Document:

Registration Rights Agreement

  
 Exhibit 4.12

  
 ACCENTIA, INC. 
 REGISTRATION RIGHTS AGREEMENT 
  
 This Registration Rights Agreement (this “Agreement”) is made as of April 3, 2002, by and among Accentia, Inc., a Florida corporation
(the “Company”), and Steven Arikian, M.D., John Doyle, Julian Casciano and Roman Casciano (the “Series B Stockholders”). 
  
 WHEREAS, the Series B Stockholders owned one hundred percent (100%) of the issued and outstanding shares of capital stock of The Analytica Group, Ltd., a
New Jersey corporation (“Analytica”); 
  
 WHEREAS, on even date herewith, Analytica merged into The Analytica Group, Inc., a Florida corporation (the “Sub”), pursuant to that certain Amended and Restated Agreement of Merger and Plan of Reorganization by and among
Analytica, the Company and the Sub; 
  
 WHEREAS, as part of the
merger consideration, the Series B Stockholders received Series B convertible preferred stock (the “Series B Preferred Stock”) of the Company which is convertible into shares of common stock of the Company and those certain Convertible
Preferred Notes which are convertible into Series B Preferred Stock of the Company; and 
  
 WHEREAS, as additional merger consideration, the Series B Stockholders have required that the Company and the Series B Stockholders enter into this Agreement. 
  
 NOW, THEREFORE, in consideration of the premises and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto agree as follows: 
  
 SECTION 1 
  
 REGISTRATION RIGHTS 
  
 1.1 Certain
Definitions. For purposes of this Agreement: 
  
 (a) The term “Form S-3” means such form under the Securities Act of 1933 (the “Securities Act”) as in effect on the date hereof or any successor form under the Securities Act. 
  
 (b) The term “Holder” means any person,
including the Series B Stockholders, owning or having the right to acquire Registrable Securities or any assignee thereof in accordance with Section 1.11 of this Agreement. 
  
 (c) The terms “register,” “registered,” and
“registration” refer to a registration effected by preparing and filing a registration statement or similar document in compliance with the Securities Act of 1933, as amended, or successor statute (the “Securities
Act”), and the declaration or ordering of effectiveness of such registration statement or document. 
  
 (d) The term “Registrable Securities” means (i) the shares of common stock of the Company (the “Common
Stock”) held by the Holders, (ii) the Common Stock issuable or 

  

 
issued upon conversion of the Series B Preferred Stock and (iii) any Common Stock of the Company issued as (or issuable upon the conversion or exercise of
any warrant, right or other security that is issued as) a dividend or other distribution with respect to, or in exchange for, or in replacement of, the shares referenced in (i) and (ii) above. Notwithstanding the foregoing, Common Stock shall only
be treated as Registrable Securities if and so long as they have not been (A) sold to or through a broker or dealer or underwriter in a public distribution or a public securities transaction, or (B) sold in a transaction exempt from the registration
and prospectus delivery requirements of the Securities Act under Section 4(1) thereof so that all transfer restrictions, and restrictive legends with respect thereto, if any, are removed upon the consummation of such sale. 
  
 (e) The number of shares of “Registrable Securities
then outstanding” shall be determined by the number of shares of Common Stock outstanding, and the number of shares of Common Stock issuable pursuant to then exercisable or convertible securities that are Registrable Securities. 

 
 (f) The term “SEC” means the United
States Securities and Exchange Commission. 
  
 1.2 Company
Registration. If the Company proposes to register (including for this purpose a registration effected by the Company for stockholders other than the Holders) any of its securities under the Securities Act in connection with the public offering
of such securities solely for cash (other than a registration relating solely to the sale of securities to participants in a Company stock plan, an offering or sale of securities pursuant to a Form S-4 (or successor form) registration statement or a
registration in which the only stock being registered is Common Stock issuable upon conversion of debt securities which are also being registered), the Company shall, at such time, promptly give each Holder written notice of such registration. Upon
the written request of each Holder given within twenty (20) days after giving of such notice by the Company, the Company shall, subject to the provisions of Section 1.7, cause to be registered under the Securities Act all of the Registrable
Securities that each such Holder has requested to be registered. 
  
 1.3 Form S-3 Registration. In case the Company shall receive from the Holders of Registrable Securities a written request or requests that the Company effect a registration on Form S-3 and any related qualification or compliance with
respect to all or a part of the Registrable Securities owned by such Holders, the Company will: 
  
 (a) promptly give written notice of the proposed registration, and any related qualification or compliance, to all other Holders; and

  
 (b) as soon as practicable, effect such
registration and all such qualifications and compliances as may be so requested and as would permit or facilitate the sale and distribution of all or such portion of such Holder’s or Holders’ Registrable Securities as are specified in such
request, together with all or such portion of the Registrable Securities of any other Holder or Holders joining in such request as are specified in a written request given within fifteen (15) days after receipt of such written notice from the
Company; provided, however, that the Company shall not be obligated to effect any such registration, qualification or compliance, 

  

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pursuant to this Section 1.3 if: (i) Form S-3 is not available for such offering by the Holders; (ii) the Holders, together with the holders of any other
securities of the Company entitled to inclusion in such registration, propose to sell Registrable Securities and such other securities (if any) at an aggregate price to the public (net of any underwriters’ discounts or commissions) of less than
$3,000,000; (iii) the Company has, within the twelve (12) month period preceding the date of such request, effected two registrations on Form S-3 for the Holders pursuant to this Section 1.3 that have been declared or ordered effective; or (iv) the
Company shall furnish to such Holders a certificate signed by the President or Chief Executive Officer of the Company stating that in the good faith judgment of the board of directors of the Company, it would be seriously detrimental to the Company
and its stockholders for such Form S-3 registration statement to be filed and it is therefore essential to defer the filing of such registration statement, in which event the Company shall have the right to defer such filing for a period of not more
than one hundred and twenty (120) days after receipt of the request of the Holder or Holders under this Section 1.3; provided, however, that the Company may not utilize this right more than once in any twelve (12) month period.

  
 (c) Subject to the foregoing, the Company
shall file a registration statement covering the Registrable Securities and other securities so requested to be registered as soon as practicable after receipt of the request or requests of the Holders. 
  
 1.4 Obligations of the Company. Whenever required under this Section
1 to effect the registration of any Registrable Securities, the Company shall, as expeditiously as reasonably possible: 
  
 (a) Prepare and file with the SEC a registration statement with respect to such Registrable Securities and use its best efforts to cause
such registration statement to become effective, and, upon the request of the Holders of a majority of the Registrable Securities registered thereunder, keep such registration statement effective for up to one hundred twenty (120) days. 

 
 (b) Prepare and file with the SEC such amendments and
supplements to such registration statement and the prospectus used in connection with such registration statement as may be necessary to comply with the provisions of the Securities Act with respect to the disposition of all securities covered by
such registration statement for up to one hundred twenty (120) days. 
  
 (c) Furnish to the Holders such numbers of copies of a prospectus, including a preliminary prospectus, in conformity with the requirements of the Securities Act, and such other documents as they may reasonably request
in order to facilitate the disposition of Registrable Securities owned by them. 
  
 (d) Use its best efforts to register and qualify the securities covered by such registration statement under such other securities or blue
sky laws of such jurisdictions as shall be reasonably requested by the Holders; provided, however, that the Company shall not be required in connection therewith or as a condition thereto to qualify to do business or to file a general
consent to service of process in any such states or jurisdictions. 
  

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 (e) In the event of any underwritten public offering, enter into and perform its
obligations under an underwriting agreement, in usual and customary form, with the managing underwriter of such offering, and each Holder participating in such underwriting shall also enter into and perform its obligations under such an agreement.
: 
  
 (f) Notify each Holder of Registrable Securities covered by such registration statement at any time when a prospectus relating thereto is
required to be delivered under the Securities Act of the happening of any event as a result of which the prospectus included in such registration statement, as then in effect, includes an untrue statement of a material fact or omits to state a
material fact required to be stated therein or necessary to make the statements therein not misleading in the light of the circumstances then existing, such obligation to continue until the earlier of (i) the sale of all Registrable Securities
registered pursuant to the registration statement of which such prospectus forms a part or (ii) the withdrawal of such registration statement. 
  
 (g) Cause all such Registrable Securities registered pursuant to this Agreement to be listed on each securities exchange on which similar
securities issued by the Company are then listed. 
  
 (h) Use its best efforts to furnish, at the request of any Holder requesting registration of Registrable Securities pursuant to this Section 1, on the date that such Registrable Securities are delivered to the underwriters for sale in
connection with a registration pursuant to this Section 1, if such securities are being sold through underwriters, or, if such securities are not being sold through underwriters, on the date that the registration statement with respect to such
securities becomes effective, (i) an opinion, dated such date, of the counsel representing the Company for the purposes of such registration, in form and substance as is customarily given to underwriters in an underwritten public offering, addressed
to the underwriters, if any, and to the Holders requesting registration of Registrable Securities and (ii) a letter dated such date, from the independent certified public accountants of the Company, in form and substance as is customarily given by
independent certified public accountants to underwriters in an underwritten public offering, addressed to the underwriters, if any, and to the Holders requesting registration of Registrable Securities. 
  
 1.5 Furnish Information. It shall be a condition precedent to the
obligations of the Company to take any action pursuant to this Section 1 with respect to the Registrable Securities of any selling Holder that such Holder shall furnish to the Company such information regarding itself, the Registrable Securities
held by it, and the intended method of disposition of such securities as shall be required to effect the registration of such Holder’s Registrable Securities. The Company shall have no obligation with respect to any registration requested
pursuant to Section 1.2 or Section 1.3 of this Agreement if, as a result of the application of the preceding sentence, the number of shares or the anticipated aggregate offering price of the Registrable Securities to be included in the registration
does not equal or exceed the number of shares or the anticipated aggregate offering price required to originally trigger the Company’s obligation to initiate such registration as specified in subsection 1.3(b)(ii). 
  

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 1.6 Expenses of Registration. 
  
 (a) Expenses of Company Registration. All expenses other than underwriting discounts and commissions
incurred in connection with registrations, filings or qualifications of Registrable Securities pursuant to Section 1.2 for each Holder, including (without limitation) all registration, filing, and qualification fees, printers’ and accounting
fees, fees and disbursements of counsel for the Company and the reasonable fees and disbursements of one (1) counsel for the selling Holders selected by them, shall be borne by the Company. 
  
 (b) Expenses of Registration on Form S-3. All
expenses other than underwriting discounts and commissions incurred in connection with registrations requested pursuant to Section 1.3, including (without limitation) all registration, filing, qualification, printers’ and accounting fees and
the reasonable fees and disbursements of one (1) counsel for the selling Holders selected by them, shall be borne by the Company. 
  
 1.7 Underwriting Requirements. In connection with any offering involving an underwriting of shares of the Company’s capital stock, the Company
shall not be required under Section 1.2 to include any of the Holders’ securities in such underwriting unless they accept the terms of the underwriting as agreed upon between the Company and the underwriters selected by it (or by other persons
entitled to select the underwriters), and then only in such quantity as the underwriters determine in their sole discretion will not jeopardize the success of the offering by the Company. If the total amount of securities, including Registrable
Securities, requested by stockholders to be included in such offering exceeds the amount of securities sold other than by the Company that the underwriters determine in their sole discretion is compatible with the success of the offering, then the
Company shall be required to include in the offering only that number of such securities, including Registrable Securities, which the underwriters determine in their sole discretion will not jeopardize the success of the offering (the securities so
included to be apportioned pro rata among the selling stockholders according to the total amount of securities entitled to be included therein (without regard to the number of securities actually requested to be included therein) owned by each
selling stockholder or in such other proportions as shall mutually be agreed to by such selling stockholders). For purposes of the preceding parenthetical concerning apportionment, for any selling stockholder which is a Holder of Registrable
Securities and which is a partnership or corporation, the partners, retired partners and stockholders of such holder, or the estates and family members of any such partners and retired partners and any trusts for the benefit of any of the foregoing
persons shall be deemed to be a single “selling stockholder” and any pro rata reduction with respect to such “selling stockholder” shall be based upon the aggregate amount of shares carrying registration rights owned by all
entities and individuals included in such “selling stockholder,” as defined in this sentence. 
  
 1.8 Delay of Registration. No Holder shall have any right to obtain or seek an injunction restraining or otherwise delaying any such registration
as the result of any controversy that might arise with respect to the interpretation or implementation of this Section 1. 
  
 1.9 Indemnification. In the event any Registrable Securities are included in a registration statement under this Section 1: 
  
 (a) To the extent permitted by law; the Company will
indemnify and hold harmless each Holder, any “underwriter” (as defined in the Securities Act) for such Holder and each person, if any, who controls such Holder or underwriter within the meaning of the 

  

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Securities Act or the Securities Exchange Act of 1934, as amended (the “Exchange Act”), against any losses, claims, damages, or liabilities
(joint or several) to which they may become subject under the Securities Act, the Exchange Act or other federal or state law, insofar as such losses, claims, damages, or liabilities (or actions in respect thereof) arise out of or are based upon any
of the following statements, omissions or violations (collectively a “Violation”): (i) any untrue statement or alleged untrue statement of a material fact contained in such registration statement, including any preliminary
prospectus or final prospectus contained in such registration statement or any amendments or supplements thereto, (ii) the omission or alleged omission to state therein a material fact required to be stated therein, or necessary to make the
statements therein not misleading, (iii) the omission or alleged omission to state in any preliminary prospectus or final prospectus a material fact necessary to make the statements therein, in light of the circumstances in which they were made, not
misleading, or (iv) any violation or alleged violation by the Company of the Securities Act, the Exchange Act, any state securities law or any rule or regulation promulgated under the Securities Act, the Exchange Act or any state securities law; and
the Company will pay to each such Holder, underwriter or controlling person, as incurred, any legal or other expenses reasonably incurred by them in connection with investigating or defending any such loss, claim, damage, liability, or action;
provided, however, that the indemnity agreement contained in this subsection 1.9(a) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability, or action if such settlement is effected without the consent
of the Company (which consent shall not be unreasonably withheld), nor shall the Company be liable to any Holder, underwriter or controlling person for any such loss, claim, damage, liability, or action to the extent that it arises out of or is
based upon a Violation which occurs in reliance upon and in conformity with written information furnished expressly for use in connection with such registration by any such Holder, underwriter or controlling person. 
  
 (b) To the extent permitted by law, each selling Holder will
indemnify and hold harmless the Company, each of its directors, each of its officers who has signed the registration statement, each person, if any, who controls the Company within the meaning of the Securities Act or the Exchange Act, any
underwriter, any other Holder selling securities in such registration statement and any controlling person of any such underwriter or other Holder, against any losses, claims, damages, or liabilities (joint or several) to which any of the foregoing
persons may become subject, under the Securities Act, the Exchange Act or other federal or state law, insofar as such losses, claims, damages, or liabilities (or actions in respect thereto) arise out of or are based upon any Violation, in each case
to the extent (and only to the extent) that such Violation occurs in reliance upon and in conformity with written information furnished by such Holder expressly for use in connection with such registration; and each such Holder will pay, as
incurred, any legal or other expenses reasonably incurred by any person intended to be indemnified pursuant to this subsection 1.9(b), in connection with investigating or defending any such loss, claim, damage, liability, or action; provided,
however, that the indemnity agreement contained in this subsection 1.9(b) shall not apply to amounts paid in settlement of any such loss, claim, damage, liability or action if such settlement is effected without the consent of the Holder
(which consent shall not be unreasonably withheld); provided further, that in no event shall any indemnity under this subsection 1.9(b) exceed the net proceeds from the offering received by such Holder. 
  

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 (c) Promptly after receipt by an indemnified party under this Section 1.9 of notice of
the commencement of any action (including any governmental action), such indemnified party will, if a claim in respect thereof is to be made, against any indemnifying party under this Section 1.9, deliver to the indemnifying party a written notice
of the commencement thereof and the indemnifying party shall have the right to participate in, and, to the extent the indemnifying party so desires, jointly with any other indemnifying party similarly noticed, to assume the defense thereof with
counsel mutually satisfactory to the parties; provided, however, that an indemnified party (together with all other indemnified parties which may be represented without conflict by one counsel) shall have the right to retain one (1)
separate counsel, with the reasonable fees and expenses to be paid by the indemnifying party, if representation of such indemnified party by the counsel retained by the indemnifying party would be inappropriate due to actual or potential differing
interests between such indemnified party and any other party represented by such counsel in such proceeding. The failure to deliver written notice to the indemnifying party within a reasonable time of the commencement of any such action, if
prejudicial to its ability to defend such action, shall relieve such, indemnifying party of any liability to the indemnified party under this Section 1.9, but the omission so to deliver written notice to the indemnifying party will not relieve it of
any liability that it may have to any indemnified party otherwise than under this Section 1.9. 
  
 (d) If the indemnification provided for in this Section 1.9 is held by a court of competent jurisdiction to be unavailable to an
indemnified party with respect to any loss, liability, claim, damage or expense referred to therein, then the indemnifying party, in lieu of indemnifying such indemnified party hereunder, shall contribute to the amount paid or payable by such
indemnified party as a result of such loss, liability, claim, damage, or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified party on the other in connection
with the Violation that resulted in such loss, liability, claim, damage or expense as well as any other relevant equitable considerations; provided, that in no event shall any contribution by a Holder under this subsection 1.9(d) exceed the net
proceeds from the offering received by such Holder. The relative fault of the indemnifying party and of the indemnified party shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact
or the omission to state a material fact relates to information supplied by the indemnifying party or by the indemnified party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such
statement or omission. 
  
 (e) The obligations of
the Company and Holders under this Section 1.9 shall survive the completion of any offering of Registrable Securities in a registration statement under this Section 1 and shall survive the termination of this Agreement and otherwise. No indemnifying
party, in the defense of any such loss, claim, change, liability or action, shall, except with the consent of each indemnified party, consent to entry of any judgment or enter into any settlement which does not include as a provision thereof, the
giving by the claimant or plaintiff to such indemnified party of a release from all liability in respect to such loss, claim, damage, liability or action. 
  
 1.10 Assignment of Registration Rights. The rights to cause the Company to register Registrable Securities pursuant to this Section 1 may be
assigned (but only with all related obligations) by a Holder to (i) any “affiliate” of such Holder (as defined under the Securities 

  

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Act), or (ii) such Holder’s spouse, parents, siblings, children or grandchildren, or other members of such Holder’s immediate or extended family
(including relatives by marriage), or to a custodian, trustee or other fiduciary for the account of such Holder or members of such Holder’s immediate or extended family in connection with an estate planning transaction. For the purposes of
determining the number of shares of Registrable Securities held by a transferee or assignee, the holdings of transferees and assignees of a business entity who are affiliates, retired affiliates of such entity (including spouses and ancestors,
lineal descendants and siblings of such affiliates or affiliates who acquire Registrable Securities by gift, will or intestate succession) shall be aggregated together and with the business entity. 
  
 1.11 Limitations on Subsequent Registration Rights. From and after the
date of this Agreement, the Company shall not, without the prior written consent of the Holders of at least two-thirds (2/3) of the Registrable Securities then outstanding, enter into any agreement with any holder or prospective holder of any
securities of the Company which would allow such holder or prospective holder (a) to include such securities in any registration filed under Section 1.2 or 1.3 hereof, unless under the terms of such agreement, such holder or prospective holder may
include such securities in any such registration only to the extent that the inclusion of its securities will not reduce the amount of the Registrable Securities of the Holders which is included, or (b) to make a demand registration which could
result in such registration statement being declared effective within one hundred eighty (180) days of the effective date of any registration effected pursuant to Section 1.2 or 1.3 hereof. 
  
 1.12 Reports under Securities Exchange Act of 1934. With a view to
making available to the Holders the benefits of Rule 144 promulgated under the Securities Act and any other rule or regulation of the SEC that may at any time permit a Holder to sell securities of the Company to the public pursuant to a registration
on Form S-3 or without registration, the Company agrees to: 
  
 (a) make and keep public information available, as those terms are understood and defined in SEC Rule 144, at all times after the effective date of the first registration statement filed by the Company for the
offering of its securities to the general public so long as the Company remains subject to the periodic reporting requirements under Sections 13 or 15(d) of the Exchange Act; 
  
 (b) take such action, including the voluntary registration of its Common Stock under Section 12 of the
Exchange Act, as is necessary to enable the Holders to utilize Form S-3 (or any successor form that provides for short-form registration) for the sale of their Registrable Securities, such action to be taken as soon as practicable after the end of
the fiscal year in which the first registration statement filed by the Company for the offering of its securities to the general public is declared effective; 
  

(c) file with the SEC in a timely manner all reports and other documents required of the Company under the Securities Act and the
Exchange Act; and 
  
 (d) furnish to any Holder,
so long as accurate and so long as the Holder owns any Registrable Securities, forthwith upon request (i) a written statement by the Company that it has complied with the reporting requirements of SEC Rule 144 (at any time after ninety (90) 

  

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days after the effective date of the first registration statement filed by the Company), the Securities Act and the Exchange Act (at any time after it has
become subject to such reporting requirements), or that it qualifies as a registrant whose securities may be resold pursuant to Form S-3 (or any successor form that provides for short-form registration) (at any time after it so qualifies), (ii) a
copy of the most recent annual or quarterly report of the Company and such other reports and documents so filed by the Company, and (iii) such other information as may be reasonably requested in availing any Holder of any rule or regulation of the
SEC which permits the selling of any such securities without registration or pursuant to such form. 
  
 1.13 “Market Stand-Off” Agreement. 
  
 (a) Each Holder hereby agrees that, during the period of duration (up to, but not exceeding, one hundred eighty (180) days) specified by
the Company and an underwriter of Common Stock or other securities of the Company, following the effective date of a registration statement of the Company filed under the Securities Act, it shall not, to the extent requested by the Company and such
underwriter, directly or indirectly sell, offer to sell, contract to sell (including, without limitation, any short sale), grant any option to purchase or otherwise transfer or dispose of (other than to donees who agree to be similarly bound) any
securities of the Company held by it at any time during such period except Common Stock included in such registration; provided, however, (i) such agreement shall be applicable only during the two (2) year period following the date of
the final prospectus distributed pursuant to the first such registration statement of the Company which covers Common Stock or other securities of the Company to be sold on its behalf to the public in an underwritten offering, and (ii) that all
officers and directors of the Company and all other persons with registration rights (whether or not pursuant to this Agreement) enter into similar agreements. 
  

(b) In order to enforce the foregoing covenant, the Company may impose stop-transfer instructions with respect to the Registrable
Securities of each Holder (and the shares or securities of every other person subject to the foregoing restriction) until the end of such period, and each Holder agrees that, if so requested, such Holder will execute an agreement in the form
provided by the underwriter containing terms which are essentially consistent with the provisions of this Section 1.13. 
  
 (c) Notwithstanding the foregoing, the obligations described in this Section 1.13 shall not apply to a registration relating solely to
employee benefit plans on Form S-1 or Form S-8 or similar forms which may be promulgated in the future, or a registration relating solely to an SEC Rule 145 transaction on Form S-4 or similar forms which may be promulgated in the future. 

 
 1.14 Termination of Registration Rights. The right of any Holder to
request registration or inclusion in any registration pursuant to Section 1.2 or 1.3 hereof shall terminate on the closing of the first registered public offering of Common Stock of the Company, if all shares of Registrable Securities held by such
Holder may immediately be sold under Rule 144 during any 90-day period, or on such date after the closing of the first registered public offering of Common Stock of the Company as all shares of Registrable Securities held by such Holder may
immediately be sold under Rule 144 during any 90-day period. 
  

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 SECTION 2 
  
 MISCELLANEOUS 
  
 2.1 Enforceability/Severability. The parties hereto agree that each provision of this Agreement shall be interpreted
in such a manner as to be effective and valid under applicable law. If any provision of this Agreement shall nonetheless be held to be prohibited by or invalid under applicable law, such provision shall be effective only to the extent of such
prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement. 
  
 2.2 Remedies. Each party hereto will be entitled to enforce its rights under this Agreement specifically, to recover damages by reason of any
breach of any provision hereof, and to exercise all other rights existing in its favor. Each party hereto agrees and acknowledges that money damages may not be an adequate remedy for any breach of the provisions of this Agreement and that each
holder may, in its sole discretion, apply for specific performance and injunctive relief in order to enforce or prevent any violations of the provisions of this Agreement. 
  
 2.3 Entire Agreement; Successors and Assigns. This Agreement constitutes the entire agreement between the parties
hereto relative to the subject matter hereof and supersedes any previous agreement among the parties. Subject to the exceptions specifically set forth in this Agreement, the terms and conditions of this Agreement shall inure to the benefit of and be
binding upon the respective executors, administrators, heirs, successors and assigns of the parties. 
  
 2.4 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Florida applicable to contracts
entered into and wholly to be performed within the State of Florida without giving effect to conflicts of laws principles. 
  
 2.5 Counterparts. This Agreement may be executed in counterparts, each of which shall be an original, but all of which together shall constitute
one and the same instrument. 
  
 2.6 Headings. The section
headings of this Agreement are for convenience and shall not by themselves determine the interpretation of this Agreement. 
  
 2.7 Notices. Any notice required or permitted hereunder shall be given in writing and shall be conclusively deemed effectively given upon personal
delivery, or delivery by overnight courier, or five (5) days after deposit in the United States mail, by registered or certified mail, postage prepaid, addressed (i) if to the Company, to the address of the Company’s principal office, and (ii)
if to a Series B Stockholder, to such Series B Stockholder’s address as set forth in the records of the Company, or at such other address as the parties may designate by ten (10) days’ advance written notice to the other parties.

  
 2.8 Amendment of Agreement. Any provision of this
Agreement may be amended by a written instrument signed by the Company and by the Series B Stockholders holding at least two-thirds (2/3) of the outstanding Registrable Securities then held by the Series B Stockholders. 
  

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 IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date above set forth.

  

			
	 “Company”

	
	 Accentia, Inc., a Florida corporation

		
	 By:
	 	 /s/ David L. Redmond

	 	 	 David L. Redmond, Secretary and Chief

	 	 	 Financial Officer

  

			
	 “Series B Stockholders”

	
	/s/ Steven Arikian
	 Steven Arikian, M.D.

	
	/s/ John Doyle
	 John Doyle

	
	/s/ Julian Casciano
	 Julian Casciano

	
	/s/ Roman Casciano
	 Roman Casciano

  
 Signature Page to
Registration Rights Agreement 
  

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 ACCENTIA BIOPHARMACEUTICALS, INC. 
  
 Amendment No. 1 to Registrations Rights Agreement 
  
 WHEREAS, Accentia Biopharmaceuticals, Inc., a Florida corporation (the
“Company”), is proposing to undertake an initial public offering of its common stock, par value $.001 per share (the “Offering”). 
  
 WHEREAS, the undersigned are the holders of shares of more than two-thirds (2/3) of the outstanding Registrable
Securities held by the stockholders of Series B Convertible Preferred Stock (“Series B Preferred Stock”) of the Company. 
  
 WHEREAS, as part of the Offering, the undersigned and the Company wish to amend the Registration Rights Agreement, dated April 3, 2002, between the
Company and the undersigned (the “Registration Rights Agreement”) as herein provided. 
  
 WHEREAS, all capitalized terms included in this Amendment shall have the meanings ascribed thereto in the Registration Rights Agreement.

  
 NOW, THEREFORE, for good and valuable consideration,
including the pursuit of the Offering by the Company, the undersigned hereby makes the following agreements to and for the benefit of the Company: 
  
 1. Amendment to Registration Rights Agreement. The Registration Rights Agreement is hereby amended in accordance with Section 2.8 of the
Registration Rights Agreement by the Company and the holders of two-thirds (2/3) of the outstanding Registrable Securities held by the Series B Preferred Stockholders as follows: 
  
 (i) Section 1.2 of the Registration Rights Agreement shall be amended by adding the following sentence to the end of said
Section 1.2: “Notwithstanding the foregoing, no Holder shall have any registration rights with respect to, nor shall they have the right to include any Registrable Securities in any registration statement relating to, an underwritten initial
public offering of the Company’s common stock per registration number 333-122769.” 
  
 (ii) Section 1.1(d) of the Registration Rights Agreement is hereby amended by deleted the words “have not been” from the last sentence of said section and replacing such words with “may not be.”

  
 2. Other Provisions. Except for the foregoing
amendments, the Registration Rights Agreement shall continue to remain in full force and effect after the date hereof in accordance with the terms and conditions thereof. 
  
  

 IN WITNESS WHEREOF, the undersigned has executed this Amendment No. 1 to the Registration Rights
Agreement effective as of March 30. 2005. 
  

					
	 	 	Steven Arikian
			
	 	 	Signature:	 	/s/    Steven Arikian         
	 	 	 	 	 Steven Arikian, individually

  

					
	 	 	John Doyle  
			
	 	 	Signature:	 	/s/    John Doyle        
	 	 	 	 	 John Doyle, individually

  

					
	 	 	ACCENTIA BIOPHARMACEUTICALS, INC.   
			
	 	 	By:	 	/s/    Samuel S. Duffey        
	 	 	 	 	 Samuel S. Duffey, General Counsel

  
 2BDSI License Agreement

  
 Exhibit 10.1

  
 LICENSE AGREEMENT 
 BETWEEN 
 BIODELIVERY SCIENCES
INTERNATIONAL, INC. 
 AND 
 ACCENTIA, INC. 
  
 This License Agreement (this
“Agreement”) effective as of April 12, 2004, by and between BioDelivery Sciences International, Inc., a Delaware corporation, having its principal place of business at 185 South Orange Avenue, Administrative Building No. 4,
Newark, NJ 07103 (“BDSI”) and Accentia, Inc. having its principal place of business at 5310 Cypress Center Drive #101, Tampa, Florida 33609 (“ACCENTIA”) (collectively the “Parties”). 
  
 WITNESSETH: 
  
 Whereas, BDSI has rights to certain BDSI Licensed Technology (hereinafter defined) relating
to cochleates, geodes, nanocochleates, and liposomes; 
  
 Whereas, ACCENTIA
recognizes that the BDSI Licensed Technology represents a valuable means of delivering Licensed Products (hereinafter defined) for the use and/or sale in the treatment or prevention of human and/or animal diseases; 
  
 Whereas, ACCENTIA wishes to enter into an agreement to obtain exclusive licenses for specific
Licensed Products which utilize BDSI Licensed Technology in the Field (hereinafter defined) from BDSI in order to research, develop and commercialize therapeutic products made in accordance therewith; and 
  
 WHEREAS, BDSI is willing to grant such licenses to ACCENTIA under the terms and conditions
set forth in this Agreement. 
  
 NOW, THEREFORE, in consideration of the various
promises and undertakings set forth herein, the Parties agree as follows: 
  
 ARTICLE 1 - DEFINITIONS 
  
 As used herein,
capitalized terms shall have the following meanings: 
  
 1.1
“Affiliate”, with respect to any Party, shall mean any person or entity controlling, controlled by, or under common control with such Party. For these purposes, “control” shall refer to (i) the possession, directly or indirectly,
of the power to direct the management or policies of a person or entity, whether through the ownership of voting securities, by contract or otherwise or (ii) the ownership, directly or indirectly, of at least 50% of the voting securities or other
ownership interest of a person or entity. 
  

 1.2 “Antifungal Products” shall mean any and all products covered by the patent rights licensed to ACCENTIA by
MAYO under the ACCENTIA/MAYO Agreement that are not Licensed Products. “Antifungal Products” include, but are not limited to, topical antifungal products contemplated by the ACCENTIA/MAYO Agreement that do not require approval by the FDA
or appropriate regulatory authority in Europe. 
  
 1.3 “BDSI Licensed
Technology” shall mean any and all information, and all patentable and non-patentable inventions (including, without limitation, all Joint Inventions), improvements, discoveries, claims, formulae, processes, methods, trade secrets,
technologies, data and know-how owned, licensed or controlled by BDSI or to which BDSI has the right to grant licenses or sublicenses before or during the term of this Agreement: (i) related to the cochleate, geode, nanocochleate, or liposome
technology described in Exhibit C, or (ii) claimed, covered or disclosed in any patent or patent application listed in Exhibit B which relates to the cochleate, geode, nanocochleate, or liposome technology described in Exhibit C. 
  
 1.4 “Effective Date” shall mean the date first written above. 
  
 1.5 “Field” shall mean the field of any topical antifungal (including Amphotericin
B) for mucosal surface application for the indications of chronic sinusitis and asthma covered by patents licensed to ACCENTIA by the Mayo Clinic (“MAYO”), and transmucosal vaccine applications covered by a patent held by MAYO for the
indications of chronic sinusitis and asthma. 
  
 1.6 “Joint Invention”
shall mean any invention for which it is determined, in accordance with applicable law, that both: (i) employees or agents of ACCENTIA or any other persons obligated to assign such Invention to ACCENTIA, and (ii) employees or agents of BDSI or any
other persons obligated to assign such invention to BDSI, are joint inventors of such invention. 
  
 1.7 “Know-How” shall mean any and all know-how shared by the Parties under this Agreement. 
  
 1.8 “Licensed Patents” shall mean any current and future Patent, owned or controlled by BDSI, or any of the same jointly owned or controlled by BDSI and that
relate to the BDSI Licensed Technology, including Patents set forth on Exhibit B. 
  
 1.9 “Licensed Product” shall mean a Product in the form of (a) antifungal preparations (including Amphotericin B preparations) for mucosal surface application for the indications of chronic sinusitis and asthma; and (b)
transmucosal vaccine preparations for the indications of chronic sinusitis and asthma. 
  
 1.10 “Net Sales” shall mean the gross amount invoiced for all Antifungal Products or Licensed Products sold by ACCENTIA and/or its Affiliates in arm’s length sales or commercial transactions to a Third Party (excluding sales
to Sublicensees for their resale), less deductions for: 
  
 (a)
commissions, trade, quantity and cash discounts or rebates actually allowed or given; 
  
 (b) credits, allowances or refunds given or made for rejected, outdated or returned Licensed Products, if applicable; 
  

 2 

 (c) any tax or government charge (other than an income tax) levied on the sale, transportation or
delivery of a Licensed Product and borne by the seller thereof; and 
  
 (d) any prepaid or invoiced charges for freight, postage, shipping, import or export taxes, insurance or charges for returnable containers. 
  
 1.11 “Party” shall mean ACCENTIA or BDSI and, when used in the plural, shall mean ACCENTIA and BDSI. 
  
 1.12 “Patent” means (i) unexpired letters patent (including inventor’s
certificates) which have not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be taken or has been taken within the required time period, including without limitation any substitution, extension,
registration, confirmation, reissue, re-examination, renewal or any like filing thereof and (ii) pending applications for letters patent, including without limitation any continuation, division or continuation-in-part thereof and any provisional
applications. 
  
 1.13 “Product” shall mean a cochleate, geode,
nanocochleate, or liposome preparation of an antifungal that is: (i) based upon, derived from, identified through or related to any BDSI Licensed Technology; and (ii) covered by one or more Licensed Patents and would infringe a Valid Claim thereof.

  
 1.14 “Sublicensee” shall mean any Third Party granted a sublicense
by ACCENTIA pursuant to Section 3.2 hereof. 
  
 1.15 “Sublicensee Net
Sales” shall mean the gross amount invoiced for all Licensed Products sold by a Sublicensee to a Third Party, less deductions for. 
  
 (a) commissions, trade, quantity and cash discounts or rebates actually allowed or given; 
  
 (b) credits, allowances or refunds given or made for rejected, outdated or returned Licensed Products, if applicable;

  
 (c) any tax or government charge (other than an income tax)
levied on the sale, transportation or delivery of a Licensed Product and borne by the seller thereof; and 
  
 (d) any prepaid or invoiced charges for freight, postage, shipping, import or export taxes, insurance or charges for returnable containers. 
  
 1.16 “Sublicensee Revenue” shall mean any and all revenue or other consideration
received by ACCENTIA from a Sublicensee for Licensed Products under this Agreement, including but not limited to, upfront revenue, milestone revenue, royalty income, and the market value at the time of transfer of all non-monetary consideration such
as barter or counter-trade in the country of disposition. 
  
 1.17
“Territory” shall mean the United States and the European Union. 
  
 1.18 “Third Party” means any person or entity other than ACCENTIA, BDSI or any Affiliate of either ACCENTIA or BDSI. 
  

 3 

 1.19 “Valid Claim” shall mean a claim of any issued or granted Licensed Patent which has not been held invalid
or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which is not admitted to be invalid or unenforceable through reissue, disclaimer
or otherwise. 
  
 ARTICLE 2 - REPRESENTATIONS AND WARRANTIES

  
 2.1 Representations and Warranties of Both Parties. Each Party
represents and warrants to the other Party that: (i) it is free to enter into this Agreement; (ii) in so doing, it will not violate any other agreement to which it is a party; and (iii) it has taken all corporate action necessary to authorize the
execution and delivery of this Agreement and the performance of its obligations under this Agreement. 
  
 2.2 Representations and Warranties of BDSI. BDSI hereby represents and warrants that: 
  
 (a) BDSI either owns or licenses all of the Licensed Patents listed on Exhibit B, and has the exclusive right to grant licenses and sublicenses therefore
without the consent or approval of any Third Party, except as provided in Section 2.3; 
  
 (b) BDSI own or licenses all of the BDSI Licensed Technology in existence on the date of this Agreement, and has the right to grant licenses and sublicenses therefore without the consent or approval of any Third
Party; 
  
 (c) To the best of BDSI’s knowledge, all the
Licensed Patents listed on Exhibit B are in full force and effect and have been maintained to date; 
  
 (d) BDSI is not aware of any asserted or unasserted claim or demand against the BDSI Licensed Technology; 
  
 (e) To the best of BDSI’s knowledge, none of the BDSI Licensed
Technology infringes upon any patent or other proprietary rights of any other Third Party; and 
  
 (f) BDSI has not entered into any agreement with any Third Party which is in conflict with the rights granted to ACCENTIA pursuant to this Agreement. 
  
 2.3 Disclaimer. 
  
 (a) Government Rights; Research and Development. BDSI’s rights in the Licensed Patents is subject to the rights of the US Government, if any,
in the Patents and BDSI’s and its Affiliates’ reserved, irrevocable, royalty-free right to manufacture, have manufactured, and use any Products, including Licensed Products, for research and development purposes. 
  
 (b) Disclaimer of Other Warranties. EXCEPT AS PROVIDED HEREIN, THE
BDSI LICENSED TECHNOLOGY IS PROVIDED WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. EXCEPT AS EXPRESSLY PROVIDED, NEITHER PARTY MAKES ANY 

  

 4 

 
REPRESENTATION OR WARRANTY THAT THE BDSI LICENSED TECHNOLOGY WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT OF A THIRD PARTY. 
  
 2.4 Employee Agreements. Each Party warrants that it has, and covenants that it will
have, entered into a proprietary information and inventions agreement with each of its employees prior to the time that any such employee shall receive confidential information from a disclosing party or begin work related to this Agreement. Such
agreement shall minimally set forth employee obligations to assign inventions to the inventing Party and to maintain confidentiality of confidential information consistent with the terms of this Agreement. 
  
 ARTICLE 3 - LICENSE GRANT 
  
 3.1 Grant of License. 
  
 (a) Subject to the terms and conditions of this Agreement, BDSI hereby grants to ACCENTIA an exclusive license throughout
the Territory, with the right to grant sublicenses (subject to Sections 3.2 and 3.3), to make, use or sell Licensed Products in the Field. 
  
 (b) Subject to the terms and conditions of this Agreement, each Party hereby grants to the other Party a nonexclusive, perpetual license to use its
Know-How to develop, manufacture, use and sell Licensed Products in the Field. 
  
 For the avoidance of doubt, no rights are granted to MAYO under this Agreement including, but not limited to, license and sublicense rights, and rights in BDSI confidential information, trade secrets, data, and other information. No rights
are granted by MAYO to either Party under this Agreement. 
  
 3.2 Right to
Grant Sublicenses. 
  
 (a) United States. ACCENTIA
shall not have the right to sublicense the BDSI Licensed Technology in the United States. 
  
 (b) European Union. ACCENTIA shall have the right to sublicense the BDSI Licensed Technology in the European Union with the prior written approval of BDSI, which approval is not to be unreasonably withheld.
Each sublicense granted by ACCENTIA pursuant to this Agreement shall be consistent the provisions of this Agreement. Prior to the grant of each sublicense hereunder, ACCENTIA shall provide BDSI a copy of the sublicense. ACCENTIA shall not grant any
paid-up license or accept equity in consideration, directly or indirectly, for such sublicenses without BDSI’s written approval. 
  
 3.3 ACCENTIA Responsibility for Sublicenses. ACCENTIA shall be responsible for and guarantees the payment of all royalties to BDSI as provided in Article 4 as
though ACCENTIA itself had sold the Licensed Product and the provision of sales and other reports hereunder. 
  
 3.4 Intellectual Property. Any and all intellectual property developed by the Parties related to the BDSI Licensed Technology, including Joint Inventions and inventions developed solely by either BDSI or
ACCENTIA, shall be the sole and exclusive property of BDSI. Such intellectual property shall be considered BDSI Licensed Technology and therefore subject to the license rights granted to ACCENTIA in this Article 3. All intellectual property
developed by ACCENTIA (Joint Inventions and inventions developed solely by ACCENTIA), related to the Licensed Products but not related to the 

  

 5 

 
BDSI Licensed Technology shall be the sole and exclusive property of ACCENTIA. All intellectual property developed solely by BDSI related to the Licensed
Products but not related to the BDSI Licensed Technology shall be the sole and exclusive property of BDSI, subject to a nonexclusive license to such intellectual property to ACCENTIA. ACCENTIA shall have no rights in any intellectual property
related to Licensed Products developed jointly by BDSI with any third parties. 
  
 ARTICLE 4 - ROYALTY PAYMENTS AND REPORTS 
  
 4.1 License Fee. As consideration for entering into this Agreement, ACCENTIA shall pay to BDSI ten (10) dollars within thirty (30) days of the Effective Date. 
  
 4.2 Royalties. As consideration for the license rights granted ACCENTIA under this agreement, ACCENTIA will pay BDSI the following:

  
 (a) Antifungal Products. In lieu of any up front fees
and milestone payments, and as an inducement to BDSI to enter into this Agreement, ACCENTIA shall pay to BDSI a royalty equal to twelve percent (12%) of Net Sales of Antifungal Products in the Territory; 
  
 (b) Licensed Products. ACCENTIA shall pay to BDSI a royalty of
fourteen percent (14%) of Net Sales of any Licensed Products in the Territory; and 
  
 (c) Sublicensee Revenue. ACCENTIA shall pay to BDSI either: (i) an amount equal to fifty percent (50%) of Sublicensee Revenue to BDSI, after the prescribed royalty payment to MAYO; or (ii) a minimum royalty of
eight percent (8%) of Sublicensee Net Sales (regardless of the prescribed royalty to MAYO), whichever is greater, for Licensed Products. 
  
 4.3 Term of Royalty Obligations. The royalty obligations specified in Section 4.2 above shall continue as to each Licensed Product in the Territory for the term of
the last to expire of the Licensed Patent rights covering the Licensed Product. 
  
 4.4 Payments for Antifungal Products. Payments under Section 4.2(a) shall be made to BDSI no later than sixty (60) days following the end of the calendar quarter during which payment is received by ACCENTIA for Antifungal Products.

  
 4.5 Payments for Licensed Products. Payments under sections 4.2(b) and
4.2(c) shall be made to BDSI no later than sixty (60) days following the end of the calendar quarter during which Net Sales and Sublicensee Net Sales are invoiced and any other Sublicensee Revenue accrued for Licensed Products. 
  
 4.6 Place of Payment. All payments due shall be payable in United States dollars by
wire transfer to a bank account designated by each Party from time to time. ACCENTIA shall convert all non-U.S. dollar sales to U.S. dollars using the average exchange rates quoted in the Wall Street Journal for the final day of each month in the
relevant period for which the royalty is being paid. In the event payment of any royalties is restricted or prohibited by the laws or regulations of a particular country, then to the extent of such a restriction and prohibition, royalties shall be
paid to BDSI in that country and in the currency of said country into an account to be designated by BDSI. BDSI shall have the option of requesting payment in Euros upon notice under Section 10.7. 
  

 6 

 4.7 Taxation of Payments. 
  

(a) Insofar as any payment that is due under this Agreement is subject to any tax, duty, levy, or other government imposition, the Party receiving the
payment agrees to bear any and all such taxes, duties, levies or impositions. Each Party hereby authorizes the other Party to withhold such taxes, duties, levies or impositions from the payments in accordance with this Agreement if ACCENTIA or BDSI
is required to do so under the laws of the United States or any country in the Territory where such taxes, duties, levies or impositions are payable. Whenever a Party deducts such tax, duty, levy or imposition from any payments due, then it shall
furnish the other Party with a certificate showing the payment of thereof to the United States or any country in the Territory. 
  
 (b) In the event any payments which are due to under this Agreement are subject to value added taxation by any government, then the Party receiving the
payment shall bear such value added tax in full and the Party making the payment shall be reimbursed therefore. If appropriate, the Party receiving payment may add such value added taxes to its royalty accounts, provided such value added taxes are
credited against the other Party’s value added tax debt and the other Party is reimbursed in full with respect thereto. Notwithstanding anything herein to the contrary, the Party making the payment shall have no liability for any value added
tax directly or indirectly relating to thereto. 
  
 (c) In the
event any payment is subject to a withholding or other income tax in any country in the Territory, promptly following becoming aware of the applicability of any such tax, the Party making the payment shall so advise the other Party. The Party
receiving the payment shall have the right to contest with the appropriate governmental body any such proposed withholding and the other Party shall provide, at receiving Party’s expense, reasonable cooperation in any such contest. The Parties
shall provide each other with such receipts or other evidence of any tax withheld as is necessary to claim any credit or deduction available to it in other jurisdictions. Payments shall only be reduced for withholding taxes imposed by the
jurisdiction out of which the payment is directly made. 
  
 4.8 Interest.
All payments due hereunder that are not paid when due and payable as specified in this agreement shall bear interest at an annual rate equal to the prime rate (“Prime Rate”) for U.S. dollar deposits in effect from time to time, as
published daily in the Wall Street Journal plus 2%, compounded monthly from the date due until paid, or at such lower rate of interest as shall then be the maximum rate permitted by applicable law. 
  
 4.9 Right to Documentation. Upon request, BDSI shall have the right to request
reasonable documentation of ACCENTIA’s calculations to determine ACCENTIA’s Net Sales, Sublicensee Revenues and/or Sublicensee Net Sales for the Licensed Products and to request discussion of such calculations with appropriate
representatives of ACCENTIA. BDSI shall make all reasonable efforts to provide to ACCENTIA any existing data or other information owned by BDSI to support ACCENTIA’s efforts to obtain FDA approval. 
  
 4.10 Records Retention. ACCENTIA, its Sublicensee and Affiliates shall keep complete
and accurate records pertaining to the sale of Licensed Products in the Territory and covering all transactions which Net Sales are derived for a period of three (3) calendar years after the year in which such sales occurred, and in sufficient
detail to permit BDSI to confirm the accuracy of royalty calculations hereunder. Such records shall be available at all reasonable times for inspection by BDSI or its representatives for verification of royalty payments or compliance with other
aspects of this Agreement. 
  

 7 

 4.11 Audit Request. At the request of BDSI, ACCENTIA, its Affiliates and Sublicensees shall permit an independent,
certified public accountant appointed by BDSI acceptable to ACCENTIA or its Affiliates, at reasonable times and upon reasonable notice, to examine those records and all other material documents relating to or relevant to Net Sales, Sublicensee
Revenue, and Sublicensee Net Sales income in the possession or control of ACCENTIA, its Affiliates or Sublicensees, for a period of three (3) years after such royalties have accrued, as may be necessary to: (i) determine the correctness of any
report or payment made under this Agreement; or (ii) obtain information as to the royalties payable for any calendar quarter in the case of ACCENTIA’s or its Affiliate’s failure to report or pay pursuant to this Agreement. Said accountant
shall not disclose to BDSI any information other than information relating to said reports, royalties, and payments. Results of any such examination shall be made available to both Parties. BDSI shall bear the full cost of the performance of any
such audit, unless such audit demonstrates underpayment of royalties by ACCENTIA of more than ten percent (10%) from the amount of the original royalty payment made by ACCENTIA. In such event, ACCENTIA shall bear the full cost of the performance of
such audit 
  
 ARTICLE 5 - PATENT PROSECUTION; ENFORCEMENT;
INFRINGEMENT 
  
 5.1 Patent Prosecution and Maintenance. 
  
 (a) Responsibility. BDSI shall continue to have full responsibility
for and shall control the preparation and prosecution and maintenance of all Licensed Patents. 
  
 (b) Cooperation. Each Party agrees to cooperate with the other Party to execute any documents necessary or desirable to secure and perfect the other Party’s legal rights and worldwide ownership in the
other Party’s intellectual property, including, but not limited to documents relating to patent, trademark and copyright applications. Each Party agrees to take actions reasonably necessary to diligently prosecute and maintain its intellectual
property in major commercial markets where viable protection is available. Each party or its representatives shall be entitled to meet and confer with the other Party and their patent counsel at reasonable times and places. 
  
 5.2 Limitations on Publications. The Parties agree that no one Party shall publish the
results of any studies, whether conducted by its own employees or in conjunction with a Third Party, carried out pursuant to this Agreement or confidential information received from the other Party that is relating to a Licensed Product, without the
prior written approval of the other Party. Each Party agrees to provide the other Party with a copy of any proposed abstracts, presentations, manuscripts, or any other disclosure which discloses clinical study results pursuant to this Agreement or
confidential information received from the other Party at least one hundred twenty (120) days prior to their intended submission for publication and agrees not to submit or present such disclosure until the Party not seeking to disclose such
information provides its prior written approval. Such written approval will not be unreasonably withheld unless such proposed disclosure could reasonably harm or impair a Party’s intellectual property assets or may reasonably cause commercial
harm to a Party. 
  
 5.3 Notification of Infringement If either Party
learns of an infringement or threatened infringement by a Third Party of any Licensed Patent granted hereunder within the Territory, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such
infringement. Section 5.4 shall then be applicable. 
  

 8 

 5.4 Patent Enforcement. BDSI shall have the first right, but not the duty, to institute patent infringement
actions against third parties based on any Licensed Patent under this Agreement. If BDSI does not institute an infringement proceeding against an offending Third Party within ninety (90) days after receipt of notice from ACCENTIA, ACCENTIA shall
have the right, but not the duty, to institute such an action. The costs and expenses of any such action (including fees of attorneys and other professionals) shall be borne by the Party instituting the action, or, if the Parties elect to cooperate
in instituting and maintaining such action, such costs and expenses shall be borne by the Parties in such proportions as they may agree in writing. Each Party shall execute all necessary and proper documents and take such actions as shall be
appropriate to allow the other Party to institute and prosecute such infringement actions. Any award paid by third parties as a result of such an infringement action (whether by way of settlement or otherwise) shall be paid to the Party who
instituted and maintained such action, or, if both Parties instituted and maintained such action, such award shall be allocated among the Parties in proportion to their respective contributions to the costs and expenses incurred in such action.

  
 5.5 Infringement Action by Third Parties. 
  
 (a) Claim or Suit Against ACCENTIA. In the event of the institution of
any claim or suit by a Third Party against ACCENTIA for patent infringement involving the manufacture, use, lease or sale of any Licensed Product in the Territory, and related to BDSI Licensed Technology, ACCENTIA shall promptly notify BDSI in
writing of such claim or suit. ACCENTIA shall have the right to defend such claim or suit at its own expense and BDSI hereby agrees to assist and cooperate with ACCENTIA, at BDSI’s own expense, to the extent necessary in the defense of such
claim or suit During the pendency of such claim or suit, ACCENTIA shall continue to make all payments due under this Agreement, but shall have a credit against royalty payments otherwise payable hereunder for the full amount of all costs and
expenses incurred by ACCENTIA in defending against such claim or suit; provided, however, that in applying the credit against any royalty payments, the amount of such payment shall not be reduced by more than 50% and any remaining credit shall be
applied against subsequent royalty payments. 
  
 If as a result of
any judgment, award, decree or settlement resulting from a claim or action instituted by a Third Party, ACCENTIA is required to pay a royalty or other amounts to such Third Party (“Third Party Royalty”), ACCENTIA shall continue to pay
royalties for such Licensed Products in the country which is the subject of such action, but shall be entitled to a credit against such payments in an amount equal to the Third Party Royalty, but in no event shall such credit be more than the
royalties due hereunder for such Licensed Products in such country which is the subject of such action and any remaining credit shall be applied against subsequent royalty payments in the Territory. In addition, if ACCENTIA is required to pay
damages to such Third Party, and such damages are not otherwise reimbursed by BDSI, ACCENTIA shall be entitled to a credit against royalty payments in an amount equal to such damages, to the extent paid by ACCENTIA to such Third Party, but in no
event shall the total credit provided hereunder be more than such royalties due hereunder for such Licensed Products in such country which is the subject of such action. 
  
 (b) Claim or Suit Against BDSI. In the event of the institution of any claim or suit by a Third Party against BDSI
for patent infringement involving the manufacture, use, lease or sale of any Licensed Product in the Territory, BDSI shall promptly notify ACCENTIA in writing of such claim or suit. BDSI shall have the right to defend such claim or suit at its own
expense and ACCENTIA hereby 

  

 9 

 
agrees to assist and cooperate with BDSI, at ACCENTIA’s own expense, to the extent necessary in the defense of such claim or suit. 
  
 ARTICLE 6 - CONFIDENTIALITY 
  
 6.1 Use of Name. BDSI agrees not to use directly or indirectly ACCENTIA’s name
without ACCENTIA’s prior written consent. ACCENTIA agrees not to use directly or indirectly BDSI’s name or information without BDSI’s prior written consent. Notwithstanding the foregoing, ACCENTIA and BDSI may include an accurate
description of the terms of this Agreement to the extent required under federal or state securities or other disclosure; and ACCENTIA may use BDSI’s names in various documents used by ACCENTIA for capital raising and financing purposes.

  
 6.2 Confidentiality; Exceptions. Except to the extent expressly
authorized by this Agreement or otherwise agreed in writing, the Parties agree that, for the term of this Agreement and for three (3) years thereafter, the receiving Party shall keep completely confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than proper performance hereunder any information furnished to it by the other Party pursuant to this Agreement, except to the extent that it can be established by the receiving Party by competent
proof that such information: 
  
 (a) was already known to the
receiving Party, other than under an obligation of confidentiality, at the time of disclosure by the other Party; 
  
 (b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; 
  
 (c) became generally available to the public or otherwise part of the public
domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; 
  
 (d) was disclosed to the receiving Party, other than under an obligation of confidentiality, by a Third Party who had no obligation to the disclosing
Party not to disclose such information to others; or 
  
 (e) was
independently developed by or for the receiving Party by persons not having access to such information, as determined by the written records of such party. 
  
 6.3. Obligations of Employees and Consultants. The Parties each represent that all of its employees and the employees of its Affiliates, and any collaborators or
consultants to such Party or its Affiliates, who shall have access to confidential information of the Parties are bound by written obligations to maintain such information in confidence and not to use such information except as expressly permitted
herein. Each Party agrees to enforce confidentiality obligations to which its employees and consultants (and those of its Affiliates) are obligated. 
  
 6.4. Restrictions on Disclosure to MAYO. ACCENTIA agrees that it shall not disclose any BDSI confidential information to MAYO without the prior written consent of
BDSI, which consent is not to be unreasonably withheld. ACCENTIA agrees mat it shall not be unreasonable for BDSI to request that MAYO execute a confidentiality agreement with BDSI and/or ACCENTIA prior to disclosure of any such confidential
information. 
  

 10 

  
 ARTICLE 7 -
INDEMNIFICATION 
  
 7.1 Indemnification by ACCENTIA. ACCENTIA shall
defend, indemnify and hold BDSI, its officers, directors, employees and consultants harmless from and against any and all Third Party claims, suits or demands, threatened or filed, (“Claims”) for liability, damages, losses, costs and
expenses (including the costs and expenses of attorneys and other professionals), at both trial and appellate levels, relating to the distribution, testing, manufacture, use, lease, sale, consumption on or application of Licensed Products by
ACCENTIA, its Affiliates or its Sublicensees pursuant to this Agreement, including, without limitation, claims for any loss, damage, or injury to persons or property, or loss of life, relating to the promotion and advertising of Licensed Products
and/or interactions and communications with governmental authorities, physicians or other Third Parties relating to the Licensed Products. The foregoing indemnification shall not apply to any Third Party Claims to the extent are caused by the gross
negligence of BDSI. 
  
 7.2 Indemnification by BDSI. BDSI shall defend,
indemnify and hold ACCENTIA, its officers, directors, employees and consultants harmless from and against any and all Third Party Claims for liability, damages, losses, costs and expenses (including the costs and expenses of attorneys and other
professionals), at both trial and appellate levels, relating to BDSI’s activities contemplated under this Agreement, including, but not limited to, (a) breach of the representations, warranties and obligations of BDSI hereunder, or (b) any tax,
duty, levy or government imposition on any sums payable by ACCENTIA to BDSI hereunder. The foregoing indemnification shall not apply to any Claims to the extent caused by the gross negligence of ACCENTIA. 
  
 7.3 Notice. In the event that either Party seeks indemnification under Sections 7.1 or
7.2, the Party seeking indemnification agrees to (i) promptly inform the other Party of the Third Party Claim, (ii) permit the other Party to assume direction and control of the defense or claims resulting therefrom (including the right to settle it
at the sole discretion of that Party), and (iii) cooperate as reasonably requested (at the expense of that Party) in the defense of the Claim. 
  
 7.4 Insurance. 
  
 (a) Prior to the first human clinical trials of a Licensed Product under this Agreement, ACCENTIA shall obtain and maintain broad form comprehensive
general liability insurance and Licensed Products liability insurance with a reputable and financially secure insurance carrier, subject to approval by BDSI’s primary insurance broker, to cover such activities of ACCENTIA and ACCENTIA’s
contractual indemnity under this Agreement. Such insurance shall provide minimum annual limits of liability of $5,000,000 per occurrence and $5,000,000 in the aggregate with respect to all occurrences being indemnified under this Agreement. Such
insurance policy shall name BDSI as an additional insured and shall be purchased and kept in force for a time period sufficient to cover liability assumed by ACCENTIA associated with this Agreement. 
  
 (b) In the event that ACCENTIA chooses to rely on any strategic partners of
ACCENTIA to satisfy any of the requirements for insurance under this Section 7.4, then ACCENTIA shall provide details of such coverage to BDSI for its information. Any such coverage must substantially comply with the form, scope and amounts set
forth in this Section 7.4(a) which are applicable to such insurance. In the event that any such insurance is a self-insured plan, ACCENTIA shall determine that such strategic partner’s self-insured plan is adequate given the financial condition
of such strategic partner. At BDSI’s 

  

 11 

 
request, which shall not be more frequently than annually, ACCENTIA shall provide BDSI with a certificate of such insurance or written verification by such
strategic partner of such self-insurance. 
  
 (c) At BDSI’s
request, which shall not be more frequently than annually, ACCENTIA shall provide BDSI evidence of any insurance obtained pursuant to Section 7.4(a). ACCENTIA shall not, and shall not permit any strategic partner to, cancel or materially reduce the
coverage of any policy of insurance required under this Section 7.4(a) without giving BDSI thirty (30) days prior written notice thereof. 
  
 ARTICLE 8 – TERM; TERMINATION 
  
 8.1 Term. This Agreement shall commence as of the Effective Date and, unless sooner terminated as provided hereunder, shall terminate as to each Licensed Product
and as to each country in the Territory, upon the expiration of the last to expire Valid Claim of a Licensed Patent necessary for the manufacture, use or sale of such Licensed Product in such country. 
  
 8.2 Breach. Failure by either Party to comply with any of the material obligations
contained in this Agreement shall entitle the other Party to give to the Party in default notice specifying the nature of the default and requiring it to cure such default. If such default is not cured within sixty (60) days after the receipt of
such notice (or, if such default cannot be cured within such sixty (60) day period, if the Party in default does not commence and diligently continue actions to cure such default), the notifying Party shall be entitled, without prejudice to any of
its other rights conferred on it by this Agreement, in addition to any other remedies available to it by law or in equity, to terminate this Agreement by giving written notice to take effect within thirty (30) days after such notice unless the
defaulting Party shall cure such default within said thirty (30) days. The right of either Party to terminate this Agreement, as hereinabove provided, shall not be affected in any way by its waiver or failure to take action with respect to any
previous default. 
  
 8.3 Termination based on ACCENTIA actions or MAYO
Agreement. 
  
 (a) Failure to file an NDA. BDSI may, at
its option, terminate the entire license if ACCENTIA has not filed an NDA within 5 years of the Effective Date, or if the License Agreement between ACCENTIA and MAYO, dated February 10, 2004 (“ACCENTIA/MAYO Agreement”), is terminated.

  
 (b) Termination of Rights to MAYO Technology. BDSI may,
at its option, terminate exclusivity to BDSI Technology if ACCENTIA’s exclusive rights to MAYO technology terminate and ACCENTIA fails to regain exclusive rights to MAYO technology under the ACCENTIA/MAYO Agreement within sixty (60) days.
ACCENTIA is responsible for immediately notifying BDSI of any such above noted circumstances. 
  
 (c) Amendment or Termination of ACCENTIA/MAYO Agreement. Should a breach or default or any other event that can trigger amendment or termination of the ACCENTIA/MAYO Agreement occur, including an event that
triggers loss of exclusive rights or termination for Material Change under the ACCENTIA/MAYO Agreement, ACCENTIA shall immediately inform BDSI of such occurrence. ACCENTIA shall thereafter continue to keep BDSI informed of the status of the
ACCENTIA/MAYO Agreement. 
  

 12 

 (d) Assumption of Agreement by MAYO Under the ACCENTIA/MAYO Agreement. BDSI agrees that MAYO may
assume this Agreement under Section 7.03(c) of the ACCENTIA/MAYO Agreement, provided that: (i) BDSI is notified that MAYO will assume this Agreement by 17 March 2009; and (ii) MAYO agrees in writing to BDSI to accept this entire Agreement, including
all responsibilities and obligations to BDSI thereunder, by 17 April 2009. 
  
 (e) Access to IND. In the event that: (i) BDSI files and holds an IND for chronic rhinosinusitus; (ii) the ACCENTTA/MAYO License Agreement is terminated; and (iii) ACCENTIA has paid, in its entirety, for the
IND to the point of termination, BDSI agrees to give MAYO access to the IND as it relates to topical encochleated Amphotericin B for chronic rhinosinusitus. For the purpose of avoiding confusion, the Parties agree that no rights under this Agreement
(including rights under Article 3 of this Agreement and rights to BDSI Licensed Technology), will transfer to MAYO under this Section 8.3(e). 
  
 8.4 Termination by ACCENTIA. ACCENTIA shall have the right to terminate the licenses granted herein, in whole or as to any Licensed Product in the Territory, at
any time, and from time to time, by giving notice in writing to BDSI. Such termination shall be effective thirty (30) days from the date such notice is given, and all ACCENTIA’s rights associated therewith shall cease as of that date, subject
to Section 8.5. 
  
 8.5 Rights to Sell Stock on Hand. Upon the termination
of any license granted herein, in part or in whole or as to any Licensed Product, for any reason other than a failure to cure a material breach of the Agreement by ACCENTIA, ACCENTIA shall have the right for one (1) year or such longer period as the
Parties may reasonably agree to dispose of all Licensed Products or substantially completed Licensed Products then on hand to which such termination applies, and royalties shall be paid to BDSI with respect to such Licensed Products as though this
Agreement had not terminated. 
  
 8.6 Termination of Sublicenses. Upon any
termination of this Agreement, all sublicenses granted by ACCENTIA under this Agreement shall terminate simultaneously, subject, nevertheless, to Section 8.5. 
  

8.7 Effect of Termination. Upon the termination of any license granted herein as to any Licensed Product in the Territory other than pursuant to Section 8.1,
ACCENTIA and its Affiliates and Sublicensees shall promptly: (i) return to BDSI all relevant records, materials or confidential information of BDSI concerning the BDSI Licensed Technology relating to such Licensed Product in such country in the
possession or control of ACCENTIA or any of its Affiliates or Sublicensees; and (ii) assign to BDSI, or BDSI’s designee, its registrations with governmental health authorities, licensees, and approvals of such Licensed Product in such country.

  
 8.8 Surviving Rights. Termination of this Agreement shall not terminate
ACCENTIA’s obligation to pay all royalties which shall have accrued hereunder. The Parties’ obligations under Articles 6, 7 and 8, and Sections 10.6 and 10.10 also shall survive termination. 
  
 8.9 Accrued Rights, Surviving Obligations. Termination, relinquishtment or expiration
of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party under this Agreement prior to such termination, relinquishment or expiration. Such termination, relinquishment or
expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. 
  

 13 

  
 ARTICLE 9 — CLINICAL
TRIALS AND SUPPLIES OF MATERIAL 
  
 9.1 BDSI Supply Requirements. BDSI
shall provide all quantities of phospholipids ACCENTIA needs to develop and/or identify Licensed Products for ACCENTIA’s preclinical studies at BDSI’s fully absorbed cost. ACCENTIA shall identify the amounts of phospholipids needed.
Provision of phospholipids shall be accompanied by applicable quantity and quality information necessary to permit use of such Licensed Product in animal testing. If necessary, based on the stage of development, BDSI shall produce Licensed Product
in accordance with regulatory requirements to permit use of such Licensed Products in such pre-clinical testing. 
  
 9.2 Costs of Preclinical and Clinical Trials. ACCENTIA will be responsible, at its sole cost and expense, for all preclinical and clinical trial expenses under
this Agreement. ACCENTIA agrees to use its best efforts to meet the regulatory timelines set forth in Exhibit A. 
  
 9.3 Assistance in Third Party Contractor Identification. In the event that either Party desires to use a Third Party contractor for supply of phospholipids and/or
to manufacture of Licensed Product, it shall obtain the other Party’s prior written approval for use of such Third Party contractor, the approval of which shall not be unreasonably withheld. 
  
 ARTICLE 10 - MISCELLANEOUS PROVISIONS 
  
 10.1 Relationship of Parties. Nothing in this Agreement is or shall be deemed to
constitute a partnership, agency, employee or joint venture relationship between the Parties. No Party shall incur any debts or make any commitments for the other, except to the extent, if at all, specifically provided herein. 
  
 10.2 Assignment. Except as otherwise provided herein, neither this Agreement nor any
interest hereunder shall be assignable by any Party without the prior written consent of the other, which approval is not to be unreasonably withheld; provided, however, that either Party may assign this Agreement to any wholly-owned subsidiary or
to any successor by merger or sale of substantially all of its assets to which this Agreement relates in a manner such that the assignor shall remain liable and responsible for the performance and observance of all its duties and obligations
hereunder. This Agreement shall be binding upon the successors and permitted assigns of the parties and the name of a Party appearing herein shall be deemed to include the names of such Party’s successors and permitted assigns to the extent
necessary to carry out the intent of this Agreement. Any assignment not in accordance with this Section 10.2 shall be void. 
  
 10.3 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instructions, and to do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement. 
  
 10.4 Force Majeure. Neither Party shall be liable to the other for loss or damages nor shall have any right to terminate this Agreement for any default or delay attributable to any act of God, flood, fire, explosion, strike, lockout,
labor dispute, shortage of raw materials, casualty, accident, war, revolution, civil commotion, act of public enemies, blockage or embargo, injunction, law, order, proclamation, 

  

 14 

 
regulation, ordinance, demand or requirement of any government or subdivision, authority or representative of any such government, or any other cause beyond
the reasonable control of such Party, if the Party affected shall give prompt notice of any such cause to the other Party. The Party giving such notice shall thereupon be excused from such of its obligations hereunder as it is thereby disabled from
performing for so long as it is so disabled and for thirty (30) days thereafter. Notwithstanding the foregoing, nothing in this Section 10.4 shall excuse or suspend the obligation to make any payment due hereunder in the manner and at the time
provided. 
  
 10.5 No Trademark Rights. Except as otherwise provided
herein, no right, express or implied, is granted by this Agreement to use in any manner the name “ACCENTIA” or “BDSI” or any other trade name or trademark of the other party in connection with the performance of this Agreement.

  
 10.6 Public Announcements. Except as required by law, neither Party
shall make any public announcement concerning this Agreement or the subject matter hereof without the prior written consent of the other. In the event of a required public announcement, the Party making such announcement shall provide the other with
a copy of the proposed text prior to such announcement. 
  
 10.7 Notices.
Any notice required or permitted to be given or delivered hereunder or by reason of the provisions of this Agreement shall be in writing and shall be deemed to have been properly served if: (a) delivered personally, (b) delivered by a recognized
overnight courier service instructed to provide next-day delivery, (c) sent by certified or registered mail, return receipt requested and first class postage prepaid, or (d) sent by facsimile transmission followed by confirmation copy delivered by a
recognized overnight courier service the next day. Such notices, demands and other communications shall be sent to the addresses set forth below, or to such other addresses or to the attention of such other person as the recipient Party has
specified by prior written notice to the sending Party. Date of service of such notice shall be: (i) the date such notice is personally delivered or sent by facsimile transmission (with issuance by the transmitting machine of confirmation of
successful transmission), (ii) three days after the date of mailing if sent by certified or registered mail, or (iii) one day after date of delivery to the overnight courier if sent by overnight courier. Unless otherwise specified in writing, the
mailing addresses of the Parties shall be as described below: 
  

	 	(a)	If to BDSI, addressed to: 

  
 Raphael J. Mannino, Ph.D. 
 Executive Vice
President and Chief Scientific Officer 
 BioDelivery Sciences International, Inc. 
 185 South Orange Avenue, Administrative Building No. 4 
 Newark, NJ 07103 
  

	 	(b)	If to ACCENTIA, addressed to: 

  
 Martin G. Baum 
 President 
 Accentia, Inc. 
 5310 Cypress Center Drive
#101 
 Tampa, Florida 33609 
  

 15 

 10.8 Amendment. No amendment, modification or supplement of any provision of this Agreement shall be valid or
effective unless made in writing and signed by a duly authorized officer of each Party. This Agreement may be executed in a series of counterparts, all of which, when taken together, shall constitute one and the same instrument. 
  
 10.9 Waiver. No provision of this Agreement shall be waived by any act, omission or
knowledge of a Party or its agents or employees except by an instrument in writing expressly waiving such provision and signed by the waiving Party. 
  
 10.10 Dispute Resolution. 
  
 (a) Senior Officials. The Parties recognize that a bona fide dispute as to certain matters may from time to time arise during the term of this
Agreement which relates to either Party’s rights and/or obligations hereunder. in the event of the occurrence of such a dispute, either Party may, by notice to the other Party, have such dispute referred to their respective senior officials
designated below or their successors, for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. Said designated senior officials are as follows: 
  

					
	 For ACCENTIA:
	  	Martin G. Baum, President	  	 
	 For BDSI:
	  	Raphael J. Mannino, Ph.D., EVP & CSO	  	 

  
 In the event the designated senior
officials are not able to resolve such dispute within the thirty (30) day period, either Party may invoke the provisions of Section 10.10(b). 
  
 (b) Arbitration. In the event of any dispute, difference or question arising between the Parties in connection with this Agreement, the
construction thereof, or the rights, duties or liabilities of either Party, and which dispute cannot be amicably resolved by the good faith efforts of both Parties, then such dispute shall be resolved by binding arbitration in accordance with the
Commercial Arbitration Rules of the American Arbitration Association. The arbitration panel shall be composed of three arbitrators, one of whom shall be chosen by BDSI, one by ACCENTIA, and the third by the two so chosen. If both or either of
ACCENTIA or BDSI fails to choose an arbitrator or arbitrators within fourteen (14) days after receiving notice of commencement of arbitration or if the two arbitrators fail to choose a third arbitrator within fourteen (14) days after their
appointment, the then President of the American Arbitration Association shall, upon the request of both or either of the Parties to the arbitration, appoint the arbitrator or arbitrators required to complete the board or, if he shall decline or fail
to do so, such arbitrator or arbitrators shall be appointed by the New York office of the American Arbitration Association. The decision of the arbitrators shall be by majority vote and, at the request of either Party, the arbitrators shall issue a
written opinion of findings of fact and conclusions of law. Costs shall be borne as determined by the arbitrators. Unless the Parties to the arbitration shall otherwise agree to a place of arbitration, the place of arbitration shall be at New York,
New York, U.S.A. The arbitration award shall be final and binding upon the Parties to such arbitration and may be entered in any court having jurisdiction. 
  
 10.11 Governing Law. This Agreement shall be governed by and interpreted in accordance with the laws of the State of Delaware. 
  

 16 

 10.12 Severabilitv. Whenever possible, each provision of this Agreement will be interpreted in such manner as to
be effective and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such provision will be ineffective only to the extent of such prohibition or invalidity, without
invalidating the remainder of this Agreement. 
  
 10.13 Entire Agreement of the
Parties. This Agreement constitutes and contains the entire understanding and agreement of the Parties and cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between the
Parties respecting the subject matter hereof. 
  
 [NEXT PAGE IS
THE SIGNATURE PAGE] 
  

 17 

 IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed by its duly authorized
officer as of the day and year first above written. 
  

					
	 BIODELIVERY SCIENCES
 INTERNATIONAL, INC.

		
	By:	 	 /s/ Raphael J. Mannino

	 	 	 Name:
	 	 Raphael J. Mannino. Ph.D.

	 	 	 Title:
	 	Executive Vice President and Chief Scientific Officer

  

					
	ACCENTIA, INC.
		
	By:	 	 /s/ Martin G. Baum

	 	 	 Name:
	 	 Martin G. Baum

	 	 	 Title:
	 	 President

  

  
 EXHIBIT A 

 
 REGULATORY TIMELINES 
  

					
		
	 Meeting with the FDA
	  	Within three (3) months of the Effective Date
		
	 File IND
	  	Within six (6) months of the Effective Date1
		
	 Should FDA require Phase I or II studies
	  	 
			
	 	 	 Start Phase I
	  	Within six (6) months of approval of IND by FDA
			
	 	 	 Start Phase II
	  	Within six (6) months of clearance from FDA to proceed
			
	 	 	 Start Phase III
	  	Within six (6) months of clearance from FDA to proceed
			
	 	 	 File NDA
	  	Within 12 months of completing registration Phase III study, subject to Section 7.03(c) hereto
		
	Should FDA permit moving directly to Phase III studies	  	 
			
	 	 	 Start Phase III
	  	Within 6 months of approval of IND by FDA
			
	 	 	 File NDA
	  	Within 12 months of completing registration phase III study, subject to Section 7.03(c) hereto.

	1	The IND may be filled up to nine (9) months from the effective Date in the event that: (a) the FDA has agreed to initiate clinical trail under the IND with a Phase
III protocol, and (b) the FDA consequently requires chronic toxicology data to support the original IND. 

  

  
 EXHIBIT B 

 
 LICENSED PATENTS 
  

					
	 Docket No./Title/
Country

	  	Appln No./Patent No.

		
	 BSZ-005: Liposome Methods and Composition
	  	 
			
	 	 	US	  	4,663,161
		
	 BSZ-005DV: Reconstituting Viral Glycoproteins Into Large Phospholipid Vesicles
	  	 
			
	 	 	US	  	4,871,488
		
	 BSZ-006: Protein-or Peptide-Cochleate Vaccines and Methods of Immunizing Using the Same
	  	 
		
	 BSZ-006CP: Stabilizing Delivery Means of Biological Molecules
	  	 

  

			
	 US
	  	5,643,574
	 Int’I (PC)
	  	US94/10913
	 Canada
	  	2,169,297
	 Australia
	  	689505
	 Europe (incl.)
	  	0 722 338
	 Great Britain
	  	94930484.4
	 Sweden
	  	0 722 338
	 Austria
	  	0 722 338
	 Switzerland
	  	E 20 3413
	 Ireland
	  	0 722 338
	 Italy
	  	0 722 338
	 France
	  	0 722 338
	 Germany
	  	0 722 338
	 US (CN)
	  	08/629,923
	 US (CP)
	  	5,840,707
	 Int’I (CP2PC)
	  	US96/01704
	 Australia (CP2AUl)
	  	49748/96
	 Australia (CP2AU2)
	  	32599/00
	 Australia (CP2AU3)
	  	2002300615
	 Canada (CP2CA)
	  	2,212,238
	 Europe (CP2EP)
	  	96906334.6
	 Japan (CP2JP)
	  	8-525713
	 US (CP3)
	  	5,994,318
	 Int’I (CP3PC)
	  	US97/02632
	 Canada (CP3CA)
	  	2,246,754

  

			
	 Docket No./Title/
 Country

	  	 Appln No./ Patent No.

  

			
	BSZ-007: Protein-Lipid Vesicles And Autogenous Vaccine Comprising The Same	  	 

  

			
	 US
	  	5,834,015
	 US (CP)
	  	6,165,502
	 Int’l (PC)
	  	US97/08422
	 Australia
	  	722647
	 Canada
	  	2,264,646
	 Europe
	  	97940721.0
	 Japan
	  	10-513692

  

			
	BSZ-009: Nanocochleate Formulations, Process Of Preparation And Method Of Delivery of Pharmaceutical Agents

  

			
	 US
	  	6,153,217
	 Int’l (PC)
	  	US00/01684
	 Australia
	  	3213/00
	 Canada
	  	2,358,505
	 Europe
	  	00 909 961.5
	 Japan
	  	2000-594446
	 US (CP)
	  	09/613,840
	 US (CPCN)
	  	10/421,358
	 Int’l (CPPC)
	  	US01/02299
	 Australia (CPAU)
	  	31114/01
	 Canada (CPCA)
	  	2,397,792
	 Europe (CPEP)
	  	01 903 273.9
	 Japan (CPJP)
	  	2001-552865

  

			
	BSZ-010: Cochleates From Purified Soy Phosphatidylserine	  	 

  

			
	 US
	  	10/105,314
	 US (CN)
	  	10/304,567
	 Int’l (PC)
	  	PCT/US03/09562

  

			
	BSZ-014: Geodate Delivery Vehicles	  	 

  

			
	 US (PR)
	  	60/422,989
	 US (PR)
	  	60/440,284
	 US
	  	10/701,364
	 PCT
	  	PCT/US03/35136

  

			
	BSZ-016: Rigid Liposomal Compositions	  	 

  

			
	 US (PR)
	  	60/531,546

  

			
	 Docket No./Title/
 Country

	  	Appln No./ Patent No.

	BSZ-017: Cochleate Preparations of Fragile Nutrients
		
	 US (PR)
	  	60/440,120
	 US (PR)
	  	60/465,754
	 US
	  	10/759,381
	 PCT
	  	PCT/US04/01236
		
	BSZ-018: Antisense Cochleates	  	 
		
	 US (PR)
	  	60/461,483
	 US (PR)
	  	60/463,076
	
	BSZ-020: Cochleates Including Aggregation Inhibitors
		
	 US (PR)
	  	60/502,557
	 US(PR)
	  	60/537,252
	
	BSZ-023: Novel Encochleation Methods, Cochleates and Methods of Use
		
	 US (PR)
	  	60/499,247
	 US(PR)
	  	60/532,755
	
	BSZ-038: Replacement Enzyme Cochleates
		
	 US (PR)
	  	60/541,707
	
	BSZ-039 Apoprotein Cochleate Compositions
		
	 US (PR)
	  	60/540,269

  

  
 EXHIBIT C 

 
 BDSI LICENSED TECHNOLOGY 
  

	I.	COCHLEATE TECHNOLOGY 

  
 Origin of cochleates 
  
 Over the years,
biochemists and biophysicists have studied artificial membrane systems to understand their properties and potential applications. In studying this topic, Demetrios Papahadjopoulos and coworkers began investigating the interactions of divalent
cations with negatively charged lipid bilayers. They reported that the addition of calcium ions to small phosphatidylserine vesicles induced their collapse into discs which fused into large sheets of lipid. In order to minimize their interaction
with water, these lipid sheets rolled up into jellyroll-like structures, termed “cochleate” cylinders, after the Greek name for a snail with spiral shell. 
  
 The Cochleate Advantage 
  
 Cochleate delivery vehicles represent a new technology platform for oral, mucosal and systemic delivery of clinically important drugs that possess poor bioavailability.
For example, oral cochleates have been successfully used in animal models for the delivery of drugs that previously were only available given by injection. 
  
 High stability: Cochleate delivery vehicles are stable phospholipids-divalent cation precipitates composed of simple, naturally occurring materials, for example,
phosphatidylserine and calcium. They have a unique multilayered structure consisting of a large, continuous, solid, lipid bilayer sheet rolled up in a spiral, with no internal aqueous space. Cochleates can be stored in a cation-containing buffer, or
lyophilized to a powder and stored at room temperature. Lyophilized cochleates can be placed in capsules and given orally, or reconstituted with liquid prior to in vitro use or in vivo administration. Lyophilization has no adverse
effects on cochleate morphology or functions. Cochleate preparations have been shown to be stable for more than two years at 4°C in a cation-containing buffer, and at least one year as a lyophilized powder at room temperature. Encochleation imparts increased stability to drugs, proteins and polynucleotides. 
  
 Encapsulation: Cochleate delivery vehicles “wrap-up” or encapsulate the
drug, rather than chemically bond with the included drug. 
  
 Target delivery:
Cochleates carry the encapsulated drug within the interior of the formulation and delivery the drug to the target cell. This results in low blood levels of free drug and high efficiency delivery to the target cell. Once at the target cell,
cochleates can be envisioned as membrane fusion intermediates. When a cochleate comes into close approximation to a target membrane, a fusion event between the outer layer of the cochleate and the cell membrane occurs. This fusion results in the
delivery of a small amount of the encochleated material into the cytoplasm of the target cell. The cochleate may slowly fuse or break free of the cell and be available for another fusion event, either with this or another cell. Cochleates may also
be taken up by endocytosis, and fuse from within endocytic vesicles. 
  
 Resistance to environmental attack: The unique structure of the cochleate provides protection from degradation for associated “encochleated” molecules. Traditionally, many drugs can be damaged from exposure to adverse
environmental conditions such as sunlight, oxygen, water and temperature. Since the entire cochleate structure is a series of solid layers, components within the interior of the cochleate structure remain intact, even though the outer layers of the
cochleate may be exposed to harsh environmental conditions or enzymes. 
  
 Oral
availability: The drug delivery technology is being developed to enable oral availability of a broad spectrum of compounds, such as those with poor water solubility, as well as polynucleotides, and protein and peptide biopharmaceuticals, which
have been difficult to formulate and administer. 
  

 Release characteristics: The cochleate technology offers the potential to be tailored to control the release of
the drug depending on the desired application. 
  
 Formulation of Cochleates

  
 BDSI scientists have investigated various aspects of the manufacturing
process, including pH, agitation method and rate, type of cation, ratio of lipid to material, and other parameters, in order to optimize the formulation and manufacturing process for a given material. In one typical manufacturing process, the
materials to be formulated (chemical drugs, proteins, peptides, DNA, antigens, nutrients) are added to a suspension of liposomes comprised mainly of negatively charged lipids. The addition of divalent metal ions such as calcium, (although other
multivalent cations can be used) induces the collapse and fusion of the liposomes into large sheets composed of lipid bilayers, which spontaneously roll up or stack into cochleates. If desired, the cochleates can be purified to remove unencochleated
material, and then resuspended in a buffer containing divalent metal ions. 
  
 Various processes have been developed by BDSI scientists to prepare cochleate formulations of a wide variety of drugs, peptides and proteins, with molecular weights ranging from 1 to greater than 200KD, and oligonucleotides or DNA of 20 to
greater than 10,000 base pairs. The percentage of encochleation of material ranges from 40-95%, depending on the material and the manufacturing conditions. 
  
 Biocompatibiliry of Cochleate Vehicles 
  
 The fundamental components of the cochleate delivery vehicle are phosphatidylserine (PS) and calcium. Phosphatidylserine is a natural component of all biologic membranes,
and is most concentrated in the brain. Clinical studies by other investigators, (more than 30 have been published), to evaluate the potential of phosphatidylserine as a nutrient supplement indicate that PS is very safe and may play a role in the
support of mental functions in the aging brain. Indeed, phosphatidylserine isolated from soy beans is sold in health food stores as a nutritional supplement. 
  
 In mice, BDSI has evaluated the in vivo safety of multiple administrations of cochleates by various routes, including intravenous, intraperitoneal, intranasal and
oral. Multiple administrations of cochleate formulations to the same animal do not result in either the development of an immune response to the cochleate matrix, or to any side effects relating to the cochleate vehicle. 
  
 Mechanism of Delivery 
  
 The interaction of calcium with negatively charged lipids has been extensively studied. Many naturally occurring membrane fusion events
involve the interaction of calcium with negatively charged phospholipids (generally phosphatidylserine and phosphatidylglycerol). Calcium induced perturbations of membranes containing negatively charged lipids, and the subsequent membrane fusion
events, are important mechanisms in many natural membrane fusion processes. Hence, cochleates can be envisioned as membrane fusion intermediates. 
  
 During the past several years substantial research by BDSI scientists has demonstrated that cochleate formulations are simple, safe and highly efficacious mediators of
the in vivo delivery of proteins, peptides and polynucleotides for the induction of antigen specific immune responses following oral, intranasal and intramuscular administration. Significantly, the ability of cochleates to mediate the
induction of antigen specific, CD8+ cytotoxic lymphocytes, as well as the efficient induction of immune responses to plasmid encoded antigens, supports the hypothesis that cochleates facilitate the cytoplasmic delivery of cochleate associated
bioactive molecules. 
  
 The observations indicate that, as the calcium rich,
highly ordered membrane of a cochleate first comes into close approximation to a natural membrane, a perturbation and reordering of the cell membrane is induced. This results 

  

 
in a fusion event between the outer layer of the cochleate and the cell membrane. This fusion also results in the delivery of a small amount of the
encochleated material into the cytoplasm of the target cell. The cochleate may slowly fuse or break free of the cell and be available for another fusion event, either with this or another cell. Cochleates may also be taken up by endocytosis, and
fuse from within endocytic vesicles. 
  
 Uptake of Cochleates by Macrophage

  
 An important observation relative to the interaction of cochleates with
cells is their uptake by macrophage. For example, in vivo, fluorescent cochleates are accumulated by macrophage. Macrophages are on the first line of defense against microbial infections. Many human pathogens cause diseases because they have
developed the capacity to survive within macrophage. Examples include viruses such as HIV, bacteria such as staphylococcus and Mycobacterium tuberculosis, fungi such as Candida and parasites such as Leishmania. 
  
 Cochleate Mediated Oral Delivery of Drugs 
  
 Cochleate formulation technology is particularly applicable to macromolecules as well as
small molecule drugs that are hydrophobic, positively, or negatively charged, and possess poor oral bioavailability. Proof-of-principle studies for cochleate mediated oral delivery of macromolecules as well as small molecule drugs is being carried
out in appropriate animal models with a well established, clinically important drug which currently can only be effectively delivered by injection, amphotericin B, a potent antifungal agent. 
  
 II. PROTEOLIPOSOME TECHNOLOGY 
  
 Proteoliposome Technology (PLT), relates to novel liposome compositions and methods for
their preparation. Utilization of PLT provides an efficient reconstitution of membrane proteins into large (0.1 to 2 micron diameter) phospholipid vesicles with a large, internal aqueous space. The method has been exemplified with the use of
glycoproteins of influenza (A/PR8/34) and Sendai (parainfluenza type I) viruses. The method comprises (A) extracting out the desired membrane protein from a source biological material with an extraction buffer comprising a detergent; (B) mixing the
extract with a phospholipid solution and deriving a cochleate intermediate; and (C) forming large phospholipid vesicles with integrated membrane protein in a biologically active state. 
  
 PLT has been used to produce liposome structures with improved delivery capabilities for drug delivery and gene therapy as well as enhanced
immune responses. In addition, BDSI PLT can be used to formulate and stabilize biologically important but structurally fragile hydrophobic proteins. 
  
 The PLT is protected by US Patent Nos. 4,663,161 and 4,871,488. 
  
 III. GEODATE TECHNOLOGY 
  
 Geodate technology generally relates to a novel delivery vehicle that encapsulates agents in a stable emulsion, slurry, or powder. Geodate technology is particularly attractive for use with hydrophobic agents, as it
can incorporate them at a high yield. It also is particularly attractive for delivery of fragile or unstable agents as the “geodes” remain intact and protect the fragile core molecules, such as beta-carotene, under environmental conditions
that normally will result in destruction or inactivation of the molecules. 
  
 It
has been discovered by BDSI scientists that a monolayer of lipid can form about a hydrophobic core, and that this monolayer can further be encrusted in a lipid/cation matrix, further protecting the hydrophobic core. The resulting “geode”
is highly stable and protects of the core from degradation or inactivation, even at elevated pressures and temperatures, such as those encountered in food processing technology. 
  

 

 
  
 March 28, 2005 
  
 BioDelivery Sciences International, Inc. 
 2501 Aerial Center Parkway, Suite 205 
 Morrisville, North Carolina 27560

  
 Gentlemen: 
  
 Reference is made to that certain License Agreement, dated effective as of April 12, 2004, as amended (the “License
Agreement”), by and between BioDelivery Sciences International, Inc. (“BDSI”) and Accentia Biopharmaceuticals, Inc. f/k/a Accentia, Inc. (“Accentia”). All capitalized terms used but not defined herein shall have the meanings
ascribed to such terms in the License Agreement. 
  
 Pursuant to
Section 10.8 of the License Agreement, BDSI and Accentia desire to, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and hereby do, amend the License Agreement as follows: 
  
 1. Section 1.2 of the License Agreement is deleted in its entirety and
replaced with the following: 
  
 “1.2 “Antifungal
Products” shall mean any and all products (but specifically excluding any product to treat asthma) covered by the patent rights licensed to ACCENTIA by MAYO under the ACCENTIA/MAYO Agreement that are not Licensed Products.” 
  
 2. In order to clarify the effects of the June 4, 2004 amendment to License
Agreement and the September 8, 2004 Asset Purchase Agreement between BDSI and Accentia, BDSI and Accentia hereby amend the License Agreement to delete Sections 4.2(a) and 4.2(b) in their entirety and replace such Sections with a new Section 4.2(a),
as follows: 
  
 “(a) BDSI shall be entitled to the following
royalty payments: 
  
 (i) In lieu of any up front
fees and milestone payments, and as an inducement to BDSI to enter into this Agreement, ACCENTIA shall pay to BDSI a 6% royalty on Net Sales in the Territory (i.e., anywhere in the world) of any Antifungal Products which have not received marketing
approval by the U.S. Food and Drug Administration (such approval, “FDA Approval”), it being agreed that, with respect to any of such Antifungal Products individually, the obligation of Accentia to make such royalty payments shall
automatically terminate with respect to sales made on or after, but not prior to, the date that the license to ACCENTIA under Section 3.01(b) the ACCENTIA/MAYO Agreement is terminated by function of the ACCENTIA/MAYO Agreement; 
  
 (ii) A 7% royalty on Net Sales in the Territory (i.e.,
anywhere in the world) of any Licensed Products for the treatment of chronic sinusitis which have received FDA Approval for such indication; 
  
 (iii) A 14% royalty on Net Sales in the Territory (i.e., anywhere in the world) of any Licensed Products for the treatment of asthma which
have received FDA Approval for such indication; 
  

 5310 Cypress Center Drive, Suite 101, Tampa, FL 33609 
 PH: (813) 864-2562 FAX: (813) 288-8757 

 

 
  
 (iv) For the
avoidance of doubt, no royalty on any sales of any products for the treatment of asthma that are not Licensed Products; and 
  
 (v) For the avoidance of doubt, no royalty on any sales of products for the treatment of chronic sinusitis that: (i) have received FDA
Approval and (ii) are not Licensed Products.” 
  
 2. The
parties agree that the terms “chronic rhinosinusitis” as used in the ACCENTIA/MAYO Agreement and the term “chronic sinusitis” as used in the License Agreement shall be interpreted to mean the same indication. 
  
 3. Except as modified hereby, the License Agreement shall remain unmodified,
unchanged and in full force and effect. Upon execution of this letter agreement by both BDSI and Accentia, this letter agreement shall become a binding amendment to the License Agreement. 
  

			
	 Sincerely,

	
	 ACCENTIA BIOPHARMACEUTICALS, INC.

		
	By:	 	 /s/ Martin Baum

	 	 	Martin Baum, President and Chief Operating Officer of Commercial Operations and Business Development

  
 Accepted and Agreed to:

  

			
	BIODELIVERY SCIENCES INTERNATIONAL, INC.
		
	By:	 	 /s/ Raphael Mannino

	 	 	 Raphael Mannino, EVP and CSO

  

 5310 Cypress Center Drive, Suite 101, Tampa, FL 33609 
 PH: (813) 864-2562 FAX: (813) 288-8757

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