- Current report filing (8-K)
November 02 2009 - 6:07AM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 30, 2009
AMYLIN PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or Other
Jurisdiction of
Incorporation)
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0-19700
(Commission
File Number)
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33-0266089
(I.R.S.
Employer Identification No.)
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9360 Towne Centre Drive
San Diego, California 92121
(Address of principal executive offices and zip code)
Registrants telephone number, including area
code:
(858)
552-2200
Check the appropriate box below if the Form 8-K is
intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions (
see
General
Instruction A.2. below):
¨
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
¨
Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CRF 240.13e-4(c))
Section 1
Registrants Business and Operations
Item
1.01. Entry into a Material Definitive
Agreement.
On October 30, 2009, Amylin Pharmaceuticals, Inc. and Takeda
Pharmaceutical Company Limited entered into a License, Development and
Commercialization Agreement, or the development agreement, pursuant to which the
companies will co-develop and commercialize pharmaceutical products containing
compounds specified in the development agreement for the treatment of human
indications including, but not limited to, (i) weight management and/or
obesity, (ii) glycemic control and (iii) cardiovascular disease. Amylin will receive a one-time,
non-refundable cash payment of $75 million from Takeda in connection with the
execution of the development agreement.
Amylin will also receive certain payments upon the achievement of
milestone events including: (i) up
to $200 million for achieving development milestones with respect to two
specific products and up to $50 million for achieving development milestones
with respect to any additional products; (ii) up to $140 million per
product for achieving commercial milestones related to the first sale of a product
in various territories; and (iii) up to $800 million per product for the
achievement of certain sales based milestones.
Takeda will also pay Amylin double-digit tiered royalties based on total
annual sales of products.
Amylin will be responsible for executing all development activities for
each product through the completion of all phase 2 clinical trials of such
products for the purpose of obtaining regulatory approval in the United
States. Amylin will also be responsible
for certain third party royalties. Takeda will be responsible for the execution
of all other development activities for the purpose of obtaining regulatory
approval in and outside the United States.
Throughout the term of the development agreement, Takeda will generally
be responsible for 80% of the development costs associated with obtaining
approval for the products in the United States and Amylin will be responsible
for 20% of such costs, except for certain clinical safety trial costs for which
Amylin will have additional cost-sharing responsibility. Takeda will be responsible for 100% of all
development costs associated with obtaining approval for the products outside
the United States.
Takeda will be responsible for commercializing the products in and
outside the United States and will be responsible for all commercialization
costs associated with the products. Amylin
will have the option to co-commercialize the first 2 approved products
containing different clinically active ingredients and any follow-on products
containing the identical ingredients.
The development agreement will terminate at Takedas election or upon
the expiration of all Takeda payment obligations to Amylin. Either party may terminate the agreement for
cause, including the commencement of insolvency, bankruptcy, reorganization or
other similar proceeding by a party or if the other party breaches any material
provision of the development agreement including breaches of payment or
commercially reasonable efforts obligations.
Further, either party may terminate the development agreement for safety
issues or failure to obtain any necessary third party license.
The above description of the development agreement is a summary and is
qualified in its entirety by the terms of the agreement, which will be filed
with Amylins annual report on Form 10-K for the year ended December 31,
2009.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
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AMYLIN
PHARMACEUTICALS, INC.
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Dated:
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November 2, 2009
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By:
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/s/ Lloyd A.
Rowland
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Lloyd A. Rowland
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Vice
President, Governance and Compliance, and Secretary
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