Common use of CLINICAL DEVELOPMENT COMMITTEE Clause in Contracts

CLINICAL DEVELOPMENT COMMITTEE. (a) The Parties shall form a Clinical Development Committee which shall: (i) oversee the implementation of (1) the clinical studies as set forth in Exhibit 3.1 and (2) the pursuit of Regulatory Approval in the U.S. Territory including but not limited to the preparation and filing of the U.S. NDA; (ii) be responsible for developing further clinical strategies for the Product in the U.S. Territory and in the EU; and (iii) shall act in an advisory capacity to the Parties with respect to (1) potential combination therapies using the Product and one or more other pharmaceutical products; and (2) studies to obtain additional approved indications for the Product. (b) The Clinical Development Committee shall consist of no more than eight (8) total members, four (4) representatives each from Xxxxxx and SuperGen, and shall be chaired alternatively on an annual basis by one (1) of the SuperGen representatives and by one (1) of the Xxxxxx representatives. It shall follow the rules established by Section 4.2(a)(i) through (v) for the U.S. Marketing Board, except that: (i) final decisions with respect to clinical development and regulatory strategy for the Product in the U.S. Territory (including but not limited to, for example, when and how to close the data base, when and how to file for Regulatory Approval, when and how to conduct interim analyses, and all protocols for clinical studies) and for clinical development in the EU shall be made by the Clinical Development CONFIDENTAIL TREATMENT REQUESTED Committee; (ii) final decisions with respect to Marketing Studies intended for use solely within the U.S. Territory shall be made by the U.S. Marketing Board, and by Xxxxxx with respect to Marketing Studies intended for use solely within the International Territory, irrespective of the country or countries in which such Marketing Studies are conducted; (iii) final decisions with respect to clinical development for the Product in the International Territory outside the EU, and for clinical development and regulatory strategy for the Product in the International Territory, shall be made by Xxxxxx; and (iv) The Clinical Development Committee shall endeavor to work by consensus. In the event of a deadlock in any vote or on any issue relating to this Section 4.4 on which the Clinical Development Committee is to make a final decision, the Parties shall refer the deadlocked issue to SuperGen's Executive Vice President of Medical Affairs and Xxxxxx'x Hospital Products Division Vice President of Medical Affairs. These individuals shall attempt, promptly and in good faith, to resolve such issue amicably. If such issue remains deadlocked, the Parties shall refer such issue to, respectively, the President of SuperGen, and the President of Xxxxxx'x Hospital Products Division. Any issue remaining deadlocked after this last step shall be resolved through an Alternative Dispute Resolution ("ADR") procedure pursuant to Section 20.3 below. (c) The cost of any clinical study for the Product in the U.S., the EU and Canada beyond those which are SuperGen's responsibility pursuant to Section 3.1 above undertaken by a Party or by the Parties shall be approved in advance by the Clinical Development Committee and shall be borne in equal shares by the Parties. The Parties shall use their reasonable efforts, working through the Clinical Development Committee, to coordinate Marketing Study strategies and the implementation of such strategies so as to maximize the benefit of Marketing Studies to the Product worldwide and to avoid duplication or conflict in such Marketing Studies. (d) At any time during the term of this Agreement, whether through the Clinical Development Committee or otherwise, if SuperGen develops or SuperGen and Xxxxxx jointly develop any improvements, modifications, enhancements, additions to or extensions of the Product (an "Improvement"), such Improvement shall be deemed to be a Product under this Agreement. The Parties shall bear in equal shares the cost of developing such Improvement for Co-Promotion by SuperGen and Xxxxxx in the U.S. Territory and for CONFIDENTAIL TREATMENT REQUESTED Promotion by Xxxxxx in the International Territory pursuant to a development plan and budget to be agreed between the Parties. For purposes of clarification, the Parties agree that no milestones shall be payable by Xxxxxx to SuperGen with respect to any such Improvement, but that the provisions for profit sharing under Article 6 below and for royalties under Article 7 below shall apply to such Improvement(s). Notwithstanding anything to the contrary in this Agreement, if both Parties agree in writing to do so, then Xxxxxx may take over the development of any one or more Improvements, at Xxxxxx'x sole cost and expense and at Xxxxxx'x sole discretion as to the development strategy and plan. In such an event: (i) for the U.S. Territory, the provisions for profit sharing under Article 6 below shall not apply to such Improvement(s) and instead, the Parties shall negotiate in good faith a royalty based on Xxxxxx'x Net Sales in the U.S. Territory; and (ii) the provisions of Article 7 below shall apply to any such Improvement(s) for the International Territory. (e) The Clinical Development Committee shall in good faith agree upon and complete a development plan for the activities required to achieve Regulatory Approvals of the Product in the U.S., the EU and Canada (the "Development Plan") within ninety (90) days after the Effective Date. The Development Plan shall include, but not be limited to, the activities set forth on Exhibit 4.4(e). It is the intent of the Parties that U.S. Phase III clinical data may be used together with European data, if needed, for the European regulatory filings and thus will be done to EMEA and U.S. standards and with EMEA and U.S. FDA acceptable endpoints.

CLINICAL DEVELOPMENT COMMITTEE. (a) The Parties shall form a Clinical Development Committee which shall: : (i) oversee the implementation of (1) the clinical studies as set forth in Exhibit 3.1 and (2) the pursuit of Regulatory Approval in the U.S. Territory including but not limited to the preparation and filing of the U.S. NDA; ; (ii) be responsible for developing further clinical strategies for the Product in the U.S. Territory and in the EU; and and (iii) shall act in an advisory capacity to the Parties with respect to (1) potential combination therapies using the Product and one or more other pharmaceutical products; and (2) studies to obtain additional approved indications for the Product. (b) The Clinical Development Committee shall consist of no more than eight (8) total members, four (4) representatives each from Xxxxxx and SuperGen, and shall be chaired alternatively on an annual basis by one (1) of the SuperGen representatives and by one (1) of the Xxxxxx representatives. It shall follow the rules established by Section 4.2(a)(i) through (v) for the U.S. Marketing Board, except that: : (i) final decisions with respect to clinical development and regulatory strategy for the Product in the U.S. Territory (including but not limited to, for example, when and how to close the data base, when and how to file for Regulatory Approval, when and how to conduct interim analyses, and all protocols for clinical studies) and for clinical development in the EU shall be made by the Clinical Development 22 <PAGE> CONFIDENTAIL TREATMENT REQUESTED Committee; ; (ii) final decisions with respect to Marketing Studies intended for use solely within the U.S. Territory shall be made by the U.S. Marketing Board, and by Xxxxxx with respect to Marketing Studies intended for use solely within the International Territory, irrespective of the country or countries in which such Marketing Studies are conducted; ; (iii) final decisions with respect to clinical development for the Product in the International Territory outside the EU, and for clinical development and regulatory strategy for the Product in the International Territory, shall be made by Xxxxxx; and and (iv) The Clinical Development Committee shall endeavor to work by consensus. In the event of a deadlock in any vote or on any issue relating to this Section 4.4 on which the Clinical Development Committee is to make a final decision, the Parties shall refer the deadlocked issue to SuperGen's Executive Vice President of Medical Affairs and Xxxxxx'x Hospital Products Division Vice President of Medical Affairs. These individuals shall attempt, promptly and in good faith, to resolve such issue amicably. If such issue remains deadlocked, the Parties shall refer such issue to, respectively, the President of SuperGen, and the President of Xxxxxx'x Hospital Products Division. Any issue remaining deadlocked after this last step shall be resolved through an Alternative Dispute Resolution ("ADR") procedure pursuant to Section 20.3 below. (c) The cost of any clinical study for the Product in the U.S., the EU and Canada beyond those which are SuperGen's responsibility pursuant to Section 3.1 above undertaken by a Party or by the Parties shall be approved in advance by the Clinical Development Committee and shall be borne in equal shares by the Parties. The Parties shall use their reasonable efforts, working through the Clinical Development Committee, to coordinate Marketing Study strategies and the implementation of such strategies so as to maximize the benefit of Marketing Studies to the Product worldwide and to avoid duplication or conflict in such Marketing Studies. (d) At any time during the term of this Agreement, whether through the Clinical Development Committee or otherwise, if SuperGen develops or SuperGen and Xxxxxx jointly develop any improvements, modifications, enhancements, additions to or extensions of the Product (an "Improvement"), such Improvement shall be deemed to be a Product under this Agreement. The Parties shall bear in equal shares the cost of developing such Improvement for Co-Promotion by SuperGen and Xxxxxx in the U.S. Territory and for 23 <PAGE> CONFIDENTAIL TREATMENT REQUESTED Promotion by Xxxxxx in the International Territory pursuant to a development plan and budget to be agreed between the Parties. For purposes of clarification, the Parties agree that no milestones shall be payable by Xxxxxx to SuperGen with respect to any such Improvement, but that the provisions for profit sharing under Article 6 below and for royalties under Article 7 below shall apply to such Improvement(s). Notwithstanding anything to the contrary in this Agreement, if both Parties agree in writing to do so, then Xxxxxx may take over the development of any one or more Improvements, at Xxxxxx'x sole cost and expense and at Xxxxxx'x sole discretion as to the development strategy and plan. In such an event: (i) for the U.S. Territory, the provisions for profit sharing under Article 6 below shall not apply to such Improvement(s) and instead, the Parties shall negotiate in good faith a royalty based on Xxxxxx'x Net Sales in the U.S. Territory; and (ii) the provisions of Article 7 below shall apply to any such Improvement(s) for the International Territory. (e) The Clinical Development Committee shall in good faith agree upon and complete a development plan for the activities required to achieve Regulatory Approvals of the Product in the U.S., the EU and Canada (the "Development Plan") within ninety (90) days after the Effective Date. The Development Plan shall include, but not be limited to, the activities set forth on Exhibit 4.4(e). It is the intent of the Parties that U.S. Phase III clinical data may be used together with European data, if needed, for the European regulatory filings and thus will be done to EMEA and U.S. standards and with EMEA and U.S. FDA acceptable endpoints.. 4.5

CLINICAL DEVELOPMENT COMMITTEE. (a) The Parties shall form a Clinical Development Committee which shall: (i) oversee the implementation of (1) the clinical studies as set forth in Exhibit 3.1 and (2) the pursuit of Regulatory Approval in the U.S. Territory including but not limited to the preparation and filing of the U.S. NDA; (ii) be responsible for developing further clinical strategies for the Product in the U.S. Territory and in the EU; and (iii) shall act in an advisory capacity to the Parties with respect to (1) potential combination therapies using the Product and one or more other pharmaceutical products; and (2) studies to obtain additional approved indications for the Product[__________________________]. (b) The Clinical Development Committee shall consist of no more than eight (8) [_______] total members, four (4) [________] representatives each from Xxxxxx and SuperGen, and shall be chaired alternatively on an annual basis by one (1) of the SuperGen representatives and by one (1) of the Xxxxxx representatives. It shall follow the rules established by Section 4.2(a)(i) through (v) for the U.S. Marketing Board, except that: (i) final decisions with respect to clinical development and regulatory strategy for the Product in the U.S. Territory (including but not limited to, for example, when and how to close the data base, when and how to file for Regulatory Approval, when and how to conduct interim analyses, and all protocols for clinical studies[__________________________]) and for clinical development in the EU shall be made by the Clinical Development CONFIDENTAIL TREATMENT REQUESTED Committee; (ii) final decisions with respect to Marketing Studies intended for use solely within the U.S. Territory shall be made by the U.S. Marketing Board, and by Xxxxxx with respect to Marketing Studies intended for use solely within the International Territory, irrespective of the country or countries in which such Marketing Studies are conducted; (iii) final decisions with respect to clinical development for the Product in the International Territory outside the EU, and for clinical development and regulatory strategy for the Product in the International Territory, shall be made by Xxxxxx; and (iv) The Clinical Development Committee shall endeavor to work by consensus. In the event of a deadlock in any vote or on any issue relating to this Section 4.4 on which the Clinical Development Committee is to make a final decision, the Parties shall refer the deadlocked issue to SuperGen's Executive Vice President of Medical Affairs and Xxxxxx'x Hospital Products Division Vice President of Medical Affairs. These individuals shall attempt, promptly and in good faith, to resolve such issue amicably. If such issue remains deadlocked, the Parties shall refer such issue to, respectively, the President of SuperGen, and the President of Xxxxxx'x Hospital Products Division. Any issue remaining deadlocked after this last step shall be resolved through an Alternative Dispute Resolution ("ADR") procedure pursuant to Section 20.3 below[__________________________]. (c) The cost of any clinical study to support Regulatory Approval for the Product in the U.S., the EU and Canada (beyond those which are SuperGen's responsibility pursuant to Section 3.1 above above) undertaken by a Party or by the Parties shall be approved in advance by the Clinical Development Committee and shall be borne in equal shares by the Parties[__________________________]. The Parties shall use their reasonable efforts, working through the Clinical Development Committee, to coordinate Marketing Study strategies and the implementation of such strategies so as to maximize the benefit of Marketing Studies to the Product worldwide and to avoid duplication or conflict in such Marketing Studies. (d) At any time during the term of this Agreement, whether through the Clinical Development Committee or otherwise, if SuperGen develops or SuperGen and Xxxxxx jointly develop any improvements, modifications, enhancements, additions to or extensions of the Product (an "Improvement"), such Improvement shall be deemed to be a Product under this Agreement. The Parties shall bear in equal shares the cost of developing [__________________________] such Improvement for Co-Promotion by SuperGen and Xxxxxx in the U.S. Territory and for CONFIDENTAIL TREATMENT REQUESTED Promotion by Xxxxxx in the International Territory pursuant to a development plan and budget to be agreed between the Parties. For purposes of clarification, the Parties agree that no milestones shall be payable by Xxxxxx to SuperGen [__________________________] with respect to any such Improvement, but that the provisions for profit sharing under Article 6 below and for royalties under Article 7 below shall apply [__________________________] to such Improvement(s). Notwithstanding anything to the contrary in this Agreement, if both Parties agree in writing to do so, then Xxxxxx may take over the development of any one or more Improvements, at Xxxxxx'x sole cost and expense and at Xxxxxx'x sole discretion as to the development strategy and plan. In such an event: (i) for the U.S. Territory, the provisions for profit sharing under Article 6 below shall not apply to such Improvement(s) and instead, the Parties shall negotiate in good faith a royalty based on Xxxxxx'x Net Sales in the U.S. Territory; and (ii) the provisions of Article 7 below shall apply to any such Improvement(s) for the International Territory[__________________________]. (e) The Clinical Development Committee shall in good faith agree upon and complete a development plan for the activities required to achieve Regulatory Approvals of the Product in the U.S., the EU and Canada (the "Development Plan") within ninety (90) days after the Effective Date. The Development Plan shall include, but not be limited to, the activities set forth on Exhibit 4.4(e). It is the intent of the Parties that U.S. Phase III clinical data may be used together with European data, if needed, for the European regulatory filings and thus [__________________________] will be done to EMEA and U.S. standards and with EMEA and U.S. FDA acceptable endpoints.