The CRADA is the only mechanism by which a Federal lab may consent to sharing of intellectual property (IP). The primary difference between CRADAs and other PHS research agreements is that CRADAs provide the commercial collaborator with an option, in advance, to licenses on inventions made under the scope of the research plan of the agreement. This is extremely important to commercial entities, particularly in volatile and undercapitalized markets.

Like the CTA, the CRADA cannot be utilized to circumvent the Federal Acquisition Regulations ( FAR), meaning that commercially available products must be purchased or gifted, they cannot be attained through a CRADA. Therefore, if a material is reasonably available commercially, its supply to a federal lab cannot be the singular reason for the collaboration.

There are two types of CRADAs, a Material CRADA (MCRADA) and a standard CRADA (CRADA). The main difference between the two is that with the MCRADA, there is no collaboration between the parties, only an exchange of material, provision of resources, and possibly provision of money by the commercial partner. Funding can be supplied by the collaborating party to NINDS, but funds cannot be supplied by the federal lab to an outside party. No funding ever flows from the government lab to a commercial entity in a CRADA. However, supplementation of one’s lab budget cannot be the motivating factor for a CRADA or MCRADA, rather, the intent and scope of the research should be well within the lab’s general research.

Typical types of exchanges can include:
The NINDS lab can contribute staff intellect, facility, or resources; promise licensing rights to any discoveries made under the research plan of the CRADA, and allow collaborators staff to work at the NINDS facilities as visiting scientists while remaining employees of the commercial collaborator.

The collaborator can contribute materials, equipment, facility, staff, and monetary support. Selection of a CRADA partner has some specific stipulations. Due to the Freedom of Information Act, a CRADA opportunity has to be advertised to allow all potential collaborators “access” to being considered. The only exception to this is where a potential collaborator has a “proprietary” product, meaning no other company can meet the requirements of the research plan.

The CRADA has a review process, so there is a longer time requirement for the successful negotiation of a CRADA depending on its complexity and whether it is a MCRADA or standard CRADA.

What Is Included In The CRADA Agreement?

For a CRADA , there is a “boilerplate” template which contains the standard terms and conditions and to which is added a well defined research plan, specification of each parties contributions in personnel, intellectual property, and definition of any funding provided by the collaborator. The federal lab may provide research personnel, laboratory, facilities, materials, equipment, supplies, and other in-kind contributions - but not funding - to the collaborator. In general, the collaborator contributes personnel, equipment, materials and funding. The collaborator also may contribute funds to cover some of the added costs to the participating agency for work done under the research program of the agreement. Ultimately, the collaborator provides the know-how needed for development and commercialization of a new product, process, or service that may arise from the collaboration.

For the MCRADA there is also a “boilerplate” template which contains the standard terms and conditions. For a MCRADA, the research plan is generally a brief summary followed by definition of funding should any funding be provided.

Both forms of CRADA include a number of standard provisions based on policy, regulatory and legal guidelines adopted by the PHS Agencies:
• Research, development, and commercialization efforts contemplated for each party.
• Contributions of the PHS agency by way of equipment, supplies, and personnel.
• Contributions of the commercial firm by way of equipment, supplies, personnel, and funding.
• Confidentiality
• Publication of results
• Inventions, focusing on definitions, ownership, and patent prosecution.
• Licensing.
• Liability.

What Are The Benefits Of Utilizing the CRADA Process?

Collaboration under either a MCRADA or CRADA results in a number of mutual benefits for PHS agencies and for commercial firms, as well as expediting public access to the technology in the form of a commercially available product.

The motivations for commercial entities to enter into CRADAs with an NIH laboratory varies depending on the market sector and capitalization of the company. CRADAs are the only mechanism by which a federal lab can provide the commercial collaborator with an option, in advance, to negotiate exclusive or non-exclusive licenses on inventions made under the scope of the research plan of the agreement. When a PHS agency enters into a C RADA, the research objective must be shown to be consistent with the agency’s/lab’s mission. PHS CRADAs do not seek "sponsorship" but rather, collaboration, making CRADAs a very cost effective way for small businesses as well as Pharma to leverage their own R&D efforts and for the PHS labs to gain a pathway to commercialize their research and discoveries.

Commercial firms benefit by:
• Improved access to PHS researchers and facilities.
• Direct access to the expertise related to research results and inventions.
• Options to exclusive licensee on inventions made under the terms of the agreement
• Compressed schedule to production of a marketable product.

The NINDS researcher benefits from a CRADA

PHS agencies benefit by:
• Commercialization of products that benefit public health and that otherwise would not be viable commercial products due to market size or costs or research and development.
• Accelerated schedule to transfer basic science findings into commercial products to benefit public health,
• Increased sensitivity to demands and costs of the process of development and commercialization of products for the benefit of the public health
• Sharing of royalties with PHS investigators as reward for excellence in research leading to Public health benefit

Guidelines for Drafting a CRADA Research Plan

1. Goal of the CRADA
Identify (three to four sentences) the research goal(s) of this CRADA including the respective research goals of the NIH and Collaborator Principal Investigators. Explain why this project is important scientifically.

2. Detailed Description of the Research Plan:
The primary purpose of this Research Plan is to permit careful monitoring of CRADA research projects by scientific and division directors of our institutes, centers and divisions. An additional purpose for the Research Plan is established by the Federal Technology Transfer Act of 1986 (FTTA). Under the FTTA, the Parties' obligations to each other in such areas as confidentiality and patent rights extend only to "specified research or development efforts." This statutory limitation will create the boundaries for license rights to inventions made under the CRADA. Appropriate care should be taken in drafting this Research Plan carefully and completely. The field(s) of use to which Article VIII of this CRADA pertains will be limited to the specified research or development efforts in view of the foregoing research goals. The Collaborator further should bear in mind that, although insubstantial changes in this Research Plan may be made by mutual written consent of the Principal Investigators under Article 7.4, substantial changes will require formal amendment under Article 14.6 in order to maintain entitlement to invention rights. Absent compelling justification for a failure to make the original Research Plan complete, amendments will be made retroactive.
Therefore, please provide a description (two to five pages) of the intended Research Plan in sufficient detail to permit reviewers of this CRADA to evaluate the scientific merit of the proposed cc] collaboration The Research Plan should be described in detail fn terms of specific research projects not in terms of a general research program or research goals. Contemplated initial and subsequent projects should be summarized along with estimated time periods for their completion. These projects, may he described sequentially in distinct phases contingent upon the success of earlier phases. Important methodological considerations should be noted, and citations to pertinent literature references may be helpful.

3. Respective Contributions of the Parties
Under Paragraph 4 of the NIH "Policy Statement" ( Is this available as URL?, CRADAs are authorized only with collaborators who will make a significant intellectual contribution to the research project undertaken, or who will contribute essential research materials or technical resources not otherwise reasonably available to NIH. CRADAS are not viewed by NIH as a general funding source or as a mechanism for sponsored research. Thus, unless essential materials or technical resources are involved, the Research Plan must indicate clearly that a true intellectual collaboration will take place. With regard to the detailed research plan required, identify in detail by Party and by principal Investigator the respective contributions of research, development, analysis, expertise, research materials, and time that is to be committed to the various specified research projects and their component steps.

4. Abstract of the Research Plan for Public Release:
In order to fulfill the NIH obligations regarding Fair Access, NIH requires an abstract of the research that can be released upon request. To protect the legitimate concerns of the Collaborator as to its research agenda, the Collaborator is requested to assist in and carefully review this abstract. Signature of this CRADA by the Collaborator shall be deemed to be agreement by the Collaborator that NTH may disclose this abstract publicly.

5. Related CRADAS:
The Collaborator should identify by Title, Principal Investigator and Institute all other CRADAS that it has with NIH. The NIH Principal Investigator should similarly identify all CRADAs that his or her laboratory has with this or any other Collaborator.

6. Related MTAs
The NIH Principal Investigator carefully must review his or her laboratory files and list any MTAs, from any source, that will provide research materials used in earlier projects that relate directly or indirectly to this CRADA, or that provided research materials used to develop any materials to be studied or utilized in this CRADA. The IC Technology Development Coordinator, utilizing the central data base, will work with the PI to identify any agreements processed by that office.

7. Related Patent Applications and Patents:
The NIH Principal Investigator and Technology Development Coordinator should identify by title and serial number any IC patent applications and Patents that are directly or indirectly related to the subject matter of this CRADA

8. Avoidance of Conflict of Interests and Assurance of Fair Access (COIFA):
NIH has implemented the FTTA with strict attention to Federal conflict of interest and ethic laws, as well as various Departmental and NIH regulations. Additionally, the Public Health Service has issued guidelines for PHS agencies in order to assure fair access to our laboratories and consideration for CRADAs. Completion and signature certification of the following conflict of interest disclosure and fair access assurance form by only the NIH Principal Investigator is mandatory prior to review of a proposed CRADA by the CRADA Subcommittee.