Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly for any reason or by Licensee pursuant to Section 12.02, at Lilly's option and upon Lilly's written request, and at Licensee's expense, the following provisions shall apply: (a) Subject to Section 12.06(b), Licensee shall, at its sole expense, transfer to Lilly (or its nominee) all physical inventories of Licensed Compound and Licensed Product, and all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications (to the extent assignable and not cancelled) assigned to Licensee by Lilly hereunder to the extent relating to Licensed Product then being Commercialized or in Development. (b) For a period of sixty (60) days after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentation, and all physical inventories of Licensed Compound and Licensed Product pursuant to Section 12.06(a) and any other transition assistance required, (ii) the grant of a royalty-bearing license to Lilly under Licensee Know-How and/or Licensee Patent Rights existing as of such effective date of termination with respect to the Licensed Product then being developed as of the date of such termination, and (iii) the transition to Lilly of all clinical trials conducted by Licensee under Licensee's IND for Licensed Product that are ongoing as of the date of termination. Such sixty (60) day period may be extended by mutual written agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within such period, the matter shall be referred to a mutually agreed upon third party expert in the valuation of life sciences assets, each Party shall provide to such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by the Parties. (c) Upon the request of Lilly, Licensee shall use reasonable efforts to assign to Lilly any sublicenses previously granted by Licensee related to Licensed Product.
Appears in 3 contracts
Samples: Exclusive Patent and Know How License Agreement, Exclusive Patent and Know How License Agreement (Cerecor Inc.), Exclusive Patent and Know How License Agreement (Cerecor Inc.)
Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly Merck for any reason or by Licensee pursuant to Section 12.02, at Lilly's Merck’s option and upon Lilly's Merck’s written request, and at Licensee's its expense, the following provisions shall apply:
(a) Subject to Section 12.06(b12.05(b), Licensee shall, at its the sole expenseexpense of Merck, transfer to Lilly Merck (or its nominee) all physical inventories of Licensed Compound and Licensed Product, and all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications (to the extent assignable and not cancelled) assigned to ), made or obtained by Licensee by Lilly hereunder or its Affiliates or any of its sublicensees to the extent relating to Licensed Product then being Commercialized or in Development.
(b) For a period of sixty (60) days after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentation, and all physical inventories of Licensed Compound and Licensed Product documentation pursuant to Section 12.06(a12.05(a) and any other transition assistance requiredthat Licensee agrees to provide, and (iib) the a license grant of a royalty-bearing license by Licensee to Lilly Merck under Licensee Know-How and/or Licensee Patent Rights existing as of such effective date of termination with respect to the Licensed Product then being developed as of the date of such termination, and (iii) . Licensee shall not have any obligation to perform such transfer or to provide such assistance or grant such licenses before the transition to Lilly of all clinical trials conducted by Licensee under Licensee's IND for Licensed Product that are ongoing as of the date of terminationParties agree upon such terms. Such The sixty (60) day period may be extended by mutual written agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within such period, the matter shall be referred to a mutually agreed upon third party expert in the valuation of life sciences assets, each Party shall provide to such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by the Parties.
(c) Upon the request of LillyMerck, Licensee shall use reasonable efforts to assign to Lilly Merck any sublicenses previously granted by Licensee related to Licensed Product.
(d) Upon the request of Merck, and to the extent that it is commercially reasonable, Licensee, its Affiliates and its sublicensees shall complete any clinical studies related to Licensed Product in the Field that (i) are being conducted under Licensee’s IND for Licensed Product and are ongoing as of the date this Agreement is terminated, and (ii) for which it is not practicable to transfer responsibility for conducting such studies to Merck; provided, however, that Merck agrees to reimburse Licensee for all Development costs incurred by Licensee after termination in completing such studies.
(e) The Parties shall use their reasonable efforts to complete the transition of the Development, Manufacture and Commercialization of the Licensed Product from Licensee to Merck pursuant to this Section 12.05 as soon as is reasonably possible.
Appears in 2 contracts
Samples: Exclusive Patent and Know How License Agreement (Cerecor Inc.), Exclusive Patent and Know How License Agreement (Cerecor Inc.)
Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly Cerecor for any reason or by Licensee pursuant to Section 12.02, at Lilly's Cerecor’s option and upon Lilly's Cerecor’s written request, and at Licensee's its expense, the following provisions shall apply:
(a) Subject to Section 12.06(b12.05(b), Licensee shall, at its Licensee’s sole expense, transfer to Lilly Cerecor (or its nomineeMerck or another nominee of Cerecor) all physical inventories of Licensed Compound and Licensed Product, and all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications (to the extent assignable and not cancelled) assigned to Licensee by Lilly hereunder to the extent relating to Licensed Product then being Commercialized or in Development[***].
(b) For a period of sixty (60) [***] days after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentation, and all physical inventories of Licensed Compound and Licensed Product documentation pursuant to Section 12.06(a12.05(a) and any other transition assistance requiredthat Licensee agrees to provide, and (iib) the a license grant of a royalty-bearing license by Licensee to Lilly Cerecor and/or Merck, as determined by Cerecor, under Licensee Know-How and/or Licensee Patent Rights existing as of such effective date of termination with respect to the Licensed Product then being developed as of the date of such termination, and (iii) . Licensee shall not have any obligation to perform such transfer or to provide such assistance or grant such licenses before the transition to Lilly of all clinical trials conducted by Licensee under Licensee's IND for Licensed Product that are ongoing as of the date of terminationParties agree upon such terms. Such sixty (60) The [***] day period may be extended by mutual written agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within such period, the matter shall be referred to a mutually agreed upon third party expert in the valuation of life sciences assets, each Party shall provide to such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by o f the Parties.
(c) Upon the request of LillyCerecor, [***].
(d) Upon the request of Cerecor, and to the extent that it is commercially reasonable, Licensee, its Affiliates and its sublicensees shall complete any clinical studies related to Licensed Product in the Field that (i) are being conducted under Licensee’s IND for Licensed Product and are ongoing as of the date this Agreement is terminated, and (ii) for which it is not practicable to transfer responsibility for conducting such studies to Cerecor; provided, however, that Cerecor agrees to reimburse Licensee for all Development costs incurred by Licensee after termination in completing such studies.
(e) The Parties shall use their reasonable efforts to assign complete the transition of the Development, Manufacture and Commercialization of the Licensed Product from Licensee to Lilly any sublicenses previously granted by Licensee related Cerecor (or Merck or another nominee of Cerecor) pursuant to Licensed Productthis Section 12.05 as soon as is reasonably possible.
Appears in 1 contract
Samples: Patent and Know How License Agreement (Alto Neuroscience, Inc.)
Licensed Product Reversion. Upon termination of this Agreement in its entirety by Lilly for any reason or by Licensee pursuant to Section 12.02, at Lilly's option and upon Lilly's written request, and at Licensee's expense, the following provisions shall apply:
(a) Subject to Section 12.06(b), Licensee shall, at its sole expense, transfer to Lilly (or its nominee) all physical inventories of Licensed Compound and Licensed Product, and all INDs, Marketing Authorizations, drug approval applications for Marketing Authorizations, and all supporting documentation for such filings and applications (to the extent assignable and not cancelled) assigned to Licensee by Lilly hereunder to the extent relating to Licensed Product then being Commercialized or in Development.
(b) For a period of sixty (60) days after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones milestones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentation, and all physical inventories of Licensed Compound and Licensed Product pursuant to Section 12.06(a) and any other transition assistance required, (ii) the grant of a royalty-bearing license to Lilly under Licensee Know-How and/or Licensee Patent Rights existing as of such effective date of termination with respect to the Licensed Product then being developed as of the date of such termination, and (iii) the transition to Lilly of all clinical trials conducted by Licensee under Licensee's ’s IND for Licensed Product that are ongoing as of the date of termination. Such sixty (60) day period may be extended by mutual written agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within such period, the matter shall be referred to a mutually agreed upon third party expert in the valuation of life sciences assets, each Party shall provide to such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by the Parties.
(c) Upon the request of Lilly, Licensee shall use reasonable efforts to assign to Lilly any sublicenses previously granted by Licensee related to Licensed Product.
Appears in 1 contract
Samples: License Agreement (Cerecor Inc.)
Licensed Product Reversion. Upon The Licensed Products existing as of the effective date of the termination of this Agreement in its entirety by Lilly for any reason or by Licensee pursuant to Section 12.02, at Lilly's option shall automatically become the “Reversion Licensed Products,” and upon Lilly's written request, and at Licensee's expense, the following provisions shall applyapply to the extent applicable:
(a) Subject to Section 12.06(b), Licensee shallTo the extent that UGNX or its Affiliates holds any Regulatory Filings or Marketing Approvals for the Reversion Licensed Products, at Mereo’s request, all of UGNX’s and its sole expenseAffiliates’ rights, transfer title and interests therein shall be assigned or transferred to Lilly (Mereo or its nominee) designee. At Mereo’s request, all physical inventories of material documents necessary to further Exploit the Reversion Licensed Compound Products and all Data generated for the Reversion Licensed ProductProducts, to the extent possessed or Controlled by UGNX or its Affiliates and not already shared with Mereo, and all INDsof UGNX’s and its Affiliates’ right, Marketing Authorizationstitle and interest therein and thereto, drug approval applications for Marketing Authorizations, shall be assigned and all supporting documentation for such filings and applications (transferred to the extent assignable and not cancelled) assigned to Licensee by Lilly hereunder to the extent relating to Licensed Product then being Commercialized Mereo or in Developmentits designee as promptly as reasonably practicable thereafter.
(b) For a period At Mereo’s request and to the extent permissible pursuant to applicable Laws, any existing agreements between UGNX or its Affiliates and any Third Party that are solely related to the Exploitation of sixty the Reversion Licensed Products, and all of UGNX’s and its Affiliates’ right, title and interest therein and thereto, shall be assigned and transferred to Mereo or its designee, in each case, to the extent permissible pursuant to the terms thereof, in which case, Mereo or its designee shall assume all of UGNX’s obligations (60but for clarity and subject to Section 14.4.4(h), not liabilities accrued by UGNX prior to such transfer) days under such transferred agreements with respect to the Exploitation of the Reversion Licensed Products after the effective date of termination, the Parties shall negotiate in good faith the financial terms (including, without limitation, royalties, mile- stones and upfronts) and conditions for (i) the transfer of all regulatory filings and documentationsuch transfer, and all physical inventories for any such agreement that by its terms cannot be so assigned, UGNX shall reasonably cooperate with Mereo to provide to Mereo the benefits of such agreement.
(c) At Mereo’s request, should UGNX or its Affiliates own or control any inventory of the Reversion Licensed Compound and Licensed Product pursuant to Section 12.06(a) and any other transition assistance required, (ii) Products suitable for use or sale in the grant of a royalty-bearing license to Lilly under Licensee Know-How and/or Licensee Patent Rights UGNX Territory existing as of such the effective date of termination with respect the termination, UGNX shall notify Mereo in writing and Mereo shall have the right (but not the obligation) to purchase such Reversion Licensed Products from UGNX at a price equal to UGNX’s or its Affiliate’s actual direct cost of procuring such Reversion Licensed Product plus an additional [***].
(d) At Mereo’s request, UGNX shall assign (or, if applicable, cause its Affiliate to assign) to Mereo all of UGNX’s (and such Affiliates’) right, title and interest in and to any trademark (including goodwill) or internet domain name or social media accounts that is specific to the Reversion Licensed Product then being developed Products and used by UGNX or any of its Affiliates in the Exploitation of the Reversion Licensed Products prior to such termination of this Agreement.
(e) Upon the effectiveness of such termination, UGNX shall grant and hereby grants (without further action required) as of such effectiveness of termination, to Mereo an exclusive perpetual, royalty-bearing, worldwide license, with the right to grant sublicenses through multiple tiers of sublicensees, under the UGNX IP and UGNX’s interest in the Joint IP, in each case, that is Controlled by UGNX or any of its Affiliates as of the date of such terminationtermination and that is necessary to Exploit such Reversion Licensed Product, solely for the purposes of Exploiting such Reversion Licensed Product, provided, to the extent a Third Party agreement under which UGNX IP is licensed to UGNX and sublicensed to Mereo pursuant to this Section 14.4.4(e) is not assigned by UGNX or its Affiliates to Mereo or its designee pursuant to Section 14.4.4(b), (iiii) Mereo shall be responsible for (A) making any payments (including royalties, milestones and other amounts) payable by UGNX to Third Parties after the transition to Lilly of all clinical trials conducted by Licensee under Licensee's IND for Licensed Product that are ongoing as of the effective date of termination. Such sixty (60) day period may be extended by mutual written such termination under such Third Party agreement of the Parties for an additional thirty (30) days. In the event that the Parties are unable to mutually agree upon the commercially reasonable compensation and terms with respect to the foregoing within Exploitation of the Reversion Licensed Product, by making such periodpayments directly to UGNX, together with necessary reporting information in sufficient time to enable UGNX to comply with its obligations under such Third Party agreements, and (B) complying with any other obligations included in such Third Party agreement and that are applicable to the Exploitation of the Reversion Licensed Products, and (ii) UGNX shall be responsible for paying or providing to any such Third Party any payments or reports made or provided by Mereo under the preceding subclause (i).
(f) During the Reversion Royalty Term, Mereo shall pay to UGNX royalties that equal to [***] of the Net Sales of the Reversion Licensed Products sold by Mereo, its Affiliates or Sublicensees, and, the matter definition of “Net Sales,” Section 8.4.3, Section 8.4.4, Section 8.5, and Section 8.8 to Section 8.11 shall be referred apply, mutatis mutandis to a mutually agreed upon third party expert the calculation, payment, recording, and auditing of such royalties payable by Mereo for the Reversion Licensed Product.
(g) At Mereo’s request and discretion, UGNX shall return to Mereo or destroy all literature, samples and other sales or sales training materials for the Reversion Licensed Product in the valuation possession of life sciences assetsUGNX and its Affiliates as promptly as practical after the date of such termination (to the extent then existing). At Mereo’s request, UGNX shall provide Mereo with copies of lists of distributors and purchasers of the Licensed Product in the UGNX Territory as of the effective date of termination.
(h) The Parties will use Commercially Reasonable Efforts to complete all transfer and transition activities required in this Section 14.4.4 as promptly as practicable following the effective date of such termination and each Party shall provide be responsible for its own Costs in connection therewith, unless this Agreement is terminated by UGNX pursuant to Section 14.2.1 or Section 14.2.2, in which case Mereo shall bear all such third party all information in its control necessary for such third party to resolve such matter, and the costs for such expert shall be borne equally by the PartiesCosts.
(c) Upon the request of Lilly, Licensee shall use reasonable efforts to assign to Lilly any sublicenses previously granted by Licensee related to Licensed Product.
Appears in 1 contract
Samples: Collaboration and License Agreement (Mereo Biopharma Group PLC)