Common use of Grants to AstraZeneca Clause in Contracts

Grants to AstraZeneca. Subject to 6.6.1 and the other terms and conditions of this Agreement, Impax hereby grants to AstraZeneca: 6.2.1. a non-exclusive, royalty-free right and license, without the right to grant sublicenses, under the Impax Patents, Impax Improvement Patents and Impax Know-How, solely for the purposes of performing its obligations under this Agreement. 6.2.2. an irrevocable, royalty-free, perpetual, non-exclusive license and right of cross-reference or right of reference under the Impax Study Data, Impax Regulatory Documentation and Regulatory Approvals that Impax or its Affiliates Control with respect to the Licensed Compound or Licensed Products solely as reasonably necessary for (i) AstraZeneca and its Affiliates or (sub)licensees (a) to comply with any requirement to report worldwide clinical studies or safety information with respect to a product containing the Licensed Compound to Regulatory Authorities or (b) to make filings seeking or maintaining Regulatory Approval of such product containing the Licensed Compound and (ii) AstraZeneca and its Affiliates to perform AstraZeneca’s obligations under this Agreement. In connection with the foregoing, in the event the FFDCA or its applicable implementing regulations, or equivalent Applicable Laws in foreign jurisdictions, require Impax to provide AstraZeneca or any of its Affiliates or (sub)licensees with a signed statement to effectuate the intent of this Section 6.2.2, Impax shall provide any such signed statement if requested by AstraZeneca in accordance with the FFDCA or other Applicable Law, or will otherwise communicate as necessary with the FDA or other Regulatory Authority to ensure that AstraZeneca or any of its Affiliates or sublicensees may conduct the activities contemplated by this Section 6.2.2. 6.2.3. an irrevocable, royalty-free, perpetual, non-exclusive right and license, with the right to sublicense through multiple tiers, under the Impax Improvement Patents to (i) Exploit the Licensed Compound and products containing the Licensed Compound outside the Territory or in the Territory in support of Exploitation outside the Territory (including to conduct Development activities in the Field in the Territory in furtherance of the right to Exploit the Licensed Compound or products containing the Licensed Compound outside the Territory), and (ii) to Manufacture or have Manufactured anywhere in the world the Licensed Compound or products containing the Licensed Compound for use in the activities provided in clause (i); provided, however, that for the avoidance of doubt, Impax shall have no obligation to disclose any Impax Improvements or Impax Improvement Patents to AstraZeneca in connection with this Section 6.2.3 or the other terms or conditions of this Agreement, except to the extent that disclosure is required in connection with activities conducted pursuant to Article 4 or Article 5. 6.2.4. a royalty-free, non-exclusive license to use Impax’ Corporate Names solely as required to Manufacture the Supplied Products in accordance with this Agreement and as required for any actions in connection with any submissions to Regulatory Authorities as contemplated hereunder or as required by Applicable Law.

Appears in 2 contracts

Sources: Distribution, License, Development and Supply Agreement (Impax Laboratories Inc), Distribution, License, Development and Supply Agreement (Impax Laboratories Inc)

Grants to AstraZeneca. Subject 2.6.1 Licensee hereby grants to 6.6.1 AstraZeneca a non-exclusive, fully paid-up, royalty-free license (with such license becoming irrevocable and perpetual) with the right to grant sublicenses through multiple tiers, including Nektar, under the Licensee Patents and the other Licensee Know-How, and Licensee’s interests in the Joint Patents and the Joint Know-How, to Exploit Licensed Products anywhere in the world for purposes of performing or exercising the Retained Rights; provided that any such sublicenses shall (a) be consistent with, and expressly made subject to, the terms and conditions of this Agreement and the Nektar Agreement, Impax (b) contain terms requiring any Information and intellectual property rights arising therein to be owned by AstraZeneca (or Licensee or Nektar, as applicable), or if owned by the sublicensee to be licensed to AstraZeneca with rights for AstraZeneca to disclose such Information to Licensee and for Licensee to use, disclose and grant further rights under such Information and intellectual property rights as contemplated by this Agreement and (c) such sublicensee shall be bound (i) by non-disclosure and non-use provisions substantially similar to those set forth in this Agreement and (ii) by terms limiting the purpose for which any confidential information under any such sublicense may be used to the activities conducted by such sublicensee in connection with the Exploitation of the Licensed Products hereunder. AstraZeneca shall ensure each sublicensee complies with the applicable terms and conditions of this Agreement and the Nektar Agreement, as if such sublicensee were a party to this Agreement, and AstraZeneca 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 AstraZeneca would be a breach of this Agreement, will be deemed a breach by AstraZeneca of this Agreement for which AstraZeneca is responsible. A copy of any sublicense agreement executed by AstraZeneca shall be provided to Licensee within [***] after its execution. 2.6.2 Licensee hereby grants to AstraZeneca: 6.2.1. a non-exclusive, royalty-free right and license, without the right AstraZeneca an exclusive (including with regard to grant sublicenses, under the Impax Patents, Impax Improvement Patents and Impax Know-How, solely for the purposes of performing its obligations under this Agreement. 6.2.2. an irrevocable, royalty-free, perpetual, non-exclusive Licensee) license and right of cross-reference or right of reference under the Impax Study Data, Impax Regulatory Documentation and Regulatory Approvals that Impax or its Affiliates Control with respect to the Licensed Compound or Licensed Products solely as reasonably necessary for (i) AstraZeneca and its Affiliates or (sub)licensees (a) to comply with any requirement to report worldwide clinical studies or safety information with respect to a product containing the Licensed Compound to Regulatory Authorities or (b) to make filings seeking or maintaining Regulatory Approval of such product containing the Licensed Compound and (ii) AstraZeneca and its Affiliates to perform AstraZeneca’s obligations under this Agreement. In connection with the foregoing, in the event the FFDCA or its applicable implementing regulations, or equivalent Applicable Laws in foreign jurisdictions, require Impax to provide AstraZeneca or any of its Affiliates or (sub)licensees with a signed statement to effectuate the intent of this Section 6.2.2, Impax shall provide any such signed statement if requested by AstraZeneca in accordance with the FFDCA or other Applicable Law, or will otherwise communicate as necessary with the FDA or other Regulatory Authority to ensure that AstraZeneca or any of its Affiliates or sublicensees may conduct the activities contemplated by this Section 6.2.2. 6.2.3. an irrevocable, royalty-free, perpetual, non-exclusive right and licensereference, with the right to sublicense grant sublicenses and further rights of reference through multiple tiers, under the Impax Improvement Patents to (i) Exploit the Existing Approvals and any other Licensee Regulatory Documentation as necessary for purposes of Exploiting Licensed Compound and products containing the Licensed Compound outside the Territory or Products in the Territory in support AstraZeneca Territory. Licensee shall, at AstraZeneca’s request and cost, use reasonable efforts to obtain any certificates of Exploitation outside pharmaceutical products for such Licensed Products (“CPP”) and provide any appropriate authorizations to the Territory applicable Health Authority to permit AstraZeneca (including to conduct Development activities or its Affiliates and designees) such rights of reference in the Field in the Territory in furtherance of the right to Exploit the Licensed Compound or products containing the Licensed Compound outside the AstraZeneca Territory), and (ii) to Manufacture or have Manufactured anywhere in the world the Licensed Compound or products containing the Licensed Compound for use in the activities provided in clause (i); provided, however, that for the avoidance of doubt, Impax shall have no obligation to disclose any Impax Improvements or Impax Improvement Patents to AstraZeneca in connection with this Section 6.2.3 or the other terms or conditions of this Agreement, except to the extent that disclosure is required in connection with activities conducted pursuant to Article 4 or Article 5. 6.2.4. a royalty-free, non-exclusive license to use Impax’ Corporate Names solely as required to Manufacture the Supplied Products in accordance with this Agreement and as required for any actions in connection with any submissions to Regulatory Authorities as contemplated hereunder or Except as required by a Health Authority or by Applicable Law, Licensee shall not withdraw or permit to be withdrawn, any Existing Approval, any CPP or any other Licensee Regulatory Documentation without the prior written consent of AstraZeneca, and on request of AstraZeneca, in lieu of such a withdrawal, shall transfer any such Existing Approval or other Licensee Regulatory Documentation to AstraZeneca solely for purposes of Exploiting Licensed Products in the AstraZeneca Territory. Licensee shall use reasonable efforts to give AstraZeneca at least [***] prior written notice of any planned variations or other amendments to the Existing Approvals or such other Licensee Regulatory Documentation that would require a new CPP to be issued.

Appears in 1 contract

Sources: License Agreement (RedHill Biopharma Ltd.)