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2015-06-04 [p.2633]
Q-1155 — Ms. Duncan (Etobicoke North) — With respect to the Ebola vaccine developed at the National Microbiology Laboratory (NML): (a) on what date did research for the vaccine begin; (b) what are the names of the scientists involved in the research, and what are their positions; (c) why was the vaccine research initially undertaken; (d) was the research undertaken at any time in relation to anti-bioterrorism, and, if so, during what periods and with what specific mandate; (e) who provided funding for the research and development of the vaccine; (f) was the Government of Canada the only contributor to the research and development fund; (g) how much funding did the government provide, broken down by (i) percentage, (ii) department, (iii) date, (iv) dollar amount of contribution; (h) on what date was a robust immune response demonstrated to the vaccine; (i) on what date were research findings published and in what journal, and, if none were published, why not; (j) on what date was the vaccine patented and when was the initial patent application brought; (k) in which countries is the vaccine patented; (l) during what specific time period was the vaccine produced, (i) how many vials were produced, (ii) who was informed of this production, (iii) how were they informed; (m) was there a competitive process to sell the licensing rights or other entitlements relating to the vaccine; (n) if the process in (m) was created, (i) who developed the criteria for the licensing rights or other entitlements, broken down by position and department, (ii) what were the criteria to obtain the licensing rights or other entitlements, (iii) on what date was the competitive process launched, (iv) how many companies bid for the rights, (v) which companies bid for the rights and on what dates, (vi) how did NewLink Genetics (including Bioprotection Systems Corporation) meet the criteria for the licensing rights or other entitlements; (o) on what date was NewLink Genetics awarded the rights or entitlements; (p) what specific experience did NewLink Genetics have with vaccines, specifically when it comes to manufacturing capacity; (q) what NewLink Genetics products had reached the point of commercial production at the time of its bidding and purchase of the rights; (r) on what date did NewLink Genetics purchase the rights or entitlements from the Public Health Agency of Canada (PHAC), and for what cost; (s) as part of the licensing agreement, was NewLink Genetics expected to meet any milestones by any particular dates, (i) if so, when, (ii) if not, why not; (t) as part of the licensing agreement, what percentage royalties would NewLink Genetics pay Canada on any sales of the vaccine; (u) to date, how much income has the government obtained from licensing the vaccine, broken down by (i) up-front payments, (ii) milestone payments, (iii) any other payments; (v) did any of the NML or PHAC scientists/staff have any associations or links or monetary or proprietary interests or any other association with NewLink Genetics, and, if so, what are they; (w) did Canadian officials and the licensee meet annually in face-to-face meetings as required by Article 7.9 of the license agreement, and, if so, for all meetings, what is (i) the date, (ii) location, (iii) the names of all persons in attendance; (x) on what date did NewLink Genetics begin clinical trials of the vaccine; (y) how long was the delay between the onset of the commercial relationship with NewLink Genetics and start of clinical trials, broken down by (i) days, (ii) months, (iii) years; (z) what reason was given for the delay in (y); (aa) did the government question the progress of the clinical trials, if so, on what specific dates, and, if not, why not; (bb) in Canada's licensing agreement with NewLink Genetics, did Canada have the right to let other manufacturers make the vaccine for use in other countries "for compassionate care purposes" if NewLink had not received regulatory approval for the vaccine in the target country; (cc) did anyone in Canada urge the government to terminate its agreement with NewLink Genetics, and, if so, (i) who did so, (ii) on what dates, (iii) why; (dd) did anyone outside Canada request that Canada cancel NewLink's rights under the license, and, if so, (i) who did so, (ii) on what dates, (iii) why; (ee) did the government terminate the agreement, (i) if so, why, (ii) if not, why not; (ff) if the government terminated the agreement with NewLink Genetics, would Merck have paid the government the $30 million up front and $20 million once larger formal trials begun that went to NewLink Genetics, and would the government have been eligible to receive royalties on sales in certain markets; (gg) did the government approve of NewLink Genetics sub-licensing the vaccine to Merck; (hh) on what date did the government pay for IDT Biologika, to manufacture approximately 1 500 vials of the vaccine suitable for human trials, (i) how much was paid, (ii) was the Department of Defence involved, and, if so, why, (iii) did the Department of Defence contribute any funds; (ii) on what date did the Ebola outbreak begin in West Africa; (jj) on what date did the government reveal it had in storage an experimental vaccine that might be of use in combating the epidemic; (kk) on what date did the government offer vaccine to the World Health Organization (WHO); (ll) how many vials were sent to the WHO by the government, (i) on what date did the vials arrive, (ii) were there any delays; (mm) what are the results of the eight, phase l clinical trials in terms of (i) safety, (ii) immunogenic response, (iii) dose strength for phase 2/3 clinical trials; (nn) on what date did phase 2/3 clinical trials begin in Guinea, Liberia, and Sierra Leone; and (oo) what was the government’s involvement overall, broken down by (i) expertise, (ii) funding, (iii) personnel, (iv) other? — Sessional Paper No. 8555-412-1155.
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