Confidential treatment has been requested with
respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and
filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.


 





Amendment #2 to the Manufacturing Agreement


 


This Amendment #2 to the Manufacturing
Agreement (this “Amendment #2”) is made effective as of August 1, 2016 (“Effective Date”),
by and between Biotest Pharmaceuticals Corporation, a Delaware corporation, having a place of business at 5800 Park of Commerce
Boulevard NW, Boca Raton, Florida 33487 USA (“BPC”) and Sanofi Pasteur S.A., a company existing and organized
under the laws of France (“Sanofi Pasteur”), having its registered head office at 2, avenue Pont Pasteur, 69007,
Lyon, France.


 


WHEREAS, BPC
and Sanofi Pasteur are Parties to that certain Manufacturing Agreement, effective September 30, 2011, as previously amended for
the production of Rabies Fraction II Paste for Sanofi Pasteur from human plasma containing rabies antibodies (collectively, the
“Agreement”);


 


WHEREAS, BPC
and Sanofi Pasteur are also Parties to a plasma supply agreement, as amended, for the production of human Rabies Hyperimmune Plasma
(“Rabies Plasma”) by BPC for Sanofi Pasteur to be used in the manufacturing of Rabies Immunoglobulin, effective
January 20, 2009 (collectively, the “Plasma Supply Agreement”), which is now an exhibit to this Agreement and
an integral part hereof;


 


WHEREAS, the
Plasma Supply Agreement and this Agreement are connected and to be read together;


 


WHEREAS, Sanofi
Pasteur is in the process of divesting the production of the rabies immunoglobulin and is negotiating with a third party (the “Assignee”)
the assignment of its rights on that product;


 


WHEREAS, in
the frame of this divestment project, and as part of the discussions with the Assignee, Sanofi Pasteur is to supply to the Assignee
certain quantities of Rabies Immunoglobulin for further commercialization by the Assignee;


 


WHEREAS, Sanofi
Pasteur is willing to secure with BPC the manufacturing and supply of the Product for the coming years in terms of quantities;
and


 


WHEREAS, BPC
and Sanofi Pasteur desire to further amend the Agreement in order to memorialize the amendment of certain provisions in the Agreement;


 


NOW, THEREFORE,
in consideration of the respective promises contained herein and other valuable consideration, the receipt and sufficiency of which
are hereby acknowledged, and intending to be legally bound hereby, the Parties hereto agree as follows:


 


1. All capitalized terms used and not defined
in this Amendment shall have the meaning as set out in the Agreement.


 






    
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Confidential treatment has been requested with
respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and
filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.


 


Section 2.1 (a) of the Agreement is deleted
in its entirety. Sanofi Pasteur shall no longer have any obligation to purchase exclusively from BPC Sanofi Pasteur’s worldwide
requirements of Product.


 


Sanofi Pasteur agrees to purchase and BPC
to manufacture the following quantities of Batches of Product:


 


		·	2017: [***] RR and [***] RA






		·	2018: [***] RR and [***] RA






		·	2019: [***] RR and [***] RA






		·	2020: Depending on Plasma collection: [***] RR and [***] RA



 


as long as BPC is providing in a timely
manner the minimum per Batch volume of RR Plasma for the above number of RR Batches.


 


If more RR plasma is delivered by BPC,
Sanofi Pasteur will purchase the following quantities of Batches of Product:


 


		·	2017: [***]






		·	2018: [***]






		·	2019: [***]






		·	2020: [***]



 


Section 2.1 (d), (e) and (0 are hereby
amended to impose on BPC an obligation to supply a minimum of [***] Batches of Product per year for the term of the Agreement.
BPC agrees to use its reasonable best efforts to manufacture, each year, at least [***] Batches of Products (hereafter the “Minimum
Volume”). BPC is informed by Sanofi Pasteur of the necessity to abide by this volume commitment, which in case of failure
will cause an important harm to Sanofi Pasteur.


 


Should BPC fail to manufacture the yearly
Minimum Volume of Product as specified in this Amendment # 2, BPC agrees that Sanofi Pasteur shall be entitled to obtain from BPC
as liquidated damages, and not a penalty, amounting to $[***] ([***]) USD for each calendar year where BPC is not able to meet
the Minimum Volume. BPC accepts and declares that the amount of the liquidated damages is a fair and equitable compensation, and
not a penalty, for such failure in consideration of the overall framework of the sums of money to be paid by Sanofi Pasteur under
the Plasma Supply Agreement and the Agreement. The liquated damages referenced above, together with the right to terminate this
Agreement, shall be Sanofi Pasteur’s exclusive remedy, with respect to the failure by BPC to supply the Minimum Volume to
Sanofi Pasteur. Sanofi Pasteur shall not be entitled to any other remedy at law or by this Agreement, should BPC fail to manufacture
the Minimum Volume.


 






    
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Confidential treatment has been requested with
respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and
filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.


 


In addition to yearly Minimum Volume of
Product to be manufactured by BPC, should BPC deliver the Minimum Volume of Product but fail to meet the supply plan as provided
in Exhibit A as attached hereto and making an integral part hereof, then it is agreed upon by the Parties that BPC shall pay to
Sanofi Pasteur an amount equal to $[***] ([***]) USD for each Batch of Product that is less than the agreed upon quantity in Exhibit
A, and not as a penalty.


 


2. The Parties have agreed to the supply plan
provided in Exhibit A, which shall make an integral part hereof and be binding on both parties.


 


3. Section 3.2, entitled “Annual Increase,”
of Article 3, entitled “Payments,” is hereby amended by deleting any reference to Product Price for the period January
1, 2017 through December 31, 2020 and replacing it by the following:


 


“The Product Price for the period
January 1, 2017 through December 31, 2020 will be as follows:


 


Batch #[***] through #[***] - [***] USD


 


Batch #[***] through #[***] - [***] USD


 


Batch #[***] through #[***] - [***] USD


 


Batch #[***] or greater - [***] USD.”


 


The Product Price is not subject to revision
from January 1, 2017 through December 31, 2020.


 


For the avoidance of doubt the following
is an example of pricing for [***] Batches:


 


	
        Batch #[***] through #[***] - [***] USD per Batch
        = [***] USD

         

        Batch #[***] through #[***] - [***] USD per Batch
        = [***] USD

         

        Batch #[***] through #[***] - [***] USD per
Batch = [***] USD



 


Total Amount owed would be [***] USD.


 


4. Section 5.1, entitled “Confidential
Information,” is hereby amended by adding the following:


 


“(c) Notwithstanding the
foregoing, BPC agrees that Sanofi Pasteur may disclose the contents of this Agreement to a prospective successor or Assignee to
the Rabies Immunoglobulin business, provided that Sanofi Pasteur and the prospective successor have entered into a confidentiality
agreement that would prevent that prospective successor from disclosing this Agreement.”


 






    
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Confidential treatment has been requested with
respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and
filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.


 


5. Section 8.13, entitled “Parties in
Interest; Assignment,” is hereby amended by adding the following:


 


“Notwithstanding the foregoing,
BPC will consent to the assignment of this Agreement to a legal entity that has been approved by both Sanofi Pasteur and BPC (the
“Assignee”). BPC shall not unreasonably withhold such approval.


 


In addition to the foregoing, BPC
shall allow Sanofi Pasteur’s successor or Assignee to perform quality audits on BPC’s manufacturing site so as to ensure
compliance to the terms of the Agreement. Sanofi Pasteur’s successor shall have access to the exact same information and
documents to which Sanofi Pasteur is actually entitled to have access to under the Agreement. This section is subject to a fully
executed confidentiality agreement between BPC and Sanofi Pasteur’s successor or Assignee.”


 


6. All other terms of the Agreement shall
remain in full force and effect except to the extent superseded by the terms of this Amendment #2.


 


IN WITNESS WHEREOF, the parties
hereby have caused this Amendment #2 to the Agreement to be executed and the persons signing below warrant that they are duly authorized
to sign for and on behalf of their respective Parties.


 


	
        Sanofi Pasteur, S.A.

         

        By: /s/ Vincent Hingot

         

        Name: Vincent Hingot

         

        Title: Head of Global Industrial Affairs

         

        Date: October 16, 2016
	
        Biotest Pharmaceuticals Corporation

         

        By: /s/ Ileana Carlisle

         

        Name: Ileana Carlisle

         

        Title: Chief Executive Officer

         

        Date: September 22, 2016



 






    
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Confidential treatment has been requested with
respect to portions of this agreement as indicated by “[***]” and such confidential portions have been deleted and
filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.


 


Exhibit A


 


[***]


 


BPC Initials ___

Sanofi Pasteur Initials ___


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