License Agreement - VaxGen Inc. and VaxGen-Celltrion Inc.
LICENSE AGREEMENT This License Agreement is entered into as of the 7th day of June, 2002, (the "Effective Date") by VaxGen, Inc., a Delaware corporation ("VaxGen"), and VaxGen-Celltrion, Inc., a California corporation ("VCI") (each also singularly a "Party" and collectively the "Parties") as follows: WITNESSETH: WHEREAS, VaxGen is the owner of certain patent rights and knowhow relating to the fermentation, purification and manufacture of recombinant proteins, as well as the owner of certain related biological materials, protocols and other knowhow; WHEREAS, VCI wishes to obtain a license under such intellectual property; and WHEREAS, VaxGen is willing to grant such a license to VCI on the terms set forth herein. NOW, THEREFORE, in consideration of the mutual promises contained herein, the Parties agree as follows: Article 1.0 Certain Definitions The terms defined elsewhere in this Agreement shall have the meanings specified herein. The following terms shall have the following meanings for purposes of this Agreement: 1.1 "Facility" shall mean a certain pharmaceutical manufacturing facility to be constructed by VCI in South San Francisco, California, pursuant to other agreements to which VCI and VaxGen are party. 1.2 "Licensed Knowhow" shall mean any and all proprietary information, methods, processes, techniques, data and biologic materials which are in the possession of or controlled by VaxGen presently or hereafter during the term of this Agreement, which VaxGen is free to license or sublicense, and which are necessary or useful for the manufacture of any Licensed Product; provided however, that "Licensed Knowhow" shall not include any rights licensed to VaxGen pursuant to that certain License and Supply Agreement between VaxGen and Genentech, Inc. dated as of May 1, 1996 (the "Genentech Agreement"). "Licensed Knowhow" shall include, without limitation, those items listed or described on Exhibit "A" attached hereto. -1- <PAGE> 1.3 "Licensed Patent Rights" shall mean all patents and patent applications, and all patents issuing therefrom, together with all extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations, continuations-in-part and foreign counterparts thereof or therefor, that are in the possession of or controlled by VaxGen presently or hereafter during the term of this Agreement, and which VaxGen is free to license or sublicense, to the extent that any of the foregoing relates to or claims the manufacture of any Licensed Product; provided however, that "Licensed Patent Rights" shall not include any rights licensed to VaxGen pursuant to the Genentech Agreement. "Licensed Patent Rights" shall include, without limitation, those patent applications and patents listed on Exhibit "B" attached hereto. 1.4 "Licensed Product" shall mean any pharmaceutical formulation that: (i) could not be manufactured without infringing one or more claims of the Licensed Patent Rights, or (ii) is manufactured, in whole or part, through the use of Licensed Knowhow. Article 2.0 License Grant 2.1 License Grant. Subject to the other terms and conditions of this Agreement, VaxGen hereby grants to VCI a non-exclusive license under the Licensed Patent Rights and Licensed Knowhow to make Licensed Products in the United States for sale any where in the world, except for AIDSVAX which is subject to a separate Sub-License Agreement. With respect to the Licensed Patent Rights or Licensed Knowhow, VCI shall have no rights other than the rights as granted under this Agreement 2.2 Sub-licenses. VCI shall have no right to sublicense its rights hereunder without the prior written consent of VaxGen, which consent may be withheld by VaxGen in its sole discretion. Article 3.0 Technology Transfer 3.1 VCI shall have the right to require VaxGen, at VCI's expense, to transfer the Licensed Patent Rights and the Licensed Knowhow to VCI. The Parties shall in good faith determine the most cost-effective and timely means of effecting such transfer. 3.2 VaxGen shall provide to VCI all the relevant documents, materials, designs, data and other information necessary for the use of the Licensed Patents Rights and the Licensed Know-how by VCI and for manufacturing the Licensed Product by VCI. -2- <PAGE> The timing and method of delivery of those documents shall be determined later based on mutual agreement by the Parties. 3.3 All other matters relating to the transfer of technology not expressly provided herein shall be agreed upon by the Parties. The Parties shall meet and discuss the detailed program for the transfer of technology as soon as practically possible. Article 4.0 Accounting Records 4.1 Reports. Within 90 days after the last day of each calendar quarter, VCI shall render to VaxGen an accounting for such calendar quarter showing, on a Licensed Product-by-Licensed Product and country-by-country basis, all sales of Licensed Products during such quarter. 4.2 VCI Accounting Records. VCI shall keep full, true and accurate books of account containing all particulars which may be necessary for the purpose of showing sales of all Licensed Products on a country-by-country basis. VCI's complete books of account and supporting data therefor shall be kept at its principal place of business for at least five years following the end of the calendar year to which they pertain (and access shall not be denied thereafter, if reasonably available), and shall be made available for inspection and copying during regular business hours by an independent accountant retained by VaxGen at VaxGen's sole expense. Article 5.0 Intellectual Property Rights 5.1 Ownership. VaxGen shall retain title to the Licensed Knowhow and Licensed Patent Rights, including, without limitation, any Licensed Knowhow and Licensed Patent Rights developed or invented by VaxGen in the future. VCI shall retain title to any improvements to the Licensed Knowhow or Licensed Patent Rights developed or invented solely by VCI; provided, however, that VaxGen shall have a royalty-free non-exclusive right to practice any such improvements as it sees fit. The Parties shall own jointly any improvements to any Licensed Knowhow or Licensed Patent Rights which are developed or invented by both Parties. Designation of inventor(s) on any patent application is a matter of law, and shall be solely within the discretion of qualified patent counsel of VaxGen and VCI to determine in accordance with United States laws of inventorship and competent written evidence of the Parties. 5.2 Patent Filing, Prosecution and Maintenance. During the term of this Agreement,. VaxGen shall be responsible for the filing, prosecution and maintenance of all Licensed Patent Rights at its sole cost and expense. -3- <PAGE> 5.3 Patent Infringement (a) If either Party learns that a third party is infringing or allegedly infringing any Licensed Patent Rights, it shall promptly notify the other Party thereof. The Parties shall cooperate and use reasonable efforts to stop such alleged infringement without litigation. (b) VaxGen shall have the sole right (but not the obligation) to take the appropriate steps to remove the infringement or alleged of Licensed Patent Rights, including, without limitation, initiating a suit, proceeding or other legal action. 5.4 Third Party Patent Rights. If a notice of infringement is received by, or a suit is initiated against, either Party with respect to any Licensed Product, the Parties shall consult in good faith regarding the best response. Article 6.0 Confidentiality 6.1 Confidentiality. In the course of performance of this Agreement, one Party may disclose to the other Party or receive from the other Party information which is confidential information of the disclosing Party. In order to be considered confidential information of the disclosing Party, such information must be in writing and designated as confidential, or if disclosed orally must be confirmed in writing to the other Party as confidential within 30 days after such oral disclosure ("Confidential Information"). In addition, for the purposes of this Agreement, Confidential Information shall not include information that (in each case as evidenced by written records or other competent evidence): (a) was known to the receiving Party at the time of disclosure hereunder by the disclosing Party; (b) was generally available to the public or was otherwise part of the public domain at the time of disclosure hereunder, or became generally available to the public or otherwise part of the public domain after disclosure hereunder other than through any act or omission of the receiving Party in breach of this Agreement; (c) became known to the receiving Party after disclosure from a source that had a lawful right to disclose such information to others; or (d) was independently developed by the receiving Party without the use of any -4- <PAGE> Confidential Information of the disclosing Party. Each Party shall protect and keep confidential and shall not use, publish or otherwise disclose to any third party the other Party's Confidential Information for a period of five years from the date of disclosure hereunder, except as otherwise permitted by this Agreement or with the other Party's prior consent. The foregoing notwithstanding, each Party may disclose Confidential Information of the other Party during any official proceeding before a court or governmental agency, or as a part of a patent application filed on inventions made under this Agreement, or as necessary in order to manufacture Licensed Products as contemplated herein; provided that the Party whose Confidential Information is included in such application shall have the opportunity to review such proposed disclosure at least 30 days prior to the date of such filing and does not reasonably object in writing to such proposed disclosure. In the event of an objection the Parties shall consult with each other in good faith and in a timely manner to resolve the matter in a manner beneficial to both Parties. Article 7.0 Representations and Warranties 7.1 Disclaimer. Except as expressly provided in this Agreement, the Parties disclaim all other representations and warranties, express or implied, including, without limitation, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, or NON-INFRINGEMENT. 7.2 Mutual Representations and Warranties. Each party represents and warrants to the other Party that the representing and warranting Party, to its best knowledge: is free to enter this Agreement and in so doing it will not violate any other agreement to which it is party or subject. 7.3 Representations and Warranties by VaxGen. VaxGen represents and warrants to VCI that (i) it has the right to grant the license set forth hereinabove, free from any inconsistent claims or restrictions in favor of any third party, and (ii) the Licensed Patent Rights and Licensed Knowhow, taken together with the intellectual property rights to be licensed and transferred to VCI pursuant to a certain sublicense agreement between the Parties of even date herewith (the "Sublicense Agreement"), are suitable and adequate to manufacture the Vaccine (as defined in the Sublicense Agreement) at the scale currently produced by Genentech. Article 8.0 Liability 8.1 Limitation of Liability. Neither Party shall be liable to the other for indirect, -5- <PAGE> incidental, special or consequential damages arising out of or resulting from any term or condition of this Agreement or with respect to their performance or lack thereof. 8.2 Indemnification by VCI. VCI shall indemnify, defend and hold harmless VaxGen and its directors, officers, employees, agents and affiliates from and against all costs, claims, suits, liabilities, expenses (including reasonable attorneys' fees) and damages arising out of or resulting from the manufacture by VCI of any Licensed Product, except to the extent that such cost, claim, suit, expense or damage arose or resulted from any willful or negligent act or omission by VaxGen. VCI's indemnification obligations hereunder shall be conditioned upon VaxGen (i) giving reasonable notice to VCI of any such claim or action, (ii) tendering the defense of such claim or action to VCI, (iii) reasonably assisting VCI (at VCI's expense) in investigating and defending such claim or action, and (iv) not compromising or settling such claim or action without VCI's prior consent. 8.3 Indemnification by VaxGen. VaxGen shall indemnify, defend and hold harmless VCI and its directors, officers, employees, agents and affiliates from and against all costs, claims, suits, liabilities, expenses (including reasonable attorneys' fees) and damages arising out of or resulting from the use or sale by VaxGen of any Licensed Product, except to the extent that such cost, claim, suit, expense or damage arose or resulted from any willful or negligent act or omission by VCI. VaxGen's indemnification obligations hereunder shall be conditioned upon VCI: (i) giving reasonable notice to VaxGen of any such claim or action, (ii) tendering the defense of such claim or action to VaxGen, (iii) reasonably assisting VaxGen (at VaxGen's expense) in investigating and defending such claim or action, and (iv) not compromising or settling such claim or action without VaxGen's prior consent. 8.4 Insurance. Without limiting any indemnification obligations under this Agreement, VCI shall obtain and maintain on an on-going basis for the time period specified herein below comprehensive general liability and products liability insurance (including contractual liability coverage of VCI's indemnification obligations under this Agreement) in the amount of at least $5 million per occurrence and annual aggregate combined single limit for bodily injury and property damage liability, with such insurance coverage to be maintained with an insurance company or companies reasonably acceptable to VaxGen and with a deductible or maximum self-insured retention not to exceed $500,000 per occurrence and annual aggregate. VCI shall obtain such insurance coverage no later than 90 days prior to the commencement of the first human clinical trial testing of any Licensed Product (other than AIDSVAX, as addressed by separate agreement of the Parties) and thereafter shall maintain such insurance coverage without interruption during the term of this Agreement and for a period of at least 10 years after the expiration or termination of this Agreement. Such insurance shall name VaxGen as an additional -6- <PAGE> insured, shall state that it is primary to any valid and collectible insurance available to VaxGen which also covers the same loss for which VCI has liability pursuant to the Agreement shall contain a cross-liability or severability of interest clause, and shall state that VaxGen will be provided with at least 30 days' advance written notice of any termination, cancellation or material change in the insurance policy. VCI shall provide VaxGen with evidence of such insurance coverage as required under this Agreement by no later than the deadline specified above for obtaining such insurance coverage, and thereafter shall continue to provide VaxGen with evidence of such required insurance coverage on an annual basis (by not later than each annual renewal date of such coverage) during the term of this Agreement and for a period of at least 10 years after the expiration or termination of this Agreement. VCI may satisfy its obligation to provide evidence of such required insurance coverage by providing VaxGen with complete copies of the insurance policies themselves or certificates from its insurance company or companies evidencing the coverage required hereunder. Article 9.0 Term and Termination 9.1 Term. This Agreement shall commence on the Effective Date and, unless earlier terminated in accordance herewith, shall expire on the 15th anniversary of the Effective Date. Following expiration, VCI shall retain a perpetual, royalty-free right to continue to use the Licensed Knowhow and Licensed Patents existing as of the date of expiration in the manner provided in Section 2.1, above. 9.2 Termination for Default. Failure by either Party to comply with any of its material obligations set forth in this Agreement shall entitle the non-defaulting Party to give the defaulting Party a notice specifying the nature of the default and requiring the defaulting Party to make good its default. If such default is not cured within 30 days after such notice, the non-defaulting Party shall be entitled, without prejudice to any of its other rights under this Agreement or available to it at law or in equity, to terminate this Agreement effective upon a notice of termination to the defaulting Party. 9.3 Termination for Insolvency or Bankruptcy. Either Party may, in addition to any other remedies available to it by law or in equity, terminate this Agreement, in whole or in part as the terminating Party may determine, by notice to the other Party in the event the other Party shall have become insolvent or bankrupt, or shall have made an assignment for the benefit of its creditors, or there shall have been appointed a trustee or receiver of the other Party or for all or a substantial part of its property, or there shall have been issued a warrant of attachment, execution, distraint or similar process against any substantial part of the property of the other Party, or any case or proceeding shall have been commenced or other action taken -7- <PAGE> by or against the other Party in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up, arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, provided that in any such case such event shall have continued for 60 days undismissed, unbonded and undischarged. Furthermore, all rights and licenses granted under to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code, licenses of rights to "intellectual property" as defined under Section 101(56) of the United States Bankruptcy Code. 9.4 Unilateral Termination. VCI shall have the right to terminate this Agreement, in its sole discretion, on six months' prior notice to VaxGen. 9.5 Effect of Termination (a) Expiration or termination of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such expiration or termination, and shall not relieve either Party from its obligations which are expressly indicated to survive expiration or termination of this Agreement; such rights and obligations include, without limitation, those under Sections 4.2, 5.3, 5.4, 6.1, 8.1, 8.2, 8.3, 9.5, 10.1, 10.2, and 10.5 of this Agreement. (b) On any termination of this Agreement (other than by virtue of expiration of its term) VCI promptly shall return to VaxGen all tangible Licensed Patent Rights, Licensed Knowhow, Confidential Information and other property owned by VaxGen (whether solely or jointly with VCI) that are in VCI's possession or control, including, without limitation, all biological materials and improvements to Licensed Patent Rights or Licensed Knowhow. Article 10.0 General Provisions 10.1 Notices. Any notice, request, delivery, demand, report, accounting, approval or consent required or permitted to be given under this Agreement shall be in writing and shall be deemed sufficiently given on the same day as delivery if delivered in person or transmitted by telecopier (with confirmed answer-back) in any case by 5:00 p.m. local time, on the next business day if sent by overnight courier service, and in three business days if sent by registered or certified mail, in any case addressed to the Party to whom it is directed at its address shown below or such other address as such Party shall have last given by notice to the other Party in accordance with this Section: -8- <PAGE> If to VaxGen, addressed to: VaxGen, Inc. 1000 Marina Boulevard Brisbane, CA 94005-1841 Attn: Dr. Lance K. Gordon, CEO If to VCI, addressed to: VaxGen-Celltrion, Inc. c/o VaxGen, Inc. 1000 Marina Boulevard Brisbane, CA 94005-1841 Attn: Mr. James P. Panek 10.2 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of California (other than its choice of law principles). 10.3 Entire Agreement. Except for a certain Sublicense Agreement between the Parties of even date herewith, this Agreement is the entire agreement and understanding between the Parties with respect to the subject matter hereof, and supersedes and cancels any and all prior negotiations, correspondence, understandings and agreements, whether written or oral, between the Parties respecting the subject matter hereof. 10.4 Binding Effect and Assignment. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective permitted successors and assigns, subject to the remainder of this Section 10.4. This Agreement shall not be assignable by either Party in whole or in part without the other Party's prior consent in its sole discretion, except that either Party may assign this Agreement in whole or in part without the other Party's consent in connection with any consolidation, merger, redemption, put or sale of stock, conveyance of substantially all of the assigning Party's assets, or change-of-control transaction that involves the assigning Party. 10.5 Dispute Resolution. In the event of any dispute, controversy or claim arising out of or relating to this Agreement, the Parties shall try to settle it amicably between themselves including first referring such dispute, controversy or claim to a member of each Party's Board of Directors for resolution. If the Parties are unable to so settle such dispute, controversy or claim within 30 days after such referral, then either Party may, by notice to the other, have it referred to their respective chief executive officers for attempted resolution by good faith negotiations within 30 days after such notice. In the event the chief executive officers are not able to resolve it, either Party may at any time after the 30-day period invoke the arbitration provisions of this Section 10.5. -9- <PAGE> All arbitration proceedings shall be conducted in accordance with the Rules of Arbitration and Conciliation of the International Chamber of Commerce, in English. All arbitration proceedings shall be in San Francisco, California. The Party requesting arbitration shall serve upon the other Party a demand for arbitration stating the substance of the controversy, dispute or claim, and the contention of the Party requesting arbitration. Within 60 days after the demand, the Parties shall each select one arbitrator, which arbitrators shall together select a third arbitrator. The three arbitrators are to act as neutral arbitrators and shall have no past, present or anticipated future affiliation with the Parties which would unduly influence the independence of an arbitrator. The decision of the arbitrators shall be in writing setting forth the basis therefore. The arbitrators shall have the authority to award compensatory damages, interest, tort damages (but not punitive or similar damages) and specific performance and other equitable relief. The Parties shall abide by the award rendered in such arbitration proceeding, and such award may be enforced and executed upon in any court having jurisdiction over the Party against whom enforcement of such award is sought. During such arbitration proceedings, each Party shall pay its arbitrators' fees, administration charges and related expenses of arbitration. The losing Party shall thereafter reimburse the prevailing Party for all such costs incurred in connection with such arbitration. 10.6 Waiver. The waiver by either Party of any breach of or default under any of the provisions of this Agreement or the failure of either Party to enforce any of the provisions of this Agreement or to exercise any right thereunder shall not be construed as a waiver of any other breach or default or a waiver of any such rights or provisions hereunder. 10.7 Severability. If any part of this Agreement shall be held invalid, illegal or unenforceable by any court of authority having jurisdiction over this Agreement or either Party, such part shall be ineffective only to the extent of such invalidity, illegality or unenforceability, and shall be validly reformed by addition or deletion of wording as appropriate to avoid such result and as nearly as possible approximate the intent of the Parties. If unreformable, this Agreement shall be divisible and deleted in such jurisdiction, but elsewhere shall not be affected. 10.8 Publicity. VCI and VaxGen shall consult and obtain mutual consent before making any public announcement concerning this Agreement, the subject matter hereof or use of the other Party's name, except for information that is already in the public domain or where the nature of such information has been previously approved for disclosure (in which case this Section 10.8 will no longer apply to that previously approved information). -10- <PAGE> 10.9 Counterparts. This Agreement may be executed in two counterparts, each of which shall be deemed an original for all purposes, but both of which together shall constitute one and the same instrument. 10.10 No Other Rights. No rights or licenses, express or implied, are granted to VCI by this Agreement to use in any manner any trade name or trademark of VaxGen, or any other intellectual property not expressly covered by this Agreement. 10.11 Force Majeure. Neither Party shall be liable to the other for loss or damages or shall have any right to terminate this Agreement (except as otherwise provided in this Agreement) for any default or delay of the other Party in its performance under this Agreement that is attributable to an act of God, flood, fire, explosion, strike, lockout, labor dispute, casualty or accident, war, revolution, civil commotion, act of public enemies, blockage or embargo, injunction, law, order, proclamation, 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 the affected 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 for the period of time that it is so disabled. 10.12 Headings. Headings are for the convenience of reference only and shall not control the construction or interpretation of any of the provisions of this Agreement. 10.13 No Partnership. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee, or joint venture relationship between the Parties. Neither Party shall incur any debts or make any commitments for the other Party. 10.14 Modification. Any modification to this Agreement shall be made in writing duly signed by both Parties. IN WITNESS WHEREOF, the Parties each have caused this Agreement to be duly executed by its duly authorized representative as of the date set forth above. VAXGEN, INC. VAXGEN-CELLTRION, INC. By: ______________________ By: ______________________ Name: Dr. Lance K. Gordon Name: Mr. James P. Panek Title: Chief Executive Officer Title: President -11- <PAGE> Exhibit A Licensed Knowhow Platform Technology VaxGen will provide to VCI all necessary knowhow to establish a platform technology capability for the design, startup and validation, operation and FDA licensure of a commercial scale cell culture manufacturing operation suitable for production of bulk human therapeutic proteins, including AIDSVAX and monoclonal antibodies. This transfer will include platform technology required for: o Seed culture preparation and culture expansion o Commercial scale cell culture o Cell separation, harvest and cell inactivation o Commercial scale affinity, ion exchange and size exclusion chromatography o Viral inactivation/removal o Ultrafiltration, diafiltration and tangential flow filtration o Media and buffer preparation o All associated analytical methods VaxGen will establish this platform technology capability by providing knowhow in the following categories: Facility Design Overall plant design and layout concepts Process flow, material flow and personnel flow requirements Area classifications and architectural finish requirements Air flow and pressurization requirements Utility requirements Support services and laboratory requirements Process Design Process descriptions Process flow diagrams Process controls and automation strategy Equipment lists -12- <PAGE> Equipment layouts Process and instrumentation drawings Startup and Validation Validation Master Plan Turn-over Package requirements Installation, Operation and Performance Qualification (IQ, OQ, PQ) requirements Controls Qualification Environmental monitoring (particulate, bioburden) requirements Equipment cleaning and product change-over requirements Sterility testing requirements Documentation system requirements Calibration and preventative maintenance requirements Operations Personnel training requirements and records Access and gowning procedures Process and equipment trouble shooting Trial run and "buffer blank" planning and execution support Process deviation and Out Of Spec (OOS) investigation requirements and support Cell Culture contamination prevention plans and investigation support Quality Systems SOP's Licensure Support FDA Facility Plan review preparation and coordination CMC section requirements to support BLA amendment FDA inspection preparation and mock audits FDA inspection participation and coordination Inspection observations resolution -13- <PAGE> Exhibit B Licensed Patent Rights There are no issued patents or patent applications filed relating to the Licensed Patent Rights as of the date of execution of the License Agreement. -14- <PAGE> Exhibit C Schedule of Technology Transfer The knowhow described in Exhibit A will be transferred in phases corresponding to the forecasted schedule for development of the Launch facility and the Incheon facility. Transfer of knowhow will be initiated in the following phases: Launch and Incheon Facilities Design 1Q02 - 4Q02 o Platform Technology Facility Design o Platform Technology Process Design o AIDSVAX Method of Manufacture Lists of raw material Process flow chart Cell substrate/host cell descriptions Expression vector descriptions Cell seed culture procedures Cell growth and harvesting procedures Purification and downstream processing procedures o AIDSVAX Process Description o AIDSVAX Validation Requirements and Master Plan Launch Facility Start-up, Validation and Operation 1Q03 - 3Q04 overlapping with Incheon Facility Construction o Platform Technology Startup and Validation o Platform Technology Operations o AIDSVAX Validation Requirements and Master Plan (Incheon Facility) o AIDSVAX Drug Substance Storage and Shipping Requirements o AIDSVAX Process validation procedures and data o Copies of completed batch history records for actual AIDSVAX launch facility qualification production lots (completed Manufacturing and Analytical Testing "tickets") o AIDSVAX Regulatory Documents (and subsequent updates) o Associated Training of VCI Staff Incheon Facility Start-up and Validation 3Q04 - 4Q05 o AIDSVAX Materials o AIDSVAX Description and Characterization o AIDSVAX Process Controls o AIDSVAX Drug Substance Specifications and Analytical Methods -15- <PAGE> o AIDSVAX Manufacturing Documents o AIDSVAX Analytical Documents o Other AIDSVAX Quality Documents and Support o Associated Training of VCI Staff Incheon Facility Licensure, Technology 4Q05 - Expiration of Supply Agreement and Quality Support o Platform Technology and AIDSVAX Specific Licensure Support o Associated Training of VCI Staff -16-