Supplementary Information for NCI SBIR Contract Topics 317 and 318
All questions on technical issues or contract administration issues related to both topics should be addressed to:
Ms. Bette Shanahan
Office of Acquisitions
Epidemiology, Therapeutics, and Sciences Branch
National Cancer Institute
6120 Executive Blvd, Suite 6054
Rockville, MD 20892
Phone: (301) 435-3782
E-mail: eshanahan@mail.nih.gov
All questions related to commercialization licenses should be directed to the responsible Licensing and Patenting Manager (LPM) in the NIH Office of Technology Transfer (OTT). For NCI SBIR Contract Topic 317, the responsible LPM is:
Betty Tong, Ph.D.
Licensing and Patenting Manager
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852
Phone: (301) 594-6565
Fax: (301) 402-0220
Email: tongb@mail.nih.gov
For NCI SBIR Contract Topic 318, the responsible LPM is:
Sabarni Chatterjee, Ph.D.
Licensing and Patenting Manager
Office of Technology Transfer
National Institutes of Health
6011 Executive Boulevard, Suite 325
Rockville, MD 20852
Phone: (301) 435-5587
Fax: (301) 402-0220
Email: chatterjeesa@mail.nih.gov
No. In the interests of ensuring that all potential offerors receive (before proposal submission) the same information in response to the same question, all questions should go to Ms. Bette Shanahan (eshanahan@mail.nih.gov), and she will work with technical personnel to develop an answer and return a response to the potential offeror.
An NIH-TT SBIR contract topic is based on a specific technology from the NIH Intramural Research Program for which the NIH has filed for patent protection or has been issued a patent. In contrast, regular SBIR contract topics are based on innovative, high impact, and high priority technologies not necessarily developed in NIH laboratories, and for which the NIH is not pursuing patent protection.
The full solicitation is available online: http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf
The forms are also available online: http://grants.nih.gov/grants/forms.htm#contracts
No. Small business concerns normally retain the principal worldwide patent rights to any invention developed with Government support. See Part I, Section 8.5 of the PHS 2013 Solicitation for SBIR Contract Proposals for further details: http://grants.nih.gov/grants/funding/SBIRContract/PHS2013-1.pdf.
If new IP has already been generated under some sort of collaborative project, we look at inventorship, which is a legal determination. If there has been a joint invention between the contractor and NIH staff, we will discuss the possibility of doing an agreement to share patent costs or patent administration, and potentially issuing a license to the awardee. We are flexible, and we let the context of the project drive the nature of the agreement. If the existing invention was made solely by the contractor, then the IP belongs solely to the contractor. On the other hand, before collaborative work even starts, it is possible to arrange with the NCI technology transfer offices Cooperative Research and Development Agreements (CRADAs) or Collaboration Agreements in order to establish the rights of both parties up front. A CRADA is the best option when significant development of new IP is anticipated. If you would like to discuss a formal collaborative agreement, contact NCI Technology Transfer Center
After the peer review step is complete (expected to occur between March and May), the Contract Office will provide those offerors/companies that do not have a chance of winning an award feedback on the outcome of peer review. Technical minutes are included in the feedback provided, and that document includes both strengths and weaknesses. For those companies selected to receive an award, those notifications are expected to go out in the summer of 2013.
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Preferably, just contact with moisture. For example, having a dry bandage on the shelf that is stable, but when it comes in contact with a moist wound, it would begin to generate the nitric oxide. There are many other ways to do it but that would perhaps be the easiest and most economical to pursue.
The polymer is made of organic materials.
Yes, the polymer processing can occur first, before the NO reaction. They do not have to occur simultaneously.
There are many different formulations and variants of polyacrylonitrile, with different ways to treat the polymer with additives to create different properties. Adding agents that can stabilize the pH buffering, for example, would be quite appropriate. For solid polymers it is only the surface that is exposed to the moisture, so physical form is a major determinant of NO release rate.
Formulation modification will be allowed; the inventors would like the contractor to express all their ingenuity to create a useful product.
The amount of material will be negotiated; reasonable amounts can be supplied. There are no costs associated with acquiring the material.
It is not biodegradable or bioabsorbable to our knowledge. Some of it can degrade eventually, but it is not a concern for topical applications.
The form of the material would be developed by the contractor. This can be discussed with the inventors.
There has not been any previous licensing activity on this invention.
The inventors' work so far has been with material of MW 150,000, but other MWs including small oligomers might be better for some applications.
Yes
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It may be, but we have not ascertained pathobiology. Others have looked, but studies vary.
All types of approaches to detecting CYP1B1*3 are welcomed. Array-based technology is not the only platform under consideration.
Preclinical validation should take place in vitro and in vivo. However, the Figg group has much experience in mouse xenografts and would be willing to support the in vivo efforts.
To our knowledge, none are known. However, it should be mentioned that CYP1B1 expression is driven by the estrogen receptor, cAMP, and the aryl hydrocarbon receptor. Thus, expression may be driven by a number of factors. Still, the factors that drive the tumor expression are currently unknown, and expression in the tumor is likely to be the most important factor with respect to docetaxel resistance in tumors.
Not at this point with stathmin. Some have observed similar relationships with paclitaxel.
Not at this point.
This is a very difficult question to respond to. First, we did not ascertain response. Second, if overall survival is the gold-standard of efficacy, none of the patients carrying these alleles survived after 12 months of therapy – which is similar to the survival of CRPC patients without treatment. Thus, we interpret the results to suggest that none of the patients had efficacy, but cannot be sure. We did not study RECIST criteria.
No genetic variant is fully penetrant, so it is not possible to say that only this SNP can drive clinical decisions. This is an important question to answer with follow-up studies.
Not that we are aware of. Nonetheless, our control population (CRPC not treated with docetaxel) did not show any relationship with overall survival. Therefore, this does not seem to be a survival predictor in the general CRPC population that was not treated with docetaxel.
There are antibodies, but none distinguish the genetic variant CYP1B1*3 vs. CYP1B1*1
We had requested a collaboration with Sanofi so that we could use DNA samples from patients treated with docetaxel; however, Sanofi did not keep a biorepository so we could not test in their samples.
Docetaxel is commercially available from Sigma (~$32.50/mg).
Sanofi has no involvement.
We will most likely be able to acquire samples from patients treated with this drug in the coming years. However, since this is a second-line therapy, it is unlikely that we can get samples from patients that were not pre-treated with docetaxel – which will be a confounder. We currently have cabazitaxel that we can use to study basic science endpoints.
We are in talks with cooperative groups at this point to obtain more samples. These cooperative groups have many samples (we approximate at least 1,000) from men treated with docetaxel. However, these talks are moving slowly.
We currently collaborate with investigators who are administering cabazitaxel. It may be possible to get samples from these trials; however, we do not have any formal clinical sample source at this point. Proof-of-concept that cabazitaxel is influenced by CYP1B1 metabolites will need to be in place before we are likely to get such samples. Following the proof-of-concept, it may also be possible to initiate a clinical trial within the NCI; however, we cannot be sure at this point as there are too many variables.
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A commercialization license is a legal agreement, subject to Federal, state, and local regulatory authorities, by which a patent owner promises not to take action to exclude the licensed party from making, using, or selling a potential invention. A license may be for patented or patent pending technology, for unpatented biological materials, and may be exclusive or non-exclusive.
An exclusive commercialization license limits the use of the invention to a single group or entity, while a nonexclusive license allows for use by multiple groups or entities.
A non-exclusive commercialization license provides your company the rights to use NIH IP to develop and sell a product based on that IP. We can also grant such a license to another company or companies for the same field of use. Therefore, we are not excluding any other companies from seeking such a license. An exclusive license, on the other hand, provides such rights to only one company, to the exclusion of all other companies.
The NIH OTT automatically awards such licenses to allow the NIH-TT contractor to develop the patented or patent-pending technology without infringing upon the patent rights for that technology. However, the license is limited to developing the technology within the scope and term of the NIH-TT contract only.
No. There are no financial payments required for the royalty-free, non-exclusive internal use license.
A commercialization license allows a licensee to make, use or sell the licensed technology. In contrast, in the context of an NIH-TT contract, a royalty-free, non-exclusive internal use license allows the contractor to develop the licensed technology only within the scope of that NIH-TT award.
The goal of the NIH-TT program is to license NIH technologies to qualified small businesses with the intent that those businesses develop those inventions into commercial products that benefit the public. While an NIH-TT contractor may complete internal research and development using the NIH technology, before the technology may be commercialized a commercialization license is required if patent claims have issued and is encouraged if patent claims are pending. Thus, we expect to invite a follow-on Phase II SBIR contract proposal only if the NIH-TT contractor has already applied for and received a commercialization license via the standard NIH license application process. The time required to complete the application process for a commercialization license may vary. To give an NIH-TT contractor ample time to obtain a commercialization license before a Phase II SBIR contract proposal would be invited, we strongly encourage the NIH-TT offeror to apply for a commercialization license as soon as possible, preferably at the same time the offeror submits the NIH-TT contract proposal.
The NIH OTT negotiates licenses for NIH Intramural Research Program inventions. The first step in obtaining a commercialization license is to contact the responsible LPM in OTT. The LPM and his/her contact information are listed within the Project Goals section of the NIH-TT Contract Topic, and are also listed above in the answer to question 1
An overview of the typical OTT licensing process is available at http://www.ott.nih.gov/licensing-process. NIH-TT contractors should begin at Step 5, contacting the LPM. NIH-TT contractors should contact the LPM for matters relating to commercialization licenses only – any questions regarding the NIH-TT contracting process or technical issues in NCI SBIR Contract Topics 317 and 318 should be directed to Ms. Bette Shanahan (email: eshanahan@nih.gov) in the NCI Office of Acquisitions, as described in question 1 of this FAQ.
Government regulations reflect a preference for nonexclusive licenses, however exclusive licenses are available when appropriate to promote successful commercial development of a licensed invention. It is anticipated that an exclusive commercialization license may be appropriate for commercial development of NIH-TT technologies. To obtain an exclusive license, a company must complete a license application and submit the application to the responsible LPM within OTT. Upon receipt of an exclusive license application, the LPM evaluates the license application using a number of criteria to determine if an exclusive license is warranted (see 37 CFR §404.7). If OTT determines an exclusive license is warranted after review of the license application, a Notice of Intent to Grant the license is published in the Federal Register for a period of 15 days.
The criteria OTT uses when evaluating an exclusive license application are based on the requirements set forth in 37 CFR §404.7. These criteria determine whether:
Yes. Applicants seeking an exclusive license are required to submit a detailed justification addressing each of these criteria as well as a complete business development plan.
Yes. Notice of a proposed exclusive license (other than those resulting from a CRADA) is required by law. Notice will be published in the Federal Register, to provide an opportunity for public comment and submit a competing license application. The competing license application generally must be received within 15 days from the publication date of the Federal Register Notice of Intent to Grant an exclusive license. Any such comments will be evaluated and a final decision will be made as to whether or not an exclusive license is warranted.
OTT has developed several model license agreements that serve as the basis for license negotiation. These can be found at http://www.ott.nih.gov/forms-model-agreements#MLA. The business development plan submitted as part of the license application process serves as the basis for establishing performance benchmarks that are included in the license agreement.
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No. The royalty-free, non-exclusive internal use license will grant the right to the specific hardware and/or reagents described in each topic as well as the right to collaborative discussions with the inventor(s). The NIH-TT SBIR contract may be fulfilled without additional formal collaborative agreements.
A formal collaborative agreement will be helpful if the NIH-TT contractor wishes to work more directly with the inventor of the technology, and utilize NCI inventions and/or resources not contained within the SBIR contract. A simple Collaboration Agreement allows the two parties confidentiality and opens the door to a research partnership where both parties are involved in the development of the NCI technology Collaboration agreements and Cooperative Research and Development Agreements (CRADAs) can be executed relatively quickly depending on what is negotiated. CRADA is used when NIH and Industry collaborate to further develop a technology for commercialization. There are 3 different versions of the CRADA; see http://ttc.nci.nih.gov/forms/ for details.
Yes, but not until you have been awarded an NIH-TT SBIR contract.
All questions related to collaborative agreements should be directed to the responsible Technology Transfer Specialist (TTS) in the NCI Technology Transfer Center.
For NCI SBIR Contract Topic 317, the responsible TTS is:
Michael Currens, Ph.D.
Technology Transfer Specialist
Technology Transfer Center
National Cancer Institute
8560 Progress Drive
Frederick, MD 21701
Main Phone: (301) 846-5465
Phone: (301) 846-1831
Fax: (301) 846-6820
Email: currens@mail.nih.gov
For NCI SBIR Contract Topic 318, the responsible TTS is:
Laura Henmueller
Technology Transfer Specialist
Technology Transfer Center
National Cancer Institute
Rockville, MD 20852
Phone: (301) 402-6429
Fax: (301) 402-2117
Email: HenmuelL@mail.nih.gov
Once the NIH-TT SBIR contract has been awarded, there are a variety of different mechanisms available to engage NCI research capabilities. The bottom line is that collaborations provide early access to NCI research materials and expertise that may be available to assist in the development of the technology. NIH-TT contractors interested in formal collaborative agreements are encouraged to contact the responsible Technology Transfer Specialist in the NCI Technology Transfer Center for more information once the award is made. See question 23 above for contact information
The NCI Technology Transfer Center (TTC) is the component of the NCI committed to supporting the National Cancer Institute's technology development activities. A large part of TTC's responsibilities includes the day-to-day negotiations of transactional co-development agreements between the NCI and outside parties, including universities, non-profits, and pharmaceutical and biotechnology companies. General information on NCI's co-development agreements can be found at http://ttc.nci.nih.gov or by contacting the TTC Specialists indicated above. Questions on technical issues or contract administration issues related to the SBIR topics should be addressed to Bette Shanahan (email: eshanahan@mail.nih.gov), as described in question 1.
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