DURECT Rights Sample Clauses

DURECT Rights. Notwithstanding Section 6.2, due to DURECT’s continuing interest in development and production of products other than the Licensed Products utilizing the SABER™ System, DURECT shall have the right to review and provide comments to those portions of any regulatory correspondence and filings relating to the SABER™ System or its function, manufacture or safety, including manufacturing specifications, adverse event reports and the relevant portions of the Chemistry, Manufacturing and Controls section of any NDA or its equivalent filing with a Regulatory Authority prior to submission thereof, provided that DURECT shall be required to provide any comments to PTI within [* * *] business days after receipt of any draft filings or correspondence from PTI, and further provided that PTI shall incorporate in any such correspondence or filing DURECT’s reasonable comments. In addition, the Chemistry, Manufacturing and Controls section of any regulatory filing, to the extent it relates to the SABER™ System, may be maintained by DURECT, in one or more of DURECT’s master files (e.g., drug master file as described in 21 C.F.R. § 314.420) to the extent permissible under applicable laws and regulations, for which PTI shall have the right of reference for each Licensed Product hereunder.
AutoNDA by SimpleDocs
DURECT Rights. To the extent permitted by Applicable Laws, at Durect’s election, the labels and packaging of all Product to be marketed, distributed or sold in any Jurisdiction shall include text identifying Durect as the licensor of the Product and a Durect trademark (other than ELADUR™) selected by Durect to be placed in a size and location determined in the reasonable, good faith discretion of Alpharma, provided that such xxxx: (i) is used in a consistent and noticeable manner sufficient to constitute trademark usage under Applicable Law, (ii) is clearly identified as a trademark (i.e., through the use of a “®”, “™” or other appropriate identifier) and (iii) is not used as combination marks with other marks or trademarks. Furthermore, Product labels and packaging shall bear appropriate patent markings and notices as may be applicable.
DURECT Rights. The Parties acknowledge and agree that Durect has the rights and licenses under the Durect Intellectual Property to conduct such activities assigned to it under this Agreement or that it otherwise has the right to conduct under this Agreement, including the Durect Development Activities and those manufacturing and supply activities to be conducted by Durect pursuant to Article 5.
DURECT Rights. Notwithstanding anything set forth in this Agreement, DURECT shall have sole discretion with regard to whether and where to file for patent protection for any DURECT Intellectual Property. In the event DURECT desires to abandon prosecution or maintenance of any patent application or patent within the DURECT Intellectual Property directly relevant to the Field in any country or region, it shall, within sufficient time, offer to permit NeuroSystec to assume the prosecution of such patent application or the maintenance of such patent. If NeuroSystec elects to assume the same, it shall have the right to offset the full cost of such maintenance and prosecution against the royalty otherwise owed to DURECT from Net Sales in such country or region.

Related to DURECT Rights

  • Data Subject Rights Participant may have a number of rights under the data privacy laws in his or her jurisdiction. Depending on where Participant is based, such rights may include the right to (i) request access or copies of Data the Company processes, (ii) rectification of incorrect Data, (iii) deletion of Data, (iv) restrictions on processing of Data, (v) portability of Data, (vi) lodge complaints with competent authorities in Participant’s jurisdiction, and/or (vii) receive a list with the names and addresses of any potential recipients of Data. To receive clarification regarding these rights or to exercise these rights, Participant understands that he or she can contact Xxxxxxxxxxx@Xxxxxxxx.xxx.

  • Contract Rights The rights granted pursuant to this Article V shall be deemed to be contract rights, and no amendment, modification or repeal of this Article V shall have the effect of limiting or denying any such rights with respect to actions taken or Proceedings arising prior to any such amendment, modification or repeal.

  • Background Technology List here prior contracts to assign Inventions that are now in existence between any other person or entity and you. [ ] List here previous Inventions which you desire to have specifically excluded from the operation of this Agreement. Continue on reverse side if necessary.

  • Review Rights Upon OIG’s delivery to CHSI of its Demand Letter or of its Exclusion Letter, and as an agreed-upon contractual remedy for the resolution of disputes arising under this CIA, CHSI shall be afforded certain review rights comparable to the ones that are provided in 42 U.S.C. § 1320a-7(f) and 42 C.F.R. Part 1005 as if they applied to the Stipulated Penalties or exclusion sought pursuant to this CIA. Specifically, OIG’s determination to demand payment of Stipulated Penalties or to seek exclusion shall be subject to review by an HHS ALJ and, in the event of an appeal, the HHS Departmental Appeals Board (DAB), in a manner consistent with the provisions in 42 C.F.R. § 1005.2-1005.21. Notwithstanding the language in 42 C.F.R. § 1005.2(c), the request for a hearing involving Stipulated Penalties shall be made within 10 days after receipt of the Demand Letter and the request for a hearing involving exclusion shall be made within 25 days after receipt of the Exclusion Letter. Community Health Systems, Inc. Corporate Integrity Agreement

  • Background Intellectual Property The Recipient must own the Background Intellectual Property or hold sufficient Background Intellectual Property Rights to permit the Project to be carried out and the Project Intellectual Property to be exploited by the Recipient.

  • Sublicensing Rights Novartis and its Affiliates may grant sublicenses of the license granted in Section 5.3.1(a), Section 5.3.2, and Section 5.3.3, and Intellia and its Affiliates may grant sublicenses of the license granted in Section 5.3.1(b), provided that (a) such sublicense (i) is in writing, (ii) is subject and subordinate to, and consistent with, the terms and conditions of this Agreement, and (iii) requires the applicable sublicensee to comply with all applicable terms of this Agreement [***]; (b) with respect to Novartis or any of its Affiliates as the sublicensing Party to the extent required by the Key License Agreements as in effect on the Effective Date or the agreements for any Included Intellia New In-Licensed Intellectual Property, Novartis promptly notifies Intellia of the grant of each sublicense and provides Intellia a copy of the final executed sublicense agreement, redacted for information not pertinent to this Agreement to the extent that such redactions do not reasonably impair Intellia’s ability to ensure compliance with this Agreement, the Key License Agreements or agreements for any Included Intellia New In-Licensed Intellectual Property, as applicable, (c) Novartis or Intellia, as applicable, shall be responsible for the failure by its sublicensees to comply with, and Novartis or Intellia, as applicable, guarantees the compliance by each of its sublicensees with, all relevant restrictions, limitations and obligations in this Agreement, 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 PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.

  • 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.

  • Assignment of Rights to Intellectual Property The Executive shall promptly and fully disclose all Intellectual Property to the Company. The Executive hereby assigns and agrees to assign to the Company (or as otherwise directed by the Company) the Executive’s full right, title and interest in and to all Intellectual Property. The Executive agrees to execute any and all applications for domestic and foreign patents, copyrights or other proprietary rights and to do such other acts (including without limitation the execution and delivery of instruments of further assurance or confirmation) requested by the Company to assign the Intellectual Property to the Company and to permit the Company to enforce any patents, copyrights or other proprietary rights to the Intellectual Property. The Executive will not charge the Company for time spent in complying with these obligations. All copyrightable works that the Executive creates shall be considered “work made for hire”.

  • 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.

  • Audit Rights Tenant, within 365 days after receiving Landlord’s statement of Expenses, may give Landlord written notice (“Review Notice”) that Tenant intends to review Landlord’s records of the Expenses for the calendar year to which the statement applies. Within a reasonable time after receipt of the Review Notice, Landlord shall make all pertinent records available for inspection that are reasonably necessary for Tenant to conduct its review. If any records are maintained at a location other than the management office for the Building, Tenant may either inspect the records at such other location or pay for the reasonable cost of copying and shipping the records. If Tenant retains an agent to review Landlord’s records, the agent must be with a CPA firm licensed to do business in the state or commonwealth where the Property is located. Tenant shall be solely responsible for all costs, expenses and fees incurred for the audit. Within 90 days after the records are made available to Tenant, Tenant shall have the right to give Landlord written notice (an “Objection Notice”) stating in reasonable detail any objection to Landlord’s statement of Expenses for that year. If Tenant fails to give Landlord an Objection Notice within the 90 day period or fails to provide Landlord with a Review Notice within the 365 day period described above, Tenant shall be deemed to have approved Landlord’s statement of Expenses and shall be barred from raising any claims regarding the Expenses for that year. If Tenant provides Landlord with a timely Objection Notice, Landlord and Tenant shall work together in good faith to resolve any issues raised in Tenant’s Objection Notice. If Landlord and Tenant determine that Expenses for the calendar year are less than reported, Landlord shall provide Tenant with a credit against the next installment of Rent in the amount of the overpayment by Tenant. Likewise, if Landlord and Tenant determine that Expenses for the calendar year are greater than reported, Tenant shall pay Landlord the amount of any underpayment within 30 days. The records obtained by Tenant shall be treated as confidential. In no event shall Tenant be permitted to examine Landlord’s records or to dispute any statement of Expenses unless Tenant has paid and continues to pay all Rent when due. EXHIBIT C

Time is Money Join Law Insider Premium to draft better contracts faster.