Royalty Report: Drugs, Respiratory, Disease – Collection: 291160

License Grant

In consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Memory and Roche agree to amend this agreement. The parties entered into a collaboration to develop MEM1414 for commercialization; develop potential back-up compounds and other PDE4 inhibitors focused on central nervous system indications; and explore potential applications for other therapeutic areas such as respiratory disease.

License Property

Product means any and all products that include, in whole or as a component thereof, a Collaboration Compound, other than MEM1414 and MEM1817.

Patent Right means all rights under any patent or patent application in any country of the Territory, including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuations-in-part thereof.

Collaboration Compound means any PDE4 inhibitor that (i) either or both Parties or their Affiliates conceive in the conduct of the Research Collaboration, (ii) Memory has rights to under an agreement with a Third Party as of the Effective Date, (iii) the JLT otherwise agreed shall constitute a Collaboration Compound pursuant to the Research Workplan, or (iv) Memory conceived prior to the date of the Original Agreement. All Collaboration Compounds identified as of the Effective Date are set forth in Schedule I hereto.

Compounds active as PDE4 inhibitors, including a compound known as MEM1414.

Field of Use

'MEM 1414 represents an ideal drug candidate for the potential treatment of respiratory indications such as asthma and chronic obstructive pulmonary disease.

The parties entered into a collaboration to develop MEM1414 for commercialization; develop potential back-up compounds and other PDE4 inhibitors focused on central nervous system indications; and explore potential applications for other therapeutic areas such as respiratory disease.

License Grant

Licensor grants to the Swiss Licensee the sole and exclusive license, including the right to grant sublicenses, under the Licensor Patents and to use the Licensor Know-How, to make, use, offer for sale, sell and import  Products in the Territory for use in the Field.

License Property

Patent Rights
U.S. #1
(a) First US provisional filed January 22, 2001 (60/262,651).
(b) Second US provisional filed February 8, 2001 (60/267,196).
(c) Third US provisional filed July 19, 2001 (60/306,140)
(d) A regular US patent application (10/051,309) was filed on January 22, 2002, claiming priority to the above-mentioned three US provisional applications.

U.S. #2
(a) First US provisional filed February 8, 2001 (60/267,195)
(b) Second US provisional filed January 7, 2002 (60/344,824).
(c) A regular US patent application (10/067,996) was filed on February 8, 2002, claiming priority to the above-mentioned two US provisional applications.
(d) Possible Second US family to be filed; awaiting analysis from MPC.

U.S.#3
A first US provisional application (Memory 3 VI) was filed October 16, 2001 (60/329,314).

U.S. #4
(a) First US provisional filed November 15, 2001 (60/331,422)
(b) Second US provisional filed January 23, 2002 (60/349,985).

U.S. #5
(a) U.S. provisional application filed June 25, 1999 (60/141,196
(b) A regular U.S. Patent Application was filed June 23, 2000 (09/602,735), claiming priority to the above-mentioned provisional application.

Licensor Compound means any PDE4 inhibitor for which Licensor either prior to the Effective Date or during the Agreement Term has rights, whether by reason of its own conception of such inhibitor, or under agreement with a Third Party.

Collaboration Compound means any PDE4 inhibitor that (i) either or both Parties or its Affiliates conceives in the conduct of the Research Collaboration, or (ii) the JLT otherwise agrees shall constitute a Collaboration Compound pursuant to the Research Workplan.

'Neurological Indication' means prophylaxis or treatment of Alzheimers' disease, prophylaxis or treatment of mild cognitive impairment ('MCI') or treatment of vascular dementia.

'Non-Memory Compound' means a PDE4 inhibitor, other than a Memory Compound or a Collaboration Compound, with respect to which the initial IND for the inhibitor is for a Neurological Indication or Psychiatric Indication.

'Psychiatric Indication' means depression, anxiety or mixed anxiety/depression.

Field of Use

MEM 1414 is a PDE4 inhibitor and our second drug candidate for the treatment of Alzheimer's disease and potentially for MCI. PDE4 inhibitors are designed to inhibit the activity of PDE4, the enzyme which breaks down neuronal cAMP.

MEM 1917 is a PDE4 inhibitor that we are developing for the treatment of depression.

License Grant

Under the original PDE4 Collaboration, Licensee received a worldwide, exclusive license to develop and commercialize any drug candidate from the Licensor’s PDE4 inhibitor program. Licensee maintains this license with respect to all other drug candidates from the Licensor’s PDE4 inhibitor program.

Under the Amendment, the Licensor has reacquired from Licensee the right to develop and commercialize the PDE4 inhibitors MEM 1414 and MEM 1917, each an Option Compound and collectively, the Option Compounds, alone or with a third party. Licensee has an option, exercisable following the completion of Phase II clinical trials for each of the Option Compounds, to continue that Option Compound’s development and commercialization. If Licensee does not exercise its option with respect to an Option Compound, then Licensee shall have no further rights or interest with respect to that Option Compound.

Licensee maintains exclusive License to Other PDE4 Inhibitors under the Collaboration.

Licensee shall assign and transfer to Licensor at no expense to Licensor the items set forth in the Agreement solely to the extent each relates to MEM 1414 and MEM 1917, free and clear of any liens or security interests; create a shareweb of the items set forth for use by both Parties as reference data, and transfer existing inventory of MEM 1414 and MEM 1917 to Licensor at no expense to Licensor, free and clear of any liens or security interests. Licensees obligations of the Agreement shall be fulfilled and discharged by Licensees transfer of existing inventory of MEM 1414 and MEM 1917 to Licensor as provided herein.

Licensee shall have the Option to obtain an exclusive license to develop and commercialize MEM 1414 and/or MEM 1917, each an Option Compound.  

If Licensee exercises the Option with respect to an Option Compound, then such Option Compound shall be deemed to be a Licensor Compound for purposes of the Agreement, and all provisions of the Agreement shall apply to such Option Compound, except for those provisions that are changed by this Second Amendment.

License Property

The PDE4 inhibitor program is for the treatment of neurological and psychiatric, and potentially other indications.

The  Option Compounds are PDE4 inhibitors MEM 1414 and MEM 1917.

Field of Use

The compounds are for the treatment of Alzheimer’s disease.

License Grant

License to Commercialize Collaboration Compounds –  Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License to Compounds (Other than Collaboration Compounds)  Derived from Licensee Compounds – Licensor grants to Licensee a worldwide, exclusive license, with the right to sublicense, under the Licensor IP and Licensors interest in the Collaboration IP, to make, have made, use, sell, offer to sell and import Collaboration Compounds, and/or Collaboration Products based on such Collaboration Compounds, for any and all uses and indications in the Licensee Field.

License Property

Collaboration Product shall mean a pharmaceutical product containing a Collaboration Compound that is sold by Licensee or Licensor, or their respective Sublicensees or Affiliates.  It is understood that, in the event any Collaboration Compound is sold for therapeutic purposes, such Collaboration Compound shall be deemed a Collaboration Product and shall be subject to milestones and royalties as set forth in this Agreement.

Collaboration Compound shall mean a Licensor Compound or a Non-Exclusive Compound or a compound that is derived, directly or indirectly, from a Licensee Compound, Licensor Compound, or Non-Exclusive Compound; in each case, that modulates the biological activity of a Collaboration Target at a level of potency to be established by the JRC.  A compound shall be deemed to have been derived directly from another compound if it (i) is the result of a chemical modification made to such a compound, (ii) is otherwise obtained from a chemical synthesis program based on one or more such compounds, (iii) is based on proprietary structure-activity data obtained from the testing of one or more such compounds, or (iv) is specifically or generically within the scope of one or more claims of any patent application or patent filed by Licensor or Licensee or their Affiliates to protect any compound in category (i), (ii) or (iii) above.  A compound shall be deemed to have been derived indirectly from another compound if it is the result of a series of iterations of any or all of (i) through (iv) above.  For purposes of clarity, any compound synthesized in the course of the Collaboration and based on a Licensee Compound, Licensor Compound, or Non-Exclusive Compound which is active against a Collaboration Target at the level of potency established by the JRC shall be deemed a Collaboration Compound.  Joint Research Committee or “JRC” shall mean the entity organized to manage the scientific implementation of the Collaboration.

Licensee IP shall mean Licensee Patents and Licensee Know-how.

Collaboration IP shall mean Collaboration Patents and Collaboration Know-how.  Collaboration IP shall not include Licensor IP or Licensee IP.

Licensor IP shall mean Licensor Patents and Licensor Know-how.  Licensor IP shall not include any intellectual property owned or licensed by Licensor or its Affiliates relating to the ECLiPSâ„¢ technology (i.e., the creation or use of encoded combinatorial libraries or any tag and/or marker compounds).

Licensee Patents shall mean all Patents in the Territory Controlled by Licensee or its Affiliates as the effective date, or any other Patent Controlled by Licensee during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Licensor Patents shall mean all Patents in the Territory Controlled by Licensor or its Affiliates as the Effective Date, or any other Patent Controlled by Licensor during the Term; in each case, necessary for the discovery, development, manufacture, importation or use of one or more Collaboration Compounds and/or the development, manufacture, use, sale, importation or commercialization of corresponding Collaboration Products.

Collaboration Patents shall mean (i) all patents and patent applications claiming any invention or discovery which was conceived or reduced to practice during the Collaboration Term and in the course of the Collaboration, by employees or agents of Licensee, Licensor or any of their respective Affiliates, either alone or jointly (including, without limitation, the synthesis and composition of matter of any Collaboration Compound, or method of use thereof; and (ii) any divisions, continuations, continuations-in-part, reissues, reexaminations, extensions or other governmental actions which extend any of the subject matter of the patent applications or patents in (i) above, and any substitutions, confirmations, registrations, revalidations, or additions of any of the foregoing, in each case, which is owned or Controlled, in whole or part, by license, assignment or otherwise by Licensor or Licensee during the term of this Agreement; provided, however, that Collaboration Patents shall not include any Licensee Patents or Licensor Patents.

Licensor Compound shall mean any compound brought to the Collaboration by Licensor, which is Controlled by Licensor at or after the Effective Date, and which is proprietary to Licensor by virtue of being within the Licensor IP.

Field of Use

The primary objective of the alliance is to identify active molecules and bring them forward to clinical proof of concept, yielding novel candidates for drug development in various therapeutic areas.

Licensor Field shall mean, with respect to each Collaboration Compound for which Licensor has received approval to develop pursuant, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

Licensee Field shall mean, with respect to each Collaboration Compound, all human and animal disorders and diseases treated by modulation of a Collaboration Target by such Collaboration Compound.

License Grant

Under this agreement the parties will collaborate to develop and commercialize once-daily LABA products for the treatment of chronic obstructive pulmonary disease (“COPD”) and asthma.

License Property

Products consist of Laba, a Long-Acting Beta2 Agonist, as well as the respiratory assets listed below.

Laba, a Long-Acting Beta2 Agonist, is a type of bronchodilator medicine. Bronchodilator medicine opens the airways in the lungs by relaxing smooth muscle around the airways. LABA are also long-term control medicines.

RELVAR®/BREO® is a once-a-day combination inhaled respiratory medicine consisting of vilanterol (VI), a long-acting beta2-agonist (LABA), and fluticasone furoate (FF), an inhaled corticosteroid (FF/VI), delivered via the ELLIPTA® dry powder inhaler.

ANORO® ELLIPTA® is a dual bronchodilator consisting of umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), and vilanterol (VI), a long-acting beta2-agonist (LABA) for the treatment of chronic obstructive pulmonary diseases (COPD). This once-a-day combination inhaled respiratory medicine is delivered via the ELLIPTA® dry powder inhaler.

TRELEGY® ELLIPTA® is a combination of fluticasone furoate (FF), an inhaled corticosteroid (ICS); umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA); and vilanterol (VI), a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) and to reduce exacerbations of COPD in patients with a history of exacerbations. This three-way combination inhaled respiratory medicine is self-administered by patients through the ELLIPTA® dry powder inhaler.

Field of Use

The field of use is for COPD/Asthma patients. Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory lung disease that causes obstructed airflow from the lungs. Symptoms include breathing difficulty, cough, mucus (sputum) production and wheezing.

License Grant

For the Exclusive License,  the Swiss Licensor grants an exclusive right and license or sublicense, as applicable, in the Territory, with the right to grant sublicenses, under the Licensor Technology and Licensor Technology Improvements to make and have made, to use and have used, to develop and have developed, to sell and have sold, to offer for sale and have offered for sale, to import and export and have imported and exported Licensed Products in the Exclusive Field in the Territory during the Term.

For the Non-Exclusive, Research License, Licensor grants a nonexclusive, research only license or sublicense, as applicable, in the Territory, with the right to grant sublicenses, under the Licensor Technology and Licensor Technology Improvements to conduct non-human studies for the development of Other Products, solely for the prevention or treatment of a Target Indication in the Target Populations.

License Property

Licensors technology is relating to the aerosolization of liquid forms of drug products and the Aerosol Devices and Disposable Dose Packs.

Licensed Product means a combination drug-device product using or otherwise practicing the Licensor Technology and delivering Pulmonary Surfactants (alone or in combination with other pharmaceutical compounds).

Drug Product means a pharmacological agent(s), including Pulmonary Surfactants, together with any excipients or inactive ingredients, formulated for use in connection with an Aerosol Device or Disposable Dose Packet.

Aerosol Device means a device to aerosolize a pharmaceutical compound for administration to humans. It is contemplated that the Aerosol Device shall consist of permanent (e.g., nondisposable) components that control power and electronics (e.g., control unit) and a physical mechanism (e.g., pump) to provide a means for dispensing the Drug Product from the container closure system.

Aerosol Technology means any technology related to the aerosolization of a liquid form of a pharmaceutical compound. Aerosol Technology does not include technology that is related to the delivery of aerosols as dry powders.

An Other Product means a combination drug-device product using or otherwise practicing the Licensor Technology and delivering pharmaceutical compounds other than Pulmonary Surfactants as an active ingredient in humans, alone or in combination with other pharmaceutical compounds, that are other than Pulmonary Surfactants.

Field of Use

Exclusive Field means the therapeutic or preventative use in humans of Aerosol Technology to deliver Pulmonary Surfactants (alone or in combination with any other pharmaceutical compound(s)) as an active ingredient for the prevention or treatment of Respiratory Indications.

Target Indications means the following Respiratory Indications Respiratory Distress Syndrome (RDS); Chronic Lung Disease (BPD); Transient Tachypnea; Hypoxemia; Pulmonary Hypertension; Pneumonia; Bronchiolitis; Diaphragmatic Hernia; Acute Lung Injury (ALI); Acute Respiratory Distress Syndrome (ARDS); Lung Transplantation; Respiratory Syncitial Virus (RSV); Cystic Fibrosis; Chronic Obstructive Pulmonary Disease (COPD); and Emphysema.

Target Populations means human patients in a Hospital Setting receiving forms of treatment for the applicable Respiratory Indication that are typically and principally provided within a Hospital Setting.

The restructure strategic alliance agreement is to unite two complementary respiratory technologies – Licensee peptide-containing synthetic surfactant technology with Licensor’ novel capillary aerosolization technology – to deliver therapeutics to the deep lung.

License Grant

The Parties have been collaborating on a project to develop in silico models that guide the identification of CFTR corrector or potentiator compounds for therapeutic intervention.

Under the Agreement, the Parties agreed to conduct additional research activities aimed at developing a compound to correct a malfunction of the cystic fibrosis transmembrane conductance regulator protein.

As of the Effective Date and until the grant of any Interruption License, the Commercial Party shall be Licensee, and, upon the grant of an Interruption License, if applicable, and thereafter, it shall be Licensor.

Interruption shall occur if before the First Commercial Sale of a Product all of the Licensee, its Affiliates, licensees, sublicensees, transferees and successors, cease to use Commercially Reasonable Efforts to research, develop and/or commercialize all Early Development Candidate or EDCs and Products in the Field.

The Parties agree to collaborate in the performance of research activities aimed at identifying Early Development Candidates, and identifying Back-Up Compounds.

For patentable inventions, Licensor grants to an exclusive, royalty free worldwide license to its rights in any Joint Invention and any invention made by made by any CFFT employee resulting from the Research Project to research, develop, manufacture, use, sell and import products.

License Property

The candidate will relate to electrophysiological assay expressing epithelial cell line.

CFTR shall mean a CF transmembrane conductance regulator protein which has the biological effect of transporting molecules across human cellular membranes.   This research and development has a goal to publish the 3D structure of CFTR including its coordinates.

CFTR is the key protein associated with cystic fibrosis.

TDN shall mean the Therapeutic Development Network established by Licensor.

Field of Use

The Field shall mean the diagnosis, treatment and/or prevention of CF and pulmonary diseases.

Cystic fibrosis (CF) is a life-threatening genetic disease that causes fatal lung infections and serious digestive complications. A mutation in the CFTR gene is one of the key factors that ultimately leads to the symptoms, complications and premature mortality in people with cystic fibrosis.

License Grant

Australia Licensor hereby grants Licensee an exclusive license to the Licensor Intellectual Property and the Third Party Patents in relation to the Field in the Territory, with the right to grant sublicense, to develop, use, make (subject to the terms and conditions of this Agreement and any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates), sell, offer for sale, export and import the Products. In no event shall Licensee use the Licensor Intellectual Property or the Third Party Patents for purposes not related to Licensee obligations to Licensor under this Agreement or any other agreement between the Parties relating to the manufacture and supply of the Products or Product Intermediates.

License Property

Licensor Intellectual Property shall mean the Licensor Know-How, the Licensor Patents and the Licensor Developed Technology. Licensor Intellectual Property excludes (a) technologies solely relating to the Compound, Formulation, or the Product; and (b) products, processes, methods, technologies and other inventions in the public domain or that are owned or made by Third Parties (other than on behalf of Licensor or its Affiliates) and not Controlled by Licensor or its Affiliates.

Licensor Developed Technology shall mean improvements to the Licesor Know-How and Licensor Patents conceived, created, developed or otherwise invented or acquired solely by an employee or agent of Licensor or one of its Affiliates or a Third Party (under contract with Licensor or one of its Affiliates) as a direct result of fulfilling obligations or exercising rights, including the sharing of Confidential Information, under this Agreement or any other agreement between the Parties.

Licensor Patents shall mean any and all rights under the Patent Applications and/or Patents as set forth as of the Effective Date and as amended from time to time, and any foreign counterparts thereof and all divisionals, continuations, continuations-in-part, any foreign counterparts thereof and all patents issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, supplemental protection certificates, or extensions thereof, and any foreign counterparts thereof. In the event any additional Licensor Patent or Patent Application is necessary or useful to allow Licensee to practice the rights granted to it by Licensor herein, Licensor shall include such Patent or Patent Application as applicable.
US application 10/497715 – Method of Particle Formation
US application 10/017135 – Synthesis of small particles.

Compound shall mean (i) any beta-agonist in combination with any steroid; (ii) any steroid; and (iii) insulin, as well as any salts, isomorphs, polymorphs, cogeners or isomers of the preceding. Initial specifications for each Compound will be agreed to by the parties and after such agreement shall be considered an original part of this Agreement.

Product shall mean the Formulation comprising the Product Intermediate and, to the extent required to effect delivery to a patient, a delivery device for use in the Field.

Formulation shall mean a composition of Product Intermediate suitable for administration by inhalation via pulmonary or nasal delivery, as applicable. A Formulation may comprise a mixture, blend or solution of the Product Intermediate combined with excipients and/or adjuvants or neat Product Intermediate and a single Product Intermediate may be covered by more than one Formulation. Specifications for each Formulation will be developed by MAP and after such development shall be considered an original part of this Agreement.

Beta-agonist shall mean any short-acting beta-agonist or any long-acting beta agonist as those terms may be further defined from time to time in a generally accepted pharmacology textbook.

Field of Use

Field shall mean the administration of a Product by inhalation as follows (i) for a Product containing any Beta-agonists and any steroid, the Field shall be limited to administration via pulmonary delivery; (ii) for a Product containing a steroid as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery; and (iii) for any Product containing Insulin as the sole active ingredient, the Field shall include administration by pulmonary or nasal delivery. The parties may add additional fields to the definition of Field as the parties may mutually agree from time to time, under the terms of this Agreement.

Licensee is engaged in the research and development of proprietary drug delivery systems for inhalation therapy by pulmonary or nasal delivery, including devices and formulations suitable for those devices.