| Preface |
|
xxxvii | |
| About the Editors |
|
xliii | |
| About the Authors |
|
xlv | |
|
Chapter One Introduction to Biotechnology and the Law |
|
|
1 | (14) |
|
|
|
|
|
|
|
4 | (1) |
|
|
|
5 | (1) |
|
|
|
6 | (1) |
|
C The Biotech Company Life Cycle |
|
|
6 | (7) |
|
|
|
7 | (1) |
|
|
|
7 | (1) |
|
|
|
8 | (1) |
|
|
|
8 | (1) |
|
2 Phase II: Early Development |
|
|
9 | (1) |
|
|
|
9 | (1) |
|
|
|
10 | (1) |
|
c Business Growth and Complexity |
|
|
10 | (1) |
|
3 Phase III: Later Stage Development and Product Approval |
|
|
11 | (1) |
|
4 Phase IV: Challenges Facing the Now Mature Company |
|
|
11 | (1) |
|
|
|
12 | (1) |
|
|
|
12 | (1) |
|
|
|
13 | (1) |
|
|
|
13 | (2) |
|
Chapter Two Managing Innovation: Patent Basics for Biotechnology Counsel |
|
|
15 | (62) |
|
|
|
|
|
A Introduction to Patents |
|
|
15 | (1) |
|
|
|
16 | (35) |
|
|
|
16 | (4) |
|
2 Changes to the U.S. Patent System |
|
|
20 | (1) |
|
|
|
20 | (1) |
|
b The America Invents Act |
|
|
21 | (2) |
|
3 What Is--and Is Not--Patentable? |
|
|
23 | (1) |
|
|
|
24 | (2) |
|
|
|
26 | (2) |
|
4 Requirements for Patentability--New, Useful, and Nonobvious |
|
|
28 | (1) |
|
|
|
28 | (1) |
|
|
|
28 | (1) |
|
|
|
29 | (1) |
|
|
|
29 | (1) |
|
5 Patent Application Process |
|
|
30 | (1) |
|
|
|
30 | (1) |
|
b Provisional Applications |
|
|
31 | (1) |
|
c Utility and Patent Cooperation Treaty Patent Applications |
|
|
32 | (1) |
|
d Preparing the Patent Application |
|
|
33 | (3) |
|
e Filing the Patent Application |
|
|
36 | (5) |
|
f Publication of Patent Applications |
|
|
41 | (1) |
|
|
|
41 | (5) |
|
6 Post-Issue Patent Considerations |
|
|
46 | (1) |
|
|
|
46 | (1) |
|
|
|
46 | (1) |
|
c Corrections to the Patent |
|
|
47 | (1) |
|
d Additional Patent Applications |
|
|
48 | (2) |
|
e Post-Issue Patent Challenges |
|
|
50 | (1) |
|
C Foreign Patent Portfolios |
|
|
51 | (14) |
|
|
|
52 | (3) |
|
2 Patentability Differences |
|
|
55 | (2) |
|
|
|
57 | (1) |
|
4 Prerequisites to Filing |
|
|
58 | (1) |
|
5 Options for Filing in Other Jurisdictions |
|
|
59 | (6) |
|
6 Additional Considerations |
|
|
65 | (1) |
|
D Managing the Company's Patent Estate |
|
|
65 | (12) |
|
|
|
65 | (2) |
|
2 Keeping It in the Family |
|
|
67 | (3) |
|
3 Skeletons in the Closet |
|
|
70 | (1) |
|
|
|
71 | (1) |
|
b Correspondence to Products or Business Strategies |
|
|
72 | (2) |
|
|
|
74 | (3) |
|
Chapter Three Company Formation |
|
|
77 | (94) |
|
|
|
|
|
|
|
77 | (6) |
|
1 "But Will It Help Us Get Money?" |
|
|
77 | (1) |
|
2 The Importance of the Board of Directors |
|
|
78 | (2) |
|
|
|
80 | (1) |
|
|
|
81 | (1) |
|
|
|
81 | (1) |
|
6 Financing and Product Development Plan |
|
|
82 | (1) |
|
7 The Role of the Company's Attorneys |
|
|
83 | (1) |
|
B Biotechnology Company Models |
|
|
83 | (7) |
|
1 Company Formed before In-Licensing While Research and Development Continues at University |
|
|
83 | (1) |
|
|
|
84 | (1) |
|
|
|
85 | (1) |
|
4 Corporate Deal-Funded Company |
|
|
85 | (1) |
|
5 Holding Company and Series LLC |
|
|
86 | (1) |
|
6 Venture Fund-Launched Company |
|
|
87 | (1) |
|
7 Angel Investor-Funded Company |
|
|
87 | (1) |
|
8 Significant Self-Funded Company |
|
|
88 | (1) |
|
9 Shoestring Self-Funded Company |
|
|
88 | (1) |
|
10 Charitable Corporation or Foundation |
|
|
89 | (1) |
|
|
|
90 | (1) |
|
|
|
90 | (9) |
|
|
|
91 | (1) |
|
2 Board of Directors or Board of Managers |
|
|
92 | (2) |
|
3 Scientific Advisory Board |
|
|
94 | (1) |
|
|
|
94 | (1) |
|
a Chief Executive Officer |
|
|
95 | (1) |
|
b Chief Financial Officer |
|
|
95 | (1) |
|
c Chief Scientific Officer |
|
|
96 | (1) |
|
|
|
96 | (1) |
|
|
|
97 | (2) |
|
D Entity Selection and Formation |
|
|
99 | (21) |
|
|
|
99 | (1) |
|
2 Sole Proprietorships and Partnerships |
|
|
99 | (1) |
|
|
|
100 | (1) |
|
|
|
101 | (1) |
|
|
|
102 | (1) |
|
|
|
102 | (1) |
|
d Transferability of Ownership |
|
|
102 | (1) |
|
|
|
102 | (1) |
|
|
|
103 | (1) |
|
|
|
103 | (1) |
|
|
|
104 | (1) |
|
|
|
104 | (1) |
|
|
|
105 | (1) |
|
|
|
105 | (1) |
|
|
|
105 | (1) |
|
|
|
105 | (3) |
|
|
|
108 | (1) |
|
|
|
108 | (2) |
|
|
|
110 | (3) |
|
|
|
113 | (3) |
|
|
|
116 | (1) |
|
7 State of Incorporation or Organization |
|
|
117 | (2) |
|
|
|
119 | (1) |
|
|
|
119 | (1) |
|
|
|
119 | (1) |
|
|
|
120 | (1) |
|
|
|
120 | (1) |
|
|
|
120 | (1) |
|
E Capital Structure and Stock Grants |
|
|
120 | (10) |
|
|
|
120 | (1) |
|
2 Securities Law Compliance |
|
|
121 | (1) |
|
3 Founders' Stock, Restricted Stock, and Stock Options |
|
|
122 | (1) |
|
a Grants or Sales of Stock |
|
|
122 | (1) |
|
|
|
123 | (1) |
|
c Warrants and Stock Options |
|
|
124 | (5) |
|
4 Common and Preferred Stock |
|
|
129 | (1) |
|
|
|
129 | (1) |
|
6 Simple Agreement for Future Equity |
|
|
130 | (1) |
|
7 Series Seed Preferred Stock |
|
|
130 | (1) |
|
|
|
130 | (1) |
|
G University Relationships |
|
|
131 | (1) |
|
H Early Stage Company Agreements |
|
|
131 | (9) |
|
1 Brief Review of Intellectual Property for the Non-Intellectual Property Attorney |
|
|
131 | (1) |
|
|
|
132 | (1) |
|
|
|
132 | (1) |
|
|
|
132 | (1) |
|
|
|
133 | (1) |
|
2 Confidentiality Agreements |
|
|
133 | (3) |
|
3 Material Transfer Agreements |
|
|
136 | (2) |
|
4 Research Collaboration Agreements |
|
|
138 | (2) |
|
I Positioning for an Exit |
|
|
140 | (31) |
|
Chapter Four Acquisition of Biotechnology--Technology Transfer |
|
|
171 | (70) |
|
|
|
|
|
172 | (16) |
|
1 Protecting Propriety of the Invention in the Early Stages |
|
|
172 | (1) |
|
a Confidentiality Agreements |
|
|
172 | (1) |
|
|
|
173 | (1) |
|
|
|
174 | (1) |
|
2 Keeping Necessary Records |
|
|
175 | (1) |
|
3 Who Owns What? (Employer versus Employee and Joint Venture Issues) |
|
|
175 | (1) |
|
|
|
175 | (3) |
|
|
|
178 | (1) |
|
|
|
178 | (1) |
|
d Canadian and European Union Laws |
|
|
179 | (1) |
|
|
|
180 | (1) |
|
f Joint Venture Ownership |
|
|
181 | (1) |
|
4 Patent Filing: Protecting an Invention and Limiting Others' Use |
|
|
182 | (1) |
|
|
|
182 | (1) |
|
|
|
182 | (1) |
|
c Patent Claims and Rights |
|
|
183 | (1) |
|
d Types and Stages of Patents |
|
|
183 | (1) |
|
|
|
184 | (1) |
|
f Post-Issue Considerations |
|
|
185 | (1) |
|
|
|
185 | (1) |
|
5 Possible Effects of Outside Funding |
|
|
185 | (1) |
|
|
|
185 | (2) |
|
|
|
187 | (1) |
|
c Manufacturing or Sales Restrictions |
|
|
187 | (1) |
|
B Forms of Technology Transfer |
|
|
188 | (8) |
|
|
|
188 | (1) |
|
|
|
188 | (1) |
|
|
|
189 | (1) |
|
|
|
189 | (1) |
|
|
|
190 | (1) |
|
a Common Form of Transfer |
|
|
190 | (1) |
|
b Alternative to Assignment |
|
|
190 | (1) |
|
|
|
191 | (1) |
|
|
|
192 | (1) |
|
a Fair Use and Experimental Use |
|
|
192 | (2) |
|
|
|
194 | (1) |
|
c Doctrine and Agreements' Effect on IP Ownership and Due Diligence |
|
|
194 | (1) |
|
|
|
195 | (1) |
|
C Typical Considerations of the Licensor |
|
|
196 | (6) |
|
1 Having Incentives to Disclose Inventions |
|
|
196 | (1) |
|
2 Considering First to Invent versus First to File |
|
|
196 | (1) |
|
3 Deciding Whether to License to Startups versus Established Companies |
|
|
197 | (1) |
|
4 Emerging and Early Stage of Technology |
|
|
197 | (1) |
|
5 Reimbursing the Cost of IP Protection |
|
|
198 | (1) |
|
6 Disconnect between Universities/Nonprofits and Industry with IP Rights Arising from Sponsored Research |
|
|
198 | (1) |
|
7 Education of Faculty and Staff Regarding IP Issues |
|
|
199 | (1) |
|
8 Free or One-Size-Fits-All Models for Technology Licensing |
|
|
199 | (1) |
|
9 Additional Considerations |
|
|
200 | (1) |
|
|
|
200 | (1) |
|
|
|
200 | (1) |
|
|
|
200 | (1) |
|
d Reimbursement of Patent Costs |
|
|
200 | (1) |
|
e Consultation/Say-So in Approving Sublicensees |
|
|
200 | (1) |
|
f Statement Licensee Will Not Sue |
|
|
201 | (1) |
|
g Requirement That Sublicensees Are Subject to License Terms |
|
|
201 | (1) |
|
|
|
201 | (1) |
|
|
|
201 | (1) |
|
j Minimal Representations and Warranties |
|
|
201 | (1) |
|
k Sufficiency of Insurance |
|
|
201 | (1) |
|
|
|
202 | (1) |
|
|
|
202 | (1) |
|
n Due Diligence Milestones and Fair Return Targets to Satisfy Bayh-Dole Act |
|
|
202 | (1) |
|
|
|
202 | (1) |
|
p Sponsored Research Opportunities |
|
|
202 | (1) |
|
|
|
202 | (23) |
|
1 University Considerations |
|
|
202 | (3) |
|
a Considerations of Employee/Researcher |
|
|
205 | (1) |
|
b Considerations of Community and Society (and Also, Sometimes, the University) |
|
|
206 | (1) |
|
2 Material Transfer Agreements |
|
|
207 | (1) |
|
3 Principal Investigator Considerations |
|
|
208 | (1) |
|
a Conflict of Interest and Conflict of Commitment |
|
|
208 | (1) |
|
|
|
209 | (1) |
|
|
|
209 | (1) |
|
|
|
210 | (1) |
|
4 Licensee Considerations |
|
|
210 | (1) |
|
a Policies and Procedures |
|
|
211 | (1) |
|
b It Is a Long Way to Market, So Wrap Up the People You Need |
|
|
211 | (1) |
|
|
|
212 | (1) |
|
|
|
212 | (1) |
|
5 Interests of Other Stakeholders |
|
|
213 | (1) |
|
|
|
213 | (1) |
|
|
|
213 | (1) |
|
c Special Government Considerations |
|
|
214 | (1) |
|
|
|
214 | (1) |
|
|
|
215 | (1) |
|
a License Only, Not an Assignment |
|
|
215 | (1) |
|
|
|
215 | (1) |
|
c Restrictions on Participation by the Inventors |
|
|
215 | (1) |
|
|
|
215 | (1) |
|
|
|
216 | (1) |
|
|
|
216 | (1) |
|
|
|
216 | (1) |
|
h Sublicensee Subject to License Terms |
|
|
216 | (1) |
|
i Original Licensee Always Liable |
|
|
216 | (1) |
|
j Cannot Use the Name of the University |
|
|
216 | (1) |
|
k Government Has a License |
|
|
216 | (1) |
|
|
|
216 | (1) |
|
7 Common Guidelines for Price and Provisions of the License |
|
|
217 | (1) |
|
|
|
217 | (1) |
|
|
|
217 | (1) |
|
c Minimum Annual Payments |
|
|
217 | (1) |
|
d Periodic Licensing Fees (Such as Quarterly or Annual) |
|
|
217 | (1) |
|
e Participation in Third-Party Payments |
|
|
217 | (1) |
|
|
|
218 | (1) |
|
|
|
218 | (1) |
|
|
|
218 | (1) |
|
|
|
218 | (1) |
|
|
|
218 | (1) |
|
|
|
218 | (1) |
|
|
|
219 | (1) |
|
8 When Equity Is the Primary Consideration for the License |
|
|
219 | (1) |
|
|
|
219 | (1) |
|
|
|
220 | (1) |
|
9 Applicability of Bayh-Dole Act |
|
|
220 | (1) |
|
a Written Employee Agreements |
|
|
220 | (1) |
|
|
|
221 | (1) |
|
|
|
221 | (1) |
|
|
|
221 | (1) |
|
e United States Retains License |
|
|
221 | (1) |
|
f License Only, No Assignment? |
|
|
221 | (1) |
|
g Termination of License If Commercialization Is Inadequate |
|
|
222 | (1) |
|
|
|
222 | (1) |
|
10 Application of "CREATE" Act of 2004 |
|
|
223 | (1) |
|
11 Conflict between Publication and Protection of IP |
|
|
224 | (1) |
|
a Academicians Want to Publish |
|
|
224 | (1) |
|
|
|
224 | (1) |
|
E Transfer from Other Nonprofit Entities |
|
|
225 | (4) |
|
1 Implications of Nonprofit Status |
|
|
225 | (1) |
|
2 Unrelated Business Income Tax |
|
|
225 | (1) |
|
3 Priorities of Nonprofit Technology Owner |
|
|
226 | (1) |
|
4 Joint Venturing (Especially Qualification for STTR Grants) |
|
|
227 | (1) |
|
|
|
227 | (1) |
|
|
|
227 | (1) |
|
c Problems with STTR and SBIR Grants |
|
|
228 | (1) |
|
|
|
228 | (1) |
|
F Transfer from Individuals |
|
|
229 | (10) |
|
|
|
229 | (1) |
|
|
|
229 | (1) |
|
|
|
229 | (1) |
|
|
|
229 | (1) |
|
|
|
229 | (1) |
|
e Scope of the Assignment or License |
|
|
230 | (1) |
|
|
|
231 | (1) |
|
|
|
231 | (1) |
|
h Follow-on and Later-Developed Technology |
|
|
231 | (1) |
|
i Term and Renewal of License |
|
|
231 | (1) |
|
|
|
232 | (1) |
|
|
|
232 | (1) |
|
|
|
232 | (1) |
|
|
|
232 | (1) |
|
|
|
233 | (1) |
|
o Reporting and Marketing Responsibility |
|
|
233 | (1) |
|
p Representations and Warranties of the Inventor |
|
|
233 | (1) |
|
|
|
234 | (1) |
|
|
|
234 | (1) |
|
|
|
234 | (1) |
|
|
|
234 | (1) |
|
|
|
234 | (1) |
|
|
|
235 | (1) |
|
|
|
235 | (1) |
|
2 Common Negotiation Points |
|
|
235 | (1) |
|
a Price Paid/Consideration |
|
|
235 | (1) |
|
b Fees and Royalties Are Both Negotiable Points |
|
|
236 | (1) |
|
|
|
236 | (1) |
|
|
|
236 | (1) |
|
|
|
237 | (1) |
|
|
|
237 | (1) |
|
g Confirmation of Ownership |
|
|
238 | (1) |
|
|
|
238 | (1) |
|
G Summary--What We Learned in Kindergarten |
|
|
239 | (2) |
|
Chapter Five Financing a Biotech Company |
|
|
241 | (70) |
|
|
|
|
|
|
|
242 | (5) |
|
|
|
243 | (2) |
|
2 Product Development Time Lines |
|
|
245 | (2) |
|
B Basic Securities Law Considerations |
|
|
247 | (9) |
|
1 Registration or Exemption under the Securities Act |
|
|
247 | (1) |
|
2 Section 4(2) Exempt Transaction |
|
|
248 | (1) |
|
3 Regulation D Exempt Transaction |
|
|
249 | (3) |
|
4 New Section 4(6) "Crowdfunding" Exempt Transaction |
|
|
252 | (3) |
|
5 Rule 701--Compensation Plans |
|
|
255 | (1) |
|
|
|
255 | (1) |
|
C Pre-Seed and Seed Capital |
|
|
256 | (24) |
|
|
|
257 | (2) |
|
a Restrictions on Transfer |
|
|
259 | (1) |
|
|
|
259 | (1) |
|
|
|
259 | (1) |
|
|
|
260 | (1) |
|
|
|
261 | (1) |
|
|
|
261 | (1) |
|
|
|
262 | (1) |
|
|
|
263 | (1) |
|
|
|
264 | (1) |
|
|
|
264 | (1) |
|
3 Stock to Service or Technology Providers |
|
|
265 | (1) |
|
|
|
266 | (1) |
|
|
|
266 | (1) |
|
|
|
267 | (1) |
|
|
|
268 | (1) |
|
|
|
268 | (1) |
|
|
|
268 | (1) |
|
|
|
269 | (1) |
|
|
|
269 | (1) |
|
|
|
270 | (1) |
|
|
|
270 | (1) |
|
|
|
271 | (1) |
|
|
|
272 | (1) |
|
|
|
273 | (1) |
|
8 Generating Revenues to Reduce or Defer Need for Investment |
|
|
273 | (1) |
|
|
|
274 | (1) |
|
|
|
274 | (1) |
|
|
|
274 | (1) |
|
|
|
275 | (1) |
|
|
|
276 | (1) |
|
c Advantages to Receiving Federal Grant Funding |
|
|
277 | (1) |
|
d Disadvantages to Receiving Federal Grant Funding |
|
|
277 | (1) |
|
e Eligibility/More Than 50 Percent Rule |
|
|
278 | (2) |
|
|
|
280 | (1) |
|
|
|
280 | (8) |
|
|
|
282 | (1) |
|
|
|
282 | (1) |
|
|
|
282 | (1) |
|
c Participating Preferred |
|
|
283 | (1) |
|
|
|
283 | (1) |
|
e Protection of Ownership Percentage |
|
|
283 | (1) |
|
|
|
284 | (1) |
|
|
|
284 | (1) |
|
b Protective Provisions/Class Voting |
|
|
285 | (1) |
|
|
|
285 | (1) |
|
|
|
286 | (1) |
|
|
|
286 | (1) |
|
|
|
286 | (1) |
|
|
|
287 | (1) |
|
5 Series B--Time to Start All Over |
|
|
287 | (1) |
|
|
|
288 | (2) |
|
F Philanthropic or Social Investing |
|
|
290 | (1) |
|
|
|
291 | (3) |
|
|
|
294 | (3) |
|
1 Private Investments in Public Equity |
|
|
294 | (1) |
|
|
|
295 | (1) |
|
|
|
296 | (1) |
|
|
|
297 | (1) |
|
Appendix A Glossary of Frequently Used Basic Equity, Venture Capital, and Securities Law Terms |
|
|
298 | (13) |
|
|
|
298 | (2) |
|
|
|
300 | (5) |
|
|
|
305 | (6) |
|
Chapter Six Employment Issues for Biotechnology Companies |
|
|
311 | (64) |
|
|
|
|
|
311 | (1) |
|
B Employee or Independent Contractor |
|
|
312 | (9) |
|
1 The Common Law Control Test |
|
|
313 | (1) |
|
|
|
314 | (1) |
|
|
|
315 | (1) |
|
|
|
316 | (1) |
|
|
|
316 | (1) |
|
|
|
317 | (1) |
|
4 The Economic Reality Test |
|
|
317 | (2) |
|
|
|
319 | (2) |
|
C Employer Coverage under Federal Civil Rights Laws |
|
|
321 | (4) |
|
1 Title VII of the Civil Rights Act of 1964(42 U.S.C. § 2000e et seq.) |
|
|
321 | (1) |
|
|
|
321 | (1) |
|
|
|
322 | (1) |
|
2 ADEA (29 U.S.C. § 621 et seq.) |
|
|
322 | (1) |
|
|
|
322 | (1) |
|
b Older Workers Benefit Protection Act |
|
|
323 | (1) |
|
3 ADA (42 U.S.C. § 12101 et seq.) |
|
|
323 | (1) |
|
|
|
323 | (1) |
|
b Reasonable Accommodation |
|
|
324 | (1) |
|
4 Equal Pay Act (29 U.S.C. § 206(d)) |
|
|
324 | (1) |
|
5 Genetic Information Nondiscrimination Act of 2008 (Pub. L. No. 110-233, 122 Stat. 881) |
|
|
324 | (1) |
|
D Employer Coverage under State and Local Civil Rights Laws |
|
|
325 | (1) |
|
|
|
325 | (1) |
|
2 Local Laws and Ordinances |
|
|
325 | (1) |
|
E Equal Opportunity and Affirmative Action Obligations of Government Contractors and Subcontractors |
|
|
325 | (1) |
|
F Other Federal Employment Laws |
|
|
326 | (26) |
|
1 FLSA (29 U.S.C. § 201 et seq.) |
|
|
326 | (1) |
|
|
|
326 | (1) |
|
|
|
327 | (1) |
|
|
|
328 | (3) |
|
|
|
331 | (1) |
|
|
|
331 | (1) |
|
2 FMLA (29 U.S.C. § 2601 et seq.) |
|
|
331 | (1) |
|
3 NLRA (29 U.S.C. § 151 et seq.) |
|
|
332 | (1) |
|
|
|
332 | (1) |
|
b Employee Rights under the NLRA |
|
|
332 | (1) |
|
c "Protected Concerted Activity" |
|
|
333 | (1) |
|
|
|
333 | (1) |
|
e NLRA Applicability to Nonunion Employers |
|
|
334 | (2) |
|
4 ERISA (29 U.S.C. § 1001 et seq.) |
|
|
336 | (1) |
|
5 Occupational Safety and Health Act (29 U.S.C. § 651 et seq.) |
|
|
336 | (1) |
|
6 Immigration Reform and Control Act of 1986 (18 U.S.C. §§ 274A-274C) |
|
|
337 | (1) |
|
7 Uniformed Services Employment and Reemployment Rights Act of 1994 (38 U.S.C. § 4301 et seq.) |
|
|
338 | (1) |
|
8 Fair Credit Reporting Act (15 U.S.C. § 1681 et seq.) |
|
|
338 | (1) |
|
a Written Notice and Authorization |
|
|
339 | (1) |
|
b Adverse Actions Procedures |
|
|
339 | (1) |
|
9 Employee Polygraph Protection Act (29 U.S.C. § 2001 et seq.) |
|
|
340 | (1) |
|
10 The Affordable Care Act--Nursing Mothers (29 U.S.C. § 207(r)) |
|
|
340 | (1) |
|
G Use of Employment Contracts |
|
|
340 | (1) |
|
1 When Is an Employment Agreement Useful? |
|
|
340 | (1) |
|
|
|
341 | (1) |
|
|
|
341 | (1) |
|
c Defined Performance Expectations |
|
|
341 | (1) |
|
d Defined Compensation Expectations |
|
|
341 | (1) |
|
e Confidentiality and Intellectual Property Ownership |
|
|
341 | (1) |
|
|
|
342 | (1) |
|
|
|
342 | (1) |
|
|
|
343 | (1) |
|
|
|
343 | (9) |
|
|
|
352 | (5) |
|
|
|
352 | (1) |
|
|
|
352 | (1) |
|
|
|
353 | (1) |
|
|
|
354 | (1) |
|
a Disclaimers and At-Will Statements |
|
|
354 | (1) |
|
|
|
354 | (1) |
|
|
|
354 | (1) |
|
d Family and Medical Leave Policy |
|
|
355 | (1) |
|
e E-mail, Computer Usage, and Social Media Policies |
|
|
355 | (1) |
|
f Description of Benefits |
|
|
356 | (1) |
|
|
|
356 | (1) |
|
I Immigration Options for Biotech Employees |
|
|
357 | (18) |
|
1 Obtaining a Visa and U.S. Entry |
|
|
357 | (2) |
|
|
|
359 | (1) |
|
a H-1B "Specialty Worker" Visa |
|
|
359 | (2) |
|
b TN "NAFTA Professional" Visa |
|
|
361 | (1) |
|
c L-l "Intracompany Transfer" Visa |
|
|
362 | (1) |
|
d E-l "Treaty Trader" and E-2 "Treaty Investor" Visas |
|
|
363 | (1) |
|
e E-3 Visa for Australian Professionals |
|
|
364 | (1) |
|
f O-1 "Extraordinary Ability Alien" Visa |
|
|
365 | (1) |
|
g F-l Student Visa and Practical Training |
|
|
366 | (2) |
|
3 Immigrant Visas and Permanent Residence Status |
|
|
368 | (1) |
|
|
|
369 | (2) |
|
b Visa Backlogs and Priority Dates |
|
|
371 | (1) |
|
|
|
371 | (2) |
|
d Immigrant Visa and Adjustment of Status |
|
|
373 | (2) |
|
Chapter Seven Regulation of Preclinical Research |
|
|
375 | (38) |
|
|
|
|
|
375 | (1) |
|
B Animal Use in Biomedical Research and Testing |
|
|
376 | (22) |
|
1 The Basic Regulatory Scheme--The Animal Welfare Act and Regulations |
|
|
376 | (1) |
|
|
|
376 | (3) |
|
b Overview of the AWA Regulations |
|
|
379 | (8) |
|
c Implementation and Enforcement of the AWA and the AWA Regulations by APHIS |
|
|
387 | (1) |
|
2 U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training |
|
|
388 | (1) |
|
3 Memorandum of Understanding among APHIS, the Food and Drug Administration, and the NIH |
|
|
389 | (1) |
|
|
|
390 | (1) |
|
a Health Research Extension Act |
|
|
390 | (1) |
|
b NIH Extramural Research |
|
|
391 | (1) |
|
c Guide for the Care and Use of Laboratory Animals and Institutional Animal Care and Use Committee Guidebook |
|
|
392 | (1) |
|
d NIH Policies Regarding the Use of Chimpanzees in Research |
|
|
393 | (2) |
|
5 FDA Considerations and Good Laboratory Practices |
|
|
395 | (2) |
|
|
|
397 | (1) |
|
|
|
398 | (1) |
|
|
|
398 | (1) |
|
C Other Regulatory Schemes Applicable to Preclinical Research-- Protection of the Environment and Public Health |
|
|
398 | (9) |
|
|
|
398 | (1) |
|
2 EPA Jurisdiction and the Resource Conservation and Recovery Act |
|
|
399 | (3) |
|
3 Applying Environmental Law to Academic Research Facilities |
|
|
402 | (1) |
|
|
|
403 | (1) |
|
5 The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 and Select Agents and Toxins |
|
|
403 | (4) |
|
D Other Regulatory Schemes Applicable to Preclinical Research-- Occupational Safety and Health Considerations and the Protection of Individuals Conducting Preclinical Research |
|
|
407 | (3) |
|
|
|
407 | (1) |
|
2 OSHA Regulation, Standards, and Resources |
|
|
407 | (2) |
|
3 Selected Resource Tools--Chemicals and Biohazards |
|
|
409 | (1) |
|
4 Radioactive Materials in the Research Setting |
|
|
410 | (1) |
|
|
|
410 | (1) |
|
|
|
411 | (2) |
|
Chapter Eight Research and Development Collaborations |
|
|
413 | (36) |
|
|
|
|
|
A Introduction: The Collaborator as Biotechnology's White Knight |
|
|
413 | (2) |
|
B Finding a Strategic Partner: Beating the Mathematical Odds |
|
|
415 | (7) |
|
1 Don't Expect Big Pharma to Find You |
|
|
417 | (1) |
|
|
|
417 | (1) |
|
3 Approaching Big Pharma with an Opportunity to Collaborate |
|
|
418 | (1) |
|
4 Use of Third Parties as Valuable Contacts |
|
|
418 | (1) |
|
C Negotiating a Term Sheet |
|
|
419 | (1) |
|
1 The Importance of the Term Sheet to the Transaction |
|
|
419 | (1) |
|
2 Issues Crucial to Address at the Term Sheet Stage |
|
|
420 | (1) |
|
3 Issues to Avoid Negotiating at the Term Sheet Stage |
|
|
421 | (1) |
|
D Key Issues in a Research Collaboration Agreement |
|
|
422 | (21) |
|
1 Governance of the Research Collaboration |
|
|
422 | (1) |
|
a Composition of the Joint Steering Committee |
|
|
422 | (1) |
|
b Duties of the Joint Steering Committee |
|
|
423 | (1) |
|
c Meetings of the Joint Steering Committee |
|
|
423 | (1) |
|
d Decision Making by the Joint Steering Committee |
|
|
424 | (1) |
|
2 The Scope of the Collaboration |
|
|
424 | (1) |
|
|
|
425 | (1) |
|
b Scope Limitations Based on Patent Family |
|
|
426 | (1) |
|
c Scope Limitations Based on Timing |
|
|
426 | (1) |
|
d Scope Limitations Based on Project Funding |
|
|
426 | (1) |
|
|
|
427 | (1) |
|
a Core IP of the Target, Developed Prior, but Highly Relevant, to the Collaboration |
|
|
427 | (1) |
|
b Core IP of the Larger Funding Partner, Developed Prior, but Highly Relevant, to the Collaboration |
|
|
428 | (1) |
|
c Background IP of the Target, Developed Prior to the Collaboration but of Possible Utility |
|
|
428 | (1) |
|
d Background IP of the Larger Funding Partner, Developed Prior to the Collaboration but of Possible Utility |
|
|
429 | (1) |
|
e IP Developed by One or Both Parties Arising out of the Collaboration |
|
|
429 | (1) |
|
f IP Developed by the Target during, but outside of, the Collaboration |
|
|
429 | (1) |
|
g Novel IP Developed by One or Both Parties during the Collaboration That Does Not Arise out of the Existing IP of Either Party |
|
|
430 | (1) |
|
|
|
430 | (1) |
|
|
|
431 | (1) |
|
b Development and Commercialization Licenses |
|
|
431 | (1) |
|
c Cross-Licenses; Freedom to Operate |
|
|
431 | (1) |
|
|
|
432 | (1) |
|
e License as Protection against Infringement Claims |
|
|
432 | (1) |
|
f Protect the IP against a Later Attack on the Patents |
|
|
432 | (1) |
|
|
|
433 | (1) |
|
|
|
433 | (1) |
|
|
|
434 | (1) |
|
|
|
434 | (3) |
|
|
|
437 | (1) |
|
6 Option to Develop and Commercialize |
|
|
438 | (1) |
|
|
|
439 | (1) |
|
|
|
439 | (1) |
|
c Right of First Negotiation |
|
|
440 | (1) |
|
d Rights in Unoptioned IP |
|
|
440 | (2) |
|
|
|
442 | (1) |
|
|
|
442 | (1) |
|
|
|
442 | (1) |
|
E Post-Closing Pitfalls That Can Derail an R&D Collaboration |
|
|
443 | (1) |
|
1 Change in Strategic Fit or Commitment to the Project |
|
|
443 | (1) |
|
2 Communication and Control Issues |
|
|
444 | (1) |
|
3 Unrealistic Expectations |
|
|
444 | (1) |
|
F Alliances with Third Parties--Keeping Other Options Open |
|
|
444 | (3) |
|
1 Right of First Refusal May Preclude Other Transactions |
|
|
446 | (1) |
|
2 Right of First Negotiation May Also Have a Chilling Effect |
|
|
446 | (1) |
|
3 The Deal May Be Worth It; Rely on Contractual Protections |
|
|
446 | (1) |
|
G Conclusion: Where Do the Parties Go from Here? |
|
|
447 | (2) |
|
Chapter Nine Federal Regulation of Clinical Research |
|
|
449 | (52) |
|
|
|
|
|
|
|
|
|
450 | (8) |
|
1 The Role of Clinical Research |
|
|
450 | (2) |
|
2 Government Entities That Regulate Clinical Research |
|
|
452 | (1) |
|
|
|
452 | (1) |
|
b HHS: Office for Human Research Protections |
|
|
453 | (1) |
|
|
|
453 | (1) |
|
d HHS: Office of Civil Rights |
|
|
454 | (1) |
|
|
|
455 | (1) |
|
f HHS: Office of Inspector General |
|
|
456 | (1) |
|
|
|
456 | (1) |
|
|
|
457 | (1) |
|
B The Roles and Responsibilities of the Parties |
|
|
458 | (4) |
|
|
|
458 | (1) |
|
|
|
458 | (1) |
|
|
|
458 | (1) |
|
|
|
459 | (1) |
|
|
|
460 | (1) |
|
|
|
460 | (1) |
|
7 Data Monitoring Committee |
|
|
461 | (1) |
|
8 Institutional Biosafety Committee |
|
|
461 | (1) |
|
C Premarket Clinical Trial Process |
|
|
462 | (24) |
|
|
|
462 | (1) |
|
a Exploratory INDs (Phase 0 Trials) |
|
|
462 | (1) |
|
|
|
463 | (1) |
|
|
|
463 | (1) |
|
3 Prior to Start of Clinical Trial |
|
|
464 | (1) |
|
a Designing the Clinical Trial |
|
|
464 | (3) |
|
b Selecting Qualified Investigators |
|
|
467 | (1) |
|
c Obtaining IRB Review and Approval |
|
|
468 | (1) |
|
d Obtaining Informed Consent from Subjects |
|
|
468 | (3) |
|
e Submitting an IND or IDE |
|
|
471 | (4) |
|
|
|
475 | (1) |
|
|
|
476 | (1) |
|
a Reporting, Auditing, and Recordkeeping |
|
|
476 | (5) |
|
b Terminating an IND or IDE |
|
|
481 | (2) |
|
|
|
483 | (1) |
|
|
|
483 | (1) |
|
b Clinical Trial Results Posting |
|
|
484 | (1) |
|
c Other Dissemination of Clinical Trial Results |
|
|
485 | (1) |
|
|
|
486 | (5) |
|
|
|
486 | (1) |
|
|
|
487 | (1) |
|
3 Warning and Untitled Letters |
|
|
488 | (1) |
|
4 Administrative Consequences |
|
|
489 | (2) |
|
5 Civil and Criminal Liability |
|
|
491 | (1) |
|
|
|
491 | (9) |
|
|
|
491 | (1) |
|
|
|
491 | (1) |
|
b Trials Required Pursuant to Section 505(o) |
|
|
492 | (1) |
|
c Deferred Pediatric Studies |
|
|
493 | (1) |
|
d Studies to Support Pediatric Exclusivity |
|
|
493 | (1) |
|
e Voluntary Research to Support New Conditions of Use |
|
|
494 | (1) |
|
f Investigator-Initiated Trials |
|
|
494 | (1) |
|
2 Sites and Trials in Foreign Countries |
|
|
494 | (2) |
|
|
|
496 | (1) |
|
|
|
496 | (2) |
|
|
|
498 | (2) |
|
|
|
500 | (1) |
|
Chapter Ten Privacy Issues for Biotechnology Companies |
|
|
501 | (74) |
|
|
|
|
|
501 | (3) |
|
1 Overview of Relevant Privacy Laws |
|
|
501 | (2) |
|
2 How Do HIPAA and the Privacy Laws Apply to Biotechnology Companies? |
|
|
503 | (1) |
|
B HIPAA, the Privacy Rule, the Security Rule, the Breach Notification Rule, and the Health Information Technology for Economic and Clinical Health Act |
|
|
504 | (48) |
|
1 Basic Overview and Important Definitions |
|
|
504 | (1) |
|
a Statutory and Regulatory Background |
|
|
504 | (1) |
|
|
|
505 | (4) |
|
|
|
509 | (1) |
|
a Notice of Privacy Practices (45 C.F.R. § 164.520) |
|
|
510 | (1) |
|
b Restriction of PHI by Individuals (45 C.F.R. § 164.522(a)) |
|
|
510 | (1) |
|
c Access to PHI by Individuals (45 C.F.R. § 164.524) |
|
|
511 | (1) |
|
d Amendment or Change of PHI (45 C.F.R. § 164.526) |
|
|
512 | (1) |
|
e Accounting of Disclosures (45 C.F.R. § 164.528) |
|
|
513 | (2) |
|
f Complaints (45 C.F.R. § 160.306) |
|
|
515 | (1) |
|
3 Permissible Uses and Disclosures of PHI That Do Not Require Authorization |
|
|
515 | (1) |
|
a Uses and Disclosures for Treatment, Payment, and Health Care Operations (45 C.F.R. § 164.506(c)) |
|
|
516 | (1) |
|
b Uses and Disclosures for Fund-Raising Activities (45 C.F.R. § 164.514(f)) |
|
|
516 | (1) |
|
c Disclosures Required by Law (45 C.F.R. § 164.512(a)) |
|
|
517 | (1) |
|
d Disclosures for Public Health Activities (Including Child Abuse Reporting) (45 C.F.R. § 164.512(b)) |
|
|
517 | (1) |
|
e Disclosures for Victims of Abuse, Neglect, or Domestic Violence (45 C.F.R. § 164.512(c)) |
|
|
518 | (1) |
|
f Disclosures for Health Oversight Activities (45 C.F.R. § 164.512(d)) |
|
|
519 | (1) |
|
g Disclosures for Judicial and Administrative Proceedings (45 C.F.R. § 164.512(e)) |
|
|
519 | (2) |
|
h Disclosures for Law Enforcement Purposes (45 C.F.R. § 164.512(f)) |
|
|
521 | (1) |
|
i Disclosures about Decedents to Coroners, Medical Examiners, and Funeral Directors (45 C.F.R. § 164.512(g)) |
|
|
521 | (1) |
|
j Uses and Disclosures for Cadaveric Organ, Eye, or Tissue Donation Purposes (45 C.F.R. § 164.512(h)) |
|
|
521 | (1) |
|
k Uses and Disclosures for Research Purposes (45 C.F.R. § 164.512(i)) |
|
|
521 | (4) |
|
l Disclosures to Avert a Serious Threat to Health or Safety (45 C.F.R. § 164.512(j)) |
|
|
525 | (1) |
|
m Disclosures for Specialized Government Functions (45C.F.R. § 164.512(k)) |
|
|
526 | (1) |
|
n Disclosures for Workers' Compensation (45 C.F.R. § 164.512(1)) |
|
|
526 | (1) |
|
|
|
526 | (1) |
|
a Disclosures to Business Associates (45 C.F.R. § 164.502(e)(l)(i)) |
|
|
526 | (1) |
|
b BAAs (45 C.F.R. § 164.504(e)) |
|
|
527 | (2) |
|
c Direct Liability of Business Associates |
|
|
529 | (1) |
|
5 Uses or Disclosures That Require Authorization |
|
|
530 | (1) |
|
a Uses and Disclosures for Marketing (45 C.F.R. § 164.508(a)(3)) |
|
|
530 | (2) |
|
b Sale of PHI (45 C.F.R. § 164.502(a)(5)(h)) |
|
|
532 | (1) |
|
6 Uses and Disclosures Requiring an Opportunity to Agree or Object (45 C.F.R. § 164.510) |
|
|
533 | (1) |
|
7 HIPAA-Compliant Authorizations (45 C.F.R. § 164.508) |
|
|
534 | (1) |
|
|
|
535 | (1) |
|
b Defective Authorizations |
|
|
535 | (1) |
|
c Compound Authorizations |
|
|
536 | (1) |
|
d Conditioning Authorizations |
|
|
536 | (1) |
|
e Authorizations for Marketing and the Sale of PHI |
|
|
537 | (1) |
|
|
|
537 | (1) |
|
a When Is an Authorization Required? |
|
|
537 | (1) |
|
b Research Authorization Requirements |
|
|
537 | (3) |
|
c Using a Limited Data Set for Research Purposes |
|
|
540 | (1) |
|
|
|
540 | (1) |
|
10 Notification of Breach Requirements |
|
|
541 | (2) |
|
a Obligations of a Covered Entity (45 C.F.R. § 164.404 et seq.) |
|
|
543 | (1) |
|
b Obligations of a Business Associate (45 C.F.R. § 164.410) |
|
|
544 | (1) |
|
c State Law Considerations |
|
|
545 | (2) |
|
|
|
547 | (1) |
|
a Required Compliance by Business Associates |
|
|
547 | (1) |
|
b Safeguards (45 C.F.R. § 164.306) |
|
|
547 | (2) |
|
12 State Law and Preemption Issues |
|
|
549 | (2) |
|
13 Penalties for Violations of the Privacy Rule and the Security Rule |
|
|
551 | (1) |
|
C The Federal Common Rule and Federal Certificates of Confidentiality |
|
|
552 | (5) |
|
1 The Common Rule and HIPAA |
|
|
552 | (4) |
|
2 Federal Certificates of Confidentiality (42 C.F.R. Part 2a) |
|
|
556 | (1) |
|
D Canadian Privacy Legislation |
|
|
557 | (1) |
|
E General Data Protection Regulation |
|
|
558 | (9) |
|
|
|
561 | (2) |
|
|
|
563 | (1) |
|
|
|
564 | (1) |
|
4 Data Protection Officers |
|
|
565 | (1) |
|
5 Cross-Border Data Transfers |
|
|
566 | (1) |
|
|
|
566 | (1) |
|
|
|
566 | (1) |
|
F California Consumer Privacy Act of 2018 |
|
|
567 | (2) |
|
G Privacy Shield Framework |
|
|
569 | (4) |
|
|
|
573 | (2) |
|
Chapter Eleven Medical Reimbursement |
|
|
575 | (32) |
|
|
|
|
|
|
|
575 | (1) |
|
|
|
576 | (13) |
|
|
|
576 | (1) |
|
|
|
576 | (1) |
|
a Determining the Scope of Benefits |
|
|
577 | (3) |
|
b Checking for Specific Exclusions from Coverage |
|
|
580 | (1) |
|
c The Reasonable and Necessary Test |
|
|
580 | (1) |
|
d Medical Necessity for the Particular Patient |
|
|
581 | (1) |
|
e Implications of Coverage/Non-coverage |
|
|
582 | (1) |
|
|
|
582 | (1) |
|
|
|
583 | (1) |
|
|
|
584 | (2) |
|
|
|
586 | (2) |
|
|
|
588 | (1) |
|
|
|
589 | (7) |
|
1 Coverage, Payment, and Coding for Drugs and Biologicals |
|
|
589 | (2) |
|
2 Coverage, Payment, and Coding for Procedures Involving the Use of Medical Devices |
|
|
591 | (2) |
|
3 Coverage Payment and Coding for DME, Prosthetics, Orthotics, and Supplies |
|
|
593 | (1) |
|
4 Coverage, Payment, and Coding for In Vitro Diagnostics |
|
|
594 | (2) |
|
D Special Payment Rules for New Technologies |
|
|
596 | (2) |
|
|
|
596 | (1) |
|
|
|
596 | (1) |
|
3 Ambulatory Surgical Centers--Payment for New Technology Intraocular Lenses |
|
|
597 | (1) |
|
4 Private Payer Carve-Outs |
|
|
597 | (1) |
|
E Reimbursement for Investigational Products |
|
|
598 | (5) |
|
1 NCD on Routine Costs of Qualifying Clinical Trials |
|
|
598 | (1) |
|
2 Investigational Device Exemptions |
|
|
599 | (1) |
|
F Compliance Considerations |
|
|
600 | (1) |
|
1 Requirements for Proper Billing |
|
|
600 | (2) |
|
2 Reimbursement Support Services |
|
|
602 | (1) |
|
3 Discounts and Related Fraud and Abuse Considerations |
|
|
603 | (1) |
|
|
|
603 | (1) |
|
|
|
604 | (3) |
|
Chapter Twelve Environmental Regulation of Biotechnology |
|
|
607 | (52) |
|
|
|
|
|
607 | (6) |
|
B Regulation of Biotechnology under TSCA |
|
|
613 | (46) |
|
|
|
613 | (5) |
|
2 EPA's TSCA Biotechnology Regulations |
|
|
618 | (1) |
|
|
|
619 | (5) |
|
b Notice of Commencement of Manufacture or Import |
|
|
624 | (1) |
|
c Exemptions from the MCAN Requirement |
|
|
624 | (3) |
|
3 TSCA Experimental Release Application |
|
|
627 | (3) |
|
4 Test Marketing Exemption |
|
|
630 | (2) |
|
5 General Exemptions from the MCAN Requirement |
|
|
632 | (1) |
|
|
|
633 | (1) |
|
|
|
634 | (1) |
|
C Biotechnology Regulation under FIFRA |
|
|
635 | (1) |
|
1 Review of Pesticide Registration Applications |
|
|
635 | (2) |
|
2 Data Requirements for Pesticide Registration Applications |
|
|
637 | (2) |
|
3 Field Tests of Genetically Engineered Pesticides |
|
|
639 | (1) |
|
a Experimental Use Permits |
|
|
639 | (3) |
|
b Information Required for EUP Applications |
|
|
642 | (2) |
|
4 Special Requirements for Biotechnology Pesticide Products |
|
|
644 | (1) |
|
|
|
644 | (1) |
|
|
|
645 | (2) |
|
c Small-Scale Field Tests of Certain Genetically Modified Microbial Pesticides |
|
|
647 | (2) |
|
|
|
649 | (3) |
|
|
|
652 | (1) |
|
f Gene Flow Assessment for PIPs |
|
|
652 | (1) |
|
|
|
653 | (6) |
|
Chapter Thirteen Approval of Biotechnology Products for Human Use |
|
|
659 | (50) |
|
|
|
|
|
|
|
659 | (7) |
|
1 Overview of the FDA Approval Process |
|
|
659 | (1) |
|
|
|
660 | (1) |
|
|
|
660 | (6) |
|
B Standard Pathways to Market |
|
|
666 | (32) |
|
1 Drugs: The Traditional New Drug Application |
|
|
666 | (1) |
|
|
|
666 | (2) |
|
b NDA Content and Format Requirements |
|
|
668 | (1) |
|
c NDA Classification Codes |
|
|
669 | (1) |
|
|
|
670 | (1) |
|
|
|
671 | (1) |
|
|
|
672 | (1) |
|
|
|
673 | (1) |
|
|
|
674 | (1) |
|
i Completion of Review and Decision |
|
|
675 | (1) |
|
j Risk Evaluation and Mitigation Strategies |
|
|
675 | (1) |
|
2 Drugs: The Faster 505(b)(2) Application |
|
|
676 | (1) |
|
|
|
677 | (1) |
|
|
|
677 | (2) |
|
|
|
679 | (8) |
|
|
|
687 | (2) |
|
|
|
689 | (1) |
|
|
|
689 | (1) |
|
b The 510(k) Notification Process |
|
|
690 | (1) |
|
|
|
691 | (1) |
|
d Investigational Device Exemption |
|
|
692 | (2) |
|
|
|
694 | (1) |
|
|
|
694 | (1) |
|
|
|
695 | (1) |
|
c Center with Primary Jurisdiction |
|
|
695 | (1) |
|
d Single or Multiple Marketing Applications |
|
|
696 | (1) |
|
e Request for Designation |
|
|
696 | (2) |
|
C Expedited Pathways to Market |
|
|
698 | (8) |
|
|
|
698 | (2) |
|
|
|
700 | (1) |
|
|
|
701 | (1) |
|
|
|
702 | (1) |
|
5 Rare Pediatric Disease Priority Review |
|
|
702 | (1) |
|
6 Orphan Drug Designation |
|
|
703 | (2) |
|
|
|
705 | (1) |
|
D Future Pathways to Market |
|
|
706 | (1) |
|
|
|
707 | (2) |
|
Chapter Fourteen Agricultural Biotechnology Approval Processes |
|
|
709 | (28) |
|
|
|
|
|
709 | (2) |
|
B U.S. Coordinated Framework |
|
|
711 | (3) |
|
|
|
714 | (2) |
|
1 Notification of Deregulation |
|
|
714 | (1) |
|
2 Permits for PMPs and Industrial Crops |
|
|
715 | (1) |
|
|
|
716 | (4) |
|
|
|
716 | (1) |
|
2 EPA Regulation of Agricultural Chemical Residues |
|
|
717 | (3) |
|
|
|
720 | (3) |
|
F Regulation of Genetic Editing in Agriculture |
|
|
723 | (2) |
|
1 U.S. Regulatory Policy Evolving |
|
|
723 | (1) |
|
2 International Regulation of Genetic Editing in Agriculture |
|
|
723 | (2) |
|
G Role of the States in Regulation of Biotech Crops |
|
|
725 | (4) |
|
1 State-Based Agricultural Management |
|
|
725 | (1) |
|
|
|
725 | (1) |
|
b GMO Labeling Movement and Federal Preemption |
|
|
725 | (2) |
|
c "Noxious" Weed Management |
|
|
727 | (1) |
|
d Managing the Economic Impact of Agricultural Biotechnology |
|
|
727 | (1) |
|
|
|
728 | (1) |
|
|
|
728 | (1) |
|
|
|
729 | (1) |
|
H Biotech Crop Regulation in Other Countries |
|
|
729 | (8) |
|
|
|
730 | (1) |
|
|
|
730 | (1) |
|
|
|
731 | (1) |
|
|
|
732 | (1) |
|
|
|
733 | (4) |
|
Chapter Fifteen Federal and State Regulation after Approval |
|
|
737 | (62) |
|
|
|
|
|
737 | (4) |
|
1 Food and Drug Administration |
|
|
737 | (2) |
|
2 Office of Inspector General, Department of Health and Human Services |
|
|
739 | (1) |
|
|
|
740 | (1) |
|
4 Federal Trade Commission |
|
|
740 | (1) |
|
5 Securities and Exchange Commission |
|
|
741 | (1) |
|
B Postapproval Responsibilities |
|
|
741 | (32) |
|
|
|
742 | (1) |
|
a Drug and Biological Products |
|
|
742 | (1) |
|
|
|
743 | (1) |
|
|
|
743 | (2) |
|
d Mitigating Cybersecurity Risks Related to Networked Medical Devices |
|
|
745 | (1) |
|
|
|
746 | (1) |
|
a Product Problem Reports |
|
|
746 | (2) |
|
b Adverse Experience Reports |
|
|
748 | (4) |
|
c Annual and Periodic Reports |
|
|
752 | (1) |
|
d Early Notification of Possible Drug Shortages |
|
|
753 | (1) |
|
|
|
753 | (2) |
|
3 Import and Export Requirements |
|
|
755 | (1) |
|
|
|
755 | (1) |
|
|
|
755 | (1) |
|
|
|
756 | (2) |
|
4 Regulation of Advertising and Labeling |
|
|
758 | (1) |
|
|
|
758 | (3) |
|
|
|
761 | (1) |
|
c Types of Advertisements |
|
|
762 | (2) |
|
d Limitations on FDA Regulation of Advertising |
|
|
764 | (1) |
|
e Off-Label Use and the Exchange of Scientific Information |
|
|
765 | (2) |
|
f The Good Reprint Practice Guidance |
|
|
767 | (2) |
|
g Proposed Guidance for Responding to Unsolicited Requests for Off-Label Information |
|
|
769 | (1) |
|
h Guidance on Industry-Supported Scientific and Education Activities |
|
|
770 | (2) |
|
i Guidance on Communication of Health Care Economic Information |
|
|
772 | (1) |
|
C Withdrawal of FDA Approval |
|
|
773 | (2) |
|
|
|
775 | (20) |
|
1 The Neurontin Case (2004) |
|
|
776 | (1) |
|
2 The Serono Laboratories Serostim Settlement (2005) |
|
|
776 | (1) |
|
3 The Bristol-Myers Squibb Abilify Settlement (2007) |
|
|
777 | (1) |
|
4 The Cephalon Actiq, Gabitril, and Provigil Settlement (2008) |
|
|
778 | (1) |
|
|
|
778 | (1) |
|
|
|
779 | (1) |
|
|
|
779 | (1) |
|
5 The AstraZeneca Seroquel Settlement (2010) |
|
|
780 | (1) |
|
6 The Allergan Botox Settlement (2010) |
|
|
781 | (1) |
|
7 The Abbott Laboratories Depakote Plea Agreement (2012) |
|
|
782 | (1) |
|
8 The Amgen Aranesp Settlement (2012) |
|
|
783 | (1) |
|
9 The Par Pharmaceuticals Megace ES Settlement (2013) |
|
|
784 | (1) |
|
10 The J&J Risperdal Settlement (2013) |
|
|
785 | (1) |
|
11 The Genzyme Seprafilm Settlement (2013) |
|
|
786 | (1) |
|
12 Endo Pharmaceuticals (2014) |
|
|
787 | (1) |
|
13 Astellas Pharma US Inc. (2014) |
|
|
787 | (1) |
|
14 Shire Pharmaceuticals (2014) |
|
|
788 | (1) |
|
15 NuVasive Inc. Settlement (2015) |
|
|
789 | (1) |
|
16 Medtronic, Inc. Settlement (2015) |
|
|
789 | (1) |
|
17 Warner Chilcott Plea Agreement (2015) |
|
|
790 | (1) |
|
|
|
791 | (1) |
|
19 Acclarent Inc. Settlement (2016) |
|
|
791 | (1) |
|
20 Aegerion Pharmaceuticals Inc. (2017) |
|
|
792 | (1) |
|
21 Shire Pharmaceuticals LLC Settlement (2017) |
|
|
793 | (1) |
|
22 Baxter Healthcare Corp. Settlement (2017) |
|
|
794 | (1) |
|
23 Novo Nordisk Settlement (2017) |
|
|
795 | (1) |
|
E Anti-Kickback Statute and Other Illegal Remuneration |
|
|
795 | (1) |
|
F The Physician Payments Sunshine Act |
|
|
796 | (1) |
|
|
|
797 | (2) |
|
Chapter Sixteen Development and Commercialization Alliances |
|
|
799 | (30) |
|
|
|
|
|
A Introduction: Why Choose to Partner? |
|
|
799 | (1) |
|
B Considerations in Choosing a Partner |
|
|
800 | (1) |
|
C The Stage of the Drug Candidate Will Define the Alliance |
|
|
801 | (5) |
|
|
|
802 | (1) |
|
a Target Identification and Validation |
|
|
802 | (1) |
|
|
|
803 | (1) |
|
|
|
803 | (1) |
|
|
|
803 | (1) |
|
2 Preclinical Stage Licensing |
|
|
804 | (1) |
|
|
|
804 | (1) |
|
b Human Trials in Australia/China |
|
|
804 | (1) |
|
c Investigational New Drug Application |
|
|
805 | (1) |
|
3 Clinical Stage Licensing |
|
|
805 | (1) |
|
|
|
805 | (1) |
|
|
|
805 | (1) |
|
c Clinical Trials (Phase III) |
|
|
805 | (1) |
|
|
|
806 | (1) |
|
D The Development and Commercialization License Agreement |
|
|
806 | (18) |
|
1 Nature and Scope of License Grant |
|
|
806 | (1) |
|
a Identifying the Subject Technology |
|
|
807 | (1) |
|
|
|
807 | (2) |
|
|
|
809 | (1) |
|
d Retained Rights of the Licensor |
|
|
810 | (1) |
|
2 Consideration for the License Grant |
|
|
811 | (1) |
|
|
|
812 | (1) |
|
b Royalty Payments, Generally |
|
|
813 | (4) |
|
c Term of Royalty Payments |
|
|
817 | (1) |
|
d Punitive Reduction in Royalty Rates |
|
|
818 | (1) |
|
e Reduction in Royalty Rates for Third-Party Licenses |
|
|
818 | (1) |
|
|
|
819 | (1) |
|
a Responsibility for Patent Prosecution and Maintenance |
|
|
819 | (1) |
|
b Abandoned Jurisdictions |
|
|
819 | (1) |
|
|
|
819 | (1) |
|
d Trademarks and the Like |
|
|
820 | (1) |
|
e Prosecution of Infringers |
|
|
820 | (1) |
|
4 Cooperation of the Parties during the Regulatory Approval Process |
|
|
821 | (1) |
|
5 Participation in the Upside |
|
|
821 | (1) |
|
|
|
821 | (3) |
|
|
|
824 | (1) |
|
E Anticipating Changes of Control of Either Party |
|
|
824 | (2) |
|
|
|
824 | (1) |
|
|
|
825 | (1) |
|
|
|
825 | (1) |
|
F Terminating the Agreement If the Alliance Fails |
|
|
826 | (2) |
|
1 Material Breach by the Licensee |
|
|
827 | (1) |
|
a The Licensor's Perspective |
|
|
827 | (1) |
|
b The Licensee's Perspective |
|
|
827 | (1) |
|
2 Material Breach by the Licensor |
|
|
827 | (1) |
|
a The Licensor's Perspective |
|
|
827 | (1) |
|
b The Licensee's Perspective |
|
|
827 | (1) |
|
3 Termination without Cause |
|
|
828 | (1) |
|
G Conclusion: The Importance of Getting It Right |
|
|
828 | (1) |
|
Chapter Seventeen Patent Litigation and Dispute Proceedings Overview for the Non-Patent Attorney |
|
|
829 | (56) |
|
|
|
|
|
|
|
829 | (2) |
|
B General Overview of Patent Litigation in Federal Court |
|
|
831 | (6) |
|
1 Patent Infringement Defined |
|
|
831 | (1) |
|
a Direct infringement (35 U.S.C. § 271(a)) |
|
|
832 | (1) |
|
b Indirect Infringement (35 U.S.C. § 271(b), (c)) |
|
|
832 | (1) |
|
c Literal Infringement and Doctrine of Equivalents |
|
|
833 | (1) |
|
|
|
834 | (1) |
|
|
|
834 | (3) |
|
b Applying the Construed Claims to the Accused Product |
|
|
837 | (1) |
|
C Pre-Litigation Considerations |
|
|
837 | (3) |
|
1 Prefiling Investigation |
|
|
837 | (2) |
|
2 Whether to Send a Cease and Desist Letter |
|
|
839 | (1) |
|
D Litigation Procedure Overview |
|
|
840 | (32) |
|
1 Choosing an Appropriate Forum |
|
|
841 | (2) |
|
2 Choosing Appropriate Parties |
|
|
843 | (2) |
|
|
|
845 | (1) |
|
|
|
845 | (1) |
|
b Defenses and Counterclaims |
|
|
846 | (18) |
|
|
|
864 | (1) |
|
|
|
865 | (6) |
|
|
|
871 | (1) |
|
|
|
871 | (1) |
|
E General Overview of Post-Grant Proceedings before the USPTO |
|
|
872 | (6) |
|
|
|
872 | (1) |
|
|
|
873 | (1) |
|
|
|
874 | (1) |
|
|
|
875 | (1) |
|
|
|
876 | (1) |
|
6 Director-Initiated Reexamination |
|
|
877 | (1) |
|
|
|
878 | (1) |
|
|
|
878 | (7) |
|
1 General ADR Considerations |
|
|
878 | (1) |
|
2 Participation by Senior Management |
|
|
879 | (1) |
|
3 Advantages of ADR Confidentiality |
|
|
880 | (1) |
|
4 ADR as an Alternative to Foreign Litigation |
|
|
881 | (4) |
|
Chapter Eighteen The Impact of Bankruptcy |
|
|
885 | (52) |
|
|
|
A Introduction--Bankruptcy Basics |
|
|
885 | (6) |
|
1 The Origin of Modern Bankruptcy Law |
|
|
885 | (2) |
|
2 Bankruptcy Protection for Individuals |
|
|
887 | (2) |
|
3 Bankruptcy Protection for Entities |
|
|
889 | (1) |
|
4 Bankruptcy in Biotech Entities |
|
|
890 | (1) |
|
B A Primer on Creditors' Rights |
|
|
891 | (19) |
|
|
|
891 | (1) |
|
|
|
892 | (1) |
|
|
|
893 | (5) |
|
|
|
898 | (3) |
|
5 Creditors' Right to Representation |
|
|
901 | (3) |
|
6 Debtor's Duty to Creditors |
|
|
904 | (4) |
|
|
|
908 | (2) |
|
C Liquidation versus Reorganization |
|
|
910 | (4) |
|
D The Debtor's Bankruptcy Estate |
|
|
914 | (2) |
|
|
|
916 | (2) |
|
F Contracts and Leases in Bankruptcy |
|
|
918 | (13) |
|
1 Assumption of Executory Contracts |
|
|
922 | (1) |
|
2 Rejection of Executory Contracts |
|
|
923 | (3) |
|
3 Assignment of Executory Contracts |
|
|
926 | (5) |
|
G Sale of Property in Bankruptcy |
|
|
931 | (3) |
|
H Equity Holders in Bankruptcy |
|
|
934 | (1) |
|
|
|
935 | (2) |
|
Chapter Nineteen Risky Business: Litigation, Risk Management, and Dispute Control |
|
|
937 | (40) |
|
|
|
|
|
937 | (1) |
|
B The Biotech Lawyer as Dispute Manager |
|
|
938 | (6) |
|
1 Dispute Management Provisions in Commercial Agreements and Documents |
|
|
939 | (1) |
|
a Indemnification Provisions and Limitations on Liability |
|
|
940 | (1) |
|
b Acquisition Hold Back Provisions |
|
|
940 | (1) |
|
c Record Retention and Control within the Deal |
|
|
941 | (1) |
|
d Alternative Dispute Provisions |
|
|
941 | (1) |
|
|
|
942 | (1) |
|
3 Early Claim Review and Response |
|
|
942 | (1) |
|
|
|
942 | (1) |
|
a Choosing the Right Litigator and Firm |
|
|
943 | (1) |
|
b Litigation and Cost Control |
|
|
943 | (1) |
|
|
|
944 | (1) |
|
C Intellectual Property and Confidential Business Information |
|
|
944 | (11) |
|
|
|
944 | (1) |
|
a Registration and Protection |
|
|
945 | (1) |
|
b Litigation Claims--Infringement and Dilution |
|
|
946 | (4) |
|
|
|
950 | (1) |
|
|
|
950 | (1) |
|
b Establishing the Foundation for Trade Secret Protection |
|
|
951 | (2) |
|
|
|
953 | (2) |
|
d Inevitable Disclosure Doctrine |
|
|
955 | (1) |
|
|
|
955 | (8) |
|
|
|
956 | (1) |
|
2 Establish a Record of Compliance and Responsibility |
|
|
957 | (2) |
|
|
|
959 | (1) |
|
1 Corporate Disclosures and Insider Trading |
|
|
959 | (1) |
|
a Misstatements and Omissions |
|
|
960 | (1) |
|
|
|
960 | (1) |
|
|
|
961 | (1) |
|
3 False Claims and Whistleblowers |
|
|
962 | (1) |
|
F Document and Information Retention |
|
|
963 | (7) |
|
1 Regulatory Recordkeeping Requirements |
|
|
964 | (1) |
|
2 Litigation Discovery Issues |
|
|
964 | (1) |
|
|
|
965 | (1) |
|
a Identify the Objectives of the Enterprise |
|
|
965 | (1) |
|
|
|
966 | (1) |
|
c Training and Simplicity of Procedures |
|
|
966 | (1) |
|
d Adequacy of Infrastructure |
|
|
967 | (1) |
|
|
|
967 | (1) |
|
|
|
967 | (1) |
|
|
|
967 | (1) |
|
|
|
968 | (1) |
|
|
|
968 | (1) |
|
|
|
969 | (1) |
|
|
|
969 | (1) |
|
|
|
970 | (7) |
|
|
|
970 | (1) |
|
|
|
971 | (1) |
|
|
|
972 | (1) |
|
2 ADR Myths and Misconceptions |
|
|
973 | (1) |
|
|
|
973 | (1) |
|
|
|
973 | (1) |
|
3 An Integrated Strategy for ADR |
|
|
974 | (1) |
|
a Before the Dispute Arises |
|
|
974 | (1) |
|
b In the Early Stages of the Dispute |
|
|
975 | (1) |
|
|
|
975 | (1) |
|
d Private Forums and Confidentiality |
|
|
976 | (1) |
|
|
|
977 | (110) |
|
|
|
|
|
|
|
|
|
979 | (8) |
|
1 How Is Bioethics Different from Other Forms of Ethics? |
|
|
979 | (1) |
|
2 Approaches to Bioethics |
|
|
980 | (1) |
|
|
|
980 | (1) |
|
|
|
981 | (1) |
|
|
|
981 | (1) |
|
d Four Principle Approach |
|
|
982 | (1) |
|
|
|
982 | (1) |
|
3 Core Principles of Bioethics |
|
|
983 | (1) |
|
|
|
983 | (1) |
|
b Beneficence/Nonmaleficence |
|
|
983 | (1) |
|
|
|
984 | (1) |
|
|
|
984 | (1) |
|
4 History and Foundational Sources of Bioethics |
|
|
985 | (1) |
|
|
|
985 | (1) |
|
b Percival's Medical Ethics |
|
|
985 | (1) |
|
|
|
985 | (1) |
|
|
|
986 | (1) |
|
|
|
986 | (1) |
|
5 Relationship of Law and Bioethics |
|
|
987 | (1) |
|
B Legal Contexts for Bioethics |
|
|
987 | (11) |
|
|
|
987 | (1) |
|
|
|
988 | (4) |
|
|
|
992 | (1) |
|
2 Special Focus on Research |
|
|
993 | (1) |
|
|
|
994 | (1) |
|
b U.S. Federal Regulations |
|
|
995 | (3) |
|
|
|
998 | (17) |
|
|
|
999 | (1) |
|
|
|
1000 | (3) |
|
|
|
1003 | (1) |
|
|
|
1004 | (2) |
|
5 Disclosure versus Privacy: A Physician's Duty to Disclose Patient Risks to a Third Party |
|
|
1006 | (2) |
|
|
|
1008 | (1) |
|
7 Property Rights/Control of Your Body |
|
|
1009 | (2) |
|
|
|
1011 | (1) |
|
|
|
1012 | (1) |
|
|
|
1013 | (1) |
|
|
|
1014 | (1) |
|
|
|
1015 | (2) |
|
Appendix A Goat-Tech Bioscience: A Legal/Biotech Case Study |
|
|
1017 | (4) |
|
Appendix B Biotechnology Resources |
|
|
1021 | (32) |
|
|
|
Appendix C Patent & Technology License Agreement |
|
|
1053 | (1) |
|
|
|
1053 | (34) |
|
|
|
1054 | (4) |
|
2 License Grant and Commercialization |
|
|
1058 | (1) |
|
|
|
1058 | (1) |
|
|
|
1059 | (1) |
|
|
|
1059 | (1) |
|
2.4 Diligent Commercialization |
|
|
1060 | (1) |
|
|
|
1061 | (1) |
|
3.1 Non-Royalty Payments Due from Licensee |
|
|
1061 | (1) |
|
|
|
1062 | (1) |
|
|
|
1062 | (1) |
|
3.4 Non-cash Consideration |
|
|
1063 | (1) |
|
3.5 Equity Consideration for License Grant |
|
|
1063 | (1) |
|
|
|
1063 | (1) |
|
4.1 Quarterly Payment and Milestone Reports |
|
|
1063 | (1) |
|
4.2 Annual Written Progress Report and Commercialization Plan |
|
|
1064 | (1) |
|
4.3 Government and Economic Development Reporting |
|
|
1065 | (1) |
|
5 Payment, Records, and Audits |
|
|
1065 | (1) |
|
|
|
1065 | (1) |
|
5.2 Sales outside the U.S. |
|
|
1066 | (1) |
|
|
|
1066 | (1) |
|
|
|
1066 | (1) |
|
|
|
1066 | (1) |
|
6 Patent Expenses and Prosecution |
|
|
1067 | (1) |
|
|
|
1067 | (1) |
|
6.2 Direction of Prosecution |
|
|
1068 | (1) |
|
|
|
1068 | (1) |
|
|
|
1068 | (1) |
|
6.5 Withdrawal from Paying Patent Costs |
|
|
1069 | (1) |
|
6.6 U.S. Patent and Trademark Office Entity Size Status |
|
|
1069 | (1) |
|
|
|
1069 | (1) |
|
|
|
1069 | (1) |
|
7.2 Termination by Licensee |
|
|
1069 | (1) |
|
7.3 Termination by Licensor |
|
|
1070 | (1) |
|
7.4 Other Conditions of Termination |
|
|
1070 | (1) |
|
7.5 Effect of Termination |
|
|
1071 | (1) |
|
|
|
1071 | (1) |
|
|
|
1071 | (1) |
|
8.2 Protection and Marking |
|
|
1072 | (1) |
|
8.3 Confidentiality of Terms of Agreement |
|
|
1072 | (1) |
|
8.4 Disclosure Required by Court Order or Law |
|
|
1073 | (1) |
|
|
|
1073 | (1) |
|
8.6 Continuing Obligations |
|
|
1073 | (1) |
|
|
|
1073 | (1) |
|
|
|
1074 | (1) |
|
9 Infringement and Litigation |
|
|
1074 | (1) |
|
|
|
1074 | (1) |
|
9.2 Licensee's Enforcement Rights |
|
|
1074 | (1) |
|
9.3 Licensor's Enforcement Rights |
|
|
1074 | (1) |
|
9.4 Cooperation between Licensor and Licensee |
|
|
1075 | (1) |
|
|
|
1075 | (1) |
|
11 Representations and Disclaimers |
|
|
1076 | (1) |
|
11.1 Licensor Representations |
|
|
1076 | (1) |
|
|
|
1076 | (1) |
|
11.3 Licensor Disclaimers |
|
|
1077 | (1) |
|
11.4 Licensee Representations |
|
|
1077 | (1) |
|
|
|
1078 | (1) |
|
|
|
1078 | (1) |
|
13.1 Indemnification Obligation |
|
|
1078 | (1) |
|
13.2 Conditions of Indemnification |
|
|
1079 | (1) |
|
|
|
1079 | (1) |
|
14.1 Insurance Requirements |
|
|
1079 | (1) |
|
14.2 Evidence of Insurance and Notice of Changes |
|
|
1080 | (1) |
|
|
|
1080 | (1) |
|
|
|
1080 | (1) |
|
|
|
1080 | (1) |
|
16.2 Governmental Approvals and Marketing of Licensed Products and/or Licensed Services |
|
|
1081 | (1) |
|
16.3 Foreign Registration and Laws |
|
|
1081 | (1) |
|
|
|
1081 | (1) |
|
|
|
1081 | (1) |
|
|
|
1082 | (1) |
|
|
|
1082 | (1) |
|
19.2 Construction of Agreement |
|
|
1082 | (1) |
|
19.3 Counterparts and Signatures |
|
|
1083 | (1) |
|
19.4 Compliance with Laws |
|
|
1083 | (1) |
|
|
|
1083 | (1) |
|
|
|
1083 | (1) |
|
|
|
1083 | (1) |
|
19.8 Third Party Beneficiaries |
|
|
1084 | (1) |
|
|
|
1084 | (1) |
|
|
|
1084 | (1) |
|
|
|
1084 | (1) |
|
19.12 Claims against Licensor for Breach of Agreement |
|
|
1084 | (1) |
|
19.13 Grant of Security Interest |
|
|
1085 | (1) |
|
20 No Other Promises and Agreements; Representation by Counsel |
|
|
1085 | (1) |
|
21 Deadline for Execution by Licensee |
|
|
1085 | (2) |
| Index |
|
1087 | |
Lisainfo e-raamatute kohta