Intellectual Property Commercialisation Agreements

Intellectual Property Commercialisation Agreements is sponsored by Wellcome. Guidance on managing and commercialising Wellcome-funded intellectual property to maximise public health benefit.

We need organisations to complete an intellectual property and commercialisation report once a year. This report covers the intellectual property and commercial activities at your organisation during the reporting period. The reporting period is the calendar year from 1 January to 31 December.

* Wellcome-funded intellectual property at your organisation * commercialisation of this intellectual property through commercial agreements * revenue or ownership in a company you have gained as a result of commercial agreements using Wellcome-funded intellectual property For information about Wellcome’s approach to intellectual property, including what we mean by intellectual property and commercialisation, and why we ask for this report, read our intellectual property policy.

## Confidentiality statement Where a party discloses information about intellectual property creation and/or commercialisation activities to the other party in this report or otherwise, the receiving party will keep such information confidential.

‘Information’ includes but is not limited to any data, results, inventions, intended publications, intended or pending patent applications, designs, plans, agreements, commercial and/or financial information, whether disclosed in writing or verbally.

‘Information’ does not include information which is available to the public, is otherwise lawfully known to the receiving party at the time of being disclosed, is obtained lawfully from a third party or independently developed by the receiving party, or which needs to be disclosed to comply with a legal requirement.

The parties acknowledge that the information contained in this report may be information which the parties reasonably consider is exempt from disclosure under the Freedom of Information Act 2000 on the basis that it is confidential and/or commercially sensitive information, which if disclosed without the prior consent of the party to which the information relates, would, or would be likely to, prejudice the commercial interests of that party.

Wellcome may disclose relevant data to co-funders (under appropriate confidentiality restrictions) and may publish aggregated data. The administering organisation on any Wellcome award is responsible for reporting to Wellcome, unless bespoke arrangements apply. If your organisation needs to submit an intellectual property and commercialisation report, we will contact you in advance.

The report must be completed by the appropriate person or people at the technology transfer or research office or any other appropriate central function at your organisation. It will not be sent to individual researchers. ## Steps to complete your report ### 1.

Join your organisation’s workspace on Wellcome Funding You must complete your report online on the Wellcome Funding platform. Only an intellectual property reporter in your organisation’s workspace can fill in and submit it. Administrators can add new team members to the workspace if needed.

If an intellectual property reporter does not already exist, organisation approvers for your organisation’s workspace will receive an invitation allowing the relevant people at your organisation to set up accounts and join the workspace. ### 2.

Complete the report online #### Fill in all sections that apply to your organisation You must report on intellectual property and commercial activities from: * all active Wellcome-funded awards at your organisation; and * awards that are no longer active but where intellectual property is still being developed. Intellectual property reporters can access and edit the report at the same time.

They cannot edit the same section of the report at the same time. #### Awards that do not always need to be included in your report #### Submit your answers to complete your report After you have filled in all sections that apply to your organisation and marked them complete: * you will be able to submit your answers.

They cannot be edited after this * after submitting your answers you must download the declaration form which needs to be signed and uploaded on your organisation’s letterhead * if applicable, you will then be able to fill in and submit a revenue retention request ### 3.

Submit a revenue retention request You can apply to keep Wellcome’s share of revenue your organisation has received in the year covered by an intellectual property and commercialisation report. We call this revenue retention.

## How to complete each section of the report ### Inventions and related patent applications We require information about any invention disclosures during the reporting period or related patent applications that use any Wellcome-funded intellectual property, in whole or in part.

If the patent is part of a patent family, you must only add information for the invention disclosure once, and provide details of the patent family and details of all the awards that have contributed to the Wellcome-funded intellectual property in the patent family. We require information about any patents granted during the reporting period that use any Wellcome-funded intellectual property, in whole or in part.

If the granted patent is part of a patent family, you will only need to add information for the patent family, including details of: * all the awards that have contributed to the Wellcome-funded intellectual property in the patent family * a title to describe the patent family * all of the patent numbers in the patent family You must also update the status of your patents, for example, if a patent is no longer active.

You can change the status of a patent, including for a patent you have told us about in previous reports, to explain the reason that it is no longer active and the date that this happened. ### Intellectual property (excluding patents) We require information about other intellectual property (excluding patents) generated during the reporting period that uses any Wellcome-funded intellectual property, in whole or in part.

This includes the type of intellectual property, such as: * commercialisable databases You must also provide a short description of its purpose and what it can be used for. ### Commercial agreements We require information about any commercial agreements you have made during the reporting period that use any Wellcome-funded intellectual property, in whole or in part. Refer to our intellectual property policy for more information.

Examples include agreements such as licences, assignments, material transfer agreements over £10,000 (excluding VAT), evaluation agreements and spin-out companies. You do not need to report confidentiality agreements, or material transfer agreements with payments below £10,000 (excluding VAT) in annual revenue. Other individual agreements with payments below £10,000 (excluding VAT) relating to anything else should be reported.

We also require information about when a commercial agreement is no longer active. You can change the status of a commercial agreement, including one you have told us about in previous reports, to explain the reason that it is no longer active and the date that this happened.

#### Things to know when filling in this section: ### Ownership of part or all of a company (equity) We require information about companies that your organisation owns or partially owns. When your organisation has made a commercial agreement within the reporting period that uses Wellcome-funded intellectual property, you must give us information about the equity that your organisation holds in the company.

We will ask you for information about the total number of shares your organisation has obtained in the company (‘Number of shares obtained’), and what proportion of the total ownership these shares represent. #### Things to know when filling in this section: ### Case studies (optional) You may provide a description of up to ten projects in your portfolio, if you would like to highlight the progress or impact of cases under development.

This can include cases where: * you are seeking new protection for Wellcome-funded intellectual property * you are seeking new commercial opportunities for existing Wellcome-funded intellectual property * licences have already been agreed, for example post-deal cases You can use examples or case studies that you have already developed for other organisations, such as the Research Excellence Framework in the UK.

We will ask you to provide a short description of the intellectual property or technology in the case study and what it can be used for. Types of intellectual property could include: Types of technology could be particular products such as therapeutics, preventatives like vaccines, or diagnostics. They could also be social approaches, surveillance measures or digital innovations.

We will also ask you to provide a short description of the expected public benefit and impact of your case study, and how they may advance Wellcome’s charitable mission. We are interested in the journey that the intellectual property has taken and how it is expected to progress, including whether there is any commercial or industry involvement.

We require information about each time your organisation has generated revenue from a commercial agreement within the reporting period that uses Wellcome-funded intellectual property. This includes revenue received indirectly by sale of shares in a company you own or partially own which includes Wellcome-funded intellectual property.

We will ask you to confirm whether the revenue sharing agreement that applies to Wellcome-funded intellectual property includes standard terms or whether bespoke terms were negotiated. We will also ask for information about the total income earned by your organisation (‘Money earned (gross income)’) and any deductible costs (‘Direct costs’ and 'Technology Transfer Fees' if applicable).

#### Things to know when filling in this section: ### Request to retain revenue payable to Wellcome If your organisation wants to keep any revenue generated from Wellcome-funded intellectual property that is payable to Wellcome, you must confirm it in this section. You will then be able to complete a revenue retention request after submitting your declaration form.

### Invoicing information If your organisation does not want to keep any revenue share payable to Wellcome, and you are returning money to Wellcome, we will issue an invoice for the whole amount of money due to Wellcome, plus VAT (if applicable). If you apply to keep Wellcome's share of revenue and are successful, we will issue an invoice for payment of VAT on the amount retained, except if VAT is not payable.

If you apply to keep Wellcome's share of revenue and are not successful, we will issue an invoice for the full amount due to Wellcome, plus VAT if applicable. A declaration template will be provided for you to download at the end of the Intellectual Property and Commercialisation report, based on the information that you have provided.

You will need to download the declaration template and insert your organisation’s letterhead or logo before signing the declaration. The declaration should be signed and dated by someone with the relevant authority at your organisation. We accept electronic signatures.

Once you have uploaded your signed declaration and confirmed that the information in your report is complete and accurate, you will be able to submit your Intellectual Property and Commercialisation report. #### Things to know when filling in this section: ## How to submit a successful revenue retention request You must complete all steps to submit a revenue retention request before the deadline.

We do not give extensions for revenue retention requests. ### 1. Request to keep revenue payable to Wellcome in your intellectual property and commercialisation report If your organisation has generated revenue from Wellcome-funded intellectual property, you must tell us in the report that you want to request to keep revenue payable to Wellcome.

### 2. Complete the revenue retention request form The revenue retention request form will only become available to you after your intellectual property and commercialisation report has been submitted. #### Things to do before you submit your request: #### What to include in your request * Full details of how activities in your request will support translational activities in line with the terms and conditions.

* How the money will be used including a breakdown of costs. * Outputs and outcomes from your proposed use of the money. * Key performance indicators or metrics to support monitoring or evaluation of the activity.

If successful, you will have to report on these to demonstrate if the planned work has resulted in the intended benefit. * If you kept money in a previous year: a summary of progress to date in addition to your request (maximum 250 words). #### How long your request should be The written length of your proposal should be proportional to the amount of money you are requesting.

If your request is for: * £50,000 or less: we expect your proposal to be around 250 words * £250,000 or more: we expect your proposal to be approximately 1,000 words. ### Previous examples of successful revenue retention requests * Proof of concept funding for translational programmes. * Concept development funding, such as evaluation of commercial or clinical feasibility.

* Support for translational funding applications and access to commercial expertise. * Therapeutic and impact accelerators, including industry engagement and project support. * Symposium for business opportunities.

* Improving health ecosystems through training, business development support or innovation partnerships. ### Requests unlikely to be successful: Proposals are unlikely to be successful if they: * ask for the Wellcome share of revenue to offset costs which have already been budgeted for.

For example, we would not allow Wellcome’s share of revenue to be used to pay the salary of an existing member of staff at a technology transfer office * are for commitments which are longer than one year, unless the request is for large amounts (see Revenue section for more detail) * are for significant translational research projects/studies or to supplement existing projects/studies.

If support is required for projects/studies, revenue retention is not an appropriate way to fund this work and a grant application must be made using Wellcome’s normal application processes. ## What happens after you submit We may discuss additional conditions of revenue retention with you, which will be agreed with you in writing after your revenue retention request has been assessed.

If you have successfully requested to retain revenue payable to Wellcome you must notify us of any changes to the proposed use after a successful application, before you re-allocate funds. Wellcome may reject an application if your organisation has misspent funds in a previous cycle. Your organisation will receive an email notification in January to start working on the report.

The report must be submitted by the end of April.

#### Invitation to start working on your report #### Deadline to submit report and to apply to retain revenue (keep Wellcome’s share of money made by your organisation in the reporting period) #### Wellcome reviews your report and revenue retention request (if applicable) #### If applicable, decision communicated about revenue retention request #### If applicable, Wellcome returns your countersigned declaration #### If applicable, invoices sent for any money due to Wellcome 7.

July-August 2027 (within 12 months of decision) #### If applicable, money retained from your revenue retention request must be committed 8. Next intellectual property and commercialisation report #### If applicable, Wellcome notifies your organisation to complete a spend report on any retained revenue 9.

Next intellectual property and commercialisation report deadline #### If applicable, deadline to submit the spend report on any retained revenue * Conflicts of interest policy: Wellcome-funded researchers and commercial organisations * How to comply with our intellectual property policy * Intellectual property guidance * Intellectual property policy