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Reported settlements in federal district court cases

This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act.

Case Name Drug Patent No(s). Publicly Available Terms
Novo Nordisk Inc. v. Mylan Pharms. Inc., 22-0023 (N.D.W.V.) Ozempic® (semaglutide injection) 8,114,833
8,129,343
8,536,122
8,684,969
8,920,383
9,108,002
9,132,239
9,457,154
9,616,180
9,687,611
9,775,953
9,861,757
10,220,155
10,355,462
10,357,616
10,376,652
11,097,063
RE46,363
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties each expressly waive any right to appeal or move for relief from this Stipulation and Order of Dismissal.
Pfizer Inc. v. Sinotherapeutics Inc., 22-1484 (D. Del.) Xeljanz® XR (tofacitinib citrate extended-release tablets) 10,639,309
11,253,523
All claims and counterclaims are dismissed without prejudice. Any protective orders entered by the Court shall remain in full force and effect notwithstanding the dismissal of this action. The parties waive any right of appeal from this Order. Each party shall bear its own costs and fees in the above-captioned actions.
Boehringer Ingelheim Pharms. Inc. v. Granules India Ltd., 24-0753 (D. Del.) Tradjenta® (linagliptin tablets) 9,486,526
10,034,877
The patents-in-suit are valid and enforceable. Unless specifically authorized, Granules is enjoined from infringing the patents-in-suit until their expiration. Nothing prohibits Granules from maintaining its Paragraph IV certification with respect to the patents-in-suit. All claims, counterclaims, and affirmative defenses are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 22-0296 (D. Del.) Ozempic® (semaglutide injection) 9,132,239
10,335,462
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties expressly waive any right to appeal or otherwise move for relief from the stipulation and order of dismissal.
Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 22-0298 (D. Del.) Ozempic® (semaglutide injection) 8,129,343
8,920,383
9,132,239
9,457,154
9,687,611
9,775,953
10,220,155
10,335,462
11,097,063
RE46,363
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties expressly waive any right to appeal or otherwise move for relief from the stipulation and order of dismissal.
Intra-Cellular Therapies, Inc. v. Alkem Labs. Ltd., 24-4312, 24-8845 (D.N.J.) Caplyta® (lumateperone capsules) 10,695,345
11,052,084
11,690,842
11,806,348
Counts IX, X, XI, XII, XIII, XIV, XV, and XVI of Plaintiff’s Complaint with respect to the ’345 patent, the ’084 patent, the ’842 patent, and the ’348 patent are hereby dismissed without prejudice. Each party shall bear its own costs, disbursements, and attorneys’ fees.
Actelion Pharms. Ltd. v. Mylan Pharms. Inc., 23-0088 (N.D.W.V.) Opsumit® (macitentan tablets) 7,094,781
10,946,015
Mylan admits that the patents-in-suit are valid and enforceable, and that the claims of the patents-in-suit would be infringed by the commercialization of Mylan’s ANDA product. Unless specifically authorized by Actelion, Mylan is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall prohibit Mylan from maintaining paragraph IV certifications in Mylan’s ANDA and nothing shall prohibit FDA from approving Mylan’s ANDA. Each party agrees that the 30-month stay with respect to Mylan’s ANDA is terminated.
Bristol-Myers Squibb Co. v. Umedica Labs. Pvt. Ltd., 24-1089 (D. Del.) Eliquis® (apixaban tablets) 9,326,945 Plaintiff dismisses the complaint without prejudice.
Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 24-6784 (D.N.J.) Erleada® (apalutamide tablets) 8,802,689
9,388,159
9,987,261
Hetero admits that the claims of the patents-in-suit are valid and enforceable with respect to the Hetero ANDA products, and that the claims of the patents-in-suit would be infringed by the commercialization of the Hetero ANDA products. Hetero is enjoined from infringing the patents-in-suit until their expiration, other than as authorized by Plaintiffs. All affirmative defenses, claims, and counterclaims, are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal or otherwise move for relief from this judgment and order.
Theravance Biopharma R&D IP, LLC v. Qilu Pharm. Co., Ltd., 24-2689 (E.D. Pa.) Yupelri® (revefenacin inhalation solution) 8,541,451
9,765,028
10,550,081
11,008,289
11,484,531
11,691,948
11,858,898
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Qilu, except as expressly licensed by Plaintiffs, will be enjoined until expiration of the patents-in-suit, from infringing the patents-in-suit. Nothing shall prevent Qilu from maintaining a Paragraph IV certification to the patents-in-suit or prohibit FDA from granting final approval to Qilu’s ANDA product. Each party will bear its own attorneys’ fees and costs.
Amicus Therapeutics US, LLC v. Teva Pharms. USA, Inc., 24-0696 (D. Del.) Galafold® (migalastat capsules) 11,833,164 Teva acknowledges Amicus’s ownership and standing to sue for infringement of the patents-in-suit. Teva acknowledges that the patents-in-suit are valid and enforceable. Teva acknowledges that it has infringed the patents-in-suit and that Amicus did not authorize the manufacture, use, sale, offer for sale, importation and distribution of the product described in Teva’s ANDA. Teva is permanently enjoined from infringing the patents-in-suit by the commercialization of its ANDA product. All claims in against Teva are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees. Final Approval of Teva’s ANDA may be granted on the date that this Consent Judgment is entered.
Pfizer Inc. v. Ajanta Pharma Ltd., 24-0953 (D. Del.) Xeljanz® XR (tofacitinib citrate extended-release tablets) RE41,783 All claims dismissed without prejudice.
Galderma Labs., L.P. v. Macleods Pharms. Ltd., 24-1105 (D. Del.) Oracea® (doxycycline capsules) 7,749,532
8,206,740
All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Bayer Intellectual Property GmbH v. Auson Pharms. Inc., 23-1103 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
All claims and defenses are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Janssen Pharms., Inc. v. Macleods Pharms., Ltd., 24-4564 (D.N.J.) Invokamet® (canagliflozin / metformin HCl tablets) 11,576,894 Submission of Macleods ANDA to FDA was a technical act of patent infringement with respect to the ’894 patent. The claims of the ’894 patent are valid and enforceable with respect to Macleods’s ANDA product. Macleods ANDA product would infringe one or more claims of the ’894 patent. Macleods is enjoined from infringing the ’894 patent until its expiration, including any patent extensions, adjustments or regulatory exclusivity. All affirmative defenses, claims, and counterlcaims are dismissed with prejudice. The parties shall bear their own fees and costs, including attorneys’ fees. The parties waive all right to appeal.
Harmony Biosciences, LLC v. Lupin Ltd., 23-1286 (D. Del.) Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
Unless otherwise specifically authorized, Novugen is enjoined from infringing the patents-in-suit. Nothing prohibits Novugen from maintaining a Paragraph IV certification with respect to the patents-in-suit. All claims of Harmony against Novugen, and all counterclaims and affirmative defenses of Novugen against Harmony with respect to the patents-in-suit are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Bayer Intellectual Property GmbH v. Ascent Pharms. Inc., 24-0588 (D. Del.) Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
All claims and defenses asserted by Plaintiffs against Ascent and all claims and defenses asserted by Ascent against Plaintiffs are dismissed with prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Pfizer Inc. v. SpecGx, LLC, 24-0927 (D. Del.) Xeljanz® (tofacitinib citrate tablets) RE41,783 All claims dismissed without prejudice.
Ferring Pharms. Inc. v. Jiangsu Hansoh Pharm. Group Co., Ltd., 24-7904 (D.N.J.) Firmagon® (degarelix for injection) 8,841,081
9,877,999
11,766,468
11,826,397
All claims, counterclaims, and affirmative defenses are voluntarily dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Pfizer Inc. v. Breckenridge Pharm., Inc., 24-1122 (D. Del.) Xeljanz® (tofacitinib citrate tablets) RE41,783 All claims dismissed without prejudice.
Jazz Pharms. Research UK Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.) Epidiolex® (cannabidiol oral solution) 9,949,937
9,956,183
9,956,184
9,956,185
9,956,186
10,092,525
10,111,840
10,137,095
10,603,288
10,709,671
10,709,673
10,709,674
10,849,860
10,918,608
10,966,939
11,065,209
11,096,905
11,154,516
11,160,795
11,207,292
11,311,498
11,357,741
11,400,055
11,406,623
11,446,258
11,633,369
11,701,330
11,766,411
11,963,937
Plaintiffs’ and Cipla’s claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Cipla shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant.
Jazz Pharms. Research UK Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.) Epidiolex® (cannabidiol oral solution) 9,949,937
9,956,183
9,956,184
9,956,185
9,956,186
10,092,525
10,111,840
10,137,095
10,603,288
10,709,671
10,709,673
10,709,674
10,849,860
10,918,608
10,966,939
11,065,209
11,096,905
11,154,516
11,160,795
11,207,292
11,311,498
11,357,741
11,400,055
11,406,623
11,446,258
11,633,369
11,701,330
11,766,411
11,963,937
Plaintiffs’ and Ascent’s claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Ascent shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant.
Jazz Pharms. Research UK Ltd. v. Teva Pharms., Inc., 23-0018, 23-3914, 23-23141, 24-7550 (D.N.J.) Epidiolex® (cannabidiol oral solution) 9,949,937
9,956,183
9,956,184
9,956,185
9,956,186
10,092,525
10,111,840
10,137,095
10,603,288
10,709,671
10,709,673
10,709,674
10,849,860
10,918,608
10,966,939
11,065,209
11,096,905
11,154,516
11,160,795
11,207,292
11,311,498
11,357,741
11,400,055
11,406,623
11,446,258
11,633,369
11,701,330
11,766,411
11,963,937
Plaintiffs’ and Taro’s claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs or attorneys’ fees to the parties. Jazz’s dismissal of these matters with respect to Taro shall not result in the dismissal of any claims, defenses, and/or counterclaims with respect to any other defendant.
Beigene USA, Inc. v. MSN Pharms. Inc., 24-1971 (D.N.J.) Brukinsa® (zanubrutinib capsules) 10,927,117
11,591,340
11,786,531
11,851,437
All claims, counterclaims, and affirmative defenses are dismissed without prejudice. All parties shall bear their own costs, disbursements, and attorneys’ fees.
Merck Sharp & Dohme LLC v. Hetero USA, Inc., 22-6820 (D.N.J.) Delstrigo® (doravirine / lamivudine / tenofovir disoproxil fumarate tablets) 8,486,975
10,603,282
10,842,751
The patents-in-suit are valid and enforceable. The ANDA product infringes the patents-in-suit. Unless specifically agreed between the parties, Hetero is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Azurity Pharms., Inc. v. Hetero Labs Ltd., 24-0396 (D. Del.) Edarbi® (azilsartan medoxomil tablets) 9,066,936 All claims, counterclaims, and defenses are dismissed without prejudice. Plaintiffs and Hetero shall bear their own attorney fees and costs.
Pierre Febre Dermatologie v. Annora Pharma Private Ltd., 22-1442 (D. Del.) Hemangeol® (propranolol HCl oral solution) 8,338,489
8,987,262
Annora’s ANDA product infringes the patents-in-suit. The claims of the patents-in-suit are valid and enforceable with respect to Annora’s ANDA product. Unless specifically authorized, Annora is enjoined from infringing the patents-in-suit. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Grünenthal GmbH v. Teva Pharms., Inc., 24-6104 (D.N.J.) Nucynta® ER (tapentadol HCl extended-release tablets) 11,344,512 All claims and counterclaims are dismissed without prejudice and with the parties to bear their own costs and attorneys’ fees.
Melinta Therapeutics, LLC v. Nexus Pharms., Inc., 24-4180 (N.D. Ill.) Minocin® (minocycline for injection) 11,944,634 Case dismissed without prejudice and with leave to reinstate on or before June 30, 2026.
Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 24-1188 (D. Del.) Viberzi® (eluxadoline tablets) 12,097,187 Sun admits that the ’187 patent is enforceable, valid, and would be infringed by the manufacture, use, and/or sale within the US of Sun’s ANDA product. The submission of Sun’s ANDA was an act of infringement of the ’187 patent. All claims, counterclaims, and defenses are dismissed without prejudice. Sun is enjoined from infringing the ’187 patent, absent a license agreement or other authorization by Plaintiffs. The parties waive any right to appeal or otherwise move for relief from the dismissal order. The order of dismissal is without prejudice to any claim, defense, or counterclaim in any possible future action between Sun and any of the Plaintiffs regarding the ’187 patent and a product other than Sun’s ANDA product.
Endo Operations, Ltd. v. Fresenius Kabi USA, LLC, 24-1065 (D. Del.) Adrenalin® (epinephrine injection) 9,119,876
9,295,657
10,130,592
Case voluntarily dismissed without prejudice.
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 23-18420 (D.N.J.) Qbrelis® (lisinopril oral solution) 9,463,183
9,616,096
9,814,751
10,039,800
10,265,370
10,406,199
10,940,177
11,179,434
All claims and counterclaims are dismissed without prejudice. Any protective orders shall remain in full force and effect notwithstanding the dismissal of this action. Each party shall bear its own costs and attorneys’ fees.
Novartis Pharms. Corp. v. Lupin Inc., 24-1045 (D. Del.) Entresto® (sacubitril / valsartan tablets) 8,101,659
11,096,918
The case is dismissed without prejudice. Each party shall bear its own costs, expenses, and attorneys’ fees.
American Regent, Inc. v. Fresenius Kabi USA, LLC, 24-0824 (D. Del.) Selenious Acid 11,998,565 Unless otherwise specifically authorized by ARI, Fresenius is enjoined from infringing the ‘565 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party, except as otherwise agreed to by the parties. Nothing prohibits Fresenius from maintaining and/or filing a “paragraph IV” certification with respect to the ‘565 patent. Nothing precludes FDA from granting final approval to Fresenius’ ANDA and any stay with respect to the approval of Fresenius’s ANDA is hereby terminated.
Novo Nordisk Inc. v. Rio Biopharms. Inc., 22-0294 (D. Del.) Ozempic® (semaglutide injection) 8,129,343
9,132,239
9,457,154
9,687,611
10,335,462
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Parties waive any right to appeal.
Aragon Pharms., Inc. v. Zydus Worldwide DMCC, 24-9134 (D.N.J.) Erleada® (apalutamide tablets) 11,963,952 Plaintiffs dismiss the case without prejudice.
Eagle Pharms., Inc. v. Accord Healthcare Inc., 24-0095 (E.D.N.C.) Belrapzo® (bendamustine HCl injection) 11,844,783
11,872,214
All claims and defenses are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
ViiV Healthcare Co. v. Hetero USA Inc., 24-1189 (D. Del.) Tivicay® (dolutegravir tablets) 9,242,986 Except as specifically authorized pursuant to the settlement agreement, Hetero is enjoined from infringing the ’986 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party.
Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 24-1188 (D. Del.) Viberzi® (eluxadoline tablets) 12,097,187 Sun admits that the ’187 patent is enforceable, valid, and would be infringed by the manufacture, use, and/or sale within the US of Sun’s ANDA product. The submission of Sun’s ANDA was an act of infringement of the ’187 patent. All claims, counterclaims, and defenses are dismissed without prejudice. Sun is enjoined from infringing the ’187 patent, absent a license agreement or other authorization by Plaintiffs. The parties waive any right to appeal or otherwise move for relief from the dismissal order. The order of dismissal is without prejudice to any claim, defense, or counterclaim in any possible future action between Sun and any of the Plaintiffs regarding the ’187 patent and a product other than Sun’s ANDA product.
Supernus Pharms., Inc. v. Aurobindo Pharma Ltd., 24-9380 (D.N.J.) Oxtellar XR® (oxcarbazepine extended-release tablets) 7,722,898
7,910,131
8,617,600
8,821,930
9,119,791
9,351,975
9,370,525
9,855,278
10,220,042
11,166,960
11,896,599
All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Novo Nordisk Inc. v. Zydus Worldwide DMCC., 22-0297 (D. Del.) Ozempic® (semaglutide injection) 9,132,239
10,335,462
All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. The parties waive any right to appeal or otherwise move for relief. 
American Regent, Inc. v. Eugia Pharma Specialities Ltd., 24-8956 (D.N.J.) Selenious Acid 11,998,565 Unless specifically authorized by Plaintiff pursuant to the Settlement Agreement or by 35 U.S.C. § 271(e)(1), Eugia is enjoined from infringing the ’565 patent. All claims, counterclaims, affirmative defenses, and demands are dismissed without prejudice and without costs, disbursements, or attorneys’ fees to any party. Nothing shall preclude FDA from granting final approval to Eugia’s ANDA or shall preclude Eugia from filing, modifying, or maintaining with the FDA any Paragraph IV Certification for the Eugia Product.
AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 20-0968 (D. Del.) Venclexta® (venetoclax tablets) 8,546,399
9,174,982
8,722,657
9,539,251
The filing of DRL’s ANDA was a technical act of infringement of the patents-in-suit. All other claims, counterclaims, and defenses are dismissed without prejudice. Other than as permitted pursuant to agreement between the Parties, DRL is enjoined from infringing the patents-in-suit, absent a license agreement or other authorization by Plaintiffs. The parties waive any right to appeal or otherwise move for relief. The stipulation and order is without prejudice to any claim, defense, or counterclaim in any possible future action between DRL and any of the Plaintiffs regarding the patents-in-suit and a product other than DRL’s ANDA product.
Astellas Pharma Inc. v. Qilu Pharm. (Hainan) Co., Ltd., 24-8217 (D.N.J.) Xtandi® (enzalutamide tablets) 7,709,517
11,839,689
The parties claim and counterclaims with respect to the patents-in suit are dismissed, with prejudice. Nothing shall prevent Qilu from maintaining a Paragraph IV certification to the patents-in-suit in Qilu’s ANDA or prohibit the FDA from granting final approval to Qilu’s ANDA at any time. Plaintiffs and Qilu shall each bear their own costs.
Par Pharm., Inc. v. Zydus Pharms. (USA) Inc., 23-0866 (D. Del.) Chantix® (varenicline tartrate tablets) 11,717,524 All claims, counterclaims, and affirmative defenses are dismissed without prejudice, and without costs, disbursements, or attorneys’ fees to any party.
Azurity Pharms., Inc. v. Bionpharma Inc., 21-1286, 21-1455 (D. Del.) Epaned® (enalapril oral solution) 11,141,405 All remaining antitrust claims, counterclaims, and defenses, and any claims for costs and attorney fees that a party may wish to bring are dismissed with prejudice.  Each party shall bear its own costs and attorneys’ fees with respect to the matters dismissed in this consolidated action.
Nexus Pharms., Inc. v. Somerset Pharma, LLC, 23-1248 (D.N.J.) Emerphed® (ephedrine sulfate injection) 11,090,278
11,478,436
11,426,369
The patents-in-suit are enforceable and valid and would be infringed by Somerset’s ANDA product. In view of the settlement and license agreement, the parties agree to forego any further litigation. All claims, counterclaims, and affirmative defenses are dismissed without prejudice. Each party shall bear its own costs, attorneys’ fees, and expenses incurred in connection with this action.
Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-0833 (D. Del.) Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249
All claims, counterclaims, and defenses are dismissed without prejudice. The parties shall bear their own attorney fees and costs.
Supernus Pharms., Inc. v. Micro Labs Ltd., 24-9338 (D.N.J.) Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
All claims, counterclaims, and defenses are dismissed without prejudice. Each party shall bear its own costs and attorneys’ fees.
Novartis Pharms. Corp. v. Umedica Labs. Pvt. Ltd., 24-1408 (D. Del.) Entresto® (sacubitril / valsartan tablets) 8,101,659
8,877,938
9,388,134
9,517,226
9,937,143
11,058,667
11,096,918
11,135,192
All claims dismissed without prejudice.

GENERICally Speaking Hatch Waxman Bulletin

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