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The recipient is the responsible authority, without recourse to DTRA (6) Written procedures for determining the reasonableness and significance to the field, their relationship to the original goals, their relevance to. The Joint Improvised-Threat Defeat Organization (JIDO) is a combat support organization of the U.S. Department of Defense (DoD) organization under the Defense Threat Reduction Agency (DTRA) that . The war eagle, adapted from the Department of Defense seal, denotes JIDO's relationship under the authority, direction. Ilya Elashvili of Defense Threat Reduction Agency, Fort Belvoir (DTRA). Rapid subarachnoid infusions clearly define an exponential relationship between.
These solicitations can specify such aspects as cost sharing and team arrangements. They are very different than requests for proposals, according to Ulrey, in that the government specifies a problem and asks for solutions to the problem.When Should You Define The Relationship?
Program solicitations are typically used for other transactions for prototypes. They typically specify performance or objectives and tend to have a less-defined structure. First, participating companies are not bound by most procurement laws and regulations, though they are bound by other regulations tied to appropriations, such as the Civil Rights Act or lobbying restrictions. OTA also allows for competition to the maximum extent practicable. Unlike OTA agreements, grants and contracts need to comply with the Bayh-Dole Act, which can be restrictive on companies, even though they retain title to inventions.
Joint Improvised-Threat Defeat Organization
Grants and contracts also do not permit the retention of trade secrets, which can be a powerful disincentive for companies to participate in government research. OTA avoids these restrictions, though the government retains certain rights to technologies if companies do not pursue the technologies further. OTA does not have termination for default or termination for convenience, which are unilateral rights specific to government contracts.
Government agencies still have termination rights under OTA, but they are negotiable. OTA encourages the use of what are called payable milestones. These are developed by the program manager and contracting officer to link payments with measurable events rather than solely with the submission of a status report.
They allow flexibility and cost savings by reducing timeframes for technology development and encouraging streamlined ways of operating. Under OTA, there are no mandatory cost principles or accounting standards, except for generally accepted accounting principles, which is much more acceptable for companies.
OTA allows companies to hire their own independent public accountant rather than having their books examined by the Defense Contract Audit Agency.
It also does not require the use of the government system for subcontracting associated with FAR. Management structures are flexible so long as sound business judgment is maintained. Creating Incentives for Investment All of these advantages make government funding under OTA more like an investment in the development and commercialization of technologies.
Government intrusion and red tape are minimized and cooperation is encouraged.
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At DARPA, authority for negotiating and approving OTA agreements is pushed down to the lowest level possible so that high-level approvals are not necessary. The flexibility of OTA also makes it possible to enter into relationships with unconventional partners, such as hackers or organizations that offer prizes for particular technological accomplishments.
If we want commercial companies to do business with us, we have to operate in a more commercial fashion. They are good-faith instruments. Everyone has understood that from the onset. But we have never had one protest on an other transaction.
When everything is negotiable, some points may require extended discussions. Ulrey noted that this can be addressed by getting everyone who is involved into the same room, including program managers, lawyers, and contracting officials, rather than having the parties work in isolation and sending proposals and proposed changes to the others.
Wattendorf noted that he talks with the contract officer at length very early in the process, close to the point of concept of a program. This approach, which is characteristic of the team-based environment at DARPA, forms a close relationship between the program manager and contract officer that can shape the use of OTA.
OTA has been extremely useful, Wattendorf concluded, but, he observed, he would not enter into it without having a contract officer who is very comfortable doing one of these agreements. The situation is different than at NIH, Wattendorf said. With academic researchers, aspects of the process such as milestones may be less carefully observed. For all three of the TIAs, the only provisions that were modified were intellectual property provisions, with none of the TIAs providing for a complete waiver of intellectual property rights.
Maarbjerg explained that, with typical contracts, the government retains two kinds of ownership rights. The first is known as government-use license—the U.
For example, the government could license a company to manufacture the patented technology for use by the U. The second ownership right is known as march-in rights. Under a march-in provision, if the patent owner does not commercialize the patented technology, the government has the right to license the patented technology to a commercial competitor to ensure that the taxpayer-funded technology reaches the marketplace.
This provision can dissuade some prospective private-sector partners, Maarbjerg noted. He added, however, that the U. To address this concern, ARPA-E agreed to include a provision that would give the company the option to buy back the government-use license and march-in rights. Under this option, the company would have to repay all the ARPA-E funds received under the award plus interest and further agree to forgo any ARPA-E funding under the award in order to buy back the government-use license and march-in rights.
In the third case, a company was concerned that some of its intellectual property that had been developed before the ARPA-E award would be seen as part of the whole, thus subjecting the older intellectual property to the government-purpose license and march-in rights. To address this concern, ARPA-E used a TIA to agree that the government-purpose and march-in rights would apply not to prior intellectual property but only to inventions conceived during the award.
If these concept papers are encouraging, a full proposal is requested. This proposal is then submitted to review by industry, government, and academia, and reviews are sent to the author of the proposal for rebuttal. OTA is a tool and not an end in itself, Maarbjerg emphasized. Universities often are more comfortable working with FAR and not starting from a blank piece of paper. If a firm is nervous about partnering with government, OTA may be a way to allay its concerns. If a project fails, said Kovacs, it should only be the result of failure of the product to achieve the desired safety or efficacy thresholds, and not as a function of an inability to provide the proper support from a technical, business, and regulatory perspective.
The Department of Homeland Security has identified 13 material threats to the health and economy of this country. Those 13 threats all require either a vaccine or a therapeutic, and most require a diagnostic. In creating EUA, Congress permitted FDA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by such agents, when there are no adequate, approved, and available alternatives.
BARDA has defined the importance of threats and has developed a portfolio of products to deal with those threats. It also has been developing a pipeline of medical countermeasures that are early in their development cycle. Most products cannot be tested in humans for safety and efficacy, so a parallel track of research has been developing animal models to use as surrogates for human clinical testing.
An additional benefit is that when individuals are in a position for a significant period of time, e. This is beneficial for the identification of opportunities for collaboration. Thus, an essential element of managing such programs is accepting and balancing risks. There may be times when it is appropriate to undertake high-risk, high-payoff projects which may ultimately fail in addition to maintaining long-term focus on a specific area with low risk in order to provide fundamental understandings that support new developments.
An effective program will create a balanced portfolio of these various research types. Care should also be taken to not introduce unnecessary risk of project failure through poor planning and management.
Understanding the eventual goal of a project or program and identifying appropriate milestones that must be completed or addressed for success can allow for corrections of approach and provide confidence at critical junctures that all required elements are in place to minimize the chances of failure due to bureaucracy.
The committee cautions that each institution might appoint separate review boards with different membership; while a diversity of opinions is good, having numerous, separate groups could prevent identifying redundancy and duplications. It is essential that reviewers are able to consider the context and larger picture, and maintain continuity. Continual disruptions due to major funding shifts and delays lead at best to inefficiencies and, at worst, failure.
Funding can roughly be considered at three levels project, program, and laboratory: Projects are narrowly scoped activities with specific, well-defined goals. Projects may only require a few years for completion, but this timeframe places a high premium on efficiency.
Programs have a broader scope than projects with desired outcomes that require multiple steps or inputs for completion. Page 94 Share Cite Suggested Citation: Some adjustments in priorities are inevitable, but major directions must be consistent and supported. Laboratories exist for multiple decades and require predictable funding to ensure a high-quality workforce and up-to-date research facilities and infrastructure.
Laboratory directors and commanders must be assured of some level of funding if they are to effectively plan for the future and manage a workforce and research infrastructure. This should not be confused with entitlements, where funding is continued independent of performance.
Effective Asset Management at the Laboratory Level Some local control of funding is considered by the committee to be an important component of successful laboratory management. A local ability to move people and resources between projects can assist in creating an efficient environment as decision making can be more responsive than if external approval is required. If a laboratory director is prevented from anticipating and acting on predicted future needs, the laboratory may find it challenging to capitalize on emerging technologies or provide for new operational needs.
Workforce management should be left in the hands of laboratory management with command oversight distinguished from managementwith external laboratory reviews providing input to help identify emerging needs or areas of concern see Element 2.