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SERONO LABORATORIES, INC. v. SHALALA

United States District Court, District of Columbia


January 21, 1999

SERONO LABORATORIES, INC., PLAINTIFF,
v.
DONNA E. SHALALA, ET AL., DEFENDANTS AND FERRING PHARMACEUTICALS INC., INTERVENOR-DEFENDANT.

The opinion of the court was delivered by: Facciola, United States Magistrate Judge

MEMORANDUM TO ACCOMPANY ISSUANCE OF PROTECTIVE ORDER

The background of this case is set out at length in the Court of Appeals's decision, vacating the issuance of a preliminary injunction. Serono Laboratories, Inc. v. Shalala, 158 F.3d 1313 (D.C.Cir. 1998). Suffice to say here that Serono Laboratories ("Serono") filed a petition urging the Federal Drug Administration ("FDA") to withhold the approval of an application by Ferring Pharmaceuticals ("Ferring") for the approval of a generic version of a drug which Serono markets. When the FDA denied Serono's petition, Serono sued it in this Court and Ferring intervened as a defendant. This Court issued a preliminary injunction against FDA approving Ferring's application but, as just noted, the Court of Appeals reversed concluding (inter alia) that Serono had not met its burden of a likelihood of success on the merits. Despite that conclusion, the Court of Appeals specifically left open the possibility that Serono could make outs its case that FDA approval of Ferring's application was arbitrary, capricious and unreasonable:

  For the foregoing reasons, we vacate the preliminary
  injunction entered by the district court and remand
  the case for further proceedings consistent with this
  opinion. Our opinion does not foreclose the
  possibility that at a trial on the merits, and upon a
  fuller record, Serono may be able to establish that
  there are grounds for overturning the grant of
  Repronex's ANDA [i.e. the drug for which Ferring
  sought ADA approval.] We hold only that upon the
  current record, Serono has failed to establish

  that it meets the criteria for the grant of a
  preliminary injunction.

Id. at 1327.

Since the matter was remanded for a trial, the first item on the agenda is to assemble the administrative record. FDA secured from Serono, Ferring and other companies documents which each of these companies claims are trade secrets. FDA does not deny that it has a statutory obligation to protect these trade secrets and expresses a willingness to comply with any protective order the court issues. For their part, Serono and Ferring differ as to the contents of such an order based on radically different interpretations of the decision of the Court of Appeals in MD Pharmaceutical, Inc. v. Drug Enforcement Admin., 133 F.3d 8, 13-15 (D.C.Cir. 1998) (hereafter "MD"). In that case the Court of Appeals upheld a federal agency's producing an administrative record, to be used in the judicial review of that agency's decision, which did not contain all of the documents which the agency had in fact collected in making its decision because the agency had purged materials containing trade secrets. Ferring finds in that decision a judicially enforceable statutory right to insist that the FDA purge from the administrative record its trade secrets before any one can see the record. Serono does not see that case as an impediment to its outside counsel*fn1 reviewing the entire administrative record, including Ferring's trade secrets, provided his access and subsequent use and reference to what he has seen is carefully restricted by a protective order.

The argument between Ferring and Serono is animated by two competing concerns or interests. In a field as competitive and technical as the pharmaceutical industry, success or failure will turn in large measure on innovation and the members of the industry justifiably hoard their trade secrets as jealously as a miser hoards his gold. Before, however, that innovation yields a profit, a government agency has the responsibility to insure that the drug is safe. In a world of stunning multiple births, cloning, and genetic engineering, the necessity for the performance of that responsibility being predicated on all available information is self evident.*fn2 Thus, concerned companies may have to disgorge their trade secrets so that the agency can fulfill its responsibilities. They would resist doing so with all their power if doing so permitted their competitors instantaneous access to what they had so carefully guarded from them. The obvious public interest in inducing the drug companies' utmost cooperation with the government's investigation of the new drug would suffer. It is therefore understandable that Congress has required the FDA to guard the trade secrets to which it has been given access and to require it to return them to the company which generated them. 21 U.S.C. § 331(j) (Supp. 1998); 5 U.S.C. § 552(b)(4) (1996) (trade secrets exempt from Freedom of Information Act); 18 U.S.C. § 1905 (1984) (crime for federal employee to disclose trade secrets).

A competing consideration is that judicial review of agency action must be premised on the administrative record and, in the ordinary course, a complete agency record is sine qua non; without it the party seeking review can claim that its right to attack the agency's action is compromised since it cannot say with certainty what the agency reviewed in making its decision. 5 U.S.C. § 706 (1996) (when conducting judicial review court is to review the whole record).

The fundamental difference between Serono and Ferring is in their interpretation of the meaning of the Court of Appeals decision inMD. In that case the Court of Appeals held that the DEA was within its statutory powers when it refused to permit a particular party which was challenging that agency's action from seeing certain documents which were part of the administrative record on which the agency action was premised because those documents would have revealed trade secrets. Since that case would support the conclusion that trade secrets need not be disclosed Serono would distinguish it by arguing that (1) in this case the agency is not insisting upon any right to withhold any documents but is ready to permit any one to see even trade secrets the moment the Court issues a protective order and (2) in that case the Court of Appeals did not have before it a proposed protective order pertaining to the trade secrets and the case therefore cannot be read to bar limited access under that order if that access is necessary for a party to perfect its right to a full administrative record in its challenge to agency action.

Ferring counters this case can only be read to create a judicially enforceable right of a party who has provided an agency with trade secrets to insist upon their removal before the administrative record is produced for inspection by any one, particularly one of its competitors.

Ironically, counsel for Ferring, which resists disclosure of its secrets to Serono, was counsel for the losing party in MD in which he had urged that his client's interest in the production of a complete administrative record rendered the agency's exclusion of certain records a default of its clear obligation to produce that complete administrative record for judicial review. He provided me with the briefs of the parties in MD and they are illuminating. The losing party, seeking disclosure of the trade secrets, insisted that its interest in a complete administrative record trumped the agency's protecting trade secrets and chastised the agency for not considering whether disclosure could not occur pursuant to a protective order. Brief for Petitioner at 26-29, MD Pharmaceutical, Inc. v. Drug Enforcement Admin., 133 F.3d 8, 13-15 (D.C.Cir. 1998). The Court of Appeals, however, rejected those arguments in favor of the creation of an absolute agency right to delete from the administrative record trade secrets. It therefore expressly held that the statutory protection afforded trade secrets trumps the interest in a complete administrative record. Moreover, while its decision did not specifically discuss the significance of a potential proposed order, the agency's withholding trade secrets, despite the criticism that it had done so without even considering whether disclosure could take place pursuant to a protective order, was upheld as a lawful exercise of its obligation to protect trade secrets. Implicit in that determination is the concomitant holding that the statutory protection of trade secrets creates an enforceable right in the party who has provided those secrets to insist upon their exclusion from the administrative record which does not evaporate merely because there is a possibility that a protective order might regulate the access which the agency is under an obligation to prevent. There was before the Court of Appeals, after all, a suggestion that a protective order could accommodate the competing interests. The breadth of the Court of Appeals' holding in the light of that suggestion must mean that a party who had provided trade secrets cannot be forced to permit any access to them whatsoever because it is under no obligation to accept less than the absolute protection the statute creates for its trade secrets.

It is therefore of little moment that the agency in this case is willing to permit access to trade secrets pursuant to a protective order. In MD, the Court of Appeals held that the agency's refusal to produce trade secrets was the correct interpretation of the statute protecting those secrets despite the claim that its protection of those secrets was inconsistent with its obligation to produce a complete administrative record. It has to follow that an agency's refusing to remove the trade secrets from the administrative record before permitting the disclosure of that record to any one other than the party which produced the secrets is an incorrect reading of the statute which protects trade secrets. If that is so, the agency's permitting the very disclosure which the Court of Appeals indicated the trade secret statute does not permit is agency action which is arbitrary, capricious and unreasonable and contrary to law which this Court is bound, by another statute to prevent. 5 U.S.C. § 706(2)(A) (1996). Therefore, Ferring is perfectly correct in insisting that the agency in this case must purge the administrative record of Ferring's trade secrets before its files the administrative record for review by any one else and that a protective order restricting access to those secrets cannot excuse the FDA from fulfilling its statutory obligation to protect Ferring's trade secrets. Simply put, the protective order cannot relieve FDA from a statutory obligation it has to Ferring and permit it to abrogate a statutory right Ferring can assert.

A judge, anxious to see this matter come to a conclusion as soon as possible, reaches this necessary conclusion with some reluctance since it will require the FDA to create three versions of the administrative record, an unexpurgated record which contains the entire record and a version from which Ferring's trade secrets have been removed to be given to Serono, and a version from which Serono's trade secrets have been removed to be given to Ferring. While that obligation is unquestionably onerous, Serono need not wait and suffer in silence. This Court has plenary power to expedite agency action which is unreasonably delayed*fn3 and will do so if Serono can make a case that the amount of time being taken to create the purged records is out of proportion to the task involved.

Additionally, while it bears more on accuracy than speed, I expect the FDA to make a conscientious determination as to whether a document does in fact contain what can truly be described as a trade secret in light of the present state of the technology involved. To continue to describe information as a trade secret when, for example, it describes a process now in the public domain, would be arbitrary and capricious and subject to nullification upon judicial review. I intend to exercise such review upon the application of Serono which will be provided with a log which will describe the documents being sought with enough particularity to permit Serono to challenge their continuing designation as trade secrets. While that log can never be a substitute for examination of the documents themselves, Serono's position is no better or worse than any litigant who confronts a claim of privilege. Cf. Fed. R.Civ.P. 26(a)(5). I also appreciate that I may lack the technical expertise to determine whether a document contains a trade secret but I contemplate the parties calling witnesses in support of their contentions and even assisting me to secure assistance from an utterly independent source if it becomes necessary to do so.

Finally, the order contemplates that there will be documents which, while not trade secrets and therefore to be purged from the administrative record without further ado, may nevertheless contain information which should only be seen by certain persons. Serono would classify this documents as either "confidential" or "highly confidential" and then restrict access to them accordingly. I have rejected this proposal as premature and unnecessarily complicated. In the course of exercising the judicial review the order contemplates I will unquestionably entertain any argument that access, if it is permitted, be permitted only to certain persons or categories of persons. I am much more comfortable making that judgment as to a particular document when I look at the document and hear the parties' arguments. It is not a good idea to try to make lapidary judgments about documents which I have not seen or to attempt to categorize them a priori without seeing them.

A final point. Documents from two companies, Organon and Instituto Massone, are part of the administrative record. At a hearing Judge Sporkin ordered that these documents be purged from the administrative record before any portion of the remainder of that record was made available to Serono. Despite Serono's invitation, I do not see myself as having any authority to modify that order. Thus, I have ordered that the FDA purge the confidential matter of both Organon and Instituto Massone in accordance with Judge Sporkin's order but also create a list of the documents they are removing. In addition, I have created a procedure whereby Instituto Massone and Organon may object to the production of this list I have ordered the FDC to create before this list may be disseminated to anyone other than counsel for Instituto Massone and Organon. At that time, I will certainly consider any argument Instituto Massone or Organon may assert to making the list available to Serono or Ferring, including the argument that the production of the list itself is in excess of or inconsistent with Judge Sporkin's order.

PROTECTIVE ORDER

Upon consideration of the proposed Protective Orders submitted by Plaintiff Serono Laboratories, Inc. ("Serono") and by Intervenor-Defendant Ferring Pharmaceuticals Inc. ("Ferring"), the response of Defendants Shalala, et al. ("FDA"), and the entire record herein, it is hereby

ORDERED THAT FDA shall make the administrative record relating to approval of the abbreviated new drug application ("ANDA") for Repronex™ available to the Court, Serono, and Ferring pursuant to the following provisions.

  1. "Private party" or "private parties" means
    Ferring, Serono, or both, as appropriate.

  2. "Third party" or "third parties" means Organon,
    Inc. ("Organon"), Instituto Massone, or both, as
    appropriate.

  3. "Confidential Matter" means a person's valuable
    trade secrets or confidential commercial
    information that has been submitted to FDA that, if
    disclosed to other persons, would likely cause
    substantial harm to the competitive position of the
    person.

  4. The "Complete Administrative Record" means the
    entire, unpurged administrative record of the
    Repronex™ ANDA approval.

  5. The "First Purged Administrative Record" means the
    Complete Administrative Record, after Confidential
    Matter belonging to third parties has been purged
    by the FDA in accordance with this order.

  6. The "Final Purged Administrative Record" means the
    First Purged Administrative Record, after
    Confidential Matter belonging to Ferring and Serono
    has been purged in accordance with this order.

  7. Within thirty days of the issuance of this order,
    the FDA shall prepare: (i) the Complete
    Administrative Record with sequentially numbered
    pages; and (ii) the First Purged Administrative
    Record by purging Confidential Matter relating to
    third parties, including all Confidential Matter
    derived from the New Drug Application for Humegon®
    of Organon and the Drug Master File of Instituto
    Massone) from the Complete Administrative Record.
    Upon completion of the First Purged Administrative
    Record, FDA shall deliver to counsel for Organon
    and Instituto Massone, and all counsel of record
    for the parties, a written notice indicating that
    all such information has been purged in accordance
    with this paragraph.

  8. The FDA shall prepare a list of the documents
    which have been purged and identify, to the extent
    reasonably practicable, the nature and general
    content of any documents that have been purged in
    their entirety from the Complete Administrative
    Record because the FDA concluded they were
    confidential matter belonging to either Organon or
    Instituto Massone. This list shall only be
    distributed to counsel for Organon and Instituto
    Massone. Organon and Instituto Massone shall have
    five business days to review the list and, if they
    believe anything in the list reveals confidential
    matter, they may object to that portion of the list
    being disclosed. If objections are made, a hearing
    shall be scheduled before Magistrate Judge Facciola
    to determine if the list does in fact contain
    confidential matter and to consider any other
    objection made by Instituto Massone and Organon. If
    there are no objections within five working days
    after the list has been provided to Organon and
    Instituto Massone then the FDA shall distribute the
    list to the private parties.

  9. Should Serono or Ferring later conclude, based on
    a review of the Purged Administrative Record or the
    list provided by the FDA (if it should be made
    available to them), that good cause exists to seek
    access to certain of the

    purged parts of the Complete Administrative Record
    containing information relating to Organon, that
    private party shall specify those parts of the
    Complete Administrative Record desired and the
    asserted reason for inclusion, and FDA shall
    release to Organon those parts of the Complete
    Administrative Record that Serono or Ferring
    specified. Serono or Ferring shall then consult
    with counsel for Organon in an attempt to obtain
    counsel's agreement to the release of any
    additional information. Similarly, should Serono or
    Ferring later conclude, based on a review of the
    First Purged Administrative Record, that good cause
    exists to seek access to certain of the purged
    parts of the Complete Administrative Record
    containing information relating to Instituto
    Massone, that private party shall specify those
    parts of the Complete Administrative Record desired
    and the asserted reason for inclusion, and FDA
    shall release to Instituto Massone those parts of
    the Complete Administrative Record that Serono or
    Ferring specified. Serono or Ferring shall then
    consult with counsel for Instituto Massone in an
    attempt to obtain counsel's agreement to the
    release of any additional information. Should
    agreement with counsel for Organon or Instituto
    Massone not be possible, Serono or Ferring may then
    file an application with the Court requesting a
    hearing. Counsel for Organon and Instituto Massone
    shall be served with copies of any such application
    on the same date that the application is filed with
    the Court. If such an application is filed with the
    Court, there will be a hearing before Magistrate
    Judge Facciola to determine whether any of the
    persons designated in paragraph 17 shall have
    access to the purged matter. Counsel for Organon or
    Instituto Massone may fully participate in that
    hearing.

  10. If, upon review of the record covered by this
      Protective Order, outside counsel determine that
      a document included in the Complete
      Administrative Record relates to a product
      manufactured by Lederle Parenterals, Inc. or any
      other division of American Home Products
      Corporation other than the products at issue in
      this litigation, such document shall not be
      shared with persons other than outside counsel
      unless and until notice has been provided to
      American Home Products and that company has been
      provided a reasonable opportunity to seek a
      protective order with respect to such document.
      If, however, a document relates both to a product
      at issue in this litigation and a product
      manufactured by an American Home Products'
      division that is not at issue in this litigation,
      counsel may share that document with other
      persons covered by this Protective Order after
      redacting the information relating to the
      American Home Products' product.

  11. Ten (10) days after the FDA gives written notice
      of the completion of the First Purged
      Administrative Record, the FDA shall provide to
      counsel for Ferring copies of the documents in
      the First Purged Administrative Record belonging
      to Ferring only and shall provide to Serono
      copies of the documents in the First Purged
      Administrative Record belonging to Serono only.

  12. Within ten (10) business days after the receipt
      of the documents under the preceding paragraph,
      counsel for Serono and Ferring shall each
      determine whether its own documents contain
      Confidential Matter. Each page of those documents
      that contains Confidential Matter shall be
      prominently stamped by counsel for the private
      party owning the Confidential Matter as
      "Confidential — Subject to Court Order." All
      documents shall be returned to the FDA within 10
      business days either stamped as confidential or
      with a notation that this document is not
      confidential.

  13. Those documents not stamped confidential will not
      be covered by the protective order.

  14. In regard to the documents marked confidential,
      the private parties shall have ten (10) business
      days, upon returning the documents to the FDA, to
      file objections with this Court and the other
      party to any document it deems to be too highly
      confidential to disclose to anyone or to certain
      persons. Upon receipt of any objections, the
      other party shall then specify, with
      particularity, all persons who, it claims, should
      be permitted access, or limited access. This
      party shall provide the names, business
      addresses, professions or occupations and present
      or past affiliations of all such persons with the
      objecting party. If an objection has been made
      regarding access to any expert, the other party
      shall submit the aforementioned information and
      shall additionally submit that expert's
      curriculum vitae. Within five (5) business days
      of receipt of this information, the party shall
      either withdraw the objections or schedule a
      hearing with Magistrate Judge Facciola.

  15. If the objections are not withdrawn, there will
      be a hearing before Magistrate Judge Facciola to
      determine who, if anyone, shall be permitted
      access (in whole or in part) to these documents
      due to the confidential nature of the information
      contained in them. If the Court determines that
      the losing party was not substantially justified
      in its position that access should be denied or
      only permitted certain persons, that party shall
      be required to pay costs and attorney's fees as
      ordered by the Court.

  16. Except as modified pursuant to an Order entered
      under the preceding paragraph, the FDA shall,
      within five (5) business days of receiving the
      documents back from Serono and Ferring, provide
      the Final Purged Administrative Record to the
      private parties' who shall permit access to them
      only in accordance with this order or any other
      order issued by the Court. FDA shall file with
      the Court the Final Purged Administrative Record,
      with those portions stamped "Confidential —
      Subject to Court Order" being filed under seal.

  17. Except as otherwise provided by any other order
      issued by this Court, access to documents stamped
      "Confidential — Subject to Court Order" in the
      Final Purged Administrative Record shall be
      limited to:

    a) counsel for the private parties, whether inside
      or outside counsel, unless properly objected to
      pursuant to paragraphs 14 & 15, including their
      legal assistants and administrative staff, and
      duplicating services;

    b) scientific experts for the private parties,
      whether employees of the parties or outside
      experts, unless objected to pursuant to
      paragraphs 14 & 15;

c) the Court, including court personnel.

  18. An individual with authorized access to these
      documents shall not have access to any document
      stamped "Confidential — Subject to Court Order"
      in the Final Purged Administrative Record unless
      and until such individual has agreed in writing
      to be bound by the terms of this Order and a copy
      of such agreement has been transmitted to counsel
      for the other parties. The requirement for such
      written agreement shall be satisfied by obtaining
      the signature of each such individual at the end
      of a copy of this Order below the words: "I have
      read and fully understand this Protective Order.
      I agree to comply with and be bound by the terms
      of this Protective Order. I agree not to disclose
      any documents marked `Confidential — Subject to
      Court Order' or the contents of those documents,
      to any person other than those specifically
      authorized by the Order. I hereby submit to the
      jurisdiction of the Court for the purpose of
      ensuring compliance with the Order." I further

      understand that the information contained in the
      documents is valuable and strictly confidential.
      I further appreciate that if I violate this order
      I may be held in contempt of court, imprisoned or
      fined.

  19. Individuals authorized access to documents
      stamped "Confidential — Subject to Court Order"
      in the Final Purged Administrative Record shall
      use such information only for purposes directly
      related to this litigation and shall not
      disseminate or discuss the contents of such
      documents in the Final Purged Administrative
      Record with any person not authorized under
      paragraph 17 or by order of the Court, except
      that: (i) nothing shall prevent representatives
      of each private party from using the Confidential
      Matter belonging to that party without
      restriction; and (ii) the terms of this
      Protective Order shall not apply to any
      disclosure of those portions of the Final Purged
      Administrative Record containing Confidential
      Matter by the FDA to its employees, agents, or
      attorneys pursuant to its regulations and
      policies and in the normal course of business.

  20. Except for copies filed with the Court, all
      copies of documents stamped "Confidential —
      Subject to Court Order" shall be maintained in a
      secured and locked area allowing access only as
      permitted by this order or any other order issued
      pursuant to it. If the documents are transmitted
      to persons authorized to receive the documents,
      the receiver is responsible to ensure that the
      documents are maintained in a locked and secured
      location when not in use. Failure to do so will
      be deemed a violation of this order. The receiver
      also understands the responsibility undertaken by
      this protective order pursuant to paragraph 18.

  21. Whenever any Confidential Matter is presented,
      quoted, referred to, or otherwise disclosed in
      any exhibit, affidavit, declaration, pleading,
      brief, memorandum, or other document filed with
      the Court or otherwise exchanged among the
      parties, that portion of such document shall, if
      filed with the Court, be filed under seal, and
      shall not be made available to persons other than
      those authorized by this Protective Order or any
      subsequent Order of this Court.

  22. The parties shall comply with Local Rule 106(j)
      of the Court governing filing of sealed or
      confidential documents.

  23. Failure to designate any information as
      Confidential Matter shall not be construed to be
      a waiver of confidentiality or an admission
      concerning the legal or commercial value of the
      information for purposes outside of this
      litigation. Failure to challenge a designation of
      Confidential Matter when made shall not preclude
      a subsequent challenge.

  24. The inadvertent or unintentional disclosure of
      any document marked "Confidential — Subject to
      Court Order" shall not be construed to be a
      waiver of confidentiality.

  25. The restrictions set forth in this Protective
      Order shall not apply to a private party's use or
      retention any material in the Final Purged
      Administrative Record marked "Confidential —
      Subject to Court Order" that:

    (a) Was, is, or becomes public knowledge in a
      manner other than by violation of this Order;

    (b) At the time of disclosure to a private party
      pursuant to this Order, was possessed by such
      private party; or

    (c) Thereafter is lawfully obtained by a private
      party other than through review of any part of
      the Final Purged Administrative Record disclosed
      under this Order.

  26. At the conclusion of this litigation, all
      documents from the Final Purged Administrative
      Record marked "Confidential — Subject to
      Protective Order" obtained pursuant to this
      Protective Order, except copies filed under seal

      with the Court, shall be returned to FDA or
      promptly destroyed by counsel for Serono and
      counsel for Ferring. Outside counsel for Serono
      and outside counsel for Ferring may each retain a
      copy of such documents from the Final Purged
      Administrative Record and copies of all
      submissions to the Court and communications among
      the parties that refer to or include documents
      from the Final Purged Administrative Record.
      Serono and Ferring shall give written notice to
      all other parties within 30 days of the
      conclusion of this litigation that discloses the
      specific manner of disposition of all copies of
      documents in the Final Purged Administrative
      Record marked "Confidential — Subject to Court
      Order" and obtained pursuant to this Order.

  27. The parties shall in good faith attempt to
      resolve disputes stemming from this Protective
      Order. Any remaining disputes shall be resolved
      by Magistrate Judge Facciola on the following
      expedited motion schedule: the party seeking
      relief shall serve on the other parties and file
      with the Court its motion; other parties shall
      file their responses within five (5) business
      days of service; any reply briefs shall be filed
      within two business days. If the Court determines
      that the losing party in any such motion was not
      substantially justified in its position, that
      party shall be required to pay costs and
      attorney's fees as ordered by the Court.

  28. This Protective Order can be modified by further
      order of the Court.

  29. This Protective Order shall survive the final
      conclusion of this litigation and continue in
      full force and effect, and the Court shall retain
      jurisdiction to enforce this Protective Order.

  30. A breach of this Protective Order shall be
      subject to sanctions, in the discretion of the
      Court. These sanctions may include contempt of
      court, and may be imposed against a party or any
      other person. The minimum amount of sanctions
      imposed shall be $1,000.00. The sanction amount
      shall be paid by the person who has violated the
      protective order and shall not be reimbursed by
      any employer.

SO ORDERED.


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