Exhibit 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.

 

First Amendment to Technology Transfer and Supply Agreement

Page 1 of 7

 

 

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

 

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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

 

 

 

First Amendment to Technology Transfer and Supply Agreement

Page 2 of 7

 

 

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

 

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ATTACHMENT 1

 

EXHIBIT 1.25

 

Product Specifications/250mg Product, EU

 

[***]

 

First Amendment to Technology Transfer and Supply Agreement

Page 3 of 7

 

 

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

 

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EXHIBIT 1.25

 

Product Specifications (cont.)

 

US/Canada Product Specifications - TLV Drug Product

 

[***]

 

First Amendment to Technology Transfer and Supply Agreement

 

 

Page 4 of 7

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

 

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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:

[***]

 

First Amendment to Technology Transfer and Supply Agreement

 

 

Page 5 of 7

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

 

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ATTACHMENT 3

 

EXHIBIT 3.2

 

Stability Studies - Assumptions

 

[***]

 

First Amendment to Technology Transfer and Supply Agreement

 

 

Page 6 of 7

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

 

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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:

 

·                  [***]

 

First Amendment to Technology Transfer and Supply Agreement

 

 

Page 7 of 7

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

 

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