Common use of Clinical Development Clause in Contracts

Clinical Development. (a) DAS shall use commercially reasonable efforts to develop the Compound for at least three (3) indications of Pharmaceutical Uses. As of the Effective Date, the parties acknowledge that only cocaine abuse and ▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compound. 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 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 DAS breaches a material obligation under this Agreement or under a Work Plan, Abbott may then advise DAS that Abbott believes that DAS has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising DAS, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in EXHIBIT C, and request the ADR to rule upon whether DAS has breached any such material obligation. In the event that the neutral party to such ADR renders a ruling that DAS has breached such material obligation and that Abbott was adversely impacted thereby, and 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, 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 ▇▇▇▇▇▇'▇ sole remedy shall be (i) the right to terminate this Agreement and the licenses granted hereunder, and to obtain from DAS a license to Improvements under 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) DAS Myogen shall use commercially reasonable efforts Commercially Reasonable Efforts to develop the Compound for at least three (3) indications of Pharmaceutical Uses. As 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 Effective DateCompound 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, the parties acknowledge that only cocaine abuse and ▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compoundit will so notify Abbott within a reasonable time. DAS Myogen 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 DAS Myogen breaches a material obligation under Section 6.3(a) or 6.5(b) of this Agreement or under a Work PlanAgreement, Abbott may then advise DAS Myogen that Abbott believes that DAS Myogen has breached such material ▇▇▇▇ ▇aterial obligation and that Abbott is adversely impacted thereby. Upon so advising DAS▇dvising Myogen, Abbott either Party may initiate an alternative dispute resolution procedure ("ADR") as set forth in EXHIBIT C, Exhibit D and request the ADR to rule upon whether DAS Myogen has breached any such material obligation. In the event that the neutral party to conducting such ADR renders a ruling that DAS Myogen has breached such material obligation and that Abbott was adversely impacted thereby, and DAS 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, DAS 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▇ ▇▇▇▇▇▇'▇ sole remedy shall be (i) the right to terminate ate this Agreement and the licenses granted hereunder, and to obtain from DAS Myogen a license to Improvements under 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 hereunderSection 15.

Clinical Development. (a) DAS Myogen shall use commercially reasonable efforts to develop the Compound for at least three (3) indications of Pharmaceutical Usesin accordance with the Work Plan. As of the Effective Date, the parties acknowledge that only cocaine abuse and ▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compound. DAS Myogen 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 DAS Myogen breaches a material obligation under this Agreement or under a Work PlanAgreement, Abbott may then advise DAS Myogen that Abbott believes that DAS Myogen has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising DASMyogen, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in EXHIBIT CExhibit D, and request the ADR to rule upon whether DAS Myogen has breached any such material obligation. In the event that the neutral party to conducting such ADR renders a ruling that DAS Myogen has breached such material obligation and that Abbott was adversely impacted thereby, and DAS 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, DAS 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 Agreement and Agreem▇▇▇ ▇▇▇ the licenses granted hereunder, and to obtain from DAS Myogen 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) DAS BSC, in accordance with the R&D Plan and the Clinical Budget, shall use devote commercially reasonable efforts to develop complete the Compound for at least three (3) indications of Pharmaceutical Uses. As Clinical Development of the Effective Date, the parties acknowledge that only cocaine abuse Products. Osiris shall reimburse BSC for any and ▇▇▇▇▇▇▇▇▇'▇ Disease are recognized indications for the Compound. DAS shall have sole responsibility for designing, conducting and paying for the [******] Confidential Treatment Requested. The confidential portions have been filed separately all Clinical Trial Costs incurred in connection with the Securities & Exchange Commission. cost Pre-Clinical Development and Clinical Development of the clinical development of Product and shall use commercially reasonable efforts to diligently conduct such clinical development as set forth below. Except Products as set forth in SECTION 3.2 aboveSection 2.14; provided, Abbott hereby agrees that it however, unless otherwise agreed to by the Parties, Osiris 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 reimburse BSC for any Clinical Trial Costs that exceed the difference between (i) the unused Commitment and (ii) the amount of the second such indication within two (2) years of commencing development of the first indication. Subject money applied by Osiris, if any, to DAS's reasonable determination of the commercial viability Pre-Clinical Development of a third indication and ▇▇▇▇▇▇'▇ rights under SECTION 4.3(c) belowProduct during the time, DAS shall be obligated if any, that the BSC Representative had final decision-making authority with respect to commence development Pre-Clinical 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)Product, 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 DAS breaches a material obligation under this Agreement or under a Work Plan, Abbott may then advise DAS that Abbott believes that DAS has breached such material obligation and that Abbott is adversely impacted thereby. Upon so advising DAS, Abbott may initiate an alternative dispute resolution procedure ("ADR") as set forth in EXHIBIT CSection 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 DAS 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 to such ADR renders a ruling that DAS has breached such material obligation and that Abbott was adversely impacted therebyLoan Agreement is terminated, and DAS fails to comply with the terms BSC exercises its rights under Section 3.03 of the neutral's ruling within the time specified therein for complianceLoan Agreement, or if such compliance cannot be fully achieved by such date, DAS has failed otherwise for any reason is no longer required or declines to commence compliance and/or has failed to use diligent efforts to achieve full compliance 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 soon thereafter as is reasonably possible, then ▇▇▇▇▇▇'▇ sole remedy shall be (i) the right to terminate this Agreement and the licenses granted hereunder, and to obtain from DAS a license to Improvements under SECTION 4.8; or specified in (ii) ifbelow), at Osiris shall have no further obligation to reimburse the time ▇▇▇▇▇▇ initiates Clinical Trial Costs of BSC, provided, however, that notwithstanding the ADRforegoing, 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 Default and ending (if applicable) upon the cure of such Default 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 the obligation to 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 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 ADR only alleges DAS's failure obligation of Osiris to develop reimburse the Product for some, but not all Clinical Trial Costs of those indications, then ▇▇▇▇▇▇ BSC shall only be entitled to a partial termination of this Agreement resume and the licenses granted hereunder as obligation to those Product indications pay any invoice submitted by BSC to Osiris pursuant to Section 2.14(a) shall resume (with the period in which such invoice must be paid automatically extending 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 period 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 hereunderobligation to pay any such invoice was stayed).