Bayer. Bayer hereby covenants that (a) during the term of this Agreement, and (b) for a period of […***…] after termination of this Agreement if terminated by Bayer for convenience pursuant to Section 9.2, Bayer and its Affiliates, either on their own or in collaboration with a Third Party, shall not conduct clinical development of or Commercialize […***…], other than the Licensed GT Products or any Compound/Vector used therein under this
Bayer. Bayer represents and warrants that: (i) it has the authority and right to enter into this Agreement and to perform all of its obligations hereunder; and (ii) this Agreement is a legal and valid obligation binding upon it and enforceable in accordance with its terms.
Bayer. Bayer agrees to indemnify, defend and hold Symyx and its Affiliates and their directors, officers, employees, agents and their respective successors, heirs and assigns (the "Symyx Indemnitees") harmless from and against any losses, costs, claims, damages, liabilities or expense (including reasonable attorneys' and professional fees and other expenses of litigation) (collectively, "Liabilities") arising, directly or indirectly out of or in connection with third party claims, suits, actions, demands or judgments, including without limitation, personal injury, product liability, patent infringement (other than claims of infringement of Symyx patents licensed to Bayer under this Agreement) and trade secret misappropriation matters, suits, actions or demands relating to (i) any Agreement Compounds or Products developed, manufactured, used, sold or otherwise distributed by or on behalf of Bayer, its Sublicensees or other designees (including, without limitation, product liability claims and patent infringement claims ) other than claims of infringement of Symyx patents licensed to Bayer under this Agreement), (ii) Bayer's performance of the Research Program, and (iii) any breach by Bayer of the representations and warranties made in this Agreement, except, in each case, to the extent such Liabilities result from the gross negligence or intentional misconduct of Symyx.
Bayer. Bayer will, and will cause its Affiliates to, give all notices to, make all filings with and use its commercially reasonable efforts to obtain all authorizations, consents or approvals from, any Governmental Authority or other Person that are set forth on Schedule 7.3 and Schedule 7.4.
Bayer. Bayer shall have the right to select the Bayer Exclusive Proteins to be removed from the list of Bayer Exclusive Proteins on each of the first, second, and third anniversaries of the Closing Date by written notice to Maxygen on or before the applicable anniversary. If Bayer does not provide written notice identifying the proteins to be removed from the list of Bayer Exclusive Proteins on or before the applicable anniversary of the Closing Date (and/or if Bayer identifies less than proteins to be removed on the applicable anniversary), then (A) Maxygen may at any time after the applicable anniversary of the Closing Date request in writing that Bayer identify the proteins to be removed pursuant to Section 2.5.2, Section 2.5.3 and/or Section 2.5.4 as applicable; (B) Bayer shall have fifteen (15) days after receipt of such a notice to identify the proteins to be removed from the list of Bayer Exclusive Proteins; and (C) if Bayer does not identify the proteins to be so removed (and/or if Bayer identifies less than the required number of proteins), then proteins (if any) identified by Bayer shall first be removed, and thereafter the first listed of the remaining Bayer Exclusive Proteins, and then the next listed of the remaining Bayer Exclusive Proteins, and so on in the order in which the remaining proteins are listed in Schedule 1.6, shall be removed until a total required number of proteins have been removed from the list as of the applicable anniversary of the Closing Date.
Bayer as Bayer would normally use to accomplish a similar objective under similar circumstances, as to a potential or actual product that is important to such Person’s overall strategy or Objectives, taking into account, without limitation, with respect to each Licensed Agent or Licensed Product, (a) issues of safety, efficacy, product profile, (b) likelihood of receiving Marketing Approval for the applicable Product, (c) potential to accelerate the development and regulatory timelines for the Licensed Product, (d) regulatory structure involved, (e) Regulatory Authority-approved labeling, (f) market potential of the Licensed Product, (g) potential benefit of the Licensed Product to patients with the relevant indication, (h) competitiveness in the marketplace, (i) proprietary position and (j) other relevant scientific, technical and business factors deemed relevant by the applicable Party. “Commercially Reasonable Efforts” shall be determined on a country-by-country basis and activities that are conducted in one country that have an effect on achieving the relevant Objective in another country shall be considered in determining whether Commercially Reasonable Efforts have been applied in such other countries.
Bayer at its sole discretion, reserves the right to limit the number of Bayer Meters provided at no cost to Distributor during the term of this Agreement.
Bayer. AE’s Reported outside Canada Provide a copy of serious, unexpected AE reports outside of Canada simultaneously to Bayer upon submission to Health Canada R PSUR Preparation of Canadian PSUR R Review of Canadian PSUR R Submission of PSUR R Product Complaints Procedures for managing product complaints R R Receipt follow-up on product compliant R Forward Product Compliant to Auxilium Pharmaceuticals, Inc. R Evaluation of Product Compliant R Conclusions provided to Bayer for technical product complaints and or when a response back to the reporter (customer) is required R C Annually summarize Canadian product complaints and provide to Bayer R C Response to Customer R Medical Information Provide Bayer with all Auxilium published literature R Assist with training Bayer Medical Information Group R Management of professional and consumer inquiries from within Canada R ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST. Schedule 4: Cost of Goods Components Material Requirement & Standard Costs Auxilium Testim Testosterone Gel—NDC# 00000-000-00 Description 2003 Costs PACKAGING COMPONENTS $ [**] CHEMICALS $ [**] Total Inventory $ [**] Contract Manufacturing Fee $ [**] Contract Lab Testing $ [**] Purchasing Agent Fees $ [**] International Freight Charges $ [**] Overhead $ [**] Product Liability Insurance $ [**] Total Cost Per Tube $ [**] Total Cost Per 30—Pack $ [**]
Bayer. Within [...*...] days after the determination that Avigen has fulfilled its obligation pursuant to Section 3.1(a)(i), Bayer shall either: (i) terminate this Agreement pursuant to Section 18.2(e)(i)(2); (ii) take action in preparation for the Phase II/III Clinical Trials; or (iii) amend the Product Target Profile with respect to the [...*...] and/or the [...*...] in accordance with the [...*...] in the Phase I/II Clinical Trials (to the extent such [...*...] than those established for the Product Target Profile as of the Effective Date) and take action in preparation for the Phase II/III Clinical Trials of the Product. Unless Bayer so terminates this Agreement, Bayer shall, at [...*...
Bayer. In the event of a Representation Default or a Performance Default by Bayer that will not have been cured within the 60-day period set forth in Section 15.2(a) above after receipt of a Notice of Default (or Bayer will not have presented a reasonably achievable plan to cure such Default as promptly as is reasonably practicable under the circumstances), and if efforts to resolve a dispute, if any, under Section 16.1 are unsuccessful, Nuvelo, at its option and on written notice to Bayer, may bring an action against Bayer for damages or equitable relief pursuant to Section 16.2; provided that such action shall be without prejudice to any of its other rights conferred on it by this Agreement and will be in addition to any other remedies available to it by law or in equity.
