Public Health Agency of Canada (PHAC) – Bioprotection Systems Corp., Ebola Vaccine License Agreement

Business model | Regulatory strategy

Structural Questions

Which party is responsible for obtaining and maintaining regulatory approvals?
In which jurisdiction(s) should the responsible party seek regulatory approvals?
Will the parties seek regulatory exclusivity in any jurisdictions?
How will the parties cooperate and share information related to regulatory approvals? Do the parties grant each other rights of reference to their regulatory materials?
What are the parties’ obligations in relation to pharmacovigilance activities?

Annotations

This Amended and Restated License Agreement between the Public Health Agency of Canada (“PHAC” or “Canada“) and Bioprotection Systems Corporation (“Company” or “BPS“) relates to PHAC’s recombinant vesicular stomatitis virus vaccine for viral hemorrhagic fevers (“VHF“).

Under the Agreement, BPS receives licenses to develop and commercialize PHAC’s technology for prevention and treatment of Ebola (Sudan) and Ebola (Zaire) (“Field of Use“) worldwide (“Territory“). The license for Ebola (Zaire) is exclusive and the license for Ebola (Sudan) is non-exclusive.

PHAC retains educational and research use rights, as well as rights to make, use, manufacture and sell vaccine products developed by BPS in the event of a public health emergency in Canada, or for compassionate care purposes in other countries, if BPS has not obtained regulatory approval for the products or cannot meet demand for approved products.

Provisions related to pricing on sales to PHAC and emergency access have been redacted from this publicly available copy of the Agreement.

BPS entered into a license and collaboration agreement with Merck for further development and potential commercialization of BPS’ Ebola vaccine product candidate. The agreement with Merck includes a sublicense of the patents under this PHAC License Agreement.

Provision Language

10.0 PATENT PROTECTION & REGULATORY REQUIREMENTS

[…]

10.3 The Company Shall Obtain Regulatory Permissions. The Company shall use commercially reasonable efforts to obtain any authorizations, permits, certificates or other regulatory permissions which may be required in order for the Company to legally carry out all of its activities under the License Agreement , including but not limited to Commercialization, at the Company’s sole cost and expense without right of set-off.

10.4 Her Majesty Not Obligated. Nothing in the License Agreement shall obligate any emanation of Her Majesty the Queen in Right of Canada to grant any required authorizations, permits, certificates or other regulatory permissions. Conversely, there is no implication by the execution of the License Agreement that the Company will be granted any required authorization, permits, certificates or other regulatory permissions necessary for the effective Commercialization of the Licensed Rights.

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Public Health Agency of Canada (PHAC) – Bioprotection Systems Corp., Ebola Vaccine License Agreement

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Public Health Agency of Canada (PHAC) – Bioprotection Systems Corp., Ebola Vaccine License Agreement

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