Common use of Clinical Development Clause in Contracts

Clinical Development. (a) Myogen shall use commercially reasonable efforts to develop the Compound in accordance with the Work Plan. Myogen shall have sole responsibility for designing, conducting and paying for the cost of the clinical development of Product and shall use commercially reasonable efforts to conduct such clinical development as set forth below. Except as set forth in Section 3.2 above, Abbott hereby agrees that it shall not undertake any research or development related to Pharmaceutical Uses of the Compound during the Term, except as may be necessary following the license granted to Abbott under Section 4.8 in the event of a termination of this Agreement under Sections 8.2, 8.3 or 8.4. (b) In the event Myogen breaches a material obligation under this Agreement, Abbott may then advise Myogen that Abbott believes that Myogen has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising Myogen, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit D, and request the ADR to rule upon whether Myogen has breached any such material obligation. In the event that the neutral party conducting such ADR renders a ruling that Myogen has breached such material obligation and that Abbott was adversely impacted thereby, and Myogen fails to comply with the terms of the neutral's ruling within the time specified therein for compliance, or if such compliance cannot be fully achieved by such date, Myogen has failed to commence CONFIDENTIAL TREATMENT REQUESTED *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406 compliance and/or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, then Abbott's sole remedy shall be (i) the right to terminate this Agreem▇▇▇ ▇▇▇ the licenses granted hereunder, and to obtain from Myogen a license to Improvements under Section 4.8.

Clinical Development. (a) Myogen DAS shall use commercially reasonable efforts to develop the Compound in accordance with for at least three (3) indications of Pharmaceutical Uses. As of the Work PlanEffective Date, the parties acknowledge that only cocaine abuse and ▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compound. Myogen DAS shall have sole responsibility for designing, conducting and paying for the [******] Confidential Treatment Requested. The confidential portions have been filed separately with the Securities & Exchange Commission. cost of the clinical development of Product and shall use commercially reasonable efforts to diligently conduct such clinical development as set forth below. Except as set forth in Section SECTION 3.2 above, Abbott hereby agrees that it shall not undertake any research or development related to Pharmaceutical Uses of the Compound during the Term, except as may be necessary following the license granted to Abbott under Section SECTION 4.8 in the event of a termination of this Agreement under Sections SECTIONS 8.2, 8.3 or 8.4, or a partial termination of this Agreement under SECTION 4.3(c). (b) After successfully completing formulation, bioavailability and delivery work for the first indication of Pharmaceutical Uses, DAS shall use commercially reasonable efforts to develop two (2) additional indications of Pharmaceutical Uses. DAS shall be obligated to commence development of the second such indication within two (2) years of commencing development of the first indication. Subject to DAS's reasonable determination of the commercial viability of a third indication and ▇▇▇▇▇▇'▇ rights under SECTION 4.3(c) below, DAS shall be obligated to commence development of the third such indication within two (2) years of commencing development of the second indication. For purposes of this SECTION 4.3(b), development of an indication shall be deemed to have commenced upon enrollment of the first subject in the first clinical study for an indication using the formulation selected for clinical development. (c) In the event Myogen DAS breaches a material obligation under this AgreementAgreement or under a Work Plan, Abbott may then advise Myogen DAS that Abbott believes that Myogen DAS has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising MyogenDAS, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit DEXHIBIT C, and request the ADR to rule upon whether Myogen DAS has breached any such material obligation. In the event that the neutral party conducting to such ADR renders a ruling that Myogen DAS has breached such material obligation and that Abbott was adversely impacted thereby, and Myogen DAS fails to comply with the terms of the neutral's ruling within the time specified therein for compliance, or if such compliance cannot be fully achieved by such date, Myogen DAS has failed to commence CONFIDENTIAL TREATMENT REQUESTED *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406 compliance and/or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, then Abbott's ▇▇▇▇▇▇'▇ sole remedy shall be (i) the right to terminate this Agreem▇▇▇ ▇▇▇ Agreement and the licenses granted hereunder, and to obtain from Myogen DAS a license to Improvements under Section SECTION 4.8; or (ii) if, at the time ▇▇▇▇▇▇ initiates the ADR, the ADR only alleges DAS's failure to develop the Product for some, but not all of those indications, then ▇▇▇▇▇▇ shall only be entitled to a partial termination of this Agreement and the licenses granted hereunder as to those Product indications for which failure to develop is alleged and determined by the ADR, and shall obtain from DAS a license to Improvements under SECTION 4.8 as to Improvements only with respect to such Product indications, with no effect on DAS's rights hereunder for those Product indications and Improvements that the [******] Confidential Treatment Requested. The confidential portions have been filed separately with the Securities & Exchange Commission. neutral party has not declared have not been adequately developed by DAS hereunder.

Clinical Development. (a) Myogen shall use commercially reasonable efforts Commercially Reasonable Efforts to develop the Compound in accordance with the Work Plan and not to materially deviate from the time schedule stated therein except as may be dictated by valid scientific, clinical and/or Regulatory circumstances and shall use Commercially Reasonable Efforts to maximize the commercial opportunity of the Compound and Product. Myogen may modify the Work Plan if required to adjust the Work Plan under such circumstances and will communicate such modifications to Abbott. If Myogen requires any other material ▇odification to the Work Plan, it will so notify Abbott within a reasonable time. Myogen shall have sole responsibility for designing, conducting and paying for the cost of the clinical development of Product and shall use commercially reasonable efforts Commercially Reasonable Efforts to conduct such [/\#/\] CONFIDENTIAL TREATMENT REQUESTED 10 [/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. clinical development as set forth below. Except as set forth in Section 3.2 above, Abbott hereby agrees that it shall not undertake any research or development related to Pharmaceutical Uses of the Compound during the Term, except as may be necessary following the license granted to Abbott under Section 4.8 in the event of a termination of this Agreement under Sections 8.2, 8.3 or 8.4[/\#/\]. (b) In the event Myogen breaches a material obligation under Section 6.3(a) or 6.5(b) of this Agreement, Abbott may then advise Myogen that Abbott believes that Myogen has breached such material ▇▇▇▇ ▇aterial obligation and that Abbott is adversely impacted thereby. Upon so advising ▇dvising Myogen, Abbott either Party may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit D, D and request the ADR to rule upon whether Myogen has breached any such material obligation. In the event that the neutral party conducting such ADR renders a ruling that Myogen has breached such material obligation and that Abbott was adversely impacted thereby, and Myogen an▇ ▇▇▇▇en fails to comply with the terms of the neutral's ruling within the time specified therein for compliancecompliance (which in no event shall be less than ninety (90) days), or if such compliance cannot be fully achieved by such date, Myogen has failed to commence CONFIDENTIAL TREATMENT REQUESTED *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406 compliance and/or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, then Abbott's sole remedy shall be (i) the right to terminate this Agreem▇▇t▇ ▇▇▇ ▇▇▇▇ate this Agreement and the licenses granted hereunder, and to obtain from Myogen a license to Improvements under Section 4.815.

Clinical Development. (a) Myogen BSC, in accordance with the R&D Plan and the Clinical Budget, shall use devote commercially reasonable efforts to develop complete the Compound Clinical Development of the Products. Osiris shall reimburse BSC for any and all Clinical Trial Costs incurred in accordance connection with the Work Plan. Myogen shall have sole responsibility for designing, conducting Pre-Clinical Development and paying for the cost Clinical Development of the clinical development of Product and shall use commercially reasonable efforts to conduct such clinical development as set forth below. Except Products as set forth in Section 3.2 above2.14; provided, Abbott hereby agrees that it however, unless otherwise agreed to by the Parties, Osiris shall not undertake be obligated to reimburse BSC for any research or development related Clinical Trial Costs that exceed the difference between (i) the unused Commitment and (ii) the amount of money applied by Osiris, if any, to Pharmaceutical Uses Pre-Clinical Development of the Compound a Product during the Termtime, except as may be necessary following if any, that the license granted BSC Representative had final decision-making authority with respect to Abbott under Section 4.8 in the event Pre-Clinical Development of a termination of this Agreement under Sections 8.2such Product, 8.3 or 8.4. (b) In the event Myogen breaches a material obligation under this Agreement, Abbott may then advise Myogen that Abbott believes that Myogen has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising Myogen, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit DSection 2.03(d) (the “Remainder Amount”); provided, and request further, in the ADR event Clinical Trial Costs exceed the Remainder Amount, the Parties shall work together in good faith to rule upon whether Myogen has breached any such material obligationnegotiate terms, reasonable to each Party in its discretion, for additional funding of development of the Products. In Osiris, at its expense, shall provide reasonable cooperation to assist BSC with Clinical Development of the Products; provided, further, (i) in the event that the neutral party conducting Loan Agreement is terminated, BSC exercises its rights under Section 3.03 of the Loan Agreement, or otherwise for any reason is no longer required or declines to make an Advance or Deemed Advance under the Loan Agreement (including without limitation because of the occurrence of an Event of Default but except as specified in (ii) below), Osiris shall have no further obligation to reimburse the Clinical Trial Costs of BSC, provided, however, that notwithstanding the foregoing, all monies paid by BSC to Osiris pursuant to the Loan Agreement before its termination shall be applied exclusively to activities pursuant to the R&D Plan and in accordance with the Budget, including without limitation to reimburse the Clinical Trial Costs of BSC and (ii) in the event that BSC is not required to make an Advance under the Loan Agreement due to the occurrence of a Default, Osiris shall have no obligation, during the period commencing upon the occurrence of such ADR renders a ruling that Myogen has breached Default and ending (if applicable) upon the cure of such material obligation and that Abbott was adversely impacted therebyDefault within the cure period specified in Article VII of the Loan Agreement in respect of such Default, to reimburse the Clinical Trial Costs of BSC, and Myogen fails the obligation to comply pay any invoice submitted by BSC to Osiris pursuant to Section 2.14(a) shall be stayed during such period, provided, however, that notwithstanding the foregoing, all monies paid by BSC to Osiris pursuant to the Loan Agreement before the occurrence of such Default shall be applied exclusively to activities pursuant to the R&D Plan and in accordance with the terms Budget, including without limitation to reimburse the Clinical Trial Costs of the neutral's ruling within the time specified therein for compliance, or if such compliance cannot be fully achieved by such date, Myogen has failed to commence CONFIDENTIAL TREATMENT REQUESTED *** TEXT OMITTED AND FILED SEPARATELY CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. SECTIONS 200.80(b)(4) AND 230.406 compliance and/or has failed to use diligent efforts to achieve full compliance as soon thereafter as is reasonably possible, then Abbott's sole remedy shall be (i) the right to terminate this Agreem▇▇▇ ▇▇▇ the licenses granted hereunderBSC, and provided further that upon the cure of such Default within such specified cure period, the obligation of Osiris to obtain from Myogen a license reimburse the Clinical Trial Costs of BSC shall resume and the obligation to Improvements under pay any invoice submitted by BSC to Osiris pursuant to Section 4.82.14(a) shall resume (with the period in which such invoice must be paid automatically extending for the period that the obligation to pay any such invoice was stayed).