BTG U. S. shall have exclusive right, title and interest in and to the Technology, and BTG ISRAEL shall have no rights with respect thereto. The parties hereto recognize and agree that BTG ISRAEL is merely rendering research and development services to BTG U.S., and that BTG U.S. is the developer of the Technology. Nothing herein is intended to derogate from BTG ISRAEL's ownership of the real property, tools, machinery and equipment acquired by it in furtherance of, or incidental to, any Sponsored Research Program, whether or not the research and development work is successful and accomplishes the results contemplated by any such Sponsored Research Program.
BTG U. S. and BTG Israel each represent that they are sufficiently self-insured or insured against any liability arising under this Article VIII.
BTG U. S. shall be responsible for obtaining FDA or other regulatory approval for each Product and shall own the all regulatory approvals. BTG Israel agrees to comply with all commitments made in any New Drug Application or similar filing regarding BTG Israel's manufacturing responsibilities as described herein. BTG Israel shall be responsible for the maintenance of the Drug Master File covering the BTG Israel Facility.
BTG U. S. shall be responsible for all obligations under the regulations of all applicable Regulatory Authorities, except for routine stability testing and sample retention. Stability testing shall be included in the Cost of Manufacturing. BTG U.S. shall immediately inform BTG Israel of all FDA or other regulatory audits pertinent to BTG U.S.'s Raw Materials, Product or Specifications. BTG U.S. shall inform BTG Israel in advance of planned FDA or other regulatory audits as soon as the schedule therefor is known. BTG U.S. shall provide BTG Israel with copies of any regulatory letters or other documents issued by the FDA or other Regulatory Authorities in connection with the audit or inspection within five (5) days of BTG U.S.'s receipt of such a document.
BTG U. S. shall bear all risks of loss attributable to the research and development activities performed on its behalf by BTG ISRAEL. BTG ISRAEL shall be entitled to retain the entire amount of Reimbursable Costs plus the Margin received pursuant to this Section, whether or not the research and development work is successful and accomplished the results contemplated by any Sponsored Research Program.
BTG U. S. shall reimburse BTG Israel for any costs reasonably expended by BTG Israel to effect the recall.
BTG U. S. Such accounts, notes, data and records shall be available for inspection and copying by BTG U.S. and its authorized representative during regular business hours.
BTG U. S. shall defend, indemnify and hold harmless BTG Israel, its officers, agents, employees and Affiliates from any loss, claim, action, damage, expense or liability (including defense costs and attorneys' fees) ("CLAIM") including, but not limited to, the costs for environmental sampling, cleanup and remediation, arising out of BTG Israel's disposal of BTG U.S.'s Waste in accordance with this Agreement, or the breach of any representation or warranty made by BTG U.S. herein or the handling, possession or use of the Product following delivery to a common carrier pursuant to Section 3.1, except to the extent that the Claim is based on, arises out of, or is due to the negligence or misconduct of, or breach of this Agreement by, BTG Israel or its officers, agents, employees or Affiliates.
BTG U. S. shall reimburse BTG Israel for all actual costs incurred by BTG Israel in having the Product formulated, vialed, packaged and labelled by a third-party. BTG Israel shall invoice BTG U.S. following receipt of an invoice from such third-party, and shall include a copy of such third-party's invoice. All invoices shall be due and payable within thirty (30) calendar days after receipt of the invoice by BTG U.S.
BTG U. S. will inform BTG Israel in writing of any modifications to the Specifications; the relevant documents and related schedules to this Agreement will be revised accordingly without requiring any formal mutual amendment. Upon written acceptance of said modifications, BTG Israel shall immediately implement the modified documents and procedures pertinent to the modified Specifications. Similarly, BTG Israel shall advise BTG U.S. in writing of any proposed or required changes in procedures prior to their implementation.
