Document:

Q1 2011 10-Q Exhibit 10.1

Exhibit 10.1

NOTE: CERTAIN CONFIDENTIAL INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT AND
REPLACED BY "[*]". A COMPLETE COPY OF THIS DOCUMENT INCLUDING THE CONFIDENTIAL INFORMATION
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 

AMENDMENT NUMBER TWO TO AMENDING AGREEMENT

THIS AMENDMENT Number Two ("Amendment Number Two"), effective as of the 28th
day of August, 2007, is entered into 

B E T W E E N:

NPS Pharmaceuticals 

                              at 550 Hills Drive, 3rd Floor, Bedminster, N.J 07921, USA

                              (hereinafter referred to as "NPS")

- and -

BOEHRINGER INGELHEIM AUSTRIA GMBH

                              at Dr. Boehringer-Gasse 5 - 11, A-1121
Vienna, Austria

(hereinafter referred to as "BI AUSTRIA")

WHEREAS, the Parties have entered into a COMMERCIAL MANUFACTURING AGREEMENT dated as of
OCTOBER 18, 2002 (hereinafter, the "AGREEMENT") for the manufacture of NPS ALLELIX proprietary
product ALX-11 (also known as PREOS®), for which the active ingredient is recombinant human parathyroid
hormone eighty-four (84) amino acids ("rhPTH"); and

WHEREAS, BI AUSTRIA and NPS (the Parties) entered into an Amending Agreement dated March 15, 2004
(hereinafter, the "AMENDING AGREEMENT"), which in addition covers the manufacture of NPS' proprietary
product ALX-0600 (also known as GATTEX®) and an Amendment Number One to the AMENDING AGREEMENT
dated December 22, 2005 (hereinafter, the "Amendment Number One"); and

WHEREAS, as a result of discussions between the Parties, the Parties now set forth their intent to amend the AGREEMENT, the AMENDING AGREEMENT and
Amendment Number One as follows:

                                                1

	NPS Pharmaceuticals represents and warrants
that it has assumed all rights and obligations of NPS Allelix Corp., 6850 Goreway Drive, Mississauga, Ontario, Canada
L4V 1V7, under the AGREEMENT and the AMENDING AGREEMENT and all and any amendments of the foregoing
agreements.
	Section 6.4.1.3 of the AMENDING AGREEMENT as amended by Amendment Number One (with regard to
RESERVE CAPACITY for 2008-2009) is deleted in its entirety.
	NPS has paid an amount of [*] Euros Remaining Compensation Fee as set forth in Revised Exhibit M to the
Amendment Number One, subsection (iii), to BI Austria. With regard to PTH batches to be manufactured by BI Austria in
2009 in accordance with the Rolling Forecast, BI Austria agrees to reduce the price for such PTH batches by [*]
Euros.
	In addition to the [*] ALX-0600 conformance batches ordered by NPS and manufactured by BI Austria in 2007, BI
Austria manufactured further [*] conformance batches at NPS' request because [*] of the aforementioned [*]
conformance batches were under investigation in 2007. In 2007, NPS has reviewed and accepted all [*] conformance
batches and BI Austria has rendered invoice for these batches in 2007. If [*] of the [*] conformance batches which were
under investigation are determined not to be fit for purpose because of stability issues with either the API or dosage form
for the cause which was the subject of the BI Austria investigation or if the Regulatory Authorities view them as not
meeting the requirements for conformance/validation batches, BI Austria will replace such ALX-0600 batch(es) at no
charge to NPS.
	BI Austria has replaced in 2007 a batch of ALX-0600 that had been lost at BI Austria in previous years, at its sole
expense.
	Section 19.1 of the AGREEMENT and the AMENDING AGREEMENT are deleted in their entirety.

[Remainder of page intentionally left blank]

                                                2

All other terms and conditions of the AGREEMENT, the AMENDING AGREEMENT and Amendment Number One
shall remain in full force and effect. In the event of any conflict and/or inconsistency between the terms and conditions of
this Amendment Number Two and the terms and conditions of the AGREEMENT, the AMENDING AGREEMENT or
Amendment Number One, this Amendment Number Two shall govern and take precedence.  

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be executed
as of the date first written above.

	
NPS Pharmaceuticals

	
BOEHRINGER INGELHEIM AUSTRIA GMBH ppa.

	
By:/s/ Joseph Rogus  

Name:Joseph Rogus

Title:VP, Technical Operations

	
/s/ Frank Ternes

Dipl Vw. Frank Ternes

SVP, Biopharmaceuticals & Operations ppa.

	
 

	
/s/ Joseph Legerer

Dr. Joseph Legerer

VP, Legal Department

                                                3Q1 2011 10-Q Exhibit 10.2

Exhibit 10.2

NOTE: CERTAIN CONFIDENTIAL INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT AND
REPLACED BY "[*]". A COMPLETE COPY OF THIS DOCUMENT INCLUDING THE CONFIDENTIAL INFORMATION
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 

	
Mr. Joseph Rogus

Vice President Technical Operations

NPS Pharmaceuticals

550 Hills Drive 3rd Floor

Bedminster, NJ 07921

 

Letter Agreement

	

BOC

Biopharmaceuticals / Operations

 

19 January 2009

Dr. Monika Henninger

  Phone++43-1-80 105-2141

  Telefax++43-1-801 05 2440

  E-Mailmonika.henninger@

  boehringer-ingelheim.com

	
Dear Mr. Rogus,

As you know, Boehringer Ingelheim RCV GmbH & Co KG ("BI RCV"), which is the universal legal successor
into all rights and obligations of Boehringer Ingelheim Austria GmbH, on the one hand, and NPS Pharmaceuticals, Inc.
("NPS", and BI RCV together with NPS, the "Parties"), which has assumed all rights and obligations of NPS
Allelix Corp. vis-à-vis Boehringer Ingelheim Austria GmbH and BI RCV, respectively, on the other hand, are the
Parties to a certain Commercial Manufacturing Agreement of 18 October 2002 for the manufacture of  product
PTH[1-84] ("rhPTH") ("Commercial Manufacturing Agreement"). The Commercial Manufacturing Agreement has subsequently
been amended by the Amending Agreement of 15 March 2004, which, inter alia, also governs services for and
the manufacture of product ALX-0600. The Commercial Manufacturing Agreement and the Amending Agreement have
subsequently been amended by Amendment Number One to Amending Agreement, effective as of 22 December 2005
("Amendment No. 1") and further by Amendment Number Two to Amending Agreement, effective as of 28 August 2007
("Amendment No. 2"), the Commercial Manufacturing Agreement, the Amending Agreement, Amendment No. 1 and
Amendment No. 2 collectively, the "Agreement").

	

Dr. Boehringer-Gasse 5-11

  A-1121 Vienna

  Phone++43-1-80 105-0

  Telefax++43-1-80 408 23

  www.boehringer-ingelheim.at

  DVR Nr.: 0030945

  Firmenbuch-Nr.: FN 312077m

  des Handelsgerichtes Wien

  Sitz: Wien

  Rechtsform:

  Kommanditgesellschaft

  UID: ATU 64226215

Bank Austria Creditanstalt AG:

  BLZ 12000

  Konto 230-101-464/00

	
In this letter ("Letter Agreement"), BI RCV and NPS formally confirm in writing the agreement already
reached at the meeting between authorized representatives of BI RCV and NPS on 10 September 2008 at the NPS site
in New Jersey. 

	

Raiffeisen Zentralbank Ö. AG

  BLZ 31000

  Konto 100661629 

Komplementär:

Boehringer Ingelheim RCV GmbH

  Firmenbuch-Nr.: 310535w

  des Handelsgerichts Wien

  Sitz: Wien

  Rechtsform:

  Gesellschaft mit beschränkter Haftung

1. Prices for rhPTH and ALX-0600 Drug Substance

At this meeting, BI RCV and NPS agreed on the prices for certain services including re-validation activities for
rhPTH Drug Substance and the prices for GMP batches of rhPTH and ALX-0600 Drug Substance for clinical and/or
commercial use as set forth in Attachments 1 and 2 to this Letter Agreement.

2. Reduction of Price for ALX-0600 Drug Substance in 2009

Pursuant to Section 3, second sentence of the Amendment No. 2, BI RCV agreed to reduce the price for PTH
batches to be manufactured by BI RCV in 2009 in accordance with the Rolling Forecast by [*]  Euros. 

In 2008 the Parties agreed that NPS' firm order for the manufacture of [*] rhPTH Drug Substance batches in 2009
shall be changed into a firm order for the manufacture of [*] ALX-0600 Drug Substance batches in 2009. The Parties
subsequently agreed by letter dated December 22, 2008 that the order for [*] batches would be reduced to [*] batches.
Therefore, the Parties agree that the aforementioned price reduction shall apply to the [*] ALX-0600 Drug Substance
batches firmly ordered for 2009. 

Hence, BI RCV herewith agrees to amend the second sentence of Section 3 of the Amendment No. 2 as follows:

"With regard to ALX-0600 Drug Substance batches to be manufactured by BI RCV in 2009 in accordance with
the Rolling Forecast, BI RCV agrees to reduce the price for such ALX-0600 Drug Substance batches by [*]
Euros."

3. Term of the Agreement and Restated Supply Agreement

Pursuant to the provisions of the Agreement, the Agreement would expire on 31 December 2010. In addition to the
prices agreed above, the Parties also agree that the Agreement term shall be extended until 31 December 2018.

For purposes of clarity, BI RCV and NPS have agreed that the Agreement shall be restated (and amended where
necessary) ("New Supply Agreement"). The Parties shall commence drafting of such restatement without
delay after signing of this Letter Agreement.

It is therefore the common understanding of the Parties that (i) with regard to the contents set forth in Attachments 1
and 2, this Letter Agreement supersedes Article 6, including Exhibits referenced therein, of the Commercial
Manufacturing Agreement and the Amending Agreement only with respect to the pricing provisions therein and (ii) this
Letter Agreement shall be a binding agreement until the New Supply Agreement has been entered into by the
Parties.

Please confirm your acknowledgement, confirmation and acceptance of the contents of this Letter Agreement by
having an original of this Letter Agreement signed by the competent authorized signatory/signatories of NPS.

                                                -2-

	
   Sincerely,

   Boehringer Ingelheim

   RCV GmbH & Co KG

   ppa.

	
     

 

 

i.V.

	/s/ Frank Ternes

Frank Ternes

SVP, Biopharmaceuticals & Operations

	/s/ Monika Henninger

Monika Henninger

VP, Customer Relations & Projects

NPS herewith acknowledges, confirms and agrees to the

contents of this letter:

	
/s/ Joseph Rogus                

Title:

	
__________________        

    Date

                                                -3-

Attachment  1:PTH Re-validation Batches and Prices for GMP rhPTH Drug Substance

1. RE-VALIDATION BATCHES AND RELATED SERVICES

The following assumptions are valid for the prices given: 

	The scale established at BI RCV is [*]
	There is [*] at the end of fermentation, one fermentation batch is [*]
	The price given is a batch price; BI RCV will deliver all the drug substance manufactured from these runs and since
the purpose of these batches is re-validation, there is no [*] commitment from BI Austria
	Price given is including [*]

	
Task
	
Price [EUR]*

	
[*] GMP batches incl. raw materials / consumables
	
[*]

	
Process re-validation (incl. protocol, report) 

Scope to be discussed and defined by technical project team of BI RCV and NPS, and price to be agreed
thereafter.
	
[*]

	
Total
	
[*]

* price basis 2008 subject to annual inflation adjustment

Optional (not included in prices above), to be discussed if required in technical project team:

	 	
Price Estimate [EUR]*

	
1 new set of resins
	
[*]

	
1 new set of membranes
	
[*]

The above described re-validation services are firmly ordered by NPS for 2010 in accordance with the Rolling
Forecast.

                                                -4-

2. Prices for GMP rhPTH Drug Substance (after completion of Re-Validation)

The following assumptions are valid for the price per gram rhPTH drug substance supplied
to NPS for future clinical use and commercial supply.

	The scale established at BI RCV is [*] with a yield of [*] per batch; 
	There is [*] at the end of fermentation, one fermentation batch is
[*];
	Process throughput time is up to [*] both, in fermentation and purification

	
Sliding Scale 
	
Price per gram

[in EUR]*

	
Up to # Batches
	
[g]
	
Net1
	
Gross2

	
4
	
[*]
	
[*]
	
[*]

	
10
	
[*]
	
[*]
	
[*]

	
14
	
[*]
	
[*]
	
[*]

	
20
	
[*]
	
[*]
	
[*]

	
41
	
[*]
	
[*]
	
[*]

* price basis 2008 subject to annual inflation adjustment

Net price is excluding [*]; gross price is
including [*];

Membranes are calculated for use in [*] batches or replacement [*]
per year. 

Resins are calculated for use in [*] batches or replacement [*]
years. Accordingly, a faster required replacement of resins and membranes would impact the gram
price for smaller bulk quantities [*]. 

                                                -5-

Attachment  2:Prices for GMP ALX-0600 Drug Substance 

1. SERVICES 2009 / [*] GMP BATCHES

The following assumptions are valid for the price given below: 

	Price per batch is [*]
	The scale established at BI RCV [*]; [*]at the end of fermentation, one fermentation batch is [*].
	The price given is a batch price; BI RCV will deliver all the drug substance manufactured from these [*] runs and
there is no [*] commitment from BI RCV since the [*] with newly employed [*].
	Price given is including [*].

	
Task
	
Price [EUR]*

	
[*] GMP batches incl. [*]
	
[*]

* price basis 2008 subject to annual inflation adjustment

2. Prices for GMP ALX-0600 Drug Substance (as of 1 January 2010)

The following assumptions are valid for the price per gram ALX-0600 drug substance supplied to NPS for future
clinical supply commercial sale of a drug product incorporating drug substance.

	Process throughput time is up to [*] both, in fermentation and purification. 
	There [*] at the end of fermentation, one fermentation batch is [*].
	The scale established at BI RCV is [*] with [*] ALX-0600 bulk per batch. 

                                                -6-

	
Sliding Scale 
	
Price per gram

[in EUR]*

	
Up to # Batches
	
[g]
	
Net1
	
Gross2

	
4
	
[*]
	
[*]
	
[*]

	
10
	
[*]
	
[*]
	
[*]

	
14
	
[*]
	
[*]
	
[*]

	
20
	
[*]
	
[*]
	
[*]

	
41
	
[*]
	
[*]
	
[*]

* price basis 2008 subject to annual inflation adjustment

Net price is excluding [*]; gross price is including [*].

                                                -7-

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00188-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00188-of-00352.parquet"}]]