Document:

exv10w7

EXHIBIT
10.7

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE
SECURITIES ACT OF 1933.

AGREEMENT

WHEREAS, Anthera Pharmaceuticals, Inc., a Delaware corporation having its principal place of
business at 25801 Industrial Blvd., Suite B, Hayward, California 94545, U.S.A. (the “Company”),
Shionogi & Co., Ltd., with a place of business at 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
(“Shionogi”) and Eli Lilly and Company, an Indiana corporation having its principal place of
business at Lilly Corporate Center, Indianapolis, Indiana 46285, U.S.A. (“Lilly”) entered into the
License Agreement dated July 31, 2006 concerning pharmaceutical products that inhibit phospholipase
(the “License Agreement”);

WHEREAS, Article 3, Section 3(a) of the License Agreement provides for a Milestone Payment by the
Company to Shionogi and Eli Lilly of $3,000,000 upon the initiation of the first Phase 3 clinical
trial of each Licensed Product in an Oral Formulation, fifty percent (50%) or US$1,500,000 of which
is payable to Shionogi (the “Phase 3 Milestone Payment”);

WHEREAS the Company and Shionogi desire to (i) extend the date on which the Phase 3 Milestone
Payment associated with the commencement of Phase 3 clinical trials of varespladib methyl (“A-002”)
is due to Shionogi and (ii) increase the amount of the payment in consideration for such extension;

NOW, THEREFORE, in consideration for the premises and for other good and lawful consideration,
receipt of which is hereby acknowledged, the parties agree as follows.

     1. Terms. Capitalized terms used but not otherwise defined herein shall have the meanings
ascribed to such terms in the License Agreement.

     2. Agreement. Each of the Company and Shionogi agree that (i) the Phase 3 Milestone Payment
associated with the commencement of a Phase 3 clinical trial of A-002 shall be due to Shionogi on
the Payment Date; and (ii) the amount of such Milestone Payment payable to Shionogi shall be
increased from $1,500,000 to $1,750,000. For the purposes of this Agreement, “Payment Date” shall
mean the earliest to occur of (i) twelve (12) months from the enrollment of the first patient in
the first Phase 3 clinical trial of A-002; (ii) [***]; (iii) [***]; (iv) [***]; or (v) [***].

     3. Counterparts; Facsimiles. This Agreement may be executed in one or more counterparts, each
of which shall be an original and all of which shall constitute together the same document. For
purposes of this Agreement and any other document required to be delivered pursuant to this
Agreement, facsimiles of signatures shall be deemed to be original signatures. In addition, if any
of the parties sign facsimile copies of this Agreement, such copies shall be deemed originals.

 

 

     4. Further Acts. Each party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.

     5. Other terms and Conditions. All other remaining terms and conditions of the License
Agreement (which relates to Shionogi and Anthera) are unchanged and remain in full force and
effect.

     In witness whereof, the parties have caused this Agreement to be executed by their duly
authorized officers as of the date set forth below.

	 	 	 	 	 	 	 
	Anthera Pharmaceuticals, Inc.	 	Shionogi & Co., Ltd.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Paul Truex
	 	By:
	 	/s/ Yasuhiro Mino
	 

	 	 
	 	 	 	 
	 
	 	 	 	 	 	 
	Name:

	 	Paul Truex
	 	Name:
	 	Yasuhiro Mino
	 
	 	 	 	 	 	 
	Title:

	 	President & Chief Executive Officer
	 	Title:
	 	Director of the Board
Senior Executive Officer
	 
	 	 	 	 	 	 
	Date:

	 	September 7, 2009
	 	Date:
	 	7/9/2009
	 

	 	 
	 	 	 	 

2exv10w8

Exhibit 10.8

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.
A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE
SECURITIES ACT OF 1933.

AGREEMENT

WHEREAS, Anthera Pharmaceuticals, Inc., a Delaware corporation having its principal place of
business at 25801 Industrial Blvd., Suite B, Hayward, California 94545, U.S.A. (the “Company”),
Shionogi & Co., Ltd., with a place of business at 1-8, Doshomachi 3-chome, Chuo-ku, Osaka, Japan
(“Shionogi”) and Eli Lilly and Company, an Indiana corporation having its principal place of
business at Lilly Corporate Center, Indianapolis, Indiana 46285, U.S.A. (“Lilly”) entered into that
certain License Agreement dated July 31, 2006 (the “License Agreement”);

WHEREAS, Article 3, Section 3(a) of the Agreement provides for a Milestone Payment by the Company
to Shionogi and Eli Lilly of $3,000,000 upon the initiation of the first Phase 3 clinical trial of
each Licensed Product in an Oral Formulation, fifty percent (50%) or US$1,500,000 of which is payable to Lilly (the
“Phase 3 Milestone Payment”);

WHEREAS the Company and Lilly desire to (i) extend the date on which the Phase 3 Milestone Payment
associated with the commencement of Phase 3 clinical trials of varespladib methyl (“A-002”) is due
to Lilly and (ii) increase the amount of the payment in consideration for such extension;

NOW, THEREFORE, in consideration for the premises and for other good and lawful consideration,
receipt of which is hereby acknowledged, the parties agree as follows.

     1. Terms. Capitalized terms used but not otherwise defined herein shall have the meanings
ascribed to such terms in the License Agreement.

     2. Agreement. Each of the Company and Lilly agree that (i) the Phase 3 Milestone Payment
associated with the commencement of a Phase 3 clinical trial of A-002 shall be due to Lilly on the
Payment Date; and (ii) the amount of such Milestone Payment payable to Lilly shall be increased
from $1,500,000 to $1,750,000. For the purposes of this Agreement, “Payment Date” shall mean the
earliest to occur of (i) twelve (12) months from the commencement the first Phase 3 clinical trial
of A-002; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***], or (vi) [***].

     2. Counterparts; Facsimiles. This Agreement may be executed in one or more counterparts, each
of which shall be an original and all of which shall constitute together the same document. For
purposes of this Agreement and any other document required to be delivered pursuant to this
Agreement, facsimiles of signatures shall be deemed to be original signatures. In addition, if any
of the parties sign facsimile copies of this Agreement, such copies shall be deemed originals.

     3. Further Acts. Each party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.

     4. Other terms and Conditions. All other remaining terms and conditions of the License
Agreement (which relates to Lilly and Anthera) are unchanged and remain in full force and effect.

[signature page follows.]

 

 

     In witness whereof, the parties have caused this Agreement to be executed by their duly
authorized officers as of the date set forth below.

	 	 	 	 	 	 	 	 	 	 	 
	Anthera Pharmaceuticals, Inc.	 	Eli Lilly and Company Incorporated
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Paul Truex
	 	By:
	 	/s/ Gino Santini	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Paul Truex
	 	Name:
	 	Gino Santini	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Title:

	 	President & Chief Executive Officer
	 	Title:
	 	Sr. Vice President	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	Date:

	 	September 14, 2009
	 	Date:
	 	September 15, 2009	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 

2exv10w9

EXHIBIT
10.9

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE
VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE
SECURITIES ACT OF 1933.

July 12, 2006

Eli Lilly and Company

Michael F. Johnson

Director, Corporate Business Development

Eli Lilly and Company

Lilly Corporate Center

Indianapolis, Indiana 46285

Re: PLA2 platform of Shionogi & Co., Ltd. And Eli Lilly and Company

Dear Michael:

We understand that Eli Lilly and Company (“Lilly”) and Shionogi & Co., Ltd. (“Shionogi”) entered
into an Amended and Restated Collaborative Research, Development and License Agreement dated March
16, 1999, as amended (the “Collaboration Agreement”), relating to the discovery, development and
commercialization of compounds and products that inhibit phospholipase A2, which Collaboration
Agreement was terminated on December 31, 2004. Anthera Pharmaceuticals, Inc. (“Anthera”), Shionogi
and Lilly entered into a Letter of Intent on April 3, 2006, a copy of which is attached hereto as
Exhibit 1 (the “Letter of Intent”), pursuant to which the parties have agreed to negotiate a
definitive license agreement (the “Definitive Agreement”) that would grant to Anthera an exclusive
license under the Licensed Technology (as defined in the Term Sheet attached as Exhibit A to the
Letter of Intent).

Concurrently with the Letter of Intent, Anthera and Lilly entered into a letter agreement dated
April 3, 2006 (the “Original Letter Agreement”), which agreement provides for the direct
compensation of Lilly in exchange for the direct assistance to be provided by Lilly to Anthera,
including, without limitation, transfer of the Licensed Technology, technical support, and the
transfer of product inventories on hand to Anthera, once the Definitive Agreement has been fully
executed by Anthera, Shionogi, and Lilly. Because the structure of Anthera’s next equities
financing is likely to be different than the structure contemplated by Anthera at the time of
execution of the Original Letter Agreement, Anthera and Lilly

 

 

Michael F. Johnson

July 12, 2006

Page 2

now enter into this letter agreement (the “Agreement”) to take into account the possibility of such
different structure. This Agreement hereby revises and supersedes, in its entirety, the Original
Letter Agreement.

Once the Definitive Agreement has been fully executed, Anthera will require Lilly’s direct
assistance and cooperation. Specifically, Lilly would need to disclose to Anthera the Licensed
Technology and transfer to Anthera or Anthera’s designated contract manufacturer all Licensed
Technology relating to the manufacture of the Compounds and Licensed Products (each as defined in
the Term Sheet attached as Exhibit A to the Letter of Intent). In addition, Lilly would provide
technical transfer and support services to Anthera in connection with Anthera’s research and
development of Licensed Products. As consideration for such direct assistance to be provided by
Lilly, Anthera will:

	 	i)	 	pay to Lilly [***] upon [***]; and
	 
	 	ii)	 	pay to Lilly [***] upon [***].

Significant technology transfer activities have occurred prior to the date of this letter. The
parties shall agree upon a process and schedule for disclosure of the remaining Licensed
Technology, with the intent that such disclosure shall be substantially completed within [***]. Substantial completion of the technology transfer activities contemplated hereby shall
be deemed to have occurred upon Anthera’s receipt from Lilly of copies of the relevant IND’s.

Lilly shall not be obligated to devote more than [***] hours after the date of this letter to the
technology transfer activities contemplated hereby. Such [***] hours shall be at no additional
charge to Anthera. If Anthera desires assistance in excess of such [***] hours, Lilly will use its
commercially reasonable efforts to provide such assistance, not to exceed an additional [***]
hours, at a fee of [***] per hour.

In addition, upon Anthera’s request after the execution of the Definitive Agreement, Lilly shall
transfer to Anthera, at Anthera’s expense, those inventories of Compounds identified on Exhibit A
attached hereto. All inventories shall be provided “AS IS”, without warranty of any type. Anthera
shall be solely responsible for determining whether such inventories are suitable for further use
in its development efforts, including whether such materials are suitable for use in humans,
provided however, that (i) none of such inventories shall be used in any pivotal trial or sold for
commercial use and (ii) those inventories identified on Exhibit A as unsuitable for use in humans
shall not be used in humans or animals intended for human consumption. As consideration for the
work involved to transfer inventories of Compounds and Licensed Products, Anthera will issue to
Lilly or its designated affiliate that number of shares of Anthera capital stock having an
aggregate original issue value equal to the [***] of (a) [***] in connection with Anthera’s next
financing through the sale of preferred equity securities occurring after the date of this
Agreement (the “Next Equity Financing”) or (b) [***], to be paid as follows. Upon the [***] the
Next Equity Financing

 

 

Michael F. Johnson

July 12, 2006

Page 3

(the “Next Equity Securities”), Anthera will issue to Lilly or its designated affiliate a number of
shares of Next Equity Securities having an aggregate original issue value equal to [***] in
connection with the Next Equity Financing (the “Issued Shares”). In the event that [***] in
connection with the Next Equity Financing is [***], Anthera will have no further obligation under this
paragraph. In the event that [***] in connection with the Next Equity Financing is [***], then in
addition to the Issued Shares, upon the [***] the Next Equity Financing (the “Second Equity
Financing”), Anthera will, at Lilly’s election, either (i) issue to Lilly or its designated
affiliate that number of shares of equity securities issued in the Second Equity Financing having
an aggregate original issue value equal to [***] and [***], or (ii) pay Lilly or its designated
affiliate in cash an amount equal to [***] and [***]. In the event that [***] the Second Equity
Financing, Anthera will pay to Lilly or its designated affiliate in cash an amount equal to [***]
and [***], in which event Anthera will have no further obligation under this paragraph.

The term of this Agreement shall commence on the effective date of the Definitive Agreement. This
Agreement shall automatically terminate upon the termination or expiration of the Definitive
Agreement; provided, however, that if the Definitive Agreement is not executed by December 15,
2006, this Agreement shall automatically terminate on December 15, 2006.

The existence and terms of this Agreement shall be treated as “Information” as such term is defined
under the Agreement between Anthera and Lilly dated December 5, 2005 (the “Confidentiality
Agreement”), and shall be subject to the obligations of confidentiality and non-use thereunder.
Notwithstanding the foregoing, Anthera and Lilly shall each be permitted to disclose the existence
and terms of this Agreement to Shionogi, provided that Shionogi is subject to obligations of
confidentiality with respect thereto. Termination of this Agreement shall not affect any
obligations of confidentiality or non-use that have accrued under this Agreement prior to
termination.

This Agreement, together with the Confidentiality Agreement, and the Letter of Intent, constitutes
the entire, final and complete agreement between the parties as to the subject matter hereof, and
replaces and supersedes all prior discussions and agreements between Anthera and Lilly with respect
to the subject matter hereof including, without limitation, the Original Letter Agreement. No
representations having been made by either of the parties except as are herein specifically set
forth. No intellectual property rights, license or obligations other than those expressly recited
herein are granted or to be implied from this Agreement. This Agreement may only be amended or
modified by a document in writing executed by Anthera and Lilly. Waiver or forbearance by either
party hereto of any of its rights under this

 

 

Michael F. Johnson

July 12, 2006

Page 4

Agreement must be in writing and signed by the waiving party and shall not be deemed to constitute
a waiver or forbearance of any other right.

	 	 	 	 	 
	 	Very truly yours,

ANTHERA PHARMACEUTICALS, INC.

 	 
	 	By:  	/s/
Paul F. Truex	 
	 	 	  Paul F. Truex 	 
	 	 	  President & Chief Executive Officer 	 
	 

	 	 	 	 	 
	ACCEPTED:	 	 
	 
	 	 	 	 
	ELI LILLY AND COMPANY	 	 
	 
	 	 	 	 
	 

	 	 	 	 
	By:
	 	/s/ Steven M. Paul, M.D.	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	Name: Steven M. Paul, M.D.	 	 
	 
	 	 	 	 
	Title: Executive VP — Science/Technology	 	 

 

 

EXHIBIT A

COMPOUND
INVENTORY

	 	 	 	 	 
	 	 	LY#	 	Est. Amt. in Stock
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]
	[***]	 	[***]	 	[***]

[***]

A-1 

 

[***]

	 	 	 
	Lot Number	 	 
	(Batch Number)	 	Estimated Quantity
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]

[***]

	 	 	 
	Lot Number	 	 
	(Batch Number)	 	Estimated Quantity
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]

[***]

	 	 	 
	Lot Number	 	 
	(Batch Number)	 	Estimated Quantity
	[***]

	 	[***]
	[***]

	 	[***]
	[***]

	 	[***]

[***]

	 	 	 
	Lot Number	 	 
	(Batch Number)	 	Estimated Quantity
	[***]

	 	[***]
	[***]

	 	[***]

A-2

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