Attached files
file | filename |
---|---|
S-1/A - FORM S-1/A - Anthera Pharmaceuticals Inc | f53438a2sv1za.htm |
EX-10.6 - EX-10.6 - Anthera Pharmaceuticals Inc | f53438a2exv10w6.htm |
EX-10.7 - EX-10.7 - Anthera Pharmaceuticals Inc | f53438a2exv10w7.htm |
EX-10.8 - EX-10.8 - Anthera Pharmaceuticals Inc | f53438a2exv10w8.htm |
EX-10.19 - EX-10.19 - Anthera Pharmaceuticals Inc | f53438a2exv10w19.htm |
EX-10.10 - EX-10.10 - Anthera Pharmaceuticals Inc | f53438a2exv10w10.htm |
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
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 Antheras 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
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 Lillys direct
assistance and cooperation. Specifically, Lilly would need to disclose to Anthera the Licensed
Technology and transfer to Anthera or Antheras 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 Antheras 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 Antheras receipt from Lilly of copies of the relevant INDs.
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 Antheras request after the execution of the Definitive Agreement, Lilly shall
transfer to Anthera, at Antheras 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 Antheras 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
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 Lillys 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
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