S T A T E   O F   N E W   Y O R K
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                                  7245--A
 
                        2021-2022 Regular Sessions
 
                           I N  A S S E M B L Y
 
                              April 29, 2021
                                ___________
 
 Introduced  by  M.  of  A.  GOTTFRIED,  McDONALD,  FRONTUS, ENGLEBRIGHT,
   J. D. RIVERA, GRIFFIN, DAVILA,  BURDICK,  SIMON,  SILLITTI,  BARNWELL,
   EPSTEIN,   L. ROSENTHAL,  WALLACE,  LUPARDO,  GONZALEZ-ROJAS,  PAULIN,
   GALEF, THIELE, ABINANTI, BICHOTTE HERMELYN,  STECK,  SOLAGES,  STIRPE,
   SMITH,  REYES,  NIOU,  FORREST, LAVINE, JEAN-PIERRE, JACKSON, GUNTHER,
   HEVESI, DINOWITZ, QUART, MAMDANI -- read  once  and  referred  to  the
   Committee  on  Health  --  recommitted  to  the Committee on Health in
   accordance with Assembly Rule 3, sec. 2 -- committee discharged,  bill
   amended,  ordered reprinted as amended and recommitted to said commit-
   tee
 
 AN ACT to amend the public health law, in relation to preserving  access
   to affordable drugs
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Article 2-A of the public health law is amended by adding a
 new title IV to read as follows:
                                 TITLE IV
                   PRESERVING ACCESS TO AFFORDABLE DRUGS
 SECTION 282. DEFINITIONS.
         283. PRESERVING ACCESS TO AFFORDABLE DRUGS.
   § 282. DEFINITIONS. FOR THE PURPOSES  OF  THIS  TITLE,  THE  FOLLOWING
 TERMS SHALL HAVE THE FOLLOWING MEANINGS:
   1.  "ANDA" SHALL MEAN ABBREVIATED NEW DRUG APPLICATION AS DESCRIBED BY
 505(J) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 335(J).
   2. "ANDA FILER" SHALL MEAN A PARTY THAT OWNS OR CONTROLS AN ANDA FILED
 WITH THE FEDERAL FOOD AND  DRUG  ADMINISTRATION  OR  HAS  THE  EXCLUSIVE
 RIGHTS UNDER THAT ANDA TO DISTRIBUTE THE ANDA PRODUCT.
   3.  "AGREEMENT" SHALL MEAN ANYTHING THAT WOULD CONSTITUTE AN AGREEMENT
 UNDER STATE LAW.
   4. "AGREEMENT RESOLVING  OR  SETTLING  A  PATENT  INFRINGEMENT  CLAIM"
 INCLUDES  ANY  AGREEMENT  THAT IS ENTERED INTO WITHIN THIRTY DAYS OF THE

  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD04644-05-2
              

 A. 7245--A                          2
 
 RESOLUTION OR THE SETTLEMENT OF THE CLAIM, OR ANY OTHER  AGREEMENT  THAT
 IS CONTINGENT UPON, PROVIDES A CONTINGENT CONDITION FOR, OR IS OTHERWISE
 RELATED  TO  THE  RESOLUTION  OR  SETTLEMENT  OF  THE  CLAIM. THIS SHALL
 INCLUDE, BUT IS NOT LIMITED TO, THE FOLLOWING:
   (A) ANY AGREEMENT REQUIRED TO BE PROVIDED TO THE FEDERAL TRADE COMMIS-
 SION  OR  THE  ANTITRUST  DIVISION  OF  THE  UNITED STATES DEPARTMENT OF
 JUSTICE UNDER THE MEDICARE PRESCRIPTION DRUG, IMPROVEMENT,  AND  MODERN-
 IZATION ACT OF 2003, PUB. L. NO. 108-173;
   (B)  ANY  AGREEMENT  BETWEEN  A  BIOSIMILAR OR INTERCHANGEABLE PRODUCT
 APPLICANT AND A REFERENCE PRODUCT  SPONSOR  UNDER  THE  BIOLOGICS  PRICE
 COMPETITION  AND  INNOVATION  ACT  OF  2009,  PUB.  L. NO. 111-148, THAT
 RESOLVES PATENT CLAIMS BETWEEN THE APPLICANT AND SPONSOR.
   5. "BIOSIMILAR BIOLOGICAL PRODUCT  APPLICATION  FILER"  SHALL  MEAN  A
 PARTY  THAT OWNS OR CONTROLS A BIOSIMILAR BIOLOGICAL PRODUCT APPLICATION
 FILED WITH THE FEDERAL FOOD AND DRUG ADMINISTRATION PURSUANT TO  SECTION
 351(K) OF THE PUBLIC HEALTH SERVICE ACT, 42 U.S.C. 262(K), FOR LICENSURE
 OF  A  BIOLOGICAL  PRODUCT  AS BIOSIMILAR TO, OR INTERCHANGEABLE WITH, A
 REFERENCE PRODUCT, OR THAT HAS THE EXCLUSIVE RIGHTS UNDER  THE  APPLICA-
 TION TO DISTRIBUTE THE BIOSIMILAR BIOLOGICAL PRODUCT.
   6. "NDA" SHALL MEAN A NEW DRUG APPLICATION.
   7. "NONREFERENCE DRUG FILER" SHALL MEAN EITHER:
   (A) AN ANDA FILER;
   (B)  A COMPANY THAT SEEKS AN ABBREVIATED APPROVAL PATHWAY FOR ITS DRUG
 PRODUCT UNDER 505(B)(2) OF THE FEDERAL FOOD, DRUG, AND  COSMETIC ACT, 21
 U.S.C. 355(B)(2); OR
   (C) A BIOSIMILAR BIOLOGICAL  PRODUCT  APPLICATION  FILER,  OR  COMPANY
 SEEKING FDA APPROVAL FOR A BIOSIMILAR UNDER 42 U.S.C. 262.
   8.  "NONREFERENCE  DRUG PRODUCT" SHALL MEAN THE PRODUCT TO BE MANUFAC-
 TURED UNDER AN ANDA OR AN APPLICATION FILED UNDER SECTION  505(B)(2)  OF
 THE  FEDERAL FOOD, DRUG, AND COSMETIC ACT, 21 U.S.C. 355(B), THAT IS THE
 SUBJECT OF THE PATENT INFRINGEMENT CLAIM, A BIOSIMILAR BIOLOGICAL  PROD-
 UCT  THAT IS THE PRODUCT TO BE MANUFACTURED UNDER THE BIOSIMILAR BIOLOG-
 ICAL PRODUCT APPLICATION THAT IS THE SUBJECT OF THE PATENT  INFRINGEMENT
 CLAIM, OR BOTH.
   9.  "PATENT  INFRINGEMENT" SHALL MEAN INFRINGEMENT OF ANY PATENT OR OF
 ANY FILED PATENT APPLICATION,  EXTENSION,  REISSUE,  RENEWAL,  DIVISION,
 CONTINUATION,  CONTINUATION IN PART, REEXAMINATION, PATENT TERM RESTORA-
 TION, PATENTS OF ADDITION, AND EXTENSIONS THEREOF.
   10. "PATENT INFRINGEMENT CLAIM" SHALL MEAN ANY ALLEGATION  MADE  TO  A
 NONREFERENCE  DRUG  FILER,  WHETHER OR NOT INCLUDED IN A COMPLAINT FILED
 WITH A COURT OF LAW, THAT ITS NONREFERENCE DRUG PRODUCT  OR  APPLICATION
 INFRINGES  ANY PATENT HELD BY, OR EXCLUSIVELY LICENSED TO, THE REFERENCE
 DRUG HOLDER.
   11. "REFERENCE DRUG HOLDER" SHALL MEAN EITHER:
   (A) A BRAND HOLDER THAT IS ANY OF THE FOLLOWING:
   (I) THE HOLDER OF AN APPROVED NDA FOR A DRUG PRODUCT APPLICATION FILED
 UNDER SECTION 505(B) OF THE FEDERAL FOOD, DRUG,  AND  COSMETIC  ACT,  21
 U.S.C. 355(B);
   (II)  A  PERSON OWNING OR CONTROLLING ENFORCEMENT OF THE PATENT LISTED
 IN THE APPROVED DRUG PRODUCTS WITH THERAPEUTIC  EQUIVALENCE  EVALUATIONS
 IN CONNECTION WITH THE NDA; OR
   (III)  THE  PREDECESSORS,  SUBSIDIARIES, DIVISIONS, GROUPS, AND AFFIL-
 IATES CONTROLLED BY, CONTROLLING, OR UNDER COMMON CONTROL WITH,  ANY  OF
 THE  ENTITIES  DESCRIBED  IN SUBPARAGRAPH (I) OR (II) OF THIS PARAGRAPH,
 WITH CONTROL TO BE PRESUMED BY DIRECT OR  INDIRECT  SHARE  OWNERSHIP  OF
 A. 7245--A                          3
 
 FIFTY  PERCENT  OR GREATER, AS WELL AS THE LICENSEES, LICENSORS, SUCCES-
 SORS, AND ASSIGNS OF EACH OF THOSE ENTITIES; OR
   (B)  A  BIOLOGICAL PRODUCT LICENSE HOLDER, WHICH SHALL MEAN ANY OF THE
 FOLLOWING:
   (I) THE HOLDER OF AN APPROVED BIOLOGICAL PRODUCT  LICENSE  APPLICATION
 FOR  A BIOLOGICAL DRUG PRODUCT UNDER SECTION 351(A) OF THE PUBLIC HEALTH
 SERVICE ACT, 42 U.S.C. 262(A);
   (II) A PERSON OWNING OR CONTROLLING ENFORCEMENT OF  ANY  PATENTS  THAT
 CLAIM THE BIOLOGICAL PRODUCT THAT IS THE SUBJECT OF THE APPROVED BIOLOG-
 ICAL PATENT LICENSE APPLICATION; OR
   (III)  THE  PREDECESSORS,  SUBSIDIARIES, DIVISIONS, GROUPS, AND AFFIL-
 IATES CONTROLLED BY, CONTROLLING, OR UNDER COMMON CONTROL WITH,  ANY  OF
 THE  ENTITIES  DESCRIBED  IN SUBPARAGRAPH (I) OR (II) OF THIS PARAGRAPH,
 WITH CONTROL TO BE PRESUMED BY DIRECT OR  INDIRECT  SHARE  OWNERSHIP  OF
 FIFTY  PERCENT  OR GREATER, AS WELL AS THE LICENSEES, LICENSORS, SUCCES-
 SORS, AND ASSIGNS OF EACH OF THOSE ENTITIES.
   12. "REFERENCE DRUG PRODUCT" SHALL MEAN THE PRODUCT TO BE MANUFACTURED
 BY THE REFERENCE DRUG HOLDER AND INCLUDES BOTH BRANDED DRUGS OF THE  NDA
 HOLDER  AND  THE  BIOLOGIC  DRUG PRODUCT OF THE BIOLOGIC PRODUCT LICENSE
 APPLICANT.
   13. "STATUTORY EXCLUSIVITY"  SHALL  MEAN  THOSE  PROHIBITIONS  ON  THE
 APPROVAL OF DRUG APPLICATIONS UNDER CLAUSES (II) THROUGH (IV) OF SECTION
 505(C)(3)(E), SECTION 527 OR SECTION 505A OF THE FEDERAL FOOD, DRUG, AND
 COSMETIC  ACT,  21  U.S.C.  355(C)(3)(E), ON THE LICENSING OF BIOLOGICAL
 PRODUCT APPLICATIONS UNDER SECTION 262(K)(7) OF TITLE 42 OF  THE  UNITED
 STATES CODE OR SECTION 262(M)(2) OR (3) OF TITLE 42 OF THE UNITED STATES
 CODE.
   §  283.  PRESERVING  ACCESS  TO  AFFORDABLE  DRUGS.  1.  (A) EXCEPT AS
 PROVIDED IN PARAGRAPH (C) OF THIS SUBDIVISION, AN AGREEMENT RESOLVING OR
 SETTLING, ON A FINAL OR INTERIM BASIS, A PATENT INFRINGEMENT  CLAIM,  IN
 CONNECTION  WITH THE SALE OF A PHARMACEUTICAL PRODUCT, SHALL BE PRESUMED
 TO HAVE ANTICOMPETITIVE EFFECTS AND SHALL BE A VIOLATION OF THIS SECTION
 IF BOTH OF THE FOLLOWING APPLY:
   (I) A NONREFERENCE DRUG FILER RECEIVES ANYTHING OF VALUE FROM  ANOTHER
 COMPANY ASSERTING PATENT INFRINGEMENT, INCLUDING, BUT NOT LIMITED TO, AN
 EXCLUSIVE LICENSE OR A PROMISE THAT THE BRAND COMPANY WILL NOT LAUNCH AN
 AUTHORIZED GENERIC VERSION OF ITS BRAND DRUG; AND
   (II)  THE  NONREFERENCE DRUG FILER AGREES TO LIMIT OR FOREGO RESEARCH,
 DEVELOPMENT, MANUFACTURING, MARKETING, OR SALES OF THE NONREFERENCE DRUG
 FILER'S PRODUCT FOR ANY PERIOD OF TIME.
   (B) AS USED IN SUBPARAGRAPH (I) OF PARAGRAPH (A) OF THIS  SUBDIVISION,
 "ANYTHING  OF VALUE" SHALL BE INTERPRETED BROADLY TO INCLUDE ANY TYPE OF
 CONSIDERATION, VALUE OR BENEFIT A REFERENCE DRUG HOLDER OR  NONREFERENCE
 DRUG FILER COULD POSSIBLY OBTAIN FROM THE AGREEMENT. "ANYTHING OF VALUE"
 SHALL  NOT  INCLUDE  A SETTLEMENT OF PATENT INFRINGEMENT CLAIMS IN WHICH
 THE CONSIDERATION GRANTED BY THE REFERENCE DRUG HOLDER TO THE  NONREFER-
 ENCE DRUG FILER AS PART OF THE RESOLUTION OR SETTLEMENT CONSISTS OF ONLY
 ONE OR MORE OF THE FOLLOWING:
   (I)  THE  RIGHT  TO  MARKET THE COMPETING PRODUCT IN THE UNITED STATES
 BEFORE THE EXPIRATION OF EITHER:
   (A) A PATENT THAT IS THE BASIS FOR THE PATENT INFRINGEMENT CLAIM; OR
   (B) A PATENT RIGHT OR OTHER STATUTORY EXCLUSIVITY THAT  WOULD  PREVENT
 THE MARKETING OF THE DRUG;
   (II) A COVENANT NOT TO SUE ON A CLAIM THAT THE NONREFERENCE DRUG PROD-
 UCT INFRINGES A UNITED STATES PATENT;
 A. 7245--A                          4
 
   (III)  COMPENSATION FOR SAVED REASONABLE FUTURE LITIGATION EXPENSES OF
 THE REFERENCE DRUG HOLDER BUT ONLY IF BOTH OF THE FOLLOWING ARE TRUE:
   (A)  THE TOTAL COMPENSATION FOR SAVED LITIGATION EXPENSES IS REFLECTED
 IN BUDGETS THAT THE REFERENCE DRUG  HOLDER  DOCUMENTED  AND  ADOPTED  AT
 LEAST SIX MONTHS BEFORE THE SETTLEMENT; AND
   (B) THE COMPENSATION SHALL NOT EXCEED THE LOWER OF THE FOLLOWING:
   (1) SEVEN MILLION FIVE HUNDRED THOUSAND DOLLARS; OR
   (2)  FIVE  PERCENT  OF  THE  REVENUE  THAT THE NONREFERENCE DRUG FILER
 PROJECTED OR FORECASTED IT WOULD RECEIVE IN THE  FIRST  THREE  YEARS  OF
 SALES  OF  ITS  VERSION OF THE REFERENCE DRUG DOCUMENTED AT LEAST TWELVE
 MONTHS BEFORE THE SETTLEMENT. IF NO PROJECTIONS OR FORECASTS ARE  AVAIL-
 ABLE,  THE  COMPENSATION  SHALL  NOT  EXCEED  TWO HUNDRED FIFTY THOUSAND
 DOLLARS;
   (IV) AN AGREEMENT BY THE REFERENCE DRUG HOLDER NOT TO  INTERFERE  WITH
 THE  NONREFERENCE DRUG FILER'S ABILITY TO SECURE AND MAINTAIN REGULATORY
 APPROVAL TO MARKET THE NONREFERENCE DRUG  PRODUCT  OR  AN  AGREEMENT  TO
 FACILITATE  THE NONREFERENCE DRUG FILER'S ABILITY TO SECURE AND MAINTAIN
 REGULATORY APPROVAL TO MARKET THE NONREFERENCE DRUG PRODUCT; OR
   (V) AN AGREEMENT RESOLVING A PATENT INFRINGEMENT CLAIM  IN  WHICH  THE
 REFERENCE  DRUG  HOLDER  FORGIVES  THE  POTENTIAL  DAMAGES  ACCRUED BY A
 NONREFERENCE DRUG FILER FOR AN AT-RISK LAUNCH OF THE  NONREFERENCE  DRUG
 PRODUCT THAT IS THE SUBJECT OF THAT CLAIM.
   (C)  PARTIES  TO AN AGREEMENT ARE NOT IN VIOLATION OF PARAGRAPH (A) OF
 THIS SUBDIVISION  IF  THEY  CAN  DEMONSTRATE  BY  CLEAR  AND  CONVINCING
 EVIDENCE THAT EITHER OF THE FOLLOWING ARE MET:
   (I)  THE  VALUE  RECEIVED  BY THE NONREFERENCE DRUG FILER DESCRIBED IN
 SUBPARAGRAPH (I) OF PARAGRAPH (A) OF THIS  SUBDIVISION  IS  A  FAIR  AND
 REASONABLE  COMPENSATION  SOLELY  FOR  OTHER  GOODS OR SERVICES THAT THE
 NONREFERENCE DRUG FILER HAS PROMISED TO PROVIDE; OR
   (II) THE AGREEMENT HAS DIRECTLY GENERATED PROCOMPETITIVE BENEFITS  AND
 THE  PROCOMPETITIVE  BENEFITS  OF THE AGREEMENT OUTWEIGH THE ANTICOMPET-
 ITIVE EFFECTS OF THE AGREEMENT.
   2. IN DETERMINING WHETHER THE PARTIES TO THE AGREEMENT HAVE MET  THEIR
 BURDEN  UNDER  PARAGRAPH (C) OF SUBDIVISION ONE OF THIS SECTION, A COURT
 OF COMPETENT JURISDICTION SHALL NOT CONSIDER ANY OF THE FOLLOWING:
   (A) THAT ENTRY INTO THE MARKETPLACE COULD NOT HAVE OCCURRED UNTIL  THE
 EXPIRATION  OF  THE  RELEVANT PATENT EXCLUSIVITY OR THAT THE AGREEMENT'S
 PROVISION FOR ENTRY OF THE NONREFERENCE DRUG PRODUCT BEFORE THE  EXPIRA-
 TION  OF  ANY  PATENT EXCLUSIVITY MEANS THAT THE AGREEMENT IS PROCOMPET-
 ITIVE WITHIN THE MEANING OF SUBPARAGRAPH (II) OF PARAGRAPH (C) OF SUBDI-
 VISION ONE OF THIS SECTION;
   (B) THAT ANY PATENT IS ENFORCEABLE AND INFRINGED BY  THE  NONREFERENCE
 DRUG  FILER  IN THE ABSENCE OF A FINAL ADJUDICATION BINDING ON THE FILER
 OF THOSE ISSUES;
   (C) THAT THE AGREEMENT CAUSED NO DELAY IN ENTRY  OF  THE  NONREFERENCE
 DRUG  FILER'S  DRUG PRODUCT BECAUSE OF THE LACK OF FEDERAL FOOD AND DRUG
 ADMINISTRATION (FDA) APPROVAL OF THAT OR OF  ANOTHER  NONREFERENCE  DRUG
 PRODUCT; OR
   (D)  THAT THE AGREEMENT CAUSED NO HARM OR DELAY DUE TO THE POSSIBILITY
 THAT THE NONREFERENCE DRUG FILER'S  DRUG  PRODUCT  MIGHT  INFRINGE  SOME
 PATENT THAT HAS NOT BEEN ASSERTED AGAINST THE NONREFERENCE DRUG FILER OR
 THAT IS NOT SUBJECT TO A FINAL AND BINDING ADJUDICATION ON THAT FILER AS
 TO THE PATENT'S SCOPE, ENFORCEABILITY, AND INFRINGEMENT.
   3.  IN DETERMINING WHETHER THE PARTIES TO THE AGREEMENT HAVE MET THEIR
 BURDEN UNDER PARAGRAPH (C) OF SUBDIVISION ONE OF THIS SECTION,  A  COURT
 OF COMPETENT JURISDICTION SHALL PRESUME THAT THE RELEVANT PRODUCT MARKET
 A. 7245--A                          5
 
 IS  THAT MARKET CONSISTING OF THE REFERENCE DRUG OF THE COMPANY ALLEGING
 PATENT INFRINGEMENT AND THE DRUG PRODUCT OF THE NONREFERENCE DRUG  FILER
 ACCUSED  OF  INFRINGEMENT  AND  ANY  OTHER  BIOLOGICAL  PRODUCT  THAT IS
 LICENSED  AS BIOSIMILAR OR IS AN AB-RATED GENERIC TO THE REFERENCE PROD-
 UCT.
   4. (A) THIS SECTION SHALL NOT MODIFY, IMPAIR, LIMIT, OR SUPERSEDE  THE
 APPLICABILITY  OF  THE  ANTITRUST  LAWS OF THE STATE PURSUANT TO ARTICLE
 TWENTY-TWO OF THE GENERAL BUSINESS LAW, UNFAIR COMPETITION LAWS  OF  THE
 STATE  PURSUANT  TO  ARTICLE TWENTY-TWO-A OF THE GENERAL BUSINESS LAW OR
 THE AVAILABILITY OF DAMAGES OR REMEDIES PROVIDED THEREIN.  THIS  SECTION
 SHALL  NOT  MODIFY,  IMPAIR,  LIMIT,  OR SUPERSEDE THE RIGHT OF ANY DRUG
 COMPANY APPLICANT TO ASSERT CLAIMS OR COUNTERCLAIMS AGAINST ANY  PERSON,
 UNDER THE ANTITRUST LAWS OR OTHER LAWS RELATING TO UNFAIR COMPETITION OF
 THE FEDERAL ANTITRUST LAW OR STATE LAW.
   (B)  IF  ANY  PROVISION OF THIS SUBDIVISION, AN AMENDMENT MADE TO THIS
 SUBDIVISION, OR THE APPLICATION OF ANY PROVISION  OR  AMENDMENT  TO  ANY
 PERSON  OR CIRCUMSTANCE IS HELD TO BE UNCONSTITUTIONAL, THE REMAINDER OF
 THIS SUBDIVISION, THE AMENDMENTS  MADE  TO  THIS  SUBDIVISION,  AND  THE
 APPLICATION  OF  THE PROVISIONS OF THIS SUBDIVISION OR AMENDMENTS TO ANY
 PERSON OR CIRCUMSTANCE SHALL NOT BE AFFECTED.
   5. (A)(I) EACH PERSON THAT VIOLATES OR ASSISTS  IN  THE  VIOLATION  OF
 THIS  SECTION  SHALL FORFEIT AND PAY TO THE STATE A CIVIL PENALTY SUFFI-
 CIENT TO DETER VIOLATIONS OF THIS SECTION, AS FOLLOWS:
   (A) IF THE PERSON WHO VIOLATED THIS SECTION RECEIVED ANY VALUE DUE  TO
 THAT  VIOLATION,  AN  AMOUNT UP TO THREE TIMES THE VALUE RECEIVED BY THE
 PARTY THAT IS REASONABLY ATTRIBUTABLE TO THE VIOLATION OF THIS  SECTION,
 OR TWENTY MILLION DOLLARS, WHICHEVER IS GREATER; OR
   (B) IF THE VIOLATOR HAS NOT RECEIVED ANYTHING OF VALUE AS DESCRIBED IN
 THIS  SUBPARAGRAPH, AN AMOUNT UP TO THREE TIMES THE VALUE GIVEN TO OTHER
 PARTIES TO THE AGREEMENT REASONABLY ATTRIBUTABLE  TO  THE  VIOLATION  OF
 THIS SECTION, OR TWENTY MILLION DOLLARS.
   (C)  FOR PURPOSES OF THIS SUBDIVISION, "REASONABLY ATTRIBUTABLE TO THE
 VIOLATION" SHALL BE DETERMINED BY THE STATE'S SHARE OF  THE  MARKET  FOR
 THE BRAND DRUG AT ISSUE IN THE AGREEMENT.
   (II) ANY PENALTY DESCRIBED IN SUBPARAGRAPH (I) OF THIS PARAGRAPH SHALL
 ACCRUE  ONLY  TO  THE  STATE  AND  SHALL  BE RECOVERED IN A CIVIL ACTION
 BROUGHT BY THE ATTORNEY GENERAL IN ITS OWN NAME, OR BY ANY OF ITS ATTOR-
 NEYS DESIGNATED BY IT FOR THAT PURPOSE, AGAINST ANY PARTY TO  AN  AGREE-
 MENT THAT VIOLATES THIS SECTION.
   (B)  EACH  PARTY  THAT  VIOLATES  OR  ASSISTS IN THE VIOLATION OF THIS
 SECTION SHALL BE LIABLE FOR ANY DAMAGES, PENALTIES, COSTS, FEES, INJUNC-
 TIONS, OR OTHER EQUITABLE OR LEGAL REMEDIES, INCLUDING, BUT NOT  LIMITED
 TO, RESTITUTION AND DISGORGEMENT, THAT MAY BE JUST AND REASONABLE.  SUCH
 REMEDIES  SHALL  INCLUDE,  BUT  NOT  BE LIMITED TO, ANY REMEDY AVAILABLE
 UNDER ARTICLES TWENTY-TWO OR TWENTY-TWO-A OF THE  GENERAL  BUSINESS  LAW
 AND SECTION SIXTY-THREE OF THE EXECUTIVE LAW.
   (C)  IF THE STATE IS AWARDED PENALTIES UNDER SUBPARAGRAPH (I) OF PARA-
 GRAPH (A) OF THIS SUBDIVISION, IT SHALL NOT RECOVER  PENALTIES  PURSUANT
 TO  ANOTHER  LAW  IDENTIFIED  IN PARAGRAPH (B) OF THIS SUBDIVISION. THIS
 SECTION SHALL NOT BE CONSTRUED TO FORECLOSE THE STATE'S ABILITY TO CLAIM
 ANY EQUITABLE OR LEGAL REMEDY AVAILABLE IN PARAGRAPH (B) OF THIS  SUBDI-
 VISION.
   (D)  AN  ACTION  TO  ENFORCE A CAUSE OF ACTION FOR A VIOLATION OF THIS
 SECTION SHALL BE COMMENCED WITHIN SIX YEARS AFTER THE  CAUSE  OF  ACTION
 ACCRUED.
 A. 7245--A                          6
 
   § 2. Severability clause. If any clause, sentence, paragraph, subdivi-
 sion,  section  or  part  of  this act shall be adjudged by any court of
 competent jurisdiction to be invalid  or  unenforceable,  such  judgment
 shall not affect, impair, or invalidate the remainder thereof, but shall
 be  confined in its operation to the clause, sentence, paragraph, subdi-
 vision, section or part thereof directly involved in the controversy  in
 which  such  judgment shall have been rendered. It is hereby declared to
 be the intent of the legislature that this act would have  been  enacted
 even if such invalid provisions had not been included herein.
   §  3.  This  act  shall take effect on the sixtieth day after it shall
 have become a law.