From: Jorgenson, Lyric (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=RECIPIENTS/CN=JORGENSONLA]

Sent: 6/21/2017 6:31:32 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Berkley, Dale (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=BERKLEYD]; Hammersia, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=Recipients/cn=hammerslaa]

Subject: link in KEI response

This link doesn’t work

https://www. broadinstitute.org/ partnerships/office-strategic-alliances-and-partnering/information-about- heensing-crispr-genome-edi

Lyric Jorgenson, PhD

Deputy Director, Office of Science Policy National Institutes of Health jorgensonla@od.nih.gov

301.496.6837

REL0000024280

From: Petrik, Amy (NIH/NIAID) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C4ECO5A179F04067B61F20605E911E7C-PETRIKA]

Sent: 12/13/2017 7:49:41 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]

CC: Salata, Carol (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=f98ca6a1f9fc4cfdbbf4036ca8cbace4-csalata]; Feliccia, Vincent (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=7f3a54860cb941clabeldf786e478e00-vfeliccia]

Subject: RE: Final Determination for A-419-2017 for review

Thanks, Mark.

I'll appreciate any advice. Thanks, Amy

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, December 13, 2017 2:43 PM

To: Petrik, Amy (NIH/NIAID) [E] <amy.petrik@nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Cc: Salata, Carol (NIH/NIAID) [E] <csalata@niaid.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vfeliccia@niaid.nih.gov> Subject: RE: Final Determination for A-419-2017 for review

Thanks Amy: b5

Grete tere Serer rere iinrnrmemenimrmemininrmrmenrmimimimimimimeminimimemenimimemimsmemememsmememameney eo noe aad om cae ect time chips i acetone bch tance isms ant in an ese Samar eeoes vs sls eStasbcny i svn io eae acl i

b5

From: Petrik, Amy (NIH/NIAID) [E]

Sent: Wednesday, December 13, 2017 2:30 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum@ocd.nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd @od.nih.gov>

Ce: Salata, Carol (NIH/NIAID) [E] <csalata@niaicl.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vieliccia@niaid.nik.eov> Subject: Final Determination for A-419-2017 for review

Hi Mark and Dale,

i've drafted the attached final determination for the proposed PaxVax exclusive license to the NIAID Zika vaccine technology, with input from my TTIPO colleagues.

Would you each, please, review and let me know if you have any suggestions/edits to improve it? If you have any questions, please don’t hesitate to call.

Thanks,

Amy

Amy F. Petrik, Ph.D. Technology Transfer and Patent Specialist

REL0000024281

Technology Transfer and Intellectual Property Office National Institute of Allergy and Infectious Diseases National Institutes of Health, HHS

5601 Fishers Lane

Suite 2G

Rockville, MD 20892-9804 240-627-3721

REL0000024281

From: Robert Hardy [RHardy@COGR.edu]

Sent: 9/26/2016 10:04:55 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]

cc: Hammersla, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=Recipients/cn=hammerslaa] Subject: FW: New CRS Report: March in Rights Under Bayh Dole

Attachments: CRS-RPT_R44640_2016-09-23.pdf

Mark,

This appears to be the same report as the one you sent me last month, but it’s dated Sept. 23.

Not sure about the date discrepancy.

Bob

From: Tony J. Mazzaschi [mailto: TMazzaschi@aspph.org] Sent: Monday, September 26, 2016 4:43 PM

To: Robert Hardy; Steve Heinig

Subject: New CRS Report: March in Rights Under Bayh Dole

In case you don’t normally see these.

Tony

Tony Mazzaschi | Senior Director, Policy and Research

Association of Schools and Programs of Public Health (ASPPH) | www esnph. ore

1900 M Street NW, Suite 710 | Washington, DC 20036 Veh 202-296-1099, ext. 132 | Fax: 202-296-1252 | Email: tmazzaschi@aspph.org

SP

Public Health is Your Health

co oe SCHOOLS & PROGRAMS

REL0000024284

Congressional _ Research Service

Informing the legislative debate since 1914

March-In Rights Under the Bayh-Dole Act

John R. Thomas Visiting Scholar September 23, 2016 Congressional Research Service 7-5700 Wwww.crs.gov R44640 CRS REPORT

Prepared for Members and

Committees of Congress

March-In Rights Under the Bayh-Dole Act

Summary

Congress approved the Bayh-Dole Act, P.L. 96-517, in order to address concerns about the commercialization of technology developed with public funds. This 1980 legislation awards title to inventions made with federal government support if the contractor consists of a small business, a university, or other non-profit institution. A subsequent presidential memorandum extended this policy to all federal government contractors. As a result, the contractor may obtain a patent on its invention, providing it an exclusive right in the invention during the patent’s term. The Bayh- Dole Act endeavors to use patent ownership as an incentive for private sector development and commercialization of federally funded research and development (R&D).

The federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act. The government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit. The Bayh-Dole Act also provides federal agencies with “march-in rights,” codified at 35 U.S.C. §203. March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself.

No federal agency has ever exercised its power to march in and license patent rights to others. In particular, the National Institutes of Health (NIH) has received six march-in petitions and has denied each one. A 2016 exchange of correspondence between Members of Congress and the Department of Health and Human Services suggests a difference of views related to agency authority under the march-in provision. Supporters of the use of march-in rights assert that they provide an unused mechanism for combatting high drug prices and ensuring that U.S. citizens enjoy the benefits of public R&D funding. Others assert that march-in rights do not provide such a broad authority, but rather are limited to four circumstances identified in the statute. They are also concerned that use of march-in rights might discourage private investment in the often considerable effort needed to bring early-stage technologies to the marketplace.

Congress possesses a number of options with respect to march-in rights. If the current situation is deemed acceptable, then no action need be taken. Congress could also consider amending the Bayh-Dole Act by specifying in greater detail the precise circumstances in which march-in rights should be exercised. Congress may also take such steps as transferring authority over the administration of march-in rights, requiring government contractors to submit periodic reports regarding the commercialization of inventions achieved through public funding, creating a centralized database of inventions subject to the Bayh-Dole Act, and taking steps to ensure that patents on inventions developed through government funding are licensed to the most capable enterprise.

Congressional Research Service

March-In Rights Under the Bayh-Dole Act

Contents

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Congressional Research Service

March-In Rights Under the Bayh-Dole Act

Introduction

Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. 96- 517, Amendments to the Patent and Trademark Act.' This legislation is commonly referred to as the “Bayh-Dole Act,” after its two primary sponsors, former Senators Robert Dole and Birch Bayh. This 1980 legislation awards title to inventions that government contractors make with federal government support, if the contractor consists of a small business, a university, or other non-profit institution. A subsequent presidential memorandum extended this policy to all federal government contractors.’ As a result, the contractor may obtain a patent on its invention, providing it with an exclusive right in the invention during the patent’s term. The legislation is intended to use patent ownership as an incentive for private sector development and commercialization of federally funded research and development (R&D).

The federal government retains certain rights in inventions produced with its financial assistance under the Bayh-Dole Act. The government retains a “nonexclusive, nontransferable, irrevocable, paid-up license” for its own benefit.* The Bayh-Dole Act also provides federal agencies with “march-in rights.” > March-in rights allow the government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.” If the patent owner refuses to do so, the government may grant the license itself.

Members of Congress have recently taken note of the fact that march-in rights have never been exercised during the 35-year history of the Bayh-Dole Act.° In particular, the National Institutes of Health (NIH) has received six march-in petitions and has denied each one. A 2016 exchange of correspondence between some Members of Congress and the Department of Health and Human Services has suggested a potential difference of views about the appropriate use of march-in rights. ’ Some observers believe that march-in rights should be rarely, if ever invoked due to the significant investment the private sector investment may make to bring early-stage inventions into practical application. These commentators further assert that the use of march-in rights would discourage private enterprise from investing in the commercial development of any invention funded in part by the government. * On the other hand, others believe that U.S. taxpayers should be protected from what they view as excessive profiteering on technologies developed with

' 94 Stat. 3015 (1980). For further information about this legislation, see CRS Report RL32076, The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology, by Wendy H. Schacht.

> See, e.g., Fred Reinharta and Stephen J. Susalkaa, “Inspired Bayh-Dole Act Turns 35,” Jes Nouvelles, vol. 51 (March 2016), p. 17.

> See Memorandum on Government Patent Policy from President Ronald Reagan, to Heads of Executive Departments and Agencies, February 18, 1983, http://www.presidency.ucsb.edu/ws/index.php?pid=40945 &st=&stl=.

435 U.S.C. §202(c)(4). 535 U.S.C. §203.

° See, e.g., William O'Brien, “March-In Rights Under the Bayh-Dole Act: The NIH’s Paper Tiger?,” Seton Hall Law Review, vol. 43 (2013), p. 1403.

7 See Michael Mezher, “Lawmakers Urge HHS to Exercise ‘March-In’ Rights to Fight Higher Drug Costs,” States News Service, January 11, 2016.

8 Letter from Patricia Harsche Weeks, Immediate Past President, Association of University Technology Managers, to Dr. Mark Rohrbaugh, Director of the Office of Technology Transfer, NIH; http://www.autm.net/advocacy-topics/ government-issues/advocacy-archives/march-in-rights/autm-response-to-march-in-provisions/.

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public funding. They consider march-in rights to constitute a long-available, but entirely unused mechanism for combatting the high and growing cost of health care.’

This report reviews the availability of march-in rights under the Bayh-Dole Act. It begins by providing a brief overview of the patent system and innovation policy. The report then introduces the Bayh-Dole Act. The specific details of the march-in authority provided to federal agencies are reviewed next. The report then considers past efforts to obtain march-in authorization from NIH. The report closes with an identification of potential issues for congressional consideration.

The Patent System: An Overview

The Mechanics of the Patent System

The patent system is grounded in Article I, Section 8, Clause 8 of the U.S. Constitution, which states that “The Congress Shall Have Power ... To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries...” As mandated by the Patent Act of 1952,'° U.S. patent rights do not arise automatically. Inventors must prepare and submit applications to the U.S. Patent and Trademark Office (USPTO) if they wish to obtain patent protection.'' USPTO officials known as examiners then assess whether the application merits the award of a patent.'” The patent acquisition process is commonly known as “prosecution.”

In deciding whether to approve a patent application, a USPTO examiner will consider whether the submitted application fully discloses and distinctly claims the invention.'* The examiner will also determine whether the invention itself fulfills certain substantive standards set by the patent statute. To be patentable, an invention must be useful, novel, and nonobvious. The requirement of usefulness, or utility, is satisfied if the invention is operable and provides a tangible benefit.'* To be judged novel, the invention must not be fully anticipated by a prior patent, publication or other state-of-the-art knowledge that is collectively termed the “prior art.”'” A nonobvious invention must not have been readily within the ordinary skills of a competent artisan at the time the invention was made.'°

If the USPTO allows the patent to issue, the patent proprietor obtains the right to exclude others from making, using, selling, offering to sell, or importing into the United States the patented invention.'’ Those who engage in these acts without the permission of the patentee during the term of the patent can be held liable for infringement. Adjudicated infringers may be enjoined from further infringing acts.'* The patent statute also provides for the award of damages

° Amy R. Schfield,""The Demise of Bayh-Dole Protections Against the Pharmaceutical Industry’s Abuses of Government-Funded Inventions,” Journal of Law, Medicine & Ethics, vol. 32 (2004), p. 780.

0D 1, 82-593, 66 Stat. 792 (codified at Title 35 United States Code). 135 U.S.C. 8111.

235 US.C. §131.

335 U.S.C. §112.

435 U.S.C. §101.

'S 35 U.S.C. $102.

'© 35 U.S.C. §103.

735 U.S.C. §271(a).

1835 U.S.C. §283.

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“adequate to compensate for the infringement, but in no event less than a reasonable royalty for the use made of the invention by the infringer.”"”

The maximum term of patent protection is ordinarily set at 20 years from the date the application is filed.” At the end of that period, others may employ that invention without regard to the expired patent.

Patent rights are not self-enforcing. Patentees who wish to compel others to observe their rights must commence enforcement proceedings, which most commonly consist of litigation in the federal courts. Although issued patents enjoy a presumption of validity, accused infringers may assert that a patent is invalid or unenforceable on a number of grounds.”' The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) possesses national jurisdiction over most patent appeals from the district courts.”” The U.S. Supreme Court enjoys discretionary authority to review cases decided by the Federal Circuit.”

Patents and Innovation Policy

The patent system is intended to promote innovation, which in turn leads to industry advancement and economic growth. The patent system in particular attempts to address “public goods problems” that may discourage individuals from innovating. Innovation commonly results in information that may be deemed a “public good,” in that it is both non-rivalrous and non- excludable. Stated differently, consumption of a public good by one individual does not limit the amount of the good available for use by others; and no one can be prevented from using that good.

The lack of excludability in particular is believed to result in an environment where too little innovation would occur. Absent a patent system, “free riders” could easily duplicate and exploit the inventions of others. Further, because they incurred no cost to develop and perfect the technology involved, copyists could undersell the original inventor. Aware that they would be unable to capitalize upon their inventions, individuals might be discouraged from innovating in the first instance. The patent system corrects this market failure problem by providing innovators with an exclusive interest in their inventions, thereby allowing them to capture their marketplace value.

The patent system potentially serves other goals as well. The patent law may promote the disclosure of new products and processes, as each issued patent must include a description sufficient to enable skilled artisans to practice the patented invention.” In this manner the patent

9 35 U.S.C. §284.

20 35 U.S.C. §154(a)(2). Although patent term is based upon the filing date, the patentee gains no enforceable legal rights until the USPTO allows the application to issue as a granted patent. A number of Patent Act provisions may modify the basic 20-year term, including examination delays at the USPTO and delays in obtaining marketing approval for the patented invention from other federal agencies.

7135 U.S.C. §282. 2 98 U.S.C. §1295(a)(1). 3-98 U.S.C. §1254(1).

>4 See Deepa Varadarajan, “Of Fences and Definite Patent Boundaries,” Vanderbilt Journal of Entertainment and Technology Law, vol. 18 (Spring 2016), p. 563.

> See Gregory N. Mandel, “Innovation Rewards: Solving the Twin Market Failures of Public Goods,” Vanderbilt Journal of Entertainment and Technology Law, vol. 18 (Winter 2016), p. 303.

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system ultimately contributes to the growth of information in the public domain. Issued patents may encourage others to “invent around” the patentee’s proprietary interest. A patent proprietor may point the way to new products, markets, economies of production, and even entire industries. Others can build upon the disclosure of a patent instrument to produce their own technologies that fall outside the exclusive rights associated with the patent.””

The patent system also has been identified as a facilitator of markets. If inventors lack patent rights, they may have scant tangible assets to sell or license. In addition, an inventor might otherwise be unable to police the conduct of a contracting party. Any technology or know-how that has been disclosed to a prospective licensee might be appropriated without compensation to the inventor. The availability of patent protection decreases the ability of contracting parties to engage in opportunistic behavior. By lowering such transaction costs, the patent system may make transactions concerning information goods more feasible.”

Patent protection may also encourage enterprises to commercialize and market existing inventions. Even though a new technology has already been patented, a firm might have to make refinements, construct manufacturing facilities, establish distribution channels, comply with government safety and regulatory requirements, and educate consumers prior to marketing. Second entrants to the market may not have to bear all of the first mover’s costs. As a result, the exclusive rights provided by a patent may encourage not just the invention of new technologies, but also their commercialization.”

Through these mechanisms, the patent system may act in a more socially desirable way than its chief legal alternative, trade secret protection.” Trade secrecy guards against the improper appropriation of valuable, commercially useful, and secret information.*' In contrast to patenting, trade secret protection does not result in the disclosure of publicly available information. That is because an enterprise must take reasonable measures to keep secret the information for which trade secret protection is sought. Taking the steps necessary to maintain secrecy, such as implementing physical security measures, also imposes costs that may ultimately be unproductive for society.

The patent system has long been subject to criticism, however. Some observers have asserted that the patent system is unnecessary due to market forces that already suffice to create an optimal level of innovation. The desire to obtain a lead time advantage over competitors may itself provide sufficient inducement to invent without the need for further incentives. Other commentators believe that the patent system encourages industry concentration and presents a barrier to entry in some markets. Additionally, while the patent incentive encourages the development of new medicines, some assert that it also contributes to the growing costs of healthcare.”

>7 See Herbert Hovenkamp, “Antitrust and the Patent System: A Reexamination,” Ohio State Law Journal, vol. 76 (2015), p. 467.

°8 Jonathan N. Barnett, “Cultivating the Genetic Commons: Imperfect Patent Protection and the Network Model of Innovation,” San Diego Law Review, vol. 36 (2000), p. 1029-1030. °° Emily Michiko Morris, “The Many Faces of Bayh-Dole,” Duquesne Law Review, vol. 54, p. 81.

*° For further information on trade secrets, see CRS Report R43714, Protection of Trade Secrets: Overview of Current Law and Legislation, by Brian T. Yeh.

3! See generally Michael R. McGurk and Jia W. Lu, “The Intersection of Patents and Trade Secrets,” Hastings Science & Technology Law Journal, vol. 7 (Summer 2015), p. 189.

= See, e.g., Dan L. Burk and Mark A. Lemley, The Patent Crisis and How the Courts Can Solve It (2009); James Bessen and Michael Meuer, Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk (2008); (continued...)

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Each of these arguments for and against the patent system has some measure of intuitive appeal. However, they remain difficult to analyze on an empirical level. We lack rigorous analytical methods for studying the impact of the patent system upon the economy as a whole. As a result, current economic and policy tools do not allow us to calibrate the patent system precisely in order to produce an optimal level of investment in innovation at the lowest social costs.

The Bayh-Dole Act

Even prior to the Bayh-Dole Act, the federal government considered the intellectual property implications of R&D projects financed by public funds.*’ In 1963, the Kennedy Administration called for greater consistency in diverse agency practices regarding the disposition of rights to inventions made by government contractors. This early “Government Patent Policy” generally allowed the U.S. government to retain rights to inventions developed through government contracts.** However, the contractor could obtain title in specified circumstances. For example:

[W]here the purpose of the contract is to build upon existing knowledge or technology to develop information, products, processes, or methods for use by the government, and the work called for by the contract is in a field of technology in which the contractor has acquired technical competence (demonstrated by factors such as know-how, experience, and patent position) directly related to an area in which the contractor has an established nongovernmental commercial position, the contractor shall normally acquire the principal or exclusive rights throughout the world in and to any resulting inventions, subject to the government acquiring at least an irrevocable non-exclusive royalty free license throughout the world for governmental purposes.*°

In those situations, the 1963 policy retained significant government rights in privately held patents that resulted from publicly funded projects. In a prelude to today’s march-in rights, the 1963 policy further provided:

Where the principal or exclusive (except as against the government) rights to an invention are acquired by the contractor, the government shall have the right to require the granting of a license to an applicant royalty free or on terms that are reasonable in the circumstances to the extent that the invention is required for public use by governmental regulations or as may be necessary to fulfill health needs, or for other public purposes stipulated in the contract.*°

The 1980 enactment of the Bayh-Dole Act altered the intellectual property landscape with respect to patents and government-sponsored R&D. Congress instead accepted the proposition that the lack of patent title discouraged private enterprise from advancing early-stage technologies into the marketplace. For example, suppose that a university researcher identifies a promising chemical compound using funds provided by the National Institutes of Health (NIH). Some observers believed that under pre-Bayh-Dole Act practices, a brand-name pharmaceutical company would be unlikely to undertake costly and risky clinical trials in order to convert that

(...continued)

Adam B. Jaffe and Josh Lerner, Innovation and Its Discontents: How Our Broken Patent System Is Endangering Innovation and Progress, and What To Do About It (2004).

33 Roberto Mazzoleni, “Patents and University-Industry Interactions in Pharmaceutical Research Before 1962: An Investigation of the Historical Justifications for Bayh-Dole,” Journal of High Technology Law, vol. 10 (2010), p. 168.

34 “Statement of Government Patent Policy,” 28 Federal Register 10943, October 10, 1963. * Thid. at 10945. °° Ibid.

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early-stage research into a drug approved by the Food and Drug Administration. Absent patent protection, generic firms could quickly introduce competing products. This view accepts that patents provide incentives not just for individuals to invent, but also to commercialize completed : . 37

inventions.

Under the Bayh-Dole Act, each nonprofit organization (including universities) or small business is permitted to elect within a reasonable time to retain title to any “subject invention” made under federally funded R&D.** The institution must commit to commercialization of the invention within a predetermined, agreed upon, timeframe. However, the government may keep title under “exceptional circumstances when it is determined by the agency that restriction or elimination of the right to retain title to any subject invention will better promote the policy and objectives of this chapter.” Additionally, the government may withhold title if the contractor “is not located in the United States or does not have a place of business located in the United States or is subject to the control of a foreign government”; in situations associated with national security; or when the work is zelated to the naval nuclear propulsion or weapons programs of the Department of Energy.

Certain other rights are reserved for the government. The government retains “a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States any subject invention throughout the world... “° The government also retains “march-in rights” which enable the federal agency to require the contractor to license a third party to use the invention under certain circumstances."' This report discusses march-in rights at greater length below.

By its own terms, the Bayh-Dole Act applies only to nonprofit organizations (including universities) and small businesses. However, in a February 1983 memorandum concerning the vesting of title to inventions made under federal funding, then-President Ronald Reagan ordered all agencies to treat, as allowable by law, all contractors within the Bayh-Dole Act framework regardless of their size.** This longstanding practice lacks a legislative basis, however.

The Bayh-Dole Act authorizes the government to withhold public disclosure of information for a “reasonable time” until a patent application can be made.** Licensing by any contractor retaining title under this act is restricted to companies that will manufacture substantially within the United States. This requirement may be waived if domestic manufacture is not commercially feasible, or if the contractor or its successors made reasonable but ultimately unsuccessful efforts to license domestic manufacturers.“* The Secretary of Commerce was provided the authority to issue regulations implementing the Bayh-Dole Act.”

37 See F. Scott Kieff, “Property Rights and Property Rules for Commercializing Inventions,” Minnesota Law Review, vol. 85 (2001), p. 697.

38 35 U.S.C. §202(a). > Tbid. 4935 U.S.C. §202(c)(4). 4135 U.S.C. §203.

“ Memorandum on Government Patent Policy from President Ronald Reagan, to Heads of Executive Departments and Agencies, February 18, 1983, http://www.presidency.ucsb.edu/ws/index.php?pid=40945 &st=&st1=.

8 35 U.S.C. §205. “435 U.S.C. §204. 5 35 U.S.C. §206. These regulations may be found at 37 C.F.R. Part 401.

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March-In Rights

The Mechanics of March-In Rights

The Bayh-Dole Act provides the government with the ability to “march in” and grant licenses for patents that resulted from publicly funded R&D. In particular, march-in rights allow the federal government, in specified circumstances, to require the contractor or successors in title to the patent to grant a “nonexclusive, partially exclusive, or exclusive license” to a “responsible applicant or applicants.””° If the patent owner refuses to do so, the government may grant the license itself. The terms of the license must be “reasonable under the circumstances.”

The Bayh-Dole Act specifies four circumstances under which march-in rights may be exercised. The federal agency that provided the funding arrangement under which the patented invention was made must reach one of the following determinations:

(1) action is necessary because the contractor or assignee has not taken, or is not expected to take within a reasonable time, effective steps to achieve practical application of the subject invention in such field of use;

(2) action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees;

(3) action is necessary to meet requirements for public use specified by Federal regulations and such requirements are not reasonably satisfied by the contractor, assignee, or licensees; or

(4) action is necessary because the agreement required by section 204 [generally requiring that patented products be manufactured substantially in the United States unless domestic manufacture is not commercially feasible] has not been obtained or waived or because a licensee of the exclusive right to use or sell any subject invention in the United States is in breach of its agreement obtained pursuant to section 204.*7

With respect to the first of these conditions, the Bayh-Dole Act further defines the term “practical application” as “to manufacture in the case of a composition or product, to practice in the case of a process or method, or to operate in the case of a machine or system; and, in each case, under such conditions as to establish that the invention is being utilized and that its benefits are to the

extent permitted by law or Government regulations available to the public on reasonable terms.”**

The Bayh-Dole Act states that any adversely affected “contractor, inventor, assignee, or exclusive licensee” may appeal a march-in rights petition to the United States Court of Federal Claims. The statute further explains that in cases described in paragraphs (1) and (3) above, march-in authority may not actually be exercised until all appeals or petitions are exhausted.”

The exercise of march-in rights does not invalidate or void the relevant patent. That patent remains extant and could presumably be enforced against entities that did not enjoy march-in rights. However, march-in rights grant a license—in other words, a permission—to the enterprise identified by the government. That entity may practice the patented invention without concern for

4 35 U.S.C. §203(a). 4735 U.S.C. §203(a). 835 U.S.C. §201(f). ” 35 U.S.C. §203(b).

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infringement, so long as it satisfies the conditions stipulated in the march-in order, such as the payment of a royalty.

March-in rights should be distinguished from the “nonexclusive, nontransferable, irrevocable, paid-up license” that the Bayh-Dole Act grants the U.S. government elsewhere.” This license solely benefits the federal government. Should another entity—such as a generic drug company or other enterprise—wish to practice the patented invention, then march-in rights provide a possible legal mechanism.

March-in rights are also distinct from the workings of another statute, 28 U.S.C. §1498(a).*! That provision states:

Whenever an invention described in and covered by a patent of the United States is used or manufactured by or for the United States without license of the owner thereof or lawful right to use or manufacture the same, the owner’s remedy shall be by action against the United States in the United States Court of Federal Claims for the recovery of his reasonable and entire compensation for such use and manufacture.

28 U.S.C. §1498(a) operates independently of the Bayh-Dole system. That statute applies to the use of a patented invention by the U.S. government, or one of its contractors with the authorization or consent of the U.S. government, without the permission of the patent proprietor. In such a case, the sole remedy for the patent owner is a suit in the U.S. Court of Federal Claims for monetary damages. An injunction is not available to the patent owner in such cases.

Three significant distinctions exist between march-in rights under the Bayh-Dole Act and 28 U.S.C. §1498(a). First, march-in rights apply only to patented inventions that were developed with the support of public funding. 28 U.S.C. §1498(a) applies to every U.S. patent, no matter what the sources of funding were. Second, private enterprises may take the initiative in requesting march-in rights from the government. 28 U.S.C. §1498(a) applies when the federal government practices the patented invention on its own behalf or requests a contractor to do so. Finally, recipients of march-in rights are awarded licenses “upon terms that are reasonable under the circumstances” and would presumably pay royalties to the patent proprietor. In contrast, under 28 U.S.C. §1498(a) the patent proprietor commences litigation and may be awarded damages to compensate for the use of the government or its contractors.

March-In Petitions

March-in rights have never been exercised during the 35-year history of the Bayh-Dole Act. Apparently the only federal agency that has even received a petition is the National Institutes of Health (NIH).” In particular, six petitions have been filed requesting that the NIH “march in” with respect to a particular pharmaceutical. Each petition was denied. A common theme of each

5! See Justin Torres, “The Government Giveth, and the Government Taketh Away: Patents, Takings, and 28 U.S.C. § 1498,” New York University Annual Survey of American Law, vol. 63 (2007), p. 315; Bradley M. Taub, “Why Bother Calling Patents Property? The Government’s Path to License Any Patent and Maybe Pay For It,” John Marshall Review of Intellectual Property Law, vol. 6, p. 151.

» The author of this report has not located any record of any march-in petition filed at any other federal agency that funds R&D. See U.S. Government Accountability Office, Federal Research: Information on the Government’s Right to Assert Ownership Control Over Federally Funded Inventions, GAO-09-742, July 2009, http://www.gao.gov/assets/ 300/293020.pdf (noting that the Department of Defense, Department of Energy, and National Aeronautics and Space Administration “have neither discovered nor received information that would lead them to initiate a march-in proceeding or exercise their march-in authority during the last 20 years.”).

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of the denials was the agency’s views that concerns over drug pricing were not, by themselves, sufficient to provoke march-in rights. The six requests were:

CellPro, Inc. (1997). CellPro requested that the government exercise march-in rights after being found to infringe patents held by the contractor. Although the NIH recognized that CellPro’s device was the only FDA-approved product on the market, the agency observed that (1) the contractor and its licensees had not sought immediately to enjoin CellPro and (2) that they were making reasonable efforts to commercialize their own product. As a result, the agency declined to initiate march-in procedures.”

Norvir/ritonavir (2004). The petitioners, which included some Members of Congress, asked the NIH to exercise march-in rights due to perceived concerns over the high price of this HIV/AIDS treatment. The agency declined to initiate march-in proceedings because it deemed Abbott Laboratories, Inc., to have made the drug available to the public on a sufficient basis.™

Xalatan/atanoprost (2004). Petitioners asserted that the price of this glaucoma treatment was higher than that of other nations. The NIH declined to initiate march-in proceedings because the drug was readily available for use by the public.”

Fabrazyme/agalsidase beta (2010). This petition asked the NIH to grant an open license on certain patents relating to this treatment for Fabry disease. According to the petitioners, Genzyme Corporation was encountering difficulties in manufacturing sufficient quantities of the drug. The NIH did not initiate a march- in proceeding because (1) Genzyme was working diligently to resolve its manufacturing difficulties and (2) other enterprises were unlikely to obtain FDA marketing approval on agalsidase beta products before those problems were addressed.”°

Norvir/ritonavir (2012). The second petition against this HIV/AIDS drug more specifically requested the NIH to invoke march-in rights when prices in the United States were greater than other high-income nations. The NIH did not initiate march-in right proceedings because, in the view of the agency, such pricing disparities did not trigger any of the four statutory criteria for marching in.

Xtandi/enzalutamide (2016). The petitioner asserted both that the prostate cancer drug Xtandi had an average wholesale price of $129,269 per year; and that this price was much higher than in other high-income nations. The NIH declined to

>3 Harold Varmus, Director, NIH, Determination in the Case of Petition of CellPro,Inc., August 1, 1997, http://web.archive.org/web/20070102183356/http:/www.nih.gov/icd/od/foia/cellpro/pdfs/foia_cellpro39.pdf.

4 Elias A. Zerhouni, Director, NIH, In the Case of Norvir Manufactured by Abbott Laboratories, Inc., July 29, 2004, http://w ww.ott.nih.gov/sites/default/files/documents/policy/March-In-Norvir.pdf.

5 Blias A. Zerhouni, Director, NIH, Jn the case of Xalatan, Manufactured by Pfizer, Inc., September 17, 2004, https://www.ott.nih. gov/sites/default/files/documents/policy/March-in-xalatan.pdf.

°° Francis S. Collins, Director, NIH, Determination in the Case of Fabrazyme Manufactured by Genzyme Corporation, December 1, 2010, https://www.ott.nih.gov/sites/default/files/documents/policy/March-In-Fabrazyme.pdf.

57 Francis S. Collins, Director, NIH, Determination in the Case of Norvir Manufactured by AbbVie, November 1, 2013, https://www.ott.nih. gov/sites/default/files/documents/policy/March-In-Norvir2013.pdf.

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initiate a march-in investigation because sales of the product were increasing and no evidence suggested that the product was in short supply.

The NIH has offered some observations about the role of march-in rights during these proceedings. In its response to the 1997 CellPro petition, the agency stated its reluctance to undermine the exclusivities offered by the patent system:

We are wary, however, of forced attempts to influence the marketplace for the benefit of a single company, particularly when such actions may have far-reaching repercussions on many companies’ and investors’ future willingness to invest in federally funded medical technologies. The patent system, with its resultant predictability for investment and commercial development, is the means chosen by Congress for ensuring the development and dissemination of new and useful technologies. It has proven to be an effective means for the development of health care technologies. In exercising its authorities under the Bayh-Dole Act, NIH is mindful of the broader public health implications of a march-in proceeding, including the potential loss of new health care products yet to be developed from federally funded research.”

In the 2004 proceedings regarding Norvir/ritonavir, the agency spoke more specifically about drug pricing: Finally, the issue of the cost or pricing of drugs that include inventive technologies made using Federal funds is one which has attracted the attention of Congress in several contexts that are much broader than the one at hand. In addition, because the market dynamics for all products developed pursuant to licensing rights under the Bayh-Dole Act could be altered if prices on such products were directed in any way by NIH, the NIH agrees with the public testimony that suggested that the extraordinary remedy of march-in is not an appropriate means of controlling prices. The issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively.”

The NIH has also observed that another statute, the Drug Price Competition and Patent Term Restoration Act, P.L. 98-417, plays a role in the public availability of medicines.°' Better known as the Hatch-Waxman Act, this legislation allows generic drug companies to develop their own products without incurring liability for patent infringement. It also allows generic drug companies to market their products prior to the expiration of relevant patents, although if they do so they may incur infringement liability at that time.”

Debate over March-In Rights

Concerns over the lack of assertion of march-in rights have been expressed for the past two decades. In 2001, Peter S. Arno™ and Michael H. Davis™ published an article in the Tulane Law

8 J etter from Francis C. Collins, Director, NIH, to Andrew S. Goldman, Knowledge Ecology International, June 20, 2016, http://keionline.org/sites/default/files/Final-Response-Goldman-6.20.2016.pdf.

» Harold Varmus, Director, NIH, Determination in the Case of Petition of CellPro,Inc., August 1, 1997, http://web.archive.org/web/20070102183356/http:/www.nih.gov/icd/od/foia/cellpro/pdfs/foia_cellpro39.pdf.

5! Francis §. Collins, Director, NIH, Determination in the Case of Fabrazyme Manufactured by Genzyme Corporation, December 1, 2010, https://www.ott.nih. gov/sites/default/files/documents/policy/March-In-Fabrazyme.pdf, p. 9.

® CRS Report R41114, The Hatch-Waxman Act: Over a Quarter Century Later, by Wendy H. Schacht and John R. Thomas, The Hatch-Waxman Act: Over a Quarter Century Later.

°} Dr. Arno was then a Professor of the Albert Eistein College of Medicine/Montefiore Medical Center.

° Mr. Davis was then a Professor of the Cleveland State College of Law.

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Review asserting that the Bayh-Dole Act “has had a powerful price-control clause since its enactment in 1980 that mandates that inventions resulting from federally funded research must be sold at reasonable prices.” * According to Arno and Davis, “the solution to high drug prices does not involve new legislation but already exists in the unused, unenforced march-in provision of the Bayh-Dole Act.”® Arno and Davis followed this article with a 2002 editorial published in the Washington Post, stating in part:

Although Bayh-Dole has been in place for 20 years, the government has never enforced it—not even once. That, despite the AIDS crisis at home and abroad, despite the millions of elderly and chronically ill Americans in need of affordable prescription drugs and the 40 million others who have no health insurance coverage whatever—and despite the general hand-wringing over the skyrocketing costs of pharmaceuticals.”

Former Senators Birch Bayh and Robert Dole, as they were then, responded with an editorial published in the Washington Post less than a month later. The editorial states in part:

Bayh-Dole did not intend that government set prices on resulting products. The law makes no reference to a reasonable price that should be dictated by the government... The [Arno and Davis] article also mischaracterizes the rights retained by the government under Bayh-Dole. The ability of the government to revoke a license granted under the act is not contingent on the pricing of the resulting product or tied to the profitability of a company that has commercialized a product that results in part from government-funded research. The law instructs the government to revoke such licenses only when the private industry collaborator has not successfully commercialized the invention as a product.

Dialogue over the use of march-in rights was renewed in 2016, resulting in several exchanges between some Members of Congress, on one hand, and the Department of Health and Human Services (HHS) on the other. In an undated letter that was reportedly sent on January 11, 2016, the Honorable Lloyd Doggett, joined by 51 Members of Congress, addressed a letter to Secretary Sylvia Matthews Burwell of HHS and NIH Director Francis S. Collins. The letter in part requested NIH to provide official guidance regarding the situations in which march-in rights should apply.”

Secretary Burwell responded by letter on March 2, 2016. Her letter states in part that the Bayh- Dole Act’s march-in right was “strictly limited and can only be exercised if the agency conducts an investigation and determines that specific criteria are met, such as alleviating health or safety needs or when effective steps are not being taken to achieve practical application of the inventions.” She also concluded that “the statutory criteria are sufficiently clear and additional guidance is not needed.”””

Representative Lloyd Doggett sent an additional letter to Secretary Burwell and Director Collins on March 28, 2016. Signed by eleven other Members of Congress, the letter encourages the NIH

® Peter S. Arno and Michael H. Davis, “Why Don’t We Enforce Existing Drug Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving in Whole or in Part from Federally Funded Research,” 75 Tulane Law Review (2001), p. 631.

66 yp: Ibid. °7 Peter Arno and Michael Davis, “Paying Twice For the Same Drugs,” Washington Post, March 27, 2002, at A21.

%8 See Birch Bayh and Robert Dole, “Our Law Helps Patients Get New Drugs Sooner,” Washington Post, April 11, 2002, at A28.

® Michael Mezher, “Lawmakers Urge HHS to Exercise ‘March-In’ Rights to Fight Higher Drug Costs,” States News Service, January 11, 2016.

” Letter from Sylvia M. Burwell, Secrtary of Health and Human Services, to The Honorable Lloyd Doggett, U.S. House of Representatives, March 2, 2016, http://freepdfhosting.com/be7532cfc0.pdf.

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to conduct a public hearing regarding the request of public interest groups to invoke march-in rights to the cancer drug Xtandi/enzalutamide. The letter explains:

NIH was recently petitioned to exercise these march-in rights on Xtandi, a prostate cancer drug developed at the University of California, Los Angeles (UCLA) through taxpayer supported research grants from the U.S. Army and NIH grants. The petition states that a Japanese licensee, Astellas, is charging Americans $129,000 for this drug, which sells in Japan and Sweden for $39,000, and in Canada for $30,000. We do not think that charging U.S. residents more than anyone else in the world meets the obligation to make the invention available to U.S. residents on reasonable terms. ”!

As noted above, the NIH denied march-rights for Xtandi/enzalutamide on June 20, 2016.”

Congressional Issues and Options

To date, no bills have been introduced in the 114"" Congress to address march-in rights under the Bayh-Dole Act. Therefore, if Congress deems the current situation to be acceptable, then no action need be taken. Other options include clarifications that further stipulate the circumstances under which march-in rights may be invoked, either by statutory amendment or the encouragement of regulatory refinements. Congress could, for example, define with greater clarity the precise circumstances under which a patented invention is deemed “available to the public on reasonable terms.”’’ Congress could also define with greater specificity when march-in rights are needed to “alleviate health or safety needs,””* particularly with respect to inventions that might be perceived as too costly for many consumers to afford.

Other options include transfer of oversight of administering march-in rights. Currently the Bayh- Dole Act assigns the agency that provided funds that led to the patented invention responsibility for exercising these rights.” Another entity might have distinct perspectives than the funding agency and might reach different conclusions on whether to exercise march-in rights.

Transferring decisionmaking authority to a distinct entity might also eliminate any perceived conflicts of interest with respect to march-in rights. Former employees of federal agencies often wish to pursue careers within the private sector and may wish to maintain good relationships with those enterprises. In addition, agency officials may themselves be named inventors on patents to which march-in rights apply.”° These factors could conceivably lead to a perception of bias against the institution of march-in rights.

Some commentators have also suggested that Congress should establish a centralized database of inventions subject to the Bayh-Dole Act.”” Such a record would potentially improve the ability of

T! Letter from Lloyd Doggett, House of Representatives, to The Honorable Sylvia Burwell, Secretary, Department of Health and Human Services, March 28, 2016, http://freepdfhosting.com/1c677ecdfc.pdf.

” “Feds Won't Lower Price of Prostate-Cancer Drug,” Seattle Times, June 21, 2016. ® 35 U.S.C. §201(f).

35 U.S.C. §203(a)(2).

® 35 U.S.C. §203(a).

’® The petition for rehearing of the Fabrazyme march-in decision asserted that NIH Director Francis Collins was named as an inventor on nineteen patents potentially subject to march-in rights. Letter from C. Allen Black, Jr., Attorney at Law, to Mark Rohrbaugh, Office of Technology Transfer, NIH, April 5, 2011, http://patentdocs.typepad.com/files/nih- petition-for-rulemaking-and-rehearing-90.pdf.

7 Ryan Whalen, “The Bayh-Dole Act & Public Rights in Federally Funded Inventions: Will the Agencies Ever Go Marching In?,” Northwestern University Law Review, vol. 109 (2015), pp. 1111-12.

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the public to track its R&D investments and observe the degree to which these investments have resulted in new products for the marketplace. If a further level of monitoring were desirable, one possibility would be to require licensees of patents subject to the Bayh-Dole Act to submit periodic reports disclosing both their efforts at introducing the patented inventions to the public and their pricing policies.

Other commentators also have urged reconsideration of the statutory requirement that in certain cases all judicial appeals be exhausted before march-in authority may actually be exercised.” Under current law, even though a federal agency has authorized march-in rights, they may at times not be used until the patent proprietor has taken his case as far as the Supreme Court of the United States. As Arti K. Rai” and Rebecca S. Eisenberg™ assert, “the tolerance for protracted delays inherent in the current process is at odds with the time-sensitive nature of the interests reflected in the substantive standard, such as achieving practical application of the invention ‘within a reasonable time’ and ‘alleviat[ing] health or safety needs.”””*' This possibility of delay could also possibly discourage march-in petitions in the first instance.

Still other commentators have suggested that Congress should take further steps to ensure that the best candidate receives licenses for patents subject to the Bayh-Dole Act. Under current law, government contractors may choose to license their inventions to anyone. Such a system may not place these inventions in the most capable hands, either from the perspective of the contractor or of the public.*’ Another option might be an open-bidding auction that might better ensure that patents on inventions developed through government funding are licensed to the most capable enterprise.

Concluding Observations

Current dialogue over march-in rights involves a familiar policy debate in intellectual property law. On the one hand, the patent laws are intended to promote the labors that lead to innovation. Critics of the use of march-in rights believe that diluting the patent incentive will discourage private investment and ultimately work against the aims of the Bayh-Dole Act. But others say that the patent laws are also intended to distribute the fruits of those labors to the public. This goal is most visibly achieved when patents expire and previously proprietary technologies enter the public domain. However, some observers believe that march-in rights provide an unused mechanism for discouraging excessive profiteering and providing the public an appropriate return on its R&D investments during a patent’s term. Striking a balance between these competing views regarding the commercialization of federally funded research remains a matter of congressional judgment.

8 35 U.S.C. §203(b). ” Arti K. Rai is the Elvin R. Latty Professor of Law at the Duke University School of Law.

°° Rebecca S. Eisenberg is the Robert and Barbara Luciano Professor of Law at the University of Michigan Law School.

5! Arti K. Rai and Rebecca S. Eisenberg, “Bayh-Dole Reform and the Process of Biomedicine,” Journal of Law and Contemporary Problems, vol. 66 (2003), p. 311.

* Deter Lee, “Transcending the Tacit Dimension: Patents, Relationships, and Organizational Integration in Technology Transfer,” California Law Review, vol. 100 (2012), p. 1521.

83 See Whalen, supra.

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Author Contact Information

John R. Thomas Visiting Scholar jrthomas @crs.loc.gov, 7-0975

Congressional Research Service

From: Kassilke, Deborah (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=OD/CN=KASSILKED]

Sent: 1/19/2017 8:19:28 PM To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM] Subject: RE: Question re: FOIA for OTT

Good info. If i draft a response will you be so kind to review it before | hit send?

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Thursday, January 19, 2017 3:15 PM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov> Subject: RE: Question re: FOIA for OTT

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Thursday, January 19, 2017 3:05 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RehrBaulM @OD. NIH. GOV> Subject: RE: Question re: FOIA for OTT

Great — can you help educate me then on how we address non- foia questions like theirs? The last item is the one where they request royalties paid to feds, which is a foia request that is being worked for them.

Working with the Foia office on foia responses is pretty straight forward @hough rarely fun}. It’s these that don't come in as foias that | don’t understand what is proper/correct way to address. Any education/ guidance you can give me?

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Thursday, January 19, 2017 3:02 PM

To: Kassilke, Deborah (NIH/OD) [E] <deborah. kassiike@nih.gov> Subject: RE: Question re: FOIA for OTT

i ils. With FOIA we do not need to do an analysis only product documents. FOIA applies to documents or reports you can run from a database. We do not have to do analyses under a FOIA.

REL0000024285

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Thursday, January 19, 2017 2:50 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RehrBauM GOD. NIH. GOV> Subject: FW: Question re: FOIA for OTT

Mark " f'm going to cc you when | respond back to our FOIA office to see what info they sent last year (2015) for the crada list.

Thanks- ’'m trying to wrap this one up, Deb

From: Kassilke, Deborah (NIH/OD) [E] Sent: Thursday, January 12, 2017 4:53 PM

Cc: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM Subject: Question re: FOIA for OTT

@OD.NIK.GOY>

Hello Marin — How did you end up dealing with FOIAs? Congratulations? Grin.

Before Susan Cornell left, she was working on some OTT related FOIA requests from KEI. We have received 3 requests from them (see the attached). Before we resound | would like to know what Susan may have sent them on previous requests. How do | find out what has been issued previously?

Mark Rohrbaugh was kind enough to speak with them on the phone today and explained that CRADAs do not require a Fed Registry Notice. I'll reference that when | respond to the request from Mr. Love.

Please advise and | appreciate your help. Deb

Deborah Kassilke

Director, Office of Technology Transfer National institutes of Health

6011 Executive Boulevard, Suite 325 Rackville, MD 20852

E-Mail: Debor

REL0000024285

From: Dodson, Sara (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DODSONSE]

Sent: 12/16/2015 9:37:28 PM To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM] Subject: RE: Documents from last meeting with Jim Onken

Attachments: DRAFT Biomedical Research Outputs and Outcomes Table 052213.xlsx; VSWHITE PAPER Gleevec_pr MLR_SED_LSR_10282015_ clean for OER.docx; FHS Data Dump_1.4 12-9-15.docx; Neurotech Data Dump_TolCs.docx; OSP_CaseStudy.pdf; Hib Background and Case Study Outline 2015-08-12.docx; OSP case study methods for OER_12092015.docx

Here you go!

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, December 16, 2015 3:54 PM

To: Dodson, Sara (NIH/OD) [E]

Subject: Documents from last meeting with Jim Onken

Sara:

Could you please send me the documents from the meeting with OER? If you already sent them, could you send them again please. | cannot locate them.

Thanks, Mark

Mark L. Rohrbaugh, Ph.D., J.D.

Special Advisor for Technology Transfer Office of Science Policy

National Institutes of Health

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Highly effective Hib

vacciies have been in use since the late 1986s.

» More than 90% ren in the US. sere a + Hib yaoone in 2O%4.

® Fhe CDC praciicts that more than 19,000 cases and 700 Hib-relatedd deaths will ba orevented over the ifesoan af the 4 million LAS. children born in 2008 alone

® For the group af children barn in 2009, Hib vaccination is pred cted fo save $1.8 billion in diract costs and $3.7 billion in total societal costs.

REL0000024289.0005

The first atismts al developing a Hib ine focused on the Sacterial

secchanides — re: ee AGW

SarCNeys to isolats, punfy, and “ub polysaccharides for

His (seen Gefow was found ho bet of en o ae

ne i Sin oh idren. and quished uncer ine

ee Sy ts distinctive cuter

§ later detenrined thal a

shain of sugar molecules

fodlysaccharide

hare ihe manor aris of thi iS Outer coal.

AS bacterial oaiysaccharices are cenerally loss elective at su mmmune responses than pr voicine researchiars began {6 : ed methods to chemically link “wes polysaccharides to proteins

By ceactivaling specific disease- causing samponents of bacteria, the first tetanus and dloninerie “toxcia” vaccines were develo ane ee advarices would later hein the effectiveness of Hig vaccines.

say ‘ee rz, PAM fH-fundaecd milestone

FDA scientists (ater al the NIN) chennoally linked the “weaker Hib polysaccharides to Immmune-stimulating orcteins (6.q., dipntherlal. producing 4 “conjugate vaccine.”

An Nik-Tunded pre-clinical study showed that ths conjugats vaccines —. mmune esoorises in infant monkeys

The conjugate vaccine developed by NIM intramural investioaiars was icensed to in - ng mianufactured, and conmpnennaily distributed,

A series of NiH-funcded clinical triais shawed thai the conjugate vaccine was safe and elective in mfants

yeccing i is recarmmendead ration scheduls.

POA ee the i first 4 oe vaccines for u

in infants.

The Food and Drug Administration (FDA) aporoved the first Hib polysaccharide vaccines (including from Praxis Biologics) far uss in chlidren two years af age, whe researchers cent inued to OUrBUS a SI rategy that wauid 58 more effective in infants.

Nikfunded o trais found a HDS

ocivsacchande vaccines worked wall for a crean two years and gids: bul only 2 fracian of infants shawed protective immune resnonses

nical

investigatars leading these clinical tiais founded a company, called Praxis Biologics fnow incorporated into Wyeth), to develon and manufactures vaccines for children, including those for Hib

>

2057) A isnawr i ines BF metioney TOPPA YOUNG girl PEC Sivan 8 VaCOMSUOn,

sred Dy a public health r

REL0000024289.0005

HEALTH

« First conlugate vaccine aooroved fo treat an uYectous disease.

* Mors than 9094 of children iy the US. receive the Hib vaccine.

SOCIETY

es Hospitalization for Hib- meningitis casts uswards of 7 $38,000 depending on the severity of the disease.

* NiH-suonarted researchers started a cammany and sucoessiully moved Hib and other experimental vaccines through the full prochuct develoomiant pipelins.

KNOWLEDGE

s Hib vaccine research provider! fundarriantal undersianding af how the infant immune system works, stimulating new strategias far developing effective vaccines for infarts.

* The Hib conjugate vaccine technology has been

against disease-causing bacteria. such

as oneumoceacel meningocace!, Salmaneiia tyonl,

group 8 streptococci, and E coll.

HIB DISEASE NEARLY ELIMINATED IN THE US. FOLLOWING THE VACCINE

FRA Approved Hib Vaccines

? Hib oases 4

mied States.

HEALTH IMPACT OF ROUTINE CHILDHOOD IMMUNIZATION FOR Hib: U.S, 199

nesses

at

Xs apis PAYG od:

43,70

RELATED RESOURCES ON HIB AND OTHER VACGINES

CDC's Child, Adolescent

CDC's Vaccines for Children Program

NIAID Health and Research Topics: Vaccines

For references, supplementary information, and more Research impact Reports, please visit ntip://www.nih.gov/about-nih/what-we-do/impact-nih-research.

REL0000024289.0005

REL0000024289.0006

REL0000024289.0007

From: Girards, Richard (NIH/NCI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=6F43C30C4A364463BF5B2C134225B7F0-GIRARDSRT]

Sent: 11/14/2017 7:59:18 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: revised draft

Attachments: Capstone Project submission as of 14 November 2017.docx

Dear Mark- Thanks for your helpful comments last week.

| have revised the document:

If you’re comfortable with this new version, I’ll go admit and submit. Barring any major suggestions on your part, | believe that this current version meets the requirements of the course. While I’m not exactly certain what the procedures are, Steve Ferguson and/or Fred Provorny might require some sort of certification from you as to the fact that we’ve discussed this project and that you generally approve of its form and content- I'll be sure to let you know.

Thanks again! -Rick

Richard T. Girards, Jr., Esq., MBA

National Institutes of Health

NCI Technology Transfer Center

9609 Medical Center Drive, Room 1E508 MSC 9702 Rockville, MD 20850-9702 for UPS/FedEx/visitors Bethesda, MD 20892-9702 for U.S. Mail richard.girards@nih.gov

Phone: 240-276-6825

Fax: 240-276-5504

http://tte.nci.nih.gov

RELO000024292

UE ee EP eR EE ER BE PT EE PC EEE ESSE EP PEO PERSE PESO a PETROL SES PTE RRS REE ORNS PORTE T ep ETEOE OEE top LE RS REPEATS ROT ne EPL

From: Petrik, Amy (NIH/NIAID) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C4ECO5A179F04067B61F20605E911E7C-PETRIKA]

Sent: 12/13/2017 7:30:20 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]

CC: Salata, Carol (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=f98ca6a1f9fc4cfdbbf4036ca8cbace4-csalata]; Feliccia, Vincent (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=7f3a54860cb941clabeldf786e478e00-vfeliccia]

Subject: Final Determination for A-419-2017 for review

Attachments: A-419-2017_FD_13Dec.docx

Hi Mark and Dale,

l’ve drafted the attached final determination for the proposed PaxVax exclusive license to the NIAID Zika vaccine technology, with input from my TTIPO colleagues.

Would you each, please, review and let me know if you have any suggestions/edits to improve it?

If you have any questions, please don’t hesitate to call. Thanks, Amy

Amy F. Petrik, Ph.D.

Technology Transfer and Patent Specialist Technology Transfer and Intellectual Property Office National Institute of Allergy and Infectious Diseases National Institutes of Health, HHS

5601 Fishers Lane

Suite 2G

Rockville, MD 20892-9804 240-627-3721

REL0000024296

Ue ERE CR ET ERY ec PE PT EE PC EN EE EE EES EP PEE PER SEE PESO oP EERO ESE SE PY RRS EE ORES Pree e r EP aT EEE aE EPRI ETE EERE TET SRO SC ene er SP

From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]

Sent: 5/28/2019 2:33:51 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Wong, Jennifer (NIH/NIMH) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=c4258c7cf58f4945a3df079942c68852-wongje]

Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Attachments: Response to FR notice comments from KEl_MLR--OGCBerkleyComments.docx

Sorry for the delay, good work Jennifer and great comments from Mark- b5

Pomme Somer cme ras ee ee eee ee eee eee et eet ete ted |

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

‘This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and st should not be disseminated, distributed, or copied to persons not authorized to recetve such information.

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Sent: Friday, May 24, 2019 4:23 PM

To: Wong, Jennifer (NIH/NIMH) [E] <jennifer.wong2@nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, May 24, 2019 4:23 PM

To: Wong, Jennifer (NIH/NIMH) [E] <jennifer. wong 2 @nih.gov>; Berkley, Dale (NIH/OD) [E] <BerkleyG@OD.NIH.GOV> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Thanks Jenny. Looks good. | made a few proposed edits. Dale?

From: Wong, Jennifer (NIH/NIMH) [E] <iennifer. wong? @nih. gov>

Sent: Friday, May 24, 2019 3:47 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaurm@ocd.nib.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd @od.nih.: Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi all,

Many thanks, Jenny

Jennifer Wong, M.S.

Technology Development Coordinator National Institute of Mental Health Office of Technology Transfer

35A Convent Drive, Room GE400 Bethesda, MD 20892-3747

REL0000024299

Phone: 301-480-4821 E-mail: wongje@mail.nih.gov

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, dissemination, distribution, copying, use of this email or information enclosed therein is strictly prohibited. If you have received this email in error, please notify the sender and destroy the message and any attachments without making a copy. Thank you.

From: Wong, Jennifer (NIH/NIMH) [E]

Sent: Wednesday, May 22, 2019 12:53 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM @OE.NIH.GOV>; Berkley, Dale (NIH/OD) [E] <BerkieyD@OD NIH .GOV> Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Great! I’ll send out a meeting invite with a call-in number.

Thanks, Jenny

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, May 22, 2019 10:55 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.ni.gov>; Wong, Jennifer (NIH/NIMH) [E] <iennifer. wong? @nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Me too

PaatvetentetenetondeentonebAieeevoenicnsereenrererssttctecsuense

Sent: Wednesday, May 22, 2019 10:54 AM To: Wong, Jennifer (NIH/NIMH) [E] <iennifer wong? @nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rchrbaum@ad.nih.goy> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Good for me

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated,

distributed, or copied to persons not authorized to recetve such information.

From: Wong, Jennifer (NIH/NIMH) [E] <iennifer.wong2 @nih. gov>

Sent: Wednesday, May 22, 2019 10:52 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaurm @od.nih.gov>; Berkley, Dale (NIH/OD) [E] <berkieyd @od.nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi, How about 1:30 pm?

Thanks, Jenny

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Tuesday, May 21, 2019 5:07 PM

Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

REL0000024299

| can do Friday after 1

From: Berkley, Dale (NIH/OD) [E] <berkleyd @od.nih.goy> Sent: Tuesday, May 21, 2019 4:50 PM

Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Oh | see that I’ll be in route to downtown at that time. You guys go ahead without me, or | could join any time Friday.

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

‘This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and st should not be disseminated, distributed, or copied to persons not authorized to receive such information.

From: Wong, Jennifer (NIH/NIMH) [E] <jennifer. wong? @nih.gov> Sent: Tuesday, May 21, 2019 2:26 PM To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum @od. nih.gov>

Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi Mark,

Thursday between 2-4 om is good. Please let me know.when it would be convenient to chat. | ac ee bs se; b5 :when KEI sent the “CAIRO TAT CORSE

Thanks,

Jenny

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Tuesday, May 21, 2019 11:29 AM To: Wong, Jennifer (NIH/NIMH) [E] <iennifer. wong2 @nih.gov>

From: Wong, Jennifer (NIH/NIMH) [E] <jennifer. wong? @nih gay> Sent: Tuesday, May 21, 2019 9:15 AM

Subject: FW: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics Hi Mark, Are you available to discuss?

Thanks, Jenny

REL0000024299

Jennifer Wong, M.S.

Technology Development Coordinator National Institute of Mental Health Office of Technology Transfer

35A Convent Drive, Room GE400 Bethesda, MD 20892-3747

Phone: 301-480-4821

E-mail: wongije@mail.nih.gov

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, dissemination, distribution, copying, use of this email or information enclosed therein is strictly prohibited. If you have received this email in error, please notify the sender and destroy the message and any attachments without making a copy. Thank you.

Sent: Monday, May 20, 2019 4:51 PM To: Wong, Jennifer (NIH/NIMH) [E] <iennifer,

KR a

Ce: claire.cassedy <claire.cassedy& @kelonline.org>

Subject: 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Dear Jennifer Wong, MS,

Attached please find the comments by KEI and James Love as an individual with regards to the license proposed in the Federal Register notice 84 FR 19090 to Repurposed Therapeutics, Inc.

Best regards,

Luis Gil Abinader

REL0000024299

Pcie create pteere ce thatch oie se eases tater ae eee aac ae cee a See See ee ese ee ae ram a Ie eee ste are Rae See ae eee a er see aie lates a etc reoe rene eect Ne ae ese, Seem, ae

From: Hammersia, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA] Sent: 5/16/2018 2:53:57 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum] Subject: RE: What was NIH response to KEI? ????

Will discuss within OPERA.

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Wednesday, May 16, 2018 10:51 AM To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>

Sent from my iPhone On May 16, 2018, at 9:46 AM, Hammersla, Ann (NIH/OD) [E] <hammersiaa@imail.nik.gov> wrote:

Request from KEI to OTT and DEITR, to discuss with KEI the policies and regulations for transfers to subsidiaries and “off-shore” development.

From: Hammersla, Ann (NIH/OD) [E] Sent: Wednesday, May 16, 2018 9:29 AM

You were working with Communications about KEI’s request to meet on compliance issues

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Wednesday, May 16, 2018 9:28 AM To: Hammersla, Ann (NIH/OD) [E] <hammersiaa@ mail nih.gov>

On what? | do not recall a recent response Sent from my iPhone

On May 16, 2018, at 9:24 AM, Hammersla, Ann (NIH/OD) [E] <harmrmnersiaa@mail.nih.gov> wrote:

Ann M. Hammiersia, J.D.

Director

Division of Extramural Inventions and Technology Resources Office of Policy for Extramural Research Administration Rockledge 1, Suite 310

6705 Rockledge Drive

REL0000024300

Bethesda, Maryland 20892-7974 PHONE: 301-435-0745

REL0000024300

From: Hammersla, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]

Sent: 8/2/2018 6:50:29 PM

To: Allen-Gifford, Patrice (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=67262490d6d441b48efeclaff0700250-allengiffor]; Rohrbaugh, Mark {NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

CC: Gale, Jamie (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=8c7c93b348c44d9a824ced1ecd6b9ae6-galejr]; Hurlebaus, Lisa (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=ae3ee4a34a70491ebc62f0caf81d729c-Imarshal]; Crone, Colleen (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=8d180cbO0cb7d4bdaa8c86d118520b72d-cronec]; Ellis, Chelsea (NIH/OD) [C] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=55244440fa5b4a8a9028147f7e19cc2e-elliscm]

Subject: RE: Vizamy!

Patrice: b5 Sees See ee b 5 fect ctceecese eee are eee eis nae ie acco J

Ann

From: Allen-Gifford, Patrice (NIH/OD) [E]

Sent: Thursday, August 02, 2018 2:45 PM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]

Ce: Gale, Jamie (NIH/OD) [E] <jamie.gale@nih.gov>; Hurlebaus, Lisa (NIH/OD) [E] <marshall@od.nih.gov>; Crone, Colleen (NIH/OD) [E] <cronec@od.nih.gov>; Ellis, Chelsea (NIH/OD) [C] <chelsea.ellis@nih.gov>

Subject: RE: Vizamyl

Patrice

From: Hammersla, Ann (NIH/OD) [E]

Sent: Thursday, August 02, 2018 2:42 PM

To: Allen-Gifford, Patrice (NIH/OD) [E] <patrice. <rohrbaum Mod nih. gsov>

Cc: Gale, Jamie (NIH/OD) [E] <iar (NIH/OD) [E] <crenec@od nih.gov> Subject: RE: Vizamy!

allen-sifford@nih.zov>; Rohrbaugh, Mark (NIH/OD) [E]

REL0000024301

Ann M. Hammersia, J.D.

Director

Division of Extramural Inventions and Technology Resources Office of Policy for Extramural Research Administration Rockledge 1, Suite 310

6705 Rockledge Drive

Bethesda, Maryland 20892-7974

PHONE: 301-435-0745

From: Allen-Gifford, Patrice (NIH/OD) [E]

Sent: Thursday, August 02, 2018 2:35 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Hammersla, Ann (NIH/OD) [E] <hammersiaa@mall nih. gov>

Cc: Gale, Jamie (NIH/OD) [E] <iamie.gale@inih.gov>; Hurlebaus, Lisa (NIH/OD) [E] <marshall@od.nih.eov>; Crone, Colleen (NIH/OD) [E] <crenec@ad.nik.gov>; Ellis, Chelsea (NIH/OD) [C] <chelsea.eilis@nih.gov>

Subject: RE: Vizamyl

Hi Mark and Ann,

Please let me know if you need us to follow up.

Best, Patrice

Patrice Allen-Gifford Director

Executive Secretariat 301-496-3976

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Thursday, August 02, 2018 1:28 PM

To: Allen-Gifford, Patrice (NIH/OD) [E] <patrice.allen-gifford @nih.gov> Cc: Hammersla, Ann (NIH/OD) [E] <hammersias@mail .nih.gov> Subject: FW: Vizamyl

Patrice:

From: Hammersla, Ann (NIH/OD) [E] Sent: Thursday, August 02, 2018 1:26 PM

REL0000024301

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum @od.nih.gov> Subject: FW: Vizamyl

Collins and | were copied on the KEI request.

From: Hammersla, Ann (NIH/OD) [E]

Sent: Thursday, August 02, 2018 1:25 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <KehrBauM@OD. NIH.GOV> Subject: Vizamyl

Ann M. Hammoersia, J.D.

Director

Division of Extramural Inventions and Technology Resources Office of Policy for Extramural Research Administration Rockledge 1, Suite 310

6705 Rockledge Drive

Bethesda, Maryland 20892-7974

PHONE: 301-435-0745

REL0000024301

From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]

Sent: 1/23/2019 5:51:51 PM

To: Mowatt, Michael (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=cb1lef7e2e54b4164ae34814574bda638-mmowatt]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b89970827 18cbb29fab-rohrbaum]; Frisbie, Suzanne (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=c402740ceaad4d4f97a8c28f16fbb349-frisbies]; Soukas, Peter (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=b1f6020157ac47948c6e34166b78e433-soukasp]; Williams, Richard (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=e5f89fe4d2 7a43abb936bb20efeca3b9-rwilliams]; Puglielli, Maryann (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=9f53ceacaf754875a948081bac5cc66a-pugliellim]

Subject: RE: KEI Response Letter

Attachments: Response to KEI J Love Comments_to DB and MR Jan 10--OGCBerkleyComments--1-23-2019--clean.docx

Dale D. Berkley, Ph.D., J.D.

office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528 (Fax)

This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information.

----- Original Message-----

From: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>

Sent: Tuesday, January 22, 2019 12:53 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>; Soukas, Peter (NIH/NIAID) [E] <peter.soukas@nih.gov>; williams, Richard (NIH/NIAID) [E] <rwilliams@niaid.nih.gov>; Puglielli, Maryann (NIH/NIAID) [E] <maryann.puglielli@nih. gov> Cc: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>

Subject: RE: KEI Response Letter

Team,

L_ran. into Dale just now at NIH. ! b5 i

5 iWe shouldn't R€SQ HOPE ERAN LS OF SO MTT EES CORO RO

Thanks Dale and everyone, Mike

----- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Tuesday, January 22, 2019 12:24 PM

To: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>

Cc: Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>; Soukas, Peter (NIH/NIAID) [E] <peter.soukas@nih.gov>; williams, Richard (NIH/NIAID) [E] <rwilliams@niaid.nih.gov>; Puglielli, Maryann (NIH/NIAID) [E] <maryann.puglielli@nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Subject: Re: KEI Response Letter

Just saw this. Do you have time now? Sent from my iPhone

> On Jan 22, 2019, at 11:59 AM, Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov> wrote:

>

REL0000024302

VVVVVVVVVVVV VV VV VV VV

Thanks, Mary.

This one is a priority, so please squeeze it in this week. Tomorrow afternoon?

Dear Mary,

we are just following up, we hope everything is going well with you.

Does Mike have any time this week to discuss these issues with Mark Rohrbaugh and Dale Berkley?

we look forward to a meeting invitation soon. Thank you.

Peter <meeting.ics>

REL0000024302

Pacts Satara that oie es a ea seca tates cea aac aie cae ea See Se ee ee cece ciate eae ace Ses eee este acre eee a See a ae eee er eae aha dea cece Moe rear ences ee dene ch Steal

From: Lambertson, David (NIH/NCI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=3C95B34F709746A8A2553CE54E74ACE2-LAMBERTSOND]

Sent: 9/11/2017 7:22:30 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Rodriguez, Richard (NIH/NCI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=8092cb5394e04733ac0d4d84d25f65e5-rodrigr]

cc: Whitney, Laurie (NIH/NCI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=903a0f2d510b4ef3a08 1c10eef17deb8-whitneyl] Subject: RE: Responses to Objecting Comments for A-381-2017 Ok, thanks. b5 bs r iphpiile tue Wt) Nee Shi dee tle tem etl alt pe op en ahh a tee oe thon AN tn ate eet 8 tah ce

David A. Lambertson, Ph.D.

Senior Technology Transfer Manager Technology Transfer Center

National Cancer Institute/NIH

david.lambertson@nih.gov

http://ttc.nci.nih.gov

9608 Medical Center Drive, Rm 1-E530 MSC 9702 Bethesda, MD 20892-9702 (USPS}

Rockville, MD 20850-9702 (Overnight/express mail} Fhone (Main Office}: 240-276-5530

Phone (direct): (240) 276-6467

Fax: 240-276-5504

Note: This email may contain confidential information. if you are not the intended recipient, any disclosure, copying or use of this email or the information enclosed therein is strictly prohibited, and you should notify the sender for return of an

attached documents

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, September 11, 2017 3:20 PM

To: Lambertson, David (NIH/NCI) [E] <david.lambertson@nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>

Cc: Whitney, Laurie (NIH/NCI) [E] <whitneyl@mail.nih.gov>

Subject: RE: Responses to Objecting Comments for A-381-2017

Happy to review the final.

Thanks Mark

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Monday, September 11, 2017 10:44 AM To: Lambertson, David (NIH/NCI) [E] <david.lambertson@nih.gov>; Rodriguez, Richard (NIH/NCI) [E]

REL0000024303

<richard.rodriguez@nih.gov> Cc: Whitney, Laurie (NIH/NCI) [E] <whitneyl@mail.nih.gov> Subject: RE: Responses to Objecting Comments for A-381-2017

| am working on that and will get back to you today.

From: Lambertson, David (NIH/NCI) [E]

Sent: Monday, September 11, 2017 10:43 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>

Cc: Whitney, Laurie (NIH/NCI) [E] <whitneyl@mail.nih.gov>

Subject: RE: Responses to Objecting Comments for A-381-2017

Thanks. My initial question was! b5

b5 Please let _

Thanks,

David A. Lambertson, Ph.D.

Senior Technology Transfer Manager Technology Transfer Center

National Cancer Institute/NIH

david.lambertson@nih.gov

http://ttc.nci.nih.gov

9609 Medical Center Drive, Rm 1-E530 MSC 9702 Bethesda, MD 20892-9702 (USPS)

Rockville, MD 20850-9702 (Overnight/express mail} Phone (Main Office}: 240-276-5530

Phone (direct): (240) 276-6467

Fax: 240-276-5504

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, copying or use of this email or the information enclosed therein js strictly prohibited, and you should notify the sender for return of any attached documents

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, September 11, 2017 10:41 AM

To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez @nih.gov>

Cc: Lambertson, David (NIH/NCI) [E] <david.Jambertson@nih.gov>; Whitney, Laurie (NIH/NCI) [E]

<whitneyl@mail.nih.gov> Subject: RE: Responses to Objecting Comments for A-381-2017

This is what OD/OC is using for public inquiries.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Monday, September 11, 2017 10:17 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Lambertson, David (NIH/NCI) [E] <david.lambertson@nih.gov>; Whitney, Laurie (NIH/NCI) [E]

<whitneyl@mail.nih.gov>

REL0000024303

Subject: FW: Responses to Objecting Comments for A-381-2017 importance: High

Hi Mark,

b5 so if you can get him a quick response, it

Thanks,

Richard

From: Lambertson, David (NIH/NCI) [E]

Sent: Tuesday, September 05, 2017 6:54 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Whitney, Laurie (NIH/NCI) [E]

<whitneyl @mail.nih.gov> Subject: FW: Responses to Objecting Comments for A-381-2017

Good morning Mark,

Thanks, Dave

David A. Lambertson, Ph.D.

Senior Technology Transfer Manager Technology Transfer Center

National Cancer Institute/NIH

david.lambertson@nih.gov http://ttc.nci.nih.gov

9609 Medical Center Drive, Rm 1-E530 MSC 9702 Bethesda, MD 20892-9702 (USPS)

Rockville, MD 20850-9702 (Overnight/express mail} Phone (Main Office}: 240-276-5530

Phone (direct): (240) 276-6467

Fax: 240-276-5504

Note: This email may contain confidential information. if you are not the intended recipient, any disclosure, copying or use of this email or the information enclosed therein is strictly prohibited, and you should notify the sender for return of any attached documents

REL0000024303

From: Lambertson, David (NIH/NCI) [E]

Sent: Wednesday, August 23, 2017 7:57 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV> Subject: Responses to Objecting Comments for A-381-2017

Good morning Mark,

The fifteen (15) day period for objections to the Notice of Intent to Grant for license application A-381-2017 ended last night. There were eight (8) total objections, seven (7) of which were in the form of comments (the eighth was a competing application which will be analyzed and addressed separately in a Final Determination). | have attached the objecting comments that | received to this e-mail for your review. Here is a list of the commenters in order of the date of their submission, for ease of reference:

1) Knowledge Ecology International (KEI) 2) Samer Nuwayhid

3) David Kolstedt

4) Bruce Korb

5) Arnold Shugarman

6) Brinsley Davis

7) Paul Stumpf

Richard wanted me to contact you about providing formal responses to the objecting comments concerning our advertisement of intent to grant, particularly in view of the recent article concerning the intent to grant. My initial

Pedi te mee Oe et GR es dip tty te a $k a ‘and send each to your attention for review and comment

i sepsis chassis mca nc chsh coal se Ns ccnp dees ecaa es adem lated eecnachenetces vida ea basstas _

prior to sending them.

Thanks, Dave

David A. Lambertson, Ph.D.

Senior Technology Transfer Manager Technology Transfer Center

National Cancer Institute/NIH david.lambertson@nih.gov

http://ttc.nci.nih.gov

9609 Medical Center Drive, Rm 1-E530 MSC 9702 Bethesda, MD 20892-9702 {USPS}

Rockville, MD 20850-9702 (Overnight/express mail} Phone (Main Office}: 240-276-5530

Phone (direct}: (240} 276-6467

Fax: 240-276-5504

Note: This email may contain confidential information. if you are not the intended recipient, any disclosure, copying or use of

this email or the information enclosed therein is strictly prohibited, and you should notify the sender for return of any attached documents

REL0000024303

From: Sent: To:

Subject:

Joe Allen [jallen@allen-assoc.com]

11/15/2017 9:37:47 PM

Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum] Re: FW: TTIPO FYI - FW: CQ on Zika vaccine

Thanks, hadn't scen this one.

On 11/15/2017 3:28 PM, Rohrbaugh, Mark (NIH/OD) [E] wrote:

CQ has now published their story:

NIH Pushes Back on Zika Vaccine Conflict Allegation

The government’s premier medical research agency is refuting allegations that its choice to help bring a Zika vaccine to market was a conflict of interest.

For more than a year, the National Institutes of Health has been ushering a Zika vaccine through clinical testing around the world. In October, it announced that it was planning to grant an exclusive license to California-based Pax Vax, Inc., a small pharmaceutical company that specializes in vaccines, to further develop the product and eventually bring it to market.

But Ken Kelley, the founder and former chief executive of PaxVax, is currently an adviser in the vaccine research center at the National Institute for Allergy and Infectious Diseases, the NIH division that has been researching the Zika vaccine.

The NIH defended its choice on Wednesday after public health groups earlier this week wrote in opposition to the exclusive license, pointing out Kelley’s connection. The NIAID released a statement noting that no other company had submitted an application to license the vaccine.

“NIAID’s intent to license the Zika vaccine candidate to Pax Vax was based solely on the merits of the company’s application and nothing else,” the statement said. “With regard to Mr. Kelley, there was and is no conflict of interest. Discussions related to a license application were conducted between Pax Vax and NIAID’s Technology Transfer and Intellectual Property Office; Mr. Kelley was not involved in those discussions, and he is not involved in decisions to grant licenses.”

The groups Doctors Without Borders and Knowledge Ecology International argued the exclusive license could mean that if the vaccine is ultimately for sale, it will be unaffordable for the vulnerable populations who could benefit from it most.

“Pax Vax has a history of marketing vaccines to travelers and tourists, and may not be willing or

able to scale access in countries where the need is the greatest,” the groups said in comments to the NIH.

RELO000024305

They also believe that the arrangement is a bad deal for the United States, which has already spent hundreds of millions of dollars on Zika vaccine research. If the vaccine is ultimately approved for use, the company would not only benefit from its sale. Because there are no other treatments for Zika, it could also get tax credits to cover half the cost of its research investment. The company could also win a voucher to bring another product to market more quickly, which it could sell for millions of dollars.

If the NIH finalizes its decision to grant an exclusive license, the groups said it should make Pax Vax agree to make it affordable in the U.S. and elsewhere.

Earlier, however, NIAID leader Anthony Fauci told CQ he wasn’t worried about price being an issue.

"I have not seen in my experience, situations in which we were involved in the development of a vaccine, particularly for low- and middle-income countries that really needed it, where the pharmaceutical companies priced it out of their reach," he said in an October interview.

The public health groups also noted that the company is now mostly owned by Cerberus Capital Management, whose CEO, they said, donated $2.2 million to President Donald Trump’s campaign and other groups supporting the Trump candidacy.

Earlier this year, a similar licensing arrangement between the government and drug company Sanofi Pasteur for a Zika vaccine developed by the Army was also criticized by public health groups.

Sanofi eventually dropped out of the deal when a separate government funding stream for the Zika research was cut off.

Joseph P. Allen President

Allen and Associates 60704 Rt. 26, South Bethesda, OH 43719 (W) 740-484-1814

REL0000024305

From: Joe Allen [jallen@allen-assoc.com]

Sent: 12/12/2017 3:39:28 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Hammersla, Ann (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=87fb28aa23744cOb855ef0683ac2e8b4-hammersiaa]

Subject: KEI: Collins falsely denies B-D march in for high drug prices

FYI: https://ww.keionline.org/23619/

Joseph P. Allen President

Allen and Associates 60704 Rt. 26, South Bethesda, OH 43719 Cw) 7240-484-1814_

(c) i b6 i

ww .allen-assoc. com

REL0000024309

From: Wojtowicz, Emma (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=WOJTOWICZEME6D]

Sent: 8/30/2016 12:43:40 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Hammersla, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=Recipients/cn=hammerslaa]

cc: Myles, Renate (NIH/OD) [E] [/O=NIH/OU=Nihexchange/cn=recipients/cn=mylesr]; Fine, Amanda (NIH/OD) [E]

[/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Fineab] Subject: RE: Canadian media question?

Thanks, Mark and Ann. Have a good day.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, August 30, 2016 8:17 AM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Cc: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov> Subject: Re: Canadian media question?

Go with it Sent from my iPhone

On Aug 30, 2016, at 7:13 AM, Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> wrote: Good Morning: The response is ok with me.

Ann

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, August 29, 2016 4:48 PM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Ce: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov> Subject: FW: Canadian media question?

Ok with you?

From: Wojtowicz, Emma (NIH/OD) [E]

Sent: Monday, August 29, 2016 2:33 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: FW: Canadian media question?

Hi Mark-

We received an inquiry from the Canadian Broadcasting Corporation about march-in rights and Xtandi. We wanted to run our response by you to see if anything has changed since June. Please let us know if you have any edits or concerns.

Response:

REL0000024310

Thank you- Emma

From: Kelly Crowe [mailto:kelly.crowe@cbe.ca] Sent: Monday, August 29, 2016 1:52 PM

To: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov> Subject: Canadian media question?

Hello

My name is Kelly Crowe and I am a medical sciences correspondent with the Canadian Broadcasting Corporation, National News, in Toronto.

I am writing to ask for a comment from the NIH about an offer by a Canadian pharmaceutical company, Biolyse Pharma Corporation, to manufacture the prostate cancer drug Xtandi (enzalutamide) at a reduce price.

I have attached the letter Biolyse wrote to Dr. Frances Collins, in April. I would also appreciate a comment on the NIH response to Knowledge Ecology International, which petitioned the NIH to exercise its march-in rights, or royalty-free rights on enzalutamide. I have attached the letter to the NIH director from Andrew Goldman, along with Dr. Collins' response.

My question concerns the NIH decision to decline the opportunity to have the drug manufactured and supplied at a more affordable price. Why did the NIH turn down this opportunity? Has the NIH ever exercised its march-in or royalty-free rights on any drug? Is the NIH reconsidering the offer from Biolyse, or the petition from Knowledge Ecology International?

I am filing a story tomorrow on the Canadian company's offer to make the drug at a more affordable price, and I would appreciate a comment from the NIH about their offer, and about Knowledge Ecology International's petition.

I appreciate any assistance you can offer.

Thank you

Kelly Crowe

REL0000024310

Medical Sciences Correspondent CBC National News 416-205-2539 (desk)

REL0000024310

From: Hammersia, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA] Sent: 5/15/2018 7:35:05 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum] Subject: RE: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt

{am working with the program officers on Dr. Griffin’s grants.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, May 09, 2018 3:39 PM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> Subject: RE: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt

i b5 What are your next steps?

From: Hammersla, Ann (NIH/OD) [E]

Sent: Wednesday, May 09, 2018 9:37 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@CD.NIH.GOV> Subject: FW: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt

Mark: The attached are DFCI’s comments regarding the KEI request.

Ann

From: Sclar, Gary M. <Gary Sclar@DFCLHARVARD EDU>

Sent: Wednesday, April 25, 2018 3:00 PM

To: Hammersla, Ann (NIH/OD) [E] <harmimerslaa@mail.nih.gov>

Cc: Rice Ackman, Rachel E. <Rachel RiceAckman@DFCLHARVARD.EDU>, Libka, Hilary

Subject: RE: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt Dear Ms. Hammersla,

Attached please find the details of our evaluation of the above-referenced patents and NIH Grants P01 CA066996 and RC1 CA147386, as you requested.

As a result of our evaluation, DFCl appropriately did not report that federal funding was used in the conception or reduction to practice of the subject matter of the patents. We are happy to set up a call to discuss further, if this would be useful to you.

Regards,

Gary

REL0000024312

Gary M. Sclar, J.D.

Vice President, Dana-Farber Innovations Dana-Farber Cancer institute

Belfer Office for Dana-Farber innovation 450 Brookline Ave., Boston, MA 02215 Phone: 617-632-5807 = Fax: 617-632-4012 Email: gary sclar@dfci.harvard.edu

From: Sclar, Gary M. Sent: Thursday, April 12, 2018 1:59 PM To: 'dammersla, Ann (NIH/OD) [E]' <kammersiaa@mail.nik.gov>

Subject: RE: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt

Dear Ms. Hammersla,

Thank you for your email. DFCl is aware of KEI’s concerns related to grants P01 CA066996 and RC1 CA147386. We have been reviewing this matter internally and plan to provide you with the results of that evaluation by April 25, 2018, as requested.

Regards,

Gary

Gary M. Sclar, J.D.

Vice President, Dana-Farber Innovations Dana-Farber Cancer institute

Belfer Office for Dana-Farber innovation 450 Brookline Ave., Boston, MA 02215 Phone: 617-632-5807 « Fax: 617-632-4012

Email: gary sclar@dfci.harvard.edu

san eesmerege owcansnesnsimen seasuenanspesseniorspremeransronattiftesrersanenstaeewereremmeat SD see

Sent: Thursday, April 12, 2018 8:33 AM To: Sclar, Gary M. <Gary Sclar@ DFCLHARVARE EDU> Subject: U.S. Patents U.S. 8,222,244, and U.S. 7,973,031; Rydapt

Dear Mr. Sclar:

On March 21, 2018 Knowledge Ecology International (KE!) brought to the National Institutes (NIH) attention its findings that NIH funding to the Dana-Farber Cancer Institute (Dana-Farber) for Dr. James Griffin was used in the development of the inventions that led to two United States patents referenced above. These patents identify Dr. Griffin as an inventor and were issued jointly to Dana-Farber and Novartis AG. The Food and Drug Administration’s Orange Book identifies these patents as being used in the manufacture of Rydapt® (INN midostaurin).

Two NIH grants, PO1 CA066996 and RC1 CA147386, have been identified as sources of research funding that may have led to the conception or the reduction to practice of the subject inventions that led to these two patents. Dana Farber disclosed to NIH 18 subject inventions in iEdison with Dr. Griffin as an inventor but has not reported the issuance of these two identified patents.

REL0000024312

KEI, in its attached March 21, 2018 letter requests that NIH take title to these two identified patents in accordance with 37 C.F.R. § 401.14(a)(d), require U.S. Manufacturing as required by 37 C.F.R. § 401.14(a)(i), and/or or based on NIH’s findings of Dana-Farber’s lack of compliance in disclosing or acknowledging NIH support of the two patents in question use NIH’s rights as set forth at 37 C.F.R. § 401.14(a)(j).

As part of the NIH’s Bayh-Dole Act oversight responsibilities, NIH requests that within ten business days of the date of this email, Dana-Farber provide detailed information concerning NIH’s research funding to Dana-Farber for research by Dr. Griffin, including the two NIH grants cited above, and its evaluation of whether federal funding was used in the conception or reduction to practice of the inventions that led to the granting of these two patents.

If you have any questions, you can contact me at the number and email address below.

Ann Hammersla

Ann M, Hammersia, J.D.

Director

Division of Extramural inventions and Technology Resources CHfice of Policy for Extramural Research Administration Rockledge 1, Suite 310

6705 Rockledge Drive

Bethesda, Maryland 20892-7974

PHONE: 301-435-0745

The information in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information, please contact the Partners Compliance HelpLine at http://Avww.partners.org/complianceline . If the e-mail was sent to you in error but does not contain patient information, please contact the sender and properly dispose of the e-mail.

REL0000024312

From: Vepa, Sury (NIH/NCATS) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=25B6C29F123544738FCBAD51627B2D23-VEPAS]

Sent: 8/1/2018 4:00:21 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Portilla, Lili (NIH/NCATS) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=9b03f548be224eb9b7b6167a32e9cc4a-portilll]

Subject: FW: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.

FYI

Sury

From: Vepa, Sury (NIH/NCATS) [E]

Sent: Wednesday, August 1, 2018 11:59 AM

To: ‘James Love' <james.love@keionline.org>

Cc: Luis Gil Abinader <luis.gil.abinader@keionline.org>; Claire Cassedy <claire.cassedy@keionline.org>; Manon Ress <manon.ress@keionline.org>; Thiru Balasubramaniam <thiru@keionline.org>

Subject: RE: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.

VIA E-MAIL ONLY

James Love

Knowledge Ecology International 1621 Connecticut Ave. NW, Suite 500 Washington, DC 20009

Re: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.

Dear Mr. Love,

Thank you for your emails dated July 10, 2018 regarding the prospective grant of an exclusive license to Apexx Oncology, which was published on June 25, 2018 in the Federal Register (83 FR 29562). The notice period provides an opportunity for public comment and possible objection to the proposed license. We consider all comments prior to negotiating the proposed license.

Specifically, we have considered your comments and address them in the following:

1. With respect to your comments about the license applicant, Apexx Oncology, Inc. (f/k/a FBIO Acquisition Corp. V1) is a majority-owned subsidiary of Fortress Biotech, Inc., a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, both at the Fortress level and within certain of its subsidiaries, also Known as Fortress Companies (http://www.fortressbiotech.com). Regarding its corporate details and business plans etc., we are unable to provide that information as we

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have learnt that information solely from the license application and as such it is privileged and confidential and is not subject to disclosure under 5 USC §552.

. Regarding your comment “did the NIH have no reasonable prospects for a license to an entity with more resources and a stronger track record than a company that seems to barely exist,” prior to posting this notice for a proposed grant of an exclusive license, the NCATS determined

qualified to be granted an exclusive license to the Government’s intellectual property in the fields of use as specified.

. With respect to your recommendations regarding pricing of products made by the licensee, NIH has not included pricing provisions in its licenses for many years, for reasons that have been extensively discussed in the literature, which is readily and publicly available.

. Regarding your recommendation that “the licensee should be required to file an annual report to the NIH, available to the public, on the research and development (R&D) costs associated with the development of any product that uses the invention, including reporting separately and individually the outlays on each clinical trial,” we already require our license applicants/licensees to provide us with sufficient information to evaluate the viability of their commercial plans and to continuously monitor the progress of the development of the licensed technology towards practical application. To the extent that this information is not already publicly available, it is confidential business information and we carefully maintain the confidentiality of that information as required by 37 C.F.R. 404, 5 USC §552 and other applicable regulations and statutes.

. Regarding your comments about limiting or reducing the exclusivity, those determinations were made prior to the advertisement of the proposed license and consistent with 37 CFR 404.7 and

other applicable regulations.

Once again, we thank you for the comments and recommendations provided by the KEI. NCATS has carefully reviewed and given serious consideration to your comments and recommendations. We have determined that KEI’s comments fail to establish that the grant of the prospective license to the

Apexx Oncology would be inconsistent with applicable regulatory and statutory requirements.

Consistent with NIH licensing practices, NCATS will review and consider all the comments and any objections it has received. If none of these are found to warrant a change in our proposed license,

NCATS will proceed with the negotiation of an exclusive license to the Apexx Oncology.

Sincerely,

Sury Vepa

Sury Vepa, Ph.D., J.D.

Senior Licensing and Patenting Manager

National Center for Advancing Translational Sciences, NIH 9800 Medical Center Drive

Rockville, MD 20850

Phone: 301-827-7181

Cell! b6 Fax: 301-217-5736"

E-Mail: sury.vepa@nih.gov Website: www.ncats.nih.gov

NIH NCATS: Improving Health Through Smarter Science Connect with us!: hitps://ncats.nih.gov/connect

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This o-mail may contain confidential and/or privileged material for the sole use of the intended recipient. Any review or distribution by others is strictly prohibited. you are not intended recipient please contact the sender and delete all copies of this e-mail.

From: James Love [mailto:james.love@keionline.org] Sent: Tuesday, July 10, 2018 4:35 PM

To: Vepa, Sury (NIH/NCATS) [E] <sury.vepa@nih.gov>

Cc: Luis Gil Abinader <luis.gil.abinader@keionline.org>; Claire Cassedy <claire.cassedy@keionline.org>; Manon Ress <manon.ress@keionline.org>; Thiru Balasubramaniam <thiru@keionline.org>

Subject: Re: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.

July 10, 2018

Sury Vepa, Ph.D., J.D.,

Senior Licensing and Patenting Manager,

National Center for Advancing Translational Sciences National Institutes of Health

Email sury.vepat@nih.gov

Re: Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer to Apexx Oncology. Notice for comment published in 83 FR 29562.

hittos /Awww federalrecister gov/documents/20 1 8/08/25/20 18-1 3486/orespective-crant-of-exclusive-patent- license-mutant-idh 1-inhibltors-useful-for-treating-cancer

Dear Dr. Vepa,

Knowledge Ecology International (KEI) offers the following comments on the, “Prospective Grant of Exclusive Patent License: Mutant IDH1 Inhibitors Useful for Treating Cancer,” to Apexx Oncology, which was noticed in the Federal Register (83 FR 29562).

As far as the public can determine, Apexx Oncology is a secretive startup company. The only information we could find using a Google search about the company was a contest for a logo of the company. There is no record of a registered trademark for Apexx Oncology with the USPTO. No web page has been located. It is not obvious if Apexx Oncology is a new name for GeneXion Oncology (as indicated today), or a new company entirely, and in any case, there is next to nothing generally known about the company under either name.

When the NIH proposes giving an exclusive license on a patent to a company for which almost nothing is known, it should provide at the very least some basic information about the company. In seeking to respond to the first FR notice in this case, we had asked if GeneXion was owned by a company in Switzerland, but the NIH declined to answer. We don’t know who is on the board of directors, who the key staff are or if another company owns this company. We would like to know if any current or former NIH employees or contractors are part of the company.

We also seek to learn -- why this company was selected in the first place? Do they have people who have worked on this particular technology, or have some special expertise? And since the patents are fairly new, did the NIH have no reasonable prospects for a license to an entity with more resources and a stronger track record than a company that seems to barely exist?

Here are some general provisions that we recommend for an exclusive license by the NIH.

1. No discrimination against US residents in pricing.

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Prices in the U.S. for any drug, vaccine, medical device or other health technology using the invention should not be higher than the median price charged in the seven countries with the largest gross domestic product (GDP), that also have a per capita income of at least 50 percent of the United States, as measured by the World Bank Atlas Method.

2. Developing countries. The license should not be exclusive for countries with a per capita income that is less than 30 percent of the US.

3. Transparency. The licensee should be required to file an annual report to the NIH, available to the public, on the research and development (R&D) costs associated with the development of any product that uses the invention, including reporting separately and individually the outlays on each clinical trial. We will note that this is not a request to see a company business plan or license application. We are asking that going forward the company be required to report on actual R&D outlays to develop the subject inventions.

4. Reduce term of exclusivity when revenues are large. The exclusivity of the license in the U.S. should be reduced by one year for every $500 million in revenue equivalents, earned after the first $1 billion, where revenue equivalent is defined as global cumulative sales plus market entry rewards as well as government grants or tax credits, for the product or products using the invention.

James Love

Knowledge Ecology International james.love@keionline.org https://keionline.org

James Love. Knowledge Ecology International http://www.keionline.org/donate.html KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584,

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From: Joe Allen [jallen@allen-assoc.com]

Sent: 12/8/2017 10:14:37 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Hammersla, Ann (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=87fb28aa23744cOb855ef0683ac2e8b4-hammersiaa]

Subject: The government could march in to control drug prices, but won't

An extended version of The Hill article, this one appeared in Above The Law (https://abovethelaw.com/2017/12/the-government-already-has-the-tools-it-needs-to-make-pharmaceutical- drugs-affordable-if-it-really-wanted-to/). Obviously, they see the Azar nomination as an opportunity to resurrect the issue

Intellectual Property

The Government Already Has The Tools It Needs To

Make Pharmaceutical Drugs Affordable — If It Really Wanted To

The government has never exercised its rights under the Bayh-Dole Act to do so.

By Krista L. Cox

Dec 7, 2017 at 12:22 PM

Th

It’s no secret that pharmaceutical drugs can be incredibly expensive. The United States spends more than $370 billion dollars each year on prescription drugs, more than any other high-income country, clearly contributing to the high costs of health care. Pharmaceutical companies that hold the monopoly rights to patented drugs can charge whatever price they want, or at least whatever the market will bear. Sometimes, this monopoly power means a company will arbitrarily raise the price five-fold overnight simply because it can, with no link to actual costs of production or other rationale.

Last week, on November 29, Trump’s new nominee for Secretary for the Department of Health and Human

prescription drug prices are too high. Azar’s nomination has been scrutinized because under his tenure as

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president of pharmaceutical giant Eli Lilly, costs of drugs steeply increased, including tripling of the price of insulin. During the hearing, Azar promised to address high drug prices as one of his priorities.

As different strategies to address the drug-pricing crisis are discussed and considered, it is worth remembering

that HHS already has the power necessary to reduce the costs for many patented, life-saving medicines through a provision of the Bayh-Dole Act of 1980. And yet, HHS has never exercised these rights, known as “march-in rights,” in the 37 years of the existence of the Bayh-Dole Act 4

These march-in rights were intended to act as safeguards — to ensure that federally funded inventions were being used for the benefit of the public, including being made “available to the public on reasonable terms” or where public health or safety needs are not being satisfied — when the Bayh-Dole Act made it easier for recipients of federal funding to seek patent ownership of federally funded research. The federal government spends billions of dollars each year on research; up to half of all new medicines in the United States are invented at universities through taxpayer funding and it therefore seems reasonable that the public should reap the benefits of publicly funded inventions.

Since the Bayh-Dole clarified the path to patent ownership, however, universities routinely patent taxpayer funded inventions, then exclusively license them to private companies who, in turn, hold monopoly power to price these drugs at whatever they want. While the Bayh-Dole Act was intended to include protections to curb abuses of taxpayer-funded research, in practice these safeguards have not been utilized. As a result, taxpayers are essentially forced to pay for federally funded pharmaceutical inventions twice: once for the underlying research that federal government grants pay for, and again as patients for the costs of the monopoly-priced medicines.

The fact that the NIH/HHS has never exercised their march-in rights in the 37 year history of the Bayh-Dole Act means one of two things: either there have never been any abuses of NIH/HHS-funded patent rights during this time period or that the government doesn’t care enough to actually step in and curb these abuses. The NIH has repeatedly denied requests for the exercise of march-in rights because, despite the fact that the Bayh-Dole Act notes that practical application of an invention means that the invention is being made available “on reasonable terms” the NIH has interpreted this phrase as not including price considerations. In essence, what the NIH has concluded is that as long as an invention is on the market, it is being made available on reasonable terms. A drug company could charge a million dollars for a single pill, but under the NIH’s reasoning, march-in rights would not be warranted.

While Azar testified that lowering drug prices is a priority, Azar’s background as the president of a company that tripled the price of insulin on a whim, the fact that he served as HHS’ general counsel from 2001 to 2005 during which time the NIH (a division of HHS) twice refused to exercise march-in rights on life-saving medicines, and the lack of any exercise of march-in rights by the agency don’t warrant much optimism. Although it would be easy and entirely possible under current law for the government, including HHS, to make many pharmaceutical drugs more affordable, history has shown little appetite for actually using the safeguards that exist under the Bayh-Dole Act.

{1] Full disclosure: I submitted one march-in petition — a second petition on ritonavir in a second petition for Knowledge Ecology International (KEI), U.S. Public Interest Research Group (U.S. PIRG), and the Universities Allied for Essential Medicines (VAEM) — which was ultimately rejected. That petition noted that the prices that Abbott was charging for ritonavir in the United States were 4-10 times higher than when compared to other high-income countries, highlighting the absurdity of the system. Not only do taxpayers pay for the underlying research and then again for the product at monopoly prices, but we do so at a much higher cost than our European counterparts.

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Krista L. Cox is a policy attorney who has spent her career working for non-profit organizations and associations. She has expertise in copyright, patent, and intellectual property enforcement law, as well as international trade. She currently works for a non-profit member association advocating for balanced

copyright. You can reach her at kristay@gmail.com.

Joseph P. Allen President

Allen and Associates 60704 Rt. 26, South Bethesda, OH 43719 (W) 740-484-1814

www.allen-assoc.com

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From: Thomas, Gina (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=OD/CN=GTHOMAS]

Sent: 1/18/2017 10:36:22 PM

To: Kassilke, Deborah (NIH/OD) [E] [/O=NIH/OU=Nihexchange/cn=od/cn=kassilked]; Rohroaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]

Subject: RE: KEI Request for CRADAs

The list that was attached by Bruce is what OTT provided. | am unsure what Susan Cornell sent. This CRADA was only for our Input.

Gina

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Wednesday, January 18, 2017 5:10 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Thomas, Gina (NIH/OD) [E] <gthomas@od.nih.gov> Subject: FW: KEI Request for CRADAs

Gina ~ please advise — do we have the actual information that was submitted to KEI! for this fola request back in 2015? It looks ike we DID provide a list of CRADAS. See below:

From: Thomas, Gina (NIH/OD) [E]

Sent: Wednesday, January 18, 2017 4:51 PM

To: Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov> Subject: FW: KE] Request for CRADAs

From: Goldstein, Bruce (NIH/OD) [E]

Sent: Tuesday, April 28, 2015 6:27 PM

To: Cornell, Susan (NIH/OD) [E] <CornellS@OD.NIH.GOV>

Cc: Ferguson, Steve (NIH/OD) [E] <FERGUSOS@o0d6100m1.od.nih.gov>; Thomas, Gina (NIH/OD) [E]

<gthomas@od.nih.gov> Subject: RE: KEI Request for CRADAs

Hi.

Tedious but very easy. | took the liberty of adding the current status of each CRADA, which might be helpful in narrowing their requests. |wasn'tsure whethe nd b5 | b5

Regards,

Bruce D. Goldstein, Esq.

NIH Office of Technology Transfer From: Thomas, Gina (NIH/OD) [E] Sent: Tuesday, April 28, 2015 4:59 PM To: Goldstein, Bruce (NIH/OD) [E]

Cc: Ferguson, Steve (NIH/OD) [E] Subject: FW: KEI Request for CRADAs

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Thanks

From: Cornell, Susan (NIH/OD) [E] Sent: Tuesday, April 28, 2015 3:19 PM To: Thomas, Gina (NIH/OD) [E]

Cc: Ferguson, Steve (NIH/OD) [E]; Berkley, Dale (NIH/OD) [E]

Subject: KEI Request for CRADAs

Good Afternoon,

| just got off the phone with Ms. Cassedy of KEI. | explained that NIH has approximately 800 CRADAS and 500

amendments that fall within her timeframe and that our very conservative estimate of a total page count was 45,000 - 50,000 pages (many thanks, Gina, for those numbers!). She said they had no idea there would be that many. |

Thanks for your ongoing help with this one!

Susan

Susan R. Cornell, J.D. Freedom of Information Officer National Institutes of Health Building 31, Room 5B35

9000 Rockville Pike

Bethesda, MD 20892

PH: 301-496-5633 FAX: 301-402-4541 EMAIL: cornells@od.nih.gov

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From: Kesselheim, Aaron Seth,M.D.,M.P.H. [akesselheim@bwh.harvard.edu]

Sent: 8/1/2018 2:12:26 AM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: RE: Questions about CRADAs

Great news! A formal invitation will follow shortly -- Looking forward to it, Aaron

----- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Tuesday, July 31, 2018 7:46 PM

To: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> Subject: Re: Questions about CRADAs

External Email - Use Caution Aaron: I am able to attend.

Regards Mark

Sent from my 71Phone

> On Jul 31, 2018, at 1:43 PM, Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh.harvard.edu> wrote: >

peceeemee eens

looking for other economists to take her place. Also happy to accept suggestions of names of people who you might think would be useful additions!

>

> Best,

> Aaron

>

> oeooe Original Message-----

> From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

> Sent: Tuesday, July 31, 2018 1:39 PM

> To: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> > Subject: RE: Questions about CRADAs

>

> External Email - Use Caution

>

> I am interested. Have there been any additions or subtractions to your list of invitees? >

> Thanks,

> Mark

>

----- Original Message-----

> From: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> > Sent: Tuesday, July 31, 2018 1:31 PM

> To: Rohrbaugh, Mark CNIH/OD) [E] <rohrbaum@od.nih.gov>

> Subject: RE: Questions about CRADAs >

>

u

>

v

Hi Mark -- just following up on this. Any feedback? Or chance we might be able to entice you to join s for one or both days? Best, Aaron

v

----- Original Message-----

From: Kesselheim, Aaron Seth,M.D.,M.P.H.

Sent: Thursday, July 19, 2018 5:30 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov> Subject: RE: Questions about CRADAs

VVVVVV

we hope so. The (at this point, confidential) list of other invitees is below. we would welcome your participation as a member of the conversation throughout the meeting, or for a half-day period, or even as a guest speaker at lunch or dinner. We will operate under ‘Chatham House Rules’ such that there will be no quotes attributed to anyone.

>

> Let me know what you think! We believe it will be very useful to have your perspective and

contri bution--

>

> Best,

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v

----- Original Message-----

From: Rohrbaugh, Mark C(NIH/OD) [E] [mailto: rohrbaum@od.nih.gov] Sent: Thursday, July 19, 2018 5:05 PM

To: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh.harvard.edu> Subject: RE: Questions about CRADAs

External Email - Use Caution Aaron:

I am considering your invitation to the Dec meeting. will the attendees represent a breadth of hinking and opinions about this issue?

Thanks Mark

VVVVtEVVV VV VV VV V

v

----- Original Message-----

From: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> Sent: Wednesday, July 18, 2018 4:05 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Subject: RE: Questions about CRADAs

So noted! This is all for our background knowledge. Thanks for responding! Any initial thoughts about joining us in Boston for the December event?

ASK

VVVVVVVVVVV

v

----- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E] [mailto:rohrbaum@od.nih.gov] Sent: Wednesday, July 18, 2018 4:03 PM

To: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> Subject: RE: Questions about CRADAs

External Email - Use Caution

Aaron:

VVVVVVVVVV

Note that I do not give permission to publish or otherwise publicize my direct comments without permission.

>

> By the late 1980s, NIH was using one standard model agreement for all types of CRADA collaborations. we noted later that some types of collaborations required fewer terms in this standard agreement. In particular, when the collaboration involved primarily the receipt and training in the use of unique research materials from a company, terms dealing with other matters such as human subjects, reports from the company, regular meetings between the parties, etc. were not relevant and therefore not needed. Rather than send a company lawyer a document with a number of nonrelevant terms to be deleted, NIH developed a M-CRADA stripped down to the terms relevant to or otherwise legally required in a

collaboration involving primarily materials. It sped up negotiation and thus benefited both the NIH and the company providing the unique materials. >

> Since then other CRADA models were developed to suit particular types of commercial collaborations, e.g. clinical research.

>

> CRADA partners do not decide on which model, NIH decides.

>

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> noe Original Message-----

From: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh.harvard. edu> Sent: Wednesday, July 18, 2018 11:21 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Subject: RE: Questions about CRADAs

VVVVVV

Thanks Mark! This is very useful--I will read this over. Here are the questions we have, which may not be covered by this overview:

>

ae Oe What's the difference between a CRADA and a Materials CRADA (MCRADA)? In particular, are there any cost benefits or differences in accessibility between a CRADA and an MCRADA?

> 2. Prior to 1996 (when the NIH initiated MCRADAs), could any of the signed CRADAs cover what is now included in an MCRADA?

> 3. How do potential CRADA partners decide between a CRADA and a MCRADA?

> 4. what motivated the NIH to introduce the MCRADA mechanism in 1996?

>

> Let me know if this is worth a phone call.

>

v

On a different note, we're organizing a Radcliffe Seminar at Harvard this winter (December 11-12) on the subject of government funding of drug development and the different strategies that are currently taken Cand that have been proposed) to account for that contribution. It's a small group session of like 15 or so experts in science, economics, law, and medicine from around the country. It would be great to have you join us if not for the whole time, at least as a guest/featured speaker over lunch or dinner -- would something like that be possible?

>

> Best,

> Aaron

>

> oooee Original Message-----

> From: Rohrbaugh, Mark (NIH/OD) [E] [mailto:rohrbaum@od.nih.gov]

> Sent: wednesday, July 18, 2018 11:16 AM

> To: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> > Subject: RE: Questions about CRADAs

>

> External Email - Use Caution

>

> Here is NIH's overview of CRADAs. https://ww.ott.nih.gov/policy/cradas >

> ocoooe Original Message-----

From: Kesselheim, Aaron Seth,M.D.,M.P.H. <akesselheim@bwh. harvard. edu> Sent: Tuesday, July 17, 2018 10:43 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Subject: Questions about CRADAs

> > > > > > Hi Mark -- hope all is well. One of the people in my research group is doing a project on CRADAs and had a few fundamental questions that I thought you might be able to help with -- would it be ok to send the questions over email, or maybe set up a time to quickly chat? > > > > > > >

Best, Aaron

Aaron S. Kesselheim, M.D., J.D., M.P.H.

Associate Professor of Medicine at Harvard Medical School Director, Program On Regulation, Therapeutics, And Law (PORTAL) Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital 1620 Tremont St, Suite 3030 Boston MA 02120 akesselheim@partners.org P: 617-278-0930; F: 617-232-8602 http://www. PORTALresearch.org

v

Faculty member, Harvard Medical School Center for Bioethics Irving S. Ribicoff Visiting Associate rofessor of Law, Yale Law School (2016-2018) Editor-in-Chief, Journal of Law, Medicine, and Ethics

Don't miss our policy and ethics seminar series

VVVVVVVUVVVV VV

>

> The information in this e-mail is intended only for the person to whom it is addressed. If you believe this e-mail was sent to you in error and the e-mail contains patient information, please contact the Partners Compliance HelpLine at http://www.partners.org/complianceline . If the e-mail was sent to you in er but does not contain patient information, please contact the sender and properly dispose of the e- mail.

>

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v

Vv

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From: Barnes, Mary (NIH/NIAID) [C] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=29EEAOC3E3FF40F299BF2EEB40BE91CE-BARNESML]

Sent: 1/22/2019 4:59:43 PM

To: Frisbie, Suzanne (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=c402740ceaad4d4f97a8c28f16fbb349-frisbies]; Soukas, Peter (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=b1f6020157ac47948c6e34166b78e433-soukasp]; Williams, Richard (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=e5f89fe4d2 7a43abb936bb20efeca3b9-rwilliams]; Puglielli, Maryann (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=9f53ceacaf754875a94808 1bac5cc66a-pugliellim]; Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49f0adf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: KEI! Response Letter Location: 5601-6C100

Start: 1/23/2019 6:00:00 PM End: 1/23/2019 7:00:00 PM

Show Time As: Tentative

Required Frisbie, Suzanne (NIH/NIAID) [E]; Soukas, Peter (NIH/NIAID) [E]; Williams, Richard (NIH/NIAID) [E]; Puglielli, Maryann Attendees: (NIH/NIAID) [E]; Berkley, Dale (NIH/OD) [E]; Rohrbaugh, Mark (NIH/OD) [E]

Leader -| b6 Participant -: b6 |

Thanks, Mary.

This one is a priority, so please squeeze it in this week. Tomorrow afternoon?

Dear Mary,

We are just following up, we hone everything is going well with you.

Does Mike have any time this week fo discuss these issues with Mark Rehrbaugh and Dale Berkley? Ve look forward to a meeting invilation soon.

Yhank you.

Pater

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From: Routh, Jennifer (NIH/NIAID) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E3B5BBA3619344E38037CA94A7 1473A8-ROUTHJ]

Sent: 10/17/2017 7:08:10 PM

To: Mowatt, Michael (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=cblef7e2e54b4164ae34814574bda638-mmowatt]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b89970827 18cbb29fab-rohrbaum]

CC: Stover, Kathy (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=c82722674ba14c2f969bd50dfa6a7 af4-stoverk]; Frisbie, Suzanne (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=c402740ceaad4d4f97a8c28f16fbb349-frisbies]

Subject: RE: For awareness

Attachments: Questions from Ed Silverman at STAT KS MM.docx

Thanks, Mike.i b5 iMark — attached is a clean version. We’re circulating this

within NIAID now and plan to send to HHS for clearance this afternoon.

Jennifer Routh [E]

Scientific Communications Editor

Office of Communications and Government Relations National Institute of Allergy and Infectious Diseases (NIAID) NIH/HHS

31 Center Drive Room 7A17B

Bethesda, MD 20892

Direct: (301) 496-8327

jennifer.routh@nih.gov

Disclaimer: The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage

devices. The National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.

From: Mowatt, Michael (NIH/NIAID) [E]

Sent: Tuesday, October 17, 2017 12:50 PM

To: Routh, Jennifer (NIH/NIAID) [E] <jennifer.routh@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> Cc: Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>

Subject: RE: For awareness

See my comments tracked. Mark will chime in with changes/additions if he has any.

In the future please do not hesitate to specify a deadline when you need our response. It helps us prioritize.

From: Routh, Jennifer (NIH/NIAID) [E]

Sent: Tuesday, October 17, 2017 10:39 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>

Cc: Stover, Kathy (NIH/NIAID) [E] <kathy.stover @nih.gov>

Subject: RE: For awareness

Mark, Mike and Suzanne —

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Thanks for your input. We’ve drafted a response to the reporter (attached) with a few questions in the margin. Please let us know what you think.

Thanks, Jen

Jennifer Routh [E]

Scientific Communications Editor

Office of Communications and Government Relations National Institute of Allergy and Infectious Diseases (NIAID) NIH/HHS

31 Center Drive Room 7A17B

Bethesda, MD 20892

Direct: (301) 496-8327

jennifer.routh@nih.gov

Disclaimer: The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage

devices. The National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, October 17, 2017 10:11 AM

To: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] <billetc@niaid.nih.gov>; Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov>

Cc: Mascola, John (NIH/VRC) [E] <jmascola@mail.nih.gov>; Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Routh, Jennifer (NIH/NIAID) [E] <jennifer.routh@nih.gov>; Conrad, Patricia (NIH/NIAID) [E] <conradpa@niaid.nih.gov>; Folkers, Greg (NIH/NIAID) [E] <gfolkers@niaid.nih.gov>

Subject: RE: For awareness

From: Mowatt, Michael (NIH/NIAID) [E]

Sent: Tuesday, October 17, 2017 10:05 AM

To: Billet, Courtney (NIH/NIAID) [E] <billetc@niaid.nih.gov>; Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov> Cc: Mascola, John (NIH/VRC) [E] <jmascola@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>; Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Routh, Jennifer (NIH/NIAID) [E] <jennifer.routh@nih.gov>; Conrad, Patricia (NIH/NIAID) [E] <conradpa@niaid.nih.gov>; Folkers, Greg (NIH/NIAID) [E] <gfolkers@niaid.nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>

Subject: RE: For awareness

Regarding Q2:

Having said this, the starting point for the license negotiation will be a publicly available “NIH model” license agreement (see https://www.ott.nih.gov/resources#MLA, “Exclusive patent license agreement”), the majority of the terms of which usually remain unmodified. The appendices include the most sensitive information.

Mark may have additional comments.

Mike

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From: Billet, Courtney (NIH/NIAID) [E]

Sent: Tuesday, October 17, 2017 9:05 AM

To: Fauci, Anthony (NIH/NIAID) [E] <afauci@niaid.nih.gov>

Cc: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>; Mascola, John (NIH/VRC) [E] <jmascola@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Routh, Jennifer (NIH/NIAID) [E] <jennifer.routh@nih.gov>; Conrad, Patricia (NIH/NIAID) [E] <conradpa@niaid.nih.gov>; Folkers, Greg (NIH/NIAID) [E] <gfolkers@niaid.nih.gov>

Subject: For awareness

We have been contacted by STAT’s Ed Silverman, author of the piece below from May re Sanofi deal. We have sent him the Fed Reg notice, and are now working on answers to some follow-up questions, which are (1) why

an *exclusive* license and (2) assuming we proceed with licensure, will the terms be disclosed. We have the answer to the first question and are seeking the answer to the second. He is not requesting an interview.

https://www.statnews.com/2017/05/29/zika-vaccine-price

US taxpayers are funding a Zika vaccine. Let’s make sure US patients can afford it

By ED SILVERMAN MAY 29, 2017

ear Acting Secretary Speer,

As you know, the United States must prepare for future outbreaks of the Zika virus, but a high- stakes debate has erupted over a the federal government may strike with a private company to develop a vaccine. As acting secretary of the US Army, you have an opportunity — and responsibility — to find a workable solution.

The issue is whether the company — in this case, Sanofi Pasteur — should be required to make the vaccine, which is based on technology discovered with US taxpayer funds, affordable for Americans in return for an exclusive license to develop it into a commercial product.

I understand there are risks, but you should find a way to ensure that Americans do not overpay.

Here’s the backstory: Last year, the government gave Sanofi, which is one of the world’s largest vaccine makers, a $43 million . Another $130 million may follow as research continues. The Army also s to award Sanofi an exclusive license to a pair of patents that are crucial to the vaccine.

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But this move upset some lawmakers and patient advocates, who fear the deal will give the company a monopoly to exploit — and might lead Sanofi to jack up prices for American consumers, assuming the virus spreads and vaccines actually become a big market.

The backdrop to such concerns is the larger controversy over the rising cost of prescription medicines, a problem that has upset many Americans, prompted a flurry of legislation, and put the pharmaceutical industry on the defensive.

Sanofi, which is already under fire over its insulin pricing, is well-aware of the problem. Earlier this month, the company sought to deflect criticism — and mounting negative publicity

— by * to limit price hikes for its medicines to a level at or below the rate of medical inflation in the US.

But an advocacy group, Knowledge Ecology International, argued Sanofi cannot be trusted

and ; for its Aubagio multiple sclerosis drug. Americans using a coupon can pay about $6,100 for a month’s supply — which is seven times more than patients pay in France and at least four times the price in the UK, Ireland, and Australia. A Sanofi spokeswoman says prices vary due to circumstances in each country.

This is why Senator Bernie Sanders and others maintain the Army should push Sanofi for fair pricing on the Zika vaccine. They want a guarantee that Americans would pay a price comparable to what other countries are charged. But as you know, Secretary Speer, Sanofi : fec such a request from your staff last month.

Drug makers generally avoid discussing pricing decisions in advance and Sanofi is no exception. In this case, the company has noted the vaccine doesn’t even exist yet.

A Sanofi executive offered further insight in a to a House subcommittee last week. “Given the high risk nature of vaccine development and unpredictability for diseases like Zika, if the US government changes its historic approach to licensing terms, it could undermine the intent of these types of collaborations,” wrote Adam Gluck, who heads US government relations for the drug maker.

In other words, if a company is forced to agree to certain pricing constraints in advance, it may not bother working with the government to develop such vaccines in the first place.

Indeed, this risk that companies might respond in this way has long worried government officials. In 1995, in fact, the National Institutes of Health removed what was called a “reasonable pricing” clause from research agreements with companies. At the time, former NIH Director Harold Varmus described such clauses as a “restraint” on new product development.

“What companies don’t like is additional uncertainty for commercial considerations piled on top of the inherent risk of doing drug development,” said Genia Long, a senior advisor at Analysis Group, an economic and strategic consulting firm. “If the federal government is going to insert pricing considerations, it might affect their willingness to enter into such agreements.”

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I understand that such notions may give your negotiating team second thoughts. Playing hardball in a situation where public health is at stake is not easy.

But while you may be worried that Sanofi could walk away if pressed too hard on pricing, consider that the company also has something to lose — it would be turning its back on a potentially money- making vaccine that can be sold in numerous markets around the world.

In an era of rising drug costs — an issue that your boss has insisted must be solved — you have an

opportunity to ensure that tax dollars spent subsidizing research provide a return on investment that benefits all Americans.

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Questions from Ed Silverman at STAT:

Why is an exclusive license going to be granted?

And will the terms be disclosed?

NIAID Response (attributed generally to NIAID):

REL0000024323.0001

From: Mowatt, Michael (NIH/NIAID) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=CB1EF7E2E54B4164AE34814574BDA638-MMOWATT]

Sent: 11/3/2017 6:51:05 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: RE: Proposed grant of an exclusive license to Zika Vaccine

Understood.

We will draft a response and circulate. b5

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, November 3, 2017 11:20 AM

To: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov> Subject: FW: Proposed grant of an exclusive license to Zika Vaccine

From: Petrik, Amy (NIH/NIAID) [E]

Sent: Friday, November 03, 2017 10:52 AM To: Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt @niaid.nih.gov> Cc: Salata, Carol (NIH/NIAID) [E] <csalata@niaid.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vfeliccia@niaid.nih.gov>; Green, Wade (NIH/NIAID) [E] <wade.green@nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov> Subject: RE: Proposed grant of an exclusive license to Zika Vaccine

Hi all,

| mistakenly added Natalie Greco instead of Wade Green so I’m adding Wade now.

Please use the recipients on this message for any new responses.

Thanks,

Amy

From: Stover, Kathy (NIH/NIAID) [E] Sent: Friday, November 3, 2017 10:35 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Petrik, Amy (NIH/NIAID) [E] <am

Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov> Cc: Salata, Carol (NIH/NIAID) [E] <csalata@niaid.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vfeliccia@niaid.nih.gov>; Greco, Natalie (NIH/NIAID) [C] <natalie.greco@nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov> Subject: RE: Proposed grant of an exclusive license to Zika Vaccine

Hi all,

Prints einen terete i minrmemimimentemimin ri mimimimimimimtmimimimrm imminent meme heveveveveve eve veveveveve eve ve veve eve eve eve eee eve neem

-petrik@nih.gov>;

REL0000024325

Kathy

Kathy Stover Branch Chief News and Science Writing Branch

National Institute of Allergy and Infectious Diseases (NIAID) Office of Communications and Government Relations National Institutes of Health/HHS

31 Center Drive, Room VALVE

Bethesda, MD 20892

Phone: (301) 496-8864

E-mail: kstover@nih gov

NIAID Media Line: (301) 402-1663

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, November 03, 2017 9:59 AM

To: Petrik, Amy (NIH/NIAID) [E] <amy.petrik@nih.gov>; Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov> Cc: Salata, Carol (NIH/NIAID) [E] <csalata@niaid.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vfeliccia@niaid.nih.gov>; Greco, Natalie (NIH/NIAID) [C] <natalie.greco@nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>; Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>

Subject: RE: Proposed grant of an exclusive license to Zika Vaccine

oO ol

From: Petrik, Amy (NIH/NIAID) [E]

Sent: Friday, November 03, 2017 8:31 AM

To: Mowatt, Michael (NIH/NIAID) [E] <mmowatt@niaid.nih.gov>

Cc: Salata, Carol (NIH/NIAID) [E] <csalata@niaid.nih.gov>; Feliccia, Vincent (NIH/NIAID) [E] <vfeliccia@niaid.nih.gov>; Greco, Natalie (NIH/NIAID) [C] <natalie.greco @nih.gov>; Frisbie, Suzanne (NIH/NIAID) [E] <suzanne.frisbie@nih.gov>; Stover, Kathy (NIH/NIAID) [E] <kathy.stover@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> Subject: FW: Proposed grant of an exclusive license to Zika Vaccine

Hi Mike, Below is the message from KEI.

Thanks, Amy

From: Kim Treanor [mailto:kim.treanor @keionline.org] Sent: Wednesday, October 25, 2017 2:53 PM

To: Petrik, Amy (NIH/NIAID) [E] <amy.petrik@nih.gov> Subject: Proposed grant of an exclusive license to Zika Vaccine

Dear Dr. Petrik,

lam writing in regards to the proposed grant of an exclusive patent license of a DNA-based vaccine for prevention of Zika virus infection to PaxVax Inc, as referenced in 82 FR 47537. As a part of this licensing agreement or separately from

REL0000024325

it, if the exclusive license is granted, will the NIAID or another division of the NIH also provide PaxVax with grants or financial support to conduct clinical trials on this vaccine candidate? PaxVax reports on their website that they have a Zika vaccine candidate in the pipeline which they are working on with the CDC. Do you know if this vaccine candidate has received any financial support from NIAID or another division of the NIH?

Thank you for your assistance.

Best regards, Kim

Kim Treanor Knowledge Ecology International

kim.treanor@keionline.org tel.: +1.202.332.2670

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From: Wong, Jennifer (NIH/NIMH) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=C4258C7CF58F4945A3DF079942C68852-WONGJE]

Sent: 5/28/2019 3:02:05 PM

To: Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b89970827 18cbb29fab-rohrbaum]

Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Thank you!

From: Berkley, Dale (NIH/OD) [E]

Sent: Tuesday, May 28, 2019 10:34 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>; Wong, Jennifer (NIH/NIMH) [E] <jennifer.wong2@nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Sorry for the delay, good work Jennifer and great comments from Mark- b5

Be ahr Se coep er teren eter are teases koe esmraniatmietersestaiaielmtavarara;atcssiannsmn acme! i

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NJH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528 (Fax)

This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to recerve such information.

From: Rohrbaugh, Mark (NIH/OD) [E] <rchrbaum@od.nih.gov>

Sent: Friday, May 24, 2019 4:23 PM

To: Wong, Jennifer (NIH/NIMH) [E] <iennifer. wong? @nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, May 24, 2019 4:23 PM

To: Wong, Jennifer (NIH/NIMH) [E] <iennifer.wone? @inih.gov>; Berkley, Dale (NIH/OD) [E] <BerkleyD@OD.NIH.GOV> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Thanks Jenny. Looks good. | made a few proposed edits. Dale?

From: Wong, Jennifer (NIH/NIMH) [E] <iennifer.wong? @nik.gov>

Sent: Friday, May 24, 2019 3:47 PM

Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi all,

Many thanks, Jenny

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Jennifer Wong, M.S.

Technology Development Coordinator National Institute of Mental Health Office of Technology Transfer

35A Convent Drive, Room GE400 Bethesda, MD 20892-3747

Phone: 301-480-4821

E-mail: wongje@mail.nih.gov

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, dissemination, distribution, copying, use of this email or information enclosed therein is strictly prohibited. If you have received this email in error, please notify the sender and destroy the message and any attachments without making a copy. Thank you.

From: Wong, Jennifer (NIH/NIMH) [E]

Sent: Wednesday, May 22, 2019 12:53 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@Op.NIH.GOV>; Berkley, Dale (NIH/OD) [E] <Berkieyb@OD. NIH. GOV> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Great! I’ll send out a meeting invite with a call-in number.

Thanks, Jenny

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, May 22, 2019 10:55 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Wong, Jennifer (NIH/NIMH) [E] <jennifer. wong? @nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Me too

From: Berkley, Dale (NIH/OD) [E] <berkleyd @od.nih.gov>

Sent: Wednesday, May 22, 2019 10:54 AM

To: Wong, Jennifer (NIH/NIMH) [E] <iennifer. wong? @inih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Good for me

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528 (Fax)

This message 1s intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to receive such information.

From: Wong, Jennifer (NIH/NIMH) [E] <jennifer.wong2 @nih.gov> Sent: Wednesday, May 22, 2019 10:52 AM

Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi,

How about 1:30 pm?

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Thanks, Jenny

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Tuesday, May 21, 2019 5:07 PM

Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

| can do Friday after 1

From: Berkley, Dale (NIH/OD) [E] <berkleyd @od.nih.goy>

Sent: Tuesday, May 21, 2019 4:50 PM

Subject: RE: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Oh | see that I’Il be in route to downtown at that time. You guys go ahead without me, or | could join any time Friday.

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

This message 1s intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to recetve such information.

Sent: Tuesday, May 21, 2019 2:26 PM To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum @od_ nih.gov>

Subject: RE: KEl-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Hi Mark,

Thursday between 2-4 pm is good. Please let me know when it would be convenient to chat.

i i Stic iatois Stas otea iets arene etola tS lori Sssetenses alarate acon ssavasmtarcteteiainsods aietarnialarbeesimraserabeeaselasatalataiesaiavasminta/atasniatsiasainvainieinlasmedjasasciwiaraicies ebsaofciieinasnaiaiesmiah oral esavarsterciaieielascter

additional comments.

Thanks, Jenny

From: Rohrbaugh, Mark (NIH/OD) [E] Sent: Tuesday, May 21, 2019 11:29 AM To: Wong, Jennifer (NIH/NIMH) [E] <iennifer wong 2 @nih.gov>

From: Wong, Jennifer (NIH/NIMH) [E] <ienn Sent: Tuesday, May 21, 2019 9:15 AM

Subject: FW: KEI-- 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

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Hi Mark, Are you available to discuss?

Thanks, Jenny

Jennifer Wong, M.S.

Technology Development Coordinator National Institute of Mental Health Office of Technology Transfer

35A Convent Drive, Room GE400 Bethesda, MD 20892-3747

Phone: 301-480-4821

E-mail: wongje@mail.nih.gov

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, dissemination, distribution, copying, use of this email or information enclosed therein is strictly prohibited. If you have received this email in error, please notify the sender and destroy the message and any attachments without making a copy. Thank you.

From: Luis Gil Abinader <iuis.gil abinader@keionline.org> Sent: Monday, May 20, 2019 4:51 PM

Cc: claire.cassedy <claire.cassedy@keilonline org>; Jamie Love <jamesjove @keionline org> Subject: 84 FR 19090, Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics

Dear Jennifer Wong, MS,

Attached please find the comments by KEI and James Love as an individual with regards to the license proposed in the Federal Register notice 84 FR 19090 to Repurposed Therapeutics, Inc.

Best regards,

Luis Gil Abinader

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From: Richard Gold, Prof. [richard.gold2@mcgill.ca]

Sent: 12/8/2017 8:00:51 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Tania Bubela [tbubela@ualberta.ca]; holmancm@umkc.edu

Subject: Re: balanced view on use of B-D march-in

Dear Mark,

Good to hear from you. | would think that Bob Cook-Deegan or Arti Rai could speak to this. Jake Sherkow may also be good but I do not know whether he has engaged in the issue of march-in rights.

Best, Richard

From: "Rohrbaugh, Mark (NIH/OD) [E]" <rohrbaum@od.nih.gov>

Date: Thursday, December 7, 2017 at 11:28 AM

To: Tania Bubela <tbubela@ualberta.ca>, Richard Gold <richard.gold2@mcgill.ca>, "holmancm@umkc.edu" <holmancm@umkc.edu>

Subject: balanced view on use of B-D march-in

Tania, Richard and Chris:

| hope all is well with you. Recent news articles about march-in have focused primarily on the opinion and quotes from KEI. Do you know anyone who has written or might write, or speak to the press if asked, with a more balanced view of the march-in statute? Probably would be better if the person was US based.

Have a wonderful holiday and a healthy, productive 2019 Mark

Mark L. Rohrbaugh, Ph.D., J.D.

Special Advisor for Technology Transfer

Director, Division of Technology Transfer and Innovation Policy Office of Science Policy

Office of the Director

National Institutes of Health

REL0000024329

From: Kassilke, Deborah (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=OD/CN=KASSILKED]

Sent: 1/18/2017 10:10:04 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Thomas, Gina (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=gthomas]

Subject: FW: KE! Request for CRADAs

Attachments: KEI FOIA 20150429.xlIsx

Gina - please advise ~ do we have the actual information that was submitted to KEI for this foia request back in 2015? It looks like we DID provide a list of CRADAS. See below:

From: Thomas, Gina (NIH/OD) [E]

Sent: Wednesday, January 18, 2017 4:51 PM

To: Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov> Subject: FW: KEI Request for CRADAs

From: Goldstein, Bruce (NIH/OD) [E]

Sent: Tuesday, April 28, 2015 6:27 PM

To: Cornell, Susan (NIH/OD) [E] <CornellS@OD.NIH.GOV>

Cc: Ferguson, Steve (NIH/OD) [E] <FERGUSOS@od6100m1.od.nih.gov>; Thomas, Gina (NIH/OD) [E]

<gthomas@od.nih.gov> Subject: RE: KEI Request for CRADAs

Hi.

Tedious but very Baey : took the ee of adding the current status of each CRADA, which might be helpful in narrowing their requests. i

Regards, Bruce D. Goldstein, Esq. NIH Office of Technology Transfer

From: Thomas, Gina (NIH/OD) [E] Sent: Tuesday, April 28, 2015 4:59 PM To: Goldstein, Bruce (NIH/OD) [E] Cc: Ferguson, Steve (NIH/OD) [E] Subject: FW: KEI Request for CRADAs

_Bruce can you please rerun the CRADA per with the items highlighted in yellow only.

Thanks

Gina

From: Cornell, Susan (NIH/OD) [E]

Sent: Tuesday, April 28, 2015 3:19 PM

To: Thomas, Gina (NIH/OD) [E]

Cc: Ferguson, Steve (NIH/OD) [E]; Berkley, Dale (NIH/OD) [E] Subject: KEI Request for CRADAs

REL0000024330

Good Afternoon,

| just got off the phone with Ms. Cassedy of KEI. | explained that NIH has approximately 800 CRADAS and 500

amendments that fall within her timeframe and that our very conservative estimate of a total page count was 45,000 -

50,000 pages (many thanks, Gina, for those numbers!). She said they had no idea there would be that many. |

suggested that she take a list of the CRADAs with the CRADA partner, the title and the date signed/executed and she

15 years ago.

So, the question is this -}

Thanks for your ongoing help with this one!

Susan

Susan R. Cornell, J.D. Freedom of Information Officer National Institutes of Health Building 31, Room 5B35

9000 Rockville Pike

Bethesda, MD 20892

PH: 301-496-5633 FAX: 301-402-4541

EMAIL: cornells@od.nih.gov

ational institutes of Mealth

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