RESEARCH CONTRACT AND POLICY OF INTELLECTUAL PROPERTY

　　WITH IMPERIAL COLLAGE LONDON

　　伦敦帝国理工学院科研合同与知识产权政策

　　CONTENTS OF TABLES

　　1. Research Contracts and Intellectual Property 科研合同与知识产权

　　(1)Contracts and intellectual property 科研合同与知识产权

　　(2)types of research contract 科研合同的种类

　　(3)Funding for Specific Research contract 基金专项科研合同

　　(4) Contracts respect to commercially led clinical trial 与商业性的临床药物试验有关的合同

　　(5) Contract with fully funded studentship 全额奖学金研究合同

　　(6) Collaborative Awards in Science and Engineering (CASE) 科学与工程研究方面的协作奖

　　(7)Collaboration agreement 科研合作协议

　　(8)European Commission Consortium Agreement 欧盟委员会协议

　　(9)Research sub agreement 研究项目分包协议

　　(10)Material Transfer Agreement (MTA) 物品移交协议

　　(11) Confidentiality or Non-Disclosure Agreement (CDA or NDA) 保密协议

　　(12) Service/Consultancy/ Purchase Agreement (relating to research)

　　与科研有关的服务、咨询和采购协议

　　(13)Memorandum of Understanding (MoU) 谅解备忘录

　　(14) Clinical Trial Single Site Participating Agreement and Sponsorship Agreement

　　临床试验现场参与协议与赞助协议

　　(15)Drug Manufacturing Agreement 药物制造协议

　　(16)Investigational Medicinal Product (IMP) / Drug Data Transfer Agreement

　　研究型医疗产品、药物数据传输协议

　　(17) Qualified Person (QP) Release Agreement 有资格的人员批准外放研究型药物的协议

　　(18) Contract negotiation process 合同洽谈程序

　　(19)IP advice and approval in research contracts 科研合同中知识产权的建议与批准

　　(20)Key contractual terms and preferred terms and conditions 合同的必备条款与优先条款

　　1. Research Contracts and Intellectual Property 科研合同与知识产权

　　(1)Contracts and intellectual property 科研合同与知识产权

　　A research contract is a legally binding agreement that sets out the rights and obligations of the parties concerned, and which forms the basis of a relationship around a particular research programme, exchange of information or materials or other collaboration.

　　This section provides an introduction to contracts and the core considerations from an academic perspective. It includes information on the types of research and research related agreements entered into by the College, the contract negotiation process, and key terms and conditions.

　　Intellectual Property is the term used to describe creative outputs that can be legally protected arising from scientific, engineering, literary and artistic endeavours such as the results arising from research.

　　College is committed to encouraging the commercialisation of College Intellectual Property, with a view to generating the greatest social and economic benefit. College’s Intellectual Property policy describes the ownership and management of Intellectual Property emanating from College and the distribution of Intellectual Property commercialisation revenue within College.

　　(2)types of research contract 科研合同的种类

　　There are several types of contract (often referred to as agreements) associated with research. They vary according to the funder and the nature of the research.

　　Research funding agreements

　　Research contract

　　Investigator led clinical trial

　　Commercially led clinical trial

　　Fully funded studentship

　　Collaborative Awards in Science and Engineering (CASE)

　　Research related agreements

　　Collaboration agreement

　　European Commission Consortium Agreement

　　Research sub agreement

　　Material Transfer Agreement (MTA)

　　Confidentiality or Non-Disclosure Agreement (CDA/NDA)

　　Service/Consultancy Purchase Agreement (relating to research)

　　Memorandum of Understanding (MoU)

　　Clinical Research related agreements

　　Clinical Trial Single Site Participating Agreement and Sponsorship Agreement

　　Drug Manufacturing Agreement

　　Investigational Medicinal Product (IMP) / Drug Data Transfer Agreement

　　Qualified Person (QP) Release Agreement

　　If you are uncertain of the specific nature of an agreement contact Faculty Research Services/Contracts.

　　(3)Funding for Specific Research Research contract 基金专项科研合同

　　This is a contract to provide funding for a specific research project or set of projects within College. It may be funded by a company, government body, charity or other body, and will contain terms and conditions governing the conduct of the project, as well as obligations incumbent upon the College and the funder.

　　The purpose of a research contract is to set out the roles and responsibilities of the parties involved in a research project, i.e. the College, the academics, researchers, students and the funding body.

　　The contract will:

　　Define the work to be undertaken

　　Define the financial contributions/payment terms

　　Define the share of technical, commercial and economic risks of each party

　　Set out publication rights of results

　　Establish who will own the results of the work and who has the right to use them

　　Set out agreed liability and indemnities.

　　(4) Contracts respect to commercially led clinical trial 与商业性的临床药物试验有关的合同

　　Commercially-led clinical trials are designed, legally sponsored and funded by pharmaceutical companies. The company contracts with individual organisations (trial centres) either directly or through a Clinical Research Organisation (CRO) to undertake the trial on its behalf.

　　Investigator led clinical trial

　　Investigator led trials are designed by academics and usually sponsored by their employer. Such trials are funded by grants from charities, Research Councils, government agencies, etc. or with support from pharmaceutical companies. Where a pharmaceutical company is providing funding (and in some cases drugs free of charge) an agreement needs to be executed between the College and the company to ensure that each party agrees to comply with the relevant laws, regulations and codes of practice applicable to the performance of the trial. The agreement includes provisions for the supply of drugs, funding, safety reporting, insurance/liabilities, publications, Intellectual Property etc.

　　(5) Contract with fully funded studentship 全额奖学金研究合同

　　A fully funded studentship is an agreement to provide a student with funding for PhD or Masters level research. The student will conduct the majority of the research under academic supervision. The focus of the research will be the PhD study itself and ultimately the award of a degree to the student. The funder will cover tuition fees and bursary/stipend, and any consumable/equipment/travel costs required. Funding often comes from industry and government departments but may also come from other sources.

　　Research Councils fund studentships through a number of routes, mainly Doctoral Training Account (DTA) awards and specific project grants. These awards are against set terms and conditions, which are available from the relevant Research Council website.

　　(6) Collaborative Awards in Science and Engineering (CASE) 科学与工程研究方面的协作奖

　　Collaborative Awards in Science and Engineering are industrially focused studentships allocated by Research Councils to companies either directly or via agents. Time is spent working in the company, and the company provides a financial top-up to the core Research Council award. The Research Council funding is often through a Doctoral Training Account (DTA) award. Occasionally a company may provide sponsorship outside of the normal CASE scheme, providing additional funding, resources and/or input. Whilst not strictly CASE, it is treated as such for the purposes of the contract.

　　(7)Collaboration agreement 科研合作协议

　　This agreement sets out the responsibilities, roles and rights of collaborating parties working in conjunction with the College on a specific research project or set of projects. All parties will be bound by the same terms and conditions, and the agreement will usually set out how the overall project will be managed between the parties. The agreement is often drawn up following a joint award/research funding agreement and the terms of this main award will often be reflected in the collaboration agreement. It may also contain funding terms, for example transfer of funding from the lead partner to the other collaborators, or the transfer of additional funding from a commercial partner.

　　A collaboration agreement is required for work involving at least one other research partner on a project.

　　(8)European Commission Consortium Agreement 欧盟委员会协议

　　Consortium Agreements for European Commission projects are mandatory for most Framework Programme 7 (FP7) projects and the Commission requires that the Consortium Agreement is negotiated and signed before it will sign the Grant Agreement (i.e. the contract) for the project. The Consortium Agreement is concluded between all partners in the consortium but the Commission is not a party to it. Consortium Agreements supplement the Grant Agreement by expanding on and clarifying key terms and conditions (e.g. Intellectual Property, confidentiality, liability, publication rights) and provide details of the internal management and working practices of the consortium (e.g. voting rights, internal reporting structure, dispute resolution).

　　(9)Research sub agreement 研究项目分包协议

　　This agreement engages a research partner on a specific work package under a research project (or set of research projects) held by College, and normally involves payments to the partner. The agreement is often drawn up following a main grant award or another research funding agreement, and will involve discrete and specific pieces of work to be undertaken by a partner organisation . College will remain responsible for the main award, but will often flow down any relevant terms and conditions to the research partner, and as such, these will be reflected in the sub-agreement.

　　(10)Material Transfer Agreement (MTA) 物品移交协议

　　A Material Transfer Agreement (MTA) is a contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use them for their own research purposes. It defines the rights of the parties in respect to scope of use of material, confidentiality, publication, and ownership of Intellectual Property. Occasionally a transfer may include software. These agreements should not include payment for the material, other than reimbursement of transport costs.

　　There are two types o f MTA:

　　An MTA-out covers the transfer of materials owned or controlled by the College to another university, company or other external body for research purposes. These are dealt with by Faculty Research Services teams.

　　An MTA-in covers the transfer of materials to the College from another university, a company or other external body. These are dealt with by the Research Office.

　　If a College employee or associate wishes to request materials from an external organisation, it is important that an MTA is drawn up with the provider, so that the College retains the right to publish the results of any work conducted using the materials, and so that the ownership of any Intellectual Property is appropriately determined.

　　Principal Investigators are required to send MTA requests with a completed MTA questionnaire and the relevant agreement to researchoffice.mta@imperial.ac.uk.

　　Where an MTA exists in hardcopy only, it should be forwarded with the completed questionnaire to the Research Office: Level 5, Sherfield Building, Exhibition Road, London SW7 2AZ

　　Where the College is approached to transfer materials to a commercial company, such supply is normally to support the company’s commercial activities. These transfers should involve a fee and are dealt with by Imperial Innovations.

　　The MTA working process is outlined below:

　　PI sends MTA request with completed questionnaire and the relevant agreement to researchoffice.mta@imperial.ac.uk

　　MTA is logged by the Research Office and assigned a reference number

　　Email sent to PI acknowledging receipt of MTA request within five working days of receipt of the MTA and questionnaire

　　If necessary, MTA revised by Research Office to comply with College’s preferred terms and conditions.

　　Marked-up version of the MTA emailed by Research Office to materials supplier and copied to PI (or a summary of changes provided) within five working days of receipt of the MTA request

　　Upon receipt of supplier’s response, attempts made (where necessary) by Research Office to negotiate reasonable terms of access to the materials; PI copied into correspondence (or provided with summary).

　　When terms and conditions agreed, final signature process for MTA completed at earliest opportunity by Research Office; details of any special conditions sent to PI.

　　Reasonable attempts are made by the Research Office to contact unresponsive providers of materials, but where the provider fails to respond after three attempts negotiations will not continue. In this situation, MTA referred back to PI. This is to help ensure MTA requests are not held indefinitely, and all requests are dealt with as quickly as possible.

　　Where the negotiated MTA continues to conflict with the terms and conditions of a charitable research funder, the PI will be informed that the materials provider is unwilling to change the provisions of the MTA. It is the responsibility of the PI to contact the grant liaison officer or other contact at the funder to enquire how to proceed, and/or whether the funder can confirm that it is willing to waive its funding provisions relating to IP for the particular research plan involving the requested materials. The Research Office will provide guidance.

　　Upon execution of an MTA, the PI is responsible for making arrangements with the provider for transportation and delivery of the requested material. Transportation costs, where charged, should be met by the PI or their department.

　　(11) Confidentiality or Non-Disclosure Agreement (CDA or NDA) 保密协议

　　This is an agreement to regulate the ways by which confidential information, including Intellectual Property, may be disclosed by one party to another. The agreement sets out the terms of disclosure and whether information is returned to the provider or destroyed upon request. Confidential information includes any information, results or know-how that is owned by someone, and which the owner wishes to be kept secret. The disclosure of confidential information requires that a confidentiality agreement is signed before any discussions take place.

　　(13) Service/Consultancy/ Purchase Agreement (relating to research)

　　与科研有关的服务、咨询和采购协议

　　This type of agreement is used to facilitate the commissioning of specific professional services from a third party by the College. No research or novel work is intended to be carried out under these agreements, rather just standard analysis, processing, manufacture or provision of expertise. All results will be owned by the College, with no right of use assigned to the consultant. These agreements are not appropriate to use for a research sub-agreement or collaboration.

　　(13)Memorandum of Understanding (MoU) 谅解备忘录

　　A Memorandum of Understanding is a document intended to de scribe a bilateral or multilateral agreement between parties. It is often a preliminary document and is generally not intended to create a legal commitment between the parties but to set out the working principles of the relationship.

　　(14) Clinical Trial Single Site Participating Agreement and Sponsorship Agreement

　　临床试验现场参与协议与赞助协议

　　This type of agreement is used for clinical trials taking place in sites external to Imperial College and, in the absence of a formalised overarching agreement with the relevant NHS authority, is also used for clinical trial activity within College’s associated NHS Trusts (Royal Brompton and Harefield, Chelsea and Westminster, North West London Hospitals, Imperial College Healthcare NHS Trust). Where the College is the Sponsor of a multi-centre trial, it must execute an agreement with each participating site (normally a university or NHS Trust). The agreement ensures the site agrees to comply with relevant laws, regulations and codes of practice applicable to the performance of the trial (Research Governance Framework for Health and Social Care/UK Medicines for Human Use (Clinical Trials) Regulations). It includes provisions such as safety reporting, insurance/liabilities, medical confidentiality, Intellectual Property, publications, funding if applicable, etc.

　　A Sponsorship Agreement is a simplified version of a Clinical Trial Single Site Participating Agreement suitable for less complex non-IMP studies (studies not involving Investigational Medicinal Product). The agreement is signed between the Sponsor and participating site and confirms College’s overall responsibility as legal Sponsor and outlines specific responsibilities of the site in relation to the study (i.e. referral or recruitment of patients to College).

　　(15)Drug Manufacturing Agreement 药物制造协议

　　This type of agreement is executed when the College wishes to contract with a pharmaceutical company to produce a medicinal product in accordance with College specifications and/or with materials supplied by the College. Manufacturing Agreements are required for both the production of experimental drugs and for the repackaging/dose alteration of existing drugs for new indications. These are complex agreements and must be reviewed carefully to include regulatory compliance (GMP facilities/standards, compliance with UK/EU/FDA regulations, Manufacturing Authorisation for Investigational Medicinal Product (MA-IMP) requirements etc), warranties and indemnities. College insurance cover must be considered under this type of agreement as well as subsequent use of the product in clinical trials.

　　(17)Investigational Medicinal Product (IMP) / Drug Data Transfer Agreement

　　研究型医疗产品、药物数据传输协议

　　This type of agreement is used when external parties wish to make "in-kind" contributions for investigator-led studies such as the supply of drugs or medical devices. Where provisions for such contributions are not within a principal funding agreement, a Transfer Agreement should be executed between the supplier and the College to outline each party's responsibilities in relation to the study and ensure compliance with regulatory framework (warranties/liabilities, quantities of supply, safety reporting, confidentiality etc).

　　If the items are paid for this may be classed as a purchase and should be referred to Purchasing.

　　(17) Qualified Person (QP) Release Agreement 有资格的人员批准外放研究型药物的协议

　　This type of agreement is used for the release of an Investigational Medicinal Product (IMP) by a Qualified Person (QP) before use. The agreement ensures Sponsor compliance with current EU Clinical Trials Directives (Article 51 of Directive 2001/83/EC, Article 55 of Directive 2001/82/EC) / UK Medicines for Human Use legislation.

　　(18) Contract negotiation process 合同洽谈程序

　　Any kind of research collaboration, including confidential discussions with another party, exchange of materials, or any other research related activity, may require a contract to be put in place before the collaboration begins. All negotiations with a funder or another party should be managed and coordinated by the Faculty Research Services contract manager (or equivalent), who is the main point of contact for matters relating to the contract.

　　Discussion between the Principal Investigator and Contract Negotiators regarding the risks and benefits associated with the activity is essential at an early stage to help expedite the process and bring swifter agreement. Delays most often occur when insufficient information is gathered and there is a poor understanding of what each party to the contract is trying to achieve.

　　The negotiation process is not necessarily linear and differing factors will affect the precise route of negotiations as well as the final agreement, however, negotiations undertaken by the College will always attempt to establish an equitable position that is both proportionate, and appropriate to the activity at hand.

　　The contractual terms will be assessed in accordance with the College Preferred Terms and Conditions whilst taking full account of any information provided to Faculty Research Services / Faculty Research Contracts. Wherever possible, a proportionate approach will be taken to negotiation. Where terms are outside of those preferred, the contract negotiation will seek approval from the relevant College Authority, such approval will be considered on the merits of the activity, value etc.

　　Often a funder will wish to use their own template agreement, which will contain those terms most beneficial to the funder, but may also contain ones detrimental to the College. Whilst the College does work with and accept funder supplied agreements, we prefer to work from our own set of standard templates (some nationally agreed), the use of which will expedite the negotiation process.

　　Agreements will be reviewed holistically to establish the key benefits and risks (if any). Onerous terms and any constraints on the research which present a risk will be negotiated by the Contract Negotiator to limit exposure wherever possible.

　　See Approval and Authorisation for guidance on approval requirements and details of authorised signatories.

　　Typically negotiations tend to focus on a few key areas, examples of which are:

　　Intellectual Property (IP)

　　Often the most contentious issue in an agreement, the College will always try to ensure the rights of the individual academic are protected with regard to future use of IP, and that any commercial benefit to be derived from the IP favours the College. Care will always be taken to balance any commercial advantage against the academic benefits of carrying out an activity, in achieving the best and most equitable deal possible for the College, and the individual academic.

　　(19)IP advice and approval in research contracts 科研合同中知识产权的建议与批准

　　Successful commercial exploitation will benefit inventors through the College’s Reward to Inventors scheme.

　　Publication rights

　　The cornerstone of academic research is the right to publicly disseminate the outcomes of the research. Whilst on occasion there may be good reason to delay or restrict publication (e.g. confidentiality, the patenting process, or arrangements with collaborators), the College always seeks to protect this fundamental right in its research agreements. This right to publish is also linked to the College’s academic mission and how it classifies its research activity. Any onerous restrictions need to be carefully considered, both from an academic perspective but also whether the activity itself may be defined as research.For further information on the most beneficial position for the College please see Key contractual terms and preferred terms and conditions.

　　Information required from the Principal Investigator. The following areas should be considered in consultation with the Faculty Contract Negotiators at the earliest opportunity. This will help inform the negotiation position for the College and may help enable swift agreement with the other party or parties.

　　(20)Key contractual terms and preferred terms and conditions 合同的必备条款与优先条款

　　The content of a contract will vary and will depend on the activity taking place or the nature of the relationship being entered into. To maintain academic freedom, and to maximise financial and Intellectual Property opportunities, the College will always seek to achieve the best possible terms in a contract. Faculty Research Services teams provide support on contracting and will advise and ensure consistency of proposals with the College's preferred terms and conditions. The College has delegated authorities to specific individuals when approval is required for a contract that is outside the preferred terms and conditions.

　　The key elements are described below.

　　Project description

　　Price

　　Payment terms

　　Confidentiality

　　Publication

　　Intellectual Property protection

　　Indemnity and liability

　　Termination

　　Warranties

　　Law and jurisdiction

　　Project description

　　A detailed description of the work is essential in a contract. The parties to the agreement must know the basis of the relationship and what activities each is expected to carry out. Providing as much detail as possible will reduce uncertainty and provide the project with a clearly agreed path to follow.

　　Price Terms. The price represents what the funder is willing to pay and what the College is willing to accept. The price can be equal to, lower or higher than the Full Economic Cost (FEC) of the research. The FEC of a research project should be recovered wherever possible. It is essential that where work is being funded it is costed and priced appropriately, and in accordance with College’s Costing and Pricing Policy and Faculty pricing policies.

　　The proposed project price should not be disclosed to the funder without due internal consultation and authorisation. The market value should be assessed, and in cases where the recovery position is outside the approved pricing policies, authorisation must be sought through the appropriate Faculty Approval mechanisms before the price is disclosed.

　　Further information is available in the costing and pricing section.

　　Payment terms. College’s preferred payment position is advance payment on a quarterly basis.

　　Confidentiality. Confidentiality is a legal principle that governs secrecy between parties. This is particularly important where information, knowledge or research results passed to another party need to be held in confidence and not misused. Terms of confidentiality vary. The core consideration should be that the arrangement is reciprocal. The period of time required to maintain something as confidential should not exceed five years as any longer is difficult to manage.

　　Dissemination of information is a vital part of academic research, but care should be taken where this involves disclosure of confidential information. Once information has been publicly disclosed (e.g. by conversation, email, seminars, poster presentations or interviews) it is no longer considered confidential, unless that disclosure was under an obligation of confidence.

　　In some cases, a funder may wish for results to remain confidential forever. This imposes considerably greater limitations than preventing publication or withholding rights to the Intellectual Property as researchers cannot discuss or refer to the results at all. Contracts are negotiated to limit confidentiality to the confidential information supplied by either party and for confidentiality to be protected for a reasonable duration after the end of the project.

　　Publication. Academics should expect the right to publish all the results of their research, including where relevant, the submission of a student thesis for examination (this is counted as public disclosure), without delay or hindrance. Funders may wish to delay publication, typically to assess Intellectual Property opportunities or to delete information that may be considered proprietary by the funder.

　　Contracts are negotiated to protect the researcher’s right to publish as much as possible, and start from the position that full publication, except for confidential information belonging to the funder, is required with minimal review and delay. If the funder has different requirements, the Principal Investigator must consider how far these are compatible with responsible publication and the College’s educational mission.

　　Intellectual Property protection. The College should expect to be able to continue building on the results and Intellectual Property (IP) it generates in the course of its research activities. Commercial sponsors may hope to gain the rights to the results of research because they want to license an application that uses them.

　　Contracts are negotiated to allow College to retain full rights to the results of its research while allowing its sponsors as much commercial advantage as possible. Any commercial advantage will be subject to a reasonable revenue return to College.

　　College has a responsibility to maximise the benefits arising from its research, and ensure that it can exercise an appropriate degree of control over the use of such IP. This may include receiving a proper share in any benefits arising from the use of such IP, even if the practicalities of its ownership and exploitation are such that IP must be held by another party. On this basis, College’s preferred starting position in any research contract is:

　　Imperial should retain ownership of IP arising from the research it conducts

　　The funder is granted an internal, non-exclusive, research and development licence (but not for the purposes of commercial exploitation)

　　Commercial licence terms should not be agreed in a research contract. This may constitute a trading activity and affect the College’s status as an exempt charity.

　　Further information is available in the Intellectual Property policy

　　Indemnity and liability. This is a complex area and what may be included in a contract, and why, requires case-by-case assessment.

　　A contract commonly includes clauses to confirm that: the results of research by definition cannot be guaranteed individual researchers and the College cannot be held liable for the sponsor's use of the results of research individual researchers and the College are not responsible for any indirect loss arising from the research there is a financial cap on the College's liability.

　　It may be appropriate to negotiate additional limits on the College’s liability depending on the project. Contracts that include any of the following will be referred to the Insurance Manager for approval.

　　Termination. It is possible that either party may need to terminate the project for a variety of reasons. These might include reduced interest in the work, resource issues, inability to complete the work, or factors that are beyond normal control, for example the death of a key investigator.

　　The College negotiates to ensure that the sponsor cannot withdraw funding without reasonable cause or notice. A contract should contain a mutual right to terminate the contract, with a notice period of no less than three months to be given and agreement to pay all costs incurred and committed up to date of termination.

　　Warranties. The College should not agree to provide any specific warranties other than that the College is able to enter into and be bound by the terms of the contract. Wherever applicable the contract should contain an ‘Experimental Research Waiver’. This is a clause stating that the results of the work are not warranted or guaranteed in any way and that any liability arising from use of the results will be entirely the responsibility of the user.

　　Law and jurisdiction. English law and jurisdiction is the preferred position of the College. This refers to the interpretation of the contract and jurisdiction of courts in its enforcement. The acceptance of another law and jurisdiction may affect the cover provided by College insurance. There may also be additional costs involved should specialist professional or legal advice be required.