Date of Proposal s1

Investigator Sponsored Trials Concept Proposal Form

INSTRUCTIONS: Please complete the form being as thorough as possible. Provide a full and concise description of your proposed work, including any key references to previous relevant work or methods. The trial details described in this form will be appended to the study agreement and define the scope and limits of the project agreed to. Please contact [email protected] with any questions

DATE OF PROPOSAL STUDY TITLE

PRINCIPAL INVESTIGATOR Name:

Institution / Organization:

Address:

Phone: Fax: Email: Have you worked with Halozyme previously ? If so, please explain. OTHER CONTACTS Legal or Contracts Name: Coordinator Phone: Email : Study Name: Coordinator Phon e: Email: Remittance Name: Address Address: Tax ID Number:

STUDY SITE INFORMATION Description Single-Center (Please check all that apply) Multi-Center

IST Concept Proposal Form 1 Version 16Nov16 Investigator Sponsored Trials Concept Proposal Form

Number of sites: Names of identified sites (list):

Cooperative Group Research Network Other (please specify) Willingness to Collaborate Yes with Other Institutions No Competing Studies at Your Yes Institution No If yes, please describe: If Yes, When Will These Complete

SUPPORT REQUESTED (Check all that apply) Please provide a basic Study Drug study budget in a COST Funding PER PATIENT format (see BUDGET PROPOSAL (If YES, please provide detailed study budget below) section below). Concepts Other: (attach description) WILL NOT be reviewed by Will funding or study drug be provided from other sources? IST Review Committee without a proposed budget. NO YES (If YES, please provide detailed study budget below)

STUDY DESIGN INFORMATION Background / Rationale:

Objectives: Primary

Secondary Design:

Key Inclusion / Exclusion 1. Criteria: 2. 3. 4. Treatment Regimen:

Planned Total Accrual:

Estimated Accrual / Mo:

Describe Accrual in Similar Clinical Study Statistical Plan:

Publication Plan:

Do you plan to submit an Yes Investigational No – If no, provide a detailed rationale. For reference, refer to regulations in New Drug (IND) 21 CFR 312.2(b)(1)(i-v), which outlines the five criteria for exemption of studies application? from IND regulations.

Study Succession Plan: (i.e. with desired results, our plan would be…) Additional Comments:

TRANSLATIONAL MEDICINE EFFORTS Prospective patient Yes selection No Selection biomarker(s) Rationale Other biomarkers (specify biomarkers, analysis methods & time points) Tumor sample(s) Whole Blood (Pharmacogenetics) Plasma Serum PBMC Surrogate Tissue (specify which tissue) Other (specify) Biomarker Rationale Where will samples be analyzed? If internal lab please provide description of relevant equipment (including storage) and personnel Willing to share samples Yes (please note all associated costs will be covered by Halozyme) with Halozyme for No research collaboration If “Yes” please specify sample type and sample volume provided Flexibility & interest in Yes inclusion of additional time No points and/or other sample types for research collaboration

STUDY TIMELINES (proposed milestone dates) Study Activation: Last Patient In: Initial Data (Abstract): Final Data (Manuscript):

BUDGET PROPOSAL (if applicable) Study Costs Per Patient Total Physician costs Study coordinator costs Regulatory submissions Data costs Report Writing Procedure costs Biop sies Blood draws Correlative studies (list) Institutional overhead (%) Start Up Costs IRB fees Other fees (list)

Any approvals, consents or oral agreements by Halozyme have no legal or other binding effect unless and until a separate written legal agreement is executed by the parties covering the study. Notwithstanding any such agreement, Halozyme reserves the right to terminate any support or involvement in the study at any time whatsoever, subject to its sole discretion.

Please attach an electronic copy of the Principal Investigator’s CV

IST Concept Proposal Form 4 Version 16Nov16