Common use of Phase I Plan Clause in Contracts

Phase I Plan. Unless decided otherwise by the JDC, the Phase I Plan for each Phase I Completed Original Product will be updated annually and approved by the JDC. The Phase I Plan will set forth (a) the activities and the resources that will be dedicated, (b) specific objectives for each year, which objectives as proposed to the JDC by the JOT will be approved, if appropriate, by the JDC as development progresses, and (c) related Development Costs for such activities as part of the Shared Development Cost Budget. The Shared Development Cost Budget shall include the anticipated Development Costs expected to be incurred pursuant to the Phase I Plan for the remainder of the then current Calendar Year and each of the next up to [***]. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the Phase I Plan for [***]. The JDC shall review the Phase I Plan on an ongoing basis and may amend the Phase I Plan to reflect the updated or amended objectives and the progress made, subject to JDC approval. Any such changes shall be reflected in written amendments to the Phase I Plan for each Phase I Completed Original Product. Drafting of the Phase I Plan shall be initiated prior to completion of a GLP Tox Study for such Phase I Completed Original Product. Roche together with C4T shall establish Phase I Plans for approval by the JDC, satisfying the Phase I Data Package.

Phase I Plan. Unless decided otherwise The JDC shall strive by consensus to prepare a Phase I Plan for each Collaboration Target no later than thirty (30) days after the start of GLP Tox Studies for such Collaboration Target. Each Collaboration Target will be designated by the JDCJDC as either a […***…] or a […***…] in the applicable Phase I Plan. […***…], the JDC shall amend the Phase I Plan for such Collaboration Target (if needed). BPM shall prepare the initial draft of each Phase I Completed Original Product will be updated annually and approved by Plan for any […***…], unless the JDCcombination is with a Roche Clinical Compound or Roche Marketed Product, in which case Roche shall prepare the initial draft of each such Phase I Plan. The JDC shall review each Phase I Plan on an ongoing basis and may amend such Phase I Plan. Any such changes shall be reflected in written amendments to such Phase I Plan. The Parties will conduct the Phase I Program in accordance with the Phase I Plans. Each Phase I Plan will set forth (ai) the activities scope of the initial Phase I Studies for such Collaboration Target and the resources that will be dedicateddedicated to the activities contemplated within the scope of such Phase I Studies, including the responsibilities of each Party, (bii) projected patient enrollment rates consistent with Roche’s historic enrollment rates for similar drug candidates in Phase I Studies, (iii) specific objectives for each yearCalendar Year end in which such initial Phase I Studies are conducted, which objectives as proposed to the JDC by the JOT will be approvedupdated or amended, if as appropriate, by the JDC as development progresses, and (civ) related Development Costs a rolling two (2) year budget for such anticipated activities as part of the Shared Development Cost Budget. The Shared Development Cost Budget shall include the anticipated Development Costs expected to be incurred pursuant to performed during the Phase I Plan for the remainder of the then then-current Calendar Year and each the next Calendar Year, and a forecast of the next up budgets for each subsequent Calendar Year thereafter through completion of all development activities set forth in such Phase I Plan; provided that BPM shall have no obligation to incur any Phase I Development Costs in excess of […***]. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the …] for all Phase I Plan Studies for [***]. The JDC shall review the Phase I Plan on an ongoing basis and may amend the Phase I Plan to reflect the updated or amended objectives and the progress made, subject to JDC approval. Any such changes shall be reflected in written amendments to the each Phase I Plan for each Phase I Completed Original ProductCollaboration Target as further described in Section 12.5. Drafting of the Phase I Plan shall be initiated prior to completion of a GLP Tox Study for such Phase I Completed Original Product. Roche together with C4T shall establish Phase I Plans for approval by the JDC, satisfying the Phase I Data Package[…***…].

Phase I Plan. Unless decided otherwise The JDC shall strive by consensus to prepare a Phase I Plan for each Collaboration Target no later than thirty (30) days after the start of GLP Tox Studies for such Collaboration Target. Each Collaboration Target will be designated by the JDCJDC as either a […***…] or a […***…] in the applicable Phase I Plan. […***…], the JDC shall amend the Phase I Plan for such Collaboration Target (if needed). ​ BPM shall prepare the initial draft of each Phase I Completed Original Product will be updated annually and approved by Plan for any […***…], unless the JDCcombination is with a Roche Clinical Compound or Roche Marketed Product, in which case Roche shall prepare the initial draft of each such Phase I Plan. The JDC shall review each Phase I Plan on an ongoing basis and may amend such Phase I Plan. Any such changes shall be reflected in written amendments to such Phase I Plan. The Parties will conduct the Phase I Program in accordance with the Phase I Plans. Each Phase I Plan will set forth (ai) the activities scope of the initial Phase I Studies for such Collaboration Target and the resources that will be dedicateddedicated to the activities contemplated within the scope of such Phase I Studies, including the responsibilities of each Party, (bii) projected patient enrollment rates consistent with Roche’s historic enrollment rates for similar drug candidates in Phase I Studies, (iii) specific objectives for each yearCalendar Year end in which such initial Phase I Studies are conducted, which objectives as proposed to the JDC by the JOT will be approvedupdated or amended, if as appropriate, by the JDC as development progresses, and (civ) related Development Costs a rolling two (2) year budget for such anticipated activities as part of the Shared Development Cost Budget. The Shared Development Cost Budget shall include the anticipated Development Costs expected to be incurred pursuant to performed during the Phase I Plan for the remainder of the then then-current Calendar Year and each the next Calendar Year, and a forecast of the next up budgets for each subsequent Calendar Year thereafter through completion of all development activities set forth in such Phase I Plan; provided that BPM shall have no obligation to incur any Phase I Development Costs in excess of […***]. Thereafter, annually, the Development Plan and the Shared Development Cost Budget shall be updated by the JDC such that the Shared Development Cost Budget shall always reflect the planned activities under the …] for all Phase I Plan Studies for [***]. The JDC shall review the Phase I Plan on an ongoing basis and may amend the Phase I Plan to reflect the updated or amended objectives and the progress made, subject to JDC approval. Any such changes shall be reflected in written amendments to the each Phase I Plan for each Phase I Completed Original ProductCollaboration Target as further described in Section 12.5. Drafting of the Phase I Plan shall be initiated prior to completion of a GLP Tox Study for such Phase I Completed Original Product[…***…]. Roche together with C4T shall establish Phase I Plans for approval by the JDC, satisfying the Phase I Data Package.​