Phase IV Clinical Trials Sample Clauses

Phase IV Clinical Trials. Each Party shall be responsible for financing such additional Clinical Trials in its respective Territory as it elects to conduct in accordance with this Agreement.

Phase IV Clinical Trials. Within five Business Days of the Effective Date, Braeburn shall notify the clinical investigative sites and investigators participating in the Phase IV Clinical Trials (collectively, the “Investigators”) regarding the termination of Braeburn’s responsibility for the applicable Phase IV Clinical Trial and the assumption of sponsorship and control of such Phase IV Clinical Trial by Titan. Following the Effective Date, Titan shall be responsible for executing any required amendments or agreements with the Investigators in connection with the foregoing, and Braeburn and Titan shall cooperate in good faith during the Transition Period to ensure that all Phase IV Clinical Trials are transferred in compliance with all Laws and regulations.

Phase IV Clinical Trials. The costs associated with Phase IV clinical trials shall be borne by the Singapore Partnership.

Phase IV Clinical Trials. After the Effective Date, all Phase IV Clinical Trials or other pre-clinical or clinical trials that are required by the FDA as a condition to or in connection with an FDA Approval in the United States shall be conducted, administered and funded solely by Esprit or its designees. Indevus shall have the right, but not the obligation, to provide appropriate personnel to support and assist in the conduct of such Phase IV Clinical Trials, as mutually agreed to between the Parties, subject to reimbursement of Indevus’ costs and expenses associated therewith.

Phase IV Clinical Trials. Notwithstanding the provisions of Section 1.83(e) of the Agreement, Indevus agrees to pay Odyssey an amount equal to [*] percent ([*]%) of the Sublicensing Royalties payable by Odyssey to Indevus pursuant to Paragraph 3 above until the Reversion Threshold is paid by Odyssey to Indevus, as a contribution towards the cost of those Phase IV post-approval marketing studies listed on Appendix A and as may be agreed to between the Parties (the “Phase IV Studies”). Odyssey shall conduct the Phase IV Studies in accordance with the Agreement. The Parties agree that the amounts payable by Indevus pursuant to this Paragraph 5 ($[*] in the aggregate) shall be due and payable on a monthly basis, with the first payment due on May 2, 2005, provided that such payments shall be effected in the form of an offset against the Sublicensing Royalties payable by Odyssey to Indevus pursuant to Paragraph 3 of this Amendment, including against any Sublicensing Royalties paid by Odyssey to Indevus pursuant to the second paragraph of Paragraph 3 of this Amendment.

Phase IV Clinical Trials. Subject to the provisions of this Agreement, Novartis shall use Commercially Reasonable Efforts to comply with any Phase IV Clinical Trial obligations, with respect to the LdT Product in any country in the Territory, imposed by applicable Law or pursuant to the applicable Regulatory Approvals.

Phase IV Clinical Trials. OraVax and Evan▇ ▇▇▇nowledge that it may be desirable to conduct certain Phase IV Clinical Trials in the Product Territory. The Parties agree to discuss opportunities for increasing market share by such additional clinical trials aimed at broadening clinical indications and demonstrating safety in subgroups requiring the vaccine (e.g. HIV-infected subjects). Any such Phase IV Clinical Trials in the Product Territory shall be conducted in a collaborative manner.