Royalty Report: Drugs, Pharmaceuticals, Hormones – Collection: 752

License Grant

Bermuda Licensor wishes to grant to Swiss Licensee an exclusive License to the Technology and Patents for use and sale of the Product in all countries and territories of the world except for the United States. Licensee will only subLicense Product containing progesterone in a concentration of 8% after prior consultation with Licensor.  Except as otherwise provided for herein, and subject to the provisions of the License, the Agreement shall commence on the Second A&R Agreement Date and remain in effect until May 19, 2015, renewable upon mutual Agreement of the parties for five year periods at commercial terms to be agreed upon.

Licensor also wishes to assign the Trademarks to Licensee.

License Property

Licensor Trademark shall mean the trademark CRINONE in the United States subject to U.S. Patent & Trademark Registration No. 2,086,161. Product shall mean progesterone/COL-1620 vaginal gel- 4% and 8%.

Crinone Patents – Case No. Application No. Patent No. Publication No. Title Country Current Status Filing Date Publication Date Issue Date Expiration Date
801505-00502 94928089.5 0719146    NOVEL METHOD OF PRGESTERONE DELIVERY AND AFFECT TEHREOF EUROPEAN PATENT CONVENTION ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00503 509291/95 3143474    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF JAPAN ISSUED 9/13/1994    12/22/2000 9/13/2014
801505-00504 2,171,939 2,171,939    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF CANADA ISSUED 9/13/1994    1/ 1/2002 9/13/2014
801505-00507 77261/94 689133    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF AUSTRALIA ISSUED 9/13/1994    7/ 9/1998 9/13/2014
801505-00508 273816 273816 1539 NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF NEW ZEALAND ISSUED 9/13/1994 9/28/2007 1/10/2008 9/13/2014
801505-00509 947089 199798    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF MEXICO ISSUED 9/14/1994    11/27/2000 9/14/2014
801505-00510 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF UNITED KINGDOM ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00511 94928089.5 69415543.8    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF GERMANY ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00512 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF FRANCE ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00513 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF SWITZERLAND ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00514 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF AUSTRIA ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00515 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF SPAIN ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00516 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF SWEDEN ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00517 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF DENMARK ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00518 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF NETHERLANDS ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00519 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF BELGIUM ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00520 94928089.5 0719146    NOVEL METHOF OF PROGESTERONE DELIVERY AND AFFECT THEREOF ITALY ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00521 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF IRELAND ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00522 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF PORTUGAL ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00523 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF MONACO ISSUED 9/13/1994    12/23/1998 9/13/2014
801505-00524 94928089.5 3029314 0719146 NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF GREECE ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00525 961044 308585    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF NORWAY ISSUED 9/13/1994    10/ 2/2000 9/13/2014
801505-00526 961221 115444    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF FINLAND ISSUED 9/13/1994    5/13/2005 9/13/2014
801505-00527 94928089.5 0719146    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF LUXEMBOURG ISSUED 9/13/1994    12/13/1998 9/13/2014
801505-00531 329462 AR 256069 V1    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF ARGENTINA ISSUED 9/14/1994    12/22/2004 12/22/2019
801505-00532 1319-94 39.553    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF CHILE ISSUED 9/ 9/1994    6/15/1998 6/15/2013
801505-00534 250745 1208    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF PERU ISSUED 9/15/1994    4/29/1999 9/15/2014
801505-00535 1817-94 1817-94    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF VENEZUELA ISSUED 11/23/1994    10/14/1999 11/23/2014
801505-00539 23,329 23,329    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF MOROCCO ISSUED 9/14/1994    4/17/1995 9/14/2014
801505-00540 94/7073 94/7073    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF SOUTH AFRICA ISSUED 9/14/1994    7/26/1995 9/14/2014
801505-00541 110972 110972    PHARMACEUTICAL PREPARATIONS FOR INTRAVAGINAL ADMINISTRATION OF PROGESTERONE ISRAEL ISSUED 9/14/1994    6/11/1998 9/14/2014
801505-00551 PI9402436 MY-111484-A    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF MALAYSIA ISSUED 9/14/1994    6/30/2000 6/30/2015
801505-00560 96108813 2148393    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF FEDERATION OF RUSSIA ISSUED 9/13/1994    3/10/2000 9/13/2014
801505-00561 P9600669 221583    NOVEL METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF HUNGARY ISSUED 9/13/1994    2/ 3/2003 9/13/2014
801505-00564 1202/01-96 1956    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF GEORGIA ISSUED 9/13/1994    12/ 5/1999 9/13/2014
801505-00565 96-027 4072    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF LITHUANIA ISSUED 9/13/1994    12/ 4/1996 9/13/2014
801505-00566 96030993 37244    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF UKRAINE ISSUED 9/13/1994    5/15/2001 9/13/2014
801505-00568 P-96-113 11527    METHOD OF PROGESTERONE DELIVERY AND AFFECT THEREOF LATVIA ISSUED 9/13/1994    2/20/1997 9/13/2014

Field of Use

Field shall mean the vaginal delivery of progesterone or progestational agents alone or in combination or co-administered with other active substances directed toward use in hormone replacement therapy as well as in the indications of secondary amenorrhea, in vitro fertilization, and prevention of endometrial hyperplasia and other indications where progesterone or progestational agents are commonly used except in a locally acting – non-systemic – contraceptive where progesterone or a progestational agent may be useful.

License Grant

Licensor of Bermuda grants to the Swiss Licensee, an exclusive right and license, with the right to sublicense, under the Patents and Technology to market, use and sell the Product in the Territory; provided, however, that Licensee will only sublicense Product containing progesterone in a concentration of eight percent (8%) after prior consultation with Licensor.

Licensor grants to Licensee, and Licensee accepts from Licensor, a nonexclusive right and license with the right to sublicense its Affiliates under the Patents and Technology to make and/or have made the Product anywhere in the world, but only for use or sale in the Territory.

Licensor grants to the Licensee an exclusive right and license, with the right to sublicense, to use the Trademarks in the distribution, advertising, marketing, use and sale of the Product in the Territory, and a nonexclusive right and license with the right to sublicense its Affiliates to use the Trademarks in the manufacture, labeling and packaging of the Product anywhere in the world.

License Property

The Product shall mean progesterone/COL-1620 vaginal gel.

Product A shall mean progesterone/COL-1620 vaginal gel containing progesterone in a concentration of four percent (4%).

Product B' shall mean progesterone/COL-1620 vaginal gel containing progesterone in a concentration of eight percent (8%).

Trademarks shall mean the trademark Crinone or the trademark Perlence for use on cosmetic and pharmaceutical products used primarily for progesterone supplementation as set forth.

Field of Use

Field shall mean the vaginal delivery of progesterone or progestational agents alone or in combination or co-administered with other active substances directed toward use in hormone replacement therapy as well as in the indications of secondary amenorrhea, in vitro fertilization, and prevention of endometrial hyperplasia and other indications where progesterone or progestational agents are commonly used except in a locally acting – non – systemic – contraceptive where progesterone or a progestational agent may be useful.

License Grant

Licensor of Bermuda grants an exclusive right and license, with the right to sublicense its Affiliates under the Patents and Technology to market, use and sell the Product in the Territory.

Licensor grants a nonexclusive right and license under the Patents and Technology to make, have made Product anywhere in the world, but only for sale in the Territory.

Licensor grants an exclusive right and license to use the Trademark in the distribution, advertising, marketing and sale of the Product, and any line extension to the Product as to which Licensee has obtained Licensors prior written consent, not to be unreasonably withheld, in the Territory, and a nonexclusive right and license to use the Trademark in the manufacture, labeling, packaging of Product and any line extensions to Product as to which Licensee has obtained Licensors prior written consent, anywhere in the world.

In countries where import duties make it impractical to import Product in Finished Package Form (eg. Argentina), Licensor will grant Licensee the right to manufacture locally if requested by Licensee for such country.

Licensor hereby appoints the Licensee as its sole and exclusive agent during the term.

License Property

Licensor owns or has the rights to the Crinone Technology.

Product shall mean the progesterone/GOL-1620 vaginal gel.

Trademark shall mean the trademark Crinone for use on cosmetic and pharmaceutical products used primarily for progesterone supplementation.

The patents cover Progesterone Delivery and Treating Agent.

Field of Use

The field of use is vaginal delivery of progesterone or progestational agents alone or in combination or co-administered with other active substances directed toward use in hormone replacement therapy as well as in the indications of secondary amenorrhea, in vitro fertilization, and prevention of endometrial hyperplasia and other indications where progesterone or progestational agents are commonly used except in a locally acting – non-. systemic – contraceptive where progesterone or a progestational agent may be useful.

Crinone is a prescription medicine used to treat the symptoms of Assisted Reproductive Technology (ART) and Secondary Amenorrhea

Assisted reproductive technology (ART) includes medical procedures used primarily to address infertility.

CRINONE® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed.

License Grant

Licensor of Bermuda grants to Swiss Licensee, and Licensee accepts from Licensor, on the terms and conditions stated herein, an exclusive (even as to Licensor and Licensor's Affiliates) right and license, with the right to sublicense, under the Patents and Technology to market, use and sell the Product in the Territory; provided, however that Licensee will only sublicense Product containing progesterone in a concentration of eight percent (8%) after prior consultation with Licensor. Licensor grants to Licensee, and Licensee accepts from Licensor, on terms and conditions stated herein, a nonexclusive right and license with the right to sublicense its Affiliates under the Patents and Technology to make and/or have made the Product anywhere in the world, but only for use or sale in the Territory. Licensor grants to the Licensee, and Licensee accepts from Licensor, on the terms and conditions contained herein (i) an exclusive right and license, with the right to sublicense, to use the Trademarks in the distribution, advertising, marketing, use and sale of the Product (and any lineextension to the Product as to which Licensee has obtained Licensor's prior written consent, not to be unreasonably withheld) in the Territory, and (ii) a nonexclusive right and license with the right to sublicense its Affiliates touse the Trademarks in the manufacture, labeling and packaging of the Product (and any line extensions to the Product as to which Licensee has obtained Licensor's prior written consent, not to be unreasonably withheld) anywhere in the world.

License Property

Product shall mean progesterone/COL-1620 vaginal gel.

Technology shall mean all pharmacological, toxicological, preclinical, clinical, technical and other information, data and analysis and know-how relating to the registration, manufacture, packaging, use, marketing and sale of the Product (including, without limitation, all works copyrighted by Licensor) and all proprietary rights relating thereto owned by Licensor or its Affiliates or to which Licensor or its Affiliates has rights so as to be able to license, whether prior to or after the Effective Date, and relating or pertaining to the Product.

Trademarks shall mean the trademark Crinone or the trademark Perlence for use on cosmetic and pharmaceutical products used primarily for progesterone supplementation.

Field of Use

Field shall mean the vaginal delivery of progesterone or progestational agents alone or in combination or co-administered with other active substances directed toward use in hormone replacement therapy as well as in the indications of secondary amenorrhea, in vitro fertilization, and prevention of endometrial hyperplasia and other indications where progesterone or progestational agents are commonly used except in a locally acting – non-systemic – contraceptive where progesterone or a progestational agent may be useful.

License Grant

The Licensor granted the rights to the commercialization of a progesterone gel to the Licensee.

License Property

The product segment of the Licensor oversees the supply chain and manufacturing of CRINONE® (progesterone gel). Licensor's sole commercialized product is indicated for progesterone supplementation or replacement as part of an Assisted Reproductive Technology treatment for infertile women with progesterone deficiency.

Progesterone is an endogenous steroid hormone involved in the menstrual cycle, pregnancy, and embryogenesis of humans and other species.

Field of Use

The Licensee will commercialize the progesterone gel product.

License Grant

The Licensor hereby agrees, unconditionally and irrevocably, that the Licensee shall have the exclusive and unrestricted right worldwide, to exercise, use and commercialize and allow third parties to exercise, use and commercialize the Invention during the Agreed Term.

Invention shall thereafter mean the inventions covered by any claim(s) of a Patent issued or validated in the USA, the United Kingdom, France or Germany and not subsequently invalidated.

License Property

Patent and Patent Applications

Israel Patent Application 123998 (which is priority document for all patents/patent applications listed below)

PCT/IL99/00173 (all patents/patent applications listed below via this application).

Europe   European Patent Application EP 1071702 B1 covering   Austria Belgium Cyprus Denmark Finland France Germany Greece

Ireland

Italy

Latvia

Lithuania

Luxembourg

Monaco

Netherlands

Portugal

Romania

Slovenia

Spain

Sweden

Switzerland (+Liechtenstein)

United Kingdom

Other European Applications

Czech Republic
PV 2000-3625

Hungary
P 01 01653

Norway
20004998

Poland
P 343 360

Ukraine
20000095546

Eurasia

Eurasian Application No. 200000888 covering

Armenia
Azerbaijan
Belarus
Kazakhstan
Kirgizstan
Moldova
Russia
Tajikistan
Turkmenistan

Americas

Brazil
9909908-0

Canada
2,325,933

Mexico
009863

United States  6,395,722(granted), 6,384,024(granted), 10/078,671

Others

Australia
30515/99 (granted)

China
99804903.4

Indonesia
W2000 1998

Japan
2000-543488

New Zealand
507309

South Korea
10-2000-7010903

Turkey
84564

License Grant

Licensor of Bermuda hereby grants to Licensee of England for the Term an exclusive license for and in the Territory to and under the Patent Rights (and to and under the copyright in the Technical Documents to use and copy, and have used and copied, the Technical Documents) to, use, import, have imported, manufacture, have manufactured, market, distribute and sell or have marketed, distributed and sold the Product.  Urology Company shall only have the right to sub-license any such rights with Licensor's prior written approval (which approval may not be unreasonably withheld or delayed).

License Property

Patent Rights means all Patent Rights owned by or licensed to Licensor or its Affiliates containing claims reciting or covering Product including but not limited to the patents set out in this Agreement.

Extended Release Buccal Bioadhesive Tablet  The present invention relates to a bioadhesive, bioerodible tablet for the extended and controlled release of active ingredients. More particularly, the present invention relates to a progressive hydration tablet for adhesion to the wall of a body cavity for the sustained release of active ingredients without premature degradation of the active ingredients caused by metabolism, or by moisture, enzymes or pH effects.

Patents and Applications
Patent No.  Title  Country  Current Status  Expiration Date  

1,105,104 Extended Release Buccal Bioadhesive Tablet
United Kingdom  Issued  8/24/2019
France  Issued  8/24/2019
Switzerland  Issued  8/24/2019
Austria  Issued  8/24/2019
Spain  Issued  8/24/2019
Sweden  Issued  8/24/2019
Denmark  Issued  8/24/2019
Netherlands  Issued  8/24/2019
Belgium  Issued  8/24/2019
Italy  Issued  8/24/2019
Ireland  Issued  8/24/2019
Portugal  Issued  8/24/2019
Monaco  Issued  8/24/2019
Finland  Issued  8/24/2019
Cyprus  Issued  8/24/2019
Luxembourg  Issued  8/24/2019

3,055,843 Extended Release Buccal Bioadhesive Tablet
Greece  Issued  8/24/2019

226,591 Extended Release Buccal Bioadhesive Tablet
Hungary  Issued  8/24/2019

2/8/69927694 Extended Release Buccal Bioadhesive Tablet
Germany  Issued  8/24/2019

Extended Release Buccal Bioadhesive Tablet
Norway  Pending  8/24/2019

Field of Use

The rights granted apply to the extended and controlled release of active ingredients relating to the Extended Release Buccal Bioadhesive Tablet.