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<div about="/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office/cellpro-march-petition-documents" typeof="sioc:Item foaf:Document" class="ds-1col node node--nih-basic-page view-mode-full node--full node--nih-basic-page--full clearfix">
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<div class='syndicate'><h1>CellPro March-In Petition Documents</h1><div><h2 class="top">First-Party Correspondence Documents</h2>
|
||
|
||
<p>Electronic and hardcopies of the following documents are available from the <a href="/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office">NIH FOIA Office</a>:</p>
|
||
|
||
<table border="0" cellpadding="10" cellspacing="0" class="table-data">
|
||
<tbody>
|
||
<tr>
|
||
<th>Date</th>
|
||
<th>Document</th>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>1.</strong> March 3, 1997</td>
|
||
<td>Original Petition from CellPro (Request that NIH excercise march-in procedures)
|
||
<ul>
|
||
<li>Exhibits A, B, C, D</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>2.</strong> March 21, 1997</td>
|
||
<td>Letter from Dr. Wendy Baldwin to Mr. Ronald R. Peterson (Notification to Johns Hopkins University of CellPro petition)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>3.</strong> March 24, 1997</td>
|
||
<td>Letter from Mr. Robert B. Lanman to Mr. Lloyd Cutler (Acknowledgment of receipt of original petition)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>4.</strong> April 24, 1997</td>
|
||
<td>CellPro Supplement to Original Petition, Letter from Mssr. L Cutler and Birch Bayh to Mr. R. Lanman (Additional comments to request)
|
||
<ul>
|
||
<li>Memorandum</li>
|
||
<li>Video: "Multiple Sclerosis Patient Treated with the CEPRATE System" (Note: Available from NIH FOIA Office)</li>
|
||
<li>Exhibit Volumes I and II</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>5. </strong>April 24, 1997</td>
|
||
<td>Letter from Mr. Frederick G. Savage to Mr. R. Lanman (Confirmation of extension until May 7 to file answer to CellPro petition)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>6.</strong> April 29, 1997</td>
|
||
<td>Letter from Mr. R. Lanman to Mr. L. Cutler (Re: April 24 CellPro letter)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>7.</strong> May 1, 1997</td>
|
||
<td>Note from Ms. Barbara McGarey to Mr. Howard Califano (Re: CellPro's supplemental submission)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>8.</strong> May 7, 1997</td>
|
||
<td>Letter from Mr. Donald R. Ware to Mr. R. Lanman (Re: JHU correction to p. 28 of plaintiff's reply brief)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>9.</strong> May 7, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Dr. W. Baldwin, Response of Johns Hopkins to CellPro's Original Petition (Reasons to deny petition)
|
||
<ul>
|
||
<li>Appendix</li>
|
||
<li>Declarations and Exhibits</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>10.</strong> May 8, 1997</td>
|
||
<td>Letter from Mr. Gary D. Wilson to Mr. R. Lanman (Re: Baxter response)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>11.</strong> May 12, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Mr. R. Lanman (Request for 30 day period to respond to CellPro April 24 memorandum)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>11.</strong> May 15, 1997</td>
|
||
<td>Letter from Dr. W. Baldwin to Mr. D. Ware (Re: extension filing date for Johns Hopkins in response to CellPro supplemental materials)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>12.</strong> May 15, 1997</td>
|
||
<td>Letter from William J. Marsden, Jr. to Judge Roderick R. McKelvie (Re: Plaintiff's proposed modification to injunction)
|
||
<ul>
|
||
<li>Order for Permanent Injunction and Partial Stay of Injunction</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>13.</strong> May 19, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Dr. W. Baldwin (Counter-response of CellPro to response of Johns Hopkins)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>14.</strong> May 19, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Mr. R. Lanman, Declaration of Scott D. Rowley, MD, Fred Hutchinson Cancer Research Center (Support from research in clinical trials of Baxter Isolex systems)
|
||
<ul>
|
||
<li>Declaration of Dr. Scott D. Rowley</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>15.</strong> May 20, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. Annette Hamburger (Replacement page 4)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>16.</strong> May 27, 1997</td>
|
||
<td>Letter from Dr. W. Baldwin to Mr. D. Ware (Re: further submissions)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>17.</strong> May 28, 1997</td>
|
||
<td>Declaration of Larry Culver, CEO CellPro (Projected financial performance and resulting viability of CellPro under various litigation outcome scenarios)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>18.</strong> May 30, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey (Supplement to CellPro counter-response)
|
||
<ul>
|
||
<li>Plaintiff's Reply Brief in Support of Motion for a Permanent Injunction, Order for Permanent Injunction and Partial Stay of Injunction</li>
|
||
<li>Declaration of Dr. Bonnie Mills</li>
|
||
<li>Declaration of Dr. James Vrednenburgh</li>
|
||
<li>Declaration of Dr. Juan Lopez</li>
|
||
<li>Declaration of Dr. Bo Bjorkstrand</li>
|
||
<li>Declaration of Dr. Kenneth Cornetta</li>
|
||
<li>Declaration of Kristen Houser</li>
|
||
<li>Declaration of Dr. Robert A. Preti</li>
|
||
<li>Declaration of Dr. Jerry A. Hausman</li>
|
||
<li>Transcript of proceedings of Delaware federal district court hearings, <em>Hopkins, Baxter and Becton Dickinson v. CellPro</em>, April 30, 1997</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>19.</strong> June 2, 1997</td>
|
||
<td>Letter from Mssr. F. Savage and D. Ware to Dr. W. Baldwin (Response to Supplemental filing of CellPro petition)
|
||
<ul>
|
||
<li>Appendix</li>
|
||
<li>Exhibits</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>20.</strong> June 6, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey, and Letter from Mr. Wilson to Mssr. D. Ware and F. Savage (Offer of settlement)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>21.</strong> June 12, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Ms. B. McGarey (Notice of letter from Baxter to DHHS)
|
||
<ul>
|
||
<li>Letter from Mr. Vernon R. Loucks to Sec. Donna Shalala (Assurance of Baxter to protect patient care and prevent gaps in treatment)</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>22.</strong> June 13, 1997</td>
|
||
<td>Letter from Mr. R. Lanman to Mr. D. Ware (Response to assurance of Baxter to DHHS)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>23.</strong> June 17, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Ms. B. McGarey (Response to declaration of CellPro CEO Mr. L. Culver dated May 28, 1997)
|
||
<ul>
|
||
<li>Supplemental Declaration of Dr. Jerry A. Hausman</li>
|
||
<li>Exhibits A-C:
|
||
<ul>
|
||
<li>Exhibit A: Hambrect & Quist Spot, Report March 13, 1997</li>
|
||
<li>Exhibit B: CellPro Press Release, May 14, 1997</li>
|
||
<li>Exhibit C: Letter from Mr. D. Ware to Mr. Coe E. Bloomberg, June 10, 1997</li>
|
||
</ul>
|
||
</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>24.</strong> June 20, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey (Protest to acceptance of further filings by CellPro, and request for time extension in the alternative)
|
||
<ul>
|
||
<li>Letter from Mr. D. Ware to Mr. G. Wilson dated June 20, Rejection of licensing proposal by CellPro</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>25.</strong> June 23, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey (Response to letter of Mr. Ware, dated June 20)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>26.</strong> June 24, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey (Submissions to district court)
|
||
<ul>
|
||
<li>Letter from Mr. W. Marsden to Judge R. McKelvie, dated May 15, 1997 & [Proposed] Order for Permanent Injunction and Partial Stay of Injunction, May 15, 1997</li>
|
||
<li>Letter from Mr. D. Ware to Judge R. McKelvie, dated May 28, 1997, & Declaration of Dr. Scott D. Rowley</li>
|
||
<li>Letter from Mr. Gerard M. O'Rourke to Judge R. McKelvie, dated June 5, 1997 & following submissions to the district court:
|
||
<ul>
|
||
<li>Supplemental Declaration of Dr. Monica S. Krieger</li>
|
||
<li>Declaration of Mr. James M. Folson</li>
|
||
<li>Supplemental Declaration of Mr. Edward Kenney</li>
|
||
</ul>
|
||
</li>
|
||
<li>Letter from Mr. D. Ware to Judge R. McKelvie, dated June 13, 1997 (Response to letter of Mr. G. O'Rourke of June 5)
|
||
<ul>
|
||
<li>Supplemental Declaration of Dr. J. Hausman</li>
|
||
</ul>
|
||
</li>
|
||
<li>Letter from Mr. Jerrold B. Reilly to Judge R. McKelvie, dated June 16, 1997</li>
|
||
<li>Declaration of Mr. David F. Weeda</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>27.</strong> June 24, 1997</td>
|
||
<td>Letter from Mr. R. Lanman to Mr. D. Ware (Response to letter of Mr. Ware, dated June 20)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>28.</strong> June 26, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Ms. B. McGarey (Response to letter of Mr. Wilson, dated June 23)
|
||
<ul>
|
||
<li>Letter from Mr. D. Ware to Judge McKelvie, dated June 25</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>29.</strong> July 2, 1997</td>
|
||
<td>Letter from Mr. D Ware to Mr. R. Lanman (Response to letter of Mr. Lanman, dated June 13)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>30.</strong> July 2, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. B. McGarey
|
||
<ul>
|
||
<li>Response of CellPro to Submissions of Johns Hopkins University and Supplement to Original Petition of CellPro</li>
|
||
<li>Exhibits</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>31.</strong> July 3, 1997</td>
|
||
<td>Letter from Mr. Robert D. Murdock to Dr. Myles P. Cunningham
|
||
<ul>
|
||
<li>Testimony of Physicians</li>
|
||
<li>Media Packet</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>32.</strong> July 7, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Ms. A. Hamburger (Correction to error in July 2 response)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>33.</strong> July 15, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Mr. G. Wilson (Re: CellPro July 2 submission)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>34.</strong> July 18, 1997</td>
|
||
<td>Letter from Mr. G. Wilson to Mr. D. Ware (Response to July 15 letter)</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>35.</strong> July 22, 1997</td>
|
||
<td>Letter from Sec. D. Shalala to Mr. V. R. Loucks
|
||
<ul>
|
||
<li>Enclosure: Letter from Mr. R. Lanman to Mr. D. Ware (Response to assurance of Baxter to DHHS)</li>
|
||
<br />
|
||
<li>Letter from Mr. V. R. Loucks to Sec. D. Shalala (July 12)</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>36.</strong> July 24, 1997</td>
|
||
<td>Final Judgment Decision in case of Johns Hopkins University, et. al v. CellPro, United States District Court for the District of Delaware (1997)
|
||
<ul>
|
||
<li>Opinion</li>
|
||
<li>Order for Permanent Injunction and Partial Stay of Injunction</li>
|
||
<li>Memorandum Opinion</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>37.</strong> July 29, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Ms. B. McGarey (Re: July 2 CellPro filing and July 24 court rulings)
|
||
<ul>
|
||
<li>Appendix</li>
|
||
<li>Exhibits</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>38.</strong> July 30, 1997</td>
|
||
<td>Letter from Mr. D. Ware to Ms. B. McGarey (Re: July 28, 1997, issue of <em>BioCentury)</em></td>
|
||
</tr>
|
||
<tr>
|
||
<td><strong>39.</strong> August 1, 1997</td>
|
||
<td>National Institutes of Health, Office of the Director<br />
|
||
DETERMINATION In the Case of PETITION OF CELLPRO, INC. Signed by Harold Varmus, M.D., Director, NIH
|
||
<ul>
|
||
<li>Transcript of FDA Biologic Response Modifiers Advisory Committee (dated Feb. 28, 1996)</li>
|
||
<li>Letter from Dr. Jay Siegel to Dr. M. Krieger</li>
|
||
<li>Medical Articles
|
||
<ul>
|
||
<li>High-dose chemotherapy for the treatment of breast and ovarian cancer</li>
|
||
<li>Transplantation of the CD34+ hematopietic progenitor cells</li>
|
||
<li>Mobilization and selection of CD34-positive hematopietc progenitors</li>
|
||
<li>High-dose chemotherapy with stem-cell rescue for the treatment of breast cancer</li>
|
||
<li>High-dose chemotherapy with an autologous stem cell support in advanced ovarian cancer</li>
|
||
<li>Autologous stem cell transplantation for solid tumors in children</li>
|
||
<li>High-dose chemotherapy with autologous stem cell rescue for breast cancer: yesterday, today, and tomorrow</li>
|
||
<li>High-dose therapy and autologous bone marrow transplantation in patients with follicular lymphoma during first remission</li>
|
||
<li>A new 'two step' procedure for 4.5 log depletion of T and B cells in allogenic transplantation and of neoplastic cells in autologous transplantation</li>
|
||
</ul>
|
||
</li>
|
||
</ul>
|
||
</td>
|
||
</tr>
|
||
</tbody>
|
||
</table>
|
||
|
||
<h2>Third-Party Correspondence Documents</h2>
|
||
|
||
<p>These documents are available from the <a href="/institutes-nih/nih-office-director/office-communications-public-liaison/freedom-information-act-office">NIH FOIA Office</a>.</p></div></div>
|
||
|
||
</div>
|
||
|
||
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<p>This page last reviewed on April 16, 2021</p> </div> </div>
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