Document:

ex42a

                                                           Exhibit 4.2                                                                                                    This Instrument Prepared By:                             /s/ Brian J. Buck                                                   Brian J. Buck                            Assistant  General  Counsel  and  Assistant  Secretary-                            Exelon Corporation                             701 Ninth Street, N.W. – Mail Stop EP1300                            Washington, D.C.  20068                                                                                        DELMARVA POWER & LIGHT COMPANY                              TO                THE BANK OF NEW YORK MELLON,                             Trustee.                            ________   ONE HUNDRED AND TWENTY-FIRST SUPPLEMENTAL INDENTURE                            ________                      Dated as of June 1, 2018          (but executed on the dates shown on the execution page)                                   

 

         This ONE HUNDRED AND   TWENTY-FIRST  SUPPLEMENTAL INDENTURE, dated as  of the 1st day of June, 2018 (but executed on the dates hereinafter shown), made and entered into by and  between DELMARVA POWER & LIGHT COMPANY, a corporation of the State of Delaware and the  Commonwealth  of  Virginia,  hereinafter  called  the  “Company,”  and  THE  BANK  OF  NEW  YORK  MELLON, a New York banking corporation, hereinafter called the “Trustee”;         WITNESSETH:         WHEREAS, the Company heretofore executed and delivered its Indenture of Mortgage and Deed  of Trust (hereinafter in this One Hundred and Twenty-First Supplemental Indenture called the “Original  Indenture”), dated as of October 1, 1943, to The New York Trust Company, a corporation of the State of  New York, as Trustee, to which The Bank of New York Mellon is successor Trustee, to secure the First  Mortgage Bonds of the Company, unlimited in aggregate principal amount and issuable in series, from  time to time, in the manner and subject to the conditions set forth in the Original Indenture granted and  conveyed unto the Trustee, upon the trusts, uses and purposes specifically therein set forth, certain real  estate, franchises and other property therein described, including property acquired after the date thereof,  except as therein otherwise provided; and         WHEREAS,  the  Original  Indenture  has  been  supplemented  by  one  hundred  and twenty  supplemental indentures specifically subjecting to the lien of the Original Indenture as though included in  the  granting  clause  thereof  certain  property  in  said  supplemental  indentures  specifically  described  and  amending and modifying the provisions of the Original Indenture (the Original Indenture, as amended,  modified and supplemented by all of the indentures supplemental thereto, including this One Hundred and  Twenty-First Supplemental Indenture, is hereinafter in this One Hundred and Twenty-First Supplemental  Indenture called the “Indenture”); and         WHEREAS, the Original Indenture provides for the issuance of bonds thereunder in one or more  series, the form of each series  of bonds and of the coupons to be attached to any coupon bonds to be  substantially in the forms set forth therein with such omissions, variations and insertions as are authorized  or  permitted  by  the  Original Indenture  and  determined  and  specified  by  the  Board  of  Directors  of the  Company; and         WHEREAS, the Company, by appropriate corporate action in conformity with the terms of the  Original Indenture, has duly determined to create a series of bonds to be designated as First Mortgage  Bonds, 4.27% Series due June 15, 2048 (hereinafter sometimes referred to as the “4.27% Series Bonds”  or the “bonds of 4.27% Series”), which said 4.27% Series Bonds are to be substantially in the following  form:                              [FORM OF FACE OF BOND]         THIS BOND HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS  AMENDED,  OR  THE  SECURITIES  OR  “BLUE  SKY”  LAWS  OF  ANY  OTHER  JURISDICTION,  AND  MAY  BE  TRANSFERRED  ONLY  IN  COMPLIANCE  WITH  SUCH  REGISTRATION  REQUIREMENTS OR UNDER AN EXEMPTION THEREFROM.                        DELMARVA POWER & LIGHT COMPANY                              FIRST MORTGAGE BOND,                           4.27% SERIES DUE JUNE 15, 2048  Number: [_______]                                                 $[_________]     

 

                                                                 PPN No.: [_______]         DELMARVA  POWER  &  LIGHT  COMPANY,  a  Delaware  and  Virginia  corporation  (the  “Company”),  for  value  received,  hereby  promises to  pay  to [_____________],  the  sum  of  [____________] Dollars ($[__________]) on June 15, 2048, at the office or agency of the Company in  the  Borough  of  Manhattan,  The  City  of  New  York,  in  such  coin  or  currency  of  the  United  States  of  America as at the time of payment shall be legal tender for public and private debts, and to pay interest  thereon, semi-annually on June 15 and December 15 of each year at the rate of four and twenty-seven  hundredths percent  (4.27%)  per  annum,  at  said  office  or  agency  in  like  coin  or  currency,  from  the  fifteenth day of June or December, as the case may be, to which interest has been paid preceding the date  hereof (unless the date hereof is a June 15 or December 15 on which interest has been paid, in which case  from the date hereof, or unless the date hereof is prior to December 15, 2018, in which case from June  [__], 2018), until this bond shall mature, according to its terms or on prior redemption or by declaration or  otherwise, and at the highest rate of interest borne by any of the bonds outstanding under the Mortgage  hereinafter mentioned from such date of maturity until this bond shall be paid or the payment hereof shall  have been duly provided for. The interest so payable on any June 15 or December 15 will be paid to the  person in whose name  this Bond is  registered at the close  of business on the  first calendar day of the  month in which the interest payment date occurs; provided, however, that interest payable at maturity will  be paid to the person to whom principal is paid. In the event that any interest payment date is a legal  holiday or a day on which banking institutions are authorized by law to close, then payment of interest  payable on such date may be made on the next succeeding day, not a legal holiday or a day on which  banking  institutions  are  authorized  by  law  to  close,  with  the  same  force  and  effect  as  if  made  on  the  interest payment date. Interest on this bond shall be computed on the basis of a 360-day year consisting of  twelve 30-day months.         The provisions of this bond are continued on the reverse hereof and such continued provisions  shall for all purposes have the same effect as though fully set forth at this place.         This  bond  shall  not  become  valid  or  obligatory  for  any  purpose  until  THE  BANK  OF  NEW  YORK  MELLON,  the  Trustee  under  the  Mortgage,  or  its  successor  thereunder,  shall  have  signed  the  certificate of authentication endorsed hereon.         IN WITNESS WHEREOF, DELMARVA POWER & LIGHT COMPANY has caused this bond  to  be  signed  in  its  name  with  the  manual  or  facsimile  signature  of  its  President  or  one  of  its  Vice  Presidents and its corporate seal, or a facsimile thereof, to be affixed hereto and attested by the manual or  facsimile signature of its Secretary or one of its Assistant Secretaries.   Dated:   Seal:                                           DELMARVA POWER & LIGHT COMPANY  Attest:                                          By:        Assistant Secretary                   Senior Vice President                             Trustee’s Authentication Certificate         This  bond  is  one  of  the  bonds  of  the  series  herein  designated,  provided  for  in  the within- mentioned mortgage.                                          3  

 

                                            THE BANK OF NEW YORK MELLON, Trustee                                            By:                                               Authorized Officer                             [FORM OF REVERSE OF BOND]                       DELMARVA POWER & LIGHT COMPANY                              FIRST MORTGAGE BOND,                           4.27% SERIES DUE JUNE 15, 2048         This bond is one of an issue of bonds of the Company (herein referred to as the “bonds”), not  limited in principal amount, issuable in series, which different series may mature at different times, may  bear interest at different rates, and may otherwise vary as in the Mortgage hereinafter mentioned, and is  one of a series known as its First Mortgage Bonds, 4.27% Series due June 15, 2048 (herein sometimes  referred to as “bonds of 4.27% Series ”). All bonds of all series and tranches issued and to be issued under  and equally and ratably secured (except insofar as any sinking fund, established in accordance with the  provisions of the Mortgage hereinafter mentioned, may afford additional security for the bonds of any  particular series or tranche) by the Mortgage and Deed of Trust, dated as of October 1, 1943, executed by  the Company to THE NEW YORK TRUST COMPANY, as Trustee, to which THE BANK OF NEW  YORK  MELLON,  a  New  York  banking  corporation,  is  successor  Trustee  (herein,  together  with  any  indentures  supplemental thereto,  including  a One  Hundred  and  Twenty-First  Supplemental Indenture,  dated  as  of June  1,  2018  (the  “One  Hundred  and  Twenty-First  Supplemental Indenture”),  called  the  “Mortgage”), to which reference is made for a description of the property mortgaged and pledged, the  nature and extent of the security, the rights and limitations of rights of the holders of the bonds and of the  Company in respect thereof, the rights, duties and immunities of the Trustee, and the terms and conditions  upon which the bonds are, and are to be, issued and secured. The Mortgage contains provisions permitting  the Company and the Trustee, with the consent of the holders of not less than seventy-five percent (75%)  in principal amount of all the bonds at the time outstanding (determined as provided in the Mortgage),  evidenced  as  in  the  Mortgage  provided,  or in  case  the  rights  under  the  Mortgage  of  the  holder  of  the  bonds of one or more, but less than all, of the series of bonds outstanding shall be affected, then with the  consent of the holders of not less than seventy-five percent (75%) in principal amount of the bonds at the  time outstanding of the one or more series, taken in the aggregate, affected (determined as provided in the  Mortgage),  evidenced  as  in  the  Mortgage  provided,  to  execute  supplemental  indentures  adding  any  provisions  to  or  changing  in  any  manner  or  eliminating  any  of  the  provisions  of  the  Mortgage  or  modifying in any manner the rights of the holders of the bonds and coupons; provided, however, that no  such supplemental indenture shall (i) extend the fixed maturity of any bonds, or reduce the rate or extend  the time of payment of interest thereon, or reduce the principal amount thereof, without the consent of the  holder of each bond so affected, or (ii) reduce the aforesaid percentage of bonds, the holders of which are  required to consent to any such supplemental indenture without the consent of the holders of all bonds  then outstanding. Any such consent by the registered holder of this bond (unless effectively revoked as  provided in the Mortgage) shall be conclusive and binding upon such holder and upon all future holders  of this bond, irrespective of whether or not any notation of such consent is made upon this bond.   No reference herein to the Mortgage and no provision of this bond or of the Mortgage shall alter or impair  the obligation of the Company, which is absolute and unconditional, to pay the principal of, premium, if  any,  and  interest  on  this  bond  at  the  time  and  place,  at  the  rate  and  in  the  coin  or  currency herein  prescribed.                                          4  

 

         The  fully  registered  bonds  of 4.27% Series  are  issuable  in  denominations  of  $1,000  and  any  integral multiple of $1,000 in excess thereof. At the office or agency to be maintained by the Company in  the  Borough  of  Manhattan,  The  City  of  New  York  and  in  the  manner  and  subject  to  the  limitations  provided in the Mortgage, fully registered bonds of such series may be exchanged for a like aggregate  principal amount of fully registered bonds of such series of other authorized denominations, and in each  case without payment of any service or other similar charge, but the Company may require payment of a  sum  sufficient  to  cover  any  tax  or  taxes  or  other  governmental  charges  required  to  be  paid  by  the  Company in relation thereto, as provided in the One Hundred and Twenty-First Supplemental Indenture.         In order to enable the Trustee to comply with its obligations under applicable tax laws, rules and  regulations in effect from time to time (“Applicable Law”), the Company shall provide to the Trustee,  following  written  request  from  the  Trustee,  such  information  concerning  the  holders  of  the  bonds  of  4.27% Series as the Trustee may reasonably request in order to determine whether the Trustee has any  tax-related obligations under Applicable Law with respect to the payments made to holders of the bonds  of 4.27% Series, but only to the  extent (a) such information is  in the  Company’s  possession, (b) such  information is not subject to any confidentiality or similar agreement or undertaking or otherwise deemed  by the  Company  to  be  confidential and  (c)  providing  such information  to the Trustee  does  not,  in  the  judgment of the Company, breach or violate or constitute a default under any applicable laws, rules or  regulations or any instrument or agreement to which the Company of any of its affiliates is a party or may  be  bound.  The  Company,  the  Trustee  or  any  paying  agent  for  the  bonds  of 4.27% Series  shall  be  permitted  to  make  any  withholding  or  deduction from  the  amount  of  principal  and  interest  payable  to  holders of the bonds of 4.27% Series to the extent required under Applicable Law.         The bonds of 4.27% Series shall be redeemable at the option of the Company prior to the express  date of the maturity hereof, in whole or in part, at any time; provided that the Company may not redeem  less than 5% of the aggregate principal amount of the bonds of the 4.27% Series in the case of any partial  redemption. The  Company shall give  notice  of its intent to redeem such bonds of 4.27% Series to the  holders of such bonds of the 4.27% Series at least 30 days but no more than 90 days prior to the date fixed  for such redemption (the “Redemption Date”). If the Company redeems all or any part of the bonds of  4.27% Series pursuant to the provisions of this paragraph, it shall pay an amount equal to 100% of the  principal amount of the bonds of the 4.27% Series to be redeemed and a Make-Whole Amount, which  shall be calculated as follows:         “Make-Whole Amount” means, as determined by the Company, with respect to any bond of the  4.27% Series, an amount equal to the excess, if any, of the Discounted Value of the Remaining Scheduled  Payments with respect to the Called Principal of such bond of the 4.27% Series over the amount of such  Called Principal of such bond of the 4.27% Series, provided, that the Make-Whole Amount may in no  event be less than zero.  For the purposes of determining the Make-Whole Amount, the following terms  have the following meanings:            “Business  Day”  means any  day  other  than  a  Saturday,  a  Sunday  or  a  day  on  which           commercial banks in New York City are required or authorized to be closed.            “Called Principal” means, with respect to any bond of the 4.27% Series, the principal of such           bond  of  the 4.27% Series that  is  to  be redeemed or  has  become  or  is  declared  to  be           immediately due and payable pursuant to the Mortgage.            “Discounted Value”  means, with respect to the  Called Principal of any bond of the 4.27%           Series, the amount obtained by discounting all Remaining Scheduled Payments with respect           to such Called Principal from their respective scheduled due dates to the Settlement Date with           respect  to  such  Called  Principal,  in  accordance  with  accepted  financial  practice  and  at  a                                         5  

 

                discount factor (applied on the same periodic basis as that on which interest on the bonds of  the 4.27% Series is  payable)  equal  to  the  Reinvestment  Yield  with  respect  to  such  Called  Principal.   “Reinvestment Yield” means, with respect to the Called Principal of any bond of the 4.27%  Series, the  sum  of  (a) 0.50%  plus  (b)  the  yield  to maturity  implied  by  the  “Ask  Yield(s)”  reported as of 10:00 a.m. (New York City time) on the second Business Day preceding the  Settlement  Date  with  respect  to  such  Called  Principal,  on  the  display  designated  as  “Page  PX1” (or such other display as may replace Page PX1) on Bloomberg Financial Markets for  the  most  recently  issued  actively  traded  on-the-run  U.S.  Treasury  securities  (“Reported”)  having a maturity equal to the Remaining Average Life of such Called Principal as of such  Settlement Date.  If there are no such U.S. Treasury securities Reported having a  maturity  equal  to  such  Remaining  Average  Life,  then  such  implied  yield  to  maturity  will  be  determined  by  (i)  converting  U.S.  Treasury  bill  quotations  to  bond  equivalent  yields  in  accordance with accepted financial practice and (ii) interpolating linearly between the “Ask  Yields”  Reported  for  the  applicable  most  recently  issued  actively  traded  on-the-run  U.S.  Treasury  securities  with  the  maturities  (1)  closest  to  and  greater  than  such  Remaining  Average  Life  and  (2)  closest  to  and  less than  such  Remaining  Average  Life.   The  Reinvestment  Yield  shall  be  rounded  to  the  number  of  decimal  places  as  appears  in  the  interest rate of the applicable bond of the 4.27% Series.   If such yields are not Reported or the yields Reported as of such time are not ascertainable  (including by way of interpolation), then  “Reinvestment Yield”  means,  with respect to the  Called Principal of any bond of the 4.27% Series, the sum of (x) 0.50% plus (y) the yield to  maturity implied by the U.S. Treasury constant maturity yields reported, for the latest day for  which  such  yields  have  been  so  reported  as  of  the  second  Business  Day  preceding  the  Settlement Date with respect to such Called Principal, in Federal Reserve Statistical Release  H.15  (or  any  comparable  successor  publication)  for  the  U.S.  Treasury  constant  maturity  having  a  term  equal  to  the  Remaining  Average  Life  of  such  Called  Principal  as  of  such  Settlement Date.  If there is no such U.S. Treasury constant maturity having a term equal to  such  Remaining  Average  Life,  such  implied  yield  to  maturity  will  be  determined  by  interpolating linearly between (1) the U.S. Treasury constant maturity so reported with the  term  closest  to  and  greater  than  such  Remaining  Average  Life  and  (2)  the  U.S.  Treasury  constant maturity so reported with the term closest to and less than such Remaining Average  Life.  The Reinvestment Yield shall be rounded to the number of decimal places as appears in  the interest rate of the applicable bond of the 4.27% Series.   “Remaining Average Life” means, with respect to any Called Principal, the number of years  obtained by dividing (i) such Called Principal into (ii) the sum of the products obtained by  multiplying (a) the principal component of each Remaining Scheduled Payment with respect  to such Called Principal by (b) the number of years, computed on the basis of a 360-day year  comprised of twelve  30-day  months  and  calculated to two decimal places, that will elapse  between the Settlement Date with respect to such Called Principal and the scheduled due date  of such Remaining Scheduled Payment.   “Remaining Scheduled Payments” means, with respect to the Called Principal of any bond of  the 4.27% Series, all payments of such Called Principal and interest thereon that would be  due  after  the  Settlement  Date  with respect to  such  Called  Principal  if  no  payment of  such  Called Principal were made prior to its scheduled due date, provided that if such Settlement  Date  is  not  a  date  on  which  interest  payments  are  due  to  be  made  under  the bonds  of the  4.27% Series,  then  the  amount  of  the  next  succeeding  scheduled  interest  payment  will  be                                6  

 

            reduced by the amount of interest accrued to such Settlement Date and required to be paid on           such Settlement Date.            “Settlement  Date”  means,  with  respect  to  the  Called  Principal  of  any bond  of  the 4.27%           Series, the date on which such Called Principal is to be prepaid or has become or is declared           to be immediately due and payable pursuant to the Mortgage, as the  context requires. The           Company’s notice of redemption to the holders of bonds of 4.27% Series shall specify such           date (which shall be a Business Day), the aggregate principal amount of the bonds of 4.27%           Series to be prepaid on such date, the principal amount of each bond of 4.27% Series held by           such holder to be prepaid (determined in accordance with the next paragraph hereof), and the           interest  to  be  paid  on  the  prepayment  date  with  respect  to  such  principal  amount  being           prepaid,  and  shall  be  accompanied  by  a  certificate  of the  chief  financial  officer,  principal           accounting  officer,  treasurer, assistant  treasurer or  comptroller  of  the  Company  (each,  a           “Senior Financial Officer”) as to the estimated Make-Whole Amount due in connection with           such prepayment (calculated as if the date of such notice were the date of the prepayment),           setting forth the details of such computation.  Two Business Days prior to such prepayment,           the  Company  shall  deliver  to the  Trustee  and each  holder  of  bonds  of 4.27% Series a           certificate  of  a  Senior  Financial  Officer  specifying  the  calculation  of  such  Make-Whole           Amount as of the specified prepayment date.         In the case of each partial prepayment of the bonds of 4.27% Series, the principal amount of the  bonds of 4.27% Series to be prepaid shall be allocated among all of the bonds of 4.27% Series at the time  outstanding in proportion, as nearly as practicable, to the respective unpaid principal amounts thereof not  theretofore called for prepayment.         In the case of each prepayment of bonds of 4.27% Series, the principal amount of each bond of  4.27% Series to  be  prepaid  shall  mature  and  become  due  and  payable  on  the  date  fixed  for  such  prepayment,  together  with  interest  on  such  principal  amount  accrued  to  such  date  and  the  applicable  Make-Whole  Amount,  if  any.   From  and  after  such  date,  unless  the  Company  shall  fail  to  pay  such  principal amount when so due and payable, together with the interest and Make-Whole Amount, if any, as  aforesaid, interest on such principal amount shall cease to accrue.  Any bond of 4.27% Series paid or  prepaid in full shall be surrendered to the Company and cancelled and shall not be reissued, and no bond  of 4.27% Series shall be issued in lieu of any prepaid principal amount of any bond of 4.27% Series.         The Company shall deliver to the Trustee before any Redemption Date for the bonds of 4.27%  Series its calculation of the amount applicable to such redemption. The Trustee shall be under no duty to  inquire into, may presume the correctness of, and shall be fully protected in acting upon, the Company’s  calculation of any Redemption Price of the bonds of 4.27% Series.         If at the time notice of redemption is given the redemption moneys are not on deposit with the  Trustee, then the redemption shall be subject to the receipt of such moneys on or before the Redemption  Date, and such notice shall be of no effect unless such moneys are received. The Mortgage provides that  if the Company shall deposit with the Trustee in trust for the purpose funds sufficient to pay the principal  of all of the bonds of any series, or such of the bonds of any series as have been or are to be called for  redemption, and premium, if any, thereon, and all interest payable on such bonds to the date on which  they become due and payable at maturity or upon redemption or otherwise, and shall comply with the  other provisions of the Mortgage in respect thereof, then from the date of such deposit such bonds shall  no longer be entitled to any lien or benefit under the Mortgage.                                          7  

 

         The principal hereof may be declared or may become due prior to the express date of the maturity  hereof on the conditions, in the manner and at the time set forth in the Mortgage, upon the occurrence of a  completed default as in the Mortgage provided.         This bond is transferable as prescribed in the Mortgage by the registered holder hereof in person,  or by his or her duly authorized attorney, at the office or agency to be maintained by the Company in the  Borough  of  Manhattan,  The  City  of  New  York,  upon  surrender  and  cancellation  of this  bond,  and  thereupon a new fully registered bond or bonds of authorized denominations of the same series and for  the same aggregate principal amount will be issued to the transferee in exchange herefor as provided in  the Mortgage, and in each case without payment of any service or other similar charge as provided in the  One Hundred and Twenty-First Supplemental Indenture. The Company and the Trustee, any paying agent  and  any  bond  registrar  may  deem  and  treat  the  person  in  whose  name  this  bond  is  registered  as  the  absolute owner hereof, whether or not this bond shall be overdue, for the purpose of receiving payment  and for all other purposes and neither the Company nor the Trustee nor any paying agent nor any bond  registrar shall be affected by any notice to the contrary.         No recourse shall be had for the payment of the principal of, premium, if any, and interest on, this  bond, or for any claim based  hereon, or otherwise in respect hereof, or based on, or in respect of, the  Mortgage,  against  an  incorporator or  any  past,  present  or  future  subscriber  to  the  capital  stock,  stockholder, officer or director, as such, of the Company or of any successor corporation, either directly  or through the Company or any successor corporation, under any rule of law, statute or constitution or by  the  enforcement  of  any  assessment  or  otherwise,  all  such  liability  of  incorporators,  subscribers,  stockholders, officers and directors, as such, being waived and released by the holder and owner hereof  by the acceptance of this bond and being likewise waived and released by the terms of the Mortgage.                               [END OF FORM OF BOND]         WHEREAS, all acts and things prescribed by law and by the charter and by-laws of the Company  necessary  to  make  the 4.27% Series  Bonds,  when  executed  by  the  Company  and  authenticated  by  the  Trustee,  as  in  the  Original  Indenture  provided,  valid,  binding  and  legal  obligations  of  the  Company,  entitled in all respects to the security of the Original Indenture and indentures supplemental thereto, have  been performed; and         WHEREAS,  provision  is  made  in  Sections  5.11  and  17.01  of  the  Original  Indenture  for  such  further instruments and indentures, supplemental to the Original Indenture, as may be necessary or proper  to  carry  out  more  effectually  the  purposes  of  the  Original  Indenture,  and  to  subject  to  the  lien  of  the  Original  Indenture  any  property  acquired  after  the  date  of  the  Original  Indenture  and  intended  to  be  covered thereby, with the same force and effect as though included in the granting clause thereof, and to  add  such further  covenants,  restrictions  or  conditions  for  the  protection of the  mortgaged  and  pledged  property and the holders of the bonds as the Board of Directors of the Company and the Trustee shall  consider to be for the protection of the holders of the bonds, and to set forth the terms and provisions of  any series of bonds to be issued under the Original Indenture and the form of the bonds and coupons of  such series; and the Company since the date of the Original Indenture has acquired additional property not  heretofore  specifically  subjected  to  the  lien  of  the  Original  Indenture;  and  it  is  desired  to  add  certain  further covenants, restrictions and conditions for the protection of the mortgaged and pledged property  and the holders of the bonds, as provided in this One Hundred and Twenty-First Supplemental Indenture,  which the Board of Directors of the Company and the Trustee consider to be for the protection of the  holders  of  the  bonds;  and  the  Company  desires  to  issue  the 4.27% Series  Bonds;  and  the  Company  therefore deems it advisable to enter into this One Hundred and Twenty-First Supplemental Indenture in  the form and terms hereof; and                                          8  

 

         WHEREAS,  the  execution  and  delivery  of  this One  Hundred  and  Twenty-First  Supplemental  Indenture  has been duly authorized  by the Board of Directors of the Company, and all conditions and  requirements  necessary  to  make  this One  Hundred  and  Twenty-First  Supplemental Indenture  a  valid,  binding and legal instrument in  accordance  with  its  terms,  for  the  purposes  herein  expressed, and  the  execution and delivery hereof, in the form and terms hereof, have been in all respects duly authorized;         NOW,  THEREFORE,  in  order  further  to  secure  the  payment  of  the  principal  and  interest  and  premium, if any, of all bonds issued and to be issued under the Original Indenture and any indentures  supplemental thereto, including this One Hundred and Twenty-First Supplemental Indenture, according to  their tenor, purport and effect and the performance and observance of all the covenants and conditions in  said  bonds  and  the  Original  Indenture  and  any  indentures  supplemental  thereto,  including  this One  Hundred and Twenty-First Supplemental Indenture, contained and to subject to the lien of the Original  Indenture, as so supplemented, with the same force and effect as though included in the granting clause  thereof, and in consideration of the premises and of the sum of One Dollar ($1.00), lawful money of the  United  States  of  America,  to  the  Company  duly  paid  by  the  Trustee  at  or  before  the  ensealing  and  delivery  hereof,  and  other  valuable  consideration,  the  receipt  whereof  is  hereby  acknowledged,  and  intending to be legally bound hereby, the Company has executed and delivered this One Hundred and  Twenty-First  Supplemental Indenture,  and  has  granted,  bargained,  sold,  released,  conveyed,  assigned,  transferred, mortgaged, pledged, set over and confirmed, and granted a security interest therein, and by  these presents does grant, bargain, sell, release, convey, assign, transfer, mortgage, pledge, set over and  confirm, and grant a security interest therein, subject to the provisions of the Indenture, unto THE BANK  OF NEW YORK MELLON, as trustee, and to its successors in trust and to its and their assigns forever,  all the following described properties of the Company, and does hereby confirm that the Company will  not cause or consent to a partition, either voluntary or through legal proceedings, of property, whether  herein  described  or  heretofore  or  hereafter  acquired,  in  which  its  ownership  shall  be  as  tenants  in  common, except  as  permitted  by,  and  in  conformity  with,  the  provision  of  the  Original  Indenture,  as  supplemented, and particularly of Article IX of the Original Indenture:         All property, real, personal and mixed, tangible and intangible, owned by the Company on the  date  of the  execution hereof or which  may be  hereafter acquired  by it (except such property as in the  Original Indenture expressly excepted from the lien and operation of the Indenture).         The  property  covered  by  this One  Hundred  and  Twenty-First  Supplemental Indenture  shall  include  particularly,  among  other  property,  without  prejudice  to  the  generality  of  the  language  hereinbefore or hereinafter contained, the following described property:         All  the  electric  generating  stations,  station  sites,  stations,  electric  reserve  generating  stations,  substations, substation sites, gas manufacturing plants, ice and cold storage plants, steam plants, hot water  plants, hydro-electric stations, hydro-electric station sites, electric transmission lines, electric distribution  systems,  gas  transportation  mains,  gas  distribution  systems,  steam  distribution  systems,  hot  water  distribution  systems,  regulator  stations,  regulator  station  sites,  office  buildings,  storeroom  buildings,  warehouse buildings, boiler houses, plants, plant sites, service plants, coal storage yards, and poleyards  now or hereafter owned by the Company, including all electric works, power houses, generators, turbines,  boilers,  engines,  furnaces,  retorts,  dynamos,  buildings,  structures,  transformers,  meters,  towers,  poles,  tower lines, cables, pole lines, tanks, storage holders, regulators, gas works, pipes, pipe lines, mains, pipe  fittings,  valves,  drips,  connections,  tunnels,  conduits,  gates,  motors,  wires,  switch  racks,  switches,  brackets,  insulators,  and  all equipment,  improvements,  machinery,  appliances,  devices,  appurtenances,  supplies  and  miscellaneous  property  for  generating,  producing,  transforming,  converting,  storing  and  distributing electric energy, gas, ice, steam and hot water, and furnishing cold storage, now or hereafter  owned by the Company, together with all furniture and fixtures located in the aforesaid buildings, and all  land now or hereafter owned by the Company on which the same or any part thereof are situated, and all                                         9  

 

   of the real estate, leases, leaseholds (except the last day of the term of each lease and leasehold), and lands  now or hereafter owned by the Company, including land located on or adjacent to any river, stream or  other water, together with all flowage rights, flooding rights, water rights, riparian rights, dams and dam  sites and rights, flumes, canals, races, raceways, head works and diversion works, and all of the municipal  and other franchises, licenses, consents, ordinances, permits, privileges, rights, servitudes, easements and  rights-of-way and other rights in or relating to real estate or the occupancy of the same now or hereafter  owned by the Company, and all of the other property, real, personal or mixed, now or hereafter owned by  the Company, forming a part of any of the foregoing property or used or enjoyed or capable of being used  or  enjoyed  in  connection  therewith  or  in  any  way  appertaining  thereto,  whether  developed  or  undeveloped,  or  partially  developed,  or  whether  now  equipped  and  operating  or  not  and  wherever  situated, and all of the Company’s presently held or hereafter acquired right, title and interest in and to the  land on which the same or any part thereof are situated or adjacent thereto, and all rights for or relating to  the construction, maintenance or operation of any of the foregoing property through, over, under or upon  any  public  streets  or  highways  or  other  lands,  public  or  private,  and  (except  as  hereinafter  expressly  excepted) all the right, title and interest of the Company presently held or hereafter acquired in and to all  other  property  of  any  kind  or  nature  appertaining  to  and/or  used  and/or  occupied  and/or  enjoyed  in  connection with any property hereinbefore described, and, as to all of the foregoing, whether now owned  by the Company or hereafter acquired by the Company.         Together with all and singular the tenements, hereditaments and appurtenances belonging or in  any  way  appertaining  to  the  aforesaid  property  or  any  part  thereof,  with  the  reversion  and  reversions,  remainder and remainders and (subject to the provisions of Section 9.01 of the Original Indenture) the  tolls, rents, revenues, issues, earnings, income, product and profits thereof, and all the estate, right, title  and  interest  and  claim  whatsoever,  at  law  as  well  as  in  equity,  which  the  Company  now  has  or  may  hereafter acquire in and to the aforesaid property and franchises and every part and parcel thereof.         IT IS HEREBY AGREED by the Company that all property, rights and franchises acquired by  the Company after the date hereof (except any in the Original Indenture expressly excepted) shall (subject  to the provisions of Section 9.01 of the Original Indenture and to the extent permitted by law) be as fully  embraced within the lien of the Original Indenture and any indentures supplemental thereto, including this  One Hundred and Twenty-First Supplemental Indenture, as if such property, rights and franchises were at  the time of the execution of the Original Indenture owned by the Company and/or specifically described  therein  and  conveyed  thereby and  as  if  such  property,  rights  and  franchises  were  now  owned  by  the  Company and/or specifically described herein and conveyed hereby;         Provided that, in addition to the reservations and exceptions herein and elsewhere contained, the  following  are  not  and are  not  intended  to  be  granted,  bargained,  sold,  released,  conveyed,  assigned,  transferred, mortgaged, pledged, set over or confirmed hereunder and are hereby expressly excepted from  the lien and operation of the Original Indenture and any indentures supplemental thereto, including this  One Hundred and Twenty-First Supplemental Indenture, viz.: (1) cash and shares of stock and certificates  or  evidence  of  interest  therein  and  obligations  (including  bonds,  notes  and  other  securities)  not  in  or  pursuant to the Original Indenture or any indenture supplemental thereto, including this One Hundred and  Twenty-First  Supplemental Indenture,  specifically  pledged  or  deposited  or  delivered  or  therein  covenanted  so  to  be;  (2)  any  goods,  wares,  merchandise,  equipment,  materials  or  supplies  held  or  acquired  for  the  purpose  of  sale  or  resale  in  the  usual  course  of  business  or  for  consumption  in  the  operation  of  any  properties  of  the  Company;  and  (3)  all  judgments,  contracts,  accounts  and  choses  in  action,  the  proceeds  of  which  the  Company  is  not  obligated  as  in  the  Original  Indenture  provided  to  deposit with the Trustee hereunder; provided, however, that the property and rights expressly excepted  from the lien and operation of the Original Indenture and any indentures supplemental thereto, including  this One Hundred and Twenty-First Supplemental Indenture, in the above subdivisions (2) and (3) shall  (to the extent permitted by law) cease to be so excepted, in the event that the Trustee or a receiver or                                         10  

 

   trustee shall take possession of the mortgaged and pledged property in the manner provided in Article X  of the Original Indenture, by reason of the occurrence of a completed default, as defined in said Article X  of the Original Indenture.         TO  HAVE  AND  TO  HOLD  all  such  properties,  real,  personal,  or  mixed,  granted,  bargained,  sold,  released,  conveyed,  assigned,  transferred,  mortgaged,  pledged,  set  over  or  confirmed  by  the  Company as aforesaid, or intended so to be, unto the Trustee and its successors in the trusts created in the  Indenture and its and their assigns forever;         SUBJECT, HOWEVER, to any reservations, exceptions, conditions, limitations and restrictions  contained in the several deeds, servitudes, franchises and contracts or other instruments through which the  Company acquired, and/or claims title to and/or enjoys the use of the aforesaid properties; and subject  also to encumbrances of the character defined in the Original Indenture as “excepted encumbrances” in so  far as the same may attach to any of the property embraced herein;         IN TRUST NEVERTHELESS upon the terms, trusts, uses and purposes specifically set forth in  the Indenture; this One Hundred and Twenty-First Supplemental Indenture being made for the purpose,  inter alia, of subjecting the real estate and premises and other property above described to the lien and  operation of the Indenture, so that the same shall be held specifically by the Trustee under and subject to  the terms and conditions of the Original Indenture in identically the same manner and for the same trusts,  uses and purposes, as though the said real estate and premises and other property had been specifically  described in the Original Indenture.         AND IT IS HEREBY FURTHER COVENANTED AND AGREED and the Company and the  Trustee have mutually agreed, in consideration of the premises, as follows:                                     ARTICLE I.                                                      DESIGNATION, PROVISIONS, DENOMINATIONS AND ISSUANCE                              OF 4.27% SERIES BONDS         SECTION 1.  The bonds of 4.27% Series shall be designated as “First Mortgage Bonds, 4.27%  Series  due June  15,  2048.”  The  bonds of 4.27% Series  shall be  issuable  from  time  to  time  as  fully  registered  bonds  in  denominations  of  $1,000  and  in any  integral  multiple  of $1,000  in  excess  thereof.  Each of the bonds of 4.27% Series shall be dated the date of issue, and shall bear interest payable from the  fifteenth day of June or December, as the case may be, to which interest has been paid preceding the date  thereof, unless such date is a June 15 or December 15 on which interest has been paid, in which case it  shall bear interest from such date, or unless such date is prior to December 15, 2018, in which case it shall  bear interest from June [__], 2018. The interest so payable on any June 15 or December 15 will be paid to  the person in whose name this Bond is registered at the close of business on the first calendar day of the  month in which the interest payment date occurs. All bonds of 4.27% Series shall be payable on June 15,  2048, in such coin or currency of the United States of America as at the time of payment shall be legal  tender for public and private debts, and shall bear interest, payable in like coin and currency, at the rate of  four  and  twenty-seven  hundredth percent  (4.27%)  per  annum,  payable  semi-annually  on June  15 and  December 15 of each year, until maturity, and at the highest rate of interest borne by any of the bonds  outstanding  under  the  Original  Indenture  and  any  indenture  supplemental  thereto,  from  such  date  of  maturity until they shall be paid or payment thereof shall have been duly provided for; provided, however,  that interest payable at maturity will be paid to the person to whom principal is paid. In the event that any  interest payment date is a legal holiday or a day on which banking institutions are authorized by law to  close, then payment of interest payable on such date may be made on the next succeeding day, not a legal  holiday or a day on which banking institutions are authorized by law to close, with the same force and                                         11  

 

   effect as if made on the interest payment date. Interest on the bonds of 4.27% Series shall be computed on  the basis of a 360-day year consisting of twelve 30-day months. The principal of, and premium, if any,  and interest on, each bond of 4.27% Series shall be payable at the office or agency of the Company in the  Borough of Manhattan, The City of New York.         The  bonds  of 4.27% Series  may  be  exchanged,  for  a  like  aggregate  principal  amount  of  fully  registered bonds of such series of other authorized denominations. No service or other similar charge shall  be made for any exchange, transfer, or registration of the bonds of 4.27% Series, but the Company may  require payment of a sum sufficient to cover any tax or taxes or other governmental charges required to be  paid by the Company in relation thereto.         The bonds of 4.27% Series shall be redeemable as set forth in the form of bond of the bonds of  4.27% Series set forth in this One Hundred and Twenty-First Supplemental Indenture.         This bond is transferable as prescribed in the Mortgage by the registered holder hereof in person,  or by his or her duly authorized attorney, at the office or agency to be maintained by the Company in the  Borough  of  Manhattan,  The  City  of  New  York,  upon  surrender  and  cancellation  of  this  bond,  and  thereupon  a  new  fully  registered  bond  or  bonds  of  authorized  denominations  of  the  same  series  and  tranche and for the same aggregate principal amount will be issued to the transferee in exchange herefor  as provided in the Mortgage, and in each case without payment of any service or other similar charge as  herein provided. The Company and the Trustee, any paying agent and any bond registrar may deem and  treat the person in whose name this bond is registered as the absolute owner hereof, whether or not this  bond shall be overdue, for the purpose of receiving payment and for all other purposes and neither the  Company nor the Trustee nor any paying agent nor any bond registrar shall be affected by any notice to  the contrary.         The bonds of 4.27% Series shall bear the following legend:         “THIS BOND HAS NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS  AMENDED,  OR  THE  SECURITIES  OR  “BLUE  SKY”  LAWS  OF  ANY  OTHER  JURISDICTION,  AND  MAY  BE  TRANSFERRED  ONLY  IN  COMPLIANCE  WITH  SUCH  REGISTRATION  REQUIREMENTS OR UNDER AN EXEMPTION THEREFROM.”         In addition to the events of default described in Article X of the Indenture, an event of default  with respect to the 4.27% Series Bonds will include the additional events of default described in Section  11 of the Bond Purchase Agreement  between the Company and the initial holders of the 4.27% Series  Bonds specified on Schedule A to the Bond Purchase Agreement.  The Trustee shall not be deemed to  have knowledge of any event of default under the Bond Purchase Agreement unless a responsible officer  of the Trustee shall have received written notice thereof from the Company or by the holders of the 4.27%  Series Bonds then outstanding.         SECTION 2.  The principal amount of the bonds of 4.27% Series that may be authenticated and  delivered hereunder is not limited, except as the Indenture limits the principal amount of bonds that may  be issued thereunder.         SECTION 3.  Bonds  of 4.27% Series  for  the  aggregate  principal  amount  of  Two  Hundred  Million Dollars ($200,000,000), being the initial issuance of bonds of 4.27% Series, shall forthwith be  executed  by  the  Company  and  delivered  to  the  Trustee  and  shall  be  authenticated by  the  Trustee  and  delivered, after the recording hereof, in accordance with the request of the Company, signed in the name  of the Company by its President or one of its Vice Presidents and its Treasurer or one of its Assistant                                          12  

 

   Treasurers, upon compliance by the Company with the applicable provisions of Articles II and IV of the  Indenture.         SECTION 4.  In order to enable the Trustee to comply with its obligations under applicable tax  laws, rules and regulations in effect from time to time (“Applicable Law”), the Company shall provide to  the Trustee, following written request from the Trustee, such information concerning the holders of the  bonds of 4.27% Series as the Trustee may reasonably request in order to determine whether the Trustee  has any tax-related obligations under Applicable Law with respect to the payments made to holders of the  bonds of 4.27% Series, but only to the extent (a) such information is in the Company’s possession, (b)  such information is not subject to any confidentiality or similar agreement or undertaking or otherwise  deemed by the Company to be confidential and (c) providing such information to the Trustee does not, in  the judgment of the Company, breach or violate or constitute a default under any applicable laws, rules or  regulations or any instrument or agreement to which the Company of any of its affiliates is a party or may  be bound. The Company, the Trustee or any paying agent for bonds of 4.27% Series shall be permitted to  make any withholding or deduction from the amount of principal and interest payable to holders of the  bonds  of 4.27% Series  to  the  extent  required  under  Applicable  Law.  Each  holder  of  bonds  of 4.27%  Series  by  accepting  such  bond  shall  be  deemed  to  have  agreed  that  the  Company  may  provide  to  the  Trustee  such  information  concerning  such  holder  as  the  Trustee  may  request  in  order  to  determine  whether the Trustee has any tax-related obligations under Applicable Law with respect to the payments  made  to  such  holder  under  this One  Hundred  and Twenty-First Supplemental Indenture; and  such  agreement by each holder is part of the consideration for the issuance of the bonds of 4.27% Series.                                     ARTICLE II.                                                                          MISCELLANEOUS         SECTION 1.  As  supplemented  and  amended  by  this One  Hundred  and Twenty-First  Supplemental Indenture, the Original Indenture and all indentures supplemental thereto are in all respects  ratified and confirmed and the Original Indenture and the aforesaid supplemental indentures and this One  Hundred and Twenty-First Supplemental Indenture shall be  read, taken  and construed as one and the  same instrument.         SECTION 2.  This One  Hundred  and Twenty-First Supplemental Indenture  shall  be  simultaneously executed in several counterparts, and all such counterparts executed and delivered, each as  an original, shall constitute but one and the same instrument.         SECTION 3.  The  recitals of  fact  contained  herein  shall  be  taken  as  the  statements  of  the  Company, and the Trustee assumes no responsibility for the correctness of the same.         SECTION 4.  The debtor and its mailing address are Delmarva Power & Light Company, Mail  Stop 92DC42, 500 North Wakefield Drive, Newark, Delaware 19702. The secured party and its address,  from  which  information  concerning  the  security  interest  hereunder  may  be  obtained,  are  The  Bank  of  New York Mellon, 500 Ross Street, 12th Floor, Pittsburgh, Pennsylvania 15262, Attn: Corporate Trust  Administration.         SECTION 5.  The Company acknowledges that it received a true and correct copy of this One  Hundred and Twenty-First Supplemental Indenture.                                (SIGNATURE PAGES FOLLOW)                                         13  

 

         IN WITNESS WHEREOF, the Company has caused this instrument to be signed in its name and  behalf by its Vice President, and its corporate seal to be hereunto affixed and attested by its Secretary and  the Trustee has caused this instrument to be signed in its name and behalf by a Vice President and its  corporate seal to be hereunto affixed and attested by an authorized officer, effective as of the 1st day of  June, 2018.                                           DELMARVA POWER & LIGHT COMPANY   Date of Execution                       By: /s/ Wendy E. Stark                                             WENDY E. STARK                                             VICE PRESIDENT AND GENERAL                                             COUNSEL  June 1, 2018                                                                              [Seal]                                  Attest:  /s/ Brian J. Buck                                                BRIAN J. BUCK                                                ASSISTANT SECRETARY          STATE OF DELAWARE          )                                                       ) SS  COUNTY OF NEW CASTLE   )       BE IT REMEMBERED that on this 1st day of June, 2018, personally came before me, a notary  public for the State of Delaware, Wendy E. Stark, Vice President of DELMARVA POWER & LIGHT  COMPANY, a corporation of the State of Delaware and the Commonwealth of Virginia (the  “Company”), party to the foregoing instrument, known to me personally to be such, and acknowledged  the instrument to be her own act and deed and the act and deed of the Company; that her signature is in  her own proper handwriting; that the seal affixed is the common or corporate seal of the Company; and  that her act of signing, sealing, executing and delivering such instrument was duly authorized by  resolution of the Board of Directors of the Company.        GIVEN under my hand and official seal the day and year aforesaid.                                /s/ Denise J. Wojcik         [SEAL]                             Notary Public, State of Delaware                                My commission expires:                                 

 

                                           THE BANK OF NEW YORK MELLON,                                          as Trustee   Date of Execution                       By:  /s/ Laurence J. O'Brien                                             LAURENCE J. O’BRIEN                                             VICE PRESIDENT  June 1, 2018                                                                              [Seal]                                  Attest:  /s/ Latoya S. Elvin                                                LATOYA S. ELVIN                                                VICE PRESIDENT                                                     STATE OF NEW JERSEY           )                                                                                                        ) SS.                    COUNTY OF PASSAIC               )                                                    BE IT REMEMBERED that on this 1st day of June, 2018, personally came before me, a Notary  Public for the State of New Jersey, Laurence J. O’Brien, Vice President of THE BANK OF NEW YORK  MELLON, a New York banking corporation (the “Trustee”), party to the foregoing instrument, known to  me personally to be such, and acknowledged the instrument to be his own act and deed and the act and  deed of the Trustee; that his signature is his own proper handwriting; that the seal affixed is the common  or corporate seal of the Trustee; and that his act of signing, sealing, executing and delivering said  instrument was duly authorized by resolution of the Board of Directors of the Trustee.        GIVEN under my hand and official seal the day and year aforesaid.                                                                                         /s/ Rosemarie Socorro-Garcia                                  Rosemarie Socorro-Garcia                                   Notary Public                                  State of New Jersey                         My Commission Expires December 5, 2021                                                                                                       Trustee’s Signature Page                      121st Supplemental Indenture dated as of June 1, 2018                 to the Delmarva Power & Light Company Mortgage and Deed of Trust                               dated as of October 1, 1943    

 

                            CERTIFICATE OF RESIDENCE         THE BANK OF NEW YORK MELLON, successor Trustee to the Trustee within named, hereby  certifies that it has a residence at 101 Barclay Street, in the Borough of Manhattan, in The City of New  York, in the State of New York.                              THE BANK OF NEW YORK MELLON, as Trustee                                                          /s/ Laurence J. O'Brien                             LAURENCE J. O’BRIEN, VICE PRESIDENT                                   

 

                                       Certification      This document was prepared under the supervision of an attorney admitted to practice before the  Court of Appeals of Maryland, or by or on behalf of one of the parties named in the within instrument.                                                    /s/ Brian J. Buck                                                Brian J. BuckEXHIBIT 10.9

 

REPLIMUNE GROUP, INC. REQUESTS THAT THE MARKED PORTIONS OF THIS EXHIBIT BE GRANTED CONFIDENTIAL TREATMENT UNDER RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED

 

Execution

 

CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT

 

This CLINICAL TRIAL COLLABORATION AND SUPPLY AGREEMENT (the “Agreement”) is made and entered into effective as of the date signed by the last Party to sign below (the “Effective Date”) by and between Replimune Inc., a corporation organized under the laws of Delaware, having a place of business at 18 Commerce Way, Woburn, MA 01801 (the “Recipient”) and Bristol-Myers Squibb Company, having a place of business at 345 Park Avenue, New York, NY 10154 (“BMS”).  The Recipient and BMS are sometimes individually referred to in this Agreement as a “Party” and collectively as the “Parties.”

 

PRELIMINARY STATEMENTS

 

A.                                    The Recipient desires to conduct, and BMS desires to supply the BMS Study Drug (as defined below) for the conduct of, a Combined Therapy Clinical Trial (as defined below) in accordance with the Protocol (as defined below) therefor and in accordance with the terms of this Agreement.

 

B.                                    The Parties desire to agree on various terms and conditions to govern the Parties’ obligations in connection with the performance of the Combined Therapy Clinical Trial.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises and covenants contained herein, the Parties agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement.

 

“Adverse Event,” (“AE”) “Serious Adverse Event” (“SAE”) and “Serious Adverse Drug Reaction” (“SADR”) shall have the meanings provided to such terms in the International Conference on Harmonization (“ICH”) guideline for industry on Clinical Safety Data Management (E2A, Definitions and Standards for Expedited Reporting).

 

“Affiliates” means, with respect to a particular Party, an entity that, directly or indirectly, through one or more intermediaries, controls, is controlled by or is under common control with such Party, only for so long as such control exists.  As used in this definition, the term “controls” (with correlative meanings for the terms “controlled by” or “under common control with”) means (a) that an entity or company owns, directly or indirectly, more than fifty percent (50%) of the voting stock of another entity, or (b) that an entity, person or group otherwise has the actual ability to control and direct the management of the entity, whether by contract or otherwise.

 

“Agreement” shall have the meaning set forth in the preamble to this Agreement, and includes the Appendices attached hereto, the Supply and Quality Documentation and any and all amendments of any of the foregoing hereafter signed by the Parties with reference to this Agreement and made part hereof.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“Applicable Law” means all applicable laws, rules and regulations (whether federal, state or local) that may be in effect from time to time, including current Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

 

“Arbitration Matter” means any disputed matter that relates to or arises out of the validity, interpretation or construction of, or the compliance with or breach of, this Agreement; provided that such disputed matter has been considered, but not resolved, by the Executive Officers as set forth in Section 13.3.  For clarity, no Publication Dispute, or any matter requiring mutual agreement of both Parties shall be an Arbitration Matter.

 

“BMS Class Drug” means (i) the BMS Study Drug and (ii) any other antibodies that are designed to selectively bind to PD-1 or PD-L1.

 

“BMS Indemnitees” shall have the meaning set forth in Section 11.2.

 

“BMS Independent Patent Rights” means any Patent Rights Controlled by BMS (or its Affiliates) (a) as of the Effective Date or (b) during the Term the subject matter of which was conceived or first reduced to practice through activities other than those performed pursuant to this Agreement, in each case of (a) or (b) that Cover the use (whether alone or in combination with other agents), manufacture, formulation or composition of matter of the BMS Study Drug.

 

“BMS Regulatory Documentation” means any Regulatory Documentation pertaining to the BMS Study Drug that exists as of the Effective Date or that is created during the Term through efforts outside this Agreement.

 

“BMS Study Data” shall have the meaning set forth in Section 8.2.

 

“BMS Study Drug” means BMS’s proprietary anti-PD-1 monoclonal antibody product known as Opdivo® (nivolumab).

 

“BMS Study Invention” means any Invention that pertains to (a) the composition of matter of any BMS Class Drug (and not any Recipient Class Drug), (b) method of manufacture or formulation of any BMS Class Drug (and not any Recipient Class Drug) as a Single Agent Compound, and/or (c) a method of use of any BMS Class Drug (and not any Recipient Class Drug) as a monotherapy or as used with other agents, antibodies or compounds (other than an Invention pertaining, whether generically or specifically, to the composition of matter, method of manufacture or formulation, or a method of use of both a BMS Class Drug and a Recipient Class Drug).

 

“BMS Study Patent Rights” means any Patent Rights that Cover any BMS Study Invention (and not a Recipient Study Invention or Combined Therapy Invention), excluding BMS Independent Patent Rights and BMS Technology.  For avoidance of doubt, any Patent Rights that cover both (a) a BMS Study Invention and (b) any other type of Invention is included within the Combined Therapy Patent Rights.

 

“BMS Technology” means all Technology Controlled by BMS (or its Affiliates) as of the Effective Date or during the Term created through efforts outside of this Agreement related to the BMS Study Drug or the Combined Therapy and necessary for the conduct of the Combined Therapy Clinical Trial. For clarity, BMS Technology does not include (a) Inventions, (b) Study Data, or (c) Combined Therapy Clinical Trial Regulatory Documentation.

 

“Breaching Party” shall have the meaning set forth in Section 12.2(a).

 

“Business Day” means a day other than Saturday, Sunday or any day on which commercial banks located in New York, NY are authorized or obligated by Applicable Law to close.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“CDA” shall have the meaning set forth in Section 9.1(a).

 

“Clinical Hold” means that (a) the FDA has issued an order to a Party pursuant to 21 CFR §312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combined Therapy or such Party’s Single Agent Compound in the United States or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries.

 

“Combined Therapy” means a therapy using the Recipient Study Drug and the BMS Study Drug in combination, with or without another agent.

 

“Combined Therapy Clinical Trial” means the human clinical trial using the Recipient Study Drug and the BMS Study Drug, which will be conducted under the Recipient’s protocol (said, protocol, as it may be amended from time to time in accordance with this Agreement, the “Protocol”) and is incorporated herein by reference.   A draft Protocol summary as of the Effective Date is attached as Appendix A hereto.  The draft Protocol shall be jointly agreed by the Parties as set forth in Section 2.1(a).

 

“Combined Therapy IND” shall have the meaning set forth in Section 2.1(b).

 

“Combined Therapy Invention” means an Invention that is not a Recipient Study Invention or a BMS Study Invention.

 

“Combined Therapy Patent Right(s)” means any Patent Rights that Cover any Combined Therapy Invention or Combined Therapy Study Data.  For clarity, “Combined Therapy Patent Right(s)” do not include any BMS Independent Patent Rights and Recipient Independent Patent Rights.

 

“Combined Therapy Clinical Trial Regulatory Documentation” means any Regulatory Documentation to be submitted for the conduct of the Combined Therapy Clinical Trial, but excluding (a) any Recipient Regulatory Documentation and (b) any BMS Regulatory Documentation.

 

“Combined Therapy Study Data” shall have the meaning set forth in Section 8.2.

 

“Commercially Reasonable Efforts” means, with respect to a Party, the level of effort and resources normally devoted by such Party to conduct a clinical trial for a biopharmaceutical product or compound that is owned by it or to which it has rights, which is of similar market potential, profit potential or strategic value and at a similar stage in its development or product life based on conditions then prevailing.

 

“Confidential Information” shall have the meaning set forth in Section 9.1(a).

 

“Control” or “Controlled” means, with respect to particular information or intellectual property, that the applicable Party owns or has a license to such information or intellectual property and has the ability to grant a right, license or sublicense to the other Party as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

 

“Cover” means, with respect to a Patent Right, that, but for rights granted to a Person under such Patent Right, the practice by such Person of an invention described in such Patent Right would infringe a claim included in such Patent Right, or in the case of a Patent Right that is a patent application, would infringe a claim in such patent application if it were to issue as a patent.  “Covered” or “Covering” shall have correlative meanings.

 

“CRO” means any Third Party contract research organization used to conduct the Combined Therapy Clinical Trial, including laboratories and Third Parties used to maintain the safety database from the Combined Therapy Clinical Trial, but, for clarity, excluding clinical trial sites and any Third Parties who are individuals.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“Cure Period” shall have the meaning set forth in Section 12.2(a).

 

[ ]*

 

[ ]*

 

“Date of First Receipt” means, with respect to a Party, the date on which any employee of such Party, its Affiliates or its Third Party subcontractors first becomes aware of safety-related information.

 

“Designated Clinical Contact” shall have the meaning set forth in Section 2.3.

 

“Designated Supply Contact” shall have the meaning set forth in Section 4.7.

 

“Dispute” shall have the meaning set forth in Section 13.3(b).

 

“Effective Date” shall have the meaning set forth in the preamble to this Agreement.

 

“Executive Officers” means the Chief Executive Officer of the Recipient and the Head of Oncology Development of BMS (or their respective designees).

 

“FDA” means the United States Food and Drug Administration, or any successor agency having the same or similar authority.

 

“Filing Party” shall have the meaning set forth in Section 6.1(c).

 

“Global Safety Database” means the database containing Adverse Events, Serious Adverse Events, Serious Adverse Drug Reactions and pregnancy reports for the Combined Therapy, and shall be the authoritative data source for regulatory reporting and responding to regulatory queries with respect to the Combined Therapy Clinical Trial.

 

“Good Clinical Practices” or “GCP” means, as to the United States and the European Union, applicable good clinical practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, clinical practices equivalent to good clinical practices as then in effect in the United States or the European Union.

 

“Good Laboratory Practices” or “GLP” means, as to the United States and the European Union, applicable good laboratory practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, laboratory practices equivalent to good laboratory practices as then in effect in the United States or the European Union.

 

“Good Manufacturing Practices” or “GMP” means, as to the United States and the European Union, applicable good manufacturing practices as in effect in the United States and the European Union, respectively, during the Term and, with respect to any other jurisdiction, manufacturing practices equivalent to good manufacturing practices as then in effect in the United States or the European Union.

 

“ICF” shall have the meaning set forth in Section 5.1(f).

 

“IND” means (a) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act, as amended, and regulations promulgated thereunder, or any successor application or procedure required to initiate clinical testing of a drug in humans in the United States, (b) a counterpart of such an Investigational New Drug Application that is required in any other country before beginning clinical testing of a drug in humans in such country, including, for clarity, a “Clinical Trial Application” in the European Union, and (c) all supplements and amendments to any of the foregoing.

 

“Indemnify” shall have the meaning set forth in Section 11.1.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“Infringe” and “Infringement” means any alleged or threatened (in writing) infringement, or misappropriation by a Third Party, of any Patent Rights.

 

“Invention” means any invention or Technology, whether or not patentable, that is made, conceived, or first actually reduced to practice after the Effective Date by, for or on behalf of a Party, or by, for or on behalf of the Parties together (including by a Third Party in the performance of the Combined Therapy Clinical Trial), (a) in relation to the Combined Therapy Clinical Trial to be conducted under this Agreement or (b) by or resulting from the use of Study Data, but excluding in each case any Study Data itself.

 

“IRB” means an Investigational Review Board or Ethics Committee (or similar body in a given country).

 

“Licensee” shall have the meaning set forth in Section 13.10(b).

 

“Losses” shall have the meaning set forth in Section 11.1.

 

“Manufacture” or “Manufacturing” means manufacturing, processing, formulating, packaging, labeling, holding (including storage), and quality control testing of a Single Agent Compound or the Combined Therapy, in each case so as to be suitable for use in the Combined Therapy Clinical Trial under Applicable Law.

 

“Material Safety Issue” means a Party’s good faith belief that there is an unacceptable risk for harm in humans based upon: (a) pre-clinical safety data, including data from animal toxicology studies, or (b) the observation of Serious Adverse Events in humans after the Recipient Study Drug or the BMS Study Drug, either as a Single Agent Compound or in combination with another pharmaceutical agent (including as the Combined Therapy), has been administered to or taken by humans, such as during the Combined Therapy Clinical Trial.

 

“NDA” means (a) any new drug application or biologics license application filed with the FDA, or any successor application or procedure required to introduce a drug or biologic into commerce in the United States, (b) a counterpart of such a new drug application or biologics license application that is required in any other country before beginning the commercialization of a drug or a biologic in humans in such country, and (c) all supplements and amendments to any of the foregoing.

 

“Non-Breaching Party” shall have the meaning set forth in Section 12.2(a).

 

“Officials” shall have the meaning set forth in Section 10.9.

 

[ ]*

 

[ ]*

 

[ ]*

 

“Operational Matters” shall have the meaning set forth in Section 5.1.

 

“Party” or “Parties” shall have the meaning set forth in the preamble to this Agreement.

 

“Patent Rights” means any (a) United States or foreign patents, (b) United States or foreign patent applications, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (c) United States or foreign patents-of-addition, reissues, reexaminations (including ex parte reexaminations, inter partes reviews, inter partes reexaminations, post grant reviews and supplemental examinations) and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates,

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

patent term extensions, or the equivalents thereof, and (d) any other form of government-issued right substantially similar to any of the foregoing.

 

“Payment” shall have the meaning set forth in Section 10.9.

 

“Person” means any individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

 

“Personal Data” means any information relating to an identified or identifiable natural person.

 

“POTV” shall have the meaning set forth in Section 9.6(a).

 

“Protocol” shall have the meaning set forth in the definition of Combined Therapy Clinical Trial.

 

“Publication Dispute” shall have the meaning set forth in Section 9.5(b).

 

“Quarter” means a calendar quarter.

 

“Recipient Class Drug” means the Recipient Study Drug and any oncolytic virus derived from a potent herpes simplex virus strain expressing gibbon ape leukemia virus glycoprotein and eliciting anti-tumor activity.

 

“Recipient Indemnitees” shall have the meaning set forth in Section 11.1.

 

“Recipient Independent Patent Rights” means any Patent Rights Controlled by the Recipient or a Recipient Affiliate (a) as of the Effective Date or (b) during the Term the subject matter of which was conceived or first reduced to practice through activities other than those performed pursuant to this Agreement, in each case (a) and (b) that Cover the use (either alone or in combination with other agents), manufacture, formulation or composition of matter of the Recipient Study Drug.

 

“Recipient Regulatory Documentation” means any Regulatory Documentation pertaining to the Recipient Study Drug that exists as of the Effective Date or that is created during the Term through efforts outside this Agreement.

 

“Recipient Study Data” shall have the meaning set forth in Section 8.2.

 

“Recipient Study Drug” means the Recipient’s proprietary oncolytic virus known as RP-1.

 

“Recipient Study Invention” means any Invention that pertains to (a) the composition of matter of any Recipient Class Drug (and not any BMS Class Drug), (b) method of manufacture or formulation of any Recipient Class Drug (and not any BMS Class Drug) as a Single Agent Compound, or (c) a method of use of the Recipient Class Drug (and not any BMS Class Drug) as a monotherapy or as used in combination with other agents, antibodies or compounds (other than Invention pertaining, whether generically or specifically, to the composition of matter, method of manufacture, formulation or a method of use of both a BMS Class Drug and a Recipient Class Drug.

 

“Recipient Study Patent Rights” means any Patent Rights that Cover any Recipient Study Invention (and not a BMS Study Invention or a Combined Therapy Invention), excluding Recipient Independent Patent Rights and Recipient Technology.  For avoidance of doubt, any Patent Rights that cover both (a) a Recipient Study Invention and (b) any other type of Invention is included within the Combined Therapy Patent Rights.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“Recipient Technology” means all Technology Controlled by the Recipient or a Recipient Affiliate as of the Effective Date or during the Term which is created through efforts outside of this Agreement related to the Recipient Study Drug or the Combined Therapy and necessary for the conduct of the Combined Therapy Clinical Trial.  For clarity, Recipient Technology does not include (a) Inventions, (b) Study Data, or (c) Combined Therapy Clinical Trial Regulatory Documentation.

 

“Regulatory Authority” means the FDA or any other governmental authority outside the United States (whether supranational, national, federal, provincial and/or local) that is the counterpart to the FDA, including the European Medicines Agency for the European Union.

 

“Regulatory Documentation” means, with respect to a Party’s Single Agent Compound, all submissions to Regulatory Authorities in connection with the development of such Single Agent Compound, as applicable, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include clinical data).

 

“Results” shall have the meaning set forth in Section 9.5(b).

 

“Right of Cross-Reference” means, with regard to a Party, allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Party’s Single Agent Compound (and, in the case of BMS, the Right to Cross-Reference the Combined Therapy IND), only to the extent necessary for the conduct of the Combined Therapy Clinical Trial in such country or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder, and, except as to information contained in the Combined Therapy IND pertaining to the Combined Therapy, without the disclosure of such information to such Party.

 

“Safety Issue” means any information suggesting an emerging safety concern or possible change in the risk-benefit balance for a drug, including information on a possible causal relationship between an Adverse Event and a drug, the relationship being unknown or incompletely documented previously.

 

“Safety Signal” means information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action.

 

“Samples” means biological specimens collected from Combined Therapy Clinical Trial study subjects (including fresh and/or archived tumor samples, serum, peripheral blood mononuclear cells, plasma, and whole blood for RNA and DNA sample isolation).

 

“Shortage” shall have meaning set forth in Section 4.5.

 

“Single Agent Compound” or “Compound” means, with respect to (a) the Recipient, the Recipient Study Drug, as monotherapy, and (b) BMS, the BMS Study Drug, as monotherapy.

 

“Sponsor” means an applicant or holder of clinical studies applications/notifications.

 

“Study Data” shall have the meaning set forth in Section 8.1.

 

“Sunshine Laws” shall have the meaning set forth in Section 9.6(c).

 

“Supply and Quality Documentation” shall have the meaning set forth in Section 4.3.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

“Technology” means information, inventions, discoveries, trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, specifications, data and results not generally known to the public (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, pre-clinical, clinical, safety, manufacturing and quality control data and know-how, including study designs and protocols), in all cases, whether or not patentable, in written, electronic or any other form now known or hereafter developed and materials, including Regulatory Documentation.

 

“Term” shall have the meaning set forth in Section 12.1.

 

“Territory” means the United States, including Puerto Rico, and the European Union (including the United Kingdom, whether or not an EU member state).  For clarity, the Territory excludes the [ ]*.

 

“Third Party” means any Person or entity other than the Recipient and BMS and their respective Affiliates.

 

“Third Party Claim” shall have the meaning set forth in Section 11.1.

 

“Third Party License Payments” means any payments (e.g., upfront payments, milestones, royalties) due to any Third Party under license agreements or other written agreements granting rights to intellectual property owned or controlled by such Third Party to the extent that such rights are necessary for (a) the making, using or importing of a Party’s Single Agent Compound for the conduct of the Combined Therapy Clinical Trial, or (b) the conduct of the Combined Therapy Clinical Trial.

 

“TP Study Costs” shall have the meaning set forth in Section 7.2.

 

ARTICLE 2

 

SCOPE

 

2.1                               Scope.

 

(a)                                      The Recipient will conduct the Combined Therapy Clinical Trial in accordance with the Protocol and the terms of this Agreement.  The Parties will use good faith efforts to jointly agree on a draft Protocol within [ ]* following the Effective Date, which shall be based on the draft Protocol summary attached as Appendix A hereto.  The Recipient shall be solely responsible for the content of the Protocol following agreement by the Parties on the draft Protocol; provided that: (i) the Recipient will notify BMS of any proposed amendments to the draft Protocol agreed by the Parties (or to the final Protocol initially approved by an IRB) and the Recipient will consider any comments provided by BMS regarding the proposed amendments (it being understood that the Parties will endeavor to set forth in writing the circumstances (e.g., administrative matters) where it may be feasible for the Recipient to make specific Protocol amendments without the need for BMS to comment), and (ii) any changes to the draft Protocol agreed by the Parties (or to the final Protocol initially approved by an IRB) that pertain to the administration of the BMS Study Drug must be reviewed and expressly approved by BMS in writing or the change may not be implemented.  BMS shall have [ ]* from the date on which the Recipient provides the applicable Protocol amendment to BMS to approve or provide any comments to the Recipient concerning the proposed amendment.  For clarity, Recipient shall not conduct any patient recruitment activities for, or otherwise initiate, the Combined Therapy Clinical Trial until the draft Protocol is jointly agreed by the Parties.

 

(b)                                      The Combined Therapy Clinical Trial shall be conducted under a combination IND, for which the Recipient will be the sponsor of record (the “Combined Therapy IND”) and shall be

 

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conducted only in the Territory.  The Recipient shall be the sole holder of all legal interests in the Combined Therapy IND; provided, however, that the Recipient may not grant any Third Party any Right of Cross-Reference with respect to any portion of the Combined Therapy IND pertaining to BMS’s Single Agent Compound for use as monotherapy or for use in combination with any molecules, agents, antibodies or compounds other than the Recipient Study Drug.

 

(c)                                       BMS will make available its current package insert for the BMS Study Drug in the Territory available to the Recipient and will provide any updates thereto at the same time as the same are made publicly available.

 

(d)                                      If the Recipient and BMS agree that the Recipient will require access to the investigator’s brochure for the BMS Study Drug in order for the site to conduct the Combined Therapy Clinical Trial, then (i) BMS will provide the current version of its investigator brochure to the Recipient promptly and (ii) will thereafter, until the conclusion of the Combined Therapy Clinical Trial, provide to the Recipient, upon reasonable request, the latest investigator’s brochure for the BMS Study Drug or any amendments thereto in accordance with BMS’s customary practices for same.  The Recipient shall, and shall require that any clinical trial sites for the Combined Therapy Clinical Trial shall, use any such data provided pursuant to this Section 2.1(d) solely (A) to evaluate the safety and efficacy of the BMS Study Drug and the Combined Therapy for use in Combined Therapy Clinical Trial, (B) to meet any regulatory requirements pertaining to the conduct of the Combined Therapy Clinical Trial and (C) to enable the Recipient to draft and update as necessary the investigator’s brochure for the Combined Therapy Clinical Trial.  The Recipient will ensure that clinical trial sites for the Combined Therapy Clinical Trial are obligated to protect such information and disclosures as set forth in Article 9.  The Recipient’s right to use the investigator’s brochure provided by BMS shall terminate upon the completion or termination of the Combined Therapy Clinical Trial and shall not be used for purposes of conducting any other clinical studies.

 

(e)                                       If requested in writing by the Recipient and agreed to by BMS (such consent not to be unreasonably withheld), BMS shall provide a Right of Cross-Reference as needed to its existing Regulatory Documentation for BMS’s Single Agent Compound for those countries in the Territory where the Combined Therapy Clinical Trial will be conducted solely as necessary to allow the Combined Therapy Clinical Trial to be conducted under the Combined Therapy IND in an applicable country; provided that such Right of Cross-Reference shall terminate upon the expiration or termination of this Agreement and shall not be used for purposes of conducting any other clinical studies, except that, in the case of termination for a Material Safety Issue pursuant to Section 12.4, such Right of Cross-Reference shall remain in effect solely (i) to the extent necessary to permit the Recipient to comply with any outstanding obligations required by a Regulatory Authority and/or Applicable Law or (ii) as necessary to permit the Recipient to continue to dose subjects enrolled in the Combined Therapy Clinical Trial through completion of the Protocol if required by the applicable Regulatory Authority(ies) and/or Applicable Laws.

 

(f)                                        If PDL-1 biomarker testing is incorporated into the Protocol, the Recipient agrees to use the commercially available [ ]* to perform such testing.

 

(g)                                      The Recipient shall refer to the applicable BMS Study identification number in all Combined Therapy Clinical Trial reports, reports of Serious Adverse Events, BMS Study Drug requests, and all other material submissions or communications to BMS relating to the Protocol.

 

2.2                         Adverse Event Reporting.

 

(a)                                      This Section 2.2 shall govern safety reporting arising from the Combined Therapy Clinical Trial.  The Recipient will manage all drug safety reporting activities for the Combined Therapy Clinical Trial.

 

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(b)                                      The Recipient will forward to BMS at the contact information below via fax or secure e-mail in a format to be agreed to by the Parties all fatal or life threatening SAE reports within four (4) calendar days of Date of First Receipt, all other SAE reports, reports of exposure during pregnancy (maternal and paternal) and reports of suspected transmission of an infectious agent via the BMS Study Drug or Combined Therapy within nine (9) calendars days of Date of First Receipt, in each case for the BMS Study Drug and the Combined Therapy administered in the Combined Therapy Clinical Trial.

 

	
 
    	
BMS – Adverse Event Reporting Contact
    
	
 
    	
E-mail
    	
 
    	
[ ]*
    
	
 
    	
Fax
    	
 
    	
[ ]*
    
	
 
    	
Acknowledgment of ICSR receipt:
    	
 
    	
[ ]*
    

 

(c)                                       Each Party shall collect, use and disclose Personal Data obtained in the course of performing the pharmacovigilance activities under this Section 2.2 solely for the purposes of complying with the regulatory obligations as described in this Agreement, or as otherwise required by Applicable Law or by a court order.  Both Parties will use electronic, physical, and other safeguards appropriate to the nature of the information to prevent any use or disclosure of Personal Data other than as provided for by this Agreement and permitted under the ICF. Both Parties will also take reasonable precautions to protect such Personal Data from accidental, unauthorized, or unlawful alteration or destruction.  Each Party will notify the other Party promptly of any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access of such Personal Data.

 

(d)                                      The Recipient will promptly make available to BMS upon request such records that the Recipient Controls as is necessary or useful to perform medical assessment of any Adverse Event associated with the use of the BMS Study Drug or Combined Therapy reported during the Combined Therapy Clinical Trial that is forwarded to BMS under this Agreement.  The Recipient will designate a single point of contact within its organization (and will provide to BMS the email address of such point of contact prior to the start of the Combined Therapy Clinical Trial) for any pharmacovigilance-related follow-up questions that BMS would have.

 

(e)                                       The Recipient shall perform case level reconciliation to confirm that BMS has received all reports required under this Agreement.  The Recipient shall e-mail [ ]* to request a reconciliation report for the Combined Therapy Clinical Trial.  The Recipient shall reconcile the cases identified as being transmitted to BMS on BMS’s reconciliation report and those contained in the Combined Therapy Clinical Trial database.  The Recipient shall send missing case-level events to BMS Global Pharmacovigilance at [ ]*  or by fax at [ ]*.  The Recipient shall perform such reconciliation every [ ]*, unless otherwise agreed by BMS in writing.

 

(f)                                        As Sponsor, the Recipient will be responsible for submitting all applicable Individual Case Safety Report (ICSRs) and aggregate report submissions to Regulatory Authorities for the Combined Therapy Clinical Trial.  The Recipient will provide BMS with the final version of any aggregate report at the time of submission.  The Recipient will also submit appropriate safety letters or safety reports to study investigators, the reviewing IRB and authorized Regulatory Authorities in accordance with Applicable Law.

 

(g)                                      In the event that BMS produces any Development Safety Update Report (“DSUR”) in respect to the BMS Study Drug, BMS will provide to the Recipient upon request, and for the duration of the Combined Therapy Clinical Trial, copies of the executive summary and any line listings of Serious Adverse Drug Reactions extracted from the final DSUR for information purposes only and to assist the Recipient in generation of their own clinical trial aggregate report, where applicable.  The Recipient agrees not to forward such BMS DSUR sections to any Third Party, except to its Affiliates, consultants, advisors and contractors under obligations of confidentiality for generation of such a clinical trial aggregate

 

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report or as otherwise permitted with respect to BMS Confidential Information under Section 9.3(b), (d), (e), and (f).

 

(h)                                      If the Recipient determines there is a significant Safety Issue or significant Safety Signals arising in a clinical trial that may be associated with the BMS Study Drug or Combined Therapy, the Recipient will disclose such information to BMS promptly after such determination.

 

(i)                                         BMS will ensure that any urgent Safety Issues or Safety Signals relating to the BMS Study Drug will be communicated to the Recipient promptly after such determination.

 

2.3                               Clinical Study Designated Contact.  Each Party will designate an employee within its organization (the “Designated Clinical Contact”) who will coordinate and/or facilitate:

 

(a)                                      the review of Protocol amendments submitted by the Recipient for BMS approval and with whom comments thereon may be discussed;

 

(b)                                      any BMS clinical and regulatory responsibilities and communications regarding the Combined Therapy Clinical Trial;

 

(c)                                       internal BMS review of any document or regulatory communication and the provision of any BMS comments; and

 

(d)                                      discussion of any other topics or issues relating to the Combined Therapy Clinical Trial requested by the Recipient or BMS.

 

2.4                               Conduct.  Each Party shall use Commercially Reasonable Efforts to (a) perform and fulfill its respective activities under the Combined Therapy Clinical Trial and this Agreement on a timely basis and in an effective manner consistent with prevailing standards, (b) supply the quantities of its Compound in accordance with Article 4 as needed to conduct the Combined Therapy Clinical Trial on a timely basis, and, in the case of the Recipient, package and deliver same to study sites on a timely basis, and (c) in the case of the Recipient, conduct and complete the Combined Therapy Clinical Trial on a timely basis in accordance with the Protocol and Third Party agreements relating thereto, and provide sufficient resources, funding and personnel to conduct and perform the Combined Therapy Clinical Trial on a timely basis in accordance with the Protocol for same and the terms of this Agreement.  Each Party shall perform its duties for the Combined Therapy Clinical Trial in accordance with Applicable Law, including GCP, GLP and GMP as applicable.

 

ARTICLE 3

 

LICENSE GRANTS

 

3.1                               Grant by BMS.  Subject to the terms of this Agreement, BMS hereby grants, and shall cause its Affiliates to grant, to the Recipient a non-exclusive, non-transferable, royalty-free license (with the right to sublicense solely pursuant to the terms of and subject to the limitations of Section 3.2) under the BMS Independent Patent Rights and BMS Technology to use the BMS Study Drug solely within the Territory and solely to the extent necessary to discharge the Recipient’s obligations under this Agreement with respect to the conduct of the Combined Therapy Clinical Trial in the Territory.

 

3.2                               Sublicensing.

 

(a)                                 The Recipient shall have the right to grant sublicenses under the licenses granted to it under Section 3.1, to Affiliates and to Third Parties, if required for an Affiliate or a Third Party to perform its duties with respect to the conduct of the Combined Therapy Clinical Trial, solely as necessary

 

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to assist the Recipient in carrying out its responsibilities with respect to the Combined Therapy Clinical Trial.

 

(b)                                 With regard to any such sublicenses permitted and made under this Agreement, (i) the sublicensees, except Affiliates (so long as they remain Affiliates of a Party), shall be subject to written agreements that bind such sublicensees to obligations that are consistent with a Party’s obligations under this Agreement including confidentiality and non-use provisions no less restrictive than those set forth in herein, and provisions regarding intellectual property that ensure that the Parties will have the rights provided under this Agreement to any intellectual property relating to their Single Agent Compound and/or the Combined Therapy created by such sublicensee, (ii) each Party shall provide written notice to the other Party of any such sublicense (and obtain approval for sublicenses to Third Parties other than clinical trial sites); and (c) the licensing Party shall remain liable to the other Party for all actions of the sublicensing Party’s sublicensees.

 

3.3                               No Implied Licenses.  Unless and except as specifically set forth in this Agreement, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, in any intellectual property of the other Party, including Confidential Information disclosed to it under this Agreement or under any Patent Rights Controlled by the other Party or its Affiliates.

 

ARTICLE 4

 

MANUFACTURE AND SUPPLY

 

4.1                               Recipient Study Drug Manufacture and Supply.

 

(a)                                 The Recipient shall be responsible, at its sole costs and expense, for manufacturing, packaging and labeling (or having manufactured, packaged or labeled) GMP-grade quantities of the Recipient Study Drug, as well as obtaining any other drug (other than the BMS Study Drug provided by BMS pursuant to Section 4.2) required for the conduct of the Combined Therapy Clinical Trial, and shall package and label if and as required by the Protocol and/or applicable Regulatory Authorities all drugs (including the BMS Study Drug) used in the Combined Therapy Clinical Trial, on a timely basis and in accordance with applicable specifications as required for the conduct of the Combined Therapy Clinical Trial.  The Recipient Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the Recipient Study Drug used by the Recipient for its other clinical trials of the Recipient Study Drug.

 

(b)                                 The Recipient shall provide BMS with prompt notice of any Manufacturing and supply issues with respect to the Recipient Study Drug, or any defects or manufacturing problems identified with respect to the BMS Study Drug supplied to Recipient, that may adversely impact the conduct or timelines of the Combined Therapy Clinical Trial.

 

4.2                               BMS Study Drug.

 

(a)                                      Manufacture and Supply.  BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial.  The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary.  The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee.  BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture,

 

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supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial.  The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug.  BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

 

(b)                                 Use of BMS Study Drug Supplied by BMS to the Recipient.  The Recipient shall use the quantities of BMS Study Drug supplied to it under this Agreement solely as necessary for, and in accordance with, this Agreement and the Protocol, and for no other purpose, including as a reagent or tool to facilitate its internal research efforts, for any commercial purpose, or for other clinical or non-clinical research unrelated to the Combined Therapy Clinical Trial.  Except as may be required or expressly permitted by the Protocol or the Supply and Quality Documentation, the Recipient shall not perform, and shall not allow any Third Party to perform, any analytical testing of the quantities of BMS Study Drug supplied to it under this Agreement. If Study Drug supplied by BMS is lost, damaged, destroyed or becomes unable to comply with applicable specifications while under the control of the Recipient or any of its (sub)contractors, including common carriers and clinical study sites contracted by the Recipient, BMS shall not be obligated to replace same, and if BMS does elect to do so, BMS may elect to charge the Recipient a reasonable replacement cost to replace same.

 

4.3                               Supply and Quality Documentation.  BMS shall supply the BMS Study Drug to the Recipient in accordance with such supply and quality addenda or agreement(s) as the Parties may agree (the “Supply and Quality Documentation”).  The Parties shall finalize and execute the Supply and Quality Documentation within [ ]* of the Effective Date, but in no event later than the date on which the first shipment of the BMS Study Drug is supplied for use in the Combined Therapy Clinical Trial.  The Supply and Quality Documentation shall outline the additional roles and responsibilities relative to the quality of BMS Study Drug in support of the Combined Therapy Clinical Trial. It shall include the responsibility for quality elements as well as exchanged GMP documents and certifications required to release the BMS Study Drug for the Combined Therapy Clinical Trial.  In addition, the Supply and Quality Documentation shall detail the documentation required for each shipment of BMS Study Drug supplied to the Recipient or its designee for use in the Combined Therapy Clinical Trial.

 

4.4                               Supply Forecast.  Estimated supply and delivery details will be outlined in the Supply and Quality Documentation and will be updated by the Parties by mutual agreement (which agreement can be effected by the Parties’ Designated Supply contacts and without need for an amendment to this Agreement) based on the actual enrollment.  The Recipient will promptly inform BMS of any change in its requirements, and BMS will endeavor to accommodate any change in the supply quantities requested by the Recipient so long as it does not unduly disrupt BMS’s ongoing business activities.

 

4.5                               Shortages.  BMS shall provide the Recipient with prompt notice of any Manufacturing and supply issues with respect to the BMS Study Drug that may adversely impact the conduct or timelines of the Combined Therapy Clinical Trial. In the event of a supply interruption or shortage of BMS Study Drug as determined by BMS pursuant to its internal processes and policies (a “Shortage”), such that BMS reasonably believes that it will not be able to fulfill its supply obligations under this Agreement, BMS will provide prompt written notice thereof to the Recipient (including the quantity of BMS Study Drug that BMS reasonably estimates it will be able to supply) and, upon request, the Parties will promptly discuss such situation (including how the quantities of BMS Study Drug that BMS is able to supply under this

 

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Agreement will be allocated within the Combined Therapy Clinical Trial).  Notwithstanding anything to the contrary contained herein, in the event of a Shortage of the BMS Study Drug, BMS will have sole discretion, subject to Applicable Law, to determine the quantity of BMS Study Drug it will be able to supply as a result of such Shortage; provided, however, that BMS shall consider in good faith the needs of patients who are actively being treated with BMS Study Drug, including Combined Therapy Clinical Trial patients, in making such determination.  BMS will not be deemed to be in breach of this Agreement for failure to supply any other quantities of BMS Study Drug hereunder as a result of a Shortage.  Any such allocation of the BMS Study Drug in accordance with this Section 4.5 will be the Recipient’s exclusive remedy with respect to a Shortage.

 

4.6                               Customs Valuation.  The Recipient will provide BMS in writing with a list of each country in which it proposes to conduct the Combined Therapy Clinical Trial prior to execution of any site agreement or CRO agreement for that country.  During the conduct of the Combined Therapy Clinical Trial, the Recipient will send in writing any changes to the list of participating countries to BMS one month prior to the end of each Quarter. If no changes are sent to BMS by the Recipient for a particular Quarter, the prior Quarter’s participating country list will be used as the basis for customs valuation for that Quarter. BMS will provide the Recipient with country-specific customs valuations initially for the BMS Study Drug prior to initiation of the Combined Therapy Clinical Trial and at the end of each Quarter during the conduct of the Combined Therapy Clinical Trial.  The Recipient will use the BMS provided values for the import/export process to the listed participating countries and not make any change to such valuations without BMS’s prior written consent.

 

4.7                               Designated Supply Contact.  Each Party will designate an individual (the “Designated Supply Contact”) that a Party may contact to assist with coordinating supplies and facilitating the resolution of any issues or concerns arising in connection with the supply of the BMS Study Drug for use in the Combined Therapy Clinical Trial.

 

ARTICLE 5

 

RESPONSIBILITIES

 

5.1                               Specific Responsibilities of the Recipient.  The Recipient shall, subject to the terms of the Protocol, applicable terms and conditions of this Agreement, and any other agreement between the Parties relating to the Combined Therapy Clinical Trial, manage and be responsible for the conduct of the Combined Therapy Clinical Trial, including timelines and contingency planning.  In particular, and not in limitation of the foregoing, the Recipient shall perform (itself and/or through Third Parties, including clinical trial sites, CROs and investigators) and/or be responsible for the following (items (a) to (p) below, collectively the “Operational Matters”) with respect to the Combined Therapy Clinical Trial:

 

(a)                                 compiling, amending and filing all necessary Combined Therapy Clinical Trial Regulatory Documentation with Regulatory Authority(ies), maintaining and acting as the sponsor of record as provided in 21 CFR 312.50 (and applicable comparable ex-US laws) with responsibility, unless otherwise delegated in accordance with 21 CFR 312.52 (and applicable comparable ex-US laws), for the Combined Therapy Clinical Trial and making all required submissions to Regulatory Authorities related thereto on a timely basis;

 

(b)                                 conducting clinical study start-up activities, communicating with and obtaining approval from IRBs for the Protocol and other relevant documents for the Combined Therapy Clinical Trial as applicable, as well as patient recruitment and retention activities;

 

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(c)                                       listing of the Combined Therapy Clinical Trial, if it is required to be listed on a public database on www.clinicaltrials.gov or other public registry in any country in which such Combined Therapy Clinical Trial is being conducted, all in accordance with Applicable Law and in accordance with its internal policies relating to clinical trial registration;

 

(d)                                 providing BMS with reasonable advance notice of scheduled meetings or other pre-planned non-written communications with a Regulatory Authority and the opportunity to participate in each such meeting or other non-written communication, to the extent involving a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter related to the Combined Therapy or Combined Therapy Clinical Trial that it determines in its reasonable judgement could potentially have an adverse effect on the BMS Study Drug.  In such case, the Recipient will provide BMS with the opportunity to review, provide comments to the Recipient within [ ]* on, and, if inconsistent with the Protocol, approve all submissions and written correspondence with a Regulatory Authority that relates to the BMS Study Drug;

 

(e)                                  provide BMS (i) a written notice to the BMS Designated Clinical Contact (via email to the email address designated by BMS) of meetings or other substantive non-written communications with a Regulatory Authority within [ ]* of such meeting or communication, and if requested by BMS following such notice, a written summary of such meeting or communication within ten (10) days of such request, and (ii) copies of any official correspondence to or from a Regulatory Authority within [ ]* of receipt or provision, in each case of (i) or (ii) to the extent involving a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter related to the Combined Therapy or Combined Therapy Clinical Trial that it determines in its reasonable judgement could potentially have an adverse effect on the BMS Study Drug, and copies of all material Combined Therapy Clinical Trial Regulatory Documentation and correspondence that relates to same within [ ]* of submission to Regulatory Authorities;

 

(f)                                   subject to the terms of this Agreement, the selection and payment of, negotiation of the terms of, contracting with, managing and overseeing compliance of its agreement by and the receipt of contract deliverables from, any CRO or vendor selected by the Recipient to assist in the performance of the Combined Therapy Clinical Trial.  The Recipient shall determine and approve contract deliverables and manage contract performance, including executing site contracts, drafting and obtaining IRB approval for site informed consent forms (each an “ICF”), obtaining signed ICFs, monitoring plans, etc.  The Recipient will be responsible for ensuring that all such contracts and ICFs: (i) do not conflict with the terms of this Agreement, (ii) allow the Recipient to provide BMS with access to and use of Study Data, Samples, and other information and documents as required pursuant to this Agreement (and in no event less than the same use rights granted to the Recipient), (iii) do not impose a new obligation, whether direct, indirect, or contingent, upon BMS that is not set forth in this Agreement, and (iv) retain each of the Parties’ respective intellectual property rights in and access to the BMS Technology, BMS Independent Patent Rights, Study Data, Samples, Recipient Study Drug, BMS Study Drug and Combined Therapy consistent with this Agreement, and (vi) comply with Applicable Law;

 

(g)                                 providing BMS (if requested by BMS) with copies of each final site template of the Combined Therapy Clinical Trial’s ICF.  The Recipient shall ensure that each ICF does not impose any financial obligation, liability, damages or other cost upon BMS with respect to any injury (including death) suffered by a Combined Therapy Clinical Trial subject whether or not resulting from the administration of the BMS Study Drug or direct a study subject to BMS to seek reimbursement for any costs or seek compensation for any injury incurred in connection with the Combined Therapy Clinical Trial;

 

(h)                                 if requested by BMS, providing BMS within [ ]* with minutes from any and all external drug safety monitoring boards for the Combined Therapy Clinical Trial after receipt by the Recipient, to the extent relating to the BMS Study Drug or the Combined Therapy;

 

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(i)                                    informing and updating BMS on a [ ]* basis (with significant issues to be communicated promptly after the Recipient becomes aware of same) regarding all Operational Matters, so that if BMS has any significant concerns or material disagreements regarding same, the matter can be discussed with the Recipient.  Without limiting the foregoing, the Recipient shall inform BMS [ ]* as to the overall Combined Therapy Clinical Trial progress, [ ]*, and any other Combined Therapy Clinical Trial-related matters requested by BMS to the extent involving a safety, efficacy or toxicology issue relating to the Combined Therapy or the BMS Study Drug or any other matter that could have an adverse effect on the BMS Study Drug;

 

(j)                                    owning and being responsible for (or appointing a Third Party to be responsible for) the maintenance of the Global Safety Database and being responsible for safety reporting, collecting, evaluating and reporting Serious Adverse Events, other safety data and any further pharmacovigilance information from the Combined Therapy Clinical Trial;

 

(k)                                 analyzing the Study Data in a timely fashion and providing BMS with access to the Study Data as follows:

 

(i)                                   top line data and a copy of all Clinical Study Reports (CSRs), in each case, as and when received by the Recipient’s clinical management;

 

(ii)                               if requested by BMS, sharing with BMS for review and comment drafts of interim and/or final clinical trial report (and/or statistical analysis in accordance with the Protocol) from the Combined Therapy Clinical Trial;

 

(iii)                           if requested by BMS, within [ ]* after database lock, access to those safety databases that will be used for any interim review by an external consultant (or drug safety monitoring board, if required);

 

(iv)                            if requested by BMS, within [ ]* after database lock, access to case report forms or patient profiles for all patients in the Combined Therapy Clinical Trial;

 

(v)                                if requested by BMS, within [ ]* of the creation of an electronic clean database for the Combined Therapy Clinical Trial, an electronic copy of the clean database (the form and format of the clean database to be reasonably acceptable to both Parties);

 

(vi)                            if requested by BMS, subject to any third party requirements, providing BMS with any programs or SAS codes to be used for any statistical analysis plan for the Combined Therapy Clinical Trial; and

 

(vii)                        (A) safety analyses, (B) new and/or changing Safety Signals and Safety Issues, (C) new and/or changing toxicology and efficacy signals, and (D) any statistical analysis, immunogenicity analysis, or bioanalysis, in each case relating to the BMS Study Drug, the Recipient Study Drug and/or the Combined Therapy, as and when the same are received by the Recipient;

 

(l)                                    obtaining supplies of any co-medications, to the extent any such co-medications are required for use in the Combined Therapy Clinical Trial, and providing to BMS any information related to the Combined Therapy Clinical Trial that is provided to the manufacturer of any co-medication within [ ]* after the provision of the information to the manufacturer;

 

(m)                             if requested by BMS, information that Recipient has available to it as of such time (and with no duty to conduct any interim analysis) regarding either (i) the pharmacokinetics and safety of the Recipient Study Drug alone or (ii) the pharmacokinetics, efficacy and safety of the Recipient Study Drug in combination with the BMS Study Drug;

 

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(n)                                 performing either directly or through third parties collection of Samples required by the Protocol;

 

(o)                                 handling and addressing inquiries from the Combined Therapy Clinical Trial subjects and investigators; and

 

(p)                                 such other responsibilities as may be agreed to by the Parties.

 

5.2                               BMS Operational Responsibilities.  BMS shall be responsible for the following activities:

 

(a)                                 Manufacturing and supplying GMP-grade quantities of the BMS Study Drug, as further described in Article 4 above, and, where and to the extent provided in the Supply and Quality Documentation, providing necessary GMP information and documentation that enables the Recipient Qualified Person (as such term will be defined in the Supply and Quality Documentation) to release BMS Study Drug for the Combined Therapy Clinical Trial;

 

(b)                                 where and to the extent provided in the Supply and Quality Documentation, providing for the release by a Qualified Person or providing the necessary documentation in support of such quality release, of the BMS Study Drug if such release is required for the Combined Therapy Clinical Trial;

 

(c)                                  to the extent necessary for the conduct of the Combined Therapy Clinical Trial, providing a Right of Cross-Reference to the relevant Regulatory Documentation for the BMS Study Drug as set forth in Section 2.1(b) and/or (e), if applicable, to the BMS investigator’s brochure for the BMS Study Drug (and updates thereto) as provided in Section 2.1(d); and

 

(d)                                 such other responsibilities as may be agreed to by the Parties.

 

5.3                               Other Clinical Trials.  Nothing in this Agreement shall preclude either Party from conducting any other clinical trials as it may determine in its discretion, so long as it does not use or rely on the Confidential Information that is solely owned by the other Party in doing so.

 

5.4                               Potential Subsequent Studies.  During the Term, each of the Parties agrees to discuss in good faith, for a period of no longer than [ ]*, additional Combined Therapy Clinical Trials of the BMS Study Drug with the Recipient Study Drug (and/or follow-on versions of the Recipient Study Drug).  If the Parties jointly agree to conduct any such further clinical trials (each, a “Subsequent Study”), this Agreement and the Supply and Quality Documentation shall be amended to provide for such Subsequent Study under the terms thereof.  The Parties agree to discuss whether it may be useful or desirable to include [ ]* as part of a Subsequent Study.  For clarity, no Party shall be obligated to collaborate with the other Party or agree on terms with the other Party with respect to any additional clinical trials (or other collaboration opportunities) pursuant to this Section 5.4.

 

ARTICLE 6

 

INTELLECTUAL PROPERTY

 

6.1                               Inventions and Related Patent Rights.  All rights to Inventions shall be allocated as follows:

 

(a)                                 Recipient Ownership.  Subject to the terms of this Agreement, all Recipient Study Inventions and Recipient Study Patent Rights shall be owned solely by the Recipient, and the Recipient will have the full right to exploit such Recipient Study Inventions and Recipient Study Patent Rights without the consent of, or any obligation to account to, BMS.  BMS shall assign and hereby assigns (and shall cause its Affiliates and contractors to assign) its right, title and interest in any Recipient Study Inventions and Recipient Study Patent Rights to the Recipient.  BMS shall execute such further documents and provide 

 

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other assistance as may be reasonably requested by the Recipient to perfect the Recipient’s rights in such Recipient Study Inventions and Recipient Study Patent Rights, all at the Recipient’s expense.  The Recipient shall have the sole right but not the obligation to prepare, file, prosecute (including any proceedings relating  to reissues, reexaminations, protests, interferences, oppositions, post-grant reviews or similar proceedings and requests for patent extensions) and maintain any Recipient Study Patent Rights at its own expense.

 

(b)                                 BMS Ownership.  Subject to the terms of this Agreement, all BMS Study Inventions shall be owned solely by BMS, and BMS will have the full right to exploit such BMS Study Inventions without the consent of, or any obligation to account to, the Recipient.  The Recipient shall assign and hereby assigns (and shall cause its Affiliates and contractors to assign) all its right, title and interest in any BMS Study Inventions and BMS Study Patent Rights to BMS.  The Recipient shall execute such further documents and provide other assistance as may be reasonably requested by BMS to perfect BMS’s rights in such BMS Study Inventions and BMS Study Patent Rights, all at BMS’s expense. BMS shall have the sole right but not the obligation to prepare, file, prosecute (including any proceedings relating to reissues, reexaminations, protests, interferences, oppositions, post-grant reviews or similar proceedings and requests for patent extensions) and maintain any BMS Study Patent Rights at its own expense.

 

(c)                                  Combined Therapy Inventions.

 

(i)                                                            All Combined Therapy Inventions and Combined Therapy Patent Rights shall be jointly owned by the Parties, and either Party shall have the right to freely exploit the Combined Therapy Inventions and Combined Therapy Patent Rights, both within and outside the scope of this Agreement, without accounting or any other obligation to the other Party (except as expressly set forth in this Section 6.1(c) and Section 6.3(d) with regard to the filing, prosecution, maintenance and enforcement of Combined Therapy Patent Rights) and each Party may use, exploit and grant licenses (with right to sublicense) to Third Parties under its interest in such Combined Therapy Inventions and Combined Therapy Patent Rights.  The Recipient, using outside counsel acceptable to both Parties, shall be responsible, at its sole discretion, for preparing and prosecuting Patent applications and maintaining Patents within the Combined Therapy Patent Rights.  The Recipient shall keep BMS advised as to material developments and steps to be taken with respect to prosecuting any such Patent Rights and shall furnish BMS with copies of applications for such Patent Rights, amendments thereto and other related correspondence to and from patent offices, and permit BMS a reasonable opportunity to review and offer comments prior to submitting such applications and correspondence to the applicable governmental authority (and will take BMS’s comments into account in preparing same).  BMS shall reasonably assist and cooperate in obtaining, prosecuting and maintaining the Combined Therapy Patent Rights.

 

(ii)                                                        Notwithstanding the foregoing clause (i), the Recipient shall not take any position in a submission to a patent office concerning a Combined Therapy Invention that interprets the scope of a Patent Right of BMS without the prior written consent of BMS, provided that BMS has notified the Recipient in writing of the existence and scope of such BMS Patent Right.  The Recipient shall be reimbursed for any costs and expenses incurred in prosecuting Combined Therapy Patent Rights and the subsequent maintenance of Combined Therapy Patent Rights by BMS such that BMS shall be responsible for [ ]* of such costs.  From time-to-time, the Recipient shall invoice BMS such amounts and BMS shall pay the Recipient such invoiced amounts within thirty (30) days after receipt of an invoice therefor.

 

(iii)                                                    The Parties shall discuss in good faith the countries in which the Combined Therapy Patent Rights will be filed.  In case one of the two Parties decides that Combined Therapy Patent Right should not be filed or maintained in a given country (and also elects not to reimburse the other Party for [ ]* of the costs of prosecution and maintenance of such Combined Therapy Patent Right in such country), the other Party shall have the right to file, prosecute and maintain such Combined Therapy Patent Right in such country in its own name and at its own expense upon the prior consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.  In this case, the Party who decides that a Combined Therapy Patent Right should not be filed or maintained (and who also decides not to 

 

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reimburse the other Party for its share of the costs of for a given country shall promptly assign its rights to the Combined Therapy Patent Right in said country to the Party (the “Filing Party”) who wishes to file or maintain said Combined Therapy Patent Right in such country and the Filing Party shall grant, and hereby  grants, to the other Party an irrevocable, perpetual, fully-paid, non-exclusive license, with the right to grant and authorize sublicenses, under such Combined Therapy Patent Rights to make, have made, use, sell, offer for sale, import and other exploit products and services in such country. The Party who does not wish to file or maintain a Combined Therapy Patent Right in any country shall assist in the timely provision of all documents required under national provisions to register said assignment of rights with the corresponding national authorities at the sole expenses of the Party who wishes to file or maintain such Combined Therapy Patent Right in that given country. If the Parties cannot agree with respect to the decision to file or maintain a Combined Therapy Patent Right within [ ]* subsequent to the initiation of the Parties’ good faith efforts to resolve any disagreement, then either Party (whichever files first) shall have the right to file or maintain any Combined Therapy Patent Right in the names of both Parties, provided that: (i) any such Combined Therapy Patent Right shall be jointly owned by the Parties and subject to the freedom to use and operate under such Combined Therapy Patent Right as set forth in the first sentence of this Section 6.1(c); (ii) such prosecuting Party obtains the prior consent of the non-prosecuting Party, which consent shall not be unreasonably withheld or delayed, and (iii) the non-prosecuting party reimburses the prosecuting party for its [ ]* share of the patent costs.

 

(d)                                 Separation of Patent Rights. In order to more efficiently enable the prosecution and maintenance of the BMS Study Patent Rights, the Recipient Study Patent Rights and Combined Therapy Patent Rights relating to Inventions as described above, the Parties will use good faith efforts to separate BMS Study Patent Rights, the Recipient Study Patent Rights, Combined Therapy Patent Rights, BMS Independent Patent Rights and the Recipient Independent Patent Rights into separate patent filings to the extent possible and without adversely impacting such prosecution and maintenance or the scope of the protected subject matter.

 

6.2                               Disclosure and Assignment of Inventions; Ownership of Independent Patent Rights.  Each Party shall disclose promptly to the other Party in writing and on a confidential basis all Inventions, prior to any public disclosure thereof or filing of Patent Rights therefor and allowing sufficient time for comment by the other Party.  In addition, each Party shall, and does hereby, assign, and shall cause its Affiliates and contractors to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Inventions as well as any Patent Rights and other intellectual property rights with respect thereto, as is necessary to fully effect, as applicable, the sole ownership provided for in Sections 6.1(a) and 6.1(b) and the joint ownership provided for in Section 6.1(c).  Each Party shall ensure that each of its employees and contractors conducting activities under this Agreement is under written obligation to assign all right, title and interest in and to all Inventions and Study Data and all intellectual property rights therein to such Party.  Except for the license granted in Section 3.1, nothing in this Agreement shall be construed to grant or transfer to Recipient any rights in the BMS Independent Patent Rights, which shall be the sole and exclusive property of BMS, and nothing in this Agreement shall be construed to grant or transfer to BMS any rights in the Recipient Independent Patent Rights, all of which shall be the sole and exclusive property of Recipient.

 

6.3                               Infringement of Patent Rights by Third Parties.

 

(a)                                      Notice.  Each Party shall promptly notify the other Party in writing of any Infringement of Combined Therapy Patent Rights, of which its in-house patent counsel becomes aware.

 

(b)                                      Infringement of Recipient Study Patent Rights.  For all Infringements of Recipient Study Patent Rights anywhere in the world, the Recipient shall have the exclusive right to prosecute such Infringements as it may determine in its sole and absolute discretion, and the Recipient shall bear all related expenses and retain all related recoveries.  BMS shall reasonably cooperate with the 

 

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Recipient or its designee (to the extent BMS has relevant information arising out of this Agreement), at the Recipient’s request and expense, in any such action.

 

(c)                                       Infringement of BMS Study Patent Rights.  For all Infringements of BMS Study Patent Rights anywhere in the world, BMS shall have the exclusive right to prosecute such Infringements as it may determine in its sole and absolute discretion, and BMS shall bear all related expenses and retain all related recoveries.  The Recipient shall reasonably cooperate with BMS or its designee (to the extent that the Recipient has relevant information arising out of this Agreement), at BMS’s request and expense, in any such action.

 

(d)                                 Infringement of Combined Therapy Patent Rights.

 

(i)                          With respect to Infringements of Combined Therapy Patent Rights, the Parties shall mutually agree as to whether to bring an enforcement action to seek the removal or prevention of such Infringements and damages therefor and, if so, which Party shall bring such action, with any costs and expenses relating thereto to be allocated in accordance with Section 6.3(d)(ii).

 

(ii)                      Regardless of which Party brings an enforcement action pursuant to Section 6.3(d)(i) or whether the Parties reach agreement to initiate such an enforcement action, the other Party hereby agrees to cooperate reasonably in any such action, including, if required, by bringing a legal action, furnishing a power of attorney or jointing as a plaintiff to such a legal action.  If  the  Parties  mutually  agree  to  bring  an  enforcement  action,  BMS  shall  be  responsible  for  [ ]*,  and  the  Recipient  shall  be  responsible  for  [ ]*, of the reasonable and verifiable costs and expenses incurred in connection with any such action.  If either Party recovers monetary damages from any Third Party in an action agreed to by the Parties, such recovery shall be allocated first to the reimbursement of any actual, unreimbursed costs and expenses incurred by the Parties in such litigation (including, for this purpose, a reasonable allocation of expenses of internal counsel) pro rata in accordance with the aggregate amounts spent by both Parties, and any remaining amounts shall be split [ ]* to the Recipient and [ ]* to BMS, unless the Parties agree in writing to a different allocation.  If the Parties do not agree to initiating such an enforcement action, (A) the Party initiating such enforcement action shall be responsible for the costs and expenses incurred in connection with such action and shall reimburse the other Party for the costs the other Party incurs for the assistance and cooperation requested by such Party and (B) the Party initiating such enforcement action shall retain all recoveries from such enforcement action.  In connection with any proceeding under this Section 6.3(d), neither Party shall enter into any settlement without the prior written consent of the other Party.

 

6.4                               Infringement of Third Party Rights.

 

(a)                                 Notice.  If the activities relating to the Combined Therapy Clinical Trial become the subject of a claim of infringement of a patent, copyright or other proprietary right by a Third Party anywhere in the world, the Party first having notice of the claim shall promptly notify the other Party and, without regard to which Party is charged with said infringement and the venue of such claim, the Parties shall promptly confer to discuss the claim.

 

(b)                                 Defense.  If both Parties are charged with infringement pursuant to a claim described in Section 6.4(a), each Party shall have the right to defend itself against such claim and the Parties shall discuss in good faith defending such claim jointly.  If only one Party is charged with infringement, such Party will have the first right but not the obligation to defend such claim.  If the charged Party does not commence actions to defend such claim within thirty (30) calendar days after request by the other Party to do so, then the other Party shall have the right, but not the obligation, to defend any such claim to the extent such claim pertains to the other Party’s Compound.  In any event, the non-defending Party shall reasonably cooperate with the Party conducting the defense of the claim and shall have the right to participate with separate counsel at its own expense, and the defending Party shall consider comments and

 

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suggestions on strategy for defending the action by the non-defending Party in good faith.  The Party defending the claim shall bear the cost and expenses of the defense of any such Third Party infringement claim and shall have sole rights to any recovery.  If the Parties jointly defend the claim, the Recipient shall bear [ ]*, and BMS shall bear [ ]* of any costs and expenses of the defense of any such Third Party infringement claim; provided, however, that, notwithstanding the foregoing, if the claim relates solely to one Party’s Compound, such Party will bear one hundred percent (100%) of the costs and expenses of the defense of such claim and shall have the sole right, but not the obligation, to defend, settle and otherwise handle the disposition of such claim.  Neither Party shall enter into any settlement concerning activities under this Agreement or the Combined Therapy that affects the other Party’s rights under this Agreement or imposes any obligations on the other Party, including any admissions of wrongdoing on behalf of the other Party, without such other Party’s prior written consent, not to be unreasonably withheld or delayed, except that a Party may settle any claim that solely relates to its Compound without the consent of the other Party as long as such other Party’s rights under this Agreement are not adversely impacted (in which case, it will obtain such other Party’s prior written consent, not to be unreasonably withheld or delayed).  If any claim described in this Section 6.4(b) is subject to a Party’s indemnification obligations under Article 11, then Article 11 shall govern such claim and not this Section 6.4(b).

 

6.5                               Combined Therapy Clinical Trial Regulatory Documentation.  Subject to the license and other rights granted by each Party to the other Party pursuant to this Agreement, the Recipient shall solely own all right, title and interest in and to the Combined Therapy Clinical Trial Regulatory Documentation; provided, however, that BMS shall retain sole and exclusive ownership of any BMS Regulatory Documentation that is submitted with or referenced in the Combined Therapy Clinical Trial Regulatory Documentation and that the Recipient shall retain sole and exclusive ownership of any Recipient Regulatory Documentation that is submitted with or referenced in the Combined Therapy Clinical Trial Regulatory Documentation.  This Section 6.5 is without limitation of any other disclosure obligations under this Agreement.

 

6.6                               No Other Use.  Except as expressly provided in Section 6.1, the Recipient agrees not to make or file any Patent Rights application based on or containing BMS Confidential Information, and to give no assistance to any Third Party for such application without BMS’s prior written authorization, and BMS agrees not to make or file any Patent Rights application based on or containing the Recipient’s Confidential Information, and to give no assistance to any Third Party for such application without the Recipient’s prior written authorization.

 

6.7                               Joint Research Agreement.  The Parties acknowledge and agree that this Agreement is a “joint research agreement” as defined in 35 USC § 100 (h).

 

ARTICLE 7

 

COSTS AND EXPENSES

 

7.1                               Manufacturing and IP Costs.  Expenses incurred as described in Article 4 (regarding Manufacturing and Supply) and Article 6 (regarding Intellectual Property) shall be borne or shared by the Parties as provided in such Articles.

 

7.2                               TP Study Costs.  For all expenses (other than those set forth in section 7.1) that are directly attributable or reasonably allocable to the conduct of the Combined Therapy Clinical Trial: (a) the Recipient will solely bear all out-of-pocket costs reasonably incurred by the Recipient (or by BMS pursuant to the following sentence) to Third Parties (including to CROs, laboratories and clinical sites/IRBs) in connection with the performance of the Combined Therapy Clinical Trial (“TP Study Costs”), and (b) each Party shall 

 

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be solely responsible for all of its own internal costs (including costs of individual independent contractors) incurred by such Party or any of its Affiliates.  It is not expected that BMS will incur any TP Study Costs; however, in the event BMS should incur any TP Study Costs in connection with the conduct of the  Combined Therapy Clinical Trial as contemplated by the budget therefor or as previously agreed to in writing by the Parties, the Recipient will reimburse BMS for same on a [ ]* following submission of an invoice therefor and appropriate supporting documentation.

 

7.3                               Third Party License Payments.  If the conduct of the Combined Therapy Clinical Trial requires a Third Party License Payment with respect to the manufacture, supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial, then BMS shall be responsible for the payment of any such Third Party License Payment.   If the conduct of the Combined Therapy Clinical Trial requires a Third Party License Payment with respect to the manufacture, supply and use of the Recipient Study Drug used in the Combined Therapy Clinical Trial, then Recipient shall be responsible for the payment of any such Third Party License Payment.

 

ARTICLE 8

 

RECORDS AND STUDY DATA

 

8.1                               Records.  Each Party shall maintain complete and accurate records of all work conducted with respect to the Combined Therapy Clinical Trial and of all results, information, data, data analyses, reports, records, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences and developments made by or provided to either Party, or by the Parties together, in the course of such Party(ies)’ efforts with respect to the Combined Therapy Clinical Trial (including any statistical analysis plan and any bioanalysis plan to be conducted pursuant to the Protocol or otherwise agreed to by the Parties) (such results, information, data, data analyses, reports, case report forms, adverse event reports, trial records, methods, processes, practices, formulae, instructions, skills, techniques, procedures, experiences, developments, and the Protocol referred to as the “Study Data”).  Such records shall fully and properly reflect all work done and results achieved in the performance of the Combined Therapy Clinical Trial in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes.

 

8.2                               Ownership of Study Data.  BMS shall own the Study Data to the extent that it relates exclusively to the BMS Study Drug (“BMS Study Data”), and the Recipient shall own the Study Data to the extent that it relates exclusively to the Recipient Study Drug (“Recipient Study Data”).  Both Parties shall jointly own any Study Data that does not relate exclusively to the Recipient Study Drug or the BMS Study Drug (“Combined Therapy Study Data”).  Each Party shall, and does hereby, assign, and shall cause its Affiliates to so assign, to the other Party, without additional compensation, such right, title and interest in and to any Study Data as is necessary to fully effect the foregoing, and agrees to execute all instruments as may be reasonably necessary to effect same.

 

8.3                               Use of Study Data.

 

(a)                                 Use of a Party’s Own Study Data.  BMS may use and analyze the BMS Study Data for any purpose without obligation or accounting to the Recipient, who shall hold the BMS Study Data in confidence pursuant to this Agreement.  The Recipient may use and analyze the Recipient Study Data for any purpose without obligation or accounting to BMS, who shall hold the Recipient Study Data in confidence pursuant to this Agreement.

 

(b)                                 Use of Combined Therapy Study Data by BMS.  BMS, [ ]* and their respective Affiliates and (sub)licensees shall have the right to use and analyze the Combined Therapy Study Data (i) in connection with the independent development, commercialization or other exploitation of the BMS Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) and/or for inclusion in the safety database for the BMS Study Drug, in each case without the consent of, or any obligation to 

 

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account to, the Recipient, and (ii) to conduct studies with Samples pursuant to Section 8.5.  Subject to Section 8.5, the results of all such analyses or uses shall be owned by BMS, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in a writing separate from this  Agreement.  BMS, [ ]*, and their respective Affiliates and (sub)licensees shall also be entitled to use the Combined Therapy Study Data during and following the Term to (1) make regulatory filings, meet regulatory requirements, and seek approvals for the BMS Study Drug, either alone or as part of the Combined Therapy, (2) evaluate the safety and efficacy of the Combined Therapy and the BMS Study Drug, (3) promote indications based on, and to disseminate, the Combined Therapy Study Data for the benefit of the BMS Study Drug, either alone or as part of the Combined Therapy, where permitted by and in accordance with Applicable Law; provided that nothing in the foregoing is intended or shall be construed as granting BMS any right or license, expressly or impliedly to make, have made, use, sell, offer for sale, or import the Recipient Study Drug; and (4) include in Patent Rights filings made in the course of the prosecution of BMS Independent Patent Rights that do not Cover both the composition of matter of the Recipient Study Drug, its manufacture or formulation, method of use and the BMS Study Drug.  The Recipient grants BMS, [ ]*, their respective Affiliates and (sub)licensees (of rights to the BMS Study Drug) a Right of Cross-Reference to the Recipient Regulatory Documentation Controlled by Recipient for the Recipient Study Drug and the Combined Therapy Clinical Trial Regulatory Documentation for the Recipient Study Drug or the Combined Therapy for the sole purpose of enabling BMS, [ ]* and their Affiliates and sublicensees to exercise its rights under clause (1) of this Section 8.3(b), which right shall survive any expiration or termination of this Agreement.

 

(c)                                        Use of Combined Therapy Study Data by the Recipient.  The Recipient and its Affiliates and licensees shall have the right to use and analyze the Combined Therapy Study Data (i) in connection with the independent development, commercialization or other exploitation of the Recipient Study Drug (alone or in combination with other drugs and/or other pharmaceutical agents) and/or for inclusion in the safety database for the Recipient Study Drug, in each case without the consent of, or any obligation to account to, BMS and (ii) to conduct studies with Samples pursuant to Section 8.5.  Subject to Section 8.5, the results of all such analyses or uses shall be owned by the Recipient, including any intellectual property arising out of same, unless the Parties shall have agreed otherwise in writing separate from this Agreement.  The Recipient, its Affiliates and (sub)licensees shall be entitled to use the Combined Therapy Study Data during and following the Term to (1) make regulatory filings, meet regulatory requirements and seek approvals for the Recipient Study Drug, either alone or as part of the Combined Therapy, (2) evaluate the safety and efficacy of the Combined Therapy and the Recipient Study Drug, (3) promote indications based on, and to disseminate, the Combined Therapy Study Data for the benefit of the Recipient Study Drug, either alone or as part of the Combined Therapy, where permitted by and in accordance with Applicable Law; provided that nothing in the foregoing is intended or shall be construed as granting the Recipient any right or license, expressly or impliedly, to make, have made, use, sell, offer for sale, or import the BMS Study Drug; and (4) and include in Patent Rights filings made in the course of the prosecution of Recipient Independent Patent Rights that do not Cover both the composition of matter of the BMS Study Drug, its manufacture or formulation, method of use and the Recipient Study Drug.  BMS grants the Recipient, its Affiliates and licensees of the Recipient Study Drug a Right of Cross-Reference to the relevant Regulatory Documentation Controlled by BMS for the BMS Study Drug for the sole purpose of enabling the Recipient, its Affiliates and (sub)licensees to exercise its rights under clause (1) of this Section 8.3(c) (for clarity, such Right of Cross-Reference shall not extend to any [ ]*-controlled Regulatory Documentation) in all countries and territories of the world, which right shall survive any expiration or termination of this Agreement.

 

(d)                                       Biomarker/Dx Agent Development.  Each Party may use and disclose to a Third Party the Combined Therapy Study Data and its Compound’s Study Data, under obligations of confidentiality consistent with this Agreement, to develop and commercialize a biomarker or diagnostic test for use with its Compound (including without limitation another combination therapy involving its Compound) and/or the Combined Therapy, and, unless otherwise mutually agreed by the Parties in writing, 

 

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will own any intellectual property arising out of the work funded or conducted by it with or through such Third Party. Each Party shall grant, and hereby grants, to the other Party a worldwide, perpetual, irrevocable, fully paid-up, royalty-free non-exclusive license, with the right to grant and authorize  sublicenses, under such intellectual property and data to develop and commercialize biomarkers and/or diagnostic tests for use with the Combined Therapy.  The Parties will discuss in good faith any opportunities to jointly participate in the development of any such biomarker or diagnostic test for use with the Combined Therapy.

 

(e)                                        No Other Uses.  All other uses of Combined Therapy Study Data (by either Party), Recipient Study Data (by BMS) and BMS Study Data (by the Recipient) are limited solely to those permitted by this Agreement, and neither Party may use such Study Data for any other purpose without the consent of the other Party during and after the Term.

 

8.4                               Access to Study Data.  Subject to the provisions of Sections 8.1, each Party shall have access to all Combined Therapy Study Data, Recipient Study Data and BMS Study Data (including de-identified patient records).  The relevant Party shall make such Study Data in its possession available to the other Party within a reasonable period, not to exceed [ ]*, after such Study Data is available to or generated by the applicable Party.

 

8.5                               Samples.

 

(a)                                 Samples shall be jointly owned by the Parties (to the extent not owned by the patient and/or the clinical trial site).  Any such Samples shall be collected in accordance with the Protocol and applicable ICFs.  Except as set forth in the Protocol, neither Party shall be permitted to use such Samples for any purpose without the prior written consent of the other Party, which consent shall not be unreasonably withheld if such use is directed to the Combined Therapy and with the terms of such use to be set forth in a written agreement between the Parties setting forth the Samples to be used, and any appropriate terms/restrictions on such use.  For clarity, Replimune shall have the right, without further consent of BMS, to use and study any such Samples as set forth in the Protocol, it being understood that if the Protocol does not reference specific assays to be utilized in the analysis of any such Samples and such analysis will be in the discretion of Replimune.  Except for intellectual property pertaining solely to the [ ]* (which shall be owned by BMS), any data and intellectual property arising out of such Sample use shall be owned by the Party conducting such study using same, provided that, to the extent that any such data or intellectual property relates solely to the Combined Therapy (or biomarkers solely for use with the Combined Therapy), shall be considered Combined Therapy Study Data, Combined Therapy Inventions and/or Combined Therapy Patent Rights, as the case may be.  All Samples, including Samples for PK and ADA serum analysis will be stored for future use in the Recipient’s sample repository, unless the Parties mutually agree that BMS would store such samples, provided that, if the Party holding the Samples determines that it no longer has a use for the Samples and the other Party determines that it does, then the Samples shall, subject to Applicable Law and the terms of the signed ICFs, be transferred to the other Party and may be used solely thereafter by the other Party.  If neither Party has any further use for the Samples, then the remaining Samples will be destroyed pursuant to the respective Party’s standard operating procedures for sample retention and destruction, subject to the terms of and permission(s) granted in the informed consent forms signed by the subjects contributing the Samples in the Combined Therapy Clinical Trial.

 

(b)                                       If required by a Regulatory Authority or necessary as part of the Protocol or related bioanalysis plan, BMS will arrange for the Recipient to use BMS’s preferred Third Party vendor(s), at the Recipient’s expense, for bioanalytical work of Samples from Combined Therapy Clinical Trial subjects on the BMS Study Drug.  Such vendor(s) will provide the results of their bioanalytical work of such Samples to the Recipient and BMS, which results will be included in the final clinical study report, along with the bioanalytical work of the Recipient Study Drug and BMS Study Drug performed by or on behalf of the Recipient.  For the avoidance of doubt, all bioanalytical results for the BMS Study Drug and 

 

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the Recipient Study Drug are deemed Study Data.  All data derived pursuant to the Protocol from such Samples is deemed Study Data.

 

ARTICLE 9

 

CONFIDENTIALITY

 

9.1                               Nondisclosure of Confidential Information.

 

(a)                                 Prior to the Effective Date, the Recipient and BMS entered into a certain Confidentiality Agreement dated March 27, 2017 (the “CDA”).  As it relates to disclosures involving the BMS Study Drug, the Recipient Study Drug or the conduct of the Combined Therapy Clinical Trial only, the CDA is hereby terminated and replaced by the terms of this Agreement.  Any Confidential Information relating thereto previously disclosed by the Parties pursuant to the CDA shall now be Confidential Information for purposes of this Agreement and the Parties shall treat it as such in accordance with the terms hereof.  All written, visual, oral and electronic data, information, know-how or other proprietary information or materials, both technical and non-technical, disclosed by one Party to the other Party pursuant to this Agreement, and disclosed in the manner specified herein, that (a) if in tangible form, is labeled in writing as “proprietary” or “confidential” (or similar reference), or (b) if in oral or visual form, is identified as proprietary or confidential or for internal use only at the time of disclosure or within thirty (30) calendar days thereafter shall be “Confidential Information” of the disclosing Party, and all Study Data and Inventions shall be the Confidential Information of the Party (or Parties) owning such Study Data or Invention (as provided in Section 8.2 with regard to Study Data and Section 6.1 with regard to Inventions).  For purposes of this Agreement, regardless of which Party discloses such Confidential Information to the other, (i) all Recipient Study Inventions, Recipient Technology and Recipient Regulatory Documentation shall be Confidential Information of the Recipient and BMS shall be the receiving Party, and (ii) all BMS Study Inventions, BMS Technology, and BMS Regulatory Documentation shall be Confidential Information of BMS and the Recipient shall be the receiving Party.

 

(b)                                 The Parties agree that the terms of this Agreement shall be treated as Confidential Information of both Parties, and thus may be disclosed only as permitted by Section 9.3.  Except as required by Applicable Law, each Party agrees not to issue any press release or public statement disclosing information relating to this Agreement or the transactions contemplated hereby or the terms hereof without the prior written consent of the other Party, except as permitted by Sections 9.3 and 9.6(b).

 

(c)                                  Except to the extent expressly authorized in this Section 9.1 and Sections 9.2, 9.3 and 9.6 below, or as otherwise agreed in writing by the Parties, each Party agrees that, for the Term and for a period of [ ]* thereafter, it shall (A) keep confidential and shall not publish or otherwise disclose and shall not use for any purpose other than as expressly provided for in this Agreement any Confidential Information of the other Party (including information relating to this Agreement or the transactions contemplated hereby or the terms hereof), (B) treat the other Party’s Confidential Information with the same degree of care the receiving Party uses for its own confidential information but in no event with less than a reasonable degree of care; and (C) reproduce the disclosing Party’s Confidential Information solely to the extent necessary or reasonably useful to accomplish the receiving Party’s obligations under this Agreement or exercise the receiving Party’s rights to use and disclose such Confidential Information as expressly provided for in this Agreement, with all such reproductions being considered the disclosing Party’s Confidential Information, provided that, with respect to BMS Confidential Information that was received as confidential information from [ ]*, the obligations of confidentiality and nonuse shall continue until BMS has obtained [ ]* written consent that the same may be freely used.  Notwithstanding anything to the contrary in this Section 9.1, and subject to Section 8.3, the receiving Party may disclose the disclosing Party’s Confidential Information to its employees, consultants, agents or permitted (sub)licensees solely on a need-to-know basis for the purpose of fulfilling the receiving Party’s obligations under this Agreement or exercising the receiving 

 

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Party’s rights to use and disclose such Confidential Information as expressly provided for in this Agreement; provided, however, that (1) any such employees, consultants, agents or permitted (sub)licensees are bound by obligations of confidentiality and non-use at least as restrictive as those set forth in this Agreement, and (2) the receiving Party remains liable for the compliance of such employees,  consultants, agents or permitted (sub)licensees with such obligations.  Each receiving Party acknowledges that in connection with its and its representatives examination of the Confidential Information of the disclosing Party, the receiving Party and its representatives may have access to material, non-public information, and that the receiving Party is aware, and will advise its representatives who are informed as to the matters that are the subject of this Agreement, that State and Federal laws, including United States securities laws, may impose restrictions on the dissemination of such information and trading in securities when in possession of such information.  Each receiving Party agrees that it will not, and will advise its representatives who are informed as to the matters that are the subject of this Agreement to not, purchase or sell any security of the disclosing Party on the basis of the Confidential Information to the extent such Confidential Information constitute material nonpublic information about the disclosing Party or such security.

 

(d)                                       Combined Therapy Study Data shall be treated as Confidential Information of each Party and shall not be disclosed to Third Parties except to the extent it falls within the exceptions set forth in Section 9.2 below, is authorized under this Section 9.1 or Section 9.3, is required to be filed with a Regulatory Authority or included in a product’s label or package insert, is reasonably necessary to be disclosed in order for a Party to exercise its rights under Section 8.3(b) or 8.3(c) or it is disclosed pursuant to Section 9.5.

 

9.2                               Exceptions.  The obligations in Section 9.1 shall not apply with respect to any portion of Confidential Information that the receiving Party can demonstrate by contemporaneous tangible records or other competent proof:

 

(a)                                 was already known to the receiving Party (or its Affiliates), other than under an obligation of confidentiality, either (i) at the time of disclosure by the disclosing Party, or (ii) if applicable, at the time that it was generated hereunder, whichever ((i) or (ii)) is earlier;

 

(b)                                 was generally available to the public or otherwise part of the public domain either (i) at the time of its disclosure to the receiving Party, or (ii) if applicable, at the time that it was generated hereunder, whichever ((i) or (ii)) is earlier;

 

(c)                                  became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d)                                 was disclosed to the receiving Party (or its Affiliates), other than under an obligation of confidentiality, by a Third Party who had no obligation to the Party owning or Controlling the information not to disclose such information to others; or

 

(e)                                  was independently discovered or developed by the receiving Party (or its Affiliates) without the use of, or reference to, the Confidential Information belonging to the disclosing Party.

 

9.3                               Authorized Disclosure.  Notwithstanding any other provision of this Agreement, each Party may disclose Confidential Information belonging to the other Party to the extent such disclosure is reasonably necessary in the following instances:

 

(a)                                 filing or prosecuting Patent Rights pursuant to Section 6.1(c);

 

(b)                                 prosecuting or defending litigation;

 

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(c)                                  complying with Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock is listed;

 

(d)                                 disclosure, in connection with the performance of this Agreement, to Affiliates, permitted (sub)licensees, contractors, IRBs, CROs, academic institutions, consultants, agents, investigators, and employees and contractors engaged by study sites and investigators involved with the Combined Therapy Clinical Trial, each of whom prior to disclosure must be bound by terms of confidentiality and non-use at least as protective of Confidential Information as those set forth in this Article 9;

 

(e)                                  disclosure of the Combined Therapy Study Data, Combined Therapy Inventions and Combined Therapy Patent Rights to Regulatory Authorities in connection with the development and obtaining of regulatory approval of the Combined Therapy, the Recipient Study Drug or the BMS Study Drug;

 

(f)                                   disclosure of relevant safety information contained within the Combined Therapy Study Data to investigators, IRBs and/or ethics committees and Regulatory Authorities that are involved in other clinical trials of the Recipient Study Drug with respect to the Recipient, and the BMS Study Drug with respect to BMS, and, in the event of a Material Safety Issue, to Third Parties that are collaborating with the Recipient or BMS, respectively in the conduct of such other clinical trials of the Recipient Study Drug or the BMS Study Drug, in each case solely to the extent necessary for the conduct of such clinical trials and/or to comply with Applicable Law and regulatory requirements; and

 

(g)                                       subject to a [ ]* advance written notice to BMS, in communications with [ ]* under confidentiality provisions as least as protective of Confidential Information as those of this Agreement; provided that with respect to [ ]* such disclosure shall be limited to the terms and conditions of this Agreement and the Combined Therapy Study Data.

 

Notwithstanding the foregoing, if a Party is required or otherwise intends to make a disclosure of any other Party’s Confidential Information pursuant to Section 9.3(b) and/or Section 9.3(c), it shall give advance notice to such other Party of such impending disclosure and endeavor in good faith to secure confidential treatment of such Confidential Information and/or reasonably assist the Party that owns such Confidential Information in seeking a protective order or other confidential treatment.

 

9.4                               Disclosure to [ ]*.  Notwithstanding any other provision of this Agreement, BMS shall be entitled to disclose to [ ]* (a) the existence (but not the terms) of this Agreement, the Combined Therapy Clinical Trial and the Protocol, and (b) any other Recipient Confidential Information necessary for BMS to fulfill its obligations to [ ]* under the [ ]*-BMS Agreements; provided that [ ]* is under confidentiality obligations at least as restrictive as set forth herein.  BMS shall be free to disclose to [ ]* and permit [ ]* to use the BMS Study Data and the Combined Therapy Study Data as BMS may determine (so long as such use is consistent with BMS’s permitted uses under Section 8.3(b)).

 

9.5                               Press Releases and Publications.

 

(a)                                 The Parties shall jointly agree to the content and timing of all public communications with respect to this Agreement, press releases, Q&As, and the content of, and wording for, any listing of the Combined Therapy Clinical Trial required to be listed on a public database or other public registry such as www.clinicaltrials.gov).  For clarity, if either Party terminates this Agreement pursuant to Section 12.4, the Parties shall mutually agree upon any external communication related to such termination, which shall not include the rationale for such termination unless (and to the extent) mutually agreed by the Parties.  Notwithstanding the foregoing in this Section 9.5(a), either Party shall be permitted to publicly disclose information that such Party determines in good faith is necessary to be disclosed to comply with 

 

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Applicable Law or the rules or regulations of any securities exchange on which such Party’s stock may be listed, or pursuant to an order of a court or governmental entity.

 

(b)                                 The Recipient and BMS agree to collaborate to publicly disclose, publish or present (i) top-line results from the Combined Therapy Clinical Trial, limited if possible to avoid jeopardizing the future publication of the Study Data at a scientific conference or in a scientific journal, solely for the purpose of disclosing, as soon as reasonably practicable, the safety or efficacy results and conclusions that are material to either Party under applicable securities laws, and (ii) the conclusions and outcomes (the “Results”) of the Combined Therapy Clinical Trial at a scientific conference as soon as reasonably practicable following the database lock date for such Combined Therapy Clinical Trial, subject in the case of (ii) to the following terms and conditions.  The Party proposing to disclose, publish or present the Results shall deliver to the other Party a copy of the proposed disclosure, publication or presentation at least [ ]* before submission to a Third Party.  The reviewing Party shall determine whether any of its Confidential Information that may be contained in such disclosure, publication or presentation should be modified or deleted, whether to file a patent application on any Recipient Study Invention (solely with respect to the Recipient) or BMS Study Invention (solely with respect to BMS) or Combined Therapy Invention disclosed therein.  The disclosure, publication or presentation shall be delayed for an additional [ ]* (i.e., a total of [ ]* from the initial proposal) if the reviewing Party reasonably requests such extension to allow time for the preparation and filing of relevant patent applications consistent with the terms of this Agreement.  If the reviewing Party reasonably requests modifications to the disclosure, publication or presentation to prevent the disclosure of Confidential Information of the reviewing Party (other than the Results or Study Data), the publishing Party shall edit such publication to prevent the disclosure of such information prior to submission of the disclosure, publication or presentation.  In the event of a disagreement as to content, timing and/or venue or forum for any disclosure, publication or presentation of the Results, such dispute (a “Publication Dispute”) shall be referred to the Executive Officers (or their respective designees); provided that, in the absence of agreement after such good faith discussions, and upon expiration of the additional [ ]* -period, (A) academic collaborators or clinical trial sites engaged by the Recipient in connection with the performance of the Combined Therapy Clinical Trial may publish Combined Therapy Study Data obtained by such academic collaborator or clinical trial site solely to the extent that such ability to publish such Combined Therapy Study Data is set forth in an agreement between the Recipient and such academic collaborator or clinical trial site relating to the conduct of Combined Therapy Clinical Trial and (B) the publishing Party may proceed with the disclosure, publication or presentation provided that such disclosure, publication or presentation is consistent with its internal publication guidelines and customary industry practices for the publication of similar data and does not disclose the Confidential Information of the other Party (other than the Results or Study Data).  Authorship of any publication shall be determined based on the accepted standards used in peer-reviewed academic journals at the time of the proposed disclosure, publication or presentation.  The Parties agree that they shall make reasonable efforts to prevent publication of a press release that could jeopardize the future publication of Study Data at a scientific conference or in a scientific journal but in no way will this or any other provision of this Agreement supersede the requirements of any Applicable Law or the rules or regulations of any securities exchange or listing entity on which a Party’s stock is listed (including any such rule or regulation that may require a Party to make public disclosures about interim results of the Combined Therapy Clinical Trial).  Notwithstanding the foregoing, nothing herein shall prevent or restrict [ ]* from making any disclosures of published Study Data disclosed to it by BMS pursuant to Section 9.4 or of the existence of this Agreement, in each case in order for [ ]* to comply with requirements of Applicable Law, the rules or regulations of any securities exchange or listing entity on which its stock may be traded or pursuant to an order of a court or governmental entity to publicly disclose the existence of the Agreement and the Study Data, provided that if any such disclosure is made 

 

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by [ ]* it will only disclose the minimum amount of information necessary to achieve compliance and will provide the Recipient with reasonable advance notice of such disclosure.

 

(c)                                        The Recipient agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trial specific mention, if applicable, of the BMS Study Drug and the support and involvement of BMS.  BMS agrees to include in all permitted press releases, presentations and publications it makes related to the Combined Therapy Clinical Trial specific mention, if applicable, of the Recipient Study Drug and the support and involvement of the Recipient.

 

9.6                               Compliance with Sunshine Laws.

 

(a)                                       For purposes of compliance with reporting obligations under Sunshine Laws, as between the Parties, the Recipient/the Recipient represents that it is not, as of the Effective Date, subject to reporting obligations under the Sunshine Laws.  Therefore, as between the Parties, BMS will report payments or other transfers of value (“POTV”) made by the Recipient or the CRO related to the conduct of the Combined Therapy Clinical Trial and any applicable associated contractor engagements as required under the Sunshine Laws for the Combined Therapy Clinical Trial.  BMS shall request delayed publication for any reported POTV for studies sponsored by the Recipient as permitted under the Sunshine Laws and if consistent with BMS’s normal business practices.  In the event that the Recipient becomes responsible for reporting POTV for studies sponsored by it in a given country during the Term, the Recipient shall provide written notification to BMS and the Parties will meet to confer to discuss how they wish to handle reporting thereafter.  Interpretation of the Sunshine Laws for purposes of reporting any POTV by a Party shall be in such Party’s sole discretion so long as the interpretation complies with Applicable Law.

 

(b)                                       The Recipient (i) will provide (to the extent in the possession of the Recipient), or will utilize Commercially Reasonable Efforts to obligate and ensure that each CRO and other applicable Third Party contractors for the Combined Therapy Clinical Trial provides, BMS with any information requested by BMS as BMS may reasonably determine is necessary for BMS to comply with its reporting obligations under Sunshine Laws (with such amounts paid to, or at the direction of, healthcare providers, teaching hospitals and/or any other persons for whom POTVs must be reported under Sunshine Laws to be reported to BMS within a reasonable time period specified by BMS) and (ii) will reasonably cooperate with, and will utilize Commercially Reasonable Efforts to obligate and ensure that each CRO and other applicable Third Party contractors for the Combined Therapy Clinical Trial reasonably cooperates with, BMS in connection with its compliance with such Sunshine Laws.  The form in which the Recipient provides any such information shall be mutually agreed but sufficient to enable BMS to comply with its reporting obligations and BMS may disclose any information that it believes is necessary to comply with Sunshine Laws.  Without limiting the foregoing, BMS shall have the right to allocate POTVs in connection with this Agreement in any required reporting under Sunshine Laws in accordance with its normal business practices. These obligations shall survive the expiration and termination of this Agreement to the extent necessary for BMS to comply with Sunshine Laws.  The Recipient shall not be required to provide any information to BMS that is subject to disclosure pursuant to the Recipient’s own obligations under the Sunshine Laws.

 

(c)                                        For purposes of this Section 9.7, “Sunshine Laws” shall mean Applicable Laws requiring collection, reporting and disclosure of POTVs to certain healthcare providers, entities and individuals.  These Applicable Laws may include relevant provisions of the Patient Protection and Affordable Health Care Act of 2010 and implementing regulations thereunder.

 

9.7                               Destruction of Confidential Information.  Upon expiration or termination of the Agreement, the receiving Party shall, upon request by the other Party, immediately destroy or return all of the other Party’s Confidential Information relating solely to its Compound as monotherapy (but not to the Combined Therapy or the Combined Therapy Study Data) in its possession; provided, however, that the receiving Party shall be entitled to retain one (1) copy of Confidential Information solely for record-keeping 

 

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purposes and shall not be required to destroy any Confidential Information required, or reasonably necessary, to be retained for any clinical trial activities that continue after expiration or termination, or off-site computer files created during automatic system back up which are subsequently stored securely by the receiving Party.

 

9.8                               Nonsolicitation of Employees.  Each Party agrees that, during the [ ]* thereafter, neither it nor any of its Affiliates shall recruit, solicit or induce any employee of the other Party directly involved in the development or other activities conducted by the other Party under this Agreement to terminate his or her employment with such other Party and become employed by or consult for such other Party, whether or not such employee is a full-time employee of such other Party, and whether or not such employment is pursuant to a written agreement or is at-will.  For purposes of the foregoing, “recruit”, “solicit” or “induce” shall not be deemed to mean (a) circumstances where an employee of one Party initiates contact with the other Party or any of its Affiliates with regard to possible employment, or (b) general solicitations of employment not specifically targeted at employees of a Party or any of its Affiliates, including responses to general advertisements.

 

ARTICLE 10

 

REPRESENTATIONS AND WARRANTIES

 

10.1                       Authority and Binding Agreement.  Each Party represents and warrants to the other Party that (a) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, (b) it has taken all necessary corporate action on its part required to authorize the execution and delivery of the Agreement and the performance of its obligations hereunder, and (c) the Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with its terms subject to bankruptcy, insolvency, reorganization, arrangement, winding-up, moratorium, and similar laws of general application affecting the enforcement of creditors’ rights generally, and subject to general equitable principles, including the fact that the availability of equitable remedies, such as injunctive relief or specific performance, is in the discretion of the court.

 

10.2                       No Conflicts.  Each Party represents and warrants to the other Party that, to the best of its knowledge, it has not entered as of the Effective Date, and shall not enter, into any agreement with any Third Party that is in conflict with the rights granted to the other Party under this Agreement, and has not taken any action that would in any way prevent it from granting the rights granted to the other Party under this Agreement, or that would otherwise materially conflict with or adversely affect the rights granted to the other Party under this Agreement.

 

10.3                       Litigation.  Each Party represents and warrants to the other Party, to the best of its knowledge as of the Effective Date, it is not aware of any pending or threatened litigation (and has not received any communication) that alleges that its activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement it would violate, any of the intellectual property rights of any other Person (after giving effect to the license grants in this Agreement).

 

10.4                       No Adverse Proceedings.  Each Party represents and warrants to the other Party that, except as otherwise notified to the other Party, as of the Effective Date, there is not pending or, to the knowledge of such Party, threatened, against such Party, any claim, suit, action or governmental proceeding that would, if adversely determined, materially impair the ability of such Party to perform its obligations under this Agreement.

 

10.5                       Consents.  Each Party represents and warrants to the other Party that, to the best of its knowledge, all necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons (a) required as of the Effective Date to be obtained by such Party in connection

 

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with the execution and delivery of this Agreement have been obtained (or will have been obtained prior to such execution and delivery) and (b) required to be obtained by such Party in connection with the performance of its obligations under this Agreement have been obtained or will be obtained prior to such performance.

 

10.6                       No Debarment. Each Party hereby certifies to the other that it has not used, and will not use the services of any person disqualified, debarred, banned, subject to debarment or convicted of a crime for which a person could be debarred by the FDA under 21 U.S.C. 335a, as amended (or subject to a similar sanction of any other Regulatory Authority), in any capacity in connection with any of the services or work provided under the Combined Therapy Clinical Trial and that this certification may be relied upon in any applications to the FDA or any other Regulatory Authority.  It is understood and agreed that this certification imposes a continuing obligation upon each Party to notify the other promptly of any change in the truth of this certification.  Upon request by a Party, the other Party agrees to provide a list of persons used to perform the services or work provided under any activities conducted for or on behalf of such Party or any of its Affiliates pursuant to this Agreement who, within the five (5) years preceding the Effective Date, or subsequent to the Effective Date, were or are convicted of one of the criminal offenses required by 21 U.S.C. 335a, as amended, to be listed in any application for approval of an abbreviated application for drug approval.

 

10.7                       Compliance with Applicable Law.  Each Party represents and warrants to the other Party that it shall comply with all Applicable Law of the country or other jurisdiction, or any court or agency thereof, applicable to the performance of its activities hereunder or any obligation or transaction hereunder, including those pertaining to the production and handling of drug products, such as those set forth by the Regulatory Authorities, as applicable, and the applicable terms of this Agreement in the performance of its obligations hereunder.

 

10.8                       Affiliates.  Each Party represents and warrants to the other Party that, to the extent the intellectual property, Regulatory Documentation or Technology licensed by it hereunder are Controlled by its Affiliates or a Third Party, it has the right to use, and has the right to grant (sub)licenses to the other Party to use, such intellectual property, Regulatory Documentation or Technology in accordance with the terms of this Agreement.

 

10.9                       Ethical Business Practices.  Each Party represents and warrants to the other Party that neither it nor its Affiliates will make any payment, either directly or indirectly, of money or other assets, including the compensation such Party derives from this Agreement (collectively a “Payment”), to government or political party officials, officials of International Public Organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively “Officials”) where such Payment would constitute violation of any law, including the Foreign Corrupt Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq.  In addition, regardless of legality, neither it nor its Affiliates will make any Payment either directly or indirectly to Officials if such Payment is for the purpose of improperly influencing decisions or actions with respect to the subject matter of this Agreement.  All activities will be conducted in compliance with the U.S. False Claims Act and the U.S. Anti-Kickback Statute.

 

10.10                Accounting.  Each Party represents and warrants to the other Party that all transactions under the Agreement shall be properly and accurately recorded in all material respects on its books and records and that each document upon which entries in such books and records are based is complete and accurate in all material respects.

 

10.11                Single Agent Compound Safety Issues.  Each Party represents and warrants that, to the best of its knowledge as of the Effective Date, it is not aware of any material safety or toxicity issues with respect to its Single Agent Compound that are not reflected in the investigator’s brochure for its Single Agent Compound existing as of the Effective Date.

 

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10.12                Compliance with Licensor Agreements.  Each Party will use, and will cause its Affiliates to use, Commercially Reasonable Efforts to comply with its obligations under any agreements entered into by it or its Affiliates with a Third Party under which it is licensed any intellectual property rights or confidential information relating to a Compound (and not to voluntarily terminate same) to the extent necessary for the Combined Therapy Clinical Trial to be conducted and completed in accordance with the terms of this Agreement and for the other Party to receive the rights and benefits provided to it under this Agreement.

 

10.13                DISCLAIMER OF WARRANTY.  THE EXPRESS REPRESENTATIONS AND WARRANTIES STATED IN THIS ARTICLE 10 ARE IN LIEU OF, AND THE PARTIES DO HEREBY DISCLAIM, ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, AND NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS.

 

ARTICLE 11

 

INDEMNIFICATION

 

11.1                       BMS Indemnification. BMS hereby agrees to defend, hold harmless and indemnify (collectively, “Indemnify”) the Recipient, its Affiliates, and its and their agents, directors, officers, employees and subcontractors (the “Recipient Indemnitees”) from and against any and all liabilities, expenses and/or losses, including reasonable legal expenses and attorneys’ fees (collectively “Losses”) resulting from Third Party suits, claims, actions and demands (each, a “Third Party Claim”) to the extent that they arise or result from (a) the negligence or intentional misconduct of any BMS Indemnitee or any (sub)licensee of BMS conducting activities on behalf of BMS under this Agreement, (b) any breach by BMS of any provision of this Agreement, (c) any injury (other than resulting from known adverse effects) to a subject in the Combined Therapy Clinical Trial to the extent caused by the BMS Study Drug, or (d) the use by BMS, its Affiliates, contractors or (sub)licensees of Combined Therapy Study Data, BMS Study Data, BMS Study Inventions, BMS Study Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights (other than with respect to Third Party Claims that are covered under Section 6.4); but excluding, in each case ((a) through (d)), any such Losses to the extent arising or resulting from a cause or event for which the Recipient is obligated to Indemnify the BMS Indemnitees pursuant to Section 11.2.

 

11.2                       Recipient Indemnification.  The Recipient hereby agrees to Indemnify BMS, its Affiliates, and its and their agents, directors, officers, employees and subcontractors (the “BMS Indemnitees”) from and against any and all Losses resulting from Third Party Claims to the extent that they arise or result from (a) the negligence or intentional misconduct of any Recipient Indemnitee or any (sub)licensee of the Recipient conducting activities on behalf of the Recipient under this Agreement, (b) any breach by the Recipient of any provision of this Agreement, (c) any injury to a subject in the Combined Therapy Clinical Trial not caused by the BMS Study Drug, or (d) the use by the Recipient, its Affiliates, contractors or (sub)licensees of Combined Therapy Study Data, Recipient Study Data, Recipient Study Inventions, Recipient Study Patent Rights, Combined Therapy Inventions and Combined Therapy Patent Rights (other than with respect to Third Party Claims that are covered under Section 6.4); but excluding, in each case ((a) through (d)), any such Losses to the extent arising or resulting from a cause or event for which BMS is obligated to Indemnify the Recipient Indemnitees pursuant to Section 11.1.

 

11.3                       Indemnification Procedure. Each Party’s agreement to Indemnify the other Party is conditioned on the performance of the following by the Party seeking indemnification: (a) providing written notice to the Indemnifying Party of any Loss and/or Third Party Claim of the types set forth in Section 11.1 and 11.2 promptly, and in any event within sixty (60) calendar days, after the Party seeking indemnification has knowledge of such Loss and/or Third Party Claim; provided that, any delay in complying with the 

 

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requirements of this clause (a) will only limit the Indemnifying Party’s obligation to the extent of the prejudice caused to the Indemnifying Party by such delay, (b) permitting the Indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such Loss and/or Third Party Claim, (c) providing reasonable assistance to the Indemnifying Party, at the Indemnifying Party’s expense, in the  investigation of, preparation for and defense of any Loss and/or Third Party Claim, and (d) not compromising or settling such Loss and/or Third Party Claim without the Indemnifying Party’s written consent, such consent not to be unreasonably withheld or delayed.

 

11.4                       Separate Defense of Claims. In the event that the Parties cannot agree as to the application of Sections 11.1 and/or 11.2 to any particular Loss, the Parties may conduct separate defenses of such Loss. Each Party further reserves the right to claim indemnity from the other in accordance with Sections 11.1 and/or 11.2 upon resolution of the underlying claim, notwithstanding the provisions of Section 11.3(b).

 

11.5                       Insurance.  Each Party shall maintain commercially reasonable levels of insurance or other adequate and commercially reasonable forms of protection or self-insurance to satisfy its indemnification obligations under this Agreement.  Each Party shall provide the other Party with written notice at least thirty (30) calendar days prior to the cancellation, non-renewal or material change in such insurance or self-insurance which would materially adversely affect the rights of the other Party hereunder.  The maintenance of any insurance shall not constitute any limit or restriction on damages available to a Party under this Agreement.

 

11.6                       LIMITATION OF LIABILITY.  NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, INCLUDING LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT AND/OR SUCH PARTY’S PERFORMANCE HEREUNDER, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF THE CAUSE OF ACTION (WHETHER IN CONTRACT, TORT, BREACH OF WARRANTY OR OTHERWISE).  NOTHING IN THIS SECTION 11.6 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF A PARTY UNDER SECTIONS 11.1 OR 11.2 IN RELATION TO, OR DAMAGES AVAILABLE FOR, BREACHES OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OR FOR A PARTY’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT.

 

ARTICLE 12

 

TERM AND TERMINATION

 

12.1                        Term.  This Agreement shall be effective as of the Effective Date and, unless earlier terminated pursuant to this Section 12.1, Sections 12.2, 12.3 or 12.4 or any other termination right expressly stated in this Agreement, shall continue in effect until completion of the Combined Therapy Clinical Trial by all centers participating in the Combined Therapy Clinical Trial, delivery of all Study Data, including all completed case report forms, all final analyses and all final clinical study reports contemplated by the Combined Therapy Clinical Trial to both Parties, and the completion of any statistical analyses and bioanalyses contemplated by the Protocol or otherwise agreed to by the Parties to be conducted under this Agreement (the “Term”).  Notwithstanding the foregoing, either Party shall have the right to immediately terminate this Agreement if the Parties do not agree to a draft Protocol pursuant to Section 2.1(a) within [ ]* after the Effective Date on written notice to the other Party within [ ]* after the end of such [ ]* period;  provided that Recipient shall reimburse BMS its cost of Manufacture and supply (including shipping, taxes and duty, if applicable) for any BMS Study Drug supplied to Recipient for the Combined Therapy Clinical Trial prior to such termination.

 

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12.2                       Termination for Material Breach.

 

(a)                                 Notice and Cure Period.  If a Party (the “Breaching Party”) is in material breach of its obligations under this Agreement, the other Party (the “Non-Breaching Party”) shall have the right to give the Breaching Party notice specifying the nature of such material breach.  The Breaching Party shall have a period of [ ]* after receipt of such notice to cure such material breach (the “Cure  Period”) in a manner reasonably acceptable to the Non-Breaching Party.  For the avoidance of doubt, this provision is not intended to restrict in any way either Party’s right to notify the other Party of any other breach or to demand the cure of any other breach.

 

(b)                                 Termination Right.  The Non-Breaching Party shall have the right to terminate this Agreement, upon written notice, in the event that the Breaching Party has not cured such material breach within the Cure Period, provided, however, that if such breach is capable of cure but cannot be cured within the Cure Period, and the Breaching Party commences actions to cure such material breach within the Cure Period and thereafter diligently continue such actions, the Breaching Party shall have an additional [ ]* to cure such breach.  If a Party contests such termination pursuant to the dispute resolution procedures under Section 13.3, such termination shall not be effective until a conclusion of the dispute resolution procedures in Section 13.3, as applicable, resulting in a determination that there has been a material breach that was not cured within the Cure Period (which Cure Period shall be tolled for the period from notice of such dispute until resolution of such dispute pursuant to Section 13.3 or abandonment of such dispute by the disputing Party).

 

12.3                        Termination for Bankruptcy.  Either Party may terminate this Agreement if, at any time, the other Party shall file in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of such other Party’s assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed or stayed within [ ]* after the filing thereof, or if the other Party will propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of its creditors.

 

12.4                       Termination due to Material Safety Issue; Clinical Hold.

 

(a)                                 Either Party shall have the right to terminate this Agreement immediately (after meeting and discussing with the other Party in good faith as described in the following sentence) upon written notice if it deems it necessary to protect the safety, health or welfare of subjects enrolled in the Combined Therapy Clinical Trial due to the existence of a Material Safety Issue.  In the event of a termination due to a Material Safety Issue, prior to the terminating Party providing written notice, each Party’s safety committee shall, to the extent practicable, meet and discuss in good faith the safety concerns raised by the terminating Party and consider in good faith the input, questions and advice of the non-terminating Party, but should any dispute arise in such discussion, the dispute resolution processes set forth in Section 13.3 shall not apply to such dispute and the terminating Party shall have the right to issue such notice and such termination shall take effect without the Parties first following the procedures set forth in Section 13.3.

 

(b)                                 If a Clinical Hold with respect to either the BMS Study Drug or the Recipient Study Drug should arise at any time after the Effective Date, the Parties will meet and discuss the basis for the Clinical Hold, how long the Clinical Hold is expected to last, and how they might address the issue that caused the clinical hold.  If, after [ ]* of discussions following the Clinical Hold, either Party reasonably concludes that the issue adversely impacts the Combined Therapy Clinical Trial and is not solvable or that unacceptable and material additional costs/delays have been and/or will continue to be incurred in the conduct of the Combined Therapy Clinical Trial, then such Party may immediately terminate this Agreement.

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

12.5                        Effect of Termination. Upon expiration or termination of this Agreement, (a) the licenses granted to the Recipient to conduct the Combined Therapy Clinical Trial in Section 3.1 (and any sublicenses granted under Section 3.2) shall terminate, and (b) the Parties shall use reasonable efforts to wind down activities under this Agreement in a reasonable manner and avoid incurring any additional expenditures or non-cancellable obligations; provided that, in the case of termination pursuant to Section 12.4, the Recipient may continue to dose subjects enrolled in the Combined Therapy Clinical Trial through completion of the Protocol if dosing is required by the applicable Regulatory Authority(ies) and/or Applicable Law.  Any such wind-down activities will include the return to BMS, or destruction, of all BMS Study Drug provided to the Recipient and not consumed in the Combined Therapy Clinical Trial, except in the event that the Recipient terminates this Agreement pursuant to Section 12.2 or 12.3, in which case the Recipient shall continue to have the right to use any BMS Study Drug provided to Recipient for the conduct of the Combined Therapy Clinical Trial.

 

12.6                        Survival.  The following Articles and Sections of this Agreement and all definitions relating thereto shall survive any expiration or termination of this Agreement for any reason: Section 2.1(b), Section 2.4, Section 4.5, Sections 5.1(e)-(h), Section 5.1(j), Section 5.1(k), Section 5.1(o), Article 6 (“Intellectual Property”), Article 7 (“Costs and Expenses), Article 8 (“Records and Study Data”), Article 9 (“Confidentiality”); Article 10 (“Representations and Warranties”), Article 11 (“Indemnification”), Section 12.5 (“Effect of Termination”), Section 12.6 (“Survival”), Section 13.1 (“Entire Agreement”), Section 13.2 (“Governing Law”), Section 13.3 (“Dispute Resolution”), Section 13.4 (“Injunctive Relief”), Section 13.6 (“Notices”), Section 13.7 (“No Waiver, Modifications”), Section 13.8 (“No Strict Construction”), Section 13.9 (“Independent Contractor”), Section 13.10 (“Assignment, Licenses”), Section 13.11 (“Headings”), Section 13.13 (“Severability”), Section 13.15 (“No Benefit to Third Parties”), and Section 13.16 (“Construction”).

 

ARTICLE 13

 

MISCELLANEOUS

 

13.1                       Entire Agreement. The Parties acknowledge that this Agreement shall govern all activities of the Parties with respect to the Combined Therapy Clinical Trial from the Effective Date forward.  This Agreement, including the Exhibits hereto and together with the Supply and Quality Documentation, sets forth the complete, final and exclusive agreement between the Parties concerning the subject matter hereof and supersedes all prior agreements and understandings between the Parties with respect to such subject matter.  There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties with respect to such subject matter other than as are set forth in this Agreement.  All Exhibits attached hereto are incorporated herein as part of this Agreement.

 

13.2                       Governing Law.  This Agreement shall be governed and construed in accordance with the internal laws of the State of Delaware, USA, excluding any choice of law rules that may direct the application of the laws of another jurisdiction.

 

13.3                       Dispute Resolution.

 

(a)                                 The Parties’ Designated Clinical Contacts (for clinical and regulatory matters) and the Parties Designated Supply Contacts (for supply matters) shall attempt in good faith to resolve any dispute or concern that either Party may bring to the other Party’s attention.

 

(b)                                 In the event of any dispute, controversy or claim arising out of, relating to or in connection with any provision of this Agreement (each a “Dispute”), other than a Publication Dispute or a dispute as to whether a Material Safety Issue exists, that cannot be resolved by the applicable Designated 

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

Contacts of each Party after a period of [ ]*, then upon the request of either Party by written notice, the Parties shall refer such Dispute to the Executive Officers.  This Agreement shall remain in effect during the pendency of any such dispute.  In the event that no resolution is made by the Executive Officers (or their designee) in good faith negotiations within [ ]* after such referral to them, then:

 

(i)                                    if such Dispute constitutes an Arbitration Matter, such Dispute shall be resolved through arbitration in accordance with the remainder of this Section 13.3; provided, however, that with respect to any such Arbitration Matter Dispute that relates to a matter described in Section 13.4, either Party shall have the right to seek an injunction or other equitable relief without waiting for the expiration of such [ ]* -period;

 

(ii)                                if such Dispute constitutes a Publication Dispute, the specific dispute resolution processes contained in Section 9.6(b) will apply;

 

(iii)                            if such Dispute regards the supply, quality or compliance with specifications of the Recipient Study Drug, the Recipient shall have the final say regarding such Dispute; provided that (A) the Recipient shall have no authority to amend, change or waive compliance with this Agreement, which matters may be approved only by the written consent of both Parties, (B) all determinations made by the Recipient shall be consistent with the terms of this Agreement;

 

(iv)                             if such Dispute regards the supply, quality or compliance with specifications of the BMS Study Drug, BMS shall have the final say regarding such Dispute; provided that (A) BMS shall have no authority to amend, change or waive compliance with this Agreement, which matters may be approved only by the written consent of both Parties, (B) all determinations made by BMS shall be consistent with the terms of this Agreement.

 

If a Dispute that constitutes an Arbitration Matter remains unresolved after escalation to the Executive Officers as described above, either Party may refer such matter to arbitration as described herein. Any arbitration of an Arbitration Matter under this Agreement shall be shall be conducted under the auspices of the American Arbitration Association by a panel of three (3) arbitrators pursuant to that organization’s Commercial Arbitration Rules then in effect.

 

(c)                                  The fees and expenses of the arbitrators shall be borne in equal shares by the Parties. Each Party shall bear the fees and expenses of its legal representation in the arbitration. The arbitral tribunal shall not reallocate either the fees and expenses of the arbitrators or of the Parties’ legal representation. The arbitration shall be held in New York, New York, which shall be the seat of the arbitration.  The language of the arbitration shall be English.

 

13.4                        Injunctive Relief.  Notwithstanding anything herein to the contrary, a Party may seek an injunction or other injunctive relief from any court of competent jurisdiction in order to prevent immediate and irreparable injury, loss or damage on a provisional basis.  For the avoidance of doubt, if either Party (a) discloses Confidential Information of the other Party other than as permitted under Article 9, (b) uses (in the case of the Recipient) the BMS Study Drug or BMS Technology or (in the case of BMS) the Recipient Study Drug or Recipient Technology in any manner other than as expressly permitted under this Agreement or (c) otherwise is in material breach of this Agreement and such material breach could cause immediate harm to the value of the Recipient Study Drug (by the Recipient) or the BMS Study Drug (by BMS), the other Party shall have the right to seek an injunction or other equitable relief precluding the other Party from continuing its activities related to the Combined Therapy Clinical Trial without waiting for the conclusion of the dispute resolution procedures under Section 13.3.

 

13.5                        Force Majeure. The Parties shall be excused from the performance of their obligations under this Agreement (other than the payment of monies owed to the other Party) to the extent that such 

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

performance is prevented by force majeure and the non-performing Party promptly provides notice of the prevention to the other Party.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition.  For purposes of this Agreement, force majeure shall mean acts of God, strikes or other concerted acts of workers, civil disturbances, fires, earthquakes, acts of terrorism, floods, explosions, riots, war, rebellion,  sabotage or failure or default of public utilities or common carriers or similar conditions beyond the control of the Parties.

 

13.6                       Notices.  Any notice required or permitted to be given under this Agreement shall be in writing, shall specifically refer to this Agreement and shall be deemed to have been sufficiently given for all purposes if such notice is timely and is: (a) mailed by first class certified or registered mail, postage prepaid, return receipt requested, (b) sent by express delivery service, or (c) personally delivered.  Unless otherwise specified in writing, the mailing addresses of the Parties shall be as described below.

 

	
 
    	
For the Recipient:
    	
Replimune Inc.
    
	
 
    	
 
    	
18 Commerce Way
    
	
 
    	
 
    	
Wolburn, MA 10801
    
	
 
    	
 
    	
Attention: Rob Coffin, CEO
    
	
 
    	
 
    	
 
    
	
 
    	
For BMS:
    	
Bristol-Myers Squibb Company
    
	
 
    	
 
    	
Route 206 and Province Line Road
    
	
 
    	
 
    	
Princeton, NJ 08543-4000
    
	
 
    	
 
    	
Attention: VP, Business Development
    
	
 
    	
 
    	
 
    
	
 
    	
With a copy to:
    	
Bristol-Myers Squibb Company
    
	
 
    	
 
    	
Route 206 and Province Line Road
    
	
 
    	
 
    	
Princeton, NJ 08543-4000
    
	
 
    	
 
    	
Attention: VP & Assistant General Counsel, Licensing   and Business Development
    

 

Any such communication shall be deemed to have been received when delivered.  It is understood and agreed that this Section 13.6 is not intended to govern the day-to-day business communications necessary between the Parties in performing their duties, in due course, under the terms of this Agreement.

 

13.7                       No Waiver; Modifications.  It is agreed that no waiver by a Party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.  No amendment, modification, release or discharge shall be binding upon the Parties unless in writing and duly executed by authorized representatives of both Parties.

 

13.8                       No Strict Construction.  This Agreement has been prepared jointly and shall not be strictly construed against either Party. No presumption as to construction of this Agreement shall apply against either Party with respect to any ambiguity in the wording of any provision(s) of this Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

 

13.9                       Independent Contractor.  The Parties are independent contractors of each other, and the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall be the agent of the other or have any authority to act for, or on behalf of, the other Party in any matter.

 

13.10                Assignment; Licensees.

 

(a)                                       Assignment.  Neither Party may assign or transfer this Agreement or any rights or obligations hereunder without the prior written consent of the other Party, except that a Party may make such an assignment without the other Party’s consent (i) to an Affiliate, (ii) to a Third Party that merges 

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

with, consolidates with or acquires substantially all of the assets or voting control of the assigning Party or (iii) to a Third Party that acquires all the rights of the assigning Party to the Recipient Study Drug, in the case of the Recipient, or the BMS Study Drug, in the case of BMS. If assigned or transferred to an Affiliate, the assigning/transferring Party shall remain jointly and severally responsible and liable with the assignee/transferee Affiliate for the assigned rights and/or obligations.  If assigned to a Third Party, any  permitted successor or assignee of rights and/or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights and/or obligations.  Any assignment or attempted assignment by any Party in violation of the terms of this Section 13.10(a) shall be null and void and of no legal effect.

 

(b)                                       Licensees.  If a Party grants a third party a license (other than a license solely to make a product for a Party and other than any license rights granted to [ ]* for the [ ]* Territory) to develop and commercialize its Single Agent Compound on a worldwide basis or in any geographic region and/or for all purposes or a limited field, (a “Licensee”), such Party will obtain the Licensee’s agreement to abide by the terms of this Agreement as and to the extent necessary in order for its obligations hereunder to be fulfilled in the same manner as the licensing Party; and in such event the licensing Party may exercise its rights granted hereunder (including rights to use Study Data and practice Inventions) through the Licensee.

 

13.11                Headings.  The captions to the several Sections and Articles hereof are not a part of this Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation.

 

13.12                Counterparts.  This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument.  This Agreement may be executed by facsimile or electronic (e.g., pdf) signatures and such signatures shall be deemed to bind each Party hereto as if they were original signature.

 

13.13                Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of a Party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid or unenforceable provision as may be possible and reasonably acceptable to the Parties.

 

13.14                Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party may reasonably request in order to perfect any license, assignment or other transfer or any properties or rights under, or pursuant, to this Agreement.

 

13.15                No Benefit to Third Parties.  The representations, warranties and agreements set forth in this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other parties.

 

13.16                Construction.

 

(a)                                       General.  Except as otherwise explicitly specified to the contrary, (i) references to a Section, Article or Exhibit means a Section or Article of, or Exhibit to, this Agreement and all subsections thereof, unless another agreement is specified, (ii) references to a particular statute or regulation include all rules and regulations promulgated thereunder and any successor statute, rules or regulations then in effect, in each case including the then-current amendments thereto, (iii) words in the singular or plural 

 

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form include the plural and singular form, respectively, (iv) the terms “including,” “include(s),” “such as,” and “for example” used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by “without limitation”, and (v) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Agreement.  No presumption as to construction of this Agreement shall apply against either Party with respect to any ambiguity in the wording  of any provision(s) of this Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

 

(b)                                       No Response.  Except as expressly set forth in this Agreement, where a provision of this Agreement provides for a Party to respond within a designated period following written notice from the other Party, and if such Party fails to respond, then the failure to respond shall not be deemed to create or imply: (i) that the non-responding Party agrees or disagrees with the proposed action to be taken by the other Party, (ii) any amendment, change or waiver of the terms of this Agreement, or (iii) any consent that an action proposed to be taken may be taken if it conflicts with the terms of this Agreement and/or waiver of any rights it may have to seek remedies at law or in equity for breach of this Agreement as a result of the action taken.

 

[Signature page follows]

 

CONFIDENTIAL

*CONFIDENTIAL TREATMENT REQUESTED.

 

 

IN WITNESS WHEREOF, the Parties, intending to be legally bound hereby, have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.

 

	
Replimune Inc.
    	
 
    	
Bristol-Myers Squibb Company
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
By:
    	
/s/ Robert Coffin
    	
 
    	
By:
    	
/s/ Fouad Namouni
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Name:
    	
Robert Coffin
    	
 
    	
Name:
    	
Dr. Fouad Namouni, MD
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Title:
    	
CEO
    	
 
    	
Title:
    	
Head of Oncology Development
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Date:
    	
21st February 2018
    	
 
    	
Date:
    	
February 26, 2018
    

 

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*CONFIDENTIAL TREATMENT REQUESTED.

 

 

APPENDIX A

 

DRAFT PROTOCOL SUMMARY

 

[ ]*

 

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*CONFIDENTIAL TREATMENT REQUESTED.

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