CO-PROMOTION AGREEMENT
This
CO-PROMOTION AGREEMENT (this “Agreement”) effective as of the [___] day of
December, 2007 (“Effective Date”)
between AURIGA LABORATORIES,
INC., a corporation organized and existing under the laws of the State of
Delaware and having its principal office at 00000 Xxxxx Xxxxxx Xxxx, Xxxxx 000,
Xxx Xxxxxxx, XX (“Auriga”), and XXXXXXXXXXX PHARMACEUTICALS INC._
a corporation organized and existing under the laws of the State of
Delaware and having its principal office at 00000 Xxxxxx Xxxxxxx Xxxxxxx,
Xxxxxxxxxx, XX (“XxxxxxXxxxx”). Auriga
and XxxxxxXxxxx may be referred to individually as a “Party” and
collectively as “Parties”.
WHEREAS,
the Parties desire to enter into this Co-Promotion Agreement with respect to the
Product in the Territory.
The
following capitalized terms, when used in this Agreement, shall have the
meanings given to them below:
“Affiliate” shall mean
any corporation or other business entity that directly or indirectly controls,
is controlled by, or is under common control with a Party. Control means
ownership or other beneficial interest in fifty percent (50%) or more of the
voting stock or other voting interest of a corporation or other business
entity.
“Baseline TRx Extended
Units”***.
“Detailing” or “Detail” shall mean an
in person visit by a professional sales representative who is part of the Sales
Force to a PCP who is legally entitled to prescribe the Product, which visit is
for the purpose of making a presentation about the Product (which may, or may
not, be in conjunction with making a presentation about Auriga products as well)
and where key attributes and characteristics of the Product are verbally
presented to the PCP along with Marketing Materials.
“Co-Promotion Fee”
shall mean have the meaning set forth in Section 2.4.
“FDA” shall mean the
United States Food and Drug Administration.
“FD&C” shall mean
the United States Food Drug and Cosmetics Act found in Title 00, Xxxxxxx 0 xx
xxx Xxxxxx Xxxxxx Code.
“Good Manufacturing
Practices” shall have the meaning set forth in 21 C.F.R.
110.
“IMS” shall mean [the
pharmaceutical marketing intelligence company IMS Health Inc.]
“IMS National Prescription
Audit” shall mean [IMS’ National Prescription Audit Plus Services that
tallies the national prescriptions of all pharmaceutical products sold from
retail pharmacies].
“Marketing Plan” shall
mean a plan for marketing and Detailing of the Product, including monthly
Product sales forecasts for the Territory and a marketing budget which may be
prepared by XxxxxxXxxxx.
“Net Sales” shall mean
* * *.
“PCP” shall mean
doctors of medicine or osteopathy with a primary practice office location in the
Territory, which includes Physicians classified by IMS as Family Practice,
Primary Care Physicians, General Medicine or Internal Medicine, and shall also
include nurse practitioners, physician assistants, and other mid-level
practitioners who may prescribe Product within their scope of practice, either
through collaborative practice arrangements with doctors of medicine or
osteopathy or otherwise and who fall into the above IMS
classifications.
“PDMA” shall mean the
Prescription Drug Marketing Act of 1987.
“Performance Metric”
shall have the meaning set forth in Schedule 1.
“Product” shall mean
XxxxxxXxxxx'x product known as * * *.
“Promotional Expenses”
shall mean actual direct costs for promotional items and Samples ordered from
XxxxxxXxxxx by Auriga for use in the promotion of the Product.
“Residual Fee” shall
have the meaning set forth in Section 2.4 (b).
“Sample”
shall mean a Unit of Product Packaged as a sample that is not intended to be
sold and is intended to promote the same of such Product.
“Territory” shall mean
the United States of America, including its territories and
possessions.
“Third Party” shall
mean a party other than Auriga or XxxxxxXxxxx or their respective
Affiliates.
“Trademark” shall mean
the trademark “Keflex”.
“TRx Extended Units”
shall mean total prescription extended units of Product in the Territory as
reported by IMS National Prescription Audit.
“Unit” shall mean a
unit of TRx Extended Units.
“Wholesale Acquisition
Cost” or “WAC” shall mean
XxxxxxXxxxx’x list price per Unit for the Product to wholesalers or direct
purchasers in the Territory, before deductions for prompt pay or other
discounts, rebates or reductions in price, the most recent month for, which the
information is available, as reported in the wholesale price guides or other
publications of drug or biological pricing data.
2.1.
Co-Promoter.
(a) XxxxxxXxxxx
hereby appoints Auriga as the co-promoter of the Product for purposes of
Auriga’s promotion of the Product through its Sales Force to
PCPs. Auriga accepts such appointment and agrees to promote the
Product through the Sales Force only to PCPs in a manner consistent with this
Agreement and the directions of XxxxxxXxxxx for the Product. Neither Party shall
authorize any Third Party to promote the Product to PCPs. XxxxxxXxxxx
represents and warrants to Auriga that as of the Effective Date, no Third Party
is authorized to promote the Product to PCPs. Auriga, through the Sales Force,
shall have the co-exclusive right, along with Xxxxxxxxxxx, to promote the
Product to PCPs.
(b) At
Auriga’s sole cost and expense, Auriga agrees to use diligent efforts at a level
equal to the highest industry standards to market and promote the Product
through the Sales Force to PCPs, all in a manner similar to the promotion of
Auriga manufactured products. Without limiting the foregoing, Auriga agrees: (1)
to establish and maintain a commercially reasonable and sufficient number of,
employed sales representatives to comprise the Sales Force whose responsibility
includes Detailing the Product to PCPs; (2) to train such Sales Force with
respect to the proper and acceptable Detailing of the Product using the training
materials provided by XxxxxxXxxxx pursuant to Section 2.2(a)(iii) below),
and (3) to use such Sales Force to actively promote the Product in accordance
with the Performance Metrics detailed in Schedule 1. XxxxxxXxxxx reserves and
retains the right to promote the Product to PCPs within the Territory, provided,
that (i) all such promotion shall be solely at XxxxxxXxxxx’x cost and
expense, and (ii) all amounts generated from sales resulting from such
promotion shall be included as Net Sales for purposes of determining Auriga’s
compensation, unless otherwise agreed to beforehand by the
Parties. Auriga sales representatives shall at all times while
marketing and promoting the Product to PCPs, be subject to XxxxxxXxxxx’x
policies and procedures (if any) related to the marketing and promotion of the
Product (“XxxxxxXxxxx
Policies”) which have been provided to Auriga. At all times, Auriga’s
sales representatives shall also be subject to Auriga’s policies and procedures
(if any) related to the marketing and promotion of Auriga’s products; to the
extent that Auriga policies and procedures are inconsistent with XxxxxxXxxxx’x
then current policies and procedures (if any) related to the marketing and
promotion of the Product which have been provided to Auriga, the policy or
procedure which is more restrictive shall apply in connection with the
Product.
(c) The
Parties agree that the commercial launch date of the Product by Auriga shall be
on or before thirty (30) days from the Effective Date.
(d) *
* *.
(e) Auriga
represents and warrants that it shall, and shall require that its Sales Force:
(1) at all times comply with any and all laws, rules, regulations, PDMA
guidelines and/or professional requirements applicable to the sale and marketing
of pharmaceutical products generally and the Product specifically; (2) at all
times provide services under this Agreement in a professional, ethical and
competent manner; (3) not make any misleading statements, claims or warranties
that are inconsistent with the FDA labeling for the Product approved at the time
such statements, claims or warranties are made; and (4) not disparage or present
in a negative light the Product, the Trademark and/or XxxxxxXxxxx. XxxxxxXxxxx
represents and warrants that it: (i) shall at all times comply with any and all
laws, rules, regulations, PDMA guidelines and/or professional requirements
applicable to the manufacture and sale of pharmaceutical products generally and
the Product specifically; (ii) shall at all times provide services under this
Agreement in a professional, ethical and competent manner; and (iii) shall not
disparage or present in a negative light Auriga.
(f) Auriga
shall promote the Product only under and by use of the Trademark and shall not
use any other trademark(s) in the promotion of the Product without the prior
written approval of XxxxxxXxxxx. Auriga represents that it shall use the
Trademark (and any other trademark(s), if any, used by Auriga as approved by
XxxxxxXxxxx) only in a manner consistent with XxxxxxXxxxx’x trademark usage
guidelines communicated to Auriga. Auriga shall permit XxxxxxXxxxx, at
XxxxxxXxxxx’x expense and upon reasonable notice, to review and audit Auriga’s
usage of the Trademark (or any other trademark(s), if any, used by Auriga as
approved by XxxxxxXxxxx).
(g) Auriga
shall be responsible for promotion of the Product in accordance with the
Marketing Plan, or as otherwise communicated to Auriga by XxxxxxXxxxx, and only
through the use of sales, promotional, Samples, advertising and/or similar
materials (the “Marketing Materials”)
provided by XxxxxxXxxxx. XxxxxxXxxxx shall be entitled to deduct
Promotional Expenses from future Co-Promotion Fee payments to Auriga
hereunder. Auriga agrees that it will not make any changes to any FDA
approved promotional materials or Samples without XxxxxxXxxxx’x prior written
consent, such consent not to be unreasonably withheld or delayed. Where
necessary, XxxxxxXxxxx shall be responsible for securing any legal or regulatory
approvals required for any Marketing Materials.
(h) Each
Party, at its sole cost and expense, shall obtain and at all times maintain in
full force and effect all necessary licenses, permits and/or other
authorizations or approvals, as required by law, regulation, ordinance or
statute as may be necessary to allow and permit it to undertake and carry out
its duties and obligations as set forth in this Agreement.
(i) *
* *.
(j)
XxxxxxXxxxx will provide access to its sales training team to train the Auriga
Sales Force. Additionally, XxxxxxXxxxx will participate in the
setting up of the initial training modules and will provide Auriga all available
training materials to assist in the completion of a sales training
module. All training materials will be approved by XxxxxxXxxxx prior
to use by the Auriga field sales team.
(k)
Auriga shall not sell or distribute the Products, place journal or other
advertisements for the Product, issue press releases regarding the Product
(however Auriga May refer to the Product in a non-promotional manner in its
corporate press releases, financial statements, annual and quarterly reports and
filings with the Securities and Exchange Commission or other regulatory bodies,
as provided in the License Agreement), conduct opinion leader development
activity in connection with the Product, establish advisory boards concerning
the Product, participate in or conduct peer selling activity concerning the
Product, enter into or discuss with customers or potential customers (including,
without limitation, managed care organizations) contracts for the sale of or
discounts or rebates on the sale of Product or conduct other general marketing
activities (other than the Detailing of the Product to the extent expressly
permitted by this Agreement) with respect to the Product. These shall be among
the activities for which XxxxxxXxxxx shall remain solely
responsible.
(a) During
the Term of this Agreement, XxxxxxXxxxx shall be responsible for:
(i) Manufacturing,
packaging, labeling, shipping, warehousing and distributing the Product in the
Territory, or having the forgoing effected by its licensors, licensees,
Affiliates or Third Parties.
(ii) Accepting
of orders, invoicing customers and the collecting of receivables resulting from
sales of the Product in the Territory.
(iii) Development
of training materials with respect to the Product, which it shall make available
to Auriga for training Auriga’s Sales Force assigned to the
Product.
(iv) Providing
customer service activities, medical information services (including response to
medical inquiries) and regulatory filings and activities.
(b) All
Product returned to Auriga shall be shipped by Auriga to the nearest facility of
XxxxxxXxxxx or its designee. Auriga shall incur no liability in the
handling or expense of such returns, provided such return to Auriga is not the
result of any action of Auriga.
(c) All
sales of the Product in the Territory shall be invoiced by XxxxxxXxxxx, and
Auriga shall be paid its compensation as specified hereunder on all sales of the
Product in the Territory, whether made by XxxxxxXxxxx, Auriga or any other party
unless otherwise agreed to beforehand by the Parties.
(d) All
terms of sale including, without limitation, policies concerning pricing, credit
terms, cash discounts and returns and allowances shall be set by XxxxxxXxxxx
consistent with XxxxxxXxxxx’x normal internal selling practices; provided,
however, that the foregoing shall not permit XxxxxxXxxxx to set any pricing
terms with respect to Product Samples sold to Auriga which are inconsistent with
the terms of this Agreement.
(e) All
customer orders for the Product shall be received and executed by XxxxxxXxxxx or
its designee. If Auriga receives any such orders it shall refer such to
XxxxxxXxxxx. XxxxxxXxxxx, or its designee, shall use reasonable efforts to fill
Product orders. It is recognized by the Parties that Auriga may from
time to time receive orders for the Product directly from Third
Parties. In such event, Auriga promptly shall advise the customer
that Auriga is not authorized to accept orders for the Product, but that Auriga
will forward the order to XxxxxxXxxxx for acceptance or rejection at
XxxxxxXxxxx’x sole discretion. Immediately thereafter, Auriga shall
transmit said orders and purchase order numbers promptly to XxxxxxXxxxx for
acceptance or rejection at XxxxxxXxxxx’x sole discretion. XxxxxxXxxxx
shall assume all shipping and handling charges with respect to such
orders.
(f) Each
Party shall promptly notify the other Party of any event(s) or occurrence that
materially affect(s) or which reasonably appear could materially affect the
marketing and sale of the Product in the Territory, including, not by way of
limitation, any and all governmental inquiries or requests for information
relating to the Product. XxxxxxXxxxx shall have the sole authority to handle all
governmental inquiries or requests for information about the content and
chemical properties concerning the Product and Auriga shall, upon the request
and at the sole cost and expense of XxxxxxXxxxx unless the inquiry is related to
Auriga’s responsibilities, including without limitation Detailing, under this
Agreement, provide XxxxxxXxxxx assistance in responding to any such governmental
inquiries or requests for information.
(g) Without
limiting the generality of Section 2.2(f) above, Auriga shall give
XxxxxxXxxxx notice of any Product complaint, including but not limited to any
“Adverse Drug
Experience” (as defined in 21 CFR 314.80 or any successor provision
thereto) about which Auriga obtains information, in accordance with the
following procedure:
(i) Information
concerning any Adverse Drug Experience or any clinical complaint associated with
the Product shall be reported to XxxxxxXxxxx’x designated medical liaison by
telefax within twenty-four (24) hours and by hard copy in writing within three
(3) days after initial receipt of such information;
(ii) Auriga’s
report to XxxxxxXxxxx under Section 2.2(g)(i) shall contain (a) the
date the report was received by Auriga; (b) the name of the reporter;
(c) the address and telephone number of the reporter; (d) how, when and
where the “occurrence” took place; (e) the names and addresses of any injured
persons and witnesses; (f) the nature and location of any injury or damage
arising out of the “occurrence”; and (g) an indication of the adverse drug
experience.
(iii) All
other non-clinical Product complaints not covered by (i) above shall be
reported to XxxxxxXxxxx in writing at least once each month.
(h) XxxxxxXxxxx
shall be responsible to respond to any patient having an Adverse Drug Experience
and to respond to any regulatory agencies with respect to technical and medical
complaints regarding the Product.
(i) Auriga
shall refer all medical information requests to XxxxxxXxxxx and shall provide
assistance as requested by XxxxxxXxxxx in responding to such
requests.
(j) XxxxxxXxxxx
shall have the authority and responsibility to: (1) investigate all Adverse Drug
Experiences and non-clinical complaints associated with the Product, including
those reported to XxxxxxXxxxx by Auriga, and (2) as required or otherwise
appropriate, to report such information to the FDA. In addition, so long as
Auriga is a co-promoter of the Product, XxxxxxXxxxx shall provide Auriga with a
summary of all Adverse Drug Experiences and clinical complaints received by
XxxxxxXxxxx, during each calendar quarter and all material comments of the FDA
with respect thereto within thirty (30) days after the end of such calendar
quarter.
(k) For
all Adverse Drug Experiences or other information reportable to XxxxxxXxxxx,
Auriga and its employees, representatives and agents will not make any statement
or give any opinion (written or verbal) to anyone that could be construed as an
admission of fault on XxxxxxXxxxx’x part or a promise that XxxxxxXxxxx will
compensate anyone. Auriga, its employees, representatives and agents
may only promise to report the Adverse Drug Experience or other information
reportable to XxxxxxXxxxx and follow the appropriate procedures as outlined
herein.
(l) XxxxxxXxxxx
shall: (i) manufacture the Product or cause the same to be manufactured in
conformance with all applicable federal, state and local statutes, ordinances
and regulations, (including, without limitation, the FD&C and the
regulations thereunder such as current Good Manufacturing Practices), as the
same may be amended from time to time, (ii) not ship Product which at the
time of shipment is known by XxxxxxXxxxx to be adulterated or misbranded within
the meaning of the FD&C, and (iii) not ship Product which at the time
of shipment is known by XxxxxxXxxxx to be a product which would violate any
section of the FD&C if introduced into interstate commerce.
(m) Subject
to Section 2.2(d), XxxxxxXxxxx agrees that it shall conduct all price
negotiations in good faith and on an arms length basis.
(n) If
in the view of either Party there is a change in market conditions which affects
the economics of this Agreement, both Parties will discuss modifications to this
Agreement to address such changed market conditions. However, neither Party
shall be obligated to agree to such modifications to the terms of this
Agreement. If the Parties are unable to reach an agreement as to modifications
to the terms of this Agreement within thirty (30) days of the Parties
beginning discussions under this Section 2.2(m), either Party may terminate this
Agreement upon ten (10) days written notice to the other
Party.
(o) XxxxxxXxxxx
shall furnish and make available, as reasonably requested by Auriga, all readily
available information on the efficacy and safety of the Product, as may
reasonably be necessary to assist Auriga in its promotion and marketing of the
Product in the Territory.
(p) If
any employee of Auriga, receives notice of Product tampering or notice of
information concerning any incident that causes any Product or its labeling to
be mistaken for, the employee of Auriga shall immediately contact XxxxxxXxxxx’x
product complaint hotline by phone at 0 (000) 000-0000 (or such person(s),
address(es) and phone numbers(a) as XxxxxxXxxxx may designate from time to time
by written notice to Auriga).
(p) *
* *.
2.3.
Dispute
Resolution.
Should
the Parties fail through good faith efforts to agree on a matter or resolve any
dispute, the matter or dispute shall be referred to the President of XxxxxxXxxxx
and the President of Auriga for their good faith efforts at a resolution. This
Section shall in no way be construed so as to limit any of the rights the
Parties may whether contained within this Agreement or otherwise.
2.4.
Reporting and
Payment.
(a)* * *.
(b) *
* *
(c) All
sums due under this Agreement shall be payable in U.S. Dollars by federal funds
wire transfer or by check as instructed in writing by the Party to receive such
payment from time to time. Auriga shall be solely responsible for all taxes that
may be due to any governmental authority in connection with the payments made to
it by XxxxxxXxxxx hereunder. All amounts due under
Section 2.4(a) shall be paid in calendar quarterly payments within
forty-five (45) days following the end of each respective calendar quarter;
provided, however, that in the event this Agreement terminates at a time other
than as of the end of a calendar quarter, amounts due under Section 2.4(a)
for such partial period ending on the date of termination shall be pro-rated and
paid within forty-five (45) days following termination. All amounts due
under Section 2.4(b) shall be paid within forty-five (45) days
following the end of each respective three (3) month period. With each such
payment, XxxxxxXxxxx shall deliver to Auriga a full and accurate accounting to
include at least the following information:
(i) *
* *
(ii) *
* *
(d) *
* *.
(e) * *
*.
2.5.
XxxxxxXxxxx shall promptly notify Auriga in writing of any facts relating to the
advisability of a recall, destruction or withholding from the market of the
Product anywhere in the world (collectively, “Recall(s)”). If at
any time: (a) any governmental or regulatory authority issues a request,
directive or order for a Recall; (b) a court of competent jurisdiction
orders a Recall; or (c) XxxxxxXxxxx determines, (except in emergency
situations in which there is insufficient time for such consultation), that a
Recall is necessary or advisable, XxxxxxXxxxx shall take all appropriate
corrective actions, at XxxxxxXxxxx’x expense, to effect the Recall; however, if
any Product Recalls, returns or market withdrawals are caused solely by the
actions or inactions of Auriga which constitute a breach of the terms of this
Agreement or a violation by Auriga of any applicable laws, regulations or rules,
then Auriga shall bear all reasonable costs (including the reasonable costs of
XxxxxxXxxxx) associated with any Recalls, returns or market withdrawals
resulting from such actions or inactions by Auriga. Auriga shall provide
XxxxxxXxxxx with cooperation, in connection with and shall respect any Recall,
returns or market withdrawals, as reasonably requested XxxxxxXxxxx.
Auriga shall make available to XxxxxxXxxxx upon request, all pertinent records
of Auriga which XxxxxxXxxxx may reasonably request to assist XxxxxxXxxxx in
effecting any recall.
3.1.
(a) XxxxxxXxxxx shall defend, indemnify and hold harmless Auriga and its
directors, officers, agents and employees, from and against any and all
liability, loss, damages and expenses (including attorneys’ fees) as the result
of Third Party claims, demands, costs or judgments which may be made or
instituted against any of them arising out of (i) any negligent act or
omission or willful misconduct of XxxxxxXxxxx or any of its officers, directors,
agents or employees with respect to Product, (ii) any violation of approved
labeling or any applicable statute or regulation with respect to Product, or
breach of this Agreement or any representation or warranty hereunder, by
XxxxxxXxxxx or any of its officers, directors, agents or employees,
(iii) the manufacture, possession, packaging, distribution, use, testing,
sale or other disposition of the Product, (iv) any claim for patent or
trademark infringement in connection with any disposition of the Product, or (v)
any breach of this Agreement or any representation or warranty hereunder by
XxxxxxXxxxx or any of its officers, directors, agents or employees. XxxxxxXxxxx
shall not be obligated to indemnify an indemnified party to the extent that any
claims against an indemnified party result solely from (i) any negligent
act or omission or willful misconduct of Auriga or any of its officers,
directors, agents, or employees with respect to the Product, (ii) any violation
of approved labeling or any applicable statute or regulation by Auriga with
respect to Product (provided that Auriga shall not be deemed to be in violation
of this provision by using promotional materials provided or approved by
XxxxxxXxxxx), (iii) any breach of this Agreement or any representation or
warranty hereunder, by Auriga or any of its officers, directors, agents, or
employees with respect to the Product, (iv) marketing of the Product or any
other action with respect to Product by Auriga or any of its officers,
directors, agents or employees, in each case which is not in compliance with
applicable law, rules or regulation, (provided that Auriga shall not be deemed
to be in violation of this provision for using promotional materials provided or
approved by XxxxxxXxxxx), or (v) any claim warranty or representation by
Auriga or any of its officers, directors, agents or employees with respect to
Product which has not been approved by XxxxxxXxxxx. XxxxxxXxxxx shall have the
exclusive right to control the defense of any action which is to be indemnified
in whole by XxxxxxXxxxx hereunder, including the right to select counsel
reasonably acceptable to Auriga to defend Auriga, and to settle any claim,
provided that, without the written consent of Auriga (which shall not be
unreasonably withheld or delayed), XxxxxxXxxxx shall not agree to settle any
claim against Auriga. The provisions of this paragraph shall survive and remain
in full force and effect after any termination, expiration or cancellation of
this Agreement and XxxxxxXxxxx’x obligation hereunder shall apply whether or not
such claims are rightfully brought.
(b) Auriga
shall defend, indemnify and hold harmless XxxxxxXxxxx and its respective
directors, officers, agents and employees, from and against any and all
liability, loss, damages and expenses (including attorneys’ fees) as the result
of Third Party claims, demands, costs or judgments which may be made or
instituted against any of them arising out of (i) any negligent act or
omission or willful misconduct of Auriga or any of its officers, directors,
agents or employees with respect to the Product, (ii) any violation of
approved labeling or any applicable statute or regulation by Auriga with respect
to Product (provided that Auriga shall not be deemed to be in violation of this
provision by using promotional materials provided or approved by XxxxxxXxxxx),
(iii) any breach of this Agreement or any representation or warranty
hereunder, by Auriga or any of its officers, directors, agents or employees with
respect to the Product, (iv) the marketing of the Product, or any other
action by Auriga or any of its officers, directors, agents or employees, with
respect to Product in each case which is not in compliance with applicable law,
rules or regulation (provided that Auriga shall not be deemed to be in violation
of this provision by using promotional materials provided or approved by
XxxxxxXxxxx), or (v) any claim, warranty or representation of Auriga or any
of its officers, directors, agents or employees, with respect to Product which
has not been approved by XxxxxxXxxxx. Auriga shall not be obligated to indemnify
an indemnified party to the extent that XxxxxxXxxxx is obligated to provide
indemnity as described in paragraph 3.1(a) above. Auriga shall have the
exclusive right to control the defense of any action which is to be indemnified
in whole by Auriga hereunder, including the right to select counsel reasonably
acceptable to XxxxxxXxxxx to defend XxxxxxXxxxx, and to settle any claim,
provided that, without the written consent of XxxxxxXxxxx (which shall not be
unreasonably withheld or delayed), Auriga shall not agree to settle any claim
against XxxxxxXxxxx. The provisions of this paragraph shall survive and remain
in full force and effect after any termination, expiration or cancellation of
this Agreement and Auriga’s obligation hereunder shall apply whether or not such
claims are rightfully brought.
3.2. A
person or entity that intends to claim indemnification under this Article 3
(the “Indemnitee”) shall
promptly notify the other Party (the “Indemnitor”) of any
loss, claim, damage, liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor, after it determines
that indemnification is required of it, shall assume the defense thereof with
counsel mutually satisfactory to the Parties; provided, however, that an
Indemnitee shall have the right to retain its own counsel, with the fees and
expenses to be paid by the Indemnitor if Indemnitor does not assume the defense,
or if representation of such Indemnitee by the counsel retained by the
Indemnitor would be inappropriate due to actual or potential differing interests
between such Indemnitee and any other person represented by such counsel in such
proceedings. The indemnity agreement in this Article shall not apply to amounts
paid in settlement of any loss, claim, damage, liability or action if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld or delayed unreasonably. The failure to deliver notice to
the Indemnitor within a reasonable time after the commencement of any such
action, if prejudicial to its ability to defend such action, shall relieve such
Indemnitor of any liability to the Indemnitee under this Article, but the
omission so to deliver notice to the Indemnitor will not relieve it of any
liability that it may have to any Indemnitee otherwise than under this Article.
The Indemnitee under this Article, its employees and agents, shall cooperate
fully with the Indemnitor and its legal representatives in the investigations of
any action, claim or liability covered by this indemnification. In the event
that each Party claims indemnity from the other and one Party is finally held
liable to indemnify the other, the Indemnitor shall additionally be liable to
pay the reasonable legal costs and attorneys’ fees incurred by the Indemnitee in
establishing its claim for indemnity.
4.1.
Except if sooner terminated as provided herein, this Agreement shall be
effective as of the date hereof and shall continue for a period of two
(2) years from the Effective Date (the “Initial Term”). The
Agreement shall be renewed for an additional two (2) year term (each the
“Renewal Term”,
and together with the Initial Term, the “Term”) should the Parties mutually
consent to such a renewal in writing.
4.2.
Expiration or termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or termination nor preclude either
Party from pursuing all rights and remedies it may have hereunder or at law or
in equity with respect to any breach of this Agreement nor prejudice either
Party’s right to obtain performance of any obligation provided for in this
Agreement which expressly survives expiration or termination. The provisions of
Article 3 and Sections 2.4(b), 2.4(c), 4.2, 4.5, 5.8, 5.12, 5.13, and
5.16 shall survive the expiration or termination of this Agreement as well as
any other provision which by its intent is meant to survive expiration or
termination of this Agreement.
4.3.
Notwithstanding any other provision of this Agreement, either Party may
terminate this Agreement by notice in writing to the other if (a) the other
commits a material breach of this Agreement which (i) in the case of a
breach capable of a remedy, shall not have been remedied within sixty
(60) days of the receipt by the other of written notice identifying the
breach and requiring its remedy and (ii) continues to exist at the time of
notice of termination, and (b) for any reason, upon ninety (90) days’ prior
notice.
4.4 * *
*.
4.5. Upon
expiration or termination of this Agreement, Auriga shall have no further rights
whatsoever in the Product in the Territory, including but not limited to any
rights to co-promote the Product. Further, in the event that this Agreement is
terminated by XxxxxxXxxxx pursuant to Section 4.3(a) or 4.4 above, Auriga shall
have no rights whatsoever to the payments set forth in Section 2.4(b)
above.
4.6.
Notwithstanding any other provision of this Agreement, XxxxxxXxxxx may suspend
or terminate sale of Product if the FDA takes any action the result of which is
to prohibit or restrict the manufacture or sale or introduction into interstate
commerce of the Product. Such termination or suspension shall not be deemed a
termination of this Agreement. XxxxxxXxxxx shall promptly notify Auriga of any
such action by the FDA.
4.7.
Either Party may terminate this Agreement if the other Party shall (i)
voluntarily enter into any form of bankruptcy or insolvency proceedings; (ii) if
any form of bankruptcy or insolvency proceedings shall be brought involuntarily
against the other Party and such proceedings shall remain undismissed, unstayed
or unvacated for a period of 60 consecutive days; (iii) is adjudicated bankrupt
or compounds with or makes any arrangement with or makes a general assignment
for the benefit of its creditors; (iv) compulsorily or voluntarily enters into
liquidation, except for the purposes of a bona fide reconstruction or
amalgamation and with the prior written approval of the other Party; or (v) the
Party has a receiver or manager appointed over the whole or a substantial part
of its undertakings or assets.
4.8. Upon
expiration or termination of this Agreement, Auriga will cooperate with
XxxxxxXxxxx in the collection and return to XxxxxxXxxxx of all promotional items
and literature, Samples, and other sales or sales training materials in the
possession of Auriga and/or any member if the Auriga sales team
5.1.
Insurance.
(a) ***.
(b) Each
Party shall, at its own expense, obtain insurance (in the case of XxxxxxXxxxx
additional insurance) covering those types or risks, and in such amounts, as are
customary in the industry (including, without limitation, in the case of Auriga,
Workers Compensation and Auto Liability coverage), and shall maintain such
policies in full force and effect throughout the Initial or any Renewal Term of
this Agreement. Each Party shall provide to the other proof of such
insurance no later than ten (10) days after the Effective Date. Each such
certificate shall provide for no less than thirty (30) days prior written notice
to the other Party of any lapse, cancellation or termination of such
insurance. Each Party named as an additional insured as herein
described shall be entitled to a copy of the then prevailing certificate of
insurance at any time, upon request.
5.2.
Independent
Contractor. The relationship between XxxxxxXxxxx and Auriga is that of
independent contractors. XxxxxxXxxxx and Auriga are not joint venturers,
partners, principal and agent, master and servant, employer or employee, and
have no relationship other than as independent contracting parties. XxxxxxXxxxx
shall have no power to bind or obligate Auriga in any manner. Likewise, Auriga
shall have no power to bind or obligate XxxxxxXxxxx in any manner. Neither Party
shall have any responsibility for the hiring, firing, compensation or employee’s
benefits of the other Party’s employees or agents
5.3.
Nonassignability.
This Agreement may not be assigned or otherwise transferred by either Party
without the consent of the other Party; provided, however, that either Party
may, without such consent, assign this Agreement and its rights and obligations
hereunder to its Affiliate(s), Kef Pharmaceuticals, Inc., a Delaware
corporation, or in connection with the transfer or sale of all or substantially
all of its business to which this Agreement relates, or in the event of its
merger or consolidation or change in control or similar transaction. Any
purported assignment in violation of the preceding sentences shall be void. Any
permitted assignee shall assume all obligations of its assignor under this
Agreement, provided that such assigning Party shall remain primarily liable
hereunder in the case of an assignment to an Affiliate.
5.4.
Modification.
This Agreement constitutes the entire agreement among the Parties with respect
to the subject matter hereof and supersedes all prior agreements,
understandings, and discussions, whether oral or written of the Parties with
respect to the subject matter hereof. Any modification of this Agreement shall
be effective only when in writing and signed by the Parties and specifically
states that it is an amendment to this Agreement.
5.5.
Notices. Any
notices expressly provided for under this Agreement shall be in writing, shall
be given either manually or by mail, facsimile message, telegram, telex or other
written means, and shall be deemed sufficiently given if and when received by
the Party to be notified at its address set forth below, or if and when mailed
by certified or registered mail, postage prepaid, addressed to the Party at such
address stated below. Either Party may, by notice to the other Party, change its
address for receiving such notices.
If
To Auriga:
|
|
00000
Xxxxx Xxxxxx Xxxx. #000
|
|
Xxx
Xxxxxxx, XX 00000
|
|
Attn:
Xxxx Xxxxx
|
|
Telephone
No.: (000) 000-0000
|
|
Fax
No.: (000) 000-0000
|
|
Copy
to:
|
|
00000
Xxxxx Xxxxxx Xxxx., #000
|
|
Xxx
Xxxxxxx, Xxxxxxxxxx 00000
|
|
Attention: Xxxxxx
X. Xxxxxxx, Corporate Counsel
|
|
Telephone: (000)
000-0000
|
|
Fax: (000)
000-0000
|
|
If
To XxxxxxXxxxx:
|
XxxxxxXxxxx
Pharmaceuticals, Inc.
|
00000
Xxxxxx Xxxxxxx Xxxxxxx
|
|
Xxxxxxxxxx,
XX 00000
|
|
Attn:
Xxxxxx Xxxxxx, Ph. D., President and CEO
|
|
Telephone
No.: 000-000-0000
|
|
Fax
No.: 000-000-0000
|
|
Copy
to:
|
Xxxxx
& XxXxxxx LLP
Attn:
Xxxxxxx X. Xxxxxxxxxx
1301
Avenue of the Americas:
Xxx
Xxxx, XX, 00000
(212)
259-8000
(000)
000-0000
|
5.6.
Severability.
If any provision(s) of this Agreement are or become invalid, are ruled illegal
by any court of competent jurisdiction or are deemed unenforceable under then
current applicable law from time to time in effect during the term hereof, it is
the intention of the Parties that the remainder of this Agreement shall not be
affected thereby provided that a Party’s rights under this Agreement are not
materially affected. It is further the intention of the Parties that in lieu of
each such provision which is invalid, illegal, or unenforceable, there be
substituted or added as part of this Agreement a provision which shall be as
similar as possible in economic and business objectives as intended by the
Parties to such invalid, illegal or unenforceable provision, but shall be valid,
legal and enforceable. In the event a Party’s rights are materially affected as
a result of a change in this Agreement under this Section, such Party may
terminate this Agreement.
5.7.
Public
Announcements. XxxxxxXxxxx and Auriga each agrees not to disclose any
terms or conditions of this Agreement to any Third Party or to make any public
statement about this Agreement or wherein the name of the other Party is used
without the prior written consent of the other Party (which shall not be
unreasonably withheld or delayed), except as is required by applicable law, rule
or regulation; provided (i) that if this Agreement is required to be filed
as part of any public document the filing Party shall, to the fullest extent
permitted under such law, rule or regulation, request that confidential
treatment be afforded to this Agreement; or (ii) that either Party may
allow a Third Party to review this Agreement as part of an overall due diligence
examination of such Party in connection with any potential financing,
acquisition, disposition or other business combination; provided that such Third
Party is under obligation of confidentiality. In the event of a disclosure
permitted under this Section, the disclosing Party shall nonetheless provide the
non-disclosing Party with notice of such disclosure prior to disclosure, and
will, to the extent reasonably possible, provide the non-disclosing Party with
an opportunity to correct same. A Party shall not be required to provide the
other Party with a disclosure which has been previously provided to a
Party.
5.8.
Applicable Law.
This Agreement shall be governed by and construed in accordance with the laws of
the State of New York without regard to choice of law principles.
5.9.
Force Majeure.
Neither Party shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached this Agreement for failure or delay
in fulfilling or performing any term of this Agreement other than a payment
provision when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected Party including but not limited to fire,
floods, embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any
governmental authority or the other Party. Upon the occurrence of such event,
the affected Party shall give prompt written notice of such event to the other
Party.
5.10.
Waiver. Any
delay in enforcing a Party’s rights under this Agreement or any waiver as to a
particular default or other matter shall not constitute a waiver of a Party’s
right to the future enforcement of its rights under this Agreement, excepting
only as to an expressed written and signed waiver as to a particular matter for
a particular period of time.
5.11.
Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall
be deemed an original, but all of which together shall constitute one and the
same instrument.
5.12.
Nondisclosure
Obligations.
(a) During
the term of this Agreement, it is contemplated that a Party will disclose to the
other Party proprietary and confidential technology, specifications, technical
information and the like which are owned or controlled by a Party (“Confidential
Information”). The receiving Party agrees to retain the disclosing
Party’s Confidential Information in confidence and not release any such
Confidential Information to a Third Party without the prior written consent of
the disclosing Party and to use the disclosing Party’s Confidential Information
only for the purposes of this Agreement. The obligations of confidentiality will
not apply to Confidential Information which:
(i) was known to the receiving
Party or generally known to the public prior to its disclosure
hereunder;
(ii) subsequently becomes known
to the public by some means other than a breach of this Agreement;
(iii) is subsequently disclosed
to the receiving Party by a Third Party having a lawful right to make such
disclosure;
(iv) is required by law or bona
fide legal process to be released, provided, however, that the receiving Party
takes all reasonable steps to restrict and maintain the confidentiality of such
Confidential Information and provides reasonable notice to the disclosing Party
prior to any such Confidential Information being released; or
(v) is approved for release by
the Parties.
(b) Upon
termination or expiration of this Agreement, each Party shall return to the
other Party all tangible forms of Confidential Information furnished by the
other Party, including all copies thereof and all memoranda of oral disclosure,
except that each Party may retain one copy in the files of its legal counsel to
ensure compliance with any legal obligations.
(c) This
Section 5.12 shall survive until the tenth anniversary of the termination
or expiration of this Agreement.
5.13.
Non-Compete. *
* *
(a) As of
the Effective Date, each Party hereby represents, warrants, and covenants to the
other Party hereto as follows:
(i) it
is a corporation or entity duly organized and validly existing under the laws of
the state or other jurisdiction of its incorporation or formation;
(ii) the
execution, delivery and performance of this Agreement by such Party has been
duly authorized by all requisite corporate action and does not require any
shareholder action or approval;
(iii) it
has the power and authority to execute and deliver this Agreement and to perform
its obligations hereunder;
(iv) the
execution, delivery and performance by such Party of this Agreement and its
compliance with the terms and provisions hereof does not and will not conflict
with or result in a breach of any of the terms and provisions of or constitute a
default under (i) a loan agreement, guaranty, financing agreement, agreement
affecting a product or other agreement or instrument binding or affecting it or
its property; (ii) the provisions of its charter or operative documents or
bylaws; or (iii) any order, writ, injunction or decree of any court or
governmental authority entered against it or by which any of its property is
bound;
(v) it
shall at all times comply with all applicable laws and regulations relating to
its activities under this Agreement; and
(b) As of
the Effective Date XxxxxxXxxxx represents and warrants to Auriga that to the
best of XxxxxxXxxxx’x knowledge, the manufacture, use, sale or offer to sell the
Product in the Territory by XxxxxxXxxxx or Auriga and the terms of this
Agreement do not infringe or violate any granted patent or any contract to which
XxxxxxXxxxx is a party. XxxxxxXxxxx further represents and warrants to Auriga
that XxxxxxXxxxx has the exclusive right to market the Product in the
Territory.
5.15.
No Grant of
License. Nothing contained herein shall be deemed to grant Auriga either
expressly or impliedly, a license or other right, title or interest in any
patent, trademark, trade name, logo, the Trademark or any other similar property
of XxxxxxXxxxx, except as may be necessary for Auriga to co-promote the Product
in the Territory as provided hereunder.
5.16.
No Consequential
Damages. Except for a Party’s obligations under Article 3, neither
Party shall be liable to the other for any consequential, special, incidental or
indirect damages.
6. Exclusivity. *
* *
IN
WITNESS WHEREOF, this Agreement has been duly executed effective on the date
first above written.
XXXXXXXXXXX
PHARMACEUTICALS, ____________
|
||||||
By:
|
By:
|
|||||
Xxxxxx
X. Xxxxxx, Ph.D.
|
Xxxxxx
X. Xxxxx
|
|||||
President
and Chief Executive Officer
|
Chief
Executive Officer
|
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SCHEDULE
1
PERFORMANCE
METRICS
The term
“Performance
Metrics” shall mean the following:
·
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* *
*
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