QuickLinks
 -- Click here to rapidly navigate through this document
  



 
 

Exhibit 10.10    
    



	 	 	***Text Omitted and Filed Separately

Confidential Treatment Requested Under

17 C.F.R. §§200.80(b)(4) and 230.406




BIOSYN—FAVRILLE  


SUPPLY AGREEMENT  


        THIS AGREEMENT is made on: November 12, 2004 (the "Effective Date") 


BETWEEN:  


        1.     FAVRILLE, Inc.,
a Delaware corporation, having offices at 10421 Pacific Center Court, San Diego, California, 92121 (along with its Affiliates, "FAVRILLE"); and 


        2.     Biosyn
Arzneimittel GmbH, a company incorporated in Germany, whose registered office is at Schorndorfer Strasse 32, D-70734 Fellbach, Germany (along with its
Affiliates, "BIOSYN" and, collectively with FAVRILLE, the "PARTIES"). 


WHEREAS:  


        A.    BIOSYN
is a pharmaceutical company engaged in the marketing and development of pharmaceuticals, including pharmaceuticals for treating and preventing a number of diseases
and conditions. BIOSYN is also engaged in the manufacturing of keyhole limpet hemocyanin ("KLH" as defined further below). 


        B.    BIOSYN
has agreed to manufacture and sell KLH to FAVRILLE and FAVRILLE has agreed to purchase KLH from BIOSYN subject to the terms below. 



        C.    BIOSYN
has a Drug Master File (DMF) filed with the FDA for KLH. 


        THIS
AGREEMENT WITNESSES as follows: 


        1.     INTERPRETATION.



        1.1.  In
this Agreement 


        "Affiliate"
means any corporation, association or other entity, which directly or indirectly controls, is controlled by or is under common control with a party. As used in this
definition, the term control shall mean direct or indirect beneficial ownership of more than 50% of the voting or equity interest in such corporation or other business entity. 


        "biosyn
KLH" means the form of KLH manufactured by BIOSYN corresponding to and having the specifications detailed on the Data Sheet attached hereto as Schedule 1 and incorporated
by reference herein; 


        "Certificate
of Analysis" shall have the meaning set forth in clause 2.3; 



1







 

        "Confidential
Information" means all materials, know-how, trade secrets or other information, including, without limitation, proprietary information and materials (whether or
not patentable) regarding a Party's technology, Vaccines or business, which is designated as confidential in writing by such Party, whether by letter or by the use of an appropriate stamp or legend,
prior to or at the time any such information is disclosed by such Party to the other Party. Notwithstanding the foregoing, information that is orally, electronically or visually disclosed by a Party,
or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information of the disclosing Party if the disclosing Party, within 30 days after such
disclosure, delivers to the other Party a written communication describing the information and referencing the place and date of such oral, visual, electronic or written disclosure and the names of
the persons to whom such disclosure was made. Notwithstanding the foregoing, Confidential Information of a disclosing Party shall not include information which the receiving Party can demonstrate by
competent written proof: (i) is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available; (ii) is known by the
receiving Party at the time of receiving such information, as evidenced by its written records; (iii) is hereafter furnished to the receiving Party by a Third Party, as a matter of right and
without restriction on disclosure; or (iv) is independently developed by the receiving Party without the use of or reference to the disclosing Party's Confidential Information; 



        "DMF"
means the Drug Master File for biosyn KLH a copy of which has been filed with the FDA; 


        "FAVRILLE
Requirement" shall have the meaning set forth in Section 2.1.3 below. 


        "FDA"
means the United States Food and Drug Administration; 


        "FD&C
Act" means the United States Food, Drug and Cosmetic Act, as amended, and any regulations and guidelines promulgated thereunder; 


        "Free
Carrier" bears the meaning set out in Incoterms 2000, a copy of the relevant section of which is included as Schedule 3 hereto; 



        "GMP"
means current Good Manufacturing Practices promulgated by the Division of Manufacturing and Product Quality of the FDA; 


        "IND"
means an Investigational New Drug Application (as more fully defined in 21 C.F.R. 312) and all amendments and supplements thereto filed with the FDA; 


        "KLH"
means Keyhole Limpet Hemocyanin, a protein from the giant limpet Megathura crenulata; 


        "Materials"
means, collectively, all raw materials, ingredients and packaging components required to produce biosyn KLH in accordance with the Specifications; 



        "NDA"
means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq.) or Biologics Licensing Application (as more fully
defined in 21 C.F.R. 601) and all amendments and supplements to any of the foregoing filed with the FDA; 


        "Regulatory
Approval" means approval by the FDA of any applicable filing and satisfaction of any related applicable FDA registration and notification requirements, if any, required to
market and sell a Vaccine in the U.S.; 


        "Specifications"
means the characteristics, processing, formulae, labeling and packaging requirements and standards pertaining to the manufacture or supply of biosyn KLH that are set
forth in Data Sheet attached as Schedule 1 hereto, as it may be amended or supplemented from time to time pursuant to clause 2.5; 



2







 

        "Term"
means the first [...***...] months of this Agreement running from the Effective Date for a period of  [...***...]. Thereafter, the Agreement will
automatically extend for successive additional twelve (12) month periods
unless, by written notice given at least thirty (30) days prior to the expiration of any such period, either party elects to cause the Agreement to terminate at the end of the then current
period; 


        "Technology"
means intellectual property rights and technology necessary for the manufacture, use or sale of Vaccines; 



        "Third
Party" means any entity other than FAVRILLE or BIOSYN; 


        "Vaccine"
means KLH and any active immuno-therapy or other KLH-conjugate therapy developed by FAVRILLE; 


        "Year"
means calendar year, first month being January and the last month being December. 


        1.2.  In
this Agreement, a reference to: 



        1.2.1. a
document in the "agreed form" is a reference to a document in a form approved and for the purposes of identification signed by or on behalf of the Parties; 



        1.2.2. persons
includes a reference to any body corporate, unincorporated association or partnership; 


        1.2.3. a
person includes a reference to that person's legal personal representatives, successors and permitted assigns; 


        1.2.4. a
Clause or Schedule, unless the context otherwise requires, is a reference to a clause or schedule of this Agreement; 


        1.2.5. an
agreement or other document is a reference to that agreement or documents as from time to time supplemented or amended. 




        1.3.  The
headings in this Agreement shall not affect the interpretation of this Agreement. 




        2.     OBLIGATIONS OF BIOSYN.



        2.1.  BIOSYN
shall: 



        2.1.1. fulfill
all orders made by FAVRILLE for biosyn KLH during the Term. Orders by FAVRILLE shall be fulfilled promptly, and in any event on or prior to the delivery date
specified in the applicable purchase order (in substantially the form set out in Schedule 2); 


        2.1.2. maintain
sufficient manufacturing and supply capacity so as to enable it to comply with this clause 2; 


        2.1.3. provide
a [...***...] of biosyn KLH to FAVRILLE ("FAVRILLE Requirement") and such additional
quantities as FAVRILLE may, in its discretion, request pursuant to purchase orders submitted to BIOSYN hereunder during the Term; 




*CONFIDENTIAL TREATMENT REQUESTED*


3







 


        2.1.4. provide
the FAVRILLE Requirement as [...***...] with  [...***...] of biosyn KLH in approximately [...***...]
total volume and [...***...] with [...***...] of biosyn
KLH in approximately [...***...]. The first [...***...]
with [...***...] shall be delivered to FAVRILLE within  [...***...] of the Effective Date. The remaining  [...***...] with [...***...] shall be delivered to
FAVRILLE in [...***...]. The first [...***...] with  [...***...] shall be delivered to FAVRILLE on or before
 [...***...] and the second shipment [...***...] with
[...***...] shall be delivered to FAVRILLE on or before  [...***...]. The Parties agree that the Certificate of Analysis and referenced shelf life for the
FAVRILLE Requirement will be
that of a [...***...]; provided, however, that all  [...***...] will be marked [...***...], that all vials
supplied will have a minimum of [...***...] shelf life, and that there will be a letter amendment to Certificate of Analysis of
the form attached hereto as Exhibit A. All other aspects of the biosyn KLH, including, but not limited to the closure, will be that of a  [...***...]. 



        2.1.5. ensure
that all biosyn KLH supplied to FAVRILLE is acquired and manufactured in accordance with GMP, applicable Regulatory Approval(s) and all other applicable
requirements of the FDA and other governmental agencies and complies in all respects (including with regard to its manufacture) with the Specifications and the DMF. 


        2.1.6. provide
FAVRILLE reasonable access two days per year to the DMF at the facilities of BIOSYN in Fellbach, Germany; provided, however, that BIOSYN shall provide
FAVRILLE additional access to the DMF if FAVRILLE reasonably believes that is necessary to confirm that the DMF is consistent with the Specifications for biosyn KLH. This access shall be limited to
those sections of the DMF relating to the characterization and analytical processing necessary to confirm that DMF is consistent with the Specifications for biosyn KLH to be supplied to FAVRILLE. In
addition, BIOSYN will provide FAVRILLE any updates, correspondence from the FDA relating to those sections of the DMF and any other correspondence relating to GMP compliance. 




        2.2.  BIOSYN
may: 



        2.2.1. in
its discretion, perform its obligations under this Agreement, in whole or in part, through biosyn Corporation, having an office at 5939 Darwin Courts, Suite 114,
Carlsbad, CA 92008 a California corporation; provided, however, that BIOSYN shall remain fully responsible for the performance of BIOSYN Corporation and
that Corporation will be subject to the terms and conditions of this Agreement to the same extent as BIOSYN. 




        2.3.  BIOSYN
shall perform such quality control and quality assurance testing prior to shipment of biosyn KLH to FAVRILLE as is reasonably required to ensure that the biosyn
KLH delivered to FAVRILLE hereunder comply with the Specifications, GMP, applicable Regulatory Approval(s) and all other applicable laws, rules and regulations governing the manufacture, packaging,
labeling, use or sale of biosyn KLH, including, without limitation, the FD&C Act. With each shipment of biosyn KLH to FAVRILLE hereunder, BIOSYN shall provide FAVRILLE with a written certificate of
analysis (i) confirming that BIOSYN has performed such tests on each batch of biosyn KLH in such shipment as required by the Specifications or applicable law; (ii) containing the quality
control and quality assurance test results for each batch shipped; and (iii) confirming that such biosyn KLH conforms to the Specifications (each, a "Certificate of Analysis"). 


        2.4.  BIOSYN
shall be responsible for obtaining, at its own expense, sufficient quantities of Materials necessary for the manufacture of FAVRILLE's requirements of biosyn
KLH. The Materials used to manufacture biosyn KLH hereunder will conform to the applicable Specifications, and BIOSYN shall verify such conformity in accordance with the testing standards and
procedures specified herein. 



*CONFIDENTIAL TREATMENT REQUESTED*


4







 

        2.5.  BIOSYN
shall not make any changes to the Specifications without the prior written consent of FAVRILLE. In addition, BIOSYN shall obtain FAVRILLE's prior written consent
before it implements any change in the manufacturing site or the Materials, equipment, process or procedures used to manufacture biosyn KLH that would constitute a major change under GMP. 


        2.6.  BIOSYN
shall complete a GMP stability study to confirm [...***...] stability of the  [...***...] biosyn KLH, within [...***...]
 of the
Effective Date. 


        2.7.  BIOSYN
shall make arrangements for, and shall implement, the imprinting of lot numbers and expiration dates for all biosyn KLH shipped hereunder. Such lot numbers and
expiration dates shall be affixed with labels on the vials containing biosyn KLH and on the shipping carton for such vials as required by GMP and applicable Regulatory Approval(s) with content and
format to be agreed upon by the Parties, similar to that on Schedule 4. 


        2.8.  BIOSYN
shall keep complete, accurate, and authentic accounts, notes, data, and records pertaining to its manufacture, processing, testing, packaging, labeling, storage,
and distribution of biosyn KLH hereunder, including, without limitation, master production and control records and complaint files, in accordance with applicable laws and regulations. In addition,
BIOSYN shall retain such records and samples of biosyn KLH manufactured pursuant to this Agreement for a period of five (5) years after FAVRILLE's acceptance of such batch or longer if required
by law. The sample size shall be twice the size necessary to conduct quality control testing. Upon request, BIOSYN shall make available to FAVRILLE copies of such records pertaining to the processing,
testing, packaging, storage, and distribution of biosyn KLH and portions of the samples. After such time period, BIOSYN shall notify FAVRILLE prior to destroying such records and samples and, at
FAVRILLE's request and expense, shall provide such records and samples to FAVRILLE. 


        2.9.  BIOSYN
shall promptly advise FAVRILLE of any notice or request it receives from a governmental agency or regulatory authority regarding inspection of its facilities
relating to its manufacture of biosyn KLH, and shall permit FAVRILLE or its designated representative to attend such inspection if requested by such governmental agency or regulatory authority;
provided, however, that any such FAVRILLE designated representative shall be bound by the same provisions of confidentiality as FAVRILLE under this Agreement. BIOSYN shall provide to FAVRILLE all
correspondence and reports that it receives from a governmental agency or regulatory authority in connection with the manufacture of biosyn KLH to the extent requested by such government agency or
regulatory authority. In addition, upon written request to BIOSYN, FAVRILLE shall have the right to have its representatives or regulatory authorities visit BIOSYN's manufacturing facilities during
normal business hours to review BIOSYN's manufacturing operations related to the processing, testing, packaging, labeling, storage, and distribution of biosyn KLH, to assess its compliance with GMP
and applicable quality control procedures, and to discuss any related issues with BIOSYN's manufacturing and management personnel. 



        2.10. BIOSYN
shall, at its own expense, obtain and maintain the necessary permits required for its acquisition, manufacture and supply of biosyn KLH in accordance with this
Agreement, including all required facility licenses. 


        2.11. BIOSYN
shall maintain the DMF in accordance with the requirements of the FDA. BIOSYN agrees to use its commercially reasonable efforts to assist FAVRILLE in obtaining
regulatory approval of Vaccines from the FDA. BIOSYN specifically agrees to cooperate with any inspection by the FDA, including, but not limited to, any inspection prior to regulatory approval. 



*CONFIDENTIAL TREATMENT REQUESTED*


5







 

        2.12. BIOSYN
shall not employ, contract with, or retain any person, directly or indirectly, in any capacity associated with or related to the performance of BIOSYN's
obligations under this Agreement who has been debarred or suspended by the FDA under 21 U.S.C. § 335a, and shall not employ, contract with, or retain any person who has been convicted of a
felony under the laws of the United States for conduct relating to the regulation of any drug product under the FD&C Act. 




        3.     OBLIGATIONS OF FAVRILLE.



        3.1.  FAVRILLE
shall procure the FAVRILLE Requirement from BIOSYN and such additional quantities as FAVRILLE may, in its discretion, request pursuant to purchase orders
submitted to BIOSYN hereunder during the Term of this Agreement. 


        3.2.  Following
FDA approval and during the Term, at the beginning of each quarter, more specifically within the first month, FAVRILLE shall place an order for the biosyn
KLH. 


        3.3.  [...***...]


        3.4.  Following
FDA approval and thereafter during the Term, of the KLH purchased by FAVRILLE for the manufacture and sale of Vaccine, not less than  [...***...]. The obligation of FAVRILLE to purchase the FAVRILLE
Requirement  [...***...] from BIOSYN shall be subject to BIOSYN's ability to provide the quantity and quality of KLH required by FAVRILLE.
[...***...] provided, however, FAVRILLE and BIOSYN may discuss alternative terms, including but not but not limited to pricing,  [...***...] the amount of
[...***...]. For the purposes
of this clause 3.4, "[...***...]" shall include but not be limited to,  [...***...]. 


        3.5.  FAVRILLE
shall pay for all freight, duty and associated taxes, including insurance, for the delivery of biosyn KLH to FAVRILLE in accordance with the applicable
purchase order and FAVRILLE's specific shipping instructions. 


        3.6.  FAVRILLE
shall pay all amounts due under this Agreement in accordance with clause 5. 




        4.     ORDERS FOR BIOSYN KLH.



        4.1.  All
orders for biosyn KLH will be placed by FAVRILLE in writing and shall be in substantially the form set out in Schedule 2. 


        4.2.  The
biosyn KLH shall be supplied to FAVRILLE by BIOSYN in accordance with the terms of this Agreement. Within seven (7) days of receipt of any purchase order
from FAVRILLE, BIOSYN shall acknowledge in writing such receipt and acceptance of such order, subject to the terms of clauses 2.1 and 2.2. The biosyn KLH delivered pursuant to this Agreement will be
suitably packaged, marked for shipment and delivered in accordance with FAVRILLE's specifications and preceded or accompanied by a Certificate of Analysis. BIOSYN shall procure insurance, in an amount
sufficient to cover the value of the contents, for all shipments and shall invoice FAVRILLE for the cost of such insurance. 


        4.3.  FAVRILLE
may reject all or any part of any order of biosyn KLH which: 



        4.3.1. has
not been manufactured in accordance with the specifications set out in the DMF filed with the FDA; 


        4.3.2. is
not of GMP quality; or 


        4.3.3. does
not comply with the Specifications, the Certificate of Analysis or any description applied to it and supplied by BIOSYN to FAVRILLE. 




*CONFIDENTIAL TREATMENT REQUESTED*


6







 

        The
notice of rejection shall be given by FAVRILLE within 30 days of actual receipt of the order (including the Certificate of Analysis) by FAVRILLE at the address for delivery
specified in the purchase order provided by FAVRILLE, except that if, after such 30-day period, FAVRILLE discovers that it has a basis for rejection of any biosyn KLH and the nature of
such basis for rejection is such that it could not have been discovered through the exercise of reasonable diligence within 30 days of FAVRILLE's receipt of such biosyn KLH, FAVRILLE may give
notice of rejection within 15 days of discovery of such latent defect. Within 15 days of receipt of any notice of rejection, BIOSYN will supply replacement biosyn KLH to FAVRILLE at no
additional cost. Within 15 days of receiving any notice of rejection, BIOSYN will respond to FAVRILLE stating whether it accepts or disputes the rejection. If BIOSYN disputes the rejection, the
Parties will refer such dispute to a mutually acceptable independent Third Party laboratory. Such independent laboratory shall analyze the applicable biosyn KLH and shall determine whether such biosyn
KLH was properly rejected. The Parties agree that such independent laboratory's determination shall be final and binding upon the Parties. The Party against whom the independent laboratory rules shall
bear the costs of analysis by such independent laboratory, and if such laboratory determines that FAVRILLE's rejection of biosyn KLH was incorrect, FAVRILLE will pay for both the initially rejected
and replacement biosyn KLH. 


        4.4.  All
orders of biosyn KLH shall be supplied and delivered to FAVRILLE by BIOSYN Free Carrier BIOSYN's manufacturing facility, subject to the terms of clause 4.2. 


        4.5.  Title
and risk in respect of biosyn KLH supplied by BIOSYN to FAVRILLE shall pass on completion of delivery in accordance with clause 4.4 above, subject to the
terms of clauses 4.2 and 4.3. 




        5.     MILESTONES, PRICE AND PAYMENTS.



        5.1.  Based
on the completion of the following milestone events, FAVRILLE shall pay to BIOSYN the following milestone payments: 



        5.1.1. Upon
the execution of the Agreement and the grant of the licenses herein, FAVRILLE shall pay to BIOSYN an initial milestone of fifty-thousand dollars ($50,000); 



        5.1.2. Upon
the completion of a GMP, stability study, confirming at least [...***...] stability for
the [...***...] biosyn KLH, FAVRILLE shall pay to BIOSYN a milestone of  [...***...]; 


        5.1.3. Upon
the filing of a NDA by FAVRILLE for its Vaccine with the FDA, FAVRILLE shall pay to BIOSYN a milestone of  [...***...]; 



        5.1.4. Upon
the first commercial sale of the FAVRILLE Vaccine, following marketing approval by the FDA, FAVRILLE shall pay BIOSYN a milestone of  [...***...]. 




        5.2.  The
price to be paid by FAVRILLE to BIOSYN for the FAVRILLE Requirement of biosyn KLH and additional biosyn KLH purchased by FAVRILLE shall be  [...***...] per [...***...]
 and  [...***...] per [...***...]; provided, however, upon
FAVRILLE's request, pursuant to purchase orders submitted to BIOSYN, for greater than [...***...] of biosyn KLH during  [...***...], the price to be paid by
FAVRILLE for biosyn KLH shall be reduced to  [...***...]. 


        5.3.  BIOSYN
shall invoice FAVRILLE for [...***...] of each order, other than the FAVRILLE
Requirement, at the time of receiving such order. Each such invoice shall be payable within [...***...] of receipt by FAVRILLE. 



*CONFIDENTIAL TREATMENT REQUESTED*


7







 

        5.4.  Payment
for any shipment of biosyn KLH accepted by FAVRILLE (net of the amount previously paid pursuant to clause 5.3) and expenses incurred by BIOSYN under
clause 5.2 with respect to such shipment shall be made by FAVRILLE to BIOSYN within [...***...] of the later of
(a) FAVRILLE's receipt of such shipment of biosyn KLH at the address specified in the purchase order provided by FAVRILLE or (b) FAVRILLE's receipt of the applicable invoice for such
shipment. 


        5.5.  FAVRILLE
shall pay BIOSYN for any special requests by FAVRILLE for biosyn KLH characterization, or any other requests for services not expressly provided for in this
Agreement at a price to be negotiated by the Parties. 


        5.6.  All
amounts due and payable under this Agreement shall be made in United States currency. 



        5.7.  If
any undisputed amounts due hereunder are not paid when due, the unpaid balance shall accrue interest at the rate of 1.5% per month until paid in full (not to exceed
the maximum interest rate permissible under applicable law). 




        6.     BIOSYN LICENSE.



        6.1.  In
consideration of the obligations undertaken by FAVRILLE in this Agreement, BIOSYN hereby grants FAVRILLE a non-exclusive license, including the right to
sublicense, under the biosyn KLH Technology, to develop, make, have made, use, sell, have sold, offer for sale and import Vaccines. 



        6.2.  At
the request of FAVRILLE, BIOSYN shall provide to the FDA appropriate letters of access and/or reference (as FAVRILLE in its discretion directs) to the DMF ("Cross
Reference Letter") authorizing FAVRILLE to reference the DMF for the purpose of obtaining and maintaining regulatory approvals for Vaccines. 



        6.2.1. FAVRILLE
will provide the following information to BIOSYN for cross-reference letter issuance: 


        Title
of the IND/NDA; Name and Address of IND/NDA Holder; IND/NDA number. 


        Name
and address of specific FDA reviewer, if available. 




        6.3.  BIOSYN
will deliver to the FDA and copy to FAVRILLE, the Cross Reference Letter, within 4 weeks from the date of request. 




        7.     CONFIDENTIALITY.



        7.1.  During
the Initial Term and for five (5) years after expiration or termination of this Agreement, each party shall hold in strictest confidence, shall not use or
disclose to any Third Party, and shall take all necessary and reasonable precautions to secure any Confidential Information of the disclosing party, whether disclosed to by the disclosing party before
or after execution of this Agreement. Disclosure of such information shall be restricted solely to employees, agents, consultants, and representatives who have been advised of their obligation with
respect to Confidential Information. Each party shall be responsible for any breach of this clause 7.1 by its employees, agents, consultants and representatives. Each party may disclose
Confidential Information of the disclosing party to the extent such disclosure is reasonably necessary in the following instances: (a) in regulatory filings and correspondence in support of an
application for approval to market any Vaccine or maintenance of any such marketing approvals; (b) complying with applicable court orders or governmental regulations; and (c) disclosure
to affiliates, licensees, employees, consultants, agents or other third parties in connection with due diligence or similar investigations by such Third Parties or the development or commercialization
of Vaccines, provided that any such person or entity agrees in writing to be bound by similar terms of confidentiality and non-use at least equivalent in scope to those set forth in this
clause 7.1. Notwithstanding the foregoing, in the event a party is required to make a disclosure of the disclosing party's Confidential Information, it will give reasonable advance notice to
the disclosing party of such disclosure and cooperate with the disclosing party's efforts to secure confidential treatment of such information. 



*CONFIDENTIAL TREATMENT REQUESTED*


8







 

        8.     REPRESENTATIONS AND WARRANTIES



        8.1.  Each
Party represents and warrants to the other Party that: (a) such Party is duly organized, validly existing, and in good standing under the laws of the place
of its establishment or incorporation; (b) such Party has taken all action necessary to authorize it to enter into this Agreement and perform its obligations under this Agreement;
(c) this Agreement will constitute the legal, valid and binding obligation of such Party; and (d) neither the execution of this Agreement nor the performance of such Party's obligations
hereunder will conflict with, result in a breach of, or constitute a default under any provision of the organizational documents of such Party, or of any law, rule, regulation, authorization or
approval of any government entity, or of any agreement to which it is a party or by which it is bound. 


        8.2.  BIOSYN
represents and warrants to FAVRILLE that all biosyn KLH delivered hereunder shall, upon delivery to FAVRILLE: (a) conform to the applicable Specifications
and comply with applicable U.S. laws, rules and regulations, including, without limitation, current GMPs and applicable Regulatory Approval(s); (b) be free and clear of any and all liens and
encumbrances; and (c) neither be adulterated or misbranded within the meaning of the FD&C Act, nor be articles that, under the provisions of Sections 404 and 505 of the FD&C Act, may not be
introduced into interstate commerce. BIOSYN further represents and warrants that: (i) the use of the biosyn KLH by FAVRILLE as contemplated by this Agreement will not infringe on or
misappropriate the intellectual property or other rights of any Third Party; and (ii) BIOSYN has not received any citations with respect to its manufacturing facilities including, without
limitation, FDA Form 483 warning letters, and is not currently subject to an FDA consent decree or other regulatory action impacting the manufacture of the biosyn KLH by BIOSYN under this
Agreement. 




        9.     TERM.


        This
Agreement shall (unless terminated at an earlier date pursuant to clause 10), shall continue in force until the end of the Term. 


        10.   TERMINATION.



        10.1. A
Party may terminate this Agreement under the following circumstances: (a) for material breach of this Agreement by the other Party upon sixty
(60) days' written notice specifying the nature of the breach, if such breach has not been cured within such sixty (60) day period; or (b) upon the institution by or against the
other Party of insolvency, receivership or bankruptcy proceedings or any other proceeding for the settlement of such Party's debts, upon the other Party making an assignment for the benefit of
creditors, or upon the other Party's dissolution or ceasing to do business. 


        10.2. In
the event of termination of this Agreement, BIOSYN agrees that it will not withdraw supplies of biosyn KLH required for the completion of any clinical trial for the
Vaccines conducted by FAVRILLE pending at the time of BIOSYN's notice of termination, so long as FAVRILLE is not in violation of clauses 3 or 5. 



        10.3. Termination
or expiration of this Agreement shall not (a) affect any other rights of either Party which may have accrued up to the date of such termination or
expiration or (b) relieve FAVRILLE of its obligation to pay to BIOSYN sums due in respect of biosyn KLH delivered prior to termination or expiration of this Agreement. Clauses 2, 5 and 6 will
survive termination or expiration of this Agreement solely with respect to biosyn KLH supplied by BIOSYN prior to such termination or expiration, or pursuant to clause 10.2. In addition,
clauses 1, 6, 7, 10.2, 10.3, 11, 13, 14, 15, 16, 17, 18, and 19 will survive termination or expiration of this Agreement. 



9







 





        11.   COSTS.


        Except
as otherwise expressly provided in this Agreement, each Party shall pay its own costs of and incidental to the negotiation, preparation, execution and implementation by it of this
Agreement and of all other documents referred to in it. 


        12.   FURTHER ASSURANCE.


        Each
Party shall at its own cost do and execute or procure to be done and executed all necessary acts, agreements, documents and things reasonably within its power to give effect to this
Agreement. 


        13.   DISCLAIMERS



        13.1. EXCEPT
AS EXPRESSLY SET FORTH IN THIS AGREEMENT, BIOSYN DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES OF ANY KIND RELATING TO biosyn KLH WHETHER EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTIBILITY AND FITNESS FOR A PARTICULAR PURPOSE. 



        13.2. EXCEPT
FOR LIABILITY FOR BREACH OF CLAUSE 2.1.7 or 3.3, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, OR EXEMPLARY
DAMAGES ARISING OUT OF THE PERFORMANCE OR NON-PERFORMANCE OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF PROFITS, LOSS OF BUSINESS, OR BUSINESS INTERRUPTION, EVEN IF
SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; provided, however, that this clause 13.2 shall not be construed to limit either
Party's indemnification obligations under clause 14. 




        14.   INDEMNIFICATION



        14.1. FAVRILLE
agrees to indemnify, hold harmless and defend BIOSYN, its affiliates and their respective directors, officers, employees and agents (the "BIOSYN Indemnitees")
from and against any and all Third Party claims, suits, losses, damages, costs, fees and expenses (collectively, "Claims") resulting from or arising out of (i) the use of biosyn KLH supplied to
FAVRILLE hereunder (except to the extent that such Claim arises out of a manufacturing defect in the biosyn KLH or any breach by BIOSYN of its obligations, warranties, or representations under this
Agreement); (ii) the gross negligence or willful misconduct of FAVRILLE or its officers, directors, employees, or agents; or (iii) FAVRILLE's breach of its obligations, warranties or
representations under this Agreement. Such indemnity shall not apply to the extent that BIOSYN has an indemnity obligation for such Claim pursuant to clause 14.2 or if BIOSYN fails to comply
with the indemnification procedures set forth in clause 14.3. 


        14.2. BIOSYN
agrees to indemnify, hold harmless and defend FAVRILLE, its affiliates and their respective directors, officers, employees and agents (the "FAVRILLE
Indemnitees") from and against any and all Claims resulting from or arising out of (i) the gross negligence or willful misconduct of BIOSYN or its officers, directors, employees, or agents; or
(ii) BIOSYN's breach of its obligations, warranties or representations under this Agreement. Such indemnity shall not apply to the extent that FAVRILLE has an indemnity obligation for such
Claim pursuant to clause 14.2 or if FAVRILLE fails to comply with the indemnification procedures set forth in clause 14.3. 



10







 




        14.3. If
either Party is entitled to indemnification under this clause 14 (the "Indemnified Party"), it shall give written notice to the Party providing
indemnification (the "Indemnifying Party") of any Claim that may be subject to indemnification promptly after learning of such Claim, and the Indemnifying Party shall assume the defense of such Claim
with counsel reasonably satisfactory to the Indemnified Party. If such defense is assumed by the Indemnifying Party with counsel so selected, the Indemnifying Party will not be subject to any
liability for any settlement of such Claim made by the Indemnified Party without the Indemnifying Party's consent (but such consent will not be unreasonably withheld or delayed), and will not be
obligated to pay the fees and expenses of any separate counsel retained by the Indemnified Party with respect to such Claim. 




        15.   GENERAL.



        15.1. This
Agreement constitutes the entire agreement between the Parties relating to the subject matter of this Agreement and supersedes all previous agreements or
understandings, written or oral, with respect to the subject matter hereof. 


        15.2. No
modification of this Agreement shall be valid unless it is in writing and signed by or on behalf of each of the Parties. 


        15.3. The
failure to exercise or delay in exercising a right or remedy under this Agreement shall not constitute a waiver of the right or remedy or a waiver of any other
rights or remedies and no single or partial exercise of any right or remedy or the exercise of any other right or remedy. 


        15.4. Except
as expressly provided in this Agreement the rights and remedies contained in this Agreement are cumulative and not exclusive of any rights or remedies provided
by law. 


        15.5. Any
date, time or period referred to in this Agreement is of the essence except only to the extent of which the Parties agree in writing to vary it in which event the
varied date, time or period is of the essence. 


        15.6. Nothing
in this Agreement be construed as creating a partnership between the Parties or as constituting either Party as the agent of the other Party for any purpose
whatsoever and neither Party shall have the authority or power to bind the other Party or to contract in the name of or create a liability against the other Party in any way or for any purpose. 


        15.7. In
the event any provision of this Agreement is held to be invalid or unenforceable, the valid or enforceable portion thereof and the remaining provisions of this
Agreement will remain in full force and effect. 




        16.   ASSIGNMENT.


        Except
as provided in clause 2.2.1, neither Party shall assign or transfer or purport to assign or transfer any of its rights or obligations under this Agreement except with the
prior written consent of the other Party; provided, however, that either Party may assign this Agreement and its rights and obligations hereunder
without the other Party's consent in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party, whether by merger,
sale of stock, sale of assets or otherwise. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the
Parties. Any assignment not in accordance with this Agreement shall be void. 


11







 



        17.   NOTICES.



        17.1. Any
notice or other communication under or in connection with this Agreement shall be in writing in the English language and shall be delivered personally or sent by
first class post pre-paid recorded delivery and air mail or by telefax, to the Party due to receive the notice or communication at its address set forth below or such other address as
either Party may specify by notice in writing to the other. 



	 	If to BIOSYN:	 	biosyn Arzneimittel GmbH

Schorndorfer Strasse 32

D-70734 Fellbach, Germany

Attention: ________________

Facsimile: ________________	 	 
	 	
 If to FAVRILLE:	
 	

FAVRILLE, Inc.

10421 Pacific Center Court

San Diego, CA 92121

Attention: Tamara A. Seymour

Facsimile: (858) 597-7040	
 	

 





        17.2. In
the absence of evidence of earlier receipt, any notice or other communication shall be deemed to have been duly given: 



        17.2.1. if
delivered personally, when left at the address referred to in clause 16.1; 


        17.2.2. if
sent by mail other than air mail, six (6) days after posting it; 



        17.2.3. if
sent by air mail, six (6) days after posting it; and 


        17.2.4. if
sent by telefax, when clearly received in full. 





        18.   GOVERNING LAW AND JURISDICTION.



        18.1. This
Agreement is governed by, and shall be construed in accordance with the laws of the State of California, U.S.A., excluding its conflicts of laws principles. 



        18.2. Each
Party irrevocably waives any objection which it might at any time have to the state and federal courts located in the State of California, U.S.A. being nominated
as the forum to hear and determine any proceedings and to settle any disputes and agrees not to claim that such courts are not a convenient or appropriate forum. 


        18.3. Each
Party agrees that the process by which any proceedings are begun in California may be served on either Party by being delivered in accordance with
clause 17. Nothing contained in this paragraph shall affect the right to serve process in any other manner permitted by law. 



        18.4. This
Agreement is drawn up in the English language and if this Agreement is translated into any language other than the English language this version shall prevail. 




        19.   COUNTERPARTS.


        This
Agreement may be executed in any number of counterparts each of which when executed and delivered shall be an original, but all the counterparts together shall constitute one and
the same instrument. 


        As
WITNESS the hands of the Parties or their duly authorized representatives the day and year first above written. 



Signed
by: /s/ John P. Longenecker

for and behalf of

FAVRILLE, Inc. 


Signed
by: /s/ S.N. Muddukrishna, Ph.D.

for and behalf of

BIOSYN ARZNEIMITTEL GmbH 



12







 
 
 

Schedule 1
  
    Data Sheet    
    


[...***...]


*CONFIDENTIAL TREATMENT REQUESTED*


13







 
[...***...]


*CONFIDENTIAL TREATMENT REQUESTED*


14








 
[...***...]


*CONFIDENTIAL TREATMENT REQUESTED*


15







 
 
 

Schedule 2
  
    Purchase order    
    



	TO:	 	biosyn Corporation

5939 Darwin Courts, Suite 114

Carlsbad, CA 92008
	FROM:	 	FAVRILLE, Inc.

10421 Pacific Center Court

San Diego, Ca 92121







Please find below an order for biosyn KLH made in accordance with the terms of the Supply Agreement entered into between us on November 12, 2004, 2004. 


Date
of order: 


Quantity
of order: 


Delivery
Date: within 90 days from date of order 


Address
in the

USA for delivery: 


Price:



Please
confirm your acceptance of this order within 7 days of the date hereof by completing the acceptance form below and returning it to us, for the attention of by fax (fax number). 


______________________________________________

Signed

For and on behalf of FAVRILLE, Inc. 


______________________________________________

Date, Place 


Order
acceptance by biosyn Arzneimittel GmbH 


______________________________________________

Signed

For and on behalf biosyn Arzneimittel GmbH 


______________________________________________

Date, Place 


16







 
 
 

Schedule 3
  
    Free Carrier    
    



        "Free Carrier" means that the seller fulfils his obligation to deliver when he has handed over the goods, cleared for export, into the charge of the carrier named
by the buyer at the named place or point. If no precise point is indicated by the buyer, the seller may chose within the place or range stipulated where the carrier shall take the goods into his
charge. When, according to commercial practice, the seller's assistance is required in making the contract with the carrier (such as in rail or air transport) the seller may act at the buyer's risk
and expense. 


        This
term may be used for any mode of transport, including multimodal transport. 



        "Carrier"
means any person who, in a contract of carriage, under-takes to perform or to procure the performance of carriage by rail, road, sea, air, inland waterway or buy a combination
of such modes. If the buyer instructs the seller to deliver the cargo to a person, e.g. a freight forwarder who is not a "carrier", the seller is deemed to have fulfilled his obligation to deliver the
goods when they are in the custody of that person. 


        "Transport
terminal" means a railway terminal, a freight station, a container terminal or yard, a multipurpose cargo terminal or any similar receiving point. 



        "Container"
includes any equipment used to unitise cargo, e.g. all types of containers and/or flats, whether ISO accepted or not, trailers, swap bodies, ro-ro equipment,
igloos, and applies to all modes of transport. 


A. The seller must  


A.1 Provision of goods In conformity with the contract  


        Provide the goods and the commercial invoice, or its equivalent electronic message, in conformity with the contract of sale and any other evidence of conformity
which may be required by the contract. 


A.2 Licenses, authorizations and formalities  


        Obtain at his own risk and expense any export license or other official authorization and carry out all customs formalities necessary for the exportation of the
goods. 


A.3 Contract of carriage and insurance  



	a)
	Contract
of carriage 




No
obligation. However, if requested by the buyer or if it is commercial practice and the buyer does not give an instruction to the contrary in due time, the seller may contract for carriage on usual
terms at the buyer's risk and expense. The seller may decline to make the contract and, if he does, shall promptly notify the buyer accordingly. 




	b)
	Contract
of insurance 





No
obligation. 





17







 





A.4 Delivery  


        Deliver the goods into the custody of the carrier or another person (e.g. a freight forwarder) named by the buyer, or chosen by the seller in accordance with
A.3.a), at the named place or point (e.g. transport terminal or other receiving point) on the date or within the period for delivery and in the manner agreed or customary at such point. If no specific
point has been agreed, and if there are several points available, the seller may select the point at the place of delivery which best suits his purpose. Failing precise instructions from the buyer,
the seller may deliver the goods to the carrier in such a manner as the transport mode of that carrier and the quantity and/or nature of the goods may require. 


        Delivery
to the carrier is completed: 



	I)
	In
the case of rail transport when the goods constitute a wagon load (or a container load carried by rail) the seller has
to load the wagon or container in the appropriate manner. Delivery is completed when the loaded wagon or container is taken over by the railway or by another person acting on its be-half. 



When
the goods do not constitute a wagon or container load, delivery is completed when the seller has handed over the goods at the railway receiving point or loaded them into a vehicle provided by the
railway. 



	II)
	In
the case of road transport when loading takes place at the seller's premises, delivery is completed when the goods
have been loaded on the vehicle provided by the buyer. 



When
the goods are delivered to the carrier's premises, delivery is completed when they have been handed over to the road carrier or to another person acting on his behalf. 



	III)
	In
the case of transport by inland waterway when loading takes place at the seller's premises, delivery is completed
when the goods have been loaded on the carrying vessel provided by the buyer. 





When
the goods are delivered to the carrier's premises, delivery is completed when they have been handed over to the inland waterway carrier or to another person acting on his behalf. 



	IV)
	In
the case of sea transport when the goods constitute a full container load (FCL), delivery is completed when the loaded
container is taken over by the sea carrier. When the container has been carried to an operator of a transport terminal acting on behalf of the carrier, the goods shall be deemed to have been taken
over when the container has entered into the premises of that terminal. 





When
the goods are less than a container load (LCL), or are not to be containerised, the seller has to carry them to the transport terminal. Delivery is completed when the goods have been handed over
to the sea carrier or to another person acting on his behalf. 



	V)
	In
the case of air transport, delivery is completed when the goods have been handed over to the air carrier or to another
person acting on his behalf.



	VI)
	In
the case of unnamed transport, delivery is completed when the goods have been handed over to the carrier or to another
person acting on his behalf.



	VII)
	In
the case of multimodal transport, delivery is completed when the goods have been handed over as specified in I)-VI),
as the case may be. 




A.5 Transfer of risks  


        Subject to the provisions of B.5., bear all risks of loss of or damage to the goods until such time as they have been delivered in accordance with A.4. 


18







 



A.6 Division of costs  


        Subject to the provisions of B.6 



	—
	pay
all costs relating to the goods until such time as they have been delivered to the carrier in accordance with A.4.;



	—
	pay
the costs of customs formalities as well as all duties, taxes, and other official charges payable upon exportation. 




A.7 Notice to the buyer  


        Give the buyer sufficient notice that the goods have been delivered into the custody of the carrier. Should the carrier fail to take the goods into his charge at
the time agreed, the seller must notify the buyer accordingly. 


A.8 Proof of delivery, transport document or equivalent electronic message  


        Provide the buyer at the seller's expense, if customary, with the usual document in proof of delivery of the goods in accordance with A.4. 



        Unless
the document referred to in the preceding paragraph is the transport document, render the buyer at the latter's request, risk and expense, every assistance in obtaining a
transport document for the contract of carriage (for example, a negotiable bill of lading, a non-negotiable sea waybill, an inland waterway document, an air waybill, a railway consignment
note, a road consignment note, or a multimodal transport document). 


        When
the seller and the buyer have agreed to communicate electronically, the document referred to in the preceding paragraph may be replaced by an equivalent electronic data interchange
(EDI) message. 


A.9 Checking packaging—marking  


        Pay the costs of those checking operations (such as checking quality, measuring, weighing, counting) which are necessary for the purpose of delivering the goods
to the carrier. Provide at his own expense packaging (unless it is usual for the particular trade to send the goods of the contract description unpacked) which is required for the transport of the
goods, to the extent that the circumstances relating to the transport (e.g. modalities destination) are made known to the seller before the contract of sale is concluded. Packaging is to be marked
appropriately. 


A.10 Other obligations  


        Render the buyer at the latter's request, risk and expense, every assistance in obtaining any documents or equivalent electronic messages (other than those
mentioned in A.8) issued or transmitted in the country of delivery and/or of origin which the buyer may require for the importation of the goods and, where necessary, for their transit through another
country. 


        Provide
the buyer, upon request, with the necessary information for procuring insurance. 


B. The Buyer Must  


B.1 Payment of the price  


        Pay the price as provided in the contract of sale. 


19







 



B.2 Licenses, authorizations and formalities  


        Obtain at his own risk and expense any import license or other official authorization and carry out all customs formalities for the importation of the goods and,
where necessary, for their transit through another country. 


B.3 Contract of carriage  


        Contract at his own expense for the carriage of the goods from the named place, except as provided for in A.3.a). 



B.4 Taking delivery  


        Take delivery of the goods in accordance with A.4. 


B.5 Transfer of risks  


        Bear all risks of loss of or damage to the goods from the time they have been delivered in accordance with A.4. 


        Should
he fail to give notice in accordance with B.7., or should the carrier named by him fail to take the goods into his charge, bear all risks of loss of or damage to the goods from
the agreed date or the expiry date of any period stipulated for delivery, provided, however, that the goods have been duly appropriated to the contract, that is to say, clearly set aside or otherwise
identified as the contract goods. 


B.6 Division of costs  


        Pay all costs relating to the goods from the time when they have been delivered in accordance with A,4. 


        Pay
any additional costs incurred, either because he fails to name the carrier, or the carrier named by him fails to take the goods into his charge at the agreed time, or because he has
failed to give appropriate notice in accordance with B.7., provided, however, that the goods have been duly appropriated to the contract, that is to say, clearly set aside or otherwise identified as
the contract goods. 


        Pay
all duties, taxes and other official charges as well as the costs of carrying out customs formalities payable upon importation of the goods and, where necessary, for their transit
through another country. 


B.7 Notice to the seller  


        Give the seller sufficient notice of the name of the carrier and, where necessary, specify the mode of transport, as well as the date or period for delivery the
goods to him, as the case may be, of the point within the place where the goods should be delivered to the carrier. 


B.8 Proof of delivery, transport document or equivalent electronic message  


        Accept the proof of delivery in accordance with A.8, 


B.9 Inspection of goods  


        Pay, unless otherwise agreed, the costs of pre-shipment inspection except when mandated by the authorities of the country of exportation. 


20







 



B.10 Other obligations  


        Pay all costs and charges incurred in obtaining the documents or equivalent electronic messages mentioned in A.1O. and reimburse those incurred by the seller in
rendering his assistance in accordance therewith and in contracting for carriage in accordance with A.3.a). 



        Give
the seller appropriate instructions whenever the seller's assistance in contracting for carriage is required in accordance with A.3.a). 


21







 
 
 

Schedule 4
  
    Label    
    


The label will be 2" × 4" and will display the following information:  



	Product Name:	 	VACMUNE® Liquid [...***...] in [...***...] total volume, or;

VACMUNE® Liquid [...***...] in [...***...] total volume
	Lot Number:	 	 
	 	 	 
	Date of Manufacture:	 	 
	 	 	 
	Expiration Date:	 	 
	 	 	 
	Manufacturer:	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	 	 	 




*CONFIDENTIAL TREATMENT REQUESTED*


22











QuickLinks



Exhibit 10.10


Schedule 1 Data Sheet

Schedule 2 Purchase order

Schedule 3 Free Carrier

Schedule 4 Label