To allow the use of the information derived from this clinical study, the Investigator agrees 
to provide Targeted Genetics with complete test results required in the case report form and 
all data developed in the study. 
The Sponsor reserves the right to review and approve any proposed publication or abstract 
prior to submission for presentation or publication. Such review will be completed within 
30 days of receipt. All publications must acknowledge the sponsorship of Targeted 
Genetics Corporation. 
12.8 Drug Inventory Records 
Targeted Genetics Corporation will ship to the Investigator vials of tgAAVCF which will 
be stored in the pharmacy or a locked area. The Investigator, or a responsible party 
(research pharmacist or other) designated by the Investigator, must maintain an inventory 
record of drug received and dispensed. Targeted Genetics will provide forms to facilitate 
the inventory control. These forms must be used unless the Investigator has previously 
established a system which is adequate to comply with FDA regulations and is approved by 
Targeted Genetics. The study drug must be dispensed only by the institution(s) specified 
on the FDA form 1572. 
12.9 Disposition of Unused Drug Supplies 
Upon completion or termination of the study, all unopened drug is to be returned to 
Targeted Genetics Corporation in the original containers. Residual solutions may be 
discarded after use. Returned drug should be shipped to the following address: 
Director of Development 
Targeted Genetics Corporation 
1 100 Olive Way, Suite 100 
Seattle WA 98101 
12.10 Final Report 
The Investigator or associate must submit a final report to Targeted Genetics Corporation. 
This report will be submitted within 90 days of the last patient's completion of the study. 
The case report forms will be completed at the site and submitted to Targeted Genetics in a 
timely fashion. 
12.11 Amendments to the Protocol 
Once the protocol has been approved by the IRB, neither the Investigator nor the Sponsor 
will modify this protocol without obtaining the prior concurrence of the other. The party 
initiating the modification will confirm it in writing. Amendments to the protocol should be 
so documented under "Amendment #" on the title page of the protocol. Each amendment 
must be dated. The investigator must obtain IRB approval of the protocol amendment and 
the sponsor must submit the modifications to the Food and Drug Administration prior to 
implementation. The Investigator will also submit protocol modifications to the 
Recombinant DNA Advisory Committee. 
12.12 Case Report Form Completion 
A case report form is provided for each study patient or subject. All forms must be filled 
out in black ink or typed. The Investigator will sign and date individual pages as indicated. 
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