Exhibit
10.5.1


 


CONFIDENTIAL
TREATMENT REQUESTED UNDER RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED.


 


[*****]
INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED
MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.


 





 


SOURCE LEUKOCYTES
AND PLASMA AGREEMENT

FOR TRANSFUSIBLE BLOOD PRODUCTS

FOR IN VIVO HUMAN SUBJECT RESEARCH USE


 


THIS SOURCE LEUKOCYTES
AND PLASMA SERVICES AGREEMENT (“Agreement”) is entered into as of the Effective Date (as defined
below) by and between The American National Red Cross, Penn-Jersey Blood Services Region (“ARC”), a
non-profit corporation with offices located at 700 Spring Garden Street, Philadelphia, PA 19123 and Macrocure Ltd. (“Customer”),
a company incorporated under the laws of the State of Israel with a place of business at 9 Bareket Street, Kiryat Matalon, Petach
Tikva 49205, Israel.


 


ARC provides blood services, including
the collection of blood from donors and the testing, packaging and distribution of blood, blood components and derivatives, to
those in need of such products and services throughout the United States.


 


Customer desires to engage ARC to provide
certain services in support of a clinical trial, as more fully described below, and ARC is willing to provide such services, subject
to the terms and conditions of this Agreement.


 


ARC and Customer are parties to a Manufacturing
Agreement dated July 11, 2010 (the “Manufacturing Agreement”), pursuant to which ARC and Customer agreed
to enter into a supply agreement to serve as the general framework for, and to govern the supply of, the BRM (as such term is
defined below) by ARC to Customer.


 


ARC has the
know-how, expertise, capability, experience and the infrastructure necessary to supply the BRM to the American Red Cross Cell
Therapy Laboratory at the Penn-Jersey Region of American Red Cross, located at 700 Spring Garden Street, Philadelphia, PA
19123 (or other location as mutually agreed by the parties), in accordance with the terms hereof.


 


This agreement constitutes the Supply Agreement
contemplated in Article 3.1 of the Manufacturing Agreement.


 


In consideration of
the foregoing, of the mutual promises set forth below and of other good and valuable consideration, the receipt and sufficiency
of which are hereby acknowledged, the ARC and Customer (the “Parties”) hereby agree as follows:


 


1.0 Responsibilities of ARC


 


1.1 ARC will use reasonable
efforts to provide source leukocytes and plasma products (“Services”) in connection with Customer’s
clinical trial (the “Clinical Trial”), the protocol for which is entitled “A Phase Ill, Multinational,
Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy
of CureXcellTM as an Adjunct to Good Wound Care Measures in Treating Lower Extremity Chronic Ulcers in Adults with Diabetes
Mellitus” (the “Clinical Protocol”). The Clinical Protocol is attached to this Agreement as Attachment
A. In providing the Services, ARC will use reasonable efforts to collect source leukocytes and plasma (“Blood Related
Material” or “BRM”) from eligible volunteer donors according to the Clinical Protocol). IRBs at
other institutions participating in the Clinical Trial (including without limitation Customer’s IRB) will be responsible
for conducting independent reviews of the Clinical Trial. The Parties agree, therefore, that the ARC IRB is not the IRB of record
for these other institutions, each of which is responsible for compliance with regulations for the protection of human subjects
of research at their respective sites. ARC will not be obligated to provide any Services to Customer until the Clinical Trial
has met applicable regulatory and other legal requirements, including without limitation, review and approval by all required
IRBs (including third party IRBs), receipt of confirmation that each such subject participating in the Clinical Trial has given
all necessary informed consent and execution of required investigator agreements. Customer will provide a copy of their institutional
IRB approval memo to ARC prior to the start of Services.


 







    	 



    	



    

1.2 To the extent that
ARC collects BRM requested by the Customer hereunder and determines that such BRM are acceptable under the terms of this Agreement
as set forth in Attachment B, ARC will notify the Customer that the BRM are ready for shipment/pickup and the Customer
will arrange for a courier. BRM supplied by ARC will meet the specifications set forth in Attachment B and will conform
to FDA requirements and will be supplied in final finished form, including primary packaging and outer labeling in compliance
with the relevant regulations, free and clear of any encumbrances or liens.ARC will document as part of the record the qualification
parameters as mutually agreed to by the Parties.


 


2.0 Responsibilities of the Customer


 


2.1 Customer will
submit a written request to ARC for Blood Products specifying the types, quantities and desired delivery dates with a minimum
of seven (7) calendar days prior to the desired delivery date. This may come via electronic mail through the ordering system being
used by Customer.


 


2.2 Customer will obtain
all necessary approvals to use the BRM, including the approval of any IRB to the extent required by the Regulations (as defined
in Article 3.0) prior to using such BRM.


 


2.3 Customer will make
timely payment to ARC in accordance with Article 6.0.


 


2.4 ACCEPTANCE Customer
will promptly inspect each shipment of BRM upon receipt and promptly upon discovery report to ARC all information concerning
any BRM for which Customer has discovered or suspects irregularity, labeling error, damage, non-compliance or loss in
shipping. In the event that the BRM delivered does not conform to the specifications or bears a labeling error and
Customer rejects the BRM, ARC shall not charge Customer for such delivered BRM, and ARC shall make reasonable efforts to
dispatch to Customer conforming replacement BRM.


 


2.4.1 Within two hours
(2) hours of delivery to Customer, Customer must notify ARC of its rejection of BRM for failure to conform to the specifications
as set forth in Attachment B and notify ARC of the circumstances giving rise to the rejection. If Customer does not reject
the BRM in conformance with this Section, the BRM will be deemed accepted. Section 6.2 notwithstanding, Customer ‘s obligation
to effect payment for any BRM alleged by Customer not to be in compliance with the specifications set forth in Attachment B shall be held in abeyance pending resolution of the matter.


 


2.5 Customer will ensure that the BRM are
only used in accordance with the Clinical Protocol. Customer understands and agrees that under no circumstances may Customer use
or permit the use of any BRM for any of the following purposes (each a “Prohibited Purpose”):


 


2.5.1.1  Resale or any other transfer to a third party, except to another entity participating in the Clinical Trial, or, with the consent of ARC; or


 


2.52 Any medical testing that is not pertinent to the Clinical Protocol.








 


2.6 Customer shall retain the right to
source or procure BRM (or other blood products) from a source which is not the ARC.


 


3.0 Regulations: The
Parties will comply with applicable laws and industry standards, including without limitation, requirements, regulations, standards,
recommendations, specifications, guidelines and directives of the Food and Drug Administration (“FDA”);
U.S. economic sanctions; anti-terrorism and anti-money laundering laws; the USA PATRIOT Act; laws administered by the U.S.
Treasury Department’s Office of Foreign Assets Control; and Executive Order 13224 (“Regulations”).


 


4.0 Withdrawals Returns and Recalls.


 


4.1 Customer understands and agrees that
ARC may withdraw or recall any BRM prior to use by Customer upon ARC determination that the BRM may not be suitable for transfusion. ARC will not accept any return of the BRM under any other circumstances.

 





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4.2 In the event of an adverse event report
or recall, or a suspected adverse event, Customer may request and ARC will assist Customer by providing relevant information to
determine whether the relevant donor (later) tested positive for any diseases tested for by the ARC; provided that the ARC will
not reveal the identity of any blood donor.


 


5.0 Ownership: Ownership of the
BRM is transferred to Customer’ upon delivery of those BRM by ARC to the carrier or Customer’s designated location,
regardless of the method of shipment. At that time, Customer will own the BRM and be solely responsible for any loss, destruction
or damage to them, as well as any liability arising from the BRM. Claims for loss of or damage to the BRM are the responsibility
of Customer and should be reported to the carrier and ARC within forty-eight (48) hours of Customer’s first awareness of
the loss or damage.


 


6.0 Fees and Payment:


 


6.1 Customer will
pay ARC the fees for the Services as listed in Attachment B (“Fee”), subject to adjustment as
provided in this Section 6.1. It is clarified that notwithstanding anything to the contrary herein or in Attachment
B, Customer shall only be required to pay the Fee in respect of BRM that Customer actually accepts in accordance with Section
2.4.


 


6.1.1 This Agreement is
subject to compliance by the Parties with: (a) all recommendations from, or requirements mandated by applicable state or federal
agencies, and (b) requirements of applicable accreditation agencies. Customer is responsible for the incremental costs of such
recommendations and requirements, so long as ARC provides Customer with sixty (60) days’ prior, written notice of such incremental
costs.




6.1.2 In addition ARC may
amend the Fees once during each twelve (12) month period of the Term (as defined in Article 8.0), so long as ARC provides
Customer with one hundred and twenty (120) days’ prior written notice, effective on the first day of each successive Term
provided that such fee increase shall not exceed the cumulative rate increase of Medical CPI from the period of the Effective
Date of this Agreement.




6.1.3 Subsection 6.1.2
notwithstanding, the ARC reserves the right to modify Fees due to Customer modifications and BRM specifications including but
not limited to the following: (a)Customer’s additional requirements, Clinical Protocol modifications or BRM specifications
such as ABO typing specificity or CMV status; or (b) modification of process which could adversely affect the usability of red
cells. In the event of such Fee increase, ARC will notify Customer prior to BRM collection.


 


6.2 ARC
will issue periodic invoices for Services provided to Customer. Customer will pay ARC in immediately available funds within sixty
(60) days of receipt of invoice. Customer will pay a late fee on all amounts outstanding in excess of thirty (30) days following
the date of invoice at an annual average rate of eighteen percent (18%), computed at one and one-half percent (1.5%) per month,
or, the maximum percentage established by the governing law referenced in Section 9.3, whichever is lower. Customer’s
eligibility for discounts is in ARC’s sole discretion. Customer and ARC, as applicable, will provide information on all
discounts or rebates, as applicable, to government health care programs and other entities in accordance with the Regulations.


 


6.3 Under no circumstances
will ARC be required to submit any bills or claims for the Services provided pursuant to this Agreement to any patient, insurance
company, health maintenance organization, governmental program, or any other third party payer.


 


6.4 In the event that the time elapsed between
the collection of BRM and the delivery to the Customer’s contracted manufacturing site (currently located at the ARC facility)
exceeds 7.5 hours, Customer is permitted to terminate the applicable order without compensation to ARC with respect to the order
as its sole remedy.


 


7.0 Exclusion of Liability and Indemnification


 


7.1
Notwithstanding anything herein to the contrary, neither Party is liable to the other for any breach, loss or damage of any
kind arising out of delay or failure to perform any obligation in this Agreement if such delay or failure occurs for reasons
beyond that Party’s control, including without limitation, delay or failure caused by: unavailability, failure or
shortage of power or supplies; fire, flood, storm or abnormally inclement weather; act of God; act of war, terrorism,
strike, work stoppage, other labor unrest, or riot; act or omission of the government (including FDA withdrawal and recall
recommendations); inadequate voluntary donations of BRM; an act or omission in the process of manufacture, production or
supply under the control of third parties; or any other emergency. In the event that such force majeure continues for a
period of more than thirty (30)) days, Customer shall be entitled to terminate this Agreement.

 





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7.2 Under no circumstances will ARC be
liable or responsible to Customer for the unavailability of BRM either in the quantity requested or at the time specified,
provided that ARC makes reasonable commercial efforts to collect and supply such BRM.


 


CUSTOMER ACKNOWLEDGES THAT RESULTS OF TESTS
PERFORMED BY ARC ARE NOT GUARANTEED BY ARC AND THAT THE ELIMINATION OF SOME ERRORS (EITHER FALSE POSITIVES OR FALSE NEGATIVES)
IS NOT POSSIBLE DUE TO THE NATURE OF THE TESTS.


 


7.3 EXCEPT FOR
THE EXPRESS WARRANTIES MADE IN THIS AGREEMENT, ARC MAKES NO REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE BRM, INCLUDING
ANY THAT MAY BE IMPLIED BY LAW, RELATING TO MERCHANTABILITY, FITNESS OF USE OR OTHERWISE. IF ARC IS FOUND LIABLE FOR
DAMAGES FOR BREACH OF THIS AGREEMENT, ARC’S TOTAL LIABILITY WILL BE LIMITED TO THE FEES PAID BY THE CUSTOMER FOR THE
BRM. ANY CLAIMS AGAINST ARC FOR INDIRECT, INCIDENTAL, PUNITIVE, RELIANCE, SPECIAL OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT
LIMITATION, DAMAGES FOR LOST PROFITS, ADVANTAGE, SAVINGS OR REVENUES OF ANY KIND, ARE EXCLUDED. THE LIMITATION ON LIABILITY
AND DISCLAIMER OF DAMAGES UNDER THIS SECTION 7.3 SHALL NOT APPLY TO AMOUNTS OWING UNDER AN INDEMNIFICATION.


 


7.4 Except to the
extent otherwise limited in this Agreement, Customer agrees to indemnify, defend and hold ARC, its directors, officers, governors,
employees, volunteers and agents (“ARC Indemnitees”) harmless from and against all liability and expense
(including court costs and attorneys’ fees) (“Liabilities”) arising from claims for bodily injury,
death or property damage, which the ARC Indemnitees may incur, suffer, become liable for, or which may be asserted or claimed
against ARC Indemnitees as a result of (a) the acts, errors or omissions of Customer, its directors, officers, employees, contractors,
affiliates, subcontractors, agents, customers or clients as a result of or while performing its obligations hereunder or arising
otherwise from the use, or handling of BRM, (b) patient care provided to the recipient of the BRM that is solely and directly
related to such recipient’s treatment with Customer’s CureXcell product and is not attributable to a pre-existing
medical condition or underlying disease, (c) the research, development, manufacture, sale, distribution and use of any BRM (or
a product that contains the BRM) by Customer or a third party, (d) any alleged infringement by the Customer of any patent, trademark, copyright, or other intellectual property, right or trade secret of a third party as it relates to the BRM and/or use of the
BRM, (e) any breach of this Agreement by the Customer, all except to the extent and proportion such Liabilities are caused by
the negligence or wrongful act or omission of ARC or any of the ARC Indemnitees or (f) for the treatment of any adverse reaction,
resulting solely from the participation in the Study in strict compliance with the Protocol, experienced by a Study Participant,
to the extent that such expenses are not otherwise covered, all except to the extent and proportion such Liabilities are caused
by the negligence or wrongful act or omission of ARC or any of the ARC Indemnitees.


 


7.5 Except to the
extent otherwise limited in this Agreement, ARC agrees to indemnify, defend and hold Customer, its directors, officers, governors,
employees, volunteers and agents (“Customer Indemnitees”) harmless from and against all liability and expense
(including court costs and attorneys’ fees) (“Liabilities”) arising from claims for bodily injury, death
or property damage, which the Customer Indemnitees may incur, suffer, become liable for, or which may be asserted or claimed against
Customer Indemnitees as a result of (a) the acts, errors or omissions of ARC, its directors, officers, employees, contractors,
as a result of or while performing its obligations hereunder and (b) the use of or handling of the BRM by ARC pursuant to this
Agreement.


 


7.6 Each of Customer
and ARC, as applicable, specifically understands and agrees that the indemnification set forth in Section 7.4 and Section 7.5
will include, but not be limited to: (a) workers compensation claims of Customer’s or ARC’s employees, agents, contractors
or subcontractors which may arise from their handling of BRM, (b) claims Customer’s or ARC’s employees, agents, contractors,
subcontractors,or clinical trial participants may personally make against ARC or Customer, Customer understands that its indemnification
obligation as set forth in Section 7.4 will include but not be limited to (a) any claim for damages arising from any subrogation
attempt against ARC by Customer’s insurers, and (b) any claim against ARC, direct or indirect, arising in any manner from
the provision of BRM by Customer to any customer of Customer, or, any other third party, whether such claim is made in a domestic
court of law or foreign court of law.


 





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7.7 The indemnification provided under
Section 7.4 and Section 7.5 is not exclusive of any other rights to which ARC or Customer, as applicable, may be entitled.


 


7.8 Any claim for
indemnification by an indemnitee made upon an indemnitor under this Article 7 shall be conditioned upon: (a) the indemnitee providing
notice to the indemnitor of any claim for indemnification (or facts likely to give rise to such claim) as soon as such indemnitee
has become aware of such a claim or such facts; (b) the indemnitee permitting the indemnitor to assume full responsibility for
the investigation of, preparation for, and defense of any claim for which indemnification is sought; (c) indemnitee assisting
indemnitor, at indemnitor’s reasonable expense, in the investigation of, preparation for, and defense of, any claim; (d)
Indemnitee not compromising or settling any such claim without indemnitor’s prior written consent. Notwithstanding anything
to the contrary contained herein, the indemnitor shall have the right to settle any such claim without the consent of the indemnitee(s),
if such settlement includes an unconditional release of the indemnitee from any liability. Nothing in this Agreement shall prevent
any indemnitee from hiring its own counsel at its own expense.


 


7.9 INSURANCE.
During the Term, the Parties shall maintain liability insurance in an amount not less than ***** and
medical malpractice insurance in an amount not less than *****. Upon request, a Party shall provide
the other Party with a certificate of such insurance.


 


8.0 Term, Termination and Survival


 


8.1 This Agreement will be effective
beginning the first instance where Customer requested BRM from ARC prior to Agreement execution (“Effective
Date”) and continue for twenty-four (24) months (“Term”) from the date last
executed below unless earlier terminated as described herein. The Term of this Agreement shall automatically renew for
subsequent twelve(12) month terms, unless written notice of termination is provided by a party to the other party at least
nine (9) months prior to the then-current term.


 


8.2 A Party may unilaterally terminate
this Agreement: (a) if the other Party fails to fulfill any one or more of its material obligations under this Agreement (“Breach”)
and the Breach continues for a period of thirty (30) days after the non-breaching Party sends written notice of the Breach, (b)
if any of the Regulations are amended in a way that precludes a Party from performing its obligations under this Agreement, and
same cannot be rectified with reasonable effort by such party, effective upon the effective date of the amended Regulation; or
(c) if a Party ceases to operate or otherwise function as a business.


 


8.2.1 Consequences of
Termination.




(a) The expiration or
termination of this Agreement will not relieve the ARC from using reasonable efforts to deliver any BRM ordered prior to the effective
date of such expiration or termination.




(b) Customer will pay
the ARC for BRM delivered in accordance with this Agreement prior to the effective date of expiration or termination of this Agreement.




(c) Promptly after the
expiration or termination of this Agreement for any reason, the Parties will return to each other all tangible manifestations
of each other’s Confidential Information (as defined in the Manufacturing Agreement) at the time in the possession of either
Party, or with the written permission of the other Party, destroy such items; provided that each Party may retain one (1) tangible
manifestation of the other Party’s Confidential Information in its legal department for archival purposes.




(d) Expiration or termination
of this Agreement will not relieve either Party of any liability having accrued hereunder prior to the effective date of such
expiration or termination.


 


8.3 Unless otherwise provided in
this Agreement, the following provisions will survive termination or expiration of this Agreement: Sections 2.5, 8.3, 9.1
–  9.5 and 9.11, Articles 4, 5, 6 and 7.


 


9.0 General Terms and Conditions


 


9.1 Confidentiality:
The provisions of Article 10 of the Manufacturing Agreement are incorporated herein by reference, and shall be applied
herein mutatis mutandis. Without derogating from the foregoing neither Party will disclose to any third party any
provision in this Agreement unless: (a) required by law, in which case, the disclosing Party will provide prompt advance
notice of disclosure so the other Party may seek a protective order or other remedy; (b) required by an accreditation or
regulatory agency during an inspection, in which case, the disclosing Party will protect the disclosures through the use of a
comprehensive nondisclosure agreement, or (c) such disclosure is to the disclosing Party’s
legal or financial advisor(s), in which case, the disclosing Party will protect the disclosures through the use of a comprehensive
nondisclosure agreement.

 





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9.2 Name and Marks: No Party
will use the name, logo or marks of the other without prior written authorization, provided, however, that the Parties may
disclose the relationship created by this Agreement.


 


9.3 Governing Law: This
Agreement is governed by the laws of the Commonwealth of Pennsylvania without giving effect to such State’s choice or
conflict of law rules or principles.


 


9.4 Notices: The Parties will provide the notices required by this Agreement by certified or registered first-class mail, return receipt
requested, or, by a recognized overnight courier service that provides proof of delivery, to the names and addresses in the signature
block. A Party may change its notice address by providing the other Party with prior written notice of the change of address.


 


9.5 Interpretation:
All references to ‘days’ in this Agreement are to calendar and not business days, unless specified otherwise.
If there is a conflict between this Agreement and any unreferenced attachment, order, request for proposal, proposal, invoice
or verbal agreement, the terms of this Agreement govern. The descriptive headings contained in this Agreement are
included for convenience of reference only and do not affect the meaning or interpretation of this Agreement. This Agreement,
which includes its preamble and attachments, is the entire understanding of the Parties for the supply of Services, and
replaces all prior agreements and undertakings between the Parties for the supply of Services. No single remedy in this
Agreement is exclusive of any other remedy in the Agreement. In addition, the rights and remedies in this Agreement are not
exclusive and are in addition to any other rights and remedies provided by the Regulations.


 


9.6 Modification, Assignment and Subcontracting: Unless otherwise provided in this Agreement, this Agreement will not be modified, assigned or subcontracted unless the Parties
agree in writing.


 


9.7 Waiver:
No waiver of any default of, or failure to enforce, any provision in this Agreement will: (a) be deemed a waiver of any other
default or right to enforce any other provision, or (b) affect the right of a Party to require prompt performance of the
defaulted or unenforced provision at any future time, or (c) be deemed a waiver of the same provision on any other
occasion.


 


9.8 Severability: If any
provision in this Agreement is unenforceable and removed, the remaining provisions will remain in full force and effect. If
applicable, the Parties will negotiate an enforceable provision that is similar to the removed provision.


 


9.9 Relationship
of the Parties: Each of the Parties will participate in this Agreement as an independent contractor. This Agreement does not
create any association, agency, partnership, employment relationship or joint venture between the Parties.


 


9.10 Counterparts:
This Agreement may be executed in two or more counterparts, and when executed by both Parties, each counterpart will be
deemed an original but all of which together will constitute one and the same Agreement.


 


9.11 Disputes:
The Parties shall make all reasonable efforts to amicably resolve any disputes arising out of or relating to this
Agreement. All disputes between the Parties arising from or relating to this Agreement or the breach hereof that cannot
otherwise be resolved informally shall be conclusively settled by binding arbitration in accordance with the CPR Institute
for Dispute Resolution Rules for Non-Administered Arbitration in effect at the time the demand for arbitration is filed by
the demanding party, as supplemented by the further requirements of this Section.


 


Such
arbitration shall be conducted by three (3) arbitrators, with each Party selecting one arbitrator within seven (7) days after
the serving of a statement of claim by the claimant on the respondent, and the two (2) selected arbitrators selecting a
mutually agreeable third arbitrator within fifteen (15) days thereafter from a list of qualified potential arbitrators, or if
such arbitrators are unable to select such third arbitrator within such time period, a third arbitrator appointed by the CPR
Institute promptly thereafter. The place of Arbitration shall be Philadelphia, PA, USA in the English language and the award
shall be rendered in the United States. The decision of the arbitrators shall be final and conclusive and shall be binding
upon the Parties. By agreeing to arbitration, the Parties
do not intend to deprive any court of its jurisdiction to issue a pre-arbitral injunction, pre-arbitral attachment, or other order
in aid of arbitration proceedings and the enforcement of any award. Without prejudice to such provisional remedies as may be available
under the jurisdiction of a court, the arbitral tribunal shall have full authority to grant provisional remedies or to order
any Party or Parties to request that a court modify or vacate any temporary or preliminary relief issued by that court, and to
award damages for the failure of any Party to comply with the arbitral tribunal’s orders to that effect.

 






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Authorized representatives of the Parties
have executed and delivered this Agreement as of the Effective Date.


 


IN WITNESS WHEREOF, the Parties, acting
through their duly authorized representatives, have executed this Agreement effective as of the Effective Date.


 





	THE AMERICAN NATIONAL RED CROSS
 PENN-JERSEY
    REGION	 	MACROCURE LTD.
	 	 	 	 	 
	SIGNATURE:	/s/ Brigid O’Neill LaGier	 	SIGNATURE :	/s/ Nissim Mashiach
	PRINTED NAME: 	Brigid O’Neill LaGier	 	PRINTED NAME:	Nissim Mashiach
	DATE:	3/26/13	 	DATE:	3/18/13
	ADDRESS:	American Red Cross	 	ADDRESS:	 
	 	700 Spring Garden St.	 	 	 
	 	Philadelphia, PA 19123	 	 	 



 







    	7



    	



    

ATTACHMENT A




CLINICAL
PROTOCOL


 








 




    	8



    	



    

ATTACHMENT B




FEE SCHEDULE AND DELIVERY


 


No pooling of blood
or blood products occurs during the manufacture of CureXcellTM, therefore each production lot of the BRM must derive
from a single donor blood unit and at no time should there be pooling of blood units or components during the manufacturing process.


 


	Table	Source and Starting BRM of Biological
    Origin


 

	Biological
    Raw

Material	 	Biological
Source	 	Country
    of

 Origin	 	Manufacturer	 	Step	 	Suitability
    for
Use
	Source Leukocytes (US Product
    code *****)	 	Donor source leukocytes derived from a

    normal blood donor	 	USA	 	***** per batch	 	Step 1: Incubation of
    leukocytes	 	Negative for blood banking infectious

    disease tests

 Suitable for intended recipient
	 	 	 	 	 	 	 	 	 	 	 
	Plasma (US Product code *****)	 	Plasma derived from the same normal donor as the source donor leukocytes 	 	USA	 	***** per batch	 	Step 1: Coagulation of Plasma by addition of CaCl2/incubation	 	Negative for blood banking infectious
    disease tests


    Suitable for intended recipient


 


Specifications: This blood unit must be
donated by an age 18-40 years old healthy volunteer repeat donor.


 


SHIPPING:  Customer shall be responsible
for shipping/pickup of BRM and related expenses.


 


STORAGE REQUIREMENTS: Storage will
be pursuant to FDA and current ARC regulations but must also comply with requirements specified in the clinical trial Investigational
Drug Application and Clinical Trial Application and be maintained at room temperature out of any direct sunlight or other severe
conditions.

 




    	9