Kasondra White

Engagement with the Government regarding the Life Science Fund seeking partnership and funding to support completion of Phase I and Phase II clinical research program associated to AMR (antimicrobial resistance) Antimicrobial Resistance (AMR) - Seek funding and support for pilot projects making anti-infective medications available to equity seeking populations, helping to combat AMR. Also discuss any applicable conditions regarding this funding. Programs and policy to support Canadian biomanufacturing and access to medicines and vaccines for Canadians. National Immunization Strategy and policies and programs that impact public access to vaccines and disease prevention in Canada. Patented Medicines Review Board (PMPRB), certified under the Patent Act and whose guidelines seek to ensure a balance between the prices set by manufacturers for patented medicines sold in Canada and the maintenance of an attractive environment for pharmaceutical research and development. Engagement with federal officials regarding the Biomanufacturing & Life Sciences Strategy and policies and programming related to biomanufacturing in Canada Access to medicines - government policies, processes, legislation, and/or regulation with potential impact on access to medicines in Canada. Trade-related matters, including policies and tariffs impacting medicines and vaccines. Policies and programs related to the health of new immigrants to Canada. Policies, programs, and funding related to Canada's Sexually Transmitted and Blood-Borne Infections (STBBI) Action Plan 2024-2030. Engagement with federal officials regarding Health Emergency Readiness Canada. The National Pharmaceutical Strategy (NPS) as agreed by First Ministers in 2004. Advocacy for ways to increase access to medicines and vaccines for Canadian patients. The Common Drug Review (CDR) process for reviewing new drugs and providing listing recommendations to publicly funded drug benefit plans in Canada. Ensuring the access needs of Canadian patients are met by advocating on activities undertaken in the context of the CDR. Science and Technology (S&T) Strategy: Mobilizing Science and Technology to Canada's Advantage. Advocacy for measures which will allow for commercialization in health care to occur and for Canada to remain competitive internationally on Intellectual Property and other fronts. Public Services and Procurement Canada (PSPC) Integrity Framework - Clarifying the process for procurement of vaccines and possibly pharmaceuticals under the evolving procurement framework. Patented Medicines (Notice of Compliance) Regulations which seek to balance the protection of Intellectual Property (IP) and patents with cost containment. Advocacy to ensure that IP rights are respected and internationally competitive in order to promote Research and Development. Legislation, regulations, policies and programs concerning the federal government's response to COVID-19, including pandemic preparedness, pharmaceutical and vaccine supply-chain management, and general administration of justice. Food and Drugs Act and the bill formerly known as Bill C-51: An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts. Specifically, with respect to the renewal of the drug approval process. Advocacy to ensure that Canada's review and approval process is timely, safe, effective, competitive and consistent with other jurisdictions. FedDev Ontario Advanced Manufacturing Fund - advancing manufacturing of innovative pharmaceutical products in southern Ontario Engage with government to strengthen the Priority Review for Drug Submissions process. Engage the Government regarding the need for clear and efficient procurement processes for COVID-19 medical countermeasures, including COVID-19 therapeutics, to ensure access for Canadians. Engagement with the Government regarding the Strategic Innovation Fund Drug Re-importation - Raise awareness regarding the potential risks to drug and vaccine supply fo

Science & Technology Strategy - promotion of enhanced measures to increase research in science and technology Indirect Costs Program - support for enhanced provisions Increased support for commercialization of university research results Federal Research Granting Councils and agencies funding of research, academic pursuits, and publication or dissemination Centres of Excellence - promotion of increased funding for establishment of Centres of Excellence in research Budget - promotion of increased funding of research and academic pursuites

Public health and prevention programs including the Public Health Agency of Canada and efforts to support the development and procurement of innovative vaccines and therapies to address major public health issues such as pandemic preparedness and RSV Federally-funded public drug plans, including the Non-Insured Health Benefits program, Canadian Armed Forces Drug Benefit List and veteran programs, with respect to reimbursement for drug products for beneficiaries Canada's Drug Agency policies and processes as it relates to reimbursement recommendation decision-making process and framework Engage with Canadian government officials to discuss and provide input on Canada’s countermeasures and policies in response to foreign tariffs affecting the pharmaceutical industry, as well as free trade agreements as they relate to the biopharmaceutical industry Establish accountability with Health Canada, Canada’s Drug Agency and the pan-Canadian Pharmaceutical Alliance, as well as Regulations, policies and programs related to the review and reimbursement processes Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products Policy measures to ensure security of drug supply in Canada and preserve Canada’s attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations Policies and frameworks to accelerate access to innovative medicines post-Health Canada approval, including efforts to reduce time-to-reimbursement and streamline federal/provincial listing processes Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Engagement with the Government regarding the Strategic Response Fund (SRF) (previously known as SIF) and investment in Canada Annual federal Budgets and Budget updates relating to the biopharmaceutical industry. Scientific Research and Experimental Development (SR&ED) Tax Incentive Program regarding eligible expenditures. Discussions on policies such as "patent box" and Investment Tax Credits.

Pharmaceutical pricing policy arising from the jurisdiction of the patented medicine prices review board (PMPRB). Arranging meetings to brief government officials on the business of Boehringer Ingelheim Canada Ltd.

International trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Internal trade regarding tobacco control, alcohol, products containing carcinogens and products associated with cancer. Funding for programs to be operated by the Canadian Cancer Society to advance cancer control. Canadian Partnership Against Cancer, as it relates to continued federal funding for the cancer control strategy Canada Health Transfer and health system bilateral funding agreements intended for provinces/territories to support the delivery of healthcare services Framework Convention on Tobacco Control, including protocols, guidelines and implementation Tobacco and Vaping Products Act, as it relates to regulations, implementation and enforcement Non-Smokers' Health Act including implementation and enforcement Food and Drugs Act and regulations, as it relates to nciotine replacement products Federal Tobacco Control Strategy, including all matters related to tobacco control Taxation, revenue measures, controlled products regulations, including implementation, for alcohol, tobacco control, products containing carcinogens and products associated with cancer. Communication regarding alcohol consumption guidance. Food and Drugs Act and regulations, as it relates to alcohol warning labels Food and Drugs Act and regulations, as it relates to restricting the advertising to children of foods high in sodium, sugars and saturated fat. Healthy Living - Supporting initiatives, legislation, regulation, policies, and programs that prevent cancer or improve the social determinants of health Adoption of HPV testing and increasing HPV vaccination rates Sustainable funding of the National Advisory Committee on Preventive Health Services to ensure timely, up?to?date cancer screening guidelines Equitable and timely access to cancer screening. Measures and funding related to the charitable sector generally Equitable access to care along the full cancer continuum for First Nations, Inuit and Métis communities Employment Insurance special benefit programs, including the sickness benefit and compassionate care benefit Canada Labour Code and Employment Insurance Act, as it relates to job-protected leave, employment insurance special benefits, return to work policies, and human rights protections for people affected by cancer Access to information and support to make decisions regarding end-of-life care, including Medical Assistance In Dying Supports for mental health during people's cancer journeys Implementation and funding of the National Grief Action Plan as part of the government's work on palliative care and mental health Canada Health Act as it relates to access to care, including long-term, home, and palliative care National Caregiving Strategy Financial supports for caregivers, including the Canada Caregiver Credit Implementation of the Framework on Palliative Care in Canada and integration of a palliative approach to care in our health system, including national standards and data, care provider training, research, and implementation of the National Grief Action Plan and distinctions?based frameworks for First Nations, Inuit and Métis people Setting and measuring pan-Canadian wait time benchmarks and targets and measures to address them, including addressing healthcare shortages, increased and sustainable funding for care, infrastructure and equipment, targeted strategic funding to PTs for workforce shortages, particularly in rural and remote communities. Sustained core funding for federal research agencies, improved coverage of indirect research costs, Canadian research sovereignty, strengthening capacity and the economic benefits of domestic research, research commercialization. Increasing access to care including models of care, removing barriers to care, particularly for underserved communities, using innovative approaches to improve access to care including AI to improve timely diagnosis and treatment. Issu

strategic policy objectives for the MedTech sector regarding 2026 CUSMA review. export permits and export controls • Government investments in Artificial Intelligence (AI) compute infrastructure; • Government policy considerations on health data trust and privacy. Substances addressed in the third phase of the Chemicals Management Plan. Support from ISED, with respect to Strategic Innovation Fund Medical device cost recovery schemes with respect to filing fees Engage in pre-market and post-market regulatory requirements to ensure efficient and predictable processes that supports safety, effectiveness, quality, and Canada’s competitiveness in the medical device sector. Amendments to Copyright Act, regarding Technology Protection Measures (TPMs)

Regulations, policies and programs related to the reimbursement recommendations decision-making process and framework done by the Canadian Agency for Drugs and Technologies in Health (CADTH)/Common Drug Review as well as the review times and processes conducted by Health Canada for the purpose of obtaining a notice of compliance. National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathways for drugs for rare diseases and the government strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs that would provide greater clarity and predictability in the tax outcomes and improvements to tax measures such as the Manufacturing & Processing (M&P) credit and the Scientific Research & Developmental (SR&ED). Common Drug Review Policies as it relates to reimbursement recommendation decision-making process and framework. Federal Public Drug Plans, with respect to the reimbursement of therapeutic products for Federal plan beneficiaries Policies related to the National Strategy for Drugs for Rare Disease as it relates to separate regulatory pathway for drugs for rare diseases and the government strategy. Policies related to Subsequent Entry Biologics (SEBs) pertaining to Draft Guidance for Sponsors; Information and Submission requirements for SEBs, regulations and intellectual property policies, naming conventions Monitoring and engaging on the Government’s commitment (Budget, SFT, Fall Economic Update) to create a national strategy for drugs for rare diseases; create a new Canadian Drug Agency; and the implementation of national, universal pharmacare. Pharmaceutical policy and any negotiations of a Health Accord or agreement with the Provinces/Territories, as it relates to National Pharmacare/universal or catastrophic drug coverage, Drug policies & Pricing. The Department of Innovation, Science and Economic Development and the Innovation Agenda for the life sciences sector: policy or program initiatives to support life science research and development conducted in Canada and manufacturing capability, and as it relates to Canada’s Biomanufacturing and Life Sciences Strategy. Monitoring and engaging the Government and Parliamentarians on policies and programs related to Canada's biomanufacturing and life sciences sector strategy National Pharmacare (Bill C-64, An Act respecting pharmacare) Canadian Environmental Protection Act and Regulations in respect of modern, science-based regulations to reflect rapidly changing new technologies. Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products. Income Tax Act as it relates to biopharmaceutical industry. Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry, and related updates and to Federal budgetary policy. Discussions around the World Trade Organization consideration of a TRIPS Patent Waiver - Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility". The Food and Drugs Act, or the Export and Imports Permits Act (Export Control List) or any other legislative and regulatory means in order to protect the Canadian supply of drugs in light of importation legislation in the United States. Standing Committee on Finance (FINA) as it relates to pre-budget consultations. Pharmaceutical intellectual property protection as it relates to international trade agreements Patent Act and Patented Medicines (Notice of Compliance) Regulations, as it relates to the regulation of intellectual property, approval for therapeutic products, changes to modernize the Right of Appeal House of Commons Standing Committee of Science and Research (SRSR) as it relates to Science in Canada and/or any other pertinent legislative proposal before the committee House of Commons Standing Committee of Industry and Technology (INDU) as it

Canada's Drug Agency policies as it relates to reimbursement recommendation decision-making process and framework Biomanufacturing and Life Sciences Strategy (BLSS) as it relates to the biopharmaceutical industry. Federal policies that relate to possible models of pharmacare Federal Buy Canadian Procurement Policy as it relates to government drug procurement practices and the implications for the biopharmaceutical industry Policies and frameworks to accelerate access to innovative medicines post-Health Canada approval, including efforts to reduce time-to-reimbursement and streamline federal/provincial listing processes Policy measures to ensure security of drug supply in Canada and preserve Canada's attractiveness for biopharmaceutical launches, including in response to foreign pricing regulations National Strategy for Drugs for Rare Diseases World Trade Organization (WTO) issues concerning the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) with respect to the protection of data, Access to Medicines, and TRIPs "flexibility" World Intellectual Property Organization (WIPO) issues concerning the biopharmaceutical industry World Health Organization (WHO) issues concerning the biopharmaceutical industry Scientific Research and Educational Design (SR&ED) Tax Credit in respect of updating the system and increasing the expenditure limit for refundable credits Pharmaceutical pricing policy issues arising from the jurisdiction of the Patented Medicines Prices Review Board (PMPRB) Patented Medicines Regulations as it relates to the regulation and protection of biopharmaceutical products Patented Medicines (Notice of Compliance) Regulations with respect to ensuring that patent rights are respected and are internationally competitive Patented Medicines (Notice of Compliance) Regulations as it relates to the regulation of intellectual property for biopharmaceutical products Patent Act as it relates to reporting requirements and pricing guidelines, and the protection of intellectual property in biopharmaceutical products Income Tax Act as it relates to biopharmaceutical products Health Canada's Regulatory Roadmap for Health Products and Food as it relates to the biopharmaceutical industry Free trade agreements as they relate to the biopharmaceutical industry Food and Drugs Act and Regulations and the Import and Export Permits Act with respect to cross-border trade as it relates to the export of Canadian biopharmaceuticals Food and Drug Regulations as it relates to data protection and the regulation and protection of biopharmaceutical products Canadian Institutes of Health Research (CIHR) Clinical Research Initiative as it relates to public/private research and development partnerships Annual federal Budgets and Budget updates as it relates to the biopharmaceutical industry

Policies aimed at reinforcing pharmaceutical supply chain. Discussion regarding the launch of new branded product in the rare disease space Improvements to the supports offered by the federal government to support R&D; in particular, generic drug research and development. Seeking support from the Strategic Innovation Fund Program for support of biomanufacturing expansion project. Policies aimed at facilitating generic drug repurposing. Discussion on the opioid crisis and the Health minister's expectations from pharmaceutical manufacturers Discussion of regulatory impediments to the launch of pediatric formulations of branded and generic products. Discussion of a possible Therapeutics Products Directorate ("TPD") workstream on complex generics regulatory pathways.

Support of the promotion of biotechnology and science education and innovation in Canada Seeking potential funding opportunities from the Strategic Innovation Fund to allow the company to further research, development and/or expansion of manufacturing. Federal/Provincial/Territorial vaccine procurement programs administered by Public Services and Procurement Canada with regard to the recommendation and funding of vaccines through Public Health programs by governments in Canada, including issues that relate to the National Immunization Strategy.