Document:

EXHIBIT 10.1

 

 

 

 

August 12,
2014

 

Mr. Michael Budnitsky

[Address]

 

Dear Mike,

 

This confirms our offer to you. 
As VP of Accounting you would report directly to our Chief Financial Officer (i.e., me).  Initially, all accounting staff
would report directly to the VP of Accounting, except for the Controller.  Employment is offered as “exempt” status,
on an “at-will” basis (i.e., meaning that either you or the company may terminate the working relationship at any time
for any reason (i.e., except the company will provide a 3-year parachute should your employment be terminated due to a change in
the company’s ownership)).  As an exempt employee of Unico American Corporation, you would be entitled to the following:

 

Compensation: $175,000 annually,
with discretionary bonuses.  Company-recognized holidays are paid as part of your base salary.

Vacation: You will accrue at
a rate of 4.33 hours per pay period (3 weeks per year).

Health Benefits: There is a 30-day
waiting period for health benefits.  Pending your election of coverage, you will be eligible for medical, dental, life, short-term
disability and long-term disability insurance on the first of the month following your eligibility date.

Profit Sharing: You will be eligible
to participate on the first plan entry date after two years of employment, given there is no break in service.  Please see
the Plan Summary for full details.

 

Your first day of work would be on or
before September 30, 2014.  On your first day you will be required to provide I-9 documentation.  Typical examples
of original, unexpired documents which would satisfy I-9 requirements are: your U.S. Passport or driver’s license
and Social Security card or birth certificate.  Also, if you would like to arrange for direct deposit of your
pay, please bring a voided check.

 

Nothing in this letter should be interpreted
as a contract.  This offer expires at 5 pm, August 15, 2014, unless accepted before that time.  We are excited by the
prospects of working with you.  Please contact me, Lynn or Cary if you have any questions or concern of any type.

 

Sincerely,

 

By: /s/ Lester A. Aaron

Lester A. Aaron

 

cc:Cary L. Cheldin

Lynn A. ClorinaExhibit 10.1

 

CONFIDENTIAL

 

FIRST AMENDMENT TO

TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT

BETWEEN HOSPIRA WORLDWIDE, INC.

and

THERAVANCE, INC.

 

This First Amendment to the Technology Transfer and Supply Agreement (“Amendment”) is made and effective as of May 16, 2013 (“Amendment Effective Date”), by and between Hospira Worldwide, Inc., (“Hospira”), and Theravance, Inc. (“Theravance”) each herein referred to individually as a “Party” and collectively as the “Parties.” Capitalized terms used in this Amendment that are not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement (as defined herein).

 

RECITALS

 

WHEREAS, Hospira and Theravance are Parties to that certain Technology Transfer and Supply Agreement dated as of May 22, 2012 (the “Agreement”); and

 

WHEREAS, the Parties now desire to amend the Agreement under the terms and conditions set forth below.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this Amendment, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree that the Agreement is amended as follows:

 

1)                                     Section 1.24.  Section 1.24, containing the definition of the term “Product” is hereby replaced in its entirety with the following new definition:

 

“1.24 “Product” or “Products” mean the VIBATIV® pharmaceutical product in 750mg and 250mg dosage forms, filled, finished and packaged in accordance with the Product Specifications.  The terms “750mg Product” and “250mg Product” shall refer to the Products having the respective dosage forms referred to herein.”

 

2)                                     Exhibit 1.25.  Exhibit 1.25 is amended by including a supplement to the 750mg Product Specifications detailing the Product Specification for the 250mg Product.  The Product Specifications supplement for the 250mg Product is appended to this Amendment as Attachment 1.

 

3)                                     Exhibit 2.1.  Exhibit 2.1 is hereby amended by adding a supplemental Statement of Work (SOW No. 2), the form of which is appended to this Amendment as Attachment 2.

 

4)                                     Exhibit 3.2.  Exhibit 3.2 is hereby amended by adding a supplemental stability studies table, appended to this Amendment as Attachment 3.

 

	
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***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE   COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE   OMITTED PORTIONS.
    

 

 

5)                                     Exhibit 5.11.  Exhibit 5.11 is hereby amended by adding a supplemental pricing table for the 250mg Product, appended to this Amendment as Attachment 4.

 

6)                                     Except as expressly amended herein, all other terms and conditions of the Agreement shall remain in full force and effect, and enforceable in accordance with its terms.  The terms and conditions of this Amendment are hereby incorporated into and made a part of the Agreement.

 

7)                                     This Amendment may be executed in three or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument.  The parties may sign and deliver this Amendment by facsimile or sent by electronic mail in portable document format (PDF) and a reproduction of this Amendment made by facsimile or PDF will have the same effect as a signed and delivered original version.

 

IN WITNESS WHEREOF, the parties intending to be bound by the terms and conditions hereof have caused this Amendment to be signed by their duly authorised representatives as of the date first above written.

 

	
HOSPIRA WORLDWIDE, INC.
    	
THERAVANCE, INC.
    
	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Kevin Orfan
    	
 
    	
By:
    	
/s/ Junning Lee
    
	
 
    	
(Signature)
    	
 
    	
(Signature)
    
	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Kevin Orfan
    	
Name:
    	
Junning Lee
    
	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
Vice President
    	
Title:
    	
Vice President,   Technical Operations
    
	
 
    	
One 2 One Contract   Manufacturing
    	
 
    	
 
    
	
 
    	
Services
    	
 
    	
 
    

 

	
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***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE   COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE   OMITTED PORTIONS.
    

 

 

ATTACHMENT 1

 

EXHIBIT 1.25

 

Product Specifications/250mg Product, EU

 

[***]

 

	
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***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE   COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE   OMITTED PORTIONS.
    

 

 

EXHIBIT 1.25

 

Product Specifications (cont.)

 

US/Canada Product Specifications - TLV Drug Product

 

[***]

 

	
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ATTACHMENT 2

 

STATEMENT OF WORK NO. 2

 

THIS STATEMENT OF WORK NO. 2 is made and entered into as of the    day of May, 2013 pursuant to that certain Technical Transfer Development and Clinical Supply Agreement between Hospira Worldwide, Inc. (“Hospira”) and Theravance, Inc. (“Theravance”) dated May 22, 2012 (“Agreement”).

 

The subject matter of Statement of Work No. 2 is as follows: 

[***]

 

	
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ATTACHMENT 3

 

EXHIBIT 3.2

 

Stability Studies - Assumptions

 

[***]

 

	
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ATTACHMENT 4

 

EXHIBIT 5.11

 

Commercial Pricing 250mg Product

 

Commercial Product Pricing

 

	
Presentation
    	
 
    	
Batch size
    	
 
    	
Package Configuration
    	
 
    	
Price per Unit
    
	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    	
 
    	
[***]
    

 

Commercial Pricing Assumptions and Terms:

 

·                  [***]

 

	
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***CERTAIN INFORMATION HAS   BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT   HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.Exhibit 10.2

 

CONFIDENTIAL

 

SECOND AMENDMENT TO

TECHNOLOGY TRANSFER AND SUPPLY AGREEMENT

between

BETWEEN HOSPIRA WORLDWIDE, INC.

and

THERAVANCE BIOPHARMA ANTIBIOTICS, INC.

 

This Second Amendment to the Technology Transfer and Supply Agreement (“2nd Amendment”) is made and effective as of 17th day of October, 2014 (“ Amendment Effective Date”), by and between Hospira Worldwide, Inc., (“Hospira”), and Theravance Biopharma Antibiotics, Inc. (“Theravance”) each herein referred to individually as a “Party” and collectively as the “Parties.”  Capitalized terms used in this 2nd Amendment that are not otherwise defined herein shall have the meanings ascribed to such terms in the Agreement (as defined herein).

 

RECITALS

 

WHEREAS, by virtue of a Consent to Assignment dated October 25, 2013 and effective June 2, 2014, Hospira and Theravance are Parties to that certain Technology Transfer and Supply Agreement dated as of May 22, 2012 (the “Agreement”); and

 

WHEREAS, by amendment dated as of May 16, 2013 the Parties included under the terms of the Agreement a second presentation of the VIBATIV® pharmaceutical product (“Product”); and

 

WHEREAS, the Parties now desire further to amend the Agreement under the terms and conditions set forth below.

 

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this 2nd Amendment, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree that the Agreement is amended as follows:

 

Amendment

 

1)                         Section 1.31.  Section 1.31, defining the term “Territory” is hereby replaced in its entirety with the following new definition:

 

“1.31      “Territory” means:  (i) the United States of America, including the District of Columbia, the Commonwealth of Puerto Rico, all territories and possessions of the United States of America, United States military bases, and any other location over which the FDA has jurisdiction to regulate medicinal products intended for human use; (ii) Canada; (iii) the European Union (“EU 28”) and any other countries that are later admitted to the European Union by acceding to the treaties of the European Union; and (iv) the following countries of the Middle East region [***].”

 

	
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Effect of Amendment

 

2)             In accordance with Section 3.3(b) of the Agreement, Hospira will determine the preparatory work that may be required to provide Theravance with necessary additional technical/developmental and regulatory support, which may include, for example, regulatory support for Theravance’s supplemental regulatory filings, packaging and product development, labeling, and relevant Regulatory Authority inspections.  Hospira shall then provide Theravance with a proposal with cost estimates for such regulatory support work, based on a [***] rate of [***]. If Theravance approves the project and the costs, the parties will implement the project as an executed supplemental project change order in accordance with the Change Control provisions of the Quality Agreement, and Hospira shall perform such agreed-upon new regulatory support work according to the executed supplemental project change order.

 

3)             In accordance with Section 7.3(c) of the Agreement, Hospira will cooperate with any Regulatory Authority of any country listed in Section 1.31(iv) of the Agreement and will allow such Regulatory Authority to conduct any PAI inspection of the Facility related to the manufacture of the Product, which the Regulatory Authority may require.  In such case, Hospira shall be entitled to charge a fee of [***], which fee shall include all PAI preparation activities and support of the audit.

 

Miscellaneous

 

4)                         If any of the activities foreseen by this 2nd Amendment are to be performed on behalf of Theravance by a Third Party, Theravance will ensure that such Third Party agrees in writing to be bound by the terms and conditions of Article 9 of the Agreement.

 

5)                         Except as expressly amended herein, all other terms and conditions of the Agreement shall remain in full force and effect, and enforceable in accordance with its terms.  Capitalized terms used herein and not otherwise defined shall have the meaning given them in the Agreement. The terms and conditions of this 2nd Amendment are hereby incorporated into and made a part of the Agreement.

 

6)                         This 2nd Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one instrument.  The parties may sign and deliver this 2nd Amendment by facsimile or sent by electronic mail in portable document format (PDF) and a reproduction of this 2nd Amendment made by facsimile or PDF will have the same effect as a signed and delivered original version.

 

REMAINDER OF PAGE INTENTIONALLY LEFT BLANK

SIGNATURE PAGE FOLLOWS

 

	
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***CERTAIN INFORMATION HAS   BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT   HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
    

 

 

IN WITNESS WHEREOF, the parties intending to be bound by the terms and conditions hereof have caused this 2nd Amendment to be signed by their duly authorised representatives as of the date first above written.

 

	
HOSPIRA   WORLDWIDE, INC.
    	
 
    	
THERAVANCE   BIOPHARMA, ANTIBIOTICS, INC.
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 By: 
    	
/s/ Kevin Orfan 
    	
 
    	
By:   
    	
/s/ Junning Lee 
    
	
 
    	
(Signature)
    	
 
    	
 
    	
(Signature)
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 Name: 
    	
Kevin   Orfan
    	
 
    	
Name:   
    	
Junning   Lee
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
 Title: 
    	
Vice   President 
   One 2 One Contract Manufacturing 
   Services
    	
 
    	
Title:   
    	
Senior   Vice President, Technical 
   Operations
    

 

	
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