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 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 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. Abbott hereby agrees that [/\#/\]. (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 ▇▇▇▇ ▇aterial obligation and that Abbott is adversely impacted thereby. Upon so ▇dvising Myogen, either Party 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 conducting such ADR renders a ruling that Myogen has breached such material obligation and that Abbott was adversely impacted thereby, an▇ ▇▇▇▇en fails to comply with the terms of the neutral's ruling within the time specified therein for compliance (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 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 the right t▇ ▇▇▇▇▇▇ate this Agreement and the licenses granted hereunder, and to obtain from Myogen a license to Improvements under Section 15.

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 ▇▇▇▇ ▇aterial such material obligation and that Abbott is adversely impacted thereby. Upon so ▇dvising advising Myogen, either Party Abbott 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, an▇ ▇▇▇▇en and Myogen fails to comply with the terms of the neutral's ruling within the time specified therein for compliance (which in no event shall be less than ninety (90) days)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 tto terminate this Agreem▇▇▇ ▇▇▇▇▇▇ate this Agreement and ▇ the licenses granted hereunder, and to obtain from Myogen a license to Improvements under Section 154.8.

Clinical Development. (a) Myogen DAS 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 for at least three (3) indications of Pharmaceutical Uses. As of the Compound Effective Date, the parties acknowledge that only cocaine abuse and Product▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compound. 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 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 commercially reasonable efforts to diligently 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, 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 Section 6.3(a) this Agreement or 6.5(b) of this Agreementunder a Work Plan, Abbott may then advise Myogen DAS that Abbott believes that Myogen DAS has breached ▇▇▇▇ ▇aterial such material obligation and that Abbott is adversely impacted thereby. Upon so ▇dvising Myogenadvising DAS, either Party Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in Exhibit D EXHIBIT C, and request the ADR to rule upon whether Myogen DAS has breached any such material obligation. In the event that the neutral conducting party to such ADR renders a ruling that Myogen DAS has breached such material obligation and that Abbott was adversely impacted thereby, an▇ ▇▇▇▇en and DAS fails to comply with the terms of the neutral's ruling within the time specified therein for compliance (which in no event shall be less than ninety (90) days)compliance, or if such compliance cannot be fully achieved by such date, Myogen DAS has failed to commence 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 the right t▇ ▇▇▇▇▇▇ate '▇ sole remedy shall be (i) the right to terminate this Agreement and the licenses granted hereunder, and to obtain from Myogen DAS a license to Improvements under Section 15SECTION 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 to develop the Compound BSC, in accordance with the Work R&D Plan and not the Clinical Budget, shall devote commercially reasonable efforts to materially deviate from complete 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 Clinical Development of the Compound Products. Osiris shall reimburse BSC for any and Product. Myogen may modify all Clinical Trial Costs incurred in connection with the Work Plan if required to adjust the Work Plan under such circumstances Pre-Clinical Development 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 Clinical Development of the clinical development of Product and shall use 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. Abbott hereby agrees that [/\#/\]. (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 ▇▇▇▇ ▇aterial obligation and that Abbott is adversely impacted thereby. Upon so ▇dvising Myogen, either Party may initiate an alternative dispute resolution procedure ("ADR") Products as set forth in Exhibit D Section 2.14; provided, however, unless otherwise agreed to by the Parties, Osiris shall not be obligated to reimburse BSC for any Clinical Trial Costs that exceed the difference between (i) the unused Commitment and request (ii) the ADR amount of money applied by Osiris, if any, to rule upon whether Myogen has breached any Pre-Clinical Development of a Product during the time, if any, that the BSC Representative had final decision-making authority with respect to Pre-Clinical Development of such material obligationProduct, as set forth in Section 2.03(d) (the “Remainder Amount”); provided, further, in the event Clinical Trial Costs exceed the Remainder Amount, the Parties shall work together in good faith to negotiate 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 conducting such ADR renders a ruling 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 Myogen has breached such material obligation 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 that Abbott was adversely impacted thereby, an▇ ▇▇▇▇en fails to comply in accordance with the terms 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 Default and ending (if applicable) upon the cure of such Default within the cure period specified in Article VII of the neutral's ruling within Loan Agreement in respect of such Default, to reimburse the time specified therein for compliance (which in no event Clinical Trial Costs of BSC, and the obligation to pay any invoice submitted by BSC to Osiris pursuant to Section 2.14(a) shall be less than ninety (90) days)stayed during such period, or if provided, however, that notwithstanding the foregoing, all monies paid by BSC to Osiris pursuant to the Loan Agreement before the occurrence of such compliance cannot be fully achieved by such date, Myogen has failed to commence 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 Default shall be applied exclusively to activities pursuant to the right t▇ ▇▇▇▇▇▇ate this Agreement R&D Plan and in accordance with the Budget, including without limitation to reimburse the Clinical Trial Costs of BSC, and provided further that upon the cure of such Default within such specified cure period, the obligation of Osiris to reimburse the Clinical Trial Costs of BSC shall resume and the licenses granted hereunder, and obligation to obtain from Myogen a license pay any invoice submitted by BSC to Improvements under Osiris pursuant to Section 152.14(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).