Exhibit 10.52

 

***Text Omitted and Filed Separately

Confidential Treatment Requested

Under 17 C.F.R. §§ 200.80(b)(4)

and 240.24b-2

 

SECOND AMENDMENT TO MASTER SERVICES AGREEMENT

BETWEEN

AMYLIN PHARMACEUTICALS, INC.

AND

WOCKHARDT UK (HOLDINGS) LTD.

 

This Second Amendment to the Amended and Restated Commercial Supply Agreement
(this “Second Amendment”) is made as of November 1, 2010 (“Effective Date”), by
and between Amylin Pharmaceuticals, Inc., a Delaware corporation having its
principal place of business at 9360 Towne Centre Dr., San Diego, CA 92121,
(“Amylin”) and Wockhardt UK (Holdings) Ltd., formerly CP Pharmaceuticals Ltd.,
having its registered office at Ash Road North, Wrexham Industrial Estate,
Wrexham LL13 9UF, United Kingdom (“Wockhardt”).

 

RECITALS

 

WHEREAS, Wockhardt and Amylin are parties to an Amended and Restated Commercial
Supply Agreement dated April 1, 2008 (the “Agreement”), that was amended on
January 23, 2009 (the “First Amendment”); and;

 

WHEREAS, in connection with extending the Term, amending the pricing and minimum
quantities and deleting the Reservation Fee, the parties desire to amend the
Amended and Restated Commercial Supply Agreement and the First Amendment.

 

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 acknowledged, the parties agree that the
Agreement is amended as follows:

 

1)              Section 9.1 of the Agreement, Term , shall be deleted in its
entirety and shall be  replaced with the following:

 

“The term of this Agreement shall commence on the Effective date of this Second
Amendment, and unless terminated earlier by the terms of the Agreement, shall
continue until December 31, 2011(the “Term”).  The Agreement shall terminate
after the Term unless extended by mutual written Agreement by both parties.”

 

2)              Section 3.3 of the Agreement, Invoices, shall be deleted in its
entirety and shall be replaced with the following:

 

“Upon completion of the manufacture of the Product under each purchase order and
the submission of a Certificate of Analysis and Certificate of Compliance duly
approved by Manufacturer to Company for the batches of Product manufactured for
such purchase order, Manufacturer shall invoice Company the Product Price for
the quantity of Product manufactured.”

 

3)              As of the Second Amendment Effective Date, Amylin and Wockhardt
agree that Exhibit A of the Agreement shall be deleted in its entirety and shall
be replaced with Exhibit A-1, attached to this Second Amendment which is
incorporated herein by this reference.

 

1

--------------------------------------------------------------------------------

 

4)              As of the Second Amendment Effective Date, the Parties agree
that all prior Minimum Quantity, including the Minimum Quantity for the
6th Period of [***] listed in Exhibit C-1 of the First Amendment has been
completed by Amylin.

 

5)              The Parties agree to add Section 3.2.1, entitled “True-Up” to
the Agreement as follows:

 

“If, at the expiration of the Term of this Agreement  and delivery of Product
ordered within the Term, the volume assumptions on which the Product  Price
reflected in any one or more invoices for Product ordered is not reflective of
the actual quantities delivered per the volume/price tiers listed in the Product
Price Table in Exhibit A-1, then within [***] days after the Term of the
Agreement and delivery of all Product ordered within the Term, Manufacturer will
send to Company an invoice detailing for each Product description and for each
previously issued invoice (i) the previously invoiced price, (ii) the actual 
Product Price based on the actual volume of Product ordered within the term of
this amendment and (iii) the difference between the invoiced price and the
actual  Product Price (the “Itemized Annual Invoice”)

 

If, when considered in aggregate, the amount paid or payable by Company  for
Product ordered during the Term of this Agreement against invoices previously
issued by Manufacturer is in excess of the amount payable by Company  based on
the Product Price for the actual volume of Product ordered, Manufacturer shall,
contemporaneous with the delivery of the Itemized Annual Invoice and at
Company’s option, give Company a full refund of the excess amount or, with
respect to any previously issued but as yet unpaid invoice, issue an appropriate
credit equal to the access amount.

 

The actual quantities delivered used in the above True-Up calculations are
cumulative delivered volumes  that includes all 1.2mL, 2.4mL and 3.0mL Product
ordered (including sample, demo, clinical, commercial, and engineering batches)
during the Term provided that the latest delivery date stated on the purchase
order  is March 31, 2012.”

 

6)              Except as expressly amended herein, all terms and conditions of
the Agreement shall remain in full force.  Capitalized terms not otherwise
defined herein shall have the meanings accorded such terms in the Agreement.

 

7)              This Second Amendment is effective as of the Effective Date.

 

IN WITNESS WHEREOF, the parties hereto have agreed to this Second Amendment by
signing below.  This Second Amendment may be executed in any number of
counterparts (with facsimile signatures acceptable), and each such counterpart
shall be deemed to be an original instrument, but all such counterparts together
shall constitute but one Agreement.

 

 

AMYLIN PHARMACEUTICALS, INC.

 

WOCKHARDT UK (HOLDINGS) LTD.

 

 

 

 

 

By:

/s/Paul Marshall

 

By:

/s/ Sirjiwan Singh

Printed Name:

Paul Marshall

 

Printed Name:

Sirjiwan Singh

Title:

Sr. Vice President, Operations

 

Title:

Managing Director

Date:

12 November 2010

 

Date:

17-11-2010

 

--------------------------------------------------------------------------------

***Confidential Treatment Requested

 

2

--------------------------------------------------------------------------------

 

Exhibit A-1

 

Pricing

 

Product Price Table:

 

Cartridge Size

 

Volume (units)

 

Price

1.2mL/2.4mL/3mL

 

[***]

 

£[***] for 1.2mL

£[***] for 2.4mL/3mL

1.2mL/2.4mL/3mL

 

[***] – [***]MM

 

£[***]

1.2mL/2.4mL/3mL

 

[***]MM – [***] MM

 

£[***]

1.2mL/2.4mL/3mL

 

> [***] MM

 

£[***]

 

Cartridge Size

 

Batch Yield

1.2mL

 

[***]

2.4mL

 

[***]

 

Materials, in-process analytical and microbiological testing, finished product
sterility and endotoxin testing, samples and packaging are inclusive in the
prices set forth above.

 

Any additional services, such as assistance with regulatory submissions,
provision of documentation copies, non-routine quality control testing and
component approval, will be charged at a rate of £UK[***] per man-hour.  These
services and document copies are in addition to those required to be supplied by
the Manufacturer under this Agreement.  All services and copies, and the charges
for them, must be agreed in advance by Amylin.

 

--------------------------------------------------------------------------------

***Confidential Treatment Requested

 

3

--------------------------------------------------------------------------------