Manufacturing and Commercialization Agreement, dated April 30, 2020, by and between the Registrant and Corium, Inc
Information in this exhibit identified by [***] is confidential and has been excluded pursuant to Item 601(b)(10)(iv) of Regulation S-K because it is both (i) not material and (ii) would likely cause competitive harm to the registrant if publicly disclosed.
MANUFACTURING AND COMMERCIALIZATION AGREEMENT
This Manufacturing and Commercialization Agreement (the “Agreement”) is entered into as of April 30, 2020 (the “Effective Date”) between Corium, Inc., a Delaware corporation having its principal place of business at 235 Constitution Drive, Menlo Park, CA 94025 and its manufacturing operations at 4558 50th Street, S.E., Grand Rapids, MI 49512, including its Affiliates (“Corium”), and Agile Therapeutics, Inc., a Delaware corporation, having its principal place of business at 101 Poor Farm Road, Princeton, NJ 08540, including its Affiliates (“Agile”). Corium and Agile shall be referred to individually as a “Party” and collectively as the “Parties”.
For purposes of this Agreement, the following terms shall have the respective meanings set forth below:
|ARTICLE 2:||MANUFACTURE OF THE PRODUCT|
(c)Technical Support. To facilitate an orderly transfer of the Manufacture of the Product to a qualified second source in the event Agile exercises its rights under Section 2.4(b), Corium shall provide the Affiliate or Third Party Manufacturer with all necessary technical assistance in the form of reasonable consulting services to be provided by Corium personnel at Agile’s or the Third Party Manufacturer’s facility at Agile’s expense. Such consulting services shall not require Corium to divulge any proprietary Know-How or trade secrets unless pursuant to specific licensing, confidentiality, and other terms and conditions reasonably agreed to by Corium in advance.
(d)Supporting License. Corium shall grant to Agile and/or its designated Affiliate or Third Party Manufacturer(s), as directed by Agile, a non-exclusive, non-transferable, non-sublicensable, limited right to [***], but solely to the extent necessary to enable Agile, its Affiliate, and/or such Third Party Manufacturer to manufacture the Product for Agile pursuant to Section 2.4(b). Such license shall be subject to the provisions of Section 6.4 hereof.
|ARTICLE 3:||COMMERCIALIZATION AND SUPPLY.|
|a.||Corium shall notify Agile promptly, in writing, of any circumstance that may cause a material delay in Manufacturing and supplying Product or a material delay or inability to meet Agile’s forecast, stating the estimated period of delay and the reasons therefor. Corium shall use commercially reasonable efforts to avoid or minimize the delay, including, when necessary or at Agile’s reasonable request, the expenditure of premium time and shipping by air or other expedited routing. Costs associated with delays directly caused by the actions or inactions of one Party shall be borne by that Party; other costs shall be allocated equitably among the Parties.|
|b.||“Supply Delay” means, solely for purposes of this Section, Corium’s failure to deliver [***] of the Product ordered under an accepted Purchase Order due to reasons under the reasonable control of the Corium within [***] of the delivery date. A Supply Delay will not be deemed to occur if (i) such failure is caused by a Force Majeure Event, or (ii) the volume ordered exceeds [***] of the volume set forth in the applicable Firm Forecast (but only in respect of the excess). Beginning [***], in the event of a Supply Delay, Corium shall credit Agile on Product invoices an amount equal to [***].|
|ARTICLE 5:||CONFIDENTIAL INFORMATION|
|ARTICLE 6:||LICENSE AND OWNERSHIP|
|ARTICLE 7:||REPRESENTATIONS AND WARRANTIES|
|ARTICLE 9:||LIMITATION OF LIABILITY|
|ARTICLE 10:||COMPLIANCE WITH LAW|
|ARTICLE 11:||TERM AND TERMINATION: MODIFICATION OF RIGHTS|
If to Agile:Agile Therapeutics, Inc.
101 Poor Farm Road
Princeton, NJ 08540
Attention: General Counsel
With a copy to: _____________
If to Corium:Corium, Inc.
235 Constitution Drive
Menlo Park, CA 94025
Attention: Head of Corporate Development/Legal Department
All notices shall be deemed to be effective five days after the date of mailing (but only if followed by certified or registered confirmation). Either Party may change the address at which notice is to be received by written notice pursuant to this Section 12.4.
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the date first written above by their duly authorized representatives.
AGILE THERAPEUTICS, INC.
The amount of Product ordered by Agile [***].
Agile Owned Equipment