Common use of Incremental Studies Clause in Contracts

Incremental Studies. (i) If all information reasonably requested by the non-proposing Party has been provided by the proposing Party and (A) by the [*] after the JDC meeting at which a particular Proposed Study in an Oncology Indication (including a Proposed Study for a New Form that is intended for use in an Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) under Section 4.4(a): (x) (1) the other Party has not notified the proposing Party in writing that the other Party wishes to cooperate in such Proposed Study on the terms (including design, budget and timeline) proposed by the proposing Party, or (2) the Parties have not agreed in writing upon the terms (including design, budget and timeline) under which they will cooperate in such Proposed Study, and (y) the other Party has not notified the proposing Party that it believes that such Proposed Study is substantially likely to create a Material Impact; or (B) by the [*] after the JSC meeting at which a particular Proposed Study in a Non-Oncology Indication (including a Proposed Study for a New Form that is intended for use in a Non-Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) the JSC does not decide to approve a Proposed Study under Section 4.4(b), then in either case ((A) or (B)), such Proposed Study will be deemed an "Incremental Study", the proposing Party shall be deemed the "Conducting Party" with respect to such Incremental Study, the other Party shall be deemed the "Non-Conducting Party" with respect to such Incremental Study and, unless the Conducting Party notifies the JDC that it does not wish to proceed with such Incremental Study, the Development Plan shall be amended pursuant to Section 4.2(c) to include such Incremental Study and to specify the Conducting Party as solely responsible for the conduct and costs of such Incremental Study and the Non-Conducting Party shall not be responsible for any costs, including milestones, unless such Non-Conducting Party opts-in to such Incremental Study pursuant to Section 4.4(c)(v). The Conducting Party may proceed with such Incremental Study after such amendment of the Development Plan. If the non-proposing Party believes that such Proposed Study is substantially likely to create a Material Impact and the proposing Party disputes whether such belief is reasonable, the JSC shall discuss and decide whether such belief is reasonable. The Proposed Study shall be deemed an Incremental Study if the JSC decides that the non-proposing Party's belief is not reasonable. If the JSC agrees that the non-proposing Party's belief is reasonable, the proposing Party shall not proceed with the Proposed Study. If the JSC cannot agree whether the non-proposing Party's belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. (ii) Notwithstanding each Party's exclusive commercial rights to its respective territory, Mundipharma shall have the right to conduct an Incremental Study in patients in the Allos Territory in accordance with the Development Plan, and Allos shall have the right to conduct an Incremental Study in patients in the Licensed Territory in accordance with the Development Plan. (iii) The Conducting Party shall promptly inform the JDC of any material changes it wishes to make to an Incremental Study, including the budget therefor, and the Development Plan shall be amended to address them unless the Non-Conducting Party believes that the amendment is substantially likely to have a Material Impact, in which case the JSC shall review such amendment and approve it only if the JSC decides that the Non-Conducting Party's belief is not reasonable. If the JSC agrees that the Non-Conducting Party's [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. belief is reasonable, the proposing Party shall proceed without such material changes. If the JSC cannot agree whether the Non-Conducting Party's belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. The Conducting Party may suspend or terminate an Incremental Study without obtaining approval from the JDC or the JSC if there is a Safety Reason or such suspension or termination is required by a Regulatory Authority or investigational review board; provided, the Conducting Party shall promptly notify the JDC of any such suspension or termination. (iv) Promptly following the availability of interim data from or completion of an Incremental Study, the Conducting Party shall deliver to the JDC the top-line data summary from such Incremental Study. The Non-Conducting Party will have no rights to use any Information resulting from such Incremental Study in any filings with Regulatory Authorities, for Commercialization in its territory, or otherwise, provided, however, that the Non-Conducting Party may file required safety information with the applicable Regulatory Authorities in its territory in accordance with Section 4.8(b).

Incremental Studies. (i) If all information reasonably requested by the non-proposing Party has been provided by the proposing Party and (A) by the [***] after the JDC JPC meeting at which a particular Proposed Study in an Oncology Indication (including a Proposed Study for a New Form that is intended for use in an Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) under Section 4.4(a4.4(b): (x) (1) the other Party has not notified the proposing Party in writing that the other Party wishes to cooperate in such Proposed Study on the terms (including design, budget and timeline) proposed by the proposing Party, or (2) the Parties have not agreed in writing upon the terms (including design, budget and timeline) under which they will cooperate in such Proposed Study, and (y) if Mundipharma is the other Party proposing Party, Allos has not notified the proposing Party Mundipharma that it believes that such Proposed Study is substantially likely to create a Material Impact; or (B) by the [*] after the JSC meeting at which a particular Proposed Study in a Non-Oncology Indication (including a Proposed Study for a New Form that is intended for use in a Non-Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) the JSC does not decide to approve a Proposed Study under Section 4.4(b), then in either case ((A) or (B)), such Proposed Study will be deemed an "“Incremental Study"”, the proposing Party shall be deemed the "“Conducting Party" ” with respect to such Incremental Study, the other Party shall be deemed the "“Non-Conducting Party" ” with respect to such Incremental Study and, unless the Conducting Party notifies the JDC JPC that it does not wish to proceed with such Incremental Study, (A) if Mundipharma is the Conducting Party, the Development Plan shall be amended pursuant to Section 4.2(c) to include such an Incremental Study and to specify the Conducting Party Mundipharma as solely responsible for the conduct and costs of such Incremental Study Study, and (B) if Allos is the Conducting Party, Allos shall be solely responsible for the conduct and costs of such Incremental Study. The Non-Conducting Party shall not be responsible for any costs, including milestones, unless such Non-Conducting Party opts-in to such Incremental Study pursuant to Section 4.4(c)(v). The Mundipharma as the Conducting Party may proceed with such an Incremental Study only after such an amendment of to the Development Plan. If the non-proposing Party Allos believes that such a Proposed Study is substantially likely to create a Material Impact and the proposing Party Mundipharma disputes whether such belief is reasonable, the JSC JPC shall discuss and decide whether such belief is reasonable. The Proposed Study shall be deemed an Incremental Study if the JSC JPC decides that the non-proposing Party's Allos’ belief is not reasonable. If the JSC JPC agrees that the non-proposing Party's Allos’ belief is reasonable, the proposing Party then Mundipharma shall not proceed with the Proposed Study. If the JSC JPC cannot agree whether the non-proposing Party's Allos’ belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. (ii) Notwithstanding each Party's ’s exclusive commercial rights to its respective territory, Mundipharma shall have the right to conduct an Incremental Study in patients in the Allos Territory in accordance with the Development Plan(subject to Section 4.4(c)(i) above), and Allos shall have the right to conduct an Incremental Study in patients in the Licensed Territory in accordance with the Development PlanTerritory. (iii) The Conducting Party shall promptly inform the JDC of any material changes it wishes to make to an Incremental Study, including the budget therefor, and the Development Plan shall be amended to address them unless the Non-Conducting Party believes that the amendment is substantially likely to have a Material Impact, in which case the JSC shall review such amendment and approve it only if the JSC decides that the Non-Conducting Party's belief is not reasonable. If the JSC agrees that the Non-Conducting Party's [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. belief is reasonable, the proposing Party shall proceed without such material changes. If the JSC cannot agree whether the Non-Conducting Party's belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. The Conducting Party may suspend or terminate an Incremental Study without obtaining approval from the JDC or the JSC if there is a Safety Reason or such suspension or termination is required by a Regulatory Authority or investigational review board; provided, the Conducting Party shall promptly notify the JDC of any such suspension or termination. (iv) Promptly following the availability of interim data from or completion of an Incremental Study, the Conducting Party shall deliver to the JDC the top-line data summary from such Incremental Study. The Non-Conducting Party will have no rights to use any Information resulting from such Incremental Study in any filings with Regulatory Authorities, for Commercialization in its territory, or otherwise, provided, however, that the Non-Conducting Party may file required safety information with the applicable Regulatory Authorities in its territory in accordance with Section 4.8(b).

Incremental Studies. (i) If all information reasonably requested by the non-proposing Party has been provided by the proposing Party and (A) by the [*[ * ] after the JDC meeting at which a particular Proposed Study in an Oncology Indication (including a Proposed Study for a New Form that is intended for use in an Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) under Section 4.4(a): (x) (1) the other Party has not notified the proposing Party in writing that the other Party wishes to cooperate in such Proposed Study on the terms (including design, budget and timeline) proposed by the proposing Party, or (2) the Parties have not agreed in writing upon the terms (including design, budget and timeline) under which they will cooperate in such Proposed Study, and (y) the other Party has not notified the proposing Party that it believes that such Proposed Study is substantially likely to create a Material Impact; or (B) by the [*[ * ] after the JSC meeting at which a particular Proposed Study in a Non-Oncology Indication (including a Proposed Study for a New Form that is intended for use in a Non-Oncology Indication) is discussed (or such longer period of time as agreed upon in writing by the Parties) the JSC does not decide to approve a Proposed Study under Section 4.4(b), then in either case ((A) or (B)), such Proposed Study will be deemed an "“Incremental Study"”, the proposing Party shall be deemed the "“Conducting Party" ” with respect to such Incremental Study, the other Party shall be deemed the "“Non-Conducting Party" ” with respect to such Incremental Study and, unless the Conducting Party notifies the JDC that it does not wish to proceed with such Incremental Study, the Development Plan shall be amended pursuant to Section 4.2(c) to include such Incremental Study and to specify the Conducting Party as solely responsible for the conduct and costs of such Incremental Study and the Non-Conducting Party shall not be responsible for any costs, including milestones, unless such Non-Conducting Party opts-in to such Incremental Study pursuant to Section 4.4(c)(v). The Conducting Party may proceed with such Incremental Study after such amendment of the Development Plan. If the non-proposing Party believes that such Proposed Study is substantially likely to create a Material Impact and the proposing Party disputes whether such belief is reasonable, the JSC shall discuss and decide whether such belief is reasonable. The Proposed Study shall be deemed an Incremental Study if the JSC decides that the non-proposing Party's ’s belief is not reasonable. If the JSC agrees that the non-proposing Party's ’s belief is reasonable, the proposing Party shall not proceed with the Proposed Study. If the JSC cannot agree whether the non-proposing Party's ’s belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. (ii) Notwithstanding each Party's ’s exclusive commercial rights to its respective territory, Mundipharma shall have the right to conduct an Incremental Study in patients in the Allos Territory in accordance with the Development Plan, and Allos shall have the right to conduct an Incremental Study in patients in the Licensed Territory in accordance with the Development Plan. (iii) The Conducting Party shall promptly inform the JDC of any material changes it wishes to make to an Incremental Study, including the budget therefor, and the Development Plan shall be amended to address them unless the Non-Conducting Party believes that the amendment is substantially likely to have a Material Impact, in which case the JSC shall review such amendment and approve it only if the JSC decides that the Non-Conducting Party's ’s belief is not reasonable. If the JSC agrees that the Non-Conducting Party's ’s [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. belief is reasonable, the proposing Party shall proceed without such material changes. If the JSC cannot agree whether the Non-Conducting Party's ’s belief is reasonable, then such dispute shall be handled in accordance with Section 13.2. The Conducting Party may suspend or terminate an Incremental Study without obtaining approval from the JDC or the JSC if there is a Safety Reason or such suspension or termination is required by a Regulatory Authority or investigational review board; provided, the Conducting Party shall promptly notify the JDC of any such suspension or termination. (iv) Promptly following the availability of interim data from or completion of an Incremental Study, the Conducting Party shall deliver to the JDC the top-line data summary from such Incremental Study. The Non-Conducting Party will have no rights to use any Information resulting from such Incremental Study in any filings with Regulatory Authorities, for Commercialization in its territory, or otherwise, provided, however, that the Non-Conducting Party may file required safety information with the applicable Regulatory Authorities in its territory in accordance with Section 4.8(b).