The Life Sciences Innovative Manufacturing Fund (LSIMF)

The Life Sciences Innovative Manufacturing Fund (LSIMF) is a capital grants fund which aims to build resilience for future health emergencies and capitalise on the UK’s world-leading research and development capabilities. The fund will enhance and accelerate affordable access to mature, new and emerging Life Sciences products for both pandemic and non-pandemic scenarios. LSIMF will provide up to £520 million in capital grants for investment in the manufacture of human medicines and medical technology (including diagnostics, and MedTech products). This is a new fund from previous UK Government Life Sciences manufacturing funds. LSIMF is open to all eligible companies, including previous manufacturing grant recipients, as long as the application is for a different project. Projects with a total cost (including capital expenditure) of at least £8 million are eligible to apply. The maximum intervention rate (ratio of grant to project costs) is 25%, with the typical intervention rate being 10-20% of your total project costs. For example, for a project with a total cost of £100m, the typical grant awarded might be £10-20m. Your project must align with the objectives of the fund: • To increase UK health resilience by strengthening the UK’s manufacturing capacity and capability. We define health resilience as the UK’s ability to withstand and recover from health emergencies such as pandemics, long-term healthcare challenges and supply chain disruption. For example, your project may improve health resilience by supporting or demonstrating a broad spectrum increase in domestic manufacturing capacity and capability that supports UK health resilience, and/or enhanced flexibility of manufacturing capability that can be redeployed or scaled during a health emergency. • To create economic opportunity through investments that will make a substantial contribution to Gross Value Added (GVA) and provide high-wage, high-skilled jobs around the UK. Both of these objectives are equally weighted. Projects scoring highly against one objective may be progressed even where they score less strongly against the other – for example, a project with a strong health resilience case may be supported despite a lower economic score, and vice-versa. Nevertheless, all applications must meet a minimum threshold against each objective in order to progress.

Your company To be eligible to apply for the fund, your company must be: • A UK registered company, or a UK registered establishment • UK establishments must also have at least one UK registered company in their group structure • A wholly private sector business • A product developer, contract development manufacturing organisation, or a generics manufacturer. Applicants must also be able to provide two years of audited accounts for the applicant company (and/or if applicable, parent entity). If this is not available – for example because the company is not required by Companies House to submit audited accounts – we will ask for demonstration that the remaining funding required for the project to go ahead is available. You may be also asked for evidence that your company (or if applicable, parent entity) has a track record of successfully manufacturing medicines or medical devices in the UK or abroad, or that you have successfully developed a product intended for commercial scale-up. Your project To be eligible for the fund, your project must: • Have a total eligible cost of at least £8 million . Eligible costs include capital, R&D and skills/training expenditure. This should exclude operational expenditure. • Be located in the UK • Be primarily a capital investment • Be a single company investment, or a joint investment between multiple entities within the same company group structure (as opposed to forming a partnership between independent companies or other types of organisations) • Require only the amount of grant requested to proceed. For example, without the specific amount of funding you are requesting your project wouldn’t go ahead or go ahead at a smaller scale, go ahead overseas or would be significantly delayed (3 years or more) Your project must be a manufacturing project for the manufacture of: • Human medicines (this includes both the manufacture of active pharmaceutical ingredients (API) / drug substance and finished product / drug product) • Medical diagnostics – for both disease identification and monitoring • MedTech products – all types of medical devices related to human health. The fund is open to applications for MHRA-licenced medicines, medical and diagnostic devices registered with the MHRA, and products in development where approval to market or manufacture the medicine or device in the UK is intended to be sought for commercial scale-up, for example a manufacturing project for clinical trials or investigational studies. • Manufacturing facilities are required to work to Good Manufacturing Practice (GMP) and the facility be intended to support clinical and/or commercial manufacture of API or drug product. • Manufacturers of medicinal diagnostics and medical devices must confirm that their device meets or intends to meet the requirements of the Medical Devices Regulations 2002. Projects relating to the following are not eligible for funding from LSIMF: • Veterinary medicine • Herbal medicines • Nutritional supplements or vitamins • Raw ingredients (e.g solvents, buffers and cleaning agents) • The production of single-use consumables that are not integrated into a larger product (e.g manufacturing syringes independently from diagnostic kits) • Secondary packaging for products or materials (e.g package inserts, labelling and boxes).

How to apply LSIMF is now open for EOIs. Please click the button above to complete and submit your EOI form. If you have any questions, please contact LSIMF@officeforlifesciences.gov.uk . The LSIMF application process is comprised of three parts: • The Expression of Interest (EOI) – we will use the EOI to evaluate your basic eligibility and identify projects that align with the Fund objectives. Eligible projects will be invited to the next stage. We are open to EOIs on a rolling basis, but submission does not constitute an application into LSIMF. • Health resilience assessment – we will assess the health resilience benefits of your project: • • Application form 1 – application windows will open on a quarterly basis. Eligible applicants will be invited to complete application form 1. Here, you will be asked to describe the health resilience benefits of your project. This stage is assessed by a panel of cross-government officials. • Panel interview – applicants will also be invited to give a brief presentation on your project and it’s health resilience benefits followed by a Q&A. This will be hosted by the panel of manufacturing experts, who will further assess the health resilience benefits of the project. • Financial and economic assessment • Application form 2 – applicants who are successful following the health resilience assessment will be invited to complete application form 2. Questions will cover eligibility, company and project specifics and financial information, markets and economic impacts and project risks​. You will be required to provide further documentation to evidence your company’s financial position, eligibility and project viability. • Due diligence - We will assess whether your grant request offers good value for money, ensure compatibility with subsidy control regulations, validate what would happen without a grant, and confirm the project’s deliverability, employment outputs and your ability to finance it. You may be required to provide further documentation to evidence your company’s financial position, eligibility and project deliverability Throughout the application process, it is the applicant’s responsibility to ensure: • All information provided in the application is current and correct • Your proposal meets the eligibility and scope criteria • All sections of the application forms are complete • In the event multiple colleagues are collaborating on the application, that all partners have completed their assigned section(s) and accepted the terms and conditions.