Exhibit 10.6
SETTLEMENT AGREEMENT
This Settlement Agreement (hereafter "Agreement") is entered into by and between
Maya, LLC ("Maya"), Rex H. Lewis and AIDS Research, LLC, on the one hand, and
Cytodyn of New Mexico, Inc. ("CNMI"), Allen D. Allen, Corinne E. Allen and
CytoDyn, Inc. (collectively hereinafter sometimes referred to as "the CytoDyn
Parties"), on the other hand, with respect to the following facts and
circumstances:
RECITALS
A. Maya filed an action in Los Angeles Superior Court entitled Maya v.
Cytodyn of New Mexico, Inc., CytoDyn, Inc., Allen D. Allen and Corinne E. Allen
and DOES 1-50; Case Number EC041590 (hereinafter "the Glendale Action").
B. In the Glendale Action, Maya's claims for relief fall into two broad
categories. The first category consists of several counts for securities fraud
consisting of the following: (1) intentional misrepresentation; (2) negligent
misrepresentation; (3) suppression of facts; and (4) violating California
Corporations Code section 25401, et seq.
C. The second category of claims consists of Maya's claims that it
asserts derivatively on behalf of Amerimmune, Inc. and Amerimmune
Pharmaceuticals, Inc. and consisting of claims for intentional interference with
contractual relations, negligent interference with contractual relations and
interference with prospective economic advantage (collectively "Maya's
Derivative Claims on Behalf of the Amerimmune Entities").
D. There is now pending in the Commonwealth of Massachusetts an action
entitled CytoDyn, Inc., et al. v. Amerimmune, Inc., et al.; Cause of Action
Number 05-0452-C (hereinafter "the Massachusetts Action"). In the Massachusetts
Action, CytoDyn, Inc. ("CytoDyn") and Allen D. Allen, the plaintiffs, and Maya,
the plaintiff-in-intervention, are asserting competing claims to a cell bank
currently being stored by Biovest International, Inc. (the "Cell Bank"). Both
CytoDyn and Mr. Allen, on the one hand, and Maya and AIDS Research, LLC, on the
other hand, maintain that they are entitled to possession and ownership of the
Cell Bank.
E. CNMI previously submitted an application to the United States Food &
Drug Administration ("the FDA") for permission to conduct clinical trials for an
Investigational New Drug ("IND"). It is commonly referred to as BB-IND 6845
("the Old IND"). CytoDyn and Mr. Allen, on the one hand, and Maya and AIDS
Research, LLC, on the other hand, have made claims to the Old IND.
F. CytoDyn, Inc. previously filed an action on or about April 20, 2004
against Amerimmune Pharmaceuticals, Inc. and Amerimmune, Inc. in the Superior
Court for the County of Ventura, Case No. SC-039250. CytoDyn, Inc. obtained a
default judgment on or about October 4, 2004 (the "Ventura County Default
Judgment"). A copy of the Ventura County Default is attached hereto as Exhibit
"A." The Ventura County Default Judgment purported to grant CytoDyn, Inc.
ownership of certain "Technology," including the Cell Bank and the "Old IND. "
G. CytoDyn, Inc. recently submitted a new and different application to
the FDA seeking its permission to conduct clinical trials for an Investigational
New Drug named Cytolin ("the New IND"). CytoDyn is the sponsor for the New IND
and possesses the rights associated with and pursuant to the New IND.
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H. It is understood and agreed that this Agreement is made to compromise
contested claims and is entered into solely for the purpose of avoiding the
expense and inconvenience of further proceedings, and that nothing contained
herein shall be interpreted or construed as an admission or acknowledgment by
any of the parties hereto of any wrongdoing or fault, of any nature whatsoever,
and that any and all such faults or wrongdoings are hereby expressly denied.
I. It is further understood and agreed that none of the dismissals filed
pursuant to this Agreement are on the merits and that they do not reflect on the
merits of any of the claims dismissed, but are the result of a settlement for
consideration, and such dismissals shall not constitute a "favorable
termination" of the claims dismissed for purposes of the torts of malicious
prosecution or abuse of process, any claims for which are in any event hereby
waived.
NOW, THEREFORE, IN CONSIDERATION OF THE FOREGOING RECITALS, THE MUTUAL
PROMISES CONTAINED HEREIN, AND FOR OTHER VALUABLE CONSIDERATION, THE RECEIPT AND
SUFFICIENCY OF WHICH IS HEREBY ACKNOWLEDGED, IT IS HEREBY AGREED AS FOLLOWS:
COVENANTS
---------
1.1 Maya will file a notice of settlement with the Court in the Glendale
Action forthwith so that all scheduled hearings and the trial will be taken off
calendar in order to allow the parties to avoid incurring additional attorneys'
fees and costs. In the event the payment due on or before December 31, 2008 is
not paid, the trial shall be placed back on the Court's trial calendar.
1.2 The CytoDyn Parties, for themselves, and for each and all of their
parents, subsidiaries, assignees, and successors, and for all others claiming
through or under them hereby release their claims, if any, to the following: (1)
the cell bank, as described more particularly on Exhibit "B" hereto, and the
documentation, electronic files, and batch files stored with Biovest
International, Inc. or elsewhere with respect to the cell bank (collectively
referred to as the "Cell Bank"); and (2) the Old IND. The CytoDyn Parties also
waive the benefits of the Ventura County Default Judgment with respect to the
Cell Bank and the Old IND. Upon the exchange of executed copies of this
Agreement, the CytoDyn Parties shall also provide to counsel for Maya a signed
letter for delivery to the United States Food & Drug Administration confirming
their release of their claims to the above-described items to it. Said letter
shall be in the form of the letter attached as Exhibit "c" hereto.
1.3 CytoDyn, Inc. shall pay Maya $50,000.00 on or before January 14,
2008, and $25,000 on or before December 31,2009 by delivering cashier's checks
payable to Maya to its counsel, Bruce M. Lorman, Esq. at his office located at
1717 Fourth Street, 3rd Floor, Santa Monica, CA 90401. The $25,000 payment due
by December 31, 2009 shall accrue simple interest at a rate of ten (10%) per
annum.
1.4 Upon delivery by CytoDyn, Inc. of the cashier's check in the amount
of $50,000 to Mr. Lorman described in Paragraph 1.3 above, Maya and the CytoDyn
Parties shall file with the Superior Court in the Glendale Action a stipulation
and order for dismissal of Maya's first amended complaint in its entirety with
prejudice in the form attached as Exhibit "D" hereto. The Cytodyn Parties and
Maya hereby stipulate and agree that judgment shall be entered in the
Massachusetts Action in the form attached as Exhibit "E" hereto. Upon the
exchange of executed copies of this Agreement, the Cytodyn Parties shall provide
to counsel for Maya a fully signed original of Exhibit "E." The stipulation and
order in the Glendale Action shall provide, inter alia, that (1) the Court in
the Glendale Action shall retain jurisdiction to enforce this Agreement
2
pursuant to California Code of Civil Procedure Section 664.6; and (2) in the
event of a failure by CytoDyn to make the second settlement payment described
above by the date due (i.e., December 3 1, 2009), the entire unpaid balance of
the settlement shall become immediately due and payable and the Court shall upon
ex parte application by Maya, vacate the dismissal and enter judgment in favor
of Maya, and against the CytoDyn Parties, in the amount of the unpaid balance of
the settlement, together with simple interest on said unpaid balance of the
settlement at a rate of ten (10%) per annum from December 31, 2008 to the date
of entry of judgment.
1.5 Upon payment of the sum of $50,000 referred to in Section 1.4, except
for the obligations created by this Agreement, Maya and AIDS Research, LLC, for
themselves and for each and all of their members, shareholders, parents,
subsidiaries, assignees, and successors, and for all others claiming through or
under them (collectively the "Maya Releasors"), hereby irrevocably and
unconditionally remise, release, acquit, absolve and forever discharge the
CytoDyn Parties and each of them, and each and all of their past or present
predecessors, successors, members, parents, subsidiaries, shareholders, assigns,
heirs, executors, administrators, agents, representatives, consultants,
directors, officers, attorneys, employees, and insurers (hereinafter
collectively "the CytoDyn Party Releasees") of and from any and all manner of
actions, causes of action, in law or in equity, debts, contracts, charges,
complaints, claims, suits, damages, obligations, promises, agreements,
controversies, losses, costs, judgments, or expenses (including attorney's fees
and court costs), of any nature whatsoever, known or unknown, fixed or
contingent, direct or derivative, subrogated or assigned, suspected or
unsuspected, which the Maya Releasors have or may have, or which the Maya
Releasors at any time heretofore had or claimed to have, or which the Maya
Releasors at any time hereafter may have or claim to have, against any of the
CytoDyn Party Releasees by reason of any matter, cause, act, omission, or thing
whatsoever from the beginning of time to the date of this Agreement.
1.6 Except for the obligations created by this Agreement, the CytoDyn
Parties, for themselves, and for each and all of their shareholders, parents,
subsidiaries, assignees and successors, and for all others claiming through or
under them, hereby irrevocably and unconditionally remise, release, acquit,
absolve and forever discharge Maya, LLC, AIDS Research, LLC and Rex Lewis, and
each and all of their past or present predecessors, successors, members,
parents, subsidiaries, shareholders, assigns, heirs, executors, administrators,
agents, representatives, consultants, directors, officers, attorneys, employees,
and insurers (hereinafter collectively "the Maya Releasees") of and from any and
all manner of actions, causes of action, in law or in equity, debts, contracts,
charges, complaints, claims, suits, damages, obligations, promises, agreements,
controversies, losses, costs, judgments, or expenses (including attorney's fees
and court costs), of any nature whatsoever, known or UnknO\\-11, fixed or
contingent, direct or derivative, subrogated or assigned, suspected or
unsuspected, which the CytoDyn Parties have or may have, or which the Cy10Dyn
Parties at any time heretofore had or claimed to have, or which the CytoDyn
Parties at any time hereafter may have or claim to have, against any of the Maya
Party Releasees by reason of any matter, cause, act, omission, or thing
whatsoever from the beginning of time to the date of this Agreement.
1.7 Upon payment of the sum of $50,000 referred to in Section 1.4, except
for the obligations created by this Agreement, Rex Lewis, for himself, and for
each and all of his assignees, successors, and for all others claiming through
or under him, hereby irrevocably and unconditionally remises, releases, acquits,
absolves and forever discharges the Cy10Dyn Party Releasees of and from any and
all manner of actions, causes of action, in law or in equity, debts, contracts,
charges, complaints, claims, suits, damages, obligations, promises, agreements,
controversies, losses, costs, judgments, or expenses (including attorney's fees
and court costs), of any nature whatsoever, known or unknown, fixed or
contingent, direct or derivative, subrogated
3
or assigned, suspected or unsuspected, which Mr. Lewis has or may have, or which
he at any time heretofore had or claimed to have, or which the he at any time
hereafter may have or claim to have, against any of the CytoDyn Party Releasees
by reason of any matter, cause, act, omission, or thing whatsoever from the
beginning of time to the date of this Agreement.
1.8 The parties hereto, and each of them, hereby expressly waive all
rights or benefits which they now have, or in the future may have, under Section
1542 of the California Civil Code, and any law or principle of similar effect of
any state or territory of the United States. Section 1542 of the California
Civil Code reads as follows:
"Section 1542. A general release does not extend to claims which the
creditor does not know or suspect to exist in his favor at the time of
executing the release, which if known by him must have materially
affected his settlement with the debtor."
1.9 The parties hereto hereby acknowledge that they are aware that they
may hereafter discover facts in addition to or different from those which they
now know or believe to exist with respect to the matters covered by this
Agreement. The parties hereto also acknowledge that such different or additional
facts, if they exist, may have given or may hereafter give rise to causes of
action, claims, demands, controversies, damages, costs, and expenses which are
presently unknown, unanticipated, and unsuspected. The parties hereto further
agree, represent, and warrant that the releases contained herein have been
negotiated and agreed upon in light of that realization, and that it is their
intention through this Agreement, and with the advice of counsel, fully,
finally, and forever to settle and release to the fullest extent permitted by
law any and all possible claims, causes of action, disputes, and differences,
known or unknown, suspected or unsuspected, arising out of all facts, events,
circumstances or occurrences from the beginning of time to the date of this
Agreement, except for those obligations created herein. In furtherance of such
intention the parties agree that the releases contained in this Agreement will
remain in effect and will be fully binding notwithstanding the discovery or
existence of any additional or different facts.
1.10 The parties hereto, and each of them, covenant and agree not to
bring any suit, action or arbitration proceeding against any of the other
parties hereto with respect to any of the matters referenced herein, including
without limitation, all claims and/or causes of action asserted in the Glendale
Action and the Massachusetts Action, and in particular including, but not
limited to, any derivative claims on behalf of Amerimmune Pharmaceuticals, Inc.
or Amerimmune, Inc.
MISCELLANEOUS PROVISIONS
------------------------
2.1 This Agreement is intended by the parties hereto as the final
expression of their agreement and as a complete and exclusive statement of the
terms and provisions thereof. Nothing other than this Agreement shall be
relevant or admissible to supplement or vary any of the terms or provisions set
forth herein. No party hereto has made any statement or representation to any
other party regarding any fact or facts relied upon by any other party in
entering into this Agreement, and each party specifically does not rely upon any
statement, representation, or promise of any other party in executing this
Agreement, or in making the settlement provided for herein. This Agreement
constitutes a single, integrated written contract expressing the entire
agreement of the parties hereto relative to the subject matter hereof. No
covenants, agreements, representations, or warranties of any kind whatsoever
have been made by any party hereto, except as specifically set forth in this
Agreement. All prior discussions and negotiations have been and are merged and
integrated into, and are superseded by, this
4
Agreement.
2.2 This Agreement may be executed in one or more counterparts including
facsimile copies, each of which when executed and delivered shall be an
original, and all of which when executed shall constitute one and the same
instrument. A signature transmitted by facsimile shall be as binding and
effective as an original. Moreover, photocopies of this Agreement, including
photocopies of the signature pages hereof, may be used as originals, in the
absence of any bona fide challenge to their authenticity.
2.3 The parties to this Agreement, and each of them, represent and
warrant that none of the claims or rights purported to be released herein has
previously been assigned or otherwise transferred to any other person or entity,
including by way of subrogation or operation of law. In the event that any
claim, demand, or suit is made or instituted against any party hereto because of
any such purported assignment, subrogation, or transfer, the party or parties so
assigning or transferring, as the case may be, agree(s) to (1) indemnify and
hold harmless each of the parties to this Agreement against any such assigned,
subrogated or transferred claim, demand or suit; (2) satisfy any such assigned,
subrogated, or transferred claim, demand, or suit; and (3) pay all reasonable
costs of defense and/or investigation, including attorneys' fees and court
costs.
2.4 This Agreement shall inure to the benefit of and bind the successors,
assigns, heirs, executors, and administrators of the parties.
2.5 For the purposes of interpretation of this Agreement, it is
specifically agreed by all parties hereto that it shall be assumed that all
parties drafted each provision of this Agreement.
2.6 Each individual signing and executing this Agreement on behalf of a
partnership, corporation, trust, or other entity, warrants that he or she is
duly authorized to sign and execute this Agreement on behalf of such
partnership, corporation, trust or other entity, in accordance with the
authority granted under the formation documents of such entity, that all
conditions to the exercise of such authority have been satisfied, and that this
Agreement is binding upon such entity in accordance with its terms.
2.7 Each party to this Agreement agrees to do all things necessary or
convenient to carry out or effectuate the terms and intent of this Agreement.
Each and every provision hereof requiring a party to do a certain act, however
expressed, shall include the obligation of such party not to take directly or
indirectly, any action or do any act, or aid, assist or cooperate with any third
party in the taking of any action or in the doing of any act, that would tend to
defeat in any way the intent of this Agreement.
2.8 All questions with respect to the construction of this Agreement and
the rights and liabilities of the parties hereto shall be governed by the laws
of the State of California.
2.9 Each person signing this Agreement has had a full and fair
opportunity to receive independent legal advice from attorneys of his, her or
its choice with respect to the advisability of making the settlement provided
for herein, and with respect to the advisability of executing this Agreement.
Prior to the execution of this Agreement, that person reviewed same at length,
made such investigation of the facts pertaining to this settlement as he, she or
it deemed necessary, and received, to the extent desired, the advice of counsel
in reviewing and explaining the terms and consequences of this Agreement. This
Agreement has been carefully read by, the contents hereof are known and
understood by, and it is signed freely by each person executing same. 2.10 In
any action to enforce this Agreement or to recover damages for its breach, the
5
revailing party shall be entitled to an award of reasonable attorneys' fees.
Wherefore, the parties have executed this agreement as of the dates set
forth below.
DATED: December __ , 2008 ___________________________
Rex H. Lewis
DATED: December __ , 2008 Maya, LLC
By: ___________________________
Rex H. Lewis, Its Manager
DATED: December __ , 2008 AIDS Research, LLC
By: ___________________________
Rex H. Lewis, Its Manager
DATED: December __ ,2008 Cytodyn of New Mexico, Inc.
By: ___________________________
Allen D. Allen
DATED: December __, 2008 CytoDyn , Inc.
By: ___________________________
Allen D. Allen, President
DATED: December __, 2008
By: ___________________________
Allen D. Allen
DATED: December __, 2008 ___________________________
Corinne E. Allen
6
APPROVED AS TO FORM:
LAW OFFICES OF BRUCE M. LORMAN
By: _______________________________
Bruce M. Lorman, Esq.
Attorneys for Plaintiff
MUNDELL, ODLUM & HAWS, LLP
By: _______________________________
Marshall Brubacher, Esq.
Attorneys for Defendants
7
EXHIBIT "A"
-----------
ATTORNEY OR PARTY WITHOUT ATTORNEY FOR COURT USE ONLY
(Name, state tax number, and address):
THOMAS C. MUNDELL#99081 VENTURA
MARSHALL L. BRUBACHER, #199100 SUPERIOR COURTS
MUNDELL, ODLUM & HAWS, LLP FILED
2829 Townsgate Rd., Ste. 320, Westlake Village, CA 91361
TELEPH0NE NO.: (805) 446-2221 FAX NO.(Optional): (805) 446-2251 OCT 04 2004
ADDRESS (Optional):
ATTORNEY FOR(Name): Plaintiffs Cytodyn, Inc. and A11en D. Allen MICHAEL D. PLANET
Executive Officer and Clerk
SUPERIOR COURT OF CALIFORNIA, COUNTY OF Ventura
STREET ADDRESS: 3855-F Alamo Street BY: _________________, Deputy
MAILING ADDRESS: P.O. Box 1200
CITY AND ZIP CODE: Simi Valley 93062-1200
BRANCH NAME: East County Division
PLAINTIFF: Cytodyn, Inc., et al.
DEFENDANT: Amerimmune, Inc., et al.
JUDGMENT CASE NUMBER:
[ ] By Clerk [X] By Default [ ] After Court Trial
[X] By Court [ ] On Stipulation [ ] Defendant Did Not SC039250
Appear at Trial
JUDGMENT
1. [X] BY DEFAULT
a. Defendant was properly served with a copy of the summons and
complaint.
b. Defendant failed to answer the complaint or appear and defend the
action within the time allowed by law.
c. Defendant's default was entered by the clerk upon plaintiff's
application.
d. [ ] Clerk's Judgment (Code Civ. Proc., ss 585(a)). Defendant was sued
only on a contract or judgment of a court of this state for the
recovery of money.
e. [X] Court Judgment (Code Civ. Proc.,ss.585(b)). The court considered
(1) [ ] plaintiff's testimony and other evidence.
(2) [X] plaintiff's written declaration (Code Civ.
Proc.,ss.585(d)).
2. [ ] ON STIPULATION
a. Plaintiff and defendant agreed (stipulated) that a judgment be entered
in this case. The court approved the stipulated judgment and
b. [ ] the signed written stipulation was filed in the case.
c. [ ] the stipulation was stated In open court [ ] the stipulation was
stated on the record.
3. [ ] AFTER COURT TRIAL The jury was waived. The court considered the evidence.
a. The case was tried on (date and 6me): before (name of judicial
officer):
b. Appearances by:
[ ] Plaintiff (name each): [ ] Plaintiff's attorney (name each):
(1) (1)
(2) (2)
[ ] Continued on Attachment 3b.
[ ] Defendant (name each): (1) [ ] Defendant's attorney (name each):
(1) (1)
(2) (2)
[ ] Continued on Attachment 3b.
c. [ ] Defendant did not appear at trial. Defendant was properly served
with notice of trial.
d. [ ] A statement of decision (Code Civ. Proc..ss.632)
[ ] was not [ ] was requested.
Page 1 of 2
________________________________________________________________________________
JUDGMENT
________________________________________________________________________________
PLAINTIFF: Cytodyn, Inc., et al. CASE NUMBER:
DEFENDANT: Amerimmune, Inc., et al. SC 039250
________________________________________________________________________________
JUDGMENT IS ENTERD AS FOLLOWS BY: [X] THE COURT [ ] THE CLERK
[ ] Stipulated Judgment. Judgment is entered according to the stipulation
of the parties.
5. Parties. Judgment is
a. [X] for plaintiff (name each):(1) Cytodyn, Inc.; and c. [ ] for cross-complainant (name each):
(2) Allen D. Allen
and against defendant (names): and against cross-defendant (name each):
(1) Amerimmune Inc.; and
(2) Amerimmune Pharmaceuticals. Inc.
[ ] Continued on Attachment 5a. [ ] Continued on Attachment 5c.
b. [ ] for defendant (name each): d. [ ] for cross-defendant (name each):
6. Amount.
a. [ ] Defendant named in item 5a above must c. [ ] Cross-defendant named in item 5c above must
pay plaintiff on the complaint: pay cross-complainant on the cross-complaint
- ------------------------------------------ ------------------------------------------
(1) [ ] Damages |$ (1) [ ] Damages |$
(2) [ ] Prejudgment |$ (2) [ ] Prejudgment |$
interest at the | interest at the |
annual rate of % | annual rate of % |
(3) [X] Attorney fees |$22.372.54 (3) [X] Attorney fees |$
(4) [X] Costs |$ 569.50 (4) [X] Costs |$
(5) [ ] Other (specify): |$ (5) [ ] Other (specify): |$
------------------------------- -------------------------------
TOTAL |$22.942.04 TOTAL |$
- ------------------------------------------ ------------------------------------------
b. [ ] Plaintiff to receive nothing from defendant d. [ ] Cross-complainant to receive nothing from
named in item 5b. cross-defendant named in item 5d.
[ ] Defendant named in item 5b to recover [ ] Cross-defendant named in item 5d to recover
costs $ costs $
[ ] and attorney fees $ [ ] and attorney fees $
7. [X] Other (specify): SEE ATTACHED
Date: October 4, 2004 [ ] ________________________
JUDICIAL OFFICER
Date: [ ] Clerk, by __________________, Deputy
________________________________________________________________________________
CLERK'S CERTIFICATE (Optional)
I certify that this is a true copy of the original
judgment on tile in the court.
Date:
Clerk, by __________________, Deputy
Page 2 of 2
________________________________________________________________________________
JUDGMENT
________________________________________________________________________________
SHORT TITLE: Cytodyn Inc., et al. v. Amerimmune Inc., et al. CASE NUMBER:
SC 039250
________________________________________________________________________________
ATTACHMENT 7
------------
IT IS HEREBY ORDERED, ADJUDGED AND DECREED that (1) the license and assignment
of plaintiffs, technology to defendants Amerimmune, Inc. and Amerimmune
Pharmaceuticals, Inc. (collectively "Defendants"), pursuant to the Conditional
License Agreement dated February 24, 2000 ("CLA"), terminated no later than
September 12, 2001; and (2) by reason thereof, plaintiffs are, and have been
since at least that date, the owners of the technology licensed and assigned,
pursuant to the CLA, including, but not limited to, Allen D. Allen's patents
(i.e., U.S. Patents Nos. 5,424,066 and 5,651,970) and the investigational new
drug application BB-IND #6485, free from any claims by Defendants.
(Required for verified pleading) The items on this page stated on information
and belief are (specify item numbers, not line numbers):
This page may be used with any Judicial Council form or any other paper filed
with the court. Page 3
________________________________________________________________________________
ADDITIONAL PAGE
Attach to Judicial Council Form or other Court Paper
Exhibit B
---------
- -------------------------------------------------------------------------------
Liquid | Location | MCB | MWCB | Cell | Batch # | Project | Total |
Nitrogen | | | | Line | | # | # of |
ID# | | | | | | | Vials |
- -------------------------------------------------------------------------------
LN003 | Rack 1 Box 1 | | | S6Fl | 006703184 | 67-02 | 35 |
Vapor | | X | | | | | |
Phase | | | | | | | |
OMP | | | | | | | |
- -------------------------------------------------------------------------------
LN002 | Rack 11 Box | | | S6Fl | 006703184 | 67-02 | 50 |
Vapor | 1 | X | | | | | |
Phase | | | | | | | |
OMP | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 5 Box 1 | | | S6Fl | 016705321 | 67-06 | 21 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 4 Box 5 | | | S6Fl | 016705321 | 67-06 | 24 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 3 Box 5 | | | S6Fl | 016705321 | 67-06 | 25 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 3 Box 4 | | | S6Fl | 016705321 | 67-06 | 25 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 2 Box 5 | | | S6Fl | 016705321 | 67-06 | 25 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 2 Box 2 | | | S6Fl | 016705321 | 67-06 | 24 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN005 | Rack 5 Box 4 | | | S6F1 in | Customer | 67 | 1 |
Liquid | | | | HSFM | Vial | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN006 | Rack 5 Box 3 | | | S6Fl | 016705321 | 67-06 | 18 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN006 | Rack 5 Box 2 | | | S6Fl | 016705321 | 67-06 | 25 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN006 | Rack 5 Box 1 | | | S6Fl | 016705321 | 67-06 | 25 |
Liquid | | | X | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
- -------------------------------------------------------------------------------
LN001 | Rack D Box 4 | | | S6F1 | 082200 | 67-01 | 20 |
Vapor | | | | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LNOO 1 | Rack D Box 4 | | | S6F1 | COOl7 | | 21 |
Vapor | | | | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
LN001 | Rack D Box 4 | | | DB9G8 | COO16 | | 5 |
Vapor | | | | | | | |
Phase | | | | | | | |
- -------------------------------------------------------------------------------
----------------------------------------------------------------------
| Freezer ID# | Sample Type | Cell Line | Batch # | Project # |
----------------------------------------------------------------------
| FR007 -20 | ILS, ICS and | S6F1 | 006702208 | 67-03 |
| degrees | Harvest | | | |
| | Retentions | | | |
----------------------------------------------------------------------
Exhibit C
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December 15,2008
Attention: Debra Birnkrant, M.D.
Director
Division of Antiviral Products
Office of Antimicrobial Products
Center for Drug Evaluation and Research
Food and Drug Administration
Therapeutic Biological Products Document Room
5901- B Ammendale Road
Beltsville, MD 20705-1266
Re: BB-IND 6845 Serial # 0025
Submission of CytoDyn, Inc., to Relinquish Claims of IND Sponsorship
Dear Dr. Birnkrant:
Reference is made to Investigational New Drug Application, BB-IND 6845, for the
product "Murine Monoclonal Antibody (Cytolin(R)) to Human Leucocyte Function
Antigen-l (LFA-l)". The ownership of BB-IND 6845 has been in dispute as
described below.
Maya, LLC, a Nevada limited liability company ("MAYA") obtained a judgment (from
the District Court of Clark County, Nevada) judicially approving its foreclosure
upon BB-IND 6845 from Amerimmune, its sponsor. Consequently, MA Y A requested
that sponsorship of BB- IND 6845 be transferred from Amerimmune to MA Y A on
October 18, 2004.
The undersigned, on behalf of CytoDyn, Inc., opposed the transfer of BB-IND 6845
sponsorship to MA Y A and requested transfer of BB- IND 6845 sponsorship to
CytoDyn, Inc., on the basis of a judgment (from the Superior Court of
California, County of Ventura) judicially ruling that CytoDyn, Inc., was the
owner of BB- IND 6845 pursuant to termination of CytoDyn' s Conditional License
Agreement with Amerimmune, no later than September 2001.
CytoDyn wishes to inform the agency that we hereby relinquish our claim of
ownership of BBIND 6845 and any data contained therein. We agree that MAYA, LLC
should be the undisputed sponsor of this IND.
This relinquishment of CytoDyn's claim of ownership of BB-IND 6845 is without
prejudice to CytoDyn's submission, sponsorship and ownership of a subsequently
submitted different Investigational New Drug application for Cytolin (the "New
IND.")
The authorized representative and contact for MAYA, LLC is:
Christine H. Schwab
Vice President
MAYA, LLC
72 W. Horizon Ridge Parkway
Suite 120 PMB 194
Henderson, NV 89012
We would appreciate having the appropriate Office in the agency respond to us
and also to MA Y A, LLC, to confirm that the agency officially recognizes MAYA
LLC as the sponsor of BB-IND 6845. We will be happy to answer any questions you
may have or provide any additional documentation that you require.
Thank you for your attention to this matter.
Sincerely,
Allen D. Allen
President and CEO
CytoDyn, Inc.
Cc: Gerald F. Masoudi, Chief Counsel, FDA
Christine Schwab, Vice President, MAYA, LLC
EXHIBIT "D"
-----------
THOMAS C. MUNDELL, #99081
MARSHALL L. BRUBACHER, #199100
MUNDELL, ODLUM & HAWS, LLP
2829 Townsgate Road, Suite 320
Westlake Village, CA 91361
Telephone: (805) 446-2221
Facsimile (805) 446-2251
Attorneys for Defendants Cytodyn of New
Mexico, Inc. Allen D. Allen, Corinne
E. Allen, Cytodyn, Inc.
BRUCE M. LORMAN, #82364
LAW OFFICES OF BRUCE M. LORMAN
1717 Fourth Street
Third Floor
Santa Monica, California 90401
Attorneys for Plaintiff Maya, LLC
SUPERIOR COURT FOR THE STATE OF CALIFORNIA
IN AND FOR THE COUNTY OF LOS ANGELES
MAYA, LLC, a Nevada Limited Liability ) CASE NO: EC 041590
Company )
) [PROPOSED] JOINT STIPULATION
Plaintiff, ) FOR DISMISSAL; ORDER THEREON
vs. )
) [Assigned for all purposes to
) Hon. Charles W. Stoll, Dept. NCGD]
)
CYTODYN OF NEW MEXICO, INC., a ) Action filed: September 30, 2005
corporation; CYTODYN, INC., a corporation; )
ALLEN D. ALLEN; CORINNE E. ALLEN; )
and DOES 1 through 50, inclusive, )
)
Defendants. )
)
)
)
___________________________________________)
The parties hereto hereby stipulate and agree as follows, subject to the
approval of the court:
1. The first amended complaint filed herein by plaintiff Maya, LLC shall
be dismissed in its entirety with prejudice pursuant to the terms of a written
settlement agreement
1
________________________________________________________________________________
Stipulation for Dismissal
entered into by the parties;
2. The court shall retain jurisdiction to enforce said written settlement
agreement pursuant to California Code of Civil Proceduress.664.6;
3. Without limiting the power of the court to enforce any and all terms
of the settlement agreement by appropriate application or motion, the parties
specifically stipulate and agree that in the event of a default by defendant
CytoDyn, Inc. in performing its obligations under Paragraph 1.3 of the
settlement agreement, cross-complainants may apply to or move the court for
appropriate relief as outlined in Paragraph 1.4 of the written settlement
agreement, including, to the extent provided for therein, an order vacating the
dismissal of this action and entering judgment in favor of plaintiff and against
defendants on the terms set forth in said Paragraph 1.4.
DATED: December ____,2008 ___________________________
Rex H. Lewis
DATED: December ____,2008 Maya, LLC
By: ___________________________
Rex H. Lewis, Its Manager
DATED: December ____,2008 Cytodyn of New Mexico, Inc.
By: ___________________________
Allen D. Allen
DATED: December ____,2008 CytoDyn , Inc.
By: ___________________________
Allen D. Allen, President
DATED: December ____,2008
By: ___________________________
Allen D. Allen
DATED: December ____,2008 ___________________________
Corinne E. Allen
2
________________________________________________________________________________
Stipulation for Dismissal
ORDER
-----
IT IS SO ORDERED.
Dated: ___________________________ ___________________________
Superior Court Judge
3
________________________________________________________________________________
Stipulation for Dismissal
CERTIFICATE OF SERVICE
----------------------
I,_________________, declare as follows:
I am employed in the County of Ventura in the State of California. I am
over the age of eighteen years. I am not a party to this action. My business
address is 2829 Townsgate Road, Suite 320, Westlake Village, California 91361.
On __________________,200_, I served the within PROPOSED] JOINT
STIPULATION FOR DISMISSAL; ORDER THEREON on the interested parties in this
action by placing a true and correct copy thereof in an envelope addressed to
said interested parties' attorneys of record as follows:
Bruce M. Lorman
LAW OFFICES OF BRUCE M. LORMAN
1717 Fourth Street
Third Floor
Santa Monica, California 90401
and by then depositing said envelope, first class postage prepaid, in a box or
other facility regularly maintained by the United States Postal Service at
Westlake Village, California, for delivery on a next business day priority basis
to the addressee(s) listed above.
I declare under penalty of perjury that the foregoing is true and correct
and this declaration is executed on _________ at Westlake Village, California.
________________________
EXHIBIT E
---------
COMMONWEALTH OF MASSACHUSETTS
WORCESTER, SS. SUPERIOR COURT
CIVIL ACTION NO. 05-0452-C
________________________________________
CYTODYN, INC. and )
ALLEN D. ALLEN, )
)
)
Plaintiffs, )
and )
)
MAYA, LLC )
)
Plaintiff In Intervention, )
v. )
)
AMERIMMUNE, INC. and )
AMERIMMUNE PHARMACEUTICALS, INC. )
)
Defendants, )
)
v. )
)
BIOVEST INTERNATIONAL, INC. )
)
Trustee Defendant. )
________________________________________)
AGREEMENT FOR JUDGMENT
----------------------
The undersigned parties, through their counsel hereby agree as follows:
1. The Complaint of Plaintiffs Cytodyn, Inc. and Allen D. Allen is
dismissed with prejudice.
2. Judgment shall enter forthwith on Maya, LLC's Complaint for
Intervention declaring that it is the lawful owner of the
materials, goods and effects of Defendants Amerimmune, Inc. and
Amerimmune Pharmaceuticals, Inc. set forth in the Trustee
Defendant Biovest International, Inc.'s Answer and Disclosure,
including without limitation any and all related technical and
scientific documentation and electronic files and batch files
stored with the Trustee Defendant Biovest International, Inc. or
elsewhere.
3. Plaintiffs withdraw their Motion to Charge the Trustee, which was
allowed on May 27, 2005, and hereby discharge the Trustee
defendant Biovest.
4. Plaintiffs and Plaintiff in Intervention hereby waive their rights
to appeal. Each party is responsible for their own costs and
attorneys' fees.
Respectfully submitted, Respectfully submitted,
CYTODYN, INC. and ALLEN D. ALLEN MAYA, LLC.
By their attorneys, By its attorneys
____________________________ ____________________________
David P. Russman, Esq. BBO #567796 Marie Mercier, Esq. BBO #343150
The Russman Law Firm, P.C. Nicholas M. Kelley, BBO#265640
33 Bellevue Street, Suite 1 Kotin Crabtree & Strong, LLP
Boston, MA 02125 One Bowdoin Square
617.282.5300 Boston, MA 02114
617.227.7031