTrials and its affiliates,
employees, directors, officers and agents and to defend and hold them harmless
against any liability, judgment, demand, action, suit, loss, damage, cost and
other expense (including but not limited to reasonable attorney’s fees and court
costs) (“Liability”) resulting from any third party claims made or proceedings
brought against RxTrials to the extent that such Liability arises as a result of
the Vaccinogen’s negligence, willful misconduct, breach of the representations
and warranties set forth in this Agreement, or other claim based upon a
defective product or other product liability, or as a result of RxTrials’
performance of the Services; except to the extent that such Liability results
from RxTrials’ negligence, wilful misconduct or breach of the representations or
warranties set forth in this Agreement.

 

13.2         RxTrials agrees to indemnify Vaccinogen and its affiliates,
employees, directors, officers and agents and hold them harmless from and
against all liability, judgment, losses, damages, costs, claims, suites and
other expenses (including reasonable attorney’s fees and court costs)
(“Liability”) against Vaccinogen resulting from any third party claims made or
proceedings brought against Vaccinogen to the extent that such Liability arises
as a result of RxTrials' negligence, willful misconduct, wrongful acts or breach
of the representations and warranties set forth in this Agreement.

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 11

 

  

13.3         Under no circumstances, will RxTrials incur liability, admit fault,
settle, or otherwise compromise any claims on behalf of Vaccinogen under this
Section 13 without the prior written consent of Vaccinogen.

 

13.4         Under no circumstances shall either Party be liable to the other
Party for incidental, indirect, consequential or special damages arising in
connection with any default or breach of obligations under this agreement or any
attachments hereto.

 

13.5         Throughout the Term of this Agreement, and for a period of five (5)
years thereafter, each Party represents and warrants that it has and will
maintain a policy of insurance at levels sufficient to support its obligations
assumed herein, but the amount shall not be less than $1 million for each
occurrence and $3 million aggregate for any injury, personal injury or death.
Such insurance shall be comprehensive general and product liability insurance or
such other forms that shall include coverage for clinical trials liability,
contractual liability and products liability to cover their respective
obligations hereunder, including indemnification obligations. Each Party shall
provide the other Party with a copy of its certificate of insurance evidencing
insurance coverage upon execution of this Agreement.

 

14         Waiver

 

14.1         No waiver of any term or condition of this Agreement in any
instance shall be deemed to be or construed as a further or continuing waiver of
such term or condition or of any other term or condition of this Agreement or
Task Order. No course of dealing, usage of trade, waiver or non-enforcement
shall be construed to modify or otherwise alter the terms and conditions of this
Agreement. The failure of either Party to insist on strict performance of any
covenant or obligation under this Agreement, regardless of the length of time
for which such failure continues, shall not be a waiver of such Party’s right to
demand strict compliance in the future.

 

15         Notices

 

15.1         All notices hereunder shall be in writing and shall be effective
(i) upon deposit in the United States mail if sent via certified mail, return
receipt requested with postage paid or (ii) when received if personally
delivered by express courier or if sent via facsimile with confirmation of the
facsimile transmission as follows:

 

  If to RxTrials, address to:       RxTrials, Inc.   Attn: Christine Pierre  
President   2838 Leaf Shade Drive   Suite B   Ellicott City, MD 21042 USA      
(Fax) 410 465 2456

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 12

 

  

  with a copy (which shall not constitute notice) to:       RxTrials   Attn:
Adam Chasse, MHA   Chief Operating Officer   2838 Leaf Shade Drive   Suite B  
Ellicott City, MD 21042 USA       If to Vaccinogen, address to:       Vaccinogen
  Attn: Andrew Tussing   Chief Executive Officer   5300 Westview Drive   Suite
406   Fredrick, MD  21703 USA       (Fax) 301 631 2970       And      
Attn:  General Counsel (at same address)

 

16         Assignment; Subcontracting

 

16.1         In the event that RxTrials is permitted to subcontract any duty
hereunder to a third party, such subcontractor must first be reviewed and found
acceptable to Vaccinogen before being engaged for any Services or to perform any
other acts hereunder. RxTrials shall obligate such subcontractor to comply with
the terms and conditions of the Agreement. RxTrials shall at all times remain
responsible and liable to Vaccinogen for the acts or omissions of such
subcontractor activities as if such activities had been performed by RxTrials.

 

16.2         This Agreement may not be assigned by RxTrials, whether voluntarily
or by operation of law, without the prior written consent of Vaccinogen, which
may be withheld at its sole discretion. This Agreement may be assigned by
Vaccinogen, upon notice to RxTrials, to a third party so long as the assignee
agrees in writing to assume all of the obligations and rights of Vaccinogen.
This Agreement shall be binding upon and inure to the benefit of the permitted
successors and assigns of the respective Parties.

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 13

 

 

 

17         Miscellaneous

 

17.1         This Agreement contains the entire understanding of the Parties
with respect to the subject matter hereof and supersedes all previous agreements
and undertakings with respect thereto. This Agreement may be modified only by
written agreement signed by the Parties.

 

17.2         In case any one of the provisions of this Agreement should be
invalid, illegal or unenforceable in any respect, the validity, legality and
enforceability of the remaining provisions contained herein shall not in any way
be affected or impaired

 

17.3         Sections 2, 3, 4, 5, 7, 8, 9, 10, 11, 13, and 18 hereof along with
any other obligations of the Parties under this Agreement which by their nature
would continue beyond the expiration or termination of this Agreement shall
survive performance, termination or expiration of this Agreement or any Task
Order for any reason, except for services performed or remaining unperformed at
the time of termination.

 

17.4         The definitions in this Agreement shall apply equally to both the
singular and plural forms of the terms defined. Whenever the context may
require, any pronoun shall include the corresponding masculine, feminine and
neuter forms. The words "include," "includes" and "including" shall be deemed to
be followed by the phrase "but not limited to." "Or" is disjunctive but not
necessarily exclusive. All references herein to Sections, Exhibits and Schedules
shall be deemed references to Sections of, and Exhibits and Schedules to, this
Agreement unless the context shall otherwise require. All Exhibits and Schedules
attached to this Agreement shall be deemed incorporated herein by reference as
if fully set forth herein. Words such as "herein," "hereof," "hereto," "hereby"
and "hereunder" refer to this Agreement and to the Exhibits and Schedules, taken
as a whole. Except as otherwise expressly provided herein: (a) any reference in
this Agreement to any agreement means such agreement as amended, restated,
supplemented or otherwise modified from time to time; (b) any reference in this
Agreement to any law shall include corresponding provisions of any successor law
and any regulations and rules promulgated pursuant to such law or such successor
law; and (c) all terms of an accounting or financial nature shall be construed
in accordance with U.S. generally-accepted accounting principles, as in effect
from time to time. Neither the captions to Sections or subdivisions thereof
shall be deemed to be a part of this Agreement. The Recitals are part of the
Agreement.

 

18         Governing Law and Jurisdiction; Dispute Resolution

 

18.1         This Agreement shall be governed by and construed in accordance
with the laws of Maryland without regard to its principles of conflicts of laws,
and any litigation arising out of this Agreement shall be conducted in a federal
or state court of competent jurisdiction located in the state of Maryland.

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

  

Page 14

 

  

18.2         If a dispute arises between the Parties in connection with this
Agreement, or a disagreement arises regarding the interpretation of any
provision hereof (a “Dispute”), the Parties shall use the following procedure in
good faith prior to either Party filing a lawsuit, commencing arbitration or
pursuing other available judicial or nonjudicial remedies:

 

(i)     A meeting of the Parties shall be held within fourteen (14) days after
either Party gives written notice of a Dispute to the other Party. The meeting
shall be attended by the CEO of each Party or an individual designated by the
CEO (of the respective Party) who has decision-making authority regarding the
Dispute. The CEO(s) and/or designated individual(s), as the case may be, shall
negotiate in good faith, be discreet, and use reasonable efforts to resolve the
Dispute.

 

(ii)    If the Parties do not succeed in resolving the Dispute within thirty
(30) days after notice of the Dispute from the other Party, either Party may
file a lawsuit, commence arbitration or pursue other available judicial or
nonjudicial remedies.

 

19         Counterparts; Electronic Signatures

 

19.1         For the convenience of the Parties, any number of counterparts of
this Agreement may be executed by any one or more Parties hereto, and each such
executed counterpart shall be, and shall be deemed to be, an original, but all
of which shall constitute, and shall be deemed to constitute, in the aggregate
but one and the same instrument.

 

19.2         This Agreement may be circulated for signature through electronic
transmission, including, without limitation, facsimile and email, and all
signatures so obtained and transmitted shall be deemed for all purposes under
this Agreement to be original signatures until such time, if ever, as original
counterparts are exchanged by the Parties.

 

[ the Signature Page follows ]

 

Page 15

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date
first set forth above.

 

Vaccinogen, Inc.   RxTrials, Inc.       By: /s/ Andrew L. Tussing   By: /s/
Christine Pierre       Name: Andrew L. Tussing   Name: Christine Pierre      
Title: Chief Executive Officer   Title: Chief Executive Officer

 

List of Exhibits at time of Execution of the Agreement:

 

Exhibit A - Task Order Form

 

Exhibit B - Change Order Form

 

Exhibit C - Fee Schedule for Task Order RXTRIALS-001

 

Exhibit D - Protocol for RXTRIALS-Task Order 001

 

Exhibit E - Task Order RXTRIALS-001 (with Schedules A and B)

 

[ Signature Page to the Master Services Agreement between

Vaccinogen, Inc. and RxTrials, Inc. ]

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

  

Page 16

 

 

 EXHIBIT A

TASK ORDER FORM

 

TASK ORDER RXTRIALS-XXX

 

This TASK ORDER is effective as of the ……. Day of …………. (the “Effective Date”)
between RXTRIALS, INC. whose principal place of business is situated at 2838
Leaf Drive, Suite B, Ellicott City, MD 21042 and VACCINOGEN, INC., with offices
located at 5300 Westview Drive, Suite 406, Frederick, MD 21703.

 

BACKGROUND

 

VACCINOGEN and RXTRIALS are Parties to Master Service Agreement with an
effective date of <INSERT DATE>.

 

TASK ORDER EFFECTIVE DATE: <INSERT DATE>     VACCINOGEN PROJECT NAME : <INSERT
PROJECT NAME>     STUDY TITLE: <INSERT STUDY TITLE>     RXTRIALS Monitor:
<INSERT NAME>     VACCINOGEN Representative: <INSERT NAME>     TASK ORDER
EXPIRATION DATE: <INSERT DATE>

 

1.          THE SERVICES

 

RXTRIALS agrees to perform the Services as outlined in Schedule A, attached and
incorporated by reference as part of this Task Order, and in accordance with the
terms of the Master Service Agreement.

 

2.          COMPENSATION

 

In consideration for its performance of Services under this Task Order,
VACCINOGEN shall pay RXTRIALS in accordance with the payment schedule as
documented in Schedule B, attached and incorporated by reference as part of this
Task Order.

 

3.          TERM; TERMINATION

 

This Project Order shall continue until the Services are completed in accordance
with the timelines set forth in Schedule A attached to this Task Order or until
terminated as provided in the Master Service Agreement.

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 1

 

  

4.          INCORPORATION OF MASTER SERVICE AGREEMENT BY REFERENCE

 

The Terms and Conditions of the Master Service Agreement are hereby incorporated
by reference into and made a part of this Task Order. Unless otherwise stated in
this Project Order, all defined terms within the Master Service Agreement shall
have the same meaning when used in this Task Order. If any provisions of this
Task Order are in direct conflict with the Master Service Agreement so that the
provisions of both cannot be given effect, the terms of this Task Order shall
govern the specific issue.

 

5.          NOTICE.

 

In addition to the recipients of notice listed in the Master Service Agreement,
notices applicable to this Task Order Agreement shall be sent to:

 

  RXTRIALS Monitor: VACCINOGEN representative:     Name: <INSERT NAME >   Name:
<INSERT NAME> Address :   Address : Email address: <INSERT E-MAIL ADDRESS>  
<INSERT ADDRESS> Copy to: <INSERT NAME contract manager>   Email address:
<INSERT E-MAIL ADDRESS>     Copy to:  

 

7.          ENTIRE AGREEMENT.

 

This Project Order, including the incorporated Terms and Conditions of the
Master Service Agreement, represent the entire and integrated agreement between
RXTRIALS and VACCINOGEN and supersedes all prior negotiations, representations
or agreements, either written or oral, regarding the Services subject of this
Task Order.

 

VACCINOGEN, INC.   RXTRIALS, INC.       By     By   Name:   Name: Title:  
       Title: Date:     Date  

 

SCHEDULE A – DESCRIPTION OF SERVICES\

 

-Reference to Study Protocol (if applicable)

-Study Plan or similar

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 2

 

 

oStudy

oGoal of Services

oMilestone schedule with timing

oDeliverables

oReporting schedule (ex. milestone reports)

 

-Key contact persons at VACCINOGEN and RXTRIALS side

-ADD specific on activity  - 

 

SCHEDULE B – BUDGET RELATING TO THE SERVICES

 

Payment schedule should be generally cost neutral throughout performance period,
i.e. payments will be made according to the Services actually achieved during
the invoiced period.

 

One invoice per Task Order should be dispatched regularly, at least but no more
than once every 30 days, no later than 30 days after the end of each month
throughout the course of the Master Services Agreement.

 

Each Invoice should include an itemized list, including services rendered,
quantity of hours, identity of service provider/consultant name, and price
extension.

 

The invoices should mention the timing of services rendered and a purchase order
(PO) to be provided by VACCINOGEN (usually noted on the first page of the
original Task Order document).

 

All payments will be made within thirty (30) days of receipt of the applicable
invoice.

 

Total budget

 

-Including cost of all requested Services

-on basis of the fee schedule or price list.

 

 Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 3

 

 

EXHIBIT B

CHANGE ORDER FORM

 

CHANGE ORDER

 

1.All Change Orders shall be identified by

 

  Change Order number:               Date submitted:               Application
date:               Task Order(s) to amend:    

 

Covered by Master Agreement with an effective date of <INSERT DATE>.

 

2.Describe and motivate changes, modifications, or additions to the Services.

 

3.These modifications were requested by

 

¨ VACCINOGEN ¨ RXTRIALS

 

4.          Impact on

 

-Cost: (if applicable)

 

oinitial cost of Study :

 

ochanges in cost :

 

onew final cost of Study :

 

-Timing / Schedule: (if applicable)

 

oTask Order will remain effective until __________

 

-any other requirement: (if applicable)

 

SIGNATURE PAGE TO FOLLOW

 

Initials by RxTrials: _________

 

Initials by Vaccinogen: _________

 

Page 1

 

  

5.          Change Order Is:

 

Approved and Accepted________

 

        Signature of VACCINOGEN   Date           Name:               Title:    
          Signature of RXTRIALS   Date           Name:               Title:    
 

 

Page 2

 

 

EXHIBIT E

 

TASK ORDER RXTRIALS-001

 

This TASK ORDER is effective as of the 10th Day of September, 2014 (the
“Effective Date”) between RXTRIALS, INC. d/b/a OnPoint CRO whose principal place
of business is situated at 2838 Leaf Shade Drive, Suite B, Ellicott City, MD
21042 and VACCINOGEN, INC., with offices located at 5300 Westview Drive, Suite
406, Frederick, MD 21703.

 

BACKGROUND

 

Vaccinogen and RxTrials are Parties to the Master Services Agreement with an
effective date of August 29, 2014.

 

TASK ORDER EFFECTIVE DATE: September 10, 2014     VACCINOGEN PROJECT NAME:
Protocol ASI-2005-03     STUDY TITLE: A Randomized Multicenter Study of Active
Specific Immunotherapy with OncoVAX® in Patients with State II Colon Cancer    
RXTRIALS Representative: Adam Chasse, MHA (COO)     VACCINOGEN Representative:
Andrew Tussing (CEO)     TASK ORDER EXPIRATION DATE: October 31, 2020

 

1.THE SERVICES

 

RxTrials agrees to perform the Services as outlined in Schedule A, attached and
incorporated by reference as part of this Task Order, and in accordance with the
terms of the Master Services Agreement. At all times, and upon Vaccinogen's
reasonable request, RxTrials shall use its best efforts, and in no event less
than commercially reasonable efforts, to cooperate with any third party selected
by Vaccinogen to assist RxTrials in performing the Services.

 

2.COMPENSATION

 

In consideration for its performance of Services under this Task Order,
VACCINOGEN shall pay RXTRIALS in accordance with the payment schedule as
documented in Schedule B, attached and incorporated by reference as part of this
Task Order.

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

1

 

 

3.RECORD KEEPING AND RETENTION

 

With respect to this Task Order, RxTrials shall collect, prepare and maintain,
and shall use its best efforts, and in no event less than commercially
reasonable efforts, to cause each investigator to collect, prepare and maintain,
complete, current, accurate, organized and legible study documentation, in each
case in a manner acceptable for the collection of data for submission to, or
review by, applicable regulatory authorities and in full compliance with the
applicable protocol, applicable laws and such other policies and procedures as
Vaccinogen may from time to time provide to RxTrials.

 

In the event of a termination of this Agreement or a Study for any reason
whatsoever, RxTrials agrees to retain all records relating to this Agreement or
the Study, as applicable, for a period of two (2) years following such
termination; provided that RxTrials and Vaccinogen may agree to a longer
retention period in writing. Any retention of records by RxTrials for longer
than two (2) years may be an additional cost to Vaccinogen. At the end of any
applicable record retention period, RxTrials shall either destroy all records
relating to the Study or return them to Vaccinogen, in either case only at the
direction of Vaccinogen.

 

4.INSPECTIONS

 

RxTrials shall notify Vaccinogen immediately if any regulatory authority (i)
contacts RxTrials with respect to any Study or study drug, (ii) conducts, or
gives notice of its intent to conduct, an inspection at RxTrials or (iii) takes,
or gives notice of its intent to take, any other regulatory action alleging
improper or inadequate research practices with respect to any activity of
RxTrials, whether or not in connection with the Services. RxTrials shall notify
Vaccinogen immediately if RxTrials receives notice or otherwise learns that any
regulatory authority (x) has contacted any investigator or institution with
respect to the Study or study drug, (y) conducts or gives notice of its intent
to conduct an inspection at any investigator or institution site or (z) takes,
or gives notice of its intent to take, any other regulatory action alleging
improper or inadequate research practices with respect to any activity of any
Study investigator, institution or review board, whether or not in connection
with the Services. RxTrials shall provide Vaccinogen with copies of such
notice(s) and related correspondence within three (3) Business Days of receipt
(or sooner if necessary to permit Vaccinogen to be present at such visit) and
permit Vaccinogen representatives to be present at, or otherwise participate in,
such inspections or regulatory actions with respect to a Study. RxTrials shall
supply Vaccinogen with all documentation and information pertinent thereto and
provide to Vaccinogen any proposed response. No submission made by RxTrials to
any regulatory authority shall include any false or misleading information
relating to any Study, study drug or Vaccinogen. RxTrials agrees to permit
inspections of RxTrials facilities by regulatory authorities as may be required
by applicable law.

 

5.TERM; TERMINATION

 

This Project Order shall continue until the Services are completed in accordance
with the timelines set forth in Schedule A attached to this Task Order or until
terminated as provided in the Master Services Agreement.

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

2

 

  

6.INCORPORATION OF MASTER SERVICES AGREEMENT
BY REFERENCE

 

The Terms and Conditions of the Master Services Agreement are hereby
incorporated by reference into and made a part of this Task Order. Unless
otherwise stated in this Project Order, all defined terms within the Master
Services Agreement shall have the same meaning when used in this Task Order. If
any provisions of this Task Order are in direct conflict with the Master
Services Agreement so that the provisions of both cannot be given effect, the
terms of this Task Order shall govern the specific issue. In the event of any
conflict between this Agreement and any provision of a Task Order, the terms of
this Agreement shall control, except to the extent the Task Order expressly
states that the provision in the Task Order takes precedence with respect to the
Services provided under such Task Order.

 

7.NOTICE

 

In addition to the recipients of notice listed in the Master Services Agreement
and the obligations set forth therein, notices applicable to this Task Order
Agreement shall also be sent to:

  

  RxTrials representative:   Vaccinogen representative:   Name: Adam Chasse  
Name: Andrew Tussing   Address: 2838 Leaf Shade Drive, Suite B   Address : 5300
Westview Drive, Sutie 406   Ellicott City, MD 21042   Frederick, MD 21703  
Email address: adam.chasse@rxtrialsinc.com   Email address:
atussing@vaccinogeninc.com   Copy to: michael.jay@rxtrialsinc.com    

 

8.ENTIRE AGREEMENT.

 

This Task Order, including the incorporated Terms and Conditions of the Master
Services Agreement, represents the entire and integrated agreement between
RxTrials and Vaccinogen and supersedes all prior negotiations, representations
or agreements, either written or oral, regarding the Services which are the
subject of this Task Order.

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

 

3

 

  

VACCINOGEN, INC.   RXTRIALS, INC. By: ____________________________   By:
___________________________ Name:   Name: Title:   Title: Date:
_________________   Date: _________________

  

  Initials by RxTrials:             Initials by Vaccinogen:  

 

4

 

  

SCHEDULE A – DESCRIPTION OF SERVICES

For Protocol ASI-2005-3, RxTrials will perform the following services:

PRE-STUDY

-Attend Vaccinogen project kickoff meeting

-Pre-qualify 120 sites via written questionnaires and phone interviews

-Perform 54 onsite qualification visits (36 in US and 18 in Europe) in order to
select 32 US sites and 15 European sites for inclusion in the study

-Qualify and recommend vendor to handle internet publicity and subject
recruitment

-Work with 47 selected sites to create customized subject recruitment plans

-Onsite training for tumor acquisition, preparation, and shipment for each of 15
US sites and 5 European sites

-Regular written and verbal status updates to Vaccinogen (format to be decided
upon at kickoff meeting)

-Develop Study Reference Manual

-Develop investigator grant template

-Create monitoring plan

-Create Trial Master File (TMF)

-Facilitate translation of Informed Consent Forms

-Distribute, negotiate, but not execute Clinical Study Agreements with selected
sites. Vaccinogen reserves the right to (1) participate in all discussions,
communications, decisions, and negotiations relating to the Study (including
sites and investigators), and (2) negotiate directly, and exclusively with
regards to RxTrials, with any sites, investigators, vendors or any other third
parties in any matter relating to the Study.

-Distribute, collect, review, and approve essential regulatory documents with
selected sites in advance of site activation

-Create study aids

-Set up regulatory binders

-Investigator Meetings – planning, management, and attendance

-Overall Project Management

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

5

 

  

ENROLLMENT AND FOLLOW-UP PHASES:

 

-Conduct Site Initiation Visits

-Monitor all sites for compliance with protocol, study instructions, and
applicable regulations throughout 26-month enrollment period and 34-month
follow-up period (60 months total)

-Administer payments to sites per the Clinical Study Agreements if directed to
do so by Vaccinogen

-Remote data review for all sites

-Manage TMF, including periodic audits and transfer to Vaccinogen at end of
study

-Manage subject recruitment such that 550 subjects are enrolled by thirty-two
(32) months after the effective date of this task order via the following
activities:

oOversight of internet vendor

oWeekly contact with each of the 47 sites to review screening and enrollment
metrics, and to work with each site to address shortcomings and unanticipated
challenges

oDuring monitoring visits and additional booster visits as necessary, hold
in-depth discussion with sites regarding progress and provide firsthand
assistance in working with other stakeholder groups (e.g., referring physicians,
hospital administrators, etc.)

oNote – above timelines assume 6-month core pre-study phase (September 15, 2014
through March 15, 2015) and that Vaccinogen and other vendors not managed by
RxTrials will complete their obligations such that sites are ready to enroll on
a rolling basis throughout the pre-study phase; most site activations are
expected to occur between March 15, 2015 and June 15, 2015

 

-Manage subject retention via above tactics

-Additional training and Quality Assurance of tumor acquisition, preparation,
and shipping for each of 15 US sites and 5 European sites

oMonthly QA visits during Year 1; two such visits will also include re-training
per Vaccinogen’s training plan

oBimonthly QA visits during Year 2; two such visits will also include
re-training per Vaccinogen’s training plan

-Create and distribute study newsletters to sites

-Manage IRB/EC annual reviews to ensure no site has an approval lapse

-Regular written and verbal status updates to Vaccinogen (format to be decided
upon at kickoff meeting)

-Support collection of outstanding data and query resolution in advance of
database lock

-Conduct Closeout Visits with each site

-Overall Project Management

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

6

 

  

THROUGHOUT THE STUDY:

 

-At all times, RxTrials shall manage performance of the following tasks: data
management and transfer (including capture), biostatistics, medical and safety
monitoring (e.g., collection, management, and review of case report forms (CRF)
and their clinical review), and safety (e.g., serious adverse event (SAE)
documentation and reporting), provided that Vaccinogen may have third party
vendors provide the forgoing. RxTrials may negotiate vendor contracts on
Vaccinogen’s behalf using Vaccinogen’s pre approved contract. RxTrials will
administer payments to such vendors on Vaccinogen’s behalf, provided that
Vaccinogen may, in Vaccinogen's sole discretion, have a third party administer
payments.

 

Projected Study Milestones:

 

These projected milestones are based upon assumptions provided to RxTrials by
Vaccinogen. As of the effective date of this Task Order, Vaccinogen has not
undertaken a recent detailed feasibility analysis for the Study; Vaccinogen
therefore acknowledges and agrees that the Parties’ understanding of enrollment
rates will evolve once additional feasibility for the conduct of this study is
concluded.

 

Vaccinogen acknowledges and agrees that for this Study there several elements
that could contribute to timeline delays that are not within RxTrials’ control,
including but not limited to:

 

1) Response time from Vaccinogen on items requiring Vaccinogen’s feedback or
approval

2) Investigators’ willingness to participate in the Study

3) Uncertainty of country selection

4) Study design not acceptable to IRBs/ECs

5) Vaccinogen positions on Clinical Study Agreement language or budgets that are
not industry standard

6) Buildout of tumor preparation rooms

7) Safety-related study holds

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

7

 

  

RxTrials shall conduct the Study in accordance with the following milestones and
timeline, provided that, failure to enroll by any sites selected by Vaccinogen
or directed by Vaccinogen shall not be considered a failure on RxTrials’ part to
meet timelines.

 

Milestone  

Days After Effective Date of Task Order 

      1st Pre-Study visit conducted   110 1st Subject Enrolled   250 100% of U.S
sites selected   260 10% of subjects enrolled   335 100% of sites activated  
415 25% of subjects enrolled   500 50% of subjects enrolled   670 75% of
subjects enrolled   850 100% of subjects enrolled   1,050

  

  Initials by RxTrials:             Initials by Vaccinogen:  

 

8

 

  

SCHEDULE B – BUDGET RELATING TO THE SERVICES

 

The Budget is based on hours spent, and assumes such hours will be distributed
as needed over the scope period (and that other vendors/stakeholders do not
experience significant delays). Below is a summary of the Budget for services
performed directly by RxTrials. The Labor Fees portion of this Budget is a fixed
price. All amounts set forth in this Schedule B are in United States dollars.

 

Operations Category  Line Item  Labor Fees   Pass-Through
(est.)                  Protocol Review/Distribution  $

-

       Pre-Study  Identify Sites and Conduct Pre-Qualification Activity (CDAs,
phone calls, forms, etc.)  $37,419          Perform Pre-Study Visits (includes
Recruitment Planning)  $223,496   $59,600                    Submit to WEU
country ECs, manage annual renewals  $73,214          Informed Consent -
translation and finalization with sites  $24,072          Negotiate Site
Contracts  $76,032          Site Regulatory Document Completion  $83,136      
Study Startup  Prepare/Distribute Study Reference Manual  $9,100          Create
study aids for sites  $3,640          Plan/manage investigator meeting 
$18,340          Attend investigator meetings (1 US, 1 WEU)  $74,544   $23,100 
   Study team training  $21,296   $4,800                    NP and Pharmacy Tech
- pre-activation  $135,304   $145,000  Training (tumor prep & vaccine admin)  NP
and Pharmacy Tech - post-activation  $286,446   $150,000                 Design
Study Recruitment & Risk Management Plan  $34,216          Create/Distribute
study newsletters  $55,328       Site Management  Weekly Site Management 
$929,292          Recruitment Booster Visits  $139,230   $57,000     Provide
Enrollment Reporting/Analysis  $-                         Create Monitoring
Plan  $2,000          Site Initiation Visits (SIVs)  $156,948   $50,000 
Clinical Monitoring  Interim Monitoring Visits (IMVs)  $3,544,848   $1,028,000 
   Remote Monitoring  $442,035          Close-out Visits (COVs)  $128,412  
$50,000     Support Database Lock  $92,888                      Quality
Assurance  NP and Pharmacy Tech  $525,378   $600,000                 Logistics 
Manage sample shipments  $50,050          Manage vaccine shipments  $50,050  
                  Financial  Administer Site/Vendor Payments, Provide Financial
Reporting  $120,114   $12,384                    Trial Master File - setup,
maintenance, transfer  $198,520       Regulatory  Regulatory binders - setup and
maintenance  $13,160          Trial Master File - periodic audits  $80,080      
                 Monthly Project Management incl. meetings, reporting, &
communication  $1,373,611   $13,000  Project Management  CRA & Clinical
oversight (Lead CRA)  $807,644          Administrative Support  $556,920      
               TOTALS     $10,366,764   $2,192,884 

  

  Initials by RxTrials:             Initials by Vaccinogen:  

 

9

 

  

PASS-THROUGH COSTS:

 

A. Performance of the Services described in this Task Order will require
RxTrials Representatives to travel to meetings and institution facilities. Such
Representatives shall make the most cost effective decisions as to which mode of
travel they will utilize and what costs they incur. Out-of-pocket costs related
to this Services-related travel activity, as well as costs related to
Services-related shipping of documents or checks, shall be considered
pass-through costs.

 

Subject to the provisions of this section and the Master Services Agreement,
Vaccinogen agrees to reimburse RxTrials for pass-through travel expenses, which
are currently estimated to be two million one hundred ninety two thousand eight
hundred and eighty four dollars ($2,192,884) for the duration of the project.
Vaccinogen acknowledges and agrees that this estimate is based on project
parameters provided by Vaccinogen (used to determine number of trips taken and
other administrative tasks) as well as current pricing information from
merchants such as airlines, hotels, couriers, etc. (to determine the dollar
amount per trip or administrative task). Vaccinogen further acknowledges and
agrees that market forces may cause price fluctuations that increase project
pass-through costs, and that it will reimburse such costs as described herein
even if there is a reasonable increase, provided that RxTrials has used its best
efforts, and in no event less than commercially reasonable efforts, to avoid and
minimize any such increase. For avoidance of doubt, if market forces cause price
fluctuations that decrease project pass-through costs, the amount due from
Vaccinogen will be adjusted accordingly.

 

B. Solely to the extent specified in this Task Order, Vaccinogen shall reimburse
RxTrials for pass-through costs incurred by RxTrials. Pass-through costs not
specified in the Budget of this Task Order shall be approved in advance and in
writing by Vaccinogen in order to be reimbursed. Vaccinogen shall have no
obligation to reimburse RxTrials for any costs that are in excess of the amounts
specified in this Budget unless, and then only to the extent, any such excess
costs are approved in writing in advance by Vaccinogen.

 

C. Only travel expenses which are in compliance with Vaccinogen’s Travel and
Expense policy (if provided to RxTrials) and which are necessary to fulfill the
Services will be invoiced to Vaccinogen. At all times, RxTrials shall use its
best efforts, and in no event less than commercially reasonable efforts, to
minimize such costs. RxTrials will prepare a summary report for Vaccinogen that
details all travel expenses and all other pass-through costs incurred. RxTrials
shall keep receipts and other supporting documentation for all pass-through
costs. Subject to the audit provisions of the Master Services agreement, if
RxTrials cannot provide supporting documentation of any pass-through cost,
Vaccinogen shall have no obligation to pay for such cost. The amount of any such
unsupported cost shall be credited or refunded to Vaccinogen upon its discovery.

 

D. As prepayment of pass-through expenses, one hundred twenty-five thousand
dollars ($125,000) shall be due and payable no later than September 30, 2014.
This will establish a pass-through pay-down account. RxTrials will track the
disbursement of pass-through costs from the pass-through pay-down account and
will invoice Vaccinogen seventy-five thousand dollars ($75,000) each month that
the balance in the pass-through pay-down account drops below one hundred twenty
five thousand dollars ($125,000), payable within thirty (30) days, until
remaining pass-through are expected to equal what is left in the pay-down
account.

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

10

 

 

EXHIBIT C

 

FEE SCHEDULE

 

Fixed Price Labor Fees

 

As shown in the table below, Vaccinogen will split the initial payment into two
installments. The “First Initial Payment” will be in the amount of seven hundred
thousand dollars ($700,000) and will made by Vaccinogen to RxTrials by 5:00 p.m
Eastern Daylight Time on the first Business Day after signing this Task Order.

 

The “Second Initial Payment” will be in the amount of eight hundred thousand
dollars ($800,000) and will be made by Vaccinogen to RxTrials no later than 5:00
p.m. Eastern Daylight Time on September 30, 2014. If the Second Initial Payment
is not made by that time, RxTrials shall reserve the right to suspend
performance of all or part of this Task Order until the Second Initial Payment
is made.

 

In addition to below, three hundred and fifty thousand dollars ($350,000) worth
of Vaccinogen Common Restricted stock priced at the closing price on the date of
this Task Order and rounded to the nearest whole share will be granted upon
contract signature and issued in the name as RxTrials directs Vaccinogen;
Restricted Stock grant is subject to Vaccinogen, Inc. Board of Directors
approval and will be in a schedule to be agreed upon. In absence of stock, the
three hundred and fifty thousand dollars ($350,000) will be paid in cash no
later than October 31, 2014.

  

  Initials by RxTrials:             Initials by Vaccinogen:  

 

11

 

  

Invoice Sent  Due Date  Amount Due           n/a  by 5pm EDT the day after
Effective Date of Task Order  $700,000  n/a  By September 30, 2014 at 5pm EDT 
$800,000  10-Sep-14  25-Oct-14  $220,000  1-Oct-14  15-Nov-14  $150,000 
1-Nov-14  16-Dec-14  $175,000  1-Dec-14  15-Jan-15  $225,000  1-Jan-15 
15-Feb-15  $225,000  1-Feb-15  18-Mar-15  $200,000  1-Mar-15  15-Apr-15 
$265,000  1-Apr-15  16-May-15  $200,000  1-May-15  15-Jun-15  $200,000 
1-Jun-15  16-Jul-15  $215,000  1-Jul-15  15-Aug-15  $250,000  1-Aug-15 
15-Sep-15  $215,000  1-Sep-15  16-Oct-15  $220,000  1-Oct-15  15-Nov-15 
$220,000  1-Nov-15  16-Dec-15  $220,000  1-Dec-15  15-Jan-16  $220,000 
1-Jan-16  15-Feb-16  $220,000  1-Feb-16  17-Mar-16  $220,000  1-Mar-16 
15-Apr-16  $220,000  1-Apr-16  16-May-16  $220,000  1-May-16  15-Jun-16 
$220,000  1-Jun-16  16-Jul-16  $220,000  1-Jul-16  15-Aug-16  $220,000 
1-Aug-16  15-Sep-16  $220,000  1-Sep-16  16-Oct-16  $200,000  1-Oct-16 
15-Nov-16  $200,000  1-Nov-16  16-Dec-16  $200,000  1-Dec-16  15-Jan-17 
$190,000  1-Jan-17  15-Feb-17  $190,000  1-Feb-17  18-Mar-17  $190,000 

 

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

12

 

 

Invoice Sent  Due Date  Amount Due  1-Mar-17  15-Apr-17  $190,000  1-Apr-17 
16-May-17  $150,000  1-May-17  15-Jun-17  $70,000  1-Jun-17  16-Jul-17  $39,772 
1-Jul-17  15-Aug-17  $33,904  1-Aug-17  15-Sep-17  $50,000  1-Sep-17  16-Oct-17 
$75,000  1-Oct-17  15-Nov-17  $75,000  1-Nov-17  16-Dec-17  $70,000  1-Dec-17 
15-Jan-18  $70,000  1-Jan-18  15-Feb-18  $70,000  1-Feb-18  18-Mar-18  $70,000 
1-Mar-18  15-Apr-18  $70,000  1-Apr-18  16-May-18  $70,000  1-May-18  15-Jun-18 
$70,000  1-Jun-18  16-Jul-18  $62,508  1-Jul-18  15-Aug-18  $51,673  1-Aug-18 
15-Sep-18  $51,673  1-Sep-18  16-Oct-18  $51,673  1-Oct-18  15-Nov-18  $51,673 
1-Nov-18  16-Dec-18  $62,462  1-Dec-18  15-Jan-19  $62,508  1-Jan-19  15-Feb-19 
$60,000  1-Feb-19  18-Mar-19  $60,000  1-Mar-19  15-Apr-19  $60,162  1-Apr-19 
16-May-19  $51,673  1-May-19  15-Jun-19  $52,462  1-Jun-19  16-Jul-19  $52,508 
1-Jul-19  15-Aug-19  $41,673  1-Aug-19  15-Sep-19  $41,673  1-Sep-19  16-Oct-19 
$41,673  1-Oct-19  15-Nov-19  $41,673  1-Nov-19  16-Dec-19  $52,462  1-Dec-19 
15-Jan-20  $52,508  1-Jan-20  15-Feb-20  $41,673  1-Feb-20  17-Mar-20  $31,673 
1-Mar-20  15-Apr-20  $36,570  1-Apr-20  16-May-20  $60,986  1-May-20  15-Jun-20 
$55,163  1-Jun-20  16-Jul-20  $37,694  1-Jul-20  15-Aug-20  $52,876  1-Aug-20 
15-Sep-20  $13,867  1-Sep-20  16-Oct-20  $9,946  LABOR PAYMENTS DUE:    
$10,366,764 

 

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

13

 

 

The initial payment of one million five hundred thousand dollars ($1,500,000)
(14.5% of the total labor budget) shall be nonrefundable, provided that, in the
event that Vaccinogen terminates this Task Order for cause per Section 7.5 of
the Master Services Agreement, Vaccinogen shall be entitled to recover a portion
of the initial payment up to a maximum of seven hundred fifty thousand dollars
($750,000), subject to the following conditions:

 

1) The uncured material breach cited by Vaccinogen as “cause” must not be
attributable, in whole or in part, to any material delay or material failure to
perform on the part of Vaccinogen or any third party (not under the direction
and control of RxTrials) providing any service related to the Study.

 

2) Such termination for cause must occur within thirty-two (32) months of the
Effective Date of this Task Order.

 

3) Such recoverable amount will be prorated based on the amount of time from the
Effective Date of this Task Order to the date of breach, and the amount of time
from the date of breach to the Expiration Date of this Task Order.

 

  Initials by RxTrials:             Initials by Vaccinogen:  

 

14