DNDi – BioDelivery Sciences International, Visceral Leishmaniasis Research Collaboration Agreement

Intellectual Property | License Grants

Structural Questions

Are any licenses granted for the use of background, sideground or foreground intellectual property?
What is the scope of the licensed intellectual property?
What is the territory of the license?
Is the license exclusive or non-exclusive?
Are there any restrictions on the use of the licensed intellectual property?
Are there any specific obligations to exploit the licensed intellectual property?
Can the licensee grant sublicenses to third parties?
Will products manufactured under license be marketed as branded or generic? (i.e. will they bear the licensor’s trademarks/trade dress)

Summary of Approaches

BDSI licenses to DNDi

Are any licenses granted for the use of background, sideground or foreground intellectual property?
- BDSI grants DNDi a royalty-free, irrevocable license to use BDSI Background IP for the purpose of conducting activities under the R&D Plan.
- BDSI grants DNDi a royalty-free, irrevocable license to use BDSI Background IP and Collaboration IPR for the purpose of seeking Regulatory Approvals and undertaking distribution of CAMB.
What is the scope of the licensed intellectual property?
- BDSI’s background IP is defined as any BDSI patents useful or necessary for the development, manufacturing or distribution of CAMB, and any BDSI know-how related to CAMB.
- Collaboration IP is the IP developed under the agreement.
Is the license exclusive or non-exclusive?
- The licenses are non-exclusive.
What is the territory of the license?
- The license to use background IP for the purpose of the R&D Plan is worldwide.
- The license for seeking regulatory approvals and distribution is for all countries of the world excluding Japan, Australia, New Zealand, Russia, CIS countries, China, North America and the European Union.
Are there any restrictions on the use of the licensed intellectual property?
- DNDi’s right to distribute CAMB is limited to distribution through public sector agencies.
Can the licensee grant sublicenses to third parties?
- DNDi may grant sublicenses to Affiliates or Third Parties with prior written consent from BDSI, provided that each sublicensee agrees to the terms of the agreement.
Will products manufactured under license be marketed as branded or generic? (i.e. will they bear the licensor’s trademarks/trade dress)
- Each party will mark the materials manufactured under the agreement at the direction of the party holding any patents.

DNDi license to BDSI

Are any licenses granted for the use of background, sideground or foreground intellectual property?
- DNDi grants BDSI a royalty-free, irrevocable license to make, use, sell and import CAMB under the Collaboration IP.
What is the scope of the licensed intellectual property?
- Collaboration IP is the IP developed under the agreement.
Is the license exclusive or non-exclusive?
- The license is exclusive.
What is the territory of the license?
- The license is worldwide.
Can the licensee grant sublicenses to third parties?
- DNDi may grant sublicenses to Affiliates or Third Parties with prior written consent from BDSI, provided that each sublicensee agrees to the terms of the agreement.
Will products manufactured under license be marketed as branded or generic? (i.e. will they bear the licensor’s trademarks/trade dress)
- Each party will mark the materials manufactured under the agreement at the direction of the party holding any patents.

Annotations

This Research Collaboration and License Agreement between the Drugs For Neglected Diseases Initiative (“DNDi”) and BioDelivery Sciences International, Inc. (“BDSI”), was signed on January 20, 2009. The agreement provides for collaboration between the parties to assess the efficiency of CAMB (a pharmaceutical formulation of Amphotericin B using BDSI’s intellectual property rights) in the treatment of visceral leishmaniasis.

The Parties will jointly conduct a Research and Development (R&D) Plan under which BDSI is responsible for making samples of CAMB available to DNDi in sufficient quantities for DNDi to conduct its activities. The parties will provide each other with the data and technical information reasonably required to conduct their respective activities under the R&D Plan. DNDi will appoint a program manager who will be responsible for the overall management of the plan.

Under the agreement, DNDi receives a license to use BDSI’s background IP and the collaboration IP to seek regulatory approvals and distribute the product for the treatment of African Human Trypanosomiasis (HAT), Chagas’ disease, and Visceral & Cutaneous Leishmaniasis (“Field”). The license grants are for all countries of the world excluding Japan, Australia, New Zealand, Russia, CIS countries, China, North America and the European Union (“Territory”), however DNDi’s rights to distribute CAMB are limited to the Public Sector within the Territory. The CAMB distributed by DNDi will be manufactured exclusively by BDSI, but DNDi may engage a secondary supplier if there is a shortfall in the quantities supplied by BDSI.

Provision Language

Definitionsstrong>em>p>
“BDSI Background IP ” b>means (a) any <a href=”#kt“>Patents a> or patent applications either granted or filed by BDSI and which are necessary or useful in the optimization, development , manufacturing, or distribution of CAMB and (b) any <a href=”#kt“>Know-How a> developed by or on behalf of BDSI which relates to CAMB.p>
“Collaboration IP ”b> means (a) any Know-How made, developed or conceived under the R&D Plan according to this Agreement in each case solely or jointly by an employee, consultant or agent of DNDi or BDSI or their respective Affiliates, subcontractors or sublicensees, (b) any Patents describing, claiming or covering the Know-How developed according to section 1.6, a, and (c) any other intellectual property rights in or to such Know-How .span>p>
“Distribution” b>means all activities that are undertaken after obtaining Regulatory Approval to make CAMB available to prescribers and/or users in the Territory for use in the Fieldp>
“Distribution Through the Public Sector” b>means Distribution, disposition or use of CAMB in the Territory for use in the Field by a <a href=”#kt“>Public Sector Agency a>.p>
“Territory” b>means all countries of the world excluding Japan, Australia, New Zealand, Russia, CIS countries, China, and all countries in North America and any country in, or that joins the European Union.p>
4. LICENSESb>span>p>
4.1 Licenses to DNDi.b> Subject to all of the terms and conditions of this Agreement, BDSI hereby grants DNDi: span>p>
(a) a worldwide, non–exclusive, royalty–free and fully paid–in, sublicensable (as permitted under Section 4.3) license to use BDSI Background IP for the purpose of conducting DNDi’s activities under the R&D Plan; span>p>
(b) an non–exclusive, royalty–free, irrevocable and fully paid–in, sublicensable (as permitted under Section 4.3) license to use BDSI Background IP and Collaboration IPR for the purpose of seeking <a href=”#kt“>Regulatory Approvals a> and undertaking Distribution Through the Public Sector in the Territory for use in the Field; provided, however that if, for any reason, BDSI is unable to supply CAMB ordered by DNDi or its nominee for Distribution Through the Public Sector, for use in the Field, in the Territory, this exclusive license shall be automatically extended to include the right for DNDi to manufacture CAMB, or to have CAMB manufactured by any Third Party, for the sole purpose of its Distribution Through the Public Sector in the Territory for use in the Field, subject to section 3.3. span>p>
4.2 License to BDSI.b> Subject to the terms and conditions of this Agreement, DNDi hereby grants BDSI a worldwide, exclusive, royalty–free, irrevocable and fully paid–in, sublicensable , license to make, have made, use, have used, offer to sell, sell, have sold, or import or have imported CAMB under the Collaboration IP (as defined under <a href=”https://ghiaa.org/provision_document/drugs–for–neglected–diseases–initiative–biodelivery–sciences–international–visceral–leishmaniasis–research–collaboration–agreement/” target=”_blank” rel=”noopener“>Section 6.1a>span>). span>p>
4.3 Sublicensing.b> DNDi may grant sublicenses to its Affiliates or to Third Parties under the licenses granted in Section 4.1 with the prior written consent of BDSI, not to be unreasonably withheld, provided that each approved sublicensee agrees to be bound by the terms of this Agreement. span>p>
4.4 No Implied Rights or Licenses;b> Retained Rights.b> Neither Party grants to the other Party any rights or licenses, including without limitation to any Patent , Know-How , or other intellectual property rights, by implication, estoppel or otherwise, except to the extent expressly provided in this Agreement. BDSI retains all rights in the BDSI Background IP and Collaboration IP that are not granted to DNDi in Section 4.1 or <a href=”https://ghiaa.org/provision_document/drugs–for–neglected–diseases–initiative–biodelivery–sciences–international–visceral–leishmaniasis–research–collaboration–agreement/” target=”_blank” rel=”noopener“>6.1a>span>, including all rights to manufacture, sell and Distribute CAMB in the Territory in any manner and context that is not Distribution Through the Public Sector. span>p>
4.5 Limitation to Territory.b> DNDi and its Affiliates, sublicensees, and distributors shall not Distribute CAMB outside the Territory or for use outside the Field, or conduct any Distribution except for Distribution Through the Public Sector. DNDi and its Affiliates, sublicensees, and distributors shall refer to BDSI any inquiries or orders for CAMB that they receive, where DNDi believes the use will be outside of the Field, or from outside the Territory or from any Third Party other than Public Sector Agencies . DNDi shall additionally take all reasonable steps ((as further described in <a href=”https://ghiaa.org/provision_document/drugs–for–neglected–diseases–initiative–biodelivery–sciences–international–visceral–leishmaniasis–research–collaboration–agreement–4/” target=”_blank” rel=”noopener“>section 3.3 (b)a>span>, and such as by example, but not limitation, changes in packaging and trade dress, use of tamper resistant materials and the like), necessary and work with and assist BDSI in preventing the redistribution, parallel importation or diversion of DNDi’s supply of CAMB.span>p>
6. b>INTELLECTUAL PROPERTYb>span>p>
[…]p>
6.6 Patent and Trademark Marking. b>Each Party shall mark, if necessary and requested by a Party, all materials manufactured, supplied or used under the terms of this Agreement, or their containers, in accordance with the applicable Patent and Trademark marking Laws in conjunction with and at the direction of the Party holding any patents or trademarks covering CAMB.span>p>

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