83 FR 58595 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Pistoia Alliance, Inc.

DEPARTMENT OF JUSTICE
Antitrust Division

Federal Register Volume 83, Issue 224 (November 20, 2018)

Page Range		58595-58596
FR Document		2018-25241

Federal Register, Volume 83 Issue 224 (Tuesday, November 20, 2018)

[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Notices]
[Pages 58595-58596]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25241]


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DEPARTMENT OF JUSTICE

Antitrust Division


Notice Pursuant to the National Cooperative Research and 
Production Act of 1993--Pistoia Alliance, Inc.

    Notice is hereby given that, on October 26, 2018, pursuant to 
Section 6(a) of the National Cooperative Research and Production Act of 
1993, 15 U.S.C. 4301 et seq. (``the Act''), Pistoia Alliance, Inc. has 
filed written notifications simultaneously with the Attorney General 
and the Federal Trade Commission disclosing changes in its membership. 
The notifications were filed for the purpose of extending the Act's 
provisions limiting the recovery of antitrust plaintiffs to actual 
damages under specified circumstances. Specifically, Andrew Hughes 
(individual member), Wilmslow, UNITED KINGDOM; Indiana Biosciences 
Research Institute, Indianapolis, IN; CAS, Columbus, OH; Genialis, 
Inc., Houston, TX; Catalytic Data Science, Wilton, CT; Incedo, Inc., 
Santa Clara, CA; Sanofi, Cambridge, MA; and Cancer Epigenetics Society, 
Vienna, AUSTRIA, have been added as parties to this venture.
    Also, WuXi AppTec, Shanghai, PEOPLE'S REPUBLIC OF CHINA; and 
BioRAFT, Cambridge, MA, have withdrawn as parties to this venture.
    No other changes have been made in either the membership or planned 
activity of the group research project. Membership in this group 
research project remains open, and Pistoia Alliance, Inc. intends to 
file additional written notifications disclosing all changes in 
membership.
    On May 28, 2009, Pistoia Alliance, Inc. filed its original 
notification pursuant to Section 6(a) of the Act. The Department of 
Justice published a notice in the Federal Register pursuant to Section 
6(b) of the Act on July 15, 2009 (74 FR 34364).
    The last notification was filed with the Department on August 10, 
2018. A notice was published in the Federal Register pursuant to 
Section 6(b) of the

[[Page 58596]]

Act on September 4, 2018 (83 FR 44903).

Suzanne Morris,
Chief, Premerger and Division Statistics Unit, Antitrust Division.
[FR Doc. 2018-25241 Filed 11-19-18; 8:45 am]
 BILLING CODE 4410-11-P

Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices 58595

FOR FURTHER INFORMATION CONTACT: containing the same that infringe the Issued: November 14, 2018.
Megan M. Valentine, Office of the ’891 patent, and soliciting United States Lisa Barton,
General Counsel, U.S. International agents or distributors for these activities. Secretary to the Commission.
Trade Commission, 500 E Street SW, On June 13, 2018, the Commission [FR Doc. 2018–25254 Filed 11–19–18; 8:45 am]
Washington, DC 20436, telephone (202) instituted a formal enforcement BILLING CODE 7020–02–P
708–2301. Copies of non-confidential
proceeding, pursuant to Commission
documents filed in connection with this
Rule 210.75(a) (19 CFR 210.75(a)), to
investigation are or will be available for
inspection during official business determine whether a violation of the
March 8, 2018 CDOs issued in the DEPARTMENT OF JUSTICE
hours (8:45 a.m. to 5:15 p.m.) in the
Office of the Secretary, U.S. original investigation has occurred and
to determine what, if any, enforcement Antitrust Division
International Trade Commission, 500 E
Street SW, Washington, DC 20436, measures are appropriate. 83 FR 27626–
Notice Pursuant to the National
telephone (202) 205–2000. General 27 (June 13, 2018). The named
Cooperative Research and Production
information concerning the Commission respondents are Sony and Sony Storage
Act of 1993—Pistoia Alliance, Inc.
may also be obtained by accessing its Media Solutions Corporation of Tokyo,
internet server at https://www.usitc.gov. Japan; Sony Storage Media Notice is hereby given that, on
The public record for this investigation Manufacturing Corporation of Miyagi, October 26, 2018, pursuant to Section
may be viewed on the Commission’s Japan; Sony DADC US Inc. of Terre 6(a) of the National Cooperative
electronic docket (EDIS) at https:// Haute, Indiana; and Sony Latin America Research and Production Act of 1993,
edis.usitc.gov. Hearing-impaired Inc. of Miami, Florida. OUII was also 15 U.S.C. 4301 et seq. (‘‘the Act’’),
persons are advised that information on named as a party. Pistoia Alliance, Inc. has filed written
this matter can be obtained by On August 23, 2018, the Commission notifications simultaneously with the
contacting the Commission’s TDD instituted a modification proceeding,
terminal on (202) 205–1810. Attorney General and the Federal Trade
pursuant to Commission Rule 210.76(b) Commission disclosing changes in its
SUPPLEMENTARY INFORMATION: The (19 CFR 210.76(b)), to determine membership. The notifications were
Commission instituted the original whether the LEO and CDOs issued in filed for the purpose of extending the
investigation on July 1, 2016, based on the underlying investigation should be Act’s provisions limiting the recovery of
a complaint filed by Fujifilm modified to exclude certain of Sony’s
Corporation of Tokyo, Japan, and antitrust plaintiffs to actual damages
redesigned tape products. 83 FR 42690 under specified circumstances.
Fujifilm Recording Media U.S.A., Inc. of
(Aug. 23, 2018). The Commission Specifically, Andrew Hughes
Bedford, Massachusetts (collectively,
consolidated the modification and on- (individual member), Wilmslow,
‘‘Fujifilm’’). 81 FR 43243–44 (July 1,
going enforcement proceedings and UNITED KINGDOM; Indiana
2016). Pertinent to this action, the
complaint alleged violations of section delegated the consolidated proceeding Biosciences Research Institute,
337 of the Tariff Act of 1930, as to the ALJ. Indianapolis, IN; CAS, Columbus, OH;
amended, 19 U.S.C. 1337 (‘‘section On October 10, Sony filed a motion to Genialis, Inc., Houston, TX; Catalytic
337’’), in the sale for importation, terminate the modification portion of Data Science, Wilton, CT; Incedo, Inc.,
importation, and sale within the United the consolidated proceeding based on Santa Clara, CA; Sanofi, Cambridge,
States after importation of certain withdrawal of its request for a MA; and Cancer Epigenetics Society,
magnetic data storage tapes and determination that its redesigned Vienna, AUSTRIA, have been added as
cartridges containing the same by reason products do not infringe the ’891 patent. parties to this venture.
of infringement of, inter alia, claims 1, The motion indicated that Fujifilm does Also, WuXi AppTec, Shanghai,
4–9, 11 and 14 of U.S. Patent No. not oppose the requested termination. PEOPLE’S REPUBLIC OF CHINA; and
6,641,891 (‘‘the ’891 patent’’). The On October 11, 2018, OUII filed a BioRAFT, Cambridge, MA, have
Commission’s Notice of Investigation response supporting the motion. withdrawn as parties to this venture.
named the Sony respondents as
On October 19, 2018, the ALJ issued No other changes have been made in
respondents. The Office of Unfair
the subject ID granting Sony’s motion either the membership or planned
Import Investigations (‘‘OUII’’) was also
named as a party to the investigation. pursuant to Commission Rule activity of the group research project.
On March 8, 2018, the Commission 210.21(a)(1) (19 CFR 210.21(a)(1)). The Membership in this group research
found a section 337 violation as to the ID finds that Sony’s motion complies project remains open, and Pistoia
’891 patent and issued a limited with the Commission’s rules and that Alliance, Inc. intends to file additional
exclusion order (‘‘LEO’’) and cease and there are no extraordinary written notifications disclosing all
desist orders (‘‘CDOs’’) to each of the circumstances that might justify changes in membership.
Sony respondents. 83 FR 11245–47 denying the motion. No party petitioned
for review of the ID. On May 28, 2009, Pistoia Alliance,
(March 14, 2018). The LEO generally Inc. filed its original notification
prohibits the Sony respondents from The Commission has determined not pursuant to Section 6(a) of the Act. The
importing certain magnetic data storage to review the subject ID. Department of Justice published a notice
tapes and cartridges containing the same The authority for the Commission’s
that infringe the ’891 patent, with in the Federal Register pursuant to
determination is contained in section Section 6(b) of the Act on July 15, 2009
certain exceptions related to service and
337 of the Tariff Act of 1930, as (74 FR 34364).
repair and verification testing. The
amended (19 U.S.C. 1337), and in Part The last notification was filed with
CDOs prohibit the Sony respondents
from importing, selling, marketing, 210 of the Commission’s Rules of the Department on August 10, 2018. A
advertising, distributing, transferring Practice and Procedure (19 CFR part notice was published in the Federal
(except for exportation) certain magnetic 210).
Register pursuant to Section 6(b) of the
data storage tapes and cartridges By order of the Commission.

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58596 Federal Register / Vol. 83, No. 224 / Tuesday, November 20, 2018 / Notices

Act on September 4, 2018 (83 FR as an Active Pharmaceutical Ingredient option, and (3) the consequence for
44903). (API) for supply to its customers. failing to elect either option. Id. (citing
Dated: November 2, 2018. 21 CFR 1301.43). The Order also
Suzanne Morris,
John J. Martin,
notified Respondent of his right to
Chief, Premerger and Division Statistics Unit, submit a corrective action plan. Id. at 2–
Antitrust Division. Assistant Administrator.
3 (citing 21 U.S.C. 824(c)(2)(C)).
[FR Doc. 2018–25241 Filed 11–19–18; 8:45 am] [FR Doc. 2018–25228 Filed 11–19–18; 8:45 am] On July 23, 2018, Respondent,
BILLING CODE 4410–11–P BILLING CODE 4410–09–P through counsel, filed a letter requesting
a hearing on the allegations. July 23,
2018 Letter from Respondent’s Counsel
DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE to Hearing Clerk (hereinafter, Hearing
Request). In his Hearing Request,
Drug Enforcement Administration Drug Enforcement Administration
Respondent ‘‘requests a hearing be
[Docket No. DEA–392] [Docket No. 18–36] conducted to contest all of the legal
issues and factual allegations raised in
Bulk Manufacturer of Controlled Eldor Brish, M.D.; Decision and Order the DEA’s Order in support of its
Substances Application: Patheon API On June 25, 2018, the Assistant proposed revocation.’’ Id. at 1.
Manufacturing, Inc. Administrator, Diversion Control Respondent specifically requested a
hearing ‘‘to determine whether the DEA
Division, Drug Enforcement
ACTION: Notice of application. is authorized to revoke’’ Respondent’s
Administration (DEA), issued an Order
registration and, ‘‘even if the DEA has
to Show Cause to Eldor Brish, M.D.
DATES: Registered bulk manufacturers of authority to revoke, whether a
(Respondent), of Houston, Texas. The
the affected basic classes, and revocation in the instant case represents
Show Cause Order proposed the
applicants therefore, may file written an abuse of power and/or a failure to
revocation of Respondent’s DEA
comments on or objections to the exercise appropriate discretion.’’ Id. at
Certificate of Registration No.
issuance of the proposed registration on 1–2.
FB2033049 on the ground that he has The matter was placed on the docket
or before January 22, 2019.
‘‘no state authority to handle controlled of the Office of Administrative Law
ADDRESSES: Written comments should substances.’’ Order to Show Cause, at 1
be sent to: Drug Enforcement Judges and assigned to Administrative
(citing 21 U.S.C. 824(a)(3)). For the same Law Judge Mark M. Dowd (hereinafter,
Administration, Attention: DEA Federal reason, the Order also proposed the
Register Representative/DPW, 8701 ALJ). On July 31, 2018, the ALJ ordered
denial of any of Respondent’s the Government to ‘‘file evidence to
Morrissette Drive, Springfield, Virginia ‘‘applications for renewal or
22152. support the allegation that the
modification of such registration and Respondent lacks state authority to
SUPPLEMENTARY INFORMATION: The any applications for any other DEA handle controlled substances’’ and file
Attorney General has delegated his registrations.’’ Id. ‘‘any motion for summary disposition’’
authority under the Controlled With respect to the Agency’s no later than August 3, 2018. Order
Substances Act to the Administrator of jurisdiction, the Show Cause Order Directing the Filing of Government
the Drug Enforcement Administration alleged that Respondent is the holder of Evidence of Lack of State Authority
(DEA), 28 CFR 0.100(b). Authority to Certificate of Registration No. Allegation and Briefing Schedule, at 1.
exercise all necessary functions with FB2033049, pursuant to which he is The ALJ also directed Respondent to file
respect to the promulgation and authorized to dispense controlled his response to any summary
implementation of 21 CFR part 1301, substances as a practitioner in schedules disposition motion no later than August
incident to the registration of II through V, at the registered address of 8, 2018. Id. at 2.
manufacturers, distributors, dispensers, 5400 Pinemont Drive, #108, Houston, On August 3, 2018, the Government
importers, and exporters of controlled Texas. Id. The Order also alleged that filed its Motion for Summary
substances (other than final orders in this registration does not expire until Disposition. In its Motion, the
connection with suspension, denial, or July 31, 2019. Id. Government argued that Respondent
revocation of registration) has been Regarding the substantive grounds for lacks authority to handle controlled
redelegated to the Assistant the proceeding, the Show Cause Order substances in Texas because the TMB
Administrator of the DEA Diversion alleged that on May 18, 2018, the Texas ‘‘suspended Respondent’s Texas
Control Division (‘‘Assistant Medical Board (TMB) ‘‘issued an Order Medical License’’ on May 18, 2018.
Administrator’’) pursuant to section 7 of of Temporary Suspension suspending’’ Government’s Motion for Summary
28 CFR part 0, appendix to subpart R. Respondent’s Texas medical license, Disposition (hereinafter Government’s
In accordance with 21 CFR and Respondent is therefore ‘‘without Motion or Govt. Mot.) at 3; Government
1301.33(a), this is notice that on authority to practice medicine or handle Exhibit (GX) 2 to Govt. Mot. The
September 26, 2018, Patheon API controlled substances in Texas, the Government also noted that the TMB
Manufacturing, Inc., 309 Delaware St., [S]tate in which [he is] registered with conducted a hearing on June 25, 2018
Greenville, South Carolina 29605 DEA.’’ Id. at 2. Based on his ‘‘lack of and then ‘‘issued a second suspension
applied to be registered as a bulk authority to [dispense] controlled order’’ on June 27, 2018. Govt. Mot. at
manufacturer for the basic classes of substances in . . . Texas,’’ the Order 3 (citing GX 3 to Govt. Mot.). The
controlled substances: asserted that ‘‘DEA must revoke’’ Government further argued that,
Respondent’s registration. Id. (citing 21 ‘‘[a]bsent authority by the State of Texas
Controlled substance Drug code Schedule U.S.C. 824(a)(3); 21 CFR 1301.37(b)). to dispense controlled substances,
Thebaine .......................... 9333 II The Show Cause Order notified Respondent is not authorized to possess
Noroxymorphone ............. 9668 II Respondent of (1) his right to request a a DEA registration in that state.’’ Id.
hearing on the allegations or to submit Lastly, the Government argued that
The company plans to manufacture a written statement in lieu of a hearing, under Agency precedent, revocation is
the above-listed controlled substances (2) the procedure for electing either warranted even where a State has

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Document Created: 2018-11-20 07:59:53
Document Modified: 2018-11-20 07:59:53

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
FR Citation		83 FR 58595

83 FR 58595 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Pistoia Alliance, Inc.

DEPARTMENT OF JUSTICEAntitrust Division

Federal Register Volume 83, Issue 224 (November 20, 2018)

DEPARTMENT OF JUSTICE
Antitrust Division