Document:

Exhibit 10.1

 

 

July 1, 2016

 

Delafield Investments Limited

40 Wall Street, 58th Floor

New York, New York 10005

Attn: Joshua Sason

 

		Re:	Reset Offer of Common Stock Purchase Warrant

 

To Whom It May Concern:

 

We are pleased to offer
to you the opportunity to reprice the exercise of all of the Common Stock Purchase Warrants (“Warrants”) issued
to you in connection with the securities purchase agreement, dated October 28, 2015 as amended on March 11, 2016 by addendum (the
“Purchase Agreement”), by and between you and Propanc Health Group Corporation (the “Company”)
and currently held by you (“Holder”). The shares of Common Stock underlying the Warrants (“Warrant
Shares”) have been registered for resale pursuant to a registration statement on Form S-1, as amended (File No. 333-208169)
(the “Registration Statement”). The Registration Statement is currently effective and, upon exercise of the
Warrants pursuant to this letter agreement, will be effective for the resale of the Warrant Shares.  Capitalized terms not otherwise
defined herein shall have the meanings set forth in the Purchase Agreement.

 

In consideration for
exercising 26,190,476 Warrants held by you (the “Warrant Exercise”) as set forth on the signature page hereto,
the Company hereby offers you a reduced exercise price of the Warrants subject to the Warrant Exercise to $0.012. Additionally,
in consideration therefore, the Company shall:

 

		(a)	Modify the July 1, 2016 Interest Payment Date (as such term is defined in the Debenture) of the
Debenture such that the Company is permitted to delay such interest payment by a minimum of 30 calendar days (the “Minimum
Extension Date”) and up to 60 calendar days, it being understood that the Holder may demand that the Company make the
July 1, 2016 interest payment at any time after the Minimum Extension Date; and

 

		(b)	Modify the October 1, 2016 Interest Payment Date (as such term is defined in the Debenture) of
the Debenture such that the Company is permitted to delay such interest payment to the Maturity Date (as such term is defined in
the Debenture), it being understood that the Holder may demand that the Company make the October 1, 2016 interest payment at any
time after October 1, 2016 and it being further understood that if the Holder has not demanded that the Company make the October
1, 2016 interest payment by October 27, 2016, then the Maturity Date will be extended until December 31, 2016 or such earlier date
as the parties may mutually agree.

 

Holder may accept this
offer by signing this letter below, with such acceptance constituting Holder's exercise of 26,190,476 Warrants for the aggregate
exercise price set forth on the Holder’s signature page hereto (the "Warrants Exercise Price") on or before
5:00 pm ET on July 1, 2016.

 

    	
 
 
Level 2, 555 Riversdale Road, Camberwell, Victoria 3124, Australia žP +61 3 9882 0780 žF + 61 3 9882 9969 ž propanc.com

     

    

 

Additionally, the parties
hereby agree to their respective representations, warranties and covenants set forth on Annex A attached hereto.

 

If this Offer is accepted
and the transaction documents are executed on July 1, 2016, then on or before 9:30 a.m. Eastern Time on July 5, 2016, the Company
shall issue a press release disclosing the material terms hereunder and file a prospectus supplement to the registration statement
disclosing the terms of this offer and the reduced exercise price of the Warrants. The Company represents, warrants and covenants
that, upon acceptance of this offer, the Warrant Shares shall be delivered electronically through the Depository Trust Company
within 1 business day of the date the Company receives the Warrants Exercise Price (or, with respect to shares in that would otherwise
be in excess of the beneficial Ownership Limitation, within 2 business days of the date the Company is notified by Holder that
its ownership is less than the Beneficial Ownership Limitation). The terms of the Warrants, including but not limited to the obligations
to deliver the Warrant Shares, shall otherwise remain in effect as if the acceptance of this offer were a formal Notice of Exercise
(including but not limited to any liquidated damages and compensation in the event of late delivery of the Warrant Shares).

 

Within two days from
the Holder’s execution of this letter: the Holder shall make available for “Delivery Versus Payment” to the Company
immediately available funds equal to $314,285.72; and the Company shall deliver the Warrant Shares via “Delivery Versus Payment.”

 

To accept this offer,
Holder must counter execute this letter agreement and return the fully executed agreement to the Company at e-mail: j.nathanielsz@propanc.com,
with a copy to amcclean@hselaw.com on or before 5:00 pm ET on July 1, 2016.

 

Please do not hesitate
to call me if you have any questions.

 

 

 

	 	Sincerely yours,
	 	 
	 	PROPANC HEALTH GROUP CORP.
	 	 	 
	 	 	 
	 	By:	/s/ James Nathanielsz
	 	Name:	James Nathanielsz
	

         
	Title	CEO

 

 

Accepted and Agreed to:

	Name of Holder: 	Delafield Investments Ltd.
	Signature of Authorized Signatory of Holder:	/s/ Joshua Sason
	Name of Authorized Signatory:	Joshua Sason
	Title of Authorized Signatory	Member

 

 

Warrant Shares being exercised: 26,190,476
shares

Aggregate Holder Exercise Price: $314,285.72

DTC Instructions:

 

Company Wire Instructions:

 

 

     

     

    

 

Annex A

 

Representations,
Warranties and Covenants of the Company. The Company hereby makes the following representations and warranties to the undersigned
(Capitalized terms not otherwise defined herein shall have the meanings set forth in the Purchase Agreement):

 

(a)               
Subsidiaries. The Company owns, directly or indirectly, all of the capital stock or other equity interests of its
only subsidiary, Propanc PTY Ltd. (the “Subsidiary”), free and clear of any Liens, and all of the issued and outstanding
shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar
rights to subscribe for or purchase securities.

 

(b)              
Organization and Qualification. The Company and its Subsidiary is an entity duly incorporated or otherwise organized,
validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite
power and authority to own and use its properties and assets and to carry on its business as currently conducted. Neither the Company
nor its Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation,
bylaws or other organizational or charter documents. Each of the Company and its Subsidiary is duly qualified to conduct business
and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted
or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as
the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity
or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects
or condition (financial or otherwise) of the Company and its Subsidiary, taken as a whole, or (iii) a material adverse effect on
the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document
(any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any such jurisdiction
revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.

 

(c)               
Authorization; Enforcement. The Company has the requisite corporate power and authority to enter into and to consummate
the transactions contemplated by this letter agreement and otherwise to carry out its obligations hereunder and thereunder. The
execution and delivery of this letter agreement by the Company and the consummation by the Company of the transactions contemplated
hereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company,
its board of directors or its stockholders in connection therewith. This letter agreement has been duly executed by the Company
and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of the Company enforceable
against the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy,
insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally,
(ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and
(iii) insofar as indemnification and contribution provisions may be limited by applicable law.

 

     

     

    

 

(d)              
No Conflicts. The execution, delivery and performance of this letter agreement by the Company and the consummation
by the Company of the transactions contemplated hereby do not and will not: (i) conflict with or violate any provision of the Company’s
certificate or articles of incorporation, bylaws or other organizational or charter documents; or (ii) conflict with, or constitute
a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien
upon any of the properties or assets of the Company in connection with, or give to others any rights of termination, amendment,
acceleration or cancellation (with or without notice, lapse of time or both) of, any material agreement, credit facility, debt
or other material instrument (evidencing Company debt or otherwise) or other material understanding to which such Company is a
party or by which any property or asset of the Company is bound or affected; or (iii) subject to the Required Approvals, conflict
with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court
or governmental authority to which the Company is subject (including federal and state securities laws and regulations), or by
which any property or asset of the Company is bound or affected, except, in the case of each of clauses (ii) and (iii), such as
could not have or reasonably be expected to result in a Material Adverse Effect.

 

(e)               
SEC Reports; Financial Statements. The Company has filed all reports,
schedules, forms, statements and other documents required to be filed by the Company under the Securities Act and the Exchange
Act, including pursuant to Section 13(a) or 15(d) thereof, for the two years preceding the date hereof (or such shorter period
as the Company was required by law or regulation to file such material) (the foregoing materials, including the exhibits thereto
and documents incorporated by reference therein, being collectively referred to herein as the “SEC Reports”) on a timely
basis or has received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration of any
such extension. As of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities
Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material
fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in
the light of the circumstances under which they were made, not misleading. The Company has never been an issuer subject to Rule
144(i) under the Securities Act. The financial statements of the Company included in the SEC Reports comply in all material respects
with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the
time of filing. Such financial statements have been prepared in accordance with United States generally accepted accounting principles
applied on a consistent basis during the periods involved (“GAAP”), except as may be otherwise specified in such financial
statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP,
and fairly present in all material respects the financial position of the Company and its Subsidiary as of and for the dates thereof
and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal,
immaterial, year-end audit adjustments.

 

(f)               
Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for
the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company
Act of 1940, as amended. The Company shall conduct its business in a manner so that it will not become an “investment company”
subject to registration under the Investment Company Act of 1940, as amended.

 

     

     

    

 

Representations,
Warranties and Covenants of the undersigned. The undersigned hereby represents, warrants and covenants as of the date hereof
to the Company as follows (unless as of a specific date therein, in which case they shall be accurate as of such date):

 

(a)              
Organization and Qualification. The undersigned is an entity duly incorporated or otherwise organized, validly existing
and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority
to own and use its properties and assets and to carry on its business as currently conducted. The undersigned is not in violation
or default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational
or charter documents.

 

(b)              
Authorization; Enforcement. The undersigned has the requisite corporate power and authority to enter into and to
consummate the transactions contemplated by this letter agreement and otherwise to carry out its obligations hereunder and thereunder.
The execution and delivery of this letter agreement by the undersigned and the consummation by the undersigned of the transactions
contemplated hereby have been duly authorized by all necessary action on the part of the undersigned and no further action is
required by the undersigned, its governing body or owners in connection therewith. This letter agreement has been duly executed
by the undersigned and, when delivered in accordance with the terms hereof, will constitute the valid and binding obligation of
the undersigned enforceable against the undersigned in accordance with its terms, except (i) as limited by general equitable principles
and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement
of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive
relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable
law.

 

(c)              
No Conflicts. The execution, delivery and performance of this letter agreement by the undersigned and the consummation
by the undersigned of the transactions contemplated hereby do not and will not: (i) conflict with or violate any provision of
the undersigned’s certificate or articles of incorporation, bylaws or other organizational or charter documents; or (ii)
conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction
of any court or governmental authority to which the undersigned is subject (including federal and state securities laws and regulations),
or by which any property or asset of the Company is bound or affected.

 

(d)              
Compliance with Securities Act. The undersigned understands and agrees that the Warrant Exercise has not been registered
under the Securities Act or any applicable state securities laws by reason of their issuance in a transaction that does not require
registration under the Securities Act (based in part on the accuracy of the representations and warranties of Subscriber contained
herein), and that the Warrant Shares must be held indefinitely unless a subsequent disposition is registered under the Securities
Act or any applicable state securities laws or is exempt from such registration.

 

(e)              
Own Account. The undersigned understands that the Warrant Shares are a “restricted security” and have
not been registered under the Securities Act or any applicable state securities law and is acquiring the Warrant Shares as principal
for its own account and not with a view to or for distributing or reselling such Warrant Shares or any part thereof in violation
of the Securities Act or any applicable state securities law, has no present intention of distributing any of such Warrant Shares
in violation of the Securities Act or any applicable state securities law and has no direct or indirect arrangement or understandings
with any other persons to distribute or regarding the distribution of such Warrant Shares in violation of the Securities Act or
any applicable state securities law. The undersigned is acquiring the Warrant Shares hereunder in the ordinary course of its business.

 

     

     

    

 

(f)              
Experience of the Undersigned. The undersigned, either alone or together with its representatives, has such knowledge,
sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the
prospective investment in the Warrant Shares and has so evaluated the merits and risks of such investment. The undersigned is
able to bear the economic risk of an investment in the Warrant Shares and, at the present time, is able to afford a complete loss
of such investment.

 

(g)              
Access to Information. The undersigned acknowledges that it has had the opportunity to review the Transaction Documents
(including all exhibits and schedules thereto) and the SEC Reports and has been afforded (i) the opportunity to ask such questions
as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions
of the offering of the Warrant Shares and the merits and risks of investing in the Warrant Shares; (ii) access to information
about the Company and its financial condition, results of operations, business, properties, management and prospects sufficient
to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses
or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to
the investment.

 

(h)              
No Market Manipulation. The undersigned has not taken, and will not take, directly or indirectly, any action designed
to, or that might reasonably be expected to, cause or result in stabilization or manipulation of the price of the Common Stock
or affect the price at which the Warrant Shares may be issued or resold.

 

(i)              
Risk of Loss.  The undersigned acknowledges that there may be no market for the Warrant Shares and that the undersigned
may not be able to sell or dispose of the Warrant Shares; the Subscriber has liquid assets sufficient to assure that its investment
will cause no undue financial difficulties and that, after purchasing the Warrant Shares the undersigned will be able to provide
for any foreseeable current needs and contingencies. The undersigned is financially able to bear the economic risk of this investment,
including the ability to hold the Warrant Shares indefinitely or to afford a complete loss of the Subscriber’s investment
in the Warrant Shares.Exhibit 10.1

 

	
AMENDMENT OF SOLICATION/MODICATION OF CONTRACT

	
Contract id code

N/A

	
   Page of pages

	
1

	
9

	
2. Amendment/modification no.

Modification 0013

	
3. Effective date

See Block 16 C

	
4. Requisition/purchase req. No

N/A

	
5. Project no. (If applicable)

N/A

	
6. issued by

HHS/OS/ASPR/AMCG

330 Independence Avenue, SW,

Room G640,

Washington, DC 20201

 

	code	
N/A

	
7. Administered by (If other than item 6)

	code	
N/A

	 	 
	 	 
	 	 
	 	 

	

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

 

	
☒

 

	
9A. Amendment of solicitation no.

	
SIGA TECHNOLOGIES, INC.

35 E 62nd Street

 New York, NY 10065

	
 

	
 

	
 

	
 

	

9B. dated (see item 11)

 

	
 

	
☒

	

10A. Modification of contract/order no.

 

HHSO100201100001C

	
CODE N/A

	
FACILITY CODE N/A

	
 

	

10B. DATED (SEE ITEM 13)

05/13/2011

	
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

 

~The above numbered solicitation is amended as set forth In Item 14. The hour and date specified for receipt of Offers ~ is extended, ~ not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods: (a) By completing Items 8 and 15, and returning ______________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers.  FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER.  If by virtue of this amendment, you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

	
12. ACCOUNTING AND APPROPRIATION DATA (If required)

N/A

	
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THAT CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

	
☐

	
A.          THIS CHANGE ORDER IS ISSUED PURSUANT TO:  (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

	 
	 	
B.          THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

	
☒

	
C.          THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

FAR 52.243-2 –Changes – Cost Reimbursement and FAR 1.605-1 – Mutual Agreement of the Parties

	 	
D.          OTHER (Specify type of modification and authority)

	
E. IMPORTANT: Contractor [ ] is not, [X] is required to sign this document and return   1  copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible)

 

	
PURPOSE:

	
This modification is to change the criteria for milestone 0001AB and reduce the CLIN 0002 holdback amount

 

	
FUNDS ALLOTED PRIOR TO MOD #13 

	
 

	
$470,314,469.00

	
FUNDS ALLOTTED WITH MOD #13 

	
 

	
$                  0.00

	
TOTAL FUNDS ALLOTED TO DATE 

	
 

	
$470,314,469.00 (Unchanged)

	
 

	
 

	
 

	
EXPIRATION DATE: 

	
 

	
September 24, 2020 (Unchanged)

	
 

	
 

	
 

	
CONTRACT FUNDED THROUGH 

	
 

	
September 24, 2020 (Unchanged)

 

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

	
15A. NAME AND TITLE OF SIGNER (Type or print)

	
16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

	 	
Linda D. Luczak, Contracting Officer

	
Dennis E. Hruby

	
 

	 	 
	
15B. CONTRACTOR/OFFEROR

	
15C. DATE SIGNED

	
16B. UNITED STATES OF AMERICA

	
16C. DATE SIGNED

	 	 	 	 
	/s/ Dennis E. Hruby	 	
28 Jun 2016

	
BY

	
/s/ Linda D. Luczak

	 	
6/28/2016

	
(Signature of person authorized to sign)

	 	(Signature of Contracting Officer)	 
	 	 	 	 
	NSN 7540-01-152-8070       OMB No. 0990—0115	STANDARD FORM 30 (rev. 10-83)  

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 2 of 9

	 	A.	The following CLINS 0001 (0001AA, 0001AB, 0001AC, and 0001AD) and 0002 under B.5 Price Schedule is hereby modified as follows:

B. 5 Price Schedule

	
BASE

	 	 	 	 	 
	
CLIN#

	
Cost

Type

	
Supply or Service

	
U/I

	
Qty

	
Unit Price

	
Extended Price

	
0001

	
FFP

	
Manufacture and deliver 1,700,000 smallpox antiviral treatment courses (minimum 60 month stability from date of manufacture) to support appropriate regulatory filing submitted by CDC as described in Section C.1)

NOTE: The maximum amount payable for all 1,700,000 FDA approved treatment courses is $409,811,755.00 (inclusive of all advance payments, milestone payments and hold back)

	
EA

	
1,700,000

	
[redacted]*

	
$368,900,000.00

	
0001AA

	 	
Advance Payments

	
JOB

	
[redacted]*

	
[redacted]*

	
$40,981,175.00

	
0001AB

	 	
Milestone Payment 1:

Documentation to BARDA that data covering the first 100 subject enrolled in the phase III pivotal safety study have been submitted to and reviewed by a DSMB, and submission of the final pivotal rabbit efficacy study report to the FDA.

	
JOB

	
[redacted]*

	
[redacted]*

	
$20,490,587.00

	
0001AC

	 	
Milestone Payment 2A: Complete FDP Commercial Validation batches and report

	
JOB

	
[redacted]*

	
[redacted]*

	
$8,196,235.00

	
0001AD

	 	
Milestone Payment 2B:

Approved product labeling strategy

	
JOB

	
[redacted]*

	
[redacted]*

	
$12,294,352.00

	
0002

	
FFP

	
Payment upon FDA Approval for all treatment courses being provided under this contract (CLIN 0001 and CLIN 0022). This CLIN contains the lump sum amount of holdback from CLIN 0001 of approximately [redacted]*

	
LS

	
[redacted]*

	
[redacted]*

	
$40,911,755.00

	NOTE:	The overall total amount of the contract remains unchanged,

		B.	Based on FDA agreeing upon the treatment dose to allow phase III efficacy trials to proceed and the Contractor’s successful enrollment of [redacted]* of projected study subjects in these trials the total amount of FDA approval hold back is being reduced from [redacted]* to approximately [redacted]*. The language under paragraph B.6.1.2. and B.6.1.2.1 is revised as follows:

B.6.1.2             FDA Approval Hold Bank

B.6.1.2.1          The negotiated dollar amount equivalent to approximately [redacted]* will be withheld from payment under CLIN 0001 until such time as the Contractor achieves FDA approval. This pertains to FDP doses that are delivered to the SNS prior to approval. 

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 3 of 9

After achieving FDA approval, the Contractor shall invoice under CLIN 0002 in the lump sum amount of $40,911,755.00 for all treatment courses required under this contract are delivered to the SNS.

 

		C.	By revising the language under paragraph H.16.2 and table as follows:

 

H. 16.2 Approvals for advance payments and or milestone payments have been agreed upon as follows:

		·	Advance Payment - [redacted]* of the total negotiated contract amount

		·	Milestone payment ([redacted]*): Upon documentation provided to BARDA that data covering the first 100 subject enrolled in the phase III pivotal safety study have been submitted to and reviewed by a DSMB, and submission of the final pivotal rabbit efficacy study report to the FDA.

		·	Milestone payment ([redacted]*): Completion of Final Drug Product (FDP) Commercial Validation batches and report. [redacted]* of the total negotiated contract amount for the completion of FDP Commercial Validation batches and report. ([redacted]*)

		·	Milestone payment ([redacted]*): Approved Product Labeling Strategy - [redacted]*  of the total negotiated contract amount for the approval of the product labeling strategy ([redacted]*)

	
1.

	
[redacted]* Project BioShield Advance Payment - $40,981,175.00

The HHS Secretary has determined that an advance payment is necessary to ensure success of this project, and has authorized a [redacted]* advance payment in accordance with 42 USC 247d-6b(c)(7)(C)(ii)(I) PAYMENT CONDITIONED ON DELIVERY. This [redacted]* advance payment equates to 40,981,175.00 and is required to be repaid if there is a failure to perform by the Contractor under the contract.

Nothing in the PAYMENT CONDITIONED UPON DELIVERY sub-clause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.

Upon notification of receipt and notification of approval of the Final Security Plan, the Contractor shall invoice for $5,000,000. The remaining balance of $35,981,175 shall be invoiced 90 days of performance (TBD).

1.  Milestone Payment at [redacted]* for a total of $20,490,587. (Upon documentation provided to BARDA that data covering the first 100 subject enrolled in the phase III pivotal safety study have been submitted to and reviewed by a DSMB, and submission of the final pivotal rabbit efficacy study report to the FDA.)

Nothing in the PAYMENT CONDITIONED UPON DELIVERY sub-clause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.

Completion of each individual milestone is required prior to the issuance of each respective milestone payment. The contractor shall submit the deliverable (See below) for each respective milestone to the Contracting Officer’s Representative and Contracting Officer for review by the appropriate date, and is subject to Government concurrence and approval. The Contractor shall invoice for the milestone payment $20,490,587) after Contracting Officer approval is provided.

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 4 of 9

2A.  1 Milestone Payment at [redacted]* for a total of $8,196,235.00 (Completion of Final Drug Product (FDP) Commercial Validation batches and report)

Nothing in the PAYMENT CONDITIONED UPON DELIVERY sub-clause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.

Completion of each individual milestone is required prior to the issuance of each respective milestone payment. The contractor shall submit the deliverable (See below) for each respective milestone to the Contracting Officer’s Representative and Contracting Officer for review by the appropriate date, and is subject to Government concurrence and approval. The Contractor shall invoice for the milestone payment $8,196,235.00 after Contracting Officer approval is provided.

2B.  1 Milestone Payment at [redacted]* for a total of $12,294,352.00 (Approved Product Labeling Strategy)

Nothing in the PAYMENT CONDITIONED UPON DELIVERY sub-clause shall be construed as affecting the rights of vendors under provisions of law or regulation (including the Federal Acquisition Regulation) relating to the termination of contracts for the convenience of the Government.

Completion of each individual milestone is required prior to the issuance of each respective milestone payment. The contractor shall submit the deliverable (See below) for each respective milestone to the Contracting Officer’s Representative and Contracting Officer for review by the appropriate date, and is subject to Government concurrence and approval. The Contractor shall invoice for the milestone payment $12,284,352.00 after Contracting Officer approval is provided.

		D.	By revising the following advanced payment and milestone from CLIN 0001 table as follows:

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 5 of 9

	
Advanced and Milestone Payments from CLIN-0001

	
#

	
Payment

Milestones

	
Deliverable

	
Date

	
Payment:

	 	 	
Advance Payment

	 	 
	
1

	
[redacted]*

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	 	 	
Payment Milestones #1

	 
	
1

	
[redacted]*

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	
2A

	
[redacted]*

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 6 of 9

	
2B

	
[redacted]*

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	
3

	
[redacted]*

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

		E.	By adding the following reporting requirement to the table under F.3.3 as follows:

	
F.3.3 — “Reporting Requirements”

	
#

	
Type of 

Deliverable

	
Frequency/Time 

Periods

	
Description of

Deliverable

	
Reporting Procedures

	
30

	
Notification and documentation of DSMB data submitted to the FDA following enrollment of the first 100 subjects in the ST-246- 008 pivotal phase III safety trial

	
At least 15 business days prior to

submission to FDA

	
The contractor shall provide BARDA the opportunity to review and comment upon all draft regulatory documents before submission to the FDA. Contractors shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either ‘Draft’ or ‘Final’

 

The Contractor must address in writing all concerns raised by BARDA to the satisfaction of BARDA before FDA submission

	
·    Contractor will submit proposed FDA Meeting Briefing Packets to BARDA at least 15 business days prior to FDA submission.

·    If corrective action is required, the Contractor must address in writing all concerns raised by BARDA staff to the satisfaction of BARDA

·    Final FDA submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its submission to CDER

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 7 of 9

		F.	By the addition of items under Table B, Section F.3, Contract Milestone and Go/No Go Decision Gates as follows:

	
Section F.3 — Table B: — "Contract Milestones and Go/NO GO Decision Gates

	
Mstn 

#

	
Go/NO GO 

Decision Gates

	
Go Criteria

	
No-Go Criteria

	
Deliverable

	
SOO/WBS #

	
16

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
17

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
18

	
 

[redacted]*

 

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

		G.	By revising the Project BioShield Specific Deliverables (Item 1 only) under Section F.3 of the contract to read as follows:

	
Project BioShield Specific Deliverables

	
#

	
Type of Deliverable

	
Frequency/Time Periods

	
Description of Deliverable

	
Reporting Procedures

	
Quantity/Form

	
1

	
Delivery of MCM

	
 

 

[redacted]*

 

 

	
 

 

[redacted]*

 

 

	
 

 

[redacted]*

 

 

	
 

 

[redacted]*

 

 

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 8 of 9

		H.	By revising the Project BioShield Delivery Schedule under F.6 Delivery Schedule (previously modified under Modification 0009) as follows:

 

	
Delivery

Number

	
Number of Bottles 

(42 x 200mg 

Capsules)

	
Number of Courses

	
Delivery Date

	
Batches

	
#1

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#2

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#3

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#4

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#5

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#6

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#7

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#8

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#9

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#10

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#11

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#12

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#13

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#14

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#15

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#16

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#17

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
#18

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
Total

	
[redacted]*

	
[redacted]*

	 	 

 

* Certain material has been omitted pursuant to a request for confidential treatment.  Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Contract No.

HHSO100201100001C

Modification No.0013

	
Continuation Sheet

Block 14

	
Page 9 of 9

		I.	By changing all references of Contracting Officer’s Technical Representative to read Contracting Officer’s Representative (COR)

		J.	All other terms and conditions of contract HHSO100201100001C remain unchanged.

END OF MODIFICATION 0013 to HHSO10020110001C

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