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): November 23, 1998
TARGETED GENETICS CORPORATION
(Exact name of registrant as specified in charter)
WASHINGTON 0-23930 91-1549568
(State or other jurisdiction of (Commission File Number) (IRS Employer Identification No.)
incorporation)
1100 OLIVE WAY, SUITE 100
SEATTLE, WASHINGTON 98101
(Address of principal executive offices) (Zip Code)
(206) 623-7612
(Registrant's telephone number, including area code)
ITEM 5. OTHER EVENTS
On November 23, 1998, Targeted Genetics Corporation (the "Company") formed
a collaboration with Medeva PLC and Medeva Pharmaceuticals, Inc. ("Medeva"), an
affiliate of Medeva PLC, to develop and commercialize tgAAV-CF, the Company's
potential gene therapy product for the treatment of cystic fibrosis. Pursuant
to the collaboration, the Company and Medeva entered into a Master Agreement, a
License and Collaboration Agreement and a Supply Agreement; the Company, Medeva
and Medeva PLC entered into a Common Stock Purchase Agreement; and the Company
and Medeva PLC entered into a Credit Agreement (collectively the "Collaboration
Agreement"). Pursuant to the Collaboration Agreement, the Company could receive
up to $54 million, including $12 million in loans.
The consideration being paid by Medeva and Medeva PLC to the Company
comprises: a $5 million technology license fee; clinical and regulatory
milestone payments totaling $19 million; a loan of $2 million; investment in the
Company equity totaling $3 million; and up to a maximum of $15 million in
development funding for this project over a three year period. Under certain
conditions, Medeva will also make available to the Company a loan of $10 million
toward the building of a manufacturing facility for the production of tgAAV-CF.
Of the above amounts, a total of $8.5 million is payable upon the signing of the
Collaboration Agreement. Medeva will cover the cost of clinical and regulatory
activities related to the development of the product for which it is responsible
under the Collaboration Agreement.
Clinical trials of tgAAV-CF in the United States will be managed by the
Company through the completion of Phase I studies. The Company may, under
certain conditions, manage Phase II clinical trials in the United States.
Medeva will manage all other trials and will be responsible for worldwide
registration of tgAAV-CF. Upon registration, Medeva will be responsible for
worldwide marketing of the product. A joint development committee, comprised of
three individuals from each company, will be formed to oversee the formation and
execution of the tgAAV-CF clinical development plan. Assuming successful
development and registration of the product, Medeva will purchase tgAAV-CF from
the Company under the Supply Agreement.
The Master Agreement is attached hereto as Exhibit 1.1, the License and
Collaboration Agreement is attached hereto as Exhibit 1.2, the Supply Agreement
is attached hereto as Exhibit 1.3, the Common Stock Purchase Agreement is
attached hereto as Exhibit 1.4, and the Credit Agreement is attached hereto as
Exhibit 1.5. A letter agreement, dated as of November 23, 1998, assigning
Medeva's rights and obligations with respect to the initial purchase and sale of
the Company's stock under the Common Stock Purchase Agreement to Medeva PLC, is
attached as Exhibit 1.6.
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ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS
(c) Exhibits.
EXHIBIT NO. DESCRIPTION
- ----------- -------------------------------------------------------------------
1.1* Master Agreement, dated as of November 23, 1998, by and between the
Company and Medeva.
1.2* License and Collaboration Agreement, dated as of November 23, 1998,
by and between the Company and Medeva.
1.3* Supply Agreement, dated as of November 23, 1998, by and between the
Company and Medeva.
1.4 Common Stock Purchase Agreement, dated as of November 23, 1998, by
and among the Company, Medeva and Medeva PLC.
1.5 Credit Agreement, dated as of November 23, 1998, by and between the
Company and Medeva PLC.
1.6 Letter agreement, dated as of November 23, 1998, assigning Medeva's
rights and obligations with respect to the initial purchase and
sale of the Company's stock under the Common Stock Purchase
Agreement, dated as of November 23, 1998, to Medeva PLC, by and
among the Company, Medeva and Medeva PLC.
* Confidential treatment requested; the omitted material has been separately
filed with the Commission.
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SIGNATURE
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.
TARGETED GENETICS CORPORATION
By: /s/ James A. Johnson
---------------------
James A. Johnson
Chief Financial Officer
(Authorized Officer and Principal
Financial Officer)
Dated: January 4, 1999
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EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
- ----------- ------------------------------------------------------------------
1.1* Master Agreement, dated as of November 23, 1998, by and between
the Company and Medeva.
1.2* License and Collaboration Agreement, dated as of November 23,
1998, by and between the Company and Medeva.
1.3* Supply Agreement, dated as of November 23, 1998, by and between
the Company and Medeva.
1.4 Common Stock Purchase Agreement, dated as of November 23, 1998, by
and among the Company, Medeva and Medeva PLC.
1.5 Credit Agreement, dated as of November 23, 1998, by and between
the Company and Medeva PLC.
1.6 Letter agreement, dated as of November 23, 1998, assigning
Medeva's rights and obligations with respect to the initial
purchase and sale of the Company's stock under the Common Stock
Purchase Agreement, dated as of November 23, 1998, to Medeva PLC,
by and among the Company, Medeva and Medeva PLC.
* Confidential treatment requested; the omitted material has been separately
filed with the Commission.
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