Common use of Representations and Warranties of Collaborator Clause in Contracts

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or become aware that any of its personnel involved in this CRADA be are debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final noticedays. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article Investigational Agent provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7Q7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD MD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days […***…] of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 . The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and PHS ICT-CRADA Case Ref. No. MODEL ADOPTED June 18, 2009 Page 15 of 52 Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced, or will be produced if not already produced, in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.. PHS ICT-CRADA Case Ref. No. _______ MODEL ADOPTED June 18, 2009

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.. PHS ICT-CRADA Page 15 of 32 Agreement Ref. No. 03039 Confidential MODEL ADOPTED June 18, 2009 Revised May 15, 2014

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD NCI that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or become aware that any of its personnel involved in this CRADA be are debarred or suspended during the term of this CRADA, Collaborator will notify ICD NCI within thirty (30) days of receipt of final noticedays. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix BA, Collaborator is financially able to satisfy these obligations in a timely mannermanner as agreed in the Research Plan. 9.2.4 The Test Article Formulary Agent provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7Q7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided, and as may be updated from time to time.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD NCI that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or become aware that any of its personnel involved in this CRADA be are debarred or suspended during the term of this CRADA, Collaborator will notify ICD NCI within thirty (30) days of receipt of final noticedays. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article Investigational Agent provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7Q7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.. PHS ICT-CRADA Model Adopted 2005

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD IC that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or become aware that any of its personnel involved in this CRADA be are debarred or suspended during the term of this CRADA, Collaborator will notify ICD IC within thirty (30) days of receipt of final noticedays. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix BA, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article Formulary Agent provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7Q7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD NCI that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or become aware that any of its personnel involved in this CRADA be are debarred or suspended during the term Term of this CRADA, Collaborator will notify ICD NCI within thirty (30) days of receipt of final noticedays. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix BA, Collaborator is financially able to satisfy these obligations in a timely mannermanner as agreed in the Research Plan. 9.2.4 The Test Article Formulary Agent provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, and ICH QA7Q7, and meets the specifications cited in the Certificate of Analysis and Investigator’s Brochure provided, and as may be updated from time to time.

Representations and Warranties of Collaborator. Collaborator hereby represents and warrants to ICD MD that: 9.2.1 Collaborator has the requisite power and authority to enter into this CRADA and to perform according to its terms, and that Collaborator’s official signing this CRADA has authority to do so. 9.2.2 Neither Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents, and contractors are presently subject to debarment or suspension by any agency of the Government. Should Collaborator or any of its personnel involved in this CRADA be debarred or suspended during the term of this CRADA, Collaborator will notify ICD within thirty (30) days of receipt of final notice. 9.2.3 Subject to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding under Appendix B, Collaborator is financially able to satisfy these obligations in a timely manner. 9.2.4 The Test Article provided has been produced in accordance with the FDA’s current Good Manufacturing Practice set out in 21 C.F.R. §§ 210-211, 211 and ICH QA7, and meets the specifications cited in the Certificate of Analysis and PHS ICT-CRADA Case Ref. No. _______ MODEL ADOPTED June 18, 2009 Page 15 of 55 Investigator’s Brochure provided.