-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OLstEKCSzqObBE47I1w4ZgdftDa+i+4o+yvuJDFlfvCMd3W5C77cbcL09gRBFKfr QCc74BmWaE+/Fws6AP/okA== 0001193125-09-012952.txt : 20090128 0001193125-09-012952.hdr.sgml : 20090128 20090128143413 ACCESSION NUMBER: 0001193125-09-012952 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090123 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Termination of a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090128 DATE AS OF CHANGE: 20090128 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ZYMOGENETICS INC CENTRAL INDEX KEY: 0001129425 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 911144498 STATE OF INCORPORATION: WA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-33489 FILM NUMBER: 09550859 BUSINESS ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 BUSINESS PHONE: 206-442-6600 MAIL ADDRESS: STREET 1: 1201 EASTLAKE AVENUE E CITY: SEATTLE STATE: WA ZIP: 98102 8-K 1 d8k.htm FORM 8-K Form 8-K

 

 

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

January 23, 2009

Date of Report (Date of earliest event reported)

ZYMOGENETICS, INC.

(Exact name of registrant as specified in its charter)

 

Washington   000-33489   91-1144498

(State or other jurisdiction of

incorporation)

  (Commission File Number)   (I.R.S. Employer Identification No.)

 

1201 Eastlake Avenue East

Seattle, Washington

  98102-3702
(Address of principal executive offices)   (Zip Code)

(206) 442-6600

(Registrant’s telephone number, including area code)

  

 

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2.):

 

¨ 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 CFR 240.13e-4(c))

 

 

 


Item 1.01 Entry into a Material Definitive Agreement.

On January 23, 2009, ZymoGenetics, Inc. (“ZymoGenetics”) and Novo Nordisk A/S (“Novo Nordisk”) restructured, as of January 16, 2009, their relationship as it relates to IL-21. As part of the restructuring, ZymoGenetics and Novo Nordisk entered into a License and Transfer Agreement for IL-21 Protein and terminated their Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein. As a result of the restructured relationship, ZymoGenetics now has worldwide development and commercialization rights for the IL-21 protein.

Under the License and Transfer Agreement for IL-21 Protein, Novo Nordisk grants to ZymoGenetics an exclusive license outside North America to the intellectual property rights that Novo Nordisk previously licensed or developed relating to the IL-21 protein. A comparable license in North America under the Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein survives the termination described below. In addition, Novo Nordisk agrees to transfer to ZymoGenetics all manufacturing processes developed and its existing stock of IL-21 protein. ZymoGenetics will pay Novo Nordisk a single digit royalty on net sales outside North America for products containing the IL-21 protein together with approval milestone fees and one sales-based milestone fee. In addition, ZymoGenetics will pay Novo Nordisk a portion of any third party license fees above a certain threshold. The term of the License and Transfer Agreement for IL-21 Protein began as of January 16, 2009 and will continue for so long as there is an obligation to pay royalties. The obligation to pay royalties under the License and Transfer Agreement for IL-21 Protein will continue on a country-by-country basis until the date on which no valid patent claims relating to a product exist or, if the product is not covered by a valid patent claim, 12 years from the date of first sale of the product.

The foregoing summary is qualified in its entirety by reference to the text of the License and Transfer Agreement for IL-21 Protein, which is expected to be filed with ZymoGenetics’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2009.

 

Item 1.02 Termination of a Material Definitive Agreement.

On January 23, 2009, ZymoGenetics and Novo Nordisk agreed to terminate, as of January 16, 2009, the Collaborative Data Sharing and Cross-License Agreement for IL-21 Protein, dated August 11, 2005. Under the terms of this agreement, the parties had been collaborating to develop and execute a global clinical development plan for the IL-21 protein to achieve regulatory approval of a common product in the parties’ respective territories. ZymoGenetics’ access to data generated by Novo Nordisk and the exclusive license in North America to the intellectual property rights that Novo Nordisk developed relating to the IL-21 protein survives termination.

Certain other relationships between ZymoGenetics and Novo Nordisk are described in the Form 10-K filed by ZymoGenetics with the Securities and Exchange Commission on February 29, 2008, which descriptions are incorporated herein by reference.

 

Item 8.01 Other Events.

On January 28, 2009, ZymoGenetics issued a press release relating to the restructured relationship with Novo Nordisk, a copy of which is filed herewith as Exhibit 99.1 and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    ZymoGenetics, Inc. press release dated January 28, 2009.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    ZYMOGENETICS, INC.
Date: January 28, 2009     By:   /s/ James A. Johnson
      James A. Johnson
      Executive Vice President, Chief Financial Officer and Treasurer


EXHIBIT INDEX

 

Exhibit No.

  

Description

99.1    ZymoGenetics, Inc. press release dated January 28, 2009.
EX-99.1 2 dex991.htm ZYMOGENETICS, INC. PRESS RELEASE DATED JANUARY 28, 2009 ZymoGenetics, Inc. press release dated January 28, 2009

Exhibit 99.1

LOGO

Contact

Investor and Media Relations

 

Susan W. Specht

Director, Corporate Communications

(206) 442-6592

  

Michael Fitzpatrick

Associate Director, Corporate Communications

(206) 442-6702

FOR IMMEDIATE RELEASE

ZymoGenetics Secures Worldwide Rights to IL-21

- Ex-North American rights licensed from Novo Nordisk A/S -

Seattle, January 28, 2009- ZymoGenetics, Inc. (NASDAQ: ZGEN) announced today the acquisition of ex-North American rights to Interleukin 21 (IL-21) from Novo Nordisk A/S, resulting in ZymoGenetics owning worldwide rights to IL-21. Novo Nordisk previously announced that they had reached a corporate decision to exit the oncology therapeutic area, resulting in the suspension of all ongoing oncology programs.

“Securing rest of world IL-21 rights supports our strategy of seeking a global partner for this oncology asset, and we’re pleased to have accomplished this without near-term cash outlays,” said Heather Franklin, Senior Vice President, Business Development. “In the first half of this year, we plan to present Phase 2 results in renal cell carcinoma and metastatic melanoma, which we believe will heighten partnering interest among oncology-focused companies.”

Under the terms of the arrangement, Novo Nordisk A/S agreed to license rest of world (ex-North American) development and commercialization rights for IL-21 to ZymoGenetics in exchange for potential regulatory approval milestones and royalties related to the ex-North American territory. In addition, upon licensing worldwide rights for IL-21 to a third party, Novo Nordisk A/S would receive a portion of related licensing fees if a certain threshold level were exceeded.

About IL-21

IL-21 has potent biological activity in regulating key classes of immune cells, including cytotoxic T cells and natural killer cells. These cell types play key roles in surveillance of the body to eliminate malignant and infected cells. Based upon the ability of IL-21 to inhibit tumor growth in a number of preclinical models, ZymoGenetics is developing IL-21 for the treatment of cancer, initially in renal cell carcinoma and metastatic melanoma.

About ZymoGenetics

ZymoGenetics discovers and develops novel protein therapeutics that are based on the company’s research and biological insights into key disease pathways. The Company developed and markets RECOTHROM® Thrombin, topical (Recombinant). Other product candidates span a wide array of clinical opportunities that include cancer, autoimmune and viral diseases. ZymoGenetics intends to commercialize product candidates through internal development, collaborations with partners, and out-licensing of patents from its extensive patent portfolio. For further information, visit www.zymogenetics.com.


This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on the current intent and expectations of the management of ZymoGenetics. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. ZymoGenetics’ actual results and the timing and outcome of events may differ materially from those expressed in or implied by the forward-looking statements because of risks associated with our unproven preclinical and clinical development and results, strategic partnering, including efforts by and results of collaborations, regulatory oversight and approvals, product sales and marketing abilities, discovery strategy, intellectual property claims and litigation and other risks detailed in the company’s public filings with the Securities and Exchange Commission, including the company’s Annual Report on Form 10-K for the year ended December 31, 2007. Except as required by law, ZymoGenetics undertakes no obligation to update any forward-looking or other statements in this press release, whether as a result of new information, future events or otherwise.

###

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