Delaware (State or other jurisdiction of incorporation) |
0-19311 (Commission file number) |
33-0112644 (IRS Employer Identification No.) |
133 Boston Post Road, Weston, Massachusetts (Address of principal executive offices) |
02493 (Zip Code) |
o | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
o | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
o | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
o | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 1.01 | Entry into a Material Definitive Agreement. |
| First New Product FDA Approval: the FDAs first approval of an anti-CD20 product other than ocrelizumab and GA101 that is acquired or developed by Genentech and is subject to the collaboration agreement (New Product). |
| First Non-CLL GA101 FDA Approval: the FDAs first approval of GA101 in an indication other than chronic lymphocytic leukemia. |
| GA101 CLL Sales Trigger: the first day of the quarter after U.S. gross sales of GA101 in any consecutive 12 month period reach $500,000,000. |
Before First New Product FDA Approval | ||||||||||||||||||
After First New | First Non-CLL GA101 | GA101 CLL Sales | ||||||||||||||||
Product FDA | FDA Approval Occurs | Trigger Occurs | ||||||||||||||||
Co-promotion Operating Profits | Approval | First | First | |||||||||||||||
I. | First $50,000,000 | 30 | % | 30 | % | 30 | % | |||||||||||
II. | Above $50,000,000 | | | 35 | % | |||||||||||||
A. | Until First GA101 Threshold Date | 38 | % | 39 | % | | ||||||||||||
B. | After First GA101 Threshold Date | | | | ||||||||||||||
1(a). | Until First Threshold Date | 37.5 | % | | | |||||||||||||
1(b). | After First Threshold Date and until Second Threshold Date | 35 | % | | | |||||||||||||
1(c). | After Second Threshold Date | 30 | % | | | |||||||||||||
2. | Until Second GA101 Threshold Date | | 37.5 | % | | |||||||||||||
C. | After Second GA101 Threshold Date | | 35 | % | |
| First GA101 Threshold Date means the earlier of (1) the date of the First Non-CLL GA101 FDA Approval if U.S. gross sales of GA101 for the preceding consecutive 12 month period reach $150,000,000 or (2) the first day of the calendar quarter following the date following the First Non-CLL GA101 FDA Approval that U.S. gross sales of GA101 within any consecutive 12 month period have reached $150,000,000. | |
Second GA101 Threshold Date means the first day of the calendar quarter after U.S. gross sales of GA101 within any consecutive 12 month period have reached $500,000,000. | ||
First Threshold Date means the earlier of (1) the GA101 CLL Sales Trigger, (2) the Second GA101 Threshold Date and (3) the later of (a) the first date that U.S. gross sales of New Products in any calendar year reach $150,000,000 and (b) January 1 of the calendar year following the calendar year in which the First New Product FDA Approval occurs if gross sales of New Products reached $150,000,000 within the same calendar year in which the First New Product FDA Approval occurred. | ||
Second Threshold Date means the later of (1) the first date that U.S. gross sales of New Products in any calendar year reach $350,000,000 and (2) January 1 of the calendar year following the calendar year in which the First Threshold Date occurs. |
Biogen Idec Inc. |
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By: | /s/ Robert A. Licht | |||
Robert A. Licht | ||||
Senior Vice President | ||||