Royalty Report: Drugs, Respiratory – Collection: 300877

License Grant

On a Licensed Product-by-Licensed Product basis, Licensor, on behalf of itself and its Affiliates, hereby grants to Licensee Cloud and its Affiliates an exclusive (even as to Licensor and its Affiliates), perpetual (unless terminated), sublicensable (through multiple tiers and in accordance with this agreement) license under the Licensed IP to Exploit Licensed Products for all OTC uses in the Field in the Territory.

License Property

Licensed Product means any aerosol salt solution formulated for administration to or through the nasal passages for use in the Field that is prepared with, compromised of, covered by or includes any Licensed IP. For clarity, Licensed Product includes any composition of such aerosol salt solution that incorporates one or more other active pharmaceutical ingredients or agents providing treatment, Prophylaxis or Licensee experience.

Prophylaxis means action taken to prevent disease and action taken to prevent the propagation of disease including through the dissemination of infective agents.

OTC means “over-the-counter”, as such term is typically understood in the pharmaceutical industry with reference to a product for the treatment of, or use by, human beings which lawfully may be distributed to patients or consumers without a prescription. For clarity, if a Regulatory Authority requires clinical testing of a product for OTC use it remains an OTC product.

Licensed IP means Licensor Background IP and Licensed Licensor Improvement IP.

Licensed Licensor Improvement IP means Licensor Improvement IP that is mutually selected by the Parties for inclusion in the Licensed IP.

Licensor Background IP means (a) any Know-How (including NasoCalm Know-How) that is necessary or useful for the Exploitation of Licensed Products and that is Controlled by Licensor as of the Effective Date (Licensor Background Know-How); and (b) the Patents (including NasoCalm Patents), which are Controlled by Licensor (Licensor Background Patents), in each case, existing on the Effective Date.

NasoCalm IP means all Patents and Know-How relating to the formulations designated by Licesor as NasoCalm 003 and NasoCalm 006 (such formulations, NasoCalm) that are Controlled by Licensor as of the Effective Date (NasoCalm Patents and NasoCalm Know-How, respectively).

Field of Use

Field means the formulation and commercialization of over-the-counter products for the prophylaxis, prevention and treatment of upper and lower respiratory disease that are delivered or administered to or through the nasal passages.

License Grant

Licensor of Malta grants the exclusive right and license under the Licensor Patents and Licensor Know-How to Develop, have Developed, market, have marketed, use, have used, Commercialize, have Commercialized, distribute, have distributed, offer for sale, sell and have sold the Products in the Territory and to package, distribute, sell, market and promote the Products in and throughout the Territory, including the right to grant sub-licenses, subject to all of the terms and conditions of this Agreement.

License Property

Licensor controls certain Licensor Know-How and Licensor Patents relating to the Products, including technology essential to the Development of stable and acceptable preparations, suspensions, or other chemical mixtures of ingredient required to Develop a product containing a corticosteriod, including Ciclesonide.

Ciclesonide, alone is the Standalone Product.
Arformoterol is the Combination Product.

Ciclesonide means the compound ciclesonide including all its isomers, titrates, hydrates, metabolites, polymorphs, prodrugs, epimers, and salts.

Field of Use

Ciclesonide is an inhaled corticosteroid that is intended for the treatment of asthma symptoms, regardless of asthma severity.

The  license and development agreement is for know-how and intellectual property rights related to stable sterile suspension formulations, for use in the development, commercialization, marketing, sale and distribution of an inhalation pharmaceutical product containing ciclesonide as its only active ingredient and an inhalation pharmaceutical product containing both ciclesonide and arformoterol as its active ingredients, throughout the world, collectively referred to as the Ciclesonide Products.

Competing Products means any nasal or inhaled corticosteroid formulations, arformoterol or formoterol, whether containing a single or two or more active ingredients, in the Territory, other than products currently marketed by Licensor as of the Effective Date and products containing budesonide, fluticasone or salmeterol, alone or in combination with any other active pharmaceutical ingredient other than Ciclesonide, arformoterol, or formoterol,

Licensee has material capabilities, resources and experience in the development, clinical testing, regulatory approvals, commercialization, marketing and distribution of branded inhalation pharmaceutical products.

License Grant

Licensor hereby grants to Licensee an exclusive (including with regard to Licensor and its Affiliates), royalty-bearing license, with the right to grant sublicenses in accordance with this Agreement, under the Licensor Technology, to Exploit the Licensed Compound or the Licensed Products in (a) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Licensee Human Excluding HIV/AIDS/ID/Pediatric Territory; (b) the HIV/AIDS/Pediatric Field in the Licensee HIV/AIDS/Pediatric Territory; and (c) the ID Field in the Licensee ID Territory.

Licensor hereby grants to Licensee an exclusive (including with regard to Licensor and its Affiliates), royalty-bearing license and right of reference, with the right to grant sublicenses and further rights of reference in accordance with this Agreement, under the Regulatory Documentation Controlled by Licensor or any of its Affiliates, if any, to Exploit the Licensed Compound or the Licensed Products in (a) the Human Excluding HIV/AIDS/ID/Pediatric Field in the Licensee Human Excluding HIV/AIDS/ID/Pediatric Territory; (b) the HIV/AIDS/Pediatric Field in the Licensee HIV/AIDS/Pediatric Territory; and (c) the ID Field in the Licensee ID Territory.

Licensor hereby grants to Licensee a non-exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses in accordance with this Agreement, to use the Product Trademarks (to the extent Controlled by Licensor) as necessary to exercise its rights under the grants in this Agreement, provided that Licensor shall have a right to monitor and comment upon the manner in which such Product Trademarks are used.

License Property

Licensed Compound means oligomeric proanthocyanidin (OPC) of varying chain lengths with an average molecular weight of approximately 2000 daltons (Crofelemer), including any Improvements thereto.

Licensed Product means any form or dosage of pharmaceutical composition or preparation in finished form labeled and packaged for sale by prescription, over-the-counter, dietary supplement, food or any other method that contains the Licensed Compound as an active ingredient (including a Licensed Product that contains the Licensed Compound as an active ingredient together with one or more other active ingredients (which may be either combined in a single formulation or bundled with separate formulations but sold as one product)), and any Improvements thereto.

Patents
5,211,944 – Proanthocyanidin polymers having antiviral activity and methods of obtaining same
5,494,661 – Methods for using proanthocyanidin polymers having antiviral activity
7,341,744 – Method of treating secretory diarrhea with enteric formulations of proanthocyanidin polymer

Product Trademarks shall mean all Trademarks for use with a Licensed Product designated in accordance with this Agreement and any registrations thereof or any pending applications relating thereto.

Trademark shall include any word, name, symbol, color, designation or device or any combination thereof, including any trademark, trade dress, brand mark, trade name, brand name, logo or business symbol, which in each case is specific to a Licensed Product. Notwithstanding anything in the foregoing, the term “Trademark” does not include any house marks, trade dress or logos of Licensee or its Affiliates.

Field of Use

Licensee is investigating crofelemer in a Phase III study as an anti-secretory anti-diarrheal agent for the treatment of chronic diarrhea in people living with HIV, or HIV-associated diarrhea

Human Excluding HIV/AIDS/ID/Pediatric Field means all indications of the Licensed Compound for human use or consumption (including by way of food or dietary supplements), other than HIV/AIDS-related diarrhea, acute infectious diarrhea and pediatric diarrhea of any etiology including cholera; HIV/AIDS/Pediatric Field means only those indications of the Licensed Compound for human use for HIV/AIDS-related diarrhea and pediatric diarrhea; and ID Field means only those indications of the Licensed Compound for human use for acute infectious diarrhea, specifically including cholera and traveler’s diarrhea. This also includes the ID Field and the  HIV/AIDS/Pediatric Field.