Population Council Research that makes a difference

Dedicated to improving the family planning and reproductive health options of people throughout the world

The Population Council has an impressive track record developing contraceptives from the preclinical phase through FDA approval. For over 40 years, the Council has developed and evaluated promising ideas for new contraceptives and, more recently, AIDS prevention products. Over 120 million women have used a Council-developed contraceptive product including Mirena®, copper intrauterine devices (IUDs), and the Norplant® and Jadelle® implants. This remarkable success would not be possible without collaborative partnerships between the Council and the pharmaceutical industry to develop, manufacture, and distribute products. Partnerships include co-development, licensing, and manufacturing agreements. 

The Council is dedicated to improving the family planning and reproductive health options of people throughout the world. The Council’s partnerships with the pharmaceutical industry enable successful research to move to the next phase and Council-developed products to reach the global market. In keeping with the Council’s mission, agreements with the Council include provisions for the product to be made available to the public sector at a negotiated fraction of the private-sector price. Read more about the foundations that have been established to meet these needs. 

If you are interested in a product currently in development, please register your interest. You may also review a generic term sheet (click the "Terms" tab above) describing the general provisions that would typically be included in any license/joint development agreement with the Population Council along with customary representations and warranties and other provisions.

Success stories

The Council has unparalleled success developing popular contraceptives used by over 120 million women. The Council has already delivered to market:

    • Three models of copper-bearing intrauterine devices (more);
    • Mirena®, a levonorgestrel-releasing intrauterine system (more);
    • Jadelle®, a two-rod levonorgestrel implant (more); and
    • Norplant®, a six-capsule levonorgestrel-releasing implant (more)

See also

    • "Building on decades of success: Pioneering contraceptive research and products," 2010 fact sheet (PDF)
    • "Nestorone gel: A novel contraceptive gel," 2010 fact sheet (PDF)

Licensing opportunities

The Council has contraceptive products in various stages of development.  Products for which we are currently soliciting licensing partners include:

Nestorone®/ethinyl estradiol ring

Nestorone® gel

    • Available for licensing worldwide
    • Transdermal contraceptive gel containing Nestorone and estradiol (PDF) (more)
    • Phase 2 complete
    • Patent protection through 2017 (offsite full text)

Progesterone ring for contraception during breastfeeding and a separate progesterone vaginal ring for hormone supplementation for in vitro fertilization programs (more)

    • Available for licensing outside South America
    • Approved in Chile (PDF); also approved in Bolivia, the Dominican Republic, Ecuador, Guatemala, Panama, and Peru
    • Patent protection through 2016 (offsite full text)

Jadelle®: NDA 20-544/S-003

    • Available to license for marketing in the United States
    • Two-rod subdermal implant for contraception (more)
    • Monograph summarizing scientific data and lessons learned about marketing (PDF)
    • FDA-approved labeling (PDF)

The Population Council has several other contraceptive products and microbicide products in pre-clinical and clinical development.  For more information on any Council products, please contact licensing@popcouncil.org.

Terms

The following general provisions would typically be included in any license/joint development agreement with the Population Council, Inc., along with customary representations and warranties and other provisions not summarized below. Specifics would be negotiated on a case-by-case basis.

Grant of license

The Council will grant the Licensee an exclusive license, with the right to grant sublicenses to entities approved by the Council, under the Council’s relevant technology and proprietary information, to manufacture and/or market and sell a defined product for one or more applications, human or otherwise (the “Product”), in a defined territory (the “Territory”), subject to certain payment and progress requirements on a country-by-country basis. The Council may also grant rights to the Licensee to use trademarks obtained by the Council in connection with the Product or any component thereof.

Payments

The Council will require negotiated milestone payments keyed to stages of the development of the Product, beginning upon signing of the agreement, as well as royalties based on sales of the Product. Up-front payments in respect of the transfer of technology to the Licensee may be required. The Licensee’s continued exclusivity on a country-by-country basis will be conditioned upon meeting both negotiated development and marketing milestones (including obtaining registrations necessary for commercial marketing), as well as minimum sales or royalty requirements. Royalty payments in US dollars, together with certified reports as to sales and such payments, will be made quarterly.

Council involvement in necessary tests

The Council generally will be involved in conducting or planning the trials necessary to obtain manufacture and marketing approvals for the Product, both in the United States and overseas. A joint steering committee normally will be established to guide the development, manufacturing, and marketing of the product. All studies will be conducted at the expense of the Licensee or sublicensee.

Compliance with law and registrations

All activities by the Licensee and its sublicensees must be conducted in accordance with applicable laws, and manufacture (if applicable) must be in compliance with FDA requirements as well. In addition, the Licensee will be required to develop appropriate quality assurance procedures. The Licensee must obtain and maintain, at its expense, all required registrations necessary to manufacture, and/or sell, the Product in each country or other subdivision of the Territory, and shall permit the Council, and others licensed by the Council, to cross-reference such registrations or filings at no cost.

Sources of supply

The Licensee will agree to obtain supplies of the Product, or components (including active ingredients) thereof (if applicable), only from sources approved by the Council and subject to such reasonable additional terms as the Council may impose.

Provisions for distribution to the public sector

The Licensee will agree to make the Product available to the public sector at a price which is limited, based upon a fraction of the private sector price for the Product, or upon a combination of the Licensee’s manufacturing cost and sales margin. A nonprofit foundation may be established to facilitate distribution to the public sector. To the extent sufficient amounts of the Product cannot be made so available to the public sector, the Licensee will permit the Council to license others, under all of the Licensee’s proprietary information, as well as that of the Council, to produce the Product for such purpose. Special considerations may apply in the United States if the Product is subject to unitary pricing restrictions.

Confidentiality

The Licensee will maintain the confidentiality of, and not use, Council proprietary information during the term of the agreement and thereafter, except as permitted by the agreement.

Indemnity

The Licensee shall indemnify the Council, its trustees, officers, employees, counsel, and other agents and representatives, against any loss, cost, expense, liability, or claim arising out of the Licensee’s and any sublicensee’s manufacture, marketing, sale, or distribution of the Product, any activities in connection therewith, and the performance of their respective obligations under the agreement or the sublicense. In each case, the indemnity obligation must be backed by insurance (including products liability insurance) in an amount, during the term of the agreement and for a period thereafter, and placed with carriers, acceptable to the Council.

Term

To be negotiated, but usually not less than ten years, with the opportunity to renew for additional negotiated periods. Upon any termination of the agreement, the license granted by the Council shall terminate. Earlier termination may occur if the Licensee, or a sublicensee, breaches any of its respective obligations under the agreement or the sublicense, or if the Licensee seeks the protection of bankruptcy or other equivalent laws.

Publication

Publication of scientific information related to the Product or the Licensee’s activities under the agreement shall be delayed if the Council believes it necessary to obtain appropriate protection for any proprietary data contained in the publication.