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): March 21, 2012
MELA Sciences, Inc.
(Exact name of registrant as specified in its charter)
| Delaware | 000-51481 | 13-3986004 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
| 50 South Buckhout Street, Suite 1 Irvington, New York |
10533 | |||
| (Address of principal executive offices) | (Zip Code) | |||
Registrant’s telephone number, including area code (914) 591-3783
(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 Instructions 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 1.01 — Entry into a Material Definitive Agreement
On March 22, 2012, MELA Sciences, Inc. (the “Company”) issued a press release announcing that it has entered into a service agreement (the “Agreement”) with Quintiles Commercial Germany GmbH, a German company (“Quintiles”). Under the terms of the Agreement, Quintiles will recruit and assist in the management of a sales and marketing team to market the Company’s MelaFind® system in Germany and provide other customer support services. The aggregate cost of these services over the term of the Agreement is expected to be approximately $520,000. The Agreement has an initial term of two years, unless earlier terminated by either party in accordance with its terms. The parties may upon mutual agreement extend the term of the Agreement. A copy of the press release is attached as Exhibit 99.1 to this current report.
Item 9.01 — Financial Statements and Exhibits
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | MELA Sciences, Inc. Press Release, dated March 22, 2012 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MELA Sciences, Inc. | ||||
| Date: March 22, 2012 | By: | /s/ Richard I. Steinhart | ||
| Richard I. Steinhart, Chief Financial Officer | ||||
Exhibit 99.1
MELA Sciences Announces Agreement with Quintiles for
Commercial Support Services for MelaFind® in Germany
IRVINGTON, NY, March 22, 2012 — MELA Sciences, Inc. (NASDAQ: MELA), the medical device company that has developed MelaFind®, today announced that the company has entered into a two-year agreement with Quintiles (Quintiles Commercial Germany GmbH) for commercialization support for MelaFind in Germany.
Under the terms of the agreement, Quintiles will provide customer service, sales and management support to MELA Sciences to supplement the commercialization and launch of MelaFind in Germany.
“We are enthusiastic to be working with Quintiles as we execute our commercialization strategy in Germany,” said Dr. Joseph V. Gulfo, President and CEO of MELA Sciences. “Under the direction of our Country Manager, Quintiles will provide sales, marketing and medical support to our staff to enable us to optimize the MelaFind launch.”
“Quintiles is a premier contract sales organization (CSO) with a 20-year history of providing commercialization support in Germany. They are providing us a tailored, economical and expandable solution that is ideally suited to our controlled and deliberate strategy.”
About MELA Sciences, Inc.
MELA Sciences is a medical device company focused on the commercialization of its flagship product, MelaFind®, and its further design and development. MelaFind is a non-invasive tool to provide additional information to dermatologists during melanoma skin examinations. The device uses light from visible to near-infrared wavelengths to evaluate skin lesions up to 2.5 mm beneath the skin. The device provides information on a lesion’s level of morphologic disorganization to provide additional objective information that may be used by dermatologists in the biopsy decision-making process. MelaFind has been approved by the US Food and Drug Administration for use in the US. In addition, MelaFind has received CE Mark approval and is approved for use in the European Union.
For more information on MELA Sciences, visit www.melasciences.com.
About Quintiles
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.
Safe Harbor
This press release includes “forward-looking statements” within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and other statements that contain words such as “expects,” “contemplates,” “anticipates,” “plans,” “intends,” “believes,” “assumes,” “predicts” and variations of such words or similar expressions that predict or indicate future events or trends, or that do not relate to historical matters. These statements are based on our current beliefs or expectations and are inherently subject to significant known and unknown uncertainties and changes in circumstances, many of which are beyond our control. There can be no assurance that our beliefs or expectations will be achieved. Actual results may differ materially from our beliefs or expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties facing the company such as those set forth in its reports on Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”). Factors that might cause such a difference include whether MelaFind® achieves market acceptance. Given the uncertainties affecting companies in the medical device industry such as the company, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. The company urges you to carefully review and consider the disclosures found in its filings with the SEC which are available at www.sec.gov and www.melasciences.com.
For further information contact:
For Investors
Lynn Pieper
Westwicke Partners
415-202-5678
For Media
Melissa Hurley
Ricochet Public Relations
212-679-3300 x128