Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-1849

2. Registrant Information.

Registrant Reference Number: M-04-15-3

Registrant Name (Full Legal Name no abbreviations): Valent Biosciences Corporation

Address: 870 Technology Way

City: Libertyville

Prov / State: Illinois

Country: USA

Postal Code: 60048

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

16-APR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

16-APR-15

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No. 24977      PMRA Submission No.       EPA Registration No.

Product Name: Foray 48B

• Active Ingredient(s)
  • BACILLUS THURINGIENSIS BERLINER SSP KURSTAKI STRAIN HD-1

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: L/ha

10. Site pesticide was applied to (select all that apply).

Site: Forest - Woods / Forêt et boisés

Préciser le type: Aerial

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

Aerial sprayed via a helicopter from approximately 100 feet.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Coughing
  • Symptom - Wheezing

4. How long did the symptoms last?

Unknown / Inconnu

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Sprayed on way to work, wheezing, coughing, called 911; put on breathing system at (name) ER and given a few drugs to ease symptoms. Now at home resting but still having difficulty breathing. Was given Ventolin to take home.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

He was driving to work before 6 AM, noticed the low flying helicopters and pulled over to take some video for his two sons who are both asthmatic and find out what was being sprayed so he could tell his wife. He parked, rolled down his window near (name) school (brand new) at (address), he was immediately overcome after the helicopter flew overhead; wound the window back up and his coughing became more severe. He came home and the helicopter passed over him again. He had trouble breathing and called 911. They took him to (name) Hospital and was released at 1230 when he went home to sleep for most of the day. Family doctor did not have any major concerns. Other correspondences noted that he had a pre-existing respiratory condition