-----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, O08LIL8GSOi7P2TRM7M3SXPJ9Gea/Mxamr97YhVxiqwk0CGthFxnikwyvtCEaDlv nkJW4AnrixU3w5QI3KWK8g== 0001193125-09-131728.txt : 20090616 0001193125-09-131728.hdr.sgml : 20090616 20090616161559 ACCESSION NUMBER: 0001193125-09-131728 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090610 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090616 DATE AS OF CHANGE: 20090616 FILER: COMPANY DATA: COMPANY CONFORMED NAME: DURECT CORP CENTRAL INDEX KEY: 0001082038 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943297098 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31615 FILM NUMBER: 09894226 BUSINESS ADDRESS: STREET 1: 10240 BUBB RD CITY: CUPERTINO STATE: CA ZIP: 95014 BUSINESS PHONE: 4087771417 MAIL ADDRESS: STREET 1: 10240 BUBB ROAD CITY: CUPERTINO STATE: CA ZIP: 95014 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

Date of Report: June 16, 2009 (June 10, 2009)

(Date of earliest event reported)

 

 

DURECT CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-31615   94-3297098

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

2 Results Way

Cupertino, CA 95014

(Address of principal executive offices) (Zip code)

(408) 777-1417

(Registrant’s telephone number, including area code)

 

 

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. 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 CFR 240.13e-4(c))

 

 

 


Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(b)

On June 10, 2009, Dr. Peter Langecker resigned as Chief Medical Officer of DURECT Corporation (“DURECT”), effective June 16, 2009.

(c)(e)

Dr. Joseph Stauffer has been appointed as DURECT’s Chief Medical Officer and Executive Vice President, Corporate Strategy, effective June 16, 2009. Dr. Stauffer, age 43, was at Alpharma Inc. from 2004 to 2009, where his latest position prior to the acquisition of Alpharma by King Pharmaceuticals was as Chief Medical Officer and Senior Vice President of Clinical Research & Medical Affairs. His responsibilities at Alpharma included oversight of all clinical pharmacology, clinical development, pharmacovigilance, medical affairs, risk management and health outcomes/pharmacoeconomics. Prior to joining Alpharma, Dr. Stauffer was employed at Abbott Laboratories from 2002 to 2004 as Global Medical Director for Pain Therapeutics. In that role, he was responsible for Phase I–III trials for Vicodin, Vicoprofen, Dilaudid, as well as novel compounds targeting neuropathic pain. Prior to Abbott, he worked at the FDA from 2000 to 2002 as a Medical Review Officer in the Analgesic Division of the Center for Drug Evaluation and Research. While there, he reviewed Investigational New Drug (IND) Applications and New Drug Applications (NDAs) for opiate, non-opiate, anti-inflammatory, and novel pain compounds.

Dr. Stauffer is a founding member of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT). This on-going collaboration between pharma, FDA, NIH, academia and patient advocacy groups helps to develop core domains and outcomes for chronic pain clinical trials. Dr. Stauffer graduated from the Philadelphia College of Osteopathic Medicine and completed residency training in Anesthesiology at the Johns Hopkins University Hospital, where he is currently an Adjunct Assistant Professor in the Department of Anesthesiology and Critical Care Medicine. Dr. Stauffer is a veteran of the U.S. Navy, honorably discharged as a Lieutenant Commander after serving eight years as a Naval Medical Officer. He will complete his MBA in September 2009 as part of the TRIUM Global Executive MBA Program, a joint degree granted by NYU Stern School of Business, HEC School of Management (Paris) and the London School of Economics and Political Science.

The principle terms of Dr. Stauffer’s employment, as set forth in his offer letter accepted by him, are as follows: (1) Dr. Stauffer’s annual starting salary shall be $375,000; and (2) subject to performance, Dr. Stauffer shall be eligible to receive an equivalent annual cash bonus that all other executive vice presidents of DURECT are eligible for, currently 40% of Dr. Stauffer’s annual base salary, in connection with the FY 2009 performance appraisal based on a full year of employment without proration based on his start date, and Dr. Stauffer shall be eligible to participate in any equity compensation plan as applicable to officers of similar standing. In connection with Dr. Stauffer’s employment with DURECT, Dr. Stauffer will be paid a one-time sign-on bonus equal to $100,000, less applicable withholding, which amount shall be repaid to DURECT in full if Dr. Stauffer voluntarily resigns or is terminated for cause within three years of his commencement of employment with DURECT, and Dr. Stauffer was granted an option to purchase 250,000 shares of the Common Stock of the Company pursuant to the 2000 Stock Plan. The exercise price per share of such option grant is the closing price of the Company’s common stock on the NASDAQ Global Market on the effective date of grant, June 16, 2009. The vesting associated with the option is as follows: one-fourth ( 1/4) of the total shares subject to such option shall vest on the one-year anniversary of the date of grant and one-sixteenth ( 1/16) of the total shares subject to the option at the end of each three-month period following the one-year anniversary of the grant date.

The foregoing description of the offer letter is qualified in its entirety by reference to the offer letter attached hereto as Exhibit 10.1 and incorporated herein by reference

On June 16, 2009, DURECT issued a press release attached hereto as Exhibit 99.1 and incorporated herein by reference relating to the changes described above.


Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

    10.1   Offer letter between Joseph Stauffer and DURECT Corporation dated June 11, 2009
    99.1   Press Release of DURECT Corporation dated June 16, 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.

 

    DURECT Corporation
Date: June 16, 2009     By:  

/s/ James E. Brown

      James E. Brown
      President and Chief Executive Officer


INDEX TO EXHIBITS

 

Exhibit
Number

  

Description

10.1    Offer letter between Joseph Stauffer and DURECT Corporation dated June 11, 2009
99.1    Press Release of DURECT Corporation dated June 16, 2009
EX-10.1 2 dex101.htm OFFER LETTER BETWEEN JOSEPH STAUFFER AND DURECT CORPORATION DATED JUNE 11, 2009 Offer letter between Joseph Stauffer and DURECT Corporation dated June 11, 2009

Exhibit 10.1

Friday, June 11, 2009

Joseph William Stauffer, D.O.

Dear Joe:

It is a pleasure to confirm the offer extended to you to join DURECT Corporation as Chief Medical Officer and Executive Vice President, Corporate Strategy reporting directly to me. As an exempt, full-time, regular employee, your starting base semi-monthly salary will be $15,625.00 which equates to $375,000.00 on an annual basis. We would like your start date to be as soon as possible. In connection with your commencement of employment and subject to obtaining required approvals, the Company will grant you an option to purchase 250,000 shares of DURECT Common Stock, one-fourth ( 1/4) of the total amount of such shares shall vest on the one-year anniversary of the date of grant, and one-sixteenth ( 1/16) of the total amount of such shares shall vest at the end of each three-month period following the one-year anniversary of the grant. The per share exercise price for the option will be the fair market value of DURECT Corporation’s Common Stock on the date of the grant of the option.

DURECT will pay you a one-time sign-on bonus in the amount $100,000.00 less applicable income taxes withheld, which amount will be included in your first pay check after you commence employment. As a condition of receiving the hiring bonus, you agree that if you voluntarily terminate your employment during the first three years with DURECT Corporation, or if your employment is terminated by DURECT Corporation for cause, you will be responsible for any income and employment taxes that become applicable to the hiring bonus provided to you on account of your termination, and you agree that you will repay the entire amount back to the company.

You will be eligible for the equivalent annual bonus that all other executive vice presidents of the Company are eligible for, which is currently 40% of your annual base salary. This bonus will not be subject to pro-ration due to your start date.

Effective your start date you will be eligible to begin accruing vacation at the rate of 13.33 hours per month, or twenty (20) days per year up to a maximum of 320 hours, or forty (40) days.

In addition, the Company will reimburse you for temporary housing and rental car expenses incurred during the course of conducting business in the Cupertino, California headquarters.

Benefits

Effective the first of the month following your start date, you will be eligible to participate in the benefits enjoyed by an indefinite term employee, including medical, dental, vision, life and disability insurances. You will be eligible for paid holidays, vacation accrual, and sick leave. You may elect to participate in the 401(k) savings plan, the Employee Stock Purchase Plan, and a Section 125 Cafeteria Plan according to the terms and conditions governing participation in the plans. If the terms and conditions governing any such benefit plan differ from any provision of this letter, the plan documents containing these terms and conditions will govern and take precedence.


Authorization to Work

Federal regulations require that you establish your identity and authorization to work in this country, so this offer is necessarily contingent upon such proof. Enclosed is a description of the original documents you will be required to bring on your first day of work, at which time we will meet with you to examine the original documents and ask that you complete the required “INS” form in our presence.

Agreements

The enclosed “Confidential Information and Invention Assignment Agreement” must be signed by you before you start your first day of work. Please sign both copies of the Agreement and return one copy. You may retain the duplicate for your records.

This offer is contingent upon successful completion of a pre-employment drug screening test and background investigation due to the fact that DURECT is engaged in the development and manufacture of pharmaceutical products, including controlled substances. Enclosed, please find a “Notification and Authorization To Conduct Employment Background Investigation” form that you must complete and return prior to your start date. Also enclosed, please find a “Forensic Drug Testing Custody and Control Form”. You must bring this form to a local Quest Diagnostics laboratory in your area prior to your start date in order to complete the pre-employment drug screen test. Included is a list of those local laboratories.

Your employment at DURECT is for an unspecified period of time and your relationship with the Company is and shall continue to be at-will, as defined under applicable law, meaning that either you or DURECT may terminate your employment relationship at any time for any reason or no reason, with or without notice.

Please indicate that these terms and conditions are acceptable and confirm your acceptance of this offer by signing and dating the enclosed original of this letter and returning it by Friday, June 19, 2009, as this offer will expire at that time. You may retain the duplicate for your records.

Congratulations on your offer to join DURECT Corporation; we look forward to working with you. Please do not hesitate to call me directly at (408) 777-1419 if you have any questions.

 

Sincerely,

/s/ James E. Brown

James E. Brown

President and CEO

JEB/km

Enclosures

 

 

 

Understood and accepted:      
Signature  

/s/ J.W. Stauffer

      Date   

15 June 2009

  
EX-99.1 3 dex991.htm PRESS RELEASE OF DURECT CORPORATION DATED JUNE 16, 2009 Press Release of DURECT Corporation dated June 16, 2009

Exhibit 99.1

DURECT Appoints Dr. Joseph Stauffer as Chief Medical Officer and Executive Vice President, Corporate Strategy

CUPERTINO, CA, June 16, 2009/ PRNewswire-First Call via COMTEX/ — DURECT Corporation (Nasdaq: DRRX) announced today that Dr. Joseph Stauffer has joined DURECT as Chief Medical Officer and Executive Vice President, Corporate Strategy.

“Dr. Stauffer’s successful leadership of clinical research and medical affairs for pain products while at Alpharma and Abbott, and first-hand experience with the regulatory approval process gained during his tenure at the U.S. Food and Drug Administration (FDA), is an ideal fit for DURECT’s pipeline of acute, chronic, neuropathic and post-surgical pain products,” stated James E. Brown, President and CEO of DURECT Corporation. “We’re looking forward to the impact he will have on the development of POSIDUR™, TRANSDUR™-Sufentanil, ELADUR™ and other programs.”

Dr. Stauffer was at Alpharma Inc. from 2004 to 2009, where his latest position prior to the acquisition of Alpharma by King Pharmaceuticals was as Chief Medical Officer and Senior Vice President of Clinical Research & Medical Affairs. His responsibilities at Alpharma included oversight of all clinical pharmacology, clinical development, pharmacovigilance, medical affairs, risk management and health outcomes/pharmacoeconomics. Prior to joining Alpharma, Dr. Stauffer was employed at Abbott Laboratories from 2002 to 2004 as Global Medical Director for Pain Therapeutics. In that role, he was responsible for Phase I-III trials for Vicodin, Vicoprofen, Dilaudid, as well as novel compounds targeting neuropathic pain. Prior to Abbott, he worked at the FDA from 2000 to 2002 as a Medical Review Officer in the Analgesic Division of the Center for Drug Evaluation and Research. While there, he reviewed Investigational New Drug (IND) Applications and New Drug Applications (NDAs) for opiate, non-opiate, anti-inflammatory, and novel pain compounds.

Dr. Stauffer is a founding member of the Initiative on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT). This on-going collaboration between pharma, FDA, NIH, academia and patient advocacy groups helps to develop core domains and outcomes for chronic pain clinical trials. Dr. Stauffer graduated from the Philadelphia College of Osteopathic Medicine and completed residency training in Anesthesiology at the Johns Hopkins University Hospital, where he is currently an Adjunct Assistant Professor in the Department of Anesthesiology and Critical Care Medicine. Dr. Stauffer is a veteran of the U.S. Navy, honorably discharged as a Lieutenant Commander after serving eight years as a Naval Medical Officer. He will complete his MBA in September 2009 as part of the TRIUM Global Executive MBA Program, a joint degree granted by NYU Stern School of Business, HEC School of Management (Paris) and the London School of Economics and Political Science.

“I should also note that Dr. Peter Langecker, DURECT’s former Chief Medical Officer, has resigned from DURECT Corporation to pursue another opportunity,” stated James E. Brown. “We want to thank Peter for his service to DURECT and wish him well on his future endeavors.”


About DURECT Corporation

DURECT is an emerging specialty pharmaceutical company developing innovative drugs for pain and other chronic diseases, with late-stage development programs including REMOXY®, POSIDUR™, ELADUR™, and TRANSDUR™-Sufentanil. DURECT’s proprietary oral, transdermal and injectable depot delivery technologies may enable new indications and superior clinical/commercial attributes such as abuse deterrence, improved convenience, compliance, efficacy and safety for small molecule and biologic drugs. For more information, please visit www.durect.com.

NOTE: POSIDUR™, SABER™, ORADUR®, TRANSDUR™, and ELADUR™ are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners. REMOXY, POSIDUR, ELADUR and TRANSDUR-Sufentanil are drug candidates under development and have not been approved for commercialization by the US Food and Drug Administration or other health authorities.

SOURCE: DURECT Corporation

CONTACT: Matthew J. Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936

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