Litigation; Regulatory Action (a) Except as set forth in Schedule 4.9 of the Buyer Disclosure Schedule, no material litigation, claim, suit, investigation or other proceeding before any court, governmental agency or arbitrator is pending against Buyer or any of its Subsidiaries, and, to the Knowledge of Buyer, (i) no litigation, claim, suit, investigation or other proceeding has been threatened and (ii) there are no facts which would reasonably be expected to give rise to such litigation, claim, suit, investigation or other proceeding. Except as publicly disclosed, neither Buyer nor any of its Subsidiaries has been subject to any order or directive by, or been ordered to pay any civil money penalty by, or has been since January 1, 2019, a recipient of any supervisory letter from, or since January 1, 2019, has adopted any board resolutions at the request of, any Governmental Authority that currently regulates in any material respect the conduct of its business or that in any manner relates to its capital adequacy, its ability to pay dividends, its credit or risk management policies, its management or its business, other than those of general application that apply to similarly-situated banks or financial holding companies or their subsidiaries.
(b) Neither Buyer nor any of its Subsidiaries nor any of their respective properties is a party to or is subject to any assistance agreement, board resolution, order, decree, supervisory agreement, memorandum of understanding, condition or similar arrangement with, or a commitment letter or similar submission to, any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits or the supervision or regulation of Buyer or any of its Subsidiaries.
(c) Neither Buyer nor any of its Subsidiaries, has been advised by a Governmental Authority that it will issue, or has Knowledge of any facts which would reasonably be expected to give rise to the issuance by any Governmental Authority or has Knowledge that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any such order, decree, agreement, board resolution, memorandum of understanding, supervisory letter, commitment letter, condition or similar submission.
Third Party Litigation In the event that a Third Party institutes a patent or other infringement suit against any of NovaDel, PAR or HANA or any of its respective Affiliates during the Term, alleging manufacture, use or sale of a Licensed Product in the Territory, infringes one or more patent or other intellectual property rights held by such Third Party (an “Infringement Suit”), the Parties shall cooperate with one another in defending such suit. PAR, as the NDA holder, shall have the first right to direct and control, at its expense, any Infringement Suit (including settlement negotiations, settlement or compromise thereof) to the extent that it relates to the manufacture, use or sale of a Licensed Product but does not implicate the Licensed Technology or Licensed Process. In the event that the Infringement Suit relates to the use of the Licensed Technology or Licensed Process, NovaDel shall have the first right to direct and control, at its expense, any such Infringement Suit (including settlement negotiations, settlement or compromise thereof). To the extent that any amounts become payable to any Third Party as a result of such action, whether through judgment or settlement, then PAR shall, unless HANA is jointly promoting and commercializing the Licensed Product pursuant to Section 2.4 and subject to Section 12.2, bear [***] percent ([***]%) of such amounts with respect to the Exploitation of the Licensed Product; provided, however, that PAR shall have the right to credit [***] percent ([***]%) of any amounts paid by PAR through judgment or settlement with respect to such country against the royalty payments to be paid by PAR to HANA with respect to the sale of the Licensed Product under Section 6.3; provided further, however, that no royalty payment when due, regardless of the amount or number of credits available to PAR shall be reduced by more than [***] percent ([***]%) of the amounts otherwise owed pursuant to Section 6.3 in any calendar quarter. Credits not exhausted in any calendar quarter may be carried into future calendar quarters. Notwithstanding the foregoing, in the event that no payments are due or owing, or contemplated to be due or owing, by PAR to HANA under Article 6 with respect to the sale of the Licensed Product, then NovaDel shall pay to PAR such amount owed to a Third Party up to a cap of [***]% of such amount owed to such Third Party, less any amount already credited to PAR under this Section 10.3. Notwithstanding the foregoing, NovaDel shall have no obligation under this Section 10.3 for any costs, expenses or damages that are paid or payable to a Third Party as a result of an actual or alleged infringement by PAR or HANA to the extent such costs, expenses or damages result from the use of a Product Trademark.
Allegations 1. The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Xxxxx-Xxxxxx Act ("Xxxxx-Xxxxxx"), created the regulatory mechanism under which the United States Food and Drug Administration can approve generic pharmaceuticals. In 2015, sales of generic pharmaceuticals in the United States were estimated at $74.5 billion dollars. Today, the generic pharmaceutical industry accounts for approximately 88% of all prescriptions written in the United States.
2. Heritage, a privately held company formed in 2006, markets a variety of products in a number of therapeutic categories, including but not limited to: cardiovascular, metabolic disease, anti-infective and pain management.
3. Xxxxxx participated in a conspiracy to suppress and eliminate competition by allocating customers, rigging bids, and fixing and maintaining prices for doxycycline hyclate delayed release sold in the United States, from in or about April 2013 and continuing until at least December 2015, in violation of the Xxxxxxx Antitrust Act, 15 U.S.C. § 1. Xxxxxx participated in a conspiracy to suppress and eliminate competition by allocating customers and fixing and maintaining prices for glyburide sold in the United States, from in or about April 2014 and continuing until at least December 2015, in violation of the Xxxxxxx Antitrust Act, 15 U.S.C. §
1. (“Relevant Conduct”).
Complaints and Disputes 28.1. If the Client wishes to report a complaint, he must send an email to the Company with the completed “Complaints Form” found on the Website. The Company will try to resolve it without undue delay and according to the Company’s Complaints Procedure for Clients.
28.2. If a situation arises which is not expressly covered by this Agreement, the Parties agree to try to resolve the matter on the basis of good faith and fairness and by taking such action as is consistent with market practice.
28.3. The Client’s right to take legal action remains unaffected by the existence or use of any complaints procedures referred to above.
Infringement Claims You may submit an infringement claim notice to us at our Contact Formavailable here if you have a good faith belief that Your Content has been copied and made accessible through the Services (including as a part of the Service Content or Third Party Content) in violation of your Inte lectual Property Rights. A copyright infringement claims notice must include at (i) the identification of such a legedly infringing materials, including information su ficient for us to locate it within our Services, ( i) a demand that such a legedly infringing materials be removed or access disabled, ( i) a statement that you have a good faith belief that use of the material in the manner complained of is not authorized by the copyright owner, its agent, or the law; (iv) a statement that the information in the notification is accurate, and under penalty of perjury, that you are authorized to act on behalf of the owner of an exclusive right that is a legedly infringed; (v) contact information for you, such as address, phone number, and, if available, an email address; and (vi) must be signed by you or the person authorized to act on behalf of the owner of the a legedly infringed work (the “Notice Requirements”). Pursuant to 17 U.S.C. 512(c)(3), if the above Notice Requirements are not met, we may disregard the notice. Pursuant 17 U.S.C. 512(f), be advised that knowingly making a material misrepresentation that online material or activity is infringing or that material or activity was removed or disabled by mistake or misidentification, may subject you to heavy civil penalties. These penalties include monetary damages, including costs and attorneys' fees, incurred by the a leged infringer, by any copyright owner or copyright owner's authorized licensee, or by a service provider who is injured by your misrepresentation. If we make a decision to remove Your Content in response to a complaint, we may notify you and provide you with contact information for the complaining party. You may also object to such determination by writing to our designated agent, which must contain the fo lowing information pursuant to 17 U.S.C. 512(g)(3), (i) your physical or electronic signature; ( i) identification of the material that has been removed or to which access has been disabled and the location at which the material appeared before it was removed or access to it was disabled; ( i) a statement under penalty of perjury that the you have a good faith belief that the material was removed or disabled as a result of mistake or misidentification of the material to be removed or disabled; and (iv) your name, address, phone number, and a statement that you consent to the jurisdiction of Federal District Court for the judicial district in which the address is located, or if you are located outside of the United States, for any judicial district in which the service provider may be found, and that you wil accept service of process from the person who provided notification under subsection 17 U.S.C. 512(c)(1)(C) or an agent of such person.
Infringement Actions Following an Option Exercise Date, subject to the provisions of any Voyager In-License, Genzyme shall have the sole and exclusive right, but not the obligation, to take any reasonable measures it deems appropriate with respect to any Competitive Infringement in the Genzyme Territory of any Genzyme Technology, Genzyme Collaboration Technology, Joint Collaboration Technology or Voyager Product-Specific Patent Rights, or with Voyager’s prior written consent, the Voyager Platform Patent Rights. Such measures may include (a) initiating or prosecuting an infringement, misappropriation or other appropriate suit or action (each an CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. “Infringement Action”) in the Genzyme Territory, or (b) subject to Section 11.1.5 (Genzyme Sublicense Rights), granting adequate rights and licenses to any Third Party necessary to render continued Competitive Infringement in the Genzyme Territory non-infringing. Voyager will consider in good faith any request from Genzyme to initiate an Infringement Action in the Genzyme Territory against any Third Party with respect to such Competitive Infringement of any Voyager Platform Patent Right; provided, however, that Voyager shall not be required to initiate any such Infringement Action or permit Genzyme to initiate any such Infringement Action with respect to any Voyager Platform Patent Right. Notwithstanding the foregoing, if Genzyme does not inform Voyager that it intends to either initiate such an Infringement Action or grant adequate rights and licenses to such Third Party within [***] after Genzyme’s receipt of a notice of infringement pursuant to Section 15.4.1 (Notice of Infringement), then Voyager will have the second right, but not the obligation, to initiate such Infringement Action, but solely with respect to any Voyager Technology, Voyager Collaboration Technology, or Joint Collaboration Technology.
Claimed Infringement Each Party will promptly notify the other Party if a Third Party brings any Action alleging patent infringement by Lian or Landos or any of their respective Affiliates or Sublicensees with respect to the Development, Manufacture or Commercialization of any Licensed Product or Joint Patent Rights (any such Action, an “Infringement Claim”) in the Territory. Lian will have the right, but not the obligation, to control the defense and response to any such Infringement Claim in the Territory with respect to Lian’s activities, at Lian’s sole cost and expense, and Landos will have the right, at its own expense, to be represented in any such Infringement Claim in the Territory by counsel of its own choice. Landos will have the sole right, but not the obligation, to control the defense and response to any such Infringement Claim with respect to Landos’ activities, including any such Infringement Claim in the Territory or outside of the Territory. Upon the request of the Party controlling the response to the Infringement Claim, the other Party will reasonably cooperate with the controlling Party in the reasonable defense of such Infringement Claim. The other Party will have the right to consult with the controlling Party concerning any Infringement Claim and to participate in and be represented by independent counsel in any associated litigation. If the Infringement Claim is brought against both Parties, then each Party will have the right to defend against the Infringement Claim. The Party defending an Infringement Claim under this Section 7.4 (Claimed Infringement) will (a) consult with the other Party as to the strategy for the prosecution of such defense, (b) consider in good faith any comments from the other Party with respect thereto and (c) keep the other Party reasonably informed of any material steps taken and provide copies of all material documents filed, in connection with such defense. The Party controlling the defense against an Infringement Claim will have the right to settle such Infringement Claim on terms deemed reasonably appropriate by such Party, provided, that, neither Party will have the right to settle any Infringement Claim under this Section 7.4 (Claimed Infringement) in a manner that diminishes the rights or interests of the other Party under this Agreement without the consent of such other Party, which consent will not be unreasonably withheld.
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.
Litigation; Claims Any rights (including indemnification) and claims and recoveries under litigation of Seller against third parties arising out of or relating to events prior to the Closing Date;
Litigation Reporting If Contractor is served with a pleading or other document in connection with an action before a court or other administrative decision making body, and such pleading or document relates to this Participating Addendum or may affect Contractor’s ability to perform its obligations under this Participating Addendum, Contractor shall, within 10 days after being served, notify the State of such action and deliver copies of such pleading or document to the State’s primary contact identified in §5 of the Participating Addendum .
