Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
No Infringement of Third Party IP Rights The Company has never infringed (directly, contributorily, by inducement or otherwise), misappropriated or otherwise violated or made unlawful use of any Intellectual Property Right of any other Person. No Owned Company Software and, to the Knowledge of the Company, no Licensed Company Software infringes, violates or makes unlawful use of any Intellectual Property Right of, or contains any Intellectual Property misappropriated from, any other Person. Without limiting the generality of the foregoing:
Joint Patent Rights With respect to any potentially patentable Joint Invention, the Parties shall confer and agree upon which Party, if any, shall prepare, file, Prosecute (including any interferences, reissue proceedings, and other administrational proceedings) and Maintain patent applications covering such Joint Invention (any such patent application and any patents issuing therefrom a “Joint Patent Right”), at the responsible Party’s expense. It is the intention of the Parties that, unless otherwise agreed in writing, ATI would prepare, file, Prosecute and Maintain any Joint Patent Rights. The Party that Prosecutes a patent application in the Joint Patent Rights (the “Prosecuting Party”) shall provide the other Party reasonable opportunity to review and comment on such Prosecution efforts regarding the applicable Joint Patent Rights in the particular jurisdictions, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts. The Prosecuting Party shall provide the other Party with a copy of all material communications from any patent authority in the applicable jurisdictions regarding the Joint Patent Rights being Prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. In particular, each Party agrees to provide the other Party with all information necessary to enable the other Party to comply with the duty of candor/duty of disclosure requirements of any patent authority. Should ATI determine that it will no longer support the continued Prosecution or Maintenance of a particular Joint Patent Right in a country or jurisdiction, ATI shall provide Rigel with written notice of such determination at least thirty (30) Business Days prior to any deadline for taking action to avoid abandonment of such Joint Patent Right. Rigel shall have the right, but not ***Text Omitted and Filed Separately Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 230.406 obligation, to file, Prosecute and Maintain such Joint Patent Rights in the applicable jurisdiction at Rigel’s expense.
Infringement of Third Party Patents (a) If a third party asserts that a patent or other proprietary right owned by it is infringed by the manufacture, use, importation, offer for sale or sale of a Licensed Product in the Field and in the Territory and such alleged infringement arises in whole or in part from Alcon's use of the Pharmacyclics Technology (a "Claim"), the Party against whom such a Claim was asserted shall immediately provide the other Party notice of such Claim and the related facts in reasonable detail. Unless it is mutually agreed that the Parties should proceed jointly in defending such an action, the Party sued shall defend such action. The other Party shall cooperate in connection therewith and shall have the right to be represented separately by counsel of its own choice, at its own expense. The entity (whether Pharmacyclics or Alcon) that controls the defense of such a Claim with respect to the Licensed Product in the Field and in the Territory shall also have the right to control settlement of such Claim; provided, however, that no settlement shall be entered into without the consent of the other Party. To the extent that any of the costs set forth in clauses (i), (ii) or (iii) of this sentence are attributable to infringement arising from Alcon's use of the Pharmacyclics Technology, Alcon shall have the right to deduct from and offset against royalties otherwise payable to Pharmacyclics under Section 4.4(a), the following: (i) all litigation costs related to such Claim; (ii) any money damages paid by Alcon or its Affiliates pursuant to any judgment or settlement resulting from such Claim; and (iii) any royalty that Alcon and/or its Affiliates and sublicensees are required to pay to a third party in settlement of such Claim in order to continue to exercise Alcon's license rights as set forth in this Agreement. Notwithstanding the foregoing, in no event shall royalties owed Pharmacyclics under Section 4.4(a) be reduced by more than (*) in any given royalty period.
Third Party Infringement Claims If a Third Party Infringement Claim occurs in the Territory with respect to one or more elements of the RLS Licensed Technical Information or RLS Licensed Software, or in Teletrac's opinion is likely to occur, Teletrac will use reasonable commercial efforts, at its option and expense, either to challenge such Third Party Infringement Claim or otherwise procure for Licensee the right to continue to use, maintain and provide support for the Radio Location System, or to replace or modify the alleged infringing element so that such element becomes non-infringing, provided that such replacement or modification does not materially affect performance of the Radio Location System. If Teletrac has spent, or anticipates that it will be required to spend, more than U.S. $100,000 for such efforts, then Teletrac may give Licensee a ninety (90) day option to pursue such efforts on its own and at its own expense. If Licensee elects to pursue such efforts on its own, then Licensee may deduct from the Annual Royalty Payments due to Teletrac in the future, the reasonable expenses Licensee has incurred in obtaining non-infringing elements, up to a maximum amount of U.S.$250,000. If Licensee has not elected to pursue such efforts on its own within such ninety (90) day option period, then Licensee must notify Teletrac in writing either (i) that this License Agreement shall continue in full force and effect without regard to such Third Party Infringement Claim and without any reduction in the Annual Royalty Payment, or (ii) that Licensee elects to terminate this License Agreement due to such Third Party Infringement Claim, which shall be deemed to be a termination under Section 7.1. If the use of any RLS Licensed Software or RLS Licensed Technical Information is enjoined and the foregoing remedies cannot reasonably be accomplished, or if Licensee elects to continue this License Agreement but fails to procure the right to use the infringing element or to replace or modify the infringing element so that it becomes non-infringing, then Teletrac may require the return of the infringing RLS Licensed Software or RLS Licensed Technical Information, and Licensee's right to use such RLS Licensed Software or RLS Licensed Technical Information shall thereupon terminate. In no event shall Teletrac have any obligation to repay or refund any amounts previously paid to it by Licensee.
Intellectual Property Infringement The Supplier warrants that the use or supply by UNDP of the goods sold under this Purchase Order does not infringe any patent, design, trade-name or trade-mark. In addition, the Supplier shall, pursuant to this warranty, indemnify, defend and hold UNDP and the United Nations harmless from any actions or claims brought against UNDP or the United Nations pertaining to the alleged infringement of a patent, design, trade-name or trade-mark arising in connection with the goods sold under this Purchase Order.
Joint Patents With respect to any potentially patentable Joint Invention, AstraZeneca shall have the first right, but not the obligation, to prepare patent applications based on such Joint Invention, to file and prosecute (including defense of any oppositions, interferences, reissue proceedings and reexaminations) such patent applications, and to maintain any Joint Patents issuing therefrom, in any jurisdictions throughout the Territory. FibroGen shall have the corresponding first right, but not the obligation, in any jurisdictions outside of the Territory other than China, in respect of which the China Agreement shall govern. If AstraZeneca determines in its sole discretion to abandon, cease prosecution or otherwise not file or maintain any Joint Patent anywhere in the Territory, then AstraZeneca shall provide FibroGen written notice of such determination at least thirty (30) days before any deadline for taking action to avoid abandonment (or other loss of rights) and shall provide FibroGen with the opportunity to prepare, file, prosecute and maintain such Joint Patent. The Party that is responsible for preparing, filing, prosecuting, and maintaining a particular Joint Patent (the “Prosecuting Party”) shall provide the other Party reasonable opportunity to review and comment on such prosecution efforts regarding such Joint Patent, and such other Party shall provide the Prosecuting Party reasonable assistance in such efforts. The Prosecuting Party shall provide the other Party with a copy of all material communications from any patent authority in the applicable jurisdictions regarding the Joint Patent being prosecuted by such Party, and shall provide drafts of any material filings or responses to be made to such patent authorities a reasonable amount of time in advance of submitting such filings or responses. In particular, each Party agrees to provide the other Party with all information necessary or desirable to enable the other Party to comply with the duty of candor/duty of disclosure requirements of any patent authority. Either Party may determine that it is no longer interested in supporting the continued prosecution or maintenance of a particular Joint Patent in a country or jurisdiction, in which case: (i) the disclaiming Party shall, if requested in writing by the other Party, assign its ownership interest in such Joint Patent in such country or jurisdiction to the other Party for no additional consideration; and (ii) if such assignment is effected, any such Joint Patent would thereafter be deemed a FibroGen Patent in the case of assignment to FibroGen, or a AstraZeneca Patent in the case of assignment to AstraZeneca; provided, however, that the disclaiming party would have an immunity from suit under such FibroGen Patent or AstraZeneca Patent, as the case may be, in the applicable country or jurisdiction. In addition, any Joint Patent that becomes a FibroGen Patent pursuant to the preceding sentence shall be excluded from the license granted to AstraZeneca in Section 7.1. Each Party shall bear its own internal costs in respect of the prosecution of Joint Patents. Out-of-pocket costs incurred in respect of the prosecution and maintenance of Joint Patents in the Territory shall be borne equally by AstraZeneca and FibroGen. In the event a Party elects to disclaim its interest in a Joint Patent, the costs incurred with respect to such Patent after the date of such disclaimer shall thereafter be borne exclusively by the other Party, without reimbursement or credit.
Third Party Patent Rights If either Party desires to bring an opposition, action for declaratory judgment, nullity action, interference, declaration for non-infringement, reexamination or other attack upon the validity, title or enforceability of a Patent Right owned or controlled by a Third Party and having one or more claims that Cover the Compound or Product, or the use, sale, offer for sale or importation of the Compound or Product (except insofar as such action is a counterclaim to or defense of, or accompanies a defense of, a Third Party’s claim or assertion of infringement under Section 7.6, in which case the provisions of Section 7.6 shall govern), such Party shall so notify the other Party and the Parties shall promptly confer to determine whether to bring such action or the manner in which to settle such action. Provention shall have the exclusive right, but not the obligation, to bring, at its own expense and in its sole control, such action in the Territory. If Provention does not bring such an action in the Territory, within ninety (90) days of notification thereof pursuant to this Section 7.7(a) (or earlier, if required by the nature of the proceeding), MacroGenics shall have the right, but not the obligation, to bring, at MacroGenics’ own expense, such action. The Party not bringing an action under this Section 7.7(a) shall be entitled to separate representation in such proceeding by counsel of its own choice and at its own expense, and shall cooperate fully with the Party bringing such action. Any awards or amounts received in bringing any such action shall be first allocated to reimburse the initiating Party’s expenses in such action, and any remaining amounts shall be allocated between the Parties as provided in Section 7.5(e).
