Master Alliance Provisions Guide (MAPGuide)

Population Council – TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement

  • Intellectual Property | License Grants

Definitions

Council Technology” means Council Patent Rights and Council Know-How.

Council Know-How” means all confidential know-how and information to the extent relating to and necessary for the development, manufacture or Commercialization of the Licensed Product, including clinical, technical, scientific, and medical information, know-how, methods, inventions, practices, and trade secrets, quality control information and procedures, pharmacological, toxicological and clinical test data and results and regulatory information, in each case, which Council Controls as of the Effective Date or at any time thereafter. Notwithstanding the foregoing, Council Know-How will not include (a) information which is or becomes part of the public domain through no breach of this Agreement by LICENSEE; (b) information which LICENSEE can demonstrate by its written records was known by LICENSEE or its Affiliates prior to the disclosure thereof by Council; (c) information which is independently developed by LICENSEE or its Affiliates outside of the Program, so long as such development does not result from use of Council Know-How, and such independent development can be demonstrated by written records; and (d) information that becomes available to LICENSEE or its Affiliates on a non-confidential basis, whether directly or indirectly, from a Third Party who is not bound by a confidentiality obligation to Council. For the avoidance of doubt, the Drug Master File jointly owned by the Council with [***] shall not be considered Council Know-How or Council Technology Controlled by Council for purposes of this Agreement until such time as Council may seek and thereafter obtains consent of [***] to the licensing thereof hereunder.

Council Patent Rights” means: (a) the patents and patent applications that are listed on Exhibit A, and (b) all patents and patent applications Controlled by The Council in the Territory that claim a Licensed Product, or its use or manufacture, in each case, as of the Effective Date or after the Effective Date, including all provisionals, substitutions, continuations, continuations-in-part, divisionals, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues, reexaminations, extensions, confirmations, revalidations, registrations, patents of addition thereof, PCTs of all such patents and patent applications.

Territory” means the United States of America including its possessions and territories.

II. LICENSE; MANUFACTURING

2.1 License Grant. Subject to the terms and conditions of this Agreement, including the payment by LICENSEE to Council of the payment due for Regulatory Approval of the Licensed Product as set forth in Section 3.1, Council hereby grants LICENSEE the sole and exclusive right and license (even as to the Council except for a retained non-exclusive right to perform research and development activities on Licensed Product as necessary or useful to fulfil Council’s obligations under this Agreement) under all Council Technology and Council’s interest in, to and under all Program Improvements solely to develop, Commercialize, manufacture, make, have made, use, import, export, offer to sell, sell, have sold and distribute Licensed Product in the Field and in the Territory and to make or have made Licensed Product outside the Territory solely for use in the Territory (the “License”).

2.2 Sublicensing

2.2.1 LICENSEE will have the right to sublicense its rights under the License to LICENSEE Affiliates and to Third Parties only with Council’s prior written consent, such consent not to be unreasonably withheld, conditioned or delayed. The terms of any sublicense permitted under the foregoing sentence will be set forth in a written agreement and fully consistent with the terms of this Agreement, including in the case of any sublicensee obtaining sublicense rights to Commercialize any Licensed Product, that such writing incorporates the terms of Sections 10.2.1, 12.4 and Article XI. With respect to all sublicenses granted under this Agreement, for purposes of determining whether any breach has occurred under this Agreement, the acts and omissions in relation to this Agreement of any sublicensee of LICENSEE hereunder will be attributable to LICENSEE as though taken or omitted by LICENSEE, itself, (ii) LICENSEE will be jointly and severally liable for any damage arising out of the acts or omissions of any of LICENSEE’s sublicensees of the LICENSEE’s licensed rights hereunder and (iii) LICENSEE will remain obligated to perform LICENSEE’s own obligations under this Agreement.

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2.3.3 Trademarks. Following grant of a registration therefor in the United States by the United States Patent and Trademark Office and upon request by LICENSEE, Council will grant to LICENSEE an exclusive license, on customary terms but without additional consideration above that set forth in this Agreement, to the specific trademarks set forth on Schedule 2.3.3 for use in connection with the Commercialization, marketing, offering for sale and sale of any Licensed Product in the Territory, in each case effective as of the date such trademark is used on such Licensed Product in commerce; provided, however, that nothing herein will require LICENSEE or any sublicensee to market or sell any Licensed Product using a Council Controlled trademark. To the extent LICENSEE Controls any Licensed-Product-specific registered trademarks that are used for Commercialization of the Licensed Product in the Territory and are available for registration in any country or region outside the Territory, Licensee agrees, upon request of Council, to grant a license to Council to such trademarks for use by Council or its designees in Commercialization of the Licensed Product in such country or region outside the Territory.

IV. JOINT PRODUCT COMMITTEE, PRODUCT DEVELOPMENT, CLINICAL TRIALS AND REGULATORY APPROVALS

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4.2 Licensed Product Development

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4.2.5 Except as provided in Sections 4.2.1 and 4.2.2, LICENSEE will use Commercially Reasonable Efforts to perform the development activities related to the Licensed Product in the Territory. Without limiting the foregoing or Council’s other remedies, if Council notifies LICENSEE that it believes LICENSEE is not using Commercially Reasonable Efforts to develop the Licensed Product: (i) the Joint Product Committee will meet within fifteen (15) days of any such notice and, at such meeting, Council will provide its rationale to the Joint Product Committee regarding why it believes LICENSEE has not been using Commercially Reasonable Efforts and LICENSEE will provide its rationale regarding why it believes it has been using Commercially Reasonable Efforts; and (ii) the Parties will use good faith efforts for a period of up to thirty (30) days following such Joint Product Committee meeting to attempt to resolve any such disputes after which time Council may pursue resolution pursuant to the terms of Section 14.3.

V. COMMERCIALIZATION

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5.3 Sales and Marketing. LICENSEE will be responsible for sales, marketing and promotional activities for the Licensed Product in the Territory in accordance with the Marketing Plan and will bear all related costs and expenses. LICENSEE will use Commercially Reasonable Efforts to Commercialize Licensed Product in the Territory in all counties of the Territory, provided that:

5.3.1 if the Licensed Product is not Launched in the United States within sixty (60) days after the date of the First Commercial Batch Release LICENSEE will be deemed to have committed a material breach of its obligations under this Agreement; and

5.3.2 unless determined otherwise by the Joint Product Committee (which determination will be subject to a veto by The Council), (a) by the end of the second year after approval by the FDA of the first Regulatory Approval for a Licensed Product, LICENSEE will ensure that audited detailing visits promoting the Licensed Product are made by its sales representatives not less than once a calendar quarter to the OB/GYN prescribers in the United States that account for at least [***] of the prescriptions by OB/GYN prescribers of contraceptive products, (b) in-person detailing visits will be augmented by commercially-reasonable digital efforts and professional education.