NVD » Topics » BUSINESS DEVELOPMENT

These excerpts taken from the NVD 10-K filed Mar 30, 2009.

BUSINESS DEVELOPMENT

 

To date, we have entered into license agreements with (i) Hana Biosciences, for the development and marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the marketing rights in the U.S. and Canada for NitroMist™, (iii) Manhattan Pharmaceuticals, in connection with propofol, (iv) Velcera, in connection with veterinary applications for currently marketed veterinary drugs and (v) BioAlliance Pharma SA, for the European rights for Ondansetron oral spray. In addition, we have entered into a sub-license agreement with Hana Biosciences and Par, pursuant to which Hana Biosciences granted a sublicense to Par to develop and commercialize Zensana™. Lindsay A. Rosenwald, M.D., a stockholder, directly and indirectly, of us, is the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular course of its business and the business of its affiliates, and outside of its arrangement with us, Paramount and/or its affiliates identify, evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. Dr. Rosenwald and Paramount may be deemed to be affiliates of Manhattan Pharmaceuticals, Velcera and Hana Biosciences.

 

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In July 2007, we entered into a Product Development and Commercialization Sublicense Agreement, or the Sublicense Agreement, with Hana Biosciences and Par, pursuant to which Hana Biosciences granted a non-transferable, non-sublicenseable, royalty-bearing, exclusive sublicense to Par to develop and commercialize Zensana™. In connection therewith, Hana Biosciences amended and restated their existing License and Development Agreement, as amended, with us relating to the development and commercialization of Zensana™, referred to herein as the Amended and Restated License Agreement, to coordinate certain of the terms of the Sublicense Agreement. Under the terms of the Sublicense Agreement, Par is responsible for all development, regulatory, manufacturing and commercialization activities of Zensana™ in the United States and Canada. We retain our rights to Zensana™ outside of the United States and Canada.

 

In addition, under the terms of the Amended and Restated License Agreement, Hana Biosciences relinquished its right to pay reduced royalty rates to us until such time as Hana Biosciences had recovered one-half of its costs and expenses incurred in developing Zensana™ from sales of Zensana™ and we agreed to surrender for cancellation all 73,121 shares of the Hana Biosciences common stock acquired by us in connection with execution of the original License Agreement.

 

Also in July 2007, we and Par agreed to terminate the agreement relating to NitroMist™. We are currently investigating strategic partners for the commercialization of NitroMist™. During the three months ended September 30, 2007, we recorded $177,000 of revenue to write-off the remaining deferred revenue relating to this agreement.

 

On May 19, 2008, we and BioAlliance Pharma SA or BioAlliance, entered into an agreement where BioAlliance acquired the European rights for our Ondansetron oral spray. Under the terms of the agreement, BioAlliance paid us a license fee of $3,000,000 upon closing. We are eligible for additional milestone payments totaling approximately $24 million (an approval milestone of $5,000,000 and sales-related milestone payments of approximately $19 million) as well as a royalty on net sales. BioAlliance and us anticipate collaborating in the completion of development activities for Europe, with BioAlliance responsible for regulatory and pricing approvals and then commercialization throughout Europe. We will be responsible for supplying the product. The upfront payment has been included in deferred revenue and is being recognized in income over the term of the agreement (nineteen and one half-years). During the three and twelve months ended December 31, 2008, we recognized $38,000 and $96,000 of income related to this contract, respectively.

 

We intend to enter into additional license agreements and strategic alliances, including:

 

Marketing partners for our NitroMist™ (nitroglycerine) and Zolpimist™ (zolpidem tartrate) oral sprays.

 

Additional marketing partners and strategic alliances as may be appropriate for the remaining present and future products in our development pipeline.

 

BUSINESS DEVELOPMENT



 



To date, we have entered into license agreements with (i) Hana Biosciences, for the development and marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the marketing rights in the U.S. and Canada for NitroMist™, (iii) Manhattan Pharmaceuticals, in connection with propofol, (iv) Velcera, in connection with veterinary applications for currently marketed veterinary drugs
and (v) BioAlliance Pharma SA, for the European rights for Ondansetron oral spray. In addition, we have entered into a sub-license agreement with Hana Biosciences and Par, pursuant to which Hana Biosciences granted a sublicense to Par to develop and commercialize Zensana™. Lindsay A. Rosenwald, M.D., a stockholder, directly and indirectly, of us, is the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular course of its business and the business of
its affiliates, and outside of its arrangement with us, Paramount and/or its affiliates identify, evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. Dr. Rosenwald and Paramount may be deemed to be affiliates of Manhattan Pharmaceuticals, Velcera and Hana Biosciences.



 






14



 






 








In July 2007, we entered into a Product Development and Commercialization Sublicense Agreement, or the Sublicense Agreement, with Hana Biosciences and Par, pursuant to which Hana Biosciences granted a non-transferable, non-sublicenseable, royalty-bearing, exclusive sublicense to Par to develop and commercialize Zensana™. In connection therewith, Hana Biosciences amended and restated their existing
License and Development Agreement, as amended, with us relating to the development and commercialization of Zensana™, referred to herein as the Amended and Restated License Agreement, to coordinate certain of the terms of the Sublicense Agreement. Under the terms of the Sublicense Agreement, Par is responsible for all development, regulatory, manufacturing and commercialization activities of Zensana™ in the United States and Canada. We retain our rights to Zensana™
outside of the United States and Canada.



 



In addition, under the terms of the Amended and Restated License Agreement, Hana Biosciences relinquished its right to pay reduced royalty rates to us until such time as Hana Biosciences had recovered one-half of its costs and expenses incurred in developing Zensana™ from sales of Zensana™ and we agreed to surrender for cancellation all 73,121 shares of the Hana Biosciences common stock acquired
by us in connection with execution of the original License Agreement.



 



Also in July 2007, we and Par agreed to terminate the agreement relating to NitroMist™. We are currently investigating strategic partners for the commercialization of NitroMist™. During the three months ended September 30, 2007, we recorded $177,000 of revenue to write-off the remaining deferred revenue relating to this agreement.



 



On May 19, 2008, we and BioAlliance Pharma SA or BioAlliance, entered into an agreement where BioAlliance acquired the European rights for our Ondansetron oral spray. Under the terms of the agreement, BioAlliance paid us a license fee of $3,000,000 upon closing. We are eligible for additional milestone payments totaling approximately $24 million (an approval milestone of $5,000,000 and sales-related
milestone payments of approximately $19 million) as well as a royalty on net sales. BioAlliance and us anticipate collaborating in the completion of development activities for Europe, with BioAlliance responsible for regulatory and pricing approvals and then commercialization throughout Europe. We will be responsible for supplying the product. The upfront payment has been included in deferred revenue and is being recognized in income over the term of the agreement (nineteen and one
half-years). During the three and twelve months ended December 31, 2008, we recognized $38,000 and $96,000 of income related to this contract, respectively.



 



We intend to enter into additional license agreements and strategic alliances, including:



 













Marketing partners for our NitroMist™ (nitroglycerine) and Zolpimist™ (zolpidem tartrate) oral sprays.





 













Additional marketing partners and strategic alliances as may be appropriate for the remaining present and future products in our development pipeline.





 



These excerpts taken from the NVD 10-K filed Mar 31, 2008.

BUSINESS DEVELOPMENT

 

To date, we have entered into license agreements with (i) Hana Biosciences, for the development and marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the marketing rights in the U.S. and Canada for NitroMist™, (iii) Manhattan Pharmaceuticals, in connection with propofol, and (iv) Velcera, in connection with veterinary applications for currently marketed veterinary drugs. In addition, we have entered into a sub-license agreement with Hana Biosciences and Par, pursuant to which Hana Biosciences granted a sublicense to Par to develop and commercialize Zensana™. Lindsay A. Rosenwald, M.D., a significant stockholder, directly and indirectly, of us, is the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular course of its business and the business of its affiliates, and outside of its arrangement with us, Paramount and/or its affiliates identify, evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. In addition, as of March 19, 2008, Dr. Rosenwald may be deemed to beneficially own approximately 14% of our outstanding common stock (assuming exercise of certain warrants beneficially owned by Dr. Rosenwald). Dr. Rosenwald and Paramount may be deemed to be our affiliates. Dr. Rosenwald and Paramount may also be deemed to be affiliates of Manhattan Pharmaceuticals, Velcera and Hana Biosciences.

 

In July 2007, the Company, entered into a Product Development and Commercialization Sublicense Agreement (the “Sublicense Agreement”) with Hana Biosciences and Par Pharmaceutical, Inc. (“Par”), pursuant to which Hana Biosciences granted a non-transferable, non-sublicenseable, royalty-bearing, exclusive sublicense to Par to develop and commercialize Zensana™. In connection therewith, the Company and Hana Biosciences amended and restated their existing License and Development Agreement, as amended, relating to the development and commercialization of Zensana™ (the “Amended and Restated License Agreement”) to coordinate certain of the terms of the Sublicense Agreement. Under the terms of the Sublicense Agreement, Par is responsible for all development, regulatory, manufacturing and commercialization activities of Zensana™ in the United States and Canada. The Company retains its rights to Zensana™ outside of the United States and Canada.

 

In addition, under the terms of the Amended and Restated License Agreement, Hana Biosciences relinquished its right to pay reduced royalty rates to the Company until such time as Hana Biosciences had recovered one-half of its costs and expenses incurred in developing Zensana™ from sales of Zensana™ and the Company agreed to surrender for cancellation all 73,121 shares of the Hana Biosciences common stock acquired by the Company in connection with execution of the original License Agreement.

 

Also in July 2007, the Company and Par agreed to terminate the agreement relating to NitroMist™. The Company is currently investigating strategic partners for the commercialization of NitroMist™. During the three months ended September 30, 2007, the Company recorded $177,000 of revenue to write-off the remaining deferred revenue relating to this agreement.

 

We intend to enter into additional license agreements and strategic alliances, including:

 

Marketing partners outside of North America for Zensana™, for which we retain marketing rights outside of North America;

 

Marketing partners for our zolpidem oral spray and sumatriptan oral spray, to commercialize these products assuming that we are successful in attaining approval for these products from the FDA; and

 

Additional marketing partners and strategic alliances as may be appropriate for the remaining present and future products in our development pipeline.

 

11

 


BUSINESS DEVELOPMENT



 



To date,
we have entered into license agreements with (i) Hana Biosciences, for the development and
marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the
marketing rights in the U.S. and Canada for NitroMist™, (iii) Manhattan
Pharmaceuticals, in connection with propofol, and (iv) Velcera, in connection with
veterinary applications for currently marketed veterinary drugs. In addition, we have
entered into a sub-license agreement with Hana Biosciences and Par, pursuant to which Hana
Biosciences granted a sublicense to Par to develop and commercialize Zensana™.
Lindsay A. Rosenwald, M.D., a significant stockholder, directly and indirectly, of us, is
the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular
course of its business and the business of its affiliates, and outside of its arrangement
with us, Paramount and/or its affiliates identify, evaluate and pursue investment
opportunities in biomedical and pharmaceutical products, technologies and companies. In
addition, as of March 19, 2008, Dr. Rosenwald may be deemed to beneficially own
approximately 14% of our outstanding common stock (assuming exercise of certain warrants
beneficially owned by Dr. Rosenwald). Dr. Rosenwald and Paramount may be deemed
to be our affiliates. Dr. Rosenwald and Paramount may also be deemed to be affiliates
of Manhattan Pharmaceuticals, Velcera and Hana Biosciences.



 



In July
2007, the Company, entered into a Product Development and Commercialization Sublicense
Agreement (the “Sublicense Agreement”) with Hana Biosciences and Par
Pharmaceutical, Inc. (“Par”), pursuant to which Hana Biosciences granted a
non-transferable, non-sublicenseable, royalty-bearing, exclusive sublicense to Par to
develop and commercialize Zensana™. In connection therewith, the Company and Hana
Biosciences amended and restated their existing License and Development Agreement, as
amended, relating to the development and commercialization of Zensana™ (the
“Amended and Restated License Agreement”) to coordinate certain of the terms of
the Sublicense Agreement. Under the terms of the Sublicense Agreement, Par is responsible
for all development, regulatory, manufacturing and commercialization activities of
Zensana™ in the United States and Canada. The Company retains its rights to
Zensana™ outside of the United States and Canada.



 



In
addition, under the terms of the Amended and Restated License Agreement, Hana Biosciences
relinquished its right to pay reduced royalty rates to the Company until such time as Hana
Biosciences had recovered one-half of its costs and expenses incurred in developing
Zensana™ from sales of Zensana™ and the Company agreed to surrender for
cancellation all 73,121 shares of the Hana Biosciences common stock acquired by the Company
in connection with execution of the original License Agreement.



 



Also in
July 2007, the Company and Par agreed to terminate the agreement relating to
NitroMist™. The Company is currently investigating strategic partners for the
commercialization of NitroMist™. During the three months ended September 30, 2007,
the Company recorded $177,000 of revenue to write-off the remaining deferred revenue
relating to this agreement.



 



We
intend to enter into additional license agreements and strategic alliances,
including:



 















Marketing partners outside of North America for
Zensana™, for which we retain marketing rights outside of North
America;





 















Marketing partners for our zolpidem oral spray and
sumatriptan oral spray, to commercialize these products assuming that we
are successful in attaining approval for these products from the FDA;
and





 















Additional marketing partners and strategic alliances as may
be appropriate for the remaining present and future products in our
development pipeline.






 




11



 










This excerpt taken from the NVD 10-K filed Mar 26, 2007.

BUSINESS DEVELOPMENT

 

To date, we have entered into license agreements with (i) Hana Biosciences, for the development and marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the marketing rights in the U.S. and Canada for our nitroglycerin lingual aerosol, (iii) Manhattan Pharmaceuticals, in connection with propofol, and (iv) Velcera, in connection with veterinary applications for currently marketed veterinary drugs. Lindsay A. Rosenwald, M.D., a significant stockholder, directly and indirectly, of us, is the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular course of its business and the business of its affiliates, and outside of its arrangement with us, Paramount and/or its affiliates identify, evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. In addition, as of March 1, 2007, Dr. Rosenwald may be deemed to beneficially own approximately 14% of our outstanding common stock (assuming exercise of certain warrants beneficially owned by Dr. Rosenwald). Dr. Rosenwald and Paramount may be deemed to be our affiliates. Dr. Rosenwald and Paramount may also be deemed to be affiliates of Manhattan Pharmaceuticals, Velcera and Hana Biosciences.

 

We intend to pursue additional strategic alliances, as well as to consider fully developing and commercializing product candidates internally. We have added two new central nervous system product candidates to our development pipeline, tizanidine oral spray for spasticity and ropinirole oral spray for Parkinson’s disease. We intend to file NDA’s on these products during 2008, with commercialization targeted for 2009. We intend to enter into additional license agreements and strategic alliances, including:

 

 

Marketing partners outside of North America for Zensana™, for which we retain marketing rights outside of North America;

 

Marketing partners for our zolpidem oral spray and sumatriptan oral spray, to commercialize these products assuming that we are successful in attaining approval for these products from the FDA; and

 

Additional marketing partners and strategic alliances as may be appropriate for future products in our development pipeline.

 

This excerpt taken from the NVD 10-K filed Oct 27, 2006.

BUSINESS DEVELOPMENT

 

To date, we have entered into license agreements with (i) Hana Biosciences., for the marketing rights in the U.S. and Canada for our ondansetron oral spray, (ii) Par, for the marketing rights in the U.S. and Canada for our nitroglycerin lingual aerosol, (iii) Manhattan Pharmaceuticals, in connection with propofol, and (iv) Velcera, in connection with veterinary applications for currently marketed veterinary drugs. Lindsay A. Rosenwald, M.D., a significant stockholder, directly and indirectly, of us, is the Chairman and sole shareholder of Paramount BioCapital, Inc., Paramount. In the regular course of its business and the business of its affiliates, and outside of its arrangement with us, Paramount and/or its affiliates identify, evaluate and pursue investment opportunities in biomedical and pharmaceutical products, technologies and companies. In addition, as of October 2, 2006, Dr. Rosenwald may be deemed to beneficially own approximately 16.8% of our outstanding common stock (assuming exercise of certain warrants beneficially owned by Dr. Rosenwald). As such, Dr. Rosenwald and Paramount may be deemed to be our affiliates. Dr. Rosenwald and Paramount may also be deemed to be affiliates of Manhattan Pharmaceuticals, Velcera and Hana Biosciences. See Item 13, “Certain Relationships and Related Transactions”. We intend to pursue additional strategic alliances, as well as to consider fully developing and commercializing product candidates internally. We have added two new central nervous system product candidates to our development pipeline, tizanidine oral spray for spasticity and ropinirole oral spray for Parkinson’s disease. We intend to file NDA’s on these products during 2008, with commercialization targeted for 2009. We intend to enter into additional license agreements and strategic alliances, including:

 

 

Marketing partners outside of North America for Zensana™, for which we retain marketing rights outside of North America.

 

Marketing partners for our zolpidem oral spray and sumatriptan oral spray, to commercialize these products assuming that we are successful in attaining approval for these products from the FDA.

 

Additional marketing partners and strategic alliances as may be appropriate for future products in our development pipeline.

 

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