definiens: shall mean any change, effect, event, condition or occurrence, individually or in the aggregate, that has a material adverse effect or impact on theProduct, the Development Program or the financial condition of the Company, including, without limitation, any delaysin meeting timelines set out in the Development Program, any negative data received, generated or otherwise madeavailable with respect to the safety or efficacy of the Product, any failure to achieve endpoints or other goals of any partof the Development Program, any decrease in the level of patient recruitment in the clinical trials or other variance fromthe projected levels of patient recruitment, any recommendations or communications to or from the FDA or otherGovernmental Authority that a clinical trial or the Development Program should be stopped or modified, or if theCompany becomes insolvent or it is reasonably determined by BDSI ’s Board of Directors that the Company does nothave, or the company can not reasonably obtain sufficient funds to continue the planned Development Program . ”(e ) Section 3.5 Collaboration with Qualified collaboration Partner . Section 3.5 of the [COMPANY] License is hereby deleted inits entirety and replaced with the following:“3.5 Collaboration with Qualified Collaboration Partner . Company shall have the right to enter into a partnership, collaboration, licensing agreement or other arrangement with a Qualified Collaboration Partner with respect to thedevelopment of the Product hereunder, provided, however, that ( i ) prior to a Change of Control of either [COMPANY] orSubsidiary or Arius Two, Inc., such Qualified Collaboration Partner shall be subject to the prior written approval of CDCwhich approval shall not be unreasonably withheld and ( ii ) from and after a Change of Control of either [COMPANY] orSubsidiary or Arius Two, Inc., such Qualified Collaboration Partner shall be subject to the prior written approval of CDCin its sole discretion . Prior to engaging in any potential discussions with any such - 2 -Qualified Collaboration Partners, Company shall consult in good faith with [COMPANY] regarding such Qualified CollaborationPartners, including, without limitation, discussions regarding alternative Qualified Collaboration Partners . In addition, once such Qualified Collaboration Partner has been selected and throughout the process of negotiation of any potentialtransaction with such Qualified Collaboration Partner, Company shall consult in good faith with [COMPANY] regarding the termsand documentation with respect to the potential transactions with such Qualified Collaboration Partners and shallconsider in good faith [COMPANY] ’s comments to such terms and documentation . In addition, Company shall provide completeand un - redacted executed copies of any agreements or other understandings entered into with such Collaboration Partnerpromptly following the execution thereof . Notwithstanding the foregoing, as a condition to entering into suchpartnership, collaboration, licensing agreement or other arrangement with a Qualified Collaboration Partner, theQualified Collaboration Partner shall expressly acknowledge to [COMPANY] than any such agreement shall be subject to therights of [COMPANY] hereunder . In addition to the foregoing, [COMPANY] shall have access to all information and documentation thatis generated or otherwise resides with the Collaboration Partner to the same extent Company would have access to suchinformation or documentation under any such agreement . ”(f ) Section 4.2 Advice of Counsel . Section 4.2 of the [COMPANY] License is hereby deleted in its entirety and replaced with thefollowing:“4.2 Advice of Counsel . If a Party is advised by its counsel that it must communicate with any Governmental Authorityrelating to a matter under the Development Program, then such Party shall promptly, but in no event more than two(2 ) Business Days, advise the other Party of the same . Company shall provide [COMPANY] in advance with a copy of anyproposed communication with such Governmental Authority in time sufficient to allow for a reasonable time to commentthereon, and shall consider in good faith all comments [COMPANY] may have with respect thereto . In addition, BDSI shallcomply with any and all reasonable requests of [COMPANY] concerning any meeting or written or oral communication with suchGovernmental Authority . ”(g ) Section 4.5.1 Receipt of Correspondence . Section 4.5.1 of the [COMPANY] License is hereby deleted in its entirety andreplaced with the following:“4.5.1 Receipt of Correspondence . Company shall promptly and in accordance with applicable Law provide to CDCcopies of any documents or correspondence received from any Governmental Authority, but in no event more than two(2 ) Business Days after such receipt, that pertains to the Products or the Development Program ( including withoutlimitation any minutes from a meeting with respect thereto ) . In addition, Company shall provide [COMPANY] with anydocuments or correspondence to be submitted to any Governmental Authority that relate to the Products in timesufficient to allow for a reasonable time to comment, and shall consider in good faith all comments [COMPANY] may have withrespect thereto . In addition, Company will consult in advance with, and shall consider in good faith any comments of, [COMPANY] with respect to any filings made or other actions taken, including without limitation any such filings or actionswith respect to any changes or modification to labeling for or the indications of the Products . ” - 3 -(h ) Section 4.5.2 Regulatory Information . The first sentence of Section 4.5.2 of the [COMPANY] License is hereby deleted in itsentirety and replaced with the following:“Company shall provide [COMPANY] with notice, in a sufficiently timely basis ( but in all cases not less than three ( 3 ) BusinessDays after notice thereof ), of notification or other information which it receives ( directly or indirectly ) from, anyGovernmental Authority ( and providing, as soon as reasonably possible ( but in all cases not less than three ( 3 ) BusinessDays after receipt thereof ), copies of any associated written requests ) or from other persons that ( i ) may reflect or indicateany concerns regarding the safety or efficacy of a Product, ( ii ) indicates or suggests a Claim of a third party arising inconnection with a Product, or ( iii ) may lead to a recall or market withdrawal of a Product . ”(i ) Section 4.6.1 Inquiries ; Adverse Events . Section 4.6.1 of the [COMPANY] License is hereby deleted in its entirety and replacedwith the following:“4.6.1 Inquiries, Adverse Events . Company shall submit reports of all Adverse Drug Experiences associated with the useof the approved Product(s ) and other required safety information ( e.g., PSUR ’s and annual safety reports ) to the FDA andother Governmental Authorities, in accordance with applicable Law . Company shall submit a copy of each such report toCDC in advance of such submission in time sufficient to allow for a reasonable time to comment, and shall consider ingood faith all comments of [COMPANY] thereto ; provided, however that [COMPANY] shall provide any such comments thereto withinfive ( 5 ) Business Days after receipt of such report from the Company . ”(j ) Section 6.6.1 Royalty on Net Sales . Section 6.6.1 of the [COMPANY] License is hereby amended by replacing the reference to at the end of Section 6.6.1 with a reference to