Effect of Certain Terminations. Upon the termination of this Agreement by either Party pursuant to Section 15.2.1 for breach or Section 15.2.2 for insolvency or by KHK under Section 15.3 or 15.4, the following provisions of this Section 15.7 will apply. In the event any such early termination concerns only a specific country or countries pursuant to Section 15.3, the following shall apply solely with respect to such country(ies) and the Agreement shall otherwise remain in effect in accordance with its terms for all non-terminated countries: 15.7.1 The rights and licenses granted by XXX to UGNX hereunder and UGNX’s obligations to share Development Costs pursuant to this Agreement will terminate with respect to the terminated country(ies); 15.7.2 UGNX shall immediately (a) cease conducting any Commercialization activities with respect to the Licensed Products and (b) discontinue making any representation regarding its status as a licensee or distributor of KHK in the Territory for the Licensed Products, subject, in either such case, to requirements of Applicable Laws and to a reasonable wind-down and transition period (not to exceed [***] days); 15.7.3 Subject to Applicable Laws, UGNX shall promptly : (a) transfer to KHK or KHK’s designee all Regulatory Filings (for clarity, including registrations as an IND holder or equivalent), Marketing Approvals and Pricing and/or Reimbursement Approvals owned by UGNX for the Commercialization of the Licensed Products, if such transfer is possible, or, if such transfer is not possible, then at KHK’s discretion (i) withdraw any such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Commercialization of the Licensed Products in its name and take all actions necessary or useful to support KHK’s or KHK’s designee’s submission of Regulatory Filings and the achievement of Marketing Approvals and Pricing and/or Reimbursement Approvals in the name of KHK or KHK’s designee with respect to the Commercialization of the Licensed Products or (ii) provide KHK with access to, and grant KHK the right and license to use and to reference, such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals then in its name applicable to the Commercialization of the Licensed Products; (b) provide KHK with copies of all material correspondence between UGNX and Regulatory Authorities with respect to such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Licensed Products, and any and all other clinical and non-clinical data, records and tabulations, in all such cases with respect to the Licensed Products, that UGNX holds as of the date of termination with respect to the Licensed Products; (c) assign to KHK all agreements specific to the conduct of Clinical Trials for the Licensed Products (to the extent assignable and excluding any such agreements that also involve Clinical Trials for other UGNX products that are not Licensed Products), including agreements or contracts with contract research organizations, clinical sites and investigators, between UGNX and any Third Party, subject to any consent required by such Third Party, which consent UGNX shall use Commercially Reasonable Efforts to obtain on behalf of KHK; and (d) provide KHK with copies of all reports and data obtained by UGNX or its Affiliates pursuant to this Agreement regarding the Development and the Commercialization of Licensed Products, including any UGNX Clinical Data, which KHK may use for any purpose. As promptly as possible after any such termination, UGNX shall execute any and all documents of any Regulatory Authorities so as to allow KHK to make immediate use of any data, records and Regulatory Filings transferred by UGNX to KHK pursuant to this Section 15.7.3. 15.7.4 KHK shall make the payments due under Section 15.5, if applicable under the provisions thereof, with respect to the applicable country(ies)
Appears in 3 contracts
Samples: Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.)
Effect of Certain Terminations. (a) Upon the termination of this Agreement by either Party 3SBio pursuant to Section 15.2.1 for breach or Section 15.2.2 for insolvency 12.2 or by KHK under Section 15.3 or 15.4, the following provisions of this Section 15.7 will apply. In the event any such early termination concerns only a specific country or countries Selecta pursuant to Section 15.312.3, the following shall apply solely or with respect to each applicable product and country as to which termination occurs pursuant to Section 12.2 (the rights and obligations of the Parties as to the remaining products and countries in which termination under Section 12.2 has not occurred, being unaffected by such country(ies) and the Agreement shall otherwise remain in effect in accordance with its terms for termination), all non-terminated countries:
15.7.1 The rights and licenses granted by XXX to UGNX hereunder and UGNX’s obligations to share Development Costs pursuant to this Agreement Selecta in Section 2.1 will terminate with respect to each such terminated product and country, and Section 2.2(a) will apply to all Sublicensees in each such terminated country for each such terminated product. In addition, upon the written request of 3SBio, Selecta will grant to 3SBio a right to access and reference all Regulatory Approvals and Regulatory Filings owned by Selecta or its Affiliates concerning each such terminated product in the terminated country(ies);country.
15.7.2 UGNX shall immediately (ab) cease conducting In the event of a termination by Selecta under Section 12.2 (3SBio breach):
(i) As of the effective date of such termination, (A) the 3SBio Distribution Option will terminate, and (B) 3SBio will, within thirty (30) days after the effective date of such termination, return to Selecta all of Selecta’s Confidential Information that is in 3SBio’s (or its Affiliates’) possession or control, provided that 3SBio may keep one copy of Selecta’s Confidential Information in its confidential legal files for purposes of confirming compliance with this Agreement.
(ii) As of the effective date of such termination, the licenses granted to Selecta by 3SBio pursuant to Section 2.1 will become perpetual, irrevocable licenses.
(iii) Selecta may exercise its co-exclusive rights under Section 2.1(b) and 3SBio will promptly assign any Commercialization activities with respect manufacturing or supply agreements relating to the Licensed Compounds or Licensed Products and (b) discontinue making any representation regarding its status as a licensee or distributor of KHK in the Territory for to Selecta or its designee;
(iv) Selecta will continue to be obligated to pay the Licensed Productsmilestone and royalty amounts under Sections 8.2 and 8.3 that would otherwise have been payable under the terms of this Agreement during its Term; provided, subjecthowever, in either that such case, to requirements of Applicable Laws and to a reasonable wind-down and transition period (not to exceed amounts will be reduced by [***] days);
15.7.3 Subject to Applicable Laws, UGNX shall promptly :
percent (a[***]%) transfer to KHK or KHK’s designee all Regulatory Filings (for clarity, including registrations as an IND holder or equivalent), Marketing Approvals and Pricing and/or Reimbursement Approvals owned by UGNX for the Commercialization of the Licensed Products, if such transfer is possible, or, if such transfer is not possible, then at KHK’s discretion (i) withdraw any such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for amounts that would otherwise have been payable under the Commercialization terms of the Licensed Products in its name and take all actions necessary or useful to support KHK’s or KHK’s designee’s submission of Regulatory Filings and the achievement of Marketing Approvals and Pricing and/or Reimbursement Approvals in the name of KHK or KHK’s designee with respect to the Commercialization of the Licensed Products or (ii) provide KHK with access to, and grant KHK the right and license to use and to reference, such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals then in its name applicable to the Commercialization of the Licensed Products;
(b) provide KHK with copies of all material correspondence between UGNX and Regulatory Authorities with respect to such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Licensed Products, and any and all other clinical and non-clinical data, records and tabulations, in all such cases with respect to the Licensed Products, that UGNX holds as of the date of termination with respect to the Licensed Products;
(c) assign to KHK all agreements specific to the conduct of Clinical Trials for the Licensed Products (to the extent assignable and excluding any such agreements that also involve Clinical Trials for other UGNX products that are not Licensed Products), including agreements or contracts with contract research organizations, clinical sites and investigators, between UGNX and any Third Party, subject to any consent required by such Third Party, which consent UGNX shall use Commercially Reasonable Efforts to obtain on behalf of KHK; and
(d) provide KHK with copies of all reports and data obtained by UGNX or its Affiliates pursuant to this Agreement regarding the Development and the Commercialization of Licensed Products, including any UGNX Clinical Data, which KHK may use for any purpose. As promptly as possible after any such termination, UGNX shall execute any and all documents of any Regulatory Authorities so as to allow KHK to make immediate use of any data, records and Regulatory Filings transferred by UGNX to KHK pursuant to this Section 15.7.3during its term.
15.7.4 KHK shall make the payments due under Section 15.5, if applicable under the provisions thereof, with respect to the applicable country(ies)
Appears in 3 contracts
Samples: License Agreement (Selecta Biosciences Inc), License Agreement (Selecta Biosciences Inc), License Agreement (Selecta Biosciences Inc)
Effect of Certain Terminations. Upon (a) In the event of termination of this Agreement by either Party pursuant to Article VIII, all rights and obligations of the parties hereto under this Agreement shall terminate, except the provisions of Section 15.2.1 5.2(b), Section 5.8, Section 5.9, Article VIII and Article IX shall survive such termination; provided that nothing herein shall relieve any party hereto from any liability for any intentional or willful and material breach by such party of any of its representations, warranties, covenants or agreements set forth in this Agreement and all rights and remedies of a nonbreaching party under this Agreement in the case of such intentional or willful and material breach, at law or in equity, shall be preserved. Except to the extent otherwise provided in the immediately preceding sentence and Section 15.2.2 for insolvency or by KHK under Section 15.3 or 15.48.7 and 8.8, the following provisions of this Section 15.7 will apply. In the event any such early termination concerns only a specific country or countries pursuant to Section 15.3, the following shall apply solely with respect to such country(ies) MLP Parties and the Buyer Parties agree that, if this Agreement shall otherwise remain in effect in accordance with its terms for all non-terminated countries:
15.7.1 The rights and licenses granted by XXX to UGNX hereunder and UGNX’s obligations to share Development Costs has been terminated, any amount payable pursuant to this Agreement will terminate with respect to Section 8.5 shall be the terminated country(ies);
15.7.2 UGNX shall immediately (a) cease conducting any Commercialization activities with respect to the Licensed Products sole and (b) discontinue making any representation regarding its status as a licensee or distributor of KHK in the Territory for the Licensed Products, subject, in either such case, to requirements of Applicable Laws and to a reasonable wind-down and transition period (not to exceed [***] days);
15.7.3 Subject to Applicable Laws, UGNX shall promptly :
(a) transfer to KHK or KHK’s designee all Regulatory Filings (for clarity, including registrations as an IND holder or equivalent), Marketing Approvals and Pricing and/or Reimbursement Approvals owned by UGNX for the Commercialization exclusive remedy of the Licensed Products, if such transfer is possible, or, if such transfer is not possible, then at KHK’s discretion (i) withdraw any such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Commercialization of the Licensed Products in its name and take all actions necessary or useful to support KHK’s or KHK’s designee’s submission of Regulatory Filings and the achievement of Marketing Approvals and Pricing and/or Reimbursement Approvals in the name of KHK or KHK’s designee with respect to the Commercialization of the Licensed Products or (ii) provide KHK with access to, and grant KHK the right and license to use and to reference, such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals then in its name applicable to the Commercialization of the Licensed Products;parties hereto.
(b) provide KHK with copies If this Agreement is terminated by MLP pursuant to Section 8.3(b), MLP shall promptly pay to Buyer a fee equal to $40,000,000 by wire transfer of all same-day funds.
(c) If this Agreement is terminated by MLP pursuant to Section 8.3(c), Buyer shall promptly pay to MLP a fee equal to $40,000,000 by wire transfer of same-day funds.
(d) If this Agreement is terminated by Buyer pursuant to Section 8.4(b), MLP shall promptly pay Buyer a fee equal to $40,000,000 by wire transfer of same-day funds.
(e) If (A)(1) prior to the MLP Unitholders’ Meeting, a bona fide MLP Takeover Proposal shall have been publicly made to the MLP Parties or shall have been made directly to the unitholders of MLP generally and thereafter this Agreement is terminated by either Buyer or MLP pursuant to Section 8.2(c) (and in the case of a termination by Buyer, the Buyer Parties shall not have been in material correspondence between UGNX breach of this Agreement) or (2) prior to the Drop-Dead Date, a bona fide MLP Takeover Proposal shall have been made and Regulatory Authorities with respect thereafter this Agreement is terminated by either Buyer or MLP pursuant to Section 8.2(a) (and in the case of a termination by Buyer, the Buyer Parties shall not have been in material breach of this Agreement) and (B) within twelve months after such Regulatory Filingstermination, Marketing Approvals MLP enters into a definitive agreement to consummate, or consummates, an MLP Takeover Proposal, then MLP shall promptly pay to Buyer a fee equal to $40,000,000 by wire transfer of same-day funds. Any amount owing pursuant to this Section 8.5(e) shall be reduced by any amount paid pursuant to Section 8.5(h). For purposes of this Section 8.5(e), the term “MLP Takeover Proposal” shall have the meaning assigned in Section 1.1, except that references to “30% or more” shall be deemed to be references to “50% or more.”
(f) If (A)(1) prior to the Buyer Unitholders’ Meeting, a bona fide Buyer Takeover Proposal shall have been publicly made to the Buyer Parties or shall have been made directly to the unitholders of Buyer generally and Pricing and/or Reimbursement Approvals thereafter this Agreement is terminated by either MLP or Buyer pursuant to Section 8.2(d) (and in the case of a termination by MLP, the MLP Parties shall not have been in material breach of this Agreement) or (2) prior to the Drop-Dead Date, a bona fide Buyer Takeover Proposal shall have been made and thereafter this Agreement is terminated by either MLP or Buyer pursuant to Section 8.2(a) (and in the case of a termination by MLP, the MLP Parties shall not have been in material breach of this Agreement) and (B) within twelve months after such termination, Buyer enters into a definitive agreement to consummate, or consummates, a Buyer Takeover Proposal, then Buyer shall promptly pay to MLP a fee equal to $40,000,000 by wire transfer of same-day funds. Any amount owing pursuant to this Section 8.5(f) shall be reduced by any amount paid pursuant to Section 8.5(g).
(g) If this Agreement is terminated by MLP or Buyer pursuant to Section 8.2(d), Buyer shall promptly pay MLP an amount equal to $10,000,000 by wire transfer of same-day funds.
(h) If this Agreement is terminated by MLP or Buyer pursuant to Section 8.2(c), MLP shall promptly pay Buyer an amount equal to $10,000,000 by wire transfer of same-day funds.
(i) The parties acknowledges that the agreements contained in this Section 8.5 are an integral part of the transactions contemplated by this Agreement, and that, without these agreements, the parties would not enter into this Agreement. Accordingly, if either party fails to pay timely any amount due pursuant to this Section 8.5 and, in order to obtain such payment, the other party commences a suit which results in a judgment against the party failing to perform for the Licensed Products, and any and all other clinical and non-clinical data, records and tabulations, in all such cases with respect amount payable to the Licensed Productsother party pursuant to this Section 8.5, that UGNX holds the party failing to perform shall pay to the other party its costs and expenses (including reasonable attorneys’ fees and expenses) in connection with such suit, together with interest on the amount so payable at the rate on six-month United States Treasury obligations (as of the date of termination with respect such payment was required to the Licensed Products;
(c) assign to KHK all agreements specific to the conduct of Clinical Trials for the Licensed Products (to the extent assignable and excluding any such agreements that also involve Clinical Trials for other UGNX products that are not Licensed Products), including agreements or contracts with contract research organizations, clinical sites and investigators, between UGNX and any Third Party, subject to any consent required by such Third Party, which consent UGNX shall use Commercially Reasonable Efforts to obtain on behalf of KHK; and
(d) provide KHK with copies of all reports and data obtained by UGNX or its Affiliates be made pursuant to this Agreement regarding the Development and the Commercialization of Licensed Products, including any UGNX Clinical Data, which KHK may use for any purpose. As promptly as possible after any such termination, UGNX shall execute any and all documents of any Regulatory Authorities so as to allow KHK to make immediate use of any data, records and Regulatory Filings transferred by UGNX to KHK pursuant to this Section 15.7.3Agreement) plus three percent (3%).
15.7.4 KHK shall make the payments due under Section 15.5, if applicable under the provisions thereof, with respect to the applicable country(ies)
Appears in 2 contracts
Samples: Merger Agreement (Pacific Energy Partners Lp), Merger Agreement (Plains All American Pipeline Lp)
Effect of Certain Terminations. Upon the termination of this Agreement by either Party CVT pursuant to Section 15.2.1 for breach 12.3 above, or Section 15.2.2 for insolvency or by KHK upon termination of CVT’s license with respect to a given Target and specific Market Area under Section 15.3 6.2(b), or 15.4, the following provisions upon termination by PTC of this Agreement under Sections 12.6 or 12.7(a) or of one or more licenses to CVT under Section 15.7 will apply. In 12.7(b), then as of the event effective date of any such early termination concerns only a specific country or countries termination, all licenses granted to CVT pursuant to Section 15.34.6 in the case of termination of this Agreement under Section 12.3, 12.6 or 12.7(a) (or only the license terminated by PTC for the applicable Market Area under Section 6.2(b) or terminated by PTC under Section 12.7(b)) shall terminate and CVT shall transfer and assign to PTC the following shall apply solely with respect in each case, only as it relates to Lead Compounds, IND Candidates and Licensed Products covered by such country(ieslicenses (or license) and the Agreement shall otherwise remain in effect in accordance with its terms for so terminated: (i) all non-terminated countries:
15.7.1 The rights clinical and licenses granted by XXX clinical data and information relating to UGNX hereunder the Lead Compounds, IND Candidates and UGNX’s obligations to share Development Costs pursuant to this Agreement will terminate Licensed Products in CVT’s, its Affiliates’ or Sublicensees’ possession; (ii) regulatory documentation with respect to the terminated country(ies);
15.7.2 UGNX shall immediately Lead Compounds, IND Candidates and Licensed Products, including all INDs, all Regulatory Approvals with respect to Licensed Products and drug master files and drug dossiers with respect to Licensed Products; (aiii) cease conducting any Commercialization copies of all reports, records, regulatory correspondence and other documents and/or materials in CVT’s, its Affiliates’ or Sublicensees’ possession relating to the non-clinical and clinical development, Regulatory Approval, manufacture, distribution and/or sale of the Lead Compounds, IND Candidates and Licensed Products as reasonably required, to transition all data and information relating to development, manufacturing and commercialization activities with respect to the Lead Compounds, IND Candidates and Licensed Products to PTC, including without limitation safety databases and such reports, records, regulatory correspondence and other materials relating to process conditions, in-process controls, analytical methodology and formulation, in each case as developed by CVT, its Affiliates or Sublicensees and relating to the manufacture of the Lead Compounds, IND Candidates or Licensed Products; and (biv) discontinue making any representation regarding with respect to product trademarks or trademark applications (specifically excluding general corporate trademarks of CVT) used in commerce that relate solely to Licensed Products, CVT’s, its status Affiliates’ and Sublicensees’ rights in and to such product trademarks. In addition, in each case only as it relates to Lead Compounds, IND Candidates and Licensed Products covered by the licenses (or license) terminated under this Section 12.4, CVT shall grant to PTC a licensee or distributor of KHK transferable (subject to Section 4.7), sublicensable (subject to Section 4.7), non-exclusive license under the CVT Base Technology in the Territory for the relating to said Lead Compounds, IND Candidates and Licensed Products, subjectfor so long as such said Lead Compounds, in either such caseIND Candidates and Licensed Products are marketed, to requirements of Applicable Laws make, have made, use, have used, sell, have sold, offer for sale, distribute, have distributed, export, have exported, import and to a reasonable wind-down have imported said Lead Compounds, IND Candidates and transition period (not to exceed [***] days);
15.7.3 Subject to Applicable Laws, UGNX shall promptly :
(a) transfer to KHK or KHK’s designee all Regulatory Filings (for clarity, including registrations as an IND holder or equivalent), Marketing Approvals and Pricing and/or Reimbursement Approvals owned by UGNX for the Commercialization of the Licensed Products, if such transfer is possible, or, if such transfer is not possible, then at KHK’s discretion (i) withdraw any such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Commercialization of the Licensed Products in its name and take all actions necessary or useful to support KHK’s or KHK’s designee’s submission of Regulatory Filings and the achievement of Marketing Approvals and Pricing and/or Reimbursement Approvals Field in the name Territory. To the extent CVT, or any of KHK its Affiliates or KHK’s designee with respect to Sublicensees, is engaged in the Commercialization manufacture of the Lead Compounds, IND Candidates or Licensed Products which are covered by such terminated licenses (or (ii) provide KHK with access tolicense), and grant KHK the right and license to use and to reference, such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals then in its name applicable to the Commercialization of the Licensed Products;
(b) provide KHK with copies of all material correspondence between UGNX and Regulatory Authorities with respect to such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Licensed Products, and any and all other clinical and non-clinical data, records and tabulations, in all such cases with respect to the Licensed Products, that UGNX holds as of the date of notice of termination by CVT under Section 12.3 (or by PTC under Sections 12.6, 12.7, or 6.2(b)), CVT or such Affiliate or Sublicensee shall, if requested in writing by PTC, manufacture and supply PTC’s requirements for such Lead Compounds, IND Candidates and/or Licensed Products from the effective date of such termination until the earlier of such time as PTC secures an alternative commercial manufacturing source, or until [*] months from the effective date of termination in the case of supply of a Lead Compound or an IND Candidate, or until [*] months from the effective date of termination in the case of supply of a marketed Licensed Product, in any case at [*] percent ([*] %) of CVT’s, its Affiliates’ or Sublicensees’ cost of goods (as determined in accordance with generally accepted accounting principles in the United States) or [*] percent ([*] %) of CVT’s, its Affiliates’ or Sublicensees’ out-of-pocket procurement cost. Nothing herein shall require CVT or its Affiliates or Sublicensees to transfer any equipment or facilities to PTC. [*] Certain information on this page has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the Licensed Products;
(c) assign to KHK all agreements specific to the conduct of Clinical Trials for the Licensed Products (to the extent assignable and excluding any such agreements that also involve Clinical Trials for other UGNX products that are not Licensed Products), including agreements or contracts with contract research organizations, clinical sites and investigators, between UGNX and any Third Party, subject to any consent required by such Third Party, which consent UGNX shall use Commercially Reasonable Efforts to obtain on behalf of KHK; and
(d) provide KHK with copies of all reports and data obtained by UGNX or its Affiliates pursuant to this Agreement regarding the Development and the Commercialization of Licensed Products, including any UGNX Clinical Data, which KHK may use for any purpose. As promptly as possible after any such termination, UGNX shall execute any and all documents of any Regulatory Authorities so as to allow KHK to make immediate use of any data, records and Regulatory Filings transferred by UGNX to KHK pursuant to this Section 15.7.3omitted portions.
15.7.4 KHK shall make the payments due under Section 15.5, if applicable under the provisions thereof, with respect to the applicable country(ies)
Appears in 1 contract
Samples: Collaboration and License Agreement (Cv Therapeutics Inc)
Effect of Certain Terminations. In the event of a termination of this Agreement pursuant to Section 11.3, or termination by Array pursuant to Section 11.2 or Section 11.4, all [***] under this Agreement shall be deemed “Abandoned Products.” Promptly after termination of this Agreement pursuant to Section 11.3, or termination by Array pursuant to Section 11.2 or Section 11.4, Amgen shall assign and transfer to Array the regulatory filings pertaining to each Abandoned Product. Should Amgen have any inventory of the Abandoned Products suitable for use in clinical trials, then Amgen and Array shall, upon request by Array, negotiate in good faith for Amgen to sell such inventory to Array (which sale would include an appropriate indemnity from Array for any liability resulting from use of such inventory). If any Abandoned Product is being commercialized as of the date of any such termination, the Parties will agree upon a plan to transition the commercialization of such Abandoned Product from Amgen to Array as soon as reasonably practicable. To facilitate continued access to Product by existing patients, Amgen (and, if applicable, its Sublicensees) shall have the right, but not the obligation, to continue to sell such Abandoned Product after any such termination in countries where such Abandoned Product was sold prior to such termination (subject to the payment to Array of royalties on Net Sales on the terms set forth in this Agreement), provided however, that (i) such right shall terminate, on a country-by-country basis, subject to Amgen’s ethical and safety obligations and compliance with Law, upon the earlier of (A) as soon as practicable, but in no event later than thirty (30) days, after transfer of the Marketing Approval for such Abandoned Product in such country to Array or (B) within ninety (90) days of such time that Array or a sublicensee of Array begins to commercially sell such Abandoned Product in the applicable country and Amgen’s receipt of a notice thereof from Array (such period of time, the “Post-Term Sales Period”), (ii) such Abandoned Product shall not be sold at discounts greater than the discounts previously provided to such purchaser for the Abandoned Product in the applicable country, and (iii) Amgen agrees to cease, and shall use reasonable efforts to wind-down as quickly as reasonably practicable, its promotion and marketing of the Abandoned Product after termination of this Agreement. Upon the request of Array following any such termination of this Agreement by either Party Array pursuant to Section 15.2.1 11.2 for breach or Section 15.2.2 for insolvency or Amgen’s material breach, by KHK under Section 15.3 or 15.4, the following provisions of this Section 15.7 will apply. In the event any such early termination concerns only a specific country or countries Array pursuant to Section 15.311.4, the following shall apply solely with respect to such country(ies) and the Agreement shall otherwise remain in effect in accordance with its terms for all non-terminated countries:
15.7.1 The rights and licenses granted or by XXX to UGNX hereunder and UGNX’s obligations to share Development Costs Amgen pursuant to this Agreement will terminate Section 11.3, Amgen shall reasonably cooperate with respect to the terminated country(ies);
15.7.2 UGNX shall immediately (a) cease conducting any Commercialization activities with respect to the Licensed Products and (b) discontinue making any representation regarding its status Array, as a licensee or distributor of KHK in the Territory for the Licensed Products, subject, in either such casemay be reasonably requested by Array, to requirements of Applicable Laws and to a reasonable wind-down and transition period (not to exceed [***] days);
15.7.3 Subject to Applicable Laws, UGNX shall promptly :
(a) transfer to KHK or KHK’s designee all Regulatory Filings (for clarity, including registrations as an IND holder or equivalent), Marketing Approvals and Pricing and/or Reimbursement Approvals owned by UGNX for the Commercialization of the Licensed Products, if such transfer is possible, or, if such transfer is not possible, then at KHK’s discretion (i) withdraw any such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Commercialization of the Licensed Products put Array in its name and take all actions necessary or useful to support KHK’s or KHK’s designee’s submission of Regulatory Filings and the achievement of Marketing Approvals and Pricing and/or Reimbursement Approvals in the name of KHK or KHK’s designee contact with respect to the Commercialization of the Licensed Products or (ii) provide KHK with access to, and grant KHK the right and license to use and to reference, such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals then in its name applicable to the Commercialization of the Licensed Products;
(b) provide KHK with copies of all material correspondence between UGNX and Regulatory Authorities with respect to such Regulatory Filings, Marketing Approvals and Pricing and/or Reimbursement Approvals for the Licensed Products, and any and all other clinical and non-clinical data, records and tabulations, in all such cases with respect to the Licensed Products, Third Party manufacturers that UGNX holds are as of the effective date of termination with respect such termination, manufacturing Abandoned Products for, and pursuant to a contract with, Amgen and reasonably cooperate in the Licensed Products;
transfer of manufacturing arrangements regarding Abandoned Products to Array (c) assign which may include, where reasonable and permitted by such contractual arrangements, assignment to KHK all agreements specific to the conduct Array of Clinical Trials for the Licensed Products (contracts to the extent assignable and excluding any such agreements that also involve Clinical Trials for other UGNX products that are not Licensed related to Abandoned Products), including agreements or contracts with contract research organizations, clinical sites and investigators, between UGNX and any Third Party, subject to any consent required by such Third Party, which consent UGNX shall use Commercially Reasonable Efforts to obtain on behalf of KHK; and
(d) provide KHK with copies of all reports and data obtained by UGNX or its Affiliates pursuant to this Agreement regarding the Development and the Commercialization of Licensed Products, including any UGNX Clinical Data, which KHK may use for any purpose. As promptly as possible after any such termination, UGNX shall execute any and all documents of any Regulatory Authorities so as to allow KHK to make immediate use of any data, records and Regulatory Filings transferred by UGNX to KHK pursuant to this Section 15.7.3.
15.7.4 KHK shall make the payments due under Section 15.5, if applicable under the provisions thereof, with respect to the applicable country(ies)
Appears in 1 contract
Samples: Collaboration and License Agreement (Array Biopharma Inc)