Common use of Assignment and Disclosure Clause in Contracts

Assignment and Disclosure. On a terminated country-by-terminated country basis, Licensee will promptly and will cause its Representatives to (and in any event within [**] after the effective date of termination) and hereby does: (a) assign and transfer to Akebia or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, and Study Data (to the extent in Licensee’s and its Representatives’ Control), in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Product, and, following such review, upon Akebia’s request and solely to the extent permitted under the terms of such agreements, assign and transfer to Akebia or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled by Licensee or that Licensee is able to obtain using reasonable efforts, and that embody the foregoing, and (e) assign and transfer to Akebia or its designee all of Akebia’s rights, title, and interests in and to any promotional materials, training materials, medical education materials, packaging and labeling, and all other literature or other information related to the Licensed Product and copyrights and any registrations for the foregoing. Licensee will and will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. To the extent that any agreement or other asset described in this Section 15.7.7 (Assignment and Disclosure) is not assignable by Licensee or its Representatives, then such agreement or other asset will not be assigned, and upon the request of Akebia, Licensee will and will cause its Representatives to take such steps as may be necessary to allow Akebia to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Licensee or such Representative has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Akebia will assume all safety and safety database activities with respect to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia or its designee, as of the effective date of termination in such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to this Section 15.7.7 (Assignment and Disclosure), Licensee will and will cause its Representatives to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain such assignment, Licensee hereby consents and grants, and will cause its Representatives to consent and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs associated with the assignments set forth in this Section 15.7.7 (Assignment and Disclosure) will be borne by Licensee.

Appears in 1 contract

Sources: License Agreement (Akebia Therapeutics, Inc.)

Assignment and Disclosure. On Upon termination of this Agreement, to the extent requested by Takeda following the date that a terminated country-by-terminated country basis, Licensee will promptly and will cause its Representatives to Party provides notice of termination of this Agreement (and in any event within event, no later than [***] after the effective date of termination) and hereby does: (a) ), Neurocrine will use reasonable efforts promptly upon request of Takeda to: a. assign and transfer to Akebia Takeda or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, and Study Data (to the extent in Licensee’s and its Representatives’ Control), in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Product, and, following such review, upon Akebia’s request and solely to the extent permitted under the terms of such agreements, assign and transfer to Akebia or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled by Licensee or that Licensee is able to obtain using reasonable efforts, and that embody the foregoing, and (e) assign and transfer to Akebia or its designee all of AkebiaNeurocrine’s rights, title, and interests in and to any promotional materialsall (i) clinical trial agreements (subject to Section 14.4.9 (Ongoing Clinical Trials)), training materialsmanufacturing and supply agreements, medical education materials, packaging and labelingdistribution agreements, and all other literature or other information related agreements to which Neurocrine is a party that relates to the Licensed Terminated Product and copyrights (ii) data from any applicable Clinical Trials in Neurocrine’s Control, in each case, solely to the extent assignable without consent of, or the provision of consideration (whether monetary or otherwise) to, any Third Party and any registrations not cancelled and solely to the extent the foregoing relate exclusively to the Terminated Products in the Terminated Territory and are necessary for the foregoing. Licensee will and will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority Exploitation of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. To Terminated Products in the Terminated Territory; and b. to the extent that any agreement or other asset described data set forth in this Section 15.7.7 the foregoing clause (Assignment and Disclosurea) is not assignable by Licensee to Takeda or its Representatives, then such agreement or other asset will does not be assigned, and upon exclusively relate to the request of Akebia, Licensee will and will cause its Representatives to take such steps as may be necessary to allow Akebia to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, Terminated Products in the form Terminated Territory, reasonably cooperate with Takeda to arrange to continue to provide such services for a reasonable time after termination of a license or other right this Agreement (not to the extent Licensee or such Representative has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements exceed [***]) with respect to safety data exchangesuch Terminated Products in the Terminated Territory to facilitate the orderly transition of all Development, provided that Akebia will assume all safety Commercialization, and safety database other activities with respect then being performed by or on behalf of Neurocrine or its Affiliates or Sublicensees for the Terminated Products in the Terminated Territory to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia Takeda or its designee, as of the effective date of termination in . Neurocrine will provide up to an aggregate (including such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data assistance provided pursuant to this Section 15.7.7 14.4.7(b) (Assignment and Disclosure), Licensee will Section 14.4.11 (Know-How Transfer Support), and will cause its Representatives Section 14.4.14 (Transition Assistance)) of [***] FTE hours of transition assistance per Terminated Product from Neurocrine FTEs at no cost to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent Takeda, up to a maximum of [***] FTE hours in the aggregate for all Licensed Product-related matters involving Regulatory Authorities until Terminated Products, provided that Takeda will thereafter be responsible and reimburse Neurocrine for all Regulatory Approvals, Regulatory Submissionsdocumented FTE Costs at the FTE Rate and expenses associated with such assistance in accordance with an agreed budget, and other governmental or regulatory filings that are not then accordingly, Neurocrine may invoice Takeda for such FTE Costs and expenses, in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain each case, incurred in connection with providing such assignment, Licensee hereby consents and grantsassistance in accordance with such budget, and Takeda will cause its Representatives to consent pay the undisputed invoiced amounts within [***] after the date of such invoice. Neurocrine will be responsible for the costs and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs expenses it incurs associated with the assignments set forth in this Section 15.7.7 14.4.7 (Assignment and Disclosure) will be borne by Licensee).

Appears in 1 contract

Sources: Exclusive License Agreement (Neurocrine Biosciences Inc)

Assignment and Disclosure. On a terminated country-by-terminated country basisTo the extent requested by uniQure, Licensee Partner will promptly and will cause its Representatives to (and in any event within [**] after the effective date of termination) and hereby does: upon such request: (a) assign and transfer to Akebia uniQure or its designee all of LicenseePartner’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, agreements (if any) and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, ; and Study Data provide copies of data and other Know-How (to the extent including commercial information) in LicenseePartner’s and its Representatives’ Control), in each case, relating to the Licensed Product extent related to the Existing Products and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Existing Product; (b) assign to uniQure or its designee or amend to have uniQure assume Partner’s rights and obligations therein, andas either option is deemed appropriate in Partner’s discretion, following such reviewany agreements or arrangements with Third Party vendors (including distributors) with respect to the Existing Products or, upon Akebia’s request and solely to the extent permitted under any such Third Party agreement or arrangement is not assignable to uniQure for such scope, reasonably cooperate with uniQure to arrange for such distributor to continue to provide such services to Partner on uniQure’s behalf for a reasonable time after termination of this Agreement with respect to such Existing Products to facilitate the terms orderly transition of all Commercialization and other activities then being performed by or on behalf of Partner or its Affiliates or Sublicensees for the Existing Products to uniQure or its designee, provided that, if Partner is required to make any payments to any Third Party to procure any consents, Partner’s obligation to procure such agreements, assign and transfer consent is contingent on uniQure agreeing to Akebia bear 100% of any such payment; (c) disclose to uniQure or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials to the extent related to the Licensed Product Existing Products that are controlled Controlled by Licensee Partner or that Licensee is able its Affiliates or Sublicensees and are necessary for uniQure to obtain using reasonable effortsexercise its above rights relating to such Existing Products, which documents, records, and that embody materials, in each case, will be deemed Partner’s “Confidential Information” to the foregoing, extent they also relate to Partner’s or its Affiliates’ other businesses or products and uniQure or its Affiliates and (esub)licensees may use the same to Exploit such Existing Products; and (d) assign and transfer to Akebia uniQure or its designee all of AkebiaPartner’s rights, title, and interests in and to the copyright in any promotional materials, Promotional Materials that are solely related to the Existing Product (and provide a non-exclusive license to uniQure and its Affiliates and (sub)licensees of all Promotional Materials that are otherwise related to the Existing Products) and provide a copy of all training materials, medical education materials, packaging and labeling, and all other literature or other information that are related to the Licensed Product Existing Product, which Promotional Materials will be deemed Partner’s “Confidential Information” to the extent they also relate to Partner or its Affiliates’ other businesses or products and copyrights uniQure or its Affiliates and any registrations (sub)licensees may use the same to Exploit such Existing Products. ​ Unless this Agreement is terminated by Partner pursuant to Section 13.2.2 (Termination for Cause), each Party will bear its own costs and expenses associated with the matters described in this Section 13.3.5 (Assignment and Disclosure). If this Agreement is terminated by Partner pursuant to Section 13.2.2 (Termination for Cause), then uniQure will reimburse Partner for the foregoing. Licensee will costs and will cause its Representatives to take all steps necessary to transfer ownership documented out-of-pocket expenses of all such assigned agreements Partner associated with the assignments set forth in this Section 13.3.5 (Assignment and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory ApprovalDisclosure). To the extent that any agreement or other asset described in this Section 15.7.7 13.3.5 (Assignment and Disclosure) is not assignable by Licensee or its RepresentativesPartner, then such agreement or other asset will not be assigned, and and, upon the request of AkebiauniQure, Licensee Partner will and will cause its Representatives to take such reasonable steps as may be necessary to allow Akebia uniQure to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Licensee or such Representative Partner has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data in the event this Agreement is terminated by Partner pursuant to Section 13.2.2 (Termination for Cause), uniQure will reimburse Partner for the costs and documented out-of-pocket expenses incurred by Partner in doing so. For clarity, uniQure will have the right to request that are held by Partner take any or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements all of the foregoing actions in whole or in part, or with respect to safety data exchange, provided that Akebia will assume all safety and safety database activities with respect to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia or its designee, as any portion of the effective date of termination assets set forth in such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to this Section 15.7.7 13.3.5 (Assignment and Disclosure), Licensee will and will cause its Representatives to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain such assignment, Licensee hereby consents and grants, and will cause its Representatives to consent and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs associated with the assignments set forth in this Section 15.7.7 (Assignment and Disclosure) will be borne by Licensee.

Appears in 1 contract

Sources: Commercialization and License Agreement (uniQure N.V.)

Assignment and Disclosure. On To the extent requested by BioCryst following the date that a terminated country-by-terminated country basisParty provides notice of termination of this Agreement, Licensee Torii will promptly and will cause its Representatives to upon request (and in any event within [***] after the effective date of termination) and hereby does: ): (a) assign and transfer to Akebia BioCryst or its designee all of LicenseeTorii’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, agreements (if any) and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, and Study Data (to the extent in Licensee’s and its Representatives’ Control), in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality data and other agreementsKnow-How (including commercial information) in Torii’s Control, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Product; (b) assign or amend, andas appropriate, following such reviewany agreements or arrangements with Third Party vendors (including distributors) with respect to the Licensed Product or, upon Akebia’s request and solely to the extent permitted under any such Third Party agreement or arrangement is not assignable to BioCryst, reasonably cooperating with BioCryst to arrange to continue to provide such services for a reasonable time after termination of this Agreement with respect to such Licensed Product to facilitate the terms orderly transition of such agreements, assign all Commercialization and transfer other activities then being performed by or on behalf of Torii or its Affiliates or Sublicensees for the Licensed Product to Akebia BioCryst or its designee; (c) disclose to BioCryst or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled Controlled by Licensee Torii or its Affiliates or Sublicensees or that Licensee Torii is able to obtain using reasonable efforts, and that embody the foregoing, and ; and (ed) assign and transfer to Akebia BioCryst or its designee all of AkebiaTorii’s rights, title, and interests in and to any promotional materialsPromotional Materials, training materials, medical education materials, packaging and labeling, and all other literature or other information related to the Licensed Product and copyrights and any registrations for the foregoing. Licensee Unless this Agreement is terminated by Torii pursuant to Section 13.2.2 (Termination for Cause) or Section 13.2.6 (Termination for Bankruptcy), Torii will bear the costs and expenses associated with the assignments set forth in this Section 13.4.6 (Assignment and Disclosure). If this Agreement is terminated by Torii pursuant to Section 13.2.2 (Termination for Cause), then BioCryst will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements reimburse Torii for the costs and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation expenses associated with the assignments set forth in this Section 13.4.6 (with a copy to Akebia) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission Assignment and Regulatory ApprovalDisclosure). To the extent that any agreement or other asset described in this Section 15.7.7 13.4.6 (Assignment and Disclosure) is not assignable by Licensee or its RepresentativesTorii, then such agreement or other asset will not be assigned, and and, upon the request of AkebiaBioCryst, Licensee Torii will and will cause its Representatives to take such steps as may be necessary to allow Akebia BioCryst to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Licensee or such Representative Torii has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data in the event this Agreement is terminated by Torii pursuant to Section 13.2.2 (Termination for Cause), BioCryst will reimburse Torii for its costs and expenses incurred in doing so. For clarity, BioCryst will have the right to request that are held by Torii take any or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements all of the foregoing actions in whole or in part, or with respect to safety data exchange, provided that Akebia will assume all safety and safety database activities with respect to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia or its designee, as any portion of the effective date of termination assets set forth in such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to this Section 15.7.7 13.4.6 (Assignment and Disclosure), Licensee will and will cause its Representatives to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain such assignment, Licensee hereby consents and grants, and will cause its Representatives to consent and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs associated with the assignments set forth in this Section 15.7.7 (Assignment and Disclosure) will be borne by Licensee.

Appears in 1 contract

Sources: Commercialization and License Agreement (Biocryst Pharmaceuticals Inc)

Assignment and Disclosure. On To the extent requested by Evelo following the date that a terminated country-by-terminated country basisParty provides notice of termination of this Agreement, Licensee ALJ will promptly and will cause its Representatives to upon request (and in any event within [***] after the effective date of termination) and hereby does: (a) ): 15.4.1 assign and transfer to Akebia Evelo or its designee all of LicenseeALJ’s and or its RepresentativesAffiliates’, Sublicensees’, or Subcontractors’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, manufacturing and supply agreements, and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, data and Study Data other Know-How (to the extent including commercial information) in LicenseeALJ’s and or its RepresentativesAffiliates’, Sublicensees’, or Subcontractors’ Control), in each case, relating exclusively to the Licensed Product Terminated Products in Terminated Countries and that are necessary or reasonably useful for the Development Exploitation of such Terminated Products in such Terminated Countries; 15.4.2 to the extent ALJ or Commercialization any of the Licensed Productits Affiliates is a party to any clinical trial agreement, manufacturing and supply agreement or distribution agreement which either (i) relates exclusively to Terminated Products in Terminated Countries but which is not assignable or (ii) relates to Terminated Products in any Terminated Countries but does not relate exclusively to Terminated Products in Terminated Countries and, in either case, is necessary or useful for the Exploitation of such Terminated Products in such Terminated Countries, ALJ shall use reasonable efforts to introduce Evelo to the extent assignment pursuant relevant Third Party counterparty to clause (i) is delayed or is not permitted by the applicable Regulatory Authoritysuch agreement and shall, permit Akebia to cross-reference upon Evelo’s request and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives at Evelo’s expense, provide Evelo with reasonable assistance with respect to the Licensed Product, (b) Evelo’s negotiation of a replacement agreement with such Third Party; 15.4.3 disclose to Akebia Evelo or its designee all documents that are controlled by Licensee documents, records, and materials relating to any Terminated Product in any Terminated Country in the possession or Control of ALJ or its Representatives Affiliates, Sublicensees, or that Licensee and its Representatives are able to obtain using reasonable effortsSubcontractors, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Product, ; and, following such review, upon Akebia’s request and solely to the extent permitted under the terms of such agreements, 15.4.4 assign and transfer to Akebia Evelo or its designee all of LicenseeALJ’s and or its RepresentativesAffiliates’, Sublicensees’, or Subcontractors’ rights, title, and interests in and to any such agreements. If such agreement is not assignablePromotional Materials, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such RepresentativeTraining Materials, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled by Licensee or that Licensee is able to obtain using reasonable efforts, and that embody the foregoing, and (e) assign and transfer to Akebia or its designee all of Akebia’s rights, title, and interests in and to any promotional materials, training materials, medical education materialsMedical Education Materials, packaging and labeling, and all other literature or other information related relating exclusively to the Licensed any Terminated Product in any Terminated Country and copyrights and any registrations for the foregoing. Licensee will and will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority of the transfer of such ownership of each Regulatory Submission and Regulatory Approval. To the extent that any agreement or other asset described in this Section 15.7.7 (Assignment and Disclosure) 15.4.3 or 15.4.4 is not assignable by Licensee ALJ or its RepresentativesAffiliates, Sublicensees, or Subcontractors or do not relate exclusively to Terminated Products in Terminated Countries, then such agreement or other asset will not be assigned, and upon the request of AkebiaEvelo, Licensee ALJ will and will take, or cause its Representatives or its Affiliates, Sublicensees, or Subcontractors to take take, such steps as may be necessary to allow Akebia Evelo to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor. For clarity, in Evelo will have the form of a license or other right to the extent Licensee require that ALJ take, or such Representative has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representativesor its Affiliates, at Licensee’s cost and expenseSublicensees, provide or Subcontractors to Akebia copies take, any or all of all substantive related documentationthe foregoing actions in whole or in part, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Akebia will assume all safety and safety database activities with respect to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia or its designee, as any portion of the effective date of termination in such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to this Section 15.7.7 (Assignment and Disclosure), Licensee will and will cause its Representatives to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain such assignment, Licensee hereby consents and grants, and will cause its Representatives to consent and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs associated with the assignments assets set forth in this Section 15.7.7 (Assignment 15.4.3 and Disclosure) will be borne by LicenseeSection 15.4.4.

Appears in 1 contract

Sources: Commercialization and License Agreement (Evelo Biosciences, Inc.)

Assignment and Disclosure. On Upon termination of this Agreement, to the extent requested by ▇▇▇▇▇▇ following the date that a terminated country-by-terminated country basis, Licensee will promptly and will cause its Representatives to Party provides notice of termination of this Agreement (and in any event within event, no later than [***] after the effective date of termination) and hereby does), Neurocrine will use reasonable efforts promptly upon request of Takeda to: (a) assign and transfer to Akebia Takeda or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, and Study Data (to the extent in Licensee’s and its Representatives’ Control), in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed Product, and, following such review, upon Akebia’s request and solely to the extent permitted under the terms of such agreements, assign and transfer to Akebia or its designee all of Licensee’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable, then Licensee will and will cause its Representatives to cooperate with Akebia in all reasonable respects to secure the consent of the applicable Third Party to such assignment or to cause such Third Party to enter into a separate agreement with Akebia on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia or its designee all data, information, documents, records, and materials related to the Licensed Product that are controlled by Licensee or that Licensee is able to obtain using reasonable efforts, and that embody the foregoing, and (e) assign and transfer to Akebia or its designee all of AkebiaNeurocrine’s rights, title, and interests in and to any promotional materialsall (i) clinical trial agreements (subject to Section 13.4.9 (Ongoing Clinical Trials)), training materialsmanufacturing and supply agreements, medical education materials, packaging and labelingdistribution agreements, and all other literature or other information related agreements to which Neurocrine is a party that relates to the Licensed Terminated Product and copyrights (ii) data from any applicable Clinical Trials in Neurocrine’s Control, in each case, solely to the extent assignable without consent of, or the provision of consideration (whether monetary or otherwise) to, any Third Party and any registrations not cancelled and solely to the extent the foregoing relate exclusively to the Terminated Products in the Terminated Territory and are necessary for the foregoing. Licensee will and will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority Exploitation of the transfer of such ownership of each Regulatory Submission Terminated Products in the Terminated Territory; and Regulatory Approval. To (b) to the extent that any agreement or other asset described data set forth in this Section 15.7.7 the foregoing clause (Assignment and Disclosurea) is not assignable by Licensee to Takeda or its Representatives, then such agreement or other asset will does not be assigned, and upon exclusively relate to the request of Akebia, Licensee will and will cause its Representatives to take such steps as may be necessary to allow Akebia to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, Terminated Products in the form Terminated Territory, reasonably cooperate with Takeda to arrange to continue to provide such services for a reasonable time after termination of a license or other right this Agreement (not to the extent Licensee or such Representative has the right and ability to do so. In addition, upon Akebia’s written request, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements exceed [***]) with respect to safety data exchangesuch Terminated Products in the Terminated Territory to facilitate the orderly transition of all Development, provided that Akebia will assume all safety Commercialization, and safety database other activities with respect then being performed by or on behalf of Neurocrine or its Affiliates or Sublicensees for the Terminated Products in the Terminated Territory to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia Takeda or its designee, as of the effective date of termination in . Neurocrine will provide up to an aggregate (including such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data assistance provided pursuant to this Section 15.7.7 13.4.7(b) (Assignment and Disclosure), Licensee will Section 13.4.11 (Know-How Transfer Support), and will cause its Representatives Section 13.4.14 (Transition Assistance)) of [***] FTE hours of transition assistance per Terminated Product from Neurocrine FTEs at no cost to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent Takeda, up to a maximum of [***] FTE hours in the aggregate for all Licensed Product-related matters involving Regulatory Authorities until Terminated Products, provided that Takeda will thereafter be responsible and reimburse Neurocrine for all Regulatory Approvals, Regulatory Submissionsdocumented FTE Costs at the FTE Rate and expenses associated with such assistance in accordance with an agreed budget, and other governmental or regulatory filings that are not then accordingly, Neurocrine may invoice Takeda for such FTE Costs and expenses, in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain each case, incurred in connection with providing such assignment, Licensee hereby consents and grantsassistance in accordance with such budget, and Takeda will cause its Representatives to consent pay the undisputed invoiced amounts within [***] after the date of such invoice. Neurocrine will be responsible for the costs and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs expenses it incurs associated with the assignments set forth in this Section 15.7.7 13.4.7 (Assignment and Disclosure) will be borne by Licensee).

Appears in 1 contract

Sources: Exclusive License Agreement (Neurocrine Biosciences Inc)

Assignment and Disclosure. On To the extent requested by ▇▇▇▇▇ following the date that a terminated country-by-terminated country basisParty provides notice of termination of this Agreement, Licensee Thera will promptly and will cause its Representatives to (and in any event within [**] no later than 30 days after the effective date of termination) and hereby does: termination unless agreed otherwise in the Transition Plan): (a) assign and transfer provide to Akebia or Ionis for its designee review unredacted copies of all of Licensee’s and its Representatives’ rights, title, and interests in and to (i) all Regulatory Submissions, Regulatory Approvals, clinical trial agreements, agreements and distribution agreements (to the extent assignable and not cancelled), confidentiality and other agreements, and Study Data (to the extent in Licensee’s and its Representatives’ Control), in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Development or Commercialization of the Licensed Product, and (ii) to the extent assignment pursuant to clause (i) is delayed or is not permitted by the applicable Regulatory Authority, permit Akebia to cross-reference and rely upon any Regulatory Submissions and Regulatory Approvals filed by Licensee and its Representatives with respect to the Licensed Product, (b) disclose to Akebia all documents that are controlled by Licensee and its Representatives or that Licensee and its Representatives are able to obtain using reasonable efforts, and that embody the foregoing, (c) subject to Licensee’s and its Representatives’ confidentiality obligations to Third Parties, provide to Akebia for its review unredacted copies of all clinical trial agreements, manufacturing and supply agreements, distribution agreements (to the extent assignable and not cancelled), and confidentiality and other agreements, in each case, relating to the Licensed Product and that are necessary or reasonably useful for the Exploitation of the Licensed ProductTerminated Product(s) in the Thera Territory, and, following such review, upon Akebia’s request and solely to the extent permitted under the terms of such agreementsIonis’ request, assign and transfer to Akebia Ionis or its designee all of LicenseeThera’s and its Representatives’ rights, title, and interests in and to any such agreements. If such agreement is not assignable; (b) assign or amend, then Licensee will and will cause its Representatives to cooperate as appropriate, any agreements or arrangements with Akebia in all reasonable respects to secure the consent of the applicable Third Party vendors (including distributors) solely related to such assignment or the Terminated Product(s) or, to cause the extent any such Third Party agreement or arrangement is not assignable to enter into Ionis, reasonably cooperate with Ionis to arrange to continue to provide such services for a separate agreement with Akebia reasonable time after termination of this Agreement to facilitate the orderly transition of all Commercialization and other activities then being performed by or on terms substantially similar to those granted to Licensee or such Representative, as applicable, (d) disclose to Akebia behalf of Thera or its designee Affiliates for the Terminated Product(s) to Ionis or its designee. Upon such assignment to Ionis, Ionis will be responsible for all data, information, documents, records, and materials related to the Licensed Product liabilities that are controlled by Licensee or that Licensee is able to obtain using reasonable efforts, and that embody the foregoing, and accrue under such Third Party agreement after such assignment. (ec) assign and transfer to Akebia Ionis or its designee, as of the effective date of termination, on an “as is, where is” basis without any representations, warranties or conditions, including those that may be provided or implied by Applicable Law, all of Thera’s rights, title, and interests in and to the applicable Thera Product Trademarks and any domain names associated with the applicable Thera Product Trademarks (to the extent that Thera or its Affiliates has any), and promptly provide to Ionis all login and password information necessary to maintain such domain names; (d) assign and transfer on an “as is, where is” basis without any representations, warranties or conditions, including those that may be provided or implied by Applicable Law, to Ionis or its designee all of AkebiaThera’s rights, title, and interests in and to any promotional materialsProduct Materials, training materials, medical education materials, packaging and labeling, and all other literature or other information related to the Licensed Product and copyrights and any registrations for the foregoing. Licensee will ; and (e) disclose to Ionis or its designee all documents, records, and will cause its Representatives to take all steps necessary to transfer ownership of all such assigned agreements and other assets to Akebia, including submitting to each applicable Regulatory Authority a letter or other necessary documentation (with a copy to Akebia) notifying such Regulatory Authority materials that embody any of the transfer of such ownership of each Regulatory Submission foregoing and Regulatory Approvalthat are controlled by Thera or that Thera is able to obtain using reasonable efforts. Subject to Section 14.11.12 (Termination by Thera for Breach), Thera will be responsible for [Redacted: Cost Sharing Liability]associated with the assignments set forth in this Section 14.11.6 (Assignment and Disclosure). To the extent that any agreement or other asset described in this Section 15.7.7 14.11.6 (Assignment and Disclosure) is not assignable by Licensee or its RepresentativesThera, then such agreement or other asset will not be assigned, and upon the request of AkebiaIonis, Licensee Thera will and will cause its Representatives to take such steps as may be necessary to allow Akebia Ionis to obtain and to enjoy the benefits of such agreement or other asset, without additional payment therefor, in the form of a license or other right to the extent Licensee or such Representative Thera has the right and ability to do so. In additionFor clarity, upon Akebia’s written requestIonis will have the right to request that Thera take any or all of the foregoing actions in whole or in part, Licensee will and will cause its Representatives, at Licensee’s cost and expense, provide to Akebia copies of all substantive related documentation, including non-clinical, preclinical, and clinical data that are held by or reasonably available to Licensee and its Representatives. The Parties will discuss and establish appropriate arrangements with respect to safety data exchange, provided that Akebia will assume all safety and safety database activities with respect to the Licensed Product no later than [**] after the effective date of termination of this Agreement. In addition, on a terminated country-by-terminated country basis, Licensee will and will cause its Representatives to promptly assign and transfer to Akebia or its designee, as any portion of the effective date of termination in such country, all of Licensee’s and its Representatives’ rights, title, and interests in and to all domain names associated with the Product Marks used in such terminated country (to the extent that they are owned by Licensee or its Affiliates and not used in any non-terminated country in the Territory), and will promptly (in any event, within [**] after the effective date of termination) provide to Akebia all login and password information necessary to maintain such domain names. In furtherance of the assignment of Regulatory Submissions and Regulatory Approvals and other data pursuant to this Section 15.7.7 (Assignment and Disclosure), Licensee will and will cause its Representatives to appoint ▇▇▇▇▇▇ as Licensee’s and its Representatives’ agent for all Licensed Product-related matters involving Regulatory Authorities until all Regulatory Approvals, Regulatory Submissions, and other governmental or regulatory filings that are not then in Akebia’s or its Affiliate’s name have been assigned to Akebia or its designee. In the event of failure to obtain such assignment, Licensee hereby consents and grants, and will cause its Representatives to consent and grant, to Akebia the right to access and reference (without any further action required on the part of Licensee and its Representatives, whose authorization to file this consent with any Regulatory Authority is hereby granted) any such item with respect to the Licensed Product. The costs associated with the assignments assets set forth in this Section 15.7.7 (Assignment and Disclosure) will be borne by Licenseethe foregoing provisions.

Appears in 1 contract

Sources: License Agreement (Theratechnologies Inc.)