0001193125-13-391769.txt : 20131004 0001193125-13-391769.hdr.sgml : 20131004 20131004172035 ACCESSION NUMBER: 0001193125-13-391769 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20130930 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131004 DATE AS OF CHANGE: 20131004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: INTREXON CORP CENTRAL INDEX KEY: 0001356090 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 000000000 STATE OF INCORPORATION: VA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36042 FILM NUMBER: 131137498 BUSINESS ADDRESS: STREET 1: 1750 KRAFT DRIVE STREET 2: SUITE 1400 CITY: BLACKSBURG STATE: VA ZIP: 24060 BUSINESS PHONE: 301-556-9809 MAIL ADDRESS: STREET 1: 1750 KRAFT DRIVE STREET 2: SUITE 1400 CITY: BLACKSBURG STATE: VA ZIP: 24060 8-K 1 d608527d8k.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 (Date of earliest event reported): October 4, 2013 (September 30, 2013)

 

 

INTREXON CORPORATION

(Exact Name of Registrant as Specified in Charter)

 

 

 

Virginia   001-36042   26-0084895

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

20374 Seneca Meadows Parkway, Germantown, Maryland 20876

(Address of Principal Executive Offices) (Zip Code)

(301) 556-9900

(Registrant’s telephone number, including area code)

N/A

(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. 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 September 30, 2013, Intrexon Corporation (“Intrexon”) entered into a worldwide Exclusive Channel Collaboration Agreement (the “ECC”) with S & I Ophthalmic, LLC (“JV”), a joint venture between Intrexon and an indirect subsidiary (“Sun Pharmaceutical Subsidiary”) of Sun Pharmaceutical Industries Ltd., an international specialty pharmaceutical company focused on chronic diseases. Pursuant to the ECC, JV may develop and commercialize in humans the treatment of diseases specifically relating to, and manifesting locally in, the eye as well as certain systemic diseases having symptoms or complications that manifest in the eye via administration of genetically modified cells, DNA or viral vectors that, when delivered to humans, will cause in-vivo expression of one or more therapeutic proteins and/or bioactive RNA species (the “Field”). The Field includes the administration of an activator molecule to induce controlled expression by a therapeutic agent but excludes the in vivo expression of an anti-cancer effector for cancer treatment.

The Exclusive Channel Collaboration Agreement

The ECC governs the “channel collaboration” arrangement in which JV will use Intrexon’s proprietary technology relating to the identification, design and production of genetically modified cells, DNA vectors and in vivo control of expression (the “Intrexon Technology”).

The ECC provides for the establishment of committees composed of JV and Intrexon representatives that will govern activities in the areas of project establishment, chemistry, manufacturing and controls, clinical and regulatory matters, commercialization efforts and intellectual property.

The ECC grants JV an exclusive worldwide license to utilize the Intrexon Technology to research, develop and commercialize products in the Field.

Under the ECC, and subject to certain exceptions, JV is responsible for, among other things, funding the further anticipated development of products toward the goal of commercialization, conducting preclinical and clinical development of candidate products, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, and certain aspects of the manufacturing process.

Subject to certain expense allocations, JV will pay Intrexon royalties with percentages ranging from mid-single digits and above of the net sales derived from the sale of products developed under the ECC.

JV may terminate the ECC upon 90 days’ written notice to Intrexon. Intrexon may terminate the ECC if JV breaches the agreement and fails to cure the breach within 60 days. JV’s failure to diligently pursue development of a product identified by Intrexon as a Superior Therapy (as defined in the ECC) would constitute grounds for Intrexon’s termination of the ECC.

Upon termination of the ECC, JV may continue to develop and commercialize any product developed under the ECC that, at the time of termination, satisfies at least one of the following criteria (i) the particular product is being sold by JV (or, as permitted under the ECC, its affiliates or licensees) triggering profit sharing payments under the ECC; (ii) the particular product has received regulatory approval; (iii) the particular product is the subject of an application for regulatory approval in the Field covered by the ECC that is pending before the applicable regulatory authority; and (iv) solely in the case of a termination by JV following a material uncured breach of the ECC by Intrexon, the particular product is the subject of an Investigational New Drug application with the U.S. Food & Drug Administration or an equivalent filing with a foreign regulatory agency.


The foregoing description of the ECC is qualified in its entirety by reference to such agreement to be filed as an exhibit with Intrexon’s next Quarterly Report on Form 10-Q.

The Limited Liability Company Agreement

Contemporaneously with the entry into the ECC, Intrexon, Sun Pharmaceutical Subsidiary and JV also entered into a Limited Liability Company Agreement (the “LLC Agreement”) which governs the affairs of JV and the conduct of JV’s business. Pursuant to the LLC Agreement, each of Sun Pharmaceutical Subsidiary and Intrexon will make an initial capital contribution in exchange for a 50% membership interest in JV. In cases in which the board of managers of JV (the “Board”) determines that additional capital contributions are necessary in order for JV to comply with its obligations under the ECC, each of Intrexon and Sun Pharmaceutical Subsidiary have committed to making additional capital contributions subject to certain limitations. Each has the right, but not the obligation, to make additional capital contributions above these limits when and if solicited by the Board.

Beginning on the seventh anniversary of the effective date of the LLC Agreement, and upon every second anniversary thereafter, either of Intrexon or Sun Pharmaceutical Subsidiary may make a cash offer to purchase all of the other’s interest in JV. Upon receipt of such an offer, the other party must either agree to tender its interests at the offered price or submit a counteroffer at a price higher than the original offer. Such offer and counteroffer may continue until one party agrees to the other’s price.

As stated, JV shall be governed by the Board which shall have four members. Each of Sun Pharmaceutical Subsidiary and Intrexon has the initial right to appoint two members to the Board. For so long as Sun Pharmaceutical Subsidiary and/or any of its affiliates is a member of JV and holds a percentage interest in JV that is at least equal to the percentage interest in JV held by Intrexon and/or its affiliates, Sun Pharmaceutical Subsidiary will have the sole authority to select and appoint on behalf of JV each of the representatives of JV on the ECC committees, and one such appointee will be an “Empowered Representative” of JV under the terms of the ECC with final authority to resolve certain ECC committee disputes.

The foregoing description of the LLC Agreement is qualified in its entirety by reference to such agreement to be filed as an exhibit with Intrexon’s next Quarterly Report on Form 10-Q.

The press release dated October 1, 2013 announcing the transactions described above is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

  (d) Exhibits

 

Exhibit
No.

  

Description

99.1    Press release of Intrexon Corporation and Sun Pharmaceutical Industries Ltd. dated October 1, 2013.


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.

Date: October 4, 2013

 

INTREXON CORPORATION
By:  

/s/ Donald P. Lehr

  Donald P. Lehr
  Chief Legal Officer


EXHIBIT INDEX

 

Exhibit
No.

  

Description

99.1    Press release of Intrexon Corporation and Sun Pharmaceutical Industries Ltd. dated October 1, 2013.
EX-99.1 2 d608527dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

Sun Pharma and Intrexon Form Joint Venture to Develop

New Class of Therapeutics for Ocular Diseases

Pipeline of Potential Ocular Therapies to Help Millions Worldwide

Suffering from Blinding Diseases

Mumbai, India, and Germantown, USA, Oct. 1, 2013 – Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715), an international specialty pharmaceutical company focused on chronic diseases, through its subsidiary, and Intrexon Corporation (NYSE: XON), a leader in synthetic biology, today announced the formation of a joint venture to develop controllable gene-based therapies for the treatment of ocular diseases that cause partial or total blindness in millions of people worldwide. Initial targets are dry age-related macular degeneration (AMD), glaucoma and retinitis pigmentosa.

The joint venture will leverage Sun Pharma’s global capabilities and experience in developing and manufacturing complex dosage forms and specialty pharmaceuticals for niche therapy areas. Intrexon and Sun Pharma will share in both the financing of, and the revenues from, the joint venture.

Through an Exclusive Channel Collaboration (ECC), the joint venture will have access to Intrexon’s full suite of proprietary synthetic biology technologies, including the RheoSwitch Therapeutic System® (RTS®) platform. RTS® is a clinically validated method for controlling the location, concentration and timing of protein expression. RTS® may address a long-standing limitation of current approaches by enabling patients to receive a targeted biologic therapy without having to endure a lifetime of injections.

In addition to the initial targets, the companies intend to further expand the future pipeline of targeted ocular diseases to potentially include wet AMD, macular edema, non-infectious uveitis and diabetic retinopathy.

Samuel Broder, M.D., Senior Vice President of Intrexon’s Health Sector and former Director of the National Cancer Institute, noted that current treatments for major ocular disorders require frequent and often painful interventions that, at best, only slow the progression of the disease.

“Using our RTS® platform, the goal is to engineer a gene-based ocular treatment in which the concentration, location and timing of protein expression can be controlled with small molecule therapy,” Dr. Broder said. “In combination with Sun Pharma’s tremendous development and manufacturing experience, we hope to produce a therapy that is minimally invasive as well as maximally effective in treating these debilitating diseases.”

 

Page 1 of 3


Dilip Shanghvi, Managing Director of Sun Pharma, said “We believe Intrexon’s biotechnology capabilities will enable us to develop not one, but several highly effective, novel treatments for multiple ocular disorders where there is currently an unmet need. Through this partnership it is our goal to provide relief for millions of people who today have very few treatment options and little hope of preserving their vision.”

Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, said the collaboration between Sun Pharma and Intrexon is a model relationship aligned to accelerate development and production of new bio-engineered therapies.

“Today, more people suffer from ocular diseases than cancer,” Kirk said. “To address this immense unmet need, our innovative collaboration will unite Sun Pharma’s global capability to develop and manufacture complex pharmaceuticals with Intrexon’s proprietary cell and gene engineering technologies. We share Sun Pharma’s enthusiasm for the potential of our venture to produce a pipeline of product opportunities aimed at well-validated therapeutic targets.”

About Sun Pharma

Established in 1983, listed since 1994 and headquartered in India, Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at www.sunpharma.com.

About Intrexon Corporation

Intrexon Corporation (NYSE: XON) is a leader in synthetic biology focused on collaborating with companies in Health, Food, Energy and the Environment to create biologically-based products that improve the quality of life and the health of the planet. Through the company’s proprietary UltraVector® platform, Intrexon provides its partners with industrial-scale design and development of complex biological systems. The UltraVector® platform delivers unprecedented control over the quality, function, and performance of living cells. We call our synthetic biology approach and integrated technologies Better DNA®, and we invite you to discover more at www.dna.com.

Trademarks

Intrexon, RheoSwitch Therapeutic System, UltraVector and Better DNA are trademarks of Intrexon and/or its affiliates. Other names may be trademarks of their respective owners.

Safe Harbor Statement

Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to our plans, objectives and expectations for the development of our business. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.

 

Page 2 of 3


###

For more information contact:

Sun Pharma Contacts:

 

Nimish Desai    Mira Desai
Tel    +91 22 6645 5645, Xtn 717    Tel    +91 22 6645 5645, Xtn 606
Tel Direct    +91 22 6645 5717    Tel Direct    +91 22 66455606
Mobile    +91-98203 30182    Mobile    +91 98219 23797
E mail    nimish.desai@sunpharma.com    E mail    mira.desai@sunpharma.com

Intrexon Corporation Contacts:

 

Peter McLaughlin

Vice President, Corporate Communications

  

Marie L. Rossi, Ph.D.

Manager, Technical Communications

Tel    +1 (323) 842-7779    Tel    +1 (301) 556-9944
E mail    pmclaughlin@intrexon.com    E mail    mrossi@intrexon.com

 

Page 3 of 3

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