SEC Filings

Form S-4/A
PDS BIOTECHNOLOGY CORP filed this Form S-4/A on 01/25/2019
Document Outline
Entire Document (18188.7 KB)
Subdocument 1 - S-4/A - S-4/A
Page 1 - As filed with the U.S. Securities and Exchange Commission on January 25, 2019
Page 2 - The information in this proxy statement/prospectus/information statement is not complete and may be
Page 3 - EDGE THERAPEUTICS, INC.
Page 4 - THE EDGE BOARD HAS DETERMINED AND BELIEVES THAT EACH OF THE PROPOSALS OUTLINED ABOVE IS ADVISABLE TO
Page 5 - TABLE OF CONTENTS
Page 6 - N/A
Page 7 - RESULTS OF OPERATIONS
Page 8 - N/A
Page 9 - QUESTIONS AND ANSWERS ABOUT THE MERGER
Page 10 - N/A
Page 11 - N/A
Page 12 - N/A
Page 13 - N/A
Page 14 - N/A
Page 15 - N/A
Page 16 - PROSPECTUS SUMMARY
Page 17 - Reasons for the Merger
Page 18 - Opinion of the Financial Advisor to the Edge Board
Page 19 - opinion and the related analyses set forth in this proxy statement/prospectus/information statement
Page 20 - Treatment of PDS Stock Options and Warrants
Page 21 - Termination of the Merger Agreement
Page 22 - Support Agreements and Written Consent
Page 23 - Lock-up Agreements
Page 24 - The Edge Special Meeting
Page 25 - Interests of Directors and Executive Officers of Edge and PDS
Page 26 - Considerations with Respect to U.S. Federal Income Tax Consequences of the Merger
Page 27 - Regulatory Approvals
Page 28 - Potential PDS Financing
Page 29 - SELECTED HISTORICAL AND UNAUDITED PRO FORMA
Page 30 - Selected Unaudited Pro Forma Condensed Combined Financial Data of Edge and PDS
Page 31 - Comparative Historical and Unaudited Pro Forma per Share Data
Page 32 - MARKET PRICE AND DIVIDEND INFORMATION
Page 33 - RISK FACTORS
Page 34 - If the conditions to the merger are not met, the merger may not occur.
Page 35 - The market price of the combined company s common stock following the merger may decline as a result
Page 36 - During the pendency of the merger, Edge and PDS may not be able to enter into a business combination
Page 37 - Failure to obtain stockholder approval for the proposed reverse stock split may result in the combin
Page 38 - The issuance of shares of Edge common stock to PDS stockholders in the merger will dilute substantia
Page 39 - Risks Related to Development and Regulatory Approval
Page 40 - The regulatory approval processes of the FDA and comparable foreign regulatory authorities are inher
Page 41 - To the extent Edge were to resume research and development activities, even if a product candidate r
Page 42 - Failure to obtain regulatory approval in international jurisdictions would prevent Edge s product ca
Page 43 - Business disruptions could seriously harm Edge s financial condition and increase Edge s costs and e
Page 44 - Edge could be required to incur significant expenses to obtain Edge s intellectual property rights,
Page 45 - From time to time Edge may need to rely on licenses to proprietary technologies, which may be diffic
Page 46 - Edge may be subject to claims that Edge s employees or consultants have wrongfully used or disclosed
Page 47 - Edge has not generated any revenues since inception and may never become profitable.
Page 48 - If Edge fails to continue to meet all applicable Nasdaq Global Select Market requirements and Nasdaq
Page 49 - Future sales of a substantial number of shares of Edge s common stock in the public market or other
Page 50 - Some provisions of Edge s charter documents and Delaware law may have anti-takeover effects that cou
Page 51 - If Edge fails to maintain an effective system of internal control over financial reporting in the fu
Page 52 - Risks Related to PDS
Page 53 - PDS is dependent on the success of PDS0101, which is still in early-stage clinical development, and
Page 54 - PDS s independent auditor has expressed doubt about PDS s ability to continue as a going concern.
Page 55 - Raising additional funds by issuing securities may cause dilution to existing stockholders, and rais
Page 56 - PDS will need to expand its organization, and may experience difficulties in managing this growth, w
Page 57 - PDS s employees, independent contractors, principal investigators, consultants, commercial collabora
Page 58 - Risks Related to Clinical Development, Regulatory Approval and Commercialization
Page 59 - Enrollment and retention of subjects in clinical trials is an expensive and time-consuming process a
Page 60 - PDS0101 may cause adverse effects or have other properties that could delay or prevent their regulat
Page 61 - If PDS is not able to obtain, or if there are delays in obtaining, required regulatory approvals, it
Page 62 - PDS s product candidates are in various stages of development.
Page 63 - Even if PDS0101 receive marketing approval, it may fail to achieve market acceptance by physicians,
Page 64 - If PDS fails to comply with state and federal healthcare regulatory laws, it could face substantial
Page 65 - Product liability lawsuits against PDS could cause it to incur substantial liabilities and could lim
Page 66 - If PDS obtains approval to commercialize PDS0101 outside of the United States, a variety of risks as
Page 67 - Risks Related to PDS s Dependence on Third Parties
Page 68 - If PDS is unable to establish or manage strategic collaborations in the future, PDS s revenue and dr
Page 69 - PDS s relationships with customers and third-party payors will be subject to applicable anti-kickbac
Page 70 - N/A
Page 71 - PDS may be involved in lawsuits to protect or enforce its patents, the patents of its licensors or i
Page 72 - PDS may not be able to protect its intellectual property rights throughout the world, which could im
Page 73 - Edge and PDS do not anticipate that the combined company will pay any cash dividends in the foreseea
Page 74 - Future sales of shares by existing stockholders could cause the combined company s stock price to de
Page 75 - Anti-takeover provisions under Delaware law could make an acquisition of the combined company more d
Page 76 - CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING STATEMENTS
Page 77 - N/A
Page 78 - THE SPECIAL MEETING OF EDGE STOCKHOLDERS
Page 79 - Voting and Revocation of Proxies
Page 80 - Required Vote
Page 81 - Other Matters
Page 82 - THE MERGER
Page 83 - N/A
Page 84 - N/A
Page 85 - N/A
Page 86 - N/A
Page 87 - N/A
Page 88 - N/A
Page 89 - N/A
Page 90 - N/A
Page 91 - Edge Reasons for the Merger
Page 92 - N/A
Page 93 - N/A
Page 94 - PDS Reasons for the Merger
Page 95 - Opinion of the Financial Advisor to the Edge Board
Page 96 - Review of Solicitation Process
Page 97 - Selected Comparable Public Companies Analysis
Page 98 - N/A
Page 99 - N/A
Page 100 - Other Information
Page 101 - N/A
Page 102 - Interests of the Edge Directors and Executive Officers in the Merger
Page 103 - Severance Payments
Page 104 - Continued Service
Page 105 - Combined Company Management
Page 106 - Form of the Merger
Page 107 - Effective Time of the Merger
Page 108 - N/A
Page 109 - Tax Consequences if the Merger Failed to Qualify as a Reorganization
Page 110 - Appraisal Rights and Dissenters Rights
Page 111 - N/A
Page 112 - N/A
Page 113 - THE MERGER AGREEMENT
Page 114 - N/A
Page 115 - Treatment of Edge Stock Options and Edge RSUs
Page 116 - Directors and Executive Officers of the Combined Company Following the Merger
Page 117 - N/A
Page 118 - Representations and Warranties
Page 119 - Non-Solicitation
Page 120 - N/A
Page 121 - Meetings of Stockholders
Page 122 - N/A
Page 123 - N/A
Page 124 - Other Agreements
Page 125 - Termination of the Merger Agreement
Page 126 - Termination Fees
Page 127 - Amendment
Page 128 - AGREEMENTS RELATED TO THE MERGER
Page 129 - Lock-up Agreements
Page 130 - MATTERS BEING SUBMITTED TO A VOTE OF EDGE STOCKHOLDERS
Page 131 - Edge Proposal No. 2 (the Reverse Stock Split Proposal): Approval of the Amendment to the Certificate
Page 132 - Potential Increased Investor Interest
Page 133 - Criteria to be Used for Determining Whether to Implement the Reverse Stock Split
Page 134 - Procedure for Effecting Reverse Stock Split and Exchange of Stock Certificates
Page 135 - Accounting Consequences
Page 136 - N/A
Page 137 - Required Vote; Recommendation of Board of Directors
Page 138 - Edge Proposal No. 3 (the Equity Incentive Plan Proposal): Approval of the Amended and Restated Edge
Page 139 - Basis for Board of Directors Adoption of the Restated Plan
Page 140 - Outstanding Awards; Burn Rate
Page 141 - Summary of Restated Plan
Page 142 - Eligibility
Page 143 - Awards Types of Awards
Page 144 - Change in Control and other Corporate Transactions
Page 145 - Amendment and Termination
Page 146 - Summary of U.S. Federal Income Tax Consequences
Page 147 - N/A
Page 148 - N/A
Page 149 - Required Vote; Recommendation of Board of Directors
Page 150 - EDGE BUSINESS
Page 151 - Intellectual Property
Page 152 - Manufacturing
Page 153 - Competition
Page 154 - Foreign Regulation
Page 155 - Legal Proceedings
Page 156 - PDS BUSINESS
Page 157 - N/A
Page 158 - Versamune - A Next Generation Immunotherapy and Cancer Immunotherapy
Page 159 - PDS Clinical Development Plan
Page 160 - PDS0101 + Keytruda in HPV-positive recurrent or metastatic head and neck cancer
Page 161 - Other Development Programs
Page 162 - Breast cancer: Breast cancer is a leading cause of cancer-related mortality among women worldwide. I
Page 163 - Commercialization of Product Candidates
Page 164 - Versamune Mechanisms of Action (MOA)
Page 165 - Example 1: In-vitro studies performed to examine the ability of Versamune to promote antigen uptake
Page 166 - Figure 4: Versamune enhances protein uptake by dendritic cells
Page 167 - Figure 6: Versamune promotes antigen cross-presentation to killer T-cells (CD8+) in-vitro
Page 168 - Figure 7: Versamune (R-DOTAP) promotes antigen cross presentation in-vivo leading to superior prolif
Page 169 - Figure 8: Versamune (R-DOTAP) administration induces in-vivo lymph node production of Type I interfe
Page 170 - Figure 9: Single subcutaneous injection of PDS0101 leads to sustained and elevated levels of the imp
Page 171 - N/A
Page 172 - Figure 13:
Page 173 - Example 4: Studies to understand the effect of the Versamune -based immunotherapy on the tumor s mic
Page 174 - Figure 14:
Page 175 - Figure 15:
Page 176 - N/A
Page 177 - Example 5: Studies to understand the effect of Versamune -based immunotherapy combined with a checkp
Page 178 - Figure 4: Versamune (R-DOTAP) synergizes with anti-mouse PD1 checkpoint inhibitor treatment to signi
Page 179 - Intellectual Property
Page 180 - Material Agreements
Page 181 - Patent License Agreement with National Institutes of Health.
Page 182 - U.S. Product Development Process
Page 183 - N/A
Page 184 - U.S. Review and Approval Processes
Page 185 - Post-Approval Requirements
Page 186 - Other U.S. Healthcare Laws and Compliance Requirements
Page 187 - N/A
Page 188 - Coverage, Pricing and Reimbursement
Page 189 - Foreign Regulation
Page 190 - Legal Proceedings
Page 191 - EDGE MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 192 - N/A
Page 193 - Key Components of Edge s Statement of Operations
Page 194 - Results of Operations
Page 195 - Comparison of the Years Ended December 31, 2017 and 2016
Page 196 - Hercules Loan and Security Agreement
Page 197 - Net Cash (Used In) Provided by Financing Activities
Page 198 - Contractual Obligations and Commitments
Page 199 - Critical Accounting Polices and Estimates
Page 200 - PDS MANAGEMENT S DISCUSSION AND ANALYSIS OF
Page 201 - PDS s independent auditor has expressed doubt about PDS s ability to continue as a going concern
Page 202 - General and Administrative Expense
Page 203 - General and Administrative
Page 204 - Cash Flows
Page 205 - Cash Flows from Financing Activities
Page 206 - Contractual Obligations and Other Commitments
Page 207 - Income Taxes
Page 208 - N/A
Page 209 - MANAGEMENT FOLLOWING THE MERGER
Page 210 - Andrew Saik
Page 211 - Robert Spiegel, M.D.
Page 212 - Gregory Freitag
Page 213 - Board Committees
Page 214 - Compensation Committee
Page 215 - Nominating and Corporate Governance Committee
Page 216 - Non-Employee Director Compensation
Page 217 - EDGE EXECUTIVE COMPENSATION
Page 218 - Outstanding Equity Awards at Year-End
Page 219 - N/A
Page 220 - Retention Arrangements
Page 221 - 2018 Summary Compensation Table
Page 222 - PDS s Employment Arrangements
Page 223 - 2009 Stock Option Plan
Page 224 - Change in Control and Other Transactions. The PDS 2018 Plan provides that in the event of a specifie
Page 225 - CERTAIN RELATIONSHIPS AND RELATED-PARTY TRANSACTIONS
Page 226 - Retention Arrangements
Page 227 - PDS
Page 228 - UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION
Page 229 - Unaudited Pro Forma Condensed Combined Balance Sheet
Page 230 - Unaudited Pro Forma Condensed Combined Statement of Operations
Page 231 - Unaudited Pro Forma Condensed Combined Statement of Operations
Page 232 - Notes to the Unaudited Pro Forma Condensed Combined Financial Information
Page 233 - Note 2 Preliminary purchase price allocation
Page 234 - Note 3 Pro forma adjustments
Page 235 - N/A
Page 236 - DESCRIPTION OF EDGE CAPITAL STOCK
Page 237 - Stock Options
Page 238 - Certificate of Incorporation and Bylaws
Page 239 - COMPARISON OF RIGHTS OF HOLDERS OF EDGE STOCK AND PDS STOCK
Page 240 - N/A
Page 241 - N/A
Page 242 - N/A
Page 243 - PRINCIPAL STOCKHOLDERS OF EDGE
Page 244 - N/A
Page 245 - PRINCIPAL STOCKHOLDERS OF PDS
Page 246 - PRINCIPAL STOCKHOLDERS OF THE COMBINED COMPANY
Page 247 - N/A
Page 248 - LEGAL MATTERS
Page 249 - OTHER MATTERS
Page 250 - INDEX TO FINANCIAL STATEMENTS
Page 251 - Report of Independent Registered Public Accounting Firm
Page 252 - EDGE THERAPEUTICS, INC.
Page 253 - EDGE THERAPEUTICS, INC.
Page 254 - EDGE THERAPEUTICS, INC.
Page 255 - EDGE THERAPEUTICS, INC.
Page 256 - N/A
Page 257 - Edge Therapeutics, Inc.
Page 258 - N/A
Page 259 - N/A
Page 260 - Note 3 - Fair Value of Financial Instruments
Page 261 - Note 7 - Stock Options
Page 262 - N/A
Page 263 - Note 8 - Income Taxes
Page 264 - Note 9 - Commitments and Contingencies
Page 265 - N/A
Page 266 - Note 10 - Debt
Page 267 - Note 11 - Retirement Plan
Page 268 - Note 12 - Selected Quarterly Financial Data (Unaudited)
Page 269 - EDGE THERAPEUTICS, INC.
Page 270 - EDGE THERAPEUTICS, INC.
Page 271 - EDGE THERAPEUTICS, INC.
Page 272 - Edge Therapeutics, Inc.
Page 273 - Note 2 - Summary of Significant Accounting Policies
Page 274 - N/A
Page 275 - Note 3 - Fair Value of Financial Instruments
Page 276 - Note 5 - Accrued Expenses
Page 277 - N/A
Page 278 - Note 7 - Income Taxes
Page 279 - Note 8 - Commitments and Contingencies
Page 280 - N/A
Page 281 - Note 9 - Debt
Page 282 - Note 10 - Retirement Plan
Page 283 - REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Page 284 - PDS Biotechnology Corporation
Page 285 - PDS Biotechnology Corporation
Page 286 - PDS Biotechnology Corporation
Page 287 - PDS Biotechnology Corporation
Page 288 - PDS BIOTECHNOLOGY CORPORATION
Page 289 - Cash and Cash Equivalents
Page 290 - Stock-Based Compensation
Page 291 - Revenue Recognition
Page 292 - Concentrations of Credit Risk
Page 293 - N/A
Page 294 - N/A
Page 295 - N/A
Page 296 - N/A
Page 297 - N/A
Page 298 - Common Stock Transactions
Page 299 - Preferred Stock Transactions
Page 300 - N/A
Page 301 - N/A
Page 302 - Operating Leases
Page 303 - Litigation
Page 304 - N/A
Page 305 - N/A
Page 306 - N/A
Page 307 - PDS Biotechnology Corporation
Page 308 - PDS Biotechnology Corporation
Page 309 - PDS Biotechnology Corporation
Page 310 - PDS Biotechnology Corporation
Page 311 - PDS BIOTECHNOLOGY CORPORATION
Page 312 - Use of Estimates
Page 313 - N/A
Page 314 - Common Stock Transactions
Page 315 - Preferred Stock Transactions
Page 316 - N/A
Page 317 - Operating Leases
Page 318 - Litigation
Page 319 - N/A
Page 320 - N/A
Page 321 - N/A
Page 322 - Annex A-I
Page 323 - TABLE OF CONTENTS
Page 324 - TABLE OF CONTENTS
Page 325 - TABLE OF CONTENTS
Page 326 - TABLE OF CONTENTS
Page 327 - THIS AGREEMENT AND PLAN OF MERGER AND REORGANIZATION (this Agreement ) is made and entered into as o
Page 328 - Company Stockholder Written Consents ).
Page 329 - Conversion of Shares.
Page 330 - Closing of the Company s Transfer Books. At the Effective Time: (a) all shares of Company Capital St
Page 331 - Appraisal Rights.
Page 332 - Pro-Forma Capitalization. The anticipated pro-forma capitalization of the Company immediately prior
Page 333 - Vote Required. The affirmative vote (or written consent) of the holders of a majority of the shares
Page 334 - Financial Statements.
Page 335 - Absence of Changes. Except as set forth on Section 2.8 of the Company Disclosure Schedule, between t
Page 336 - Company Real Estate Leases ), each of which is in full force and effect (assuming the due execution
Page 337 - N/A
Page 338 - Agreements, Contracts and Commitments.
Page 339 - Compliance; Permits; Restrictions.
Page 340 - Company Permits ). Section 2.14(b) of the Company Disclosure Schedule identifies each Company Permit
Page 341 - HIPAA ), including the standards for the privacy of Individually Identifiable Health Information at
Page 342 - N/A
Page 343 - Employee and Labor Matters; Benefit Plans.
Page 344 - N/A
Page 345 - Environmental Matters. The Company is and since January 1, 2016 has complied with all applicable Env
Page 346 - Anti-Bribery. Neither the Company nor any of its directors, officers, employees or, to the Company s
Page 347 - Due Organization; Subsidiaries.
Page 348 - Non-Contravention; Consents. Subject to obtaining the Required Parent Stockholder Vote, the filing o
Page 349 - SEC Filings; Financial Statements.
Page 350 - Absence of Undisclosed Liabilities. As of the date hereof, Parent does not have any Liability, indiv
Page 351 - Intellectual Property.
Page 352 - Agreements, Contracts and Commitments. Section 3.11 of the Parent Disclosure Schedule identifies eac
Page 353 - Parent Material Contract ). There are no Parent Material Contracts that are not in written form. Par
Page 354 - Legal Proceedings; Orders.
Page 355 - Tax Matters.
Page 356 - Employee and Labor Matters; Benefit Plans.
Page 357 - N/A
Page 358 - Environmental Matters. Parent is and since January 1, 2016 has complied with all applicable Environm
Page 359 - Title to Assets. Parent owns, and has good and valid title to, or, in the case of leased properties
Page 360 - Disclaimer of Other Representations or Warranties. Except as previously set forth in this Section 3
Page 361 - Operation of the Company s Business.
Page 362 - N/A
Page 363 - Access and Investigation. Subject to the terms of the Confidentiality Agreement, which the Parties a
Page 364 - Company Non-Solicitation.
Page 365 - Notification of Certain Matters.
Page 366 - DLA ) and to Dechert LLP ( Dechert ) the applicable Tax Representation Letter referenced in Section
Page 367 - Stockholder Notice ) to every stockholder of the Company that did not execute the Company Stockholde
Page 368 - Parent Board Recommendation ); and (iii) the Parent Board Recommendation shall not be withheld, amen
Page 369 - Regulatory Approvals. Each Party shall use reasonable best efforts to file or otherwise submit, as s
Page 370 - Employee Benefits.
Page 371 - Additional Agreements. The Parties shall use commercially reasonable efforts to cause to be taken al
Page 372 - Listing. (a) Parent shall use its commercially reasonable efforts, to the extent required by the rul
Page 373 - Legends. Parent shall be entitled to place appropriate legends on the book entries and/or certificat
Page 374 - Allocation Certificate ); provided that the Company may update the Allocation Certificate by written
Page 375 - Calculation of Net Cash; Adjustment to Company and Parent Allocation Percentage.
Page 376 - Accounting Firm ) shall be engaged to resolve any remaining disagreements as to the determination of
Page 377 - Reverse Split ). Parent shall use commercially reasonable efforts, including engaging a proxy solici
Page 378 - Performance of Covenants. The Company shall have performed or complied with in all material respects
Page 379 - Performance of Covenants. Parent and Merger Sub shall have performed or complied with in all materia
Page 380 - N/A
Page 381 - Effect of Termination. In the event of the termination of this Agreement as provided in Section 9.1,
Page 382 - Non-Survival of Representations and Warranties. The representations and warranties of the Company, P
Page 383 - Attorneys Fees. In any action at law or suit in equity to enforce this Agreement or the rights of an
Page 384 - Cooperation. Each Party agrees to cooperate fully with the other Party and to execute and deliver su
Page 385 - N/A
Page 386 - IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above
Page 387 - IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the date first above
Page 388 - EXHIBIT A
Page 389 - Company Capital Stock means the Company Common Stock and the Company Preferred Stock.
Page 390 - Company Net Cash Measurement Date means the Anticipated Closing Date; provided that if (i) the Closi
Page 391 - Contract means, with respect to any Person, any agreement, contract, subcontract, lease (whether for
Page 392 - GAAP means generally accepted accounting principles and practices in effect from time to time within
Page 393 - Governmental Authorization means any: (a) permit, license, certificate, franchise, permission, varia
Page 394 - Knowledge of Parent, Parent s Knowledge or similar terms means the actual knowledge of the individua
Page 395 - Parent Deficiency Amount means the amount equal to the minimum amount of the Parent Collar Range min
Page 396 - Parent Options means options or other rights to purchase shares of Parent Common Stock issued by Par
Page 397 - Permitted Encumbrance means: (a) any liens for current Taxes not yet due and payable or for Taxes th
Page 398 - Takeover Statute means any fair price, moratorium, control share acquisition or other similar anti-t
Page 399 - Treasury Regulations means the United States Treasury regulations promulgated under the Code.
Page 400 - N/A
Page 401 - Annex A-II
Page 402 - Section 7. Miscellaneous Provisions. This Amendment shall be subject to the general provisions conta
Page 403 - N/A
Page 404 - Annex B
Page 405 - Annex C
Page 406 - AMENDED AND RESTATED EDGE THERAPEUTICS, INC.
Page 407 - N/A
Page 408 - N/A
Page 409 - N/A
Page 410 - N/A
Page 411 - N/A
Page 412 - N/A
Page 413 - N/A
Page 414 - N/A
Page 415 - N/A
Page 416 - N/A
Page 417 - N/A
Page 418 - Annex D
Page 419 - N/A
Page 420 - N/A
Page 421 - Annex E
Page 422 - N/A
Page 423 - N/A
Page 424 - N/A
Page 425 - PART II
Page 426 - N/A
Page 427 - N/A
Page 428 - N/A
Page 429 - N/A
Page 430 - N/A
Page 431 - N/A
Page 432 - N/A
Page 433 - N/A
Page 434 - SIGNATURES
Subdocument 2 - EX-5.1 - EXHIBIT 5.1
Page 1 - N/A
Subdocument 3 - EX-8.1 - EXHIBIT 8.1
Page 1 - Exhibit 8.1
Page 2 - N/A
Page 3 - N/A
Subdocument 4 - EX-8.2 - EXHIBIT 8.2
Page 1 - Exhibit 8.2
Page 2 - DLA Piper LLP (US)
Subdocument 5 - EX-10.24 - EXHIBIT 10.24
Page 1 - Exhibit 10.24
Page 2 - TABLE OF CONTENTS
Page 3 - CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT
Page 4 - Applicable Law FDAEMARegulatory AuthorityRegulatory AuthoritiesHIPAA
Page 5 - Continuing Party
Page 6 - GCP
Page 7 - Liability
Page 8 - PDS
Page 9 - Right of Reference
Page 10 - Generally
Page 11 - Compounds
Page 12 - Regulatory Matters
Page 13 - Ownership and Use of Clinical Data
Page 14 - Joint Development Committee; Alliance Managers
Page 15 - Licensingprovided however
Page 16 - Protocol
Page 17 - Financial Disclosure
Page 18 - Pharmacovigilance Agreement
Page 19 - Mutual Termination Right for Patient Safetyprovided, however,
Page 20 - No Prejudice
Page 21 - Supply of the Compounds
Page 22 - Delivery
Page 23 - Non-Conformance
Page 24 - Resolution of Discrepancies
Page 25 - VAT.
Page 26 - Inventions
Page 27 - Joint Patent ApplicationFiling PartyNon-Filing PartyOpting-out PartyContinuing Party
Page 28 - Inventions Owned by PDS
Page 29 - Merck Background Patents
Page 30 - Press Releases
Page 31 - Anti-Corruption
Page 32 - DISCLAIMER
Page 33 - Insurance
Page 34 - LIMITATION OF LIABILITY
Page 35 - providedhoweverprovided
Page 36 - N/A
Page 37 - orincludingwithout limitationwillhereofheretohereinhereunder ArticleSectionAppendixScheduleAgreement
Page 38 - N/A
Page 39 - N/A
Page 40 - N/A
Page 41 - Sponsor:
Page 42 - PROTOCOL SYNOPSIS
Page 43 - N/A
Page 44 - N/A
Page 45 - N/A
Page 46 - N/A
Page 47 - N/A
Page 48 - N/A
Page 49 - N/A
Page 50 - N/A
Page 51 - Schedule of Events
Page 52 - N/A
Page 53 - N/A
Page 54 - Schedule of Deliveries for PDS0101
Page 55 - N/A
Page 56 - N/A
Subdocument 6 - EX-10.25 - EXHIBIT 10.25
Page 1 - Exhibit 10.25
Page 2 - N/A
Page 3 - N/A
Page 4 - N/A
Page 5 - NATIONAL INSTITUTES OF HEALTH
Page 6 - NIHLicensee
Page 7 - CONFIDENTIAL
Page 8 - CONFIDENTIAL
Page 9 - CONFIDENTIAL
Page 10 - CONFIDENTIAL
Page 11 - CONFIDENTIAL
Page 12 - CONFIDENTIAL
Page 13 - CONFIDENTIAL
Page 14 - CONFIDENTIAL
Page 15 - CONFIDENTIAL
Page 16 - SIGNATURES BEGIN ON NEXT PAGE
Page 17 - NIH PATENT LICENSE AGREEMENT NONEXCLUSIVE
Page 18 - GovernmentAgreementAgreement
Page 19 - APPENDIX A PATENT(S) OR PATENT APPLICATION(S)
Page 20 - APPENDIX B LICENSED FIELDS OF USE AND TERRITORY
Page 21 - APPENDIX C ROYALTIES
Page 22 - CONFIDENTIAL
Page 23 - APPENDIX D BENCHMARKS AND PERFORMANCE
Page 24 - APPENDIX E COMMERCIAL DEVELOPMENT PLAN
Page 25 - APPENDIX F - EXAMPLE ROYALTY REPORT
Page 26 - APPENDIX G ROYALTY PAYMENT OPTIONS
Page 27 - Checks
Page 28 - N/A
Page 29 - N/A
Page 30 - N/A
Page 31 - N/A
Page 32 - N/A
Page 33 - NATIONAL INSTITUTES OF HEALTH
Page 34 - FIRST AMENDMENT TO L-048-2015/0
Page 35 - GovernmentAgreementAgreement
Page 36 - ATTACHMENT 1 ROYALTY PAYMENT OPTIONS
Page 37 - Checks
Page 38 - ATTACHMENT 2 APPENDIX C ROYALTIES
Page 39 - LicenseeNIHNIH
Subdocument 7 - EX-10.26 - EXHIBIT 10.26
Page 1 - Exhibit 10.26
Page 2 - N/A
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - Attachment 1
Page 7 - Attachment 2
Subdocument 8 - EX-10.27 - EXHIBIT 10.27
Page 1 - Exhibit 10.27
Page 2 - University of Kentucky Research Foundation
Page 3 - N/A
Page 4 - N/A
Page 5 - N/A
Page 6 - N/A
Page 7 - N/A
Page 8 - Attachment 1
Page 9 - Attachment 2
Subdocument 9 - EX-10.28 - EXHIBIT 10.28
Page 1 - COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Page 2 - COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Page 3 - Confidential Information
Page 4 - IC Materials
Page 5 - Raw Data
Page 6 - N/A
Page 7 - N/A
Page 8 - Article 4.Reports
Page 9 - Article 5.Staffing, Financial, and Materials Obligations
Page 10 - N/A
Page 11 - Article 7.Licensing
Page 12 - N/A
Page 13 - Article 8.Rights of Access and Publication
Page 14 - N/A
Page 15 - Article 9.Representations and Warranties
Page 16 - Article 10.Expiration and Termination
Page 17 - Article 11.Disputes
Page 18 - Article 13.Miscellaneous
Page 19 - N/A
Page 20 - N/A
Page 21 - SIGNATURE PAGE
Page 22 - CONTACTS INFORMATION PAGE
Page 23 - SUMMARY PAGE
Page 24 - APPENDIX A
Page 25 - Experimental Plan
Page 26 - Clinical Studiesand the Support Thereof:
Page 27 - Description Of The Contributions And Responsibilities Of The PartiesCCR Vaccine Branch, NCI
Page 28 - Collaborator
Page 29 - CCR VB, NCI and Collaborator
Page 30 - NCI Patents and Patent Applications
Page 31 - APPENDIX B
Page 32 - N/A
Page 33 - Materials/Equipment Contributions
Subdocument 10 - EX-10.29 - EXHIBIT 10.29
Page 1 - Exhibit 10.29
Page 2 - DOTAP CHLORIDE ENANTIOMER LICENSE AGREEMENT
Page 3 - N/A
Page 4 - DOTAP CHLORIDE ENANTIOMER LICENSE AGREEMENT
Page 5 - N/A
Page 6 - N/A
Page 7 - ARTICLE II - CURRENCY
Page 8 - ARTICLE III - GRANT OF LICENSE
Page 9 - ARTICLE IV - TECHNICAL INFORMATION AND CONFIDENTIALITY
Page 10 - ARTICLE V - REPRESENTATIONS, WARRANTIES AND INDEMNIFICATION
Page 11 - N/A
Page 12 - ARTICLE VI - PAYMENTS AND REPORTS DURING THE ROYALTY PERIOD
Page 13 - N/A
Page 14 - N/A
Page 15 - ARTICLE VII - PDS DELIVERABLES
Page 16 - ARTICLE VIII - INTELLECTUAL PROPERTY
Page 17 - ARTICLE IX - ABATEMENT OF INFRINGEMENT
Page 18 - ARTICLE X - TERMINATION
Page 19 - N/A
Page 20 - ARTICLE XI - ASSIGNABILITY
Page 21 - ARTICLE XIV - DISPUTE RESOLUTION
Page 22 - ARTICLE XV - ADJUDICATION OF LICENSED PATENTS
Page 23 - [SIGNATURE PAGE FOLLOWS]
Page 24 - N/A
Page 25 - EXHIBIT A
Subdocument 11 - EX-23.1 - EXHIBIT 23.1
Page 1 - N/A
Subdocument 12 - EX-23.2 - EXHIBIT 23.2
Page 1 - N/A
Subdocument 13 - EX-99.1 - EXHIBIT 99.1
Page 1 - Exhibit 99.1
Subdocument 14 - EX-99.3 - EXHIBIT 99.3
Page 1 - N/A
Subdocument 15 - EX-99.5 - EXHIBIT 99.5
Page 1 - N/A
Subdocument 16 - EX-99.6 - EXHIBIT 99.6
Page 1 - N/A
Subdocument 17 - EX-99.7 - EXHIBIT 99.7
Page 1 - N/A
Subdocument 18 - EX-99.8 - EXHIBIT 99.8
Page 1 - N/A
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