RIGHTS OF REFERENCE; CLINICAL DATA RIGHTS Sample Clauses

RIGHTS OF REFERENCE; CLINICAL DATA RIGHTS. 2.6.1 Subject to the terms of this Agreement, Ambrx hereby grants Sino, its Affiliates and Sublicensees (solely to the extent permitted to make or own any Regulatory Filings or Regulatory Approvals) access to, and a Right of Reference with respect to (a) Regulatory Filings, Regulatory Approvals and all corresponding documentation, and (b) all Regulatory Data (including Safety Data and CMC Data contained or referenced in any Regulatory Filings), and all corresponding documentation, in each case ((a) and (b)) (i) to the extent Controlled by Ambrx or its Affiliates at any time during the Term, (ii) associated with the Pre-Clinical Development and/or the Phase I Clinical Trial conducted hereunder for a Licensed Product in the Field and (iii) for the sole purpose of Sino exercising its rights under the License in the Sino Territory during the Term. Upon written request from Sino, Ambrx shall provide to Sino or its Affiliates or Sublicensees (if permitted) a cross- reference letter or similar communication to the applicable Regulatory Authority to effectuate such Right of Reference.
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Related to RIGHTS OF REFERENCE; CLINICAL DATA RIGHTS

  • Rights of Reference Upon mutual agreement, Regeneron will grant to the Government a right of reference to any Regulatory Application submitted in support of this Project Agreement, solely for the purpose of the Government conducting a clinical trial with the drug product supplied under this Project Agreement under a protocol approved by Regeneron for performance by the Government. In such a case, Regeneron agrees to provide a letter of cross-reference to the Government and file such letter with the appropriate FDA office. Nothing in this paragraph reduces the Government’s data rights as articulated in other provisions of this award.

  • Contracts (Rights of Third Parties) Xxx 0000 No term of this Agreement is enforceable under the Contracts (Rights of Third Parties) Xxx 0000 by a person who is not a party to this Agreement.

  • Rights in Data 4.1 Any MTI Work Product will be considered a “work for hire” and will remain the exclusive property of MTI.

  • Rights to Work Product The Employee agrees that all work performed by the Employee pursuant hereto shall be the sole and exclusive property of the Company, in whatever stage of development or completion. With respect to any copyrightable works prepared in whole or in part by the Employee pursuant to this Agreement, including compilations of lists or data, the Employee agrees that all such works will be prepared as “work-for-hire” within the meaning of the Copyright Act of 1976, as amended (the “Act”), of which the Company shall be considered the “author” within the meaning of the Act. In the event (and to the extent) that such works or any part or element thereof is found as a matter of law not to be a “work-for-hire” within the meaning of the Act, the Employee hereby assigns to the Company the sole and exclusive right, title and interest in and to all such works, and all copies of any of them, without further consideration, and agrees, to the extent reasonable under the circumstances, to cooperate with the Company to register, and from time to time to enforce, all patents, copyrights and other rights and protections relating to such works in any and all countries. To that end, the Employee agrees to execute and deliver all documents requested by the Company in connection therewith, and the Employee hereby irrevocably designates and appoints the Company as the Employee’s agent and attorney-in-fact to act for and on behalf of the Employee and in the Employee’s stead to execute, register and file any such applications, and to do all other lawfully permitted acts to further the registration, protection and issuance of patents, copyrights or similar protections with the same legal force and effect as if executed by the Employee. The Company shall reimburse the Employee for all reasonable costs and expenses incurred by the Employee pursuant to this Section 11.

  • Certain Additional Actions Regarding Intellectual Property If any Event of Default shall have occurred and be continuing, upon the written demand of the Collateral Agent, each Pledgor shall execute and deliver to the Collateral Agent an assignment or assignments of the registered Patents, Trademarks and/or Copyrights and Goodwill and such other documents as are necessary or appropriate to carry out the intent and purposes hereof. Within five (5) Business Days of written notice thereafter from the Collateral Agent, each Pledgor shall make available to the Collateral Agent, to the extent within such Pledgor’s power and authority, such personnel in such Pledgor’s employ on the date of the Event of Default as the Collateral Agent may reasonably designate to permit such Pledgor to continue, directly or indirectly, to produce, advertise and sell the products and services sold by such Pledgor under the registered Patents, Trademarks and/or Copyrights, and such persons shall be available to perform their prior functions on the Collateral Agent’s behalf.

  • Procedure for Third Party Claims Any person that intends to claim indemnification under this Article 13 (an "Indemnitee") arising out of a Third Party claim shall promptly notify the indemnifying party (the "Indemnitor") of such claim in respect of which the Indemnitee intends to claim such indemnifi- cation, and the Indemnitor shall, to the extent applicable, assume the defense thereof with counsel mutually satisfactory to the parties; provided, however, that an Indemnitee shall have the right to retain its own counsel, with the reasonable fees and expenses thereof to be paid by the Indemnitor, if representation of such Indemnitee by the counsel retained by the Indemnitor would be inappropriate due to actual or potential differing interests between such Indemnitee and any other party represented by such counsel in such proceedings. The parties' indemnity obligations under this Article 13 shall not apply to amounts paid in settlement of any loss, claim, liability or action if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld unreasonably. Any Indemnitee's failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action, if materially prejudicial to the Indemnitor's ability to defend such action, shall relieve the Indemnitor of any liability to the Indemnitee under this Article 13, but not any liability that it may have to the Indemnitee otherwise than under this Article 13. The Indemnitee and its employees and agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any action, claim or liability covered by this indemnification.

  • Procedures for Third Party Claims In the case of any claim for indemnification arising from a claim of a third-party other than an Infringement Claim subject to Section 13.3 above (a “Third-Party Claim”), a party seeking indemnification hereunder (each an “Indemnified Party”) shall give prompt written notice, following such Indemnified Party’s receipt of such claim or demand, to the party from which indemnity is sought (each an “Indemnifying Party”) of any claim or demand of which such Indemnified Party has knowledge and as to which it may request indemnification hereunder; provided, however, that failure to give such notice will not affect such Indemnified Party’s rights hereunder unless, and then solely to the extent that, the rights of the Indemnifying Parties from whom indemnity is sought are prejudiced as a result of such failure. The Indemnifying Party shall have the right (and if it elects to exercise such right, shall do so within twenty (20) days after receiving such notice from the Indemnified Party) to defend and to direct the defense against any such claim or demand, in its name or in the name of the Indemnified Party, as the case may be, at the expense of the Indemnifying Party, and with counsel selected by the Indemnifying Party; provided, that the Indemnifying Party shall be entitled to assume control of the defense of such action only if the Indemnifying Party acknowledges in writing its indemnity obligations and assumes and holds the Indemnified Party harmless from and against all Losses resulting from such Third-Party Claim; and provided further that the Indemnifying Party shall not be entitled to assume control of such defense if (i) the Indemnifying Party shall not have notified the Indemnified Party of its exercise of its right to defend such Third-Party claim within such twenty (20) day period; (ii) such claim or demand seeks an injunction or other equitable relief against the Indemnified Party, (iii) the Indemnified Party shall have reasonably concluded that (x) there is a conflict of interest between the Indemnified Party and the Indemnifying Party in the conduct of the defense of such claim or demand or (y) the Indemnified Party has one or more defenses not available to the Indemnifying Party, (iv) such claim relates to or arises in connection with any criminal proceeding, action, indictment, allegation or investigation, or (v) the appropriate court rules that the Indemnifying Party failed or is failing to vigorously prosecute or defend such Third-Party Claim. Notwithstanding anything in this Agreement to the contrary, the Indemnified Party shall, at the expense of the Indemnifying Party, cooperate with the Indemnifying Party, and keep the Indemnifying Party fully informed, in the defense of such claim or demand. The Indemnified Party shall have the right to participate in the defense of any claim or demand with counsel employed at its own expense; provided, however, that, in the case of any claim or demand described in clause (i) or (ii) of the second preceding sentence or as to which the Indemnifying Party shall not in fact have employed counsel to assume the defense of such claim or demand, the reasonable fees and disbursements of such counsel shall be at the expense of the Indemnifying Party. The Indemnifying Party shall have no indemnification obligations with respect to any such claim or demand which shall be settled by the Indemnified Party without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, delayed or conditioned. The Indemnifying Party shall not settle any such claim without the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld, delayed or conditioned if such settlement is accompanied by a document releasing the Indemnified Party from all liability with respect to the matter in controversy that is binding, valid and enforceable against all applicable Parties). Notwithstanding the foregoing, if the Indemnified Party fails to object to the settlement within five (5) Business Days of receipt of a written notice from the Indemnifying Party containing the terms and condition of such settlement, the Indemnified Party shall be deemed to have consented to the settlement.

  • License Rights The rights granted herein in favor of each Service Recipient are in the nature of a license and shall not create any leasehold or other estate or possessory rights in Shared Real Property, and if the license granted under this Article III expires or is terminated, the Service Recipient shall vacate the Shared Real Property, and any occupancy or activity of the Service Recipient thereafter in the Shared Real Property shall be considered a trespass.

  • Sublicense Rights Subject to the terms and conditions of this Agreement, Astellas shall have the right to grant sublicenses of the rights granted to it under Section 3.1.1 and 2.5.3(c) through multiple tiers to its Affiliates, provided that Astellas shall be and remain responsible for performance of all its obligations under this Agreement, and any action by an Affiliate shall be deemed an action by Astellas for which it is responsible. Astellas and its Affiliates may grant sublicenses through multiple tiers to Third Parties (a) whose primary business is contract manufacturing, solely for manufacturing and supplying Licensed Compound or Product to Astellas or any Related Party or (b) to a subcontractor to perform Astellas’s assigned responsibilities under this Agreement or any Research Plan, Development Plan or Co-Promotion Plan. All other sublicenses to be granted by Astellas or any Astellas Affiliate in the Joint Development Territory prior to […***…] will require prior written approval from Ambit, which shall not be unreasonably withheld or delayed, provided that in the event such sublicense is to all of Astellas’s rights in the U.S. or the Joint Development Territory to a Person who is not an Astellas Affiliate such approval shall be at Ambit’s sole discretion. In the case of sublicenses pursuant to the immediately preceding sentence above, Astellas shall provide to Ambit, upon Ambit’ written request, a copy of all executed agreements in which rights granted by Ambit under this Agreement are sublicensed (and Astellas shall have the right to make reasonable redactions prior to providing such agreements(s)). Ambit shall treat all such sublicense agreements as Astellas’s Confidential Information. Astellas or its Affiliates may grant sublicenses (i) in the Joint Development Territory at any time after the first NDA Submission in the Joint Development Territory, provided that, with respect to each applicable Product in the U.S., the Required Exercise Date has occurred and Ambit has not exercised the Co-Promotion Option or the Co-Promotion Term has expired or terminated and (ii) outside the Joint Development Territory, in each case ((i) and (ii)) through multiple tiers of Sublicensees without Ambit’s approval. Each sublicense granted by Astellas pursuant to this Section 3.1.2 shall be subject and subordinate to the terms and conditions of this Agreement. Any sublicense granted by Astellas shall impose on the Sublicensee obligations consistent with the terms and conditions of this Agreement, with each Sublicensee being required to comply with the obligations under this Agreement applicable to Sublicensees, and also to comply with the generally-applicable obligations of this Agreement that are appropriate for application to Sublicensees. Astellas shall ensure that all Persons to which it (or its Affiliate) grants sublicenses comply with all applicable terms and conditions of this Agreement, and Astellas shall be responsible for any failure of any such Sublicensee to comply with such terms or conditions, with the further understanding that any action or omission by any such Sublicensee that, if committed by Astellas would be a breach of this Agreement (with respect to those country(ies)) in which such Sublicensee is sublicensed), will be deemed a breach by Astellas of this Agreement (with respect to those country(ies) in which such Sublicensee is sublicensed) for which Astellas is responsible. Without limiting the foregoing, no sublicense shall modify Ambit’s rights or obligations under this Agreement (including Ambit’s Co-Promotion rights). Without limiting the foregoing, any sublicense agreement shall contain the following provisions, as applicable: (i) a requirement that such Sublicensee submit applicable Net Sales or other reports consistent with those required hereunder; (ii) audit requirements similar to those set forth in this Agreement; and (iii) a requirement that such Sublicensee comply with the confidentiality provisions of Article 6 with respect to Ambit’s Confidential Information.

  • Rights to Intellectual Property All rights and licenses now or hereafter granted by Palatin to AMAG under or pursuant to any Section of this Agreement, including Sections 2.1, 2.2, 2.3, 2.5, 2.7, 2.8 and 2.9 hereof, are rights to “intellectual property” (as defined in the Bankruptcy Code). The Parties hereto acknowledge and 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 24B-2 PROMULGATED UNDER THE SECURITIES ACT OF 1934, AS AMENDED. agree that the payments provided for under Sections 3.1, 3.2, 3.3 and 3.4 and all other payments by AMAG to Palatin hereunder, other than royalty payments pursuant to Section 3.5, do not constitute royalties within the meaning of Section 365(n) of the Bankruptcy Code or relate to licenses of intellectual property hereunder. If (a) a case under the Bankruptcy Code is commenced by or against Palatin, (b) this Agreement is rejected as provided in the Bankruptcy Code and (c) AMAG elects to retain its rights hereunder as provided in Section 365(n) of the Bankruptcy Code, then Palatin (in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) shall provide to AMAG all intellectual property licensed hereunder, and agrees to grant and hereby grants to AMAG and its Affiliates a right to access and to obtain possession of and to benefit from and, in the case of any chemical or biological material or other tangible item of which there is a fixed or limited quantity, to obtain a pro rata portion of, each of the following to the extent related to any Compound, Product, Pharmaceutical Product or Product Delivery Device, or otherwise related to any right or license granted under or pursuant to this Agreement: (i) copies of pre-clinical and clinical research data and results; (ii) Product samples; (iii) Palatin Technology, (iv) laboratory notes and notebooks; (v) Product data or filings, and (vi) Rights of Reference in respect of regulatory filings and approvals, all of which constitute “embodiments” of intellectual property pursuant to Section 365(n) of the Bankruptcy Code, and (vii) all other embodiments of such intellectual property, whether any of the foregoing are in Palatin’s possession or control or in the possession and control of any Third Party but which Palatin has the right to access or benefit from and to make available to AMAG. Palatin shall not interfere with the exercise by AMAG or its Affiliates of rights and licenses to intellectual property licensed hereunder and embodiments thereof in accordance with this Agreement and agrees to use Commercially Reasonable Efforts to assist AMAG and its Affiliates to obtain such intellectual property and embodiments thereof in the possession or control of Third Parties as reasonably necessary or desirable for AMAG or its Affiliates or Sublicensees to exercise such rights and licenses in accordance with this Agreement.

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