General Allegations The Settling Entity enters into this Settlement Agreement on behalf of the noticed violator described in subsection 1.4 below, with whom such Settling Entity has a contract for one or more of the products at issue which contains indemnity and defense clauses. The Settling Entity has accepted a tender from the noticed violator and approached Xxxxxxx to resolve such violator’s alleged liability. Additionally, the Settling Entity is making commitments in furtherance of the public interest as set forth below. Xxxxxxx alleges that the Settling Entity manufactures, imports, distributes, sells and/or otherwise facilitates for sale in California the lead products defined below, and that it does so without providing the health hazard warning required by Proposition 65 for consumer exposures to lead. Lead is listed pursuant to Proposition 65 as a chemical known to the State of California to cause cancer, and birth defects or other reproductive harm.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
PATENT PROTECTION 10.1 LICENSEE shall be responsible for all present and future costs of filing, prosecution and maintenance of all United States patent applications contained in the LICENSED PATENTS that are incurred by YALE after the EFFECTIVE DATE. Any and all such United States patent applications, and resulting issued patents, shall remain the property of YALE. Notwithstanding the foregoing, YALE agrees to negotiate in good faith with LICENSEE to reduce LICENSEE’s payment on LICENSED PATENTS in the event that the LICENSED PATENTS outside of FIELD is licensed by YALE to a third party.
10.2 LICENSEE shall be responsible for all ongoing costs of filing, prosecution and maintenance of all foreign patent applications and patents contained in the LICENSED PATENTS in the countries outside the United States in the LICENSED TERRITORY selected by YALE in good faith together with LICENSEE, in each case that are incurred by YALE after the EFFECTIVE DATE. All such applications or patents shall remain the property of YALE. Notwithstanding the foregoing, YALE agrees to negotiate in good faith with LICENSEE to reduce LICENSEE’s payment on LICENSED PATENTS in the event that the LICENSED PATENTS outside of FIELD is licensed by YALE to a third party.
10.3 If, upon receipt of written notice of the request of YALE, LICENSEE does not agree to pay the expenses of filing, prosecuting or maintaining a patent application or patent within the LICENSED PATENTS in any country outside the United States, or fails to pay the expenses of filing, prosecuting or maintaining such a patent application or patent in the United States, in each case as required under Articles 10.2 and 10.3, then LICENSEE’s rights under this Agreement shall terminate automatically with respect to such patent application or patent in that country.
10.4 The costs mentioned in Articles 10.2 and 10.3 shall include, but are not limited to, any past, present and future taxes, annuities, working fees, maintenance fees, renewal and extension charges. Payment of such costs shall be made, at YALE’s option, either directly to patent counsel or by reimbursement to YALE. In either case, LICENSEE shall make payment directly to the appropriate party within [***] of receiving its invoice. If LICENSEE fails to make payment to YALE or patent counsel, as appropriate, within the [***] period, LICENSEE shall be responsible for any surcharge on the invoiced amount as may be charged by patent counsel. Failure of LICENSEE to comply with Articles 10.1 and 10.2 shall be grounds for termination by YALE under Article 13.1(b).
10.5 All patent applications under the LICENSED PATENTS shall be prepared, prosecuted, filed and maintained by independent patent counsel chosen by YALE and reasonably acceptable to LICENSEE. Said independent patent counsel shall be ultimately responsible to YALE. YALE shall instruct patent counsel to keep both YALE and LICENSEE fully informed of the progress of all patent applications and patents, and to give both YALE and LICENSEE reasonable opportunity to comment on the filing and prosecution of patent applications in the LICENSED PATENTS, including the type and scope of useful claims and the nature of supporting disclosures, and including the opportunity to review and comment on all draft responses to applicable patent offices prior to submission thereof. YALE will ensure that LICENSEE’s comments are taken into account in good faith. YALE will not abandon any patent application or patent for which LICENSEE is bearing expenses without LICENSEE’s consent. YALE shall have no liability to LICENSEE for damages, whether direct, indirect or incidental, consequential or otherwise, allegedly arising from its good faith decisions, actions and omissions in connection with such prosecution.
10.6 LICENSEE shall xxxx, and shall require AFFILIATES and SUBLICENSEES to xxxx, all LICENSED PRODUCTS, that are tangible products, with the numbers of all patents included in LICENSED PATENTS that cover the LICENSED PRODUCTS. Without limiting the foregoing, all LICENSED PRODUCTS shall be marked in such a manner as to conform with the patent marking notices required by the law of any country where such LICENSED PRODUCTS are made, sold, used or shipped, including, but not limited to, the applicable patent laws of that country.
Patent Applications It is understood by the parties that, pursuant to the Baylor Technology Transfer Agreement, MAS has the initial responsibility for filing, prosecution and maintenance of Patents and Patent Applications covering the Baylor Technology. The parties agree that, as between MAS and CTI, MAS shall be responsible for deciding whether and how to file, prosecute and maintain the Patents and Patent Applications, provided that:
(a) all decisions of MAS (whether substantive or procedural) concerning whether and how to file, prosecute and/or maintain any Patents and Patent Applications shall be acceptable to CTI, such acceptance not to be unreasonably withheld;
(b) with respect to any action permitted under Section 5.5 of the Baylor Technology Transfer Agreement or Section 5.5 of this Agreement, MAS will use legal counsel reasonably acceptable to CTI;
(c) MAS will provide CTI with (i) drafts of all filings relating to the Patents and Patent Applications and (ii) drafts of all correspondence to be sent by MAS to Baylor, the Patent and Trademark Office (the “PTO”) or any third party relating to the Patents and Patent Applications. Final versions of all such filings and correspondence shall be acceptable to CTI, such acceptance not to be unreasonably withheld;
(d) MAS will promptly provide CTI with copies of any notices and other correspondence received by CTI from Baylor, the PTO or any other third party relating to the Patents and Patent Applications, including, but not limited to, any notices received by MAS pursuant to Section 5.5 of the Baylor Technology Transfer Agreement;
(e) MAS will, if requested by CTI, provide notice to Baylor under any of the circumstances permitting notice pursuant to Section 5.5 of the Baylor Technology Transfer Agreement;
(f) MAS agrees to cooperate with CTI to whatever extent is reasonably necessary to procure patent protection of any rights regarding the Licensed Technology and agrees to execute any and all documents to give CTI the full benefit of the sublicenses and licenses granted herein;
(g) MAS represents and warrants that, as of the Effective Date, it has not received any notices from Baylor pursuant to Section 5.5(c) or Section 5.5(d) of the Baylor Technology Transfer Agreement. In the event MAS receives any notices from Baylor pursuant to Section 5.5(c) or Section 5.5(d) of the Baylor Technology Transfer Agreement after the Effective Date. MAS will provide a copy of such notice to CTI within five (5) business days of receipt of such notice by MAS. MAS will then take all actions requested by CTI to allow CTI to retain its rights granted under this Agreement, including, but not limited to, promptly notifying Baylor in the event CTI wishes MAS to proceed with any actions in connection with the Patents or Patent Applications.
Civil Actions Except where there has been gross negligence on the part of an employee, the Employer will:
(1) exempt and save harmless employees from any liability action arising from the proper performance of their duties for the Employer; and
(2) assume all costs, legal fees, and other expenses arising from any such action.
Trials The Ship shall run the following test and trials:
(1) Harbour Acceptance Tests, including setting to work of the various equipment;
Office of Justice Programs The Provider must report suspected fraud, waste and abuse to the OAG’s Office of the Inspector General at 000-000-0000.
Competent Authorities The Parties shall inform each other about the structure, organisation and division of competences of their competent authorities during the first meeting of the Sanitary and Phytosanitary Sub-Committee referred to in Article 65 of this Agreement ("SPS Sub-Committee"). The Parties shall inform each other of any change of the structure, organisation and division of competences, including of the contact points, concerning such competent authorities.
Patent Disputes Notwithstanding anything in this Agreement to the contrary, any and all issues regarding the scope, construction, validity, and enforceability of any patent in a country within the Territory shall be determined in a court or other tribunal, as the case may be, of competent jurisdiction under the applicable patent laws of such country.
Patent Prosecution 6.1 UNIVERSITY has or shall apply for and seek prompt issuance of and maintain during the term of this Agreement the PATENT RIGHTS in the United States and in such foreign countries as may be designated by LICENSEE in a written notice to UNIVERSITY within a reasonable time in advance of the required foreign filing dates. LICENSEE shall have the opportunity to advise and cooperate with UNIVERSITY in the prosecution, filing and maintenance of such patents. If UNIVERSITY decides to abandon the preparation, filing, prosecution or maintenance of any patent or patent application covered by the PATENT RIGHTS, then UNIVERSITY shall provide written notice to LICENSEE, and LICENSEE shall have the right at its sole expense to assume control of the preparation, filing, prosecution and maintenance of such patent application or patent. If LICENSEE no longer wishes to support the prosecution or maintenance of any patent or patent application covered by the PATENT RIGHTS, then LICENSEE shall provide written notice to UNIVERSITY, and LICENSEE shall not be responsible for such corresponding patent expenses that are incurred subsequent to the date of receipt by UNIVERSITY of such written notice by LICENSEE; such returned patent or patent application shall be excluded from the PATENT RIGHTS. LICENSEE shall notify UNIVERSITY immediately if, at any time during the term of this Agreement, LICENSEE or any of its sublicensees does not qualify as a “Small Entity” as provided by the United States Patent and Trademark Office.
6.2 All fees and costs including attorneys’ fees relating to the filing, prosecution and maintenance of the PATENT RIGHTS whether incurred prior to or after the EFFECTIVE DATE of this Agreement shall be the responsibility of LICENSEE. LICENSEE shall not be required to reimburse the UNIVERSITY for any fees under this section that have been paid to the UNIVERSITY by prior licensees or any other third party. Fees and costs shall be paid by LICENSEE within thirty (30) days after receipt of UNIVERSITY’S invoice therefore. Payments pursuant to this Section 6.2 are not creditable against royalties.
6.3 LICENSEE shall own any new patent application, and any patent that issues therefrom, or new technology in the SLE FIELD developed independently of the UNIVERSITY and UNIVERSITY employees and shall not owe the UNIVERSITY any fee or royalty under section 4 relating to such a new patent application, and any patent that issues therefrom, or new technology.
