Provision Language
Definitions
“Intellectual Property” means all Patents, trade-marks, copyrights, industrial designs, trade-names, trade secrets, Confidential Information and other intellectual property rights whether registered or not, whether proprietary or not
(i) owned by or licensed to Canada, relating to the Licensed Rights; or
(ii) owned by or licensed to the Company, relating to the Improvements made by the Company, its Affiliates or sub-licensees,
as the case may be.
“Licensed Rights” means the exercise, as of, on or after the Execution Date, in whole or in part, of
(i) the Patents and related Intellectual Property and Confidential Information and any subsequent changes thereto that are expressly incorporated into the License Agreement;
(ii) any Improvements owned by or licensed to Canada and related Intellectual Property and Confidential Information; and any subsequent changes thereto that are expressly incorporated into the License Agreement; and
(iii) Confidential Information respecting the manufacturing processes for products resulting from the exercise of other Licensed Rights (including without limitation Patents and Improvements) either owned by Canada or licensed to Canada. This Confidential Information includes, without limitation, information pertaining to production of prophylactic and therapeutic vaccines in sufficient quantities for use in the event of a bio-terrorist event involving filoviruses (EBOV Zaire and EBOV Sudan) and was provided to the Company prior to the Execution Date of this License Agreement, within the Field of Use.
“Patents” means:
(i) the patents and patent applications as listed in Appendix A (Description of the Patents);
(ii) any author certificates, inventor certificates, utility certificates, improvement patents and models and certificates of addition, and includes any divisions, reissues, renewals, reexaminations and extensions thereof, and all continuations, continuations-in-part and divisionals of the applications for such patents, continuations, continuations-in-part, extensions, re-issues thereof for those patents listed in “Appendix A”;
(iii) subsequently patented Improvements to Patents where those Improvements are made and patented by Canada; and
(iv) any and all foreign equivalents of any of the foregoing.
“Territory” means the entire world, always subject to:
(i) the United Nations Act, R.S.C. 1985, Chap. U-2;
(ii) the Export & Import Permits Act, R.S.C. 1985;
(iii) Chap. E-19, Special Economic Measures Act, S.C. 1992, Chap. 17;
(iv) Foreign Extra-Territorial Measures Act, R.S.C. 1985 c. F-29; and
(v) any other pertinent Canadian statutory or regulatory strictures.
For greater clarity Territory means all countries and jurisdictions of the world.
INTRODUCTION
[…]
G. WHEREAS the salient elements of this License Agreement are:
i) Canada grants to the Company (a) a sole, worldwide, revocable and royalty-bearing license to make, use, improve, Develop and Commercialize the technology in the field of prevention and prophylaxis against and treatment of Ebola (Zaire), a VHF virus, in humans, whether before or after exposure; and (b) a non-exclusive, worldwide, revocable and royalty-bearing license to make, use, improve, Develop and Commercialize the technology in the field of prevention and prophylaxis against and treatment of Ebola (Sudan), a VHF virus, in humans, whether before or after exposure;
ii) Canada will retain non-commercial rights in the technology, including rights to use and further develop the technology for educational and research purposes;
iii) Canada will retain commercial and non-commercial rights to license the technology to any third party outside the Ebola (Zaire) Field of Use and, subject to the foregoing, to license the technology to third parties within and outside the Ebola (Sudan) Field of Use, in each case, in the Territory;
iv) The Company grants to Canada a non-exclusive and royalty-free license to make, use, manufacture and sell in the Field of Use the VHF vaccine products Developed by the Company in the exercise of the Licensed Rights, in the event of a public health emergency; […]
H. WHEREAS the expectations of the Parties are that the Company will use commercially reasonable efforts to Develop a VHF vaccine and, assuming that any relevant and necessary statutory, regulatory and administrative authorizations or permits that may be required for a vaccine product are obtained, Commercialize it;
2.0 GRANT & RESERVATIONS
2.1 Grant: Subject to:
2.1.1 the definitions, terms and conditions of the License Agreement,
2.1.2 the Company complying with and not being in breach of any of the provisions of the License Agreement; and
2.1.3 any third party peremptory rights, Canada hereby grants to the Company: (a) a personal, non-transferable, sole, revocable, royalty-bearing license for Development and Commercialization in the Ebola (Zaire) Field of Use, and (b) a personal, non-transferable, non-exclusive, revocable, royalty-bearing license for Development and Commercialization in the Ebola (Sudan) Field of Use. Nothing herein shall constitute in any manner whatsoever:
2.1.4 an assignment or other transfer of proprietary rights in the Licensed Rights to the Company; or
2.1.5 any authorization or permission beyond that expressly given in this License Agreement.
2.2 Carve Out
Notwithstanding anything to the contrary in the License Agreement, Canada retains from the License Agreement, any and all absolute and unfettered rights necessary to do the following:
2.2.1 improve the Licensed Rights or Patents;
2.2.2 to carry out educational activities;
2.2.3 to pursue research and development, directly or indirectly, related to the Licensed Rights or Patents with or without the Company, collaborators or sponsors, with all attendant rights of publication;
2.2.4 to make, have made, manufacture, use, license sell and distribute and to administer (directly or through health care providers) to Canadians products resulting from the exercise of the Licensed Rights, the Patents and the Improvements in the event of a public health emergency pertaining or related to VHF in Canada, for the purpose of prevention or treatment of VHF, where:
2.2.4.1 neither the Company nor any of its Affiliates or sub-licensees has obtained regulatory approval of its product(s) under the Food and Drugs Act of Canada at the time the emergency is identified by Canada; or
2.2.4.2 neither the Company nor any of its Affiliates or sub-licensees is able to satisfy the demand for its approved product(s) in Canada at the time the emergency is identified by Canada;
2.2.5 to make, have made, manufacture, use and distribute and to administer to Canada’s staff products resulting from the exercise of the Licensed Rights, the Patents and the Improvements, for the purpose of prevention and treatment of VHF, whether in or outside a public health emergency in Canada or abroad;
2.2.6 to make, have made, manufacture, use, license, sell and distribute and to administer (directly or through health care providers) products resulting from the exercise of the Licensed Rights, the Patents and the Improvements, outside of Canada, for compassionate care purposes for the prevention or treatment of VHF, where:
2.2.6.1 neither the Company nor any of its Affiliates or sub-licensees has obtained regulatory approval of its product(s) under the laws of the foreign country in question at the time the compassion care is identified by Canada; or
2.2.6.2 neither the Company nor any of its Affiliates or sub-licensees is able to satisfy the demand for its approved product(s) in the foreign country in question at the time the compassionate care is identified by Canada; and
2.2.7 to grant licenses to any third party, for commercial and non-commercial purposes, concerning the Patents and related Intellectual Property and the Confidential Information of Canada:
a) outside the Ebola (Zaire) Field of Use; and
b) subject to subsection (a) above, within and outside the Ebola (Sudan) Field of Use, in each case of (a) and (b), in the Territory.
2.3 Non Compete by Canada
Subject to clause 2.2, Canada shall not commercially compete with the Company, or grant a license to any third party for commercial purposes, within the Ebola (Zaire) Field of Use concerning the Licensed Rights in the Territory. Without limiting the generality of the foregoing, Canada hereby verifies that, with the exception of biological reagents used for non-compendial release testing, it has provided access to and use of Materials (as defined in the MTA) to third parties only for use outside the scope of the license under the Licensed Rights in the Field of Use.
2.4 Sub-licensing Permitted
As regards sub-licensing:
2.4.1 The Company is permitted to sub-license Affiliates and non-affiliated or non-controlled parties, on the same terms and conditions of this License Agreement. The Company has no right to encumber any contractual, legal or equitable rights the Company may have against any Affiliate or sub-licensee in favour of any financial institution or any third party whatsoever;
2.4.2 The Company is permitted to grant to its sub-licensee Merck a right to sub-sublicense or subcontract to: (i) Merck’s affiliates; and (ii) Merck’s non-affiliated or non-controlled parties pursuant to or in connection with contracts with, or services by, such non-affiliated or non-controlled parties for Development, manufacture or Commercialization; ((i) and (ii), collectively referred to hereafter as “Merck Ordinary Course Sub-licenses“), and, subject to clause (ii) of Section 2.4.3, no consent for a Merck Ordinary Course Sub-license shall be required. The Company shall require that any Merck Ordinary Course Sub-licenses be consistent with the terms of the License Agreement and not exceed the scope and rights granted to the Company under this License Agreement; provided that Merck Ordinary Course Sub-licenses are not required to carry a royalty payable to Canada and will not be subject to the obligations set forth in Section 2.5 (save and except for the obligation set forth in 2.5.4), 2.6 or 5.4 of the License Agreement; however, any Sale by a Merck Ordinary Course Sub-licensee shall be deemed a Sale by Merck for the purpose of section 5.2 of the License Agreement and any royalty paid by Merck relating to a Sale by a Merck Ordinary Course Sub-licensee to the Company shall be counted as a royalty for the purpose of section 5.4 of the License Agreement; and
2.4.3 To the extent that the Company’s sub-licensee Merck desires to enter into a sub-sub-license (i) other than the Merck Ordinary Course Sub-licenses or (ii) a Merck Ordinary Course Sub-license which would include a sub-sub-license of the majority of Merck’s Commercialization rights to a third party in the Territory, the Company shall, on behalf of Merck, seek the prior written consent of Canada. Canada shall have thirty (30) calendar days, from the date it receives from the Company a notice in compliance with section 20.1 of the License Agreement, to respond to the request. Canada’s consent to the request shall not be unreasonably withheld.
2.4.4 For greater certainty, the Company acknowledges and agrees that it remains primarily liable to Canada for all of the Company’s duties and obligations contained in the License Agreement, including duties and obligations relating to sub-licenses and sub-sub-licenses mentioned in 2.4.1, 2.4.2 and 2.4.3.
2.5 Sublicensing Conditions
Except as otherwise set forth in the License Agreement (including with respect to any Merck Ordinary Course Sub-licenses, save and except for the obligation set forth in 2.5.4), any sub-license or any amendment to any sub-license granted by the Company to Affiliates and non-affiliated or non-controlled parties, shall:
2.5.1 be royalty-bearing, revocable, without the right to sub-sub-license, except with the prior written consent of Canada, which consent shall not be unreasonably withheld;
2.5.2 carry a royalty rate no less than that prescribed in the License Agreement;
2.5.3 be only within the Territory or any portion thereof
2.5.4 be only within the Field of Use or a subset thereof;
2.5.5 be subject to the same obligations and restrictions as those required of the Company under the License Agreement;
2.5.6 be copied to Canada immediately following execution; and
2.5.7 not be a de facto assignment.
For greater clarity, Canada shall receive from the Affiliates and sub-licensees not less than the same amount of consideration Canada would have received from the Company, had the Company conducted the Commercialization rather than the Affiliates or sub-licensees. The Company shall ensure that any monies owing to Canada from the Affiliates or sub-licensees are paid to Canada when due, and shall be liable for any such monies irrespective of whether or not the Affiliate or sub-licensee paid the Company.
2.6 Sub-Licensee Consideration
In addition to the royalties payable by the Affiliates and sub-licensees to Canada as contemplated in paragraph 2.5 (Sub-licensing Conditions), the Company shall also pay to Canada [*] paid by the Affiliates and sub-licensees to the Company in accordance with paragraph 5.4.
2.7 Termination
Except as otherwise set forth in the License Agreement, termination of the License Agreement shall also terminate any subsisting sub-licenses, but any consideration due or owing to Canada shall be paid promptly thereafter, and any and all unsatisfied obligations and rights shall subsist until satisfied.
4.0 EXPLOITATION OF LICENSED RIGHTS
4.1 Business Plan
The Company shall submit a business plan to Canada by no later than December 31, 2017, containing Company’s then-current development plans for the Licensed Products and commercial plans. Company shall provide Canada with an update to the business plan at least once every twelve (12) months to reflect Company’s then-current plans. Canada shall have the right to request amendments to the business plan in order to ensure maximum commercial return to the Company and Canada in accordance with this Article 4 (Exploitation of Licensed Rights). The Company shall use commercially reasonable efforts to ensure that the business plan submitted to Canada pursuant to this section 4.1 includes Merck’s (and its affiliates’ and sub-licensees’) then-current development plans for the Licensed Products and, if available, commercial plans.
4.2 Disclosure Requirements
The business plan shall provide sufficient detail to show how the Company plans to diligently research, Develop and promote and make commercially reasonable efforts to Commercialize. This business plan shall also disclose any
4.2.1 distribution and agency arrangements contemplated by the Company;
4.2.2 market studies pertinent to the Licensed Rights;
4.2.3 pro forma financial statements of sufficient detail to allow a thorough financial analysis of the Company’s assumptions, projected revenue streams and costs.
[…]
4.6 Commercially Reasonable Efforts to Commercialize
As an inducement to Canada to enter into the License Agreement, during the Term (or the renewal) of the License Agreement, the Company shall:
4.6.1 use commercially reasonable efforts to Commercialize;
4.6.2 use commercially reasonable efforts to create and satisfy demand for the Licensed Rights; and
4.6.3 not do, or assist anyone to do, anything inimical to the Commercialization.
Payment of fees and royalties under Article 5 (Fees & Royalties) does not relieve the Company of its obligation under paragraph 4.6 (Commercially Reasonable Efforts to Commercialize).
4.7 Shelving a Fundamental Breach
Any “parking”, “shelving” or other activity or inactivity concerning the Licensed Rights whereby the Company is not using its commercially reasonable efforts to diligently and aggressively Commercialize the Licensed Rights in the Territory, is a fundamental breach of the License Agreement.
8.0 OWNERSHIP OF TECHNOLOGY / IMPROVEMENTS
[…]
8.6 Company Improvements – License to Canada
The Company hereby grants to Canada a personal, non-transferable, non-exclusive, worldwide, perpetual, irrevocable, royalty-free and fully paid-up license for the Improvements (including data and reports related thereto), made by or on behalf of the Company under paragraph 8.4 (Improvements – Ownership) and disclosed to Canada under paragraph 8.5 (Improvements – Disclosure) for the purposes set out in paragraph 2.2 (Carve Out), save and except for the purposes set out in paragraph 2.2.7. Further, Canada may sub-license such Improvements for the purposes of carrying out the purposes set out in paragraph 2.2 (Carve Out). Termination of the License Agreement shall not terminate the foregoing license to Canada or any subsisting sub-licenses. For greater certainty, the Company shall ensure that its sub-licensee Merck (and its affiliates and sub-licensees) complies with this section.