Portions of this document have been redacted pursuant to a Request for
Confidential Treatment filed with the Securities and Exchange Commission
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
Redacted portions are indicated with the notation “*”.

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 1 of 15

 

CONTRACT RESEARCH AGREEMENT

 

This agreement “Agreement” is entered into on February 28th, 2012 by and
between:

 

Crucell Holland B.V., a private company with limited liability, with offices
located at Archimedesweg 4, 2333 CN Leiden, the Netherlands, (“Crucell”),

 

and

 

Enumeral Biomedical Corp., a company organized under the laws of Delaware,
U.S.A., with offices located at 1450 Broadway, 24th Floor, New York, NY, 10018,
U.S.A. (“Contractor”);

 

Each of Crucell and Contractor hereinafter individually referred to as “Party”
and collectively as “Parties”;

 

Whereas:

 

ØCrucell is engaged in the business of researching, developing, manufacturing,
testing, marketing and selling vaccines and proteins to combat infectious
diseases;

ØCrucell is the owner or licensee of certain molecules, proteins and antibodies
(“Materials”) and of associated information and know-how, including assays and
intellectual property rights thereto as further specified in Appendix I as
attached to this Agreement;

ØContractor is an independent biotech company providing a broad range of
services for the research and development of products;

ØCrucell wishes to hire Contractor, and Contractor wishes to be hired by
Crucell, to perform * screening services, antibody * services, and discovery of
* services as further specified in Appendix I as attached to this Agreement
(“Research Project”);

ØCrucell is willing to provide the Materials and related Confidential
Information to Contractor for such purposes;

ØCrucell and Contractor recognize the need to make suitable arrangements herein
with respect to the use of the Materials and the use of the Results stemming
from the Research Project.

 

IT IS HEREBY AGREED as follows:

 

1.Statement of Work (SOW). The Research Project will be carried out in
accordance with one or more specific detailed statements of work that will be
issued by Crucell, signed by both Parties and attached to this Agreement by
written amendment in Appendix 1 (each a “Statement of Work” or “SOW”). Each SOW
will also contain the financial terms and conditions, including an invoicing
schedule, for such SOW.

 

 

 

 

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Crucell Holland B.V. – Contractor

Page 2 of 15

 

2.Provision of Information and Materials. Crucell shall make arrangements to
provide Contractor with information and Materials as necessary and at its
disposal for the performance of the SOW.

 

3.Quality Agreement. The SOW will be performed in accordance with the terms of
any quality agreement agreed between Parties, as may be updated from time to
time.

 

4.Materials and Results. The Materials are proprietary to Crucell. During the
term of this Agreement, Contractor agrees to maintain control over the Materials
and all the results of the Research Project, including any materials, data,
know-how and other information resulting from the Research Project (“Results”),
and further agrees not to disclose, give access to or transfer the Materials and
Results to persons not under its supervision and who do not need to receive or
have access to the Materials and Results for the performance of the Research
Project, without the prior written approval of Crucell. Results shall promptly
be reported to Crucell during the performance of each SOW. Furthermore, the
Materials shall only be used within the laboratories of Contractor and by its
employees for the purpose of performing the SOW and the Materials shall not be
modified, altered, changed and/or reconstructed other than as described in the
SOW.

 

5.Intellectual Property. All right, title and interest to any intellectual
property rights with respect to the Results will vest in Crucell. Contractor
will respond to reasonable inquiries of Crucell regarding the status of each SOW
and any inventions and intellectual property rights arising therefrom. If during
the course and performance of the SOW, inventions are conceived or reduced to
practice, Contractor agrees that all right, title and interest in and to all
such inventions, shall vest in Crucell. Contractor will disclose promptly any
inventions or improvements made or conceived by Contractor either alone or
jointly with others, in the course of or as a result of the performance of the
Research Project. Contractor shall assign its entire right, title and interest
in and to any and all such inventions and improvements to Crucell and execute
such documents as may be required to file applications and to obtain patents in
the name of Crucell or its nominees, in any countries, covering such inventions
or improvements. For the avoidance of doubt, the rights to any intellectual
property rights with respect to Results as set forth herein shall not include
the rights to any underlying background technology, materials or information
that is proprietary to Contractor. Except as expressly set forth otherwise
herein, nothing in this Agreement grants either Party rights or a license to any
patent, copyright, trademark, or other intellectual property rights of the other
Party. For the avoidance of doubt, nothing in this agreement expressly or
otherwise provides for a license to Enumeral's technology: Platform for
quantitative single cell functional profiling (“Enumeral Technology”), nor any
inventions, discoveries or improvements to Enumeral’s Technology, whether
patentable or not, which if practiced would constitute an infringement of any
Enumeral patent or other intellectual property rights, that arise from
Enumeral’s application of the Enumeral Technology in performance of the work as
described in the Statements of Work. For clarity, such improvements to
Enumeral’s technology, including, but not limited to, the use of microengraving
technology to measure, within * materials, the * with potential utility in
determining the presence or absence of disease processes will be owned solely by
Enumeral provided that such improvements do not claim or require the use of
Crucell’s Material.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 3 of 15

 

6.Deliverables. Deliverables from Contractor to Crucell shall be defined in each
SOW and include all remaining Materials and all Results. The invoicing schedule
for each SOW will be based on these defined deliverables.

 

7.Compliance. Contractor shall use commercially reasonable efforts to perform
each SOW within the term specified in the respective SOW, and in accordance with
the specifications, instructions, and guidelines in the SOW and this Agreement.
The Parties shall work together in good faith to ensure that each SOW clearly
describes all methods, requirements, and obligations (other than those set forth
in this Agreement or a separate quality agreement). Contractor shall furthermore
conduct its activities under this Agreement in accordance with the highest
ethical standards and best industry practices, including any voluntary codes of
practice applicable in the industry for the research, and all applicable laws
and regulations, including the U.S. Foreign Corrupt Practices Act. Contractor
will comply with all applicable national and international laws, regulations and
guidelines relating to protection of the personal information of study subjects,
including the European Commission Directive 95/46/EC as it relates to the
protection of the personal information, and the Standards for Privacy of
Individually Identifiable Health Information (Privacy Rule) under the United
States Health Insurance Portability and Accountability Act of 1996 (HIPAA).

 

8.Payment. In consideration of Contractor’s performance of all activities set
out in each SOW, Crucell will pay Contractor the respective amounts specified in
each such SOW. Parties will agree on the specifications that the Deliverables
have to meet for the fees to become due and payable, and include these in the
SOW. If the Deliverables do not meet these specifications, Contractor shall, at
Crucell’s request, re-perform the SOW (or such portions thereof as may be
reasonably required to be re-performed), at Contractor’s cost, until the
Deliverables are met. Payments will be made by Crucell within sixty (60) days
after receipt of a pertinent invoice from Contractor.

 

9.Use of Names. Neither Party will use the name of the other Party in relation
to this Agreement in any advertising or other form of publicity without the
prior written consent of the other Party.

 

10.Confidentiality. Contractor will keep all information, whether in oral or
written (electronic or paper) form or in the form of a physical object or
material disclosed or otherwise received in connection with the Research Project
(“Confidential Information”), and all Materials, and any derivatives and
modifications thereof, and Results (together with Confidential Information,
collectively “Information”) confidential and will not use such Information or
give access or disclose the same to anyone other than those of its direct
employees who need to receive such for the execution of the Research Project.
Contractor will make sure that confidentiality of Information is assured by a
written confidentiality agreement with such employees (which may include an
employment agreement), the obligations of which are not less stringent than the
obligations in this Agreement. The confidentiality obligations shall not apply
to the extent that Contractor is required to disclose Information by order or
regulation of a governmental agency or court of competent jurisdiction provided
that Contractor gives Crucell prior written notice of such disclosure and takes
reasonable actions to avoid such disclosure or to minimize its extent, and to
secure the confidentiality of such disclosure.

 

 

 

 

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Crucell Holland B.V. – Contractor

Page 4 of 15

 

Information shall not be deemed Information, to the extent Contractor can
demonstrate that:

 

a.the disclosed Information was at the time of such disclosure already in the
public domain other than as a result of actions of Contractor in violation
hereof;

 

b.the disclosed Information was rightly known by Contractor (as shown by its
written records) prior to the date of disclosure by Crucell in connection with
this Agreement, and was not acquired directly or indirectly from Crucell or from
any other party under an agreement of confidentiality to Crucell; or

 

c.the disclosed Information was received by Contractor (as shown by its written
records) on an unrestricted basis from a source unrelated to Crucell and not
under a duty of confidentiality to Crucell.

 

11.Contractor’s R&W. Contractor represents and warrants that it has the
experience, capability, and resources necessary to perform the activities
described in each SOW in a commercially reasonable manner and that it shall
devote the necessary personnel to perform the activities described in each SOW
hereunder in a commercially reasonable manner.

 

12.No Crucell R&W’s. Contractor acknowledges that the Materials are experimental
in nature and are provided by Crucell for purposes of the Research Project only
and “as is” with no warranties, express or implied, including any warranty of
merchantability, title, non-infringement or fitness for a particular purpose.

 

13.Liability and Indemnification.

 

a.Except for willful misconduct or gross negligence by Crucell, Crucell shall
not be liable to Contractor for any direct, consequential, incidental or
indirect damages and/or loss arising from the use, handling or storage of the
Materials and the performance of the Research Project by Contractor, and
Contractor shall hold Crucell harmless from, and indemnify Crucell for, any such
damage or claim relating thereto.

 

b.Except for willful misconduct or gross negligence by Contractor, Contractor
shall not be liable to Crucell for any direct, consequential, incidental or
indirect damages and/or loss arising from the use of the Results by Crucell, and
Crucell shall hold Contractor harmless from, and indemnify Contractor for, any
such damage or claim relating thereto.

 

14.Term and Termination.

 

a.This Agreement shall take effect on the date set out on the first page of this
Agreement and will terminate after the completion of the SOW’s under this
Agreement.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 5 of 15

 

b.Crucell may terminate this Agreement (i) with immediate effect in the event of
insolvency or bankruptcy of Contractor or (ii) at any time with thirty (30) days
prior written notice. In the event of early termination, Contractor shall be
paid for all services performed and related expenses incurred in accordance with
this Agreement until the date of notice of termination is given or, with
Crucell’s written approval, until the date of termination.

 

c.Either Party may terminate this Agreement upon the other Party’s breach of
this Agreement, provided that the terminating Party has given the defaulting
Party no less than thirty (30) days’ prior written notice of such breach and the
defaulting Party has not cured such default by the end of the notice period.

 

d.Upon completion of the activities under the Research Project by Contractor or
upon termination of this Agreement, Contractor shall return to Crucell, or, if
approved by Crucell in writing, destroy, all Information received from Crucell
hereunder and any tangible Materials, including any derivatives or modifications
thereof received from Crucell hereunder or generated as a result of the SOW
performed by Contractor hereunder. Contractor shall have the right to retain one
copy of all documents to determine ongoing obligations under this Agreement,
which documents shall be kept securely and in strict confidentiality and only
for such purpose.

 

e.Unless expressly provided to the contrary, the following provisions shall
survive any termination of this Agreement: Articles 5, 9, 10, 12 through 17, 19,
20 and 21.

 

f.Termination in accordance with this Article shall not prejudice any other
remedy that a Party might have.

 

15.Notice and Reports. All notices required by this Agreement shall be in
writing. All notices and reports shall be sent by fax or e-mail followed by
registered or certified airmail to the Parties at the following addresses or
such other addresses as may be designated in writing by the respective Parties:

 

To Crucell: Crucell Holland B.V.   Archimedesweg 4   2333 CN Leiden   The
Netherlands   Attn. *   FAX:  +31-71-5199800       With a copy to the Legal
Department at same address.     To Contractor: Enumeral Biomedical Corp.   1450
Broadway, 24th Floor   New York, NY 10018   Attn. Derek Brand, Director of
Business Development   Email: Derek@enumeral.com

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 6 of 15

 

16.Relationship of the Parties. Contractor shall perform the Research Project as
an independent contractor and not as Crucell’s agent, representative or
employee. Neither Party has any express or implied right or authority to assume
or create any obligations on behalf of or in the name of the other Party or to
bind the other Party to any other contract, agreement, or undertaking with any
third party.

 

17.Assignability. Contractor’s duties and obligations assumed under this
Agreement may not be delegated to another party, and this Agreement may not be
assigned or transferred (in whole or in part) by Contractor, without the written
consent of an authorized representative of Crucell. Crucell may assign this
Agreement to any of its Affiliates or to a purchaser of all or substantially all
of Crucell’s assets relating to the subject matter of this Agreement. Crucell’s
Affiliate means with respect to this Agreement, any company, whether a
corporation or other business entity, that is Controlling, Controlled by or
under common Control with Crucell; whereby “Control” means the direct or
indirect ownership of more than fifty percent (50%) of the equity interest in an
entity, or the ability in fact to control the management decisions of such
entity. Crucell may assign this Agreement to an Affiliate, without the approval
of Contractor.

 

18.Entire Agreement. This Agreement, including its Appendices, constitutes the
entire agreement of the Parties relating to the subject matter set out herein.

 

19.Amendment. This Agreement may not be changed, modified, amended, or
supplemented except by a written instrument duly signed by authorized
representatives of both Parties hereto.

 

20.Choice of Law and Dispute Resolution. This Agreement shall be governed by and
construed under the laws of the Netherlands (without giving effect to the laws,
rules or principles thereof regarding conflict of laws). If any dispute arises
out of or in connection with this Agreement, the Parties will themselves
endeavor to settle such dispute amicably. If the Parties fail to reach an
amicable settlement of the dispute within a reasonable period of time, such
dispute shall, to the exclusion of all others, be referred to a competent
federal court in New York, U.S.A., which court shall have exclusive jurisdiction
to settle any such disputes. The Parties agree that any judgment of a competent
New York, U.S.A., court is enforceable in any court having jurisdiction over the
Parties.

 

21.Rules of Construction.

 

a.“Including”. The words “include”, “including” or “included” are used to
indicate that the matters listed are not a complete enumeration of all matters
covered and should be read such as “including but not limited to”.

b.Singular, Plural, Gender. Words denoting the singular, shall include the
plural and vice versa. Words denoting one gender shall include all others.

c.Severability. If any part of this Agreement shall be held invalid and/or
unenforceable, the remaining provisions of this Agreement shall nevertheless
remain in full force and effect provided that such provisions will permit the
transaction contemplated herein to take place in substantially the same manner
as originally contemplated by the Parties.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 7 of 15

 

d.Translations. This Agreement has been written and executed in the English
language. Any translation into any other language shall not be an official
version of this Agreement. In the event of any conflict in interpretation
between the English version and such translation of this Agreement, the English
version shall prevail.

e.Waiver. The waiver by either Party of a breach of any provisions contained
herein shall be in writing and shall in no way be construed as a waiver of any
prior or succeeding breach of such provision or the waiver of the provision
itself. No delay or omission on the part of either Party to exercise or avail
itself of any right or remedy that it has or may have hereunder shall operate as
a waiver of any right or remedy.

 

AGREED and signed by:

 

Crucell Holland B.V. Enumeral Biomedical Corp.     /s/ Bart van Zijll Langhout
/s/ Arthur Tinkelenberg Name: Bart van Zijll Langhout Name: Arthur Tinkelenberg
Function: Managing Director Function: President and CEO Date: 10/5/2012 Date:
4/16/2012

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 8 of 15

 

Appendix 1

 

STATEMENT OF WORK (SOW)

 

This Statement of Work (“SOW”) is made and entered into as of March 29, 2012
(the “SOW Effective Date”) by and between Enumeral Biomedical Corp.
(“Contractor” or “Enumeral”) and Crucell Holland B.V. (“Crucell”).

 

This SOW is pursuant to, and incorporates the provisions of, the Contract
Research Agreement, dated February 28, 2012, by and between Contractor and
Crucell (“Agreement”).

 

Under this SOW Parties agree as follows:

 

Research Project:

 

Background

 

Overview

 

This SOW includes two projects with direct applications to the development of
vaccines and therapeutics *.

 

Project 1: Screening of *. Enumeral will identify * that react with * antibodies
and display favorable aqueous solubility.

 

Project 2: * analysis of * antibodies. Enumeral will screen samples from *,
along with a control group to identify the frequency and isotype of * (along
with cell surface phenotype), and retrieve any cells producing antibodies *.

 

Timelines Project 1:

 

Project 1: * Screening (see pages 5-6)

Phase 1: Assay development *

Phase 2: Screen of Crucell *

 

Commercial conditions Project 1:

 

* Screening

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 9 of 15

 

Total amount for the services performed under Phase 1, including FTE costs,
equipment access, and necessary supplies and reagents to complete the specified
work. The employees involved will include *.

 

Total Amount: * will be paid by Crucell as follows:

 

·* will be paid by Crucell after demonstration of the developed assay and
completion of screening program for one of the three delivered * (estimated *)
and receipt of the related invoice by Crucell;

 

·* will be paid by Crucell after completion of screening of remaining *
(estimated *) and receipt of the related invoice by Crucell;

 

·* will be paid by Crucell after delivery of * (estimated *) and receipt of the
related invoice by Crucell.

 

All payments will be made by Crucell in accordance with the payment schedule as
set out above and within 60 (sixty) days after receipt of a pertinent invoice
from Enumeral containing a specification of the costs and a reference to
Purchase Order number (to be supplied by Crucell after execution of this SOW).

 

As may be appropriate, development and commercial milestones arising from future
work requested by Crucell related to each of the aforementioned projects can be
discussed at the conclusion of the respective projects. Any additional services
are subject to Article 19 of the Agreement.

 

Programs, Materials and requirements and Deliverables

 

The services includes specified reagents and materials developed by Crucell (see
Materials), along with specific technological expertise, materials, and
instrumentation as provided by Enumeral.

 

Materials are defined as follows and will be provided by Crucell:

 

·Project 1: *-Screening: Crucell will provide * expressing * molecules, along
with appropriate * and * antibodies for binding analyses, including various
un-tagged and tagged versions, per previous conversations between Enumeral and
Crucell and described in more detail below.

 

Enumeral Materials:

 

·Devices & standard-reagents; including microwell arrays, cover-slides,
commercially-available capture and detection antibodies, and other elements
necessary to carry out the work described.

 

·Enumeral will acquire * and from * controls for the “Pilot Phase” of the *
program.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 10 of 15

 

Project Details:

 

Project 1:

 

Assay Development

 

Assay development will be carried out as the first step for both programs; this
will allow selection of the best reagents that will provide consistency across
each program. Key factors include:

 

·Ensuring proper binding of captured * during the microengraving process;

 

·Selecting appropriate antibody reagents for either capture or detection during
the microengraving process and in-well cytometry.

 

Enumeral will discuss results for both the * and * assay development processes
with Crucell prior to initiating screening in either program. The decision to
continue to the screening of * will be made upon Crucell’s sole discretion. If
Crucell decide not to continue the SOW shall be deemed to be terminated after
completion of the Assay Development under Project 1.

 

* Screening Program

 

Program Goal: To identify, * that (i) bind robustly to * antibodies provided by
Crucell and (ii) display favorable aqueous solubility. Enumeral’s technology
will be utilized to identify, from * Crucell *, soluble * that bind strongly to
the provided * antibodies.

 

Crucell will supply *(or related *). In each case, * will be interrogated using
Enumeral’s Technology to simultaneously measure the binding of up to * different
Crucell * antibodies against soluble *microengraved from * assayed per well.
Successful implementation of this screen would provide for the option to extend
the SOW to test *. Such decision to extend the SOW is upon Crucell’s sole
discretion. Enumeral and Crucell will then jointly determine conditions for
selecting cells for retrieval. Cells will be retrieved during screening with
Enumeral’s Technology and transferred to 96 well plates. Cells will undergo
RT-PCR and/or sequencing and the results will be provided to Crucell.

 

Deliverables

 

·Validated assay results presented to Crucell, which will demonstrate the
ability to identify soluble clones that bind strongly to * antibodies provided
along with desired solubility. Both Parties will decide on conditions for cell
recovery during the second phase of testing (*).

 

·Frequency data and sequencing from recovered cells during screening of * using
the assay developed above (*).

 

Detailed Statement of Work: * Screening

 

Delivery of Materials:

 

·Crucell will provide Enumeral with *

 

·Crucell with also provide * antibody (and additional * antibodies if desired)
and * antibodies for the assay development phase.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 11 of 15

 

·Crucell will provide Enumeral with * to undergo screening using the developed
assay.

 

Establishing Capture and Detection Conditions

 

·Limits of detection will be established using *. Pair—wise testing of all
combinations of antibodies as capture and detection reagents will be performed
(as appropriate) to determine limits of detection and optimal assay conditions
for the different reagents.

 

·Example: *.

 

·Serial microengraving from the same * will be performed to establish base-line
binding of each of the Crucell antibodies to the soluble *. These tests will be
run on * channels in parallel, which effectively tests whether the * antibodies
compete for *.

 

·Enumeral and Crucell will establish criteria for selecting cells for retrieval
during * screening.

 

Screen of *

 

·Each of the * will undergo screening using the microengraving assay developed.

 

·Each * will undergo sufficient screening to assess “saturation” and detection
of best * e.g. based on rank-ordering of amount of * and affinity of binding by
up to * antibodies provided by Crucell, including *.

 

·Enumeral will recover cells that fit a retrieval profile decided upon by
Crucell and Enumeral (above), and corresponding * will be recovered and
sequenced.

 

Timelines Project 2;

 

Project 2: * Program (see pages 7-9)

Phase 1: Assay Development (*)

Phase 2: Frequency Analysis – *

Phase 3: Screening and analysis of *

 

Commercial conditions Project 2:

 

* Program

 

Phase 1: Research fees cover FTE costs, equipment access, and necessary supplies
and reagents to complete the specified work. The employees involved will include
*. The higher costs of this phase reflect a greater level of FTE involvement,
which will principally be led by the Director on the program.

 

Total Amount: * will be paid by Crucell as follows

 

·Phase 1-2”: * after delivery of frequency data pertaining to * and receipt of
the related invoice by Crucell.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 12 of 15

 

In case Crucell has decided to continue to Phase 2 of Project 2, the Total
Amount for the work under Phase 2 will be paid by Crucell as follows:

 

·Phase 3: * upon delivery of data including *

 

Phase 2: the costs include all FTE costs and increased instrument time in order
to process a high number of samples. A Research Associate will be primarily
associated with data collection, while a Director will oversee program progress
and data analysis. Costs for the Patient Phase can be adjusted if there are
substantial changes to the statement of work after delivery of the Pilot Phase
milestone (Discussed in more detail on Page 9) and after the prior written
approval of Crucell.

 

All payments will be made by Crucell in accordance with the payment schedule as
set out above and within 60 (sixty) days after receipt of a pertinent invoice
from Enumeral containing a specification of the costs and a reference to
Purchase Order number (to be supplied by Crucell after execution of this SOW).

 

As may be appropriate, development and commercial milestones arising from future
work requested by Crucell related to each of the aforementioned projects can be
discussed at the conclusion of the respective projects. Any additional services
are subject to Article 19 of the Agreement.

 

Program, Materials and requirements and Deliverables

 

The services includes specific reagents and materials developed by Crucell (see
Materials), along with specific technological expertise, materials, and
instrumentation as provided by Enumeral.

 

·*: If suitable reagents are not commercially-available, Crucell will provide *
and appropriate tags or secondary detection reagents that will be appropriate
for Enumeral’s assay development strategies. Crucell will provide * for the
“Patient Phase”)(Phase 2) of the project, which entails measuring *.

 

Enumeral Materials:

 

·Devices & standard reagents; includes microwell assays, cover slides,
commercially-available capture and detection antibodies, and other elements
necessary to carry out the work described.

 

·Enumeral will acquire * and from * controls for the “Pilot Phase” of the *
program.

 

Project Details:

 

Project 2:

 

Assay Development

 

Assay development will be carried out as the first step for Project 2; this will
allow selection of the best reagents that will provide consistency across each
program. Key factors include:

 

·Ensuring proper binding of captured * during the microengraving process;

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 13 of 15

 

·Selecting appropriate antibody reagents for either capture or detection during
the microengraving process and in well cytometry.

 

Enumeral will discuss results for the * assay development processes with Crucell
prior to initiating screening in either program.

 

Phase 1: * Analysis & Discovery of * Antibodies

 

Program Goal: To determine the * and to recover and sequence antibodies that *.
The program will include two phases:

 

* Analysis (“Pilot Phase”). Enumeral will obtain * and controls. Samples will be
screened using Enumeral’s technology to determine *.

 

* will be characterized with respect to antibody specificity to the * described
above as well as *. Cell surface markers will be assessed using in well
cytometry to identify common * markers based on *.

 

Pilot Phase Deliverables

 

·Phase I: Assay developed to demonstrate binding to *. Data demonstrating
binding to the provided * will be presented, along with data showing that the
assay is feasible for measurements on *

 

·Phase II: Assessment of *. Data identifying the frequency of antibodies binding
* as well as * will be presented from *

 

Assessment Point: Crucell and Enumeral will discuss results of pilot phase in
order to make any recommended changes in the scope of work for the “Patient
Phase” of the program. Any such decision to continue or to amend the Project
shall be made by Crucell upon its discretion.

 

Identification and Recovery of * (“Patient Phase”). * will be provided by
Crucell and screened to identify cells secreting antibodies *. Cells of interest
will be retrieved and the * of each cell sequenced. * analysis will first be
processed to enrich for * populations, either by Crucell or Enumeral as
appropriate. Information on * is provided in Appendix 1.

 

Patient Phase Deliverable

 

·Data identifying the * antibodies, along with conserved sequences and other
elements of the antibody repertoire analysis from * will be presented. Sequences
from antibodies * will be provided. *

 

Detailed statement of work: *

 

Delivery of Materials:

 

·Crucell will provide Enumeral with *, and additional reagents specific to the
detection of said antibodies as deemed appropriate by Enumeral and Crucell.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 14 of 15

 

·Crucell will provide Enumeral with * samples the final numbers and respective
inclusion criteria will be determined at the conclusion of the “Pilot Phase”.
The current estimate is that samples will comprise *.

 

Establishing Capture and Detection Conditions:

 

·* will be isolated from * (see Appendix 1 for details on *)

 

·Different activation conditions, including a comparison of “resting” and
activated will be compared to determine baseline and stimulated * events.

 

·Using * as a capture antibody, all * will be microengraved from *

 

·Cells will be arrayed in Enumeral devices the following analyses will be
performed to validate and characterize detection antibodies and cell surface
marker reagents (including *:

 

·Detection of * antibodies will be performed using * antibodies to validate best
conditions for measuring baseline * events in the both resting and activated
populations. This will allow characterization of detection reagents and
determination of appropriate sample sizes for screening patient samples.

 

·In well cytometry will be performed to determine cell surface markers of
highest interest. A specific set of markers will be chosen following correlation
of * and cell population patterns (e.g. * antibodies).

 

·Deliverable: Data demonstrating binding to provided * will be presented, along
with data showing that the assay is feasible for measurements on * samples, e.g.
*.

 

Analysis of *:

 

·Enumeral will obtain * and controls *. Samples will be frozen and stored
appropriately. Samples will undergo enrichment as described above based on
discussions between Enumeral and Crucell.

 

·Samples will be screened employing the assay conditions developed above;
screens will be performed under activated and unactivated (“resting”) conditions

 

·*. Cell surface markers will be enumerated to determine *.

 

·Cell retrieval conditions will be discussed between Crucell and Enumeral. Cells
secreting antibodies * will be retrieved using Enumeral’s specialized
instrumentation and transferred to 96 well plates for subsequent RT-PCR and
sequencing.

 

·Deliverable: Data identifying the frequency of antibodies * as well as * will
be presented.

 

Assessment point: Results of the pilot phase will be discussed to determine the
appropriate structure for the Patient Phase and serve as a “go/no-go” decision
point for the program. Criteria for progressing to Patient Phase should include
* antibodies. The decision to continue to the Patient Phase will be made by
Crucell upon its sole discretion. In case Crucell decided not to continue to the
Patient Phase this SOW and the Agreement shall be deemed to be terminated.

 

 

 

 

Agreement Contract Research

Crucell Holland B.V. – Contractor

Page 15 of 15

 

Phase 3: “Patient Phase: Screening of patient samples Analysis of *

 

·Samples provided by Crucell will be processed and screened employing assay
conditions as above or modified per discussions at the conclusion of pilot
phase.

 

·*. As above, cell surface markers will be enumerated to determine marker
dependent subsets that are also * antibody secreting cells.

 

·Cells secreting antibodies * will be retrieved using Enumeral’s specialized
instrumentation and transferred to 96 well plates for RT-PCR and sequencing.
Retrieval criteria will be as above or modified per discussions after Pilot
Phase.

 

·Deliverable: Data identifying * will be provided.

 

Agreed and signed by:

 

Crucell Holland B.V. Enumeral Biomedical Corp. /s/ Bart van Zijll Langhout /s/
Arthur Tinkelenberg Name: Bart van Zijll Langhout Name: Arthur Tinkelenberg
Function: Managing Director Function: President and CEO Date: 11-05-2012 Date:
4/16/2012