Document:

Exhibit 10.6

 

Confidential
Treatment Requested.  Confidential
portions of this document have been redacted and have been separately filed
with the Commission.

 

AMENDMENT

 

This
Amendment (“Amendment”) is entered into effective June 22, 2010 (the “Amendment
Effective Date”) by and between Incyte Corporation,  a Delaware Corporation having an office at
Experimental Station, Route 141 & Henry Clay Road, Wilmington,
Delaware (“Incyte”), and Eli Lilly and Company (“Lilly”), an Indiana
corporation having an office at Lilly Corporate Center, Indianapolis, Indiana
46285.

 

RECITALS

 

A.           Incyte and Lilly are parties
to a License, Development and Commercialization Agreement (“Agreement”),
effective December 18, 2010 (“Effective Date”)   pursuant to which Incyte has granted Lilly
an exclusive license to develop and commercialize Licensed Compounds and
Licensed Products in the Field.

 

B.             The parties now
desire to amend the Agreement to ***.

 

C.             Unless
otherwise defined herein, all capitalized terms appearing in this Amendment
shall have the meaning as set forth in the Agreement.

 

AGREEMENT

 

The
parties hereby agree as follows:

 

1.             Section 4.2(b)(ii) of the
Agreement is hereby amended and restated to read in its entirety as follows:

 

“Within ***, Lilly shall
complete the first patient visit for the first patient in a Phase IIb Study of
the Initial Lead Compound  for rheumatoid
arthritis; provided that (1) the *** study results from the Phase
IIa Study INCB28050-201 supports initiation; (2) the clinical trial
protocol is approved and does not require any specialized equipment, testing,
or site preparation; (3) the clinical trial material is acceptable; (4) there
are no delays caused by a Regulatory Authority; (5) there are no delays
caused by a contract research organization that could not have been reasonably
avoided by Lilly; and (6) there are no other factors that cause a delay
that could not have been reasonably avoided by Lilly.  If any of the factors set forth in items (2) through
(6) prevent Lilly from completing the first patient 

 

 

*** Confidential material redacted and filed
separately with the Commission.

 

visit as set forth above
within ***, Lilly shall complete such first patient visit within a reasonable
time after the relevant factors are addressed.

 

2.             Sections 4.4(general statement),
4.4(a) and 4.4(b) of the Agreement are hereby amended and restated to
read in their entirety as follows:

 

“4.4 Licensed Product
Co-Development Option.

 

(a)   Generally

 

On a Licensed
Product-by-Licensed Product basis, for each Indication for which (x) Lilly
anticipates initiating a Phase IIb Study and (y) there is a means to
separately track the Annual Net Sales of such Licensed Product for such
Indication (each a “Co-Development Indication”) based on a new formulation or a
new targeted prescribing specialist group ***, and provided that Incyte has not
exercised the Incyte Development Opt Out in accordance with Section 4.4(c)(ii) for
any Licensed Product, Incyte shall have the option to co-fund Development
of such Co-Development Indication (the “Co-Development Option”) as follows:

 

(i)            Licensed Product containing Initial Lead Compound for
Rheumatoid Arthritis:

 

Within *** of Lilly’s
receipt of the *** study results generated in the Phase IIa Study
INCB28050-201, Lilly shall provide to Incyte Lilly’s then current Development
Plan, including the then current estimated total global Development Budget
(including the overall estimated costs for each study, annualized over the
course of each such study) for the development of the Initial Lead Compound for
rheumatoid arthritis (the “RA Co-Development Budget”) .  Incyte shall have the option to co-fund
Development of such Co-Development Indication under this paragraph, exercisable
by (i) providing Lilly written notice within *** after receipt of such
information and (ii) co-funding thirty percent (30%) of Lilly’s total
global Development Costs for such Co-Development Indication incurred after the
date of such notice through the Regulatory Approval of such Co-Development
Indication on a country by country basis (“Incyte Target Global Funding”). As
used herein in this Section 4.4, Regulatory Approval costs include costs
for any post-launch studies required by a Regulatory Authority.

 

(ii)                                  Licensed
Product containing Licensed Back Up Compound or Licensed Product containing
Initial Lead Compound for Indication other than Rheumatoid Arthritis

 

Not later than *** prior to
the anticipated initiation of a Phase IIb Study for (1) a Licensed Product
containing the Initial Lead Compound for a Co-Development Indication other than
rheumatoid arthritis;  or (2)  a
Licensed Product containing a Licensed Back Up Compound for a Co-Development
Indication, Lilly shall notify Incyte of such anticipated initiation and shall
provide Incyte with the following information to the extent not already
provided: all material pre-clinical and clinical data and related analysis and
regulatory 

 

 

*** Confidential material redacted and filed
separately with the Commission.

 

information submitted to any
Regulatory Authorities prior to the applicable time-period mentioned above with
respect to such Co-Development Indication, and Lilly’s then current Development
Plans and then current estimated total global Development Budget (including the
overall estimated costs for each study, annualized over the course of each such
study) with respect to any such Co-Development Indication (each an “Additional
Co-Development Indication Budget”). Incyte shall have the option to co-fund
Development of such Co-Development Indication under this paragraph, exercisable
by (i) providing Lilly written notice within *** after receipt of such
information and (ii) co-funding thirty percent (30%) of Lilly’s total
global Development Costs for such Co-Development Indication incurred after the
date of such notice through the Regulatory Approval of such Co-Development
Indication on a country by country basis (“Incyte Target Global Funding”). As
used herein in this Section 4.4, Regulatory Approval costs include costs
for any post-launch studies required by a Regulatory Authority.  As used in this Agreement, the term “Co-Development
Indication Budget” means the RA Co-Development Indication Budget or each
Additional Co-Development Indication Budget, as appropriate.

 

(b)        If Incyte timely delivers such notice of such exercise as
provided in paragraphs (a)(i) or (a)(ii), within *** following the end of
each Calendar Quarter after Incyte has delivered such notice, Lilly shall
prepare and deliver to Incyte a quarterly report detailing its Development
Costs incurred during such period with respect to such Co-Development
Indication. Lilly shall submit any supporting information reasonably requested
by Incyte related to such Development Costs included in its report within ***
after its receipt of such request. Lilly shall issue an invoice to Incyte for
thirty percent (30%) of the Development Costs identified in such report. Incyte
shall pay all amounts payable under any such invoice within *** after its
receipt of such invoice, subject to Section 4.4(c). Incyte shall have the
right to audit the records of Lilly with respect to any purported Development
Costs included in such reports, in accordance with Section 7.6.”

 

3.             *** of the Agreement is hereby
amended to include *** as follows:

 

***

 

***

 

 

*** Confidential material redacted and filed
separately with the Commission.

 

4.             The Parties hereby acknowledge that *** the date of this
Amendment.

 

5.             All other terms and conditions of
the Agreement shall remain in full force and effect.  Section 13.1 (Governing Law), 13.2
(Consent to Jurisdiction), and 13.13 (Execution in Counterparts) of the
Agreement shall apply to this Amendment.

 

6.             This Amendment shall be effective
as of the Amendment Effective Date.

 

IN
WITNESS WHEREOF, the parties by their respective authorized representatives,
have executed this Agreement as of the date first written above.

 

 

Incyte
Corporation

 

 

	
  By:

  	
  /s/
  Patricia S. Andrews

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Patricia
  S. Andrews

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  EVP
  and Chief Commercial Officer

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Eli Lilly and Company

  	
   

  
	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:
  

  	
  /s/
  Bryce Carmine

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Bryce
  Carmine

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Executive
  Vice President and President Lilly Bio-MedicinesExhibit 10.1

 

[on Amylin Letterhead]

 

July 13,
2006

 

Alkermes
Controlled Therapeutics Inc. II

88
Sidney Street

Cambridge,
MA  02139

Attn:  Mike Landine

 

Dear
Mr. Landine:

 

Amylin
Pharmaceuticals, Inc. (“Amylin”) and Alkermes Controlled
Therapeutics Inc. II (“ACT II”) are parties to a Development and License
Agreement effective as of May 15, 2000, as amended (the “Development
and License Agreement”), pursuant to which the Parties are developing a
synthetic exendin-4 long-acting injectable product (“Exenatide LAR”)
(capitalized terms used but not defined herein shall have the meaning set forth
in the Development and License Agreement). 
The Parties now wish to amend the Development and License Agreement to
incorporate the following additional terms and conditions set forth in this
letter agreement (the “Letter Agreement”):

 

1.             In connection with the development
of Exenatide LAR, Amylin and ACT II have agreed to conduct a single species
nonclinical carcinogenicity study, as described in the March 16, 2006
meeting of the Core Oversight Group, which study will have three arms — a
diluent control arm, a placebo microsphere control arm and an Exenatide LAR arm
(the “Carcinogenicity Study”).  In
addition to its existing obligations under the Development and License Agreement,
ACT II has agreed to supply Amylin solely for use in the Carcinogenicity Study
and such other studies as mutually agreed upon by both Parties, both placebo
microspheres (in the amount of either 240g or 1000g depending upon the final
protocol(s) for each of the Carcinogenicity Study and such other mutually
agreed studies) and diluent (in the amount of either 18.1L or 23.5L depending
upon such final protocol(s)).  Amylin
will compensate ACT II for the technical and scientific time devoted to the
production of these materials at the FTE Hourly Rate and reimburse ACT II for
any reasonable out-of-pocket expenses incurred in connection with the supply of
these materials.  Payments to ACT II for
the supply of these materials shall be made within thirty days after receipt of
invoices therefor, and the provisions of Section 4.7(d) of the
Development and License Agreement regarding retention of records and audits by
Amylin shall apply with regard to payments under this Letter Agreement.

 

As
additional consideration for ACT II’s supply of these materials, Amylin agrees
that ACT II will receive a separate report of any information, data and/or
results generated with respect to both the diluent control arm and the placebo
microsphere control arm of the Carcinogenicity Study as well as such other
information, data and/or results as may be mutually agreed upon by the Parties
in connection with any other studies mutually agreed upon by the Parties (the “Data”).  Amylin and ACT II agree that, subject to Section 8.3(c) of
the Development and License Agreement, ACT II has the right to use the Data for
any and all purposes, except the research, development and commercialization of
a Product prior to the termination of the Development and License Agreement.  As used in the prior sentence, the term “Product”
means any Field Product the manufacture, use, sale, offer for sale or import of
which by a party, other than one who has a right or license to the ACT II
Patents, would infringe a Valid Claim of any of the ACT II Patents.  In addition Amylin agrees that ACT II will
have the right to review the final protocol for the Carcinogenicity Study, and
Amylin agrees to consider in 

 

 

good
faith any comments suggested by ACT II with respect to such final
protocol.  Amylin also agrees to furnish
to ACT II copies of any proposed communications to the FDA regarding the
Carcinogenicity Study and to consider in good faith any comments suggested by
ACT II with respect thereto.  Amylin will
promptly inform ACT II of any written or oral communications received from the
FDA with respect to the Carcinogenicity Study and provide to ACT II a copy of
any such written communications or notes of any such oral communications.

 

2.             Except as
specifically amended herein, all provisions of the Development and License
Agreement shall remain in full force and effect in accordance with their
terms.  In the event of a conflict
between the provisions of the Development and License Agreement and those of
this Letter Agreement, this Letter Agreement shall control.  This Letter Agreement and the Development and
License Agreement constitute the entire agreement between the Parties regarding
the subject matter hereof, and supersede all prior understandings and
agreements, whether written or oral, regarding the subject matter hereof.  No amendment or modification of the terms and
conditions of this Letter Agreement shall be binding on either Party unless
reduced to a writing referencing this Letter Agreement and signed by an authorized
officer of the Party to be bound.

 

3.             This Letter
Agreement may be executed in two or more counterparts, each of which shall be
deemed an original for all purposes, but all of which together shall constitute
one and the same instrument.  This Letter
Agreement may be executed and delivered by facsimile and upon such delivery the
facsimile signature will be deemed to have the same effect as if the original
signature had been delivered to the other Party.

 

4.             This Letter Agreement shall be governed by and
construed in accordance with the laws of the State of Delaware, without giving
effect to the principles of conflict of laws.

 

If
this Letter Agreement correctly sets forth our understanding, please sign in
the space provided below and return a copy of this Letter Agreement to me.

 

Sincerely
yours,

 

	
  Amylin
  Pharmaceuticals, Inc.

  	
   

  
	
   

  	
   

  
	
  By
  

  	
  /s/
  Lloyd A. Rowland

  	
   

  
	
   

  	
  Lloyd
  A. Rowland

  	
   

  
	
   

  	
  Vice
  President and General Counsel

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  Accepted
  and Agreed:

  	
   

  
	
   

  	
   

  
	
  Alkermes
  Controlled Therapeutics Inc. II

  	
   

  
	
   

  	
   

  
	
  By
  

  	
  /s/
  Michael Landine

  	
   

  
	
   

  	
   

  
	
  Printed
  Name

  	
  Michael
  Landine

  	
   

  
	
   

  	
   

  
	
  Title
  

  	
  Vice
  President

  	
   

  
	
   

  	
   

  
	
  Date

  	
  7-17-06

  	
   

  
				

 

2

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