Prometheus. AstraZeneca
Prometheus. Will report all adverse events to AstraZeneca according to separate Safety Information Agreement. X
Prometheus. Will abide by AstraZeneca's decision to recall the PRODUCT and fully cooperate with AstraZeneca's requests for information required to prepare recall strategy and to inform FDA of recall. X 4.3.5 Responsible for notification of recall or PRODUCT withdrawal to the FDA. X 4.3.6 Responsible for providing Prometheus, with recall communication and customer notifications/actions necessary. X
Prometheus. General SDE enquiries Xxxx Xxxxx Manger, Safety Medical & Regulatory Affairs 0000 Xxxxxxx Xxxx Drive San Diego, CA 92121 Tel: [***] Fax: [***] e-mail: [***] Medical Inquiries Xxxx Xxxxx Manger, Safety Medical & Regulatory Affairs 0000 Xxxxxxx Xxxx Drive San Diego, CA 92121 Tel: [***] Fax: [***] e-mail: [***] AE reports Xxxx Xxxxx Manger, Safety Medical & Regulatory Affairs 0000 Xxxxxxx Xxxx Drive San Diego, CA 92121 Tel: [***] Fax: [***] e-mail: [***] *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Prometheus. (A) has three representatives on the Board of Directors of Fortress;
(B) is therefore fully informed as to the business, affairs and prospects of Fortress; and
(C) is not relying upon you for any information concerning such business, affairs or prospects or otherwise with respect to its sale of the Securities to you hereunder and hereby waives any claim of any nature whatsoever which it may have against you with respect to such matters or such information or any omission thereof or therefrom.
Prometheus. The parties hereto acknowledge that, as of the Eighth Amendment Effective Date, the Loan Parties’ interest in the Mercury Joint Venture is held through Prometheus Holdco, LLC (“Prometheus”), a Delaware limited liability company and a Wholly Owned Subsidiary of the Borrower. Notwithstanding anything to the contrary in Article VII or this Article VIII, (a) so long as substantially all of the assets of Prometheus consist of Equity Interests in the Mercury Joint Venture, Prometheus shall be deemed listed on Schedule 1.01(a) as of its date of formation, (b) the Loan Parties’ interest in the Mercury Joint Venture shall be permitted to be held through Prometheus, and (c) the provisions of Section 8.05(c), addressing Dispositions of the Loan Parties’ interest in the Mercury Joint Venture, shall apply also to a Disposition by Prometheus of its interest in the Mercury Joint Venture, and/or to a Disposition by the Loan Parties of their interest in Prometheus.
Prometheus. Cedars-Sinai and UCLA, without any of them conceding the correctness of the positions of the other, have agreed to settle the above-described dispute existing among them as of the date hereof in connection with the 1996 License, fully, finally and completely on the following terms:
1.1. In full and final settlement of any claims of Cedars-Sinai and UCLA related to the payments pursuant to the 1996 License through June 30, 2006, the parties have agreed to the following:
(a) As soon as possible following complete execution of this Agreement, Prometheus shall pay to Cedars-Sinai (on behalf of Cedars-Sinai and UCLA) the sum of [***] Dollars ($[***]); and
(b) Prometheus shall calculate Royalties for the quarter ending June 30, 2006 consistent with the calculation of Royalties for the quarter ended March 31, 2006 and will pay such Royalties to Cedars-Sinai and ULCA by August 15, 2006 as required by the License.
1.2. Cedars-Sinai and UCLA shall, in consideration of the payments from Prometheus described in paragraph 1.1 above, refrain from pursuing any and all collection activity, and take all actions necessary to cause any agent or subcontractor to refrain from pursuing any and all collection activity, against Prometheus in connection with any claims resolved by this Agreement. If *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Prometheus fails to make the payments described in either paragraphs 1.1(a) or (b) above, Cedars-Sinai and UCLA shall have the right to initiate collection activity for the amount due and owing under this Agreement and this shall be their sole remedy for breach of Prometheus' obligations under Paragraph 1.1 above. For clarification purposes, except as set forth in paragraph 1.1 above, Cedars-Sinai and UCLA shall not have the right to pursue collection activities and are forever giving up their rights to any Royalty claims under the License for any period prior to July 1, 2006.
Prometheus. Cedars-Sinai and UCLA shall continue to fulfill the obligations set forth in the 1996 License throughout the terms of such 1996 License or in the case of UCLA and Prometheus the 1999 License where applicable, except as modified by this Agreement. Capitalized terms used in this Agreement but not otherwise defined herein shall have the meanings ascribed to them in the License.
2. The parties agree that the initial payment amount described in Section 1.1(a) above is payment in resolution of disputed claims and is being paid to avoid the expense, inconvenience and uncertainty of litigation. The parties hereto understand and acknowledge that this is a compromise settlement without admission of wrongdoing or liability on the part of (i) Cedars-Sinai or UCLA; or (ii)
Prometheus. The parties hereby agree that the recipient of the payment described above is responsible for the payment of any and all taxes, if any, and penalties and interest thereon, which may be assessed on the payment amounts by the state, federal or local government.
Prometheus. Subject to the rights granted in Section 3.2, all communications with Regulatory Authorities concerning any Assay, BSP Array or Diagnostic Product shall be the sole responsibility of Prometheus. BSP shall not, without the consent of Prometheus or unless so required by Applicable Law, correspond or communicate with the Regulatory Authority concerning an Assay, the BSP Array or a Diagnostic Product, or otherwise take any action concerning any filings or communications with any applicable Regulatory Authorities in connection with the development or Commercialization of any Assay, the BSP Array or a Diagnostic Product; provided that during the Term, BSP shall have the right to communicate with any Regulatory Authority regarding an Assay, the BSP Array or a Diagnostic Product if such communication is necessary to comply with the terms of this Agreement or any Applicable Law and BSP shall promptly notify Prometheus of such communication unless prevented from doing so under Applicable Law. At Prometheus’ request, BSP will, consistent with the other terms of this Agreement, take Commercially Reasonable Efforts to co-operate with Prometheus ( including attending meetings with Regulatory Authorities) in communicating with the Regulatory Authorities about Compounds, when such communications are important in seeking Regulatory Approval of any Assay, BSP Array or Diagnostic Product.
